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DMF# STATUS TYPEI SUBMIT DATE HOLDER
II
0
I
2/8/1981
HEXCEL CHEMICAL PRODUCTS
1
I
III
11/4/1947
ROHM AND HAAS CO

SUBJECT
CPC
LETHANE 384 SPECIAL

3
4
5

6
7
8

II

5/8/1943

MONSANTO CHEM CO DIV MONSANTO CO

SUCCINYL SULFATHIAZOLE

5/13/1943

NIACET CORP

SUCROSE OCTA ACETATE

6/5/1943

CALCO CHEM CO DIV AMERICAN CYANAMID CO

N' BUTYRYL SULFANILAMIDE SODIUM-N' BUTYRYL SULFANILAMIDE

1/1/1940

NATIONAL RESEARCH COUNCIL

PENICILLIN

4/9/1943

FRIES BROS INC

META HOMO MENTHOL

6/19/1943

WF STRAUB & CO

HEXESTROL

1/1/1950

EASTMAN CHEMICAL CO

C-A-P(TM) CELLULOSE ESTER, NF

2/20/1944

NATIONAL RESEARCH COUNCIL

GELATIN & OTHER BLOOD SUBSTITUTES

10

2/23/1944

HERCULES POWDER CO

SODIUM CARBOXYMETHYLCELLULOSE

11

3/12/1944

ROHM AND HAAS CO

HYAMINE X (QUATERNARY AMMONIUM CHLORIDE COMPOUND)

12

II

2/21/1947

NATIONAL RESEARCH COUNCIL

BAL IN OIL

13

II

1/1/1945

YEAST PRODS INC

RIBOFLAVIN, ACETYLATED

14

15

16

17

18

II

IV

NOT AN ASSIGNED NUMBER


6/1/1946

FLUORDENT INC

FLUORIDES

9/1/1947

VETERANS ADMINISTRATION

STREPTOMYCIN

1/1/1940

PENICK CORP

TYROTHRICIN

8/22/1946

FRIES BROS INC

DESOXYEPHEDRINE

19

1/1/1940

THIOURACIL

20

7/25/1946

21

11/3/1947

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SMITH KLINE & FRENCH LABS DIV SMITHKLINE
BECKMAN CORP
MERCK AND CO INC

22

7/30/1946

DEPT OF DEFENSE-ARMY

PROTEIN HYDROLYSATES

23

6/2/1946

STERILE FILLED PHARMACEUTICAL PREPARATIONS

24

3/22/1946

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
JOHNS HOPKINS HOSPITAL

25

9/12/1946

VITAMIN K, HYKIMONE (ABBOTT)

26

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
CINBERG B L MD

27

28

9/3/1946

BOOTS FLINT INC SUB BOOTS CO USA INC

AMINO ACIDS

29

12/26/1946

NATIONAL RESEARCH COUNCIL

SN 13,276; PALUDRINE (CHLORUGUAN); SN 12-837

30

5/22/1947

NEW YORK QUININE & CHEMICAL WORKS INC

METOPON

31

10/13/1946

STEPAN CO INC

B.T.C.(ACTIVE INGRED: BENZALKONIUM CHL)

32

12/12/1946

SB PENICK AND CO ORIG

RUTIN

33

1/1/1947

CARBOWAX--POLYETHYLENE GLYCOLS & OTHER GLYCOLS

34

12/13/1946

UNIVERSITY OF CHICAGO DEPARTMENT OF


MEDICINE
NATL INST HLTH CLINCL CTR PHARMACY

35

2/11/1947

PARKE DAVIS & CO

ANTIMALARIAL SN 10751

II

II

II

1/1/1946

CARBOXYMETHYLCELLULOSE
NITROGEN MUSTARDS

P-ARSENOSOPHENYLBUTYRIC ACID

PROGESTERONE

NOT AN ASSIGNED NUMBER

II
II

PALUDRINE

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DMF# STATUS TYPEI SUBMIT DATE HOLDER
36
I
4/17/1947
UNIVERSITY OF MINNESOTA

SUBJECT
AMIDONE, DOLPHINE, (4,4-DIPHENYL-6-DIMETHYLAMINO-3-HEPTANONE HCL)

37

3/7/1947

GIVAUDAN-DELAWANNA INC

DIBENAMINE

38

8/2/1946

US ATOMIC ENERGY COMMISSION

RADIO ISOTOPES

39

6/6/1947

DR. KARL JOHN KARNAKY

STILBESTROL, INJ. & TABLETS

40

10/21/1947

WISC ALUMNI RES FDTN

MOHIS CANCER PASTE; ZINC CHLORIDE FIXAIVE

41

10/1/1947

JOHNS HOPKINS HOSPITAL

THE ADMINISTRATION OF DI-ISOPROPYL FLUOROPHOSPHATE (DFP) TO MAN

42

10/29/1947

SCHERING CORP SUB SCHERING PLOUGH CORP

ANTIHISTAMINICS

43

1/16/1947

US PUBLIC HEALTH SERV

VIRUS, THERAPEUTIC SERUM, TOXIN ANTITOXIN

44

12/19/1947

ICI AMERICAS INC

SORBITOL, MANITOL, HEXITOL EMULSIF. AGENT-TN: SPAN; TWEENS; ARLACEL

45

2/12/1948

USPHS HOSPITAL

ISOMETHADON

46

2/9/1948

BATTELLE MEMORIAL INSTITUTE

SELENIUM SULFIDE

47

12/23/1947

ENDO PRODS INC

ENCODOL (DIHYDROHYDROXY CODEINONE)

48

3/26/1948

LEDINAC PARENTERAL

49

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
ROHM AND HAAS CO

50

51

9/20/1949

52

10/17/1949

53

54

1/20/1950

WYETH INC

ARTISONE ACETATE

55

3/9/1950

SNYDER AND SNYDER

ANTIHISTAMINE INSOMNIA TREAMENT (MISCELLANEOUS)

56

57

4/27/1950

HEYDEN CHEM CORP

P.A.S. (PARA-AMINOSALICYLIC ACID & SODIUM PARA-AMINOSALICYLATE )

58

1/1/1940

ENDO PRODS INC

MANIBEE-C-FORTE

59

1/1/1940

PENICK CORP

KHELLIN

60

II

1/1/1950

FIRMENICH INC

SOLPROTEX (DIGALLOYL TRIOLEATE)

61

II

9/16/1963

ROHM AND HAAS CO

RESINS - ION EXCHANGE AMBERLITE IRP 276 (CHOLESTYRAMINE RESIN USP)

62

1/31/1967

AMERICAN CYANAMID CO

DIOCTYL SODIUM SULFOSUCCINATE

63

3/5/1951

NATL INST HLTH CLINCL CTR PHARMACY

LEVO-ISO-METHADONE

64

3/9/1951

GENERAL METHODS OF ASSAY AND CONTROLS

65

1/1/1951

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
DEPT AGRICULTURE

66

1/1/1940

COMMERCIAL SOLVENTS CORP

DEXTRAN(DWAS DISCN 7.31.51) MADE PAET OF NDA 8008

67

68

3/22/1951

UNITED STATES PHARMACOPEIA

ACTH

69

1/1/1940

CHAS PFIZER AND CO INC

POLYMYXIN

70

6/11/1951

SB PENICK AND CO ORIG

CASANTHRANOL

71

6/27/1951

INTERNATL HORMONES INC

AQUEOUS MICROSUSPENSION OF HORMONES

72

7/19/1951

METAL & THERMIT CORP

DIBUTYL TIN DILAURATE

II

II

II

9/10/1963

AMBERLITES IRC-50 & XE 64

NOT AN ASSIGNED NUMBER


SMITH KLINE & FRENCH LABS DIV SMITHKLINE
BECKMAN CORP
SCHENLEY LABS INC

KELLIN--TOXICITY STUDIES
CONTEBEN

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER

STARCH SPONGE

NOT AN ASSIGNED NUMBER

II
II

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DMF# STATUS TYPEI SUBMIT DATE HOLDER
73
I
7/31/1951
PACIFIC YEAST PRODUCTS INC

SUBJECT
B 12 SSUPPLEMENT (B-MEGAHERIUM)

74

7/30/1951

PERMUTIT CO

PERMUTIT Z-AMMONIUM; PERMUTIT Z P-POTASSIUM

75

7/31/1951

SB PENICK AND CO ORIG

VERABORE--SPECIAL AMORPHOUS ALKALOIDS OF VERARUM VIRIDE

76

3/10/1950

DOW CHEMICAL CO

METHOCEL HG --HYDROXYPROPYL METHYLCELLULOSE

77

7/18/1939

SCHERING CORPORATION

CORTATE (DESOXYCORTICOSTERONE ACETATE)

78

9/8/1966

ASHLAND INC

PLASDONE POLYVINYL PYRROLIDONE

79

7/16/1951

MAYO CLINIC

COMMITTEE ON SAFETY OF THERAPEUTIC AGENTS

80

10/18/1951

DIAMOND SHAMROCK CHEM CORP

DIPHENYLPYRALINE(THIS FORMERLY HELD BY NOPCO CHEM. CO)

81

8/11/1950

NATIONAL STARCH & CHEMICAL CORP

DRYFLO

82

1/31/1952

CHLORAMINT CO

O-SILVER ANTISEPTIC DISPOSABLE DIAPERS & ANTISEPTIC SURGICAL DRESSING

83

1/1/1940

TRACER LAB INC

RADIOACTIVE ISOTOPES (CONTAINS MEMO ON)

84

1/1/1940

NATIONAL RESEARCH COUNCIL

PLASMA EXPANDERS

85

1/1/1940

HOFFMANN LA ROCHE INC

TREAMENT FOR TB

86

1/1/1940

DEPT OF DEFENSE-ARMY

PRIMAQUINE

87

2/25/1952

AMES CO DIV MILES LABS INC

N-ACETYL-PARAAMINOPHEMOL

88

1/1/1940

PLAVOLEX

PLAVOLEX (PLASMA VOLUME EXPANDER)

89

4/4/1979

ER SQUIBB & SONS PHARMACEUTICAL LABS

NYDRAZID

90

3/4/1954

WORTHINGTON BIOCHEM CORP

HYALURONIDASE

91

3/25/1952

AMERICAN CHOLESTEROL PRODUCTS INC

AMERCHOL

92

5/9/1952

A MASCHMEIJER JR INC

ISONICOTINIC ACID HYDROZIDE

93

6/23/1952

EI DUPONT DE NEMOURS AND CO

ALAHON (POLYTHENE RESIN)

94

5/19/1952

NIPA LABORATORIES INC

OTTAFECT AND OTTASEPT

95

1/1/1940

NEPERA CHEM CO

COMPOUND 1318

96

9/22/1952

MONSANTO CHEM CO DIV MONSANTO CO

ACTAMER

97

98

99

100

6/2/1965

BASF CORP

PLURONICS (L62 F68) L44 PLURONIS POLYOLS

101

8/26/1952

PARKE DAVIS & CO

GENERAL METHODS OF MANUFACTURE $ CONTROL

102

10/29/1952

GEORGE A BREON CO INC

METHODS ,FACILITIES $ CONTROLS

103

9/16/1952

SB PENICK AND CO ORIG

AQUEESTROL

104

1/1/1940

CHAS PFIZER AND CO INC

STREPTOMYCIN HYDRAZIDE ISONICOTINYL

105

1/1/1940

NATL INST HLTH CLINCL CTR PHARMACY

DARAPRIM (PYRIMETHAMINE)

106

2/3/1953

ROUSSEL CORPORATION

CORTISONE ACETATE

107

12/16/1952

DEXTRAN CORP

PLASMA EXPANDERS

108

3/18/1953

NORDA ESSENTIAL OIL AND CHEM CO INC

DICHLOROSAN

109

5/28/1953

LLOYD BROS INC

COBALT

110

5/29/1953

SB PENICK AND CO ORIG

NEOMYCIN SULFATE USP

111

IV
IV
II

II

II

NOT AN ASSIGNED NUMBER


1/1/1940

PFIZER AND CO

LUDOX

NOT AN ASSIGNED NUMBER


IV

II
II

II

NOT AN ASSIGNED NUMBER

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DMF# STATUS TYPEI SUBMIT DATE HOLDER
112
I
5/21/1953
TERRA CHEMICALS INC

SUBJECT
AEROSIL

113

DIHYDROXY ALUMINUM-SODIUM CARBONATE

114

7/3/1953

CHATTEM CHEMS DIV CHATTANOOGA MEDICINE


CO
RT VANDERBILT CO

115

7/5/1953

SARATOGA TRADING CORP

RAUWOLFIA SERPENTINA

116

8/14/1953

SB PENICK AND CO ORIG

PROTAVERARINE

117

9/11/1953

PASADENA RESEARCH LABORATORIES INC

HYDROCORTISONE ACETATE

118

5/9/1952

ER SQUIBB & SONS

VITAMINE B-12

119

9/21/1953

H REISMAN CORP

EPOXYTROPINE TROPATE METHYLBROMIDE

120

10/23/1953

NEPERA CHEM CO

COMPOUND NO.1112

121

11/18/1953

NORDA ESSENTIAL OIL AND CHEM CO INC

HALOSAN

122

11/20/1953

SB PENICK AND CO ORIG

PHTHALAMAQUIN

123

10/20/1953

UNION CARBIDE AND CARBON CORP

VINYLITE VAGH RESIN

124

7/23/1953

PFIZER AND CO

NEOMYCIN SULFATE CAPS (THIS DCHANGED TO NDA 9-579)

125

1/20/1954

MEER CORP

RAUWOLFIA SERPENTINA

126

2/9/1954

DOW CORNING CORP

SILICONES

127

2/1/1954

WARWICK CHEM CO

WARCO A-266

128

2/23/1954

GENERAL ANILINE AND FILM CORP

SODIUM N-LAUROYL SARCOSINATE

129

1/27/1954

RK LAROS CO

FRUCTOSE

130

9/23/1953

UNION CARBIDE AND CARBON CORP

LINDE SILICONE L-45

131

1/1/1940

CENTRAL SOYA

SOYBEAN STEROL PRODUCTS

132

1/25/1954

GIVAUDAN-DELAWANNA INC

SUNSCREEN M.E.C.

133

2/10/1954

NATIONAL RESEARCH COUNCIL

DRUG ADDICTION $ NARCOTICS

134

9/28/1953

LIDD DAVID MD

POLYVINYL PYRROLIDONE

135

5/20/1954

AMGER CHEMICALS INC

DEHYDROACETIC ACID

136

4/27/1954

SB PENICK AND CO ORIG

RESERPINE

137

5/26/1954

DOW CHEMICAL CO MICHIGAN DIV

SHORT TERM CHRONIC DIETARY FEEDING OF METHOCEL 2602 TO RAS

138

5/25/1954

NEPERA CHEM CO

THONZONIUM BROMIDE

139

1/1/1940

RG TAYLOR CO INC

A-THYMOXY-A-A-DICHLORACETIC ACID, A(1 METHYL-4-ISOPROPL-3-PHENOXY)-A-A

140

10/21/1947

SE MASSENGILL CO-ORIG

FACILITIES $ CONTROL

141

10/6/1941

ORGANICHEM CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

142

1/1/1940

BF GOODRICH COMPANY

PARACHLORPHENOL MONOSULFIDE

143

7/2/1954

BF GOODRICH COMPANY

MONOBENZYL ETHER OF HYDROQUINONE

144

1/17/1977

US ATOMIC ENERGY COMMISSION

RADIO ISOTOPES, IODINE 131 AND PHOSPHORUS 32

145

7/14/1954

CENTAUR CALDWELL DIV STERLING DRUG INC

FACILITIES $ CONTROL

146

II

9/3/1954

3M PHARMS

VARIOUS RAUWOLFIA SPECIES

147

II

9/2/1954

CHAS PFIZER AND CO INC

RESERPINE

148

II

1/1/1940

IOWA STATE COLLEGE

DIETHYLSTILBESTROL AS A CATTLE FEED ADDITIVE

6/23/1953
II

II
IV

II

II

VANCIDE 89 (CAPTAN)

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DMF# STATUS TYPEI SUBMIT DATE HOLDER
149
I
9/15/1954
THOS LEEMING & CO SUB CHAS PFIZER &
COMPANY INC
150
I
II
1/1/1940
OHIO AGRICULTURE EXPERIMENT STATION

SUBJECT
FACILITIES ,CONTROL

151

6/1/1955

LLOYD BROS INC

COBALT

152

10/1/1954

NATIONAL RESEARCH COUNCIL

NRC.MEETING $ OTHER MEETINGS

153

9/29/1954

LUBRIZOL ADVANCED MATERIALS INC

CARBOPOL 934, 940NF, 910NF, AND 941NF

154

4/25/1955

SB PENICK AND CO ORIG

RAUSERFIA TABLETS

155

11/3/1954

SUPRAMAR CHEMS

RESERPINE

156

11/4/1954

MEER CORP

P.E. VERARUM, MEER 4-5% MIXED

157

11/5/1954

GENERAL ELECTRIC CO

SILICONES

158

11/9/1954

MEER CORP

RESERPINE CONCENTRATE

159

11/9/1954

CORN PRODS INC

GLUCURONO-LACTONE $ THE SALTS OF GLUCURONIC ACID

160

1/1/1940

BF GOODRICH COMPANY

DIPHENYL-P-PHENYLENEDIAMINE

161

1/11/1955

ROUSSEL CORPORATION

HYDROCORTISONE,FREE ALCOHOL

162

1/27/1955

WORTHINGTON BIOCHEM CORP

CRYSTALLINE TRYPSIN

163

1/25/1955

WEST DISINFECTING CO

WESCODYNE

164

2/1/1955

CF BOEHRING AND SOEHNE GMBH

RESERPINE 100% PURE AIKALOID $ RAUWOLFIA SERPENTINA BENTH

165

3/29/1955

SUNKIST GROWERS

BIOFLAVONOIDS

166

2/25/1955

CF BOEHRING AND SOEHNE GMBH

RESERPINE PURE ALKALOID $ RAUWOLFIA VOMITIORIA

167

3/10/1958

SPECIFICATIONS AND METHODS OF ASSAY

168

II

1/1/1940

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
PENICK CORP

169

7/13/1955

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

170

IV

6/15/1955

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
EASTMAN CHEMICAL CO

171

8/16/1955

NEW DRUG INSTITUTE

RAUWOLFIA SERPERTINA WHOLE ROOT,MANNITOL HEXANITRATE ,

172

8/18/1955

CHEM SPECIALTIES CO INC

RESERPINE PURE CRYSTALLINE COMPOUND PRONAL (BULK)

173

8/18/1955

CHEM SPECIALTIES CO INC

RESERPINE PURE CRYSTALLINE COMPOUND PRONA (BULK)

174

6/14/1955

CF BOEHRING AND SOEHNE GMBH

RESERPINE

175

8/24/1955

MERCK AND CO INC

PROCESS $ CONTROL DATE CONCERNING MANUFACTURE OF 2-ACETYLAMINA ETC.

176

1/1/1940

NEW DRUG INSTITUTE

RESERPINE;PROTOVERARINES A&B;SUCROSE;STARCH;LACTOSE;ACACIA;MAGNESIUM

177

5/12/1955

STERO-KEMS CO

RALUBEN

178

179

10/28/1955

CITRUS & CANNED PRODUCTS ASSOCIATION

HESPERDIN

180

10/13/1955

NATIONAL RESEARCH COUNCIL

PLASTIC BAG CONTAINERS

181

1/1/1940

NEW DRUG INSTITUTE

NDI FORMULA 200

182

1/1/1940

WORTHINGTON BIOCHEM CORP

DESOXYRIBONUCLEASE, PANCREAIC

183

2/29/1952

ASHLAND INC

POLYVINYL PYRROLIDONE-IODINE 10

184

12/5/1955

COLLETT-WEEK CORP

CRYSTALLINE RESERPINE FORM R. VOMITORIA

185

12/22/1955

ELI LILLY AND CO

TOPICAL ANESTHETIC COMPOUND C-10

IV

II

II

MASSIVE VIT D FOR MILK FEVER PREVENTION

UTERASE

D-ALPHA-TOCOPHERYL POLYETHYLENE GLYCOL 1000 SUCCINATE

NOT AN ASSIGNED NUMBER

II
II

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DMF# STATUS TYPEI SUBMIT DATE HOLDER
186
I
7/24/1956
CHATTEM CHEMS DIV CHATTANOOGA MEDICINE
CO
187
I
1/11/1956
NEW DRUG INSTITUTE

SUBJECT
TETRAHYDROXY DIALUMINUM MAGNESIUM DIGLUTAMATE

188

189

190

191

192
193

NDI. FORMULA 156

1/20/1956

WYETH INC

MANUFACTURING: METHODS AND CONTROLS

1/1/1940

DIETHYLSTILBESTROL IN CATTLE FEEDS --SAFETY OF USE OF

1/24/1956

COLORADO AGRICULTURAL & MECHANICAL


COLLEGE
ABBOTT LABORATORIES PHARMACEUTICAL
PRODUCTS DIV
MALLINCKRODT INC

2/2/1956

MALLINCKRODT INC

PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) AS MANUFACTURED IN ST. LOUIS,


MISSOURI
RESERPINE

2/17/1956

FINE CHEMICALS OF CANADA LTD

RESERPINE

194

2/16/1956

PENNWALT CORPORATION PHARMACEUTICAL DIV CONTROL PROCEDURES MANUFACTURING

195

3/8/1956

CF BOEHRING AND SOEHNE GMBH

ANTIDIABETIC COMPOUND BZ 55

196

5/1/1956

REPORT OF MEETING

197

5/2/1956

INSTITUTE FOR THE STUDY OF ANALGESIC &


SEDATIVE DRUGS
UPJOHN CO

198

4/9/1956

CHEM SPECIALTIES CO INC

HORMONE AQUEOUS SUSPENSION

199

1/1/1940

NEW DRUG INSTITUTE

HYDROCORTISONE

200

3/29/1956

ESKASUL MANUFACTURING DETAILS

201

II

1/1/1940

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
PENICK CORP

202

IV

3/4/1964

INTERNATIONAL FLAVORS AND FRAGRANCES INC

ALVA FLAVORS, SEALVA FLAVORS

203

II

1/1/1940

ER SQUIBB & CO/NJ

STILBETIN SUPPLEMENT 50 (DIETHYLSTILBESTROL IN POLYETHYLENE GLYCOL)

204

205

206

207

208

209

210

211

212

213

214

215

216

II

1/24/1956
II

SYSTEMS FOR THE CONTROL OF MANUFACTURE PROCESSING $ PACKING OF DRUGS

ORINASE

GRAMICIDIN

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER
4/30/1956

TREEMOND CO

RESERPINE (BULK)

5/9/1956

NEW YORK QUININE & CHEMICAL WORKS INC

DIHYDROCODEINE BITARTRATE ANHYDROUS

5/24/1956

TESTING FACILITIES FOR RAW MATERIALS & FINISHED GOODS

5/23/1956

BRISTOL LABORATORIES INC DIV BRISTOL MYERS


CO
UPJOHN CO

5/26/1959

SB PENICK & CO

RAUNORMINE

1/1/1940

MALLINCKRODT INC

FERROUS FUMARATETOLERON

1/1/1940

PHARMACRAFT INC

ZIRCONIUM

7/13/1956

SOCIETE DES LABORATOIRES LABAZ

SULFANILAMIDE -2,4-DIMETHOXY-5-TRIAZINE (HB-182)

II

1/1/1940

SOCIETE DES LABORATOIRES LABAZ

CARNITINE CARNITINATE DICHLORIDE

II

5/21/1965

ARCHIMICA LTD

TCCTRICLOCARBAN (3,4,4'-TRICHLORO CARBANILIDE)

7/16/1956

PHARMACEUTICAL PRODUCTS COMPANY INC

A DESCRIPTION OF THE FACILITIES & OPERATING PROCEDURES

217

7/9/1956

SUMNER CHEMICAL COMPANY INC

POTASSIUM PARA AMINOSALICYLATE

218

1/1/1940

STYLOMYCIN (PUROMYCIN)

219

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
ANHEUSER BUSCH INC

II

II

12/8/1958

COMBINED ADRENAL HORMONE ANTIBIOTIC THERAPY

VITA-BUSCH-12 CONCENTRATE

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DMF# STATUS TYPEI SUBMIT DATE HOLDER
220
I
7/23/1956
FRANK SAMUEL & COMPANY INC

SUBJECT
POWDERED WHOLE RAUWOLFIA SERPENTINA ROOT

221

7/18/1956

GALAT ALEXANDER

N-(3'DIMETHYLAMINO)PROPYL PHENOTHIAZING HCL (PROMAZINE HCL)

222

8/7/1956

SB PENICK AND CO ORIG

AMMOIDIN (8-METHOXYPSORALEN, XANTHATOXIN)

223

8/6/1956

SOCIETE DES LABORATOIRES LABAZ

SODIUM DI-TERTIARY BUTYL-NAPHTHALENE SULFONATE

224

8/1/1956

REHEIS CHEMICAL CO

SODIUM ALUMINUM CHLORHYDROXY LACTATE COMPLEX(CHLORACEL)

225

II

1/1/1940

DIETHYLSTILBESTROL PWD & DIETHYLSTILBESTROL 50% SUSPEN. IN SOYBEAN OIL

226

II

5/24/1956

227

4/8/1957

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
BRISTOL LABORATORIES INC DIV BRISTOL MYERS
CO
ELI LILLY AND CO

228

10/12/1956

AMERICAN CYANAMID CO

AEROSOL OT-B POWDER MIX

229

1/1/1940

NEW YORK ACADEMY OF SCIENCES

MEETINGS, MISCELLANEOUS

230

1/1/1940

CHEMO PURO MFG CO

PIPERAZINE PREPARATIONS

231

1/1/1940

VA MEDICAL CENTER

CHEMOTHERAPY IN PSYCHIARY

232

11/1/1956

PENCO OF LYNDHURST INC

METHOCARBAMOL

233

1/1/1940

WALLERSTEIN

TYROTHRICIN & GRAMICIDIN

234

12/11/1956

SYNTHETIC FERTILIZERS & CHEMICALS INC

P HYDROXYPHENYLSALICYLAMIDE

235

1/1/1940

PIPERAZINE, TECHNICAL

236

CARBIDE AND CARBON CHEMS CO DIV UNION


CARBIDE AND CARBON COR
NOT AN ASSIGNED NUMBER

237

11/13/1956

AMERICAN ROLAND CORP

RESERPINE FROM RAUWOLFIA VOMITORIA

238

11/2/1956

ELLAY RUBBER COMPANY DIV WR GRACE AND CO VINYL SHEETING & GRANULES - 0445X3

239

2/8/1957

GANE & INGRAM INC

BENACTYZINE HCL

240

1/11/1957

WATSON LABORATORIES INC

NORETHINDRONE

241

1/29/1957

SYNTEX LABORATORIES INC SUB SYNTEX CORP

PREDNISONE, CRUDE AND CRYSTALLINE

242

II

1/1/1940

APOTHEKERNES LABORATORIUM A/S

NEOMYCIN SULFATE

243

II

2/7/1957

3,3' - ALLYLDIETHYLSTILBESTROL & 3,3' - ALLYL HEXESTROL

244

II

1/1/1940

245

2/25/1957

ARMOUR LABORATORIES DIV ARMOUR


PHARMACEUTICAL CO
ARMOUR LABORATORIES DIV ARMOUR
PHARMACEUTICAL CO
CHAS PFIZER AND CO INC

246

4/5/1957

STERWIN CHEMS INC SUB STERLING DRUG INC

SOLUTION OF COBALAMINE CONCENTRATE

247

3/14/1957

NORDSON PHARMACEUTCAL LABS INC

LEVONOR (1-AMPHETAMINE ALGINATE)

248

10/5/1953

CARLEN CORP

CARLENDACIDE: VAGISEC (NAME UNDER WHICH MK'T BY JULIUS SCHMID, INC.)

249

3/14/1957

ER SQUIBB & SONS

PACKAGING OF SQUIBB RADIOPHARMACEUTICALS

250

1/1/1940

XYLOCAINE

251

JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC


MEER CORP

252

SODIUM POLYTHIONATE SOLUTION(VET MED)

253

JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC


MERCK AND CO INC

II

II
II

II

II

4/12/1957
II

1/1/1940
4/27/1957

CALCIUM AMPHOMYCIN OINTMENT


CHLORDIETHYLNOL (DIETHYL CHLORO ETHYNYL CARBINOL)

VITAMIN B12 CONC. (FEED GRADE MILORGANITE)(VET MED)


COBALAMIN CONCENTRATE SOLUTION

RESERPINE

AQUEOUS SOLN RADIO-ACTIVE VITAMIN B12

Page 7

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
254
I
IV
4/4/1957
SYBRON CORPORATION CHEMICAL DIVISION

SUBJECT
IONAC C-269 AS MFG. IN NEW JERSEY (FORMERLY PERMUTIT COMPANY)

255

256

257

258

259

260

261

262

263

5/1/1957

SOCIETE DES LABORATOIRES LABAZ

ADRENOCHROME MONO SEMI CARBAZONE

1/1/1940

FERRING AB

TRICORTAN(VET MED)

4/2/1957

RK LAROS CO

FERLARON

5/23/1967

GENERAL PACKAGING SERVICE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6/13/1957

SYNTEX LABORATORIES INC SUB SYNTEX CORP

HORMONE COCKTAIL

7/9/1957

ROUSSEL CORPORATION

PREDNISONE

5/15/1957

ROBECO CHEMICALS INC

ROBANE

1/1/1940

UPJOHN CO

NEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP

6/18/1957

ROHM AND HAAS CO

POLYMER MC 2242

264

7/26/1957

SB PENICK AND CO ORIG

NEOMYCIN PALMITATE

265

II

1/1/1940

RHODIA INC

HYDROCHLORIDE6484 R.P. (VET MED)

266

II

1/1/1940

STEROSAN (VET MED)

267

8/21/1951

JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC


IVERS-LEE DIV BECTON-DICKINSON AND CO

268

II

1/1/1940

RHODIA INC

PIPERAZINE DIHYDROCHLORIDE AMMONIUM)RHODEX(VET MED)

269

9/25/1957

NORDA ESSENTIAL OIL AND CHEM CO INC

BIS (2-HYDROXY-5-CHLORO PHENYL) SULFIDE

270

II

1/1/1940

CHAS PFIZER AND CO INC

NEOMYCIN SULFATE(VET MED)

271

II

1/1/1940

MERCK AND CO INC

NEOMYCIN SULFATE

272

II

1/1/1940

NEW YORK QUININE & CHEMICAL WORKS INC

HYDROCORTISONE, HYDROCORTISONE ACETATE & CORTISONE ACETATE

273

II

9/3/1957

DOW CHEMICAL CO MICHIGAN DIV

DISIDIUM DIHYDROGEN VERSENATE, A.R.

274

II

1/1/1940

F.X. GASSNER, COLORADO STATE UNIVERSITY

TESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY?

275

1/1/1940

DEXOXYEPHEDRINE HCL

276

11/1/1957

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SYNTEX SA

277

11/6/1957

NYSCO LABS INC

PENTA - ERYTHRITOL TETRANITRATE TIMED DISINTEGRATION CAPSULES

278

II

10/28/1957

ORTHANA KEMISK FABRIK A/S

CORTICOTROPIN - GEL

279

II

8/8/1960

GENERAL MILLS INC

L-ARGININE MONHYDROCHLORIDE AND L-ARGININE AND L-GLUTAMATE

280

11/19/1957

SYNTEX SA

17A - ACETOXY PROGESTERONE

281

II

11/21/1957

MEDA PHARMACEUTICALS INC

2 HYDROXY-METHYLENE-17 ALPHA METHYL-DIHYDRO-TESTOTERONE

282

II

11/14/1957

PETER HAND FOUNDATION

VITAMIN A-DESOXYCHOLIC ACID COMPLEX

283

12/5/1957

NEW DRUG INSTITUTE

SYNTHESIS OF RESPERINE

284

12/18/1957

SB PENICK AND CO ORIG

RESCINNAMINE

285

1/16/1965

SPARKS CORP

PROCEDURE FOR HANDLING MEDICAL TABLETS

286

2/5/1958

EMERY PERSONAL CARE PRODUCTS GROUP

ETHOXYLAN

287

12/24/1957

MYVARET VITAMIN A FEED SUPPLEMENT RETINENE QUINOLATE(VET MED)

288

3/4/1958

DISTILLATION PROD INDS DIV EASTMAN KODAK


CO
GENERAL ANILINE AND FILM CORP

II
I

II
II

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

PREDNISOLONE

DITHIAZANINE IODIDE (3,3'-DIETHYLTHIODICARBOCYANINE IODIDE)

Page 8

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
289
I
3/10/1958
LEDERLE LABORATORIES DIV AMERICAN
CYANAMID CO
290
I
3/19/1958
UPJOHN CO

SUBJECT
AEROSOL OT-N

291

3/19/1958

GENERAL CONTROL PROCEDURES

292

II

1/1/1940

293

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC
MERCK AND CO INC

294

INDOCYANINE GREEN

295

4/29/1958

DISTILLATION PROD INDS DIV EASTMAN KODAK


CO
SCHUYLKILL CHEM CO

296

1/16/1958

SYNTEX LABORATORIES INC SUB SYNTEX CORP

19 NOR - 17 ALPHA - METHYL - TESTOSTERONE

297

5/19/1958

SULFACHLOROPYRAZINEM - MFR & SPECS

298

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
SOCIETE DES LABORATOIRES LABAZ

299

II

1/1/1940

DEQUADIN(COMMON NAME DEQUALINIUM CHL)

300

II

1/1/1940

301

6/23/1958

JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC


JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC
HOFFMANN LA ROCHE INC

302

7/16/1958

SOMATOTROPIC HORMONE - JOURNAL REFERENCES

303

8/29/1958

JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC


ELI LILLY AND CO

304

II

9/18/1958

UPJOHN CO

CHLORPROPAMIDE TABLETS-PHARMACOLOGY, CLIN RPTS,MFG'S PROCEEDS. & CNTRL

305

8/5/1958

RALSTON PURINA CO

MF'G PROCEDURES FOR PURINA CHOWS

306

9/29/1958

GIVAUDAN CORPORATION

GIV - TAN F OIL & LOTION - PHARMACOLOGY, SPECS.

307

9/29/1958

AMERCHOL CORP

CHOLESTEROL & LANOLIN PRODUCTS

308

10/1/1958

CHEMO PURO MFG CO

OXELADIN CITRATE PHARAMCOLOGY, CLIN REPT., MF'G PROCESS

309

10/22/1958

ZIRCONIUM ALUMINUM CHLORHYDRATE ANTIPERSPIRANT & TOXCITY TESTS

310

II

1/1/1940

CHATTEM CHEMS DIV CHATTANOOGA MEDICINE


CO
CHEMICALS INC

311

10/27/1958

SE MASSENGILL CO-ORIG

CONTROL PROCEDURES STANDARD OPERATION PROCEDURES

312

11/4/1958

ICN PHARMACEUTICALS INC

PACKAGING OPERATIONS A MURRAY HILL PLANT

313

11/6/1958

RHODIA INC

4632 R.P. MALEATE

314

10/24/1958

PFIZER AND CO

TERRAMYCIN-HYGROMYCIN PREMIX

315

11/21/1958

SYNTEX LABORATORIES INC SUB SYNTEX CORP

19-NOR-17A-ETHINYL-TESTOSTERONE-17 B ACETATE

316

12/19/1958

RHODIA INC

3828 R.P. FUMARATE - MF'G PROCEDURE

317

12/22/1958

SYNTHETIC FERTILIZERS & CHEMICALS INC

N-DIETHYLVANILLAMIDE (MFR. & SPECS)

318

12/31/1958

ICI AMERICAS INC

ARLACEL; 165 ARLACEL; 161 MYRJ 59 - SPECIFICATION

319

12/22/1958

JORDAN KENNETH L MD

MEPHENESIN & PROCAINE HCL

320

1/6/1959

WALLERSTEIN CO DIV TRAVENOL LABS INC

MYLASE, PHARMACEUTICAL

321

1/7/1959

ICI AMERICAS INC

SPAN 85 - SPECS & ASSAY METHODS

4/14/1958
II

II

4/9/1958

5/22/1958

IV

II

III

IV

COMPRESSED TABLETS UPRIN, 5GR(ASPIRIN ANHYDRIDE)

FRAMYCETIN (SOFROMYCIN ROUSSEL)


HYDROCORT. 21-PHOSPHATE & NEOMYCIN SO4--OPTHAL. SOL. 0.5% & INJECT

ALUMINUM ALLANTOINATES - SPECS, TOXICITY & CLINICAL TESTS

PROPYNYL CYCLOHEXANOL CARBAMATE

TEOQUIL
FACILITIES AND CONTROLS --TRETINOIN

1 - CYCLOPPENTYL - 2 - AMINO PROPANE

DRXTRAN POWDER-SPEC & MFG PROCESSES

Page 9

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
322
I
1/15/1959
AYERST LABORATORIES INC DIV AMERICAN HOME MF'G CONTROL PROCEDURES - SPECS FOR COMMONLY USED IN RAW MATERIALS
PRODUCTS CORP
323
I
1/19/1959
VICTOR M HERMELIN CO DIV K-V PHARMACAL CO RAUVERTIN (IMPROVED) TABLETS (SPACE RELEASE)
324

1/21/1959

SB PENICK AND CO ORIG

CANDICIDIN

325

1/29/1959

SEARLE CHEM INC

MANUFACTURING PROCESSES 6A-METHYL-17-A-ACETOXYPROGESTERONE

326

2/9/1959

PARKE DAVIS DIV WARNER LAMBERT CO

1-DESOXYEPHEDRINE

327

2/18/1959

GEIGY CHEM CORP

3,5,3,4,-TETRACHLOROSALICYLANILIDE

328

3/2/1959

RUSPACK CORP

PROCEDURES FOR PRODUCING PHYSICIANS SAMPLES

329

3/19/1959

DOW CHEMICAL CO MICHIGAN DIV

DOW 132 (4-TERT-BUTYL-2-CHLOROPHENYLMETHYL METHY PHOSPHORAMIDATE)

330

3/4/1959

MONSANTO COMPANY

HEMA (HYDROLYZED ETHYLENE MALEIC ANHYDRIDE) RESIN

331

3/31/1959

PABST LABS DIV PABST BREWING CO

ZYMO-PABST

332

4/14/1959

UPJOHN CO

SOLKETAL (GLYCEROL 1,2 - ISOPROPYLIDENE ETHER)

333

4/13/1959

SOLVAY PHARMACEUTICALS

DUVADILAN (ISOXSUPRINE HCL)

334

4/20/1959

ELI LILLY AND CO

MYRISTYL - 3 - HYDROXYBUTYLAMINE HCL - COMPOUND 06537

335

II

1/1/1940

NOVO NORDISK AS

AMYLASE CONCENTRATE, CRUDE BACTERIAL

336

II

5/18/1959

CHEMICALS INC

IRON - HYDRODEXTRAN

337

II

1/1/1940

RHODIA INC

SPIRAMYCIN--MFG PROCEDURES

338

IV

6/23/1959

DONDREN (MINERAL OIL)

339

II

7/8/1959

KNOLL PHARMACEUTICAL CO UNIT BASF K&F


CORP
SOLVAY USA INC

340

7/13/1959

UPJOHN CO

STYRENE - MALEIC ACID COPOLYMER-TOXIC. DAA, CLIN REPTS & PHYSI CHARAC

341

8/6/1959

STECKER CHEMICALS INC

ASC-4, BRAND OF DIAPHENE

342

8/16/1959

KV PHARMACEUTICAL CO

NOLAMINE REPEA ACTION TABLETS

343

8/18/1959

SB PENICK AND CO ORIG

PHOLCODINE - MFR' & SPECS

344

8/24/1959

GEIGY CHEM CORP

MFG PROCEDS, ANALYTICAL METHODS & SPECS (SEQUESTRENE NA2CO)

345

9/10/1959

AVECIA INC

SDM-40 (25% ISOSORBIDE DINITRATE IN LACTOSE) MANUFACTURED IN TAMAQUA, PA

346

9/4/1959

MINERALS & CHEMICALS PHILIPP CORP

PHARMASORB - REGULAR & COLLOIDAL

347

10/14/1959

MONSANTO COMPANY

SANTOPHEN1, O-BENZYL-P-CHLOROPHENOL

348

10/19/1959

WARNER LAMBERT CO

PARENTERAL MANUFACTURE

349

10/16/1959

ARMOUR PHARMACEUTICAL CO

MANUFACTURING CONTROL PROCEDURES

350

11/2/1959

SB PENICK AND CO ORIG

INOSITOL HEXANICOTINATE

351

11/2/1959

PRINCETON LAB PRODS CO

TRYPSIN, CHYMOTRYPSIN & RIBONUCLEASE - MF'G PROCEDURES & ASSAYS

352

11/16/1959

ELI LILLY AND CO

VORTEL TABLETS

353

11/16/1959

PHARMACIA LABS INC

LOW MOLECULAR DEXTRAN

354

12/2/1959

WALLERSTEIN

ENZYMES

355

12/11/1959

GEIGY CHEM CORP

SEQUESTREN NA FE, MF'G PROCEDURES & SPECS

356

12/17/1959

AMERICAN CYANAMID CO

NEOMYCIN BASE - MF'G PROCEDURES & SPECS

357

1/6/1960

HELENA RUBINSTEIN INC

WHITE MAGNOLIA PERFUME OIL, FORMULATION

358

II

1/13/1960

SYNTEX LABORATORIES INC SUB SYNTEX CORP

6A - CHLORO - PREDNISONE ACETATE (MFG PROCEDURE & SPECS)

359

II

1/21/1960

EASTMAN CHEMICAL CO

MYVACET MANUFACTURED IN KINGSPORT, TENNESSEE.

II

II

I
II
II

II

IGEPAL CO-630 SPECIAL

Page 10

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
360
I
1/21/1960
ROBAPHARM LTD

SUBJECT
ROBUDEN - MF'G PROCEDURES & SPECS

361

2/1/1960

LABAZ LABORATORIES

ETHYL (DIIODO-HYDROXY-BENZOYL) COUMARONE - MF'G PROCEDURES & SPECS

362

II

1/27/1960

EATON LABS DIV NORWICH PHARMACAL CO

NIDRAFUR MIX

363

2/5/1960

MF'G PROCEDURES, & CONTROLS

364

KNOLL PHARMACEUTICAL CO UNIT BASF K&F


CORP
WALLERSTEIN

365

IV

3/3/1960

366

II

2/16/1960

367

II

2/17/1960

368

IV

369
370
371

372

373

374

375

376

II

377

378

2/8/1960

AMYLOLYTIC AND PROTEOLYTIC ENZYMES

RHONE POULENC PHARMACEUTICALS DIV RHONE EMULPHOR EL - 620 & EL - 719


POULENC INC
KV PHARMACEUTICAL CO
PYRILAMINE - PHENYLEPHRINE SUSTAINED ACTION CAPSULES
TRYPSIN & A - CHYMOTRYPSIN - PREPARTION & ASSAY METHODS

2/24/1960

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD
GIVAUDAN FLAVORS CORP

2/25/1960

BENZOL PROD CO

TRANS 2 - PHENYLCYCLOPROPYL AMINE SULFATE - MANUF PROCEDURES

2/29/1960

HAYNIE PRODS

ADMIRAL 123 - MF'G PROCEDURES

3/14/1960

REED-LANE INC

CONTRACT PACKAGING FACILITIES LOCATED IN WAYNE, NJ

3/21/1960

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DELFETA-SED PLUS T STEDYTABS

3/23/1960

WORTHINGTON BIOCHEM CORP

DESOXYRIBONUCLEASE, PANCREAIC

3/31/1960

SB PENICK AND CO ORIG

PHENAZOCINE HYDROBROMIDE - MF'G PROCED., SPECS, CLIN. & TOXICITY DATA

4/5/1960

JOHN MANVILLE PRODUCTS CORP

MICRO-CEL & CELKATE

4/28/1960

ROUSSEL CORPORATION

DESERPIDINE SYNTHETIC

II

4/29/1960

ROYAL NETHERLANDS FERMENTATIONS LTD

PIMARICIN

II

5/16/1960

ELI LILLY AND CO

IMIDAZOLIUM BROMIDE DERIVAIVE

379

5/25/1960

NIHYDRAZONE - FIELD RESEARCH DATA

380

381

5/12/1960

HESS AND CLARK CO DIV RICHARDSON-MERRELL


INC
LEDERLE LABORATORIES DIV AMERICAN
CYANAMID CO
GB FERMENTATIONS

382

6/16/1960

ELI LILLY AND CO

TYLOSIN

383

6/27/1960

REYNAUD LTD

PERBRO CLOUD

384

II

7/5/1960

SANOFI AVENTIS CHIMIE

1-(A-HYDROXYETHYL)-2-METHYL-5-NITRO-IMIDAZOLE,A NEW TRICHOMONOCIDE

385

II

7/7/1960

WYETH AYERST LABORATORIES INC

DIETHYLSTILBESTROL IMPLANTATION PELLETS

386

II

6/27/1960

GALLIMYCIN -10+ ZOALENE

387

II

7/11/1960

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
NORWICH PHARMACAL CO

388

7/13/1960

GEIGY CHEM CORP

TINOPAL GS

389

7/15/1960

RP SCHERER CORP

FERROUS CITRATE

390

1/17/1960

DRAGOCO INC

AZULENE

391

7/18/1960

DOLE CO

BROMELAIN - COMMERICAL GRADE MF'G PROCEDURES

392

II

7/25/1960

SYNTEX LABORATORIES INC SUB SYNTEX CORP

MFG OF BULK--19-NOR-17A-ETHINYL-TESTOSTERONE-17B-MONOENANTHATE

393

8/1/1960

MCMILLEN FEED MILLS

METHODS IN FACILS & CONTROLS FOR THE MFG, PROCESSING, PACK. OF DRUGS

394

8/2/1960

GENERAL MILLS INC

METHODS FACILS & CONTROLS - FOR MFG PROCESSING & PACK. OF DRUGS.

III
II

6/6/1960

II

FLAVOR FORMULATIONS

FORMULATE FOR VARIOUS STANDARD COATING SOLUTIONS ,LAKEDYE


PROLASE 300

FURALTADONE MASTITIS PREPARATION - SQUEEJET DISPENSER

Page 11

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
395
A
II
8/10/1960
DSM NUTRITIONAL PRODUCTS INC

SUBJECT
5% D-METHORPHAN HYDROBROMIDE ADSORBATE POWDER

396

II

1/1/1940

BIO-RAMO DRUG CO INC

IRON POLYSACCHARIDE RAW MATERIAL USED IN MFG OF DI-FERRON INJECTION

397

9/6/1960

SHARP CORP

398

9/19/1960

UPJOHN CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CONSHOHOCKEN, PENNSYLVANIA.
MANUFACTURING ,PACKAGING AND CONTROLS PROCEDURES-THIS IS A VET MED DMF

399

IV

10/3/1960

EMERY PERSONAL CARE PRODUCTS GROUP

NIMLESTROL; LANFRAX; LANTROL; LANFRAX WS55 (LANOLIN PRODUCTS)

400

10/6/1960

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP CONTROLS, RAW MATERIAL SPECIFICATIONS

401

II

10/10/1960

CHAS PFIZER AND CO INC

OLEANSOMYCIN AND COCCIDIOSTAS IN POULTRY FEED

402

II

1/1/1940

ICI AMERICAS INC

SORBITAN MONOOLEATE (SPAN 80)(VET MED) REFERRED TO PESTICIDE BRANCH

403

10/20/1960

BIPHENAMINE HYDROCHLORIDE

404

II

10/27/1960

405

II

10/27/1960

406

II

11/7/1960

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
RHONE POULENC PHARMACEUTICALS DIV RHONE
POULENC INC
RHONE POULENC PHARMACEUTICALS DIV RHONE
POULENC INC
SB PENICK AND CO ORIG

407

II

11/7/1960

WORTHINGTON BIOCHEM CORP

CHYMOTRYPSIN (MANUF PROCEDURE)

408

11/4/1960

WALLERSTEIN

CELLASE 1000

409

11/10/1960

SYNTEX SA

PARAMETHASONE ACETATE--MANUF PROCEDS,

410

11/14/1960

ER SQUIBB & SONS

PICCOLITE RESIN S 115 L

411

II

11/25/1960

SYNTEX SA

DROMOSTANOLONE PROPIONATE

412

II

11/28/1960

WITHMORE FEEDS INC

ZOALENE (IMPROVED HIGH ENER-G-BROILER RATION Z MEDICATED W/ ZOALENE)

413

11/28/1960

DIMETHADIONE

414

12/5/1960

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SYNTEX SA

415

12/21/1960

SYNTEX SA

62 FLUORO-16 2 METHYL HCL 62 FLUORO - 16 2 METHYL PREDNISOLONE ACETATE

416

12/15/1960

SYNTEX SA

6- CHLORO - 6 - DEHYDRO- 17A - ACETOXY PROGESTERONE

417

II

12/28/1960

WATSON LABORATORIES INC

MESTRANOL3-METHOXY-17-ETHINYL-ESTRADIOL- MANUF PROCEDURES

418

II

1/3/1961

DR REDDYS LABORATORIES LTD

419

1/3/1961

420

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
CREMER OLEO GMBH AND CO KG

FLUOCINOLONE ACETONIDE MANUFACTURED IN FREEPORT, BAHAMAS AND CUERNAVACA,


MEXICO.
BUTYLPHENAMIDE

421

422

423

424
425

II

II

IV

12/7/1960

IGEPAL CO 887 (SAME AS IGEPAL 880) CONTRLS & TOXICITY


BIOPAL VRO-20
NEODECYLLIN (NEOMYCIN UNDECYLENATE)

FLURANDRENOLIDE

WITEPSOL, HARD FAT SUPPOSITORY BASE

NOT AN ASSIGNED NUMBER


1/19/1961

GEIGY CHEM CORP

CHEL 330 ACID (DIETHYLENETRIAMINE PENTACETIC ACID)

2/24/1961

HALES & HUNTER

STANDARD OPERATING PROCEDS FOR MANUF MEDICATED FEEDS

3/1/1961

SB PENICK AND CO ORIG

MEPHENOXALONE- METHODS OF MANUF.

3/16/1961

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

FACILS & CONTROLS USED FOR MANUF PROCESSING & PACKAGING OF NEW DRUGS

426

2/6/1961

UNION CARBIDE CORPORATION

SILICONE X-251

427

4/4/1961

DUPHAR BV

DYDROGESTERONE(FORMERLY ISOPREGNENONE)

428

4/11/1961

RP SCHERER CORP

FERROUS CITRATE, MANUF SPECS & CLINICAL DATA

II

Page 12

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
429
I
11/21/1960
KAY-FRIES CHEMS

SUBJECT
BUTYLPHENAMIDE

430

431

432

433

434

II

4/18/1961

SB PENICK AND CO ORIG

GLYCOPYRROLATE

4/27/1961

STRONG COBB ARNER INC

VICKS SINUS ANTICONGESTION TIME COVE TABLETS TRI-SPAN

4/28/1961

HOFFMANN LA ROCHE INC

AMPROTROPINE RESINATE POWDER

5/12/1961

H LUNDBECK AND CO AS

CALCIUM - AMPHOMYCIN

6/22/1961

TROMETHAMINE

435

6/22/1961

IMC CHEMICAL GROUP INC SUB INTL MINERALS &


CHEM CORP
RHODIA INC

436

437

6/30/1961

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

FACILITIES & CONTROL (SPOT WELDING)

438

6/30/1961

DOW CHEMICAL CO MICHIGAN DIV

FACILITIES & CONTROLS (METHOXY FLURANE)

439

6/6/1961

UNION CARBIDE AND CARBON CORP

UCON FLUID 50-HB-660

440

7/12/1961

NATIONAL STARCH & CHEMICAL CORP

INSTANT CLEARJEL

441

7/21/1961

PRODOTTI CHIMICI DOTTORI RE

MEPROBAMATE

442

2/10/1961

CHEMAGRO CORP

NEGUVON

443

444

445

446

447

448

449

450

II

ETHIONAMIDE

NOT AN ASSIGNED NUMBER

IV
II

NOT AN ASSIGNED NUMBER


8/9/1961

II

SULFACHLOROPYRIDAZINE

8/21/1961

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
GEIGY CHEM CORP

8/28/1961

CHAS PFIZER AND CO INC

L'-LYSINE MONOHYDROCHLORIDE

IRGASAN CF3

NOT AN ASSIGNED NUMBER


7/6/1961

ORTHO PHARMACEUTICAL CORP

QUALITY CONTROL PROCEDURE

9/18/1961

FMC CORP FMC BIOPOLYMER DIV

AVICEL MICROCRYSTALLINE CELLULOSE

9/22/1961

SCHWARTZ BIORES INC

THIOGEL

451

9/29/1961

NYSCO LABS INC

CHLORPHENIRAMINE MALEATE 4MGS TIMED RELEASED PELLETS

452

10/21/1961

NYSCO LABS INC

PHENYLPRIPANOLAMINE HCL 50MG TIMED RELEASE PELLETS

453

7/13/1965

FABBRICA ITALIANA SINTETICI SPA

NITROFURANTION

454

12/7/1961

PRODOTTI CHIMICI DOTTORI RE

NITROFURANTOIN

455

12/12/1961

FINE ORGANICS INC

TEMASEPT

456

II

12/11/1961

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

CHLOROTHIAZIDE (BULK) - HYDROCHLOROTHIAZIDE

457

12/12/1961

ALLIED MILLS, INC.

FEED MANUF PLANTS AND CONTROL LABORATORIES WAYNE FEEDS

458

12/28/1961

RT VANDERBILT CO

VANCIDE ZP AND VANCIDE ZP DISPERSION

459

1/4/1962

RT VANDERBILT CO

VANCIDE BL

460

1/4/1962

RT VANDERBILT CO

VANCIDE BN

461

1/8/1962

RT VANDERBILT CO

METHYL TUADS

462

1/8/1962

PHARMACIA LABS INC

RHEOMACRODEX

463

2/6/1962

SB PENICK AND CO ORIG

BENZOMETHAMINE CHLORIDE

464

2/7/1962

ELANCO PRODS DIV ELI LILLY AND CO

HYGROMIX - CHICKENS

465

2/6/1962

RHODIA INC

PIPERACETAZINE

466

2/15/1962

A WASSERMANN SPA

TOLBUTAMIDE BULK

IV

II

IV
II

Page 13

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
467
A
II
2/15/1962
FIS FABBRICA ITALIANA SINTETICI SPA

SUBJECT
CHLORDIAZEPOXIDE HCL

468

II

2/13/1962

INDUSTRIA CHIMICA MILANESE SPA

PROCHLORPERAZINE MALEATE

469

II

2/26/1962

INDUSTRIA CHIMICA MILANESE SPA

CHLORPROMAZINE HYDROCHLORIDE

470

2/26/1962

SYNTEX SA

2A-METHYL-DIHYDROTESTOSTERONE (CRYSTALLINE)

471

2/26/1962

EI DUPONT DE NEMOURS AND CO

BAYMAL COLLOIDAL ALUMINA

472

3/12/1962

DOW CHEMICAL CO MICHIGAN DIV

BROMINATED SALICYLANILIDE

473

3/21/1962

STRONG COBB ARNER INC

MATRIX GEL SUSTAINED RELEASE SYSTEM

474

3/21/1962

EI DUPONT DE NEMOURS AND CO

TEREPHTHALIC ACID IN COMBINATION W/ TETRACYCLINES MED. TURKEY FEEDS

475

3/23/1962

METAL & THERMIT CORP

STANNOUS FLUORIDE

476

3/28/1962

NEISLER LABS INC DIV MALLINCKRODT INC

DURABOND PRINCIPLE

477

3/27/1962

CHAS PFIZER AND CO INC

TEREPHTHALIC ACID IN POULTRY FEEDS CONTAINING OXYTETRACYCLINE

478

2/13/1962

ARAPAHOE CHEMS INC DIV SYNTEX LABS INC

HYDROXYPHENAMATE

479

4/12/1962

RT VANDERBILT CO

VANCIDE 2B

480

4/18/1962

BAXTER LABS INC DIV TRAVENOL LABS INC

TYROTHRICIN CHEMPLEXES

481

4/30/1962

WORTHINGTON BIOCHEM CORP

ARGINASE PRODUCTION

482

4/26/1962

A WASSERMANN SPA

MEPROBAMATE

483

5/14/1962

SPENCER LABS DIV UNIMED INC

SERC

484

5/18/1962

PACO PACKAGING INC

PHARMACEUTICAL PACKAGING OPERATION

485

5/29/1962

CHAS PFIZER AND CO INC

EPITHIAZIDE (P=2105)

486

6/12/1962

CONTINENTAL CAN COMPANY

CONALOY (INTERNAL)

487

6/11/1962

CONTINENTAL CAN COMPANY

CONALOY (EXTERNAL)

488

6/12/1962

ARSANILIC ACID (SODIUM ARSANILATE)

489

6/8/1962

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SEARLE CHEMS INC SUB GD SEARLE AND CO

490

II

6/22/1962

ELANC0 DIV ELI LILLY & CO

CHYMOTRYPSIN TRYPSIN CRYSTALLIZED

491

II

6/27/1962

SALSBURY LABS

3-NITRO-4-HYDROXYPHENYLARSONIC ACID

492

493

7/6/1962

ROHM AND HAAS CO

ASPERKINASE PRODUCTION

494

II

7/20/1962

METAL & THERMIT CORP

STANNOUS OCTOATE

495

IV

7/25/1962

MARKEM IMAJE CORP

INKS USED ON CAPSULES & TABLETS

496

II

8/15/1962

ICI AMERICAS INC

STANDARD DRUG MIXTURE #35--SDM#35

497

498

8/24/1962

YARDLEY ELECTRIC CORP

AGOSAN

499

8/27/1962

IRWIN NEISLER AND CO

IN 836 (FENYRIPOL)

500

8/1/1962

SCHUYLKILL CHEM CO

ALLANTOIN - METHIONINE COMPLEXES

501

10/8/1962

BD MEDICAL PHARMACEUTICAL SYSTEMS

BD HYPAK (R) SCF (R) (STERILE) AND BULK (NON-STERILE) SYRINGE SYSTEMS

502

10/10/1962

PRIVATE BRANDS CO

PACKAGING AND CONTROL SPECIFICATIONS

503

10/12/1962

2 PAM CHLORIDE

504

10/17/1962

DEPT OF DEFENSE-ARMY DEFENSE MEDICAL


MATERIEL BOARD
SCHERING AG

II

II

II

II

ANAVAR, PESA

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER

III

17 ALPHA-ETHINYL-19-NOR-TESTOSTERONE

Page 14

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
505
I
11/14/1962
PENTAPHARM AG

SUBJECT
REPTILASE

506

11/28/1962

RHODIA INC

DIMETRIDAZOLE [EMTRYL]

507

12/3/1962

INTERNATL CHEM & NUCLEAR PHARMS INC

5-IODODEOXYURIDINE

508

11/30/1962

ALLERGAN SPA

5-IODODEOXYURIDINE (5IUDR)

509

IV

12/13/1962

DOG LIFE CORP

TABLETTING MIXURE AND FLAVORING TECHNIQUES

510

III

1/3/1963

DOW CHEMICAL CO

SENTRY POLYOX WATER SOLUBLE RESINS - NF GRADE

511

12/28/1962

ROHM AND HAAS CO

RHOZYME J-25 CONCENTRATE

512

513

1/17/1963

GIST BROCADES

FLURANDRENOLONE ACETATE

514

1/22/1963

ULTRAVIOLET ABSORBERS (U.V.Q, U.V. 24, & U.V.24 PHARMACEUTICAL GRADE)

515

12/19/1962

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
SCHERING AG

516

2/6/1963

SHELL CHEM CO

DDVP-RESIN (2,2-DICHLOROVINYL DIMETHYL PHOSPHATE)

517

2/8/1963

PILLSBURY CO

PROCESS EQUIPMENT AND PROCEDURES

518

2/15/1963

LEEDS DIXON LABORATORIES INC

OPERATING PROCEDURES

519

II

2/18/1963

ORGANON INC

DEXAMETHASONE

520

2/28/1963

COOPERATIVE MILLS

METHODS USED IN MANUFACTURING, PROCESSING AND PACKING DRUGS

521

522

3/29/1963

PFIZER AND CO

CURRICULA VITAE

523

II

3/19/1963

TANABE SEIYAKU CO LTD

DL-CARNITINE HYDROCHLORIDE

524

8/19/1970

WEST CO

PLEASE REFER TO D1545 AMD/OR D1546 WHICH REPLACE D524

525

3/11/1963

WITCO CHEM CO INC

EMCOL E-607 QUATERNARY AMMONIUM COMPOUND

526

3/14/1963

GENERAL ANILINE AND FILM CORP

UVINUL MS-40

527

3/20/1963

ORGANIC CHEMICAL RSCH SECTION, PERSONNEL QUALIFICATIONS

528

IV

3/25/1963

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
ALABAMA FLOUR MILLS

529

II

3/27/1963

CALBIOCHEM CORP

5-IODO-2-DEOXYURIDINE

530

531

532

II

4/5/1963

533

534

535

536

537

538

539
540

NOT AN ASSIGNED NUMBER

17A-ETHINYL-19-NOR-TESTOSTERONE ACETATE

NOT AN ASSIGNED NUMBER

RED HA BROILER CONCENTRATE NON-MEDICATED FEEDS

NOT AN ASSIGNED NUMBER


4/1/1963

SK&F LABS PERSONNEL SUMMARY OF TRAINING AND EXPERIENCE

3/27/1963

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
SMITH KLINE & FRENCH LABS DIV SMITHKLINE
BECKMAN CORP
ALBERS MILLING CO

3/14/1963

CHEMAGRO CORP

STUDY RESIDUE PROBLS RELATED TO U/OF EXPERIMENTAL ORGANOPHOSPHORUS COM

4/9/1963

PARKE DAVIS & CO

QUALIFICATIONS OF PARKE, DAVIS & CO. RESEARCH PERSONNEL

4/12/1963

RHODIA INC

ETHOPROPAZINE

4/23/1963

MASON-KELLER CORP

MASON-KELLER CORPORATION

II

4/25/1963

GANES CHEMICALS INC

7 BETA-HYDROXYPROPYL THEOPHYLLINE

4/25/1963

WYETH INC

INVESTIGATIONAL NEW DRUG MASTER FILE

5-IODO-2-DEOXYURIDINE (IUDR)
EQUIPMENT & CONTROL PROCDS FOR MANUF MEDICATED FEEDS FOR ALBERS FEED

NOT AN ASSIGNED NUMBER

Page 15

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
541
I
II
12/12/1962
SALSBURY LABS

SUBJECT
EMTRYL TABLETS

542

543

544

545

546

II

5/1/1963

ORGANON INC

DEXAMETHASONE

5/1/1963

MALLINCKRODT INC

INVESTIGATIONAL DRUGS

IV

4/23/1963

WITHMORE FEEDS INC

36% POULTRY CONCENTRATE 291A /44% BROILER CONCENTRATE UNMEDICATED 190A

II

5/6/1963

OZARK-MAHONING CO

SODIUM MONOFLUOROPHOSPHATE

5/9/1963

RUSON LABS INC

ASSAY INFOR RUSON LABS [PRINCIPAL QUANTITAIVE DETER QUATERNARY VITAE]

547

5/10/1963

ARMOUR PHARMACEUTICAL CO

PANCREAIC ENZYME CONCENTRATE

548

5/14/1963

NUTRENA MILS, DIV OF CARGILL, INC.

FACILITIES FOR CARGILL, INC (THIS IS A VETDMF)

549

5/10/1963

INVESTIGATIONAL EXEMPTION FOR WIN 5063 (VETERINARY USE)

550

II

5/20/1963

STERLING-WINTHROP RES INST DIV STERLING


DRUG INC
BURROUGHS WELLCOME CO

551

II

4/19/1963

THIABENDAZOLE

552

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
NOT AN ASSIGNED NUMBER

553

II

5/17/1963

ARMOUR PHARMACEUTICAL CO

CHYMOTRYPSIN CRYSTALLIZED

554

IV

5/20/1963

ONYX CHEM CO DIV MILLMASTER ONYX CORP

ISOTHAN Q-75

555

5/16/1963

M-259 (NSC 51954)

556

5/20/1963

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ARMOUR PHARMACEUTICAL CO

557

II

5/20/1963

CHEMAGRO CORP

BAYER 2353 (YOMESAN)

558

II

5/20/1963

ICI AMERICAS INC

BRIJ 30 POLYOXYETHYLENE (4) LAURYL ETHER

559

11/14/1962

RHODIA INC

FLAVORS: PHARMACEUTICAL FLAVOR RF451, IMITATION FLAVOR 520B

560

II

5/21/1963

DOW CHEMICAL CO MICHIGAN DIV

TROLENE FM MEDICATED PREMIX

561

4/24/1963

562

563

5/22/1963

AYERST LABORATORIES INC DIV AMERICAN HOME STUDIES ON ORBENIN, CLOXACILLIN , BRI 1621 , AY 6203
PRODUCTS CORP
WARNER LAMBERT CO PHARMACEUTICAL
PERSONNEL FACILITIES AND OPERATING PROCEDURE
RESEARCH DIVISION
BAXTER LABS INC DIV TRAVENOL LABS INC
RESEARCH AND DEVELOPMENT GROUP

564

5/16/1963

UPJOHN CO

BULK CHEMICALS , METHOD OF PREPARATION

565

5/23/1963

INVESTIGATIONAL EXEMPTION FOR WIN 18,320-3 (VETERINARY USE)

566

STERLING-WINTHROP RES INST DIV STERLING


DRUG INC
NOT AN ASSIGNED NUMBER

567

5/23/1963

COMBINED W/INVEST. EXEMPTION FOR WIN 18,320-3

568

STERLING-WINTHROP RES INST DIV STERLING


DRUG INC
NOT AN ASSIGNED NUMBER

569

5/20/1963

NATL INST HLTH CLINCL CTR PHARMACY

STATEMENT OF PERSONNEL FACILS AND CONTROLS FOR PROCESSING A NEW DRUG

570

5/28/1963

3M PHARMS

INVESTIGATIONAL NEW DRUG PROCEDURES

571

5/31/1963

SYNTEX SA

INVESTIGATIONAL DRUG, 6APLHS-FLUORO-16-ALPHA-HYDROCORTISOME

572

5/29/1963

SB PENICK AND CO ORIG

BISMUTH SUBSALICYLATE PASTE

573

6/3/1963

SB PENICK AND CO ORIG

DOXAPRAM HCL; AHR-619

574

575

5/28/1963
I

II

DARVISIL

PURIFIED ENZYME CONCENTRATE

NOT AN ASSIGNED NUMBER


6/5/1963

CUTTER BIOL DIV MILES LABS INC

MANUF RESCH AND PERSONNEL FILE RSCH FACILS, EQUIPMENT & CONTROLS 11-16

Page 16

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
576
I
II
6/11/1963
RHODIA INC

SUBJECT
SPIRAMYCIN

577

6/12/1963

RHODIA INC

METHOTRIMEPRAZINE

578

6/12/1963

RHODIA INC

ISOMETAMIDIAM

579

6/11/1963

RHODIA INC

HEVOPHACETOPERANE (LIDEPRAN)(RP8228) HCL

580

6/7/1963

BURROUGHS WELLCOME CO

PERTINANT DATA ON THE RESEARCH ACTIVITIES

581

6/5/1963

FARM BUREAU SERVICES

DEALERS USING THIS MASTER FILE AND MILL LOCATION

582

II

6/11/1963

ORGANON INC

DEXAMETHASONE 21-PHOSPHATE

583

6/5/1963

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

PERSONNEL, FACILITIES & TESTING PROCEDS, AND LABELING INVEST DRUGS

584

II

3/5/1963

585

5/28/1963

AYERST LABORATORIES INC DIV AMERICAN HOME METHYRIDINE


PRODUCTS CORP
SANDOZ CONSUMER PHARMACEUTICALS DIV
DORSEY LABORATORIES

586

6/7/1963

INOLEX CHEM CO

MANUF PROCEDURE FOR HIGH POTENCY LIPASE

587

6/26/1963

DOW CHEMICAL CO MICHIGAN DIV

INVESTIGATIONAL DRUG MASTER FILE FOR FUTURE REFS NOTICES T/B SUBMITT

588

6/10/1963

NATL INST HLTH CLINCL CTR PHARMACY

COOPERATIVE STUDY GROUPS OF CLINICAL STUDIES PANEL

589

6/10/1963

RORER PHARM CORP SUB RORER GROUP

RECOSEN, INVESTIGATIONAL DRUG

590

6/21/1963

PARKE DAVIS & CO

VIRAL AND BACTERIAL VACCINES

591

5/24/1963

ADAMHA NIMH ADDICTION RESCTR

INVESTIGATIONAL DRUGS SKF-5390,ARC VII-B-4;V-B-1;V-C-5;V-A-29

592

593

594

595

II

596

597
598

NOT AN ASSIGNED NUMBER


6/6/1963

SANDOZ PHARMS CORP DIV SANDOZ INC

INVESTIGATIONAL DRUGS

7/5/1963

ROUSSEL CORPORATION

INOSITOL HEXANICOTINATE

5/31/1963

AMERICAN CYANAMID CO

CL 45,167 OR STYRYLPYRIDINIUM (INVESTIGATIONNAL DRUG)

II

5/31/1963

AMERICAN CYANAMID CO

STYRYLQUINOLINIUM (CL40,001) INVESTIGATIONAL USE

II

6/13/1963

AMERICAN CYANAMID CO

SULFATETHOXYPYRIDAZINE W/& WITHOUT CHLORTETRACYCTINE IN SWINE FEED EXP

II

7/11/1963

NOVO INDUSTRI AS

CRYSTALLINE TRYPSIN - NOVO DELETED 10 - 11 - 63

599

IV

6/18/1963

ALBERS MILLING CO.

ALBERS LAB - MIX POULTRY

600

II

6/18/1963

TRIAMTERENE

601

II

6/27/1963

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
SYNTEX LABORATORIES INC SUB SYNTEX CORP

602

6/24/1963

AH ROBINS CO

FACILITIES, METHODS AND PERSONNEL INVESTIGATIONAL DRUG

603

6/3/1963

HADACIDIN SOD. DIHYDRATE (NSC 521778) & HADACIDIN POTASS. NSC 72962

604

7/5/1963

605

6/25/1963

606

2/14/1963

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
MERRELL DOW PHARMS INC SUB MARION
MERRELL DOW INC
WARNER LAMBERT CO PHARMACEUTICAL
RESEARCH DIVISION
CORVEL, INC.

607

7/30/1963

SCHWARTZ BIORESEARCH INC

ADENOSINE-5' MONOPHOSPHATE (AMP) ---MFG PROCEDURE

608

5/31/1963

ACTINOGAN (NSC 54496 D)

609

6/3/1963

610

6/11/1963

BRISTOL LABORATORIES INC DIV BRISTOL MYERS


CO
BRISTOL LABORATORIES INC DIV BRISTOL MYERS
CO
WYETH INC

II

(VET) 6-ALPHA-9-A-DIFLUORO-16-A-METHYL PREDNISOLONE DESIGNATED RS 2177

MFG & PROCESS DATA;MONITORS RESPONS. FOR CLIN. & PHARMACOLOG. DATA
W 3361, A LIQUID ANTACID FORMULATION ---CHITOSAN ANTACID
TYLOSIN; DIHYDROSTREPTOMYCIN; VIT. A & D ARE ACT. INGREDS. (VET MED)

A649 (NSC 38270)


GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS

Page 17

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
611
I
6/11/1963
WARNER LAMBERT CO PHARMACEUTICAL
RESEARCH DIVISION
612
I
7/30/1963
BRISTOL LABORATORIES INC DIV BRISTOL MYERS
CO
613
I
5/10/1963
VA MEDICAL CENTER

SUBJECT
GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS

614

3/14/1963

PROCTER AND GAMBLE CO

COMPANY'S PROCEDURES FOR TESTING NDA PRIOR TO SUBMITTING FOR APPROVAL

615

3/14/1963

MALLINCKRODT CHEMICAL WORKS

GENERAL INFO--DISCONTINUED INVESTIGATIONAL DRUGS

616

7/29/1963

KIERNAN-HUGHES INC

METHODS, FACILITIES AND CONTROLS

617

618

6/18/1963

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP GENERAL INFO-DISCONTINUED INVESTIGATIONAL DRUGS

619

8/5/1963

AMERICAN CYANAMID CO

SULFATETHOXYPYRIDAZINE AND CHLORTETRACYCLINE(VET)

620

7/30/1963

C ALBERT SAUTER CO

PACKAGING OF MEDICATION (BLISTER PACKAGES)

621

7/17/1963

WALLERSTEIN

DIHYDROXYACETONE (THIS DSENT TO COLOR ADD. ON 9.6.63)

622

6/12/1963

CUDAHY LABS DIV CUDAHY PACKING CO

ELASTASE

623

7/26/1963

WISC ALUMNI RES FDTN

FORMULA 7100 (VET)

624

4/25/1963

CYTOMEL IMPLANT PELLETS(VET)

625

7/2/1963

626

7/24/1963

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
IVERS-LEE MIDWEST CO INC DIV BECTONDICKINSON AND CO
DOMINION PRODUCTS INC

627

7/22/1963

PABST LABS DIV PABST BREWING CO

5-IODO-2'-DEOXYURIDINE

628

8/8/1963

SPECTINOMYCIN (M-141, ABBOTT)(VET)

629

8/8/1963

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ABBOTT LABS

630

8/12/1963

DOW CHEMICAL CO MICHIGAN DIV

PROPYLENE GLYCOL--TRADE NAME SIRLENE(VET)

631

632

633

634

635

636

637

638

639

7/22/1963

DORSEY LABORATORIES DIV SANDOZ INC

VASCULA (IS KNOWN IN GERMANY-USED TO IMPROVE PERIPHERAL CIRCULATION)

640

8/8/1963

HAMPSHIRE CHEMICAL CORP

HAMPSHIRE NTA NA3 (TRISODIUM NITRILOTRIACETATE MONOHYDRATE)

641

7/19/1963

1-METHYL-1-(B-CHLOROETHYL) ETHYLENIMONIUM PICRYSULFONATE

642

8/27/1963

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
FINE ORGANICS INC

643

8/20/1963

RT VANDERBILT CO

VANGARD MB (MONOBENZONE)

644

1/1/1940

UPJOHN CO

NSC-51173, (U-10955)--5A-ANDROSTAN-3-ONE,2A-FLUORO-17B-HYDROXY

MITOMYCIN C (NSC 26,980)


VA INVESTIGATORS

NOT AN ASSIGNED NUMBER

IV

II

II

PACKAGING FACILITIES AND CONTROLS


PHARMACEUTICAL FLAVORS #124-B-12 & 121-B-12

2-(2-FORMYLHYDRAZINO)-4-(5-NITRO-2-FURYL)-THIAZOLE(AS-L7665)&A-2L203

NOT AN ASSIGNED NUMBER


8/9/1963

CURRICULA VITAE OF CLINICAL INVESTIGATORS

8/5/1963

BRISTOL LABORATORIES INC DIV BRISTOL MYERS


CO
ELANC0 DIV ELI LILLY & CO

3/8/1963

SOLVAY PHARMACEUTICALS

GENERAL INFO-DISCN. INVESTIGATIONAL DRUGS

8/16/1963

JT BAKER CHEMICAL CO

DIETHYLPROPION CONTAINING TARTARIC ACID

III

8/16/1963

JT BAKER CHEMICAL CO

DIETHYLPROPION

II

8/15/1963

FORT DODGE LABORATORIES

P-234 (INJECT. ANTHELMINTIC IN SWINE) CALLED TRICHLORPHON & NEGUVON

II

INVEST DRUG STREPTOMYCIN,TYLOSIN, ERYTHROMYCIN & PENICILLIN BOLUS(VET)

NOT AN ASSIGNED NUMBER

II

TEMASEPT II (TBS) (CHEM NAME-3,4'5 TRIBROMSALICYLANILIDE)

Page 18

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
645
I
II
1/1/1940
CHEMAGRO CORP

SUBJECT
C0-RAL--0,0 DIETHYLO-3-CHLORO-4 METHYL-2-OXO-2H-1-BENZOPYRAN-7-YL

646

647

648

649

II

650

651

II

8/27/1963

HOFFMANN LA ROCHE INC

LIBRIUM; TRANIMAL(VET)

8/26/1963

CREATIVE PACKAGING CO DIV ELI LILLY AND CO

CONTRACT PACKAGING

9/10/1963

WARNER PACKAGING

PACKAGING FACILITIES AND CONTROLS

8/26/1963

CORVEL, INC.

TYLOSIN 20MG PER CC AND NEOMYCIN 10MG PER CC (VET)

III

9/4/1963

KIRKHILL RUBBER CO

KIRKHILL COMPOUND 270-A-905 AND 285-C-1156

8/22/1963

MOORMAN MANUFACTURING CO.

RESEARCH EXPERIMENT # 1192 (VET)

652

8/22/1963

MOORMAN MANUFACTURING CO.

RESEARCH EXPERIMENT # 1167(VET)

653

4/15/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION 461

654

9/9/1963

VOCATIONAL REHABILITATION SERVICES

PROCESSING--UNDER SUB-CONTRACTING ARRANGEMENTS FOR PHARMACEUT. FIRMS

655

4/15/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI-446

656

4/22/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION --CI 442

657

4/25/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI423

658

4/11/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATIONS--CI 400 AND 421

659

4/15/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI 384

660

4/15/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI 344

661

4/15/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI-383

662

5/27/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION-- CI-395

663

9/24/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI-499 (BUSCOPAN)

664

4/15/1963

PARKE DAVIS & CO

CLINICAL INVESTIGATION--CI-462

665

II

8/1/1963

COMMERCIAL SOLVENTS CORP

COMBINATION-FEED GRADE ZINC BACITRACIN & DES IN CATTLE FEEDS (VET)

666

II

8/27/1963

NITROFURAZONE(VET)

667

HESS AND CLARK CO DIV RICHARDSON-MERRELL


INC
NOT AN ASSIGNED NUMBER

668

NOT AN ASSIGNED NUMBER

669

II

9/3/1963

CUDAHY PACKING CO

DIETHYLSTILBESTROL MIX IN-CUDAHY 3% PHOSPHORUS MIXER W/DES 0.0088%(VET

670

II

9/12/1963

PACIFIC NORTHWEST PRODUCTS, INC.

DIETHYLSTILBESTROL(VET)

671

II

8/15/1963

INTERMOUNTAIN ELEVATOR CO.

DIETHYLSTILBESTROL(VET)

672

II

8/15/1963

IMPERIAL PRE-MIX CO.

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

673

II

9/9/1963

ALBION VETERINARY SUPPLY

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

674

IV

9/19/1963

INTERNATIONAL SPECIALTY PRODUCTS

GANTREZ AN (PVM/MA)-CHEM NAME:POLY(METHYL VINYL ETHER/MALEIC ANHYDRIDE

675

II

9/26/1963

NORWICH PHARMACAL CO

VALSYN (FURALTADONE) WATER MIX(VET)

676

II

5/20/1963

STANOZOLOL (PYRAZOLE C 14), LABELLED (VET)

677

9/27/1963

STERLING-WINTHROP RES INST DIV STERLING


DRUG INC
SCHERING AG

678

9/3/1963

MERCK AND CO INC

PRO-STREP CRUMBLES (VET)

679

II

8/26/1963

CORVEL, INC.

TYLOSIN & DIHYDROSTREPTOMYCIN (VET)

680

II

9/13/1963

MERCK AND CO INC

AMPROL SUPER PLUS (AMPROLIUM & ETHOPABATE)(VET)

681

II

8/26/1963

CORVEL, INC.

TYLOSIN & NEOMYCIN USED AS AN EXPERIMENTAL PRODUCT(VET)

682

9/27/1963

DOW CORNING CORP

SILICONE RUBBER DOW CORNING SILASTIC

SH-714

Page 19

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
683
I
II
8/5/1963
ARIZONA MILLING CO.

SUBJECT
DIETHYLSTILBESTROL INTERMEDIATE PREMIXES --BEEF CATTLE FEEDS (VET)

684

10/1/1963

CELANESE CORP

1,3 BUTYLENE GLYCOL

685

9/24/1963

GRAIN PROCESSING CORP

REQUEST TO MARKET EGGS OF PULLETS FED MANGANESE BACITRACIN(VET)

686

9/24/1963

GRAIN PROCESSING CORP

REQUEST TO MARKET STEERS FED MANGANESE BACITRACIN(VET)

687

II

8/27/1963

HOFFMANN LA ROCHE INC

CLEARANCE FOR SALE OF PPOULTRY, TREATED WITH SULFADIMETHOXINE(VET)

688

IV

9/23/1963

UNION CARBIDE CORPORATION

UCONPROPELLANTS

689

10/3/1963

FORMULATION OF THE RUBBER COMPOUND USED BY RIKER LABS

690

AMERICAN GASKET AND RUBBER CO DIV DART


INDUSTRIES INC
GRAIN PROCESSING CORP

691

SULFAMETHAZINE

692

4/10/1963

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
ADRIA LABORATORIES DIV ERBAMONT INC

693

II

10/2/1963

ALBER MILLING CO.

MFG OF DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

694

II

10/7/1963

GEM FEED CO.

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

695

II

10/11/1963

ORGANON INC

PREPARATION OF CORTICOSTERONE FROM HYDROCORTISONE

696

5/20/1963

SALSBURY LABS

REQUEST AUTH. TO MARKET BROILERS FED NOVASTA(VET)

697

II

3/11/1963

ELANCO PRODS DIV ELI LILLY AND CO

VET. INVEST. DRUGS-TYLOSIN FOR BROILER HENS,BROOD SOWS & CATTLE(VET)

698

4/26/1963

CHAS PFIZER AND CO INC

COMPOUND P-3693A (VET)

699

II

4/19/1963

ELANCO PRODS DIV ELI LILLY AND CO

RS-1280 RESIDUALS IN LAYING CHICKENS(VET)

700

II

10/25/1963

DOW CHEMICAL CO MICHIGAN DIV

ZOALENE W/ARSANILIC ACID OR SODIUM ARSANILATE IN MEDICATED FEED (VET)

701

II

8/30/1962

ARSANILIC ACID--SODIUM ARSANILATE WITH ZOALENE (VET DMF)

702

II

6/30/1961

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
MERCK AND CO INC

703

1/21/1963

DORSEY LABORATORIES DIV SANDOZ INC

TARPAN (HF/1984; HF/1931 HCL)

704

II

8/5/1963

ELANCO PRODS DIV ELI LILLY AND CO

CHLORMADINONE ACETATE PREMIX (VET)MADE PART OF DMF-699V

705

II

10/16/1963

SALSBURY LABS

NOVASTA-A FINISHED CHICKEN FEED(VET)

706

707

II

6/16/1963

MERCK AND CO INC

AMPROLIUM IN CHICKENS(VET)

708

II

4/2/1963

ER SQUIBB AND SONS INC

MYCOSTAIN -20 IN PIGS (VET)

709

II

10/24/1963

GALLIMYCIN (R)-10(ERYTHROMYCIN THIOCYANATE, ABBOTT)

710

10/16/1963

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
CREATIVE PACKAGING CO DIV ELI LILLY AND CO

711

II

8/15/1963

CALIFORNIA CATTLE SUPPLY CO., INC.

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

712

II

8/19/1963

CAPITAL FEED AND SEED CO.

DIETHYLENESTILBESTROL INTERMEDIATE PREMIXES (VET)

713

II

10/11/1963

STEPAN COMPANY

LIPAL 9-LA (POLYOXYETHYLENE (9) LAURYL ETHER

714

10/16/1963

OZARK-MAHONING CO

SODIUM FLUOROSTANNITES

715

10/8/1963

OWENS ILLINOIS INC

DISPOSABLE SYRINGE

716

11/4/1963

SKF 385 TRANYLCYPROMINE (VET)

717

11/4/1963

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
SYNTEX SA

718

10/23/1963

STEPAN SPECIALTY PRODUCTS LLC

MCT (MEDIUM CHAIN TRIGLYCERIDES)

10/1/1963
10/4/1963

REQUEST TO MARKET TURKEYS FED MANGANESE BACITRACIN (VET)

LORAMINE SBU -185 (UNDECYLENIC ACID-MONOETHANOLAMIDE)

AMPROLIUM MEDICATED FEED -(3-NITRO-4-HYDROXYPHENYLARSONIC ACID) (VET)

NOT AN ASSIGNED NUMBER

II

II

CONTRACT PACKAGING OF FOOD & DRUG ADM. CONTROLLED PRODUCTS

6A-FLUORO-16A-METHYL DELTA 1,4-PREGNADIENE-11B,17A-DIOL-3,20-DIONE

Page 20

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
719
I
I
10/28/1963
LILLY RES LABS DIV ELI LILLY CO

SUBJECT
PERSONNEL FILE: REQUIREMENTS FOR TECHNICAL & PROFESSIONAL STAFF

720

IV

10/23/1963

STEPAN SPECIALTY PRODUCTS LLC

WECOBEE BASES

721

IV

11/5/1963

COLORCON INC

COLOR DISPERSIONS AND MIXED EXCIPIENTS

722

II

11/5/1963

OHIO AGRICULTURAL EXPERIMENT STATION

HESPERIDIN IN CATTLE (VET)

723

7/11/1963

NOVO NORDISK AS

CRYSTALLINE PORCINE TYPSIN, NOVO (FOR MFG,CONTROL SEE DMF-598)

724

3/7/1963

NATL INST HLTH NCI

DRUG DEVELOPMENT PROGRAM

725

12/10/1963

PUREX LABS

DRAKEOL-ARLACEL

726

IV

7/18/1963

JOHN W. ESHELMAN

RED ROSE SUPPLEMENTS AND CONCENTRATES (VET)

727

II

8/8/1963

ELANCO PRODS DIV ELI LILLY AND CO

TAPAZOLE AND DIETHYLSTILBESTROL FOR CATTLE (VET)

728

II

11/13/1963

BURROUGHS WELLCOME CO

CANOPAR BRAND THENIUM CLOSYLATE (VET)

729

11/4/1963

ELANCO PRODS DIV ELI LILLY AND CO

INVESTIGATIONS W/SWINE FED A COMBINATION OF TYLOSIN-STREPTOMYCIN (VET)

730

II

11/7/1963

ELANCO PRODS DIV ELI LILLY AND CO

STREPTOMYCIN-TYLOSIN-ERYTHROMYCIN-PENICILLIN COMBIN. ALONE & W/DES(VET

731

8/6/1963

OZARK-MAHONING CO

STANNOUS FLUORIDE

732

II

10/21/1963

STATE OF UTAH, DEPT. OF FISH AND GAME

ENHEPTIN (2-AMINO-5 NITROTHIAZOLE) IN RAINBOW TROUT(VET)

733

II

11/14/1963

LAKELAND CASH FEED

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

734

II

11/15/1963

GALLIMYCIN-10(ERYTHROMYCIN,ABBOTT) & PRO-GEN (ARSANILIC ACID) (VET)

735

II

10/14/1963

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ROMER AGRICULTURAL ENTERPRISES

736

II

11/7/1963

PRO-VITA CO.

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

737

11/18/1963

SEARLE CHEMS INC SUB GD SEARLE AND CO

METRULEN,METRULEN-M,AND OVULEN --ETHYNODIOL DIACETATE

738

II

11/15/1963

GD SEARLE AND CO

S N-263, A SULFATED POLYSACCHARIDE (VET)

739

10/31/1963

MOORMAN MFG. CO.

RESEARCH EXPERIMENT #946(MOORMAN'S RID-EZY MINERAL BLOCKS) (VET)

740

IV

11/26/1963

KANSAS STATE UNIV.

POLYOXYPROPYLENE,POLYOXYETHYLENE BLOCK POLYMER;SKF&WYANDOTTE EXP. (VET

741

II

11/20/1963

DOW CHEMICAL CO MICHIGAN DIV

ZOALENE, AMPROLIUM PLUS-COMBINATION W/ARSANILIC ACID & GALLIMYCIN (VET

742

11/29/1963

CURRICULUM VITAE OF ABBOTT'S THERAPEUTIC COMMITTEE

743

11/1/1963

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
AMERICAN CYANAMID CO

744

745

II

12/2/1963

CAMBREX PROFARMACO MILANO SRL

CHLORIDAZEPOXIDE (KNOW IN ITALY AS METHAMINODIAZEPOXIDE)

746

11/6/1963

WITHMORE FEEDS INC

TEREPHTHALIC ACID PLUS CHLORTETRACYCLINE-INVEST. PROGRAM IN FEED (VET)

747

II

11/12/1963

DOW CHEMICAL CO MICHIGAN DIV

ZOAMIX AND ERYTHROMYCIN THIOCYANATE(VET)

748

II

12/10/1963

AJINOMOTO CO INC

L-ARGININE MONOHYDROCHLORIDE

749

II

11/22/1955

DIETHYLSTILBESTROLTRADE NAME:RUMESTROL 1 AND 2(VET)

750

II

12/11/1963

MERCK CHEM MANUFACTURING DIV MERCK & CO


INC
THOMPSON HAYWARD CHEMICAL CO

751

II

12/26/1963

MILBUR-ELLIS CO./TX

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

752

II

12/3/1963

AMERICAN HOME PRODUCTS

INJECTABLE NOLVASAN(VET)

753

II

12/6/1963

AMERICAN HOME PRODUCTS

TRICHLORFON IN SWINE (INJECTABLE) (VET)--ADD. CORRES. TO DMF-637

754

II

12/6/1963

AMERICAN HOME PRODUCTS

TENIACIDE IN DOGS, MICE AND CAS(VET)

755

12/6/1963

AMERICAN HOME PRODUCTS

P-223 HORSE ANTHELMINTIC(VET)

FEEDS CONTAINING DES(VET)

APP TO EA POULTRY TREATED W/SULFACHLOROPYRAZINE FOR COCCIDIOSIS (VET)

NOT AN ASSIGNED NUMBER

MFGR OF DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

Page 21

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
756
I
II
12/3/1963
AMERICAN HOME PRODUCTS

SUBJECT
RENACIDEN IN DOGS AND CAS(VET)

757

II

12/9/1963

AMERICAN HOME PRODUCTS

DYREX INJECTABLE IN SWINE AND HORSES(VET)

758

II

12/16/1963

ORGANON INC

PREDNISOLONE SODIUM PHOSPHATE

759

II

1/6/1964

UPJOHN CO

PROMONE(MEDROXYPROGESTERONE ACETATE(VET)

760

II

12/23/1963

MERCK SHARP & DOHME RESEARCH LABS

PRO-STREP IN SWINE(VET)

761

1/9/1964

ALCON LABORATORIES INC

DAROIL INVESTIGATORS

762

12/31/1963

CHEMETRON CHEMS DIV CHEMETRON CORP

FACILITIES, PERSONNEL & CONTROLS PROCEDURES

763

12/24/1963

PRONTO ADDRESSING AND MAILING SERVICE INC

MEDICAL ADDRESSING AMD MAILING SERVICE

764

1/7/1964

CUSTOM PACKAGING

PACKAGING OF WALLACE LABS--ETHICAL PRODUCTS

765

II

10/8/1963

IOWA STATE UNIV.

ARSANILIC ACID(VET)

766

II

12/12/1963

NORTH CAROLINA STATE

LACTOSTA FOR EXPERIMENTAL PURPOSES-PERMISSION TO RECIEVE (VET)

767

II

12/19/1963

ARLIN CHEMICALS INC

MECLIZINE HCL

768

1/10/1964

RM HOLLINGSHEAD CORP

QUATERNARY AMMONIUM SACCHARINATES

769

II

1/16/1964

SOUTHWEST FLOUR AND FEED CO.

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

770

II

1/21/1963

CONSUMERS COOPERATIVE ASSOCIATION

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES-STILBOSOL(VET)

771

II

1/15/1964

CHAS PFIZER AND CO INC

POLYMYXIN METHANE SULFONATE FOR TREA. OF DISEASE IN POULTRY(VET)

772

6/21/1963

PARKE DAVIS & CO

VIRAL AND BACTERIAL VACCINE

773

774

II

1/14/1964

775

II

776

II

777

II

778

779

780

781

III

782

783

784
785

NOT AN ASSIGNED NUMBER


USE OF FURAZOLIDONE TO MEDICATE DUCKS(VET)

9/30/1963

HESS AND CLARK CO DIV RICHARDSON-MERRELL


INC
THE FARR COMPANY

1/17/1964

CHEMAGRO CORP

BAYER 9002 (BAYER S-940)(VET)

1/21/1964

STUART DIV ATLAS CHEM INDS INC-ORIG

VITAMINS B-6, B-12--INTRINSIC FACTOR CONCENTRATE TABLETS

1/24/1964

GANES CHEMICALS INC

CALCIUM PHENOBARBITAL

2/6/1964

GEIGY PHARMACEUTICALS DIV CIBA GEIGY CORP

SPECIFICATIONS AND TEST METHODS FOR INERT INGREDS.

2/7/1964

RHONE POULENC INC

METRONIDAZOLE

2/5/1964

PLASTICOID CO

RUBBER FORMULATIONS

IV

2/5/1964

FELTON WORLDWIDE INC

FELCOFIX IMITATION WILD STRAWBERRY FLAVOR T.F. #1347

2/12/1964

SYNTEX SA

GENERAL MASTER FILE --SPECIFICATIONS

1/21/1964

PRINCETON LAB PRODS CO

PREPARATION & PURIFICATION OF ACTH FROM HOG PITUITARY GLANDS

2/18/1964

RHODIA INC

PROPERICIAZINE-3-CYANO-10-(3'(4-HYDROXY PIPERIDINO PROPYL)PHENOTHIAZI

786

2/24/1964

PRECISION PACKAGING COMPANY INC

PACKAGING FACILITIES AND CONTROLS

787

2/18/1964

CONTROLS AND FACILITIES

788

2/24/1964

WM S MERRELL CO DIV RICHARDSON-MERRELL


INC-ORIG
ROBINSON WAGNER COMPANY INC

789

2/28/1964

SYNTEX SA

FLUMETHASONE

790

3/2/1964

SYNTEX SA

PARAMETHASONE PHOSPHATE DISODIUM SALT

791

2/12/1964

COLUMBIA UNIV

MULTIDOSE JET INJECTION DEVICE --INVESTIGATIONAL USE

792

793

II

DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

LANOLIN DERIVAIVES

NOT AN ASSIGNED NUMBER


II

3/18/1964

DOW CHEMICAL CO MICHIGAN DIV

DOWEX 1 X 2 RESIN --FACILS & CONTROLS

Page 22

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
794
I
4/10/1964
PITMAN-MOORE CO DIV DOW CHEM CO

SUBJECT
METHODS AND CONTROLS

795

4/17/1964

CUSTOM PACKAGING OF TABLETED OR CAPSULATED MEDICATION

796

5/6/1964

DON SPARKS ASSOCIATES DIV L GORDON & SON


INC
JENSON HJ

797

5/7/1964

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

MEPROBAMATE 400MG AND 200MG PROLONGED RELEASE CAPS

798

III

5/8/1964

UNETTE CORP

CUSTOM PACKAGING OF DRUG AND PHARMACEUTICAL PRODUCTS

799

IV

5/11/1964

PINACYANOLE CHLORIDE

800

IV

5/7/1964

DISTILLATION PROD INDS DIV EASTMAN KODAK


CO
CREMER OLEO GMBH AND CO KG

801

1/20/1964

HENKEL KGAA

EUTANOL G; SUPPOS. BASE I & II; SUPPOS. G. CETIOL & TOXAPON CS PASTE

802

5/19/1964

LILLY RES LABS DIV ELI LILLY CO

MONITORS--CLINICAL INVESTIGATORS

803

II

5/13/1964

SPI PHARMA INC

MANNITOL MANUFACTURED IN NEW CASTLE ,DELAWARE

804

1/22/1964

NATL INST HLTH NCI

DIMETHYL SULFOXIDE

805

III

5/15/1964

SPENCER CHEMICAL CO

POLY-ETH POLYETHYLENE RESIN 1099

806

II

5/20/1964

DR REDDYS LABORATORIES LTD

FLUOCINOLONE ACETONIDE ACETATE MFG IN MEXICO AND THE BAHAMAS

807

6/1/1964

2,6 DICHLOROINDOPHENOL SODIUM SALT

808

3/17/1964

DISTILLATION PROD INDS DIV EASTMAN KODAK


CO
PACINI AUGUST J MD

809

6/2/1964

MANUFACTURING AND CONTROL FACILITIES A RAHWAY, NJ

810

6/8/1964

MERCK CHEM MANUFACTURING DIV MERCK & CO


INC
PHARMACHEM CORP

811

6/15/1964

SYNTEX SA

MFGR CONTROLS-50% CHLORMADINONE ACETATE TRITURATION IN LACTOSE USP

812

6/16/1964

WADLEY INSTITUTES OF MOLECULAR MEDICINE

INFORMATION $ METHODS

813

9/2/1964

HEWITT SOAP COMPANY INC

DETERGENT CLEANSING BAR

814

NOT AN ASSIGNED NUMBER

815

NOT AN ASSIGNED NUMBER

816

NOT AN ASSIGNED NUMBER

817

NOT AN ASSIGNED NUMBER

818

819

820
821
822

II

823

II

824

825

IV

826

827

828
829

II

ADENYLIC ACID

MIGLYOL 812 AND 810 MANUFACTURED IN WITTEN, GERMANY.

ALOE VERA ACTIVE PRINCIPLE

MFGR OF LOW MOLECULAR WEIGHT DEXTRAN POWDER

NOT AN ASSIGNED NUMBER


IV

10/23/1962

FIRMENICH INC

FLAVOR FORMULAS

6/26/1964

CLORO-BAC PRODS INC

CHLORINE DIOXIDE; CHLORODOXINE X-2;AQUA-SAN CHLORINE DIOXIDE FORMULA.

6/19/1964

ANTIBIOTIC M-188(MACROLIDE ANTIBIOTIC OF THE ERYTHROMYCIN GROUP)

7/2/1964

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
NYSCO LABS INC

7/2/1964

NYSCO LABS INC

DEXTROMETHORPHAN HYDROBROMIDE (IN BULK TIME RELEASE PELLETIZED FORM)

7/21/1964

NYSCO LABS INC

METH & FACIL-T.R. CAP W/DEXTROMETHORPHAN,CHLORPHENIRAMINE&PHENYLEPHRIN

6/25/1964

STEPAN COMPANY

POLYGLYCEROLS & ESTERS OF FATY ACIDS

III

6/3/1963

SILGAN PLASTICS CORP

HIGH & LOW DENSITY POLYETHYLENE EPOXY RESIN FROMULATION #LA-16

9/9/1964

PARKE DAVIS DIV WARNER LAMBERT CO

METHODS, FACILS & CONTRLS

8/11/1964

RP SCHERER CORP

HARDSHELL GELATIN CAPS

9/3/1964

FEDERAL MAILING AND PACKAGING

METHODS, FACILITIES AND CONTROLS

PAPAVERINE HCL-TIME RELEASE PELLETS (BULK)

Page 23

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
830
I
II
8/27/1964
NYSCO LABS INC

SUBJECT
PAPAVERINE HCL-METHODS, FACIL,CONTRL-IN MFGR OF T.R. CAPS

831

8/21/1964

SANOFI CHIMIE

TRIMEPRIMINE(TRIMIPRAMINE-USAN)

832

8/19/1964

RHONE-POULENC

METHODS FACILS & CONTROLS --REGARDING MFGR OF RP 8599

833

8/7/1964

REYNAUD LTD

COUGH SYRUP FLAVOR R 446

834

8/13/1964

SCHUTZ & CO

MESO-INOSITOL HEXANICOTINATE

835

II

9/9/1964

SOLVAY DUPHAR BV

LACTULOSE SOLUTION

836

IV

9/14/1964

STEPAN COMPANY

VEGETABLE OIL 1400

837

IV

9/14/1964

STEPAN COMPANY

NEOBEE O

838

9/16/1964

LAWSON PACKAGING CORP

HANDLING & PACKAGING OF DRUG PRODS IN PHARMACEUTICAL PROGRAMS

839

9/14/1964

JT BAKER CHEMICAL CO

ETHYL DIBUNATE (PRODUCTION)

840

9/3/1964

HENKEL KGAA

DEPLASTOL

841

IV

8/28/1964

STEPAN COMPANY

AR 13026 AND AR 13027

842

IV

8/10/1964

HENKEL KGAA

NASUNA A AND NASUNA B

843

844

845

846

847
848

II

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER
9/30/1964

PFIZER LABS DIV CHAS PFIZER AND CO INC

ALTHIAZIDE

10/6/1964

INTERNATL CHEM & NUCLEAR PHARMS INC

CHROMIUM-51 (HIGH SPECIFIC ACTIVITY ISOTOPE)

10/1/1964

DRAGOCO INC

PUR-CELLIN OIL, DRAGOCO

10/15/1964

EI DUPONT DE NEMOURS AND CO

SCIENTIFIC PERSONNEL

849

6/30/1964

CHEMIRAD CORP

TRIETHYLENE MELAMINETEM

850

10/28/1964

MEADE THOMAS J

MARIV 240 (HIGH IODINE VALUE FISH OIL FRACT.)-S. AFRICAN PILCHARD OIL

851

10/30/1964

WYANDOTTE CHEMS CORP-ORIG

URETHANE LATEX E-204

852

11/25/1964

IRON-58 STERILE SOLUTION

853

11/23/1964

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
JT BAKER CHEMICAL CO

854

11/5/1964

HOSPIRA ASHLAND

FAULTLESS COMPOUNDS

855

11/19/1964

PARKE DAVIS & CO

PROCEDURES

856

12/15/1964

SUCROSE MONOPALMITATE

857

11/5/1964

COLONIAL SUGARS COMPANY SUCRO CHEMICAL


DIV
JT BAKER CHEMICAL CO

858

11/10/1964

3M PHARMS

MANUFACTURING AND CONTROL FACILITIES AND PERSONNEL

859

II

12/10/1964

WORTHINGTON BIOCHEM CORP

BETA LIVER FRACTION -B

860

6/26/1967

SCHUYLKILL CHEM CO

ALLANTOIN AND THE ALUMINUM ALLANTOINATES

861

12/22/1964

VAN DYK AND CO INC

CERAPHYL 28 (CETYL LACTATE)

862

12/16/1964

WHEATON SCIENTIFIC

GLASS MANUF. PROCEDURES

863

11/23/1964

ARCH CHEMICALS INC

ZINC OMADINE MANUFACTURED IN ROCHESTER NY

864

12/21/1964

PILLSBURY CO

POLYTETRAN (BRAND OF BETA-GLUCAN)

865

866

867

II

III
IV

II

CHLOROTRIANISENE

AZACYCLONOL HCL

NOT AN ASSIGNED NUMBER


II

12/2/1964

CHRISTIAN BRUNNENGRABER AND CO

METHOCARBAMOL

12/22/1964

SYNTEX SA

FLUMETHASONE

Page 24

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
868
I
II
1/14/1965
SYNTEX SA

SUBJECT
FLUMETHASONE ACETATE

869

1/14/1965

FINE ORGANICS INC

TEMASEPT III

870

1/5/1965

ROHM AND HAAS CO

RHOZYME 41 CONCENTRATE

871

872

1/7/1965

SCHIEFFELIN AND CO

FACILS, MFG, PROCESSING AND PACKAGING

873

2/15/1965

PFISTER CHEMICAL COMPANY INC

FLUOROPHENE

874

1/15/1990

STOCKHOLMS GUMMIINDUSTRI AB

RUBBER STOPPERS QUALITY 2213

875

9/24/1964

GARRETT LABS INC

BACITRACIN AEROSOL SPRAY

876

2/26/1965

MYERS-CARTER LABS INC

FACILS., CONTROLS AND PERSONNEL & PROCEDS.

877

2/24/1965

MANUFACTURING AND CONTROL FOR PRODUCTION OF MEPROBAMATE

878

3/2/1965

PHILADELPHIA LABS INC DIV PHILA PHARMS AND


COSMETICS INC
DAY BALDWIN INC

879

3/15/1965

QUADRA INC

RUBBER FORMULATIONS

880

3/5/1965

PACKAGING COMPONENTS INC

METHODS, CONTROLS AND FACILITIES

881

1/2/1965

CAMBREX PROFARMACO MILANO SRL

HYDROCHLOROTHIAZIDE MANUFACTURED IN MILAN, ITALY.

882

3/8/1965

BF GOODRICH COMPANY

CARBOSET RESINS

883

3/18/1965

CAMBREX PROFARMACO MILANO SRL

CHLOROTHIAZIDE

884

3/31/1965

US PUBLIC HEALTH SERV

INVESTIGATOR INFO

885

3/29/1965

LYONDELLBASELL INDUSTRIES

POLYMERS FOR USE IN PACKAGING

886

4/19/1965

INOLEX CHEMICAL CO

METHODS, FACILS & CONTROLS

887

4/19/1965

CROWN ZELLERBACH CORP

DIMETHYL SULFOXIDE(DMSO)FACILITIES AND CONTROLS

888

4/29/1965

NYSCO LABS INC

FACILITIES AND CONTROLS

889

5/6/1965

SHELL CHEM CO

HUMAN STUDIES FOR NEW DRUGS

890

5/6/1965

SHELL CHEM CO

INVESTIGATORS FOR HUMAN STUDIES

891

5/6/1965

SHELL CHEM CO

FACILITIES-GENERAL MFGR PROTOCOL AND RAW MATERIAL CONTROLS

892

5/12/1965

RHODIA INC

RP 9965

893

5/13/1965

ER SQUIBB AND SONS INC

SILICONE FLUIDS

894

5/17/1965

NYSCO LABS INC

DIPHENHYDRAMINE HCL -PELLETS

895

6/1/1965

GEIGY CHEM CORP

IRGASAN CH 3549

896

II

6/10/1965

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

PETN - BUTABARBITAL

897

IV

6/9/1965

HENKEL KGAA

DEHYMULS E AND DEHYMULS K

898

6/9/1965

MILAN PHARMACEUTICALS INC

MEPROBAMATE TABLETS

899

6/24/1965

MURRAY RODERICK MD

IND LISTING DIV. OF BIOLOGICS STANDARDS

900

III

7/19/1965

AMERICAN NATIONAL CAN CO

POLYOLEFIN PRODUCTS (C-70 SERIES)

901

II

7/22/1965

ORGANON INC

MESTRANOL

902

7/29/1965

P-L BIOCHEMS INC

DIPHOSPHOPYRIDINE NUCLEOTIDE (DPN)

903

8/13/1965

MEPROBAMATE POWDER-WITH TRACER

904

8/24/1965

WALLACE LABORATORIES DIV CARTER WALLACE


INC
DOW CHEMICAL CO MICHIGAN DIV

905

8/23/1965

GD SEARLE AND CO

METHODS, FACILITIES & CONTROLS

NOT AN ASSIGNED NUMBER

II

III
II
II
III
I

IV

FACILITIES AND PERSONNEL

TEFLURANE

Page 25

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
906
I
IV
8/23/1965
HENKEL KGAA

SUBJECT
DEHYDAG-PRODUCTS1. DEHYDAG WAX O

907

8/25/1965

PACIFIC BIOCHEM INC

METHODS & FACILITIES

908

II

8/28/1965

SYNTEX SA

DIMETHISTERONE

909

IV

9/2/1965

UNGERER AND CO

COMPOUND FLAVOR #5218

910

9/2/1965

CONNAUGHT MED RES LABS

PHENOXALID(COMPOUND #377)

911

9/2/1965

JUNICE LABS INC

PROMETHAZINE HYDROCHLORIDE U.S.P. (MANUF. & SPECIFICATIONS)

912

7/6/1965

MANUFACTUER PROCEDURES

913

9/7/1965

FIRST TEXAS PHARMACEUTICALS INC SUB


SCHERER LABS INC
JUNICE LABS INC

914

9/15/1965

PHARMA-RES CANADA LTD

FLOOR PLAN ---- EQUIPMENT ---- PERSONNEL

915

9/10/1965

KLINE NATHAN S MD

RESEARCH INFORMATION

916

9/24/1965

CIBA CORP

TRICLOSAN TOXICOLOGY INFORMATION

917

9/24/1965

CROWN ZELLERBACH CORP

TRICHLOROLEVULINIC ACID (TCLA) IN POLYETHYLENE LINED CONTAINERS

918

10/11/1965

COMPOUND 904

919

11/9/1965

WINTHROP PHARMACEUTICALS DIV STERLING


DRUG INC
PARKE DAVIS & CO

920

11/17/1965

STIEFEL LABORATORIES INC

SULFOXYL

921

11/13/1965

CARRON PRODUCTS CO

342 RED NATURAL RUBBER COMPOUNDS AND P & H COATING

922

11/15/1965

SB PENICK AND CO ORIG

QUERCETIN

923

11/23/1965

OWENS ILLINOIS INC

PROJECT NO. 84258 EXTRACTION STUDIES FROM TIN OXIDE COATED BOTTLES

924

11/30/1965

BROCKWAY GLASS CO INC

THE CHEMICAL DURABILITY OF F-GLASS

925

11/24/1965

EJ TRUM INC

PACKAGING CARTON MANUFACTURING MAILING

926

12/8/1965

NORTON CO

HISTORY AND PROCEDURES

927

II

12/8/1965

EURAND AMERICA INC

ENCAPSULATION

928

12/9/1965

BOEHRINGER MANNHEIM GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

929

12/9/1965

PCM CORP

PACKAGING METHODS AND FACILITIES

930

12/3/1965

CUSTOM PACKAGING

OPERATION AND PROCEDURE

931

III

12/15/1965

HOSPIRA INC

PLIA-LITER (TM) BAGS

932

IV

12/16/1965

WR GRACE

SYLOID - SILICA PRODUCTS (SILICA GEL)

933

II

12/27/1965

ELI LILLY AND CO

AMPOULES SODIUM THIOCYANATE, INJECTION COMPOUND #23206

934

II

12/8/1965

935

1/11/1966

AYERST LABORATORIES INC DIV AMERICAN HOME PREMARIN (CONJUGATED ESTROGENS-EQUINE)


PRODUCTS CORP
FINE ORGANICS INC
TEMASEPT IV

936

1/26/1966

BERLIN LABS INC

DMSO INFORMATION

937

2/1/1966

TUBED CHEMICALS CORP

FACILITIES & CONTROLS

938

2/4/1966

EI DUPONT DE NEMOURS AND CO

POLYETHYLENE FILM TYPE A-101 (DRUG PACKAGING) AND MYLAR POLYESTER FILM

939

2/11/1966

DIAMOND ALKALI CO

CP 519-2 POLYVINYL CHLORIDE RESINPOLYVINYL CHLORIDE RESIN, CP 519-2

940

2/21/1966

VYPAK CORP

P-2, P-6 & P-7 POLYVINYL CHLORIDE COMPOUNDS

941

2/17/1966

CLARK ONIELL INC

ASSEMBLING AND MAILING OF DRUG SAMPLE AND LITERAURE

II

III

CHLORPROMAZINE HYDROCHLORIDE U.S.P.

GYNECOLOGY BOOK

Page 26

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
942
I
I
2/28/1966
ARMSTRONG LABORATORIES INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN WEST ROXBURY, MASSACHUSETTS.
PRESERVAIVE C

943

2/28/1966

HENKEL KGAA

944

2/25/1966

INVESTIGATIONAL NEWN DRUG LISTINGS

945

3/11/1966

WARNER LAMBERT CO PHARMACEUTICAL


RESEARCH DIVISION
HUMBLE OIL AND REFINING CO

946

10/28/1965

GUARDIAN CHEMICAL CORP

SURTENOL

947

2/2/1966

STANDARD AROMATICS INC

IMITATION FLAVOR

948

3/16/1966

ROBIN PHARMACAL CORP-ORIG

MANUFACTURING AND PROCEDURES

949

3/18/1966

DOW CHEMICAL CO MICHIGAN DIV

ETHOXYLATED POLYETHYLENIMINE, MONTREK600E

950

3/15/1966

CF BOEHRING AND SOEHNE GMBH

NICOTINAMIDE-ADENINE-DINUCLEOTIDENADDPN

951

3/30/1966

RHODIA INC

CLOREXOLONE

952

III

4/6/1966

KLOCKNER PENTAPLAST OF AMERICA INC

GENOTHERM TYPE PVC FILMS

953

III

4/1/1966

CP HALL CO

PARAPLEX G-50(THIS FORMERLY HELD BY ROHM AND HAAS CO)

954

1/6/1966

NATL INST HLTH CLINCL CTR PHARMACY

LISTING ----DIV BIOLOGICS NOTICES (IND'S)

955

4/19/1966

FISONS PHARM LTD

LOMODEX (DEXTRAN 40 INJECTION)

956

4/19/1966

TRI X CORP

FACILITIES AND CONTROLS

957

4/22/1966

ER SQUIBB AND SONS INC

FACILITIES AND CONTROLSPERSONNEL FOR MANUFACTURE AND CONTROL

958

4/26/1966

SYNTEX (USA) INC

FACILITIES AND CONTROLS

959

5/6/1966

GANES CHEMICALS INC

EBNZOMETHAMINE CHLORIDE

960

5/11/1966

JT BAKER CHEMICAL CO

CLOMIPHENE CITRATE

961

5/11/1966

FISHER STEVENS

DESCRIPTION OF FACILITIESPROCEDURESCONTROLSPERSONNEL

962

5/13/1966

INTRA PRODS DIV DURR PRODS

CONTROLS AND FACILITIES

963

5/5/1966

CALGON CORP DIV MERCK & COMPANY INC

BIOCHEK 60

964

5/13/1966

SCHERING AG

MESTRANOL

965

6/7/1966

NORTH AMERICAN PHILIPS CO INC

MEBEVERINE HYDROCHLORIDE

966

6/6/1966

MILES PHARMACEUTICAL DIV MILES INC

CURRICULUM VITAE (PERSONNEL)

967

12/21/1965

COLORCON INC

POLYVINYL ACETATE PHTHALATE

968

6/20/1966

DAVIS-EDWARDS PHARMACAL CORP

METHODS, FACILITIES, CONTROLS AND PACKAGING OF DRUGS

969

6/22/1966

ER SQUIBB AND SONS INC

SUMMARIES OF THE BACKGROUND & QUALIFICATION OF INVEST & MONITORS

970

6/23/1966

DOW CORNING CORP

DOW CORNING (R) 555 FLUID

971

6/27/1966

AMERICAN CYANAMID CO

CYTOX (R) 2013 DODECYLGUANIDINE HYDROCHLORIDE

972

6/27/1966

ARMOUR PHARMACEUTICAL CO

LYOSZYME

973

6/22/1966

HENKEL KGAA

TEXAMID S 058 AND CUTINA OR

974

6/28/1966

SHELTERED EMPLOYMENT SERVICES INC

FACILITIES, CONTROLS AND PROCEDURES

975

II

7/6/1966

RHODIA INC

PENTAMIDINE ISETHIONATE

976

II

7/11/1966

ATOMIC ENERGY OF CANADA LTD

RADIOISOTOPE MASTER FILE

977

III

7/1/1966

BAXTER HEALTHCARE CORP

POLYVINYL CHLORIDE PLASTIC (PL-146)

978

II

7/13/1966

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

NITROGLYCERIN

979

III

7/12/1966

HELVOET PHARMA

FORMULAS AND INGREDIENTS

IV

II

IV
I

ISOPAR

Page 27

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
980
I
IV
7/16/1966
SHIONOGI QUALICAPS INC

SUBJECT
FORMULA INDENTIFICATION CODE--IDENTI-CODE INDEX

981

982

983

984

III

985

986

987

988

989

990
991
992

993

9/15/1966

BECTON DICKINSON AND CO

PARENTOPAK PHARMACEUTICAL SYRINGE

994

9/22/1966

HENKEL KGAA

EDENOL BS (STEARIC ACID BUTYL ESTER)

995

9/7/1966

PACKAGING FACILITIES AND CONTROLS

996

8/22/1966

IVERS-LEE MIDWEST CO INC DIV BECTONDICKINSON AND CO


HENKEL KGAA

997

9/20/1966

LEMMON CO

FACILITIES, EQUIPMENT AND CONTROLS

998

9/21/1966

MALLINCKRODT INC

FACILITIES, PROCEDURES AND PERSONNEL

999

9/14/1966

EJ TRUM INC

FACILITIES AND CONTROLS

1000

9/15/1966

GENERAL FOODS CORP

MONSODIUM DIHYDROGEN PHOSPHATE

1001

9/16/1966

SLOAN-KETTERING INST CANCER RES

CLINICAL INVESTIGATORS FILE.

1002

10/13/1966

NYSCO LABS INC

PSEUDOEPHEDRINE HCL TIMED RELEASE PELLETS

1003

10/19/1966

NYSCO LABS INC

PHENOBARBITAL TIMED RELEASE PELLETS

1004

10/21/1966

TROPONWERKE GMBH CO KG

METHAQUALONE BASE AND HCL

1005

10/28/1966

SCHERING CORP SUB SCHERING PLOUGH CORP

THIHEXINOL METHYLBROMIDE

1006

11/4/1966

NYSCO LABS INC

PAVABID-PB TIMED RELEASE CAPSULES

1007

11/1/1966

HOFFMANN LA ROCHE INC

COMPOSITION & MFGR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307

1008

10/31/1966

HENKEL CORP

GELVA? MULTIPOLYMER RESIN EMULSIONS (GME)

1009

11/10/1966

BARR-STALFORT DIV PITTWAY CORP

AEROSOL PRODUCTION OPERATIONS

1010

5/20/1965

COLONIAL SUGAR REFINING CO LTD

CLINICAL TESTING OF ANTI-CARIES AGENTS

1011

11/21/1966

HENKEL KGAA

FATY ACIDS

1012

11/18/1966

DRUG & ALLIED PRODUCTS GUILD INC

EFFECTIVENESS OF ANTIBIOTIC DRUGS

1013

12/13/1966

DOWNINGTON PAPER CO

PROCEDURE FOR CONTRACT PACKAGING OF DRUGS

1014

12/14/1966

ER SQUIBB AND SONS INC

PATIENT STARTER PACKAGES

1015

II

12/2/1966

SCHERING AG

AMIDOTRIZOIC ACID(UROGRAFIN ACID)

1016

III

12/14/1966

CHEVRON PHILLIPS CHEMICAL CO LP

MARLEX RESINS-POLYOLEFINS FOR DRUG PACKAGING USE

1017

12/22/1966

GENERAL ANILINE AND FILM CORP

UVINUL N-539

7/22/1966

LABORATORIES GLAXO EVANS

CARRAGRRIN DERIVAIVE C.16

7/25/1966

MARION LABORATORIES INC

FACILITIES AND CONTROLS

8/1/1966

PHARMACIA FINE CHEMS

DEAE-SEPHADEX (C-800 074)

8/10/1966

REYNOLDS PACKAGING LLC

FOIL-VINYL SPECIFICATION

II

8/15/1966

NYSCO LABS INC

BROMODIPHENHYDRAMINE HYDROCHLORIDE

III

8/29/1966

VCF PACKAGING FILMS INC

CAST VINYL FILMS C-102 & C-105 FORMERLY HELD BY CADILLAC PLASTIC)

2/11/1966

SERUMWERK BASEL AG

TOQUILONE COMPOSITUM

9/14/1966

ALCON LABORATORIES INC

FACILITIES AND CONTROLS

8/25/1966

HOSPIRA

STERILE MANUFACTURING FACILITY IN CLAYTON NC

III

10/1/1966

HOFFMANN LA ROCHE INC

PACKAGING MATERIALS

9/3/1966

HOFFMANN LA ROCHE INC

RAW MATERIAL

NOT AN ASSIGNED NUMBER


III

V
II

II
III

LUBRICANTS FOR PLASTICS

Page 28

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1018 I
IV
1/5/1967
ICI AMERICAS INC
1019

1020

1021

1022

1023

1024

1025

1026

1027

SUBJECT
PGAC-112(THIS FORMERLY HELD BY CHATEM CHEMICALS)

1/5/1967

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP ORISUL TABS, SUSPENSION & SUSPENSION FOR CHILDREN

1/13/1967

GEIGY CO SA

FACILITIES AND PERSONNEL CONTROL OPERATIONS,MANUFACTURING OPERATIONS

1/12/1967

NYSCO LABS INC

ISOSORBIDE DINITRATE TIMED RELEASE PELLETS

1/19/1967

CHAS PFIZER AND CO INC

METAMINE

1/16/1967

OXYVINYLS LP

POLYVINYL CHLORIDE

12/6/1966

MURRAY E CORN ASSOC INC

TETRACYCLINE HCL S.R.

II

1/31/1967

VPI MIRREX CORP

RP 16,091 (10-METHYL-2-PHENOTHIAZINYL) ACETIC ACID

II

2/1/1967

ICI AMERICAS INC

STANDARD DRUG MIXTURE NO. 23 (20% PETN)

2/2/1967

GENERAL ATOMIC

ISOTOPE RESEARCH PROGRAM

1028

2/6/1967

FLUORITAB CORP

DURABONE #5 TABLETS (11.25MG. SODIUMFLUORIDE)

1029

2/6/1967

FLUORITAB CORP

DURABONE #10 (22.5MG SODIUM FLUORIDE) TABLETS

1030

2/6/1967

FLUORITAB CORP

DURABONE # 25 (56.25MG SODIUM FLUORIDE) TABLETS

1031

2/6/1967

P-L BIOCHEMS INC

TRIFLUOROTHYMIDINE (F3TDR), FACILITIES AND CONTROLS

1032

2/9/1967

MICRO CHEMS LTD

MEPROBAMATE N.F.

1033

3/10/1966

ER SQUIBB AND SONS INC

LISTING OF INDS

1034

2/16/1967

KAROLINSKA INST

CHOLECYSTOKININ-PANCREOZYMIN --CCK-PZ

1035

2/16/1967

CHATTEM DRUG & CHEMICAL COMPANY

ALUMINUM CHLORHYDROXIDE COMPLEX ACH-TYPE A-23

1036

2/2/1967

PARKE DAVIS & CO

BENADRYL POWDER

1037

3/1/1967

HOFFMANN LA ROCHE INC

PROTAMINE HCL, RO 6-1588/1

1038

IV

3/7/1967

UNKNOWN

STANDARD DRUG MIXTURE NO. 24 (10% PETN-LACTOSE MIXTURE)

1039

II

3/9/1967

NAFTONE INC

6-AMINOCAPROIC ACID

1040

II

3/7/1967

ATLAS CHEMICAL INDUSTRIES INC

STANDARD DRUG MIXTURE NO. 16 (10% NITROGLYCERIN-LACTOSE MIXTURE)

1041

3/15/1967

VALE CHEMICAL COMPANY INC

FACILITIES, METHODS AND PERSONNEL

1042

3/17/1967

MONSANTO COMPANY

POLYVINYL CHLORIDE CONTAINERS

1043

3/27/1967

OLIN MATHIESON CHEM CORP

SODIUM OMADINE

1044

3/29/1967

SPECTRASORB UV 531

1045

3/28/1967

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
FINE ORGANICS INC

1046

3/27/1967

PHILLIPS PETROLEUM CO

MARLEX 0202 POLYOLEFIN RESIN

1047

III

3/31/1967

LILLY RESEARCH LABORATORIES

POLYVINYL CHLORIDE CONTAINERS

1048

II

3/24/1967

GANES CHEMICALS INC

BUTABARBITAL

1049

II

3/21/1967

SIEGFRIED USA LLC

PHENOBARBITAL AND PHENOBARBITAL SODIUM USP AS MANUFACTURED IN PENNSVILLE, NJ

1050

II

3/22/1967

SIEGFRIED USA LLC

SECOBARBITAL SODIUM USP

1051

II

3/23/1967

SIEGFRIED USA LLC

AMOBARBITAL SODIUM USP

1052

4/3/1967

DOW CHEMICAL CO MICHIGAN DIV

UNS-TETRAFLUOROETHANE

1053

4/17/1967

CHATTEM DRUG & CHEMICAL COMPANY

ALUMINUM CHLORHYDROXIDE COMPLEX, TYPE A-34

1054

4/21/1967

FUJISAWA PHARMACEUTICAL COMPANY LTD

SYNTHESIS OF PYRROINITRIN

II
III

II

ALLANTOIN

Page 29

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1055 I
4/25/1967
FRANK H FLEER CORP

SUBJECT
CHEWING GUM COMPOUND

1056

4/26/1967

MACLIN CO

MACLIN COMPOUND VM-1921---POLYVINYL CHLORIDE ACETATE

1057

5/2/1967

DICHLOROMETHOTREXATE

1058

5/2/1967

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
ALLIED CHEM CORP

1059

II

5/10/1967

MICRO CHEMS LTD

HYDROCHLOROTHIAZIDE USP

1060

III

5/2/1967

KLOCKNER PENTAPLAST OF AMERICA INC

MIRREX MCFD RIGID VINYL SHEET.PRODS

1061

5/2/1967

ALLIED CHEM CORP

X-2002M PVC BOTTLE BLOWING RESIN

1062

5/19/1967

SYNTEX CORP

FREEPORT FACILITIES

1063

II

5/29/1967

CALBIOCHEM-BEHRING CORP

DOPAMINE HCL

1064

6/6/1967

FERRING AB

ACTH

1065

II

6/21/1967

ICI PHARMA

STANDARD DRUG MIXTURE NO. 22

1066

6/21/1967

SYNTEX CHEMICALS INC

GENERAL MASTER FILE (THIS FORMERLY ARAPAHOE CHEMICALS, INC)

1067

II

6/29/1967

ARAPAHOE CHEMS INC DIV SYNTEX LABS INC

DIMETHYL SULFOXIDE

1068

5/6/1967

WINGENROTH LEONORA

JOST STERILE PACK AND PROCESS

1069

7/17/1967

MILES INC

METHOXYPHENAMINE HCL

1070

6/22/1967

IMPERIAL CHEMICAL INDUSTRIES PLC

COOMASSIE BLUE

1071

7/19/1967

PURDUE FREDERICK CO

CLINICAL INVESTIGATORS

1072

7/26/1967

EI DUPONT DE NEMOURS AND CO

SR-87M GENERATORS

1073

8/4/1967

INDOPOL POLYBUTENES

1074

AMOCO CHEMS CORP AFFILIATE AMERICAN OIL


CO
SOLVAY PHARMACEUTICALS

1075

NEOCARZINOSTAIN

1076

II

8/15/1967

BRISTOL LABORATORIES INC DIV BRISTOL MYERS


CO
AJINOMOTO CO INC

1077

II

8/25/1967

ER SQUIBB AND SONS INC

MANUFACTURE OF HYDROXYUREA

1078

8/28/1967

NORWICH PHARMACAL CO

MANUFACTURING AND QUALITY CONTROL

1079

9/6/1967

NYSCO LABS INC

DEXTRO-AMPHETAMINE SULFATE

1080

9/7/1967

PHARMACEUTICAL FLAVORS

1081

9/6/1967

PHARMACEUTICAL FLAVOR CLINIC DIV OF FOOTE


& JENKS
BILCARE RESEARCH GMBH

1082

9/15/1967

NYSCO LABS INC

PENITE TIMED RELEASE CAPSULES

1083

II

9/25/1967

SYNTEX USA INC

RESEARCH STEROIDS

1084

II

9/13/1967

SYNTEX USA INC

NORETHINDRONE ACETATE

1085

10/4/1967

AMERICAN CYANAMID CO

CONSUMER PRODUCTS DIVISION

1086

10/6/1967

PURDUE FREDERICK CO

MANUFACTURE AND CONTROL OPERATIONS

1087

10/18/1967

RICHARDSON-MERRELL INC

DIETHYLPROPION HCL

1088

10/17/1967

RICHARDSON-MERRELL INC

DIETHYLPROPION HCL WITH TARTARIC ACID

1089

10/17/1967

MEPROBAMATE

1090

10/19/1967

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
NYSCO LABS INC

II

II

6/27/1967
8/7/1967

III

CP 014 COPOLYMER

MANUFACTURING CONTROL INFORMATION FOR--LITHIUM CARBONATE

AMINO ACID PRODUCTS

PVC FILM MANUFACTURED IN SCHLOSSMATENSTRASSE 2, GERMANY.

BUTA-PENITE TIMED RELEASE CAPSULES

Page 30

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1091 I
10/23/1967
VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

SUBJECT
PETN 80MG SUSTAINED RELEASE CAPSULES

1092

1093

1094
1095

10/24/1967

CENTURY PACKAGING CORP

PACKAGING FACILITIES AND CONTROLS

10/25/1967

SCHERING AG

ESTRADIOL ENANTHATE

10/27/1967

CHEMDEX INC

IRON HY-DEX HUMAN USE

11/2/1967

SF DURST AND CO INC

DEXAMETHASONE

1096

11/8/1967

DELAWARE CITY PLASTICS CORP

DIAMOND PVC-500 RESIN

1097

II

11/9/1967

UNITED STATES DEPARTMENT ENERGY

TIN-113/INDIUM-113M (FORMERLY HELD BY UNION CARBIDE CORP)

1098

IV

11/17/1967

ER SQUIBB AND SONS INC

PLASTIBASE (SQUIBB PLASTICIZED HYDROCARBON GEL)

1099

III

11/24/1967

HERCULES INC

STAYBELITE RESIN

1100

11/27/1967

STANDARD PHARMACAL CORP

MANUFACTURING FACILITIES AND CONTROLS

1101

III

9/11/1967

PECHINEY PLASTIC PACKAGING INC

PACKAGING FILMS

1102

11/30/1967

RICHLYN LABORATORIES INC

FACILITIES, PERSONNEL AND CONTROLS IN CONNECTION WITH NEW DRUGS

1103

12/1/1967

PHILLIPS FILMS COMPANY INC

ELASTOTHERM F. FILM

1104

12/6/1967

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DRISTAN CAPSULES

1105

12/8/1967

1106

12/11/1967

AYERST LABORATORIES INC DIV AMERICAN HOME CF-100 OINTMENT


PRODUCTS CORP
CONTINENTAL CAN COMPANY
104 CLS CAN ENAMEL

1107

12/11/1967

1108

1109
1110
1111

1112

1113

1114

1115

1116
1117

II

II

ETHYL PHENYLUNDECYLATE (EASTMAN 7045)

12/15/1967

DISTILLATION PROD INDS DIV EASTMAN KODAK


CO
DAVIES ROSE HOYT PHARM DIV KENDALL CO

12/18/1967

TENNESSEE EASTMAN CO-ORIG

METHYL 2-CYANOACRYLATE

12/18/1967

SCHERING AG

DROXONE

12/12/1967

INTERNATIONAL FLAVORS AND FRAGRANCES INC

FLAVORS AS MANUFACTURED IN THE EMERSON, NEW JERSEY FACILITY.

12/20/1967

VALSPAR CORP

MOBILE PACKAGING COATING FORMULATION S-988-025

12/20/1967

VALSPAR CORP

MOBILE PACKAGING COATING FORMULATION S-7007-006

1/2/1968

CHATTEM DRUG & CHEMICAL COMPANY

ALUMINUM CHLORHYDROXIDE COMPLEX

IV

12/28/1967

EVONIK CORP

AEROSIL

II

1/2/1968

UNITED STATES DEPARTMENT ENERGY

CESIUM-131 (FORMERLY HELD BY UNION CARBIDE CORP)

II

1/18/1967

UNITED STATES DEPARTMENT ENERGY

MERCURY-197 (FORMERLY HELD BY UNION CARBIDE CORP)

1118

II

12/18/1967

UNITED STATES DEPARTMENT ENERGY

MERCURY-203 (FORMERLY HELD BY UNION CARBIDE CORP)

1119

II

1/3/1968

U.S. DEPARTMENT OF ENERGY

IODINE-123 (FORMERLY HELD BY UNION CARBIDE CORP)

1120

1/4/1968

REYNAUD LTD

REYNO CLOUD

1121

1/5/1968

1122

II

1/17/1968

GLENBROOK LABORATORIES DIV STERLING DRUG GENERAL DESCRIPTION OF FACILITIES, MANUFACTURING AND CONTROLS
INC
UNITED STATES DEPARTMENT ENERGY
MOLYBDENUM-99-P-2 (FORMERLY HELD BY UNION CARBIDE CORP)

1123

II

1/17/1968

UNITED STATES DEPARTMENT ENERGY

MOLYBDENUM-99-P-1 (FORMERLY HELD BY UNION CARBIDE CORP)

1124

II

1/17/1968

U.S. DEPARTMENT OF ENERGY

PHOSPHORUS-32 (FORMERLY HELD BY UNION CARBIDE CORP)

1125

1/10/1968

HEXAGON LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

1126

1/15/1968

EI DUPONT DE NEMOURS AND CO

IN-113M GENERATORS

IV
III

MANUFACTURING, PACKAGING AND CONTROL PROCEDURES

Page 31

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1127 I
1/15/1968
CILAG CHEMIE AG

SUBJECT
3-AMINOOPROPIONITRILE FUMARATE

1128

1/16/1968

ROUSSEL CORPORATION

MAHAQUALONE

1129

1/18/1968

WARNER CHILCOTT DIV WARNER LAMBERT CO

SPECIAL MATERIALS

1130

1/22/1968

HOECHST CELANESE CORP

BLOOD PLASMA TUBES TYPE BLU 1 AND TF70

1131

II

1/25/1968

TROJAN POWDER CO

PENTAERYTHRITOL TETRANITRATE (PETN)

1132

II

1/24/1968

UNITED STATES DEPARTMENT ENERGY

CHROMIUM-51 (FORMERLY HELD BY UNION CARBIDE CORP)

1133

II

1/24/1968

MALLINCKRODT INC

DIARIZOIC ACID

1134

1/31/1968

AMERICAN CYANAMID CO

VITAMIN B 12 WITH INTRINSIC CONCENTRATE

1135

II

1/30/1968

UNITED STATES DEPARTMENT ENERGY

STRONTIUM-85 (FORMERLY HELD BY UNION CARBIDE CORP)

1136

II

2/1/1968

UNITED STATES DEPARTMENT ENERGY

IRON-59 (FORMERLY HELD BY UNION CARBIDE CORP)

1137

II

1/30/1968

U.S. DEPARTMENT OF ENERGY

IODINE-131 (FORMERLY HELD BY UNION CARBIDE CORP)

1138

II

2/2/1968

INTERNATL CHEM & NUCLEAR PHARMS INC

5-FLUOROURACIL

1139

2/5/1968

SCHWARTZ MANN

TRITURATED THYMIDINE IN STERILE PYROGEN-FREE SOLUTION

1140

2/1/1968

QUALIFICATIONS OF RESEARCH PERSONNEL

1141

III

2/9/1968

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
VALSPAR CORP

1142

II

2/9/1968

DBI INC

DEXAMETHASONE ACETATE

1143

2/14/1968

NEPERA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1144

2/16/1968

MONSANTO COMPANY

ETHANE-1-HYDROXY-1,1-DIHOSPHONIC ACID DISODIUM SALT

1145

2/8/1968

DEWEY AND ALMY CHEM DIV WR GRACE AND CO

DAREX CAN SEALING COMPOUND

1146

1147

3/5/1968

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

PENTRITOL (PENTAERYTHRITOL TETRABUTRATE) TEMPULES 30MG C.R.C

1148

3/7/1968

UNION CARBIDE CORPORATION

BAKELITE BRAND VGAB-0613 NATURAL 7 VINYL SHEET

1149

3/7/1968

UNION CARBIDE CORPORATION

BAKELITE BRAND VGAB-0607 NATURAL 7 VINYL SHEET

1150

3/8/1968

GENERAL ELECTRIC CO

MOLYBDENUM-99

1151

3/8/1968

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1152

II

3/11/1968

UNITED STATES DEPARTMENT ENERGY

MOLYBDENUM-99-P-3 (FORMERLY HELD BY UNION CARBIDE CORP)

1153

3/11/1968

HARTE & COMPANY INC

PVC RESIN COMPOUNDS

1154

3/15/1968

PHARMACAPS INC

METHODS, FACILITIES AND CONTROLS

1155

3/8/1968

GENERAL ELECTRIC CO

MERCURY-197

1156

III

2/28/1968

AMCOR FLEXIBLES INC

METALAM AND MARAFLEX 7F-452

1157

3/21/1968

STRIP-PACK CO

MANUFACTURE & CONTROL PROCEDURES FOR PACKAGING

1158

3/7/1968

KIMBERLY CLARK CORP

KIMFOL BRAND POLYCARBONATE FILM

1159

3/29/1968

METHODS, FACILITIES AND CONTROLS

1160

3/26/1968

WARNER LAMBERT CO PHARMACEUTICAL


RESEARCH DIVISION
NAPP CHEMICALS INC

1161

4/8/1968

NYSCO LABS INC

SODIUM FLUORIDE TIMED RELEASE CAPSULES

1162

4/8/1968

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

MFG, PROCESS & PACK. OF DIMEHYDRINATE S.R.C.

III

CONTAINER COATING, PRE-STRIPS GOLD ENAMEL (#563-803)

NOT AN ASSIGNED NUMBER

MANUFACTURING PROCEDURES AND CONTROLS

Page 32

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1163 I
4/10/1968
RHODIA INC

SUBJECT
DICHLOROPHEN (ANTHIPEN)

1164

4/1/1968

RHODIA INC

S.D. IMITATION CREME DE MENTHE FLAVOR RF 1487 (CODE 1201487)

1165

4/18/1968

GANES CHEMICALS INC

MANUFACTURE OF SODIUM BARBITAL

1166

4/9/1968

SIEGFRIED USA LLC

BUTALBITAL USP

1167

1168

1169

1170

1171

4/17/1968

GANES CHEMICALS, INC., PENNSVILLE DIVISION

MFG. PACKAGING AND ANALYSIS OF SODIUM PHENOBARBITAL

1172

4/22/1968

BROWN CO

SOLKA FLOCS

1173

4/24/1968

PHYTOGEN PRODS INC

FACILITIES, PERSONNEL AND PROCESS

1174

4/24/1968

PHYTOGEN PRODS INC

IDENTIFICATION, ASSAY & SPECIFICATION FOR MESTRANOL

1175

4/24/1968

PHYTOGEN PRODS INC

IDENTIFICATION, ASSAY & SPECIFICATION FOR DIMETHISTERONE

1176

4/24/1968

TROPONWERKE GMBH CO KG

D714

1177

5/6/1968

RHODIA INC

MFG. ANALYTICAL SPECS. & METHODS OF ANALYSIS FOR MEL B (ARSOBAL)

1178

5/6/1968

RHODIA INC

POT. MELARSONYL-MEL W (TRIMELARSAN)-MFG, SPECS, & METH. OF ANALYSIS

1179

4/24/1968

CP HALL CO

METH. FACILS. & CONTROL-IN MFG TETRAMETHYL SUCCINAMIDE (TMS) & ANALOGS

1180

III

5/8/1968

KRATON POLYMERS US LLC

KRATON FG1924, G1657 MS & G1660 HU

1181

IV

5/9/1968

STEPAN COMPANY

NEOBEE M 20

1182

II

5/13/1968

KAY-FRIES CHEMS

ADENINE

1183

II

5/7/1968

FISONS LTD

MANUFACTURE OF DEXTRAN 40 POWDER

1184

II

5/7/1968

FISONS LTD

MANUFACTURE OF DEXTRAN 70 POWDER

1185

5/13/1968

EI DUPONT DE NEMOURS AND CO

PRODUCTION PROCEDURE FOR GA-68 GENERATORS

1186

III

5/10/1968

EXXONMOBIL CHEMICAL CO

PLASKON-HIGH DENSITY POLYETHYLENE RESINS--PAXON

1187

5/13/1968

TRAVENOL LABORATORIES INC

MANUFACTURE, CONTROLS & PACKAGING OF ELLIOTT'S SOLUTION

1188

5/20/1968

UNION CARBIDE CORPORATION

BAKELITE BRAND POLYETHYLENE RESIN DMD-5130 NATURAL 7

1189

5/20/1968

UNION CARBIDE CORPORATION

BAKELITE BRAND POLYETHYLENE RESIN DMD-5140 NATURAL 7

1190

5/24/1968

LYNE LABORATORIES INC

LITHIUM CARBONATE TABLETS

1191

5/29/1968

AMERICAN CYANAMID CO

SALICYLAZOSULFAPYRIDINE

1192

6/3/1968

RETINOIC ACID (EASTMAN 8098)

1193

5/31/1968

DISTILLATION PROD INDS DIV EASTMAN KODAK


CO
EISAI CO LTD

1194

III

6/12/1968

BF GOODRICH CHEM CO

GEON 85542 (POLYVINYL CHL RESIN)

1195

IV

6/17/1968

JRS PHARMA LP

SUGAR PRODUCT TO BE USED AS A NON-ACTIVE INGREDIENT BY TABLET DRUG

1196

6/18/1968

UNION CARBIDE CORPORATION

BAKELITE' BRAND VINYL SHEET VGA-0403 NATURAL 7 AND CLEAR 1007

1197

6/19/1968

UNION CARBIDE CORPORATION

BAKELITE' BRAND DMDB-4300 NATURAL 7 POLYETHYLENE RESIN

1198

6/20/1968

RHODIA INC

RHODIA FLAVOR RF-1698 (IMITATION PINEAPPLE FLAVOR)

1199

IV

6/24/1968

HENKEL KGAA

DEHYDOPLAST

1200

II

7/5/1968

VICTOR M HERMELIN AND CO DIV KV PHARMACAL PENTRITOL (PENTAERYTHRITOL TETRANITRATE) TEMPULES 60MG CONT RLSE CAPSL
CO

II

NOT AN ASSIGNED NUMBER


II

4/8/1968

VIVONEX AND CO

VIVONEX-100

4/19/1968

SIEGFRIED USA LLC

PENTOBARBITOL AND SODIUM PENTOBARBITOL, USP, MANUFACTURED IN PENNSVILLE, NJ

NOT AN ASSIGNED NUMBER

II

II
II

III

XYLITOL FOR INJECTION

Page 33

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
1201 I
7/15/1956
CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP SYNACTHEN (BA-30920)
1202

1203

7/12/1968

NOT AN ASSIGNED NUMBER


HENKEL KGAA

EDENOL 133

1204

7/15/1968

CONTINENTAL CAN COMPANY

SEPRO

1205

7/16/1968

KOLMAR LABORATORIES INC

POROSITONES R

1206

II

7/31/1968

TROPONWERKE GMBH CO KG

CLOFOREX AS MFG. IN KOLN MULHEIM, GERMANY

1207

III

7/19/1968

DOW CHEMICAL CO MICHIGAN DIV

SARAN FORMULATIONS

1208

7/18/1968

SYNTEX CORP

1-(3'B-HYDROXYCHOLEST -5' -EN-7'E-YL)-1,5-DIAZABICYELO-(4,3,0)-NONECHL

1209

7/19/1968

PFISTER CHEMICAL COMPANY INC

TRIBROMOSALICYLANILIDE (TBS-100)

1210

7/22/1968

EDLAW PACKAGING CO INC

UNIT PACKAGING

1211

7/25/1968

ETHYL CORP

ETHYL 9013 CL 09 POLYVINYL CHLORIDE COMPOUND

1212

1213

1214

1215

1216

III

1217

1218

1219

1220

1221

1222

1223
1224
1225

1226

1227

1228

1229

NOT AN ASSIGNED NUMBER


7/26/1968

MONSANTO COMPANY

ENZYME AP, A PROTEOLYTIC ENZYME DERIVED FROM B. SUBTILLIS

8/1/1968

TROPONWERKE GMBH CO KG

PHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE)

6/21/1968

C ALBERT SAUTER CO

MANUFACTURING FACILS. (PHILADELPHIA PLANT)

7/22/1968

FLEXEL INC

AVISCO CELLOPHANES

II

8/2/1968

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

PENTRITOL-B (PETN 30MG & BUTABARBITAL 50MG TEMPULES)

8/6/1968
8/15/1968

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SYNTEX CORP

MANUFACTURING SITE,FACILITES,PERSONNEL, AND GENERAL MANUFACTURING


PROCEDURES.
6A-FLUORO-11B,17A,21-TRIHYDROXY-16A-METHYLPREGN-4-ENE-3,20-DIONE(RS166

8/15/1968

SYNTEX CORP

6A,9A,DIFLUORO-11B,17A,21-TRIHYDROXY-16A-METHYLPREGN-4-ENE-3,20-DIONE

8/14/1968

UNION CARBIDE CORPORATION

BAKELITE BRAND DFD-3201

IV

8/13/1968

TASTEMAKER

ORANGE FLAV-O-LOK (MM 3X 610047) (FORMERLY HELD BY POLAK'S FRUTAL)

II

8/14/1968

KNOLL AG CHEMISCHE FABRIKEN

ETHAVERINE HYDROCHLORIDE (BARBONIN)

III

8/19/1968

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DUOTRATE 30 PLATEAU CAPSULES

8/20/1968

ANABOLIC INC

PLACENTAL LYSATE - LYOPHILIZED

8/21/1968

PCR INC

5-FLUOROURACIL

9/3/1968

CILAG CHEMIE AG

MANUF FACILS AND CONTROLS FOR ISOPROTERENOL HYDROCHLORIDE

IV

8/16/1968

QUALICAPS PHARMAPHIL DIVISION

HARD SHELL GELATIN CAPSULES MANUFACTURED IN WINDSOR, CANADA

9/4/1968

D P T LABS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1230

III

9/4/1968

UNION CARBIDE CORPORATION

POLYETHYLENE RESINS (BAKELITE SERIES)

1231

II

9/9/1968

SYNTEX LABORATORIES INC SUB SYNTEX CORP

6A-FLURO-9A,11BDICHLORO-16A,17A,21-TRIHYDROXYPREGNA-1,4-DIENE-3, 20-DI

1232

9/10/1968

UNION CARBIDE CORPORATION

BAKELITE BRAND DYNH RESIN

1233

IV

9/11/1968

ABITEC CORPORATION

HARD BUTTER PRODUCTS

1234

II

9/11/1968

SYNTEX LABORATORIES INC SUB SYNTEX CORP

D-2-(6-METHOXY-2-NAPHYTHYL) PROPIXONIC ACID

1235

9/13/1968

NUTRITIONAL BIOCHEMS CORP

L-DOPA

1236

9/16/1968

EGYPTIAN LACQUER MANUFACTURING CO

CV-1443 HEAT SEAL COATING

1237

9/16/1968

GANES CHEMICALS INC

DIPHENHYDRAMINE HYDROCHLORIDE

II

II

II

Page 34

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1238 I
9/19/1968
PHYTOGEN PRODS INC

SUBJECT
ANAGESTONE ACETATE

1239

III

9/17/1968

AMERICAS STYRENICS LLC

BAKELITEBRAND RUBBER MODIFIED POLYSTYRENE TMD(F) A-9501 NATURAL

1240

IV

9/19/1968

GULF OIL CORP

BAKELITE BRAND POLYSTRENE SMD(F) 3500 NATURAL

1241

II

9/30/1968

FMC LITHIUM SUB FMC CORP

LITHIUM CARBONATE, MFG PROCEDURES

1242

IV

10/2/1968

EVONIK ROHM GMBH

EUDRAGITS

1243

9/19/1968

CAMDEN CHEM CO LTD

CAMCOLIT

1244

10/18/1968

ER SQUIBB AND SONS INC

DESFLUORO TRIAMCINOLONE ACETONIDE

1245

10/17/1968

HAGER PACKAGING CORP

PHYSICAL FACILITIES & OPERATIONS

1246

10/23/1968

ROUSSEL CORPORATION

METHYLOXINE BROMOMETHYLOXINE METHYLOXINE N-DODECYLSULFATE

1247

II

10/21/1968

KEMKO INC

MEPROBAMATE N.F.XII

1248

II

10/23/1968

TANABE SEIYAKU CO LTD

L-THREONINE

1249

II

10/25/1968

TANABE SEIYAKU CO LTD

L-METHIONINE

1250

II

10/23/1968

TANABE SEIYAKU CO LTD

L-ISOLEUCINE

1251

II

10/25/1968

TANABE SEIYAKU CO LTD

L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE

1252

II

10/23/1968

TANABE SEIYAKU CO LTD

L-TRYPTOPHAN

1253

II

10/25/1968

TANABE SEIYAKU CO LTD

L-VALINE

1254

11/6/1968

DIAMOND CHEM CO

CUSTOM PACKAGING OPERATION

1255

11/25/1968

HUNTINGDON RES CTR

HUNTINGDON RESEARCH CENTRE BROCHURE

1256

12/5/1968

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

1257

10/30/1968

MERRELL DOW RESEARCH INSTITUTE DIV


MERRELL DOW PHARMACEUTICAL INC
ANABOLIC INC

1258

12/3/1968

ALUMINUM COMPANY OF AMERICA

PILFERPROOF CLOSURE (38MM) FOR STERILE SOLUTIONS

1259

12/3/1968

BECTON DICKINSON AND CO

TRITIATED CYTIDINE

1260

12/6/1968

NAPP CHEMICALS INC

MANUFACTURE AND CONTROL OPERATIONS

1261

12/13/1968

DOW CORNING CORP

DOW CORNING 556 FLUID

1262

12/16/1968

GENERAL ELECTRIC CO

CALCIUM 45, PRODUCT SPECIFICATIONS AND PROCESS DESCRIPTIONS

1263

12/16/1968

GENERAL ELECTRIC CO

CALCIUM-47

1264

12/16/1968

GENERAL ELECTRIC CO

CHROMIUM-51

1265

12/16/1968

GENERAL ELECTRIC CO

SELENIUM-75

1266

12/16/1968

GENERAL ELECTRIC CO

RUBIDIUM-86

1267

II

12/16/1968

GENERAL ELECTRIC CO

YTTERBIUM-169

1268

II

12/16/1968

GENERAL ELECTRIC CO

MERCURY-203

1269

12/19/1968

BECTON DICKINSON AND CO

ADENOSINE CYCLIC PHOSPHATE MANUF. BY SCHWARZ BIORESEARCH

1270

II

5/13/1968

BECTON DICKINSON AND CO

DIBUTYRYL CYCLIC MONOPHOSPHATE SODIUM MANUF. BY SCHWARZ BIORESEARCH

1271

II

12/13/1968

CHATTEM CHEMICALS INC

AMINOACETIC ACID (GLYCINE) AS PREPARED BY CHATTEM CHEMICALS

1272

II

12/27/1968

TANABE SEIYAKU CO LTD

L-ASPARTIC ACID

1273

II

12/27/1968

TANABE SEIYAKU CO LTD

L-PHENYLALANINE

1274

II

12/31/1968

TANABE SEIYAKU CO LTD

L-ARGININE MONOHYDROCHLORIDE

1275

II

12/31/1968

TANABE SEIYAKU CO LTD

L-LEUCINE

I
II

II

MANUF, CONTROL & HOUSEKEEPING STANDARD OPER. PROCEDS, EQUIPMENT PERSON

Page 35

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1276 I
12/26/1968
GENERAL ELECTRIC CO

SUBJECT
IRON-59

1277

12/26/1968

GENERAL ELECTRIC CO

STRONTIUM-85

1278

12/26/1968

GENERAL ELECTRIC CO

TIN-113

1279

12/26/1968

GENERAL ELECTRIC CO

TIN-119M

1280

11/12/1968

MILPRINT INC

PHARMACEUTICAL PACKAGING MATERIAL, NEALAM (R) 40455

1281

III

12/2/1968

VALSPAR CORP

37 MOBIL PACKAG. COATINGS FORMULATIONS:S-1299-001;005;010;013;024;&030

1282

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-9658-501

1283

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-9094-001, S-9094-002

1284

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-9092-001

1285

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-9087-001

1286

III

11/27/1968

VALSPAR CORP

37 MOBIL PAKAGING COATINGS FORMULATIONS S-9075-001,S-9075-002,003,004

1287

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8998-001

1288

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8998-004

1289

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8988-003

1290

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8988-002

1291

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8958-002

1292

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8958-001

1293

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8586-002

1294

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8480-001, S-8480-002

1295

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8327-001

1296

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-8279-001

1297

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-3208-004

1298

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING FORMULATIONS S-1961-106, S-1961-107

1299

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-1961-101

1300

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULAS S-1300-001,S1300-004, S-1300-009

1301

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-1299-018, S-1299-029

1302

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-1299-026

1303

III

11/27/1968

VALSPAR CORP

37 MOBIL PACKAGING COATINGS FORMULATIONS S-1298-001

1304

III

12/31/1968

VALSPAR CORP

MOBIL PACKAGING FORMULATION S-1167-025

1305

1/6/1969

WALLERSTEIN

MICROBIAL LIPASE

1306

III

1/6/1969

FLINT HILLS RESOURCES LP

POLYETHYLENE PE 107 MANUFACTURED IN ODESSA, TEXAS.

1307

III

1/13/1969

VALSPAR CORP

PACKAGING FORMULATION S-6265-011

1308

III

1/13/1969

VALSPAR CORP

PACKAGING FORMULATION S-1518-016

1309

III

1/13/1969

VALSPAR CORP

PACKAGING FORMULATION S-1518-018

1310

1/17/1969

TENNESSEE EASTMAN CO-ORIG

PRODUCT ISOBUTYL 2-CYANOACRYLATE, MED GRADE & VISCOUS ISOBUTYL

1311

1/13/1969

GEIGY PHARMS

CALCIUM CHEL 330

1312

1/22/1969

UOP FRAGRANCES US

PERFUME BOUQUET #15741 (ANTOINE CHIRIS)

1313

1/22/1969

MILPRINT INC

MILSEAL 42601

1314

1/23/1969

SYNAPSE INC

L-DOPA

II

Page 36

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1315 I
1/23/1969
TANABE SEIYAKU CO LTD

SUBJECT
DL-VALINE

1316

1317

1318

1319

1320

1321

II

1/23/1969

TANABE SEIYAKU CO LTD

DL-PHENYLALANINE

1/23/1969

TANABE SEIYAKU CO LTD

DL-TRYPTOPHAN

1/23/1969

TANABE SEIYAKU CO LTD

DL-THREONINE

2/3/1969

CURWOOD INC

CURWOOD'S 3802 PHARMACEUTICAL PACKAGING FILM

2/10/1969

SOLVAY PHARMACEUTICALS

LITHIUM CITRATE SYRUP

2/7/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DILAC 30MG SUSTAINED RELEASE CAPSULES

1322

2/12/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DILAC 30MG /PHENOBARBITAL 45MG SUSTAINED RELEASE CAPSULES

1323

2/6/1969

PHYTOGEN PRODS INC

19-NOR-17-ALPHA-ETHINYLTESTERONE

1324

2/7/1969

COLONIAL SUGAR REFINING CO LTD

CALCIUM SUCROSE PHOSPHATES (ANTICAY)

1325

2/10/1969

EASTMAN CHEMICAL CO

PROPYLENE-ETHYLENE POLYALLOMERS(TENITE POLALLOMERS)

1326

2/17/1969

MILPRINT INC

MILSEAL 31100 SERIES

1327

2/17/1969

MILPRINT INC

MILSEAL 31600 SERIES

1328

2/17/1969

MILPRINT INC

MILSEAL 32000 SERIES

1329

2/17/1969

MILPRINT INC

MILSEAL 33200 SERIES

1330

2/17/1969

MILPRINT INC

MILSEAL 34050 SERIES

1331

2/17/1969

MILPRINT INC

NEALAM 43550 SERIES

1332

2/17/1969

MILPRINT INC

SUPEREL 55300 SERIES

1333

2/17/1969

MILPRINT INC

NEALAM 60550 SERIES

1334

2/13/1969

MILPRINT INC

NEALAM 60650 SERIES, PACKAGING MATERIALS

1335

III

2/14/1969

ROHM AND HAAS CO

ADHESIVE FORMULATIONS

1336

III

2/24/1969

PIERCE & STEVENS CHEMICAL CORPORATION

PROXSEAL E-9327

1337

2/20/1969

FOOD AND DRUG RES LABS INC

PACKAGING MATERIALS STRUCTURES

1338

2/28/1969

GENERAL ELECTRIC CO

CADMIUM-109

1339

2/28/1969

GENERAL ELECTRIC CO

IRON-55

1340

2/28/1969

GENERAL ELECTRIC CO

PHOSPHORUS-32

1341

2/26/1969

GENERAL ELECTRIC CO

THALLIUM-204

1342

2/28/1969

GENERAL ELECTRIC CO

THULIUM-170

1343

3/14/1969

ORGANON INC

DEXAMETHASONE 21-TERTIARY BUTYLACETATE

1344

3/17/1969

RSA CORPORATION

DITHIOTHREITOL

1345

3/14/1969

CORMEDICS CORP

KEY PERSONNEL, MANUF FACILS, CONTROL PROCEDURES AND QUALITY STANDARDS

1346

3/18/1969

MIDLAND DIVISION DEXTER CORPORATION

321-177A CLEAR COATING (PERMANENT MIDLAND CODE V-1073) AND 321-177B

1347

3/24/1969

PIERCE & STEVENS CHEMICAL CORPORATION

PROXSEAL E- 9133

1348

3/21/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

MANUF, FACILS, PERSONNEL, CONTROLS & SPECIFS FOR METRANIL 80MG SUS CPS

1349

3/28/1969

SYNTEX LABORATORIES INC SUB SYNTEX CORP

A DESCRIPTION OF OUR CLARK, NEW JERSEY WAREHOUSE

1350

II

4/24/1969

DINAMITE DIPHARMA SPA

1351

4/8/1969

ALLERGAN PHARMACEUTICAL

1352

4/14/1969

PHARMATON LTD

PROPOXYPHENE HYDROCHLORIDE MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN),


ITALY FACILITIES
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF OPTHALMIC PREPS IN IRVINE, CALIFORNIA.
NEO-LIDOCATION

II
II

III

III

II
II

III

Page 37

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1353 I
4/18/1969
FOOD AND DRUG RES LABS INC

SUBJECT
IDENTITY & STRUCTURE OF A COMB. CLOSURE & DOSAGE MEAS SPOON MANUF ALCO

1354

6/8/1969

EL PASO POLYOLEFINS CO

POLYPROPYLENE RESIN COMPOUNDS USED IN MANUF. PLASTIC CONTAINERS

1355

II

4/21/1969

EI DUPONT DE NEMOURS AND CO

RUBIDIUM-84

1356

II

3/18/1969

DOW CHEMICAL CO

CARBOWAX POLYETHYLENE GLYCOL

1357

II

4/28/1969

SYNTEX LABORATORIES INC SUB SYNTEX CORP

GUANADREL (CL-1388-R)

1358

4/28/1969

EASTMAN CHEM PRODS INC

TENITE POLYETHYLENE 860E-69141 WHITE

1359

4/11/1969

MAUMEE CHEM CO

TRIBROMOSALICYLANILIDE

1360

4/30/1969

REICHHOLD CHEMICALS INC

BLACK TUBING

1361

4/28/1969

RT VANDERBILT CO

VANCIDE TBS.

1362

III

4/24/1969

INEOS OLEFINS AND POLYMERS USA

FORTIFLEX (R) POLYETHYLENE RESIN

1363

III

5/2/1969

CHEVRON PHILLIPS CHEMICAL CO LP

POLY-ETH POLYETHELYNE 5555 RESIN

1364

5/9/1969

P-L BIOCHEMS INC

POLYCYTIDYLIC ACID (POLY C)

1365

5/12/1969

P-L BIOCHEMS INC

POLYINOSINIC ACID (POLYI)

1366

III

5/5/1969

PARAMOUNT PACKAGING CORP

FLEXIBLE PACKAGING MATERIALS

1367

II

5/7/1969

LILLY RES LABS DIV ELI LILLY CO

LEVODOPA (COMPOUND 7550)

1368

III

5/13/1969

VALSPAR CORP

FORMULATION S-3414-102

1369

II

5/21/1969

SOLVAY PHARMACEUTICALS

SODIUM FLUORIDE TABLETS AND CAPSULES

1370

5/28/1969

MICROBIOLOGICAL ASSOC

POLYRIBOINOSINIC ACID AND POLYRIBOCYTIDYLIC ACID

1371

5/26/1969

P-L BIOCHEMS INC

DITHIOTHREITOL

1372

III

5/20/1969

EI DUPONT DE NEMOURS INC

SURLYN IONOMER RESINS

1373

6/4/1969

PROCTER AND GAMBLE CO

1374

6/9/1969

UNION CARBIDE CORPORATION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GREENVILLE, SOUTH CAROLINA.
VINYLITE BRAND COATED PAPER VDI 6645 WHITE 1435

1375

6/10/1969

MIDCO PRODS CO

PACKAGING

1376

6/11/1969

CALBIOCHEM CORP

L-DOPA TABLETS

1377

6/10/1969

MILPRINT INC

MILSEAL 33250 SERIES

1378

6/23/1969

TEKNI PLEX INC

1379

6/19/1969

GEORGE UHE CO

PACKAGING FILMS-LAMINATED, CLOSURE LINER MATERIALS, AND LIDDING MATERIALS


MANUFACTURED AT FLEMINGTON NJ AND SOMERVILLE NJ.
METHAQUALONE BASE

1380

6/26/1969

GENERAL SILICONES PTY LTD

GENSIL 39 ANTI-FOAM COMPOUND

1381

7/1/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DARVON (PROPOXYPHENE HCL) SUSTAINED RELEASE CAPSULES

1382

4/25/1969

REICHHOLD CHEMICALS INC

RUBBER TUBING

1383

6/26/1969

PRINT PACK INC

LAMINATIONS AND LAMINAING PROCEDURES.

1384

7/1/1969

RHODIA INC

RP 4763, (SPECIA) BEMARSAL

1385

7/11/1969

DELTA RUBBER CO

FORMULAS #B-501, #B-502 RED BUTYL AND #R-503, #R-505 BLUE RUBBER

1386

II

6/27/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DILAC 80MG (PENTAERYTHRITOL TETRANITRATE RIMED DISINT CAPSULES

1387

III

6/10/1969

REXHAM CORP

LAMINAING ADHESIVE, RIEGEL CODE NO. A-1708

1388

II

7/14/1969

ORGANON INC

ALPHA-ESTRADIOL

1389

7/1/1969

HOWMEDICA INC

SURGICAL SIMPLEX P AND SURGICAL SIMPLEX RADIOPAQUE

1390

7/15/1969

MONSANTO COMPANY

MONSANTO POLYETHYLENE MPE 80

III

III

II
III

Page 38

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1391 I
7/16/1969
ER SQUIBB AND SONS INC

SUBJECT
D-GLUCOSAMINE HYDROCHLORIDE SOLUTION, 2N SODIUM HYDROXIDE SOLUTION

1392

7/18/1969

PECHINEY PLASTIC PACKAGING INC

MANUFACTURING PROCEDURES & FACILITIES, PACKAGING

1393

7/24/1969

WORTHINGTON BIOCHEM CORP

DEXTRANASE

1394

7/24/1969

ROHM AND HAAS CO

HYDROXYETHYL METHACRYLATE 94%

1395

7/30/1969

SPARKS CORP

MANUFACTURING PROCEDURE, EQUIPMENT AND CONTROL PLANT #2

1396

7/8/1969

SPARKS CORP

MANUF PROCEDURE, EQUIPMENT AND CONTROLS OF PLANT #1

1397

7/25/1969

CALBIOCHEM-BEHRING CORP

CYTOSINE ARABINOSIDE AND CYSTOSINE ARABINOSINE HYDROCHLORIDE

1398

7/30/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

NEO-COROVAS TYM CAPS 30MG (PENTAERYTHRITOL TETRANITRATE

1399

7/31/1969

M AND T CHEMS INC

M AND T SPECIAL WHITE TIN OXIDE-POLISHING GRADE

1400

8/1/1969

UNIV OF WISCONSIN

25-HYDROXY-CHOLECALCIFEROL

1401

8/1/1969

L-DOPA

1402

8/1/1969

KEY PHARMACEUTICALS INC SUB SCHERING


PLOUGH CORP
VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

1403

8/5/1969

DOW CORNING CORP

DOW CORNING 386 FOAM ELASTOMER

1404

1405

7/29/1969

FARMITALIA SPA

FORMOCORTAL

1406

II

8/13/1969

PHARMACIA AND UPJOHN INC

CORTISONE (MICRONIZED, ACETATE AND STERILE)

1407

II

8/12/1969

ORGANON INC

ESTRIOL

1408

III

8/20/1969

SILGAN PET CORP

MONSANTO POLYETHYLENE M.P.E. 212: ALSO IN FOOD ADDITIVE FILE #118

1409

8/18/1969

EDWARD MENDELL CO INC

CAPILLACT (DISINTERGRAING AGENT)

1410

8/15/1969

VISION PACKAGING CO

PERSONNEL AND FACILITIES

1411

8/21/1969

GENERAL ELECTRIC CO

NICKEL-63

1412

II

9/2/1969

PFIZER INC

PREDNISONE,MICRONIZED,STERILIZED AND ACETATE

1413

II

9/2/1969

PHARMACIA AND UPJOHN

1414

III

8/27/1969

THE DOW CHEMICAL COMPANY

HYDROCORTISONE MICRONIZED AND NON-MICRONIZED AS MANUFACTURED IN


KALAMAZOO, MICHIGAN
BAKELITE BRAND POLYETHYLENE RESIN DNDA-01800 NATURAL 7

1415

III

8/29/1969

ALUMINUM COMPANY OF AMERICA

ALCOA NUMBERS 9003, 9004, 9005 (PHAR 9003, 9004, 9005)

1416

8/29/1969

BF SCHOEN

PREGNANEDIOL

1417

9/3/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DUROTATE PB (PETN 30MG AND PHENOBARBITAL 45MG) SUSTAINED RELEASE CAPS

1418

9/4/1969

PHARMACIA AND UPJOHN

PROGESTERONE MICRONIZED AND CRYSTALS

1419

9/2/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

ANTORA B TIMED DISINTEGRATING CAPS

1420

9/5/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

PENTRAYTE TIMED CAPSULES (PETN 30MG)

1421

8/29/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

ANTORA (PETN) TIMED DISINTEGRATING CAPS

1422

9/4/1969

ARMOUR PHARMACEUTICAL CO

SALMON CALCITONIN

1423

9/8/1969

SCHWARTZ BIORESEARCH INC

RIBONUCLEIC ACID RNA, YEAST NUCLEIC ACID

1424

III

9/8/1969

HENKEL CORP

GELVA? MULTIPOLYMER RESIN SOLUTIONS (GMS)

1425

III

9/4/1969

SABIC INNOVATIVE PLASTICS

1426

II

9/7/1969

FORNOVO FARMACHIMICI SRL

NORYL* RESINS AS MANUFACTURED IN SELKIRK, NEW YORK (USA), AND BERGEN-OP-ZOOM,


THE NETHERLANDS.
IMINODIBENZYL

1427

II

9/11/1969

ZENITH LABORATORIES INC

TOLAZAMIDE POWDER

III

II
II

II

COROVAS TYMCAPS(PENTAERYTHRITOL TETRA NITRATE)

NOT AN ASSIGNED NUMBER

II

Page 39

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1428 I
8/20/1969
TERRA MARINE BIORESEARCH

SUBJECT
CYTOSINE ARABINOSIDE

1429

1430

1431

1432

1433

1434

1435

1436

1437

1438

1439

II

1440

1441

1442

10/28/1969

ISO-MED INC

SODIUM RADIOFLUORIDE

1443

10/31/1969

ORGANON INC

HUMAN CHORIONIC GONADOTROPIN

1444

11/7/1969

CERTIFIED LABS INC

MANUFACTURING STANDARD OPERATING PROCEDURES

1445

11/21/1969

KNOLL AG CHEMISCHE FABRIKEN

VERARYL CYANIDE AND HOMOVERARYLAMINE

1446

II

11/26/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

DUOTRATE 45MG PLATEAU CAPSULES

1447

12/3/1969

MANUF.CONTROL,FACILITIES &PROCEDURES-A RAHWAY, NJ PLANT

1448

9/23/1969

1449

9/23/1969

1450

9/23/1969

1451

9/23/1969

1452

8/18/1969

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
MERCK SHARP & DOHME RESEARCH LABS DIV
MERCK & CO INC
MERCK SHARP & DOHME RESEARCH LABS DIV
MERCK & CO INC
MERCK SHARP & DOHME RESEARCH LABS DIV
MERCK & CO INC
MERCK SHARP & DOHME RESEARCH LABS DIV
MERCK & CO INC
RECHERCHES ET INFORMATIONS BIOLOGIQUES

1453

12/5/1969

ESSEX SAIC SUB SCHERING CORP

METHODS, FACILS, AND CONTROLS USED IN MANUF. CHEMICAL SUBSTANCES

1454

12/12/1969

UPJOHN CO

FLUPREDNISOLONE & FLUPREDNISOLONE ACETATE

1455

12/5/1969

SHERAMEX SA DE CV

METHODS, FACILITIES, CONTROLS, PROCESSING AND PACKAGING

1456

12/4/1969

VITARINE CO INC

GENERAL OPERATING PROCEDURE FOR PARENTERAL PREPARATIONS

1457

1458

1459

1460

1461

1462

II

3/3/1969

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

ISORDIL TEMBIDS (ISOSORBIDE DINITRATE) SRC

6/10/1969

ALUMINUM COMPANY OF AMERICA

POLYMERIC HEA-SEAL COATED ALUMINUM FOIL 9403, 9404, AND 9405

II

9/16/1969

ORGANON INC

ETHINYL ESTRADIOL

II

9/18/1969

PHARMACIA AND UPJOHN SUB PFIZER INC

PREDNISOLONE USP MANUFACTURED IN KALAMAZOO, MICHIGAN.

III

9/4/1969

MILPRINT INC

FLEXIBLE PACKAGING MATERIALS

10/6/1969

ER SQUIBB AND SONS INC

PROLIXIN ELIXIR (FLUPHENAZINE HYDROCHLORIDE)

10/7/1969

SCHERING AG

GENERAL OPERATING PROCEDURES FOR BULK PRODUCTS

II

10/8/1969

OLIN CHEMICAL GROUP

PYRIDINETHIONE DISULFIDE (OMADINE DISULFIDE)

10/8/1969

OLIN CHEMICAL GROUP

2,2' PYRIDYLDISULFIDE (2,2' PYRIDINE DISULFIDE)

10/20/1969

HERCULES INC

POLYMER S2062

10/24/1969

UNITED STATES DEPARTMENT ENERGY

RADIOISOTOPE MOLYBDENUM-99-P-2 UNPROCESSED(FORMERLY UNION CARBIDE CORP

10/29/1969

PHARMACIA LABS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PISCATAWAY, NEW JERSEY.

NOT AN ASSIGNED NUMBER

II

MANUF, CONTROL FACILITIES PROCEDURES FOR ALBANY, GA. PLANT


MANUF. CONTROL FACILITIES & PROCEDURES FOR DANVILLE PA PLANT
MANUF. & CONTROL,FACILITIES & PROCEDURES-FOR ELKTON, VA. PLANT
MANUFACTURING, CONTROLS, FACILITIES & PROCEDURES
MEETHODS, FACILITIES AND CONTROLS, USED IN PACKING DRUG SUBSTANCES

NOT AN ASSIGNED NUMBER


II

II

12/15/1969

ERYTHROMYCIN B

12/18/1969

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
BIO DERIVATIVES CORP

12/18/1969

P ROBERTET INC

DERMODOR LAVENDER FOUGERE 3066 BIS

12/15/1969

ORGAMOL SA

METHAQUALONE HYDROCHLORIDE POWDER

12/30/1969

CHATTEM DRUG & CHEMICAL COMPANY

ALUMINUM HYDROXIDE LOW TEMPERAURE GLYCINE 2:1 DRIED GEL AHLTG-21

L-DOPA

Page 40

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1463 I
12/22/1969
VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

SUBJECT
DUOTRATE PB 45MG PLATEAU CAPSULES

1464

III

12/17/1969

AMERICAS STYRENICS LLC

BAKELITE BRAND OF POLYSTYRENE (RESIN SMD-3700 NATURAL.

1465

3/25/1970

EON LABS MFG OF THE VIRGIN ISLANDS INC

MANUFACTURING INFO ON CARIBE CHEMICAL CO., INC.

1466

III

1/8/1970

AMCOR RIGID PLASTICS USA INC

PLASTIC BOTTLES MANUFACTURED IN MAYS LANDING, NEW JERSEY.

1467

II

12/31/1969

DOW CORNING CORP

DOW CORNING R Q7-2243 LVA SIMETHICONE USP

1468

III

1/15/1970

POLYTHERM KASSEL

POLYVINYL CHLORIDE FILM

1469

1470

11/21/1969

1471

1472

1473

1474

1475

1476

1477

1478

1479

1480

1481

1482

NOT AN ASSIGNED NUMBER


MFG. FACILS. (FORMERLY ENDO LABS INC.)

12/16/1969

DUPONT PHARMACEUTICALS DIV EI DUPONT DE


NEMOURS & CO
SERVICE MAILING & PRINTING COMPANY INC

1/14/1970

DEWEY AND ALMY CHEM DIV WR GRACE AND CO

DEWEY AND ALMAY AEROSOL COMPOUNDS S1419 AND S1420

1/21/1970

SYNTEX USA INC

GENERAL DESCRIPTION OF RENO, NEVADA WAREHOUSE

1/29/1970

ALUMINUM COMPANY OF AMERICA

PHAR ALWARP 9802, 9803, 9804, FOIL CONTAINER AND ALWARP 9606 CLOSURE

1/26/1970

GOODYEAR TIRE AND RUBBER CO

POLYESTER RESINS

1/23/1970

BEECHAM PHARMS DIV BEECHAM PRODS

TRAUMAIC ACID

III

12/29/1969

MODERN PACKAGING INC

PACKAGING FORMULATIONS.

II

2/3/1970

CAMBREX PROFARMACO MILANO SRL

DIAZEPAM

2/6/1970

USV PHARMACEUTICAL CORP SUB RORER GROUP METHOD, FACILITIES, CONTROLS, PROCESSING AND PACKING OF DRUGS

III

2/6/1970

KERR GLASS MANUFACTURING CORP

II

2/6/1970

ORGANICHEM CORP

STRONTIUM 87M GENERATOR

1483

II

2/11/1970

GALLARD-SCHLESINGER CHEM MFG CORP

IMINODIBENZYL

1484

2/12/1970

DONELAIN PHARMACEUTICALS INC

PLANT FACILITIES, PERSONNEL AND CONTROL PROCEDURES FOR DRUG ITEMS

1485

2/6/1970

SCHERING AG

GEN. OPERATING PROCEDS FOR BULK PRODUCTS-SCHERING AG BERGKAMEN PLANT

1486

NOT AN ASSIGNED NUMBER

1487

NOT AN ASSIGNED NUMBER

1488

2/13/1970

DOW CHEMICAL CO MICHIGAN DIV

PEI 600 POLYETHYLENIMINE

1489

2/16/1970

GENERIC PHARMS INC

PLANT FACILITIES, MANUFACTURING AND QUALITY CONTROL

1490

2/18/1970

DOW CORNING CORP

SILASTIC 9711 MEDICAL GRADE ELASTOMER

1491

1492

1493

1494

1495

1496

1497

3/19/1970

1498

3/9/1970

I
III

PERSONNEL, FACILITIES, METHODS & CONTROLS

PERMA CLEAR 2000 RESIN COMPOUND

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER


3/6/1970
IV
I

CYCLAMATE, SACCHARIN AND CYCLOHEXYLAMINE

1/12/1970

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
STEPAN COMPANY

3/9/1970

RICHLYN LABORATORIES INC

PHARMACEUTICAL MANUF, FACILITIES, PERSONNEL AND QUALITY CONTROL

2/27/1970

ZENITH LABORATORIES INC

MANUFACTURING FACILS, PERSONNEL AND CONTROL PROCEDS OF NORTHVALE PLANT

DEFOAMER FD 101, FD 102,FD 104, L-500 AND DREWFLOC 225 AND 412

NOT AN ASSIGNED NUMBER


WINTHROP PHARMACEUTICALS DIV STERLING
DRUG INC
WINTHROP PHARMACEUTICALS DIV STERLING
DRUG INC

FACILITIES, METHODS AND CONTROLS


MANUFACTURING DETAILS FOR SPECIFIC CHEMICALS

Page 41

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1499 A
IV
3/6/1970
DOW CORNING CORP

SUBJECT
DOW CORNING 360 MEDICAL GRADE FLUID

1500

3/12/1970

DUPONT PERFORMANCE POLYMERS

DUPONT NYLON RESIN

1501

3/18/1970

CMW LABS LTD

C.M.W. BONE CEMENT POWDER AND LIQUID

1502

3/16/1970

AMERICAN CYANAMID CO

DESCRIPTION OF DAVIS AND GECK PLANT FACILS AND PERSONNEL

1503

3/16/1970

GENERAL ELECTRIC CORP

COMPOSITION OF LEXAN (R) 144-803)

1504

2/11/1970

EASTMAN CHEMICAL CO

TENITE POLYPROPYLENE PRODUCTS

1505

3/21/1970

BENEFICIADORA E INDUSTRIALIZADORA SA

METHODS, FACILITIES, AND CONTROLS

1506

3/19/1970

MANBRITT INDUSTRY INC

INJECTION BLOW MOLDING OF PLASTIC CONTAINERS

1507

3/27/1970

GLAXO WELLCOME INC

1508

II

3/25/1970

LILLY RES LABS DIV ELI LILLY CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GREENVILLE, NORTH CAROLINA.
1-METHADONE HYDROCHLORIDE

1509

3/11/1970

ZENITH LABORATORIES INC

PENICILLIN PLANT OPERATION IN ENGLEWOOD, NEW JERSEY

1510

3/25/1970

SEMBL INC

PACKAGING, FACILITIES, CONTROLS

1511

4/7/1970

UNION CARBIDE CORPORATION

POLYMER JR & LR RESINS

1512

4/8/1970

UNION CARBIDE CORP

SHELL POLYPROPYLENES

1513

4/16/1970

HERCULES INC

DIVINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (ALSO CALLED PYRAN COPOLYMER)

1514

3/13/1970

SOLAR CHEMICAL CORP

POLYSTYRENE RESINS

1515

II

4/23/1970

MALLINCKRODT INC

METHADONE HYDROCHLORIDE

1516

II

4/23/1970

SANOFI AVENTIS CHIMIE

CHLORPROMAZINE HYDROCHLORIDE

1517

II

4/23/1970

AMINACRINE HYDROCHLORIDE

1518

III

4/20/1970

STERLING-WINTHROP RES INST DIV STERLING


DRUG INC
TOTAL PETROCHEMICALS AND REFINING USA INC

1519

5/4/1970

RICHLYN LABORATORIES INC

FACILITIES, PERSONNEL, AND CONTROLS ON ANTIBIOTIC DRUG PRODUCTION

1520

II

4/28/1970

BEECHAM PHARMS DIV BEECHAM PRODS

6-AMINOPENICILLANIC ACID

1521

4/27/1970

WYETH INC

MANUF FACILITIES FOR VARIOUS PLANTS OF WYETH LABORATORIES, INC.

1522

4/27/1970

WYETH INC

MANUF FACILITIES FOR VARIOUS PLANTS OF WYETH LABORATORIES, INC.

1523

4/27/1970

WYETH INC

MFGR FACILS FOR THE VARIOUS PLANTS OF WYETH LABS INC (CHICAGO PLANT)

1524

4/27/1970

WYETH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1525

5/11/1970

MANUF, PACKAGING AND LABELING OF BULK CALCIUM AND SODIUM CYCLAMATE

1526

5/27/1970

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ELI LILLY AND CO

1527

2/18/1970

SPARKS CORP

MANUF PROCEDURES, EQUIPMENT, PACKAGING AND CONTROLS

1528

III

5/13/1970

1529

IV

5/20/1970

EI DUPONT DE NEMOURS CO DUPONT PACKAGING DUPONT SPECIALTY POLYETHYLENE RESINS


AND INDUSTRIAL POLYMERS
STEPAN SPECIALTY PRODUCTS LLC
WECOBEE M

1530

5/26/1970

CORD LABS INC

MANUFACTURING AND QUALITY CONTROL PROCEDURES

1531

6/4/1970

ELKINS SINN INC SUB AH ROBINS CO

CONTRACT FILLING METHODS, FACILITIES AND CONTROLS

1532

6/8/1970

CHASE CHEMICAL CO

PHYSICAL FACILITIES, MANUFACTURING METHODS, AND CONTROLS

1533

III

6/4/1970

KERR GROUP SUB BERRY PLASTICS CORP

HIGH DENSITY POLYETHYLENE RESIN PACKAGINGS.

1534

II

6/1/1970

PHARMACIA AND UPJOHN

CYTARABINE AS MANUFACTURED IN KALAMAZOO MI

III

III

III

II

ETHYLENE PROPYLENE COPOLYMER RESIN & POLYPROPYLENE HOMOPOLYMER RESIN

MANUF AND CONTROL INFOR. FOR METHADONE HYDROCHLORIDE DISPERSIBLE TBLS

Page 42

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1535 I
II
6/11/1970
PHARMACIA AND UPJOHN SUB PFIZER INC

SUBJECT
MEDRYSONE

1536

1537

1538

1539

1540

1541

1542

1543

1544

1545

1546

1547

1548

1549

1550

1551

1552

6/9/1970

NOVO NORDISK AS

BOVINE PROTEOLYTIC ENZYME MIXTURE(BOVINE PEM) BVF 8001 70)

6/9/1970

NOVO NORDISK AS

CRYSTALLINE TRYPSIN NOVO

6/23/1970

PHILLIPS PETROLEUM CO

FIBER FINISH FORMULATION S-2031

6/17/1970

PRETIUM PACKAGING

PHARMACEUTICAL BOTTLES

6/25/1970

KNOLL AG CHEMISCHE FABRIKEN

BIPERIDEN AND BIPERIDEN HYDROCHLORIDE (AKINETON)

II

6/25/1970

PHARMACIA AND UPJOHN INC

FLUOROMETHOLONE MICRONIZED

II

6/25/1970

PHARMACIA AND UPJOHN INC

16-METHYLDIOLONE ACETATE AND S.D. VII) 9(11)-ANHYDRO-16A METHYLPREDNIS

7/7/1970

ASSIA CHEMICAL LABORATORIES LTD

MANUFACTURE OF NITROFURANTOIN

7/14/1970

HERCULES INC

HI-FAX SA 181A (A HIGH DENSITY POLYETHYLENE-POLYPROPYLENE ALLOY)

III

8/19/1970

WEST PHARMACEUTICAL SERVICES INC

RAW MATERIAL DESCRIPTIONS AND SPECIFICATIONS FOR RUBBER FORMULATIONS

III

8/13/1970

WEST PHARMACEUTICAL SERVICES INC

RUBBER FORMULATIONS

8/26/1970

COMPOSITION OF FASSON S-201 ADHESIVE

7/23/1970

FASSON INDUSTRIAL DIVISION OF AVERY


INTERNATIONAL
AMSA ANONIMA MEDICINALI SINTETICI & AFFINI
SPA
REHEIS CHEM CO DIV ARMOUR AND CO

7/16/1970

ROUSSEL-UCLAF

TRIAMCINOLONE ACETATE AND TRIAMCINOLONE (ALCOHOL)

6/3/1970

ROBECO CHEMICALS INC

CETINATE

7/23/1970

MEPROBAMATE

1553

7/22/1970

MILLMASTER CHEM CO DIV MILLMASTER ONYX


CORP
PLASKON PRODUCTS INC

1554

7/29/1970

UNION CARBIDE CORPORATION

BAKELITE BRAND VINYL RESIN QMDA-4361 CLEAR 847

1555

8/6/1970

EI DUPONT DE NEMOURS AND CO

METHYL METHACRYLATE NONOMER H-112

1556

8/11/1970

BIO DERIVATIVES CORP

MFGR & CONTROL FOR L-DOPA MADE BY HAMARI PHARMACEUTICALS IN JAPAN

1557

8/14/1970

FISONS PLC PHARMACEUTICAL DIV

1558

II

8/7/1970

SYNTEX USA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LOUGHBOROUGH, UNITED KINGDOM.
FLURANDRELIDE ACETATE

1559

8/17/1970

UNION CARBIDE CORPORATION

BAKELITE BRAND OF POLYETHYLENE RESIN DFDA-3210 NATURAL 7

1560

8/20/1970

ER SQUIBB AND SONS INC

TESTOLACTONE TABLETS, 250 MG

1561

8/25/1970

1562

III

8/26/1970

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SABIC INNOVATIVE PLASTICS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROCKY MOUNT, NORTH CAROLINA.
LEXAN * RESINS AS MANUFACTURED IN MT VERNON, INDIANA (USA), BURKVILLE, ALABAMA
(USA), COBOURG, ONTARIO, CANADA, SINGAPORE, BERGEN-OP-ZOOM, THE NETHERLANDS,
AND CARTAGENA, SPAIN

1563

III

9/8/1970

FISONS CORP

SPINHALER, TORBO-INSUFFLATOR DEVICE

1564

9/16/1970

MFGR, CONTROL PROCEDURES & FACILITIES-MYERSTOWN, PA., PLANT

1565

III

9/14/1970

WINTHROP PHARMACEUTICALS DIV STERLING


DRUG INC
PHILLIPS PETROLEUM CO

1566

9/25/1970

BROCKTON CONTRACT PACKAGING

GENERAL INFO ON PLANT, QUAL. CONTROL, EQUIP, PERSONNEL & MANAGEMENT

1567

9/25/1970

GRIFFIN LABS INC

GRIFFIN BIONITE CONTACT LENS

1568

8/3/1970

REYNAUD LTD

IMITATION CITRUS FLAVOR #379LLA

II
III

II

II

7/23/1970

PHENYLBUTAZONE
ALUMINUM CHLORHYDROXIDE COMPLEX (S/6 BASIC ALUMINUM CHLORIDE)

UREA & MELAMINE FORMALDEHYDE MOLDING COMPOUNDS(PLASKON)

CLEAR POLYOLEFIN BOTTLES (CPO BOTTLES)

Page 43

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1569 I
III
8/28/1970
BF GOODRICH COMPANY

SUBJECT
GEON 85658 GRADE BOTTLE COMPOUND

1570

III

8/28/1970

BF GOODRICH COMPANY

GEON 85692 FOOD GRADE BOTTLE COMPOUND

1571

III

9/16/1970

ALBEA AMERICAS INC

PLASTIC TUBES

1572

III

9/21/1970

CHEVRON PHILLIPS CHEMICAL CO LP

GULF POLY-ETH POLYETHYLENE RESINS

1573

9/28/1970

HOUSTON BIOCHEMICAL IND

FACILITIES FOR DRUG MANUFACTURING

1574

9/29/1970

FINE ORGANICS INC

ZINC TEMASEPT IV (F.O. BRAND OF ZINC TRIBROMSALAN)

1575

9/14/1970

PFANSTIEHL LABORATORIES INC

D-XYLOSE

1576

10/9/1970

REXHAM CORP

RIEGEL RS HEAT SEAL COATING FORMULATION

1577

II

10/8/1970

EI DUPONT DE NEMOURS AND CO

COBALT-57

1578

III

9/3/1970

HONEYWELL

ACLAR FLUOROCARBON RESIN & FILM; PLASKON & CAPRAN NYLON 6 RESIN & FILM

1579

10/3/1970

ALLIED CHEM CORP

PREPARATION-FLUOROMETHYL HEXAFLUOROISOPROPYL ETHER-STEP PROCEDS 1 & 2

1580

II

10/1/1970

1581

II

9/21/1970

NORTHEASTERN PHARMACEUTICALS & CHEMICAL HEXACHLOROPHENE


COMPANY INC
AVENTIS PHARMA SA
CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND

1582

9/3/1970

HERCULES INC

HERCULON TYPE 123- POLYPROPYLENE STAPLE FIBER

1583

9/8/1970

ALPINE AROMATICS INC

CORDIAL TYPE FLAVOR

1584

9/3/1970

BRASKEM AMERICA INC

MOPLEN F---D NATURAL

1585

1586

1587

1588

1589

III

NOT AN ASSIGNED NUMBER


9/15/1970

NATIONAL STARCH & CHEMICAL CORP

ADHESIVE 14-9800

III

9/24/1970

QUANTUM CHEMICAL COMPANY DIV

POLYETHYLENE RESIN COMPDS

II

10/5/1970

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

NITORA (NITROGLYCERIN) 2.5MG SUSTAINED RELEASE CAPSULES

III

10/19/1970

ALUMINUM COMPANY OF AMERICA

PACKAGING STRUCTURES ALWARP SERIES 9406-9413

1590

III

10/19/1970

ALUMINUM COMPANY OF AMERICA

ALWRAP 9414

1591

III

10/16/1970

ALUMINUM COMPANY OF AMERICA

ALWRAP 9007 (COATED ALUMINUM FOIL PAPER)

1592

II

10/14/1970

GIVAUDAN CORPORATION

HEXACHLOROPHENE

1593

10/30/1970

GIVAUDAN CORPORATION

G-4 (DICHLOROPHENE)

1594

IV

8/13/1970

SHIONOGI QUALICAPS INC

EMPTY GELATIN CAPSULES MANUFACTURED IN INDIANAPOLIS, INDIANA.

1595

II

10/26/1970

ORGANON INC

SYNTHETIC OXYTOCIN

1596

10/26/1970

UNIROYAL IND PRODS INC DIV UNIROYAL INC

DRUG SOLUTION BOTTLE CAP LINER STRIP

1597

10/26/1970

H REISMAN CORP

PYRAZINAMIDE

1598

10/24/1970

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

NITORA (NITROGLYCERIN) 6.5MG

1599

10/16/1970

ALLIED CHEM CORP

DYES AND PIGMENTS

1600

1601

10/26/1970

PHARMACOSMOS AS

IRON DEXTRAN

1602

11/4/1970

TABLET MANUFACTURING AND PACKAGING

1603

10/30/1970

VITARINE COMPANY INC SUB WEST CHEMICAL


PRODUCTS INC
GANES CHEMICALS INC

1604

11/24/1970

LANNETT CO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1605

NOT AN ASSIGNED NUMBER

N,N-DIMETHOXYMETHYLPHENOBARBITAL

NOT AN ASSIGNED NUMBER

Page 44

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1606 N
NOT AN ASSIGNED NUMBER

SUBJECT

1607

II

11/28/1970

METHADONE HCL EFFERVESCENT TABLETS, 40MG

1608

II

11/10/1970

1609

1610

1611

8/5/1970

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

NITROGLYCERIN 6.5MG SUSTAINED RELEASE CAPS

1612

9/4/1970

BEECHAM PHARMS DIV BEECHAM PRODS

AMPICILLIN TRIHYDRATE TABLESTS 250MG

1613

11/19/1970

BRACCO IND CHIMICA SPA

IODAMIDE (METIODID)

1614

II

11/18/1970

ROUSSEL CORPORATION

MESTRANOL

1615

III

11/18/1970

UNION CARBIDE CORPORATION

BAKELITE BRAND ETHYLENE ACRYLIC ACID COPOLYMER DRDA-2300 NATURAL 7/

1616

II

7/2/1970

DOLDER AND CO LTD

CHLORPROMAZINE HCL

1617

II

9/1/1998

TETRACYCLINE

1618

11/24/1970

1619

11/27/1970

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ABBOTT LABORATORIES PHARMACEUTICAL
PRODUCTS DIV
SAVAGE LABS INC

1620

11/28/1970

NATCON CHEMICAL COMPANY INC

NACOM'S PROCESSING & PACKAGING FACILITIES & CONTROLS

1621

11/27/1970

BEECHAM PHARMS DIV BEECHAM PRODS

PISCATAWAY, N.J. PLANT'S GENERAL OPERATING PROCEDURES

1622

II

11/19/1970

DIOSYNTH INC

SODIUM HEPARIN

1623

III

11/25/1970

DOW CHEMICAL CO MICHIGAN DIV

POLYSTYRENE PRODUCTS, COMPOSITION OF

1624

III

12/2/1970

UNION CARBIDE CORPORATION

BAKELITE, BRAND POLYETHYLENE RESIN

1625

II

12/7/1970

GENERAL ELECTRIC CO

FISSION PRODUCT XENON-133

1626

III

12/8/1970

PRODUCTS IN LCFLEX SERIES

1627

III

12/8/1970

CAPTIVE PLASTICS LLC WHOLLY OWNED SUB


BERRY PLASTICS CORP
VALSPAR CORP

1628

1629

1630

1631

1632

1633

1634

1635

1636

1637

1638

1639

1640

VITARINE COMPANY INC SUB WEST CHEMICAL


PRODUCTS INC
BRISTOL MYERS SQUIBB CO

TRIAMCINOLONE AND TRIAMCINOLONE ACETONIDE

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER

QUALITY ASSURANCE OPERATIONS STANDARDS MANUAL


MANUFACTURING PRACTICES

RESIN FORMULATIONS

NOT AN ASSIGNED NUMBER


I
II

12/16/1970

FOREST LABORATORIES INC

MANUFACTURING SITE,FACILITIES,OPERATING PROCEDURES, AND PERSONNEL.

12/22/1970

P-L BIOCHEMS INC

POLYINOSINIC-POLYCYTIDYLIC ACID (STERILE SOLUTION)

1/5/1971

NATIONAL INSTITUTE DRUG ABUSE

DELTA-9-TRANS-TETRAHYDROCANNABINOL-DELTA-9-TRANS-TETRAHYDROCANNABINOL

12/22/1970

TENNECO CHEMICALS INC

MANUFACTURING AND PACKAGING

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER
III

1/18/1971

EDWARD MENDELL CO INC

EXPLOTAB-PER CORRES 9.23.77 THIS DHAS BEEN SUPERSEDED BY DMF-3015

1/27/1971

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
NOT AN ASSIGNED NUMBER

ABBOTT LABS QUALITY ASSURANCE OPERATIONS STANDARDS MANUAL PHARM. DIV.

III

1/11/1971

COLE POLYMERS LTD

BEAD COPOLYMER GRADE DISS-120 MESH

1/5/1971

SYNERGY HEALTH STERILISATION UK LTD

III

1/15/1971

BAKELITE XYLONITE LTD

GAMMA RADIATION STERILIZATION PROCESSES AND FACILITIES AS LOCATED IN SWINDON,


ENGLAND
DFDG 4250 NATURAL LOW DENSITY POLYETHYLENE

Page 45

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1641 I
II
3/4/1971
UNITED STATES DEPARTMENT ENERGY

SUBJECT
GOLD 198 COLLOID (RADIOISOTOPE) (FORMERLY HELD BY UNION CARBIDE CORP)

1642

1643

1644

1645

1646

1647

1648

1649

II

2/1/1971

GD SEARLE AND CO

L-DOPA (OR LEVODOPA) IN BULK ONLY

1650

III

10/26/1970

LANXESS CORPORATION

STYRENE ACRYLONITRILE COPOLYMER

1651

2/8/1971

COVINTGON & BURLINGTON

AMINOFUSIN L600

1652

1653

1654

1655

II

1656

III

1657

1658

1659
1660
1661

1662

1663

1664

1665

1666

1667

1668

1669

1670

1671

II

1672

III
III

12/28/1970

USV PHARMACEUTICAL CORP SUB RORER GROUP METHODS, FACILITIES AND CONTROLS

1/6/1971

SHAW MUDGE & CO

ALLERDERM INTRUDER M3225

1/26/1971

ALCAN ROLLED PRODUCTS CO

ALUMINUM FOIL PACKAGING

11/23/1970

ALLIED CHEM CORP

R-40 POLYVINYL CHL. SHEET AND R-20A POLYVINYL CHL. SHEET

12/9/1970

CHEVRON PHILLIPS CHEMICAL CO LP

GULF HID 9414, 9406, 9410 RESIN

2/2/1971

ALUMINUM COMPANY OF AMERICA

PILFERPROOF CLOSURE (28MM)

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER
2/18/1971

MFGR PROCEDS,CTRLS,FACILS & PACKAGING P.RICO PLANT

1/28/1971

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ORTHO PHARMACEUTICAL CORP

1/29/1971

HUNTSMAN CHEMICAL CORP

POLYSTYRENE PRODUCTS--UNDER TRADE NAME HOSTYREN (FORMERLY TUF-FLEX)

2/19/1971

MEDWICK LABS INC

FACILITIES AND CONTROLS

3/2/1971

DOW CHEMICAL CO MICHIGAN DIV

DOWICIL 200 PRESERVAIVE

2/1/1971

CALBIOCHEM-BEHRING CORP

DL AND L-5-HYDROXYTRYPTOPHAN, 100MG AND 250MG CAPSULE

2/9/1971

THERMOPLASTIC PROCESSES INC

POLYVINYL CHLORIDE PLASTIC TUBING

III

2/16/1971

ALCAN ROLLED PRODUCTS CO

C-250 VINYL LACQUER LAMINATED FOIL & COATED FOIL

III

3/19/1971

WATSON STANDARD CO

LINING FOR ALUMINUM COLLAPSIBLE TUBES #XB-8298

3/4/1971

UPJOHN CO

U-32, 070E (25-HYDROXYCHOLECALCIFEROL)

3/2/1971

ALTANA INC

MANUF FACILITIES, PERSONNEL AND MANUF. CONTROLS

1/15/1971

AMERICAN CHEWING GUM INC

MANUF FACILS, PERSONNEL AND CONTROL INFORMATION

1/15/1971

DOW CORNING CORP

PERSONNEL HANDLING NEW DRUG SUBSTANCES

12/16/1970

SYNTEX USA INC

NORANDROSTENDIONE (NAD) --METHODS, FACILITIES AND CONTROLS

1/22/1971

HERCULES INC

HI-FAX A-60 008 NATURAL (HIGH DENSITY POLYETHYLENE PELLETS)

1/22/1971

HERCULES INC

HI-FAX B53-003 NATURAL (HIGH DENSITY ETHYLENE-BUTENE 1 COPOLYMER)

1/18/1971

ROXANE LABORATORIES INC

STERILE VALIDATION DAA FOR COLUMBUS, OHIO LOCATION

1/19/1971

LINSON LTD

DESONIDE

2/5/1971

MONSANTO COMPANY

SODIUM TRIMETAPHOSPHATE (NAPO3)3

1673

12/28/1970

BRONOPOL, A PRESERVAIVE IMPORTED FROM BOOTS PURE DRUG CO.,LTD/ENGLAND

1674

GOLDSCHMIDT CHEMICAL DIV OF WILSON


PHARMA & CHEMICAL CORP
NOT AN ASSIGNED NUMBER

1675

2/12/1971

MERCK SHARP & DOHME RESEARCH LABS

DROCODE BITARTRATE FROM NDA# 11-526

1676

3/5/1971

CALBIOCHEM-BEHRING CORP

L-TRYPTOPHAN

1677

3/12/1971

DANBURY PHARMACAL INC

PERSONNEL,FACILITIES AND CONTROLS

IV

II

ESTRADIOL 17-A-IN PROPYLENE GLYCOL : PARENTERAL

Page 46

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1678 I
3/15/1971
JWS DELAVAU CO INC

SUBJECT
DESCRIPTION OF PLANT

1679

11/23/1970

GANES CHEMICALS INC

ERIODICTYOL BULK

1680

1/22/1971

CROWN ZELLERBACH CORP

CROWN ZEELON 300P COMPOSITE FILM CONSTRUCTION

1681

3/26/1971

NATIONAL STARCH & CHEMICAL CORP

RESYN 30-1268

1682

1683

1684

1685

1686

III

1687

1688

1689
1690
1691

1692

1693

1694

1695

1696

III

2/26/1971

DOW CHEMICAL CO

POLYMER/COPOLYMER FORMULATIONS, ADHESIVES INCLUDED

1697

II

3/11/1971

GANES CHEMICALS INC

SODIUM THIAMYLAL FOR INJ MANUF BY SIEGFRIED LTD, SWITZERLAND

1698

III

3/29/1971

EQUISTAR CHEMICALS LP

PRO-FAX NATURAL POLYPROPYLENE MATERIALS

1699

3/26/1971

KEMWORTH LABS INC

1700

3/29/1971

ROBECO CHEMICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF CUSTOM LYPHILIZATION OF DRUGS FORHUMAN USE
SPERMWAX

1701

III

12/8/1970

DYLAN POLYETHYLENE 1020 F-40 RESIN COMPOUNDS-MANUF PLASTIC BOTTLES

1702

II

12/17/1970

ARCO CHEMICAL COMPANY DIV OF ATLANTIC


RICHFIELD CO
INQUIME INDS QUIMECA ESTENE SA

1703

II

12/30/1970

TROPONWERKE GMBH CO KG

BUPHENINE HCL(NYLIDRIN)

1704

II

4/20/1971

PFIZER INC

TINIDAZOLE BULK

1705

4/14/1971

CALIF RADIOCHEMICALS INC

EXTRACTION OF TC-99M FROM MO-99 SOURCE

1706

1707

III

4/16/1971

DOW CHEMICAL CO

EXPERIMENTAL FILM PZ-2005.07

1708

III

4/16/1971

REXHAM CORP

RPL-1

1709

4/22/1971

JOHN DICKINSON & COMPANY LTD

POUCHES SUPPLIED TO NORTH HILL PLASTICS, LTD.

1710

II

4/23/1971

SSL INTERNATIONAL

CHLORHEXIDINE GLUCONATE 20% SOLUTION MANUFACTURED IN BRISTOL, UK

1711

III

4/14/1971

EASTMAN CHEMICAL CO

TENITE POLYETHYLENE 1572E-60804, WHITE

1712

1713

II

4/28/1971

LILLY RES LABS DIV ELI LILLY CO

INSULIN DRUG SUBSTANCES

1714

IV

4/30/1970

GIVAUDAN ROURE CORP

FLAVORS

III

NOT AN ASSIGNED NUMBER


III

3/18/1971

ALBEA AMERICAS INC

4/9/1971

GANES CHEMICALS INC

GLAMINATE (R) TUBES, MANUFACTURED IN WASHINGTON, NJ, SHELBYVILLE, TE AND


CLEVELAND, OH
MANUFACTURE OF METHAQUALONE & METHAQUALONE HCL

4/12/1971

ACETO CHEMICAL CO INC

DEXTROPROPOXYPHENE IN BULK

4/9/1971

COMMONWEALTH PACKAGING CORP

CONTRACT PACKAGING OF DRUGS

III

4/9/1971

NASHUA CORP

WP-1 AND RX-1 LABEL ADHESIVES

II

3/2/1971

GENERAL ELECTRIC CO

IODINE-131 AS SODIUM IODIDE IN SODIUM HYDROXIDE--FISSION PRODUCT

3/2/1971

GENERAL ELECTRIC CO

MOLYBDENUM-99 AS AMMONIUM MOLYBDATE IN AMMONIUM HYDROXIDE-FISSION PROD

3/2/1971

GENERAL ELECTRIC CO

MOLYBDENUM-99 AS SODIUM MOLYBDATE IN SODIUM HYDROXIDE--FISSION PRODUCT

1/22/1971

CALBIOCHEM CORP

MANUFACTURING PROCEDURE FOR 5-AZACYTIDINE

II

NOT AN ASSIGNED NUMBER


III

4/20/1971

RT VANDERBILT CO

VANCIDE FP

12/29/1970

REXENE CORP

POLYETHYLENE PE 253 MANUFACTURED IN ODESSA, TEXAS.

NOT AN ASSIGNED NUMBER

PHENYLBUTAZONE USP

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER

Page 47

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1715 I
5/25/1971
AMCON INDUSTRIES INC

SUBJECT
AMGLO FILM COATING BASE

1716

5/25/1971

BEECHAM PHARMACEUTICALS UK DIVISION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1717

IV

8/18/1969

ESSCHEM CO DIV SARTOMER RESINS INC

ETHYLENE GLYCOL DIMETHACRYLATE

1718

5/25/1971

BILCHEM LTD

GEN OPER PROCEDS OF WESTERN FHER LABORATORIES, INC.

1719

5/25/1971

SERVASSEM DIV METAL EDGE INDS

FACILITIES & CONTROL USED IN PACKAGING & LABELS OF DRUGS

1720

5/17/1971

PHYSIOLOGICAL POLYMERS INC

P.H.P. POLYMER

1721

4/26/1971

NORTHVILLE LABORATORIES

FORMULATION FOR CINNAMON EXTRACT

1722

5/17/1971

CALBIOCHEM-BEHRING CORP

INOSINNE (CALBIOCHEM CA. #800101)

1723

5/18/1971

MANUF&CONTROL FACILITIES&PROCEDURES AT SUBSIDIARY PLANT BARCELONETA,PR

1724

5/28/1971

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
DOW CORNING CORP

1725

III

5/12/1971

DOW CHEMICAL CO

DOW POLYETHYLENE RESINS

1726

III

6/8/1971

FLUID CHEM CO

COMPOUNDING OR PACKAGING

1727

II

5/25/1971

U.S. DEPARTMENT OF ENERGY

RADIOISOTOPE MOLYBDENUM-99-P-4 (FORMERLY HELD BY UNION CARBIDE CORP)

1728

6/9/1971

AMERICAN CYANAMID CO

DIOCTYL CALCIUM SULFOSUCCINATE

1729

6/1/1971

RP SCHERER CORP

DIOCTYL SODIUM SULFOSUCCINATE 100MG & GASANTHRANOL 30MG. CAPSULES.

1730

5/28/1971

TARO VIT CHEMICAL INDS

CHLORPROMAZINE HCL

1731

3/11/1971

FERRO CORP

STABILIZER FOR VINYL PLASTICS, FERRO 760X, 765B, 5376, 5650

1732

6/8/1971

WITCO CHEM CO INC

NON-TOXIC VINYL STABILIZERS, MARK 577A, MARK 152, MARK 329

1733

6/8/1971

GEMA SA

NITROFURANTOIN U.S.P

1734

IV

5/6/1971

STEPAN CHEMICAL COMPANY

SUPER-PRO 5A, AND SURFA M-801

1735

IV

4/20/1971

GIVAUDAN CORPORATION

FLAVORINGS

1736

IV

5/13/1971

UNIVERSAL FOODS CORP

FORMULATIONS FOR FLAVORINGS AND COLORANTS

1737

6/10/1971

DUPONT PHARMACEUTICALS CO

PERSONNEL, FACILITIES AND CONTROLS

1738

II

6/10/1971

SYNTEX USA INC

MEGESTROL ACETATE

1739

1/18/1971

EI DUPONT DE NEMOURS AND CO

TEFLON: FLUOROCARBON RESINS

1740

II

6/15/1971

ER SQUIBB AND SONS INC

MYCOSTAIN (NYSTATIN)

1741

II

6/14/1971

TARO VIT CHEMICAL INDS

CHLORPROMAZINE HCL

1742

III

6/15/1971

AMERICAN CYANAMID CO

UREA-FORMALDEHYDE RESIN (BEETLE MUP-01)

1743

6/7/1971

DRAGOCO INC

MICROSEAL IMITATION ORANGE-PINEAPPLE FLAVOR

1744

6/21/1971

PREMO PHARMACEUTICAL LABORATORIES INC

GENERAL PLANT AND MANUF PROCEDURE

1745

2/9/1971

FELTON WORLDWIDE INC

FELCOFIX IMITATION PINEAPPLE #952 (CODE #10650)

1746

6/18/1971

NATIONAL NOVELTY BRUSH

COMPRESSION-MOLDED CLOSURES

1747

6/16/1971

AVICON INC

AVITENE R COLLAGEN

1748

II

6/21/1971

SANOFI CHIMIE

DEXAMETHASONE MANUFACTURED IN VERTOLAYE, FRANCE

1749

III

6/17/1971

AMETEK-WESTCHESTER PLASTICS

WHITE UNICOLOR (POLYETHYLENE COLOR CONCENTRATES)

1750

2/3/1971

DELMAR CHEMS LTD

METHAQUALONE BASE AND METHAQUALONE HCL

1751

6/29/1971

DELMAR CHEMS LTD

CHLORPROMAZINE HCL

1752

6/29/1971

REXOLIN CHEMS AB

MEPROBAMATE

II
III

III

II

SILASTIC 1808 ELASTOMER

Page 48

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1753 I
II
6/25/1971
MONSANTO COMPANY

SUBJECT
L-3-O-METHYLDOPA

1754

6/29/1971

UPJOHN CO

(U-31, 583) 1-B-D-ARABINOFURANOSYLCYTOSINE 5'-PALMITATE

1755

7/2/1971

KETCHUM LABORATORIES INC

FACILITIES, CONTROL AND PERSONNEL

1756

6/23/1971

BANNER PHARMACAPS INC

SOFT GELATIN CAPSULES

1757

6/21/1971

WELLCOME FOUNDATION LTD

COMPOUND 57C65

1758

5/24/1971

HEINRICH MACK NACHF

CYTOSINE-ARABINOSIDE HCL & CYSTOSINE-ARABINOSIDE FREE BASE

1759

1760

III

7/14/1971

ANCHOR CAP & CLOSURE CORP OF CANADA LTD

CLOSURES FOR CONTAINERS (METAL SCREW CAP)

1761

III

7/9/1971

INEOS ACRYLICS UK LIMITED

METHYL METHACRYLATE

1762

7/14/1971

VICTOR M HERMELIN CO DIV K-V PHARMACAL CO

BONTRIL #1 TIMED TABLETS AND BONTRIL #2 TIMED TABLETS

1763

II

7/19/1971

ORGANON SUB AKZONA INC

PROGESTERONE

1764

6/28/1971

MAURRY BIOLOGICAL CO INC

MANUFACTURE, PROCESSING AND PACKAGING DRUGS

1765

III

7/27/1971

NORTHERN PETROCHEMICAL COMPANY

NORCHEM LOW DENSITY POLYETHYLENE NPE 80

1766

II

7/28/1971

ORGANON SUB AKZONA INC

ANDROSTERONE

1767

6/28/1971

LYPHOMED INC

MANUFACTURING FACILITIES AND OPERATIONAL CONTROLS

1768

1769

1770

1771

1772

1773

1774

1775

IV

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER


7/26/1971

AS SYNTHETICS

PHENYLBUTAZONE

7/26/1971

LA QUINOLEINE

5-CHLORO-8-HYDROXYQUINOLINE (CHLOROHYDROXYQUINOLINE)

7/26/1971

HEINRICH MACK NACHF

5-IODO-2'-DEOXY-URIDINE

7/29/1971

AMERICAN CYANAMID CO

STERWIN COMPOUND 904

8/2/1971

CUTTER BIOL DIV MILES LABS INC

NORTON PLASTIC S-500-304

8/2/1971

ELI LILLY AND CO

ASPIRIN CAPSULES 325MG

8/9/1971

CROMPTON AND KNOWLES CORP

SALICYLAZOSULFAPYRIDINE

1776

8/9/1971

TANABE SEIYAKU CO LTD

SODIUM THIOPENTAL INJECTION

1777

8/9/1971

GOTHAM PHARMACEUTICAL COMPANY INC

METHODS, FACILITIES AND CONTROLS

1778

8/10/1971

ACETO CHEMICAL CO INC

IMIPRAMINE HCL IN BULK

1779

II

8/17/1971

PCR INC

CHLORPROMAZINE HCL

1780

II

8/21/1971

FREDERIKSBERG CHEM LABS LTD

CORTICOTROPIN (ACTH)

1781

8/16/1971

BURJON INC

PACKAGING OF TOPICAL POWDERS

1782

9/1/1971

CYCLO CHEM CO

CYCLOCHEM SPS

1783

9/2/1971

METHAPYRILENE HCL

1784

9/2/1971

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
WYETH INC

1785

II

9/7/1971

US ATOMIC ENERGY COMMISSION

12 RADIOISOTOPE PRODUCTS

1786

II

9/7/1971

BURDICK & JACKSON LABS,INC

METHDILAZINE; METHDILAZINE HCL

1787

9/13/1971

MANUFACTURING CHEMISTS INC

FACILITIES AND PERSONNEL

1788

9/13/1971

AMERICAN CYANAMID CO

CYASORB UV-9---SPECTRA-SORB

1789

NOT AN ASSIGNED NUMBER

1790

NOT AN ASSIGNED NUMBER

II

II

MANUFACTURING FACILS A HAVANT PLANT, HAMPSHIRE, ENGLAND

Page 49

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1791 I
II
9/13/1971
NAPP-LEMKE CHEMS INC

SUBJECT
ISOSORBIDE DINITRATE

1792

9/15/1971

RP SCHERER CORP

CAPSULES VITAMIN D, 50,000 UNITS (1.25MG)

1793

III

9/16/1971

AMERICAN NATIONAL CAN CO

CONOLAM 5000 PACKAGING MATERIAL (FORMERLY HELD BY CONTINNETAL CAN CO

1794

III

9/16/1971

AMERICAN NATIONAL CAN CO

CONOLAM 6000 PACKAGING MATERIAL (FORMERLY HELD BY CONTINENTAL CAN CO

1795

9/13/1971

MIRANOL CHEM CO

MIRANOLC2M CONCENTRATE

1796

9/9/1971

ALDRICH CHEMICAL COMPANY INC

1797

9/20/1971

COLAB LABS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WISCONSIN.
CALGITEX PRODUCTS

1798

10/27/1970

FLINT HILLS RESOURCES LP

POLYETHYLENE PE102 MANUFACTURED IN ODESSA, TEXAS.

1799

9/20/1971

RP SCHERER CORP

CAPSULES VIT. A, 50,000 UNITS (15.0MG) AND 100,000 UNITS (30.0MG)

1800

II

9/20/1971

CIBA GEIGY CORP

2(2'-HYDROXY-5-METHYLPHENYL) BENZOTRIAZOLE

1801

9/22/1971

UNIT PACK COMPANY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

1802

II

9/21/1971

MALLINCKRODT INC

METHADONE HCL FLAVORED CONCENTRATE

1803

9/27/1971

H LUNDBECK AND CO AS

LU 3-010

1804

II

9/24/1971

TANABE SEIYAKU CO LTD

L-ALANINE

1805

II

9/24/1971

TANABE SEIYAKU CO LTD

L-PROLINE

1806

II

9/20/1971

TANABE SEIYAKU CO LTD

L-SERINE

1807

9/29/1971

LUDLOW FLEXIBLE PACKAGING

PACKAGING MATERIALS

1808

8/24/1971

REGIS CHEM CO

6-HYDROXYDOPAMINE (6-OHDA)

1809

9/30/1971

CENTERCHEM INC

METHSCOPOLAMINE BROMIDE, N.F. XIII

1810

10/18/1971

DELMAR CHEMS LTD

GENERAL INFORMATION ON FACILITIES & CONTROL

1811

10/14/1971

TERA PHARMS INC

FACILS CONTROLS AND PERSONNEL

1812

10/19/1971

FISONS CORP

FACILITIES, CONTROLS, EQUIP & PERSONNEL (INTAL)

1813

10/18/1971

KV PHARMACEUTICAL CO

ORTHO-NOVUM 1/5OE21

1814

II

10/22/1971

LILLY RES LABS DIV ELI LILLY CO

IRON BILE SALTS CAPSULES

1815

II

10/20/1971

CALBIOCHEM-BEHRING CORP

URIDINE

1816

II

10/22/1971

OLIN CHEMICAL CORP

OMADINE MDS (MAGNESIUM SULFATE ADDUCT OF PYRIDINETHIONE DISULFIDE)

1817

II

11/21/1971

PHARMACIA AND UPJOHN SUB PFIZER INC

MEGESTROL ACETATE

1818

III

11/21/1971

EMERY IND INC

PLASTOLEIN 9250

1819

IV

11/2/1971

EGON MEYER SA

EMAPLAST 812

1820

II

11/10/1971

GLAXO LABS LTD

CEPHALEXIN

1821

II

11/17/1971

ABBOTT LABORATORIES

SUCCINYLCHOLINE CHL MANUFACTURE

1822

II

11/12/1971

GYMA LABORATORIES OF AMERICA INC

PROPOXYPHENE HYDROCHLORIDE

1823

III

11/22/1971

BF GOODRICH COMPANY

RUBBER COMPOUNDS 117254, 59386-F

1824

11/29/1971

CARROLL CHEM CO DIV SPERTI DRUG CORP

STANDARD OPERATING PROCEDURE

1825

11/29/1971

SPECIALTY COATING SYSTEMS INC

BAKELITE BRAND PARAYLENE N AND C

1826

12/6/1971

ALLIED CHEM CORP

PHENYLBUTAZONE

1827

12/6/1971

SUMITOMO CHEMICAL CO LTD

AC - 485 MICROBEADS

1828

12/6/1971

DREVCO CORP

DESCRIPTION OF OUR PLANT AND FACILITIES

III

II

III
II

Page 50

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1829 I
11/22/1971
CHEMICAL CORPORATION OF AMERICA INC

SUBJECT
CADOX BCP - SILICA - TALC

1830

II

12/9/1971

SIGMA CHEM CO

CARBAMYL PHOSPHATE, DILITHIUM SALT

1831

II

12/17/1971

TANABE SEIYAKU CO LTD

L - TYROSINE ETHYLESTER MONOHYDROCHLORIDE

1832

II

12/17/1971

TANABE SEIYAKU CO LTD

DL - METHIONINE

1833

II

12/17/1971

TANABE SEIYAKU CO LTD

L-GLUTAMINE

1834

II

11/22/1971

HOECHST CELANESE CORP

FUROSEMIDE

1835

II

12/6/1971

TANABE SEIYAKU CO LTD

L-LYSINE MONOHYDROCHLORIDE

1836

III

12/3/1971

REXENE CORP

POLYETHYLENE RESIN PE 117 MANUFACTURED IN ODESSA, TEXAS.

1837

12/22/1971

FISONS CORP

CROMOLYN SODIUM/LACTOSE BLEND

1838

III

11/24/1971

GUTMANN PLASTICS INC

PACKAGING MATERIALS AS MFG IN BROOKLYN, NEW YORK

1839

II

12/16/1971

COPPERHEAD INVESTMENTS INC

SDM-17 (10% NITROGLYCERIN IN LACTOSE) MANUFACTURED IN TAMAQUA, PA

1840

IV

11/22/1971

SARTOMER RESINS INC

SR 205, TRIETHYLENE GLYCOL DIMETHACRYLATE

1841

12/6/1971

ESSCHEM CO DIV SARTOMER RESINS INC

SR-240-2-HYDROXYETHYL METHACRYLATE

1842

12/14/1971

ROBECO CHEMICALS INC

CETINA

1843

12/30/1971

COOPER LABORATORIES INC

PLIAGEL (TM) CONTACT LENS CLEANER

1844

12/22/1971

FLAVOR FORMULATIONS

1845

12/28/1971

PHARMACEUTICAL FLAVOR CLINIC DIV FOOTE


AND JENKS
LETRASET LTD

1846

II

12/22/1971

ROUSSEL CORPORATION

NORETHINDRONE ACETATE

1847

III

1/4/1972

DOW CHEMICAL CO

BAKELITE BRAND POLYETHYLENE RESIN

1848

12/15/1971

AMPICILLIN TRIHYDRATE (PEDIARIC DROPS)

1849

1/7/1972

BEECHAM-MASSENGILL PHARMS DIV BEECHAM


INC
SIMKINS INDS INC

1850

11/15/1971

DEWEY AND ALMY CHEM DIV WR GRACE AND CO

THERMOPLASTIC COATINGS---TC AMR 12; TC AMR 22; AND TC AMR 44

1851

12/14/1971

UNION CARBIDE CORPORATION

TERGITOL MONIONIC SURFACTANT 12-M-10

1852

1/10/1972

BORDEN CHEM CO

2-HYDROXYETHYL METHACRYLATE

1853

12/17/1971

SHANKMAN LABS

FACILITIES AND PERSONNEL

1854

III

1/12/1971

DUPONT DENEMOURS & CO

TYVEK SPUNBONDED OLEFIN

1855

II

1/7/1972

EUTICALS LIMITED

ISOSORBIDE DINITRATE BULK

1856

7/17/1969

ALCOLAC CHEM CORP

SIPOMER HEM (HYDROXYETHYL METHACRYLATE

1857

1/17/1972

PALMER RESEARCH LABS

ISOSORBIDE DINITRATE TRITURATE

1858

1/18/1972

BARGER PACKAGING CORP

PACKAGING FACILITIES AND CONTROL

1859

1/20/1972

BURTON,PARSONS & COMPANY,INC.

BOILSOAK---BUFFERED NORMAL SALINE SOLUTION

1860

II

1/26/1972

CAMBREX PROFARMACO MILANO SRL

NITROFURANTOIN MACROCRYSTALS

1861

II

1/26/1972

CAMBREX PROFARMACO MILANO SRL

NITROFURANTOIN

1862

II

1/25/1972

MALLINCKRODT INC

NALOXONE HCL USP DIHYDRATE AS MANUFACTURED IN ST LOUIS MO

1863

2/4/1972

CINTICHEM INC

MANUFACTURING FACILS.-(THIS FORMERLY HELD BY UNION CARBIDE CORP)

1864

2/2/1972

CALBIOCHEM-BEHRING CORP

GAMMA-HYDROXYBUTYRIC ACID SODIUM SALT

1865

1/17/1972

EASTMAN CHEMICAL CO

TENITE ACETATE 036E-00969-H2

1866

1/19/1972

HOOKER CHEM CORP

DODECYL MERCAPTAN

IV
IV

III

II

III

LABEL FOR INCORPORATION IN BLOOD BAG

FACILITIES, ANDMANUFACTURE PROCEDURES

Page 51

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1867 I
2/8/1972
PARKE DAVIS & CO

SUBJECT
HYDROGEN PEROXIDE SOLUTION 3%

1868

III

1/28/1972

EASTMAN CHEMICAL CO

EASTMAN DOP PLASTICIZER

1869

II

12/5/1971

TEVA PHARMACEUTICAL INDUSTRIES LTD

PROBENECID

1870

IV

10/20/1971

DOW CHEMICAL CO

METHOCEL

1871

2/14/1972

AMERICAN BIO SYNTHETICS CORP

METHYLENE CASEIN-ESMA TAB NO. 609

1872

2/14/1972

MEDI PHYSICS INC

SPECIFICATION AND PLANT PROCEDURES IN MANUFACTURING

1873

2/23/1972

PARKE DAVIS & CO

METHAQUALONE HYDROCHLORIDE & METHAQUALONE BASE

1874

2/25/1972

PHARMACHEM CORP

EXTRACELLULAR WATER SOLUTION (ECWASOL)

1875

2/22/1972

FANSTEEL METALS DIV FANSTEEL INC

TANTALUM MEDICAL POWDER

1876

2/24/1972

PACKAGING COORDINATORS INC

PACKAGING OPERATIONS IN PHILADEPHIA, PA

1877

3/1/1972

DOW CHEMICAL CO MICHIGAN DIV

POLYTHIOL RESIN

1878

2/27/1972

BIO NUCLEAR INC

MANUFACTURING FACILITIES IN DALLAS TEXAS

1879

2/25/1972

SYMRISE INC

FLAVORS

1880

2/27/1972

BIO NUCLEAR INC

MANUFACTURING FACILITIES HIALEAH FLORIDA

1881

3/3/1972

DEXTER CORPORATION

V-1243 AND V-1269 COATING MATERIALS.

1882

3/6/1972

GANES CHEMICALS INC

HEXAFLUORENIUM BROMIDE

1883

3/8/1972

SYNCOR INTERNATIONAL CORP

FACILITIES AND SUPERVISORY PERSONNEL

1884

3/7/1972

BIO NUCLEAR INC

FACILITIES AND SUPERVISORY PERSONNEL, TEXAS PLANT

1885

3/7/1972

HASTINGS RADIOCHEMICAL WORKS

PLANT FACILITIES, FLORIDA

1886

3/7/1972

HASTINGS RADIOCHEMICAL WORKS

FACILITIES AND SUPERVISORY PERSONNEL, DALLAS PLANT

1887

3/7/1972

BIO NUCLEAR INC

FACILITIES AND SUPERVISORY PERSONNEL N.O. PLANT

1888

II

3/8/1972

MEDI PHYSICS INC

99M TC-PERTECHNETATE-SULFUR COLLOID

1889

II

3/10/1972

UNIV OF WISCONSIN

1,25-DIHYDROXYCHOLECALCIFEROL

1890

3/8/1972

CIBA GEIGY CORP

PERSONNEL

1891

IV

7/21/1971

DOW CORNING CORP

MDX-4-4159 FLUID

1892

3/14/1972

PFIZER PHARMS DIV CHAS PFIZER AND CO INC

DESCRIPTION OF FACILS AND PERSONNEL OF DEVELOPMENTAL RESEARCH

1893

III

3/14/1972

BEMIS HEALTHCARE PACKAGING INC

PAPER & VINYL ADHESIVE COATING

1894

3/20/1972

AMERICAN LABS

COENZYME I-10

1895

7/11/1986

GEDEON RICHTER LTD

ETHYNODIOL DIACETATE AS MFG. IN BUDAPEST, HUNGARY

1896

3/24/1972

CEDONA HAARL PHARM FABRIEK NV

CEDOCARD TABLETS (ISOSRBIDE NITRATE)

1897

1898

1899

1900

1901

1902

1903

II

III

IV

II

NOT AN ASSIGNED NUMBER


3/21/1972

BIP CHEMICALS LTD

UREA-FORMALDEHYDE MOULDING

3/1/1972

TANABE SEIYAKU CO LTD

GLYCINE (AMINOACETIC ACID)

1/5/1971

F RITTER & CO

IMITATION VANILLA CONCENTRATE 20 X #20

2/2/1972

ETHYL CORP

ETHYL 8237 POLYVINYL CHLORIDE

3/20/1972

PIERCE & STEVENS CHEMICAL CORPORATION

PROXMELT A-4624

3/16/1972

PUERTO RICO PLASTIC PRODUCTS CO INC

FORTIFLEX B54-25H

1904

3/26/1972

BAKELITE XYLONITE LTD

BAKELITE POLYETHYLENE DND2450 NATURAL & PX527/1 NATURAL

1905

3/8/1972

PLANTEX LTD CHEM AND PHARM WORKS

L - DOPA

II
III

Page 52

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1906 A
II
3/8/1972
TEVA PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
IMIPRAMINE HYDROCHLORIDE

1907

3/7/1962

PLANT INDUSTRIES INC

SELVAC CONTAINERS

1908

3/27/1972

AMERICAN CAN

PLASTIC BOTTLES

1909

3/27/1972

ALLIED CHEM CORP

HYDRALAZINE HCL

1910

3/28/1972

PARKE DAVIS & CO

CI -404 - ACTINOBOLIN SULFATE

1911

4/4/1972

GANES CHEMICALS INC

8 - BROMOTHEOPHYLLINE

1912

4/10/1972

WHATMAN BIOCHEMS LTD

SODIUM CELLULOSE PHOSPHATE

1913

II

4/5/1972

LUNDBECK PHARMACEUTICALS ITALY SPA

IMIPRAMINE HYDROCHLORIDE

1914

II

4/12/1972

TROPONWERKE GMBH CO KG

GLUTETHIMIDE

1915

4/12/1972

SCHERING CORP SUB SCHERING PLOUGH CORP

FACILITIES A KENILWORTH, NEW JERSEY

1916

III

4/5/1972

AMOCO CORP

AMOCO'S POLYPROPYLENE RESINS FOR DRUG PACKAGING

1917

4/14/1972

SANOFI WINTHROP INC

MANUFACTURING FACILITIES AND CONTROLS

1918

4/17/1972

TRAVENOL LABORATORIES INC

POLYOLEFIN (PL325 PLASTIC) CONTAINERS

1919

4/17/1972

WARNER LAMBERT CO

MANUFACTURING, FACILITIES, CONTROLS

1920

II

4/17/1972

ROUSSEL CORPORATION

NORETHINDRONE

1921

4/20/1972

MONSANTO COMPANY

POLYVINYL CHL PLASTIC - VYRAM 2830,2831, 2880

1922

4/27/1972

CUTTER LABORATORIES INC

CONCENTRATED PERITONEAL DIALYZING SOLUTIONS WITH SORBITOL

1923

5/1/1972

ELI LILLY AND CO

NITROGLYCERIN AMPOULES

1924

5/1/1972

RP SCHERER CORP

OXYPHENBUTAZONE CAPSULE 100MG

1925

5/1/1972

RP SCHERER CORP

PHENYLBUTAZONE CAPSULES 100MG

1926

5/3/1972

HELVOET PHARMA NV

BUTYL RUBBER STOPPER FM 50

1927

4/7/1972

BADISCHE ANILIN UND SODA FABRIKEN AG

LUTONAL I 30 POLY (ISOBUTYL VINYL ETHER)

1928

II

5/9/1972

TANABE SEIYAKU CO LTD

L-TYROSINE

1929

II

5/9/1972

TANABE SEIYAKU CO LTD

L-ARGININE BASE

1930

II

5/9/1972

TANABE SEIYAKU CO LTD

L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE

1931

II

5/9/1972

TANABE SEIYAKU CO LTD

L-HISTIDINE BASE

1932

5/16/1972

TANABE SEIYAKU CO LTD

L-ASPARAGINE MONOHYDRATE

1933

11/15/1971

DRUG PLASTICS AND GLASS CO INC

PLASTIC BOTTLES

1934

5/15/1972

NAPP CHEMICALS INC

PROBENECID, USPXVIII

1935

5/18/1972

DOLDER AND CO LTD

IMIPRAMINE HCL

1936

III

5/22/1972

ELI LILLY AND CO

POLYETHYLENE PLASTIC BOTTLES

1937

II

5/15/1972

TANABE SEIYAKU CO LTD

L-LYSINE ACETATE

1938

II

5/17/1972

MINN 3M LABS LTD

ISOETHARINE SALTS INCLUDING ISOETHARINE MESYLATE

1939

IV

5/18/1972

ABITEC CORP

SYNTHETIC VEGETABLE OILS--CAPTEX 200, 300, & 350

1940

5/31/1972

INTERNATIONAL MEDICATION SYSTEMS LTD

MANUFACTURING PROCEDURES

1941

III

5/30/1972

AMCOR FLEXIBLES SINGEN GMBH

LACQUER FORMULAE AND FOIL COMBINATIONS AS MANUFACTURED IN SINGEN GERMANY

1942

III

6/1/1972

INTERNATIONAL SPECIALTY PRODUCTS

N-VINYLPYRROLIDONE

1943

6/5/1972

YOSHITOMI PHARMACEUTICAL INDUSTRIES LTD

CHLORPROMAZIN HCL

1944

6/5/1972

CLARKOTE CHEMICAL CO INC

HEAT SEAL VINYL COATING #1098

II
II

III

III

Page 53

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1945 I
6/5/1972
GELMAN INSTRUMENT CO

SUBJECT
MEDICAL INSTRUMENTATION--MEMBRANE FILTERS & RELATED EQUIP.

1946

1947

1948

1949

1950

5/24/1972

GLAXO WELLCOME INC

FACILITIES & CONTROLS OF THE WELLCOME FOUNDATION IN KENT ENGLAND

6/7/1972

ICN NUTRITIONAL BIOCHEMS DIV

L PROLYL L LEUCYL GLYCINE AMIDE (L PLGA)

II

6/9/1972

LABORATORI DERIVATI ORGANICI

SODIUM HEPARIN

II

6/9/1972

SANOFI CHIMIE

PROMETHAZINE HCL

6/14/1972

ACETO CHEMICAL CO INC

PROPANTHELINE BROMIDE BULK

1951

6/14/1972

DELUCA HECTOR F PHD

5, 6 - TRANS-VITAMIN D3

1952

6/14/1972

DELUCA HECTOR F PHD

5,6 - TRANS - 25 - HYDROXYVITAMIN D3

1953

6/19/1972

AUTOMATED OPTICS INC

N-VINYL-2-PYRROLIDONE (N-VP); 2-HYDROXYETHYL METHACRYLATE (HEMA)

1954

6/19/1972

EI DUPONT DE NEMOURS AND CO

1. TYZOR TE ORGANIC TITANATE2.TYZOR TPT

1955

6/19/1972

NAPP CHEMICALS INC

PROMETHAZINE HCL (THIS DORIG HELD BY VITAMERICAN CORP BY DOLDER LTD

1956

6/23/1972

CONSUPAK INC

CONSUPAK BRAND POLYETHYLENE BOTTLES

1957

1958

6/30/1972

REHEIS CHEM CO DIV ARMOUR AND CO

BASIC ALUMINUM BROMIDE

1959

6/30/1972

EASTMAN KODAK CO

N,N- DIMETHYL - P -TOLUIDINE

1960

III

7/6/1972

NATL PATENT DEVELOPMENT CORP

HYDRON TM BIOMEDICAL POLYMER TYPE N

1961

IV

6/30/1972

UNION CARBIDE CORPORATION

CELLOSIZE HYDROXYETHYL CELLULOSE

1962

III

6/20/1972

BASELL USA INC

PRO-FAX 6313;6413;6513 NATURAL POLYPROPYLENE(FORMERLY HELD BY HERCULES

1963

III

6/20/1972

PRO-FAX 6528 NATURAL POLYPROPYLENE (FORMERLY HELD BY HERCULES)

1964

7/11/1972

EQUISTAR CHEMICALS LP A LYONDELLBASELL


INDUSTRIES CO
MINN 3M LABS LTD

1965

7/17/1972

DEWEY AND ALMY CHEM DIV WR GRACE AND CO

DAREX EXPERIMENTAL COMPOUND H-1453

1966

7/17/1972

PFIZER INC

QUALITY CONTROL INFORMATION FOR NDA ANTIBIOTIC

1967

2/20/1970

P ROBERTET INC

DERMODOR 4775

1968

7/17/1972

TEKNI PLEX INC

FLEXIBLE LAMINATES MANUFACTURED IN FLEMINGTON, NEW JERSEY.

1969

7/21/1972

GANES CHEMICALS INC

PROBENECID

1970

7/24/1972

UPJOHN CO

ARA-CYTIDINE 5 - BENZOATE (U - 32,072E)

1971

7/24/1972

WATSON STANDARD CO

LACQUER PE-1090-21

1972

7/27/1972

ASHLAND CHEM CO DIV ASHLAND OIL INC

5-CHLORO-8-HYDROXYQUINOLINE

1973

7/27/1972

EASTMAN KODAK CO

GLYCOLIDE

1974

8/2/1972

PHENCHEM INDUSTRIES LTD

PROMETHAZINE HYDROCHLORIDE

1975

7/1/1972

TITE PAK INC

PERSONNEL FACILITIES AND CONTROL

1976

II

7/24/1972

SANOFI AVENTIS DEUTSCHLAND GMBH

D-PROPOXYPHENE HYDROCHLORIDE BULK

1977

IV

7/28/1972

SCHERER HARTKAPSEL GMBH

EMPTY GELATIN CAPSULES (HARD SHELL)

1978

III

7/10/1972

EQUISTAR CHEMICALS LP

NORCHEM'S POLYETHYLENE RESIN NPE-810--PRODUCTION & SPECS FOR

1979

IV

8/4/1972

LILLY RES LABS DIV ELI LILLY CO

COMPOUND 56997-SWEETENING AGENT (TETRAZOLE)

1980

II

8/8/1972

LILLY RES LABS DIV ELI LILLY CO

STERAPS SULFATHIAZOLE 2.5GM, 5GM

1981

8/16/1972

TRAVENOL LABORATORIES INC

STERILITY TESTING OF LARGE VOLUME PARENTERAL SOLUTION

1982

II

NOT AN ASSIGNED NUMBER

I
III

III

METHAGUALONE AND METHAGUALONE HYDROCHLORIDE

NOT AN ASSIGNED NUMBER

Page 54

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
1983 I
8/10/1972
VERNAY LABORATORIES INC

SUBJECT
VL201N25 & VL201X22 COMPOUNDS

1984

II

8/11/1972

MINN 3M LABS LTD

ISOETHARINE HCL USP & NUMOTAC TABLETS WITH ISOETHARINE HCL

1985

II

8/16/1972

BAYER PHARMA AG

ETHINYL ESTRADIOL

1986

8/25/1972

BURTON,PARSONS & COMPANY,INC.

FLEXSOL CLEANING SOLUTION

1987

IV

8/25/1972

BURTON,PARSONS & COMPANY,INC.

PREFLEX, NORMAL--FLEXSOL CLEANING & STORAGE SOLUTION

1988

II

8/28/1972

SEARLE

NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE

1989

8/30/1972

M AND T CHEMS INC SUB AMERICAN CAN

APOSET 445P

1990

II

9/1/1972

TANABE SEIYAKU CO LTD

AMINO ACID MIXTURE

1991

III

8/7/1972

GLENROY INC

PACKAGING FILMS

1992

II

9/7/1972

SWORDS LABORATORIES LTD

FLUPHENAZINE DECANOATE

1993

II

9/9/1972

TANABE SEIYAKU CO LTD

L-GLUTAMIC ACID

1994

9/18/1972

SHIONOGI AND CO LTD

2A,3A-EPITHIO-5A-ANDROSTAN-17B-OL (10275-S) EPITIOSTANOL

1995

9/20/1972

ASHLAND CHEM CO DIV ASHLAND OIL INC

5,7-DICHLORO-8-HYROXYQUINOLINE

1996

1997

1998

1999

2000

2001

2002

NOT AN ASSIGNED NUMBER


III

9/14/1972

GIST BROCADES

HYDROCORTISONE BULK

7/31/1972

WEST PHARMACEUTICAL SERVICES INC

ACRYLONITRILE RESINS: TYRIL 867 SERIES

NOT AN ASSIGNED NUMBER


9/29/1972

CLINTON CORN PROCESSING CO

HIGH FRUCTOSE CORN SYRUPS

9/29/1972

ROUSSEL CORPORATION

CHENODEOXYCHOLIC ACID

9/29/1972

MIDLAND DIVISION DEXTER CORPORATION

V-746 VALVE COATING, V-804 CLEAR TOPCOA

2003

10/5/1972

AMERICAN CYANAMID CO

ABATE INSECTICIDE

2004

8/14/1972

GIVAUDAN CORPORATION

CHERRY FLAVOR F232

2005

10/6/1972

SYNTEX LABORATORIES INC SUB SYNTEX CORP

FACILITIES AND METHODS

2006

IV

10/23/1972

DOW CORNING CORP

DOW CORNING MEDICAL ADHESIVE A (SILASTIC MED ADHESIVE SILICONE A)

2007

9/28/1972

FOREST PHARMACEUTICALS INC

PERSONNEL,FACILITIES,CONTROLS (FORMERLY HELD BY WESTERFIELD LABS)

2008

IV

10/25/1972

WR GRACE

X-PAL CONTACT LENS POLISH

2009

10/26/1972

2010

10/26/1972

AYERST LABORATORIES INC DIV AMERICAN HOME INDERAL


PRODUCTS CORP
ORGANON INC
NORETHISTERONE

2011

10/30/1972

USV LABORATORIES INC SUB RORER GROUP

MANUFACTURING FACILITY (PUERTO RICO PLANT)

2012

9/8/1972

ADAMHA NIMH

1-ALPHA ACETYLMETHADOL (LAAM)

2013

10/30/1972

MALLINCKRODT INC

SILVER SULFADIAZINE

2014

10/17/1972

PFIZER PHARMS INC

PRODUCTION METHODS, FACILITIES AND CONTROLS

2015

10/13/1972

CONTINENTAL CAN COMPANY

PRESS-SEAL SAFETY CLOSURES

2016

11/3/1972

SCHERING AG

GENERAL OPERATING PROCEDURES

2017

10/16/1972

ACETO CHEMICAL CO INC

PHENYLBUTAZONE (BULK)

2018

11/21/1972

SIEGFRIED AG

PROPOXYPHENE HYDROCHLORIDE

2019

11/20/1972

ATLANTIC RICHFIELD CO

ARCOPRIME 90

2020

11/10/1972

UNITED STATES DEPARTMENT ENERGY

MOLYBDENUM-99-P-5 (FORMERLY HELD BY UNION CARBIDE CORP)

II

II
II
I
I

II

Page 55

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2021 I
II
11/22/1972
UNITED STATES DEPARTMENT ENERGY

SUBJECT
MOLYBDENUM-99-P-6 (FORMERLY HELD BY UNION CARBIDE CORP)

2022

11/24/1972

WARNER LAMBERT CO

FACILITIES, CONTROL, PACKAGING

2023

III

12/4/1972

VINYL ACETATE MONOMER

2024

II

12/1/1972

US INDUSTRIAL CHEMICALS CO DIV NATL


DISTILLERS & CHEM CORP
MALLINCKRODT MEDICAL INC

2025

12/5/1972

FOOD AND DRUG RES LABS INC

PERSONNEL SCIENTIFIC & MANAGEMENT ORGANIZATION

2026

12/14/1972

BIOCONTACTS INC

CHEM-101

2027

12/14/1972

BIOCONTACTS INC

BIO-139, POLYBUTON SOLUTION

2028

12/14/1972

COOPER LABORATORIES INC

SILISOL OR TRILISOL TM

2029

II

12/22/1972

SCHERING AG

NORETHISTERONE ENANTHATE

2030

II

12/18/1972

DR REDDYS LABORATORIES LTD

NAPROXEN

2031

12/18/1972

NATL PATENT DEVELOPMENT CORP

HYDRON BIOMEDICAL POLYMER TYPE A-1

2032

12/11/1972

AE STALEY CO

ISOSWEET (HIGH FRUCTOSE CORN SYRUP)

2033

12/22/1972

BAYER SCHERING PHARMA AG

NORETHISTERONE ACETATE (NORETHINDRONE ACETATE)

2034

12/26/1972

ORTHO PHARMACEUTICAL CORP

MANUFACTURING, PACKAGING AND CONTROL

2035

II

12/28/1972

PFIZER INC

TRIAMCINOLONE

2036

II

1/3/1973

GANES CHEMICALS INC

SODIUM THIOPENTAL INJ

2037

1/5/1973

ALZA CORP

MANUFACTURE FACILITIES AND CONTROLS

2038

1/10/1973

CARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ

2039

1/15/1973

BRISTOL LABORATORIES INC DIV BRISTOL MYERS


CO
ER SQUIBB AND SONS INC

2040

1/15/1973

LINSON LTD

DROCINONIDE PHOSPHATE POTASSIUM (BULK)

2041

12/4/1972

EDWARD MENDELL CO INC

(FARINEX 100M), FARINEX

2042

1/15/1973

NAPP CHEMICALS INC

PROPOXYPHENE HCL

2043

II

2/1/1973

SCHERING AG

CYPROTERONE ACETATE

2044

III

2/1/1973

PACKAGING MATERIALS

2045

III

2/7/1975

BPREX HEALTHCARE PACKAGING INC DBA BERRY


PLASTICS
AMCOR FLEXIBLES INC

2046

II

2/8/1973

SCHERING AG

NORETHISTERONE

2047

2048

II

2/8/1973

PFANSTIEHL LABORATORIES INC

CREATINE

2049

2/8/1973

IMPERIAL CHEMICAL INDUSTRIES PLC

SONYL NOVUM UNIT (PLASTIC BOTTLE)

2050

2051

II

1/26/1973

3M

C8F17BR

2052

III

2/8/1973

REXAM HEALTHCARE PACKAGING INC

PACKAGING COMPONENTS

2053

2/7/1973

LONZA INC

FACILS & PERSONNEL (FORMERLY HELD BY CYCLO CHEM DIV TRAVENOL INC)

2054

1/8/1973

RHODIA INC

PIPOTHIAZINE PALMITATE

2055

1/30/1973

MCGAW INC

SORBITOL IN PERITONEAL DIALYSIS SOL.

2056

2/15/1973

UNIV OF WISCONSIN

SYNTHETIC VITAMIN D ANALOG

2057

2/13/1973

SCHERING AG

CLOCORTOLINE TRIMETHYL ACETATE

II

II

MOLYDENUM 99:TECHNETIUM-99M

DROCINONIDE PHOSPHATE POTASSIUM

PHARMACEUTICAL TABLET PACKAGING MATERIAL

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER

II

Page 56

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2058 A
III
2/14/1973
WATSON STANDARD CO

SUBJECT
TUBE COATINGS

2059

2060

2061

2062

2063

II

2064

III

2065
2066
2067

2068

2069

2070

2071

2072
2073
2074

2075

II

1/12/1973

ALCOLAC INC

SIPON (MLS) MAGNESIUM LAURYL SULFATE

1/11/1973

SOGO PHARMACEUTICAL COMPANY LTD

MANUFACTURE OF SULFISOXAZOLE

1/9/1973

STYROLUTION AMERICA LLC

POLYSAR LUSTREX HIGH TEST 88-5 & 92 POLYSTYRENE PLASTIC

1/18/1973

REPACKING MEPROBAMATE

1/15/1973

KEY PHARMACEUTICALS INC SUB SCHERING


PLOUGH CORP
PALL CORP

11/6/1972

LUBRIZOL ADVANCED MATERIALS INC

ESTANE 5701

1/30/1973

PROJECTS DEVELOPMENT CORP

MANUFACTURING FACILITIES; OF INVERN DELLA BEFFA

2/1/1973

MCCLURE ROBERT E MR

ULTRASONIC DEVICE

1/15/1973

SYNTEX USA INC

OLEIC DIETHANOLAMIDE, RS-6648

1/29/1973

ORMA ISTITUDO TERAPEUTICO

NORTHINDRONE

IV

12/6/1972

VIKING CHEMICAL CO

VIKOFLEX 7190

III

12/5/1972

HOOKER CHEM CORP

RUCON B-341

II

1/31/1973

ASHLAND CHEM CO DIV ASHLAND OIL INC

8-HYDROXYQUINOLINE

2/21/1973

CYCLO CHEM DIV TRAVENOL LABS INC

L-PROLYL-L-LEUCYLGLYCINE AMIDE

2/23/1973

G&W LABORATORIES INC

MANUFACTURING FACILITIES AND CONTROLS

2/14/1973

MIL PAK INC

DESC. OF FACILITIES FOR PACKAGING PHARMACEUTICALS,LYNDHURST, N.J.

2/21/1973

WEST CO

FACILITIES & PROCEDURES OF PLASTICS DIV. FOR WYETH IV ADDITIVE DEVICE

2076

3/1/1973

INDUSTRIA FARMACEUTICA SERONO

FACILS. & CONTROLS OF ISTITUTO FARMCOLOGICO SERONO,ROME, ITALY

2077

3/5/1973

SCHERING AG

MESTEROLONE (SH723)

2078

II

3/2/1973

KNOLL PHARMA CHEMICALS

IBUPROFEN MANUFACTURED IN NOTTINGHAM, ENGLAND.

2079

IV

2/9/1973

COSDEN CHEM COATING CORP

TRANSPARENT COATING #82-9096A

2080

II

3/8/1973

ONYX CHEM CO DIV MILLMASTER ONYX CORP

AMMONYX LO

2081

2082

2083

2084

2085

2086

2087

2088

2089

2090

II

2091

IV

2092
2093
2094

NOT AN ASSIGNED NUMBER

2095

NOT AN ASSIGNED NUMBER

III

II

FILTER CARTRIDGE

NOT AN ASSIGNED NUMBER


II

3/9/1973

LINSON LTD

HYDROFLUMETHIAZIDE

3/8/1973

GYMA LABORATORIES OF AMERICA INC

HYDROQUINIDINE ALGINATE

II

2/27/1973

NAPP CHEMICALS INC

SODIUM SULFACETAMIDE USP XX

III

3/13/1973

BROWN BRIDGE DIV KIMBERLY CLARK

HEAT SEALEABLE LABELS 400BL, 420BL, 63BAK

3/20/1973

EI DUPONT DE NEMOURS AND CO

ELVAX 40

10/26/1972

PROTOTYPE PACKAGING INC

BLOW MOLDED PLASTIC CONTAINERS

4/9/1973

IMCO CONTAINER CO

PLASTIC BOTTLES

3/27/1973

MALLINCKRODT INC

MANUFACTURING & CONTROLS FOR LEVO ALPHA METHADYL ACETATE HYDROCHLORIDE

3/30/1973

SYNTEX USA INC

RS-7068

4/2/1973

ALLERGAN PHARMACEUTICAL

GSH-1157-1738 ENZYME--CLEANING FORMULATION FOR POLYHEMA SOFT LENSES

4/5/1973

KORONIS AG

PSORIASIS VULGARIS (DISEASE) ANTI-PSORIAICUM

4/6/1973

DELMAR CHEMS LTD

PHENDIMETRAZINE BITARTRATE (BULK POWDER)

III

Page 57

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2096 I
4/17/1973
ADAMHA NIMH CTR FOR STUDIES NARCOTIC &
DRUG ABUSE
2097 I
II
4/25/1973
GANES CHEMICALS INC

SUBJECT
NALTREX HCL AMP

2098

2099

4/27/1973

PHARMACIA AND UPJOHN CO WHOLLY OWNED


SUB PFIZER INC
FARMITALIA

DOXORUBICIN HYDROCHLORIDE AS MANUFACTURED IN TURIN, ITALY FOR PHARMACIA AND


UPJOHN CO WHOLLY OWNED SUB PFIZER INC
ADRIAMYCIN HCL INJ 10MG VIAL

2100

5/2/1973

HOECHST CELANESE CORP

5, 7-DICHLORO-8-HYDROXYQUINOLINE

2101

5/4/1973

WILTEX MANUFACTURING CORP

VIRGIN POLYESTER FIBER SANI-COIL

2102

5/14/1973

WORTHINGTON BIOCHEM CORP

ONTOSEIN, HUMAN GRADE ORGOTEIN

2103

II

5/16/1973

PHENCHEM INDUSTRIES LTD

CHLORDIAZEPOXIDE HCL USP (FORMERLY HELD BY MICRO CHEMICALS LTD)

2104

II

5/16/1973

PHENCHEM INDUSTRIES LTD

CHLORPROMAZINE HYDROCHLORIDE

2105

II

5/16/1973

EURAND INTERNATIONAL SPA

MICROENCAPSULATIONPROCEDURE

2106

5/17/1973

EURAND INTERNATIONAL SPA

MICROENCAPSULATION PROPOXYPHENE HCL

2107

5/21/1973

ARMOUR PHARMACEUTICAL CO

TAUROCHOLIC ACID

2108

5/31/1973

PACKAGING CORP AMERICA

PHYSICAL FACILITIES

2109

6/5/1973

CREST FOAM CORP

CRESTHANE 3310, 3615

2110

II

6/7/1973

ORGANON INC

NORETHISTERONE ACETATE (NORETHINDRONE ACETATE)

2111

II

6/7/1973

ORGANON INC

ESTERIFIED ESTROGENS U.S.P.

2112

6/13/1973

INMONT CORP

FORMULA M76LC002, C294-23 GOLD ENAMEL; 83 GOLD ENAMEL; 13782 GOL ENA

2113

II

6/13/1973

LILLY RES LABS DIV ELI LILLY CO

COLCHICINE TABLETS

2114

6/15/1973

BEECHAM SA

GENERAL OPERATING PROCEDURES FOR THE HEPPIGIES, BELGIUM--ANTIBIOTICS

2115

II

6/14/1973

TEVA PHARMACEUTICAL INDUSTRIES LTD

HYDROCHLOROTHIAZIDE AND CHLOROTHIAZIDE

2116

6/21/1973

HOFFMANN LA ROCHE INC

B-AMINOPROPIONITRILE FUMARATE

2117

IV

6/19/1973

GLIDDEN DURKEE

SILCRONS

2118

6/25/1973

PCR INC

FACILITIES AND CONTROL

2119

6/25/1973

DELMAR CHEMS LTD

IMIPRAMINE HYDROCHLORIDE

2120

6/20/1973

MONSANTO COMPANY

SANTICIZER 334 F

2121

6/25/1973

UNION CARBIDE CORPORATION

BAKELITE BRAND VINYLRESIN QYNA

2122

6/27/1973

NUCLEPORE CORP

NUCLEPORE MEMBRANE

2123

6/25/1973

MONSANTO COMPANY

ROSAFIX FRAGRANCE FORMULA ONLY

2124

IV

6/25/1973

NORDA INC

NORDA PERFUME OIL BOUQUET #6061

2125

III

6/28/1973

GRAHAM PACKAGING COMPANY L.P.

PLASTIC PRODUCTS

2126

II

7/11/1973

SYNTHETIC LUTEINIZING HORMONE-RELEASING HORMONE (PORCINE, OVIVE)

2127

8/7/1973

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
ROHM AND HAAS CO

2128

7/11/1973

LILLY RES LABS DIV ELI LILLY CO

7-AMINO CEPHALOSPORANIC ACID

2129

7/13/1973

ICI AMERICAS INC

BRIJ 76

2130

7/13/1973

KV PHARMACEUTICAL CO

PILOT PARENTERAL MANUFAC FACILITY, HANLEY INDUSTRIAL COURT

2131

III

7/6/1973

ALUMINUM COMPANY OF AMERICA

ALCOA PVC 103, ALCOA PVC 115

2132

II

7/23/1973

ACETO CHEMICAL CO INC

OXYPHENBUTAZONR BULK

II

III

II

4/27/1973

PHENDIMETRAZINE BITARTRATE BULK

HYAMINE 1622 CRYSTALS (BENSETHONIUM CHLORIDE)

Page 58

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2133 I
II
7/23/1973
GANES CHEMICALS INC

SUBJECT
PROCAINAMIDE HYDROCHLORIDE

2134

8/1/1973

MOUNT SINAI MEDCTR

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

2135

II

7/30/1973

GYMA LABORATORIES OF AMERICA INC

CHLORPROMAZINE HYDROCHLORIDE

2136

III

7/30/1973

ARMSTRONG PRODUCTS CO

392 GLD POWDER SIDE STRIPE

2137

II

10/3/1972

RACHELLE LABORATORIES INC

IDOXURIDINE

2138

8/1/1973

BIOQUEST

TEST DISCS (TRIMETHOPRIM PLUS SULFAMETHOXAZOLE)

2139

8/13/1973

COOPER LABORATORIES INC

BOIL N SOAK (TM) PLIASOL

2140

II

8/7/1973

OLON SPA

PHENDIMETRAZINE TARTRATE

2141

IV

8/8/1973

RP SCHERER HARD CAPSULE INC

EMPTY HARD GELATIN CAPSULES

2142

8/21/1973

GYMA LABORATORIES OF AMERICA INC

DIETHYLPROPIONE HCL

2143

8/21/1973

GYMA LABORATORIES OF AMERICA INC

CHLORPHENTERMINE HCL

2144

8/18/1973

GYMA LABORATORIES OF AMERICA INC

PHENTERMINE HCL MADE IN ITALY

2145

8/6/1973

PERFUMERY ASSOCIATES INC

ORANGE NATURAL EXTRACT #25 (TAMARIND FANTAISIE)

2146

8/20/1973

THATCHER GLASS MANUFACTURING CO

SC 100 COLD END GLASS COATING; SC 300

2147

8/27/1973

SCHWARTZ MANN

SYNTHETIC BIOLOGICALLY-ACTIVE BRADYKININ

2148

2149

II

8/21/1973

NAPP CHEMICALS INC

SULFAMETHAZINE USP.

2150

II

9/4/1973

UPJOHN CO

BETAMETHASONE, 17-BENZOATE

2151

IV

9/6/1973

SHIN ETSU CHEMICAL CO LTD

HPMCP(HYPROMELLOSE PHTHALATE)

2152

9/7/1973

HAZELTON LABS INC

FACILITIES, EQUIPMENT, PERSONNEL

2153

9/10/1973

WHEATON PLASTIC CONTAINERS

S-1980F1 4OZ BOSTON ROUND AEROSOL BOTTLE

2154

II

9/10/1973

KV PHARMACEUTICAL CO

PSEUDOEPHEDRINE HCL 120MG S.R. CAPS.

2155

II

9/12/1973

RHODIA INC

CERUBIDINE

2156

9/28/1973

LEPETIT LABS SA

LEVODOPA (BULK)

2157

10/1/1973

WEDDEL PHARMS LTD

CHENODEOXYCHOLIC ACID (CHENDOL)

2158

10/2/1973

CALBIOCHEM-BEHRING CORP

CB-351 CAPS

2159

10/2/1973

WARNER LAMBERT CO

MANUFACTURING FACILITY LITITZ, PA

2160

10/10/1973

EDWARD F PRODIGO ENTERPRISES INC

FACILITIES, METHODS AND CONTROL FOR PACKAGING

2161

10/10/1973

AYERST LABORATORIES INC

PRIMIDONE CAP

2162

II

10/4/1973

HOFFMANN LA ROCHE INC

R03-0749/607 DISODIUM PYRIDOXAL PHOSPHATE INJ

2163

II

10/4/1973

DELMAR CHEMS LTD

PHENAZOPYRIDINE HYDROCHLORIDE (BULK POWDER)

2164

10/9/1973

CONTINENTAL CAN COMPANY

142 CLS ENAMEL

2165

III

10/2/1973

CHEVRON PHILLIPS CHEMICAL CO.,LP.

PLASTIC BOTTLES PRODUCED BY AN INJECTION BLOW MOLDING PROCESS

2166

10/16/1973

PROQUINA SA

GENERAL OPERATING PROCEDURE

2167

II

10/17/1973

HOECHST MARION ROUSSEL INC

PROBUCOL (DH-581)

2168

10/10/1973

REXHAM CORP

INK AND COLOR FORMULATIONS

2169

10/24/1973

KYOWA HAKKO USA INC

MANUFACTURING FACILITIES & CONTROLS (BULK DRUGS)

2170

10/24/1973

KYOWA HAKKO KOGYO CO LTD

L-ARGININE, L-ARGININE MONOHYDROCHLORIDE

II
III

NOT AN ASSIGNED NUMBER

II

II

Page 59

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2171 I
II
10/24/1973
PFIZER INC

SUBJECT
L-LYSINE MONOHYDROCHLORIDE

2172

10/19/1973

BEL MAR LABORATORIES INC

STANDARD OPERATING PROCEDURE

2173

10/5/1973

ROBINSON BROTHERS LTD

PIPERIDINE HYDROCHLORIDE

2174

10/5/1973

UNION CARBIDE CORPORATION

BAKELITE BRAND VINYL CHLORIDE-ACETATE COPOLYMER, VYNW5 & VYNW 6

2175

10/10/1973

ETHYL CORP

ETHYL 9110 POLUVINYL CHLORIDE COMPOUND

2176

10/30/1973

AMERICAN CAN

WAX LINED ALUMINUM TUBE

2177

10/3/1973

GEORGE ANGUS & CO LTD

COMPOUND KL 1104

2178

10/26/1973

TELEDYNE WIRZ

MATERIALS USED/POLYETHYLENE BOTTLES MADE BY EXTRUSION BLOW MOLD METHOD

2179

10/30/1973

MANUFACTURING OPERATIONS

2180

10/15/1973

LAFAYETTE PHARMACAL DIV ALCON


LABORATORIES INC
RHODIA INC

2181

1/2/1973

SCHWARZ MANN DIV BECTON DICKINSON AND CO PRODUCT 90-1431,90-1432 SYTHETIC SECRETIN

2182

1/2/1973

TRAVENOL LABORATORIES INC

STABILITY & COMPAIBILITY OF DRUG ADDITIVES INTRO INT INJ

2183

11/12/1973

CELANESE COATINGS CO

# 86 GOLD HS CAN LINING

2184

II

10/9/1973

PFANSTIEHL LABORATORIES INC

L-ARGININE MONOHYDROCHLORIDE

2185

II

10/17/1972

ANTIBIOTICOS SPA

HYDROCORTISONE 17-VALERATE

2186

11/15/1973

METRONIDAZOLE

2187

11/12/1973

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
AYERST LABORATORIES INC

2188

II

10/29/1973

COLLETT MARWELL HAUGE A/S

PROCAINAMIDE S.R. TAB 300 & 500MGS

2189

11/16/1973

KV PHARMACEUTICAL CO

MANUFACTURING FACILITIES AND CONTROLS

2190

III

11/7/1973

CELANESE PLASTICS

CELCON

2191

11/20/1973

COOPER LABORATORIES INC

REN-O-GEL (TM) I AND II KIT

2192

11/21/1973

ER SQUIBB AND SONS INC

PLASTIC CONTAINERS

2193

11/20/1973

SIFAVITOR SRL

TRICHLORMETHIAZIDE NF XIII

2194

11/27/1973

SARGENT INDUSTRIES

NITRILE COMPOUND SR 3013-70

2195

II

11/27/1973

ROUSSEL-UCLAF

HEMATOPORPHYRIN HCL

2196

II

11/27/1973

INDUSTRIA CHIMICA MILANESE SPA

DEXTRO-PROPOXYPHENE HCL

2197

11/29/1973

ICN PHARMACEUTICAL INC

MFG. FACILITIES AND CONTROLS FOR ICN PLAINT, AQUADILLA, PUERTO RICO

2198

II

12/3/1973

LILLY RES LABS DIV ELI LILLY CO

ERYTHROMYCIN ESTOLATE

2199

II

12/7/1973

SIEGFRIED LTD

PRIMIDONE USP XVIIII

2200

II

12/12/1973

SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS)

CHLORDIAZE POXIDE & CHLORDIAZE POXIDE (BULK)

2201

12/13/1973

ER SQUIBB AND SONS INC

COMPOUND SQ 21, 286

2202

12/20/1973

BRACCO IND CHIMICA SPA

IODOXAMIC ACID (BULK)

2203

II

12/21/1973

BRISTOL MYERS SQUIBB CO

HALCINONIDE BULK, MANUFACTURED IN HUMACAO, PUERTO RICO

2204

II

12/31/1973

ANTIBIOTICOS SPA

NON-STERILE BETAMETHASONE (BULK)

2205

II

12/31/1973

ANTIBIOTICOS SPA

DEXAMETHASONE, NON-STERILE (BULK)

2206

II

12/31/1973

ANTIBIOTICOS SPA

TRIAMCINOLONE

2207

II

12/31/1973

ANTIBIOTICOS SPA

TRIAMCINOLONE DIACETATE

2208

12/18/1973

CYCLO CHEM DIV TRAVENOL LABS INC

PHENDIMETRAZINE TARTRATE

II

FORMULAS: RHODIAL & BOUQUET 5886

AY-22,284 ANALDOSE REDUCTASE INHIBITOR

Page 60

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2209 I
II
1/4/1974
ORGANON INC

SUBJECT
TUBOCURARINE CHLORIDE

2210

12/19/1973

ALUMINUM COMPANY OF AMERICA

PILFERPROOF CLOSURE (18MM)

2211

1/8/1974

SOLVAY PHARMACEUTICALS

QUALITY CONTROL MANUAL

2212

12/11/1973

3-M NUCLEAR PRODUCTS

MICROSPHERES

2213

II

1/16/1974

HOECHST MARION ROUSSEL SA

TRIENE

2214

1/22/1974

ICN CANADA LTD

PLANT MASTER FILE

2215

II

1/21/1974

SYNTEX USA INC

SODIUM 7-ISOPROPOXYANTHONE-2-CARBOXYLATE (RS-6818)

2216

1/22/1974

VERNAY LABORATORIES INC

STOPPERS

2217

1/23/1974

ORGANICHEM CORP

GENERAL DESCRIPTION OF PLANT

2218

II

1/25/1974

GYMA LABORATORIES OF AMERICA INC

SULFAMETHAZINE

2219

1/23/1974

ICN PHARMACEUTICALS INC

MANUFACTURING FACILITIES & CONTROLS

2220

IV

1/29/1974

KALSEC KALAMAZOO SPICE EXTRACTION CO

SPICES AND SPICE EXTRACTIONS

2221

1/17/1974

PHARMACIA AND UPJOHN INC

ANTIBIOTIC GENERAL INFORMATION

2222

1/17/1974

2223

1/18/1974

AYERST LABORATORIES INC DIV AMERICAN HOME QUILENE


PRODUCTS CORP
GLOGAU AND CO INC
MANUFACTURE PROCEDURES

2224

1/28/1974

ADAMHA NIDA

2225

2/1/1974

2226

1/31/1974

AYERST LABORATORIES INC DIV AMERICAN HOME 6-AM (6-DEOXY-6-AZIDIDIHYDROMORPHINE BITARTRATE) AMP.
PRODUCTS CORP
EASTMAN KODAK CO
1-CHLORO-2, 4-DINITROBENZENE

2227

2228

2229

2230

2/4/1974

BPREX HEALTHCARE BROOKVILLE INC DBA BERRY CLIC-LOC CHILD AND FINAL GENERATION (FG) CHILD RESISTANT CLOSURES
PLASTICS
MANUFACTURED AT BROOKVILLE, PA
ANDRE GUERBET LABS
IOCARMIC ACID

2231

8/17/1973

KV PHARMACEUTICAL CO

PSEUDOEPHEDRINE HCL & CHLORPHENIRAMINE MALEATE S.R.C.

2232

2/20/1974

FIRMENICH INC

CHEMODERM 840 & 985

2233

2/21/1974

2234

2/20/1974

BEECHAM-MASSENGILL PHARMS DIV BEECHAM


RAW MATERIALS SPECIFICATIONS
INC
SCHWARZ MANN DIV BECTON DICKINSON AND CO BRADYKININ POTENTIAING FACTOR-NONAPEPTIDE

2235

2/26/1974

PECHET MAURIC M MD

1A-HYDROXY VITAMIN D3

2236

2/27/1974

KV PHARMACEUTICAL CO

FACILITIES, CONTROL, PERSONNEL

2237

III

3/1/1974

AMCOR FLEXIBLES SHELBYVILLE

PACKAGING LAMINATES

2238

II

3/1/1974

BOFORS INDS

ISOSORBIDE DINITRATE

2239

II

3/1/1974

CAMBREX CHARLES CITY INC

SALICYLAZOSUSULFAPYRIDINE, MANUFACTURED IN CHARLES CITY, IOWA

2240

12/14/1973

CYCLO PRODUCTS INC

N-DECYLMETHYL SULFOXIDE

2241

2/26/1974

P-L BIOCHEMS INC

POLYADENYLIC ACID

2242

2/26/1974

P-L BIOCHEMS INC

POLYURIDYLIC ACID

2243

2/22/1974

TROPONWERKE GMBH CO KG

BUFENOID COMPOUND

2244

3/14/1974

BRACCO IND CHIMICA SPA

IOPRONIC ACID

II

METHADONE

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER
III

II

2/5/1974

Page 61

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2245 I
3/4/1974
DOW CORNING CORP

SUBJECT
DOW CORNING X-95704 ANTIMICROBIAL

2246

II

3/5/1974

6-AMINO PENICILLANIC ACID

2247

II

3/12/1974

BEECHAM-MASSENGILL PHARMS DIV BEECHAM


INC
KYOWA HAKKO KOGYO CO LTD

2248

II

3/21/1974

CAMBREX PROFARMACO MILANO SRL

BISACODYL

2249

III

3/22/1974

MYLAN TECHNOLOGIES INC

PLASTIC BOTTLES

2250

3/28/1974

CARTRIX PARENTERAL SYSTEMS

MANUFACTURE OF PARENTERAL PRODUCTS (FACILITIES, CONTROLS PERSONNEL)

2251

II

3/18/1974

ORGANON INC

NORANDROS TENEDIONE (NANDROLONE)

2252

3/14/1974

JOHNSON & JOHNSON PRODUCTS INC

POLYETHYLENE CONTAINERS

2253

II

3/28/1974

RP SCHERER CORP

DIGOXIN CAPS

2254

3/27/1974

RHONE POULENC LTD

2255

3/14/1974

DOW CHEMICAL CO MICHIGAN DIV

FACILITIES, PERSONNEL & PROCEDURES FOR PHARMACEUTICAL FINISHED PRODUCT


PRODUCTION IN DAGENHAM, ENGLAND.
PZ 5561.21 (DURAFILM PRODUCT)

2256

4/2/1974

KERR GROUP SUB BERRY PLASTICS CORP

CR-I CHILD-RESISTANT CLOSURES

2257

4/8/1974

PFW INC

MENTHYL ANTHRANILATE 263610,260160

2258

4/9/1974

FERMENTA FRANCE SA

HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)

2259

4/11/1974

SQUIBB

HYDROXYUREA

2260

4/7/1974

MARVI SA

MANUFACTURE OF GLASS AMPULS, VIALS

2261

4/10/1974

CALBIOCHEM-BEHRING CORP

4-EPI-TETRACYCLINE HYDROCHLORIDE

2262

3/28/1974

LABORATORIO ELEA SACIFYA

HUMAN CHORIONIC GONADOTROPHIN

2263

II

4/24/1974

SYNTEX USA INC

RS 8584

2264

III

4/17/1974

BASF CORPORATION

POLYSTYRENE PLASTICS

2265

II

4/25/1974

AYERST LABORATORIES INC

DEXPROPRANOLOL INJ

2266

4/19/1974

ISOMEDIX INC

RADIATION PROCESSING OF DRUGS

2267

5/1/1974

CAMBRIDGE NUCLEAR CORP

CALCIUM CHLORIDE CA-45, CA-47

2268

II

4/30/1974

SOLVAY PHARMACEUTICALS

CHENODEOXYCHOLIC ACID

2269

4/26/1974

STERIS-ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN MORTON GROVE,IL

2270

II

4/30/1974

H REISMAN CORP

CHLORPROMAZINE HYDROCHLORIDE (BULK)

2271

III

5/1/1974

SEMI-RIGID CONTAINER PLASTIC BOTTLE

2272

5/13/1974

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
AYERST LABORATORIES INC

2273

5/10/1974

CELLO FOIL PRODUCTS INC

STRUCTURED PACKAGING MATERIALS

2274

5/8/1974

WILLIAM FREEMAN & COMPANY LTD

RUBBER COMPOUND 161063

2275

5/2/1974

IMCO CONTAINER CO

CONTAINERS, CLOSURES AND FITMENTS

2276

5/15/1974

DELMAR CHEMS LTD

KETAZOLAM, BULK POWDER

2277

5/17/1974

ROCHE DIAGNOSTICS GMBH

DIGOXIN PRODUCTS

2278

5/23/1974

KV PHARMACEUTICAL CO

CHLORPHENIRAMINE MALEATE 12 MG SRC

2279

5/23/1974

NAPP CHEMICALS INC

MEGLUMINE SALICYLATE

2280

5/31/1974

DELMAR CHEMS LTD

D.M.M.P.(1,3-BISMETHOXYMETHYL-5-ETHYL-5-PHENYL-BARBITURIC ACID)BULK

2281

5/31/1974

UNION CARBIDE CORPORATION

ZIRCONIA TEXTILES

III
II

II

III
II

II

L-TRYPTOPHAN, L-TYROSINE, L-ASPARTIC ACID (L-PROLINE, L-GLUTAMIC)

GRISACTIN

Page 62

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2282 I
II
5/30/1974
PCR INC

SUBJECT
PROMAZINE HYDROCHLORIDE

2283

THYROTROPIN RELEASING HORMONE

2284

6/3/1974

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
SHEFFIELD TUBE CORP

2285

6/3/1974

OCONNOR PACKAGING CO

PACKAGING

2286

II

6/11/1974

CAMBRIDGE NUCLEAR RADIOPHARM CORP

SODIUM CHLORIDE NA-24

2287

II

6/12/1974

ARMOUR PHARMACEUTICAL CO

DIPALMITOYL-DL-3-LECITHIN

2288

III

6/14/1974

AMERICAN NATIONAL CAN CO

ALUMINUM FOIL-POLYPROPYLENE LAMINATE

2289

6/12/1984

UNION CARBIDE CORPORATION

SYNTHETIC SODIUM ALUMINOSILICATE ABSORBENTS (MOLECULAR SIEVES)

2290

6/12/1984

CAMBRIDGE NUCLEAR RADIOPHARM CORP

SODIUM BROMIDE BR82

2291

II

6/18/1974

ROUSSEL CORPORATION

ESTRADIOL BENZOATE

2292

II

6/19/1974

HOFFMANN LA ROCHE INC

PROCARBAZINE HYDROCHLORIDE PARENTERAL

2293

II

6/21/1974

GANES CHEMICALS INC

GLUTETHIMIDE BULK AS MANUF A PENNSVILLE, NJ

2294

II

6/24/1974

ETHYL CORP

TOLMETIN (MCN2559-21-98)

2295

III

5/30/1974

REEVES BROTHERS INC

COMPOUND #5165 RUBBER GASKET MATERIAL

2296

8/23/1973

EMSON RESEARCH INC

DISPENSING DEVICES

2297

6/14/1974

ASHLAND INC

POLYVINYLPOLYPYRROLIDONE (CROSPOVIDONE)

2298

II

7/1/1974

KNOLL AG CHEMISCHE FABRIKEN

DIHYDROXYPROPYL-THEOPHYLLIN

2299

7/3/1974

KYOWA HAKKO KOGYO CO LTD

FACILITIES & CONTROLS (UBE PLANT IN JAPAN)

2300

7/5/1974

BEECHAM PHARMACEUTICALS PTE LTD

GENERAL OPERATING PROCEDURES SINGAPORE PLANT

2301

7/11/1974

INDUSTRIAL REACTOR LABORATORIES INC

RADIOCHEMICAL 99 MOO 3

2302

7/11/1974

GANES CHEMICALS INC

DIPYRONE

2303

II

7/11/1974

OLON SPA

DICYCLOMINE HYDROCHLORIDE

2304

II

7/16/1974

KYOWA HAKKO USA INC

L-VALINE, L-THREONINE, L-GLUTAMINE

2305

III

7/17/1974

NATIONAL STARCH & CHEMICAL CORP

ADHESIVES E 56620 & 56635 (FORMERLY CODED 4620 & 4635)

2306

II

1/16/1974

SSL INTERNATIONAL

TOXICOLOGY STUDIES ON CHLORHEXIDINE GLUCONATE

2307

7/22/1974

CAMBRIDGE NUCLEAR RADIOPHARM CORP

SODIUM SULFATE S-35

2308

II

7/30/1974

BRACCO IND CHIMICA SPA

DIARIZOIC ACID

2309

II

3/15/1974

FERRING AB

DESURIN, MINRIN, DDAVP

2310

7/30/1974

KV PHARMACEUTICAL CO

METHYLTESTOSTERONE

2311

II

8/6/1974

TRAVENOL LABORATORIES INC

PROTEIN HYDROLYSATE BULK POWDER FOR PARENTERAL SOLUTIONS

2312

8/8/1974

SYNTEX PUERTO RICO INC

FACILITIES AND CONTROLS

2313

8/6/1974

PFIZER LABORATORIES DIV PFIZER INC

ANTIBIOTIC SUSCEPTIBILITY DISCS

2314

II

8/8/1974

BOEHRINGER INGELHEIM CHEMICALS INC

AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE

2315

7/26/1974

BEN VENUE LABORATORIES INC

STERILE PROCESSING FACILITY IN BEDFORD, OHIO

2316

8/16/1974

MALLINCKRODT INC

MANUFACTURING FACILITY AT RALEIGH, NORTH CAROLINA

2317

8/19/1984

USV PHARMACEUTICAL CORP SUB RORER GROUP MANUFACTURE, PACKAGING AND DISTRIBUTION

2318

8/23/1974

TAKEDA PHARMACEUTICAL COMPANY LTD.

FOLIC ACID

2319

8/26/1974

ORTHO PHARMACEUTICALS INC

DESCRIPTION , BLDG, EQUIP., KEY PERSONNEL

5/28/1974
III

II

TUBE LINERS, TUBE CLOSURE SEALANTS AND CAP LINERS

Page 63

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2320 I
II
8/27/1974
SWORDS LABORATORIES LTD

SUBJECT
FLUPHENAZINE ENANTHATE N.F.

2321

PROPANTHELINE BROMIDE

2322

2323

2324

2325

2326

2327

2328

2329

III

2330
2331

8/26/1974

GANES CHEMICALS INC


NOT AN ASSIGNED NUMBER
NOT AN ASSIGNED NUMBER

9/6/1974

BURTON,PARSONS & COMPANY,INC.

BURTON PARSONS BUTTON FOR HYDROPILIC SOFT CONTACT LENSES

II

9/10/1974

OHIO MEDICAL PRODUCTS DIV AIRCO INC

ETHRANE (ENFLURANE) FORANE (ISOFLURANE)

III

8/21/1974

FLINT HILLS RESOURCES LP

POLYETHYLENE RESINS

9/18/1974

GAF CORPORATION CHEMICAL DIV

FLUOROL 7GA

9/20/1974

TRAVENOL LABORATORIES INC

LARGE VOLUME PARENTERAL PRODUCTS - PYROGEN TESTING

9/26/1974

HOECHST CELANESE CORP

PACKAGING

9/25/1974

UNIV MICHIGAN MEDCTR

O-IODOBENZYLTRIMETHYL AMMONIUM IODIDE

10/7/1974

WIMMER KG

RUBBER STOPPERS A-40 GREY FOR INFUSION BOTTLES

2332

10/10/1974

MERRELL-NATIONAL LABORATORIES INC

FACILITIES AND CONTROLS

2333

10/9/1974

UPJOHN CO

PELLETHANE MDI BASED URETHANE ELASTOMER

2334

2335

2336

2337

2338

2339

NOT AN ASSIGNED NUMBER


IV

10/16/1974

BARNES HIND PHARMACEUTICALS INC

BARNES-HIND BOILING SOLUTION

10/24/1974

ALCON LABORATORIES INC

STEROID/ANTI-INFECTIVE OPHTH.COMBINATIONS;SAFETY/EFFICACY ANALYSIS

III

10/7/1974

REXENE CORP

POLYPROPYLENE PLASTICS 14B AND 14S SERIES

III

10/3/1973

GLYCO CHEMICALS INC

ACRAWAX C

7/30/1974

DIAMOND SHAMROCK CORP

FOAMASTER VF

2340

9/10/1974

DIAMOND SHAMROCK CORP

NOPCOWAX 22 DS MICRO

2341

9/4/1974

DEWEY AND ALMY CHEM DIV WR GRACE AND CO

DAREX CAP COMPOUND 64

2342

II

10/17/1974

SIGMA F AND D DIV LTD

L-TRYPTOPHAN

2343

III

10/28/1974

INEOS BAREX USA LLC

BAREX 210 RESIN

2344

II

10/17/1974

KV PHARMACEUTICAL CO

LEVODOPA S.R.C. 300MG

2345

10/29/1974

DOW CORNING CORP

DOW CORNING F-218 FLUID

2346

10/24/1974

BURTON,PARSONS & COMPANY,INC.

SOACLENS (SILICO) CONTACT LENS SOLUTION

2347

II

10/31/1974

BARNES HIND PHARMACEUTICALS INC

SOFT CONTACT LENS CLEANER FOR USE WITH FLEXLENS (TRANSF. TO DEVICES)

2348

II

11/1/1974

HOECHST AG

HALOTHANE

2349

11/4/1974

DENVER CHEM MFG CO

MANUFACTURING FACILITIES AND CONTROLS

2350

9/17/1974

UNITED STATES DEPARTMENT ENERGY

RADIOISOTOPE MOLYBDENUM-99-P-7 (FORMERLY HELD BY UNION CARBIDE CORP)

2351

11/11/1974

SIGMA F AND D DIV LTD

6,9-DIAMINO-2-ETHOXYACRIDINE LACTATE

2352

11/12/1974

PIERCE & STEVENS CHEMICAL CORPORATION

FOAMCOAT (TM) A7673A

2353

11/18/1974

PFANSTIEHL LABORATORIES INC

SUCROSE MONOOLEATE

2354

II

11/11/1974

MALLINCKRODT CHEMICAL WORKS

CHLORZOXAZONE

2355

II

11/19/1974

MALLINCKRODT INC

STEAR-O-WET C (CALCIUM STEARATE)

2356

II

11/6/1974

CHENODEOXYCHOLIC ACID

2357

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD
CUTTER LABORATORIES INC

II

11/8/1974

CUTTER STABILITY DATA

Page 64

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2358 I
II
11/18/1974
WARNER LAMBERT CO

SUBJECT
PLEXIGEL(POLYETHYLENE OINT. BASE)

2359

11/19/1974

SCIENTIFIC ASSOC INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

2360

III

11/25/1974

UNION CARBIDE CORPORATION

UDEL POLYSULFONE RESIN P-1700

2361

11/29/1974

QUALITY ASSURANCE OPERATION STANDARDS

2362

11/25/1974

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
WESLEY-JESSEN INC

2363

II

11/27/1974

RENASA, INC. SUBSIDIARY OF E.R. SQUIBB

HALOG (HALCINONIDE) 0.1% CREAM MANUFACTURED IN HUMACAO, PUERTORICO.

2364

II

11/26/1974

SANOFI AVENTIS CHIMIE

NORGESTERAL ACETATE OXIME

2365

II

12/20/1974

MERCK FROSST CANADA INC

TECHNETIUM TC 99M POLYPHOSPHATE KIT

2366

12/6/1974

WACKER CHEMIE GMBH

SILICONE RUBBER HL 44

2367

III

12/6/1975

HB FULLER CO

FULLER'S HM-777-R INNER SEAL

2368

II

12/10/1974

TRIFARMA SPA

PROCHLORPERAZINE BASE,PROCHLORPERAZINE MALEATE

2369

2370

2371

2372

DURASOFT (TM) AUTOCLAVE STERILIZER

NOT AN ASSIGNED NUMBER


12/3/1974

FLOW PHARMS INC

PLIACIDE

II

12/12/1974

STUDSVIK ISOTOPSERVICE AB

RADIOACTIVE XENON-133 GAS

II

12/16/1974

EI DUPONT DE NEMOURS AND CO

SODIUM-24 RADIOISOTOPE (FORMERLY NEW ENGLAND NUCLEAR)

2373

II

12/13/1974

HOFFMANN LA ROCHE INC

1A,25-DIHYDROXYCHOLECALCIFEROL (RO21,5535) IN USAN IS CALCITRIOL

2374

II

12/18/1974

ER SQUIBB AND SONS INC

FLUPHENAZINE DECANOATE INJ.

2375

12/18/1974

SIGMA F AND D DIV LTD

DEOXYCHOLIC ACID

2376

II

12/18/1974

ANTIBIOTICOS SPA

PREDNISOLONE SODIUM PHOSPHATE BULK

2377

II

12/18/1974

ANTIBIOTICOS SPA

BETAMETHASONE SODIUM PHOSPHATE, N.F. XIII BULK

2378

II

12/18/1974

ANTIBIOTICOS SPA

DEXAMETHASONE SODIUM PHOSPHATE BULK

2379

12/26/1974

ASTRA USA INC

FACILITIES AMD CONTROLS

2380

12/20/1974

ALLERGAN PHARMACEUTICAL

GSH-1157-2333X PROLASE 300 (SOFT CONTACT LENS CLEANER)

2381

12/6/1974

PFANSTIEHL LABORATORIES INC

A LACTULOSE

2382

12/31/1974

EI DUPONT DE NEMOURS AND CO

MANUFACTURING FACILITIES AND CONTROL

2383

12/31/1974

EI DUPONT DE NEMOURS AND CO

MANUFACTURING FACILITIES AND CONTROLS (FORMERLY NEW ENGLAND NUCLEAR)

2384

1/3/1975

SIGMA F AND D DIV LTD

2-DEOXY-D-GLUCOSE

2385

1/3/1975

CIECH POLFA

SULFAMERAZINE

2386

II

1/3/1975

CIECH POLFA

SULFAMETHAZINE

2387

II

1/3/1975

CIECH POLFA

SULFATHIAZOLE

2388

1/7/1975

STERIGENICS INTERNATIONAL

2389

1/10/1975

LILLY RES LABS DIV ELI LILLY CO

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN


ROCKAWAY, NJ
PRODUCTION OPERATIONS

2390

1/14/1975

ER SQUIBB AND SONS INC

PERSONNEL FOR PUERTO RICO PLANTS

2391

1/17/1975

SYNTEX RES DIV SYNTEX LABS INC

METHODS, FACILITIES AND CONTROLS

2392

III

1/16/1975

EQUISTAR CHEMICALS LP SUB LYONDELLBASELL

PROFAX (R) PD 191 NATURAL POLYPROPYLENE RESINS

2393

1/28/1975

CALBIOCHEM CORP

KEYHOLE LIMPET HEMOCYANIN

2394

2/17/1975

GENERAL ELECTRIC CORP

VALOX DR-140 GRADE RESIN

II

III

Page 65

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2395 I
II
1/29/1975
DELMAR CHEMS LTD

SUBJECT
CHLORDIAZEPOXIDE HYDROCHLORIDE

2396

2/7/1975

LEHIGH PACKAGING

GENERAL INFO., BURLINGTON PLANT NEW JERSEY

2397

2/7/1975

SYNTEX USA INC

7-METHYLSULFINYLXANTHONE-2-CARBOXYLIC ACID (RS-7337)

2398

1/23/1975

MANUFACTURING, FACILITIES, PERSONNEL

2399

II

2/11/1975

WEST INDIES PHARMACEUTICAL & COSMETICS


INC
ROUSSEL-UCLAF

2400

II

2/19/1975

SYNTEX USA INC

INHALER DEVICE

2401

III

2/19/1975

DUPONT TEIJIN FILMS US LP

MELIFORM POLYESTER FILM

2402

2/21/1975

ENTRENOL

2403

2/26/1975

WINTHROP PHARMACEUTICALS DIV STERLING


DRUG INC
ER SQUIBB AND SONS INC

2404

2/26/1975

TAYLOR PHARMACAL CO

DYMASIL BRAND DIMETHICONE 350

2405

2/21/1975

ELLIS PHARMACEUTICAL CONSULTING INC

NORETHINDRONE ENANTHATE

2406

III

2/19/1975

CHEVRON PHILLIPS CHEMICAL CO LP

K-RESIN BDS POLYMER

2407

III

2/20/1975

FLINT HILLS RESOURCES LP

POLYETHYLENE RESIN PE 143, 207, AND 178 MANUFACTURED IN ODESSA, TEXAS.

2408

2/26/1975

PARKE DAVIS & CO

MINOCYCLINE HYDROCHLORIDE CAP

2409

1/21/1975

KV PHARMACEUTICAL CO

ANTIPRESS TAB

2410

2/25/1975

BOEHRINGER MANNHEIM GMBH

DOXEPIN

2411

3/5/1975

COLUMBIA RESEARCH CORP

IRRADIATION STERILIZATION PROCEDURE

2412

3/3/1975

JANAR CO INC

FACILITIES AND CONTROLS

2413

3/10/1975

HOFFMANN LA ROCHE INC

AMITRIPTYLINE HYDROCHLORIDE

2414

3/10/1975

BARNES HIND PHARMACEUTICALS INC

SOFT LENS COMFORT DROPS--SOFT LENS HYDRAING SOLUTION(TRANS TO DEVICE)

2415

3/7/1975

UNIV MICHIGAN MEDCTR

6-IODOMETHYL-19-NORCHOLESTEROL (NP-59)

2416

3/12/1975

CORD LABORATORIES INC

MANUFACTURING & QUALITY ASSURANCE PROCEDURE

2417

III

1/13/1975

SELIG SEALING PRODUCTS INC

CAPSEAL BRAND SA-66 CLOSURE LINER & CAPSEAL BRAND SA-22 CLOSURE LINER

2418

II

2/24/1975

PHARMACIA AND UPJOHN SUB PFIZER INC

GLIPIZIDE, BULK

2419

3/28/1975

KERR MANUFACTURING CO

TITANIUM TETRAFLOURIDE SOLUTION (MOUTHWASH)

2420

II

3/11/1975

STARKS ASSOC INC

LOMUSTINE (CCNU) BULK

2421

II

3/14/1975

SUMITOMO CHEMICAL CO LTD

HYDRALAZINE HYDROCHLORIDE

2422

3/20/1975

NORTH AMERICAN BIOLOGICALS INC

SOLUTION FILLED BLOOD COLLECTION UNITS

2423

3/27/1975

NAPP CHEMICALS INC

PHENYLBUTAZONE

2424

3/6/1975

UNIROYAL CHEM DIV UNIROYAL INC

CELOGEN AZ

2425

II

3/27/1975

ROUSSEL-UCLAF

ETHINYL ESTRADIOL

2426

II

3/28/1975

LILLY RES LABS DIV ELI LILLY CO

PAPAVERINE HYDROCHLORIDE

2427

II

3/19/1975

HEINRICH MACK NACHF

TRIFLUOROTHYMIDINE

2428

II

3/13/1975

SIGMA F AND D DIV LTD

SODIUM PARA-AMINOBENZOATE

2429

3/18/1975

GENERAL ELECTRIC CORP

VALOX 310 GRADE RESIN

2430

4/4/1975

ANALYTICA CORP

CHLOROTRIANISENE

2431

3/11/1975

MONSANTO COMPANY

PLASTIC CLOSURES AND FITMENTS MADE BY AN INJECTION MOLDING PROCESS

2432

4/1/1975

CHEM AID PHARM SPEC

PACKAGING

II

II

II

III

19-NOR-ANDROSTENEDIONE(NANDROLONE)

DIARIZOIC ACID

Page 66

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2433 I
III
4/8/1975
LUDLOW SPECIALTY PAPERS

SUBJECT
HEAT SEAL LABEL PAPER

2434

III

3/14/1975

TRI SEAL INTERNATIONAL INC

TRI-SEAL LINING MATERIALS

2435

II

3/13/1975

AESICA PHARMACEUTICALS LTD

FLURBIPROFEN AND SODIUM FLUBIPROFEN

2436

IV

4/8/1975

ICI AMERICAS INC

ARLAMOL E(PPG-15 STEARYL ETHER)

2437

4/9/1975

RHODIA INC

RUBIDAZONE HYDROCHLORIDE RP 22, 050

2438

4/21/1975

CHLORTHALIDONE USP AT INST MEDICAMENTA SPA ITALY

2439

4/8/1975

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
RHODIA INC

2440

II

3/25/1975

SYNTEX LABS

HEPARIN, SODIUM

2441

II

4/30/1975

MALLINCKRODT INC

GALLIUM CHLORIDE (GA-67)

2442

II

4/21/1975

LILLY RES LABS DIV ELI LILLY CO

ERGONOVINE MALEATE 0.2MG

2443

4/2/1975

MOLECULAR DESIGN INC

BAROPHANE (LAMINATED PLASTIC SHEET)

2444

4/30/1975

TAYLOR PHARMACAL CO

TEMPORARY FILLING FACILITIES

2445

5/1/1975

TRENT PHARMACAL INC

FACILITIES AND CONTROLS

2446

5/7/1975

NOVO LABORATORIES LTD

SULPHATED INSULIN

2447

4/14/1975

YAMAKAWA CHEMICAL INDUSTRY CO LTD

3.3.5-TRIMETHYLCYCLOHEXYL MANDELATE (CYCLANDELATE)

2448

5/1/1975

AMERICAN NATIONAL CAN CO

POLYESTER LIDDING STOCK

2449

5/6/1975

ARMOUR PHARMACEUTICAL CO

CALCITONIN-SALMON SYNTHETIC

2450

5/20/1975

HUECK & CIE

ALUMINUM BLISTER FOIL

2451

5/13/1975

SAUTER SPARKS INC

FACILITIES

2452

5/21/1975

HYDREA

2453

2454

6/7/1975

BRISTOL MYERS SQUIBB CO PHARMACEUTICAL


RESEARCH INSTITUTE
WINTHROP PHARMACEUTICALS DIV STERLING
DRUG INC
ACCUPAC INC

2455

5/23/1975

FG OKIE INC

PHARMACEUTICAL IMPRINTING INK-WHITE A8154

2456

II

5/28/1975

P-L BIOCHEMS INC

THYMUS GLAND FRACTION 3

2457

III

5/16/1975

KERR GROUP SUB BERRY PLASTICS CORP

CLOSURE LINING MATERIALS

2458

III

5/21/1975

HYDRO POLYMERS LTD.

BEETLE PVC COMPOUNDS FOR MEDICAL APPLICATIONS

2459

II

5/9/1975

INORP SA

HEPARIN SODIUM

2460

6/16/1975

OAK PARK PHARMACEUTICAL, INC

FACILITIES, CONTROLS AND PERSONNEL

2461

6/16/1975

ALLERGAN

PLASTIC COMPONENTS

2462

6/3/1975

PHOENIX LABORATORIES INC

STANDARD OPERATING PROCEDURE

2463

5/22/1975

REHEIS CHEM CO DIV ARMOUR AND CO

ZIRCONIUM-ALUMINUM-GLYCINE COMPLEZ (ZAG)

2464

6/20/1975

FM HOWELL AND CO

PERSONNEL, FACILITIES & CONTROLS

2465

5/26/1975

PROQUIMIO LTD

HEPARIN

2466

5/29/1975

TECHNICAL PLASTIC EXTRUDERS INC

TPX SHEETING

2467

II

6/10/1975

BRISTOL MYERS SQUIBB CO

WARFARIN SODIUM AS MANUFACTURED AT DUPONT CHEMOSWED IN SWEDEN

2468

II

6/17/1975

PERKINELMER LIFE ANALYTICAL SCIENCES INC

CHROMIUM-51

2469

II

6/17/1975

EI DUPONT DE NEMOURS AND CO

SELINIUM SE-75

II

II

II

5/23/1975
III

III

TETRAMISOLE HYDROCHLORIDE, LEVOROTATORY

DOPAMINE HYDROCHLORIDE
PACKAGING

Page 67

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2470 I
II
6/17/1975
PERKIN ELMER LIFE SCIENCES

SUBJECT
IODINE I-125

2471

2472

6/13/1975

NOT AN ASSIGNED NUMBER


AIR PRODUCTS AND CHEMICALS INC

PHENOLPHTHALEIN

2473

6/17/1975

REHEIS CHEM CO DIV ARMOUR AND CO

ALUMINUM-ZIRCONIUMCHLORHYDRATE COMPLEX AZ-4

2474

6/17/1975

TERRA MARINE BIORESEARCH

N-5-METHYLTETRAHYDROFOLIC ACID

2475

III

7/3/1975

BURTON,PARSONS & COMPANY,INC.

BUFILCON A --PLASTIC BUTTON FOR HYDROPHILIC SOFT CONTACT LENSES

2476

II

7/3/1975

ARMAK INDUSTRIAL CHEMICAL DIV

POLYETHYLENE GLYCOL 6000 DISTEARATE

2477

6/27/1975

PARKE DAVIS DIV WARNER LAMBERT CO

PACKAGING OPERATION

2478

II

6/24/1975

SYNTEX USA INC

NAPROXOL PROPIONATE (RS-65198-00-00-1)

2479

II

6/20/1975

MALLINCKRODT INC

IOTHALAMIC ACID U.S.P.

2480

7/9/1975

AS SYNTHETICS

PHENYLBUTAZONE BULK

2481

7/11/1975

ALLIED CHEM CORP

PETRA POLYESTER SHEET PRODUCT

2482

7/3/1975

ACETO CHEMICAL CO INC

SUFANILAMIDE

2483

II

7/14/1975

CIECH POLFA

SULFADIMETHOXINE

2484

II

7/3/1975

CIECH POLFA

SULFAGUANIDINE

2485

III

6/12/1975

CAPTIVE PLASTICS INC

PLASTIC CONTAINERS PRODUCTION

2486

7/16/1975

RHONE-POULENC

FACILITIES & PROCEDURES A VITRY SUR-SEIN PLANT

2487

II

7/17/1975

SYNTEX USA INC

7-METHYLTHIOANTHONE-2-CARBOXYLIC ACID (RS-7311) & SODIUM SALT RS-7603

2488

7/18/1975

H REISMAN CORP

2489

II

9/3/1974

ARMOUR PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR BULK AND DOSAGE FORM PACKAGING IN ORANGE , NEW JERSEY.
ZINC INSULIN CRYSTALS, INSULIN SALT CAKE (BULK)

2490

III

6/25/1975

MTC PHARMACEUTICALS

HEPARIN

2491

7/23/1975

SINCLAIR AND VALENTINE

SILKSCREEN INKS

2492

II

6/30/1975

MEDIMPEX NORTHAMERICA INC

DIHYDROCHLOROTHIAZIDE

2493

II

7/18/1975

ORGANICHEM CORP

HYDROCORTISONE-17-VALERATE

2494

7/23/1975

GLAXO LABS LTD

MEGESTROL ACETATE

2495

8/4/1975

P-L BIOCHEMS INC

METHYLENE DIPHOSPHONIC ACID

2496

7/25/1975

COSMECEUTICALS INC

MANUFACTURING PROCEDURES & CONTROLS

2497

II

7/29/1975

UPJOHN CO

CYCLOHEXIMIDE (ACTIDIONE) U-4527

2498

II

6/18/1975

LUSOCHIMICA S P A

XYLOMETAZOLINNE HYDROCHLORIDE

2499

7/28/1975

ARMOUR PHARMACEUTICAL CO

ADRENOCORTICOTROPIC HORMONE--HUMAN, SYNTHETIC

2500

7/28/1975

POLYSTYRENE RESINS

2501

7/25/1975

AMOCO CHEMS CORP AFFILIATE AMERICAN OIL


CO
GANES CHEMICALS INC

2502

7/28/1975

GANES CHEMICALS, INC., PENNSVILLE DIVISION

GUAIFENESIN GLYCERYLGUAIACOLATE

2503

8/4/1975

SYNTEX USA INC

RS-40584

2504

8/4/1975

SCOTT LABORATORIES INC

SCOTT SB SERIES FILTER SHEETS

2505

8/8/1975

STIEFEL LABORATORIES INC

GAMOPHEN

2506

8/13/1975

TEVA PHARMACEUTICAL INDUSTRIES LTD

ALLOPURINOL

III

II

II

BETHANECHOL CHLORIDE

Page 68

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2507 I
8/25/1975
SMITH KLINE & FRENCH LABS DIV SMITHKLINE
BECKMAN CORP
2508 I
8/12/1975
ADRIA DEVELOPMENT PARTNERSHIP H

SUBJECT
CARBUTEROL HYDROCHLORIDE (SK&F 40383-A)

2509

8/15/1975

FACILITY AND ITS OPERATIONS, PUERTO RICO PLANT

2510

II

8/28/1975

PROCTER AND GAMBLE PHARMACEUTICALS INC


SUB PROCTER AND GAMBLE CO
UPJOHN MANUFACTURING CO

2511

IV

8/26/1975

INTERNATIONAL GROUP INC

WAXES & WAX FORMULATIONS

2512

II

9/2/1975

REDEVAN LABS INC

TRIPROLIDINE HYDROCHLORIDE

2513

II

8/13/1975

KV PHARMACEUTICAL CO

PSEUDOEPHEDRINE HCL SRC

2514

II

8/22/1975

ETHYL CORP

TOLMETIN (MCN 2559-21-98)

2515

8/25/1975

I-125-FIBRINOGEN (HUMAN) SENSOR

2516

II

8/28/1975

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
NOVUS FINE CHEMICALS LLC

2517

III

8/27/1975

FLINT HILLS RESOURCES LP

23M2A AND 23M2Acs038 AS MANUFACTURED IN TEXAS

2518

III

9/4/1975

SANCAP LINER TECHNOLOGY INC

CAP LINER MATERIALS

2519

9/19/1975

BARNES HIND PHARMACEUTICALS INC

CONTACT LENS CLEANER USED W/BRUCKNER TENITE BUTYRATE LENS(TRANS DEVCS)

2520

2521

2522

2523

II

2524

2525

STALLIMYCIN

MOTRIN TAB

PSEUDOEPHEDRINE HCL, SULFATE, AND BASE BULK POWDER

NOT AN ASSIGNED NUMBER


8/21/1975

ATI

PLANT FACILITIES FOR AI EASTERN DIVISION

9/18/1975

SEAL BAG COMPANY INC

SURGI-PEEL POUCHES

6/23/1975

SIGMA F AND D DIV LTD

AMINO ACIDS: L-ARGININE, FREE BASE AND L-ARGININE, HYDROCHLORIDE

III

9/4/1974

NOVA CHEMICALS USA INCORPORATED

POLYSTYRENE RESINS

8/22/1975

KALI

QUALIF OF PROFESSIONAL STAFF--(FORMERLY HELD BY MID-WEST MEDICAL)

2526

II

8/3/1975

EI DUPONT DE NEMOURS AND CO

COPPER-64 (NITRATE & CHLORIDE)

2527

II

9/24/1975

NAPP CHEMICALS INC

CHLOROTHIAZIDE

2528

II

9/17/1975

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

THIORIDAZINE HCL

2529

II

9/15/1975

HOECHST AG

PROCAINE HCL--METHODS, FACILS, CONTROLS USED IN MFG.PROCESS. & PACKING

2530

9/18/1975

H REISMAN CORP

VITAMIN B-12 TRITURATIONS

2531

9/12/1975

MALLINCKRODT INC

LENPERONE 4'-FLUORO-4-[4-(P-FLUORO-BENZOYL)-PIPERDINO] BUTYROPHENONE

2532

10/8/1975

APOTEKSVARUCENTRALEN VITRUM AB

BRANCHED-CHAIN AMINO ACID SOLU

2533

II

9/25/1975

LILLY RES LABS DIV ELI LILLY CO

TYRAMINE HCL INJ

2534

II

10/13/1975

DINAMITE DIPHARMA SPA

ALLOPURINOL

2535

II

10/6/1975

INDUSTRIA CHIMICA MILANESE SPA

AMITRYPTILINE HCL

2536

7/23/1975

GARDENA RUBBER COMPANY INC

COMPOUND GRC 604-70

2537

10/21/1975

CILAG CHEMIE AG

TOLMETIN SODIUM DIHYDRATE

2538

10/20/1975

MALLINCKRODT CHEMICAL WORKS

DIFENOXIN

2539

10/23/1975

BARNES HIND PHARMACEUTICALS INC

SOFT CONTACT LENS CLEANER

2540

III

10/23/1975

FLOW PHARMS INC

PORTA-FLOW DEVICE(HYDROPHILIC LENS STORAGE AND DISINFECTION)

2541

IV

10/3/1975

FOREST LABORATORIES INC

SYNCHRON ORAL-CARRIER

2542

10/22/1975

PFANSTIEHL LABORATORIES INC

MALTOSE MONOHYDRATE

2543

10/28/1975

LLOYD MANUFACTURING CO INC

14-B WHITE RUBBER LINING MATERIAL

II

II

III

Page 69

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2544 I
10/31/1975
CONVERTERS INK CO

SUBJECT
INK FORMULATIONS

2545

II

11/6/1975

COMMOMWEALTH SERUM LABS

INSULIN SALT CAKE & INSULIN CRYSTALS

2546

III

11/6/1975

CONTINENTAL CAN COMPANY

IRRIGATION BOTTLES

2547

II

10/31/1975

MEDIMPEX NORTHAMERICA INC

PHENYLBUTAZONE

2548

II

10/31/1975

MEDIMPEX NORTHAMERICA INC

DIHYDROERGOTOXIN METHANESULPHONATE

2549

III

11/4/1975

GENERAL ELECTRIC CO

RADIOISOTOPES

2550

III

11/12/1975

BURTON,PARSONS & COMPANY,INC.

FLEXSOL 43 PLASTIC BUTTON

2551

II

11/3/1975

RESEARCH INDUSTRIES CORP

DIMETHYL SULFOXIDE (DMSO)

2552

11/14/1975

JT BAKER CHEMICAL CO

MASTER FACILITIES

2553

III

3/8/1976

PRINTPACK INC

COMPOSITE CONSTRUCTION LAYER FILMS

2554

11/4/1975

INTERNATIONAL NUTRONICS INC

FACILITY DESCRIPTION & PERSONNEL (THIS FORMERLY HELD BY RSA CORP)

2555

11/6/1975

AMERICAN CYANAMID CO

XT ACRYLIC POLYMER

2556

10/31/1975

3-M NUCLEAR PRODUCTS

FACILITIES, PERSONNEL METHODS AND CONTROLS

2557

II

11/7/1975

HAFSLUND NYCOMED PHARMA AG

HEXOPRENALINE SULFATE

2558

IV

11/12/1975

BURTON,PARSONS & COMPANY,INC.

ADAPETTES, (LUBRICAING SOLUTION)

2559

III

11/21/1975

BURTON,PARSONS & COMPANY,INC.

FLEXSOL 55 PLASTIC BUTTON

2560

III

11/21/1975

BURTON,PARSONS & COMPANY,INC.

FLEXSOL 72 PLASTIC BUTTON

2561

8/30/1975

KV PHARMACEUTICAL CO

ACETAZOLAMIDE 500MG SRC

2562

11/13/1975

PHARMA-WALDHOF GMBH

GLUTAHIONE, OXIDIZED HYDRATE

2563

11/21/1975

SYNTEX USA INC

MANUFACTURING FACILITIES AND CONTROLS (NASAL+-SUFFLATOR SYSTEM)

2564

II

11/20/1975

SANWA CHEMICAL COMPANY LTD

CYCLANDELATE

2565

II

11/12/1975

TEVA PHARMACEUTICAL INDUSTRIES LTD

FUROSEMIDE MANUFACTURED IN PETAH TIQVA, ISRAEL.

2566

II

11/25/1975

GANES CHEMICALS INC

DIETHYLPROPION HYDROCHLORIDE

2567

12/1/1975

KORO CORP

KORACRYL THERMOPLASTIC SHEETING

2568

12/5/1975

SYNTEX USA INC

TRALONIDE

2569

II

11/21/1975

SIGMA F AND D DIV LTD

TAURINE

2570

II

7/21/1975

SIGMA F AND D DIV LTD

D-PHENYLALANINE

2571

12/17/1975

SCHERING CORP SUB SCHERING PLOUGH CORP

MANUFACTURING AND CONTROL (PALACOS W/GENTAMICIN)

2572

II

11/13/1975

EMERY IND INC

SPECS & COMPOSITION EMERSOL 315-LINLEIC ACID

2573

II

12/3/1975

PFEIFER & LANGEN

MANUFACTURING AND DESCRIPTION (DEXTRAN)

2574

12/10/1975

OTSUKA PHARM CO LTD

MANUFACTURING FACILITIES AND SPECS--MALTOSE SUGAR

2575

10/31/1975

SIGMA F AND D DIV LTD

DL-N-5-METHYLTETRAHYDROFOLIC ACID, SODIUM

2576

12/16/1975

MK LABORATORIES INC

PLANT FACILITIES AND CONTROLS

2577

12/22/1975

TECHNICAL WAREHOUSE SERVICES INC

MANUFACTURING FACILITIES AND CONTROLS

2578

II

12/17/1975

ER SQUIBB AND SONS INC

MANUFACTURE AND CONTROLS (AMPHOTERICIN B, METHYL ESTER)

2579

II

12/26/1975

MANUFACTURING ENTERPRISES INC

HALOG (HALCINONIDE) 0.1% SOL.

2580

II

12/26/1975

WESTWOOD SQUIBB PHARMACEUTICALS INC

HALOG (HALCINONIDE 0.1% OINTMENT) MANUFACTURED IN HUMACAO, PR

2581

12/15/1975

AMERICAN LABS

OPERATING PROCEDURE NO. 180 (CALF THYMUS-FRACTIONS)

2582

1/6/1976

DELMAR CHEMS LTD

DIAZEPAM USP BULK-MANUF AT LA SALLE, QUEBEC FACILITIES

II

II

Page 70

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2583 I
II
12/16/1975
NEN LIFE SCIENCE PRODUCTS

SUBJECT
GALLIUM-68 MFG IN NO. BILLERICA, MA

2584

IV

12/19/1975

EVONIK ROHM GMBH

EUDRAGIT L 30 D-55

2585

II

12/19/1975

MANUFACTURING, FACILITIES AND CONTROLS (CHLORDIAZEPOXIDE HCL USP)

2586

II

12/19/1975

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
LONZA RIVERSIDE

2587

II

12/17/1975

CHOAY SA

HEPARIN CALCIUM

2588

11/28/1975

EASTMAN KODAK CO

GUANIDINE HCL

2589

1/13/1976

OPOCRIN LABORATORIO FARMACOBIOLOGICA

PLANT FACILITIES AND CONTROLS

2590

II

1/19/1976

SB PENICK AND CO ORIG

ALPHACETYLMETHADOL HCL (LEVOROTATORY)

2591

1/20/1976

UPJOHN CO

GEN. INFO APPLICABLE TO THE FINE CHEMICAL OPERATIONS

2592

1/23/1976

PHENCHEM INDUSTRIES LTD

IMIPRAMINE HCL

2593

II

1/23/1976

PHENCHEM INDUSTRIES LTD

PROCHLORPERAZINE MALEATE

2594

II

1/23/1976

PHENCHEM INDUSTRIES LTD

TRIFLUOPERAZINE HCL

2595

2596

II

1/16/1976

SIGMA F AND D DIV LTD

5 ALPHA-ANDROSTAN-17B-OL-3-ONE (5 ALPHA-DIHYDROTESTOSTERONE)

2597

II

1/16/1976

SIGMA F AND D DIV LTD

B-MERCAPTOCTHYLAMINE HYDROCHLORIDE (CYSTEAMINE)

2598

II

1/28/1976

SIFAVITOR SRL

AMITRIPTYLINE HCL

2599

III

1/29/1976

PRODUCTION OF PLASTIC BOTTLES

2600

1/29/1976

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
PHARMACEUTICAL PACKAGING SERVICES

2601

II

2/10/1976

MALLINCKRODT INC

THALLOUS CHLORIDE (T1-201)

2602

2/12/1976

SG HAUSER ASSOCIATION INC

SOFT LENS STERILIZER

2603

2/13/1976

MOBAY CHEMICAL CORP

MERLON PRODUCTS

2604

2/19/1976

AMPHETAMINE SULFATES

2605

2/18/1976

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
A SCHULMAN INC

2606

II

2/5/1976

FALK GMBH AND CO

CHENOFALK(CHENODEOXYCHOLIC ACID)

2607

III

2/23/1976

AMERICAN MIRREX CORP

MIRREX (MCFD-1047 CLEAR) (FORMERLY HELD BY TENNECO CHEMICALS)

2608

2/24/1976

SYNTEX LABORATORIES INC SUB SYNTEX CORP

FACILITIES AND CONTROLS

2609

2/6/1976

CURWOOD INC

PRODUCT SPEC. AND TOXICITY TESTS RVCY 700 RIGILAM BC HIPS

2610

III

2/18/1976

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK FILMS

2611

2/2/1976

SIGMA F AND D DIV LTD

PHOSPHORYLCHOLINE CHLORIDE, CA SALT

2612

3/1/1976

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

HEMAC POLYMER NETWORKS

2613

1/30/1976

SPECIALTY PAPERS CO

PACKAGING CONSTRUCTIONS (CEFE, CE-1, CE-2)

2614

II

2/17/1976

PFANSTIEHL INC

STREPTOZOTOCIN

2615

3/1/1976

STARKS ASSOCIATES INC

FACILITIES AND CONTROLS

2616

II

2/27/1976

SCIENTIFIC PROTEIN LABORATORIES LLC

HEPARIN SODIUM

2617

3/2/1976

SYNTHETIC PRODUCTS CO

SYNPRON 1005 VINYL HEAT STABILIZER

2618

3/2/1976

HENKEL INC

LOXIOL GH-4 AND LOXIOL G-70

2619

3/9/1976

PLANTEX LTD CHEM AND PHARM WORKS

FACILITIES AND PROCEDURES

TRIAMTERENE, USP AS MANUFACTURED IN CONSHOHOCKEN, PA)

NOT AN ASSIGNED NUMBER

II

III

METHODS AND PROCESSES FOR PACKAGING AND LABELING

1B-35A PELLETS (IV BAG) --MANUFACTURING SPECIFICS.

Page 71

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2620 I
3/4/1976
KYOWA HAKKO USA INC

SUBJECT
L-CYSTINE AND L-CYSTINE MONOHYDROCHLORIDE

2621

2622

2623

2624

2625

II

3/2/1976

KYOWA HAKKO USA INC

L-ALANINE

2/4/1976

KYOWA HAKKO USA INC

L-LEUCINE

II

2/11/1976

KYOWA HAKKO USA INC

L-ISOLEUCINE--MANUFACTURING INFO

II

3/11/1976

KYOWA HAKKO USA INC

AMINO ACIDS--GENERAL INFO ON BULK DRUG SUBSTANCES

3/10/1976

BORG-WARNER CHEMICALS

CYCOPAC 930

2626

3/23/1976

DELMAR LABS

MANUFACTURING FACILITIES

2627

2628

III

1/21/1976

AVERY DENNISON SPECIALTY TAPE DIV

ADHESIVE SYSTEMS

2629

III

3/18/1976

MX-1834 E.P.D.M. I.V. STOPPER FORMULATION

2630

II

2/19/1976

STEVENS ELASTOMERIC & PLASTIC PRODS SUB


JP STEVENS & CO INC
CYCLO PRODUCTS INC

2631

II

3/18/1976

KYOWA HAKKO KOGYO CO LTD

AMINO ACIDS

2632

3/5/1976

AS SYNTHETICS

SULFAMETHIZOLE

2633

II

3/1/1976

INDOMETHACIN

2634

IV

3/12/1976

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
EASTMAN CHEMICAL CO

2635

3/8/1976

CENTERCHEM INC

PAPAIN

2636

3/25/1976

BELL MORE LABS INC

FILLING & FREEZE DRYING METHODS FOR IN-VIVO MATERIAL

2637

2638

2639

II

3/8/1976

CENTERCHEM INC

SODIUM HEPARIN

2640

II

3/18/1976

ROUSSEL-UCLAF

DELTA-5 (10)-NORANDROSTENEDIONE

2641

3/25/1976

SYNTEX USA INC

CLOPREDNOL

2642

3/19/1976

AYERST LABORATORIES INC

AY-24,910 SOMATOSTATIN

2643

3/23/1976

BARNES HIND PHARMACEUTICALS INC

B-H SOFT LENS RINSING AND BOILING SOLUTION-HYDROCURVE(TRANS-DEVICES)

2644

2645

2646

2647

2648

2649

2650

2651

II

4/26/1976

ANTIBIOTICOS SPA

TRIAMCINOLONE ACETONIDE

2652

4/6/1976

AZIENDE CHIMICHE RIUNITE

FACILITIES IN APRILIA, ITALY

2653

II

4/19/1976

MALLINCKRODT INC

SELENOMETHIONINE

2654

III

4/22/1976

BORDEN CHEM CO

PVC HOMOPOLYMER RESINS

2655

4/1/1976

PIERREL SPA

TRIAMCINOLONE ACETONIDE

2656

4/1/1976

PIERREL SPA

TRIAMCINOLONE ALCOHOL

NOT AN ASSIGNED NUMBER

TRIPROLIDINE HCL(THIS FORMERLY HELD BY TRAVENOL LABS, INC)

TENITE BUTYRATE (FOR CONTACT LENS)

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER


4/6/1976

II
II

SYNTHETIC ANGIOTENSIN III

3/30/1976

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
SCHERING CORP SUB SCHERING PLOUGH CORP

4/7/1976

LILLY RES LABS DIV ELI LILLY CO

EPHEDRINE SULFATE

4/8/1976

MONSANTO COMPANY

HEXAMETHYLENE DIAMINETETRA ACID (METHYLENE PHOSPHONIC)

4/2/1976

SOLMAG SPA

FUROSEMIDE

MANUFACTURING PROCEDURES

NOT AN ASSIGNED NUMBER

Page 72

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2657 I
II
4/26/1976
ANTIBIOTICOS SPA

SUBJECT
SPIRONOLACTONE

2658

MANUFACTURE AND CONTROL

2659

4/13/1976

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
3M PHARMS

2660

4/20/1976

SCHERING PLOUGH LABO N V

METHODS,FACILITIES AND CONTROLS FOR ESSEX LABO NV BELGIUM

2661

II

5/4/1976

SIGMA F AND D DIV LTD

AMINO ACIDS & THEIR SODIUM SALT DERIVAIVES RELAIVE TO HFN-130 INDS

2662

4/9/1976

THERMOPLASTIC PROCESSES INC

BEV-A-LINE

2663

II

5/7/1976

DOTTIKON EXCLUSIVE SYNTHESIS AG

ISOSORBIDE DINITRATE LACTOSE 25:75%

2664

II

4/28/1976

HOFFMANN LA ROCHE INC

LEVODOPA INJECTABLE

2665

4/30/1976

B BRAUN MEDICAL INC

PERSONNEL

2666

5/7/1976

CONTINENTAL PHARMA SA

SULACTIDIL

2667

3/22/1976

DIOSYNTH INTERNATL NV

METHYLTESTOSTERINE

2668

II

5/4/1976

LONZA RIVERSIDE

TRIMEPRAZINE TARTRATE

2669

5/10/1976

N&N MENICON INC

MAFILCON, SOFT CONTACT LENS MATERIAL

2670

4/29/1976

CILAG CHEMIE AG

PRODUCTION & CONTROL(HOLDER NAME CHANGED 4.9.81 TO CILAG AG)

2671

II

5/13/1976

OTSUKA PHARM CO LTD

CARTEOLOL HCL, MANUFACTURED IN TOKUSHIMA, JAPAN

2672

II

5/10/1976

PCR INC

CHLORDIAZEPOXIDE AND CHLORDIAZEPOXIDE CHL

2673

5/13/1976

BARNES HIND PHARMACEUTICALS INC

BARNES-HIND SOFT LENS RINSING AND BOILING SOLUTION

2674

III

5/21/1976

MERCK MANUFACTURING DIVISION

2675

II

5/20/1976

ROUSSEL CORPORATION

INJECTION AND EXTRUSION BLOW MOLDED CONTAINERS MANUFACTURED IN WEST POINT,


PA
FLUPREDNYLIDENE-21-ACETATE

2676

II

5/20/1976

GANES CHEMICALS INC

DISODIUM ETIDRONATE

2677

II

5/4/1976

ORGANON INC

ESTRADIOL

2678

III

6/8/1976

CARIX

2679

5/3/1976

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD
PHARMACEUTICAL BASICS INC

2680

3/25/1976

UNION CARBIDE CORPORATION

TERGITOL ANIONIC SURFACTANT 4

2681

II

5/27/1976

DRUGS INC

CHLORDIAZEPOXIDE HCL

2682

6/3/1976

SICOR SA FACILITIES IN LIMAY, FRANCE

2683

6/16/1976

SOCIETE INDUSTRIELLE POUR LA CHIMIE


ORGANIQUE ET LA RECHERCHE SICOR
MELWOOD STEELE CENTER ITERNATIONAL

2684

6/15/1976

DAIICHI SEIYAKU CO LTD

EPIRIZOLE (MEBRON)

2685

III

6/6/1976

SELIG SEALING PRODUCTS INC

W SERIES OF CAP-SEAL BRAND CLOSURE LINER(W-77)

2686

III

6/10/1976

ALDEN OPTICAL LAB INC

2-HYDROXYETHYL METHACRYLATE AL-47 MONOMER

2687

II

5/24/1976

ANTIBIOTICOS SPA

PROGESTERONE 16A, 17A- ACETOPHENIDE

2688

II

5/24/1976

ANTIBIOTICOS SPA

METHYLPREDNISOLONE AND METHYLPEDNISOLONE ACETATE

2689

III

6/9/1976

VOLTEK INC

MINICEL(R) L-200 FOAMS (CROSS LINKED POLYETHYLENE FOAM)

2690

II

5/27/1976

GANES CHEMICALS INC

PHENTERMINE HCL

2691

5/27/1976

GANES CHEMICALS INC

XYLOMETAZOLINE HCL

2692

6/22/1976

GEORGE F DEFONEY PHARMACEUTICAL

SODIUM HEPARIN

II

4/22/1976

3M BRAND TRACER MICROSPHERES

MANUF, QUALITY CONTROL & OPERATIONAL PROCEDURES

FORMULA - HG/MJS

Page 73

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2693 A
II
6/16/1976
OLON SPA

SUBJECT
BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL.)

2694

6/23/1976

H REISMAN CORP

RESERPINE -LACTOSE TRITURATIONS

2695

6/14/1976

JANSSEN PHARMACEUTICA INC

FACILS & COMTRLS-JANSSEN PHARMA. N.V.-BELL TELEFOONLAAN, GEEL, BELGIUM

2696

II

6/2/1976

ANTIBIOTICOS SPA

METHYLDOPA USP

2697

II

6/9/1976

GANES CHEMICALS INC

ISOPROTERENOL HCL AND ISOPROTERENOL SULFATE

2698

II

6/21/1976

SIEGFRIED LTD

PROPARACAINE HCL

2699

II

6/10/1976

CHEMAPOL LTD

DIHYDROERGOTOXINE METHANE SULFONATE

2700

6/25/1976

B BRAUN MEDICAL INC

STERILIZATION OF LARGE VOL PARENTERAL SOL AS MANUFACTURED IN IRVINE CA

2701

6/2/1976

CV CHEMIE COMBINATIE

L (-) LACTIDE

2702

6/11/1976

NYEGAARD AND CO AS

METRIZOIC ACID

2703

II

6/21/1976

CHEMAPOL LTD

LYSENYL (LISURIDE HYDROGEN MALEATE)

2704

6/15/1976

DIFFUCAP SA

2705

7/5/1976

SORIN BIOMEDICA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SWITZERLAND.
MANUFACTURING PROCESS

2706

7/1/1976

HOECHST MARION ROUSSEL

MANUFACTURING FACILITY

2707

II

7/19/1976

HERCULES INC

CROSSLINKED SODIUM CARBOXYMETHYLCELLULOSE (AQUALON ABSORB. FIBERS)

2708

II

7/8/1976

NAPP CHEMICALS INC

LIDOCAINE, USP

2709

II

7/15/1976

EI DUPONT DE NEMOURS AND CO

CALCIUM-45

2710

II

7/19/1976

MEDIMPEX NORTHAMERICA INC

CLOFIBRATE

2711

IV

7/9/1976

XYROFIN AG

XYLITOL

2712

II

8/3/1976

PFIZER INC

HEPARIN, SODIUM U.S.P.

2713

II

7/22/1976

LUSOCHIMICA S P A

DILUTED ISOSORBIDE DINITRATE

2714

II

7/21/1976

ANALYTICA CORP

TRIPROLIDINE HCL, NF

2715

II

7/30/1976

DOW CHEMICAL CO MICHIGAN DIV

PROPOXYPHENE HCL, USP

2716

II

8/10/1976

CIMETIDINE AND CIMETIDINE HCL MANUFACTURED IN CORK, IRELAND.

2717

II

5/25/1976

SMITHKLINE BEECHAM CORP DBA


GLAXOSMITHKLINE
WEDDEL PHARMS LTD

2718

7/28/1976

CIMETIDINE AND CIMETIDINE HCL

2719

II

8/9/1976

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
TEVA PHARMACEUTICAL INDUSTRIES LTD

2720

8/16/1976

PHARMACIA AND UPJOHN INC

FACILS. AND CONTROL SPECIFS IN KALAMAZOO, MICH. FACILITY (IBUPROFEN)

2721

II

3/27/1976

FARMABOIS

6-ALPHA-METHYL-PREDNISOLONE N.F.

2722

II

8/16/1976

AINC

ZETA PLUS 'CP' & 'SP' FILTER MEDIA FOR PHARMACEUTICAL USE

2723

II

8/5/1976

SOCIETE CHIMIQUE POINTET GIRARD SA

QUINIDINE GLUCONATE

2724

II

8/11/1976

ANTIBIOTICOS SPA

MEDROXYPROGESTERONE ACETATE

2725

II

8/13/1976

MANUFACTURING ENTERPRISES INC

TRIAMCINOLONE ACETONIDE 10%

2726

II

8/5/1976

BAYER SCHERING PHARMA AG

NORETHINDRONE

2727

III

7/28/1976

UNIVERSAL SHELLAC & SUPPLY COMPANY INC

LENS POLISHING PITCHES, LENS BLOCKING PITCHES AND STACKING WAX

2728

8/30/1976

AEROJET-GENERAL CORPOATION, PROPULSION


DIVISION.

FACILITIES AND CONTROLS

HEPARIN SODIUM USP

AMITRIPTYLINE HCL

Page 74

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2729 I
II
9/3/1976
GANES CHEMICALS INC

SUBJECT
BRETYLIUM TOSYLATE

2730

2731

2732

2733

2734

II

8/27/1976

CORD LABORATORIES INC

THEOPHYLLINE CAPS., 250MG

8/25/1976

VERNAY LABORATORIES INC

ELASTOMER FORMULATION VL 201 N 46

II

8/30/1976

NOVO NORDISK AS

INSULIN (SALT CAKE AND CRYSTALS)

III

8/20/1976

CELANESE PLASTICS

CELGARD MICROPOROUS FILM AND HOOLOW FIBER PRODUCTS

II

9/2/1976

SYNTHETIC BOVINE PARAHYROID HORMONE (1-34) PEPTIDE

2735

II

8/10/1976

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
ROUSSEL CORPORATION

2736

II

7/19/1976

SANOFI CHIMIE

DEXAMETHASONE ACETATE ANHYDROUS USP MANUFACTURED IN VERTOLAYE, FRANCE.

2737

II

7/19/1976

ROUSSEL CORPORATION

DEXAMETHASONE SODIUM METASULFOBENZOATE

2738

II

8/2/1976

OLON SPA

DIETHYLPROPION HCL.

2739

II

8/30/1976

SULFISOXAZOLE

2740

II

9/3/1976

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
ER SQUIBB AND SONS INC

2741

II

9/3/1976

ER SQUIBB AND SONS INC

TRIAMCINOLONE ACETONIDE CONCENTRATE

2742

9/1/1976

ROCHE PRODUCTS INC

2743

III

8/23/1976

ONYX CHEM CO DIV MILLMASTER ONYX CORP

MAPROLYTE XL AND LX

2744

9/9/1976

PHARM ECO LABORATORIES INC

FACILITIES FOR PHARM-ECO LABS

2745

II

8/18/1976

HOFFMANN LA ROCHE INC

RO 21-5816/000 24R,25-DIHYDROXYCHOLECALCIFEROL

2746

III

8/10/1976

AMERICAN NATIONAL CAN CO

LAMINATED PACKAGING FILMS (THIS FORMERLY HELD BY CONTINENTAL CAN CO.)

2747

III

8/2/1976

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK BRAND FILMS

2748

II

8/20/1976

WESTWOOD-SQUIBB

KENALOG CREAM (THIS FORMERLY HELD BY MANUFACTURING ENTERPRISES,INC

2749

6/7/1976

BORG-WARNER CHEMICALS

CYCOPAC PRODUCTS PART 2

2750

III

9/15/1976

DUPONT PERFORMANCE POLYMERS

DELRIN (R) ACETAL RESIN

2751

II

9/17/1976

NAPP CHEMICALS INC

N-ACETYL PROCAINAMIDE HCL

2752

8/13/1976

DELVCO INDUSTRIES INC

PACKAGING GUIDELINE

2753

II

10/15/1976

KYOWA HAKKO KOGYO CO LTD

2754

II

10/27/1976

AINC

L-CYSTINE & DERIVATIVE L-CYSTINE HCL & N-ACETYL-L-CYSTEIN MANUFACTURED IN SAKAI,


OSAKA, JAPAN.
ZETA/PLUS PRE-TEK (3 NORMAL DIAMETER) CARTRIDGES FOR PHARMACEU. USE

2755

10/26/1976

MERCK SHARP & DOHME RESEARCH LABS

FACILITIES & CONTROLS FOR MERCK FROSST LABS FOR TROCOSONE

2756

10/26/1976

MERCK SHARP & DOHME RESEARCH LABS

TROCOSONE

2757

10/8/1976

3M DRUG DELIVERY SYSTEMS

CORDRAN (FLURANDRENOLIDE) TAPE

2758

9/27/1976

KV PHARMACEUTICAL CO

HYBEPHEN -LA CAPSULES

2759

II

8/10/1976

BUCHLER AND CO

QUINIDINE SULFATE AND QUINIDINE PRODUCTS

2760

10/5/1976

MANUFACTURING PROCESS AND FACILITY AT NORTH NORWICH, NY

2761

10/14/1976

2762

9/28/1976

PROCTER AND GAMBLE PHARMACEUTICALS INC


SUB PROCTER AND GAMBLE CO
WINTHROP PHARMACEUTICALS DIV STERLING
DRUG INC
CYCLO PRODUCTS INC

2763

9/27/1976

MALLINCKRODT INC

TOLMETIN SODIUM DIHYDRATE--MANUFACTURING PROCEDURES

2764

10/5/1976

BF GOODRICH COMPANY

VYNALOY COMPOUNDS

II

II

HEMATOPORPHYRIN BASE

KENALOG LOTION

SYNTHESIS & QUALITY CONTROLS FOR 5,7-DICHLORO-8-HYDROXYQUINOLONE


SYNTHESIS OF DIETHYLPROPIN HCL, NF XIV

Page 75

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2765 I
II
10/12/1976
SIGMA F AND D DIV LTD

SUBJECT
L-VALINE

2766

II

11/2/1976

ABBOTT LABORATORIES

ESTERIFIED ESTROGENS USP

2767

II

11/2/1976

TEVA PHARMACEUTICAL INDUSTRIES LTD

CONJUGATED ESTROGEN USP POWDER

2768

11/3/1976

FACILS., CONTROLS AND DRUG SYNTHESIS AND PRODUCT INFORMATION

2769

II

10/8/1976

4 QUATRUM-EMPRESA NACIONAL DE QUIMICA


ORGANICA SARL
BACON AND THOMAS

2770

10/1/1976

BF GOODRICH COMPANY

AMERIPOL POLYMERS, EPCAR POLYMERS AND HYCAR POLYMERS

2771

10/1/1976

POLYSAR INC

EPCAR POLYMERS

2772

10/1/1976

BF GOODRICH COMPANY

HYCAR POLYMERS (1022)

2773

II

10/25/1976

B BRAUN MEDICAL INC

BRANCHED CHAIN AMINO ACID SOLUTION

2774

II

10/25/1976

ORGANON INC

CONJUGATED ESTROGENS

2775

II

10/1/1976

GANES CHEMICALS INC

PROBENECID

2776

II

10/1/1976

SIEGFRIED AG

XIPAMIDE

2777

II

10/20/1976

SIEGFRIED USA INC

PROPOXYPHENE HYDROCHLORIDE

2778

II

10/22/1976

SIGMA F AND D DIV LTD

L-LEUCINE

2779

IV

11/2/1976

SIGMA F AND D DIV LTD

DIHYDROXYACETONE

2780

IV

10/29/1976

SIGMA ALDRICH MANUFACTURING LLC

PATENT BLUE VIOLET

2781

10/21/1976

LESCARDEN LTD

CARIX-S INJECTION

2782

10/28/1976

MONSANTO RES CORP DIV MONSANTO CO

GMP RELAING TO THE MANUFACTURE OF BULK PHARMACEUTICALS

2783

10/29/1976

ISOMEDIX INC

FACILS & CONTROLS FOR IRRADIATION PROCESSING-COLUMBUS, MISS. FACILITY

2784

II

11/4/1976

PCR INC

FTORAFUR

2785

II

11/5/1976

ORGANICHEM CORP

TRIHEXYPHENIDYL HCL

2786

11/16/1976

BARR LABORATORIES INC

MANUFACTURING AND CONTROLS

2787

11/2/1976

ANTIBIOTICOS SPA

FLUOCINOLONE ACETONIDE

2788

11/19/1976

LIFE CARE FLEXIBLE CONTAINERS

2789

II

11/11/1976

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SANOFI AVENTIS CHIMIE

2790

II

11/10/1976

MALLINCKRODT INC

TOLMETIN SODIUM DIHYDRATE T.A.

2791

11/12/1976

ACIC LTD

PHENFORMIN HCL

2792

11/24/1976

ST ONGE MAYERS STEWARD & REENS

GLOVE JUICE TEST

2793

II

10/18/1976

ANTIBIOTICOS SPA

BECLOMETHASONE 17, 21- DIPROPIONATE

2794

III

11/15/1976

B BRAUN MEDICAL INC

PLASTIC LARGE VOLUME PARENTERAL CONTAINERS

2795

III

11/23/1976

INEOS ACRYLICS UK LIMITED

PERSPEX CQ POLYMETHYLMETHACRYLATE SHEET

2796

II

11/24/1976

MALLINCKRODT INC

OXYCODONE TEREPHTHALATE

2797

11/18/1976

HERCULES INC

PENTRINITROL

2798

II

11/12/1976

CONNAUGHT LABORATORIES INC

ISOPHANE INSULIN SUSPENSION USP (NPH)

2799

III

12/13/1976

BAYER CORP

COMPLETE BUTYL PRODUCT LINE MANUF AT THE SARNIA FACILITY

2800

II

11/30/1976

ORGANICS DIV LA GRANGE INC

NATURAL ESTROGENIC SUBSTANCE

2801

II

11/8/1976

SANOFI PHARMACEUTICALS INC

LIDOCAINE HCL

2802

12/10/1976

DIAGNOSTIC ISOTOPES INC

XENON, XE-127

HEPARIN SODIUM

HYDROCORTISONE USP

Page 76

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
2803 A
V
12/10/1976
NATIONAL INSTITUTES HEALTH NATIONAL CANCER PRECLINICAL EVALUATIONS
INSTITUTE DIV CANCER TREATMENT
2804 I
12/1/1976
SIEGFRIED AG
DIETHYLPROPION HCL
2805

11/22/1976

KESTREL

THERMAL DISINFECTION UNIT, CONTACT LENS CARRYING/STORAGE CASE-FACILS

2806

12/1/1976

STANFORD RES INST

PHARMACEUTICAL ANALYSIS

2807

II

11/22/1976

INDUSTRIA CHIMICA PROFARMACO SPA

HYDROXYZINE HCL

2808

II

11/29/1976

INDUSTRIA CHIMICA PROFARMACO SPA

HYDROXYZINE PAMOATE

2809

II

12/10/1976

OLON SPA

CLIDINIUM BROMIDE

2810

12/10/1976

INST CHEMIOTERAPICO ITALIANO

SULFAMETHOXAZOLE

2811

12/6/1976

DOW CORNING CORP

MDX-4-4210 CLEAN GRADE ELASTOMER

2812

12/23/1976

CORNEAL SCIENCES INC

CRAFILCON A (TM) SOFT CONTACT LENSES

2813

12/22/1976

SYNTEX USA INC

SYNTHESIS OF RS-40974-00-00-0

2814

II

12/15/1976

CHLORTHALIDONE

2815

II

12/14/1976

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
ORGANON INC

2816

II

12/16/1976

ORGANON INC

DEXAMETHASONE

2817

II

1/7/1977

CILAG CHEMIE AG

AMANTADINE HCL

2818

II

1/3/1977

KV PHARMACEUTICAL CO

POTASSIUM CHLORIDE SUSTAINED RELEASE CAPSULES 600MG

2819

II

1/22/1977

SYNTEX USA INC

RS-44872-00-10-3 (D,L-1[2,4-DICHLORO-BETA-[4-CHLOROBENZYL)THIO]PHENETH

2820

II

1/25/1977

LILLY RES LABS DIV ELI LILLY CO

EMETINE HCL INJECTION

2821

II

1/4/1977

MALLINCKRODT CHEMICAL INC

OXYCODONE HYDROCHLORIDE PURIFIED RECRYSTALLIZED

2822

IV

12/23/1976

EVONIK ROHM GMBH

EUDRAGIT E 30 D ACRYLATE ESTER COPOLYMER COATING

2823

II

12/23/1976

UNION CARBIDE CORPORATION

XENON-133 PL AND XENON-133 P2

2824

III

12/8/1976

WRAPS INC

LAMINATES AND FILM-COATED PAPERS

2825

10/27/1976

CENTERCHEM INC

COSMETIC COLLAGEN

2826

1/24/1977

BARNES HIND PHARMACEUTICALS INC

BARNES-HIND CLEANING SOL'N FOR SOFT CONTACT LENSES (TRANS. TO DEVICES)

2827

1/25/1977

BARNES HIND PHARMACEUTICALS INC

BARNES-HIND RINSING SOLUTION FOR SOFT CONTACT LENSES(TRANS.TO DEVICES)

2828

2829

1/26/1977

BARNES HIND PHARMACEUTICALS INC

BARNES-HIND STORAGE CASE FOR SOFT CONTACT LENSES

2830

12/30/1976

SIGMA F AND D DIV LTD

CYCLOHEXIMIDE

2831

12/23/1976

H REISMAN CORP

KETAZOLAM

2832

1/28/1977

LAKE AND CRUICKSHANK

QUINIDINE PRODUCTS

2833

II

1/12/1977

TEVA PHARMACEUTICAL INDUSTRIES LTD

ACETAZOLAMIDE

2834

1/13/1977

KOLMAR LABORATORIES INC

MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

2835

1/13/1977

KOLMAR LABORATORIES INC

MANUF & PACKAGING OF DRUG PRODUCTS A THE MILWAUKEE, WIS. FACILITY

2836

III

1/26/1977

SABIC INNOVATIVE PLASTICS

2837

II

1/27/1977

2838

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD
BARNES HIND PHARMACEUTICALS INC

VALOX * RESINS AS MANUFACTURED IN MT VERNON, INDIANA (USA), AND BERGEN-OP-ZOOM,


THE NETHERLANDS.
CHYMOTRYPSIN AND/OR TRYPSIN

IV

DEXAMETHASONE ACETATE

NOT AN ASSIGNED NUMBER

1/25/1977

STORAGE AND RINSING SOLUTION FOR SOFT CONTACT LENSES(TRANS.TO DEVICES)

Page 77

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2839 A
III
1/1/1977
SEKISUI VOLTEK LLC

SUBJECT
VOLARA FOAMS---CROSS-LINKED POLYETHYLENE FOAMS

2840

II

2/4/1977

DELMAR CHEMS LTD

TOLBUTAMIDE (COARSE)

2841

II

2/4/1977

DELMAR CHEMS LTD

TOLBUTAMIDE (FINE)

2842

III

1/14/1977

ORACLE FLEXIBLE PACKAGING

COMPOSITION AND MANUF PROCESSES FOR PACKAGING MATERIAL

2843

II

2/7/1977

SIGMA F AND D DIV LTD

CHOLIC ACID SODIUM SALT

2844

1/3/1977

UNITED STATES STEEL CORP

POLYSTYRENE COMPOUNDS

2845

9/16/1976

MIRANOL CHEM CO

MIRAMINE (R) TA 30

2846

2/2/1977

TRUETT LABS DIV SOUTHWESTERN DRUG CORP

FACILITIES AND CONTROLS

2847

2/4/1977

MECLIZINE HCL

2848

1/28/1977

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
BARNES HIND PHARMACEUTICALS INC

2849

1/26/1977

BLASCHIM SPA

DEXAMETHASONE 21 SODIUM PHOSPHATE

2850

1/26/1977

BLASCHIM SPA

PREDNISOLONE 21 DISODIUM PHOSPHATE

2851

1/26/1977

BLASCHIM SPA

TRIAMCINOLONE DIACETATE

2852

1/26/1977

BLASCHIM SPA

TRIAMCINOLONE ALCOHOL

2853

2/1/1977

TRIFARMA SPA

TRIFLUOPERAZINE HYDROCHLORIDE NF XIV

2854

2/3/1977

NATL INST HLTH CLINCL CTR PHARMACY

LYMPHILIZED PRODUCT OF AMINOPTERIN (NSC 739), 50MG

2855

IV

2/8/1977

BASF CORP

KOLLIDON (R)POLYVINYLPYRROLIDONE

2856

II

2/16/1977

UPJOHN CO

HYDROXYPROGESTERONE CAPROATE

2857

II

2/10/1977

GANES CHEMICALS INC

DEHYROACETIC ACID & SODIUM DEHYDROACETATE

2858

1/19/1977

API SYSTEM SA

MASTER FORMULA RECORDS

2859

II

2/10/1977

TAKEDA CHEMICAL INDUSTRIES LTD

ESTAZOLAM (TA-8)

2860

II

2/15/1977

LONZA INC

CHLORPROMAZINE HCL

2861

2/7/1977

RP SCHERER CORP

PRODUCTION FACILITY IN DETROIT, MICH.

2862

II

2/10/1977

SCHERING AG

FLUOCORTIN BUTYLESTER (RECOMMENDED GENERIC NAME IS FLUOCORTIN BUTYL)

2863

2/2/1977

BEECHAM LABORATORIES DIV OF BEECHAM INC

FACILITIES AND CONTROLS

2864

II

2/24/1977

BOEHRINGER MANNHEIM GMBH

DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYLLINE)

2865

II

2/24/1977

BOEHRINGER INGELHEIM KG

DIHYDROERGOTOXINE METHANESULFONATE (DEMS)

2866

2/10/1977

SOCHINAZ SA

DIHYDROERGOTOXINE METHANE SULFONATE

2867

II

3/7/1977

MEDI PHYSICS INC

INDIUM III OXINE (FORMERLY HELD BY DIAGNOSTIC ISOTOPES INC)

2868

II

2/24/1977

SIGMA F AND D DIV LTD

ACETYL-BETA-METHYLCHOLINE CHLORIDE

2869

2/16/1977

ABBOTT LABORATORIES

2870

II

2/18/1977

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MCPHERSON, KANSAS.
ALLOPURINOL

2871

II

2/18/1977

PLANTEX LTD CHEM AND PHARM WORKS

QUINIDINE SULFATE

2872

II

3/1/1977

TEVA PHARMACEUTICAL INDUSTRIES LTD

TRIMETHOPRIM

2873

3/4/1977

TROPONWERKE GMBH CO KG

AMFEPRAMON HCL (FORMERLY DIETHYLPROPION)

2874

II

2/28/1977

SANOFI AVENTIS CHIMIE

PREDNISONE

2875

II

2/10/1977

UCB PHARMACEUTICALS

PIRACETAM (NOOTROPIL)

2876

II

2/24/1977

BUCKEYE CELLULOSE CORP

SODIUM CARBOXYMETHYLDICELLULOSE GLYCEROL (CLD)

II

II

II

BOILING AND RINSING SOLUTION FOR SOFT CONTACT LENSES(TRANS.TO DEVICES)

Page 78

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2877 I
II
3/2/1977
CILAG CHEMIE AG

SUBJECT
ECONAZOLE NITRATE

2878

3/18/1977

FRONTIER CONTACT LENSES INC

HYDRO-MARC (TM) (ETAFILCON A) SOFT CONTACT LENSES

2879

3/3/1977

APPLETON PAPER DIV NCR

ASCOT HEAT SEAL STERILE PACKAGING TYPE 1A

2880

III

2/15/1977

CLARIANT CORPORATION

SORB-IT DESSICANT CANISTERS

2881

3/1/1977

CELANESE PLASTICS & SPECIALTIES CO

CRE 5G2-85D

2882

II

3/21/1977

LONZA RIVERSIDE

PROCHLORPERAZINE, PROCHLORPERAZINE EDISYLATE,PROCHLORPERAZINE MALEATE

2883

II

3/18/1977

MALLINCKRODT CHEMICAL INC

NALBUPHINE HYDROCHLORIDE CODE 3300 MANUFACTURED IN ST. LOUIS, MISSOURI

2884

3/24/1977

ORGANON INC

PREDNISONE

2885

II

3/17/1977

CHLORPROPAMIDE

2886

IV

3/25/1977

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
SIGMA F AND D DIV LTD

2887

II

3/22/1977

SIEGFRIED AG

N-ACETYL PROCAINAMIDE HCL

2888

2889

II

3/21/1977

SCHERING AG

HYDROCORTISONE HEMISUCCINATE

2890

II

3/18/1977

LILLY RES LABS DIV ELI LILLY CO

NORTRIPTYLINE HCL CAPSULES

2891

II

3/18/1977

LILLY RES LABS DIV ELI LILLY CO

NORTRIPTYLINE HCL SOLUTION

2892

II

3/8/1977

HEINRICH MACK NACHF

5-FLUOROURACIL

2893

III

3/25/1977

PARAMOUNT PACKAGING CORP

COEXTRUSION HIGH DEN. POLYETHYLENE W/ETHYLENE VINYL ACETATE COPOLYMER

2894

2/17/1977

EDWARD MENDELL CO INC

SODIUM GLYCINE CARBONATE

2895

3/30/1977

PF LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

2896

4/6/1977

PFANSTIEHL LABORATORIES INC

GLUCOSE POLYMER (G-130)

2897

4/8/1977

BARNES HIND PHARMACEUTICALS INC

BARNES-HIND SOLUTION FOR SOFT CONTACT LENSES

2898

II

4/14/1977

GANES CHEMICALS INC

DIMENHYDRINATE, BULK POWDER FORM

2899

II

4/11/1977

SHIONOGI AND CO LTD

SULFAMETHOXAZOLE N.F.

2900

II

4/6/1977

SANOFI CHIMIE

HYDROCORTISONE HEMISUCCINATE

2901

4/7/1977

FACILS. & CONTROLS FOR AN ADDITIONAL MANUF FACILITY IN MANALI, P.R.

2902

4/19/1977

USV (PR) DEVELOPMENT CORP SUB RORER


GROUP
SOCIETE CHIMIQUE POINTET GIRARD SA

2903

3/22/1977

INDUSTRIA CHIMICA PROFARMACO SPA

BENZBROMARONE BULK

2904

II

4/13/1977

ERTHROMYCIN PHOSPHATE

2905

III

3/22/1977

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
UNIPAC CORP

2906

III

1/22/1973

3M PHARMS

CLOSURE LINERS ST-25 AND SW-25 ---CAP-SEAL BRAND

2907

II

4/28/1977

ETHYL CORP

IBUPROFEN---AS MANUF BY ETHYL CORP A THEIR FACIL. IN ORANGEBURG, S.C.

2908

II

3/18/1977

DIPHARMA FRANCIS SRL

AMITRIPTYLINE HYDROCHLORIDE

2909

II

4/29/1977

H REISMAN CORP

SODIUM SULFATHIAZOLE SESQUIHYDRATE & SODIUM SULFATHIAZOLE

2910

4/1/1977

DUPONT MERCK PHARMA

FACILITIES AND CONTROLS

2911

II

4/12/1977

BASF PHARMA EVIONNAZ SA

BUPIVACAINE HCL

2912

II

12/22/1976

ELI LILLY CO

ZINC INSULIN CRYSTALS--ARGENTINA DMF-2912

ALPHA-AMYLASE TYPE III-A

NOT AN ASSIGNED NUMBER

II

QUINIDINE SULFATE

CLOSURE LINER-CAP-SEAL II BRAND

Page 79

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2913 I
10/26/1976
SYNTHETIC PRODUCTS CO

SUBJECT
SYNPRON 1375 PVC HEAT STABILIZER

2914

9/14/1976

GLASROCK POREX DIV

FACILITIES AND CONTROLS FOR T-17

2915

10/4/1976

MICROBIOLOGICAL RESEARCH ESTABLISHMENT

ACHROMOBACTER GLUTAMINASE

2916

5/2/1977

SUMITOMO BAKELITE CO LTD

SUMILITE PRODUCTS SERIES

2917

4/1/1977

SAUFLON INTERNATL INC

SAUFLON PW

2918

4/1/1977

SAUFLON INTERNATL INC

SAUFLON 70

2919

4/18/1977

CLM SPECIAL POLYMERS LTD

SAUFLON 70 POLYMER

2920

4/18/1977

CLM SPECIAL POLYMERS LTD

SAUFLON 85 POLYMER

2921

II

5/6/1977

ER SQUIBB AND SONS INC

INSULIN

2922

II

5/2/1977

SANOFI CHIMIE

6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE

2923

III

4/5/1977

AXIALL CORP

PVC RESINS

2924

3/28/1977

FACILS., METHODS & CONTROLS FOR PROCESSING & PACKAGING OF DRUG PRODS.

2925

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
NOT AN ASSIGNED NUMBER

2926

5/11/1977

TEVA PHARMACEUTICAL INDUSTRIES LTD

STERILE MFG FACILITIES IN KVAR SAVA,ISRAEL

2927

II

5/3/1977

SIGMA F AND D DIV LTD

DL-BETA-HYDROXYBUTYRIC ACID, SODIUM SALT

2928

4/27/1977

THE CENTRAL PHARMACAL COMPANY

STANDARD OPERATING PROCEDURES

2929

II

5/13/1977

ANTIBIOTICOS SPA

BOMBASIN

2930

II

4/25/1977

DIOSYNTH BV

CHENODEOXYCHOLIC ACID

2931

5/18/1977

ROUSSEL-UCLAF

25 HYDROXYCHOLECALCIFEROL (RU 4682)

2932

5/4/1977

JANSSEN PHARMACEUTICA INC

2933

4/26/1977

KASAR LABORATORIES DIV KASAR CO

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN BEERSE, BELGIUM.
FACILITIES AND CONTROLS

2934

II

4/28/1977

MEMPHIS CHEMICAL CO

METHOXSALEN USP

2935

II

5/9/1977

PROCOS SPA

ISOPROPAMIDE IODIDE

2936

II

6/1/1977

AINC

ZETA PLUS 12 NOMINAL DIAMETER CARTRIDGES FOR PHARMACEUTICAL USE

2937

5/2/1977

SYNCOR INTERNATIONAL INC

FACILS. & CONTROLS

2938

II

5/9/1977

PROCOS SPA

PHENYLTOLOXAMINE CITRATE

2939

5/11/1977

BLASCHIM SPA

METHYLPREDNISOLONE

2940

5/27/1977

SIEGFRIED AG

ISOXSUPRINE HCL, NF XIV AS MANUF AND SOLD UNDER SIEGFRIED LABEL

2941

4/22/1977

JOHNS MANVILLE SALES CORP

MEMBRA-FIL MEMBRANE FILTERS AND ASSOCIATED EQUIPMENT

2942

II

5/9/1977

PROCOS SPA

ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE

2943

II

5/12/1977

SIGMA F AND D DIV LTD

ETIOCHOLAAN-3 ALPHA-OL-17-ONE

2944

II

5/11/1977

NOBEL CHEMICALS AB DIV FINE CHEMICALS INC

FLUOCINOLONE ACETONIDE

2945

III

5/9/1977

BRANDYWINE COMPOUNDING CO

OLEFINIC POLYMER BLEND BCC 5005H

2946

1/17/1977

WERTHENSTEIN CHEMIE AG

CHEMICAL PRODUCTION OPERATIONS

2947

5/13/1977

FARMITALIA SPA

DIHYDROERGOTOXINE MESYLATE

2948

IV

10/25/1976

COLORCON INC

LAKE, DYE, AND PIGMENT BLENDS

2949

II

5/11/1977

GYMA LABORATORIES OF AMERICA INC

TRIAMCINOLONE ACETONIDE

2950

6/6/1977

BARVILLE CAOUTCHOUC MANUFACTURE

PLURIBAR 30

III

II

Page 80

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2951 I
II
5/26/1977
SIGMA F AND D DIV LTD

SUBJECT
L-AMINO-N-BUTYRIC ACID

2952

6/10/1977

GANES CHEMICALS INC

PHENYLEPHRINE HCL, USP XIX, BULK POWDER FORM

2953

5/11/1977

BLASCHIM SPA

METHYPREDNISOLONE ACETATE

2954

6/16/1977

PARKE DAVIS & CO

COVIDARABINE

2955

6/2/1977

PLATINUM ON CARBON, SULFIDE

2956

6/21/1977

ENGLEHARD INDS DIV ENGLEHARD MINERALS &


CHEMICALS
GANES CHEMICALS INC

2957

IV

4/29/1977

STEPAN CHEMICAL COMPANY

SURFA M-801G

2958

5/24/1977

EMERY IND INC

TOXICITY STUDIES ON COSMETIC PRODUCTS: EYE & SKIN IRRITATION TEST,ETC.

2959

5/24/1977

MALMSTROM CHEMICALS

TOXICITY STUDIES ON LANOLIN ALCOHOLS AND LANOLIN ALCOHOL DERIVATIONS

2960

III

4/25/1977

BOEHRINGER MANNHEIM GMBH

AMPOULE & VIAL PRODUCTION AT THE MANNHEIM FACILS

2961

II

6/7/1977

NOVO NORDISK AS

GLUCAGON (BULK)

2962

II

6/6/1977

TAISHO PHARMACEUTICAL COMPANY LTD

CARBINOXAMINE MALEATE

2963

IV

6/1/1977

INTERNATIONAL FLAVORS AND FRAGRANCES INC

FLAVORINGS

2964

II

6/7/1977

KV PHARMACEUTICAL CO

ACTIFED S.A. CAPS--PSEUDOEPHEDRINE HCL 120MG/TRIPROLIDINE

2965

II

6/29/1977

SB PENICK AND CO ORIG

DIPHENOXYLATE HYDROCHLORIDE USP BULK

2966

III

6/24/1977

CROWN ZELLERBACH CORP

CROWN POLYPROPYLENE A-40 & A-63--SINGLE LAYER FILMS

2967

7/12/1977

PFANSTIEHL LABORATORIES INC

L-TRYTOPHAN

2968

6/24/1977

ACIC LTD

PROPRANOLOL HCL USP XIX

2969

6/27/1977

NATL INST HLTH CLINCL CTR PHARMACY

THYMIDINE (NSC21548)

2970

6/7/1977

KV PHARMACEUTICAL CO

ACTIFED SUSTAINED RELEASE CAPSULES

2971

II

6/27/1977

GANES CHEMICALS INC

PHENTERMINE RESINATE

2972

II

6/15/1977

NAPP CHEMICALS INC

DIOCTYL SODIUM SULFOSUCCINATE 45% IN POLYETHYLENE GYLCOL 400-55%

2973

II

7/1/1977

SB PENICK AND CO ORIG

DIPHENOXYLATE HYDROCHLORIDE USP WITH 1% AROPINE SULFATE USP BULK

2974

6/28/1977

PHARMACIA AND UPJOHN INC

MANUFACTURING FACILITIES IN COLUMBUS, OHIO

2975

III

7/12/1977

TREDEGAR MOLDED PRODS

VISQUEEN 0-102 (MD-30) C-1 TREATED POLYETHYLENE SHEETING

2976

II

6/23/1977

ACIC LTD

CLOFIBRATE B/P/USP/NF

2977

III

6/10/1977

NICE-PAK PRODUCTS INC

SPONGE AND SPONGE BRUSH PACKAGING

2978

7/7/1977

COLORCON COMPANY

OPACODE S-1-8100-HV, BLACK; OPACODE S-1-8215, GREY

2979

7/11/1977

NUCLEAR PHARMACY INC

CENTRALIZED NUCLEAR PHARM FOR DISPENSING RADIOPHARM: 1. NA PERTECNETA

2980

6/24/1977

JOHNSON MATTHEY PLC

WEST WHITELAND & DEVON PLANTS

2981

II

7/27/1977

BASF SE

GLYCERINE-POLYETHYLENE GLYCOL-RICINOLEATE;MNFG&TESTED IN GERMANY

2982

5/26/1977

LAKE AND CRUICKSHANK

D-PSEUDO EPHEDRINE ALKALOID, SULPHATE AND HYDROCHLORIDE

2983

7/8/1977

MITSUBISHI CHEMICAL CORP

NORETHINDRONE, BULK

2984

7/8/1977

MITSUBISHI CHEMICAL INDUSTRIES LIMITED

NORETHINDRONE ACETATE, BULK

2985

7/19/1977

HAARMANN & REIMER GMBH

APRICOT FLAVOR 41 231 ARTIFICAL AND NATURAL

2986

6/30/1977

AIR PRODUCTS AND CHEMICALS INC

1. VINAC ASB 516 BEAD COPOLYMER (BEAD COPOLYMERS)

2987

7/6/1977

RP SCHERER CORP

PRODUCTION FACILITIES A MONROE, NORTH CAROLINA

2988

7/25/1977

ROBECO INC.

ROBANE (HYDROGENATED SQUALENE)

II

II

II

III
II

AMINOPHYLLINE, USP XIX, BULK POWDER

Page 81

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
2989 I
II
7/20/1977
CROCKER NUCLEAR LAB

SUBJECT
RADIOCHEMICAL PREPARATIONS

2990

2991

2992

2993

2994

2995

2996

2997

8/18/1977

MONSANTO COMPANY

POLYOLEFIN CONTAINERS MANUFACTURED BY PLAX CANADA LTD, BURLINGTON,ONT.

2998

7/6/1977

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

ZINC PYRIDINETHIONE

2999

III

12/28/1977

3M PHARMS

SCOTCHMARK LABEL STOCK SERIES;1)7000 2)7110

3000

7/21/1977

SYNTEX USA INC

FACILITIES AND CONTROLS A SYNTEX IRELAND LTD.

3001

7/21/1977

BEECHAM INC

RAW MATERIALS SPECIF & TEST METHODS AT BEECHAM PHARM, U.K. DIV.

3002

IV

7/20/1977

BANNER PHARMACAPS INC

3003

II

8/12/1977

ZENECA PHARMACEUTICALS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF SOFT GELATIN CAPS.
CHLORHEXIDINE GLUCONATE 20% SOLUTION B.P.

3004

II

7/22/1977

ORGAMOL SA

DIETHYLCARBAMAZINE CITRATE

3005

II

8/5/1977

BOFORS AB

PENTAERYTHRITOL TETRANITRATE (PETN)

3006

II

7/7/1977

LAB FOR COMPARATIVE BIOCHEMISTRY

ADENINE FOR USE IN HUMAN BLOOD PRESERVAIVE FORMULATION

3007

IV

8/8/1977

SYMRISE

FLAVORINGS

3008

II

7/17/1977

SIEGFRIED LTD

AMITRIPTYLINE HCL-MANUF & SOLD UNDER SIEGFRIED LABEL

3009

8/1/1977

PFANSTIEHL LABORATORIES INC

14 AMINO ACIDS FOR USE IN PARENTERAL FEEDING

3010

IV

7/29/1977

ALZA CORP

ALZAMER CELLULOSIC RATE CONTROLLING MEMBRANE PRECURSORS

3011

II

8/24/1977

PLANTEX LTD CHEM AND PHARM WORKS

CONJUGATED ESTROGENS, USP

3012

6/2/1976

EI DUPONT DE NEMOURS AND CO

PERFLUOROCTYLBROMIDE

3013

7/29/1977

SIGMA F AND D DIV LTD

CHOLINE CHLORIDE

3014

8/5/1977

BURDICK & JACKSON LABS,INC

DYCLONINE HYDROCHLORIDE

3015

IV

8/24/1977

DMV FONTERRA EXCIPIENTS GMBH CO KG

PRIMOJEL (NA STARCH GLYCOLATE)

3016

II

7/15/1977

PYRION CHEMIE GMBH

ZINC PYRION (ZINC PYRIDINTHIONE)

3017

II

7/22/1977

BASF CORP

POVIDONE-IODINE

3018

III

8/8/1977

PARKER HANNIFIN CORP

SEAL FORMULATIONS MANUFACTURED IN CULVER CITY, CALIFORNIA.

3019

III

3/24/1977

BASF AKTIENGESELLSCHAFT

LUPOLEN 1810 H RED 974

3020

III

8/29/1977

ALDEN OPTICAL LAB INC

AL-47 POLYMER

3021

9/16/1977

DIAMOND SHAMROCK CORP

DUOLITE ARA-1157 AND DUOLITE ARA-2157

3022

II

9/23/1977

3023

8/17/1977

3024

9/23/1977

LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL DIHYDROERGOTOXINE METHANESULFONATE (ERGOLOID MESYLATES)


CO
ABBOTT LABORATORIES PHARMACEUTICAL
FACILITIES
PRODUCTS DIV
ROURE BERTRAND DUPONT INC
FRAGRANCE F 9819

3025

9/26/1977

SCHERING AG

8/4/1977

ASH STEVENS INC

FACILITIES AND CONTROLS FOR THE CARLETON, MICHIGAN FACILITY

8/17/1977

SYNTEX USA INC

CIMETIDINE

II

7/12/1977

DIOSYNTH BV

ESTRADIOL CYPIONATE

II

7/18/1977

DIOSYNTH BV

HYDROXYPROGESTERONE CAPROATE

II

7/12/1977

DIOSYNTH BV

TESTOSTERONE CYPIONATE

7/22/1977

GANES CHEMICALS INC

HEXOBARBITAL, NF XIV

NOT AN ASSIGNED NUMBER

II

QUINESTROL

Page 82

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3026 I
II
9/19/1977
SIGMA F AND D DIV LTD

SUBJECT
DL-5-FLUOROTRYPTOPHAN

3027

9/26/1977

ALDEN OPTICAL LAB INC

AL-47 SEMIFINISHED CONTACT LENS

3028

II

8/30/1977

SIEGFRIED AG

ISOXSUPRINE HYDROCHLORIDE, NF XIV

3029

10/22/1977

SIGMA F AND D DIV LTD

L-PHOSPHATIDYL CHOLINE TYPE IX-E

3030

9/6/1977

CONTINUOUS CURVE

MFG AND CONTROL (HYDROCURVE PATIENT DISINFECTION UNIT)

3031

9/9/1977

GANES CHEMICALS INC

SODIUM P-AMINOBENZOATE-POTASSIUM P-AMINOBENZOATE-P-AMINOBENZOIC ACID

3032

9/20/1977

N&N MENICON INC

SOFT CONTACT LENS

3033

II

9/15/1977

PLANTEX LTD CHEM AND PHARM WORKS

FUROSEMIDE USP

3034

III

9/21/1977

EQUISTAR CHEMICALS LP

POLYETHYLENE RESINS

3035

III

8/30/1977

BORG-WARNER CHEMICALS

CYCOLAC CIT 31336 AND CYCOLAC X-11-2783 F

3036

IV

9/26/1977

SYMRISE INC

FLAVORINGS

3037

II

10/13/1977

TEIKOKU CHEM INDUSTRY

HYDROXYZINE HCL

3038

II

10/12/1977

IVAX PHARMACEUTICALS SRO

ERGOTAMINE TARTRATE

3039

II

10/10/1977

LOFTUS BRYAN CHEMICALS LTD

PROMETHAZINE HCL

3040

II

10/24/1977

CORD LABORATORIES INC

THEOPHYLLINE CAP

3041

10/24/1977

PLANTEX LTD CHEM AND PHARM WORKS

TOLNAFTATE

3042

10/24/1977

SSL INTERNATIONAL

LISTING OF PRECLINICAL TOXICOLOGY STUDIES (CHLORHEXIDINE GLUCONATE 20%)

3043

II

10/21/1977

SIGMA F AND D DIV LTD

GLUTAHIONE OXIDIZED

3044

9/29/1977

GELMAN SCIENCES INC

ACROFLOW 121 AND PREFLOW N.F.R. FILTER CARTRIDGE LINES

3045

11/8/1977

WM LEMAN INC

NATURAL PEPPERMINT OIL

3046

11/7/1977

HENKEL KGAA

NOVAA R SUPPOSITORY BASES

3047

II

11/8/1977

MONSANTO RES CORP DIV MONSANTO CO

METHOTREXATE

3048

II

10/25/1977

DINAMITE DIPHARMA SPA

3049

11/14/1977

PACO PACKAGING INC

D-PROPOXYPHENE NAPSYLATE MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN),


ITALY FACILITIES
LAKEWOOD FACILITY FOR DRUG PACKAGING

3050

11/9/1977

PCR INC

FACILITIES AND CONTROLS FOR THE HUMACAO, PUERTO RICO PLANT

3051

II

10/17/1977

SIGMA F AND D DIV LTD

L-ALPHA-PHOSPHATIDYL CHOLINE TYPE II-S

3052

II

10/18/1977

DIPHARMA FRANCIS SRL

SPIRONOLACTONE AS MG IN MILAN

3053

II

11/17/1977

PFIZER INC

TESTOLACTONE, USP

3054

11/17/1977

HOFFMANN LA ROCHE INC

BIOTIN

3055

11/11/1977

DESMO CHEMICAL CORP

BENBROMARONE AS MANUF BYRSA. CORP, ARDLEY, N.Y.

3056

11/1/1977

GAELEO LTD

METHODS, FACILITIES AND CONTROLS

3057

II

8/30/1977

DISCO LTD

MICRO-ENEMA

3058

II

11/21/1977

CYCLO PRODUCTS INC

CHLORPROMAZINE HCL U.S.P.

3059

II

11/11/1977

TANABE SEIYAKU CO LTD

DILTIAZEM HCL

3060

II

11/22/1977

KYOWA HAKKO KOGYO CO LTD

L-DOPAMINE HYDROCHLORIDE (3-HYDROXYTYRAMINE HYDROCHLORIDE )

3061

II

11/14/1977

DUPONT NUTRITION BIOSCIENCES APS

VALPROIC ACID

3062

II

11/9/1977

TEVA PHARMACEUTICAL INDUSTRIES LTD

5-FLUOROURACIL AS MANUF IN HUMACAO, PUERTO RICO

3063

II

11/2/1977

HOFFMANN LA ROCHE INC

URSODEOXYCHOLIC ACID (RO13-1798)

IV

Page 83

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3064 I
II
11/4/1977
STAUFFER CHEM CO

SUBJECT
EMCOMPRESS (DICALCIUM PHOSPHATE DIHYDRATE)

3065

11/23/1977

MILTON ROY CO

PHP (HEFILCONA) SOFT CONTACT LENS BUTTONS

3066

II

10/13/1977

KIMIA FARMA

QUINIDINE SALTS

3067

II

11/2/1977

HOFFMANN LA ROCHE INC

CHENODEOXYCHOLIC ACID TABLETS, 250MG (R08-2871)

3068

II

11/9/1977

PHARMA-WALDHOF GMBH

GLUTAHIONE REDUCED (GSH)

3069

10/31/1977

ROHM CHEMICAL LABORATORY COMPANY LTD

MANUF PROCESSES OF CAP-PLATE MENICON & MAFILCON SOFT CONTACT LENS MA.

3070

11/23/1977

OLC LABORATORIES INC

STANDARD OPERATING PROCEDURES FOR DISTRIBUTING L-TRYPTOPHAN

3071

10/6/1977

STANDARD PHARMACAL CORP

PRODUCT SPECIFICATIONS

3072

11/9/1977

ROUSSEL-UCLAF

ESTRADIOL VALERATE

3073

11/8/1977

NYEGAARD AND CO AS

METRIZAMIDE (AMIPAQUE)

3074

11/17/1977

SIGMA F AND D DIV LTD

5,5-DIPHENYLHYDANTOIN

3075

II

11/21/1977

SIEGFRIED AG

DIBENZOSUBERONE AS MANUF & SOLD UNDER SIEGFRIED LABEL

3076

11/15/1977

FACILS & CONTRLS-PLEASANTVILLE, NJ (THIS FORMERLY CITATION PLASTIC

3077

12/6/1977

THE WEST CO PLASTIC CONTAINER DIV SUB OF


THE WEST COMPANY
CYCLO PRODUCTS INC

3078

12/6/1977

CYCLO PRODUCTS INC

PROCHLORPERAZINE MALEATE U.S.P.

3079

12/6/1977

CYCLO PRODUCTS INC

IMIPRAMINE HCL U.S.P.

3080

II

11/29/1977

RHONE-POULENC

TRIFLUOPERAZINE CHLORHYDRATE

3081

12/8/1977

WEST PHARMACEUTICAL SERVICES INC

OAK STREET LIQUID DRUG PRODUCTION, LAKEWOOD, NEW JERSEY

3082

III

11/14/1977

WEBER INTERNATIONAL PACKAGING CO LLC

PLASTIC BOTTLES MANUFACTURED IN PLATTSBURGH, NY

3083

11/28/1977

AS SYNTHETICS

SULFAMETHIZOLE N.F. XIV

3084

11/15/1977

STANDARD PASTE & GLUE COMPANY INC

ADHESIVE FORMULATION-S-200-K-1-B

3085

II

11/21/1977

INDENA GRUPPO INVERNI DELLA BEFFA

CASANTHRANOL(THIS FORMERLY HELD BY INVERNI DELLA BEFFA, ITALY)

3086

II

12/5/1977

SODIUM HEPARIN USP

3087

11/22/1977

LAOB LABORATORIO OPOTERAPICO BRASILEIRO


SA
PLANTEX LTD CHEM AND PHARM WORKS

3088

12/9/1977

GENEVA GENERICS

FACILITIES AND STANDARD OPERATING PROCEDURES

3089

12/9/1977

TUTAG PHARMS

FACILITIES AND STANDARD OPERATING PROCEDURES

3090

12/15/1977

GRAVURE FLEX CORPORATION

FACILITIES & CONTROLS--SPECIALITY LAMINATIONS

3091

II

12/12/1977

GANES CHEMICALS INC

DIBENZOSUBERONE BULK FORM

3092

11/21/1977

LONGVIEW FIBRE CO

PACKAGING MATERIALS

3093

11/21/1977

MASCHEMIJER AROMATICS INC

FRAGRANCES

3094

12/14/1977

SHAWANO PAPER MILLS INC

GRADE NO. 181-1-165-3 WHITE MG FOIL MOUNTING TISSUE

3095

12/14/1977

NORTHWESTERN CHEMICAL CO

GLYCEROL MONOSTEARATE

3096

12/15/1977

ARLIN MANUFACTURING COMPANY INC

TEAR TAPES

3097

1/9/1978

ANTIBIOTICOS SPA

HYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE

3098

1/9/1978

SYNTEX OPHTHALMICS INC

CONTACT LENSES

3099

II

1/3/1978

ANTIBIOTICOS SPA

ENDRYSONE (BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED)

3100

II

1/3/1978

ANTIBIOTICOS SPA

DESONIDE, BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED

3101

12/16/1977

AM TODD CO

NATURAL OILS-PEPPERMINT & SPEARMINT FRACTIONATED (REDISTILLED)

II

II

TRIFLUORPERAZINE HCL NF

TOLNAFTATE U.S.P.

Page 84

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3102 I
1/13/1977
SYNTEX USA INC

SUBJECT
SILAFOCON A

3103

II

1/13/1977

GRUPPO LEPETIT SPA

L-ALANOSINE

3104

II

12/27/1977

ANTIBIOTICOS SPA

MEDRYSONE USP XIX, NON-MICRONIZED AND MICRONIZED

3105

II

1/3/1978

ANTIBIOTICOS SPA

BETAMETHASONE 17-VALERATE, NF BULK, NON STERILE, NON MICRON & MICRON

3106

II

1/6/1978

E MERCK

DIOCTYL SODIUM SULFOSUCCINATE (45% SOLUTION)

3107

II

12/27/1977

ANTIBIOTICOS SPA

PREDNACINOLONE ALCOHOL, MICRONIZED & NON MICRONIZED

3108

II

1/16/1978

ANTIBIOTICOS SPA

FLUROMETHOLONE-(BULK, NON-MICRONZIED & MICRONIZED)

3109

II

12/27/1977

ANTIBIOTICOS SPA

6-ALPHA-METHYLPREDNISOLONE-21-HYDROGEN SUCCINATE

3110

II

12/27/1977

KNOLL AG LUDWIGSHAFEN

HYDROXYZINE HYDROCHIORIDE

3111

1/18/1977

ALDEN OPTICAL LAB INC

AL-47 CONTACT LENS

3112

II

1/3/1978

ANTIBIOTICOS SPA

FLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED)

3113

IV

11/18/1977

COLORPLAST LTD

PLASKO WHITE 80-F

3114

III

12/22/1977

CORNING GLASS WORKS

PHARMACUETICAL ROLLER BOTTLES-PRODUCT NO.25140

3115

IV

1/11/1978

NAARDEN UOP FRANGANCES

LADINA FRAGANCES RO 57.836

3116

II

12/27/1977

BASF PHARMACHEMIKALIEN GMBH CO KG

DOPAMINE HYDROCHLORIDE

3117

1/6/1978

TOKYO KASEI KOGYO CO LTD

A,A,-AZOBIS(ISOBUTYRONITRILE)FOR N&N MENICON(MAFILCON)SFT CONTACT MA.

3118

11/17/1977

SHIONOGI AND CO LTD

KEFLEX R SUSTAINED RELEASE CAPSULES (CEPHALEXIN MONOHYDRATE LILLY)

3119

12/30/1977

HOUBA INC

METHODS, FACILITIES AND CONTROLS FRO D-BIOTIN

3120

12/15/1977

LA DREYFUS CO

SOFT IDEAL R BUBBLE GUM BASE AND NT CHEWING GUM BASE

3121

II

1/26/1978

MERCK SHARP & DOHME LTD

PREPARATION OF TEN STABLE ISOTOPE-LABELLED COMPOUNDS

3122

III

12/19/1977

EASTMAN CHEMICAL CO

ETHYLENE METHYL ACRYLATE COPOLYMERS (EMAC) MANUFACTURED IN LONGVIEW TX

3123

II

1/24/1978

MALLINCKRODT CHEMICAL INC

DIOCTYL SODIUM SULFOSUCCINATE IN P E G AS MANUF. IN RALEIGH, N.C.

3124

II

2/3/1978

FACILS & CONTROLS FOR LEDERLE METHOTREXATE, INC. & LEDERLE PARENTERALS

3125

II

1/20/1978

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
ISOCHEM SA

3126

1/24/1978

TRIO PRODUCTS INC

FACILITIES AND CONTROLS

3127

IV

2/16/1978

SHIN ETSU CHEMICAL CO LTD

L-HPC (LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE)

3128

1/5/1978

AMERSHAM CORP SUB RADIOCHEMICAL CENTER

FACILS, CONTROLS & PERSONNEL-A THE FREEZE DRYING UNIT GLOUCESTER ENG

3129

II

1/20/1978

KV PHARMACEUTICAL CO

ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 125MG (THEOPHYLLINE)

3130

II

1/20/1978

KV PHARMACEUTICAL CO

ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 250MG. (THEOPHYLLINE)

3131

II

2/27/1978

KYOWA HAKKO BIO CO LTD

MANUFACTURING AND QUALITY INFORMATION ON BULK DRUG SUBSTANCES

3132

II

1/8/1978

PLANTEX LTD CHEM AND PHARM WORKS

ESTERIFIED ESTROGENS, U.S.P.

3133

12/21/1977

DR ROSE INC

FACILS, CONTROL & MANUF OF GLYCERINE SUPPOSITORIES

3134

1/24/1978

CIECH POLFA

FUROSEMIDE

3135

12/15/1977

KV PHARMACEUTICAL CO

PHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG.

3136

1/23/1978

FIS FABBRICA ITALIANA SINTETICI SPA

INDOMETHACIN, USP

3137

1/24/1978

WARD BLENKINSOP AND CO LTD

LIDOCAINE (LIGNOCAINE)

3138

2/21/1978

SIGMA F AND D DIV LTD

L-CARNITINE

3139

2/28/1978

DIPHARMA FRANCIS SRL

TOLBUTAMIDE USP

II

II
II

II

QUINIDINE PRODUCTS

Page 85

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3140 I
III
2/9/1978
AMERICAN NATIONAL CAN CO

SUBJECT
PAPER-FOIL-POLYETHYLENE LAMINATE FILM-MANUF AT MT. VERNON OH FACILITY

3141

1/4/1978

BOEHRINGER MANNHEIM GMBH

TABLETTING AND ENCAPSULAING FACILITIES

3142

II

2/1/1978

RHONE POULENC PHARMACEUTICALS RP INC

ACETAMINOPHEN (BULK) AS MANUFACTURED AT THE BARTON PLANT IN LULING, LA

3143

2/20/1978

PFANSTIEHL LABORATORIES INC

L-GLUCOSE, C.P., CATALOG NO. G-117

3144

II

2/28/1978

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

SULFAMETHOXAZOLE

3145

II

2/28/1978

DR REDDYS LABORATORIES LTD

FLUNISOLIDE AS MANUF AT THE GRAND BAHAMA AND GUERNAVACA FACILITIES

3146

II

3/10/1978

PRB CHEMIE

QUINIDINE SULPHATE USP 19

3147

II

2/8/1978

ISTITUTO CHEMICOTHERAPICO ITALIANO

TRIMETHOPRIM BULK, BP 1973

3148

3/15/1978

MASS INSTITUTE OF TECHNOLOGY

FACILITIES AND CONTROLS

3149

II

3/15/1978

KYOWA HAKKO BIO CO LTD

AMINO ACIDS MANUFACTURED IN HOFU, YAMAGUCHI, JAPAN.

3150

II

3/16/1978

CORD LABORATORIES INC DIV SJ TUTAG AND CO

THEOPHYLLINE CAPSULES, T.D.

3151

3/3/1978

AKTIEBOLAGET LEO

METHODS, FACILITIES AND CONTROLS

3152

2/24/1978

ANDERSON PACKAGING INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

3153

2/14/1978

EKCO PRODUCTS INC

DRAWN ALUMINUM UNIT DOSE CONTAINERS

3154

II

2/27/1978

HEINRICH MACK NACHF

THYMIDINE

3155

3/27/1978

FACILS., PROCEDS., & CONTROLS-A THE BARCELONETA, PUERTO RICO PLANT

3156

II

3/21/1978

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
CHEMIE GRUNENTHAL GMBH

3157

II

2/24/1978

ERCOPHARM

L-ALPHA METHYLDOPA

3158

2/28/1978

HENKEL INC

STANDAPOL SH-135 SPEC.

3159

1/31/1978

DIPHENHYDRAMINE HCL & DIMENHYDRINATE

3160

3/21/1978

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
CHEMIE GRUNENTHAL GMBH

3161

2/27/1978

PLANTEX USA INC DIV IKAPHARM INC

SULFAMETHOXAZOLE, N.F.

3162

II

2/28/1978

KV PHARMACEUTICAL CO

THEOPHYLLINE SUSTAINED RELEASE CAPSULES, 125 MG.

3163

II

2/28/1978

KV PHARMACEUTICAL CO

THEOPHYLLINE S.R. CAPSULES, 250 MG.

3164

II

2/28/1978

FIS FABBRICA ITALIANA SINTETICI SPA

DIAZEPAM USP XIX

3165

II

2/22/1978

SYNTHA

DOPAMIN HCL

3166

2/8/1978

CILAG CHEMIE AG

ACETRIZOIC ACID

3167

II

2/27/1978

MACH ENTERPRISES

SODIUM HEPARIN

3168

2/28/1978

ALZA CORP

FACILITIES OF ALZA MEXICANA S.A. -ESTADO DE MEXICO

3169

II

3/6/1978

SANOFI CHIMIE

DIHYDROERGOTOXIN MESYLATE

3170

2/8/1978

CILAG CHEMIE AG

3-AMINOPROPIONITRILE FUMARATE

3171

3/20/1978

CADALLAC PACKAGING INC

FACILITIES, PROCEDURES AND CONTROLS

3172

3/23/1978

SYNTEX USA INC

CIPROCINONIDE-MANUF BY SYNTEX RES IN CA, BAHAMAS CHEM DIV SYNTEX

3173

3/23/1978

ARNAR-STONE LABS INC

SVP FACILITY AT ARNAR-STONE LABS,INC-MOUNT PROSPECT, ILL

3174

3/24/1978

SYNTEX USA INC

PROCINONIDE AS MANUF BY SYNTEX RESEARCH IN CA, BAHAMAS CHEMICAL DIV.

3175

3/16/1978

MITSUBISHI CHEMICAL INDUSTRIES LIMITED

ESTRADIOL

3176

4/4/1978

LYNE LABORATORIES INC

PROCEDURES, FACILITIES AND CONTROLS

II

II

SUPIDIMIDE (FACILITIES AND CONTROLS) (CG 3033)

SUPIDIMIDE(CG 3033) PRECLINICAL & CLINICAL STUDIES OUTSIDE THE U.S.

Page 86

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3177 I
4/4/1978
LEON INDUSTRIES INC

SUBJECT
PROCEDURES, FACILITIES AND CONTROLS (FORT LAUDERDALE, FLA)

3178

TICRYNAFEN (DOMESTIC PRODUCTION)

3179

3180

3181

4/21/1978

PHARMAKINETICS LABORATORIES INC

FACILITIES AND PROCEDURES (ADMINISTRAIVE AND OPERATING)

3182

4/11/1978

PENN CHEMICALS BV SUB SK BECKMAN CORP

TICRYNAFEN (AS PRODUCED A THE CORK, IRELAND FACILITY)

3183

3/31/1978

REITECH CORP

ROFLEX P INK SERIES

3184

4/14/1978

FERRO PFANSTIEHL INC

EGG PHOSPHATIDE

3185

3/9/1978

RHONE-POULENC SANTE

PERCHLORPERAZINE BIS-MALEATE ACID

3186

4/6/1978

HOECHST AG

OCTOPIROX

3187

4/7/1978

SIEGFRIED AG

FLUORESCEIN SODIUM, U.S.P. XIX

3188

4/28/1978

SIGMA F AND D DIV LTD

METHYLENE DIPHOSPHORIC ACID

3189

4/28/1978

PFANSTIEHL LABORATORIES INC

METHOTREXATE

3190

4/28/1978

PHARMACIA AND UPJOHN SUB PFIZER INC

TESTOSTERONE, USP

3191

4/19/1978

IMPERIAL CHEMICAL INDUSTRIES PLC

POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE

3192

3/20/1978

TAKASAGO PERFUMERY CO LTD

FLAVORS, FACILITIES AND CONTROLS FOR THE LOCATION IN JAPAN

3193

4/5/1978

WYETH INC

TEMAZEPAM

3194

2/27/1978

H REISMAN CORP

SODIUM SULFAMETHAZINE

3195

4/21/1978

AQUALON CO

TOXICOLOGICAL STUDIES OF NAROSOL HYDROXYETHYL CELLULOSE

3196

II

5/17/1978

PHARMACIA AND UPJOHN INC

17A-METHYLTESTOSTERONE

3197

IV

5/10/1978

ICI AMERICAS INC

TWEEN 80 (POLYSORBATE 80)

3198

II

5/11/1978

ROUSSEL-UCLAF

DELTADIIODOMEDRANE

3199

IV

4/25/1978

TAKASAGO PERFUMERY CO LTD

MILK FLAVOR ON-1366

3200

III

4/21/1978

AMERICAN NATIONAL CAN CO

RETORT. PHARMACEU. PKGS-IN MT. VERNON, OH. (CONTINENTAL CAN CO -ORIG)

3201

II

5/11/1978

ANTIBIOTICOS SPA

17A-HYDROXYPROGESTERONE CAPROATE USP, BULK, NON-STERILE,NON-MICRONIZED

3202

III

5/19/1978

ALUMINUM COMPANY OF AMERICA

ALUMINUM CLOSURES W/COMPOSITE LINER - MFG.RICHMOND, INDIANA

3203

3/17/1978

PFANSTIEHL LABORATORIES INC

SODIUM GLUCOHEPTONATE, NRC GRADE, CATOLOG NO. S-105

3204

3/8/1978

GLASFLEX

FACILITIES AND CONTROLS FOR CONTACT LENS MATERIALS

3205

4/19/1978

G AND W LABORATORIES INC

MFG FACILS & CONTROLS FOR G&W LABS,INC., SO. PLAINFIELD, NJ

3206

4/13/1978

ALUMINUM COMPANY OF AMERICA

PHAR 9012 (PAPER MOUNTED LAMINATION OF ALUM. FOIL & POLYOLEFIN-IN IOWA

3207

II

4/28/1978

HEINRICH MACK NACHF

CARBINOXAMINE MALEATE

3208

II

5/25/1978

DR REDDYS LABORATORIES LTD

NAPROXEN SODIUM-AT BAHAMAS CHEM DIV., SYNTEX S.A. & SYNTEX IRELAND,LTD

3209

II

4/17/1978

DIPYRIDAMOLE

3210

II

4/11/1978

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
FARMITALIA SPA

3211

5/23/1978

SYNTEX USA INC

VALPROIC ACID

3212

5/1/1978

AAA LABORATORY

PROCEDURES FOR AMINO ACID ANALYSIS

3213

4/12/1978

CONWAY CHEMICAL CO LTD

BETHANECHOL CHL N.F.

3214

5/17/1978

PCR INC

5-TRIFLUOROMETHYL-2-DEOXYURIDINE

4/11/1978
III

3/13/1978

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
BAYER CORP

THE COMPLETE BUTYL PRODUCT LINE MANUF BY POLYSAR BELGIUM N.V.

NOT AN ASSIGNED NUMBER


I

IV
II
II
II

ERGOTAMINE TARTRATE USP

Page 87

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3215 I
II
5/5/1978
SIGMA F AND D DIV LTD

SUBJECT
17 ALPHA-ESTRADIOL

3216

IV

6/7/1978

ROUSSEL CORPORATION

HUMAN CHORIONIC GONADOTROPIN AS REC'D FROM COHELFRED

3217

6/23/1978

JANSSEN PHARMACEUTICA NV

FACILS. & CONTROLS FOR PRODUCTION UNIT II AT GEEL, BELGIUM

3218

6/2/1978

TOWA PHARMACEUTICAL CO LTD

GASTROLUFT TABLETS

3219

5/26/1978

DM GRAHAM LABORATORIES INC

PROBANTHINE (P.A.) FACILS&CONTRL FOR PREPAR. & PACKAG.-FIN. DOS. FORM

3220

6/14/1978

ROUSSEL-UCLAF

TESTOSTERONE CYPIONATE

3221

6/6/1978

PARCOR SA

FACILITIES AND CONTROLS

3222

II

5/23/1978

FARMITALIA SPA

CYANOCOBALAMIN (VITAMIN B 12)

3223

II

6/16/1978

KYOWA HAKKO KOGYO CO LTD

AMINO ACID BLEND KYOWA,TYPE TR-1

3224

II

6/15/1978

SIGMA F AND D DIV LTD

DIETHYLENETRIAMINE PENTACETIC ACID TRISODIUM ZINC SALT, 0.5 MOLAR SOL.

3225

5/25/1978

ORMA ISTITUDO TERAPEUTICO

NANDROLONE PHENYLPROPIONATE

3226

6/22/1978

KOLMAR LABORATORIES INC

FACILITIES AND CONTROLS AT THE DENTON, TX LOCATION

3227

III

9/27/1978

3M PHARMS

AEROSOL VALVES

3228

IV

5/31/1978

ICI LTD

VICTREX (TM) POLYETHERSULFONO RESIN

3229

II

5/28/1978

ORMA ISTITUDO TERAPEUTICO

NANDROLONE DECANOATE

3230

II

5/26/1978

TEVA PHARMACEUTICAL INDUSTRIES LTD

DOXEPIN HCL B.P.

3231

7/10/1978

DIAMOND SHAMROCK CORP

TREAMENT OF HYDROPHILIC SOFT CONTACT LENSES

3232

6/2/1978

PACKAGING INK CORP

FLEXO CELLOPHANE BLACK INK -FBK-7828

3233

6/26/1978

SIGMA F AND D DIV LTD

5-HYDROXYTRYPTAMINE CREAININE SULFATE COMPLEX

3234

6/28/1978

ACF CHEMIEFARMA NV

MANUFACTURING FACILITIES

3235

II

6/22/1978

DIOCTYL ESTERS OF SULFOSUCCINIC ACID (NA, CA, K, SALTS)BOUND BROOKS NJ

3236

II

6/14/1978

CYTEC INDUSTRIES BUSINESS UNIT AMERICAN


CYANAMID CO
LEMMON CO

3237

6/5/1978

LEO PHARMACEUTICAL PRODUCTS LTD

MECILLINAM FOR INJECTION

3238

III

6/27/1978

FRANK B ROSS COMPANY INC

ROSS CARNAUBA WAX,POWDERED, REFINED # 80(NATURAL & SYNTHETIC WAXES)

3239

II

7/18/1978

SK&F LAB CO SUB SK BECKMAN CORP

CIMETIDINE AND CIMETIDINE HCL-MANUF A THE GUAYAMA, PUERTO RICO FACILS

3240

II

6/30/1978

ROCHE PALO ALTO LLC

RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT)

3241

II

6/28/1978

DSM MINERA BV

QUINIDINE GLUCONATE USP XIX

3242

II

6/30/1978

SIGMA F AND D DIV LTD

GLYCINE

3243

II

6/22/1978

PLANTEX LTD CHEM AND PHARM WORKS

METHYLDOPA USP

3244

II

7/6/1978

SULFA DRUGS & MISC. SULFA PRODS AS MANUF AT BOUND BROOK, N.J.

3245

II

1/16/1978

CYTEC INDUSTRIES BUSINESS UNIT AMERICAN


CYANAMID CO
DIOSYNTH BV

3246

6/16/1978

MALLINCKRODT INC

DIOCYTL SODIUM SULFOSUCCINATE IN POLYETHYLENE GLYSOL 400 MFG ST.LOUIS

3247

7/14/1978

KV PHARMACEUTICAL CO

THEOPHYLLINE S.R. CAPSULES 125MG

3248

4/11/1978

SCHARPER SPA

ALGLUTAMOL

3249

7/19/1978

MEDIMPEX NORTHAMERICA INC

SULFADIMIDINE/SUPERSEPTYL (R)

3250

6/2/1978

HOWMEDICA INC

FACILITIES, METHODS & CONTROLS FOR THE DEKNATEL DIVISION

3251

5/29/1978

LABAZ LABORATORIES

PERSONNEL, METHODS, FACILITIES AND CONTROLS

3252

7/14/1978

KV PHARMACEUTICAL CO

THEOPHILLINE S.R. CAPSULES 250MG

II

II
II

CHENODEOXYCHOLIC ACID CAPSULES, 250MG

NORANDROSTENEDIONE --NANDROLONE

Page 88

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3253 I
6/28/1978
BERK PHARMACEUTICALS LTD

SUBJECT
MANUFACTURING & PACKAGING OF 1-TRYPTOPHAN (PACITRON TABLESTS, 500MG)

3254

6/23/1978

REXHAM CORP

PACKAGING CONSTRUCTIONS MANUF A MEMPHIS, TENN FACILITY

3255

6/27/1978

REHEIS CHEM CO DIV ARMOUR AND CO

ALIMINUM ZIRCONIUM CHLORHYDRATES CONTAINING MAGNESIUM SALTS

3256

II

7/14/1978

SIGMA F AND D DIV LTD

PROGESTERONE

3257

7/21/1978

PERSONNEL, FACILITIES AND CONTROLS(GENERAL OPERATING PROCEDURES)

3258

8/9/1978

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
BARNES HIND PHARMACEUTICALS INC

3259

7/5/1978

ANCHOR HOCKING CORP

COMPONENT, PROCESS & MANUF DATA FOR PLASTIC CONTAINERS

3260

8/9/1978

WARD BLENKINSOP AND CO LTD

PROBENECID

3261

II

7/10/1978

DOW CHEMICAL CO MICHIGAN DIV

VERSENE CA. CALCIUM CHELAING AGENT

3262

III

5/25/1978

HATCO CHEMICAL CORP

HATCOL 200

3263

6/13/1978

UNION CARBIDE CORPORATION

20% OXYGEN, 80% ARGON AS MANUF A TORRENCIE, CA

3264

II

7/14/1978

STEROID SRL

DICHLORPHENAMIDE (1,2 DICHLOR 3,5 DISULPHONAMIDO BENZENE)

3265

II

4/11/1978

SCHARPER SPA

FUROSEMIDE

3266

7/21/1978

SIGMA F AND D DIV LTD

PERSONNEL, FACILITIES AND CONTROLS

3267

8/4/1978

BUCKEYE CELLULOSE CORP

PRODUCT CLD-2

3268

6/9/1978

BARDAHL CHICAGO INC

FOOD MACHINERY GREASE

3269

8/9/1978

PROSINTEX SPA

PERSONNEL, FACILITIES AND CONTROLS

3270

II

8/21/1978

MEDIMPEX NORTHAMERICA INC

TOLBUTAMIDE USP XIX

3271

8/11/1978

ORION CORP

GENERAL METHODS, FACILITIES, AND CONTROLS

3272

II

6/2/1978

FERMION OY

CYCLOPHOSPHAMIDE ORAL GRADE

3273

II

7/21/1978

ORION CORPORATION FERMION OULU PLANT

PERPHENAZINE

3274

II

7/31/1978

SIGMA F AND D DIV LTD

CAABATE, SODIUM OXYBATE, GAMMA-HYDROXYBUTYRIC ACID, SODIUM SALT

3275

II

8/15/1978

UNION CARBIDE CORPORATION

20% OXYGEN, 80% ARGON AS MANUF A THE EAST CHICAGO

3276

6/20/1978

PHARMA-WALDHOF GMBH

THYMIDINE

3277

4/11/1978

SCHARPER SPA

TRIAMTERENE

3278

8/30/1978

SIGMA F AND D DIV LTD

THYMIDINE

3279

6/6/1978

ACE LUBE OIL CO

LUBRICANTS: 1. ALUMPLEX FM 2-EP

3280

8/10/1978

NATL INST HLTH NCI

DON (NORLEUCINE, 6-DIAZO-5-OXO-,L).

3281

6/21/1978

FISKE BROTHERS REFINING CO

OIL AND GREASESLUBRIPLATE

3282

9/11/1978

FUJISAWA PHARMACEUTICAL COMPANY LTD

(TIARAMIDE HCL) GENERAL PROCEDURES

3283

7/24/1978

SIGMA F AND D DIV LTD

L-ALANINE

3284

7/18/1978

SIEGFRIED AG

BISACODYL, U.S.P. XIX

3285

8/29/1978

ALPHA ONE BIOMEDICALS INC

SYNTHETIC THYMOSIN (RO 21-9199)

3286

9/13/1978

SIFAVITOR SRL

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

3287

8/7/1978

BASF AKTIENGESELLSCHAFT

KOLLIDON 12 PF, POLYVINYLPYRROLIDONE

3288

8/17/1978

COMATIC LABORATORIES INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

3289

8/8/1978

SIGMA F AND D DIV LTD

L-GLUTAMIC ACID MONO SODIUM SALT

3290

6/27/1978

ORION CORP LTD

CHLORHEXIDINE GLUCONATE SOLUTION BP 20%

II
II

II
II
IV

II

MFG. CONTROLS & DISTR. OF STERILE AND NON STERILE PROD.(TRANS-DEVICES)

Page 89

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3291 I
II
9/15/1978
SIFAVITOR SRL

SUBJECT
NORTRIPTYLINE HCL, USP

3292

3293

3294

3295

3296

3297

3298

3299

3300

6/13/1978

UNION CARBIDE CORPORATION

UCC MASTER MILKER SYSTEM FOR TC-99 EXTRACTION FROM MO-99

3301

9/19/1978

MEDI PHYSICS INC

FACILITIES, CONTROLS, AND PERSONNEL A THE SOUTH PLAINFIELD, NJ LOC

3302

9/19/1978

MEDI PHYSICS INC

FACILS., CONTROLS & PERSONNEL-EMERYVILLE, CA.--MEDI-PHYSICS NO. I-E

3303

9/19/1978

MEDI PHYSICS INC

FACILS.CONTROLS & PERSONNEL-ARLINGTON HGTS, ILL--MEDI-PHYSICS NO. I-A

3304

9/19/1978

MEDI PHYSICS INC

FACILITIES, CONTROLS AND PERSONNEL A THE MIAMI LAKES, FLA LOCATION

3305

9/19/1978

MEDI PHYSICS INC

FACILITIES, CONTROLS AND PERSONNEL A THE ROSEMONT, ILL LOCATION

3306

9/19/1978

MEDI PHYSICS INC

FACILITIES, CONTROLS AND PERSONNEL A THE GLENDALE, CA FACILITY

3307

7/8/1978

MEDI PHYSICS INC

QUALITY CONTROL OF RAW MATERIAL & FINAL PRODUCT RELEASE & DISTRIBUTION

3308

9/19/1978

MEDI PHYSICS INC

CORPORATE ADMIN & MANUF. CONTROLS A THE EMERYVILLE, CA. LOCATION

3309

II

6/15/1978

PAPAVERINE BASE

3310

III

9/21/1978

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
NOVA CHEMICALS CORP

3311

II

7/18/1978

E MERCK

TECHNETIUM TC-99M PYROPHOSPHATE NDA 17-913

3312

II

8/9/1978

MITSUBISHI TANABE PHARMA CORP

URSODEOXYCHOLIC ACID

3313

IV

9/7/1978

AMERICAN CYANAMID CO

CYMEL 1077

3314

II

9/12/1978

SIGMA F AND D DIV LTD

DL-CARNITINE

3315

IV

6/28/1978

PVO INTERNATL INC

SAFFLOWER OIL

3316

II

8/30/1978

RHONE-POULENC

ZOPICLONE (26,267 R.P.)

3317

II

10/6/1978

MASSACHUSETTS GENERAL HOSPITAL

1 ALPHA-HYDROXYDIHYDROTACHYSTEROL 3

3318

II

9/21/1978

SIEGFRIED AG

TRIAMTERENE

3319

III

9/5/1978

BCL LTD

SINGLE-SIDE COATED REGENERATED CELLULOSE FILMS

3320

10/10/1978

APOTEX INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

3321

II

8/30/1978

RHONE-POULENC

FUMARATE (30,356 R.P.)

3322

II

6/20/1978

YODOGAWA PHARMACEUTICAL CO LTD

VALPROIC ACID

3323

II

8/28/1978

SIGMA F AND D DIV LTD

L-LYSINE MONO HCL

3324

9/22/1978

ORTHO PHARMACEUTICAL LTD

OPERATING PROCEDS & PLANT FACILS AT THE DON MILLS, ONTARIO LOC.

3325

IV

10/13/1978

SCM CORPORATION

PARAMOUNT B

3326

II

10/20/1978

EGIS PHARMACEUTICALS PUBLIC LTD CO

ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST

3327

III

10/2/1978

AMERICAS STYRENICS LLC

RUBBER MODIFIED POLYSTYRENE PRODS: 1. TMDB-6800-MANUF MARIETTA OH

3328

II

6/14/1978

ACRAF SPA

TRAZODONE HCL

9/15/1978

SIFAVITOR SRL

CYCLANDELATE

9/13/1978

SIFAVITOR SRL

CYPROHEPTADINE, USP

9/15/1978

SIFAVITOR SRL

CHLOROTRIANISENE N.F. XIV

8/2/1978

SIGMA F AND D DIV LTD

L-GLUTAMIC ACID

9/5/1978

WERNER G SMITH INC

ESTERFIED FATY ACIDS & FATY ALCOHOL: 1.W.G.S. SYNACETI 116 NG/USP

IV

9/21/1978

JOHN L ARMITAGE AND CO

H-852 CLEAR LINER (CHEMICAL COATINGS)

IV

9/7/1978

ETHICHEM CORP

SORBITOL

II
II

NOT AN ASSIGNED NUMBER

SCLAIR POLYOLEFINE RESINS

Page 90

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3329 I
II
7/13/1978
SUMIKA FINE CHEMICALS CO LTD

SUBJECT
SODIUM VALPROATE

3330

IV

9/14/1978

M AND T CHEMS INC

DM-9327 STABILIZER

3331

II

10/20/1978

FUROSEMIDE USP XIX, BULK

3332

II

10/3/1978

CHINOIN PHARMACEUTCAL AND CHEMICAL


WORKS LTD
SCHERING AG

3333

II

7/12/1978

SOCIETE CHIMIQUE POINTET GIRARD SA

QUINIDINE POLYGALACTURONATE

3334

II

7/4/1978

ORSAN SOCIETE ANONYME

PURE L-GLUTAMIC ACID

3335

II

7/4/1978

ORSAN SOCIETE ANONYME

PHARMACEUTICAL GRADE L-GLUTAMIC ACID

3336

II

7/4/1978

ORSAN SOCIETE ANONYME

L-GLUMAIC ACID HCL

3337

II

7/4/1978

ORSAN SOCIETE ANONYME

CALIUM L-GLUTAMATE MONOHYDRATE TETRAHYDRATE

3338

II

7/4/1978

ORSAN SOCIETE ANONYME

POTASSIUM L-GLUTAMATE

3339

II

7/4/1978

ORSAN SOCIETE ANONYME

POTASSIUM L-GLUTAMATE (LOW SODIUM CONTENT)

3340

II

7/4/1978

ORSAN SOCIETE ANONYME

MAGNESIUM L-GLUTAMATE

3341

II

7/4/1978

ORSAN SOCIETE ANONYME

L-ASPARTIC ACID

3342

II

9/27/1978

SIGMA F AND D DIV LTD

PYRIDOXAL HYDROCHLORIDE

3343

II

9/29/1978

MEDIMPEX NORTHAMERICA INC

SPIRONOLACTONE USP XIX

3344

10/24/1978

UPSHER SMITH LABS INC

FACILITIES AND CONTROLS

3345

II

10/11/1978

BOEHRINGER MANNHEIM GMBH

ALPHA-METHYLDOPA, BULK FORM USP XIX

3346

II

10/7/1978

MALLINCKRODT INC

ZOMEPIRAC AS MANUFACTURED IN THE ST. LOUIS, MISSOURI PLANT

3347

10/26/1978

STERILE PROCESSING FACILITES LOCATED IN LAKEWOOD, NEW JERSEY.

3348

II

10/24/1978

WEST PHARMACEUTICAL SERVICES LAKEWOOD


INC
MEDIMPEX NORTHAMERICA INC

3349

II

10/24/1978

SIGMA F AND D DIV LTD

URIDINE

3350

II

10/11/1978

BOEHRINGER MANNHEIM GMBH

SPIRONOLACTONE (BULK FORM) USP XIX, BP 1973

3351

II

10/31/1978

ROCHE PALO ALTO LLC

BUTOCONAZOLE NITRATE

3352

II

10/20/1978

KV PHARMACEUTICAL CO

SEARLE ANTACID

3353

II

11/10/1978

GEDEON RICHTER LTD

NORETHISTERONE

3354

II

10/24/1978

ANTIBIOTICOS SPA

FLUMETHASONE 21-PIVALATE, MICRONIZED AND NON-MICRONIZED

3355

II

10/13/1978

ROCHE DIAGNOSTICS GMBH

QUINIDINE GLUCONATE & SULFATE USP XIX (BULK) & BP 1973

3356

III

9/22/1978

AVON INDUSTRIAL POLYMERS LTD

RUBBER COMPONENTS FOR AEROSOL VALVES: 1.AVON COMPOUND 55 P14

3357

III

10/2/1978

JAITE PACKAGING

PACKAGING LAMINATIONS: MMP-7

3358

II

10/13/1978

MEDIMPEX NORTHAMERICA INC

ERGOTAMINE TARTRATE

3359

II

10/10/1978

ORION CORP LTD FERMION

CHLORHEXIDINE ACETATE, BPC

3360

III

10/23/1978

BRITISH SIDAC LTD

TRANSPARENT CELLULOSE FILMS

3361

II

11/20/1978

DELMAR CHEMS LTD

BRETYLIUM TOSYLATE, BULK FORM

3362

11/8/1978

PARKE DAVIS & CO

CAPSULE PLANT OPERATION AT THE DETROIT, MICHIGAN FACILITY

3363

II

8/10/1978

SANOFI CHIMIE

PROPIONYL PROMAZINE (PROPIOPROMAZINE)

3364

II

8/29/1978

DINAMITE DIPHARMA SPA

3365

II

10/27/1978

SIGMA F AND D DIV LTD

FUROSEMIDE USP MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY


FACILITIES
FUSARIC ACID

SPIRONOLACTONE

NORETHISTERONE ACETATE

Page 91

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3366 I
II
11/20/1978
DELMAR CHEMS LTD

SUBJECT
HALAZEPAM

3367

IV

11/8/1978

CAPSUGEL

CAPSULES MANUFACTURED IN GREENWOOD, SOUTH CAROLINA FACILITY

3368

II

9/11/1978

SYNTEX SA

CHORIONIC GONADOTROPIN

3369

III

10/13/1978

VERTA FOAM COMPONENTS LTD

POLYETHER FOAM WADS1. VFC 70

3370

II

11/20/1978

DELMAR CHEMS LTD

OXTRIPHYLLINE, BULK FORM

3371

IV

9/8/1978

WARNER JENKINSON CO

FLAVORS 1. 0042 VANILLA BOURBON NA AL WS

3372

II

10/25/1978

MIRANOL CHEM CO

AMPHOTERIC SURFACE ACTIVE AGANTS (MIRANOL 2MCA MODIFIED)

3373

III

11/3/1978

DUPONT CANADA LTD

SLAIRFILM PRODUCTS AND DARTEK NYLP NOYLON FILM (SL-1,2&3)

3374

II

10/4/1978

LUNDBECK PHARMACEUTICALS ITALY SPA

DESIPRAMINE HCL

3375

III

10/27/1978

AVERY DENNISON CORP

PRESSURE SENSITIVE ADHESIVE LABEL CONSTRUCTIONS

3376

III

10/3/1978

DEERFIELD PLASTICS CO INC

POLYTHYLENE FILM PRODUCTS

3377

II

11/18/1978

SIEGFRIED AG

HYDROXYZINE HCL N.F. XIV

3378

III

10/24/1978

MORTON INTERNATIONAL INC

EPOXY ADHESIVES CONTAINING P-51 WHITE PASTE

3379

II

11/2/1978

BAYER SCHERING PHARMA AG

ESTRADIOL-VALERATE

3380

II

10/24/1978

ANTIBIOTICOS SPA

FLUMETHASONE, MICRONIZED AND NONMICRONIZED

3381

II

11/21/1978

KV PHARMACEUTICAL CO

DIPHENHYDRAMINE HCL 100MG S.R. CAPSULES

3382

II

11/2/1978

SIEGFRIED AG

CYPROHEPTADINE HCL, USP AS MFG AND SOLD UNDER SIEGFRIED LABEL

3383

II

11/1/1978

ACF CHEMIEFARMA NV

SULFAMETHIZOLE NF XIV

3384

12/1/1978

JANSSEN PHARMACEUTICA NV

3385

III

10/24/1978

MORTON INTERNATIONAL INC

CHEMICAL PRODUCTION & CONTROL OF BPC'S FOR INVESTIGATIONAL USE IN BEERSE,


BELGIUM.
EPOXY ADHESIVES CONTAINING P-32 BLACK PAST MANUF A WARSAW, INDIANA

3386

II

12/1/1978

DSM ANDENO

QUININE HYDROCHLORIDE FF II / NF XI

3387

II

11/14/1978

BRACCO IND CHIMICA SPA

(B15000), IOPAMIDOL, BULK FORM

3388

II

11/30/1978

MEDIMPEX NORTHAMERICA INC

4 NORANDROSTHENDIONE

3389

II

11/1/1978

DSM MINERA BV

QUINIDINE SULFATE AS MFG. IN HOLLAND

3390

12/15/1978

MERCK MANUF FACIL IN CLONMELCOUNTY TIPPERARY, BALLYDINE, IRELAND

3391

II

10/31/1978

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
BAYER SCHERING PHARMA AG

3392

10/24/1978

ANTIBIOTICOS SPA

FACILITIES AND CONTROLS

3393

II

11/22/1978

MANUFACTURING ENTERPRISES INC

HALOG-H CREAM (HALCINONIDE CREAM 0.1%)

3394

II

12/1/1978

ICI AMERICAS INC

SPAN -65 (SORBITAN TRISTEARATE

3395

II

11/1/1978

SHIONOGI AND CO LTD

COMPOUND NUMBER 6059-S

3396

II

11/30/1978

GANES CHEMICALS INC

METHOHEXITAL AS MANUF ON A CUSTOM BASIS FOR ELI LILLY CO.-BULK POWDER

3397

12/6/1978

FRESENIUS USA INC

FACILITIES AND CONTROLS FOR DELKA, S.A. (SAN SALVADOR, EL SALVADOR CA)

3398

II

11/1/1978

DSM MINERA BV

QUININE SULFATE USP XIX/ NF XII

3399

II

12/7/1978

ICI AMERICAS INC

TWEEN 65 (SORBITAN TRISTEARATE) (POLYOXYETHYLENE)

3400

11/30/1978

SCHMID LABORATORIES INC

CANDICIDIN-FACILS FOR THE PRODUCTION OF--LOCATED IN SO.ANDERSON, S.C.

3401

II

12/28/1978

SIGMA F AND D DIV LTD

O-PHTHALDIALDEHYDE

3402

II

1/12/1979

NOVO NORDISK AS

INSULIN USP(MONOCOMPONENT-MC)

3403

II

12/6/1978

MERCK KGAA

MANNITOL, PYROGEN-FREE, PRODUCT #5980

TESTOSTERONE ENANTHATE

Page 92

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3404 I
I
12/14/1978
PROSINTEX SPA

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF NALIDIXIC ACID.
HYALURONIDASE.

3405

II

1/9/1979

SIGMA F AND D DIV LTD

3406

1/12/1979

USV PHARMACEUTICAL CORP SUB RORER GROUP FACILS & CONTROLS FOR THE MANUF OF BULK SUBSTANCE A TUCKAHOE, NY

3407

II

1/9/1979

KYOWA HAKKO BIO CO LTD

MANUFACTURING AND QUALITY INFORMATION ON AMINO MIXTURE TYPE MC

3408

III

11/28/1978

CITIES SERVICE COMPANY

HDPE IN THE CS 200 SERIES AS MANUF AT MONSANTO PLANT, TX.

3409

II

12/12/1978

PRODUCTOS QUIMICOS NATURALES SA DE CV

PIPERAZINE ESTRONE SULFATE

3410

II

12/20/1978

HOECHST AG

PROCAINAMIDE HCL, BULK DRUG SUBSTANCE

3411

III

12/7/1978

HELVOET PHARMA NV

CHLOROBUTYL COMPDS: FM 61 AND 62 (PACKAGING MATERIALS (CLOSURES)

3412

II

12/20/1978

PHARMA-WALDHOF GMBH

ADENINE AND ADENINE HCL (SYNTHETIC & FROM RNA OR ADENOSINE)

3413

II

10/17/1978

MERCK KGAA

METHYL GLUCAMINE (PRODUCT #6143)

3414

II

1/23/1979

TAKEDA CHEMICAL INDUSTRIES LTD

CEFSULODIN SODIUM (SCE-129)

3415

II

12/14/1978

SIGMA F AND D DIV LTD

ARECOLINE HYDROBROMIDE

3416

II

1/24/1979

ACIC LTD

TRIAMTERENE USP

3417

1/9/1979

CUTTER LABORATORIES INC

IRRIGATION SOLUTIONS IN POLYOLEFIN BOTTLES

3418

II

12/22/1978

MD PHARMACEUTICAL INC

CARAMIPHEN ETHANE DISULFONATE

3419

II

1/9/1979

GANES CHEMICALS INC

PHENYLPROPANOLAMINE HCL NF XIV BULK FORM

3420

IV

10/25/1978

BASF SE

CREMOPHOR SURFACTANT RH40 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

3421

II

1/9/1979

SIGMA F AND D DIV LTD

METHYL COBALAMINE

3422

1/11/1979

FACILITIES AND MANUFACTURING

3423

II

1/19/1979

WINTHROP PHARMACEUTICALS DIV STERLING


DRUG INC
E MERCK

3424

1/24/1979

ERREGIERRE SPA

FACILITIES AND CONTROLS

3425

12/21/1978

MD PHARMACEUTICAL INC

FACILITIES, PROCEDURES

3426

IV

1/17/1979

BELL FLAVORS AND FRAGANCES INC

FLAVORS

3427

1/16/1979

CONTINENTAL DIVERSIFIED INDUSTRIES

MANUF CONTROLS FOR PLASTIC CONTAINERS FOR IRRIGATION & IV SOLUTIONS

3428

II

1/26/1979

SIGMA F AND D DIV LTD

L-ASPARTIC ACID

3429

8/3/1978

N&N MENICON INC

COUPLER MONOMER FOR N & N MENICON, INC (MAFILCON) SOFT CONTACT LENS

3430

12/29/1978

KOLMAR LABORATORIES INC

FACILS, CONTROLS & PERSONNEL AT RIVERSIDE CALIFORNIA LOCATION

3431

II

12/5/1978

SOMATOSTATIN (OVINE)

3432

II

1/9/1979

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
SIEGFRIED USA LLC

3433

2/22/1979

SYNTEX LABORATORIES INC SUB SYNTEX CORP

FACILITIES,PERSONNEL AND GEN.OPER.PROC.FOR FIELDCREST WAREHSE,ELGIN,IL

3434

III

5/11/1979

DOWTY SEALS LTD

DOWTY SEALS COMPOUNDS: 1. REFERENCE 0117

3435

II

1/25/1979

ORION CORP FARMOS CHEMICAL PLANT

FUROSEMIDE

3436

II

1/5/1979

ISLAND CHEMICAL COMPANY INC

QUINIDINE AND QUINIDINE SALTS

3437

II

11/30/1978

MIDAS PHARMA GMBH

DIETHYLPROPIONE HCL

3438

12/15/1978

MOXNESS PRODUCTS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

3439

II

12/6/1978

MEDI PHYSICS INC

CS-22 CYCLOTRON IN EMERYVILLE,CA AND NEW JERSEY; MC-40 SCANDITRONIX

N,N-DICYCLOHEXYLCARBODIIMIDE, PRODUCT #11650

PHENTERMINE & PHENTERMINE HCL USP - GANES

Page 93

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3440 I
II
1/12/1979
SCHERING AG

SUBJECT
LISURIDE HYDROGEN MELEATE

3441

2/9/1979

PAR PHARMACEUTICAL INC

FACILITIES AND CONTROLS

3442

III

12/15/1978

MOXNESS PRODUCTS INC

PRODUCT & PRODUCT PACKAGING INFORMATION

3443

II

2/2/1979

CYANAMID GREAT BRITAIN LTD

DIAMOX POWDER (ACETAZOLAMIDE)

3444

1/17/1979

PFANSTIEHL LABORATORIES INC

A-D-MELIBIOSE MONOHYDRATE & RAFFINISE PENTAHYDRATE

3445

II

11/1/1977

FARCHEMIA

CHLORTHALIDONE

3446

II

2/6/1979

SANTEN PHARMACEUTICAL CO LTD

THIOLA

3447

II

2/2/1979

AMERICAN CYANAMID CO

LOXITANE (LOXAPINE SUCCINATE POWDER), AMOXAPINE

3448

II

1/12/1979

SCHERING AG

LISURIDE HYDROGEN MALEATE

3449

II

2/26/1979

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

AMITRIPTYLINE HCL

3450

II

1/10/1979

COWAY CHEM CO LTD

HYDRALAZINE HCL, USP

3451

II

2/12/1979

GANES CHEMICALS INC

HALAZEPAM, BULK POWDER-MANUF FOR SCHERING CORP A PENNSVILLE DIVISION

3452

II

2/8/1979

SANOFI CHIMIE

METHYL PREDNISOLONE ACETATE

3453

2/22/1979

SEA & SKI CORP

FACILITIES AND CONTROLS

3454

2/6/1979

ORTHO PHARMACEUTICAL CORP

FACILITIES AND CONTROLS; MANATI, PUERTO RICO PLANT CITE

3455

2/19/1979

SUNBEAM PLASTICS CORP

FACILS AND CONTROLS A THE EVANSVILLE, INDIANA LOCATION

3456

II

12/21/1978

BASF CORP

VITAMIN A ACID (TRETINOIN)

3457

II

2/27/1979

KYOWA HAKKO KOGYO CO LTD

DACARBAZINE (AS MANUFACTURED BY SANYO-KOKUSAKU PULP CO.,LTD.)

3458

II

2/26/1979

ASSIA TEVA

NITROFURAZONE NF-BPC (PETAH TIQWA PLANT)

3459

IV

2/5/1979

PHILLIPS PETROLEUM CO

PHILLIPS HYDROCARBON PROPELLANTS AS MANUF IN THE OKLAHOMA FACILS

3460

II

3/7/1979

E MERCK

DIBENZOSUBERONE

3461

III

2/22/1979

SUMMIT PACKAGING SYSTEMS INC

AEROSOL VALVE SYSTEMS: 1. SV-73

3462

III

2/22/1979

HELVOET PHARMA NV

BROMOBUTYL COMPOUNDS: FM 153 AND FM 154

3463

II

2/19/1979

ERREGIERRE SPA

URSODEOXYCHOLIC ACID

3464

II

2/15/1979

MALLINCKRODT INC

DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA) AS MANUFACTURED IN ST. LOUIS, MO.

3465

II

3/7/1979

RUETGERS-NEASE CHEMICAL COMPANY INC

ZINC PYRION 48% AS IT WILL BE MANUF IN STATE COLLEGE, PA. FACILS

3466

II

2/19/1979

ACIC LTD

SULFAMETHOXAZOLE

3467

III

6/21/1978

KANEGAFUCHI CHEMICAL INDUSTRY CO LTD

KANE ACE B-31

3468

II

2/19/1979

ACIC LTD

TRIMETHOPRIM

3469

II

1/10/1979

BASF PHARMA EVIONNAZ SA

MEPIVACAINE HCL

3470

IV

3/14/1979

HENRY H OTTENS MANUFACTURING CO INC

FLAVORS:OTTENS PLUS (FLAVOR POTENTIATOR) #3096 AS MANUF IN PA.

3471

III

2/22/1979

NATIONAL STARCH & CHEMICAL CORP

ADHESIVES

3472

II

2/19/1979

ACIC LTD

METHYLDOPA USP

3473

III

3/6/1979

INVISTA SARL

RESINS FOR PHARMACEUTICAL PACKAGING

3474

II

2/19/1979

ACIC LTD

CHLORTHALIDONE USP

3475

II

12/22/1978

ORGAMOL SA

CHOLINE THEOPHYLLINATE

3476

2/1/1979

CIBA GEIGY LTD

THE KEY PERSONNEL AT THE BASLE FACILITIES IN SWITZERLAND

3477

5/11/1978

DIAMOND SHAMROCK CORP

NOPCO JMY AS MNFG. IN THE NEW JERSEY FACILITIES

Page 94

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3478 I
II
2/9/1979
WAITAKI INTERNATIONAL BIOSCIENCES SUB
WAITAKI CANADA LTD
3479 A
V
3/9/1979
JRS PHARMA LP

SUBJECT
N-ACETYL-L-CYSTEINE

3480

II

3/9/1979

SIEGFRIED AG

ALLOPURINOL (BULK)

3481

3/9/1979

ROQUETTE NATIONAL CHIMIE OF LILLE

3 MONTHS TOXICITY STUDY IN RAS--WITH 2-CARBOXYMETHYL STARCHES IN FEED

3482

II

3/14/1979

DELMAR CHEMS LTD

CK-0569A (BULK) ANTI-PLAQUE AGENT

3483

3/6/1979

DUPHAR BV

3484

IV

3/9/1979

FMC CORP FMC BIOPOLYMER DIV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEESP, THE NETHERLANDS.
AC-DI-SOL CROSCARMELLOSE SODIUM NF AS MANUFACTURED IN NEWARK, DELAWARE

3485

III

3/6/1979

MCGAW ADDITIV (R) TRANSFER VIAL (THIS FORMERLY MCGAW LABS.

3486

3/6/1979

SEARLE LABORATORIES DIV SEARLE


PHARMACEUTICALS INC
DUPHAR BV

3487

III

2/23/1979

VALSPAR CORP

PLASTIC TUBE--KOROLITH COATING 550X308 & KOROLITH CATALYST 910-801

3488

3/23/1979

FACILITIES AND CONTROLS

3489

II

2/19/1979

AMBIX LABORATORIES DIV ORGANICS CORP


AMERICA
ERREGIERRE SPA

3490

II

3/6/1979

DUPHAR BV

RITODRINE HCL

3491

II

1/30/1979

SOGO PHARMACEUTICAL COMPANY LTD

SULPHADIMETHOZINE

3492

III

3/7/1979

HAENDLER & NATERMANN GMBH

PACKAGING FOILS - ALUMINUM

3493

3/14/1979

LEE LABS INC

FACILS., CONTROLS & PERSONNEL AT PETERSBURG PLANT FOR GUAIFENESIN

3494

II

4/9/1979

BLASCHIM SPA

FLUOXYMESTERONE

3495

IV

3/16/1979

ROQUETTE NATIONAL CHIMIE OF LILLE

EXPLOTAB BRAND OF SODIUM STARCH GLYCOLATE

3496

IV

7/20/1978

CUSTOMCOLOR INC

COLOR COMPOUNDS: 1.BLACK 21,201 CP 24/1 CONCENTRATE

3497

III

3/27/1979

AMOCO HIGH DENSITY POLYETHYLENE RESINS (MANUF IN ALVIN, TX)

3498

II

10/15/1978

AMOCO CHEMS CORP AFFILIATE AMERICAN OIL


CO
CLIN-MIDY SA

3499

II

4/5/1979

GEDEON RICHTER LTD

VINBLASTIN S04

3500

3/5/1979

PARKE DAVIS DIV WARNER LAMBERT CO

FACILS. & CONTROLS LOCATED IN FJARDO, PUERTO RICO FACILITY

3501

II

2/28/1979

CAMBREX PROFARMACO MILANO SRL

FLURAZEPAM HCL

3502

II

10/23/1978

DINAMITE DIPHARMA SPA

TRIMETHOPRIM BP 73

3503

II

4/5/1979

GEDEON RICHTER LTD

NANDROLONE DECANOATE

3504

IV

5/1/1979

DOW CORNING CORP

70000 AND 70001 SILICONE ELASTOMERS MANUFACTURED IN HEMLOCK, MI.

3505

II

4/11/1979

CAMBREX PROFARMACO MILANO SRL

AMIODARONE HCL

3506

II

4/24/1979

BAXTER HEALTHCARE CORP

IFOSFAMIDE

3507

II

4/27/1979

GEDEON RICHTER LTD

VINCRISTINE SULFATE

3508

II

4/18/1979

NAPP TECHNOLOGIES

MFG & CONTRL PROCEDS.--PRODUCT. OF HYDROXYZINE PAMOATE NF XIV-LODI,NJ

3509

4/20/1979

HOECHST CELANESE CORP

FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES (COVENTRY, R.I.)

3510

IV

4/4/1979

DEGUSSA CORPORATION

ELCEMA MICROFINE CELLULOSE AS MANUF AT THE TETERBORO, N.J. LOCATION

3511

II

3/27/1979

SIEGFRIED AG

PROPOXYPHENE NAPSYLATE

3512

IV

1/18/1979

ER SQUIBB AND SONS INC

PLACEBO FOR FLUPHENAZINE HCL TABLETS

3513

II

3/8/1979

FIS FABBRICA ITALIANA SINTETICI SPA

FUROSEMIDE

EXPLOTAB FEEDING STUDY-UNIV OF R.I.(SOD. STARCH GLYCOLATE USP/NF)

FACILITIES AND CONTROLS, PART II - PHARMACEUTICAL DEVELOPMENT

DIPYRIDAMOLE

URATE OXIDASE (URICOZYME)

Page 95

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3514 A
II
3/2/1979
DIPHARMA FRANCIS SRL

SUBJECT
CHLORPROPAMIDE

3515

II

4/2/1979

IRISH FINE CHEMICALS LIMITED

TRIFLUOPERAZINE

3516

II

3/30/1979

DIPHARMA FRANCIS SRL

TRIAMTERENE USP XIX/BP '73

3517

II

3/5/1979

DIOSYNTH BV

PREGNANT MARE SERUM GONADOTROPHIN (PMSG) FROM PREGNANT MARE PLASMA

3518

3/14/1979

ELI LILLY AND CO

ROTOWEIGH (TM) CAPSULE WEIGHING MACHINE AT USED IN THE INDIANAPOLIS PL

3519

II

2/10/1979

BACHEM FINE CHEMICALS INC

PENTAPEPTIDE, L-ARG-L-LYS-L-ASP-L-VAL-L-TYR

3520

5/9/1979

BEECHAM LABORATORIES DIV OF BEECHAM INC

3521

5/10/1979

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

3522

II

5/4/1979

LEIRAS OY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BRISTOL, TENNESSEE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BASLE, SWITZERLAND.
GLYCOPYRROLATE, USP

3523

II

2/22/1979

POLFA TARCHOMIN

DIAZEPAM, BULK -MANUF BY POLFA-TARCHOMIN

3524

II

2/8/1979

DIPHARMA FRANCIS SRL

CYPROHEPTADINE HCL, USP

3525

II

5/1/1979

GANES CHEMICALS INC

TRIAMTERENE, BULK FORM MANUF IN THE NEW JERSEY FACILITIES

3526

4/13/1979

3527

II

5/4/1979

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
CIBA GEIGY CORP PHARMACEUTICAL DIVISION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF PRECLINICAL STUDIES IN PHILADELPHIA.PHILADELPHIA LOCATION
LAMPRENE (CLOFAZIMINE) AS PRODUCED IN CAPSULE FORM

3528

III

1/4/1979

POLYONE CORP

RUCOBLEND COMPOUNDS VEO-600 & VEO-601 PACKAGING MATERIALS

3529

II

5/30/1979

SANOFI CHIMIE

PREDNISOLONE ACETATE

3530

5/11/1979

APPLIED BIOLOGICAL SCIENCES LAB

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

3531

II

3/14/1979

NISSHIN PHARMA INC

PHYTONADIONE, USP (VITAMIN K1) MANUFACTURED IN TOKYO, JAPAN

3532

II

5/8/1979

SIGMA F AND D DIV LTD

OROTIC ACID ANHYDROUS

3533

5/4/1979

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

PERSONNEL, FACILS., CONTROLS COVERING THE CRANSTON, R.I. FACILITY

3534

II

4/17/1979

DM GRAHAM LABORATORIES INC

ACCURBRON, S.R. (CONTROLLED RELEASE THEOPHYLLINE)

3535

II

6/4/1979

SANOFI CHIMIE

PREDNISOLONE USP MANUFACTURED IN PUTEAUX, FRANCE

3536

II

6/14/1979

NOVO NORDISK AS

INSULINS, USP--PREPARATION AND PACKAGING, DOSAGE FORMS

3537

II

5/30/1979

TRAVENOL LABORATORIES INC

BRANCHED CHAIN AMINO ACID INJECTION ENCLOSURES

3538

II

4/3/1979

SIGMA ALDRICH ISRAEL LTD

DACTINOMYCIN

3539

III

3/29/1979

SPARTECH PLASTICS

THERMOPLASTIC SHEET PRODUCTS: 1. NO. 5RTC-911-32C

3540

II

4/3/1979

NAPP CHEMICALS INC

MANUFACTURING & CONTROLS PROCEDURES USED IN PRODUCTION OF TOLBUTAMIDE

3541

II

5/31/1979

3542

II

6/12/1979

AYERST LABORATORIES INC DIV AMERICAN HOME ANTABUSE WITH RIBOFLAVIN TABLETS AND PLACEBO
PRODUCTS CORP
CHUGAI PHARMACEUTICAL CO LTD
SUCRALFATE ;CARAFATE TM

3543

III

1/26/1979

VERNAY LABORATORIES INC

COMPOUND VL 1001 M 422

3544

II

5/22/1979

PET INC

CALIUM STEARATE CONTAING SODIUM LAURYL SULFATE (CS-SLS)

3545

II

5/25/1979

SANOFI INC

PROCHLORPERAZINE EDISYLATE

3546

II

5/12/1976

LABORATORY MAG

MECLIZINE 2HCL

3547

II

6/6/1979

CYCLO CHEM DIV ALAMEDA LABS

2-CHLOROPHENOTHIAZINE

3548

IV

5/22/1979

PET INC

MAGNESIUM STEARATE CONTAINING SODIUM LAURYL SULFATE (MS-SLS)

3549

6/4/1979

SUPERPHARM CORP

STANDING OPERATING PROCEDURES

Page 96

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3550 I
II
6/26/1979
GANES CHEMICALS INC

SUBJECT
ISOXSUPRINE HCL, BULK FORM AS MANUF IN CARLSTADT, NJ

3551

II

7/3/1979

CARAMIPHEN EDISYLATE

3552

5/16/1979

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
LUSOCHIMICA S P A

3553

II

7/3/1979

PROCOS SPA

PRENILAMINE LACTATE

3554

III

7/13/1979

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

POLYETHYLENE BOTTLES

3555

II

7/12/1979

ANTIBIOTICOS SPA

17A-HYDROXYPROGESTERONE, BULK

3556

II

6/29/1979

SIGMA F AND D DIV LTD

PHENYLACETIC ACID

3557

6/26/1979

MILLIPORE CORP

DURAPORE (TM)--FILTER MATERIAL & CARTRIDGES AS MFGR IN BEDFORD, MA

3558

II

6/22/1979

SIEGFRIED USA INC

PROPOXYPHENE NAPSYLATE, BULK FORM-MANUF CARLSTADT, NJ FACILITY

3559

II

7/6/1979

DIPYRIDAMOLE

3560

II

5/16/1979

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
LUSOCHIMICA S P A

3561

II

6/26/1979

MILLIPORE CORPORATION

DURAPORE (TM) FILTER MATERIAL-FILTER CARTRIDGES -JAFFREY NH FACILITY

3562

II

7/9/1979

ASH STEVENS INC

BULK PREPARATION OF 5-AZACYTIDINE

3563

II

7/2/1979

SIGMA F AND D DIV LTD

ADENINE - PRODUCT NO. 8626 FD

3564

II

4/30/1979

FRANCO INDIAN PHARMACEUTICALS PVT LTD

METHOXSALEN

3565

II

7/6/1979

PROPRANOLOL HCL.

3566

II

7/20/1979

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
UPJOHN CO

3567

III

7/11/1979

AMCOR PHARMACEUTICAL PACKAGING USA INC

MANUFACTURING OF INJECTION MOLDED PARTS

3568

II

7/20/1979

SYNTEX USA INC

RS-5888R (AS MANUF BY SYNTEX RESEARCH IN PALO ALTO, CA )

3569

III

7/17/1979

WEST CO

3570

II

7/20/1979

SANOFI CHIMIE

CR-1 CHILD RESISTANT CLOSURE MANUFACTURED BY PLASTICS DIVISION IN MONTGOMERY,


PENNSYLVANIA.
HYDROCORTISONE ACETATE

3571

7/6/1979

PROSINTEX CHIMICHE ITALIANE SRL

FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN MILAN, ITALY

3572

8/9/1979

3573

8/6/1979

3574

III

8/7/1979

AYERST LABORATORIES INC DIV AMERICAN HOME PRECLINICAL STUDIES USING AY-25,650; SCHALLY ANALOGUE; (D-TRP6)-LH/RH
PRODUCTS CORP
ADRIA LABORATORIES DIV ERBAMONT INC
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN PLAIN CITY, OHIO.
BP CHEMICALS SA
POLYETHYLENE PLASTIC PELLETS: PRODUCT NO. DFDM 0111 (NATURAL)

3575

IV

8/10/1979

HORII PHARMACEUTICAL INDUSTRIES LDT

3576

II

8/9/1979

3577

7/31/1979

3578

II

7/15/1979

AYERST LABORATORIES INC DIV AMERICAN HOME MFG & CONTROL PROCEDS FOR INJECT. DOS FORM AY-25,650; SCALLY ANALOGUE
PRODUCTS CORP
RECKITT & COLMAN PRODUCTS LTD
PHARMACEUTICAL PRODUCTION FACILITY
PHARMACEUTICAL DIV
BTB CO SPA
ANISOTROPINE METHYLBROMIDE

3579

8/7/1979

PARKEDALE PHARMACEUTICALS INC

3580

II

8/6/1979

DIOSYNTH BV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROCHESTER, MICHIGAN.
ESTRADIOL BENZOATE

3581

III

4/5/1979

ROHM AND HAAS CO

BLENDEX SERIES (FORMERLY HELD BY BORG-WARNER)

3582

7/27/1979

DIAGNOSTIC ISOTOPES INC

GENERAL PLANT MASTER FILE

3583

II

7/22/1979

GANES CHEMICALS INC

ALLOPURINOL, BULK FORM AS MANUF A PENNSVILLE, NJ FACILITY.

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

ISOXSUPRINE HYDROCHLORIDE

A-125 (U-42,126) ANTI-TUMOR AGENT

BAROS TM EFFERVESCENT GRANULES

Page 97

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3584 I
II
8/6/1979
DIOSYNTH BV

SUBJECT
PREDNISOLONE TEBUTATE

3585

III

2/7/1979

BORDEN CHEM CO

HOT MELT PRODUCTS: 1. HA-6335

3586

III

4/5/1979

VINYL PLASTICS INC

HEAT SEAL COATINGS, SP SERIES : 1. SP-20002. SP-2015

3587

II

7/4/1979

LAEVOSAN GMBH AND CO KG

LACTULOSE CONCENTRATE (BULK)

3588

II

8/6/1979

DIOSYNTH BV

ESTRONE MICRONIZED

3589

8/28/1979

MCNEIL PHARMACEUTICAL DIV MCNEILAB INC

3590

III

7/20/1979

KINGLY PRODUCTS CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DORADO, PUERTO RICO.
PLASTIC MEDICINE SPOONS

3591

8/10/1979

NOVOPHARM LTD

3592

II

8/6/1979

DIOSYNTH BV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SCARBOROUGH, ONTARIO, CANADA.
METHYLPREDNISOLONE

3593

II

6/15/1979

HOECHST AG

ACESULFAME K (ACETOSULFAM-KGERMAN)

3594

II

6/11/1979

BAXTER HEALTHCARE CORP

CYCLOPHOSPHAMIDE--MANUF AND CONTROLS (PURE SUBSTANCE)

3595

II

8/22/1979

ELI LILLY AND CO

ACETAMINOPHEN CAPSULES

3596

II

8/6/1979

DIOSYNTH BV

METHYLPREDNISOLONE ACETATE

3597

IV

8/16/1979

NORTHVILLE LABORATORIES

F-1888 ARTIFICAL PEACH FLAVOR AS MANUF IN THE NORTHVILLE, MICH FACILS

3598

II

8/21/1979

SYNTEX USA INC

NEW DRUG SUBSTANCE RS-35909-00-00-0

3599

II

8/22/1979

ORGAMOL SA

TICLOPIDINE

3600

III

7/30/1979

SOLVAY & CIE SA

PVC HOMOPOLYMER SOLVIC 271 GA

3601

II

8/6/1979

DIOSYNTH BV

METHYLPREDNISOLONE HEMISUCCINATE

3602

II

8/22/1979

FINORGA

TRITHIOZINE

3603

II

9/11/1979

ERCOPHARM

PROPANTHELINE BROMIDE

3604

8/31/1979

CONTINENTAL PHARMA SA

FACILS., METHODS & PRECLINICAL DATA FOR PRODUCT CP 804 S

3605

II

9/5/1979

SANOFI CHIMIE

KETOPROFEN (19,583 R.P.)

3606

II

9/19/1979

OTSUKA PHARM CO LTD

PROCATEROL HYDROCHLORIDE HEMIHYDRATE, MANUFACTURED IN TOKUSHIMA, JAPAN

3607

II

9/10/1979

AMERCHOL CORP

PROMULGEN D (EMULSIFIER)

3608

II

1/30/1979

GIULIANI SPA

URSODEOXYCHOLIC ACID

3609

II

9/3/1979

FARCHEMIA SRL

METRONIDAZOLE, USP

3610

II

9/11/1979

HOFFMANN LA ROCHE INC

RO 3-1428 (5,8,LL,L4-EICOSATETRAYNOIC ACID) -MANUF IN NJ FACILITIES

3611

9/13/1979

TOXICOL LABORATORIES LTD

PERSONNEL, FACILS., AND STANDARD OPERATING PROCEDURES

3612

9/19/1979

ORTHO PHARMACEUTICAL CORP

3613

II

8/31/1979

KV PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NEW RARITAN, NEW JERSEY.
NORPACECR 100MG CAPSULES

3614

III

9/18/1979

SURGICOT INC

FLEXIBLE PACKAGING PRODUCTS AND COMPONENTS

3615

9/18/1979

MUNDIPHARMA GMBH

FACILITIES AND CONTROLS

3616

II

9/10/1979

JT BAKER CHEMICAL CO

TICRYNAFEN

3617

II

8/31/1979

KV PHARMACEUTICAL CO

NORPACE (R) CR 150MG CAPSULES

3618

II

7/9/1979

ASSIA CHEMICAL LABORATORIES LTD

TRIAMTEREN AND TRIAMTERENE

3619

II

8/29/1979

CILAG AG

NDC 12502 - 1819 METHIMAZOLE

3620

II

9/6/1979

DM GRAHAM LABORATORIES INC

D-PSEUDOEPHEDRINE FOR TIME RELEASE BEAD

Page 98

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3621 I
III
9/13/1979
MITSUI CHEMICALS INC

SUBJECT
TPX PRODUCTS (POLYMERS AND COPOLYMERS OF 4-METHYLPENTENE

3622

II

8/23/1979

BOEHRINGER INGELHEIM KG

SCOPOLAMINE AMINOXIDE HYDROBROMIDE

3623

II

8/27/1979

UCB PHARMA SA

HYDROXYZINE HCL

3624

III

9/21/1979

CUTTER BIOL DIV MILES LABS INC

IV SOLUTIONS IN POLYOLEFIN BOTTLES-MANUF IN CHATTANOOGA, TN.

3625

10/12/1979

PROGRESSIVE PLASTICS INC

QUALITY CONTROL PROCEDURES RELAIVE TO THE CLEVELAND, OHIO FACILITY

3626

10/12/1979

ETHYL CORP

3627

II

9/28/1979

METALLGESELLSCHAFT AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BATON ROUGE, LOUISIANA.
LITHIUM CARBONATE

3628

III

10/5/1979

GUARDSMAN PRODUCTS

ADHESIVES USED AS TUBE END SEALANT FOR FLEXIBLE TUBES

3629

II

10/5/1979

SCIENTIFIC PROTEIN LABORATORIES INC

CONDRANOL BRAND OF CHONDROITIN 4-SULFATE, BULK

3630

II

10/3/1979

CILAG CHEMIE AG

PRODUCT NDC 12502 - 1848 PHENAZOPYRIDINE HCL

3631

III

10/9/1979

SILGAN PET CORP

3632

II

10/22/1979

PFANSTIEHL LABORATORIES INC

PACKAGING MATERIALS FOR PHARMACEUTICAL PRODUCTS MANUFACTURED IN PORT


CLINTON AND FAIRFIELD, OHIO
2-DEOXY-D-GLUCOSE, NRC-CATALOG NO. D-101--MANUF IN WAUKEEGAN. ILL

3633

II

10/15/1979

3634

10/4/1979

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
PHARMACIA AS

3635

II

11/1/1979

MITSUBISHI CHEMICAL INDUSTRIES LIMITED

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HILLEROD, DENMARK.
ETHINYLESTRADIOL, BULK FORM

3636

II

11/2/1979

DIOSYNTH BV

6A-METHYLPREDNISOLONE

3637

II

11/1/1979

KV PHARMACEUTICAL CO

MEPROSPAN 200MG S.R. CAPS-MANUF ST. LOIUS, MO. FACILS FOR WALLACE LABS

3638

III

10/29/1979

APTAR FRANCE SAS

APTAR PACKAGING COMPONENTS

3639

II

11/9/1979

CHEMSERVICES INC

SULFAMETHOXAZOLE

3640

10/29/1979

ICN PHARMACEUTICALS

PERSONNEL, FACILITIES AMD CONTROLS

3641

II

11/1/1979

KV PHARMACEUTICAL CO

MEPROSPAN 400MG S.R. CAPS.-MANUF ST. LOUIS, MO. FOR WALLACE LABS

3642

II

11/1/1979

MITSUBISHI CHEMICAL INDUSTRIES LIMITED

METHYLTESTOSTERONE, USP

3643

II

11/9/1979

FREDERICK CANCER RESEARCH CTR

DAUNORUBICIN

3644

10/27/1979

FUTURE PAK LTD

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

3645

II

11/27/1979

ROUSSEL-UCLAF

ESTRONE

3646

II

10/6/1979

DM GRAHAM LABORATORIES INC

SOMOPHYLLIN CONTROLLED RELEASE THEOPHYLLINE 250MG

3647

III

11/5/1979

SABIC INNOVATIVE PLASTICS

3648

III

10/23/1979

BUNDER GLAS GMBH

CYCOLAC * RESINS AS MANUFACTURED IN OTTAWA, ILLINOIS (USA), TAMPICO, MEXICO,


CAMPINAS, BRAZIL, AND SINGAPORE, SINGAPORE
PACKAGING MATERIALS/BRONCHOLATOR AND RHINOLATOR

3649

II

12/5/1979

AINC

TSM MEDIA AND CARTRIDGES FOR PHARMACEUTICAL USE

3650

12/12/1979

NEW ENGLAND PHARMACEUTICALS INC

PERSONNEL, FACILITIES AND GENERAL PROCEDURES

3651

II

12/6/1979

SIGMA F AND D DIV LTD

AMINOOXY ACETIC ACID

3652

II

11/29/1979

HOFFMANN LA ROCHE INC

DOXYLAMINE SUCCINATE AS MANUF IN THE NUTLEY, NEW JERSEY FACILITY

3653

II

12/17/1979

QUINIDINE BASE/SULPHATE/GLUCONATE AND POLIGALACTURONATE

3654

12/3/1979

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
HEALTH CARE INDUSTRY INC

3655

II

12/10/1979

PFANSTIEHL LABORATORIES INC

PAPAVERINE HCL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MICHIGAN, INDIANA.
L-LACTIC ACID, SODIUM SALT, 40% SOLUTION (CATALOG #L-104)AS MFG IN ILL

Page 99

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3656 I
II
11/15/1979
UNION CARBIDE CORPORATION

SUBJECT
CUSTOM GRADE GAS MIXTURE CONTAINING 'CYCLOPROPANE USP'

3657

II

12/6/1979

SALK INST BIOLOGICAL STUDIES

LRF SUPERAGONIST (D-TRP6,PRO9-NET)-LRF

3658

II

12/7/1979

CORD LABORATORIES INC

THEOPHYLLINE S.R. CAPS 300MG MANUFACTURED IN BROOMFIELD CO.

3659

II

11/15/1979

SIFAVITOR SRL

CLIDINIUM BROMIDE, USP

3660

11/21/1979

SCHWARZ PHARMA DIV KREMERS URBAN CO

PERSONNEL, FACILS, & GEN OPER PROCEDS AT MEQUON, WIS. LOCATION

3661

12/4/1979

SIDMAK LABORATORIES INC

STANDARD OPERATING PROCEDURES MANUAL FOR THE EAST HANOVER, NJ FACILS

3662

II

12/17/1979

DEGUSSA AG

FACILS & CONTROLS FOR MANUFACTURE OF L-PROLINE IN REXIM PLANT

3663

II

11/27/1979

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

PROPRANOLOL HCL

3664

II

9/25/1979

ELI LILLY AND CO

VIALS DANTRIUM (R)- MANUF INDIANAPOLIS, IND. FOR NORWICH-EATON PHARM.

3665

II

12/21/1979

MECLIZINE HCL

3666

II

12/20/1979

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
ADAMHA NIDA

3667

II

12/13/1979

PFANSTIEHL LABORATORIES INC

3668

II

12/20/1979

SIGMA F AND D DIV LTD

N-BENZOYL-L-TYROSOL-P-AMINOBENZOIC ACID (BENTIROMIDE) MFG. IN WAUKEGAN,


ILLINOIS
L-PROLINE

3669

II

12/17/1979

HYDROXYZINE HCL

3670

II

12/28/1979

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
ORGAMOL SA

3671

III

10/26/1979

AMERICAN NATIONAL CAN CO

LAMINATED PACKAGINGS (VINYL TO POLYETHYLENE) AS MANUF IN THE OH FACILS

3672

II

12/26/1979

BAYER HEALTHCARE AG

NIFEDIPINE

3673

II

12/7/1979

BURDICK & JACKSON LABS,INC

DOXYLAMINE SUCCINATE

3674

12/12/1979

DIGIPAK CORP

FACILS & CONTROLS FOR THE PRODUCTION OF CAP LINER CLOSURES MATERIALS

3675

II

12/7/1979

UNIQUE CHEMICALS

METRONIDAZOLE

3676

III

12/26/1979

INMONT CORP

EXTERIOR COATINGS:1002 BARAFENE SYSTEMS MANUF IN CINCINNATI OHIO

3677

II

12/20/1979

BUCHLER GMBH

QUINIDINE BASE, SULFATE, BISULFATE AND GLUCONATE

3678

3679

3680

III

1/8/1980

CELANESE PLASTICS & SPECIALTIES CO

PETPAC (TM) 2413 (POLYESTER RESINS)

3681

II

12/5/1979

FOREST LABORATORIES INC

CAPTOPRIL-F 250MG C.R. TABLETS AS MANUF IN INWOOD, L.I. N.Y. FACILS

3682

1/31/1980

BLASCHIM SPA

MANUFACTURING PROCEDURES

3683

III

12/28/1979

PHILLIPS PETROLEUM CO

SOLPRENE STYRENE BLOCK COPOLYMERS AS MANUF IN THE BORGER, TX FACILS.

3684

II

1/3/1980

ANTIBIOTICOS SPA

DEXAMETHASONE 21-SODIUM M-SULFOBENZOATE

3685

III

1/3/1980

BEACH PRODUCTS INC

LIQUID UNIT DOSE (ORAL) PACKAGING SYSTEM AS MANUF IN TAMPA, FL

3686

II

1/31/1980

BLASCHIM SPA

DEXAMETHASONE

3687

II

12/5/1979

FOREST LABORATORIES INC

CAPTOPRIL-S 250MG C.R. TABLETS AS MANUF IN THE INWOOD, L.I. NY FACILS

3688

1/2/1980

YAMANOUCHI PHARMACEUTICAL COMPANY LTD

PERSONNEL, FACILITIES AND CONTROLS

3689

II

1/16/1980

UCB PHARMA SA

MECLIZINE HCL

3690

III

12/26/1979

MITSUBISHI POLYSTER FILM INC

HOSTAPHAN (R) POLYESTER FILMS-MANUF IN GREER, SC

3691

II

1/10/1980

SIGMA F AND D DIV LTD

L-CARNITINE HCL (FIRST RUN)

3692

1/22/1980

RUETGERS-NEASE CHEMICAL COMPANY INC

PERSONNEL, FACILITIES AND CONTROLS

CANNABININOID FORMULATIONS

CHLOROPROCAINE HCL

NOT AN ASSIGNED NUMBER


NOT AN ASSIGNED NUMBER

Page 100

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3693 I
II
1/23/1980
EASTMAN CHEMICAL CO

SUBJECT
NOXELL COMPOUND--1131-69 AS MANUF IN TENNESSE FACILS.

3694

III

1/14/1980

ORACLE FLEXIBLE PACKAGING

PEELABLE BACKING STOCK FOR PVC BLISTER (ALTERNATIVES 1&2) MANUF IN N.C

3695

II

1/16/1980

UCB PHARMACEUTICALS INC

HYDROXYZINE PAMOATE

3696

IV

1/28/1980

FMC CORP FMC BIOPOLYMER DIV

AQUACOAT TM ECD-30 AS MANUF UNDER CONTRACT BY RSA CORP, IN ARDSLEY NY

3697

II

1/9/1980

ISLAND CHEMICAL COMPANY INC

QUINIDINE GLUCONATE

3698

1/21/1980

TAYLOR PHARMACAL CO

3699

II

1/18/1980

ROCHE DIAGNOSTICS GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DECATUR, ILLINOIS.
5'-IODO-2'-DEOXYURIDINE (IDOXURIDINE, IDU)

3700

IV

1/22/1980

ABITEC CORP

MONO-DIGLYCERIDE, TRADE NAME CAPMUL 8210 (MCM)

3701

1/16/1980

HOECHST AG

PERSONNEL, PROCEDS, FACILS & CONTROL FOR BULK PHARMACEUTICAL PROD.

3702

1/24/1980

MERCK SHARP & DOHME BV

FACILITIES AND CONTROLS

3703

II

1/9/1980

ISLAND CHEMICAL COMPANY INC

QUINIDINE SULFATE USP XX

3704

2/5/1980

BEECHAM PHARMACEUTICALS

FACILITIES&CONTROLS AT HARLOW AND GREA BURGH RESEARCH SITES, ENGLAND

3705

IV

2/4/1980

DOW CORNING CORP

3706

1/30/1980

BIO-TECHNICS LABS INC

3707

II

2/6/1980

KV PHARMACEUTICAL CO

DOW CORNING Q7-2245 AND Q7-2245 SILICONE ELASTOMER MNFG. IN MIDLAND, MI


FACILITIES
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN LOS ANGELES, CALIFORNIA.
THEOPHYLLINE SR62.5MG MNFG IN ST.LOUIS,MO FOR SCHERING,KENILWORTH N.J.

3708

II

2/4/1980

DIOSYNTH BV

PORCINE INSULIN (HIGHLY PURIFIED)

3709

II

2/1/1980

UPJOHN CO

SODIUM MECLOFENAMATE AS MFG IN MICHIGAN FACILITIES

3710

2/13/1980

CLARK STEK-O CORP

PERS.FACIL.CNTRLS RE.MNFG ADHESIVE PROD.(CLARCAP SERIES) BAYONNE,NJ

3711

2/1/1980

ALLTECH APPLIED SCIENCES

PERS,FACIL,CNTRLS AT OAK HALL PA

3712

II

1/30/1980

UCB SECTEUR PHARMACEUTIQUE

CARBETAPENTANE CITRATE

3713

II

2/1/1980

MILTON ROY CO

BENTIROMIDE(BTABA= E-2663) AND INTERMEDIATE

3714

II

1/30/1980

SIGMA F AND D DIV LTD

6-AMINONICOTINAMIDE

3715

II

2/11/1980

CYANAMID GMBH

LEUCOVORIN CALCIUM MANUFACTURED IN WOLFRASHAUSEN, GERMANY.

3716

II

1/29/1980

ASTA-WERKE AKTIENGESELLSCHAFT

CYCLOPHOSPHAMIDE INJECTION VIALS

3717

II

1/28/1980

GANES CHEMICALS INC

PHENTERMINE RESINATE (BULK FORM)

3718

II

2/4/1980

DIOSYNTH BV

SPIRONOLACTONE MICRO

3719

II

10/30/1979

KV PHARMACEUTICAL CO

PHENYLPROPANOLAMINE75MG/CHLORPHENIRAMINE12MG SRCAP.:WHITEHALL LABS,INC

3720

III

2/6/1980

INEOS OLEFINS AND POLYMERS USA

FORTILENE (R) POLYPROPYLENE RESINS MANUFACTURED IN TEXAS.

3721

II

2/13/1980

SIEGFRIED LTD

SOTALOL HCL AS MFG & SOLD UNDER THE SIEGFRIED LABEL

3722

II

1/29/1980

FARMAKON

PROTHIADEN/DOSULEPIN HCL MNFG BY FARMAKON NATIONAL CORP FOR SPOFA

3723

II

2/6/1980

SANOFI PHARMACEUTICALS INC

LEVONORDEFRIN MNFG A RENSSELAER, NY FACILITIES

3724

II

2/21/1980

HOECHST MARION ROUSSEL SA

1,A,24-DIHYDROXYCHOLECALCIFEROL

3725

II

2/7/1980

DIPHARMA FRANCIS SRL

3726

II

2/15/1980

HOFFMANN LA ROCHE INC

ISOSORBIDE DINITRATE (ISDN) MANUFACTURED IN THE MERETO DI TOMBA (UD), ITALY


FACILITIES
LEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL.

3727

III

2/15/1980

DRG MEDICAL PACKAGING INC

GRID PATERN LACQUERED PAPER

3728

2/23/1980

SEARLE LABORATORIES DIV SEARLE


PHARMACEUTICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NAUCALPAN, MEXICO

Page 101

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3729 I
II
2/7/1980
DINAMITE DIPHARMA SPA

SUBJECT
PENTHRITE (PETN)---PENTAERYTHRITOL TETRANITRATE

3730

II

2/5/1980

COWAY CHEM CO LTD

CHLOZOXAZONE, PHARMACOPEA NORDICA

3731

II

2/7/1980

DIPHARMA FRANCIS SRL

GLYCERIN TRINITRATE (NITROGLYCERIN-NG)

3732

2/22/1980

ORGANON CANADA LTD

PERSONNEL, FACILITIES AND CONTROLS

3733

II

2/6/1980

CYCLO PRODUCTS INC

DEXAMETHASONE

3734

II

3/7/1980

WARNER LAMBERT CO

THYMOXAMINE HCL BULK,MNFG BY GODECKE AG CHEMICAL,GERMANY(SUBSIDIARY)

3735

3/4/1980

MALLINCKRODT SPECIALTY CHEMICALS CO

FACILITIES, PERSONNEL,AND G.O.P. FOR THE ST. LOUIS, MISSOURI PLANT

3736

2/28/1980

COMATIC LABORATORIES INC

PERSONNEL, FACILITIES AND CONTROLS

3737

II

2/26/1980

CYCLO PRODUCTS INC

DEXAMETHASONE ACETATE

3738

II

3/14/1980

NOVO NORDISK AS

ZINC PROTAMINE GLUCAGON NOVO, PREPARATION AND PACKAGING DOSAGE FORMS

3739

II

2/21/1980

DUPONT CHEMOSWED

1-AMINOADAMANTANE HCL (AMANTADINE HCL)

3740

III

3/3/1980

COMATIC LABORATORIES INC

COMPONENTS AND COMPOSITION OF FOIL COMPOSITES

3741

III

12/19/1979

SPARTECH PLASTICS

COEXTRUDED LAYERED SHEETS IN THE 5XTR SERIES

3742

IV

2/14/1980

FOOD INDUSTRIES INTERNATIONAL LTD

FLAVRS:MNFG BROMBOROUGHPORT,WIRRAL,MERSEYSDE,UK:PEACH#23789,31-67-060

3743

II

3/10/1980

GE HEALTHCARE

CYCLOTRON OPERATION, INDIUM CL (IN 111)MANUFACTURED IN EMERYVILLE, CALIFORNIA.

3744

IV

3/10/1980

WARNER JENKINSON CO

SPRAY DRIED FLAVORS:MNFG MO.,NATURAL&ART.ORANGE FLAVOR #4168

3745

II

3/7/1980

PROCOS SPA

PROGLUMIDE

3746

II

3/10/1980

GE HEALTHCARE INC

THALLOUS CL (TL-201) (CYCLOTRON OPERATION), NORTH ARLINGTON, ILLINOIS

3747

II

3/11/1980

NV ORGANON

MEDROXYPROGESTERONE ACETATE MICRO

3748

IV

3/10/1980

SHIN ETSU CHEMICAL CO LTD

3749

II

3/10/1980

MEDI PHYSICS INC

PHARMACOAT AND METOLOSE ( LOW DEGREE OF POLYMERIZATION ) METOLOSE(HIGH


DEGREE OF POLYMERIZATION
CYCLOTRON-I-123 EMERYVILLE,CA; SOUTH PLAINFIELD,NJ; NORTH ARLINGTON,IL

3750

II

2/28/1980

PHARMA-WALDHOF GMBH

5-BROMO-2' -DEOXYURIDINE (BDU)-PRODUCT NO. 6706

3751

IV

3/7/1980

PHILLIPS PETROLEUM CO

PHILPRENE STYRENE-BUTADIENE COPOLYMERS MNFG IN OKLAHOMA FACILITIES

3752

II

3/10/1980

MEDI PHYSICS INC

GALLIUM (GA 67) EMERYVILLE,CA; SOUTH PLAINFIELD,NJ; NORTH ARLINGTON,IL

3753

II

3/12/1980

DIOSYNTH INC

HEPARIN SODIUM USP (BEEF LUNG) AS MFG. IN THE ILLINOIS FACILITIES

3754

II

3/12/1980

GANES CHEMICALS INC

SOTALOL HCL

3755

II

3/10/1980

MEDI PHYSICS INC

KRYPTON (KR 81M) EMERYVILLE,CA;SOUTH PLAINFIELD,NJ;NORTH ARLINGTON,ILL

3756

II

2/28/1980

KV PHARMACEUTICAL CO

HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS

3757

4/3/1980

MEIJI SEIKA KAISHA LTD

PERSONNEL, PROCEDURES, FACILITIES AND CONTROLS

3758

II

4/7/1980

SIGMA F AND D DIV LTD

BETA-ESTRADIOL-3-BENZOATE

3759

II

4/7/1980

DIOSYNTH BV

TRIAMCINOLONE MICRO

3760

II

4/3/1980

LEVO-ALPHA-ACETYLMETHADOL (LAAM)-PRODUCED FOR NA'L INST. DRUG ABUSE

3761

IV

4/1/1980

UNIV OF IOWA PHARMACEUTICAL SERVICES


COLLEGE OF PHARMACY
V MANE FILS INC

3762

IV

3/27/1980

REXENE CORP

POLYPROPYLENE RESINS IN THE PP 11M AND PP 21M SERIES-

3763

II

4/7/1980

DIOSYNTH BV

TRIAMCINOLONE ACETONIDE MICRO

3764

III

3/21/1980

KLOCKNER PENTAPLAST GMBH

THERMOFORMABLE RIGID PVC SHEET (PENTAPHARM)

3765

III

3/26/1980

3M PHARMS

SECUR-A-SEAL EDGE SEALING TAPES: L. TAPE YR-8027-2--IN MINNESOTA FACIL

3766

II

4/9/1980

ARSYNCO INC

PHENYL PROPANOLAMINE HCL AS MANUF.IN THE CARLSTADT,N.J. FACILITY

FLAVORS AS MANUF IN FRANCE BY V. MANE FILS, S.A.1.WONF LEMOM E10054

Page 102

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3767 I
III
3/25/1980
CONTOUR PACKAGING CORP

SUBJECT
PLASTIC BOTTLES AS MANUF IN THE PENNSYLVANIA FACILITY

3768

II

4/17/1980

NAPP CHEMICALS INC

MEPIVACAINE HCL AS MANUF IN THE LODI, NJ FACILITIES

3769

3/6/1980

POLAROID CORP

PERSONNEL AND FACILITIES IN MASSACHUSETTS

3770

II

3/30/1980

SIGMA F AND D DIV LTD

THIOPROLINE

3771

II

4/15/1980

SANOFI AVENTIS CHIMIE

METHYLPREDNISOLONE MANUFACTURED IN VERTOLAYE, FR.

3772

II

3/25/1980

AINC

1DEP MEDIA & CARTRIDGES FOR PHARMACEUTICAL USE-MANUF IN CT. FACILITIES

3773

II

4/18/1980

FOOTE MINERAL COMPANY

LITHIUM CARBONATE, USP

3774

II

3/28/1980

FISONS LTD

IRON DEXTRAN INJECTION

3775

II

4/15/1980

ROUSSEL-UCLAF

METHYLTESTOSTERONE USP

3776

II

3/7/1980

FIS FABBRICA ITALIANA SINTETICI SPA

PENTAZOCINE AND PENTAZOCINE HCL

3777

III

4/10/1980

BAXTER HEALTHCARE CORP

3778

II

4/7/1980

ANI PHARMACEUTICALS INC

POLYOLEFIN (PL-325) POUR BOTTLE (FOUR VOLUMES) MANUFACTURED IN ROUND LAKE,


ILLINOIS AND CLEVELAND, MISSISSIPPI.
LITHIUM CARBONATE PILOT PROCESS AS MANUF IN THE MINNESOTA FACILITIES

3779

II

4/15/1980

ROUSSEL-UCLAF

METHYLPREDNISOLONE HEMISUCCINATE MANUF FOR ROUSSEL UCLAF

3780

II

3/14/1980

KNOLL AG LUDWIGSHAFEN

PAMABROM (8-BROMOTHEOPHYLLINE-ISOBUTANOLAMINE)

3781

II

4/15/1980

ROUSSEL-UCLAF

TESTOSTERONE ENANTHATE

3782

III

4/9/1980

SELIG SEALING PRODUCTS INC

INNERSEAL MATERIALS MANUFACTURED IN MINNESOTA.

3783

II

4/17/1980

THOMPSON HAYWARD CHEMICAL CO

FORMULA T-DET N-9.5 AS MANUF IN THE KANSAS FACILITY

3784

III

4/17/1980

ALUMINUM COMPANY OF AMERICA

FORMED FOIL CONTAINERS IN THE PHAR SERIES-MANUF IN PENN. FACILITIES

3785

II

3/24/1980

MUSKEGON CHEMICAL CO

DIETHYL CARBAMAZINE AS MANUF IN THE MICH. FACILITIES

3786

II

3/24/1980

ANTIBIOTICOS SPA

FLUOROMETHOLONE 17-ACETATE NON-MICRONIZED AND MICRONIZED

3787

II

4/15/1980

ROUSSEL-UCLAF

TRIAMTERENE

3788

3/26/1980

MALLINCKRODT SPECIALTY CHEMICALS CO

FACILITIES-PERSONNEL-GEN. OPERATING PROCEDURES RALEIGH NC CHEM. PLANT

3789

3/31/1980

EON LABS MFG OF THE VIRGIN ISLANDS INC

FACILITIES, PERSONNEL & GEN. OPERT. PROCEDS-SPRINGFIELD GARDENS, NY

3790

II

4/18/1980

M AND T CHEMS INC

STANNOCHLOR (STANNOUS CHL., ANHYDROUS)-MANUF IN CARROLLTON, KY. FACILS

3791

III

4/22/1980

SPARTECH PLASTICS

COMPOSITE THERMOPLASTIC SHEETS IN THE HTR SERIES-MANUF IN MASS.

3792

II

4/23/1980

RUETGERS-NEASE CHEMICAL COMPANY INC

LITHIUM CARBONATE, BULK--MANUF IN THE PENN. FACILITIES

3793

II

3/13/1980

THE CENTRAL PHARMACAL COMPANY

DYPHYLLINE SUSTAINED RELEASE CAPSULES

3794

4/8/1980

UNIV IOWA COLL PHARMACY

STERILE PRODUCTS MANUFACTURING PROCEDURES IN IOWA CITY, IOWA

3795

II

5/7/1980

CHEMSERVICES INC

TRIAMCINOLONE ACETONIDE, USP IN THE EAST HANOVER, NJ FACILITIES

3796

IV

5/1/1980

E MERCK

PRODUCT 8198 TABLETING AID T

3797

5/9/1980

GIST BROCADES

FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

3798

II

4/29/1980

ROUSSEL-UCLAF

CORTISONE ACETATE

3799

II

5/20/1980

DIOSYNTH BV

'D' TUBOCURARINE CHLORIDE

3800

II

5/9/1980

BETAXOLOL

3801

11/7/1979

LABORATOIRES D'ETUDES ET DE RECHERCHES


SYNTHELABO
DM GRAHAM LABORATORIES INC

3802

3/18/1980

FARCHEMIA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

3803

II

5/20/1980

ASPEN OSS BV

ETHINYL ESTRADIOL

PERSONNEL, FACILS. AND CONTROLS

Page 103

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3804 I
II
4/11/1980
LOFTUS BRYAN CHEMICALS LTD

SUBJECT
IMIPRAMINE HCL

3805

4/28/1980

BERLEX LABORATORIES INC

PERSONNEL, FACILS, & CONTROLS AT WAYNE, NJ LOCATION

3806

II

3/18/1980

FARCHEMIA

TRIAMTERENE, USP

3807

II

5/20/1980

ASPEN OSS BV

HUMAN CHORIONIC GONADOTROPHIN (HCG)

3808

II

5/9/1980

CENTRAL PHARMACEUTICALS INC

USP SODIUN CHLORIDE TABLETS AS MANUF IN THE SEYMOUR, INDIANA FACILS

3809

III

5/6/1980

ABBOTT LABORATORIES HOSP PRODUCTS DIV

PHYSICAL COMPAIBILITY: PHASE IV LIFECARE FLEXIBLE CONTAINERS

3810

5/19/1980

SCHERING CORP SUB SCHERING PLOUGH CORP

FACILS, PERSONNEL & GEN OPERATING PRCEDS A ST. LOUIS MISSOURI FACILS.

3811

II

5/20/1980

DIOSYNTH BV

NOERTHINDRONE ACETATE MICRONIZED

3812

5/14/1980

TIME CAPS LABORATORIES INC

3813

III

3/18/1980

SARGENT INDUSTRIES

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NEW CASSEL, LI, NY.
O-RINGS, RUBBER SEAL & COMPONENTS AS MANUF IN THE CARLSBAD, CA FACILS.

3814

5/23/1980

PARKE DAVIS DIV WARNER LAMBERT CO

WARNER-LAMBERT, CAPS PLANT OPER, BROCKVILLE, ONTARIO, CAN FACILITY

3815

II

5/20/1980

DIOSYNTH BV

OXYTOCIN ACETATE

3816

5/23/1980

HOPE CO

PERSONNEL, FACILITIES AND CONTROLS

3817

II

5/20/1980

MALLINCKRODT INC

DIARIZOIC ACID USP (HYDROUS) PRODUCED IN ST. LOUIS, MISSOURI PLANT

3818

5/29/1980

PARKE DAVIS DIV WARNER LAMBERT CO

PERSONNEL, FACILS & GEN OPER PROCEDS AT THE LITITZ, PA FACILITY

3819

II

5/21/1980

DIOSYNTH

PREDNISOLONE SODIUM PHOSPHATE

3820

8/9/1979

PARAMOUNT PACKAGING CORP

PRODUCT SPECIFICATIONS (SOME FORMERLY LISTED IN D1366)

3821

4/18/1980

SCHARPER SPA

FACILITIES AND CONTROLS

3822

IV

6/11/1980

SIGMA F AND D DIV LTD

GUM, LOCUST BEAN

3823

II

5/20/1980

ASPEN OSS BV

PROGESTERONE

3824

6/10/1980

PRESS PAK INC

PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES

3825

II

4/22/1986

CAMBREX PROFARMACO MILANO SRL

ACETOHEXAMIDE MFG.PAULLO(MILANO)FACILITY ON VIA CURIEL(WAS LIDOCAINE)

3826

III

5/27/1980

CELANESE PLASTICS

MED PACKAGING ADHESIVES: 1. ADHESIVE XP-22189-66-4 (MANUF IN KY & ILL)

3827

II

5/21/1980

DIOSYNTH BV

ANDROSTADIENOLONE UNDECYLENATE

3828

II

6/11/1980

AMINO GMBH

L-LEUCINE

3829

II

5/21/1980

ASPEN OSS BV

ESTRADIOL MICRONIZED

3830

II

5/30/1980

NOVO NORDISK AS

PURIFIED INSULIN

3831

II

6/10/1980

NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT

3832

III

4/14/1980

3833

II

5/21/1980

MCNEIL CONSUMER HEALTHCARE DIV MCNEIL


PPC INC
CONOCO CHEMICAL DIVISION CONTINENTAL OIL
CO
DIOSYNTH INC

3834

6/11/1980

PERSONNEL, FACILS AND CONTROLS FOR THE HAMMONTON, NJ PLANT

3835

II

6/10/1980

3836

II

6/12/1980

WHITEHALL LABS DIV AMERICAN HOME PRODS


CORP
MCNEIL CONSUMER HEALTHCARE DIV MCNEIL
PPC INC
SIGMA F AND D DIV LTD

3837

II

5/21/1980

DIOSYNTH BV

ESTRIOL

3838

II

6/16/1980

AMERCHOL CORP

PROPAL (ISOPROPYL PALMITATE) AS MANUF IN THE MAMARONECK, NY FACILS

3839

II

6/10/1980

AB LEO

NICORETTE (R): PRODUCTION OF ION EXCHANGE RESIN AT THE RAA, SWEDEN PLA

POLYETHYLENE RESINS IN THE NP SERIES AS MANUF IN THE OKLA FACILITIES


ESTRADIOL CYPIONATE

NICORETTE
4-AMINOPYRIDINE

Page 104

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3840 A
II
6/10/1980
INSTITUTO MASSONE S A

SUBJECT
HUMAN CHORIONIC GONADOTROPIN

3841

II

5/21/1980

DIOSYNTH BV

DEXAMETHASONE SODIUM PHOSPHATE

3842

II

6/11/1980

DISODIUM PAMOATE MONOHYDRATE (DISP)

3843

6/16/1980

CYTEC INDUSTRIES BUSINESS UNIT AMERICAN


CYANAMID CO
NOVARTIS PHARMACEUTICALS CORP

3844

5/30/1980

ANALYTICAL BIO-LABS INC

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES-COLUMBIA MO

3845

II

5/21/1980

DIOSYNTH BV

HYDROXYPROGESTERONE CAPROATE

3846

II

6/25/1980

LONZA INC

DEXTROMETHOPHAN HYDROBROMIDE AS MFG. IN THE LOS ANGELES, CA.FACILITIES

3847

5/29/1980

IVERS LEE AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

3848

II

6/18/1980

SIGMA F AND D DIV LTD

DL-THREO-3,4-DIHYDROXYPHENYLSERINE

3849

II

5/22/1980

ASPEN OSS BV

NORETHINDRONE

3850

5/28/1980

LYNE LABORATORIES INC

PERSONNEL, FACILS, METHODS & CONTROLS AT THE WESTWOOD, MASS. LOCATION

3851

II

3/26/1980

ISF

ISF 2522 (4-HYDROXY-2-0X0-1-PYRROLIDIN-ACETAMIDE)

3852

II

6/23/1980

MERCK SHARP & DOHME RESEARCH LABS

DIFLUNISAL-MANUF A MSD,LTD PLANT IN PONDERS END,MIDDLESEX, ENGLAND

3853

II

6/6/1980

NV ORGANON

STABILIZED MIXTURE OF CONJUGATED ESTROGENS

3854

II

6/13/1980

MEDIMPEX NORTHAMERICA INC

VINPOCETINE (CAVITON R)-MANUF BY CHEMICAL WORKS OF GEDEON RICHTER LTD.

3855

5/29/1980

SCHUPBACH AG

METHODS, FACILS & CONTROLS RELATED TO PACKAGING MATERIALS

3856

4/23/1980

PRB CHEMIE

QUININE DERIVAIVES FACILITIES DESCRIPTION

3857

II

5/21/1980

ASPEN OSS BV

TESTOSTERONE CYPIONATE

3858

II

7/3/1980

SIGMA F AND D DIV LTD

BACITRACIN ZINC

3859

II

7/4/1980

3M PHARMS

ADRENALONE HYDROCHLORIDE

3860

IV

7/9/1980

SYMRISE INC

COLORS,FLAVORS,SCENTS,OTHER ADDITIVES MANUFACTURED IN FAIRLAWN, NEW JERSEY.

3861

II

5/21/1980

ASPEN OSS BV

METHYLTESTOSTERONE

3862

II

6/23/1980

GEDEON RICHTER, LTD.

SULFINPYRAZONE MFG BY CHEMICAL WORKS OF GEDEON RICHTER, LTD (BUDAPEST)

3863

II

7/3/1980

MARION LABORATORIES INC

PAVABID (R) HP CAPULETS,300MG AS MANUF. IN THE KANSAS CITY,MO. FACILS

3864

II

7/10/1980

DAIICHI SEIYAKU CO LTD

TRANEXAMIC ACID

3865

II

6/19/1980

DIOSYNTH BV

BOVINE INSULIN

3866

II

7/3/1980

DEGUSSA AG

GLYCINE AS MANUF BY THE REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE

3867

II

6/20/1980

SA AJINOMOTO OMNICHEM NV

DIPYRIDAMOLE

3868

II

6/20/1981

UCB PHARMACEUTICALS INC

PIRACETAM

3869

II

6/13/1980

DIOSYNTH BV

MEGESTROL ACETATE MICRO

3870

II

7/14/1980

KONGO CHEMICAL CO LTD

FOLIC ACID

3871

II

7/9/1980

SIGMA F AND D DIV LTD

DL-PHENYLALANINE

3872

II

7/11/1980

EVONIK CORP

L-LYSINE.H20 AS MANUF. BY THE REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE

3873

II

6/16/1980

ASPEN OSS BV

STABILIZED MIXTURE OF ESTERIFIED ESTROGENS

3874

II

6/27/1980

UCB PHARMACEUTICALS INC

BUCLIZINE HCL

3875

II

7/4/1980

3M PHARMS

ADRENALINE (EPINEPHRINE) AND SALTS OF EPINEPHRINE

3876

II

6/10/1980

FERRING AB

OXYTOCIN

PERSONNEL, FACILS & GEN OPERATING PROCEDURES AT EAST HANOVER, NJ.

Page 105

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3877 A
II
6/25/1980
ASPEN OSS BV

SUBJECT
TESTOSTERONE ENANTHATE

3878

6/18/1980

BIDACHEM SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

3879

II

7/14/1980

KONGO CHEMICAL CO LTD

DIPHENHYDRAMINE HCL USP

3880

II

6/20/1980

UCB PHARMA SA

MESNA

3881

II

6/30/1980

DIOSYNTH BV

BOVINE INSULINE HIGHLY PURIFIED

3882

III

5/16/1980

WEST AMERICAN RUBBER CO

PHARMACEUTICAL DIAPHRAGM & AEROSOL VALVE MATERIALS-ORANGE,CA FACILS.

3883

II

6/25/1980

BETA-ENDORPHIN (HUMAN) - MANUF. IN THE PALO ALTO,CA FACIL.

3884

II

7/3/1980

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
DEGUSSA AG

3885

II

7/14/1980

KONGO CHEMICAL CO LTD

CHLORPHENIRAMINE MALEATE USP

3886

7/11/1980

SA ISOPLAST AG BRUGG

FACILITIES AND GENERAL OPERATING PROCEDURES.

3887

II

7/22/1980

ROEHR CHEMICALS INC

PHENYLPROPANOLAMINE HCL AS MAUF IN LONG ISLAND CITY FACILITIES

3888

II

7/3/1980

DEGUSSA AG

L-HISTIDINE HCL MONOHYDRATE -MANUF. BY REXIM S.A. DIV. DEGUSSA,FRANCE

3889

6/2/1980

SOCIETA ITALIANA CORTICOSTEROIDI SPA

FACILITIES,PERSONAL AND GENERAL OPERATING PROCEDURES

3890

NOT AN ASSIGNED NUMBER

3891

NOT AN ASSIGNED NUMBER

3892

NOT AN ASSIGNED NUMBER

3893

NOT AN ASSIGNED NUMBER

3894

NOT AN ASSIGNED NUMBER

3895

NOT AN ASSIGNED NUMBER

3896

NOT AN ASSIGNED NUMBER

3897

NOT AN ASSIGNED NUMBER

3898

NOT AN ASSIGNED NUMBER

3899

3900

II

7/11/1980

CINTICHEM INC

SELENIUM SE 75 MOSE MANUFACTURED IN TUXEDO, NEW YORK.

3901

II

6/26/1980

ICI AMERICAS INC

BRIJ 58 (POLOXYETHYLENE(20)CETYL ETHER)-MANUF. IN THE DEL.FACILS.

3902

II

7/16/1980

CARBONYL CHLORIDE MNFG A BOUND BROOK, NEW JERSEY

3903

II

6/24/1980

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
MEDIMPEX NORTHAMERICA INC

3904

II

8/4/1980

MCGAW INC

METRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES

3905

II

8/8/1980

SIGMA F AND D DIV LTD

QUINACRINE HCL.

3906

II

8/5/1980

EVONIK CORP

L-LYSINE.ACETATE-MANUF.BY REXIM S.A. OF DEGUSSA IN HAM,FRANCE

3907

8/11/1980

RACHELLE LABORATORIES INC

FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES

3908

II

7/17/1980

DIOSYNTH BV

CORTISONE ACETATE MICRO

3909

III

1/15/1980

CELANESE PLASTICS & SPECIALTIES CO

MEDICAL PACKAGING ADHESIVES;1.22188-54 IN THE KENTUCKY FACILITY

3910

II

7/18/1980

3911

6/16/1980

3912

II

7/18/1980

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA DIPHENHYDRAMINE HCL USP


SPA
SELOC PHARMA AG
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF ISOSORBIDE DINITRATE DILUTED BY SIFA LTD IN CLARE, IRELAND.
POLIPHARM SPA
IMIPRAMINE HCL USP

L-LYSINE 50% - MANUF. BY REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE

NOT AN ASSIGNED NUMBER

METHANDROSTENOLONE AS MANUF-BY CHEM WORKS OF GEDEON RICHTER, LTD

Page 106

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3913 I
II
4/4/1980
DIOSYNTH BV

SUBJECT
L-PROPLYL-L-LEUCYL-GLYCINAMIDE (MIF)

3914

II

8/5/1980

DEGUSSA AG

L-ARGININE - MANUF. BY REXIM S.A. DIVISION OF DEGUSSA IN HAM,FRANCE

3915

II

7/21/1980

COSMA SPA

SULFINPYRAZONE

3916

II

7/21/1980

FBA PHARMS INC DIV BAYCHEM CORP

CHLOROQUINE DIPHOSPHATE

3917

II

7/17/1980

DIOSYNTH INC

HYDROCORTISONE MICRONIZED

3918

II

7/18/1980

POLIPHARM SPA

HYDRALAZINE HCL USP

3919

7/16/1980

STANNIOLFABRIK BURGDORF AG

MANUFACTURING FACILITIES FOR BLOW EXTENSION THERMOPLASTIC MATERIALS

3920

II

8/5/1980

DEGUSSA AG

L-HISTIDINE -MANUF. BY REMIX S.A. DIV.OF DEGUSSA IN HAM,FRANCE

3921

II

7/17/1980

DIOSYNTH BV

HYDROCORTISONE ACETATEMICRO

3922

II

7/18/1980

POLIPHARM SPA

DOXYLAMINE SUCCINATE USP

3923

8/18/1980

ASTRA USA INC

FACILITIES AND CONTROLS AT THE WESTBORO, MASS LOCATION

3924

II

8/5/1980

DEGUSSA AG

L-ORNITHINE HCL -MANUF.BY REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE

3925

7/24/1980

WEST PHARMACEUTICAL SERVICES INC

MANUFACTURING FACILITIES

3926

II

7/31/1980

SANOFI SYNTHELABO INC.

CLOROQUINE PHOSPHATE -MANUF. IN THE RENSSALATER,NEW YORK FACILITIES.

3927

8/6/1980

LABORATOIRE FISONS SOCIETE ANOMYME

FACILITIES AND GENERAL PROCEDURES

3928

II

8/5/1980

DEGUSSA AG

L-TYROSINE-MANUF.BY REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE

3929

III

8/8/1980

SCHIONNING & ARVE AS

RUBBER SHEET COMPOUNDS: COMPOUND 6247

3930

II

8/18/1980

GLYCO CHEMICALS INC

TRADE NAME GLYDANT-MFG. IN WILLIAMSPORT,PA FACILITIES

3931

II

9/3/1980

HERCULES INC

NITROGLYCERINE/PROPYLENE GLYCOL

3932

II

9/10/1980

SIGMA F AND D DIV LTD

ADENYLOSUCCINIC ACID

3933

III

9/3/1980

BALL AEROCAN FRANCE SAS

EPOXY COATED ALUMINUM CANISTERS MFG IN BELLEGARDE FRANCE

3934

II

9/9/1980

SHIONOGI AND CO LTD

COMPOUND # 450088-S MANUFACTURED IN OSAKA, JAPAN.

3935

II

8/21/1980

CHLORPHENIRAMINE MALEATE

3936

III

8/27/1980

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
SANTA FE RUBBER PRODUCTS INC

3937

2/15/1980

CEBAL

FACILITIES & PROCEDURES

3938

II

9/12/1980

SIGMA F AND D DIV LTD

ACETOHYDROXAMIC ACID

3939

II

9/11/1980

ASPEN OSS BV

DESONIDE MICRO

3940

IV

9/18/1980

CAPSUGEL

GELATIN CAPSULES MANUFACTURED IN COLMAR, FRANCE

3941

II

9/5/1980

ACF CHEMIEFARMA NV

SULFADIAZINE

3942

II

8/29/1980

THEOPHYLLINE, ANHYDROUS

3943

IV

9/2/1980

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
CAPSUGEL

3944

II

7/30/1980

CENTRE DE RECHERCHES CLIN MIDY

SOMATOSTATIN ACETATE HYDRATE (CM 9357)

3945

II

5/17/1980

DIOSYNTH BV

PREDNISOLONE MICRO

3946

II

8/11/1980

FOREST PHARMACEUTICALS INC

ANTILIRIUM (PHYSOSTIGMINE SALICYLATE)

3947

10/9/1980

AMERICAN CONTRACT PACKAGERS INC

PERSONNEL,FACILITIES AND GENERAL OPERATING PROCEDURES

3948

III

10/15/1980

SELIG SEALING PRODUCTS INC

3M BRAND PRESSURE ACTIVATED INNERSEAL CLOSURE MATERIALS-ST.PAUL,MN

3949

II

7/17/1980

DIOSYNTH BV

PREDNISOLONE ACETATE MICRO

3950

II

10/8/1980

EASTMAN CHEMICAL CO

CET ISOTHIOUREA-MFG BY EASTMAN CO,TENN.--USED BY SKF IN CIMETIDINE

MOLDED RUBBER PROD,FOR PHARM.PCKG MNFG WHITTIER, CA., COMPOUND 70-13

GELATIN CAPSULES MFG IN BORNEM, BELGIUM

Page 107

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3951 I
II
9/22/1980
NV ORGANON

SUBJECT
MESTRANOL

3952

III

10/7/1980

SARONG SPA

LAMINATED PACKAGING MATERIALS: 1. POLYVINYLCHL. POLYETHYLENE FILM

3953

II

8/20/1980

KLINGE CHEMICALS LTD

POTASSIUM CHLORIDE USP

3954

II

9/22/1980

SIGMA F AND D DIV LTD

BETA-GLYCEROPHOSPHATE GRADE XII CALCIUM SALT

3955

II

10/8/1980

HOPE CO

SYNTHESIS OF BULK SODIUM SULFATHIAZOLE SESQUIHYDRATE

3956

II

7/17/1980

DIOSYNTH BV

PREDNISONE MICRO

3957

II

10/6/1980

TEVA PHARMACEUTICAL INDUSTRIES LTD

CLOMIPHENE CITRATE USP

3958

II

10/8/1980

SIGMA F AND D DIV LTD

DEHYROISOANDROSTERONE

3959

II

9/3/1980

CIECH POLFA

ACETOZOLAMIDE

3960

II

9/30/1980

ELI LILLY AND CO

AMPOULES SODIUM THIOSULFATE MANUFACTURED IN INDIANAPOLIS.

3961

II

10/6/1980

DIOSYNTH BV

HYDROCORTISONE HEMISUCCINATE MICRO

3962

II

9/25/1980

BOEHRINGER MANNHEIM GMBH

AMINOPHYLLINE,ANHYDROUS(THEOPHYLLINE ETHYLENEDIAMINE,ANHYDROUS)

3963

II

10/10/1980

SANOFI CHIMIE

DEXAMETHASONE SODIUM PHOSPHATE

3964

10/17/1980

MALLINCKRODT INC

CYCLOTRON FACILITY-MARYLAND HEIGHTS, MO.

3965

10/16/1980

LINSON LTD

PERSONNEL QUALS LISTINGS FOR 3 SUBSIDS IN SWORDS, DUBLIN, IRELAND

3966

II

9/26/1980

BOEHRINGER MANNHEIM GMBH

AMINOPHYLLINE, HYDROUS (THEOPHYLLINE ETHYLENEDIAMINE, HYDROUS)

3967

II

10/23/1980

BIOFAR INSUMOS QUIMICO FARMACEUTICOS SA

ZINC INSULIN CRYSTALS AS MANUFACTURED IN MONTES CLAROS MG BRAZIL.

3968

II

10/21/1980

KV PHARMACEUTICAL CO

THEOBID & THEOBID JR. S.R. CAPS 130MG & 260MG-MANUF FOR GLAXO LABS INC

3969

II

11/3/1980

KV PHARMACEUTICAL CO

THEOPHYL S.R. CAPS 125MG & 250MG (THEOPHYLLINE)-FOR KNOLL PHARMA CO.

3970

11/7/1980

PERSONNEL, FACILS, & GEN OPER PROCEDS FOR ELKHART, IN LOCATION

3971

II

11/6/1980

WHITEHALL LABS DIV AMERICAN HOME PRODS


CORP
JT BAKER CHEMICAL CO

3972

II

9/12/1980

BOEHRINGER MANNHEIM GMBH

OXTRIPHYLLINE (CHOLINE THEOPHYLLINATE)

3973

II

5/22/1980

DEGUSSA AG

L-THREONINE (PYROGEN FREE)

3974

II

10/23/1980

DIOSYNTH BV

TESTOSTERONE

3975

IV

11/6/1980

HETERENE CHEMICAL COMPANY INC

HETOXOL D(CETEARYL ALCOHOL&CETEARETH-20) MNFG IN PATERSON,NJ FACILITY

3976

II

11/10/1980

SIGMA F AND D DIV LTD

BETA-ESTRADIOL

3977

II

5/22/1980

DEGUSSA AG

L-SERINE (PYROGEN FREE)

3978

II

11/4/1980

INDUSTRIA CHIMICA PROFARMACO SPA

CLORAZEPATE DIPOTASSIUM, BULK FORM

3979

II

11/13/1980

SOCIETA ITALIANA CORTICOSTEROIDI SPA

HYDROCORTISONE 17-VALERATE (THIS FORMERLY HELD BY S.I.R.S)

3980

II

10/21/1980

PARKE DAVIS DIV WARNER LAMBERT CO

BETAMETHASONE 17-BENZOATE MNFG BY VISTER S.P.A.(ITALY)(FACIL.OF PD/WL

3981

II

5/22/1980

DEGUSSA AG

L-VALINE, PYROGEN FREE-MFGR BY REXIM S.A., DIV. OF DEGUSSA, HAM FRANCE

3982

III

8/29/1980

PARCOR (USA)

FORMULATIONS FOR MOLDED RUBBER COMPOUNDS, PARCO 4418-70

3983

II

11/17/1980

RADIOCHEM CTR

MANUF. METHODS AND CONTROLS FOR BULK LEAD 201 & THALLIUM 201

3984

11/17/1980

FACILITIES AND KEY PERSONNEL INCLUDING DRUG QUALITY PROCEDS. MANUAL

3985

11/21/1980

AEROJET-GENERAL CORPORATION, PROPULSION


DIVISION.
GENENTECH INC

3986

II

11/18/1980

WARNER LAMBERT CO

ZOMEPIRAC SODIUM DIHYDRATE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SOUTH SAN FRANCISCO.
E-Z SCRUB W/HIBICLENS (CHLORHEXIDINE GLUCONATE) MANUFACTURED BY DESERET CO
IN UTAH.

Page 108

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
3987 I
II
11/5/1980
DEGUSSA AG

SUBJECT
L-ALANINE (PYROGEN FREE)

3988

III

11/17/1980

ADHESIVES AS USED IN TRANSDERMAL DRUG DELIVERY MFG IN PA. FACILS

3989

11/18/1980

FASSON INDUSTRIAL DIVISION OF AVERY


INTERNATIONAL
ANTIBIOTICOS SPA

3990

II

11/24/1980

ORGANICHEM CORP

ZOMEPIRAC SODIUM DIHYDRATE

3991

II

5/22/1980

EVONIK CORP

L-LYSINE HYDROCHLORIDE PYROGEN FREE

3992

IV

11/4/1980

PARKE DAVIS DIV WARNER LAMBERT CO

EMPTY GELATIN CAPSULES AS MFG. IN PONTYPOOL, UNITED KINGDOM

3993

II

9/15/1980

UNION CARBIDE CORPORATION

UNION CARBIDE'S SENTRY SIMETHICONE USP & 30% EMUL.-MFG SISTERVILLE, WV

3994

III

11/18/1980

BASF WYANDOTTE CORP

PALAINOL PLASTICIZERS--HAS BEEN SOLD AND SHOULD BE DISCN PER CORRES

3995

12/10/1980

DUPONT MERCK PHARMA

FACILS & CONTROLS FOR THE MANATI, PUERTO RICO LOCATION

3996

II

12/3/1980

PFANSTIEHL LABORATORIES INC

THERAFECTIN, PRODUCT CODE # T-124

3997

II

12/9/1980

NV ORGANON

PIPERAZINE ESTRONE SULPHATE

3998

II

11/10/1980

DEGUSSA AG

L-ARGININE HCL AS MANUF BY REXIM S.A. DIV OF DEGUSSA IN HAM, FRANCE

3999

11/14/1980

ORMONT DRUG AND CHEM CO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4000

III

12/8/1980

INMONT CORP

DRUM LININGS AS MANUF IN THE OHIO FACILIS: 4A DRUM LINING (66)

4001

IV

12/1/1980

CAPSUGEL

GELATIN CAPSULES MANUFACTURED IN PUEBLA, MEXICO

4002

II

11/10/1980

DEGUSSA CORPORATION

L-ASPARTIC ACID AS MANUF BY REXIM S.A. DIV DEGUSSA IN HAM, FRANCE

4003

IV

10/30/1980

CALBIOCHEM-BEHRING CORP

EGG YOLK PHOSPHATIDES (TYDOL)TM - AS PRODUCED IN CALIFORNIA FACILS

4004

II

12/5/1980

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

BETAMETHASONE BASE USP XX MANUF BY CESQUISA OF SPAIN

4005

II

11/26/1980

MEDIMPEX NORTHAMERICA INC

GLUETHIMIDE MANUF BY CHEM WORKS OF GEDEON RICHTER, LTD. HUNGARY

4006

12/8/1980

BOEHRINGER INGELHEIM PHARMACEUTICALS INC PRODUCTION AND DISTRIBUTION FACILITY IN DANBURY, CONNECTICUT

4007

III

12/8/1980

RICHMOND TECHNOLOGY INC

THERMOPLASTIC FILMS AND SHEETS

4008

II

12/5/1980

ER SQUIBB AND SONS INC

DESONIDE

4009

II

11/12/1980

DEGUSSA AG

L-LEUCINE AS MANUF BY REXIM S.A. DIV. DEGUSSA IN HAM, FRANCE

4010

II

11/26/1980

MEDIMPEX NORTHAMERICA INC

NANDROLONE PHENYLPROPIONATE MANUF-BY CHEM WORK OF GEDEON RICHTER LTD.

4011

II

9/25/1980

CALBIOCHEM-BEHRING CORP

L-ALPHA-LECITHIN, BETA, GAMMA-DIPALMITOYL

4012

II

12/15/1980

LONZA INC

CHLORHEXIDINE GLUCONATE, 20% SOLUTION, BP 73 & CHLORHEXIDINE DIACETATE

4013

II

12/15/1980

KNOLL AG LUDWIGSHAFEN

CHOLINE THEOPHYLLINATE (OXTRIPHYLLINE)

4014

III

12/18/1980

HS CROCKER COMPANY INC

ADHESIVES IN THE CXL SERIES AS MANUF IN THE ILLINOIS FACILS

4015

II

11/19/1980

EVONIK CORPORATION

L-GLUTAMIC ACID AS MANUF BY REXIM S.A. DIV. DEGUSSA IN HAM, FRANCE

4016

II

11/27/1980

DIPYRIDAMOLE

4017

II

12/10/1980

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
3M PHARMS

4018

II

11/11/1980

PFIZER LTD

METHOTREXATE AS MANUFACTURED IN SANDWICH, KENT,ENGLAND

4019

II

11/19/1980

DEGUSSA AG

L-ISOLEUCINE AS MANUF BY REXIM S.A. OF DEGUSSA IN HAM, FRANCE

4020

II

2/6/1981

ER SQUIBB AND SONS INC

FLUPHENAZINE DECANOATE AND FLUPHENAZINE ENANTHATE

4021

III

11/7/1980

INTEX PLASTIC SALES CO

RIGID PVS PACKAGING MATERIALS: INTEX 15001

4022

II

1/5/1981

SIGMA F AND D DIV LTD

PHENOLPHTHALEIN GLUCURONIC ACID

4023

II

1/9/1981

FERMION OY

ACETONIDE HYDROLYSATE CODE 2543

PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES

ISOPRENALINE (ISOPROTERENOL) AND ITS SALTS

Page 109

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4024 I
II
1/6/1981
DEGUSSA AG

SUBJECT
L-PHENYLALANINE AS MANUF BY REXIM S.A. DIV. OF DEGUSSA IN HAM, FRANCE

4025

II

1/6/1981

SIGNA SA

CRUDE METRONIDAZOLE

4026

II

1/8/1981

DIOSYNTH BV

HYDROCORTISONE SODIUM PHOSPHATE

4027

10/8/1980

STERIGENICS INTERNATIONAL

4028

II

12/10/1980

TEVA PHARMACEUTICAL INDUSTRIES LTD

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN


TUSTIN, CA
HYDROCHLOROTHIAZIDE

4029

II

1/6/1981

DEGUSSA AG

L-METHIONINE AS MANUF BY REXIM S.A. DIV. OF DEGUSSA IN HAM, FRANCE

4030

11/21/1980

JUBILANT HOLLISTERSTIER LLC

SVP FACILITY

4031

II

12/19/1980

SOCIETA ITALIANA CORTICOSTEROIDI SPA

HYDROCORTISONE-17-BUTYRATE

4032

II

12/23/1980

GANES CHEMICALS INC

DYCLONINE HCL

4033

II

10/22/1980

AMINO GMBH

L-PHENYLALANINE

4034

II

1/16/1981

MALLINCKRODT CHEMICAL INC

POTASSIUM NITRATE TAC AS MANUF IN THE ST. LOUIS MISSOURI FACILS.

4035

II

1/6/1981

DEGUSSA AG

L-TRYTOPHAN AS MANUF BY REXIM S.A. DIV OF DEGUSSA IN HAM, FRANCE

4036

II

12/18/1980

ORION CORP FERMION

METHOCARBAMOL NF XV

4037

12/24/1980

TANABE SEIYAKU CO LTD

FACILS., PERSONNEL & GENERAL OPERATING PROCEDS-OF TOKYO,JAPAN PLANT

4038

II

1/20/1981

SIEGFRIED AG

CARBATCHOL-AS MANUF & SOLD UNDER SIEGFRIED LABEL

4039

II

4/22/1980

ZENECA PHARMACEUTICALS DIV ZENECA INC

POLYOXYETHYLENE FA. ACID ESTERS-MFG BY ALAS CHEM GERMANY

4040

II

12/10/1980

TEVA PHARMACEUTICAL INDUSTRIES LTD

ACETYLSULFISOXAZOLE

4041

II

10/22/1980

AMINO GMBH

L-ISOLEUCINE

4042

12/24/1980

TANABE SEIYAKU CO LTD

FACILS.,PERSONNEL, & GENERAL OPERATING PROCEDS-OF OSAKA, JAPAN PLANT

4043

II

12/31/1980

MEPROBAMATE-PRODUCED BY SHANSHI CORP IN TAIYUAN, PEOPLES' REPUB CHINA)

4044

II

12/5/1980

4045

II

1/16/1981

SHANSHI PHARMACEUTICAL INDUSTRY


CORPORATION
SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL
DEVELOPMENT
DIOSYNTH BV

4046

II

10/3/1980

HOPE CO

BULK SULFAMETHAZINE AND SODIUM SULFAMETHAZINE

4047

III

1/6/1981

MLI ACQUISITION CORP II

PRESSURE SENSITIVE LAMINATES - FACILS & CONTROLS A ST. ALBANS VT

4048

II

1/1/1981

MEDIMPEX NORTHAMERICA INC

PREDNISOLONE AS MANUF BY CHEM WORKS OF GEDEON RICHTER, LTD. BUDAPEST

4049

12/24/1980

TANABE SEIYAKU CO LTD

FACILS.,PERSONNEL, & GENERAL OPERATING PROCEDS-ONODA, JAPAN PLANT

4050

II

1/14/1981

MALLINCKRODT INC

PRODUCTION OF TALLOUS T1-201 CHL A THE BURLINGAME, CA

4051

II

2/5/1981

SANOFI CHIMIE

PREDNISOLONE SODIUM PHOSPHATE

4052

II

1/28/1981

CYCLO PRODUCTS INC

ISOXSUPRINE HCL AS MANUF IN THE LOS ANGELES CALIFORNIA FACILITIES

4053

II

1/28/1981

SIGMA F AND D DIV LTD

L-TYROSINE

4054

II

2/9/1981

HEXAGON LABORATORIES INC

ZOMEPIRAC SODIUM DIHYDRATE AS MANUF IN THE BRONZ NEW YORK LOCATION

4055

II

2/10/1981

EGIS PHARMACEUTICALS

CYPROHEPTADINE HCL AS MANUF BY EGYT PHARMACOCHEMICAL WORKS

4056

II

1/29/1981

BRISTOL MYERS SQUIBB COMPANY

JM-9 FOR INJECTION AS MANUF IN THE SYRACUSE, N.Y. FACILITIES

4057

III

1/27/1981

VACUMET CORP

METALLIZED POLYESTER FILMS AS MANUF IN THE WAYNE NJ FACILS: BARRIERMET

4058

II

1/23/1981

SIEGFRIED LTD

PHENAZOPYRIDINE HCL AS MANUF & SOLD UNDER THE SIEGFRIED LABEL

4059

II

1/29/1981

MALLINCKRODT PHARMS DIV MALLINCKRODT INC

DOXYLAMINE SUCCINATE USP AS PRODUCED IN THE ST. LOUIS MO PLANT

4060

II

2/17/1981

MEDIMPEX NORTHAMERICA INC

FURAZOLIDONE AS MANUF BY CHINOIN PHARMACEUTICAL & CHEMICAL WORKS, LTD.

TENIPOSIDE (VM 26)


PREGNENOLONE HEMISUCCINATE

Page 110

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4061 I
II
2/6/1980
HOFFMANN LA ROCHE INC

SUBJECT
RO 20 5933 AS MANUF IN THE NEW JERSEY FACILITIES ( INJECTABLE)

4062

IV

1/13/1981

SOLAE LLC

EMCOSOY AS MANUFACTURED IN OKLAHOMA AND TENNESSEE

4063

12/23/1980

SHANGHAI FOURTH PHARMACEUTICALS LTD

FACILITIES AND CONTROLS

4064

II

2/2/1981

SIGMA F AND D DIV LTD

DEUTERIUM OXIDE

4065

II

2/20/1981

BASF PHARMA EVIONNAZ SA

TETRACAINE HCL

4066

II

1/21/1981

GEDEON RICHTER LTD

ESTRADIOL MNFG IN BUDAPEST

4067

II

1/21/1981

JAMES RIVER CORPORATION

SODIUM CELLULOSE PHOSPHATE (SCP) AS MANUF ON THE N.H. FACILS

4068

II

1/30/1981

SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS)

FACILITIES AND CONTROLS FOR THE PRODUCTION OF MEFENAMIC ACID

4069

2/10/1981

REHEIS CHEM CO DIV ARMOUR AND CO

PERSONNEL & GEN OPER PROCEDS FOR THE BERKELEY HEIGHTS, NJ LOCATION

4070

II

2/17/1981

DIOSYNTH INC

HEPARIN SODIUM (CRUDE) FROM BEEF LUNGS AS MANUF IN THE CHICAGO,ILL FAC

4071

1/26/1981

ANTIBIOTICOS SPA

4072

III

11/18/1981

NORTH CHEMICAL COMPANY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RODANO, ITALY.
COLLOID 581B AS MANUF IN THE MARIETTA, GEORGIA FACILITIES

4073

II

1/21/1981

MEDIMPEX NORTHAMERICA INC

ESTRADIOL DIPROPIONATE AS MANUF BY CHEM WORKS OF GEDEON RICHTER, LTD.

4074

II

1/20/1981

FOURTH PHARMACEUTICAL WORKS

DIPHENHYDRAMINE, BULK FORM (SYNTHESIS)

4075

III

12/10/1980

EQUISTAR CHEMICALS LP SUB LYONDELLBASELL

POLYPROPYLENE RESINS

4076

12/22/1980

JOHNSON AND JOHNSON GMBH

FACILITIES AND PROCEDURES FOR THE MANUF. OF TAMPONS

4077

II

2/18/1981

DIOSYNTH BV

HEPARIN SODIUM

4078

II

2/18/1981

RHONE POULENC INC

TRIMIPRAMINE MALEATE AS MANUF IN THE NEW BRUNSWICK, NJ PLANT

4079

II

1/21/1981

LONZA INC

CHLORHEXIDINE HCL B.P. 73

4080

III

2/19/1981

B BRAUN MEDICAL INC

PARENTERAL DRUGS IN PLASTIC CONTAINERS

4081

II

3/3/1981

ROUSSEL-UCLAF

TRIAMCINOLONE

4082

3/13/1981

ENGELHARD MINERALS AND CHEMICAL CORP

FACILS & GEN OPERT. PROCEDS AT THE EDISON,NJ FACILITIES

4083

3/16/1981

R P SCHERER

4084

II

2/26/1981

EGIS PHARMACEUTICALS PUBLIC LTD CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ST. PETERSBURG, FLORIDA.
ALLOPURINOL AS MANUF BY EGYT PHARMACOCHEMICAL WORKS

4085

II

3/3/1981

ROUSSEL-UCLAF

TRIAMCINOLONE ACETONIDE

4086

2/27/1981

COSMA SPA

PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES

4087

III

2/25/1981

MONSANTO COMPANY

CARBETHIMER (N-137)(CARBETIMER) BULK FORM-MANUF IN DAYTON,OH. FACILS

4088

II

2/27/1981

SIEGFRIED LTD

TRIMETHOBENZAMIDE HCL.

4089

3/9/1981

STERLING ORGANICS

4090

3/13/1981

HOECHST MARION ROUSSEL SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN UNITED KINGDOM.
FACILS & GENERAL OPERATING PROCEDS AT NEUVILLE-SUR-SAONE LOCATION

4091

II

3/4/1981

ORGAMOL SA

SALICYLAZOSULFAPYRIDINE (SULFASALAZINE)

4092

II

2/25/1981

DANISCO INGREDIENTS

MEPROBAMATE

4093

II

3/25/1981

HOFFMANN LA ROCHE INC

RO 21-5535 (CALCITRIOL) AMPULS 2.5 MCG/0.5ML-MANUF IN NJ FACILITIES

4094

3/6/1981

GLAXO WELLCOME INC

FACILS AND GEN OPER PROCEDS AT THE ULVERSTON PLANT

4095

II

2/27/1981

SANOFI AVENTIS CHIMIE

CYANOCOBALAMIN MANUFACTURED IN ELBEUF, FRANCE

4096

II

2/20/1981

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP TRAFURIL(THURFYL NICOTINATE)MNFG BY CIBA LABS,TESTED IN BASIL

Page 111

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4097 A
II
2/24/1981
BASF PHARMACHEMIKALIEN GMBH CO KG

SUBJECT
THEOPHYLLINE ANHYDROUS AS MANUFACTURED IN MINDEN, GERMANY

4098

II

3/13/1981

ENGELHARD MINERALS AND CHEMICAL CORP

CISPLATIN-MANUF IN EDISON, NEW JERSEY

4099

III

3/6/1981

OLIN CORP

NITROCELLULOSE&POLYMER(SARAN)COATED SERIES:HEAT SEALABLE CELLOPHANES

4100

II

3/6/1981

GLAXOSMITHKLINE

7-ACA TOSYLATE AS MANUFACTURED IN ULVERSTON PLANT

4101

II

3/26/1981

KYOWA HAKKO KOGYO CO LTD

L-MALIC ACID

4102

II

2/23/1981

SCHERING AG

NANDROLONE DECANOATE

4103

III

12/24/1980

TSCHEULIN ROTHAL GMBH

ALUMINUM FOILS & PVDC COATED PVC FILMS FOR PHARMACEUTICAL PACKAGING

4104

II

2/27/1981

COSMA SPA

PROPRANOLOL HCL AS MANUFACTURED IN CISERANO, ITALY

4105

III

3/4/1981

3M PHARMS

HEA-SEALABLE MICROPORUS TAPES, CORDOVA, ILLINOIS

4106

3/6/1981

GLAXO WELLCOME INC

CEPHALOSPORINS FILLING UNIT LOC IN BERNARD CASTLE, COUNTY DURHAM ENG.

4107

II

3/3/1981

SOCIETA ITALIANA CORTICOSTEROIDI SPA

FLURANDRENOLIDE

4108

3/22/1981

ETHYL CORP

4109

II

3/23/1981

ORGANICHEM CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


BATON ROUGE, LOUISANA.
TOLMETIN SODIUM DIHYDRATE AS MANUF IN THE RENSSALATER NY FACILITY

4110

II

3/17/1981

4111

II

3/27/1981

TIANJIN MEDICINES & HEALTH PRODUCTS IMPORT METHOCARBAMOL MFG BY XIN XIN PHARMACEUTICAL MANUFACTORY
AND EXPORT CO
KNOLL AG LUDWIGSHAFEN
DIPHENHYDRAMINE HCL

4112

II

3/20/1981

CALBIOCHEM-BEHRING CORP

GRINDING OF SODIUM BISULFITE (LA JOLLA, CALIF. PLANT)

4113

II

3/25/1981

INTERNATIONAL MINERALS & CHEMICAL CORP

PENTAERYTHRITOL(PETN) MFGR IN SPANISH FORK, UTAH FACILS.(BULK)

4114

2/28/1981

YAMASA SHOYU COMPANY LTD

4115

3/5/1981

NORDION INTERNATIONAL INC

4116

3/18/1981

CRISPEN LABORATORIES & ASCOT INJECTABLES

4117

4/10/1981

SYNCOR INTERNATIONAL CORP

4118

II

4/9/1981

TEVA PHARMACEUTICAL INDUSTRIES LTD

4119

II

4/1/1981

CHUGAI PHARMACEUTICAL CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CHOSHI.
MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN
VANCOUVER OPERATIONS.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MELROSE PARK, ILL
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SYLMAR, CALIFORNIA.
BETAMETHASONE VALERATE AS MANUFACTURED IN RHO (MILAN), ITALY FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
SG-75 (N-(2-HYDROXYETHYL) NICOTINAMIDE NITRATE TABS

4120

II

2/27/1981

TRIFARMA SPA

THIORIDAZINE HYDROCHLORIDE

4121

II

4/1/1981

SIGMA F AND D DIV LTD

YOHIMBINE HYDROCHLORIDE

4122

II

4/7/1981

DIOSYNTH BV

HYDROCORTISONE SODIUM SUCCINATE

4123

II

4/14/1981

ROCHE PRODS LTD

RO 12-1989 (DIHOMO-GRAMMA-LINOLENIC ACID)-MFGR BY ROCHE PRODS.,LTD

4124

4/7/1981

HOECHST AG

4125

II

2/28/1981

YAMASA SHOYU COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FRANKFURT.
URIDINE, 5-BROMO-2' -DEOXY.THIS INFO WAS SUBMITTED NCI/NIH

4126

II

2/27/1981

TRIFARMA SPA

FLUPHENAZINE HCL

4127

III

11/20/1986

CP HALL CO

MONOPLEX S-75 (FORMERLY HELD BY ROHM AND HAAS COMPANY)

4128

II

3/31/1981

MALLINCKRODT INC

THALLOUS CHLORIDE TI 201

4129

II

4/7/1981

DIOSYNTH BV

HEPARIN CALCIUM

4130

II

2/27/1981

TRIFARMA SPA

PERPHENAZINE U.S.P.

Page 112

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4131 I
I
4/20/1981
GD SEARLE AND CO
4132

II

4/20/1981

H REISMAN CORP

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MT. PROSPECT, ILL.LOCATION.
PSEUDOEPHEDRINE HCL; BULK PSEUDOEPHEDRINE HCL

4133

4/21/1981

WHEATON CLOSURES INC

FACILITIES,CONTROLS & PERSONNEL MILLVILLE, NJ

4134

II

3/31/1981

MALLINCKRODT INC

4135

2/27/1981

INDUSTRIA CHIMICA MILANESE SPA

4136

II

4/14/1981

PERKINS ELMER LIFE SCIENCES

GALLIUM CHL GA-67 AS MANUFACTURED IN MARYLAND HGTS., MISSOURI CYCLOTRON


FACILITY
MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES
AT MILANO, ITALY.
INDIUM-111 PRODUCED IN NORTH BILLERICA, MASS FACILITIES

4137

II

3/23/1981

ETHYL CORP

ZOMEPIRAC SODIUM DIHYDRATE PROCESSED MD UNIT, BATON ROUGE, LA

4138

II

4/23/1981

SIGMA F AND D DIV LTD

DIMETHYL SULFOXIDE

4139

II

3/27/1981

SIMS SRL

LIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HCL

4140

II

3/3/1981

PROFARMACO SRL

LIDOCAINE HCL & BASE---2-(DIETHYLAMINO)-2-6 ACETOXYLIDIDE HCL

4141

II

3/24/1981

MAY AND BAKER LTD

ACEBUTOLOL HCL/SECTRAL

4142

3/16/1981

SMITH LABORATORIES INC

MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES .

4143

II

4/13/1981

ERYTHRITOL TETRANITRATE(ETN) MNFG IN SPANISH FORK, UTAH FACILITIES

4144

II

4/16/1981

IMC CHEMICAL GROUP INC SUB INTL MINERALS &


CHEM CORP
GANES CHEMICALS INC

4145

II

4/6/1981

CAMBREX PROFARMACO MILANO SRL

NAPROXENE

4146

II

1/31/1981

US COTTON LLC

NICLOSAMIDE

4147

III

1/23/1981

WACKER CHEMIE GMBH

VINNOL H 70 DF

4148

II

4/28/1981

TEVA PHARMACEUTICAL INDUSTRIES LTD

BETAMETHASONE DIPROPIONATE

4149

4/8/1981

GEDEON RICHTER

FOR CHEMICAL WORKS OF GEDEON RICHTER, LTD -BUDAPEST

4150

II

5/5/1981

DIOSYNTH BV

PREDNISOLONE SUCCINATE

4151

5/7/1981

CCL CUSTOM MANUFACTURING INC

4152

5/7/1981

INDUSTRIA FARMACEUTICA SERONO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DANVILLE, ILL.
FACILITIES, CONTROLS & PROCEDURES FOR MANUF OF ANTI-HCG

4153

5/1/1981

DENKA PHARMCEUTICAL CO LTD

MANUF PROCEDS HUMAN CHORIONIC GONADOTROPIN (HCG)

4154

II

4/28/1981

GRINDSTED PRODUCTS

SULFAMETHAZINE

4155

5/5/1981

LYPHOMED INC

MANUF. PROCEDS FOR OXYTOCIN INJECT (BULK)--IN CHICAGO, ILL. FACILITIES

4156

4/17/1981

VANGARD LABS DIV MIDWAY MED CO

4157

2/18/1981

GAELEO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GLASGOW, KENTUCKY.
METHODS, FACILS. & CONTROLS FOR THE MFGR OF POLYESTRADIOL PHOSPHATE

4158

5/11/1981

MEIJI SEIKA KAISHA LTD

4159

5/21/1981

SCHERING PLOUGH AVONDALE CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ASHIGARA, JAPAN.
RAHDRUM, COUNTY WICKLOW, IRELAND

4160

III

4/23/1981

EASTMAN CHEMICAL CO

ECDEL ELASTOMERS AS MANUFACTURED AT TENNESSEE EASTMAN DIVISION

4161

II

4/29/1981

CENTRAL PHARMACEUTICALS INC

PSEUDOEPHEDRINE HCL CAPS 120MG--AS MFGR IN SEYMOUR, IND.,FACILS.

4162

III

5/1/1981

TECNOCAP LLC

PACKAGING MATERIALS-CLOSURES MANUFACTURED IN BROOKLYN, NEW YORK.

4163

III

4/29/1981

FLEXEL INC

NITROCELLULOSE & POLYMER COATED CELLOPHANES-MFGR COVINGTON, IND. FACIL

4164

III

4/30/1981

BARNHARDT MANUFACTURING CO

COTTON & RAYON COILERS MANUFACTURED IN DAYVILLE, CONNECTICUT.

FLUTAMIDE-MANUF IN CARLSTADT,NJ--CUSTOM BASIS FOR SCHERING PLOUGH CORP

Page 113

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4165 I
I
5/21/1981
IRISH FINE CHEMICALS LIMITED
4166

III

5/13/1981

EKA NOBEL INC PAPER CHEMICALS DIV

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
IN RAHDRUM, IRELAND.
BEROCELLS DEBONDING AGTS FOR PROCESS FLUFF PULPS: MANUF SWEDEN

4167

3/31/1981

PROFARMACO SRL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4168

II

5/7/1981

GLUTETHIMIDE (CHEM NAME: 2-ETHYL-2-PHENYL GLUTARIMIDE)

4169

III

5/20/1981

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
BAXTER HEALTHCARE CORP

4170

5/21/1981

BRYAN LOFTUS

4171

II

4/6/1981

G POHL BOSKAMP GMBH AND CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RAHDRUM, CO WICKLOW IRELAND.
NITROGLYCERINE PRODS, NITROLINGUAL SPRAY IN PARTICULAR. IND 18-483

4172

II

5/21/1981

STUART PHARMACEUTICALS DIV ICI AMERICAS

SDM 50 (STABILIZED 50/50 ISOSORBIDE DINITRATE-LACTOSE MIXTURE)

4173

5/29/1981

ABBOTT LABORATORIES HOSP PRODUCTS DIV

STD TEST METHODS FOR TESTING SVP & LVP PRODUCTS(PERIOD 5-1-80 - 5-1-81

4174

5/28/1981

MARION LABORATORIES INC

RESEARCH & DEVELOPMENT FACILS AT THE KANSAS CITY MISSOURI LOCATION

4175

II

5/4/1981

ONCOLOGY RESEARCH & DEVELOPMENT INC

HEMATOPORPHYIN DERIVAIVE (PHOTOFIN) FOR HUMAN USE--CHEEKTOWAGA, NY

4176

5/7/1981

SCHERING CORP SUB SCHERING PLOUGH CORP

4177

III

5/8/1981

HOSPIRA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MANATI, PUERTO RICO.
CR3 FLEXIBLE CONTAINER AS MANUF IN NORTH CHICAGO, ILL FACILITIES

4178

II

5/21/1981

BAYER PHARMA AG

LEVONORGESTREL AS MANUFACTURED IN BERGKAMEN, GERMANY

4179

II

5/1/1981

CILAG CHEMIE AG

ZOMEPIRAC SODIUM DIHYDRATE

4180

6/1/1981

ABBOTT LABORATORIES HOSP PRODUCTS DIV

STANDARD TEST METHODS FOR TESTING SVP & LVP PRODUCTS (5-1-80 - 5-1-81)

4181

II

6/10/1981

DIOSYNTH BV

CORTICOTROPIN

4182

II

6/23/1981

NAPP CHEMICALS INC

LIDOCAINE HCL

4183

5/7/1981

SISA INC

4184

5/29/1981

ABBOTT LABORATORIES HOSP PRODUCTS DIV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CAMBRIDGE, MASSACHUSETTS.
STD.CONTROL PROCEDURES,RAW DRUG CODES FOR SVP & LVP PRODUCTS(5-80 5-81

4185

II

5/27/1981

BASF PHARMACHEMIKALIEN GMBH CO KG

PSEUDOEPHEDRINE HCL AS MANUFACTURED IN MINDEN, GERMANY

4186

II

6/12/1981

PHARMACO LABORATORIES INC

METHDILAZINE--A THE TITUSVILLE, FLA. LOCATION

4187

II

6/23/1981

NAPP CHEMICALS INC

SILVER SULFADIAZINE MANUF. AT LODI, NJ 07644

4188

6/18/1981

ASAHI CHEM INDUSTRY CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4189

II

5/26/1981

SALK INSTITUTE

4F-ANTAGONIST

4190

III

6/22/1981

B BRAUN MEDICAL INC

PACKAGING MATERIAL MANUFACTURED IN IRVINE CA

4191

II

6/24/1981

BIOCHEMIC GESELLSCHAFT MBH

OXYTOCIN SOLUTION 200 I.U./ML

4192

IV

6/18/1981

ASAHI KASEI FINECHEM CO LTD

REFINED EGG PHOSPHATIDE

4193

II

6/11/1981

SELENIUM SULFIDE AS MANUF IN NORTH CHICAGO ILL, FACILITIES

4194

II

5/29/1981

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
TANABE SEIYAKU CO LTD

4195

II

5/11/1981

CAMBREX PROFARMACO MILANO SRL

LORMETAZEPAM

4196

5/28/1981

PFIZER INC

4197

II

6/30/1981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PARSIPPANY, NEW JERSEY.
TRIAMCINOLONE ACETONIDE USPXX

4198

6/1/1981

ABBOTT LABORATORIES HOSP PRODUCTS DIV

STD CONTROL PROCEDURES,RAW DRUG CODES FOR SVP & LVP PRODUCTS,5-80 5-81

PRODUCTION OF PARENTERAL INJ. - PLASTIC CONTAINERS(PL-146) CAROLINA PR

AMINO ACID MIXTURE ABBU

Page 114

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4199 I
III
5/22/1981
OLIN CORP

SUBJECT
LAMINA. OF CELLOPHANE W/ALUM. FOIL OR POLYPROPYLENE FILM, N.C. LOCA

4200

II

6/10/1981

DIOSYNTH BV

METOCURINE IODIDE

4201

6/5/1981

UDL LABORATORIES INC

4202

II

5/29/1981

TANABE SEIYAKU CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROCKFORD, ILLINOIS.
AMINO ACID MIXTURE ABBX

4203

II

6/12/1981

MALLINCKRODT INC

COMPAP AS MANUFACTURED IN THE RALEIGH, NORTH CAROLINA FACILITIES

4204

II

6/19/1981

H REISMAN CORP

PSEUDOEPHEDRINE SULFATE, BULK FORM MFG. ORANGE, NEW JERSEY FACILITIES

4205

II

5/5/1981

FABBRICA ITALIANA SINTETICI

TRIMETHOPRIM USP, BULK FORM

4206

II

7/8/1981

POLYSCIENCES INC

INDICINE-N-OXIDE

4207

II

7/3/1981

DIOSYNTH BV

TRIAMCINOLONE DIACETATE

4208

II

7/8/1981

SIGMA F AND D DIV LTD

ADENOSINE, SIGMA GRADE

4209

7/9/1981

LAPORTE ORGANICS FRANCIS SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4210

7/16/1981

AH ROBINS CO

PLANT MASTER FILE FOR ARECIBO, PUERTO RICO LOCATION

4211

II

6/12/1981

FERMION OY

SULPHINPYRAZONE USP 80

4212

II

7/17/1981

LONZA RIVERSIDE

AURANOFIN

4213

II

6/5/1981

BIOCHEMIC GESELLSCHAFT MBH

PLEUROMULIN

4214

5/19/1981

CYANAMID GREAT BRITAIN LTD

4215

II

6/30/1981

KV PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GOSPORT.
DIDRONEL TABLETS, 200 MG, MNFG IN WESTPORT FACIL., ST.LOUIS, MISSOURI

4216

7/22/1981

SANOL-SCHWARZ

PERSONNEL,FACILITIES AND GENERAL OP. PROCEDURES, MONHEIM FACIL.

4217

II

5/14/1981

FALK GMBH AND CO

URSODEOXYCHOLIC ACID (URSOFALK CAPS)

4218

II

6/15/1981

ORION CORP LTD FERMION

CHLORHEXIDINE ACETATE BP 80

4219

7/15/1981

JOHNSON AND JOHNSON MEDICAL INC

4220

II

3/18/1981

ESTEVE QUIMICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN


GURABO, PUERTO RICO.
INDOMETHACIN FOR HUMAN USE

4221

6/30/1981

HOVIONE SOCIEDADE QUIMICA LDA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4222

7/20/1981

PFANSTIEHL LABORATORIES INC

4223

7/21/1981

B BRAUN MEDICAL INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WAUKEGAN, ILLINOIS.
FACILITIES & GENERAL OPERATING PROCEDS AT IRVINE, CALIF

4224

II

7/22/1981

SANOL-SCHWARZ

ISOSORBIDE DINITRATE TRANSDERMAL SUSPENSION

4225

II

6/24/1981

HOFFMANN LA ROCHE INC

RO 5-9963 (DESMETHYLMISON IDAZOLE--MFGR BY HOFFMANN LA ROCHE AG. SWITZ

4226

II

6/12/1981

LINSON LTD

BENDROFLUMETHIAZIDE (BULK)--MFG BY LINSON, LTD, SWORDS, DUBLIN,IRELAND

4227

III

5/28/1981

BORDEN CHEM CO

CASCO FLEX ADHESIVE IN THE NT SERIES MFG A DELAWARE, OH FACIL

4228

II

7/28/1981

STEROID SRL

NANDROLONE DECANOATE (USAN)

4229

7/21/1981

MCGAW INC

FACIL & GENERAL OPER PROCEDS AT MILLEDGEVILLE, GA LOCATION

4230

II

6/15/1981

SIEGFRIED AG

OXYMETAZOLONE HCL (BULK) AS MFG & SOLD UNDER SIEGFRIED LABEL

4231

II

6/16/1981

PERKINELMER LIFE ANALYTICAL SCIENCES INC

IODINE-131-PRODUCED IN NORTH BILLERICA, MA.

4232

II

6/25/1981

PIERCE CHEM CO

DIMETHYL ADIPIMIDATE HCL AS MFG IN ROCKFORD, ILL FACILITIES

4233

II

4/8/1981

PHARMACIA AND UPJOHN SUB PFIZER INC

TESTOSTERONE PROPIONATE AS MFG IN THE MICHIGAN FACILITIES

Page 115

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4234 I
I
8/3/1981
AYERST LABORATORIES INC DIV AMERICAN HOME
PRODUCTS CORP
4235 I
II
8/5/1981
TAIHO PHARMACEUTICAL CO INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN ROUSES POINT, NEW YORK.
FTORAFUR (ALSO CALLED FUTRAFUL OR TEGAFUR)

4236

II

8/6/1981

G POHL BOSKAMP GMBH AND CO

NITROLINGUAL CHEWABLE CAPSULE

4237

III

8/5/1981

POLYMER CORP

POLYBOND ADHES. SYSTEMS IN THE GA-83 SERIES-MFG STAMFORD, CT. FACILS.

4238

III

11/11/1980

BASF AKTIENGESELLSCHAFT

LUPOLEN 1810 H WHITE 950/LUPOLEN 1800H NATURAL/POLYSTROL 143E WHT 200

4239

II

6/26/1981

PHARMACIA AND UPJOHN INC

TESTOSTERONE ENANTHATE USP AS MANUF IN THE MICHIGAN FACILITIES

4240

II

6/26/1981

CAMBREX PROFARMACO MILANO SRL

CLORAZEPATE DIPOTASSIUM

4241

II

7/29/1981

GANES CHEMICALS INC

BUSPIRONE HCL AS MFG IN CARLSTADT, NJ FACILS FOR THE MEAD JOHNSON CO

4242

II

8/12/1981

ROCKWOOD LITHIUM INC

LITHIUM CARBONATE AS MANUFACTURED IN KINGS MOUNTAIN, NC

4243

8/5/1981

GLAXO WELLCOME INC

4244

II

7/31/1981

AMERSHAM RADIOCHEMICAL CENTER

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MONTROSE, ANGEES, SCOTLAND.
INDIUM IN 111 OXINE

4245

II

8/13/1981

PHARMACIA AND UPJOHN SUB PFIZER INC

TESTOSTERONE CYPIONATE USP AS MFG IN THE MICHIGAN FACILITIES

4246

II

8/6/1981

FERMION OY

METHOTREXATE

4247

II

7/21/1981

PFANSTIEHL LABORATORIES INC

FTORAFUR (1-TETRAHYDRO-2-FURANYL) 5-FLUOROURACIL) PROD CODE #F-107

4248

II

7/20/1981

ICI AMERICAS INC

SDM 37 (ETHYL ALCOHOL-NITROGLY DRUG MIXTURE)-MFG REYNOLDS PLANT, PENN.

4249

III

6/19/1981

POLYMER CORP

POLYBOND ADHES. SYSTEMS IN THE PF-SERIES-MFG IN STAMFORD, CTPF-99

4250

II

8/6/1981

G POHL BOSKAMP GMBH AND CO

NITRONEL-GEL

4251

III

8/24/1981

DOW CHEMICAL CO

DOWLEX POLYETHYLENE RESINS

4252

II

8/10/1981

SANOFI SA

CHLORAZEPATE MONOPOTASSIUM MFG FOR CLIN-MIDY

4253

II

8/5/1981

GANES CHEMICALS INC

AMITRIPYLINE BULK FORM AS MANUF - PENNSVILLE NJ FACILITIES

4254

II

8/5/1981

GLAXO OPERATIONS UK LTD

DIONOSIL OILY (NDA 9-309)

4255

II

7/8/1981

ALPS PHARMACEUTICAL IND CO LTD

PHENYLPROPANOLAMINE HYDROCHLORIDE

4256

8/25/1981

SANOFI WINTHROP INC

4257

II

8/10/1981

SANOFI SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FAWDON, NEWCASTLE TYNE NE3 3TT, ENGLAND.
CLORAZEPATE DIPOTASSIUM MFG FOR CLIN-MIDY

4258

III

7/30/1981

APTAR STELMI SAS

PACKAGING MATERIALS:ELASTOMERIC CLOSURES AND ITEMS

4259

II

7/24/1981

TANABE SEIYAKU CO LTD

AMINO ACID MIXTURE ABBC

4260

II

8/28/1981

RUETGERS-NEASE CHEMICAL COMPANY INC

ZINC PYRION (TM)-MFG IN STATE COLLEGE, PENN. FACILS.

4261

II

8/28/1981

SIGMA F AND D DIV LTD

DL-6,8-THIOTIC ACID, OXIDIZED FORM CLINICAL STUDIES BY DR. R. JACOBSON

4262

8/25/1981

CHIREX LTD

4263

II

8/10/1981

SANOFI SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CRAMLINGTON, NORTHUMBERLAND, ENGLAND.
MINAPRINE AS MFG BY SEMPA-CHIMIE FOR CLIN-MIDY

4264

II

9/4/1981

LONZA RIVERSIDE

PHENOXYBENZAMINE HCL AS MFG IN THE PA FACILITIES

4265

9/1/1981

GRINDSTED PRODUCTS

4266

8/21/1981

PHARMACIA AND UPJOHN INC

4267

II

9/3/1981

DIOSYNTH BV

BULK VITAMINSFACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN


GRENNA, DENMARK
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN
SCHAUMBURG,IL.
ESTRADIOL VALERATE MICRO

4268

7/16/1981

PROCESSING COMPANY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PARAMOUNT CALIFORNIA.

Page 116

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4269 I
II
8/31/1981
ROEHR CHEMICALS INC

SUBJECT
PHENYLPROPANOLAMINE BASE AS MFG IN LONG ISLAND CITY,NY FACILITIES

4270

9/1/1981

DANISCO INGREDIENTS

4271

9/10/1981

FH FAULDING & COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GRINSTED, DENMARK.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4272

II

8/25/1981

RHONE POULENC INC

SURICLONE (31, 264 R.P.)

4273

II

7/15/1981

BAYER PHARMA AG

TRASYLOL (APROTININ)-DRUG SUBSTANCE AS MANUFACTURED IN WUPPERTAL, GERMANY

4274

II

9/2/1981

PLANTEX LTD CHEM AND PHARM WORKS

HYDRALAZINE HCL U.S.P.

4275

II

8/21/1981

KV PHARMACEUTICAL CO

MEDIGESIC PLUS CAPS--MFG IN ST. LOUIS, MO. FACILS FOR MEDICS PHARMACEU

4276

9/23/1981

INDUSTRIA FARMACEUTICA SERONO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4277

II

9/8/1981

NV ORGANON

TESTOSTERONE PROPIONATE

4278

II

9/17/1981

SIGMA F AND D DIV LTD

GLUTAHIONE, FREE ACID REDUCED FORM

4279

II

9/23/1981

ROUSSEL-UCLAF

PREDNISOLONE SUCCINATE (PREDNISOLONE HYDROGEN SUCCINATE)

4280

II

9/22/1981

GANES CHEMICALS INC

DISOPYRAMIDE PHOSPHATE,BULK FORM-MANUF IN CARLSTADT, NJ FACILITIES

4281

II

9/23/1981

INDUSTRIA FARMACEUTICA SERONO

HUMAN CHORIONIC GONADOTROPIN (HCG)

4282

II

9/10/1981

JT BAKER CHEMICAL CO

CHLOROPROCAINE HCL MFG IN PHILLIPSBURG, NJ FACILITIES

4283

8/31/1981

SCHERING AG

FACILITIES FOR THE MFG OF LIQUID & SOFT GELATIN CAPSULE PRODUCTS

4284

II

10/8/1981

FOREST LABORATORIES INC

SODIUM FLUORIDE 22MG, SUSTAINED ACTION CAPSULES MFG IN INWOOD, NY

4285

II

10/2/1981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

DEXAMETHASONE BASE, USP XX

4286

III

9/9/1981

DEXTER CORPORATION

COATINGS IN 8500-A--AND 8510-A SERIES--MFG WAUKEGAN, ILLINOIS FACILS

4287

II

10/2/1981

MERCK KGAA

PRAZIQUANTEL 2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11B-4HPYRAZINO-(2,1-A)

4288

II

10/4/1981

SIFAVITOR SRL

PROPRANOLOL HCL

4289

II

9/29/1981

LEK PHARMACEUTICAL & CHEMICAL WORKS

CALCIUM (GLUCOHYTONATE) GLUCEPTATE

4290

II

10/8/1981

LUSOCHIMICA S P A

OXYMETAZOLINE HCL USP XX

4291

II

9/25/1981

TEVA PHARMACEUTICAL INDUSTRIES LTD

SULFAMETHOXAZOLE

4292

10/21/1981

BIOCRAFT LABORATORIES INC

FOR NON-PENICILLIN PRODS FACILS A BANK STREET LOCATION

4293

II

9/29/1981

LEK PHARMACEUTICAL & CHEMICAL WORKS

LITHIUM CARBONATE

4294

II

9/29/1981

SOCIETA ITALIANA CORTICOSTEROIDI SPA

BETAMETHASONE NA PHOSPHATE

4295

II

10/19/1981

HUHTAMAKI OY LEIRAS PHARMACEUTICALS

DISOPYRAMIDE PHOSPHATE BULK FORM

4296

II

8/28/1981

ORGANICHEM CORP

SUPROFEN AS MFG IN RENSSELAER, NY FACILITIES

4297

II

9/29/1981

LEK PHARMACEUTICALS DD

SILVER SULFADIAZINE

4298

II

10/22/1981

SCHERING PLOUGH AVONDALE CO

DEXCHLORPHENIRAMINE MALEATE

4299

10/7/1981

FLOW LABORATORIES INC

SOP FOR STORAGE & DISTRIB. OF CLINICAL DRUGS-MCLEAN,VA.-(NCI CONTRACT)

4300

8/14/1981

SPEC, STANDARD CONTROL PROCEDS & TEXT METHODS FOR INACTIVE INGREDS.

4301

10/27/1981

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
AINC

4302

II

10/19/1981

ACIC LTD

PROCEDURES FOR THE MANUF OF PROCHLORPERAZINE EDISYLATE

4303

II

9/29/1981

LEK PHARMACEUTICAL & CHEMICAL WORKS

3-HYDROXYMETHYLNITROFURANTOIN

4304

II

9/24/1981

ACF CHEMIEFARMA NV

SULFAMETHOXAZOLE USP XX

MANUF OF MICROSPOROUS MEMBRANE FLA STOCK PRODUCTS FOR PHARM USE

Page 117

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4305 A
II
10/22/1981
SCHERING PLOUGH AVONDALE CO

SUBJECT
CHLORPHENIRAMINE MALEATE

4306

III

10/5/1981

ALUMINUM COMPANY OF AMERICA

SPECIFS FOR ALCOA CLOSURE STRUCTURES IN THE 6000 SERIES

4307

II

10/19/1981

ACIC LTD

PROCEDURES FOR THE MANUF OF ALLOPURINOL

4308

II

8/28/1981

SCHERING AG

MEGLUMINE (D(-) N- METHYLGLUIAMINE)

4309

II

10/23/1981

SIGMA F AND D DIV LTD

N-(2-MERCAPTOPROPIONYL) GLYCINE

4310

9/30/1981

AMERICAN PLASTICS CO INC

PERSONNEL FACILS & GEN OPER PROCEDS - INDEPENDENCE MISSOURI LOCATION

4311

II

10/19/1981

ACIC LTD

PROCEDURES FOR MFG OF AMITRIPTYLINE HCL

4312

II

10/21/1981

SCHERING PLOUGH AVONDALE CO

DEXBROMPHENIRAMINE MALEATE

4313

II

11/3/1981

COPPERHEAD INVESTMENTS INC

SDM 27 (10% NITROGLYCERIN IN PROPYLENE GLYCOL) MANUFACTURED IN TAMAQUA, PA.

4314

II

11/9/1981

AZIENDE CHIMICHE RIUNITE

LONIDAMINE

4315

II

10/19/1981

ACIC LTD

PROCEDURES FOR THE MFG OF CHLOROTHIAZIDE

4316

11/6/1981

TOXICOL-SISA INC

PRROGENICITY TESTING OF THALLOUS CHLORIDE T1-201 INJECT

4317

II

10/15/1981

SCHERING PHARMACEUTICAL CORPORATION

BETAMETHASONE USP

4318

11/5/1981

ISP

FACILITY FOR BULK PHARMS. (FORMERLY ALBANY INTER. CORP)

4319

II

10/19/1981

ACIC LTD

PROCEDURES FOR THE MFG OF DIPYRIDAMOLE

4320

II

11/10/1981

SHERWIN-WILLIAMS CO

4-ETHYL-2-NITROPHEND AS MFG IN THE CHICAGO ILLNOIS FACILITIES

4321

II

10/19/1981

ACIC LTD

PROCEDURES FOR MFG OF FUROSEMIDE

4322

II

10/8/1981

SUNEETA LABORATORIES LTD

PROBENECID USPXX

4323

II

11/10/1981

ALBEMARLE CORP

LIDOCAINE USP XX AND HCL USP XX MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

4324

II

10/1/1981

SIGMA F AND D DIV LTD

5-BROMO-2'-DEOXYURIDINE

4325

II

10/19/1981

ACIC LTD

CHLOROTHIAZIDE PROCEDURES FOR MFG OF

4326

9/2/1981

FLESSEN PLASTIC INC

PERSONNEL, FACILS & GEN OPER PROCEDS AT THE GREENVILLE, N.C. LOCATION

4327

11/10/1981

PHARMACIA AND UPJOHN INC

A THE CHRISTIANSTED, ST. CROIX LOCATION

4328

II

10/2/1981

PROCOS SPA

PHENELZINE SULFATE

4329

II

10/19/1981

ACIC LTD

PROCEDURES FOR THE MANUF OF IBUPROFEN

4330

II

10/23/1981

ORGAMOL SA

LIDOCAINE BASE / LIDOCAINE HCL

4331

II

10/19/1981

ACIC LTD

IMIPRAMINE HCL

4332

III

9/23/1981

PACKAGING MATERIALS IN THE HS-SERIES AS MANUF IN NUTLEY, NJ FACILS

4333

II

11/25/1981

TECHNICAL COATINGS CO SUB OF BENJAMIN


MOORE & CO
DIOSYNTH BV

4334

II

10/28/1981

ACRAF

DAPIPRAZOLE

4335

II

10/19/1981

ACIC LTD

MANUF PROCEDURES FOR PROCHLORPERAZINE MALEATE

4336

II

10/30/1981

D M PHARMACEUTICALS INC

CAPSULES --ACETAMINOPHEN-325MG; CAFFEINE 40MG; & BUTALBITAL 50MG

4337

II

10/21/1981

MK-803 (MEVINOLIN) AS SYNTHESIZED-PILOT PREPARATION OF RAHWAY NJ PLANT

4338

II

10/16/1981

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
FABBRICA ITALIANI SINTETICI SPA

4339

II

10/19/1981

ACIC LTD

PROCEDURE FOR THE MANUF OF SULFINPYRAZONE

4340

III

9/23/1981

PACKAGING MATERIALS IN THE FT-SERIES-PAPER HEAT SEAL PRODS.-NUTLEY,NJ

4341

II

11/18/1981

TECHNICAL COATINGS CO SUB OF BENJAMIN


MOORE & CO
BASF PHARMA EVIONNAZ SA

METHDILAZINE HYDROCHLORIDE

FURAZOLIDONE BULK

CARBAMAZEPINE

Page 118

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4342 I
II
10/19/1981
ACIC LTD

SUBJECT
PROCEDURES FOR THE MANUF OF TRIFLUOPERAZINE HCL

4343

III

8/5/1981

BARNHARDT MANUFACTURING CO

COTTON & RAYON PHARMACEUTICAL COILS AS PRODUCED IN THE MA FACILS.

4344

II

10/30/1981

SHOWA DENKO KK

SPECIFIC DRUG SUBSTANCE-EG-626

4345

II

10/27/1981

SALK INSTITUTE

COMPOUND [IMBZL)-D-HIS 6, PRO 9-NET}-GNRH

4346

II

10/19/1981

ACIC LTD

PROCEDURES FOR THE MANUF OF THIORIDAZINE HCL

4347

II

12/3/1981

ZENECA PHARMACEUTICALS

LEUKOTRIENES-MANUF IN WILMINGTON DEL. FACILITIES

4348

II

12/8/1981

GANES CHEMICALS INC

BETHANECHOL CHLORIDE AS MANUF IN THE CARLSTADT, NJ FACILITIES

4349

II

12/2/1981

GLAXOSMITHKLINE

CLAVULANATE POTASSIUM, BULK FORMS-MANUF AT BEECHAM IN SUSSEX, ENGLAND

4350

III

12/4/1981

NASHUA CORP

MANUF OF BP-1 A THE MERRIMACK NEW HAMPSHIRE LOCATION

4351

II

12/11/1981

CIPLA LTD

TRIOXSALEN, PROCEDS.FOR THE MFG OF

4352

II

11/19/1981

MALLINCKRODT INC

SOD. IODIDE I-123 RADIOCHEM. SOL.-BURLINGAME,CA-(FORMERLY RADPHARM

4353

II

11/30/1981

SIGMA F AND D DIV LTD

MELATONIN

4354

II

11/25/1981

GRINDSTED PRODUCTS

SODIUM ASCORBATE

4355

II

11/6/1981

HOECHST AG

ACETAMINOPHEN, BULK FORM

4356

10/15/1981

LABOCHIM

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4357

III

11/20/1981

ALZA CORP

ALZAMER BIOERODIBLE POLYMERIC MATERIALS--PRODUCED IN THE PALO ALTO CA.

4358

II

10/20/1981

BASF PHARMACHEMIKALIEN GMBH CO KG

(-)-EPHEDRINE SALTS

4359

II

11/25/1981

GRINDSTED PRODUCTS

THIAMINE HCL (VITAMINE B1)

4360

II

10/15/1981

LABOCHIM

TOLBUTAMIDE

4361

II

12/8/1981

SIGMA F AND D DIV LTD

DIAMINE OXIDASE

4362

II

11/13/1981

RUETGERS-NEASE CHEMICAL COMPANY INC

SUPROFEN AS MANUF IN THE STATE COLLEGE PENN. FACILITIES

4363

II

11/9/1981

PLANTEX LTD CHEM AND PHARM WORKS

TRIAMTERENE U.S.P.

4364

11/20/1981

VITAGEN COATING INC

PERSONNEL, FACILS & GEN OPER PROCEDS A THE UPPER SADDLE RIVER, NJ LOC

4365

II

9/22/1981

SCHERING AG

IPODATE SODIUM

4366

II

11/25/1981

GRINDSTED PRODUCTS

BUTABARBITAL SODIUM

4367

II

12/14/1981

MALLINCKRODT PHARMS DIV MALLINCKRODT INC

STRONTIUM NITRATE PURIFIED MNFG ST.LOUIS, MISSOURI FACILITIES

4368

II

12/8/1981

SIGMA F AND D DIV LTD

CATALASE

4369

II

12/8/1981

CAMBREX PROFARMACO MILANO SRL

METHYCLOTHIAZIDE

4370

III

10/28/1981

HOECHST CELANESE CORP

HOSTALEN (R) GF-7750 M-POLYETHYLENE RESIN OLEFIN POLYMERS-PASADENA, TX

4371

III

11/20/1980

ARMSTRONG PRODUCTS CO

SIDE STRIPE POWDERS IN 77-AP SERIES MNFG WARSAW,IN FACILITIES

4372

II

11/25/1981

BASF HEALTH AND NUTRITION AS

ASCORBIC ACID

4373

II

11/10/1981

PIERREL SPA

L-AMINO ACIDS

4374

II

12/21/1981

MALLINCKRODT INC

INDIUM CHL IN 111 RADIOCHEM. SOL. AS PRODUCED IN BURLINGAME CA. FACILS

4375

II

10/8/1981

MONSANTO COMPANY

DEQUEST 2041-D (METHYLENE PHOSPHORIC ACID (EDTEMP)ETHYLENEDIAMIN TETRA

4376

II

11/12/1981

CAMBREX PROFARMACO MILANO SRL

TEMAZEPAM

4377

III

10/30/1981

EXXONMOBIL CHEMICAL CO

LOW DENSITY POLYETHYLENE RESINS MANUFACTURED IN BEAUMONT, TEXAS.

4378

II

11/25/1981

GRINDSTED PRODUCTS

GRINDTAB MEPRO 246

4379

II

12/16/1981

KOR INC

13C-AMINOPYRINE PROCESSED CAMBRIDGE, MA., SECOND SUBMISSION 12-16-81

Page 119

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4380 I
II
10/26/1981
PROCOS SPA

SUBJECT
VALPROIC ACID

4381

II

9/14/1981

DINAMITE DIPHARMA SPA

4382

II

12/7/1981

ALTANA LOMBERG CHEMISCHE FABRIK

METOCLOPRAMIDE HYDROCHLORIDE MANUFACTURED IN THE BARANZAE DI BOLLATE


(MILAN), ITALY FACILITIES
URAPIDIL DRUG SUBSTANCE

4383

11/17/1981

CYANAMID GREAT BRITAIN LTD

4384

II

12/17/1981

SALK INSTITUTE

4385

II

11/6/1981

ETOPOSIDE (VP 16-213) (ETHYLIDENE)

4386

II

6/25/1982

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
FABBRICA ITALIANI SINTETICI SPA

4387

II

11/23/1981

LONZA INC

CHORHEXIDINE DIACETATE BP 73 MFG IN VISP, SWITZERLAND

4388

II

11/25/1981

GRINDSTED PRODUCTS

PYRIDOXINE HYDROCHLORIDE

4389

II

12/17/1981

DIOSYNTH BV

VECURONIUMBROMIDESECOND SUBMISSION 12-17-81

4390

II

1/14/1982

BETA-CAROTENE CAPS., 30MG AS PRODUCED IN NUTLEY,NJ FACILITIES

4391

II

1/5/1982

ROCHE VITAMINS AND FINE CHEMICALS DIV


HOFFMAN LAROCHE INC
UNION CARBIDE CORPORATION

4392

III

1/14/1982

OLIVER TOLAS HEALTHCARE PACKAGING

HEAT SEAL LABEL MATERIAL AS PRODUCED IN PENNSYLVANIA

4393

II

1/14/1982

LINSON LTD

FLUPHENAZINE HYDROCHLORIDE, BULK FORM

4394

II

1/18/1982

CHEMI SPA

INDOMETHACINE USP XX

4395

II

11/25/1981

DUPONT NUTRITION BIOSCIENCES APS

BUTALBITAL

4396

II

12/24/1981

VIS FARMACEUTICA

METHYLCLOTHIAZIDE

4397

II

12/22/1981

HOVIONE FARMACIENCIA SA

BETAMETHASONE 17-VALERATE

4398

II

12/15/1981

KV PHARMACEUTICAL CO

KETOPROFEN S.R. CAPS., 150MG & 200MG-MFGR IN ST. LOUIS, MO. FOR IVES

4399

II

12/18/1981

WYCKOFF CHEMICAL CO INC

DIPHENHYDRAMINE HCL USP XX-MANUF IN THE KALAMAZOO, MICHIGAN FACILS

4400

II

12/24/1981

NAPP CHEMICALS INC

SULFACETAMIDE

4401

II

11/25/1981

GRINDSTED PRODUCTS

SULFAMERAZINE

4402

II

12/23/1981

LONZA RIVERSIDE

HYDROXYAMPHETAMINE HYDROBROMIDE

4403

II

12/22/1981

DM GRAHAM LABORATORIES INC

ISORBIDE DINITRATE C.R. CAPS 80MG

4404

II

1/12/1982

KV PHARMACEUTICAL CO

NICOTINIC ACID CAPSULES 125,250, & 500MG

4405

12/21/1981

MALLINCKRODT INC

4406

II

1/15/1982

SCHERING AG

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN PETTEN, HOLLAND FACILITY.
NANDROLONE PHENPROPIONATE,17 B-(3-PHENYLPROPIONYLOXY-)4-ESTREN-3-ONE

4407

II

11/25/1981

BASF HEALTH AND NUTRITION AS

RIBOFLAVINE

4408

II

1/15/1982

LINSON LTD

FLUMETHIAZIDE AS MANUF BY SWORDS LABS., LTD OF IRELAND

4409

1/18/1982

ORGANON OSS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4410

II

1/7/1982

HOECHST AG

GONADORELIN BULK DRY SUBSTANCE

4411

1/22/1982

POLYSCIENCES INC

4412

II

12/18/1981

KV PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE IN


WARRINGTON, PA.
HEXASTA CAPS, 50 & 100MG-MFGR IN ST. LOUIS, MO. FOR IVES LABS INC

4413

II

1/11/1982

TROPONWERKE GMBH CO KG

CROTAMITON

4414

II

12/21/1981

GRINDSTED PRODUCTS

SULFAMERAZINE SODIUM

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GREAT BRITAIN.
CORTICOTROPIN RELEASING FACTOR (CRF)

QUAZEPAM--BULK DRUG

LECITHIN (BOLEC PC 80+)

Page 120

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4415 I
II
1/20/1982
HOECHST CELANESE CORP

SUBJECT
DOPAMINE HCL, BULK DRUG SUBSTANCE-MFGR IN THE COVENTRY, R.I. FACILITY

4416

II

1/23/1982

LABORATORIO CHIMICO INTERNAZIONALE SPA

CARISOPRODOL

4417

II

1/27/1982

NATL INST HLTH NCI

SANGIVAMYCIN HCL (NSC 143648) AS PREPARED BY THE FREDERICK CANCER RES.

4418

II

1/11/1982

E MERCK

PRODUCT 502006, VITAMIN K PHYTONADIONE

4419

II

12/21/1981

GRINDSTED PRODUCTS

SULFAMETHAZINE SODIUM

4420

II

2/3/1982

TEVA PHARMACEUTICAL INDUSTRIES LTD

DESONIDE

4421

II

2/1/1982

DIPHENIDOL HCL AS MFGR IN THE PENNA. FACILS

4422

II

2/1/1982

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
SWORDS LABORATORIES LTD

4423

II

2/3/1982

SANOFI CHIMIE

FLUOROMETHOLONE

4424

1/29/1982

PHARMACEUTICAL RESEARCH INSTITUTE

4425

II

1/20/1982

SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS)

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WORTHINGTON, OHIO.
DISOPYRAMIDE PHOSPHATE

4426

12/21/1981

NORAMCO INC

4427

III

10/19/1981

VALSPAR CORP

4428

III

12/22/1981

FGC ACQUISITION COMPANY LLC

4429

1/25/1982

YAMANOUCHI PHARMACEUTICAL COMPANY LTD

CLOSURES FOR USE IN PACKAGING OF PHARMACEUTICAL PRODUCTS MANUFACTURED IN


BROOKLYN, NEW YORK
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4430

II

2/3/1982

LONZA INC

FLAVOXATE HYDROCHLORIDE MFG. PENNSYLVANIA FACILITY

4431

II

1/21/1982

BROMODIPHENHYDRAMINE HCL BULK

4432

III

1/27/1982

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
HELVOET PHARMA NV

4433

II

12/21/1981

NORAMCO INC

ZOMEPIRAC SODIUM DIHYRATE AS MFG., AHENS, GA. FACILITY

4434

II

2/17/1982

SODIUM THIAMYLAL AS MANUFACTURED IN NORTH CHICAGO ILLINOIS FACILITY

4435

II

1/29/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
COSMA SPA

4436

II

2/4/1982

HYDROCHLOROTHIAZIDE IN PHIL PA

4437

II

1/25/1982

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
MONSANTO COMPANY

4438

II

2/18/1982

CAMBREX PROFARMACO MILANO SRL

OXAZEPAM

4439

II

4/14/1981

BENE PHARMACHEM GMBH AND CO KG

PENTOSAN POLYSULFATE SP54

4440

II

2/18/1982

BLASCHIM SPA

IBUPROFEN

4441

II

12/21/1981

NORAMCO INC

TOLMETIN SODIUM DIHYDRATE AS MANUF IN ATHENS, GA.

4442

II

2/18/1982

ACIC LTD

CHLORPROMAZINE HCL--ACIC PROCEDURES FOR THE MANUF.

4443

II

2/5/1982

DAIICHI SEIYAKU CO LTD

CETRAXATE HYDROCHLORIDE MFG. IN OSAKA, JAPAN FACILITY

4444

II

6/22/1982

SANOFI INC

AMIODARONE HCL

4445

III

2/2/1982

HELVOET PHARMA ITALIA SPA

BLACK CHLOROBUTYL RUBBER STOPPERS S 450/60

4446

2/10/1982

FARMA FOOD

4447

2/5/1982

AJINOMOTO USA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BIRKEROED, DENMARK.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF CRYSTALLINE AMINO ACIDS IN RALEIGH, NORTH CAROLINA.

TRIFLUPROMAZINE & TRIFLUPROMAZINE HCL AS MANUF IN SWORDS LABS.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AHENS, GEORGIA.
LAMINAING ADHESIVES AS PRODUCED IN THE ILLINOIS FACILITIES

RUBBER COMPOUNDS

HYDROXYZINE HCl

EMA AS MANUFACTURED A THE LULING, LOUISIANA FACILITIES

Page 121

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4448 I
II
2/5/1982
DAIICHI SEIYAKU CO LTD

SUBJECT
CETRAXATE HCL CAPSULES MFG IN THE SHIZUOKA, JAPAN FACILITY

4449

2/11/1982

PHARMICHEM TESTING SERVICES INC

4450

II

3/3/1982

LILLY RES LABS DIV ELI LILLY CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TINLEY PARK, ILLINOIS.
PROTAMINE S04?MANUF IN FACILS ON SO. DELAWARE ST., INDIANAPOLIS, IND.

4451

2/25/1982

SIGMA F AND D DIV LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4452

IV

3/4/1982

NAARDEN INTERNATIONAL USA INC

FRAGRANCES: 1. FRAGRANCE N-7043

4453

II

2/12/1982

ISF

ISF 2469 (CADRALAZINE)

4454

III

6/29/1981

REXENE CORP

POLYPROPYLENE RESINS IN THE PP 23M SERIES

4455

II

3/4/1982

SIGMA F AND D DIV LTD

TYRAMINE HYDROCHLORIDE

4456

II

2/22/1982

ISOPROPAMIDE IODIDE AS MFGR IN PENN. FACILS.

4457

II

2/8/1982

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
ORGAMOL SA

4458

II

2/24/1982

LEK PHARMACEUTICAL & CHEMICAL WORKS

PROPRANOLOL HCL

4459

II

3/3/1982

SIGMA F AND D DIV LTD

DL-6-METHYL-5,6,7,8-TETRAHYDROPTERINE

4460

II

3/11/1982

CYCLO PRODUCTS INC

THIORIDAZINE HCL AS MANUF IN THE L.A., CALIF FACILITY

4461

II

2/25/1982

LABORATOIRES SERONO SA

PROFASI (HCG) HUMAN CHORIONIC GONADOTROPIN)

4462

II

3/8/1982

H FINZELBERG'S NACHFOLGER

CASANTHRANOL --FACILITIES (MANUFACTURING)

4463

II

2/24/1982

BASF AKTIENGESELLSCHAFT

7,-8-DIDEHYDRO-RETINOIC ACID

4464

IV

3/5/1982

GATTEFOSSE SAS

LABRAFIL M 1944 CS MANUFACTURED IN CEDEX,FRANCE

4465

3/18/1982

CENTRAL PHARMACEUTICALS INC

4466

II

3/17/1982

LONZA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SEYMOUR, IND.
CARSONON L-4--MANUF IN LONG BEACH, CA FACILS

4467

5/19/1985

LABORATOIRES SERONO SA

4468

II

1/25/1982

TAKEDA CHEMICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AUBONNE, SWITZERLAND (FORMERLY 4473 AND 4547).
PHARMACEUTICAL PROCESSING OF CEFMENOXINE HCL FOR INJECT -HIKARI PLANT

4469

2/25/1982

FERROSAN AB

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

4470

3/10/1982

QUINTILES SCOTLAND LTD

FOR THE SYNTEX RES. CTR. IN RICCARTON, EDINBURGH, SCOTLAND

4471

II

3/8/1982

H FINZELBERG'S NACHFOLGER

CASANTHRANOL

4472

II

3/17/1982

LONZA INC

CARSONON L-23

4473

3/10/1982

LABORATOIRES SERONO SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

4474

II

3/18/1982

SIGMA F AND D DIV LTD

GLUCOSIDASE

4475

II

3/12/1982

DELMAR CHEMICALS INC

ESMOLOL (FORMERLY ASL - 8052)

4476

II

1/25/1982

TAKEDA CHEMICAL INDUSTRIES LTD

TAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION

4477

IV

2/25/1982

WP DEVELOPMENT AB

MULTIPOR COATING POLYMER AS MANUFACTURED IN MALMO, SWEDEN

4478

II

3/10/1982

LABORATOIRES SERONO SA

ASELLACRIN (SOMAROPIN)

4479

II

3/24/1982

SIGMA F AND D DIV LTD

ANGIOTENSIN I

4480

3/19/1982

MEIJI SEIKA KAISHA LTD

4481

III

3/18/1982

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GIFU PLANT, JAPAN.
POLYVINYL ACETATE PHTHALATE(PVAP)AS MFG.IN TORONTO,ONTARIO FACILITIES

ORPHENADRINE CITRATE/ORPHENADRINE HCL (TRANSFER TO DMF 4811 1/13/88)

Page 122

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4482 I
II
1/15/1982
SCHERING AG

SUBJECT
NANDROLONE PHENPROPIONATE

4483

II

3/11/1982

INDUSTRIA FARMACEUTICA SERONO

PURE URINARY FSH ALSO REFERRED TO AS UROFOLLITROPHIN AND PERGONAL FSH

4484

III

2/3/1982

SOLVAY & CIE SA

HD-PE HOMOPOLYMER ELTEX A 1050 P

4485

3/19/1982

MEIJI SEIKA KAISHA LTD

4486

II

4/5/1982

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OSAKA CITY, JAPAN.
FLUOCINOLONE ACETONIDE

4487

III

4/2/1982

TRAVENOL LABORATORIES INC

PROD. OF FROZEN PARENTERAL INJECTS IN PLASTIC CONTAINERS

4488

II

4/5/1982

LABORATORIOS JULIAN DE MEXICO SA

HYDROCHLOROTHIAZIDE

4489

II

2/2/1982

DIOSYNTH BV

HYALURONIDASE

4490

4/2/1982

LYPHOMED INC

4491

3/29/1982

WYCKOFF CHEMICAL CO INC

4492

II

4/6/1982

SIGMA F AND D DIV LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ORLANDO, FLORIDA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SOUTH HAVEN, MICHIGAN.
BIOACTIVE PEPTIDES (FORMERLY SOMATOSTATIN)

4493

II

4/5/1982

CLONIDINE HCL

4494

II

3/10/1982

4495

II

2/25/1982

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
SMITH KLINE & FRENCH LABS DIV SMITHKLINE
BECKMAN CORP
LABORATORIE GUERBET

4496

4/6/1982

MY K LABORATORIES INC

4497

II

3/15/1982

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SKOKIE, ILL.
DEXAMETHASONE SODIUM PHOSPHATE USP XX

4498

III

3/12/1982

IMPERIAL CHEMICAL INDUSTRIES PLC

MELINEX 800 AND ALKAHENE MASTERBACH 0121 WHITE 1036

4499

II

4/15/1982

DM GRAHAM LABORATORIES INC

ACTIFED S.A. BRAND OF PSEUDOEPHEDRINE HCL 120MG & TRIPTOLIDINE 5MG

4500

3/25/1982

MCNEIL PHARMACEUTICAL DIV MCNEILAB INC

4501

III

3/10/1982

BP CHEMICALS LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SPRING HOUSE, PENNSYLVANIA.
RIGIDEX TYPE HPDE POLYMERS

4502

III

2/17/1982

ALATHON 3120 RESIN--ELVAX (R) RESINS MANUFACTURED IN DELAWARE.

4503

III

2/18/1982

EI DUPONT DE NEMOURS AND CO DIAGNOSTIC


IMAGING DIV
JOHNSON LAMINATING AND COATING INC

4504

II

3/18/1982

SOCIETE SUISSE DES EXPLOSIFS

NITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE

4505

II

4/26/1982

ALBEMARLE CORP

PARA-AMINOHIPPURIC ACID USP XX - MANUF IN SOUTH HAVEN, MICHIGAN

4506

II

3/18/1982

TAKEDA PHARMACEUTICAL COMPANY LTD

PYRIDOXINE HYDROCHLORIDE

4507

II

4/14/1982

ELANCO SA

BENOXAPROFEN TECHNICAL

4508

II

4/6/1982

HYDROCHLOROTHIAZIDE-MANUF IN NORTH CHICAGO, ILLINOIS FACILITIES

4509

4/4/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
KALI-CHEMIE PHARMACEUTICA GMBH

4510

II

4/19/1982

DIOSYNTH BV

METHDILAZINE

4511

4/20/1982

HYGENIC CORP

FOR NATURAL LATEX SHEETING-MFGR IN AKRON, OHIO FACILS.

4512

II

4/23/1982

ROUSSEL-UCLAF

TESTOSTERONE (DIOSYNTH BV)

4513

II

3/29/1982

DIBENZOSUBERONE

4514

II

4/16/1982

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
COSMA SPA

DOXEPIN HCL AS MANUF IN THE PENN. FACILS.


IOXAGLIC ACID MANUFACTURED A AULNAY, FRANCE

LAMINATED PACKAGING MATERIALS MANUFACTURED IN CARSON CITY.

(PILOT PLANT)

HYDROXYZINE PAMOATE AS MANUFACTURED IN BERGAMO ITALY

Page 123

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4515 I
II
5/7/1982
MALLINCKRODT INC

SUBJECT
COMPAP (TM)--MFGR BY DR. MADIS LABORATORIES, INC --SO. HACKENSACK,NJ

4516

II

5/4/1982

SCHERING AG

6A-METHYLPREDNISOLONE-21-ACETATE

4517

II

5/4/1982

CAMBREX PROFARMACO MILANO SRL

LORAZEPAM

4518

IV

5/17/1982

KABI PHARMACIA HEPAR INC

EGG YOLK PHOSPHATIDE--MFGR IN THE FRANKLIN, OHIO FACILS

4519

II

4/30/1982

ABBVIE INC

PRAMOXINE HCL AS MANUFACTURED IN THE NORTH CHICAGO, ILLINOIS FACILITIES

4520

4/26/1982

DUPHAR BV

4521

II

4/7/1982

SIGMA F AND D DIV LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OLST, THE NETHERLANDS.
ALPHA-LINOLENIC ACID

4522

3/12/1982

SPECTOR MOLDING INC

FACILITIES AND GENERAL OPERATING PROCEDS

4523

II

5/3/1982

COSMA SPA

METOCLOPRAMIDE HCL AS MANUFACTURED IN ITALY

4524

II

5/10/1982

PHARMACIA AND UPJOHN SUB PFIZER INC

DEXAMETHASONE USP MICRONIZED AS MANUF IN KALAMAZOO MI FACILITY

4525

II

4/20/1982

AMRI RENSSELAER INC

MEPERIDINE HCL USP-MANUF IN RENSSELAER,NY FACILITIES

4526

II

4/20/1982

DIOSYNTH BV

METHANDRIOL DIPROPIONATE

4527

II

4/26/1982

DUPHAR BV

YUTOPAR (RITODRINE HCL) TABLETS & INJECTION FORMS,OLST,HOLLAND

4528

III

5/11/1982

ABBOTT LABORATORIES HOSP PRODUCTS DIV

SPECS FOR CONTAINER & CLOSURE USED IN MANUF OF SVP & LVP PRODUCTS

4529

II

5/5/1982

SIGMA F AND D DIV LTD

D-BIOTIN

4530

4/16/1982

SP INDUSTRIES

4531

II

4/7/1982

4532

II

5/10/1982

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EDISON, NEW JERSEY.
RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA DIPHENYLHYDANTOIN
SPA
PFIZER INC
DEXAMETHASONE ACETATE USP ANHYDROUS MICRONIZED-MANUF IN KALAMAZOO MI

4533

4/9/1982

MAR-KAY PLASTICS INC

PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES

4534

II

5/7/1982

SCHERING AG

6-METHYLPREDNISOLONE-21-HEMISUCCINATE

4535

II

5/7/1982

ABBVIE INC

CLORAZEPATE DIPOTASSIUM (TRANXENE) AS MANUFACTURED IN N. CHICAGO, ILL FACIL

4536

5/14/1982

AMERICAN PHARMACEUTICAL PARTNERS, INC.

STERILE PROCESSING FACILITY IN MELROSE PARK, IL

4537

II

4/7/1982

DIPHARMA FRANCIS SPA

HYDROFLUMETHIAZIDE USP

4538

II

4/7/1982

4539

II

5/17/1982

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA DIPHENYLHYDANTOIN SODIUM SALT


SPA
R MASON CHEMICALS LTD
SELENIUM DISULFIDE

4540

II

5/18/1982

SIGMA F AND D DIV LTD

DIETHYLENETRIAMINEPENTAACETIC ACID (CLINICAL STUDY BY D.HONEYCHURCH)

4541

III

4/20/1982

PACKAGING MATERIALS AS MFG IN ROCHESTER, NEW YORK.

4542

5/14/1982

AMERICAN PACKAGING CORP EXTRUSION


LAMINATING AND COATING DIV
UG CLOSURES & PLASTICS LTD

4543

III

5/20/1982

RJR PACKAGING

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF BOTTLES AND CLOSURES.
PUSH-THROUGH BLISTER BACKING MATERIALS PRODUCED WINSTON-SALEM, N.C.

4544

III

5/21/1982

SELIG SEALING PRODUCTS INC

CAP LINERS MANUFACTURED IN FORREST, ILLINOIS.

4545

II

5/13/1982

SCHERING AG

PIRAZOLAC

4546

II

5/18/1982

SIGMA F AND D DIV LTD

PYRUVIC ACID SODIUM SALT

4547

5/24/1982

LABORATOIRES SERONO SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

4548

3/18/1982

LEO PHARMACEUTICAL PRODUCTS LTD

FACILS & CONTROLS USED IN MFGR OF SODIUM FUSIDATE CAPS.

Page 124

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4549 I
I
5/11/1982
KEY PHARMACEUTICALS INC SUB SCHERING
PLOUGH CORP
4550 I
I
4/23/1982
ABBOTT LABORATORIES PHARMACEUTICAL
PRODUCTS DIV
4551 I
II
6/7/1982
MEDIMPEX NORTHAMERICA INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MIAMI, FLORIDA ON 176 ST.
QUALITY ASSURANCE OPERATIONS STANDARDS

4552

II

6/7/1982

ACEPAM

4553

II

6/2/1982

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
DURHAM PHARMACEUTICALS LLC

4554

III

6/7/1982

PHOENIX CLOSURES INC

CLOSURES & LINING MANUFACTURED IN NAPERVILLE, ILLINOIS.

4555

II

3/17/1982

AJINOMOTO AMINOSCIENCE LLC

AMINO ACIDS MANUFACTURED IN RALEIGH, NORTH CAROLINA.

4556

IV

5/10/1982

GATTEFOSSE ESTABLISSEMENTS

PRECIROL ATO 5.

4557

II

5/25/1982

HERCULES INC

PENTAERYTHRITOL TETRANITRATE DILUTED (PETN)

4558

5/25/1982

PLOUGH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4559

4/29/1982

AH ROBINS CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

4560

III

4/5/1982

ST GOBAIN PERFORMANCE PLASTICS CORP

TFE/POLYETHYLENE LAMINATES AS PRODUCED IN THE WAYNE NEW JERSEY PLANT

4561

II

5/12/1982

FINE CHEMICALS CORP PTY LTD

VINCRISTINE SULPHATE/VINBLASTINE SULPHATE

4562

4563

II

6/18/1982

ALTANA INC

URAPIDIL AMPULES AS PRODUCED IN THE HICKSVILLE, NY FACILITY

4564

II

5/14/1982

MEIJI SEIKA KAISHA LTD

NEOTHRAMYCIN

4565

4566

III

6/9/1982

4567

III

2/10/1982

4568

II

4569

IV

4570

4571
4572

OXYTOCIN-MANUF BY CHEMICAL WORKS OF GEDEON RICHTER LTD-BUDAPEST

AZONE

NOT AN ASSIGNED NUMBER

NOT AN ASSIGNED NUMBER


TFE/14B RUBBER LAMINATES AS PRODUCED IN HOOSICK FALLS AND POESTENKILL NY

4/23/1982

SAINT-GOBAIN PERFORMANCE PLASTICS


CORPORATION
ROLLING DIV NATIONAL ALUMINUM UNIT OF
NATIONAL STEEL CORP
PHARMA-WALDHOF GMBH

4/28/1982

NEWMANN BUSLEE & WOLFE INC

NATURAL & ARTIFICIAL FLAVOR #390170 & 365070

II

5/21/1982

FERMION OY

TRAZODONE HYDROCHLORIDE MANUFACTURED IN OULU, FINLAND.

IV

6/10/1982

HENKEL CORP

PRESSURE SENSITIVE ADHESIVES MANUFACTURED IN PLAINFIELD, NEW JERSEY.

III

6/9/1982

ST GOBAIN PERFORMANCE PLASTICS CORP

TFE SILICONE LAMINATES AS PROD IN THE WAYNE, NJ PLANT

4573

II

5/4/1982

PHARMA-WALDHOF GMBH

ADENOSINE-5-MONOPHOSPHORIC ACID, PRODUCT #2030

4574

II

6/2/1982

ICI AMERICAS INC

G-100 DIMETHYL ISOSORBIDE/ANIMAL STUDIES-IN VITRO BLOOD COMPA TESTS

4575

II

4/29/1982

CIECH POLFA

SULFAQUINOXALINE

4576

II

4/21/1982

CILAG CHEMIE AG

SUPROFEN

4577

II

4/30/1982

MEIJI SEIKA KAISHA LTD

NEOTHRAMYCIN, BULK

4578

II

6/9/1982

GLAXOCHEM LIMITED

BETAMETHASONE VALERATE MANUFACTURED IN MONTROSE, ANGUS, SCOTLAND.

4579

II

5/24/1982

LABORATOIRES SERONO SA

STILAMIN (SOMATOSTIN)--MFGR IN DEDEENENS, SWITZ.(FORMERLY HYPOLAB)

4580

II

6/3/1982

MD PHARMACEUTICAL INC

DIPHENOXYLATE HCL W/1% AROPINE SULFATE SUBSTANCE

4581

IV

6/4/1982

AH ROBINS CO

PLACEBO TABLET MACHING PONDIMIN EXTENTAB

4582

II

6/11/1982

AINC

MICROPOROUS MEMBRANE CARTRIDGE FOR PHARM USE-MFG IN MERIDEN, CT. FACIL

4583

II

6/15/1982

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

ANAFRANIL INJECTABLE (CLOMIPRAMINE HCL) MFG SUMMIT, NEW JERSEY

ALUM FOIL/PAPER LAMINATIONS AS PROD IN SOMERVILLE, MASS FACILITY


URIDINE PRODUCT #3401

Page 125

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4584 I
II
5/14/1982
FARMABOIS

SUBJECT
NANDROLONE-17-DECANOATE USP XX

4585

II

5/25/1982

ACIC LTD

CHENODEOXYCHOLIC ACID

4586

II

5/19/1982

TOLBUTAMIDE

4587

II

6/14/1982

STAROGAREZKIE ZAKLADY FARMACEUTYCZNE


POLFA
SCHERING AG

4588

4/23/1982

GREEN CROSS CORP

4589

7/7/1982

4590

7/8/1982

4591

II

7/9/1982

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN YODOGAWA.
CONNAUGHT LABORATORIES INC
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SWIFTWATER, PA.
MICRO BIO TESTING & RESEARCH LABORATORIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN NORTH HOLLYWOOD, CA.
TEVA PHARMACEUTICAL INDUSTRIES LTD
FLUOCINONIDE

4592

7/9/1982

GLAXO WELLCOME INC

CEPHALOSPORINS FILLING UNIT IN EVREUX, FRANCE

4593

7/7/1982

LEO PHARMACEUTICAL PRODUCTS LTD

PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES

4594

II

5/17/1982

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

IBUPROFEN USP

4595

II

6/14/1982

DIOSYNTH BV

NALOXONE HYDROCHLORIDE

4596

II

6/17/1982

GANES CHEMICALS INC

SULFINPYRAZONE

4597

II

6/16/1982

SCHERING AG

PREDNISOLONE-21-ACETATE

4598

6/11/1982

APPLIED ANALYTICAL INDUSTRIES

FACILITIES & INSTRUMENTATION

4599

II

6/16/1982

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

RITALIN

4600

II

6/21/1982

MD PHARMACEUTICAL INC

TRIPROLIDINE HCL MONOHYDRATE-MANUF IN SANTA ANA, CALIF. FACILS.

4601

II

6/23/1982

BIDACHEM SPA

CHLORTHALIDONE U.S.P.

4602

7/15/1982

BANNER GELATIN PRODUCTS CORP

FACILS/PERSONNEL/GOP FOR THE OLDS, ALBERTA PLANT

4603

II

7/2/1982

FREEDOM CHEMICAL DIAMALT GMBH

CHENODEOXYCHOLIC ACID

4604

II

7/18/1982

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

PREDNISOLONE SODIUM PHOSPHATE, USP XX

4605

II

6/15/1982

OCE ANDENO BV

PROLINE THIOESTER

4606

6/29/1982

HARRIS LABORATORIES INC

PERSONNEL,FACIL.FLOOR PLANS & EQUIP. LIST FOR LABS & CLINIC-LINCOLN,NE

4607

II

7/23/1982

PFIZER INC

FLUOXYMESTERONE USP

4608

II

7/14/1982

ORION CORPORATION FERMION OULU PLANT

THIORIDAZINE HYDROCHLORIDE

4609

7/13/1982

SCHERING PHARMACEUTICAL CORPORATION

FACIL, PERSONNEL & GEN OPERATING PROCEDS FOR MANATI, PR PLANT

4610

II

6/16/1982

CHLOROTHIAZIDE

4611

II

6/17/1982

4612

II

2/16/1982

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
PT RIASIMA ABADI INDUSTRI KIMIA FARMASI
PERTAMA
BAYER

4613

6/24/1982

SIBEFAT SPA

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

4614

III

6/15/1982

STALCON PLASTICS LTD

PLASTICS BOTTLES

4615

II

7/22/1982

KNOLL AG LUDWIGSHAFEN

DIMENHYDRINATE

4616

II

7/12/1982

TAKEDA CHEMICAL INDUSTRIES LTD

MANUF OF CEFMENOXIME HCL IN THE HIKARI PLANT

4617

7/7/1982

PHARMACIA INFUSION AB

4618

II

8/6/1982

HOECHST ROUSSEL PHARMACEUTICALS DIV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FYRISLUND.
PENBUTOLOL SULFATE (BULK FORM)

6-METHYLPREDNISOLNE

ACETAMINOPHEN
PARACETAMOL

Page 126

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4619 I
II
8/2/1982
DIOSYNTH BV

SUBJECT
METHANDRIOL

4620

III

8/3/1982

FC81 FLEXIBLE,CONTAINER-PRODUCED IN NORTH CHICAGO, ILL. FACILITIES

4621

II

8/9/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SIGMA F AND D DIV LTD

4622

II

8/11/1982

CHEMI SPA

HYDROXYZINE HCL.USP. XX 093082

4623

6/10/1982

TARO PHARMACEUTICALS INC

FACIL & GEN OPER PROCEDS A DOWNSVIEW, ONTARIO, CANADA LOCATION

4624

II

7/27/1982

FOREST LABORATORIES INC

THIORIDAZINE HCL100MG CR(LD IN SYCHRON VEHICLE)MNFG INWOOD,NY

4625

II

7/13/1982

METHYCLOTHIAZIDE MANUFACTURED IN NORTH CHICAGO, ILLINOIS.

4626

II

7/30/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
YUKI GOSEI KOGYO CO LTD

4627

II

7/13/1982

4628

II

8/11/1982

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA DIMENHYDRINATE


SPA
SIGMA F AND D DIV LTD
POLY (ALA,GLU,LYS-HBR,TYR) 6:2:5:1

4629

II

8/11/1982

CHEMI SPA

HYDROXYZINE PAMOATE USP. XX

4630

II

7/13/1982

SPECTINOMYCIN DIHDROCHLORIDE PENTAHYDRATE MFG IN N. CHICAGO, ILL FACIL

4631

7/22/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
PHARMAFAIR INC

4632

II

7/27/1982

FOREST LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING IN HAUPPAUGE,


NEW YORK.
THIORIDAZINE HCL C.R. TABLETS (IN SYNCHRON VEHICLE) MFG INWOOD, N.Y.

4633

II

7/28/1982

SHANDONG XINHUA PHARMACEUTICAL CO LTD

THEOPHYLLINE AS MANUFACTURED IN SHANDONG, P.R. CHINA

4634

II

8/24/1982

SOCIETA ITALIANA CORTICOSTEROIDI SPA

METHYLPREDNISOLONE ACETATE

4635

II

8/10/1982

NORTH EAST SIXTH PHARMACEUTICAL FACTORY

SULFAMETHOXAZOLE USP 20

4636

7/29/1982

CADEMA MEDICAL PRODUCTS INC

PERS, FACIL & GEN OP PROC/PRODUC-ANTIMONY TRISULFIDE COLLOID KIT

4637

II

8/13/1982

HOECHST AG

SECRETIN PENTAHYDROCHLORIDE, BULK FORM

4638

8/18/1982

MFG, PROCESS & PACK OF INDS IN MORRIS PLAINS, NJ FACIL (710 TABOR RD)

4639

II

7/12/1982

4640

8/27/1982

4641

IV

8/10/1982

WARNER LAMBERT CO PHARMACEUTICAL


RESEARCH DIVISION
BECKMAN INSTRUMENTS INC DIV SMITHKLINE
BECKMAN CORPORATION
HEALTH CHEM CORPORATION HERCON
PHARMACEUTICAL DIV
CIBA GEIGY CORP PHARMACEUTICAL DIVISION

4642

II

9/1/1982

ALKALOIDA CHEMICAL CO ZRT

PHENOBARBITAL

4643

III

9/1/1982

HELVOET PHARMA MARYLAND

E0608 MFG AT MORRISTOWN, IND

4644

II

9/2/1982

FOREST LABORATORIES INC

IBUPROFEN 800 MG C.R. TABLETS (IN SYNCHRON VEHICLE)

4645

II

9/10/1982

BASF AKTIENGESELLSCHAFT

LUROTIN TM CAPSULES

4646

II

9/9/1982

STIEFEL LABORATORIES INC

COMPOUND C-205

4647

II

8/5/1982

CAMBREX PROFARMACO MILANO SRL

ACETAZOLAMIDE

4648

III

7/20/1982

CARR LOWREY DIV ANCHOR HOCKING CORP

GLASS PRODUCTS (DEFINED BY USP) MFG BALTIMORE, MD PLANT

4649

II

7/16/1982

AMINO GMBH

L-TYROSINE

4650

II

8/24/1982

SICOR SPA

METHYLPREDNISOLOME HEMISUCCINATE (FORMERLY HELD BYS.I.R.S.)

4651

II

9/7/1982

NATL INST HLTH NCI

ELLIOTT'S B SOLUTION

4652

II

8/10/1982

SANOFI AVENTIS CHIMIE

NALOXONE HCL AS MANUF BY SEMPA-CHIMIE IN ARAMON, FRANCE

METHIONINE ENKEPHALIN-ACETATE SALT

PROTAMINE SULFATE

D-NA 16 LUTENINIZING HORMONE RELEAS. HORMONE-PRODUCED BY BIOPRODUCTS


PERSONNEL, FACIL & GEN OPERATING PROCEDS FOR EMIGSVILLE, PA PLANT
PLACEBO FOR LITHOBID SLOW RELEASE TABLETS; MFG SUMMIT, NEW JERSEY

Page 127

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4653 I
II
9/13/1982
PROFARMACO SRL

SUBJECT
MICONAZOLE NITRATE & BASE

4654

II

7/27/1982

SANOFI SYNTHELABO INC.

CHLORMEZANONE

4655

II

9/15/1982

EASTMAN KODAK CO

METOLAZONE (ZAROXOLYN) AS MFGR IN THE SYNTHETIC CHEM DIV- ROCHESTER NY

4656

II

9/15/1982

ERIMOS TECHNOLOGIES LLC

NORDIHYDROGUAIARECTIC ACID (NDGA), BULK FORM AS MANUF IN CHIHUAHUA,MX.

4657

II

9/9/1982

4658

II

9/14/1982

4659

II

8/24/1982

ABBOTT LABORATORIES PHARMACEUTICAL


VALPROIC ACID MFG IN N.CHICAGO, ILL FACILITIES
PRODUCTS DIV
AYERST LABORATORIES INC DIV AMERICAN HOME RAPAMYCIN (DOSAGE FORM) MFG BY AYERST LABS IN ROUSES PT, NY FACIL
PRODUCTS CORP
SOCIETA ITALIANA CORTICOSTEROIDI SPA
METHYLPREDNISOLONE SOD. SUCCINATE (THIS FORMERLY HELD BY S.I.R.S)

4660

9/24/1982

WESTWOOD PHARMACEUTICALS INC

4661

II

9/30/1982

SHIONOGI AND CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BUFFALO, NEW YORK.
CERULETIDE DIETHYLAMINE

4662

II

9/23/1982

SANOFI CHIMIE

HYDROCORTISONE VALERATE USP BULK SUBSTANCE

4663

IV

9/16/1982

GATTESFOSSE SA

COMPRITOL 888 (AN EXCIPIENT)

4664

II

9/8/1982

BAYER HEALTHCARE AG

NIMODIPINE AS MANUFACTURED IN WUPPERTAL, GERMANY

4665

II

9/28/1982

DAIICHI PHARMACEUTICAL CO LTD

DL-8280, BULK FORM

4666

II

9/27/1982

WYCKOFF CHEMICAL CO INC

MEPIVACAINE HCL USP XX MFG IN SOUTH HAVEN, MICHIGAN FACIL

4667

10/5/1982

STERIGENICS INTERNATIONAL

STERILE AND NON-STERILE MFG FACILITIES IN KALAMAZOO,MI

4668

10/5/1982

TEKNI PLEX INC

FACIL & GEN OPER PROCEDS FOR RIDGEFIELD, NJ PLANT

4669

10/8/1982

LIFE LABORATORIES INC

FACILITIRES AND GENERAL OPERATING PROCEDURES

4670

8/18/1982

ECHO THERAPEUTICS INC

TOXICOLOGY STUDIES FOR AZONE

4671

III

8/17/1982

PARADIGM PACKAGING

BLOW MOLDED BOTTLES (INJECTION BLOW MOLDING PROCESS)

4672

II

10/16/1982

MEDIMPEX NORTHAMERICA INC

METRONIDAZOLE USP XX AS MANUF-BY CHEM WORK OF GEDEON RICHTER LTD.

4673

II

10/15/1982

LILLY RES LABS DIV ELI LILLY CO

FLUOXETINE HYDROCHLORIDE, BULK MANUF. IN LAFAYETTE, INDIANA

4674

9/30/1982

CILAG CHEMIE AG

FACIL.,PERS.,GEN OP PROC.;MNFG SOLID,SEMI-SOLID,&LIQUID DOSAGES

4675

9/22/1982

BARD PHARMS LTD

PERSONNEL,FACILS,& GEN.OPERATING PROCEDS.-A THE OLD FARM RD LOCATION

4676

II

9/27/1982

BASF SE

13-CIS-RETINOIC ACID (ISOTRETINOIN)

4677

II

9/30/1982

SANOFI CHIMIE

TRIAMTERENE MFG BY SEMPA-CHIMIE IN ARAMON,FRANCE

4678

II

9/28/1982

DAIICHI PHARMACEUTICAL CO LTD

DL-8280 CAPSULES

4679

4/14/1982

QUAD PHARMACEUTICALS

4680

II

10/28/1982

4681

III

9/17/1982

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
BAXTER HEALTHCARE CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN INDIANAPOLIS PLANT ON GUION ROAD
TRANYLCYPROMINE SULFATE AS MANUF BY BRIDGE CHEM

4682

II

10/15/1982

ORION CORP LTD FERMION

CHLORTHALIDONE USP XX AND BP 80

4683

II

10/18/1982

KV PHARMACEUTICAL CO

PHENYLPROPANOLAMINE HCL/CHLORPHENIRAMINE MALEATE S.R.(B.F. ASCHER &CO)

4684

II

10/13/1982

BAYER PHARMA AG

ESTRADIOL MANUFACTURED IN BERLIN, GERMANY.

4685

II

10/14/1982

RADPHARM INC

GALLIUM CHLORIDE GA-67 RADIOCHEMICAL SOLUTION

4686

II

10/15/1982

ORGANICHEM CORP

DIARIZOATE MEGLUMINE USP

4687

II

10/14/1982

SUMITOMO CHEMICAL CO LTD

DISOPYRAMIDE PHOSPHATE USP XX

4688

II

10/16/1982

KONGO CHEMICAL CO LTD

DEXCHLORPHENIRAMINE MALEATE

PRODUCTION OF PARENTERAL INJECTIONS IN GLASS CONTAINERS

Page 128

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4689 I
II
9/29/1982
CAMBREX PROFARMACO MILANO SRL

SUBJECT
ECONOZOLE NITRATE

4690

II

10/13/1982

BAYER PHARMA AG

ESTRADIOL-3-BENZOATE

4691

II

10/19/1982

DISHMAN NETHERLANDS BV

DIHYDROTACHYSTEROL AS MFG IN WEESP THE NETHERLANDS

4692

II

10/22/1982

HOSPIRA BOULDER INC

SODIUM NITROPRUSSIDE

4693

II

10/13/1982

SANOFI SYNTHELABO INC.

HYDROXYCHLOROQUINE SULFATE MFG A FAWDON & DUDLEY

4694

II

10/14/1982

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

TRIMETHOBENZAMIDE HCL USP

4695

II

10/14/1982

SCHERING AG

TESTOSTERONE

4696

II

10/18/1982

INDUSTRIA CHIMICA PROFARMACO SPA

2 BROMOACETAMIDO-5 CHLORO-2' FLUOROBENZOPHENONE

4697

II

10/27/1982

ROQUETTE FRERES

ROFEROSE (DEXTROSE MONOHYDRATE)

4698

II

10/11/1982

HEXACHIMIE

2-CHLORO NICOTINIC ACID (INTERMEDIATE)

4699

10/18/1982

SCHERER G.C. CORP

4700

11/4/1982

ELI LILLY AND CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF HARDSHELL CAPS IN SPRINGVILLE, UTAH.
PROCEDURES FOR STERILE OPERATIONS IN INDIANAPOLIS AND GREENFIELD INDIANA

4701

II

11/1/1982

DESTILERIAS ADRIAN & KLEIN SA

TERPIN HYDRATE USP XX

4702

11/3/1982

OY STAR AB

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

4703

II

10/22/1982

ER SQUIBB AND SONS INC

FLUPHENAZINE HYDROCHLORIDE

4704

II

10/25/1982

SCHERING AG

METHYLTESTOSTERONE

4705

II

11/1/1982

KV PHARMACEUTICAL CO

APTROPINE SULFATE CAPSULES

4706

II

11/2/1982

DINAMITE DIPHARMA SPA

TOLAZAMIDE MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES

4707

II

10/26/1982

SOCIETA ITALIANA CORTICOSTEROIDI SPA

BETAMETHASONE ACETATE

4708

11/9/1982

JAMES ROBINSON GMBH

FACILITIES, PERSONNEL, GENERAL OPERATING PROCEDURES-DIEBURG, GERMANY

4709

II

11/12/1982

DIOSYNTH BV

NORETHYNODREL

4710

II

10/29/1982

YANGZHOU PHARMACEUTICAL CO LTD

HYDROCORTISONE BASE & ACETATE MANUFACTURED IN CHINA.

4711

II

11/16/1982

MEDIMPEX NORTHAMERICA INC

VINCRISTINE S04 FOR INJECT, USP 1MG & 5MG AS MANUF BY GEDEON RICHTER

4712

II

10/26/1982

TEVA PHARMACEUTICAL INDUSTRIES LTD

TRIAMCINOLONE ACETONIDE

4713

11/8/1982

DURAMED PHARMACEUTICALS INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

4714

II

11/10/1982

FOURTH PHARMACEUTICAL WORKS

SYNTHESIS OF PHENOBARBITAL, BULK FORM

4715

10/22/1982

TENCO ASSEMBLIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4716

II

11/15/1982

FARCHEMIA SRL

IMIPRAMINE HCL USP

4717

II

11/10/1982

MALLINCKRODT SPECIALTY CHEMICALS CO

CODACET-60 (TM) AS MFG IN THE ST. LOUIS, MISSOURI PALNT

4718

II

11/10/1982

SOCIETA ITALIANA CORTICOSTEROIDI SPA

TRIAMCINOLONE DIACETATE

4719

II

11/10/1982

TEVA PHARMACEUTICAL INDUSTRIES LTD

CARBAMAZEPINE USP.

4720

11/15/1982

PHARMACIA AND UPJOHN INC

PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES

4721

IV

11/19/1982

CAPSULE TECHNOLOGY INTERNATIONAL LTD

MANUFACTURING OF EMPTY HARD GELATIN CAPSULES; WINDSOR, ONTARIO PLANT

4722

II

11/12/1982

VEPESID AMPULS, 100MG./5ML.

4723

10/25/1982

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
LABORATOIRE CHOAY

4724

II

9/9/1982

ASTA-WERKE AKTIENGESELLSCHAFT

CYCLOPHOSPHAMIDE TABLETS

4725

II

11/23/1982

SALK INSTITUTE

HUMAN PANCREAIC GROWTH RELEASE FACTOR (1-40)-OH -- HP GRF (1-40)-OH

FACILITIES & GEN OP PROC.,MANUFACTURE OF PARENTERAL PRODUCTS

Page 129

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4726 I
II
11/17/1982
SIGMA F AND D DIV LTD

SUBJECT
TRIMETHOPRIM

4727

II

12/8/1982

SALK INSTITUTE

SOMATOCRININ-GROWTH HORMONE RELEASING FACTOR

4728

12/1/1982

3M PHARMS

PERSONNEL,FACILITIES AND GEN.OPERATING PROCEDURES DECATUR ALABAMA

4729

II

12/2/1982

SIGMA F AND D DIV LTD

L-ORNITHINE HCL

4730

II

12/7/1982

YUKI GOSEI KOGYO CO LTD

AMINOACETIC ACID

4731

II

11/30/1982

ORGANICHEM CORP

DIARIZOATE SODIUM U.S.R.

4732

11/17/1982

VOCATIONAL INDUSTRIES OF SOMERSET AREA

FACILITIES AND GENERAL OPERATING PROCEDURES

4733

III

9/10/1982

BCL CANADA INC

SARAN COATED REGENERATED CELLULOSE FILMS

4734

II

12/1/1982

LEIRAS PHARMACEUTICALS

TAMOXIFEN CITRATE TABLETS

4735

II

11/29/1982

COSMA SPA

TOLAZAMIDE-MANUF UNDER CONTRACT FOR COSMA S.P.A.

4736

II

11/19/1982

SIGMA F AND D DIV LTD

D-GLUCONIC ACID HEMI CALCIUM SALT

4737

II

12/13/1982

ADAMHA NIDA

PILOT PLANT SCALE SYNTHESIS AND PURIFICATION OF CANNABIDIOL

4738

II

11/29/1982

KV PHARMACEUTICAL CO

TROCINATE 100MG & 400MG AS MANUF IN THE ST. LOUIS MISSOURI FACILS.

4739

II

12/7/1982

PHARMACIA AND UPJOHN INC

TOLBUTAMIDE, USP AND TOLBUTAMIDE, USP MILLED -MANUF IN KALAMAZOO, MI.

4740

II

10/19/1982

NV ORGANON

DANAZOL

4741

II

11/15/1982

FARCHEMIA SRL

DOXYLAMINE SUCCINATE USP

4742

II

11/29/1982

COSMA SPA

ZOMPIRAC SODIUM AS IT WILL BE MANUF UNDER CONTRACT FOR COSMA S.P.A.

4743

II

11/18/1982

BASF HEALTH AND NUTRITION AS

SODIUM ASCORBATE

4744

11/10/1982

LABORATOR MAG VIA MILANO

FACILITIES AND GENERAL OPERATING PROCEDURES

4745

II

11/30/1982

SCHERING AG

HYDROCORTISONE ACETATE

4746

II

12/9/1982

DIOSYNTH BV

BEPRIDIL HYDROCHLORIDE

4747

III

12/16/1982

SPARTECH PLASTICS

THERMOPLASTIC SHEET MATERIALS IN THE GTB-BTG SERIES

4748

II

11/29/1982

COSMA SPA

TERBUTALINE SULPHATE AS IT WILL BE MANUF UNDER CONTRACT FOR COSMA SPA

4749

II

11/11/1982

MALLINCKRODT INC

IOTHALAMIC ACID USP - MANUFACTURED IN DIEBURG

4750

II

12/6/1982

BLASCHIM SPA

NAPROXEN

4751

II

1/4/1983

DIOSYNTH BV

FENTANYL CITRATE

4752

II

1/6/1983

PENCO OF LYNDHURST INC

FENTANYL CITRATE, BULK FORM

4753

II

1/4/1983

BIOSEARCH LABORATORIES LTD

VINYPYRROLIDONE CARRIERS

4754

IV

1/11/1983

FMC CORP

CELLULOSE ACETATE AS ANALYZED & DISTRIBUTED FROM NEWARK, DEL. FACILITY

4755

II

1/11/1983

LUDWIG HEUMANN AND CO GMBH

TRIMETHOPRIM

4756

II

12/10/1982

SOCIETE FRANCAISE D'ORGANO

DACARBAZINE

4757

II

11/30/1982

BAYER SCHERING PHARMA AG

HYDROCORTISONE

4758

II

12/20/1982

GUERBET

IOXAGLIC ACID

4759

9/27/1982

CARIBBEAN BIORESEARCH INC

4760

II

10/18/1982

KV PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAN GERMAN, PUERTO RICO.
FLURBIPROFEN 200MG CAPS AS MANUF IN THE ST. LOUIS, MISSOURI FACILS.

4761

II

12/17/1982

SICOR SPA

FLUOROMETHOLONE

4762

II

12/14/1982

SYLATEC

TRIVEMIL

4763

1/10/1983

UCB PHARMACEUTICALS INC

FACILITIES AND GENERAL OPERATING PROCEDURES

Page 130

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4764 I
II
1/6/1983
PLANTEX LTD CHEM AND PHARM WORKS

SUBJECT
LAURYLMETHACRYLATE-ACRYLIC ACID COPOLYMER (POLYMER TP-1980)

4765

II

12/20/1982

DISOPYRAMIDE PHOSPHATE AND DISOPYRAMIDE BASE

4766

II

12/10/1982

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
CK FINE CHEMICALS INC

4767

11/5/1982

RP SCHERER

FACILITIES AND GENERAL OPERATING PROCEDURES

4768

II

10/15/1982

GRUPPO LEPETIT SPA

TERFENADINE AS MANUFACTURED IN THE GARESSIO (CUNEO) PLANT

4769

II

10/14/1982

SCHERING AG

4-DIMETHYLAMINO PYRIDINE

4770

II

1/10/1983

UCB PHARMACEUTICALS INC

CARBETAPENTANE TANNATE

4771

II

12/20/1982

INDUSTRIA CHIMICA MILANESE SPA

OXPRENOLOL HCL

4772

II

12/7/1982

YUKI GOSEI KOGYO CO LTD

ISONIAZID BULK FORM

4773

1/28/1983

FACILS, PERSONNEL & GEN OPER PROCEDS FOR THE MURINE CO. FACILS.

4774

II

12/22/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SOCIETA ITALIANA CORTICOSTEROIDI SPA

4775

II

12/6/1982

PLANTEX LTD CHEM AND PHARM WORKS

PILOCARPINE (SOLUTION IN ACETONE)

4776

II

10/14/1982

SCHERING AG

TESTOSTERONE PROPIONATE

4777

II

12/14/1982

BRIDGE CHEMICALS

DIETHYLCARBAMAZINE CITRATE

4778

II

1/21/1983

PCAS

CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND.

4779

12/29/1982

GANES CHEMICALS INC

FACILITIES AND GENERAL OPERATING PROCEDURES

4780

IV

11/23/1982

ICI AMERICAS INC

ARLACEL 481 &ARLACEL 986 MNFG ALAS CHEMIE IN ESSEN,GERMANY

4781

1/11/1983

PROCOS SPA

PERSONNEL, FACILS AND GEN OPERATING PROCEDURES

4782

II

12/27/1982

ETHCHLORVYNOL AS MANUF IN THE NORTH CHICAGO ILLINOIS FACILITY

4783

II

11/5/1982

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
H REISMAN CORP

4784

II

12/6/1982

GUANFACINE HCL

4785

II

1/21/1983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
OY STAR AB

4786

II

12/15/1982

SCHERING AG

PREDNISOLONE 21-HEMISUCCINATE

4787

II

12/7/1982

YUKI GOSEI KOGYO CO LTD

NIACINAMIDE

4788

II

1/20/1983

TRIFLUOPERAZINE HYDROCHLORIDE

4789

II

1/6/1983

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
SANDOZ GMBH

4790

II

11/26/1982

EVONIK TECHNOCHEMIE GMBH

LORMETAZEPAM (MACRO)

4791

II

1/26/1983

BRIDGE CHEMICALS

TRIFLUOPERAZINE DIHYDROCHLORIDE & HCL-MFG BY BRIDGE CHEM LTD,ENGLAND

4792

II

1/21/1983

OY STAR AB

METHOXSALEN

4793

II

1/12/1983

LEIRAS PHARMACEUTICALS

TAMOXIFEN CITRATE, BULK FORM

4794

II

2/1/1983

CLARIANT CORPORATION

HOECHST WAX E PHARMA, BULK DRUG SUBSTANCE

4795

II

2/9/1983

TECHNOCHEMIE GMBH

INTERMEDIATE FOR LORAZEPAM (WY 4088)

4796

II

1/6/1983

PHARMACIA AND UPJOHN SUB PFIZER INC

METHYLPREDNISOLONE USP AS MANUF. IN KALAMAZOO, MICH FACILS.

4797

II

1/31/1983

DAIWA PHARMACEUTICAL CO LTD

CHLORZOXAZONE USP AS MANUFACTURED IN TOYAMA, JAPAN

4798

II

12/22/1982

SIFAVITOR SRL

AMILORIDE HCL BP 80

4799

II

11/22/1982

INDUSTRIA CHIMICA MILANESE SPA

DEXBROMPHENIRAMINE MALEATE USP. XX

BETHANECHOL CHLORIDE

FLUNISOLIDE HEMIHYDRATE

PSEUDOEPHEDRINE HYDROCHLORIDE AS PROCESSED IN THE ORANGE, NJ FACILITY

DISOPYRAMIDE PHOSPHATE

LEVOTHYROXINE SODIUM

Page 131

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4800 I
I
1/20/1983
HOUBA INC

SUBJECT
METHODS,FACILS & CONTRLS-FOR PRODUCT. OF BULK AL (ACT.LIPIDS)CULVER,IN

4801

III

1/31/1983

3M PHARMS

DRUG PROTECTIVE CAPS AS MANUF IN THE ST. PAUL, MINN. FACILITIES

4802

II

1/24/1983

4803

II

12/29/1982

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA VERAPAMIL HCL


SPA
TEVA PHARMACEUTICAL INDUSTRIES LTD
PILOPEX 2 EYE DROPS

4804

III

12/20/1982

PROMENS PACKAGING LTD

PLASTIC BOTTLES AND CLOSURES

4805

II

1/14/1983

BAYER

ACETYLSALICYLIC ACID (ASPIRIN)

4806

III

1/17/1983

BALL CORP

BALL PLASTIC 656(TM) COEXTRUD. PACKAG. MTRLS-PRODUCED-EVANSVILLE, IND.

4807

II

1/31/1983

3M PHARMS

POLYURETHANE FOAM CIRCLES AS MAMUF. IN THE ST. PAUL, MINN. FACILITIES

4808

II

2/18/1983

INDENA GRUPPO INVERNI DELLA BEFFA

DESERPIDINE USP

4809

II

11/16/1982

FARMABOIS

MEDROXYPROGESTERONE ACETATE USPXX

4810

III

2/2/1983

BALL CORP

BALL SARAN COEXTRUSIONS AS PRODUCED IN THE EVANSVILLE, IN FACILITY

4811

II

1/21/1983

ORGAMOL SA

ORPHENADRINE CITRATE AND ORPHENADRINE HCL.

4812

IV

1/31/1983

3M PHARMS

TAPE LAMINATE PACHS--MFGR IN ST. PAUL, MINN FACILS

4813

II

1/6/1983

PHARMACIA AND UPJOHN

METHYLPREDNISOLONE ACETATE

4814

II

12/20/1982

NIPPON KAYAKU COMPANY LTD

L-ALANINE, L-METHIONINE & GLYCINE AS MANUF IN TOKYO, JAPAN FACTORY

4815

II

8/24/1982

IRE NATL INST RADIOISOTOPES

XENON -133 GAS

4816

II

12/22/1982

BAYER

NIMODIPINE CAPS 10MG (BAY E 9736)

4817

II

2/22/1983

OMNICHEM NV (PRB)

VERAPAMIL HCL

4818

II

1/12/1983

MEDI PHYSICS INC

1231-M-123 OR 1231-D,1-N-ISOPROPYL-P-IODOAMPHETAMINE HYDROCHLORIDE

4819

II

12/6/1982

CAMBREX PROFARMACO MILANO SRL

METOPROLOL TARTRATE

4820

II

1/17/1983

OTSUKA PHARM CO LTD

PROCAEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORY

4821

II

9/17/1982

IRE NATL INST RADIOISOTOPES

MOLYBDENUM-99

4822

II

12/20/1982

NIPPON KAYAKU COMPANY LTD

L-THREONINE, L-TRYTOPHAN & L-ISOLEUCINE

4823

3/2/1983

SIFAVITOR SRL

4824

II

3/3/1983

PLANTEX LTD CHEM AND PHARM WORKS

MANUFACTURING SITE, FACILITIES, PERSONEL & GENERAL OPERATING PROCEDURES IN


MILAN, ITALY
CISPLATIN

4825

III

3/8/1983

3M PHARMS

HEAT SEALABLE MICROPOROUS TAPE NO. 1781

4826

II

2/25/1983

SYNTHETIC HUMAN PROINSULIN C-PEPTIDE

4827

II

3/3/1983

BECKMAN INSTRUMENTS INC DIV SMITHKLINE


BECKMAN CORPORATION
REGIS TECHNOLOGIES INC

4828

II

2/15/1983

ORGAMOL SA

METHOCARBAMOL

4829

II

1/26/1983

SIGMA F AND D DIV LTD

L ETHYL-3-(3-DIMETHYLAMINOPROPYL) CARBODIIMIDE HCL ST. LOUIS,MO PLANT

4830

II

1/28/1983

KNOLL AG LUDWIGSHAFEN

PROPRANOLOL HCL MANUFACTURED IN LIESTAL, SWITZERLAND

4831

II

12/15/1982

SCHERING AG

PREDNISOLONE

4832

3/22/1983

4833

1/11/1983

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
GANES CHEMICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WILSON, NORTH CAROLINA.
GENERAL OPERATING PROCEDS FOR PENNSVILLE, NJ FACILITY

4834

II

2/24/1983

ERREGIERRE SPA

CHENO DESOXYCHOLIC ACID

4835

II

2/25/1983

SCM CORPORATION

ENCAPSULATED POTASSIUM CHLORIDE DURKOTE KCL 150-92

4-AMINOPYRIDINE REGIS CODE #002054-PROCESSED-MORTON GROVE, ILL FACILS

Page 132

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4836 I
II
3/4/1983
SIGMA F AND D DIV LTD

SUBJECT
ANTIPYRINE AS PRODUCED IN THE ST. LOUIS, MISSOURI PLANT

4837

III

3/10/1983

BERRY PLASTICS

ARGUS-LOC CHILD RESIST. CLOSURES-MFGR AT BROOKVILLE, PA. LOCATION

4838

12/15/1982

DOW CHEMICAL CO MICHIGAN DIV

4839

II

3/11/1983

MALLINCKRODT INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MIDLAND, MICHIGAN.
CODEINE PHOSPHATE MANUFACTURED IN ST. LOUIS, MISSOURI.

4840

III

1/25/1983

PANTASOTE INC

PVC COMPD AND/OR FILM: 1. 4575 PVC CMPD AND/OR FILM MFGR IN NJ FACILS

4841

III

9/10/1982

UNION CARBIDE CORPORATION

BAKELITE BRAND POLYETHYLENE (GRSN SERIES):1. GRSN-7144 NATURAL 7

4842

II

3/7/1983

SIGMA F AND D DIV LTD

ADENOSINE 5' TRIPHOSPHATE (AP) DISODIUM SALT MFG ST.LOUIS, MO PLANT

4843

II

1/7/1983

SCHERING AG

MICRONIZING LORMETAZEPAM

4844

1/11/1983

CIS US INC

4845

II

1/4/1983

DIOSYNTH BV

MANUAFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DEANGELO DRIVE.
PROTEIN HYDROLYSATE

4846

II

3/11/1983

SANOFI AVENTIS DEUTSCHLAND GMBH

HUMAN INSULIN-SEMISYNTHETIC, BULK MATRLS & FINISHED DOS. FORM

4847

II

3/7/1983

NOBEL KEMI AB

N,N-BIS (2,3-DIHYDROXYPROPYL)-5-AMINOISOPHTALAMIDE OR (5-AIPA-DIAMIDE)

4848

2/17/1983

AMERICAN CHEMICAL INDUSTRIAL CORP

4849

II

3/8/1983

SCHERING AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RICHMOND, CALIFORNIA.
L-5-HYDROXYTRYPTOPHAN AS MANUFACTURED BY DIAMALT AG IN MUNICH

4850

III

3/11/1983

PERSTORP CHEMICALS AB

UREA MOLDING CMPDS MFG IN FLORENCE,MA 1. UREA MOLDING CMPD GRADE 151

4851

IV

12/7/1982

ARCHER DANIELS MIDLAND COMPANY

SOYBEAN OIL

4852

3/17/1983

LANHAM PACKAGING

FACILS AND GENERAL OPERATING PROCEDS-A 20TH & L ST., S.W., WASH, DC

4853

III

3/28/1983

TOTAL PETROCHEMICALS AND REFINING USA INC

CRYSTAL POLYSTYRENE PRODUCTS (COSDEN 535) MANUF WINDSOR, NJ FACILS

4854

II

3/7/1983

BOFORS AB

N,N'-BIS (2,3-DIHYDROXYPROPYL)-5-NITROISOPHTALAMIDE

4855

II

3/9/1983

SHOWA DENKO KK

CHENODEOXYCHOLIC ACID-PROCEDS FOR PRODUCTION A THE KAWASAKI WORKS

4856

II

2/17/1983

PHARMACIA AND UPJOHN INC

TRANEXAMIC ACID

4857

2/28/1983

BECTON DICKINSON MONOCLONAL CENTER INC

4858

3/11/1983

SANOFI AVENTIS DEUTSCHLAND GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MOUNTAIN VIEW, CALIFORNIA.
PRECLINICAL STUDIES USING HUMAN INSULIN SEMISYNTHETIC (HOE 21 PH INJ)

4859

II

4/8/1983

CILAG CHEMIE AG

BEPRIDIL HCL

4860

II

4/7/1983

SIGMA F AND D DIV LTD

SELENO-DL-METHIONINE AS SUPPLIED BY SIGMA (ISRAEL)CHEMICAL COMPANY

4861

II

1/25/1983

GANES CHEMICALS INC

1-EPHEDRINE SULFATE-MANUF IN THE PENNSVILLE, NJ FACILITY

4862

II

3/30/1983

PLANTEX LTD CHEM AND PHARM WORKS

VINCRISTINE SULFATE USP MANUF PLANTEX-NETANYA & ASSIA-PETACH TIKVA FAC

4863

II

3/31/1983

ASTRA RESEARCH LABORATORIES

OMEPRAZOLE CAPSULES

4864

III

3/23/1983

INEOS FILMS ITALIA SRI

PVC FILM FOR PHARMACEUTICAL PACKAGING MANUFACTURED IN SICOFORM IT

4865

II

12/30/1982

MEDIMPEX NORTHAMERICA INC

HEPARIN SODIUM-AS MFGR BY CHEM. WORKS OF GEDEON RICHTER LTD, HUNGARY

4866

II

3/8/1983

PEBOC LTD

GUAIFENESIN USP

4867

III

3/21/1983

30049 PEEL SEAL

4868

III

3/16/1983

TECHNICAL COATINGS CO SUB OF BENJAMIN


MOORE & CO
SPARTECH PLASTICS

4869

11/18/1982

CELL PRODUCTS INC

4870

II

12/30/1982

MEDIMPEX NORTHAMERICA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING IN NEW


BRUNSWICK, NEW JERSEY.
ERGONOVINE MALEATE-MFGR BY CHEM WORKS OF GEDEON RICHTER, LTD, HUNGARY

THERMOPLASTIC SHEET TYPE RTB,BTR SERIES PRODUCED A MEDFORD,MASS FACIL

Page 133

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4871 A
II
3/14/1983
TEVA PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
BECLOMETHASONE DIPROPIONATE

4872

II

3/18/1983

SODIUM BUTABARBITAL-MANUF IN NORTH CHICAGO, ILL. FACILITIES

4873

IV

3/28/1983

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
MONA INDUSTRIES INC

4874

III

3/16/1983

SPARTECH PLASTICS

THERMOPLASTIC SHEETS TYPE FTB,BRT SERIES MNFG MEDFORD,MASS.FACILITY

4875

II

3/21/1983

KETOPROFEN CR CAPSULES 200&300MG, MNFG IN MARBURG, GERMANY

4876

II

2/24/1983

TEMMLER WERKE VEREINIGTE CHEMISCHE


FABRIKEN
MEDIMPEX NORTHAMERICA INC

4877

II

3/26/1983

LUNDBECK PHARMACEUTICALS ITALY SPA

METOCLOPRAMIDE HCL MONOHYDRATE

4878

II

2/21/1983

DINAMITE DIPHARMA SPA

NAPROXEN MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES

4879

2/28/1983

BIOREX LABORATORIES INC

4880

II

3/16/1983

AAI PHARMA LLC

MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN


LONDON ON QUEENSLAND ROAD.
PROPOXYPHENE NAPSYLATE-MFGR BY ELI LILLY INDUST. INC-MAYAQUEZ, P.R.

4881

II

10/14/1983

PFIZER LTD

TIOCONAZOLE AS MANUF PFIZER LTD, SANDWICH, UK

4882

II

2/1/1983

ANTIBIOTICOS SPA

CHEM. & PHARMACY OF ANTIBIOTIC LM 427 AS IT WILL BE REFERENCED BY INDS

4883

II

4/4/1983

PLANTEX LTD CHEM AND PHARM WORKS

VINBLASTINE SO4 USP AS MFGR IN PLANTEX-NETANYA AND ASSIA-PETACH TIKVA

4884

II

3/15/1983

MALLINCKRODT INC

4885

II

3/1/1983

BIOREX LABORATORIES INC

HYDROCODONE BITARTRATE USP CRYSTALS, CODE 1582 AS MANUFACTURED IN ST. LOUIS,


MO.
CICLOXOLONE SODIUM

4886

II

3/16/1983

AAIPHARMA INC

PROPOXYPHENE HCL AS MANUF BY ELI LILLY INDUST. IN MAYAQUEZ, P.RICO

4887

II

3/23/1983

EASTMAN KODAK CO

13-CIS-RETINOIC ACID (ISOTRETINOIN)-MFG IN ROCHESTER, NY FACILS

4888

III

3/16/1983

SPARTECH PLASTICS

THERMOPLASTIC SHEET IN MTB-BTM SERIES MNFG IN MEDFORD, MASS FACILITIES

4889

III

3/16/1983

CONSTANTIA TEICH GMBH

ALUMINUM FOIL PACKAGING MATERIALS FOR DRUG PRODUCTS

4890

II

3/31/1983

JANSSEN PHARMACEUTICA NV

DROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES

4891

II

3/30/1983

ASTA-WERKE AKTIENGESELLSCHAFT

CORMELIAN COATED TABLETS

4892

II

12/27/1982

FENBUFEN MNFG BY CYANAMID OF GREAT BRITAIN, LIMITED

4893

II

8/4/1982

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
NORDION INTERNATIONAL INC

4894

II

12/20/1982

SPRET MAUCHANT LABORATORIES

BAMIFYLLINE (TRENTADIL)

4895

II

5/9/1983

TROPONWERKE GMBH CO KG

ETOFENAMATE MFG IN THE KOLN, GERMANY PLANT

4896

II

5/10/1983

OMNICHEM NV (PRB)

PROPRANOLOL HCL MANUFACTURED IN COOPALLAAN.

4897

5/10/1983

DINAMITE DIPHARMA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4898

II

4/2/1983

SUMIKA FINE CHEMICALS CO LTD

FOLIC ACID

4899

III

3/16/1983

SPARTECH PLASTICS

COMPOSITE THERMOPLASTIC SHEETS OF PTR,RTP SERIES,MNFG IN MEDFORD, MASS

4900

III

7/31/1984

UNION CARBIDE CORPORATION

UCAR SOLUTION VINYL RESINS

4901

II

3/10/1983

KONGO CHEMICAL CO LTD

L- CARNITINE HYDROCHLORIDE

4902

II

3/14/1983

FINE CHEMICALS CORP PTY LTD

THIORIDAZINE HCL-MANUF IN THE CAPE PROVINCE, SOUTH AFRICA

4903

III

3/16/1983

SPARTECH PLASTICS

COMPOSITE THERMOPLASTIC SHEETS IN PTF,FTP SERIES;MNFG IN MEDFORD, MASS

4904

3/28/1983

AH ROBINS CO

4905

II

3/23/1983

ORGAMOL SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RICHMOND, VIRGINIA.
SOBREROL

MONAMID 150-LW MANUF IN THE PATERSON, JN FACILITIES

TRIMETHOPRIM AS MFGR BY EGYT PHARMACOCHEMICAL WORKS OF BUDAPEST

XENON-127 (PROD VANCOUVER, BRITISH COLUMBIA) ORIG SUBMITTED TO DMF4115

Page 134

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4906 I
IV
4/7/1983
MING TAI CHEMICAL CO LTD

SUBJECT
MICROCRYSTALLINE CELLULOSE PROCEDURES USE IN THE MANUFACTURING

4907

4/28/1983

PITMAN-MOORE CO DIV ALLIED LABS INC

PERSONNEL, FACILS & GEN OPERATING PROCEDS WASHINGTON CROSSING NJ PLANT

4908

II

2/15/1983

PFIZER INC

5-ETHYL-2-DEOXYURIDINE AS MANUF.BY HEINRICH MACK,ILLERTISSEN,GERMANY

4909

II

3/16/1983

SIEGFRIED AG

METHACHOLINE CHL-MANUF AND SOLD UNDER THE SIEGFRIED LABEL

4910

II

3/31/1983

ABBOTT LABORATORIES

VERAPAMIL AS MNFG IN N.CHICAGO, ILLINOIS

4911

II

4/18/1983

ALBEMARLE CORP

PROCAINAMIDE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

4912

II

4/20/1983

4913

3/31/1983

AYERST LABORATORIES INC DIV AMERICAN HOME MYSOLINE (PRIMIDONE) TABLETS MANUF IN ROUSESPOINT, NEW YORK FACILS
PRODUCTS CORP
MIKART INC
ALANTA, GA. PLANT ON MARIETTA BLVD.

4914

II

2/15/1983

PFIZER INC

DECARBAZINE AS MANUF BY HEINRICH MACK NACHF IN ILLERTISSEN, GERMANY

4915

II

3/4/1983

ALZA CORP

OSMET DELIVERY MODULES AS PRODUCED IN THE PALO ALTO, CA. FACILITIES

4916

II

5/16/1983

VITARINE CO INC

PSEUDOEPHEDRINE HCL 120MG S.R. CAPS--MFGR IN SPRINGFIELD GARDENS, NY

4917

II

4/18/1983

KNOLL AG LUDWIGSHAFEN

AMINOPHYLLINE

4918

II

5/10/1983

OMNICHEM NV (PRB)

PROPANETRIOL TRINITRATE 10% WITH LACTOSE

4919

II

4/25/1983

SIGMA F AND D DIV LTD

TRIZMA HYDROCHLORIDE AS MFG IN THE ST. LOUIS, MISSOURI FACILITIES

4920

III

2/17/1983

ER SQUIBB AND SONS INC

PROCEDURES FOR PACKAGING DRUG PRODUCTS

4921

III

4/11/1983

ALUMINUM PACKAGING MATERIALS

4922

II

3/17/1983

FOLIENWALZWERK BRUEDER TECH


AKTIENGESELLSCHAFT
SCHERING AG

4923

II

4/18/1983

BASF PHARMACHEMIKALIEN GMBH CO KG

(+)-PSEUDOEPHEDRINE SULFATE

4924

II

4/29/1983

CHANGZHOU PHARMACEUTICAL FACTORY

HYDROCHLOROTHIAZIDE-MANUF BY CHANG ZHOU PHARMACEUTICAL WORKS

4925

II

8/8/1983

HOECHST MARION ROUSSEL SA

DEZOCINE AS MANUF IN THE VERTOLAYE, FRANCE PLANT

4926

4/13/1983

WHITEWORTH TOWNE PAULSEN INC

4927

II

5/24/1983

TIANJIN HEBEI PHARMACEUTICAL FACTORY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MONROVIA, CALIFORNIA.
METRONIDAZOLE MANUFACTURED IN TIANJIN, CHINA

4928

II

3/22/1983

HERBRAND PHARMACHEMICALS GMBH

PROPYLTHIOURACIL

4929

II

3/17/1983

TARO PHARMACEUTICAL INDUSTRIES LTD

CARBAMAZEPINE

4930

II

5/19/1983

SCHERING AG

ETHINAMATE

4931

4/12/1983

ELAN CORP PLC

4932

II

6/1/1983

SA AJINOMOTO OMNICHEM NV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MONKSLAND, ATHLONE.
VINCRISTINE SULFATE

4933

II

6/3/1983

ROUSSEL-UCLAF

TESTOSTERONE PROPIONATE

4934

II

3/25/1983

HEXAGON LABORATORIES INC

BEPRIDIL HCL-MANUF IN BRONX,NY

4935

II

6/7/1983

FMC CORP

CELOCAL(R) CO-PROCESSED CELLULOSE GEL/CALCIUM SULFATE MANUF NEWARK ,DE

4936

II

6/1/1983

NORDIC SYNTHESIS AB

MEPIVACAINE HCL

4937

II

1/20/1983

DIOSYNTH BV

DEXAMETHASONE MICRO AND NON-MICRO

4938

II

3/31/1983

LOFTUS BRYAN CHEMICALS LTD

BROMPHENIRAMINE MALEATE AS MANUF. IN RAHDRUM IRELAND

4939

II

1/21/1983

OXAZEPAM

4940

IV

3/29/1983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
DOW CORNING CORP

4941

II

4/26/1983

SIGMA F AND D DIV LTD

TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES

DEFLAZACORT

SILASTIC Q3-9595 LIQUID POLYMER SYSTEM-MIDLAND MI.

Page 135

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4942 A
II
4/29/1983
INDENA SPA

SUBJECT
RESERPINE USP

4943

4/25/1983

SANOFI WINTHROP INDUSTRIE

4944

II

1/10/1983

DIOSYNTH BV

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN AMBARES, FRANCE.
DEXAMETHASONE ACETATE MICRO AND NON MICRO

4945

4/28/1983

AB ASTRA

4946

4/26/1983

DESITIN WERK CARL KLINKE GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING


PROCEDURESIN SODERTALFE, SWEDEN.
PRODUCTION OF PHENYTOIN SODIUM, INJECT. IN HAMBURG,GER

4947

4/27/1983

MALLINCKRODT INC

FACILS & PERSONNEL FOR THE RAD PHARM INC CYCLOTRIN ON MAHLER RD. CA.

4948

6/8/1983

HOECHST AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

4949

II

5/23/1983

JT BAKER CHEMICAL CO

METHENAMINE HIPPURATE-MFGR IN PHILLIPSBURG, NJ FACIL ON NO. BROAD ST.

4950

II

2/15/1983

DIOSYNTH BV

ALLOPURINOL

4951

5/25/1983

FDC PRIVATE LTD

FACILS & GEN. OPERATING PROCEDS. FOR MFGR OF BULK DRUG PRODS: W/FORMU

4952

4/28/1983

AB ASTRA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4953

II

5/31/1983

SEKISUI MEDICAL CO LTD

L-METHIONINE

4954

4/21/1983

EUDERMA SRL

4955

II

4/22/1983

SANOFI SYNTHELABO INC.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ITALY.
AMIODARONE HYDROCHLORIDE

4956

II

4/11/1983

CILAG CHEMIE AG

CHLORZOXAZONE

4957

II

5/17/1983

FARMABOIS

TRIAMCINOLONE ACETONIDE

4958

II

2/15/1983

DIOSYNTH BV

CHENODEOXYCHOLIC ACID H.M.

4959

II

5/18/1983

PHARMA-WALDHOF GMBH

5-FLUORO-URACIL,PRODUCT 4965

4960

II

5/31/1983

DAIICHI PURE CHEMICALS CO LTD

L-TRYPTOPHAN

4961

4/19/1983

SANOFI CHIMIE

4962

II

5/20/1983

PAN MEDICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ARAMON.
SYNTHESIS & INVEST. DOSAGE FORM PREPARATION FOR TRIPTOSINE

4963

II

5/9/1983

ZYMA SA

ZY-15029

4964

III

3/22/1983

PFIZER INC

PACKAGING COMPONENTS-PRIMARILY USED IN PRODUCTION A BKLYN, NY PLANT

4965

6/21/1983

PROTER LABORATORY SPA

4966

II

3/14/1983

BOEHRINGER MANNHEIM GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OPERA, MILAN, ITALY.
D-PHENYLALANINE

4967

4/7/1983

JUSTE SAQF

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4968

II

5/17/1983

GLAXO PHARMACEUTICALS LTD

0/4 DIHYDROCHLORIDE DIHYDRATE (CEPHALORIDINE ROUTE-CP)-ULVERSTON PLANT

4969

5/18/1983

PAN MEDICA SA

PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE

4970

II

4/7/1983

GANES CHEMICALS INC

BEPRIDIL HCL AS MFGR IN PENNSVILLE NJ PLANT

4971

5/14/1983

COPLEY PHARMACEUTICAL INC

4972

II

3/31/1983

EGIC LABORATORY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BOSTON, MASS.
ORAL ASPEGIC

4973

II

4/7/1983

JUSTESA IMAGEN SAU

DIATRIZOIC ACID

4974

6/10/1983

ZYMA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

Page 136

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
4975 A
II
7/5/1983
PHARMACIA AND UPJOHN SUB PFIZER INC

SUBJECT
MEDROXYPROGESTERONE ACETATE USP -MFGR IN FACILITIES ON PORTAGE RD.

4976

II

7/7/1983

RHONE-POULENC

SUPROCLONE (37,162 RP)-MANUF IN THE VITRY SUR SEINE CEDEX FACILITIES

4977

II

5/13/1983

TANABE SEIYAKU CO LTD

THIOPENTAL SODIUM FOR INJECT--MANUF IN THE OSAKA, JAPAN PLANT

4978

II

7/6/1983

MEDIMPEX NORTHAMERICA INC

VINBLASTINE SO4 FOR INJECT, USP 10 MG-MANUF BY GEDEON RICHTER, HUNGARY

4979

II

5/26/1983

PLANTEX LTD CHEM AND PHARM WORKS

PROPRANOLOL HCL. USP. AS MANUF. IN FACILITIES DESCRIBED IN DMF.2619

4980

II

5/31/1983

EASTMAN CHEMICAL CO

METHOCARBAMOL USP AS MANUF IN THE LLANGEFNI FACILITY

4981

4/11/1983

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

4982

II

6/15/1983

INNOVATION PHARMACEUTICALS INDUSTRY INTL


PRIVATE LTD
LUSOCHIMICA S P A

4983

II

7/7/1983

RHONE-POULENC

SUPROCLONE CAPSULES (37, 162 RP) MANUFACTURED IN ANTOMY, FRANCE.

4984

II

6/30/1983

PROTER LABORATORY SPA

BULK SUBSTANCE PTT-119 AS MANUF IN THE OPERA (MILANO) PLANT

4985

II

4/22/1983

SANDOZ PHARMS CORP DIV SANDOZ INC

GUANFACINE HYDROCHLORIDE AS MFG. IN THE EAST HANOVER, N.J. FACILITY

4986

II

6/17/1983

SIEGFRIED AG

DISULFIRAM MANUF & SOLD UNDER SIEGFRIED LABEL

4987

II

6/14/1983

MALLINCKRODT INC

MERCURY 195M/GOLD 195M GENERATORS-FACILS,METHDS,CONTRL FOR PREPARATION

4988

6/9/1983

PARKE DAVIS & COMPANY

FACILITIES & GENERAL OPERATING PROCEDURES (SANDY, UTAH LOCATION)

4989

II

6/28/1983

RHONE-POULENC

GUAIFENESIN (GLYCEROL GUAIACOLATE)--MFGR IN USINE DE SAINT-FONS,FRANCE

4990

II

6/21/1983

SANDOZ GMBH

7-AMINO-CEPHALOSPORANIC ACID (7-ACA)

4991

II

5/28/1983

TEVA PHARMACEUTICAL INDUSTRIES LTD

HALOPERIDOL

4992

II

6/21/1983

ANTIBIOTICOS SPA

TRIPROLIDINE HCL. BULK FORM

4993

IV

2/15/1983

DIOSYNTH BV

EGG-YOLK PHOSPHOLIPID

4994

IV

7/13/1983

LA DREYFUS CO

DREYCO CHEWING GUM BASE MANUF BY L.A. DREYFUS IN BISSHEIM, FRANCE

4995

II

4/22/1983

YODOGAWA PHARMACEUTICAL CO LTD

CHLORZOXAZONE USP XX AS MANUF IN THE GIFU PLANT

4996

II

6/21/1983

SANDOZ GMBH

(7-ACT)--7AMINO-3-(2,5DIHYDRO-2METHYL-5-OXO-6HYDROXY-1,2,4TRIAZINE-3YL

4997

II

7/8/1983

SMITHKLINE & BECKMAN INC

DIPHENYLPYRALINE HCL--PRODUCED IN SMITHKLINE FACILS-CONSHOHOCKEN, PA.

4998

II

5/9/1983

SF86-327 (E)-N-(6,6-DIMETHYL-2-HEPTEN-4-YUL)-N--METHYL-1-NAPHTHALALENE

4999

5/26/1983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
PROCTER AND GAMBLE CO

5000

5001

II

6/15/1983

GLAXOCHEM LIMITED

VITAMIN B 12(CYANOCOBALAMIN) AS MANUF IN ULVERSTON, CUMBRIA PLANT

5002

5/31/1983

PERSTORP CHEMICALS AB

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5003

II

5/19/1983

DEGUSSA AG

L-TYROSINE ETHYLESTER HCL-BY REXIM S.A. DIV. OF DEGUSSA, HAM, ENGLAND

5004

III

6/20/1983

AMERICAN GASKET AND RUBBER CO

RUBBER COMPOUNDS & GASKETS-MANUF IN SCHILLER PARK, IL

5005

II

5/3/1983

SANOFI CHIMIE

AMIODARONE HCL AS MANUF BY SEMPA-CHIMIE IN ARAMON, FRANCE

5006

II

6/29/1983

SMITHKLINE BEECHAM ANIMAL HEALTH

DIETHYLCARBAMIZINE CITRATE-MANUF-SMITHKLINE CHEM DIV-CONSHOHOCKEN PA

5007

II

6/23/1983

SALK INSTITUTE

NAL-ARG ANTAGONIST

5008

II

6/14/1983

VITARINE CO INC

PHENYLEPHRINE HCL 20MG S.R. CAPS-MANUF IN SPRINGFIELD GARDENS, NY

5009

IV

7/11/1983

PETROLITE CORP BARECO DIV

SILTEX M AS PROCESSED IN OKLAHOMA FACILITIES

5010

IV

7/14/1983

KV PHARMACEUTICAL CO

PROTECTIVE CREAMS,LOTIONS-WESTPORT FACIL. ON SCHUETZ RD, ST. LOUIS, MO

5011

II

8/1/1983

INNOTHERA

CETIEDIL

PROPRANOLOL HYDROCHLORIDE USP XX, NF XV

MIAMI VALLEY LABS-EAST MIAMI RIVER RD., CINCINNATI,OHIO

NOT AN ASSIGNED NUMBER

Page 137

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5012 I
II
8/4/1983
INDUSTRIA FARMACEUTICA SERONO

SUBJECT
TP-1 SERONO (THYMOSTIMULIN) MFG BY I.F. SERONO, S.P.A. ROME, ITALY

5013

7/29/1983

JAME FINE CHEMICALS INC

5014

III

2/1/1983

AMCOR FLEXIBLES SELESTAT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BOUND BROOK PLANT.
ALUMINUM FOIL PACKAGING MATERIALS

5015

III

7/22/1983

BALL CORP

COEXTRUDED PKG MATLS-EVANSVILLE, IND, FACIL: 1.BALL PLASTICS 454(TM)

5016

II

4/20/1983

E MERCK

CHLORTHALIDONE USP

5017

II

5/19/1983

DEGUSSA AG

AMINO ACID MIXTURES I AS PRODUCED BY REXIM SA DIV DEGUSSA HAM FRANCE

5018

II

7/29/1983

JAME FINE CHEMICALS INC

METHENAMINE HIPPURATE MFG IN THE BOUND BROOK, N.J. FACILITIES

5019

II

6/29/1983

BASF PHARMA EVIONNAZ SA

PRILOCAINE HCL

5020

III

5/5/1983

KURZ TRANSFER PRODUCTS LP

COLORIT P 912 BLACK PIGMENT FOIL-PRODUCED IN THE PHIL., PA FACILITIES

5021

II

7/18/1983

ANDRULIS RESEARCH CORP

BULK SYNTHESIS OF NSC 271674

5022

II

3/22/1983

L(-)-POLYLACTIC ACID FOR USE IN DRUG DOSAGE FORMS

5023

II

7/25/1983

5024

II

6/28/1983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
WAITAKI INTERNATIONAL BIOSCIENCES SUB
WAITAKI CANADA LTD
BASF PHARMA EVIONNAZ SA

5025

II

7/21/1983

SIFAVITOR SRL

DOXEPINE HYDROCHLORIDE USP XX.

5026

7/26/1983

MEIJI SEIKA KAISHA LTD

5027

II

5/17/1983

FABBRICA ITALIANA SINTETICI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR ANTIBIOTIC PRODUCTIONIN ASHIGARA, JAPAN
LORAZEPAM, BULK FORM

5028

7/28/1983

UCB,SOCIETE ANONYME PHARM DIV

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES BRAINE-L'ALLEUD

5029

II

7/29/1983

EUTICALS LIMITED

ISOSORBIDE-5-MONONITRATE, DILUTED

5030

II

4/27/1983

JUSTE SAQF

SODIUM DIATRIZOATE

5031

II

6/30/1983

FERMION OY

VERAPAMIL HCL BP 80 ADD. 82

5032

II

8/5/1983

BASF PHARMACHEMIKALIEN GMBH CO KG

CAFFEINE (HYDROUS, ANHYDROUS FORMS)

5033

II

5/19/1983

DEGUSSA AG

L-ARGININE ACETATE AS PRODUCED BY REXIM S.A.DIV DEGUSSA -HAM FRANCE

5034

II

5/31/1983

ER SQUIBB AND SONS INC

TRIFLUPROMAZINE AND TRIFLUPROMAZINE HCL AS MANUF BY VON HEYDEN

5035

IV

5/6/1982

SCM CORPORATION

SAINA III-PROCESSED IN JOLIET, ILLINOIS FACILITIES

5036

III

5/6/1982

SUNOCO CHEMICAL CO

POLYPROPYLENE RESINS IN PP11M12ACS SERIES MANUFACTURED IN ODESSA, TEXAS.

5037

III

7/12/1983

BALL CORP

COEXTRUDED PACKAGING MATERIALS-PROCESSED EVANSVILLE FACILITIES

5038

II

8/15/1983

FENTANYL CITRATE (BULK) AS MANUFACTURED IN WEST DEPTFORD, NJ

5039

II

7/26/1983

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
ARCO CHEMICAL CO

5040

II

7/15/1983

UPJOHN CO

MENOGAROL (U-52,047,NSC-269148)PRODUCED KALAMAZOO, MICHIGAN FACILITIES

5041

II

7/9/1983

EVONIK TECHNOCHEMIE GMBH

LORAZEPAM MFG IN DOSSENHEIM, GERMANY

5042

III

6/22/1983

BALL CORP

COEXTRUDED PACKAGING MATERIALS AS PROCEDURES IN EVANSVILLE IN

5043

5/26/1983

SCHERING CANADA INC

5044

II

8/9/1983

DAIICHI SANKYO CHEMICAL PHARMA CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN POINTE CLAIRE, QUEBEC.
LEVODOPA AS PRODUCED IN THE HIRATSUKA PLANT

5045

II

11/28/1983

UCB,SOCIETE ANONYME PHARM DIV

MECLIZINE HCL TABS IN BULK 12.5MG-MANUF IN BRAINE-1'ALLEUD PLANT

5046

II

6/30/1983

CERBIOS PHARMA SA

LEUCOVORIN CALCIUM AS MANUFACTURED IN BARBENGO SWITZERLAND

METOCLOPRAMIDE MONOHYDROCHLORIDE
BENOXINATE HYDROCHLORIDE

TEBOL 99 ALCOHOL (HIGH PURITY TERTIARY BUTYL ALCOHOL) PASEDENA TX

Page 138

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5047 A
II
7/25/1983
PHARMACIA AND UPJOHN

SUBJECT
ESTRADIOL CYPIONATE USP MANUF-KALAMAZOO, MI FACILITIES ON PORTAGE RD.

5048

II

7/22/1983

SANOFI PHARMACEUTICALS INC

ACETAMINOPHEN

5049

II

6/30/1983

DIAMALT AG

S-CARBOXYMAHYL-L-CYSTEINE

5050

II

7/28/1983

UCB,SOCIETE ANONYME PHARM DIV

MECLIZINE HCL TABS-BULK 25MG MANUF -BRAINE-L'ALLEUD PLANT

5051

6/24/1983

5052

II

4/7/1983

LABORATOIRES D'ETUDES ET DE RECHERCHES


SYNTHELABO
JUSTE SAQF

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PORCHVILLE, ANTONY, FRANCE.
MEGLUMINE DIATRIZOATE

5053

4/11/1983

SPECIALTES SEPTODONT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES.

5054

6/24/1983

EMSON RESEARCH INC

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES

5055

7/27/1983

SYNCOR INTERNATIONAL CORP

PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES-GLENDALE CA PLANT

5056

II

9/7/1983

ROUSSEL-UCLAF

L-5-HYDROXYTRYPTOPHAN AS MANUF,IN VERTOLAYE PLANT

5057

9/1/1983

CONTECH LABORATORIES

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES-GREENVILLE ILL

5058

III

9/1/1983

FOIL TO PVC HEAT SEAL PRODS-PRODUCED IN NUTLEY NJ FACILITIES

5059

III

9/9/1983

TECHNICAL COATINGS CO SUB OF BENJAMIN


MOORE & CO
INTERNATIONAL PACKING CORP

5060

II

6/13/1983

FUJISAWA DEUTSCHLAND GMBH

TAMOXIFEN CITRATE

5061

II

8/22/1983

5062

II

7/14/1983

CHUNGHWA CHEMICAL SYNTHESIS & BIOTECH CO ACETAMINOPHEN USP XX PWD & ACETAMINOPHEN W/10% STARCH
LTD
SCHERING AG
QUINIDINE GLUCONATE MANUF. IN BERLIN PLANT

5063

II

9/5/1983

ANTIBIOTICOS SPA

FLURANDRENOLIDE USP BULK FORM (NON-STERILE)

5064

III

5/9/1983

PANTASOTE INC

PVC COMPOUNDS AND/OR FILMS (PRO.N.J. FACILITIES):1. 4504P1000 PVC

5065

II

7/22/1983

SIGMA F AND D DIV LTD

MUSCIMOLMANUF BY BACHEM AG

5066

9/6/1983

YAMANOUCHI PHARMACEUTICAL COMPANY LTD

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES

5067

II

8/31/1983

5068

II

6/22/1983

AYERST LABORATORIES INC DIV AMERICAN HOME GONADORELIN HCL AS MFG IN THE ROUSES POINT, NY PLANT(FACTREL)
PRODUCTS CORP
NORDION CANADA INC
LEAD & THALLIUM 201-PRODUCED IN AECL TRIDCHEM. ANNEX-VANCOUVER, CAN

5069

7/27/1983

MEMBRANA INC

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES

5070

II

7/26/1983

DINAMITE DIPHARMA SPA

GUANETHIDINE MONOSULFATE

5071

III

8/19/1983

AMERICAN NATIONAL CAN CO

LACQUERED PRINTED ALUMINUM FOIL HEAT SEAL COATED PACKAGING PRODUCTS

5072

III

8/14/1983

NATIONAL STARCH & CHEMICAL CORP

56065/RC-803 ADHESIVE AS PRODUCED IN THE NEW JERSEY FACILITIES

5073

II

7/15/1983

ORGANICHEM CORP

PHENYLEPHRINE HCL USP MANUF. IN RENSSELEAR, NY FACILITIES

5074

II

9/6/1983

ASTELLAS PHARMA INC

CEFOTETAN AS MANUFACTURED AT TAKAHAGI PLANT

5075

II

8/22/1983

MDS NORDION

IODINE 125 PRODUCED IN KANATA ISOTOPE PROCESSING FACIL (AECL-KIPE)

5076

II

5/24/1983

SUMIKA FINE CHEMICALS CO LTD

DOXEPIN USP XX MANUF IN GIFU PLANT

5077

II

9/14/1983

VETERANS ADMINISTRATION

TC-99M-PROPYLENE AMINE OXIME (TC-99M-PNAO)

5078

II

9/12/1983

OMNICHEM SA

5-HYDROXY-L-TRYPTOPHAN-MANUF IN COOPPALLAAN PLANT

5079

II

8/24/1983

KLINGE PHARMA GMBH

PROPRANOLOL HCL MFG BY KLINGE & CO-IRELAND;SUBSID. KLINGE PHARMA GMBH

5080

7/4/1983

ZAMBON SPA

5081

II

8/11/1983

ORGAMOL SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALMISANO DI LONIGO (VICENZA).
DISOPYRAMIDE

5082

II

9/30/1983

SIGMA F AND D DIV LTD

BETAINE FREE BASE ANHYDROUS PURCHASED BY SIGMA LTD LONDON FOR USA

PRODUCT BO-401-MANUF IN MORRISTOWN, IND. FACILS. ( A FORMULATION)

Page 139

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5083 I
I
7/15/1983
NATIONAL RUBBER AND BACKING CORP
5084

II

6/24/1983

EASTMAN KODAK COMPANY

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN LONG ISLAND, NEW YORK.
5-2(3-AMINOPROPYLAMINO) ETHYL DIHYDROGEN PHOSPHOROTHIOATE TRIHYDRATE

5085

II

8/30/1983

ROMAN INDUSTRIES COMPANY LTD

HUMAN CHORIONIC GONADOTROPIN (MFG KANAGAWA PLANT)MKD BY TOHRI & CO.LTD

5086

II

7/29/1983

IRISH FINE CHEMICALS LIMITED

DEXCHLORPHENIRAMINE MALEATE AS MANUF IN RAHDRUM FACILITY

5087

8/8/1983

ELI LILLY INDUSTRIES INC

GENERAL OPERATING PROCEDURES FOR THE PUERTO RICO FACILITY

5088

II

8/15/1983

CHIREX LTD

PHENTERMINE BASE & HCL MANUF-FAWDON & DUDLEY NEAR CRAMLINGTON FACILS.

5089

II

9/20/1983

SIGMA F AND D DIV LTD

3,3',5-TRIIODOTHYROACETIC ACID, DIETHANOLAMINE SALT

5090

II

7/20/1983

ACF CHEMIEFARMA NV

QUINIDINE BISULFATE

5091

II

7/4/1983

ZACH SYSTEM SPA

ACETYLCYSTEINE USP (MFG ALMISANO DI LONIGO, VICENZA, ITALY PLANT

5092

II

10/12/1983

BACHEM INC

SOMATOSTATIN; BULK FORM AS MFG IN THE TORRANCE, CALIFORNIA FACILITIES

5093

II

10/3/1983

KABI PHARMACIA HEPAR INC

HEPARIN CALCIUMAS MFG IN THE FRANKLIN, OHIO FACILITIES

5094

II

10/10/1983

DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN THE LATINA FACTORY

5095

II

10/12/1983

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
VITARINE CO INC

5096

IV

9/14/1983

VMF

MFG OF EMPTY GELATIN CAPSULES. BY ELI LILLY FRANCE, FERGERSHEIM, FRANCE

5097

II

8/22/1983

EPROVA AG

PHOSPHORIC ACID (76541-72-5) DESIGNATED AS SR-202

5098

III

9/30/1983

BALL CORP

COEXTRUDED PKG MATERIALS MFG EVANSVILLE, INDIANA: 1. BALL PLASTICS 858

5099

II

8/4/1983

EASTMAN KODAK CO

ACETOHYDROXAMIC ACID (LITHOSTA)PROCESSED ROCHESTER, N.Y. FACILITIES

5100

III

5/26/1981

3M PHARMS

HDPE CLOSURE LINER AS PROCESSED IN ST. PAUL, MINN. FACILITIES

5101

II

7/18/1983

SIGMA F AND D DIV LTD

D-PANTETHINE AS MANUF BY SOGO PHARMACEUTICAL CO.

5102

II

9/16/1983

ELI LILLY AND CO

FENOPROFEN CALCIUM, BULK FORM MFG TIPPECANOE LABS (LAFAYTETTE, INDIANA

5103

II

8/23/1983

SCHERING AG

IOTROL USING 5-NITROISOPHTHALIC ACID AS STARTING MATERIAL

5104

II

7/25/1983

TEVA PHARMACEUTICAL INDUSTRIES LTD

CHLORTHALIDONE

5105

9/27/1983

QUANTUM PHARMICS LTD

5106

II

9/20/1983

SOCIETE LIPHA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AMITYVILLE, NEW YORK.
LORTALAMINE (LM 1404) AS PROCESSED IN THE LYON FACILITY

5107

9/15/1983

AMIDE PHARMACEUTICAL INC

5108

II

9/9/1983

JANSSEN PHARMACEUTICA NV

5109

II

9/2/1983

CHLORTHALIDONE AS MFG. IN THE BASLE, SWITZERLAND FACILITIES

5110

II

8/26/1983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
AMERSHAM RADIOCHEMICAL CENTER

5111

8/31/1983

THATCHER CHEMICAL COMPANY

5112

6/22/1983

CYANAMIDE OF CANADA

5113

II

9/15/1983

GOEDECKE AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN


SALT LAKE CITY, UTAH.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BAIE D'URFE, QUEBEC CANADA.
LEVOBUNOLOL HYDROCHLORIDE (1-BUNOLOL HYDROCHLORIDE)

5114

II

9/20/1983

LIPHA SA

LORTALAMINE (LM 1404) IN FINISHED DOSAGE FORMS PRODUCED LYON FACILITY

5115

9/12/1983

L PERRIGO CO

5116

IV

5/23/1983

GATTEFOSSE SAS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALLEGAN, MICHIGAN.
PRECIROL A05 MANUFACTURED IN CEDEX,FRANCE

L-LYSINE MONOHYDROCHLORIDE TABLETS AS MFG SPRINGFIELD GARDENS, NY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LITTLE FALLS, NEW JERSEY.
OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY

TAURO-23-[75SE]-SELENA-25 HOMOCHOLIC ACID (DESIGNATED AS SEHCA)

Page 140

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
5117 A
III
9/14/1983
THE NIPPON SYNTHETIC CHEMICAL INDUSTRY CO ETHYLENE-VINYLACETATE-VINYLALCOHOL COPOLYMER (TRADE NAME SOARNOL)
LTD
5118 I
III
9/19/1983
OWENS ILLINOIS INC
PLASTIC PRODUCTS MFG IN THE KALAMAZOO, MICHIGAN FACILITIES,KILGORE RD
5119

II

9/20/1983

SIGMA F AND D DIV LTD

DEHYDROISOANDROSTERONE-3-SULFATE,SODIUM SALT MFG SYNTEX S.A.OF MEXICO

5120

II

10/14/1983

KABI PHARMACIA HEPAR INC

CHONDROITIN SULFATE AS MFG IN THE FRANKLIN, OHIO FACILITIES

5121

II

10/11/1983

BULK FORM OF DRUG PRODUCT L-590,153 PROCESSED RAHWAY, N.J. FACILITIES

5122

II

8/26/1983

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
FARCHEMIA

5123

II

9/30/1983

SMITHKLINE & BECKMAN INC

CIMETIDINE MFG BY FRANKLIN CHEMICALS, LTD IN THE BAHAMAS

5124

III

8/31/1983

ALLERGAN PHARMACEUTICAL

CONTAINER/CLOSURE INFO PERTAINING TO CONTAINER/CLOSURE SYSTEMS

5125

II

11/7/1983

CHINOIN

HYDROCHLOROTHIAZIDE MFG DIOSGYOR, HUNGARY PLANT, DIST. BY MEDIMPEX

5126

II

11/3/1983

GANES CHEMICALS INC

ESMOLOL HYDROCHLORIDE AS MFG IN THE CARLSTADT, NEW JERSEY FACILITIES

5127

II

11/7/1983

HOECHST AG

CHLORZOXAZONE, BULK FORM

5128

II

11/5/1983

PENINSULA LABS

SYNTHETIC SOMATOSTATIN AS SYNTHESIZED IN BELMONT, CA. FACILITIES

5129

II

10/21/1983

HEINRICH MACK NACHF

5-AZACYTIDINE MFG BY HEINRICH MACK NACHFIN ILLERTISSEN, GERMANY

5130

II

9/30/1983

INOLEX CHEMICAL CO

AMMONIUM LACTATE MFG IN PHILADELPHIA PA AND SELMA,NC

5131

II

6/30/1983

SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS)

HYDRALAZINE CHLORIDRATE MFG IN FILARONE REGELLO (FRANCE) PLAN

5132

II

10/21/1983

SUMIKA FINE CHEMICALS CO LTD

ISOPROTERENOL HYDROCHLORIDE USP XX AS MANUFACTURED IN THE GIFU PLANT

5133

II

10/7/1983

SIGMA F AND D DIV LTD

HEPES, FREE ACID AND HEPES, SODIUM SALT

5134

II

6/10/1983

DOPAMINE HCL PRODUCED CAMPOVERDE DI APRILIA, LATINA FACILITY

5135

II

9/28/1983

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
SALSBURY CHEMICALS INC

5136

II

9/16/1983

SYNTHA

METHOCARBAMOL

5137

5/27/1983

PANCREOLAURYL TEST

5138

II

10/27/1983

TEMMLER WERKE VEREINIGTE CHEMISCHE


FABRIKEN
SANOFI CHIMIE

5139

II

7/20/1983

PROPRANOLOL AS MANUF IN THE FILARONE, REGGELLO FACILITIES

5140

9/23/1983

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
NOMAX INC

5141

II

11/15/1983

FINE CHEMICALS CORPORATION

5142

10/26/1983

ZENITH LABORATORIES INC

5143

II

11/16/1983

HOECHST AG

5144

11/14/1983

ORION CORP FARMOS CHEMICAL PLANT

5145

II

10/18/1983

SCHERING AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TURKU, FINLAND.
SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT

5146

II

8/11/1983

SIGMA F AND D DIV LTD

CHOLESTEROL AS MFG BY SIGMA CHEMICAL COMPANY IN ST. LOUIS, MISSOURI

5147

II

10/28/1983

TETRAHYDROZOLINE HCL MFG IN THE FILARONE REGELLO (FLORENCE) PLANT

5148

II

11/10/1983

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
RHONE-POULENC

5149

9/15/1983

AMERICAN THERAPEUTICS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BOHEMIA, NEW YORK.

GUANETHIDINE SULFATE, USP

PROBENECID USP AS MFG IN THE CHARLES CITY, IOWA FACILITY

CYANOCOBALAMIN AS MFG IN ROMAINVILLE, FRANCE(PLANTS I AND IV)

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ST. LOUIS, MISSOURI.
VERAPAMIL HYDROCHLORIDE
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CIDRA, PUERTO RICO.
6-AMINOPENICILLANIC ACID (6-APA) BULK FORM

ACETAMINOFEN AS MANUFACTURED IN THE USINE DE SAINT-FONS PLANT SITE

Page 141

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5150 I
I
9/22/1983
BIOTEK INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN WOBURN, MASSACHUSETTS.
ORG 7417

5151

II

9/16/1983

DIOSYNTH BV

5152

10/21/1983

APPLIPHARM

5153

II

11/15/1983

ELI LILLY INDUSTRIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MARSEILLE, FRANCE.
CINOXACIN, BULK FORM AS MFG IN THE TIPPECANOE LABS LAFAYETTE, INDIANA

5154

II

11/21/1983

KABI PHARMACIA HEPAR INC

RD HEPARIN AS PRODUCED IN THE FRANKLIN, OHIO FACILITIES

5155

III

11/30/1983

WHEATON INDUSTRIES

GLASS LUBRICITY COATINGS/MILLVILLE,NJ FACILS/PHARMACOTE-P AND W

5156

II

9/22/1983

BIOTEK INC

LEVONORGESTREL MICROCAPSULES AS MFG IN THE WOBURN, MA. PLANT

5157

II

11/23/1983

GLAXOCHEM LIMITED

BETAMETHASONE DIPROPIONATE PRODUCED IN THE MONTROSE, SCOTLAND PLANT

5158

II

10/3/1983

DIETHYLPROPION-HYDROCHLORIDE AS MFG IN THE MARBURG PLANT

5159

II

12/5/1983

TEMMLER WERKE VEREINIGTE CHEMISCHE


FABRIKEN
DANISCO INGREDIENTS

5160

II

12/7/1983

TRAVENOL LABORATORIES INC

20% MCT INTRAVENOUS FA EMULSION AS PROCESSED IN THE ILLINOIS FACILITY

5161

II

12/1/1983

SELEGILINE HYDROCHLORIDE AS MANUFACTURED IN BUDAPEST HUNGARY

5162

II

12/1/1983

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS PRIVATE CO LTD
GIVAUDAN SA

5163

II

12/1/1983

ROUSSEL-UCLAF

COLCHICINE AS MFG A THE VERTOLAYE, FRANCE PLANT

5164

II

11/24/1983

MEPIVACAINE HCL AS MFG IN THE FILARONE, REGELLO (FLORANCE) PLANT

5165

II

11/10/1983

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
AIWA CHEMICAL CO LTD

5166

II

11/29/1983

INDUSTRIAS QUIMICAS ESTEVE SA

IBUPROFEN AS MFG IN THE BARCELONA, SPAIN PLANT

5167

12/1/1983

GIVAUDAN SA

TOXICOLOGY OF PARSOL 1789 PARTS A & B AS STUDIED BY GIVAUDAN S.A.

5168

II

12/20/1983

SCHERING AG

CYPROTERONE ACETATE AS PRODUCED IN THE BERLIN-WEDDING PLANT

5169

II

12/15/1983

DUPHAR BV

FLUVOXAMINE MATEATE MANUFACTURED IN WEESP, THE NETHERLANDS.

5170

II

11/24/1983

SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS)

PIRFENIDONE

5171

IV

9/15/1983

GATTEFOSSE ESTABLISSEMENTS

PRODUCTION OF GELUCIRE 62/05; TOXICITY DATA INCLUDED

5172

II

11/25/1983

JANSSEN PHARMACEUTICA NV

ASTEMIZOLE-R 43512 AS MFG IN GEEL AND BEERSE, BELGIUM PLANTS

5173

IV

11/28/1983

SHIONOGI QUALICAPS INC

THE MANUFACTURE OF EMPTY GELATIN CAPSULES BY ELI LILLY MEXICO

5174

III

9/12/1983

FISONS PHARM LTD

HALERMAIC DEVICE

5175

12/15/1983

PHARMACHEMIE BV

5176

II

12/19/1983

ORGANICHEM CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HAARLEM, HOLLAND.
ENCAINIDE HCL AS MFG IN THE RENSSELAER, NEW YORK FACILITY

5177

II

11/4/1983

SIBEFAT SPA

ACEPROMAZINE MALEATE AS MFG IN THE TRIBIANO (MILANO) FACILITIES

5178

11/30/1983

LABORATORY FOR ANALYTICAL BIOLOGY INC

NITROGLYCREINE ANALYSIS IN PLASMA CARRIED OUT BY LAB IN GERMANY

5179

II

12/13/1983

SALK INSTITUTE

NORLEUCINE 27, HUMAN PANCREAIC GROWTH HORMONE RELEASING FACTOR (NG-29

5180

III

7/22/1983

HENKEL CORP

ADHESIVE PRODUCTS AS MANUFACTURED IN SAEGERTOWN, PA AND ELGIN, IL.

5181

II

12/27/1983

WARD BLENKINSOP AND CO LTD

CARISOPRODOL AS MFG IN THE HALEBANK (WIDNES, CHESHIRE PLANT)

5182

IV

10/31/1983

GATTEFOSSE SAS

LABRAFIL M 2130 CS MANUFACTURED IN CEDEX,FRANCE

5183

II

9/15/1983

MARION LABORATORIES INC

PHENYLPROPANOLAMINE 50 MG.TABS (MFG IN KANSAS CITY, MISSOURI FACILITY)

5184

III

11/23/1983

MALLINCKRODT INC

PLASTIC SYRINGES C RUBBER CLOSURES (PKG OF CONTRAST MEDIA)RALEIGH,N.C.

SODIUM VALPROATE

PARSOL 1789 (AVOBENZONE) MANUFACTURED IN GENEVA SWITZERLAND

CHLOFIBRATE USP AS MFG IN THE YAMATO CITY, KANAGAWA PLANT (JAPAN)

Page 142

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5185 I
II
10/26/1983
FOREST LABORATORIES INC

SUBJECT
FLURBIPROFEN 100 MG C.R.TABS (IN SYNCHRON VEHICLE)MFG INWOOD, N.Y.

5186

II

9/27/1983

SYLATEC

INJECTABLE ASPEGIC

5187

11/3/1983

JANSSEN INC

PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES (GURABO, P.R.)

5188

12/22/1983

B BRAUN MEDICAL INC

MOIST HEAT STERILIZATION PARAMETRIC RELEASE PROGRAM (CA AND GA PLANTS)

5189

II

12/20/1983

SOCIETE FRANCAISE D'ORGANO

CISPLATIN

5190

II

9/15/1983

MARION LABORATORIES INC

PHENYLPROPANOLAMINE 150 MG CAPS MFG KANSAS CITY, MISSOURI FACILITY

5191

9/8/1983

SANDOZ PHARMS CORP DIV SANDOZ INC

DATA FOR THE PHARMACOLOGY,TOXICOLOGY AND METABOLISM OF SOLULAN C-24

5192

II

10/26/1983

FOREST LABORATORIES INC

FLURBIPROFEN 200 MG C.R. TABS (IN SYNCHRON VEHICLE)MFG INWOOD, N.Y.

5193

10/17/1983

JACOBUS PHARMACEUTICAL CO

5194

II

8/31/1983

TAKEDA CHEMICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PLAINSBORO, NEW JERSEY.
STERILE ANHYDROUS SODIUM CARBONATE AS MFG IN THE HIKARI PLANT

5195

II

12/21/1983

KYORIN PHARMACEUTICAL CO LTD

NORFLOXACIN MANUFACTURED AT OKAYA PLANT,NAGANO, JAPAN

5196

II

12/13/1983

ALBEMARLE CORP

BENZONATATE USP XX MFG SOUTH HAVEN, MICHIGAN FACILITIES

5197

11/14/1983

SPECTRUM COLORS INC

5198

II

10/26/1983

MALLINCKRODT INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KALAMAZOO, MICHIGAN.
COMPAP L AS PROCESSED IN THE RALEIGH, N.C. FACILITIES

5199

II

9/15/1983

MARION LABORATORIES INC

PHENYLPROPANOLAMINE 100MG CAPS MFG KANSAS CITY, MISSOURI FACILITY

5200

1/4/1984

SYLATEC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5201

1/3/1984

FRESENIUS USA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5202

II

1/3/1984

PHARMACIA AND UPJOHN SUB PFIZER INC

DINOPROSTONE SYNTHETIC (BULK) MFG KALAMAZOO, MI FACILITIES (PORTAGE RD

5203

II

1/3/1984

HEINRICH MACK NACHF

MITOXANTRONE DIHYDROCHLORIDE MANUFACTURED IN ILLERTISSEN.

5204

II

12/22/1983

EXCELLA GMBH

TAMOXIFEN CITRATE AS MANUFACTURED IN FEUCHT, GERMANY

5205

II

1/11/1984

ORION CORP FARMOS CHEMICAL PLANT

IBUPROFEN MFG BY FARMOS GROUP LTD/MEDIPOLAR IN OULU, FINLAND

5206

1/11/1984

USV LABORATORIES INC SUB RORER GROUP

5207

12/7/1983

LTS LOHMANN THERAPIE SYSTEME GMBH

5208

II

1/9/1984

FABBRICA ITALIANA SINTETICI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MANATI, PUERTO RICO FACILITY ON SAN JOSE ROAD.
MANUFACTURING SITE, FACILITIES, PERSONNEL, GENERAL OPERATING PROCEDURES IN
NEUWEID, FEDERAL REPUBLIC OF GERMANY.
OXAZEPAM,BULK FORM AS PRODUCED IN THE VICENZA FACILITIES

5209

IV

12/30/1983

JRS PHARMA LP

EMCOMPRESS (DIBASIC CALCIUM PHOSPHATE, DIHYDRATE USP XX)MFG IN ENGLAND

5210

1/26/1984

ISOMEDIX INC

FACILITIES & CONTROLS FOR IRRADIATION PROCESSING(PLANT IN PUERTO RICO)

5211

2/8/1984

CUSTOM CHEMICAL LABORATORIES INC

5212

II

12/1/1983

SIEGFRIED AG

MANUFACTURING SITE, FACILITIES, PERSONNEL , AND GENERAL OPERATING PROCEDURES


IN INDIANAPOLIS PLANT ON GUION ROAD.
AMILORIDE HCL AS MFG AND SOLD UNDER THE SIEGFRIED LABEL

5213

II

6/15/1983

SIGMA F AND D DIV LTD

PYRIDOXAL 5-PHOSPHATE MFG BY DE. BI. DERIVAI BIOLOGICI INT'L S.P.A.

5214

III

11/22/1983

DOW CORNING CORP

EXPERIMENTAL LATEX XD 30612.05 PRODUCED MIDLAND, MICHIGAN FACILITIES

5215

II

11/21/1983

SCHERING AG

MICRONIZED PREDNISONE

5216

12/9/1983

DAIICHI SEIYAKU CO LTD

5217

II

12/1/1983

5218

II

12/16/1983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
AINC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SHIZUOKA JAPAN.
NAFTIFINE HCL (SN 105-843 CH) PRODUCED IN THE BASLE, SWITZERLAND PLANT
ZETAPREP DEAE-CELLULOSE ION EXCHANGE MEDIA (PRODUCED CT. FACILITIES)

Page 143

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5219 I
II
12/23/1983
WAITAKI INTERNATIONAL BIOSCIENCES SUB
WAITAKI CANADA LTD
5220 I
I
1/17/1984
AYERST WYETH PHARMACEUTICALS INC

SUBJECT
5-AMINOSALICYLIC ACID MFG BY DELMAR CHEMICALS,LASALLE, QUEBEC FACILITY

5221

II

12/29/1983

HEICO CHEMICALS DIV WHITTAKER CORP

MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GUAYAMA, PUERTO RICO.
POTASSIUM CHLORIDE MFG IN THE DELAWARE WATER GAP, PA. FACILITIES

5222

1/19/1984

MALLINCKRODT INC

BIOLOGICAL INDICATOR PROGRAM APPLIED MARYLAND HEIGHTS, MO PLANT SITE

5223

II

12/16/1983

FIS FABBRICA ITALIANA SINTETICI SPA

TEMAZEPAM, BULK FORM

5224

II

1/18/1984

UPJOHN CHEM CO

ESMOLOL HCL AS MFG IN THE KALAMAZOO, MICHIGAN FACILITIES, PORTAGE ROAD

5225

II

12/5/1983

RS-86 AMPULS 10 MG/ML AS PRODUCED IN THE BASLE, SWITZERLAND PLANT

5226

II

1/20/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
RUETGERS-NEASE CHEMICAL COMPANY INC

5227

II

12/20/1983

GANES CHEMICALS INC

VERAPAMIL HYDROCHLORIDE AS MFG AND SOLD UNDER THE SIEGFRIED LABEL

5228

II

1/18/1984

DOW CORNING CORP

ION EXCHANGE RESINS (DOWEX TRADE MARK) MANUFACTURED IN MIDLAND, MICHIGAN.

5229

III

2/9/1984

PANTASOTE INC

PVC FILMS MFG PASSAIC, N.J. FACILITIES: 1. 7506H4347 PVC FILM

5230

IV

11/15/1983

ICI AMERICAS INC

BRIJ 93 (POLYOXYETHYLENE (2) OLYL ETHER) MFG NEW CASTLE,DE FACILITIES

5231

II

2/22/1984

MONSANTO POLYMER PRODUCTS CO

LACTIC ACID, BULK FORM MFG IN THE TEXAS CITY, TEXAS FACILITIES

5232

II

12/27/1983

IBARAKI KASEI COMPANY LTD

THE MANUFACTURE AND QUALITY CONTROL OF CHLORZOXAZONE

5233

II

2/17/1984

MALLINCKRODT INC

CODEINE SULFATE AS MANUFACTURED IN THE SAINT LOUIS, MISSOURI PLANT

5234

II

2/20/1984

ROHM AND HAAS CO

AMBERLITE IRP-69 & AMBERLITE IRP-70 (MFG PHILA PA. ON RICHMOND ST.)

5235

II

1/25/1984

ORGAMOL SA

ALLOPURINOL

5236

II

2/10/1984

SHOWA INDUSTRY COMPANY LTD

DIMETHYL SULFOXIDE (DMSO-P) MFG MORIYAMA CITY FACILITIES

5237

IV

1/20/1984

SUTTON LABORATORIES

GERMALL 115 (IMIDUREA NF) MFG CHAHAM, N.J. FACILITIES

5238

II

2/16/1984

DYNAMIT NOBEL AKTIENGESELLESCHAFT

NITROGLYCERINE 10% IN LACTOSE

5239

2/27/1984

STERIS-ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN WHITBY, ONTARIO, CANADA

5240

II

2/9/1984

BASF PHARMA EVIONNAZ SA

CARISOPRODOL

5241

II

3/19/1984

FINE CHEMICALS CORPORATION

TRIFLUOPERAZINE HCL

5242

II

1/24/1984

ACF CHEMIEFARMA NV

SULFADIMIDE PH EUR/SULFAMETHAZINE USP

5243

II

12/7/1983

RS-86 HYDROBROMIDE AS PRODUCED IN THE BASLE, SWITZERLAND PLANT

5244

II

2/9/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
CIBA GEIGY LTD

5245

III

1/20/1984

LABLABO

METERED AEROSOL VALVES

5246

III

1/25/1984

ARTEK SYSTEMS CORP

GENERATOR FLUID PAH KITS AS MFG IN THE FARMINGDALE, N.Y. FACILITY

5247

II

2/7/1984

BIOCHEMIE GMBH

7-ACA, BULK FORM (7-AMINOCEPHALOSPORANIC ACID)MFG FRANKFURT MAIN PLANT

5248

II

1/11/1984

DAIICHI SEIYAKU CO LTD

DL 8280 MEFOXACIN ACTIVE & PLACEBO TABS

5249

II

1/3/1984

PHOTOFRIN INC

DIHEMATOPORPHYRIN ETHERS (DHE) TRADE NAME, PHOTOFRIN II

5250

II

12/15/1983

RS-86 CAPSULES IN 0.25 MG AND 1.0 MG (BASLE, SWITZERLAND PLANT)

5251

II

2/9/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
CIBA GEIGY LTD

5252

1/24/1984

PATHEON INC TORONTO REGION OPERATIONS

5253

IV

12/28/1983

GATTEFOSSE SAS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MISSISSAUGA, ONTARIO, CANADA.
GELUCIRE 44/14; GELUCIRE 50/02 AND GELUCIRE 50/13

ZINC PYRION - NS AS MANUFACTURED IN THE STATE COLLEGE, PA. FACILITIES

CGP LL637 ADJUVANT--CHEMISTRY & GMP

ADJUVANT CGP 11637:TOXICITY STUDIES & RESULTS CONDUCTED IN EUROPEAN FA

Page 144

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5254 I
II
1/16/1984
SANOL-SCHWARZ

SUBJECT
DEPONIT NITROGLYCERINE TRANSDERMAL THERAPEUTIC SYSTEM (MONHEIM PLANT)

5255

II

2/23/1984

SANOFI WINTHROP INC

TYROPANOATE SODIUM MFG IN THE DUDLEY NEAR CRAMLINGTON PLANT SITE

5256

II

1/30/1984

MORINAGA MILK INDUSTRY COMPANY LTD

LACTULOSE SYRUP (MLS-50) AS MANUFACTURED IN THE FUJI PLANT

5257

II

5/11/1983

SANTEN PHARMACEUTICAL CO LTD

TROPICAMIDE MYDRIAIC MFG FOR SANTEN BY OKAMI CHEM INDUSTRY CO LTD.

5258

II

7/20/1983

SIGMA F AND D DIV LTD

INDOMETHACIN AS MFG BY CO. FARMACEUTICA MILANESE S.P.A.

5259

2/8/1984

WATSON LABORATORIES INC

5260

III

1/25/1984

3M PHARMS

MANUFACTURING SITE, FACILITIES , PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LIBERTYVILLE, ILLINOIS.
SCOTCHPAR BRAND FILMS AS MANUFACTURED IN THE MINNESOTA FACILITIES

5261

II

1/23/1984

MERCK AND CIE

CALCIUM FOLINATE (CALCIUM LEUCOVORIN)

5262

1/18/1984

VAN DYK AND CO INC

5263

12/1/1983

PREMIUM PLASTICS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BELLEVILLE, NEW JERSEY.
SOP FOR MFG PKG MATERIALS (EAST BRUNSWICK, N.J.) PRODUCT INFO INCLUDED

5264

II

7/27/1983

SIGMA F AND D DIV LTD

STEARYLAMINE AS PROCESSED BY ARMAK FOR SIGMA F & D

5265

II

1/18/1984

PFANSTIEHL LABORATORIES INC

5-THIO-D-GLUCOSE AS MFG IN THE WAUKEGAN, ILLINOIS FACILITIES

5266

2/7/1984

SCHNELL PLASTIC INC

5267

2/17/1984

STERIS-ISOMEDIX SERVICES

5268

II

10/20/1983

INDUSTRIA CHIMICA PROFARMACO SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HUNTINGTON BEACH, CALIFORNIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CERIANO LAGHETTO PLANT.
ACETYL OXIDE (OXAZEPAM INTERMEDIATE) MFG IN THE PAULLO (MILANO) PLANT

5269

IV

8/12/1983

SIGMA F AND D DIV LTD

L-ALPHA-PHOSPHATIDYLCHOLINE, TYPE III-E (HEXANE SOLUTION)

5270

II

11/29/1983

DIOSYNTH BV

L-ALPHA-METHYLDOPATE HYDROCHLORIDE

5271

2/21/1984

HOUBA INC

FACILITIES & GENERAL OPERATING PROCEDURES ON STATE ROAD, CULVER,IN.

5272

II

3/2/1984

NATL INST HLTH NCI

3% URIDINE INJECTION (NSC 20256) AS USED WITHIN NCI OF NIH

5273

3/8/1984

GALIBIA SPA

5274

II

3/1/1984

HOVIONE FARMACIENCIA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GALIBI-TODI.
BETAMETHASONE 17,21-DIPROPIONATE AS PRODUCED IN THE LISBON FACILITIES'

5275

IV

1/31/1984

GATTEFOSSE ESTABLISSEMENTS

TEFOSE 2561

5276

II

3/2/1984

DYNAMIT NOBEL GMBH

NITROGLYCERINE 5% IN MIGLYOL 812 NEUTRAL OIL MFG LEVERKUSEN PLANT

5277

II

2/21/1984

HOUBA INC

ETIOCHOLANOLONE (3,-ALPHA-HYDROXY-5,-BETA-ANDROSTAN-17-ONE)CULVER,IND

5278

II

2/17/1984

NORDION CANADA INC

XENON-133 AS PROCESSED IN THE KANATA ISOTOPE PROCESSING FACILITY

5279

II

3/8/1984

INDUSTRIA FARMACEUTICA SERONON SPA

HUMAN MENOPAUSAL GONADOTROPIN (HMG)PROCESSED IN THE GALIBIA-TODI PLANT

5280

II

4/20/1984

ALDRICH CHEMICAL COMPANY INC

PENTAMIDINE ISETHIONATE (PRODUCT W149-5) MFG MILWAUKEE, WI.FACILITIES

5281

3/31/1984

NITA PHARMACEUTICAL LTD

5282

II

2/27/1984

FIS FABBRICA ITALIANA SINTETICI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FREEPORT, GRAND BAHAMA.
FLURAZEPAM HCL PRODUCED IN THE VICENZA FACILITIES

5283

II

11/2/1983

DIOSYNTH BV

ANDROSTERONE

5284

II

8/12/1983

SIGMA F AND D DIV LTD

ETHANOL SOLUTION OF CARDIOLIPIN SODIUM SALT (SIGMA CHEMICAL COMPANY)

5285

II

2/28/1984

EASTMAN KODAK CO

N-(4-HYDROXYPHENYL)-ALL-TRANS-RETINAMIDE(HPR;4-RETINOYLAMINOPHENOL)

5286

2/27/1984

APPLIED LABORATORIES INC

5287

II

2/17/1984

H REISMAN CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN COLUMBUS, INDIANA.
TRIPROLIDINE HYDROCHLORIDE AS MFG IN THE ORANGE, NEW JERSEY FACILITIES

Page 145

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5288 I
I
3/7/1984
BEECHAM LABORATORIES DIV OF BEECHAM INC
5289

3/9/1984

CONTINENTAL PLASTICS INC

5290

II

3/12/1984

KABI PHARMACIA HEPAR INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN IRVINE, SCOTLAND.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN DALLAS PIKE INDUSTRIAL PARK, TRIADELPHIA, WEST VIRGINIA.
PREGNANT MARE SERIUM GONADOTROPIN AS PROCESSED FRANKLIN,OH.FACILITIES

5291

IV

9/15/1983

SIGMA F AND D DIV LTD

L-ALPHA-PHOSPHATIDYLCHOLINE, TYPE IV-S (SIGMA CHEMICAL COMPANY)

5292

III

3/29/1984

NOVA CHEMICALS LTD

POLYSTYRENE PRODUCTS MFG SARNIA, ONTARIO FACILITIES:1. POLYSAR 203

5293

3/16/1984

KIRBY WARRICK PHARMACEUTICAL LTD

FACILITIES AND PROCEDURES FOR CONTRACT MANUFACTURING

5294

II

12/28/1983

DIOSYNTH BV

CORTICOSTERONE

5295

II

3/18/1984

KRKA PHARMACEUTICAL & CHEMICAL WORKS

NIFEDIPINE

5296

II

3/15/1984

BAYER SCHERING PHARMA AG

MEGESTROL ACETATE

5297

1/9/1984

JANSSEN PHARMACEUTICA INC

5298

II

3/23/1984

ORION CORP FARMOS CHEMICAL PLANT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR LITTLE ISLAND, COUNTY CORK (IRELAND).
CYCLOPHOSPHAMIDE 50 MG TABLETS AS MFG IN THE TURKU FACILITIES

5299

2/14/1984

COOPERVISION DIV COOPER LABORATORIES INC

5300

II

3/16/1984

PENCO OF LYNDHURST INC

5301

9/29/1983

EXPANSIA

5302

2/24/1984

SKYLAND SCIENTIFIC SERVICES INC

5303

11/21/1983

SIPSY CHIMIE FINE S.C.A.

5304

2/8/1984

VICKS HEALTH CARE DIV RICHARDSON VICKS INC

5305

II

3/14/1984

ASTA-WERKE AKTIENGESELLSCHAFT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


ARAMON, FRANCE.
MANUFACTURING SITE, FACILITEIS, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BELGRADE, MONTANTA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN AVRILLE, FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN HABORO, PENNSYLVANIA.
MESNA AMPOULES AS MANUFACTURED IN THE KUNSEBECK PLANT

5306

IV

3/12/1984

ELAN CORP PLC

ELANPRES CAPSULES AS MANUFACTURED IN THE MONKSLAND, ATHLONE FACILITY

5307

3/30/1984

5308

II

2/29/1984

IOLAB PHARMACEUTICALS SUB JOHNSON &


JOHNSON CO
BEECHAM LABORATORIES DIV BEECHAM INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAN GERMAN, PUERTO RICO (NORTE INDUSTRIAL PARK)
STERILE AMOXICILLIN SODIUM AS MFG IN THE PISCATAWAY, NEW JERSEY PLANT

5309

II

2/16/1984

ORION CORP FERMION

TRIOXSALEN, USP XX AS MANUFACTURED IN THE MANKKAA PLANT

5310

II

2/13/1984

EGIS PHARMACEUTICALS

TAMOXIFEN CITRATE MFG BY EGYT & TRADED BY MEDIMPEX HUNGARIAN TRADING C

5311

II

3/19/1984

HEINRICH MACK NACHF

CYTARABINE AS MANUFACTURED IN THE ILLERTISSEN FACILITIES

5312

3/20/1984

MAPRIMED SA

5313

II

3/2/1984

ISOCHEM SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MORGUIONDO 2011, ARGENTINA
MANUFACTURING PROCEDURES FOR ETINTIDINE HYDROCHLORIDE

5314

II

4/11/1984

KYOWA HAKKO KOGYO CO LTD

ACEGLUTAMIDE ALUMINUM GRANULES (KW-110) MFG IN THE FUJI PLANT

5315

II

2/27/1984

TDM-85-530 B AS MANUFACTURED IN THE BASLE, SWITZERLAND FACILITIES

5316

II

3/26/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
ROCHE DIAGNOSTICS GMBH

5317

3/19/1984

DIOSYNTH BV

5318

II

4/5/1984

SCHERING AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OSS, HOLLAND.
HYDROXYPROGESTERONE CAPROATE AS MANUFACTURED IN THE BERLIN FACILITIES

5319

II

4/6/1984

PHARMACIA AND UPJOHN SUB PFIZER INC

DINOPROST TROMETHAMINE AS MANUFACTURED IN KALAMAZOO, MICH.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MOUNTAIN VIEW, CALIFORNIA.
CODEINE PHOSPHATE MFG NEWARK, N.J. FACILITIES ON MT. OLIVET AVENUE

METHYLDOPATE HYDROCHLORIDE AS MANUFACTURED IN THE MANNHEIM FACILITIES

Page 146

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5320 I
II
4/6/1984
HOECHST CELANESE CORP

SUBJECT
TOLBUTAMIDE USP, BULK FORM AS MFG IN THE COVENTRY, R.I. FACILITIES

5321

II

1/26/1984

HUNTINGTON LABS INC

POVIDONE IODINE AS PRODUCED IN THE HUNTINGTON, INDIANA FACILITIES

5322

II

4/2/1984

VIS FARMACEUTICA

IMIPRAMINE PAMOATE AS MANUFACTURED IN THE PADOVA FACILITIES

5323

III

4/12/1984

SILGAN PLASTICS CORP

PET BOTTLES MANUFACTURED IN THE US AND CANADA

5324

III

3/23/1984

NATIONAL CAN CORP

PLASTIC CAPS AS MFG IN THE BEDFORD PARK, ILLINOIS FACILITIES

5325

II

3/15/1984

UNIQUE PHARMACEUTICAL LABORATORIES

PROPRANOLOL HYDROCHLORIDE (U.S.P.)

5326

II

4/5/1984

MALLINCKRODT INC

ACETAMINOPHEN USP AS MANUFACTURED IN RALEIGH, NORTH CAROLINA. PLANT

5327

II

3/27/1984

LUSOCHIMICA SPA

METAPROTERENOL SULFATE AS MANUFACTURED IN THE LOMAGNA (COMO) FACILITY

5328

II

3/30/1984

INDUSTRIA CHIMICA MILANESE SPA

DEXCHLORPHENIRAMINE MALEATE AS MANUFACTURED IN ROZZANO (MILANO) PLANT

5329

II

10/7/1983

SIGMA F AND D DIV LTD

6-MERCAPTOPURINE HYDRATE AS OBTAINED FROM PHARMA-WALDHOF GMBH

5330

II

4/13/1984

KABI PHARMACIA HEPAR INC

HEXURONYL HEXOSAMINOGLYCAN SULFATE MFG IN THE FRANKLIN,OHIO FACILITIES

5331

II

3/15/1984

UNIQUE PHARMACEUTICAL LABORATORIES

DILOXANIDE FUROATE (B.P.)MFG IN THE ANKLESHWAR, GUIJARA FACILITIES

5332

III

2/28/1984

NANIWA RUBBER CO LTD

RUBBER CLOSURES AS MANUFACTURED IN THE NARA, JAPAN FACILITIES

5333

4/5/1984

MAPRIMED SA

5334

II

4/17/1984

PERSTORP CHEMICALS AB

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EUGENIO GARZON, BUENOS AIRES.
CADEXOMER IODINE

5335

II

4/13/1984

SA AJINOMOTO OMNICHEM NV

VINBLASTIN SULFATE AS MANUFACTURED IN THE LOUVAIN-LA-NEUVE FACILITIES

5336

4/13/1984

SHOWA DENKO KK

SOP USED IN PRODUCTION OF SPECIFIC DRUG SUBSTANCES IN KANAGAWA PLANT

5337

II

4/11/1984

KYOWA HAKKO KOGYO CO LTD

ACEGLUTAMIDE ALUMINUM AS MANUFACTURED IN THE SAKAI PLANT'

5338

II

12/7/1983

DIOSYNTH BV

GONADORELIN ACETATE

5339

II

2/15/1984

HEXAGON LABORATORIES INC

CHLORZOXAZONE AS MANUFACTURED IN THE BRONX, NEW YORK FACILITIES

5340

II

4/9/1984

HOUBA INC

B ETHIOCHOLANOLONE(3 B-HYDROXY-5B-ANDROSTAN-17-ONE)MFG CULVER,INDIANA

5341

III

4/12/1984

NUODEX INC

NUOPLAZ 6959 HIGH PURITY PLASTICIZER AS MFG CHESTERTOWN, MARYLAND

5342

4/17/1984

SOLCO BASLE LTD

5343

II

4/11/1984

SATO YAKUHIN KOGYO COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BIRSFELDEN.
ACEGLUTAMIDE GRANULES (BULK) AS MANUFACTURED IN THE NARA PLANT

5344

5/1/1984

INDENA INDUSTRIA DERIVATI NATURALI

5345

5/3/1984

AB ASTRA

5346

II

5/3/1984

5347

II

5/3/1984

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
DAIICHI SEIYAKU CO LTD

5348

II

3/14/1984

HEXAGON LABORATORIES INC

PYRILAMINE MALEATE AS MANUFACTURED IN THE BRONX, NEW YORK FACILITIES

5349

III

4/11/1984

ALCAN PACKAGING TSCHEULIN ROTHAL GMBH

LAMINATED DRUG PACKAGING PRODUCTS

5350

III

5/10/1984

BASF AKTIENGESELLSCHAFT

NOVOLEN POLYPROPYLENE PRODUCTS: 1. NOVOLEN 1400 MX

5351

II

5/17/1984

ORGANICHEM CORP

TRIETHYLENETETRAMINE DIHYDROCHLORIDE (TRIENE) MFG ROCHESTER, N.Y.

5352

5/11/1984

5353

II

4/30/1984

SOCIEDAD MEXICANA DE QUIMICA INDUSTRIAL SA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SANTA CLARA, EDO DE MEXICO.
NITA PHARMACEUTICAL LTD
TRIAMCINOLONE AND RELATED PRODUCTS MFG FREEPORT, GRAND BAHAMA FACILITY

5354

II

3/28/1984

HEXAGON LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SETTALA PLANT.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SODERTALJE.
ETODOLAC (ETODOLIC ACID) AS MFG IN THE BOUND BROOK,NEW JERSEY FACILITY
MALOTILATE 200 MG TABLETS AS MANUFACTURED IN THE SHIZUOKA FACILITY

DEXBROMPHENIRAMINE MALEATE USP XX MFG IN THE BRONX, N.Y. FACILITIES

Page 147

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5355 I
II
4/11/1984
SANOFI WINTHROP INC

SUBJECT
DIARIZOATE SODIUM USP MFGDUDLEY NEAR CRAMLINGTON, NORTHUMBERLAND.

5356

II

5/3/1984

NIHON NOHYAKU CO LTD

MALOTILATE AS MANUFACTURED IN THE IBARAKI AND KASHIMA PLANT

5357

II

4/17/1984

KV PHARMACEUTICAL CO

ORABASE HYDROCORTISONE ACETATE 0.5% ORAL PASTE MFG ST. LOUIS, MO.

5358

4/25/1984

5359

II

4/18/1984

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
FARMITALIA CARLO ERBA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NORTH CHICAGO, ILLINOIS.
EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN THE RODANO (MI) FACILITY

5360

III

4/30/1984

3M DRUG DELIVERY SYSTEMS

5361

III

5/29/1984

NOVEON INC

CONTAINER-CLOSURE SYSTEM FOR CFC INHALATION AEROSOLS MANUFACTURED IN


NORTHRIDGE, CA
ESTANE 5714 MANUFACTURED IN THE AVON LAKE, OHIO FACILITY

5362

5/11/1984

GUARDIAN PACKAGING

5363

II

4/18/1984

FERMION OY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LANSDALE, PENNSYLVANIA.
TAMOXIFEN CITRATE AS MANUFACTURED IN OULU, FINLAND.

5364

II

4/27/1984

A NATTERMANN AND CIE GMBH

HALOPERIDOL AS MANUFACTURED IN THE APPENWEIER FACILITY

5365

II

5/14/1984

NITA PHARMACEUTICAL LTD

FLUOCINOLONE 16,17 ACETONIDE & FLUOCINOLONE MFG FREEPORT,GRAND BAHAMAS

5366

4/30/1984

BIO-RESPONSE, INC.

FACILITY IN HAYWARD, CALIFORNIA (TRANS TO BIOLOGICS 7/18/86)

5367

II

4/20/1984

FARCHEMIA

DESIPRAMINE HYDROCHLORIDE USP MFG IN THE TREVIGLIO (BERGAMO) PLANT

5368

5/4/1984

POLYPLASTICS INC

5369

5/14/1984

LEIRAS PHARMACEUTICALS

5370

II

3/28/1984

SCHERING AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HUMACAO.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TURKU, FINLAND.
BOLDENONE UNDECYLENATE AS MANUFACTURED IN THE BERLIN PLANT

5371

4/23/1984

SYNTEX USA INC

FOR THE SYNTEX AGRIBUSINESS FACILITY IN SPRINGFIELD, MO.

5372

II

4/30/1984

NEWPORT PHARMACEUTICALS (IRELAND)

ISOPRINOSINE (INOSIPLEX) BULK FORM (MFG BALDOYLE, DUBLIN FACILITY)

5373

5/24/1984

PRIVATE FORMULATIONS INC

5374

II

5/23/1984

5375

5/17/1984

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
FRESENIUS USA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EDISON, NEW JERSEY.
METHOCARBAMOL AS MFG IN THE NORTH CHICAGO, ILLINOIS FACILITIES

5376

II

5/24/1984

5377

IV

5/29/1984

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
DAVID MICHAEL & COMPANY INC

5378

II

2/9/1984

SIGMA F AND D DIV LTD

D-AMPHETAMINE SULFATE # A5880 FD & (+) METHAMPHETAMINE HCL NO. M8750FD

5379

II

6/1/1984

PFANSTIEHL LABORATORIES INC

9-BETA-D-ARABINOFURANOSYL ADENINE MFG WAUKEGAN, ILLINOIS FACILITIES

5380

II

5/11/1984

ORION CORP FARMOS CHEMICAL PLANT

DETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN THE OULU PLANT

5381

II

6/1/1984

SI GROUP

IBUPROFEN AS MANUFACTURED IN THE ORANGEBURG, SOUTH CAROLINA FACILITY

5382

5/22/1984

FABBRICA ITALIANI SINTETICI SPA

5383

II

6/1/1984

UPJOHN CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALTE DI MONTECCHIO MAGGIORE.
ETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY

5384

II

6/6/1984

KATWIJK CHEMIE BV

PHENYTOIN/PHENYTOIN SODIUM MANUFACTURED IN KATIJK AAN ZEE, THE NETHERLANDS.

5385

6/8/1984

ELAN PHARM RES CORP

QUALITY CONTROL LABORATORY AND PRODUCTION FACILITIES, GAINESVILLE, GA.

5386

II

5/3/1984

SANDOZ PHARM CORP

CHLORPHENIRAMINE MALEATE MFG IN THE EAST HANOVER, NEW JERSEY FACILITY

5387

5/24/1984

AYERST LABORATORIES INC DIV AMERICAN HOME MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
PRODUCTS CORP
IN ROUSES POINT, NEW YORK.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CANTON, MASSACHUSETTS.
YOHIMBINE HYDROCHLORIDE AS PROCESSED IN THE INGELHEIM PLANT
FLAVORING FORMULATION (PRODUCED IN PHIL. PA) 1. ARTIFIC. GRAPE # 7201

Page 148

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5388 I
II
5/17/1984
YONEZAWA HAMARI CHEMICALS LTD

SUBJECT
L-CARNITINE AS MANUFACTUREED IN THE YONEZAWA, YAMAGATA PLANT

5389

II

5/11/1984

BAYER SCHERING PHARMA AG

MEDROXYPROGESTERONE ACETATE MANUFACTURED IN BERLIN, GERMANY.

5390

II

6/6/1984

KATWIJK CHEMIE BV

SULFACETAMIDE/SULFACETAMIDE SODIUM AS MFG KATWIJK AAN ZEE FACILITIES

5391

4/17/1984

XACTDOSE INC

5392

II

5/21/1984

YONEZAWA HAMARI CHEMICALS LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROSCOE, ILLINOIS.
IBUPROFEN MFG BY YONEZAWA HAMARI CHEM LTD (YONEZAWA, YAMAGATA PLANT)

5393

II

5/31/1984

AINC

AQAE-CELLULOSE-1 ION EXCHG.MEDIA(STAFFORD SPRINGS & TALCOTTVILLE,CT

5394

5/24/1984

BACHEM FINE CHEMICALS INC

5395

II

5/31/1984

EISAI CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR THE TORRANCE, CALIFORNIA PLANT ON KASHIWA STREET.
BENTIROMIDE AS MFG IN THE KAWASHIMA PLANT, GIFU-KEN LOCATION

5396

II

6/12/1984

SUMIKA FINE CHEMICALS CO LTD

THIOTEPA USP XX AS MFG IN THE GIFU PLANT

5397

II

5/21/1984

GANES CHEMICALS INC

BUSPIRONE HYDROCHLORIDE MFG AND SOLD UNDER THE SIEGFRIED LABEL

5398

III

2/20/1984

GEORGIA GULF CORP

PROCEDURES & FORMULAS FOR MFGR OF POLYVINYL CHL CMPDS-IN GALLMAN, MISS

5399

II

5/22/1984

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

DOXYLAMINE SUCCINATE USP AS MANUFACTURED IN BARCELONA, SPAIN

5400

5/21/1984

AMERICAN PHARMACEUTICAL PARTNERS, INC.

STERILE PROCESSING OF GLASS VIALS IN GRAND ISLAND, NY

5401

II

6/18/1984

BAYER

NITRENDIPINE, RAW MATERIAL SUB.(TM:BAYPRESS)--MFG WUPPERTAL FACILITIES

5402

II

5/17/1984

JANSSEN PHARMACEUTICA NV

DOMPERIDONE (RESEARCH CODE R-33812) AS MFG IN THE BELGIUM FACILITIES

5403

3/19/1984

MERCK KGAA

5404

II

4/10/1984

DIPHARMA FRANCIS SRL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALCALA, SPAIN.
DOXEPIN HCL MFG IN THE MILANO FACILITIES (VIA G.B. GRASSI, 97)

5405

II

5/25/1984

7-ETHYLTRYPTOPHOL (INTERMEDIATE FOR ETODOLAC)MFG BY AMERICAN CYANAMID

5406

III

2/20/1984

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
GEORGIA GULF CHEMICALS AND VINYLS LLC

5407

II

4/20/1984

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA

CLOFIBRATE USP AS MFG IN THE CARONNO PERTUSELLA (VARESE) FACILITIES

5408

II

3/19/1984

FERMION OY

AZATHIOPRINE AS MFG. IN ESPOO, FINLAND

5409

II

5/23/1984

BRACCO IND CHIMICA SPA

IOPANOIC ACID USP AS MFG IN THE MILANO FACILITIES

5410

II

4/4/1984

PARKE DAVIS DIV WARNER LAMBERT CO

8-ARGININE VASOPRESSIN (8-AVP) MFG PARKE-DAVIS FAC (HOLLAND, MICHIGAN)

5411

II

5/31/1984

BAYER

MYCOSPOR (BIFONAZOLE) CREAM 1% MANUFACTURED IN WUPPERTAL.

5412

II

2/7/1984

INALCO SAS DI GIOVANNI CIPOLLETTI AND C

LACTULOSE 50% SYRUP AS MFG IN PISTOIA (ITALY) BY INFRA S.R.L.

5413

II

5/9/1984

BIOGAL PHARMACEUTICAL WORKS

PENICILLAMINE AS MFG IN THE DEBRECEN (HUNGARY) FACILITIES

5414

6/18/1984

SERONO INC

BIOEQUIVALANCE STUDY ON THREE CLOMIPHENE CITRATE PRODUCTS

5415

II

6/12/1984

DM GRAHAM LABORATORIES INC

AEROLATE CONTROLLED-RELEASE CAPSULES CONTAINING THEOPHYLLINE

5416

II

6/8/1984

PRODUCTOS QUIMICOS NATURALES SA DE CV

PROGESTERONE MFG IN THE IXTACZOQUITLAN, VER FACILITY IN MEXICO

5417

II

6/20/1984

ELI LILLY INDUSTRIES INC

ACETOHEXAMIDE BULK FORM MFG IN THE TIPPECANOE LABS, LAFAYETTE, INDIANA

5418

II

6/21/1984

ROUSSEL-UCLAF

CIRAMADOL HYDROCHLORIDE MFGIN THE VERTOLAYE (FRANCE) FACILITIES

5419

5/25/1984

JANSSEN PHARMACEUTICA NV

5420

II

5/22/1984

DINAMITE DIPHARMA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN PHARMACEUTICAL PRODUCTION UNIT, BEERSE, BELGIUM.
VERAPAMIL HCL MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES

5421

II

3/2/1984

MTM CHEMICALS INC

AZONE PHARM AS MFG IN THE COLUMBUS, OHIO FACILITIES ON ALAS STREET

5422

II

6/25/1984

LABORATORIO CHIMICO INTERNATIONAL SPA

THIORIDAZINE HCL USP AS MFGR IN THE SEGRATE, MILAN, ITALY FACILITY

POLYVINYL CPDS-MFGR/PROCEEDS/FORMULAS--TIPTONVILLE,TN

Page 149

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
5423 A
II
5/1/1984
CHINA NATIONAL CHEMICAL IMPORT AND EXPORT GUAIFENESIN USP MFG BY XIN XIN & SOLD BY CHINA NATIONAL
CORP
5424 I
II
6/20/1984
ELI LILLY INDUSTRIES INC
ACETOHEXAMIDE BULK FORM MFG BY ELI LILLY IND. INC.MAYAGUEZ,PUERTO RICO
5425

II

1/26/1984

NV ORGANON

PROCHLORPERAZINE EDISYLATE MFG. IN THE OSS FACILITY AT KLOOSTERSTRAAT6

5426

7/5/1984

MOLDCRAFT DIV ANCHOR HOCKING CORP

FAC. & PROCEDURES FOR INJECTION MOLDING,CLOSURES & CLOSURE COMPONENTS

5427

II

7/9/1984

LUSOCHIMICA S P A

TOLNAFTATE USP XX AS MFG IN THE MILANO, ITALY FACILITIES

5428

6/29/1984

KRKA PHARMACEUTICAL & CHEMICAL WORKS

FOR THE NOVO MESTO PLANT

5429

II

7/9/1984

MONSANTO COMPANY

LEUCOVORIN CALCIUM, BULK MFG DAYTON,OHIO BY DAYTON LABS OF MONSANTO CO

5430

II

7/3/1984

AAI PHARMA LLC

PROPOXYPHENE HCL BULK & INTERMEDIATE PRODUCED BY TIPPECANOE LABS

5431

II

5/21/1984

NITA PHARMACEUTICAL LTD

BETAMETHASONE AND BETAMETHASONE SALTS MFG FREEPORT, GRAND BAHAMA FAC.

5432

II

6/14/1984

JANSSEN PHARMACEUTICA NV

OXATOMIDE TABLETS 30 MG AS MFG. IN THE BEERSE, BELGIUM PHARM. PLANT

5433

6/12/1984

ANDERSEN LABORATORIES INC

5434

III

5/29/1984

ARMOUR PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NORWICH, NEW YORK.
FORM/FILL/SEAL PROCESSING IMPLEMENTED IN THE KANKAKEE, ILL. FACILITIES

5435

II

6/28/1984

ROCHE DIAGNOSTICS GMBH

METAXALONE MFG IN MANNHEIM, GERMANY

5436

II

6/25/1984

KYOWA HAKKO USA INC

AMINOETHYLSULFONIC ACID (TAURINE) MFG IN THE OHMIYA FACTORY

5437

II

6/22/1984

LONZA INC

ETODOLAC INTERMEDIATES AS MFG INVISP, SWITZERLAND PLANT

5438

II

5/1/1984

CIPLA LTD

IBUPROFEN USP AS PROCESSED IN FACTORIES NO.2, NO. 3, NO.4 CITED IN DMF

5439

II

6/29/1984

SANOFI PHARMACEUTICALS INC

MEPHENTERMINE (BASE & SULFATE) MFG DUDLEY NEAR CRAMLINGTON & FAWDON.

5440

II

6/29/1984

CHEMTRADE SOLUTIONS LLC

POTASSIUM CHLORIDE MANUFACTURED IN MIDLOTHIAN, TEXAS.

5441

II

5/24/1984

PRODUCTION PROCEDURE:HOMATROPINE METHYLBROMIDE(INGELHEIM AM RHEIN PLT)

5442

5/21/1984

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
ARZNEIMITTEL GMBH

5443

II

6/29/1984

ROQUETTE FRERES

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RAVENSBURG.
MANNITOL AS MFG IN THE LESTREM, FRANCE FACILITIES

5444

II

10/7/1983

SIGMA F AND D DIV LTD

HYDRAZINE SULFATE (FAIRMOUNT CHEMICAL)

5445

III

6/28/1984

AMCOR FLEXIBLES KREUZLINGEN AG

ALUMINUM FOIL (BLISTER PACKAGING),MANUFACTURED IN KREUZLINGEN, SWITZERLAND

5446

II

6/4/1984

CIPLA LTD

CLONIDINE HCL MFG IN THE VIKHROLI, BOMBAY FACILITY

5447

III

7/17/1984

BETHAM CORP

PRESSURE SENSITIVE ADHESIVES MFG.MIDDLESEX,N.J.FACIL:1.PRODUCT X1266-A

5448

II

2/8/1984

ROQUETTE FRERES

SODIUM STARCH GLYOLATE LOW PH MFG IN THE LESTREM, FRANCE FACILITIES

5449

II

6/25/1984

GEDEON RICHTER

FLUMECINOL MFG BY GEDEON RICHTER LTD & TRADED BY MEDIMPEX (HUNGARY)

5450

II

6/25/1984

KNOLL PHARMACEUTICAL CO

BTS 49 465 MFG IN THE BEESTON, NOTTINGHAM (ENGLAND) FACILITY

5451

6/26/1984

MOEHS SA DIV OF SANOF

5452

II

7/2/1984

5453

II

2/20/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
WHITMOYER LABS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN RUBI, BARCELONA(SPAIN) PLANT
BOPINDOLOL MFG IN THE BASLE, SWITZERLAND FACILITIES

5454

II

6/25/1984

ORION CORP LTD

SUCRALFATE AS MANUFACTURED IN THE HANKO, FINLAND PLANT

5455

II

6/26/1984

KETOPROFEN S.R. CAPSULES MFG IN THE MARBURG, GERMANY FACILITY

5456

II

7/18/1984

TEMMLER WERKE VEREINIGTE CHEMISCHE


FABRIKEN
SCHERING AG

5457

IV

6/22/1984

FMC CORP FMC BIOPOLYMER DIV

AQUATERIC CD-910 AQUEOUS ENTERIC COATING MFG NEWARK, DELAWARE FAC.

CHLORHEXIDINE (BASE, DIHYDROCHLORIDE, GLUCONATE AND DIACETATE)

DIFLUCORTOLONE-21-VALERATE MFG IN THE WEDDING PLANT (BERLIN)

Page 150

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5458 I
IV
6/29/1984
GATTEFOSSE ESTABLISSEMENTS

SUBJECT
GELUCIRE 46/07; 48/09; AND 53/10 AS MFGR IN SAINT-PRIEST FRANCE FACILS

5459

6/27/1984

ORGANICHEM CORP

5460

II

7/18/1984

AVECIA INC.

5461

II

7/20/1984

SANKYO CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HVIDOVRE AND COPENHAGEN, DENMARK.
SDM-25 (25/75 ISOSORBIDE DINITRATE-MANNITOL MIXTURE)MANUFACTURED IN TAMAQUA,
PA.
BULK FORM OF NIMUSTINE HCL (NIDRAN) MFG IN THE SHINAGAWA PLANT, SANKYO

5462

II

7/17/1984

GEDEON RICHTER

KETAMINE HCL-MFG GEDEON RICHTER & MEDIMPEX HUNGARIAN TRADING CO.

5463

II

7/20/1984

BIOTEK INC

VAGINAL CONTRACEPTIVE SUPPOSITORIES MFG WOBURN, MASSACHUSETTS FACILITY

5464

II

7/19/1984

BETAXOLOL HYDROCHLORIDE-MFG. IN PORCHEVILLE, ANALYZED IN ANTONY(FRANCE

5465

II

7/20/1984

LABORATOIRES D'ETUDES ET DE RECHERCHES


SYNTHELABO
COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

5466

II

6/27/1984

ALFRED BENZON AS

ACETARD(ACETYSALICYLIC ACID)C.R. TABS(3 DOSAGE FORMS) MFG IN DENMARK

5467

II

7/18/1984

AVECIA INC

SDM-47 (10/90 NITROGLYCERIN-PLASTISOL MIXTURE) MANUFACTURED IN TAMAQUA, PA..

5468

II

7/20/1984

SANKYO CO LTD

NIMUSTINE HCL (NIDRAN) IN VIALS MFG IN THE HIRASUKA PLANT

5469

II

8/1/1984

OMNICHEM NV (PRB)

CIRAMADOL HYDROCHLORIDE AS MANUFACTURED IN THE WETTEREN FACILITIES

5470

8/1/1984

MCNEIL PHARMACEUTICAL LTD

5471

IV

8/8/1984

GATTEFOSSE ESTABLISSEMENTS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN STOUFFVILLE, ONTARIO, CANADA.
GELUCIRE 35/10 & GELUCIRE 42/12 MANUFACTURED IN SAINT-PRIEST, FRANCE.

5472

II

3/30/1984

AMERSHAM RADIOCHEMICAL CENTER

111 INDIUM CHL RADIOCHEM SOLUTION

5473

7/25/1984

WEST CO

5474

8/8/1984

EURAND AMERICA INC

5475

7/20/1984

DIAMALT AG

5476

II

7/5/1984

NITA PHARMACEUTICAL LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEST CO, MED PLASTICS DIV, JERSEY SHORE, PA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN DAYTON, OHIO.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF PEPTIDES IN MUNICH, GERMANY.
DESONIDE (PREDNACINOLONE 16,17 ACETONIDE)MFG FREEPORT, GRAND BAHAMA

5477

II

7/24/1984

AAI PHARMA LLC

PROPOXYPHENE NAPSYLATE PRODUCED BY TIPPECANOE LABS IN LAFAYETTE, IN.

5478

II

7/19/1984

DINAMITE DIPHARMA SPA

5479

III

5/22/1984

PRECISE TECHNOLOGY INC

NAPROXEN SODIUM MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY


FACILITIES
PACKAGING MATERIAL

5480

II

4/24/1984

89 STRONTIUM CHL. RADIOCHEM SOLUTION-PROCESSED IN BUCKINGHAMSHIRE,ENG.

5481

II

7/20/1984

AMERSHAM INTERNATIONAL PLC AMERSHAM


LABORATORY
DIAMALT AG

5482

II

8/11/1984

PROSINTEX SPA

TRIFLUOPERAZINE HCL MFG IN THE VILLANTERIO (PAVIA) ITALY FACILITIES

5483

II

7/20/1984

HOECHST CELANESE CORP

CHLORPROPAMIDE USP AS MFG IN THE COVENTRY, RHODE ISLAND FACILITIES

5484

II

8/1/1984

SANOFI SA

NALMEFENE HYDROCHLORIDE MFG BY SEMPA-CHIMIE IN ARAMON, FRANCE

5485

II

7/25/1984

ZAMBON SPA

IBUPROFEN USP XX AS MFG IN THE ALMISANO DI LONIGO (VICENZA) PLANT

5486

II

7/17/1984

FINE CHEMICALS CORPORATION

MEDROXYPROGESTERONE ACETATE MFG IN THE CAPE PROVINCE FACILITIES

5487

II

6/13/1984

UPJOHN CO

CORTISONE ACETATE USP, MICRO & NON MICRO MFG KALAMAZOO, MICHIGAN FAC.

5488

III

7/27/1984

HOSPIRA INC

PLASTIC SHROUD FOR ADD-VANTAGE VIAL MFG BUFFALO NY AND ASHLAND, OH FAC

5489

II

7/20/1984

SIFAVITOR SPA

CLOTRIMAZOLE USP XX AS MFG IN THE TRIBIANO (MILANO) ITALY PLANT

5490

7/12/1984

NOVOPHARM LTD

FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR THE


SCARBOROUGH, ONTARIO CANADA PLANT.

BETAMETHASONE VALERATE USP XX

SOMATOSTATIN AS MANUFACTURED IN THE MUNICH PLANT

Page 151

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5491 I
II
7/31/1984
LABORATOR MAG VIA MILANO

SUBJECT
NYLIDRIN HCL AS MFG IN THE GARBAGNAE MILANESE FACTORY

5492

II

6/12/1984

UPJOHN CO

PREDNISONE ACETATE, MICRO & NON-MICRO MFG KALAMAZOO, MICHIGAN FAC.

5493

II

4/18/1984

INDUSTRIAL PHARMACEUTICAL SERVICE LTD

HYDROFLUORIC ACID BURN JELLY MFG CROWN CHEM CO FOR IND PHARM SER LTD

5494

II

1/11/1984

ATROPINE SULFATE AS PRODUCED IN THE INGELHEIM FACILITIES

5495

IV

4/18/1984

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
AE STALEY CO

5496

II

8/10/1984

ORTHO PHARMA PRIVATE LTD

CHLORPROPAMIDE AS MFG IN THE KALYANI, WEST BENGAL FACILITY

5497

II

7/30/1984

FARCHEMIA SRL

CIMETIDINE MANUFACTURED IN TREVIGLIO (BERGAMO), ITALY.

5498

II

6/11/1984

PHARMACIA AND UPJOHN

HYDROCORTISONE ACETATE USP,MICRO & NON-MICRO

5499

II

7/30/1984

AMERICAN CHEMICAL INDUSTRIAL CORP

CHLORPROMAZINE HCL USP(BULK) MFG RICHMOND,CA (FORMERLY BENZYL PROD INC

5500

II

8/15/1984

TEVA PHARMACEUTICALS INDUSTRIES LTD

TAMOXIFEN CITRATE USP AS MFG IN THE NETANYA, ISRAEL FACILITIES

5501

II

7/24/1984

SUMIKA FINE CHEMICALS CO LTD

NIFEDIPINE USP XX AS MFG IN THE GIFU PLANT

5502

II

8/1/1984

REGIS CHEM CO

CLORGYLINE (REGIS CODE NO. 002061) AS MFG IN MORTON GROVE,ILLINOIS FAC

5503

8/23/1984

MEIJI SEIKA KAISHA LTD

5504

II

6/23/1984

PFIZER INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KAWASAKI, KANAGAWA, JAPAN.
PREDNISOLONE ACETATE USP,MICRO & NON MICRO

5505

II

7/16/1984

VALEANT PHARMACEUTICALS NORTH AMERICA

PYRIDOSTIGMINE BROMIDE MFG BY ROCHE PRODUCTS LTD,WELWYN GARDEN CITY

5506

III

8/17/1984

HOSPIRA INC

MICROBIOLOGICAL VALIDATION OF THE ADD-VANTAGE FLEXIBLE CONTAINER

5507

II

7/23/1984

TEMAZEPAM AS MFG. IN BASLE, SWITZERLAND, FACILITY

5508

8/20/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
PARKE DAVIS DIV WARNER LAMBERT CO

5509

II

8/17/1984

KV PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GWENT, UNITED KINGDOM.
UNISOM CAPS(DOXYLAMINE USP)MANUFACTURED IN ST. LOUIS, MISSOURI.

5510

IV

9/6/1984

BAYER AG

BAYER PRODUCTS IN THE MAKROLON SERIES AS MFG. IN UERDINGEN FACILITY

5511

II

9/7/1984

GEDEON RICHTER

PIPECURONIUM BROMIDE MFG BY GEDEON RICHTER&TRADED BY MEDIMPEX,HUNGARY

5512

IV

9/1/1984

PT GELATINDO MUKTI GRAHA

PROCEDURES & COMPONENTS FOR MFG HARD SHELL EMPTY GEL CAPS (JAWA BARA)

5513

II

9/7/1984

CHEMSPEC CHEMICALS PRIVATE LTD

HEXACHLOROPHENE MFG IN THE ANAND CHEMICALS COMPOUND POWAI POINT BOMBAY

5514

II

7/6/1983

SIGMA F AND D DIV LTD

AROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED

5515

II

7/23/1984

STRONTIUM-82 MANUFACTURED IN LOS ALAMOS, NEW MEXICO.

5516

IV

8/27/1984

LOS ALAMOS NATIONAL LABORATORY DEPT


ENERGY
MORGAN ADHESIVES CO

5517

II

8/14/1984

HOUBA INC

DEXBROMPHENIRAMINE MALEATE AS MFG. IN THE CULVER, INDIANA, FACILITIES

5518

III

9/6/1984

GE SILICONES

BAYILONE LIQUID SILICONE RUBBER PRODUCTS MFG LEVERKUSEN: 1. LSR 3174

5519

II

9/5/1984

SUTTON LABORATORIES

GERMALL II (DIAZOLIDINYL UREA) AS MFG. CHAHAM, N.J. FACILITIES

5520

6/15/1984

DAVID BULL LABORATORIES PTY LTD

5521

II

8/16/1984

BIOCHEMIC GESELLSCHAFT MBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MULGRAVE, AUSTRALIA.
D-PENICILLAMINE MFG IN THE KUNDL, TYROL (AUSTRIA) FACILITIES

5522

II

8/30/1984

MOEHS SA DIV OF SANOF

SULFAMETHOXAZOLE USP XX MFG IN RUBI (BARCELONA) FACILITIES

5523

9/12/1984

NATL INST HLTH NCI

MESNA:PRECLINICAL TOXICOLOGY & PHARMACOLOGY STUDIES CONDUCTED FOR NCI

5524

III

7/12/1984

BESPAK DIV CONSORT MEDICAL PLC

BESPAK BK 356 AEROSOL PHAR METERING VALVES MFG KING'S LYNN, NORFOLK

5525

II

8/29/1984

HAZER CHEMICALS INC

SIMETHICONE USP (BULK FORM) MFG IN THE GURNEE, ILLINOIS FACILITIES

PURIFIED SOYBEAN OIL AS PROCESSED IN THE DECATUR, ILLINOIS FACILITIES

PRESSURE SENSITIVE ADHESIVE SUBSTRATES MFG MOOSIC PA

Page 152

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5526 I
II
9/17/1984
KNOLL AG LUDWIGSHAFEN

SUBJECT
GALLOPAMIL HCL AS MANUFACTURED IN THE LUDWIGSHAFEN PLANT

5527

II

9/14/1984

NOVO NORDISK AS

HUMAN INSULIN (SEMI-SYNTHETIC) AS PROCESSED IN KALUNDBORG & BAGSVATERD

5528

II

9/13/1984

ROUSSEL-UCLAF

DESERPIDINE AS MFG IN THE VERTOLAYE, FRANCE FACILITY

5529

II

9/13/1984

SIGMA F AND D DIV LTD

HISTOPAQUE (1077 & 1119) & PHYSIOLOGICAL SALTS MIXTURES PROC ST. LOUIS

5530

II

9/21/1984

UPSHER SMITH LABS INC

5531

II

7/23/1984

BROOKHAVEN NATIONAL LABORATORY

TROFAN (L-TYPTOPHAN)TABLETS & PLACEBO MANUFACTURED IN MINNEAPOLIS,


MINNESOTA.
STRONTIUM-82 AS PREPARED AT THE BROOKHAVEN NATIONAL LABORATORY

5532

III

9/20/1984

INNOVATION TECHNOLOGY INC

COATING FORMULATIONS/HEAT SEAL COATED MATERIALS PKG/LABEL,WARRINGTON

5533

II

9/14/1984

NOVO NORDISK AS

HUMAN INSULIN INJ NEUTRAL 500 UNITS/ML PREPARED & PKG BAGSVATERD PLANT

5534

II

9/18/1984

MITSUBISHI CORP

L-CIS CIRAMADOL HYDROCHLORIDE(BULK)MFG IN Y.H.CHEM.,YONEZAWA,YAMAGATA

5535

II

9/19/1984

DYNAMIT NOBEL AKTIENGESELLESCHAFT

NITROGLYCERINE 2.2% IN MIGLYOL(R)812 NEUTRAL AS PROC.IN LEVERKUSEN PLT

5536

II

9/27/1984

PENCO OF LYNDHURST INC

THEBAINE ALKABOID POWDER MANUFACTURED IN NEWARK, NEW JERSEY.

5537

9/25/1984

ROHM AND HAAS CO

KAHON CG (KAHON 886):TOXICOLOGICAL INFO. GENERATED TOX.DEPT,R-H CO.

5538

IV

10/1/1984

GATTEFOSSE ESTABLISSEMENTS

5539

II

10/1/1984

SCHERING AG

GELUCIRE 33/01, GELUCIRE 64/02, OVUCIRE WL 2558, PRECIROL WL 2155, PRECIROL WL 2155
ATO MFG SAINT-PRIEST (LYON)
ROLIPRAM AS PRODUCED IN THE BERLIN PLANT

5540

II

10/12/1984

DSM PHARMA CHEMICALS SOUTH HAVEN INC

SALICYLSALICYLIC ACID AS MFG IN THE SOUTH HAVEN, MICHIGAN FACILITY

5541

II

9/27/1984

BEN VENUE LABORATORIES INC

CYCLOPHOSPHAMIDE LYOPHILIZED FOR INJ(5 DOSAGE FORMS)BEDFORD,OHIO FAC

5542

II

9/27/1984

NORDION CANADA INC

INDIUM-111 AS MANUFACTURED A THE VANCOUVER, B.C. FACILITY

5543

II

9/12/1984

HOECHST CELANESE CORP

CHLORZOXAZONE(BULK)AS MFG. IN THE COVENTRY, RHODE ISLAND, FACILITY

5544

II

9/17/1984

EASTMAN KODAK CO

RIBAVIRAN;VIREZOLE AS PREPARED IN THE ROCHESTER,NEW YORK FACILITY

5545

III

8/31/1984

HLG, INC

BLOW-MOLDING PROCEDURES CARRIED OUT IN THE KANSAS CITY,KANSAS FACILITY

5546

II

9/20/1984

DIOSYNTH BV

GLUCAGON MFG BY DIOSYNTH FRANCE IN ERAGNY SUR EPTE (GISORS) FRANCE

5547

II

10/2/1984

SELOC AG

FUROSEMIDE AS MFG BY SIFA, LTD, A SELOC AFFILIATE IN SHANNON,IRELAND

5548

II

9/26/1984

KALI UND SALZ AG

POTASSIUM CHLORIDE USP PRODUCED IN THE HERINGEN (GERMANY) PLANT.

5549

II

9/20/1984

YAMAMOTO CHEMICAL INDUSTRIES COMPANY LTD ACETAMINOPHEN USP XX AS MANUFACTURED IN THE WAKAYAMA FACILITIES

5550

II

9/27/1984

JANSSEN PHARMACEUTICA NV

LORCAINIDE HCL (JANSSEN CODE NO.R 15889)MFG IN THE BELGIAN FACILITIES

5551

II

6/27/1984

NORDION CANADA INC

PROCEDURES FOR THE PRODUCTION OF STRONTIUM-82 VANCOUVER, B.C. FACILITY

5552

II

9/17/1984

ORION CORP FARMOS CHEMICAL PLANT

IBUPROFEN,200 MG TABLETS, AS MFG. IN THE TURKU FACILITIES

5553

II

10/1/1984

SELOC AG

TRIAMTERENE USP XX MFG BY SIFA, LTD(SELOC AFFILIATE IN SHANNON IRELAND

5554

II

10/11/1984

DIOSYNTH BV

BETAMETHASONE VALERATE AS MFG. IN THE OSS FACILITIES,KLOOSTERSTRAA 6

5555

II

10/1/1984

COPPERHEAD INVESTMENTS INC

SDM-7 (20/80 NITROGLYCERIN/POLYMER MIXTURE) MANUFACTURED IN TAMAQUA, PA.

5556

III

6/18/1984

HAENDLER AND NATERMANN GMBH

COMP. & MFG. PROCEDS. DOUBLE LAYER TABS FOIL-PROCESS IN HANN-MUNDEN PL

5557

II

9/26/1984

MILES PHARMACEUTICAL DIV MILES INC

CLOTRIMAZOLE 250 MG ORAL TABLETS MANUFACTUREDIN WEST HAVEN, CONNECTICUT.

5558

9/28/1984

LIPHA SA

5559

II

10/4/1984

SELOC AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PITHIVIERS, FRANCE.
PROMAZINE HCL MFG BY SIFA,LTD,(A SELOC AFFILIATE IN IRELAND)

5560

II

10/10/1984

ISOCHEM SAS

INDORAMIN HYDROCHLORIDE PRODUCED IN GENNEVILLIERS FACILITY.

5561

III

9/26/1984

HELVOET PHARMA ITALIA SPA

CHLOROBUTYL RUBBER COMPOUNDS AS MFG IN THE MILAN FACILITIES.

Page 153

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5562 I
II
10/11/1984
DIOSYNTH BV

SUBJECT
ORF 170 70 MANUFACTURED BY OSS IN KLOOSTERSTRAA 6.

5563

III

6/18/1984

HAENDLER AND NATERMANN GMBH

COMP & MFG PROC. FOR SINGLE LAYER TAB. FOILS AS PROCES. IN HANN MUNDEN

5564

II

10/4/1984

SELOC AG

VERAPAMIL HYDROCHLORIDE MFG BY SIFA, LTD A SELCO AFF. IN SHANNON,IREL.

5565

III

8/30/1984

BCL LTD

COEXTRUDED POLYPROPYLENE FILM MFG BY BCL SHORKO FILMS LTD.IN WIL. ENG.

5566

II

9/28/1984

ORGAPHARM SAS

THIOTHIXENE MANUFACTURED IN PITHIVIERS, FRANCE.

5567

10/10/1984

SUMMA MEDICAL CORP

5568

III

9/28/1984

5569

10/5/1984

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
CONTRACT COATING INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALBUQUERQUE, NEW MEXICO.
POLYETHYLENE TEREPHAHALATE PLASTIC VIALS INJECTION MOLDED IN NOR.CHIC.

5570

9/9/1984

TECH PLASTICS INC

5571

III

6/18/1984

TEICH AG

5572

9/19/1984

FARMACAPSULAS DE COLUMBIA SA

5573

II

10/12/1984

LAPORTE ORGANICS FRANCIS SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BARRANQUILLA, COLUMBIA.
TOLAZAMIDE USP AS MANUFACTURED IN THE CARONNO PERTUSELLA FACILITY

5574

II

11/1/1984

SYNCOR PHARMACEUTICALS INC

SODIUM IODIDE (1-123) SOLUTION MANUFACTURED IN GOLDEN, COLORADO.

5575

III

11/2/1984

LOW DENSITY POLYETHYLENES/BEEK FACIL: STAMYLAN 3400 SERIES & 3400C

5576

III

8/16/1984

DSM MARKETING CENTRE CHEMICALS &


POLYMERS
ALUMINUM COMPANY OF AMERICA

5577

11/5/1984

INTERPHARM PHARMACEUTICAL PRODUCTS INC

BIO-CHEMICL LABS.,INC.,DIV.OF INTERPHARM PHARM PROD

5578

IV

10/26/1984

HAZER CHEMICALS INC

BULK PRODUCTION OF SUCROSE POLYESTER IN THE GURNEE, ILLINOIS FACILITY

5579

II

10/22/1984

SIEGFRIED LTD

OXICONAZOLE NITRATE MFG AND SOLD UNDER THE SIEGFRIED LABEL

5580

II

11/7/1984

PENINSULA LABS

D-ALA2, D-LEU5 - ENKEPHALIN AS PROCESSED IN THE BELMONT, CA. FACILITY

5581

II

10/30/1984

DIOSYNTH BV

BETAMETHASONE SODIUM PHOSPHATE IN THE OSS FACIL. ON KLOOSTERSTRA 6

5582

III

10/22/1984

5583

II

11/5/1984

GETTIG PHARMACEUTICAL INSTRUMENT CO DIV


GETTIG TECHNOLOGIES INC
SCHERING AG

RAW MATERIAL SPECIFICATIONS AND TEST PROCEDURES FOR MANUFACTURE OF RUBBER


COMPONENTS IN KNOX, INDIANA
PREDNISOLONE 21-DISODIUM PHOSPHATE AS MFG.IN BERLIN PLANT MULLERSTRABE

5584

II

11/13/1984

ALBEMARLE CORP

MECLOFENAMATE SODIUM USP MANUFACTURED IN MICHIGAN.

5585

II

10/23/1984

SIEGFRIED AG

AZAPROPAZONE AS MFG AND SOLD UNDER THE SIEGFRIED LABEL

5586

III

11/12/1984

LUTZ KG

GLASS PHARMACEUTICAL AMPULES MFG IN WERTHHEIM, GERMANY FACILITY

5587

11/14/1984

HOFFMANN LA ROCHE INC

5588

III

10/22/1984

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NUTLEY, NEW JERSEY.
RUBBER CLOSURE FORM. IN GP 2001 SERIES AS MFG. IN KNOX, IND. FACILITY

5589

II

10/3/1984

GETTIG PHARMACEUTICAL INSTRUMENT CO DIV


GETTIG TECHNOLOGIES INC
SOCIEDAD MEXICANA DE QUIMICA INDUSTRIAL SA CHLORPROPAMIDE USP (BULK)-MFG IN THE SANTA CLARA DE JUAREZ FACILITY

5590

II

10/24/1984

GEDEON RICHTER

TOLPERISONE HCL,MFG.IN BUDAPEST PLANT,TRADED-MEDIMPEX HUNGARIAN TR.CO.

5591

III

11/12/1984

TOTAL PETROCHEMICALS RESEARCH FELUY SA

POLYPROPYLENE RESINS PROCESSED ORTHEZ,FRANCE (LACQTENE P 3020 SM 3)

5592

II

11/1/1984

ACF CHEMIEFARMA NV

PRECURSOR OF PH 3976 INTERMED. X-MFG IN MAARSSEN (2',5-DIHYDROXY-9,9-

5593

III

9/28/1984

ROHM AND HAAS CO

PRODUCTS IN THE 76-RES SERIES MFG BRIDGEVIEW, ILL. & CHARLOTTE, N.C.

5594

III

10/22/1984

GETTIG PHARMACEUTICAL INSTRUMENT CO DIV


GETTIG TECHNOLOGIES INC

RUBBER CLOSURE FORM. IN GP 3001 SERIES, MFG. IN KNOX, IND.FACIL (RED)

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING HACKENSACK,


NEW JERSEY FACILITY ON BEECH STREET.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SOUTH MCCLINTOCK DR. TEMPE, ARZ.
COATED TABLET FOILS MANUFACTURED IN HANN MUNDEN, GERMANY.

LAMIN. OF ALUM. FOIL TO POLYESTER FILM & PAPER AS PROC. RIVERDALE IOWA

Page 154

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5595 I
I
10/31/1984
ASTA PHARMA AG
5596

II

11/14/1984

GANES CHEMICALS INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN KONSTANZ PLANT.
MEPHOBARBITAL AS MFG IN THE PENNSVILLE, NEW JERSEY FACILITY.

5597

II

11/9/1984

EGIS PHARMACEUTICALS PLC

CHLORPROMAZINE HCL,MFG.BY EGYT,BUDAPEST,TRADED-MEDIMPEX HUNGARIAN T.CO

5598

III

11/19/1984

NISSIN CHEMICAL INDUSTRY COMPANY LTD

ST-FILM AS MANUFACTURED IN THE TAKEFU PLANT

5599

11/19/1984

WINTHROP LABS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5600

10/31/1984

5601

II

10/3/1984

ARAB CENTER FOR PHARMACEUTICALS &


MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
CHEMICALS
OF EMPTY HARD GELATIN CAPSULES IN AMMAN, JORDAN.
SOCIEDAD MEXICANA DE QUIMICA INDUSTRIAL SA TOLBUTAMIDE USP (BULK) AS MFG IN THE SANTA CLARA DE JUAREZ FACILITY

5602

II

11/9/1984

BAYER SCHERING PHARMA AG

5-AMINOSALICYLIC ACID, PURE MFG WERK ELBERFELD FACILITY IN WUPPERTAL

5603

II

11/9/1984

PCAS

TRIMEPRAZINE TARTRATE USP MFG BY SIFA,LTD SHANNON(COUNTY CLARE)IRELAND

5604

II

11/7/1984

GEDEON RICHTER LTD

ETHIONAMIDE, MFG. CHEM.WORKS OF G.R.,TRADED,MEDIMPEX HUNGARIAN TR.CO.

5605

II

11/9/1984

METOPROLOL TARTRATE MFG IN THE FILARONE REGELLO (FLORENCE) FACILITY

5606

II

10/18/1984

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
MORTON THIOKOL INC

5607

II

11/15/1984

NORDIC SYNTHESIS AB

ISOSORBIDE-5-MONONITRATE MANUFACTURED IN BOFORS, SWEDEN.

5608

11/19/1984

WINTHROP LABS

FOR STERLING-WINTHROP RESEARCH CENTRE IN ALNWICK

5609

II

10/24/1984

TAKEDA CHEMICAL INDUSTRIES LTD

BULK PRODUCTION OF OXENDOLONE IN THE HIKARI PLANT

5610

II

12/3/1984

SANDOZ PHARMS CORP DIV SANDOZ INC

BUTALBITAL

5611

II

12/10/1984

DAIWA PHARMACEUTICAL CO LTD

HYDRALAZINE HYDROCHLORIDE

5612

II

12/3/1984

PCAS

TAMOXIFEN CITRATE MFG BY SIFA,LTD A SELOC AFFILIATE IN SHANNON,IRELAND

5613

II

11/29/1984

SUMIKA FINE CHEMICALS CO LTD

THIORIDAZINE HCL USP XXI

5614

II

12/11/1984

SMITHKLINE & BECKMAN INC

HYDROCHLOROTHIAZIDE

5615

II

10/24/1984

JANSSEN PHARMACEUTICA NV

CARFENTANIL CITRATE (CODE NO. 33799) MFG BEERSE, BELGIUM FACILITIES

5616

II

10/17/1984

CIPLA LTD

DANAZOL USP AS MANUFACTURED IN VIKHRELI,BOMBAY FACTORY

5617

II

10/26/1984

MORTON SALT INC

POTASSIUM CHLORIDE (USP) MFG BY MORTON SALT DIV IN GRAND SALINE, TEXAS]

5618

II

10/24/1984

TAKEDA CHEMICAL INDUSTRIES LTD

PROCESSING OF OXENDOLONE AQUOSUSPENSOID INJ IN THE OSAKA PLANT

5619

II

11/19/1984

KNOLL AG

PROCORUM (GALLOPAMIL HCL,50MG)TABS MFG LUDWIGSHAFEN AM RHINE FOR KNOLL

5620

11/14/1984

NITTO ELECTRIC INDUSTRIAL CO LTD

5621

IV

10/26/1984

GATTEFOSSE ESTABLISSEMENTS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TOHOKU PLANT IN MIYAGI, JAPAN.
TEFOSE 2000 MFG IN THE SAINT-PRIEST FACILITY

5622

II

10/26/1984

DUMEX AS DIV DUMEX LTD

DISULFARIM AND DISULFARIM HYDROPHILE AS MFG. IN INDONESIA

5623

11/14/1984

SOLOPAK LABORATORIES

METHODS, FACILITIES & GOP FOR THE FACILITIES,CHICAGO & FRANKLIN PARK

5624

II

11/23/1984

JANSSEN PHARMACEUTICA NV

RITANSERIN (CODE NO. R 55667 )

5625

II

11/15/1984

TAKEDA CHEMICAL INDUSTRIES LTD

SODIUM DEACETYL CEPHALOSPORIN C (DCPE-NA) PRODUCTION IN HIKARI PLANT

5626

II

11/27/1984

SUMMA MEDICAL CORP

ANTI-HUMAN CHORIONIC GONADOTROPIN - SUMMATECH-HCG-BETA (ALBUQUERQUE)

5627

III

11/20/1984

CIBA GEIGY CORP

IRGANOX 1010 USED IN THE MFG. OF PKG. MATERIALS

5628

II

11/14/1984

NITTO ELECTRIC INDUSTRIAL CO LTD

AMIAID ISDN TAPE

5629

II

12/14/1984

ASTRA USA INC

TOCAINIDE HCL. INJECTION

5630

II

11/21/1984

JANSSEN PHARMACEUTICA NV

CARFENTANIL INJECTION 3MG./ML.

N-(2 METHYL-1-NAPHTHYL) MALEIMIDE.

Page 155

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5631 I
II
11/30/1984
SUMITOMO CHEMICAL CO LTD

SUBJECT
SUMITHRIN

5632

II

12/21/1984

HOFFMANN LA ROCHE INC

HUMAN GROWTH HORMONE RELEASING FACTOR-(1-44)-AMIDE

5633

II

12/12/1984

BAYER

ETOFENAMATE AS MFG IN THE WUPPERTAL FACILITIES

5634

II

11/30/1984

LORAZETYL

5635

III

12/11/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
HOSPIRA INC

5636

10/26/1984

SCHERING AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5637

II

12/14/1984

JANSSEN PHARMACEUTICA NV

ALTANSERIN TARTRATE (CODE NO. R 53200) MFG IN THE BELGIUM FACILITIES

5638

II

11/28/1984

FOREST LABORATORIES INC

THIORIDAZINE HCL 200 MG C.R. TABS (IN SYNCHRON VEHICLE)MFG INWOOD N.Y.

5639

II

12/17/1984

VELSICOL CHEMICAL CORP

HEXACHLOROPHENE AS MANUFACTURED IN THE BEAUMONT, TEXAS FACILITY

5640

II

10/25/1984

HEINRICH MACK NACHF

ALEXAN AMPOULES

5641

II

12/20/1984

DICUMAROL

5642

II

12/17/1984

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
NV ORGANON

5643

II

12/20/1984

SIEGFRIED LTD

MEPHOBARBITAL

5644

II

12/21/1984

AINC

AFM SP-CELLULOSE-1 ION-EXCHANGE MEDIA

5645

II

12/7/1984

BUTALBITAL

5646

III

12/20/1984

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
CELANESE SPECIALTY RESINS

5647

II

12/13/1984

ORION CORP LTD FERMION

CHLORHEXIDINE BASE AS MFGR IN THE NANKKAA AND HANKO PLANTS

5648

II

12/7/1984

FINE CHEMICALS CORP PTY LTD

FLUPHENAZINE HYDROCHLORIDE AS MFG. IN THE EPPING FACILITY

5649

II

12/17/1984

NV ORGANON

EDROPHONIUM CHLORIDE

5650

III

1/7/1985

ADHESIVES RESEARCH INC

MEDICAL GRADE ADHESIVES

5651

II

1/3/1985

ALDRICH CHEMICAL COMPANY INC

9-AMINO-1,2,3,4,-TETRAHYDROCRIDINE HCL. (THA)

5652

II

1/4/1985

SIGMA F AND D DIV LTD

COUMARIN

5653

II

11/6/1984

UNICHEM LABORATORIES LTD

DIPHENHYDRAMINE HYDROCHLORIDE

5654

III

10/3/1984

HOSTALEN PACKAGING PRODS: HOSTALEN G & HOSTALEN PP

5655

1/4/1985

BASELL POLYOLEFINE ITALIA SRL


LYONDELLBASELL INDUSTRIES CO
JOHNSON MATTHEY PLC

5656

IV

11/5/1984

ROQUETTE FRERES

5657

1/18/1985

SYLATEC GROUPE SYNTHELABO

5658

1/21/1985

MEDICHEM SA

5659

II

12/18/1984

ASTA PHARMA AG

5660

12/18/1984

PACKAGING CORP AMERICA

5661

II

11/6/1984

UNICHEM LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PISCATAWAY, N.F.
THIACETAZONE

5662

II

1/17/1985

PENNISULA LABORATORIES INC

GROWTH HORMONE RELEASING FACTOR (HUMAN )

5663

1/14/1985

ALRA LABORATORIES INC

GURNEE,ILL. FACILITY

5664

II

1/12/1985

MEDICHEM SA

LIDOCAINE BASE $ LIDOCAINE HYDROCHLORIDE

STANDARD MICROBIOLOGICAL METHODS FOR THE FLEXIBLE CANTAINER

NALMEFENE HYDROCHLORIDE

CAN END COATING (X-1174CL CLEAR EPOXY)

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEST DEPTFORD, NEW JERSEY.
LYCASIN BRAND HYDROGENATED GLUCOSE SYRUP(LYCASIN HGS)MFG IN LESTREM,FR
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TOURS FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CELRA (GERONA) SPAIN.
FLUPIRTINE MALEATE

Page 156

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5665 I
II
12/27/1984
ORION CORP LTD FERMION

SUBJECT
CARBAMAZEPINE USP XX

5666

II

1/18/1985

CGS-9896

5667

II

1/14/1985

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
OMNICHEM NV (PRB)

5668

II

1/23/1985

REGIS CHEM CO

3,4-DIAMINOPYIDRINE

5669

II

1/4/1985

ISP

DEXBROMPHENIRAMINE MALEATE

5670

II

11/20/1984

INNOPHOS

TRIBASIC CALCIUM PHOSPHATE ( GRANDULAR )

5671

II

1/22/1985

WITCO CHEM CO INC

FOMREZ PRODUCTS

5672

III

1/7/1985

ALUMINUM COMPANY OF AMERICA

COATED ALUMINUM SHEET WITH TEXTURING LUBRICANT

5673

II

12/10/1984

ROHM AND HAAS CO LLC

DUOLITE AP 143 (CHOLESTYRAMINE RESIN USP )

5674

II

12/20/1984

FIS FABBRICA ITALIANA SINTETICI SPA

CLOMIPHENE CITRATE

5675

II

1/4/1985

MTM CHEMICALS INC

D,I-BROMPHENIRAMINE MALEATE

5676

II

11/20/1984

INNOPHOS INC

DIBASIC CALCIUM PHOSPHATE ,ANHYDROUS

5677

II

12/20/1984

YUNG ZIP CHEMICAL IND CO LTD

ACETAMINOPHEN AND MEFENAMIC ACID

5678

II

1/18/1985

PCAS

VALPROIC ACID

5679

III

1/25/1985

MOBAY CHEMICAL CORP

MERLON PRODUCTS (MERLON M-40RF-1000 )

5680

II

11/20/1984

INNOPHOS INC

DIBASIC CALCIUM PHOSPHATE ,DIHYDRATE (BULK)

5681

1/15/1985

EI DUPONT DE NEMOURS AND CO

5682

III

11/2/1984

5683

II

1/21/1985

DSM MARKETING CENTRE CHEMICALS &


POLYMERS
MALLINCKRODT SPECIALTY CHEMICALS CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DEEPWATER, NEW JERSEY .
LOW DENSITY POLYETHYLENE PRODUCTS (STAMYLAN 1300 SERIES )

5684

II

9/4/1984

TEVA PHARMACEUTICAL INDUSTRIES LTD

FLUOROMETHOLONE-17-ACETATE MICRONIZED-MFG IN KALAMAZOO,MI

5685

2/1/1985

FH FAULDING & COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5686

II

2/7/1985

ROUSSEL-UCLAF

ESTRADIOL USP

5687

II

2/5/1985

ORGAMOL SA

RIBAVIRIN

5688

IV

11/20/1984

INNOPHOS

DIBASIC CALCIUM PHOSPHATE ,DIHYDRATE (UNMILLED BULK PRODUCT)

5689

II

1/25/1985

YODOGAWA PHARMACEUTICAL CO LTD

DOXYLAMINE SUCCINATE USP XXI

5690

2/11/1985

EI DUPONT DE NEMOURS AND CO

5691

2/11/1985

PACO PACKAGING INC

5692

II

1/28/1985

FINE ORGANICS LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WILMINGTON, DELAWARE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CONAVANAS, CAROLINE PLANT, PUERTO RICO.
ETINTIDINE HYDROCHLORIDE

5693

II

1/24/1985

CAMBREX KARLSKOGA AB

5-AMINOSALICYLIC ACID

5694

II

11/20/1984

INNOPHOS INC

TRIBASIC CALCIUM PHOSPHATE (BULK POWDER )

5695

III

1/30/1985

TITAN PLASTICS

PLASTIC BOTTLES AS MFG IN EAST RUTHERFORD,N.J.

5696

III

2/4/1985

MOBAY CHEMICAL CORP

MERLON PRODUCTS IN M40RF-SM SERIES

5697

II

2/7/1985

ALDRICH CHEMICAL COMPANY INC

N-METHYLFORMIDE (CODE NO. W150-9)

5698

1/30/1985

BALL UNIMARK PLASTICS DIV BALL CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MILROY, PA.

METHOCARBAMOL USP

ACETAMINOPHEN AS MANUF. IN LYNDHURST,N.J.

Page 157

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5699 I
II
1/18/1985
ORCHIMIE SA (PRODUITS CHIMIQUES ET
BIOCHIMIQUES)
5700 I
III
2/11/1985
MONSANTO POLYMER PRODUCTS CO

SUBJECT
TRIFLUOPERAZINE

5701

II

2/13/1985

BEECHAM LABORATORIES DIV BEECHAM INC

PROCESSING OF STERILE BULK CLAVULANATE POTASSIUM

5702

II

2/14/1985

FOREST LABORATORIES INC

THIORIDAZINE HCL 400MG S.R.TABS (IN SYNCHRON VEHICLE) AS MFG INWOOD,NY

5703

II

2/12/1985

SIEGFRIED AG

BENZPHETAMINE HYDROCHLORIDE

5704

1/30/1985

BALL UNIMARK PLASTICS DIV BALL CORP

5705

2/4/1985

ZUMBRO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES


IN MILROY, PA. CENTER II.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

5706

1/31/1985

SIMBEC RESEARCH LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5707

2/11/1985

GLAXO WELLCOME INC

MANUFACTURING SITE AND FACILITIES FOR ANNAN, UK PLANT

5708

II

1/21/1985

GEDEON RICHTER PLC

NORGESTIMATE AS MFG. INBUDAPEST, HUNGARY

5709

IV

2/11/1985

SUMITOMO CHEMICAL AMERICA INC

EGG YOLK PHOSPHATIDE

5710

1/30/1985

BALL UNIMARK PLASTICS DIV BALL CORP

5711

IV

2/22/1985

FIRMENICH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GREENVILLE, SOUTH CAROLINA, CENTER II.
CHEMODERM 1001

5712

III

2/19/1985

HUB PLASTICS INC

BLOW MOLDED CONTAINER PRODUCTS

5713

III

2/14/1985

BERRY PLASTICS CORP

INJECTION MOLDED/LINED CLOSURES MANUFACTURED IN BALTIMORE, MD.

5714

1/11/1985

PACKAGE CRAFT INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5715

II

2/11/1985

GLAXOCHEM LIMITED

LABETALOL HYDROCHLORIDE

5716

2/13/1985

IG SPRUHTECHNIK GMBH

5717

II

2/6/1985

FERMION OY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEHR/BADEN.
DILTIAZEM HCL

5718

IV

2/11/1985

GATTEFOSSE SAS

TRANSCUTOL, MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE

5719

III

2/15/1985

LABELTAPE MEDITECT INC

TRANSDERMAL DRUG DELIVERY SYSTEM

5720

II

2/25/1985

SIEGFRIED AG

HYDRALAZINE HYDROCHLORIDE

5721

II

2/19/1985

BACHEM FINE CHEMICALS INC

GROWTH HORMONE RELEASING FACTOR (GRF),(1-44)AMIDE,HUMAN (BULK)

5722

II

2/22/1985

ALBEMARLE CORP

ORPHENADRINE CITRATE USP

5723

II

2/27/1985

PFIZER INC

ZINC GLUCONATE

5724

II

2/14/1985

PROCOS SPA

DISOPYRAMIDE PHOSPHATE

5725

II

12/3/1984

ALPHA-METHYLDOPA

5726

II

2/4/1985

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
KLINGE PHARMA CO

5727

2/7/1985

CONTAINER SUPPLY CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5728

II

3/6/1985

CHEMISCHE WERKE LAHR GMBH

CROTAMITON

5729

3/4/1985

QUALITY CHEMICALS INC

5730

II

3/5/1985

ROUSSEL-UCLAF

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TYRONE, PA.
DIHYDROTACHYSTEROL

5731

3/5/1985

ACME UNITED CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

SANTOPRENE (R) THERMOPLASTIC ELASTOMER,270 GRADE SERIES

DIPIVEFRINE HCL.

Page 158

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5732 I
II
2/28/1985
GEDEON RICHTER

SUBJECT
DISOPYRAMIDE PHOSPHATE

5733

II

2/26/1985

SANDOZ PHARMS CORP DIV SANDOZ INC

PHENIRAMINE MALEATE

5734

IV

2/28/1985

GATTEFOSSE SAS

LABRASOL, LABRAFAC HYDRO WL 1219AS MANUFACTURED IN THE SAINT-PRIEST, (LYON),


FRANCE

5735

2/27/1985

SERONO LABORATORIES INC

VIA CASILINA PLANT IN ROME, ITALY

5736

3/5/1985

PARKE DAVIS DIV WARNER LAMBERT CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

5737

II

2/12/1985

ENPROSTIL CAPSULES

5738

3/1/1985

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
TRINITY TECHNOLOGIES CORP

5739

II

3/13/1985

TECHNOCHEMIE GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DETROIT, MICHIGAN.
GUANABENZ ACETATE

5740

II

2/27/1985

GEDEON RICHTER PLC

ETHINYL ESTRADIOL

5741

II

3/11/1985

PROFARMACO SRL

MECLOFENAMATE SODIUM

5742

II

8/17/1984

ELI LILLY INDUSTRIES INC

ALMITRINE BISMESYLATE TABLETS

5743

3/11/1985

5744

II

2/28/1985

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
GEDEON RICHTER

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BOUND BROOK, NEW JERSEY.
MESTRANOL-MFG BY CHEM.WORKS OF GEDEON RICHTER,LTD-TRADED BY MEDIMPEX

5745

II

2/12/1985

TEGRETOL S.R. CAPSULES

5746

II

3/20/1985

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
ASTELLAS PHARMA INC

5747

II

3/13/1985

LORAZEPAM

5748

II

3/11/1985

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
BASF PHARMA EVIONNAZ SA

5749

II

3/4/1985

MICROCHEM LABORATORIES IRELAND LTD

CONTRACT MICRONIZATION SERVICES LOCATED IN FIORENZUOLA D'ARDA, ITALY

5750

II

3/11/1985

DIOSYNTH INC

PREGNANT MARE SERUM GONADOTROPIN (PMSG)(CRUDE)

5751

IV

3/21/1985

VIRGINIA DARE EXTRACT CO INC

EXTRACTS & FLAVORS-PROCESSED IN BKLYN,NY-3RD AVE

5752

3/18/1985

CP PACKAGING INC

5753

II

3/27/1954

BOEHRINGER INGELHEIM PHARMA KG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN JAMESBURG, NEW JERSEY.
CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES

5754

II

3/20/1985

CILAG CHEMIE AG

DISULFIRAM

5755

2/27/1985

SHIONOGI QUALICAPS INC

5756

II

3/29/1985

LUDWIG HEUMANN AND CO GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


MANUFACTURED BY LILLY RESEARCH CENTER IN ENGLAND.
METOCLOPRAMIDE HCL.

5757

II

2/19/1985

NICOTINE RESIN COMPLEX 20%

5758

2/18/1985

MCNEIL CONSUMER HEALTHCARE DIV MCNEIL


PPC INC
NOVO NORDISK AS

5759

II

2/18/1985

DOW CHEMICAL CO

CHOLESTYRAMINE USP MANUFACTURED IN GARESSIO PONTE, GARESSIO.

5760

3/18/1985

PLAISTOW LTD

5761

II

3/19/1985

LYPHOMED INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LITTLE ISLAND, COUNTY CORK.
ISOSORBIDE DINITRATE INJECTION (50ML AND 100ML)

5762

2/28/1985

SQUIBB DIAGNOSTICS

RUBIDIUM-82 PERCLINICAL STUDIES

5763

II

3/28/1985

ORTHO DIAGNOSTIC SYSTEMS DIV ORTHO


PHARMACEUTICAL LTD

PHOTOFRIN AS MFG UNDER CONTRACT IN RARITAN,NJ FACIL.FOR PHOTOFRIN MED.

FAMOTIDINE MANUFACTURED IN JAPAN

METOLAZONE

PRODUCTION OF INSULIN

Page 159

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5764 I
I
11/30/1984
TEXBERRY CONTAINER CORP

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5765

II

3/27/1985

ERGOTAMINE TARTRATE

5766

3/15/1985

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
INJECTRONICS INC

5767

3/27/1985

STERIS-ISOMEDIX

MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BURLINGTON, NORTH CAROLINA.
CONTRACT STERILIZATION FACILITY IN SANDY, UTAH.

5768

2/28/1985

SQUIBB DIAGNOSTICS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5769

IV

3/7/1985

EKA NOBEL INC PAPER CHEMICALS DIV

BEROCELLS 584 AND 588

5770

IV

4/8/1985

EMPTY HARD GELATIN CAPSULES

5771

4/1/1985

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
DELTA SYNTHETIC CO LTD

5772

II

4/1/1985

DOW CHEMICAL CO MICHIGAN DIV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TAIPEI HSIEN, CHINA.
ETHYCELLULOSE DISPERSIONS

5773

II

3/27/1985

NV ORGANON

DROPERIDOL AS MANUF. IN OSS

5774

4/3/1985

MASTER-PAK LABORATORIES INC

5775

3/21/1985

NORAMCO OF DELAWARE INC

5776

II

3/8/1985

FABBRICA ITALIANI SINTETICI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PATERSON, NEW JERSEY.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN WILMINGTON, DELAWARE.
PRAZEPAM

5777

II

4/9/1985

ORION CORP FARMOS CHEMICAL PLANT

TAMOXIFEN (10MG. TABLET)

5778

II

3/27/1985

SIGMA F AND D DIV LTD

L-B-3,4-DIHYDROXYPHENYLALANINE (L-DOPA) AND METHYL ESTER HCL.

5779

II

5/4/1984

EPHINEPHRINE BITARTRATE

5780

II

4/12/1985

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
AJAY CHEMICALS INC

5781

II

3/28/1985

NORTH EAST SIXTH PHARMACEUTICAL FACTORY

TRIMETHOPRIM USP BULK MANUFACTURED IN SHENYANG CHINA

5782

II

4/8/1985

XTTRIUM LABORATORIES INC

CHLORHEXIDINE GLUCONATE B.P-81 AS MANUFACTURED IN MT. PROSPECT, ILLINOIS

5783

II

3/22/1985

UNICHEM LABORATORIES LTD

METRONIDAZOLE USP

5784

II

4/16/1985

SIGMA F AND D DIV LTD

DIPYRIDAMOLE: SPECIFICATIONS AND RELABELLING

5785

II

3/27/1985

THIORIDAZINE

5786

II

4/10/1985

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
JAGSONPAL PHARMACEUTICALS PVT LTD

5787

II

3/29/1985

PHARMACIA AND UPJOHN INC

DIFLORASONE DIACETATE

5788

II

3/29/1985

ZAMBON SPA

DOPAMINE HCL USP XX -MFG ALMISANO DI LONIGO (VICENZA) ITALY

5789

II

3/15/1985

MALLINCKRODT INC

PROCEDS & CONTRLS FOR PROCESSING OF INDIUM IN-111(CHL & CITRATE)

5790

II

4/18/1985

PENINSULA LABS

LEUCINE-ENKEPHALIN

5791

II

3/27/1985

ATROPINE AS MFG IN THE INGELHEIM AM RHEIN FACILITIES

5792

II

4/4/1985

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
SCHERING AG

5793

II

4/10/1985

BASF AKTIENGESELLSCHAFT

BETA-CAROTENE CAPSULES,50MG.

5794

6/1/1985

BRUNSWICK TECHNETICS

PRODUCTION OF MEMBRANE FILTER PRODUCTS

5795

II

4/10/1985

LONZA AG

ETODOLAC AS MANUFACTURED IN VISP, SWITZERLAND

5796

II

4/3/1985

FERMION OY

TOLNAFTATE USP XX

POTASSIUM IODIDE USP AS MFG IN THE POWDER SPRINGS, GEORGIA FACILITY

TRIMETHOPRIM

GADOPENTETIC ACID,MEGLUMINE SALT

Page 160

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5797 I
IV
3/28/1985
GATTEFOSSE ESTABLISSEMENTS

SUBJECT
MAISINE AS MANUF. IN SAINT-PRIEST FACILITY

5798

III

4/18/1985

ALPHA PACKAGING

5799

4/9/1985

DAINIPPON PHARMACEUTICAL CO LTD

5800

II

4/9/1985

BAYER

PACKAGING MATERIALS MANUFACTURED IN YPSILANTI, MICHIGAN AND THOMASVILLE,


GEORGIA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN OSADA, JAPAN.
MYCOSPOR (BIFONAZOLE) SOLUTION 1%

5801

4/23/1985

COMPAGNIE ORIS INDUSTRIE

LABORATORY OF BIOMEDICAL IMAGING PRODUCTS

5802

II

2/27/1985

ALCHYMARS

TRIHEXIPHENIDYL HYDROCHLORIDE

5803

II

4/23/1985

PROCHLORPERAZINE

5804

4/24/1985

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
BEHRING DIAGNOSTICS

5805

II

4/15/1985

L&P PROM EXPORT AS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LA JOLLA, CALIFORNIA.
PHENYLACETIC ACID

5806

III

2/1/1985

FORTIFIBER CORP

PACKAGING MATERIALS/CAP LINING AS MFG IN ATTLEBORO,MASSACHUSSETTS

5807

4/5/1985

RADIATION STERILIZERS INC

5808

III

4/17/1985

MOBAY CHEMICAL CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DECATUR, GEORGIA.
NYDUR C-38F AS MFG IN KREFELD/UERDINGEN FACILITY (GERMANY)

5809

II

4/11/1985

DELTA SYNTHETIC CO LTD

GUAIFENESIN MFG IN TAIPEI,HSIEN,TAIWAN

5810

II

5/7/1985

GANES CHEMICALS INC

CYCLOBENZAPRINE HYDROCHLORIDE

5811

II

5/10/1985

DIOSYNTH INC

PREGNANT MARE SERUM GONADOTROPIN (PMSG), CRUDE

5812

II

5/8/1985

GA TECHNOLOGIES INC

YTTRIUM-90 RAW MATERIAL PRODUCTION

5813

II

5/7/1985

ORGAMOL SA

METOCLOPRAMIDE

5814

5/10/1985

MASCHMEIJER AROMATICS BV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5815

II

4/30/1985

NAPP CHEMICALS INC

TRIMETHOPRIM USP

5816

II

4/8/1985

ALBERT DAVID LTD

CHLORPROPAMIDE USP XX

5817

III

3/27/1985

ABBOTT INDUSTRIES INC

PLASTIC CONTAINER PRODUCTION IN NEW JERSEY

5818

II

5/6/1985

BASF SE

VITAMIN E ACETATE

5819

II

4/29/1985

HOECHST CELANESE CORP

TOLAZAMIDE USP MFG IN COVENTRY,RHODE ISLAND FACIL ON QUIDNICK STREET

5820

II

5/13/1985

FOREST LABORATORIES INC

PENTAERYTHRITOL TETRANITRATE (P.E.T.N.) 80MG. & 160MG C.R. TABLETS

5821

4/29/1985

STERIS ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN WHIPPANY, NJ

5822

II

5/29/1985

EPINEPHRINE

5823

III

5/13/1985

5824

II

5/23/1985

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
ARCO CHEMICAL COMPANY DIV OF ATLANTIC
RICHFIELD CO
SIGMA F AND D DIV LTD

5825

II

5/14/1985

ORGAMOL SA

SUCRALFATE AS MFG IN THE EVIONNAZ,SWITZERLAND FACILITIES

5826

II

5/6/1985

BASF AKTIENGESELLSCHAFT

VITAMIN E (400 I.U.) SOFT GELATIN CAPSULE

5827

II

5/10/1985

MEDICHEM SA

CYCLOBENZAPRINE HCL.

5828

III

4/17/1985

VAN BLARCOM CLOSURES INC

CHILD RESISTANT CLOSURES

5829

5/15/1985

STERIS ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN NORTHBOROUGH, MA.

5830

II

5/22/1985

SOLVAY PHARMACEUTICALS

URSODEOXYCHOLIC ACID (250MG. TABLETS)

ARRALENE POLYSTYRENE RESINS


TETRATETHYLAMMONIUM CHLORIDE

Page 161

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5831 I
II
5/10/1985
ORION CORP LTD FERMION

SUBJECT
IMIPRAMINE HCL.

5832

II

5/15/1985

PENINSULA LABS

CORTICOTROPIN RELEASING FACTOR (HUMAN RA CRF)

5833

II

5/20/1985

BASF AKTIENGESELLSCHAFT

VITAMIN E (400 I.U.)/BETA-CAROTENE(25MG.) SOFT GELATIN CAPSULES

5834

II

5/7/1985

SCHERING AG

BETAMETHASONE

5835

2/25/1985

FIDIA PHARMACEUTICALS

5836

II

3/29/1985

PHARMAZELL GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ABANO TERMA (PADOVA) ITALY.
N-ACETYL-L-CYSTEINE

5837

4/24/1985

FINORGA

5838

II

5/23/1985

AJINOMOTO USA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CHASSE-SUR-RHONE, FRANCE.
ALPHA-KETO ACID SALTS OF L-AMINO ACIDS

5839

II

5/6/1985

BASF AKTIENGESELLSCHAFT

VITAMIN C (1,000MG.)TABLET & VITAMIN C PLACEBO TABLETS

5840

II

5/17/1985

PENNISULA LABORATORIES INC

BOMBESIN

5841

IV

5/21/1985

DOW CHEMICAL CO

DOWEX 1 & 2 ANION EXCHANGE RISIN

5842

II

5/23/1985

LILLY RES LABS DIV ELI LILLY CO

VIALS BOVINE PANCREAIC POLYPEPTIDE

5843

5/10/1985

3M PHARMS

MFG. SITE,LOUGHBOROUGH,ENGLAND

5844

II

5/7/1985

BASF AKTIENGESELLSCHAFT

BETA-CAROTENE,VITAMIN E,BETA-CAROTENE/VITAMIN E PLACEBO GELATIN CAPS.

5845

II

5/23/1985

AJINOMOTO USA INC

KETO ACID MIXTURE

5846

3/18/1985

5847

II

4/19/1985

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
JANSSEN PHARMACEUTICA NV

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN BASLE, SWITZERLAND.
LEVOCABASTINE HCL.(BULK)

5848

II

5/30/1985

RHODIA INC

ASPIRIN AND ASPIRIN STARCH GRANULATION

5849

IV

5/22/1985

GATTEFOSSE SAS

LABRAFIL M 2125 CS, LABRAFIL WL 2609 BS

5850

3/20/1985

PHARBITA BV

5851

II

5/20/1985

BASF AKTIENGESELLSCHAFT

MANUFACTURING SITE, FACILTIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ZANADAM.
BETA-CAROTENE (25MG.) SOFT GELATIN CAPSULES

5852

II

5/22/1985

ORGAMOL SA

CLOFIBRATE

5853

II

3/9/1985

CELLULOSE PRODUCTS OF INDIA LTD

MICROCRYSTALLINE CELLULOSE NF/FCC (EX-CEL TM)

5854

II

5/20/1985

PALISADES PHARMACEUTICALS INC

YOCON (YOHIMBINE) TALBETS 1/12GR.

5855

4/30/1985

ZETACHRON INC

5856

5/20/1985

5857

II

6/3/1985

KEY PHARMACEUTICALS INC SUB SCHERING


PLOUGH CORP
MALLINCKRODT INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN STATE COLLEGE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN
PUERTO RICO.
MORPHINE SULFATE AS MANUFACTURED IN ST LOUIS MO

5858

II

6/3/1985

FOREST LABORATORIES INC

ERYTHROMYCIN 500MG. C.R.TABLETS

5859

II

6/14/1985

FINE ORGANICS LTD

1,METHYLAMINO-1-METHYTHIO-2-NITROETHENE

5860

6/13/1985

BALENCO ENTERPRISES INC

5861

II

6/5/1985

ALBEMARLE CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN COMPTON, CALIFORNIA.
PROPRANOLOL HCL.

5862

II

6/5/1985

BACHEM FINE CHEMICALS INC

(DES-GLY 10)-{ D-TRP6-PRO 9-ETHYLAMIDE }-LEUTINIZING HORMONE

5863

II

5/22/1985

SCHERING AG

BETAMETHASONE VALERATE

5864

II

6/6/1985

DIPHARMA FRANCIS SRL

CYCLOBENZAPRINE HCL.

5865

II

5/17/1985

BASF AKTIENGESELLSCHAFT

LUROTIN TM BETA-CAROTENE (DRY POWDER FORMULATION)

Page 162

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5866 I
I
6/14/1985
WINTEK INC
5867

II

5/29/1985

DIOSYNTH INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MEDFIELD, MASSACHUSETTS.
ISOLATION AND PURIFICATION OF HEPARIN SODIUM USP FROM BEEF LUNGS

5868

II

6/12/1985

ALDRICH CHEMICAL COMPANY INC

N-ACETYL-DL-PENICILLAMINE

5869

III

6/20/1985

SCOTFOAM CORP SUB GENERAL FELT IND

CRP(R) 9900-1.2F GOLD MA

5870

6/17/1985

PRAGMA BIO TECH INC

5871

II

6/13/1985

BALENCO ENTERPRISES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BLOOMFIELD, NEW JERSEY.
TRIPROLDINE HCL.

5872

III

6/12/1985

REXAM MEDICAL PACKAGING INC

PLASTIC FLEXIBLE POUCHES

5873

II

6/7/1985

PENINSULA LABS

PARAHYROID HORMONE (HUMAN),1-34

5874

II

5/20/1985

CLONIDINE HCL. 0.6MG. C.R. CAPSULES

5875

6/5/1985

TEMMLER WERKE VEREINIGTE CHEMISCHE


FABRIKEN
BEECHAM PHARMACEUTICALS PTE LTD

5876

II

6/10/1985

MOEHS IBERICA SL

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN SINGAPORE
LIDOCAINE USP XXI AND LIDOCAINE HCL. USP XXI

5877

IV

5/6/1985

HAAGEN CHEMIE BV

MAGNESIUM STEARATE

5878

II

5/29/1985

ASPEN API INC

HEPARIN SODIUM CRUDE

5879

II

6/21/1985

ALDRICH CHEMICAL COMPANY INC

1-(3-CHLOROPHENYL) PIPERAZINE HCL.

5880

II

5/24/1985

SIGMA F AND D DIV LTD

5-AMINOSALICYLIC ACID AS ASSAYED AND REPACKAGED

5881

II

6/12/1985

CIPLA LTD

NIFEDIPINE USP XXI

5882

II

6/27/1985

PUROLITE CORPORATION

5883

II

3/11/1985

SIPSY CHIMIE FINE S.C.A.

SODIUM POLYSTYRENE SULFONATE IS MANUFACTURED IN VICTORIA, ROMANIA FOR


PUROLITE CORPORATION
PROPRANOLOL HCL & BASE

5884

II

6/7/1985

FARCHEMIA SRL

CARBADOX

5885

II

6/14/1985

GLAXOCHEM LTD

ALBUTEROL (SALBUTAMOL) AS PRODUCTED IN THE MONTROSE,SCOTLAND FACILITY

5886

4/18/1985

5887

II

6/5/1985

KNOLL PHARMACEUTICAL CO UNIT BASF K&F


CORP
BEECHAM PHARMACEUTICALS PTE LTD

MANUFACTURING SITE,FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LUDWIGSHAFEN, GERMANY.
6-AMINO PENICILLANIC ACID

5888

II

3/27/1985

ALFRED BENZON AS

IBUMETIN (IBUPROFEN) TABLETS:200,300,400,&600 MG.

5889

II

5/21/1984

CIBA GEIGY LTD

CGP 17,582B

5890

II

6/21/1985

BAYER

ISONIAZID (NEOTEBEN)

5891

II

6/28/1985

PENCO OF LYNDHURST INC

HYDROCODONE BITARTRATE POWDER

5892

II

6/3/1985

SANDOZ GMBH

6-METHYLERGOLENE-8-CARBOXYLIC ACID

5893

4/18/1985

5894

IV

6/13/1985

KNOLL PHARMACEUTICAL CO UNIT BASF K&F


CORP
MALLINCKRODT INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, GENERAL OPERATING PROCEDURES IN


LUDWIGSHAFEN, GERMANY.
STEAR-O-WET M AS MANUFACTURED IN GREENVILLE, ILLINOIS

5895

II

4/19/1985

ALFRED BENZON AS

KALINORM CONTROLLED RELEASE TALBETS 750MG.

5896

II

6/24/1985

NIPPON RIKAGAKUYAKUHIN CO LTD

AMINO ACIDS MANUFACTURED IN ASHIKAGA, JAPAN.

5897

II

6/10/1985

HELSINN CHEMICALS SA

GUANABENZ ACETATE

5898

III

6/28/1985

ACCU FORM INC

PACKAGING MATERIALS.

5899

6/13/1985

TEST PAK INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR CONTRACT PACKAGING FACILITY IN WHIPPANY, NJ.

Page 163

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5900 A
II
4/22/1985
LUNDBECK PHARMACEUTICALS ITALY SPA

SUBJECT
TRIMIPRAMINE MALEATE AS MANUFACTURED IN PADOVA, ITALY

5901

II

7/2/1985

DOW CHEMICAL CO MICHIGAN DIV

ASPIRIN USP AS MANUFACTURED IN MIDLAND, MICH.

5902

II

7/9/1985

BACHEM FINE CHEMICALS INC

LUTEINIZING HORMONE-RELEASING HORMONE

5903

7/5/1985

SYNTHELABO PHARMACIE

5904

II

7/1/1985

FOREST LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AMILLY, FRANCE.
QUINIDINE GLUCONATE 650 MG. C.R. TABLETS

5905

II

7/3/1985

BAYER

BAYPRESS R(NITRENDIPINE)TABLETS 5MG.,10MG.AND 20MG.

5906

II

8/23/1985

SANDOZ HUNINGUE SA PRODUCTION PHARMA

TIAMULIN BASE

5907

II

7/5/1985

SYNTHELABO PHARMACIE

KETOVALINE L-LYSINE SALT

5908

II

6/26/1985

FINE CHEMICALS CORPORATION

SILVER SULFADIAZINE

5909

II

6/27/1985

BRACCO IND CHIMICA SPA

PYRAZINAMIDE

5910

II

7/3/1985

TRIOCHEM PRODUCTS LTD

PARACETAMOL USP (ACETAMINOPHEN USP)

5911

II

7/5/1985

SYNTHELABO PHARMACIE

KETOLEUCINE L-HISTIDINE SALT

5912

II

5/15/1985

PHENYLEPHRINE HYDROCHLORIDE

5913

II

7/10/1985

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
ALBRIGHT AND WILSON LTD

5914

7/5/1985

HN PHARMA AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

5915

II

7/5/1985

SYNTHELABO PHARMACIE

KETOVALINE L-ORNITHINE SALT

5916

IV

6/17/1985

AVANTI POLAR LIPIDS INC

DISTEAROYLGLYCEROPHOCHLINE

5917

II

4/15/1985

SHANGHAI NO 6 PHARMACEUTICAL FACTORY

DIPYRIDAMOLE MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA.

5918

III

6/17/1985

KINETICON PHARMACEUTICALS INC

TPH BIOMED.POLYMERS(TYPE D SER.)MFG.TYNDALE PLAINS-HUNTER,RINGOES,N.J.

5919

III

7/17/1985

ELI LILLY INDUSTRIES INC

5920

II

7/5/1985

SYNTHELABO PHARMACIE

QUALITY CONTROL PROCEDURES FOR IN-COMING INSPECTION OF PACKAGING


COMPONENTS USED IN INDIANA
KETOLEUCINE L-LYSINE SALT

5921

II

7/20/1985

HOECHST AG

LIDOCAINE HYDROCHLORIDE AND BASE(BULK)MFG.FRANKFURT(MAIN) GERMANY FAC

5922

II

7/24/1985

FABBRICA ITALIANI SINTETICI SPA

CLORAZEPATE DIPOTASSIUM

5923

7/3/1985

PACO PHARMACEUTICAL SERVICES INC

5924

II

7/5/1985

SYNTHELABO PHARMACIE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LAKEWOOD, NEW JERSEY.
KETOISOLEUCINE L-ORNITHINE SALT

5925

II

7/19/1985

JANSSEN PHARMACEUTICA NV

TERCONAZOLE (PRODUCT # R42470)

5926

II

7/2/1985

EVONIK TECHNOCHEMIE GMBH

CHLORHEXIDINE BASE MANUFACTURED IN HANAU, GERMANY.

5927

II

6/24/1985

TIAMULIN FUMARATE

5928

II

7/15/1985

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
HEXACHIMIE

5929

II

7/10/1985

NAKSOL STOCK SOLUTION

5930

II

5/22/1985

HUMAN INSTITUTE FOR SEROBACTERIOLOGICAL


PROD & RES
DELTA SYNTHETIC CO LTD

5931

7/31/1985

ILKIM AS

5932

III

7/16/1985

NYPRO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TUZLA (ISTAMBUL) TURKEY.
INJECTION MOLDED MATERIALS

5933

II

7/26/1985

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)

ALBRITESODIUMMONOFLUOROPHOSPHATE

PROPACETAMOL HYDROCHLORIDE

CHLORHEXIDINE GLUCONATE (BULK)

ACEPROMAZINE MALEATE

Page 164

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5934 I
III
6/28/1985
3M

SUBJECT
POROUS MEMBRANE TAPE

5935

7/15/1985

MISSION PHARMACAL CO

5936

7/18/1985

DOW CHEMICAL CO MICHIGAN DIV

5937

II

5/31/1985

KOTHARI PHYTOCHEMICALS INTERNATIONAL

MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES


IN SAN ANTONIO, TEXAS.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN PITTSBURG, CAL.
PROPRANOLOL HYDROCHLORIDE

5938

7/16/1985

NYPRO INC

COMBINATION I & III FOR INJECTION MOLDED MATERIALS MANUFACTURED IN PUERTO RICO.

5939

II

7/26/1985

THIOTHIXENE DIHYDROCHLORIDE ANHYDROUS

5940

II

7/25/1985

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
HOECHST AG

5941

II

6/26/1985

AMERICAN CHEMICAL INDUSTRIAL CORP

PROCHLORPERAZINE EDISYLATE USP XXI

5942

II

7/24/1985

PHARM ECO LABORATORIES INC

D,L,N,-BENZYL-ALPHA-ACETOXPHENYLACETAMIDE (BPA)

5943

4/26/1985

3M PHARMS

5944

II

7/17/1985

5945

II

8/5/1985

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
DIOSYNTH BV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RAMA-GAN, ISRAEL.
6-METHYLERGOLINE-8B-CARBOXYLIC ACID

5946

III

8/2/1985

CATTY CORP

A COMBO.TYPES I/III PROD.VINYL HEATSEALABLE ALUM.FOILS,HUNTLY,IL.FACIL

5947

II

8/6/1985

RHONE-POULENC SANTE

TRIMEPRAZINE TARTRATE

5948

II

8/7/1985

WYCKOFF CHEMICAL CO INC

PRILOCAINE HYDROCHLORIDE USP

5949

8/6/1985

INVAMED INC

5950

II

7/30/1985

FMC CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FAIRFIELD, NEW JERSEY.
TETRAPOTASSIUM PEROXYDIPHOSPHATE

5951

II

8/9/1985

MERCK SANTE SAS

METFORMIN HYDROCHLORIDE (LA 6023)

5952

II

8/14/1985

SANKYO CO LTD

CEFMETAZOLE SODIUM INJECTION(VIALS) AS MFG.IN THE HIRASUKA MFG.FACIL.

5953

II

6/26/1985

PENINSULA LABS

ALPHA-ARIAL NARIURETIC PEPTIDE (HUMAN 1-28)

5954

II

7/9/1985

BOEHRINGER INGELHEIM CHEMICALS INC

METHOCARBAMOL

5955

III

7/25/1985

NATIONAL STARCH & CHEMICAL CORP

PRESSURE SENSITIVE ADHESIVES FOR TRANSDERMAL MEDICAL APPLICATION

5956

7/16/1985

NYPRO INC

INJECTION MOLDED MATERIALS MANUFACTURED BY AMITECH INC IN MARIETTA, GEORGIA.

5957

III

7/31/1985

VICTOR TUBE CORP

PRODUCTION OF COLLAPSIBLE TUBES IN HARRISONBURG,VA.

5958

II

8/15/1985

KV PHARMACEUTICAL CO

CAPTOPRIL TABLETS, 100MG.

5959

II

8/9/1985

LIPHA SA

METFORMIN ( LA-6023),500MG.&850MG. TABLETS

5960

7/30/1985

FREEDOM CHEMICAL DIAMALT GMBH

5961

II

8/27/1985

FMC CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RAUBLING (FRG).
CELLULOSE TRIACETATE

5962

II

8/16/1985

SOCIETE INDUSTRIELLE DES OLEAGINEUX

SEMI-SYNTHETIC GLYCERIDES

5963

8/8/1985

PAR PHARMACEUTICAL INC

5964

II

8/7/1985

CALIFORNIA BIOTECHNOLOGY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SPRING VALLEY, NEW YORK.
NAZDEL TM MEMBRANE PERMEATION ENHANCER

5965

II

8/26/1985

GLAXOCHEM LIMITED

O/4 DIHYDROCHLORIDE DIHYRATE (CPZ ROUTE)

5966

II

8/8/1985

ESTEVE QUIMICA SA

ALPHA METHYLDOPA

ANTIPYRINE

MIANSERIN HYDROCHLORIDE

Page 165

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
5967 A
II
8/13/1985
SARTORIUS STEDIM NORTH AMERICA INC
5968

II

8/29/1985

SANKYO CO LTD

SUBJECT
FILTER MEMBRANE MATERIALS MANUFACTURED AT GOTTINGEN, GERMANY AND YAUCO,
PUERTO RICO
CS-514BULK SUBSTANCE PROCESSED TANASHI(TOKYO)& SHINAGAWA(TOKYO)PLANTS

5969

IV

8/27/1985

FMC CORP

CELLULOSE ACETATE BUTYRATE

5970

7/19/1985

BIO NUTRITION INC

5971

II

8/7/1985

SOCIETA ITALIANA CORTICOSTEROIDI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RONKONKOMA, NEW YORK.
DEXAMETHASONE SODIUM PHOSPHATE AS MFG. IN RHO (MILAN) ITALY

5972

II

8/13/1985

BOEHRINGER INGELHEIM CHEMICALS INC

GUAIFENESIN

5973

II

7/26/1985

STEPAN CHEMICAL COMPANY

LAHANOL LAL

5974

II

8/20/1985

NAPP TECHNOLOGIES LLC

SULFANILAMIDE

5975

8/6/1985

SMITHKLINE & BECKMAN INC

5976

8/13/1985

PDI LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TONBRIDGE, KENT, ENGLAND.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

5977

II

8/19/1985

TRIFARMA SPA

MINOXIDIL USP

5978

II

8/5/1985

EURAND AMERICA INC

INDOMETHACIN

5979

8/16/1985

SANOFI AVENTIS SPA

STERILE PROCESSING FACILITY IN ANAGNI (FROSINONE) ITALY

5980

II

8/27/1985

BOEHRINGER INGELHEIM CHEMICALS INC

CALCIUM POLYCARBOPHIL

5981

II

9/4/1985

SELOC AG

PROMETHAZIN HCL.

5982

II

9/4/1985

ALBERT DAVID LTD

TOLBUTAMIDE USP

5983

II

8/29/1985

SCHERING AG

HYDROCORTISONE-17 VALERATE AS MFG. IN BERLIN (GERMANY) FACILITY

5984

II

8/27/1985

CAMBREX KARLSKOGA AB

BUPIVACAINE HYDROCHLORIDE

5985

9/6/1985

STERILE PROCESSING FACILITY IN NEW MEXICO

5986

II

9/3/1985

OSO BIOPHARMACEUTICALS MANUFACTURING


LLC
ABBOTT LABS

5987

9/5/1985

SCM CORPORATION

FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES

5988

III

8/30/1985

3M DRUG DELIVERY SYSTEMS

POLYETHYLENE FOAM TAPES AS MFG. IN BROOKINGS SOUTH DAKOTA

5989

9/9/1985

ABLE LABORATORIES INC

FACILITY IN SOUTH PLAINFIELD, NEW JERSEY

5990

II

8/19/1985

TRIFARMA SPA

PROCYCLIDINE HYDROCHLORIDE USP

5991

II

9/3/1985

TEVA PHARMACEUTICAL INDUSTRIES LTD

ALPHA METHYLDOPA USP

5992

IV

9/6/1985

EGG PHOSPHATIDE

5993

II

8/26/1985

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SALSBURY CHEMICALS INC

5994

II

9/6/1985

FOREST LABORATORIES INC

THIORIDAZINE HCL. 50MG.C.R.TABLETS

5995

II

8/13/1985

DAIICHI FINE CHEMICAL CO LTD

SULFADIMETHOXINE AS MFG. IN TOYAMA, JAPAN

5996

III

9/4/1985

BAYER AG

MAKROFOL KG AS MFG. IN THE DORMAGEN PLANT SITE

5997

II

8/8/1985

HOFFMANN LAROCHE F AND CO LTD

DECLINAX (DEBRISOQUIN SULFATE) TABS 10MG MFG. IN BASLE, SWITZ

5998

II

5/28/1985

LUSOCHIMICA S P A

CLONIDINE HYDROCHLORIDE

5999

II

9/9/1985

SELOC AG

THIORIDAZINE HYDROCHLORIDE

6000

III

8/30/1985

3M PHARMS

MEDICAL GRADE ACRYLIC ADHESIVES MANUFACTURED IN CORDOVA, ILLINOIS.

6001

8/13/1985

BROWNS BOTTLE (CANADA) LTD

PACKAGING MATERIALS

METHYLPREDNISOLONE HEMISUCCINATE AS MFG. IN CHICAGO, ILLINOIS

FUROSEMIDE USP

Page 166

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6002 A
II
7/30/1985
PURAC BIOCHEM BV

SUBJECT
ZINC GLUCONATE

6003

II

8/13/1985

DAIICHI FINE CHEMICAL CO LTD

SODIUM SULFADIMETHOXINE

6004

II

8/30/1985

FINORGA

TOLRESTA MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE.

6005

II

8/6/1985

METHIONINE-ENKEPHALIN AS PRODUCED IN THE FUNABORI FACTORY (TOKYO)

6006

II

9/9/1985

DAIICHI PURE CHEMICALS COMPANY,


LIMITED(JAPAN)
AMCIS AG

6007

II

7/30/1985

SYNTEX USA INC

MEDROXYPROGESTERONE ACETATE,BULK MFG SYNTEX SA CHEM.DIV(MORELOS)MEXICO

6008

II

6/28/1985

EISAI CO LTD

MENFEGOL

6009

II

9/27/1985

PENICK CORP

DIDRATE (DIHYDROCODEINE BITARTRATE ANHYDROUS )

6010

II

8/30/1985

FINORGA

6-METHOXY 5, TRIFLUOROMETHYL 1-NAPHTHOLIC ACID MFG. CHASSE-SUR-RHONE

6011

II

8/14/1985

SEKISUI MEDICAL CO LTD

EPSILON-AMINO-N-CAPROIC ACID

6012

II

9/9/1985

PCAS

DESIPRAMINE HCL.

6013

8/30/1985

3M PHARMS

FOR BROOKINGS,S.D.

6014

II

6/13/1985

CLONIDINE HYDROCHLORIDE

6015

II

8/29/1985

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
SIEGFRIED AG

6016

II

8/30/1985

FINORGA

METHYL SARCOSINATE HCL AS MFG. IN THE CHASSE-SUR-RHONE(FRANCE)FACILITY

6017

II

9/12/1985

DAEWOONG CHEMICAL CO LTD

TRIMETHOPRIM

6018

II

9/17/1985

SOCIETA ITALIANA CORTICOSTEROIDI SPA

BETAMETHASONE

6019

II

9/23/1985

ILKIM AS

ASPIRIN USP

6020

II

9/18/1985

DIOSYNTH BV

BETAMETHASONE ACETATE

6021

8/30/1985

3M PHARMS

FOR CORDOVA,ILLINOIS

6022

III

7/29/1985

NORTON PERFORMANCE PLASTICS INC

PTFE SKIVED TAPE

6023

9/11/1985

WATSON LABORATORIES INC

6024

II

9/16/1985

BOEHRINGER INGELHEIM CHEMICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CORONA, CALIFORNIA.
BROMPHENIRAMINE MALEATE

6025

9/6/1985

CHURCH AND DWIGHT CO INC

FOR THE TAYLORS, SOUTH CAROLINA FACILITY ON NORTH WASON RD

6026

II

9/3/1985

FINE CHEMICALS CORP PTY LTD

FLUPHENAZINE DECANOATE

6027

II

9/23/1985

ILKIM AS

ACETAMINOPHEN USP

6028

II

8/12/1985

GATTEFOSSE SAS

SUPPOCIRE

6029

II

9/23/1985

ELI LILLY INDUSTRIES INC

NIZATIDINE MANUFACTURED IN SHADELAND, IN AND MAYAGUEZ, PR.

6030

II

9/17/1985

SOCIETA ITALIANA CORTICOSTEROIDI SPA

DEXAMETHASONE

6031

II

8/29/1985

LAEVOSAN GMBH AND CO KG

HYDROXYETHYL STARCH

6032

III

9/4/1985

ALZA CORP

TRANSDERMAL THERAPEUTIC SYSTEM

6033

II

9/11/1985

FUKUZYU PHARMACEUTICAL COMPANY LTD

CHLORPHENIRAMINE MALEATE

6034

II

9/23/1985

ELI LILLY INDUSTRIES INC

NIZATIDINE MANUFACTURED IN MAYAGUEZ, PR.

6035

II

9/18/1985

BIOCHEMIC GESELLSCHAFT MBH

CEFTAZIDINE-BENZHYDRYLESTER,DIHYDROCHLORIDE

6036

II

10/2/1985

ASTRA CLINICAL RESEARCH ASSOCIATES INC

FOSCARNET SODIUM INTRAVENOUS SOLUTION

6037

II

10/4/1985

DM GRAHAM LABORATORIES INC

IBUPROFEN TIMED-RELEASE 600 MG. TALBETS

6038

II

10/9/1985

SHOWA DENKO KK

GYLCINE

TROPICAMIDE

VALPROIC ACID & SODIUM VALPROATE

Page 167

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6039 I
I
10/1/1985
SMITHKLINE & BECKMAN INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CIDRA, PUERTO RICO.
PROD.FLEXIBLE PKG.MATERIAL (KFAR SABA PLANT)

6040

III

9/27/1985

ISRAEL CAN COMPANY LTD

6041

5/31/1985

CARLSBERG BIOTECHNOLOGY LTD

6042

II

9/16/1985

BACHEM FINE CHEMICALS INC

6043

7/10/1985

PHARMACIA AB

6044

II

10/1/1985

BOEHRINGER INGELHEIM CHEMICALS INC

6045

9/30/1985

SMITHKLINE & BECKMAN INC

6046

II

10/7/1985

GEDEON RICHTER

6047

9/26/1985

GIULIANI SPA

6048

II

9/27/1985

NIPPON KAYAKU COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CERNUSCO SUL NAVIGLIO.
SUCRALFATE

6049

II

5/31/1985

CARLSBERG BIOTECHNOLOGY LTD

NAFARELIN ACETATE AS MFG. IN THE COPENHAGEN, DENMARK FACILITY

6050

10/7/1985

BIOCHEMIC GESELLSCHAFT MBH

6051

IV

10/7/1985

PHARMACIA AB

MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES IN


KUNDL, AUSTRIA
SEPHAROSE GEL FILTRATION MEDIA AS MFG IN THE BOLANDERNA FACILITIES

6052

II

10/7/1985

FUJISAWA PHARMACEUTICAL COMPANY LTD

NILVADIPINE (FK 235,FR 34235)

6053

II

10/2/1985

ASAHI CHEM INDUSTRY CO LTD

EGG PHOSPHATIDYLCHOLINE

6054

10/11/1985

CHELSEA LABORATORIES INC

6055

II

9/24/1985

6056

10/2/1985

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
INTERPHARM INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LAKEVIEW, NEW YORK.
HYDROCHLOROTHIAZIDE

6057

II

9/5/1985

SHANGHAI NO 6 PHARMACEUTICAL FACTORY

6058

II

8/16/1985

MITSUBISHI YUKA FINE CHEMICALS COMPANY LTD ZPT SLURRY

6059

III

10/1/1985

COMAR INC

GLASS PACKAGING MATERIALS AS MFG IN VINELAND, NJ

6060

10/11/1985

PHARMACIA AB

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF LARGE VOLUME PARENTERALS IN GLASS BOTTLES IN UPPSALA, SWEDEN.

6061

9/19/1985

6062

II

9/25/1985

ORTHO DIAGNOSTIC SYSTEMS DIV ORTHO


PHARMACEUTICAL LTD
NIPPON KAYAKU COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DON MILLS, ONTARIO.
AMINO ACID

6063

II

9/30/1985

BASF PLC

BTS 54 524

6064

10/17/1985

HALDANE CONSULTANTS LTD

6065

II

10/16/1985

PHARMACIA AND UPJOHN SUB PFIZER INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN POOLE, DORSET (ENGLAND), NUFFIELD ROAD.
EPOPROSTENOL SODIUM (U-53,217A)

6066

II

10/8/1985

SCIENTIFIC POLYMER PRODUCTS INC

POLY (2-HYDROXYETHYL METHACAYLATE)

6067

10/3/1985

GLATT AIR TECHNIQUES INC

6068

II

9/30/1985

ALDRICH CHEMICAL COMPANY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RAMSEY, NEW JERSEY.
4-METHYLPYAZOLE

MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES


IN COPENHAGEN, DENMARK.
ARIAL NARIURETIC PEPTIDE (4-28).HUMAN
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN UPPSALA, SWEDEN.
GLYCOPYRROLATE
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CIDRA, PUERTO RICO.
RGH-4417

FOR PLAINVIEW,N.Y.
SUCRALFATE

Page 168

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6069 I
I
10/11/1985
BIOMED LABORATORIES
6070

II

10/21/1985

BOEHRINGER INGELHEIM CHEMICALS INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SAN DIMAS, CALIFORNIA.
METOCLOPRAMIDE

6071

II

10/7/1985

GEDEON RICHTER

DIAZEPAM USP

6072

II

6/18/1985

KONOSHIMA CHEMICAL COMPANY LTD

MAGNESIUM OXIDE

6073

9/11/1985

BEECHAM LABORATORIES DIV OF BEECHAM INC

6074

IV

10/18/1985

GATTEFOSSE SAS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MAYENNE, FRANCE.
TEFOSE 1500, POLYSTATE B, POLYSTATE C, STEARATE 1500, STEARATE 4000,
SUPERPOLYSTATE

6075

II

7/2/1985

ISOPRINOSINE SYRUP 5% AS MANUFACTURED BY TRUETT LABS (AZUSA, CA.)

6076

9/27/1985

NEWPORT PHARMACEUTICALS INTERNATIONAL,


INCORPORATED
WICKHAM RESEARCH LABORATORIES LTD

6077

IV

10/15/1985

INTERNATIONAL SPECIALTY PRODUCTS

M-PYROL (N-METHYLPYRROLIDONE)

6078

9/30/1985

MEDI NUCLEAR CORPORATION INC

6079

II

10/21/1985

JANSSEN PHARMACEUTICA NV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BALDWIN PARK, CA.
LEVAMISOLE HCL-R 12564

6080

II

8/6/1985

THEOPHYLLIN

6081

II

9/26/1985

HANGZHOU MINSHENG PHARMACEUTICAL


FACTORY
ALTANA LOMBERG CHEMISCHE FABRIK

6082

II

11/6/1985

APTALIS PHARMATECH INC

ACETAMINOPHEN,MICROENCAPSULATED

6083

11/4/1985

BEECHAM LABORATORIES DIV OF BEECHAM INC

BLOW MOLDING FACILITY IN BRISTOL,TN.

6084

II

11/4/1985

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

BECLOMETHASONE DIPROPIONATE USP

6085

11/7/1985

OTSUKA PHARM CO LTD

6086

II

10/25/1985

RHONE-POULENC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TOKUSHIMA, JAPAN.
SPIRAMYCIN BASE

6087

10/29/1985

VICKS INC

6088

11/8/1985

MATRIX RESEARCH LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CAYEY, PUERTO RICO.
AL-721

6089

II

11/13/1985

MIKART INC

ACETAMINOPHEN & CODEINE PHOSPHATE TABS. 650/60

6090

II

11/12/1985

ELI LILLY INDUSTRIES INC

CEPHALEXIN HYDROCHLORIDE,BULK

6091

11/7/1985

OTSUKA PHARM CO LTD

6092

II

11/13/1985

ORGAMOL SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TOKUSHIMA, JAPAN.
TRILOSTANE

6093

III

10/9/1985

WEST PHARMACEUTICAL SERVICES, INC.

PLASTIC INJECTION MOLDED CLOSURES

6094

III

8/30/1985

YOKO BUSSAN COMPANY LTD

O-RING SEAL MATERIALS

6095

II

11/1/1985

SIEGFRIED LTD

ACETYLCHOLINE CHLORIDE

6096

11/22/1985

SMITHKLINE & BECKMAN INC

6097

10/18/1985

DVB ASSOCIATES

6098

II

10/23/1985

ANDARD-MOUNT INTERNATIONAL LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CAROLINA, PUERTO RICO.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BETHLEHEM, PENNSYLVANIA.
FLUOROURACIL

6099

II

11/19/1985

6100

11/25/1985

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
SMITHKLINE & BECKMAN INC

WICKHAM, HAMPSHIRE FACILITIES ON WINCHESTER RD.

BUDIPINE-HYDROCHLORIDE

EDROPHONIUM CHLORIDE,BULK
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CAROLINA, PUERTO RICO.

Page 169

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6101 I
I
11/15/1985
CHEMISCHE FABRIK WEYL GMBH
6102

II

11/14/1985

MTM CHEMICALS INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEURES IN
MANNHEIM 31, GERMANY.
PROPRANOLOL HYDROCHLORIDE,BULK

6103

9/26/1985

ROUSSEL-UCLAF

ESBIOL

6104

II

11/20/1985

SMITHKLINE BEECHAM PHARMACEUTICALS

ALBENDAZOLE

6105

II

10/28/1985

SOCIETA ITALIANA CORTICOSTEROIDI SPA

TRIAMCINOLONE

6106

II

10/17/1985

SUNIL SYNCHEM LD

L-METHYL DOPA

6107

II

9/25/1985

JANSSEN PHARMACEUTICA NV

CARNIDAZOLE-MFG BEERSE & GEEL IN BELGIUM (12.10.86 DSENT TO VET MED

6108

II

10/11/1985

ACE JAPAN CO LTD

SUCRALFATE (SUCROSE SULFATE ALUMINUM SALT) AS MFG. IN JAPAN

6109

II

11/22/1985

PROPOXYPHENE HCL.& PROPOXYPHENE NAPSYLATE

6110

II

11/20/1985

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SMITHKLINE BEECHAM PHARMACEUTICALS

6111

10/28/1985

GELMAN SCIENCES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6112

IV

12/4/1985

MITSUBISHI CHEMICAL INDUSTRIES LIMITED

SUCROSE MONOPALMITATE AS MANUF IN YOKKAICHI PLANT

6113

II

12/3/1985

CHEMIE LINZ AG

CELIPROLOL HCL AS MANUF IN THE LINZ,AUSTRIA FACIL. ON ST.PETER-STRABE

6114

II

12/2/1985

BOEHRINGER INGELHEIM CHEMICALS INC

DOXAPRAM

6115

11/27/1985

TUCKAHOE PLASTIC CONTAINERS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6116

II

11/25/1985

HOUBA INC

BETAPRONE (BETAPROPIOLACTONE)

6117

II

12/10/1985

DISULFIRAM

6118

II

12/12/1985

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
APTALIS PHARMATECH INC

6119

II

11/27/1985

OMNICHEM NV (PRB)

DESERPIDINE AS PRODUCED IN LOUVAIN-LA-NEUVE PILOT PLANT

6120

12/11/1985

VEGA BIOTECHNOLOGIES INC

6121

II

12/10/1985

GANES CHEMICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TUCSON, ARIZONA.
THIORIDAZINE HYDROCHLORIDE

6122

II

12/12/1985

BEN VENUE LABORATORIES INC

METHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED

6123

II

11/25/1985

CERETEC TC HMPAO

6124

II

1/8/1986

AMERSHAM INTERNATIONAL PLC AMERSHAM


LABORATORY
NIPPON KAYAKU COMPANY LTD

6125

II

11/29/1985

ELAN CORP PLC

QUINIDINE SULFATE SUSTAINED ACTION PELLETS

6126

II

12/16/1985

CHEMISCHE FABRIK WEYL GMBH

1-(METHYLAMINOMETHYL)- NAPHTHALENE

6127

7/29/1985

HELOPHARM KG, ARZNEIMITTELFABRIK

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6128

II

11/20/1985

YUNG ZIP CHEMICAL INDUSTRY COMPANY LTD

CLONIDINE HYDROCHLORIDE

6129

IV

12/16/1985

LA DREYFUS CO

CHEWING GUM BASES (PD SERIES)

6130

III

8/20/1985

CENTOR INC

6131

11/15/1985

6132

II

12/18/1985

IPEC INTERNATIONAL PACKAGING & EQUIPMENT


CORP
LEE LABS INC

VIALS, CLOSURES, OVALS AND SPECIALTY ITEMS FOR THE Rx INDUSTRIES MANUFACTURED
AT BERLIN, OH
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURS

6133

III

11/8/1984

BORDEN PACKAGING AND INDUSTRIAL PRODUCTS FILM FORMULATIONS,TERMOVIR R FLIM

'ZENTEL' 'TILTAB' TABLETS

POTASSIUM CHLORIDE, MICROENCAPSULATED

L-~-METHYLDOPA

LENPERONE

Page 170

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6134 I
II
12/16/1985
GANES CHEMICALS INC

SUBJECT
TOLRESTA AS MFG.ON CUSTOM BASIS

6135

II

12/17/1985

SYNTEX LABORATORIES INC SUB SYNTEX CORP

INVESTIGATIONAL DRUG SUBSTANCE,RS-82917-030

6136

II

12/20/1985

MALLINCKRODT CHEMICAL INC

PROPOXYPHENE NAPSYLATE

6137

II

12/23/1985

ROUSSEL-UCLAF

16 - MEYHYLPERDNISONE 21-PROPIONATE

6138

II

12/9/1985

HOECHST AG

PENICILLIN G SODIUM (BULK)

6139

II

12/20/1985

ELAN CORP PLC

PN-200-LA TABLETS AND PLACEBO TABLETS

6140

II

12/20/1985

FARCHEMIA

METHYLDOPA

6141

12/21/1985

FARMABOIS

6142

II

12/23/1985

TAKEDA CHEMICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GROPELLO CAIROLI, ITALY.
TAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE)

6143

II

1/4/1985

LABORATORIO CHIMICO INTERNATIONAL SPA

SALBUTAMOL BASE AND SALBUTAMOL SULFATE (ALBUTEROL BASE ETC.)

6144

II

11/1/1985

LONZA INC

TOLRESTA AND ITS INTERMEDIATES

6145

II

12/9/1985

ELAN CORP PLC

PARACETAMOL (ACETOMINOPHEN) ORAL LA SUSPENSION

6146

III

1/2/1986

ELI LILLY INDUSTRIES INC

6147

1/13/1986

S-P PRODUCTS INC

6148

II

12/23/1985

SIGMA ALDRICH MANUFACTURING LLC

QUALITY CONTROL PROCEDURES FOR IN-COMING INSPECTION OF PACKAGING


COMPONENTS USED IN PUERTO RICO
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
S-P PRODUCTS, INC.
TRIPALMITIN

6149

III

12/6/1985

ADVANCED ELASTOMER SYSTEMS

6150

II

1/7/1986

DSM ANDENO

SANTOPRENE THERMOPLASTIC ELASTOMER GRADE 271-64-W144 AS MFG FOR ADVANCED


ELASTOMER SYSTEMS BY PLASTICOLORS, INC., ASHTABULA, OHIO.
SILVER SULFADIAZINE

6151

III

11/11/1985

GEORGIA GULF CHEMICALS AND VINYLS LLC

POLYVINYL CHLORIDE PRODUCTS

6152

II

2/15/1983

SCOPOLAMINE HYDROBROMIDE AS MFG. IN THE INGELHEIM AM RHEIN FACILITY

6153

II

1/2/1986

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
SIGMA F AND D DIV LTD

6154

II

12/17/1985

ALDRICH CHEMICAL COMPANY INC

TERT-BUTYL METHYL ETHER

6155

II

12/20/1985

MALLINCKRODT CHEMICAL INC

PROPOXYPHENE HYDROCHLORIDE

6156

1/13/1986

WYETH AYERST LABORATORIES INC

6157

II

12/19/1985

MAY AND BAKER LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ENGLAND.
PROMAZINE HYDROCHLORIDE

6158

II

12/19/1985

FREEDOM CHEMICAL DIAMALT GMBH

URSODEOXYCHOLIC ACID

6159

II

12/30/1985

CAMBREX PROFARMACO MILANO SRL

CHLORDIAZEPOXIDE BASE

6160

II

12/26/1985

SIGMA F AND D DIV LTD

POLYETHYLENE GLYCOL

6161

II

11/4/1985

EVANS MEDICAL LTD

DIAMOPHINE HYDROCHLORIDE

6162

II

1/13/1986

WYETH AYERST LABORATORIES INC

TEMAZEPAM

6163

II

11/21/1985

ETHYL CORP

TOLRESTA MANUF IN ORANGEBURG,S.C FACIL. ON CANNON BRIDGE ROAD

6164

II

10/3/1985

BIOCON BIOCHEMICALS, LIMITED

SODIUM HEPARIN AS MANUFACTURED IN THE KILNAGLEARY CARRIGALINE FACILITY

6165

II

12/30/1985

GONADORELIN DIACETATE TETRAHYDRATE (GNRH) MANUF.IN N.CHICAGO

6166

II

1/10/1986

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
BAYER AG

6167

II

1/3/1986

FUJI CHEMICAL INDUSTRY CO LTD

KB-2413,1-(2-ETHOXYETHYL)-2-(4-METHYL-I-HOMOPIPERAZINYL)BENZIMIDAZOLE-

6168

II

1/20/1986

MATERIALS PROCESSING TECHNOLOGY INC

ACETAMINOPHEN,73% GRANULATION

NALOXONE HCL.AS RELABELLED FOR SIGMA

EDRUL TABS (20,30 & 240MG) AS MANUF IN WUPPERTAL, GERMANY FACILS.

Page 171

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6169 I
II
1/23/1986
ORGAMOL SA

SUBJECT
MINAPRINE

6170

II

1/24/1985

ISOCHEM SA

ACETOHYDROXAMIC ACID AS MFG BY ISOCHEM S.A. IN GENNEVILLIERS, FRANCE

6171

II

1/14/1986

DELMAR CHEMICALS INC

N-[,3-5-DI(PYROLIDNYLMETHYL)-4-HYDROXY]BENZOYL ANILINE(A.CC.-9358)

6172

II

1/10/1986

BAYER AG

MUZOLIMINE SEMIHYDRATE

6173

II

1/3/1986

ORION CORP LTD FERMION

RITODRINE HCL AS MFG. IN ESPOO, FINLAND

6174

II

12/19/1985

BAYER SCHERING PHARMA AG

GESTODENE AS MANUF IN THE BERLIN FACILS. ON MULLERSTRABE

6175

II

1/27/1986

LEIRAS PHARMACEUTICALS

LEVONORGESTREL INTRAUTERINE DEVICE-MANUF IN TURKU,FINLAND FACILS.

6176

12/10/1985

PALMER RESEARCH

6177

III

1/29/1986

HOOVER UNIVERSAL INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HOLYWELL, WALES, UNITED KINGDOM.
POLYETHYLENE TEREPHTHALATE (PET) BOTTLES

6178

II

1/23/1986

ROUSSEL-UCLAF

TRIPROLIDINE HCL.

6179

II

5/30/1985

ISOCHEM SA

1-METHYL AMINO-1-METHYL-THIO-2-NITROETHYLENE AND MFG BY ISOCHEM S.A.

6180

12/27/1985

3M PHARMS

MANUFACTURE AND ASSEMBLY FACILITIES

6181

1/17/1986

MERCK AND CO INC

6182

II

2/7/1986

CULTOR FOOD SCIENCE INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HOBBESDON, HERFORDSHIRE, ENGLAND.
CAFFEINE

6183

II

2/6/1986

HEUMANN

PRAZOSIN HYDROCHLORIDE

6184

II

2/4/1986

ELAN CORP PLC

THEOPHYLLINE PHARMAZOME TM POWDER

6185

II

1/30/1986

SOCIETA ITALIANA CORTICOSTEROIDI SPA

HYDROCORTISONE HEMISUCCINATE AS MFG. IN MILAN, ITALY

6186

II

1/29/1986

PARKE DAVIS DIV WARNER LAMBERT CO

N-ACETYLPROCAINAMIDE HCL.

6187

II

2/11/1986

ZACH SYSTEM SPA

SULINDAC AS MFG. IN VICENZA, ITALY

6188

II

2/11/1986

ETHRANE (ENFLURANE)-MFG BY ABBOTT S.P.A.-CAMPOVERDE DI APRILIA (ITALY)

6189

II

1/30/1986

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ORION CORPORATION FERMION OULU PLANT

6190

II

2/4/1986

ELAN CORP PLC

IBUPROFEN CAPSULES

6191

II

2/22/1986

DINAMITE DIPHARMA SPA

D-OXYPHENE AS MFG. IN THE MILANO (ITALY) FACILITIES

6192

II

1/17/1986

ZAMBON SPA

THIAMPHENICOL AS MFG. IN THE ALMISANO DI LONIGO(VICENZA)ITALY FACILITY

6193

II

2/3/1986

GANES CHEMICALS INC

EPHEDRINE HYDROCHLORIDE

6194

II

1/30/1986

SIGMA F AND D DIV LTD

DELTA-AMINOLEVULINIC ACID HCL AS MFG IN THE ST. LOUIS, MO. FACILITY

6195

III

1/25/1986

PACKAGING COORDINATORS INC

PCI CARIBE,INC.FACILITY,GURABO,PUERTO RICO

6196

II

2/12/1986

GUAIFENSEIN USP AS MFG. IN TAIWAN

6197

II

12/3/1985

CP PHIBROCHEM DIV PHILIPP BROTHERS


CHEMICALS INC
TEVA PHARMACEUTICAL INDUSTRIES LTD

6198

II

1/21/1986

KOTHARI PHYTOCHEMICALS INTERNATIONAL

CHLORPROPAMIDE AND TOLBUTAMIDE AS MFG.IN THE NAGARI,THANICHCHIYAM FAC.

6199

II

12/20/1985

SAN FU CHEMICAL COMPANY LTD

MANNITOL AS MFG. IN THE TAICHUNG CITY (INDUSTRIAL ZONE) FACILITY

6200

II

2/12/1986

HALOPERIDOL AS MFG IN THE NORTH CHICAGO, IL FACILITY

6201

II

2/11/1986

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SIGMA F AND D DIV LTD

6202

III

2/22/1986

BEMIS CO INC

PRODUCTION OF DRUG PACKAGING MATERIALS IN MURPHUSBORO, IL

6203

11/12/1985

BERKELEY ANTIBODY CO

IMMUNOLOGICAL SERVICES AS RELATED TO VITRO QUALITY ASSURANCE

6204

II

1/10/1986

GEDEON RICHTER

DISOPYRAMIDE PHOSPHATE CAPSULES MFG. BY CHEMICAL WORKS OF ABOVE

BENZTROPINE MESYLATE

NIFEDIPINE MANUFACTURED IN MILANO, ITALY.

DEOXYCHOLIC ACID,SODIUM SALT

Page 172

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6205 I
III
2/17/1986
B BRAUN MEDICAL INC

SUBJECT
MCGAW TM PLASTIC CONTAINER

6206

II

2/21/1986

BRACCO IND CHIMICA SPA

IOTHALAMIC ACID AS MFG IN THE MILANO, ITALY FACILITY

6207

II

2/21/1986

MIKART INC

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

6208

II

1/16/1986

CHINOIN PHARM & CHEM WORKS LTD

VERAPAMIL HYDROCHLORIDE AS MFG. IN BUDAPEST, HUNGARY

6209

II

12/9/1985

BIOCON BIOCHEMICALS LTD

PAPAIN AS MFG. IN THE COUNTY CORK, IRELAND FACILITY

6210

II

3/4/1986

ELAN CORP PLC

IBUPROFEN 300MG. LA CAPSULES

6211

3/3/1986

R P SCHERER LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6212

2/7/1986

STERIS LABORATORIES INC

6213

II

3/5/1986

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEST BETHANY, ARIZONA.
ATENOLOL MANUFACTURED IN MILANO, ITALY.

6214

III

3/4/1986

MID-STATE PLASTICS, INC.

INJECTION MOLDED PARTS IN SEAGROVE, NORTH CAROLINA

6215

II

1/23/1986

ASAHI KASEI FINECHEM CO LTD

CYTARABINE AS MFG IN THE PHARMACEUTICAL PLANT IN NOBEOKA-SHI, JAPAN

6216

II

2/20/1986

SIGMA ALDRICH MANUFACTURING LLC

PALMITIC ACID AS RELABELLED FOR SIGMA F AND D DIVISION, LTD, MO

6217

II

2/25/1986

FENTANYL BASE AS MANUFACTURED IN WEST DEPTFORD, NJ

6218

III

3/12/1986

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
REXAM MEDICAL PACKAGING INC

6219

III

2/11/1986

PALMYRA NONWOVENS CORP

FIBROUS RAYON PHARMACEUTICAL COILS AS MFG IN PALMYRA, NY FACILITY

6220

II

3/7/1986

EASTMAN KODAK CO

MEROCYANINE 540 AS MFG BY THE SYNTHETIC CHEMICAL DIV IN ROCHESTER

6221

II

2/17/1986

CHEMWERTH

VINCRISTINE SULFATE AS MFG. IN YUHANGTANG, HANGZHOU

6222

II

2/20/1986

BALENCO ENTERPRISES INC

DECYLMETHYL SULFOXIDE USP AS MFG. IN COMPTON, CALIFORNIA

6223

II

12/16/1985

FABBRICA ITALIANA SINTETICI

TRIMETHOPRIM AF (ANILINE FREE) AS MFG IN ALTE DE MONTECCHIO MAGGIORE

6224

II

2/27/1986

FINE CHEMICALS CORPORATION

MECLOFENAMATE SODIUM AS MFG IN THE EPPING (CAPE PROVINCE) SOUTH AFRICA

6225

II

2/20/1986

BIOTEK INC

LEVONORGESTREL MICROCAPSULES AS MFG IN THE WOBURN, MASS FACILITY

6226

II

9/6/1985

PFIZER LABORATORIES DIV PFIZER INC

TINIDAZOLE AS MFG BY PFIZER CHEMICAL CORP IN RINGASKIDDY, IRELAND

6227

II

2/26/1986

ROUSSEL-UCLAF

DISOPYRAMIDE PHOSPHATE AS MFG. IN MILAN, ITALY

6228

III

12/4/1985

DUPONT POLYESTER

CARODEL POLYETHYLENE TEREPHTHALATE (PET) RESINS X5122

6229

IV

2/18/1986

BRASKAP INDUSTRIA E COMERCIO LTDA

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN THE SOROBACA - SP - BRAZIL


FACILITY

6230

6231

II

3/11/1986

SIEGFRIED USA LLC

METHADONE HYDROCHLORIDE AS MFG IN THE PENNSVILLE, NJ FACILITY

6232

III

10/7/1985

KEY INTERNATIONAL INC

POLYVINYLCHLORIDE/POLYETHYLENE THERMOPLASTIC FILM AS MFG IN ITALY

6233

II

2/17/1986

QUATRUM

DEXAMETHASONE BASE BP/KUSP AS MGF IN THE SACAVEM, PORTUGAL FACILITY

6234

3/3/1986

ZEELAND CHEMICALS INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

6235

IV

12/17/1985

PRODUCERS COTTON OIL CO

SAFFLOWER OIL AS PROCESSED IN THE FRESNO, CA FACILITY

6236

IV

2/28/1986

HETERENE CHEMICAL COMPANY INC

ETHYLENE OXIDE ADDUCTS OF NONYL PHENOL AS MFG IN PATERSON, NJ FACILITY

6237

II

6/10/1985

UNICHEM LABORATORIES LTD

HYDROCHLOROTHIAZIDE B.P. AS MFG IN BOMBAY, INDIA FACILITY

6238

II

11/11/1985

PHARM ECO LABORATORIES INC

D-TUBOCURARINE AS MGF IN THE SIMI VALLEY, CA FACILITY ON CHAIN DRIVE

6239

II

3/4/1986

MEDICHEM SA

METOCLOPRAMIDE HYDROCHLORIDE MANUFACTURED IN CELRA, SPAIN.

6240

II

3/16/1986

BACHEM FINE CHEMICALS INC

CORTICOTROPIN RELEASING FACTORS (CRF), (HUMAN, RA)

HEAT SEALABLE AND PEELABLE ADHESIVE COATINGS AS MFG IN WISCONSIN

NOT AN ASSIGNED NUMBER

Page 173

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6241 I
I
3/11/1986
LIQUIPHARM INC

SUBJECT
LIQUID AND TOPICAL PRODUCTS FOR HUMAN USE

6242

II

3/3/1986

SYNTEX LABORATORIES INC SUB SYNTEX CORP

RS-82856-130

6243

II

3/19/1986

ORION CORP LTD

CHLORHEXIDINE DIHYDROCHLORIDE BP 80

6244

IV

4/3/1986

ROQUETTE FRERES

POLYSORB 85/70/00 (SORBITOL SORBITAN SOLUTION)

6245

II

4/9/1986

ACETAMINOPHEN USP AS MFG. IN THE UNITED KINGDOM

6246

II

3/26/1986

HARTINGTON CHEMICALS DIV STAVELEY


CHEMICALS LTD
SIEGFRIED AG

6247

II

4/4/1986

FERMION OY

NADOLOL AS MFG. IN FINLAND

6248

III

3/31/1986

FUJIMORI KOGYO CO LTD

PLASTIC FILM

6249

IV

3/26/1986

SHIONOGI QUALICAPS INC

EMPTY GELATIN CAPSULES

6250

II

4/3/1986

LYPHOMED INC

STERILE CEFTIZOXIME SODIUM USP

6251

II

4/4/1986

NIPPON FINE CHEMICAL COMPANY LTD

PHOSPHOLIPID DPPC

6252

IV

4/4/1986

NIPPON FINE CHEMICAL CO LTD

PHOSPHOLIPID-DSPC AS MFG. IN HYOGO, JAPAN

6253

1/13/1986

VICTOR INDUSTRIES

6254

II

4/1/1986

HOVIONE SOCIEDADE QUIMICA LDA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NEWPORT, AK.
BECLOMETHASONE 17,21-DIPROPIONATE

6255

4/8/1986

HOECHST MARION ROUSSEL SA

6256

4/2/1986

TRINITY TECHNOLOGIES CORP

6257

4/8/1986

RETAIL DRUG INSTITUTE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN COMPIEGNE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN STERLING HEIGHTS.
AEROSOLS PRODUCED AT LONG ISLAND UNIVERSITY

6258

II

3/27/1986

PHARMACIA AND UPJOHN SUB PFIZER INC

ESTRAMUSTINE PHOSPHATE SODIUM AS MFG. IN COUNTY CORK,IRELAND

6259

3/6/1986

CHEMICAL FACTORY IN CAMPOVERDE DI APRILIA

6260

II

4/4/1986

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
SIGMA F AND D DIV LTD

6261

II

4/10/1986

SOCIETA ITALIANA CORTICOSTEROIDI SPA

METHYLPREDNISOLONE AS MANUF IN MILAN,ITALY

6262

II

4/9/1986

AWARD CORP

PHENYLPROPANOLAMINE HCL USP XXI.

6263

II

4/11/1986

PFANSTIEHL LABORATORIES INC

FLESTOLOL SULFATE

6264

II

4/14/1986

OY STAR AB

RITODRINE HCL

6265

II

4/11/1986

MALLINCKRODT INC

NALTREXONE HCL AS MANUFACTURED IN ST LOUIS MO

6266

II

4/11/1986

RHONE POULENC

IGEPAL CA-630G (OCTOXYNOL 9) AS MFG. IN LINDEN, NEW JERSEY

6267

II

4/14/1986

ATABAY KIMYA SANAYI VE TICARET AS

ACETAMINOPHEN

6268

II

4/14/1986

ATABAY KIMYA SANAYI VE TICARET AS

ASPIRIN 100% (U.S.P.).

6269

3/24/1986

PMC PUERTO RICO INC

6270

III

3/28/1986

DEERFIELD SPECIALTY PAPER INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PUERTO RICO.
CAP LINER PAPER

6271

II

4/15/1986

ELAN CORP PLC

POTASSIUM CHL SUSPENSION

6272

II

4/14/1986

ZEELAND CHEMICALS INC

OXYBUTYNIN CHLORIDE

6273

III

4/18/1986

ERIE PLASTICS

PACKAGING MATERIALS AS MFG. IN CORRY, PENNSYLVANIA

6274

3/28/1986

CENTURY PLASTICS INC

6275

II

4/21/1986

FARCHEMIA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EL DORADO, KANSAS.
TINIDAZOLE USP XXI

NIFEDIPINE

L-SERINE - (S 4500 FD

Page 174

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6276 I
II
4/22/1986
FARMSON PHARMACEUTICAL GUJARAT PVT LTD

SUBJECT
ACETAMINOPHEN

6277

II

4/1/1986

PFANSTIEHL, INC

1-B-D-ARABINOFURANOSYL CYTOSINE (CYTARABINE) AS MFG. IN IL.

6278

II

4/16/1986

ERREGIERRE SPA

METOPROLOL TARTRATE USP

6279

II

4/21/1986

SANOFI SYNTHELABO INC.

NALBUPHINE HYDROCHLORIDE AS MFG. IN ARAMON, FRANCE FACILITY

6280

II

4/1/1986

ZEELAND CHEMICALS INC

PHENYLPROPANOLAMINE HYDROCHLORIDE AS MFG. IN ZEELAND, MI.

6281

II

3/27/1986

HOECHST MARION ROUSSEL SA

TRIAMCINOLONE USP AS MFG. IN FRANCE

6282

III

3/25/1986

ALLIANCE TOOL CORP

INJECTION MOLDED PARTS MANUFACTURED IN ROCHESTER, NEW YORK.

6283

II

3/28/1986

SIGMA F AND D DIV LTD

BETA-AMINOPROPIONITRILE MONOFUMARARTE SALT AS MFG.IN ST.LOUIS

6284

II

3/27/1986

CHEMISCHE FABRIK WEYL GMBH

ZINK PYRION PLATELETS AS MFG. IN GERMANY

6285

3/4/1986

SYNTHELABO PHARMACIE

FACILITY A MOURENX, FRANCE

6286

II

3/4/1986

FINORGA SAS

BETAXOLOL HYDROCHLORIDE AS MFG.ATMOURENX, FRANCE FACILITY

6287

II

3/17/1986

HOVIONE SOCIEDADE QUIMICA LDA

DANAZOL AS MFG. IN LISBON, PORTUGAL

6288

II

12/13/1985

RHONE POULENC RORER INC

PENTAMIDINE ISETHIONATE AS MFG. IN ENGLAND

6289

II

4/23/1986

CU CHEMIE UETIKON GMBH

METHIMAZOLE AS MFG. IN LAHR, GERMANY

6290

II

4/21/1986

SAPCOL INTERNATIONAL LTD

VINCRISTINE AS MFG IN PAKISTAN

6291

II

4/25/1986

BACHEM AG

DECAPEPTYL AS MFG BUBENDORF/SWITZERLAND

6292

6293

4/24/1986

MULTIDISCIPLINARY ASSN PSYCHEDELIC STUDIES MDMA (3,4-METHYLENEDIOXYMETHAMPHETAMINE) IN RATS AND DOGS

6294

II

4/23/1986

ABBOTT LABORATORIES

ETHRANE (ENFLURANE) AS MFG. IN QUEENBOROUGH, KENT, ENGLAND

6295

II

4/18/1986

HEINRICH MACK NACHF

M-AMSA AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY

6296

II

4/4/1986

SIGMA F AND D DIV LTD

TRYPSIN INHIBITOR,-T AND ALPHA-CHYMOTRYPS

6297

III

4/23/1986

CHEMICAL FABRICS CORP

FLUOROPOLYMER FILMS

6298

II

4/23/1986

SIGMA F AND D DIV LTD

TRYPSIN TYPE III, BOVINE

6299

II

4/18/1986

SIGMA F AND D DIV LTD

APROTININ, BOVINE LUNG

6300

III

4/22/1986

TIROS PLASTICS CANADA

PLASTIC PACKAGING COMPONENTS AS MFG. A ONTARIO,CANADA FAC.

6301

II

4/23/1986

DIOSYNTH BV

CODEINE PHOSPHATE AS MFG. A THE OSS, HOLLAND FACILITY

6302

II

3/5/1986

UNITIKA RAYON LTD

MICROCRYSTALLINE CELLULOSE AS MFG. A KYOTO-FU, JAPAN

6303

II

4/28/1986

FARMOS GROUP LTD MEDIPOLAR

NIFEDIPINE AS MFG IN FINLAND

6304

II

4/24/1986

PHARM ECO LABORATORIES INC

VINCRISTINE SULPHATE AS MFG. IN SIMI VALLEY, CALIFORNIA

6305

II

4/28/1986

HEXAGON LABORATORIES INC

CHLORPHENIRAMINE MELEATE USP

6306

4/28/1986

NORTH AMERICAN SCIENCE ASSOCIATES INC

FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT IRVINE, CA.

6307

4/25/1986

DAIWA PHARMACEUTICAL CO LTD

CLONIDINE HYDROCHLORIDE AS MFG IN TOYMA CITY, JAPAN

6308

4/30/1986

CP PHARMACEUTICALS LTD

FACILITY AT WREXHAM, WALES

6309

II

5/5/1986

FINE CHEMICALS CORP PTY LTD

THIOTHIXENE AS MFG IN CAPE PROVINCE, SOUTH AFRICA

6310

II

3/11/1986

PLANTEX LTD CHEM AND PHARM WORKS

DISOPYRAMIDE PHOSPHATE USP AS MFG. IN TEL AVIV

6311

5/5/1986

ALMEDICA SERVICES CORP

6312

II

3/19/1986

KV PHARMACEUTICALS CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WALDRICK, NEW JERSEY.
DISOPYRAMIDE S.R. CAPSULES 150 MG.

6313

II

3/13/1986

ELAN CORP PLC

PINDOLOL

NOT AN ASSIGNED NUMBER

Page 175

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6314 I
II
3/3/1986
CILAG CHEMIE AG

SUBJECT
THYMOPENTIN ACETATE HYDRATE AS MFG. IN SWITZERLAND

6315

II

3/10/1986

NYCOMED AUSTRA GMBH

MIDODRINE HYDROCHLORIDE

6316

2/5/1986

FACILITIES, PERSONNEL AND OPERATING PROCEDURES

6317

II

5/6/1986

INTERMEDI CHIMICI SINTETICI SPA ZONA


INDUSTRIALE
MEDICHEM SA

6318

II

3/4/1986

NORAMCO INC

OXYCODONE HYDROCHLORIDE AS MFG. IN WILMINGTON, DE AND ATHENS, GA

6319

III

3/18/1986

EI DUPONT DE NEMOURS AND CO

ND-G-3681

6320

II

3/18/1986

VELSICOL CHEMICAL CORP

HEXACHLOROPHENE-GRADE G AS MFG IN THE BEAUMONT,TEXAS FACILITY

6321

II

2/5/1986

NIFEDIPINE AS MFG IN LENDINARA, ITALY FACILITIES

6322

II

2/5/1986

6323

II

2/5/1986

6324

II

3/1/1986

INTERMEDI CHIMICI SINTETICI SPA ZONA


INDUSTRIALE
INTERMEDI CHIMICI SINTETICI SPA ZONA
INDUSTRIALE
INTERMEDI CHIMICI SINTETICI SPA ZONA
INDUSTRIALE
ERREGIERRE SPA

6325

II

3/1/1986

ERREGIERRE SPA

ATENOLOL AS MFG. BY THE HOLDER IN ITALY

6326

III

4/30/1986

CENTURY PLASTICS INC

PIPETTE INJECTION MOLDED FOR DORSEY LABS

6327

II

5/8/1986

ELAN CORP PLC

THEOPHYLLINE CONTROLLED RELEASE BEADS MANUFACTURED IN IRELAND.

6328

II

2/20/1986

YAMAMOTO CHEMICAL INDUSTRIES COMPANY LTD MEFENAMIC ACID AS MFG. IN WAKAYAMA, JAPAN

6329

2/14/1986

ZAPPA PLASTICS INC

BUILDINGS, FACILITIES, AND PERSONNEL IN GREENBROOK, N.J.

6330

II

5/9/1986

CUNO INC

MICROFLUOR CARTRIDGES FOR STERILE FILTRATION MANUFACTURED INMERIDEN,CT

6331

II

10/25/1985

UNICHEM LABORATORIES LTD

SUCRALFATE AS MFG. IN THE BOMBAY, INDIA FACILITY

6332

9/3/1985

PFIZER CANADA INC

6333

3/31/1986

EMERY CHEMICALS

6334

II

1/9/1986

AWARD CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ARNPRIOR, ONTARIO, CANADA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MAULDIN, SOUTH CAROLINA.
PHENYLPROPANOLAMINE HYDROCHLORIDE USP AS MFG. IN NEW YORK

6335

II

3/21/1986

LEK PHARMACEUTICAL & CHEMICAL WORKS

NIFEDIPINE MANUFACTURED IN MENGES, SLOVENIA

6336

II

10/25/1985

UNICHEM LABORATORIES LTD

CLOMIPHENE CITRATE AS MFG. IN BOMBAY, INDIA

6337

II

1/20/1986

MATERIALS PROCESSING TECHNOLOGY INC

ACETAMINOPHEN 90% AS MFG. IN THE PATERSON,NEW JERSEY,FACILITY

6338

III

5/30/1986

VALSPAR CORP

550 X 352 EPOXY-UREA BASE COATING MANUFACTURED IN ILLINIOS.

6339

II

3/14/1986

ZACH SYSTEM SPA

NIFEDIPINE USP AS MFG. IN THE VICENZA, ITALY FACILITY

6340

II

2/10/1986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

MEDROXY PROGESTERONE ACETATE AS MFG IN SEGOVIA, SPAIN

6341

II

2/4/1986

UNIV OF MISSOURI RESEARCH REACTOR

SM-153-ETHYLENEDIAMINETETRAMETHYLENEPHOSPHONIC ACID (SM-153-EDTMP)

6342

5/14/1986

CHANTAL PHARMACEUTICAL CORP

BUILDINGS AND FACILITIES IN BUBENDORF SWITZERLAND

6343

II

5/14/1986

CHANTAL PHARMACEUTICAL CORP

CYOCTOL AS MFG. IN BUBENDORF, SWITZERLAND

6344

III

5/9/1986

BAXTER HEALTHCARE CORP

STERILE SVP INJECTIONS IN SEAL/FILL/SEAL PLASTIC CONTAINERS

6345

III

2/20/1986

FLINT HILLS RESOURCES LP

REXENE POLYPROPYLENE RESINS PP23S2, CS-225, AND PP 23S2A

6346

5/28/1986

BAYER AG

FACILITIES AND PERSONNEL IN LEVERKUSEN, GERMANY

6347

II

5/19/1986

ACF CHEMIEFARMA NV

SULFAPYRIDINE AS MFG IN THE HOLLAND FACILITY

6348

II

5/12/1986

ORGAMOL SA

ACETOHEXAMIDE MANUFACTURED IN SWITZERLAND.

DIPYRIDAMOLE AS MFG. IN SPAIN

THIORIDAZINE HYDROCHLORIDE USP AS MFG. IN LENDINARA, ITALY


FUROSEMIDE USP AS MFG. IN THE LENDINARA, ITALY FACILITIES
CLOTRIMAZOLE MANUFACTURED IN ITALY.

Page 176

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6349 I
II
5/5/1986
ZAMBON SPA

SUBJECT
THIAMPHENICOL GLYCINATE HCL AS MFG IN VICENZA,ITALY

6350

III

3/11/1986

APTAR RADOLFZELL GMBH

6351

II

5/29/1986

DAIICHI SANKYO PROPHARMA CO LTD

MULTIDOSE DISPENSING SYSTEMS AS MANUFACTURED IN RADOLFZELL AND EIGELTINGEN,


GERMANY
OFLOXACIN BULK DRUG SUBSTANCE AS MFG. IN AKITA, JAPAN

6352

5/14/1986

CLASSIC INDUSTRIES INC

CONTROLS, FACILITIES AND PERSONNEL IN LAROBE, PENNSYLVANIA

6353

II

5/15/1986

NOVO NORDISK AS

NORETHINDRONE ACETATE AS MFG. IN DENMARK

6354

II

5/15/1986

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

PRAZOSIN HYDROCHLORIDE AS MFG. IN NIMIS (UDINE) ITALY

6355

II

5/15/1986

NORAMCO INC

SUPROFEN AS MFG IN AHENS, GEORGIA

6356

II

5/12/1986

UNICHEM LABORATORIES LTD

METRONIDAZOLE BENZOATE AS MFG. IN BOMBAY, INDIA

6357

II

5/12/1986

UNICHEM LABORATORIES LTD

CLONIDINE HYDROCHLORIDE MFG. IN BOMBAY, INDIA

6358

IV

5/16/1986

QUALICAPS CO LTD

EMPTY GELATIN CAPSULES AS MFG. IN YAMATO-KORIYAMA,NARA,JAPAN

6359

II

5/14/1986

RHONE-POULENC SANTE

MEGLUMINE AS MFG. IN CLEON, FRANCE

6360

III

5/14/1986

CENTURY PLASTICS INC

CANNULA ASSEMBLY INJECTION MOLDED FOR DORSEY LABS

6361

9/30/1985

3M PHARMS

6362

II

10/4/1984

UCB MANUFACTURING IRELAND LIMITED

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF SPUNLACED FABRIC TAPE IN BROOKINGS, SD.
ISOSORBIDE 5-NITRATE DILUTED

6363

II

5/16/1986

SIGNA SA

ALPHA METHYL DOPA USP AS MFG. IN MEXICO

6364

2/14/1986

JANSSEN PHARMACEUTICA NV

6365

5/16/1986

CUNO INC

MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES


AT GEEL, BELGIUM.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES .

6366

II

5/16/1986

CONTROLLED RELEASE PELLETS OR PACKED CAPSULES CONTAINING SAME

6367

II

5/20/1986

TEMMLER WERKE VEREINIGTE CHEMISCHE


FABRIKEN
HOECHST MARION ROUSSEL SA

6368

II

1/16/1986

INDUSTRIAS QUIMICAS ESTEVE SA

BELLAFOLINE SUBSTANCE 60% AS MFG. IN BRAZIL

6369

II

5/23/1986

OXYBUTYNIN CHLORIDE

6370

II

5/22/1986

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
KV PHARMACEUTICAL CO

6371

5/22/1986

ORGANON INC

ORGANIZATION, FACILITIES AND MANUFACTURING FACILITIES

6372

II

5/16/1986

NORDION CANADA INC

SODIUM IODIDE I-131 MANUFACTURED IN KANATA, ONTARIO, CANADA.

6373

II

5/23/1986

FABBRICA ITALIANI SINTETICI SPA

ALLOPURINOL AS MFG. IN ITALY

6374

II

5/30/1986

BACHEM INC

GROWTH HORMONE RELEASING FACTOR (GRF) (1-29) AMIDE, HUMAN

6375

II

5/27/1986

SALSBURY CHEMICALS INC

CHLORPROPAMIDE, U.S.P.

6376

II

5/30/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

GC-MS FOR QUANTITAIVE DETERMINATION OF CLONIDINE IN PLASMA

6377

III

6/2/1986

DORLYL USINE DU HAVRE

PVC PRODUCTS AS MFG. AT LE HAVRE CEDEX, FRANCE

6378

III

5/30/1986

NOVA CHEMICALS LTD

IMPACT POLYSTYRENE FORMULATIONS AS MFG. IN ONTARIO, CANADA

6379

II

6/17/1986

STEROID SRL

NANDROLONE PHENPROPIONATE USP MANUFACTURED IN MILAN, ITALY.

6380

II

6/3/1986

CARRINGTON LABORATORIES INC

CSN-GEL AS MFG. IN DALLAS, TEXAS

6381

II

6/3/1986

CARRINGTON LABORATORIES INC

CSN BULK PRODUCT

6382

II

5/27/1986

CHINOIN PHARM & CHEM WORKS LTD

ETHAMBUTOL HYDROCHLORIDE AS MFG. BUDAPEST, HUNGARY

6383

6/2/1986

BAYER AG

FACILITIES AND PERSONNEL AT WUPPERTAL, GERMANY

TRIAMCINOLONE ACETONIDE MANUFACTURED IN FRANCE

RU-VERT M TABLETS (MECLIZINE HCL)

Page 177

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6384 I
I
5/19/1986
PHARMEXPERT
6385

II

5/5/1983

SANOFI WINTHROP INDUSTRIE

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN HUNGARY.
CORDARONE (AMIODARONE HYDROCHLORIDE) AS MFG.IN AMBARES,FRANCE

6386

II

5/15/1986

ALDRICH CHEMICAL COMPANY INC

3-ISOBUTYL-1-METHYLXANTHINE AS MFG. IN MILWAUKEE, WISCONSIN

6387

II

5/9/1986

SALK INSTITUTE

NAL-GLU ANTAGONIST AS RESEARCHED IN SAN DIEGO, CALIFORNIA

6388

II

2/21/1986

NV ORGANON

NALBUFINE HYDROCHLORIDE AS MFG. IN THE NETHERLANDS

6389

8/6/1985

ORION CORP LTD

METHOCARBAMOL MANUFACTURED IN HANKO, FINLAND.

6390

II

6/4/1986

FINE CHEMICALS CORPORATION

DANAZOL USP MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

6391

II

5/9/1986

DIPHARMA FRANCIS SRL

BENDROFLUMETHIAZIDE USP AS MFG. IN VARESE ITALY

6392

5/30/1986

PHARMACIA & UPJOHN AB

6393

II

6/4/1986

HYBRITECH INC

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN


UPPSALA, SWEDEN.
INDIUM-III CITRATE ANTIBODY GRADE 7590 AS MFG. IN SAN DIEGO

6394

II

12/17/1982

DINAMITE SPA

TOLAZAMIDE AS MFG. IN UDINE, ITALY

6395

II

6/2/1986

SIGMA F AND D DIV LTD

ESERINE SALICYLATE SALT AS MFG. IN ST. LOUIS, MISSOURI

6396

II

6/6/1986

GANES CHEMICALS INC

TRAZODONE HYDROCHLORIDE AS MFG. IN CARLSTADT, NEW JERSEY

6397

6/9/1986

6398

II

8/1/1985

MEDICAL UNIV OF SOUTH CAROLINA HOSP


PHARMACY
PHARM ECO LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CHARLESTON, SOUTH CAROLINA.
CYCLOPHOSPHAMIDE MONOHYDRATE AS MFG. IN SIMI VALLEY, CALIF.

6399

II

6/4/1986

PHARM ECO LABORATORIES INC

HALOPROGIN MANUFACTURED IN SIMI VALLEY, CALIFORNIA.

6400

6/5/1986

HOFFMANN LAROCHE

6401

II

6/3/1986

EASTMAN KODAK CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN VILLIAGE-NEUF, FRANCE.
1-METHYL-2-(3-PYRIDYL) PYRROLIDINE (NICOTINE) MANUFACTURED IN NEW YORK.

6402

II

6/10/1986

FINE ORGANICS LTD

1, METHYLAMINO-1-METHYLTHIO-2-NITROETHENE AS MFG. IN ENGLAND

6403

II

6/2/1986

HEICO CHEMICALS DIV WHITTAKER CORP

6404

II

6/2/1986

HEICO CHEMICALS DIV WHITTAKER CORP

POTASSIUM BICARBONATE, USP MANUFACTURED IN DELAWARE WATER GAP,


PENNSYLVANIA.
PSEUDOEPHEDRINE HCL USP,AS MFG IN DELAWARE WATER GAP,PA

6405

II

6/9/1986

PFIZER INC

BETAMETHASONE VALERATE AS MFG. IN KALAMAZOO, MICHIGAN

6406

III

6/11/1986

CONSOLIDATED CONTAINER CO

POLYETHYLENE AND POLYPROPYLENE CONTAINERS MFG.-NEW CASTLE,PA.

6407

II

6/15/1982

TENNECO CHEMICALS INC

NUOPLAZ 6959 (PLASTICIZER) AS MFG. IN CHESTERTOWN, MD

6408

III

5/28/1986

INTERTECH CORP

PLASTIC BOTTLE CONTAINERS AS MFG. IN GREENSBORO, NC.

6409

II

6/5/1986

NV ORGANON

FLUPHENAZINE DECANOATE AS MFG. IN THE NETHERLANDS

6410

IV

6/10/1986

JRS PHARMA LP

MICROCRYSTALLINE CELLULOSE USP MANUFACTURED IN FINLAND.

6411

II

6/12/1986

MERCK KGAA

TITRIPLEX VS (DIETHYLENETRIAMINEPENTAACETIC ACID) MFG. GERMANY

6412

II

6/12/1986

PCAS

OXYBUTYNIN HYDROCHLORIDE AS MFG. IN LIMAY FRANCE

6413

II

6/6/1986

NORAMCO INC

CODEINE PHOSPHATE AS MFG. IN WILMINGTON, DELAWARE

6414

II

6/9/1986

IDAZOXAN CAPSULES AS MFG. IN THE UNITED KINGDOM

6415

II

6/12/1986

6416

6/10/1986

RECKITT & COLMAN PRODUCTS LTD


PHARMACEUTICAL DIV
RECKITT & COLMAN PRODUCTS LTD
PHARMACEUTICAL DIV
HOFFMANN LAROCHE F AND CO LTD

6417

III

4/25/1986

ABBOTT LABORATORIES HOSP PRODUCTS DIV

FC85 PLASTIC (FLEXIBLE CONTAINERS) AS MFG. IN NO.CHICAGO,IL.

6418

II

6/2/1986

CYCLO PRODUCTS INC

BUSPIRONE HYDROCHLORIDE AS MFG IN LOS ANGELES, CALIFORNIA

IDAZOXAN DRUG SUBSTANCE AS MFG. IN THE UNITED KINGDOM


MANUFACTURING FACILITY LOCATED IN BASLE, SWITZERLAND

Page 178

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6419 I
III
7/1/1985
HELVOET PHARMA NV

SUBJECT
RUBBER CLOSURES AS MFG. IN BELGIUM

6420

II

6/5/1986

NEN LIFE SCIENCE PRODUCTS

IONIC GALLIUM-68 MFG IN NO. BILLERICA, MA

6421

II

6/18/1986

FINE CHEMICALS CORP PTY LTD

BACLOFEN AS MFG. IN CAPE PROVINCE, SOUTH AFRICA

6422

II

6/11/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

ERGOTAMINE IN HUMAN PLASMA MANUFACTURED IN MORRISTOWN, NEW JERSEY.

6423

II

5/16/1986

CARBON-14 ALBENDAZOLE SUSPENSION AS MFG. IN PHILADELPHIA, PA.

6424

III

2/28/1986

6425

II

6/11/1986

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
GETTIG PHARMACEUTICAL INSTRUMENT CO DIV
GETTIG TECHNOLOGIES INC
SANOFI PHARMACEUTICALS INC

6426

6/12/1986

STERIGENICS INTERNATIONAL

6427

6/13/1986

DAINIPPON PHARMACEUTICAL CO LTD

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN


WESTERVILLE, OHIO
FACILITIES, PERSONNEL, AND PROCEDURES AT SUZUKA-SHI, JAPAN

6428

II

6/18/1986

KATWIJK CHEMIE BV

VALPROIC ACID AS MFG IN THE NETHERLANDS

6429

II

6/9/1986

OLIN RESEARCH CENTER

OMADINE MDS AS MFG. IN SWORDS, IRELAND

6430

II

6/17/1986

DC CHEMICAL CO LTD

HEXACHLOROPHENE MANUFACTURED IN KYUNG BUK, KOREA.

6431

II

6/19/1986

CARLSBERG BIOTECHNOLOGY LTD

IGE PENTAPEPTIDE ACETATE AS MFG. IN COPENHAGEN, DENMARK

6432

II

6/17/1986

STEROID STABILIMENTS

OXYMETHOLONE USP MANUFACTURED IN MILAN, ITALY.

6433

II

6/17/1986

STEROID SRL

STANOZOLOL USP AS MFG. IN MILAN, ITALY

6434

II

1/9/1984

HOFFMANN LA ROCHE INC

PROTIRELIN (THYROTROPIN RELEASING HORMONE),MFG IN BASLE, SZ

6435

II

6/18/1986

SIGMA F AND D DIV LTD

FRUCTOSE 1,6-DIPHOSPHATE AS MFG IN ST.LOUIS, MISSOURI

6436

6/25/1986

SOLVAY PHARMACEUTICALS

HORMONE MFG. FACILITY LOCATED IN BAUDETTE, MINNESOTA

6437

II

6/18/1986

HONEYMEAD PRODUCTS CO

EDIBLE LIQUID SOYBEAN OIL MANUFACTURED IN MANKATO, MINNESOTA.

6438

II

6/25/1986

SUMIKA FINE CHEMICALS CO LTD

METOLAZONE AS MFG. IN JAPAN

6439

II

6/23/1986

DINAMITE DIPHARMA SPA

SULINDAC USP AS MFG. IN MILAN, ITALY

6440

II

6/27/1986

NORDION CANADA INC

IODINE 123 CP VCR 804-2 MANUFACTURED IN VANCOUVER, CANADA.

6441

III

6/26/1986

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5000-45 GRAY MFG IN SALISBURY MD

6442

III

6/26/1986

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5000-55 GRAY-MFG IN SALISBURY,MD

6443

II

6/23/1986

PHARMACIA AND UPJOHN INC

OLSALAZINE SODIUM AS MANUFACTURED IN DOTTIKON, SWITZERLAND

6444

6/26/1986

NORDEN ANDBRO

6445

II

6/27/1986

WYETH AYERST LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PITMAN, NEW JERSEY.
OXAZEPAM AS MFG. IN HAVANT, ENGLAND

6446

III

6/11/1986

SOLVAY & CIE SA

BENVIC EB 652/5405-A, RIGID PVC COMPOUND MANUFACTURED IN ITALY.

6447

II

7/2/1986

JOHNSON MATTHEY PLC

PENTAMIDINE ISETHIONATE,(BULK) AS MFG. IN WEST DEPTFORD, NJ

6448

6/10/1986

HOLOPAK GMBH

6449

II

7/2/1986

6450

6/25/1986

AMERSHAM INTERNATIONAL PLC AMERSHAM


LABORATORY
STEROID SRL

ASEPTIC PROCESSING FACILITY FOR ROMMELAG(R) BOTTELPACK(R) BLOW-FILL-SEAL


TECHNOLOGY IN SULZBACH AND UNTERGRONINGEN, GERMANY
YTTRIUM 90Y SILICATE AS MFG. IN BUCKINGHAMSHIRE, ENGLAND

6451

II

4/24/1986

SIGMA F AND D DIV LTD

BETA-PHENYLETHYLAMINE HYDROCHLORIDE AS MFG IN ST. LOUIS, MO.

6452

II

7/2/1986

RHONE-POULENC SANTE

ALLOPURINOL AS MFG. IN SEINE CEDEX, FRANCE

6453

III

5/14/1986

DRG MEDICAL PACKAGING INC

2438 COATING PAPER AS MFG. IN MADISON, WISCONSIN

RUBBER CLOSURE FORMULATION, GP 1502/45 AS MFG. IN KNOX, IN.


CHLOROQUINE BASE AND PHOSPHATE AS MFG. IN NORTHUMBERLAND,ENG.

FACILITIES,PERSONNEL,AND OPERATING PROC. A COLOGNO MONZESE,IT

Page 179

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6454 I
III
7/3/1986
INTERNATIONAL MEDICATION SYSTEMS LTD

SUBJECT
RUBBER CLOSURES AND VIAL INJECTORS AS MFG. IN CALIFORNIA

6455

II

7/1/1986

CUNO INC

ZETAPOR O.45 WP MEMBRANE CARTRIDGES MANUFACTURED IN MERIDEN, CONNECTICUT.

6456

II

6/18/1986

EPROVA AG

FENOFIBRATE (PROCETOFEN) MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

6457

III

6/30/1986

B BRAUN MEDICAL INC

6458

III

6/30/1986

B BRAUN MEDICAL INC

STERILIZATION PROGRAM FOR THE EXCEL PLASTIC CONTAINER AS MANUFACTURED IN


IRVINE CA
MATERIAL QUALIFICATION FOR THE EXCEL PLASTIC CONTAINER

6459

III

6/30/1986

B BRAUN MEDICAL INC

VAPOR TRANSMISSION STUDIES FOR THE EXCEL PLASTIC CONTAINER

6460

III

6/30/1986

B BRAUN MEDICAL INC

CHEMISTRY MANUFACTURING AND CONTROLS FOR THE EXCEL PLASTIC CONTAINER

6461

III

6/30/1986

B BRAUN MEDICAL INC

6462

III

6/30/1986

B BRAUN MEDICAL INC

INK QUALIFICATION STUDIES FOR THE EXCEL PLASTIC CONTAINERS AS MANUFACTURED IN


IRVINE, CA
ACCELERATED STUDIES FOR THE EXCEL PLASTIC CONTAINER

6463

III

1/7/1986

SOLVAY & CIE SA

ELTEX B 4921 AS MFG. IN BRAZIL

6464

6/20/1986

METHODS, FACILITIES, AND CONTROLS IN MAYAGUEZ, PUERTO RICO

6465

III

1/7/1984

BRISTOL LABORATORIES INC DIV BRISTOL MYERS


CO
SOLVAY & CIE SA

6466

II

6/25/1986

ORION CORPORATION FERMION OULU PLANT

MINOXIDIL AS MFG IN FINLAND

6467

II

7/11/1986

MIKART INC

LORTAB TABLETS AS MFG. IN ALANTA, GEORGIA

6468

II

6/17/1986

HEXAGON LABORATORIES INC

METHOCARBAMOL AS MFG. IN BRONX, NEW YORK

6469

II

6/15/1986

HEXAGON LABORATORIES INC

PROPANTHELINE BROMIDE AS MFG. IN BRONX, NEW YORK

6470

6/30/1986

PHARMACIA AND UPJOHN INC

FACILITIES AND CONTROLS IN WEST SUSSEX, U.K.

6471

II

7/9/1986

CUNO INC

MFG. OF ZETAPOR 0.20UM ST MEMBRANE CARTRIDGES, MERIDEN, CT

6472

II

1/23/1985

HEXAGON LABORATORIES INC

THIORIDAZINE HYDROCHLORIDE AS MFG. IN BRONX, NEW YORK

6473

III

6/25/1986

INTRAPAC CORP

PLASTIC BOTTLES AND CLOSURES AS MFG. IN SWEDESBORO, N.J.

6474

7/11/1986

NOVOPHARM LTD

FACILITIES, PERSONNEL,OPERATING PROC. AT ONTARIO, CANADA

6475

II

7/9/1986

HOECHST CELANESE CORP

ACETOHEXAMIDE USP AS MFG IN COVENTRY, RHODE ISLAND

6476

III

7/14/1986

WEST AMERICAN RUBBER CO

WEST AMERICAN RUBBER COMPOUND 55-P-146 MFG IN ORANGE, CA

6477

7/17/1986

CIPLA LTD

FACILITIES, CONTROLS, AND OPERATING PROC. AT BANGALORE, INDIA

6478

7/17/1986

CIPLA LTD

FACILITIES, CONTROLS, AND OPERATING PROC. AT VIKHROLI, INDIA

6479

7/17/1986

CIPLA LTD

6480

7/17/1986

CIPLA LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PATALGANGA, INDIA.
FACILITIES, CONTROLS AND OPERATING PROC. AT BOMBAY, INDIA

6481

II

1/31/1986

BAYER CORP

BOVINE THROMBIN AS MFG IN ELKHART, INDIANA

6482

III

9/9/1985

HUBERT DEBACKER & CO PVB

INJECTION MOULDED PLASTIC CONTAINERS AS MFG. IN BELGIUM

6483

III

6/2/1986

WINGFOOT FILMS CORP

POLYETHYLENE FILM AS MFG IN CARROLLTON, OHIO

6484

III

6/2/1986

WINGFOOT FILMS CORP

POLYETHYLENE FILM AS MFG IN BOWLING GREEN, KENTUCKY

6485

II

7/7/1986

LABOCHIM

PENTOXIFYLLINE MANUFACTURED IN MILAN, ITALY.

6486

II

7/17/1986

MIKART INC

LORTAB 7 TABLETS AS MFG. IN ALANTA, GEORGIA

6487

II

3/3/1986

HEXAGON LABORATORIES INC

METOLAZONE AS MFG. IN BRONX, NEW YORK

6488

II

7/18/1986

SOCIETA ITALIANA CORTICOSTEROIDI SPA

MEDROXYPROGESTERONE ACETATE AS MFG. IN MILANO, ITALY

6489

II

7/17/1986

ACF CHEMIEFARMA NV

SULFASALAZINE AS MFG. IN MAARSSEN, THE NETHERLANDS

HD-PE COPOLYMER ELTEX A 4009 AS MFG. IN ROSIGNANO, ITALY

Page 180

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6490 I
II
6/17/1986
DANISCO INGREDIENTS

SUBJECT
BUTABARBITAL MANUFACTURED IN GRINDSTED, DENMARK.

6491

II

7/24/1986

MIKART INC

LORCET PLUS TABLETS MANUFACTURED IN ALANTA, GEORGIA.

6492

II

7/23/1986

DELMAR CHEMICALS LTD

PENTAMIDINE ISETHIONATE MANUFACTURED IN QUEBEC, CANADA.

6493

III

7/17/1986

SEDA SPECIALTY PACKAGING CORP

JARS, CLOSURES AND VIALS MANUFACTURED IN PLATSBURGH, NEW YORK.

6494

II

7/31/1986

FLAVOXATE HYDROCHLORIDE AS MFG. IN LATINA, ITALY

6495

II

5/23/1986

6496

II

7/18/1986

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS
SRL
HEINRICH MACK NACHF

6497

II

7/29/1986

QUATRUM

TRIAMCINOLONE ACETONIDE AS MFG. IN PORTUGAL

6498

II

7/29/1986

SHOWA DENKO KK

SPECIFIC DRUG SUBSTANCES FOR L-TRYPTOPHAN IN JAPAN

6499

II

7/28/1986

CIPLA LTD

VINBLASTINE SULFATE USP AS MANUFACTURED IN BANGALORE, India

6500

II

7/28/1986

CIPLA LTD

VINCRISTINE SULFATE AS MANUFACTURED IN BANGALORE, INDIA

6501

6/18/1986

STERIS ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN LIBERTYVILLE (NORTH), ILLINOIS.

6502

II

7/18/1986

HEINRICH MACK NACHF

5-FLUORO-2'-DEOXYURIDINE AS MFG. IN THE FED. REP. OF GERMANY

6503

II

7/21/1986

HILL DERMACEUTICALS INC

DERMA-SMOOTHE CAPSULES AS MFG BY MIKART,INC IN ALANTA, GA.

6504

II

7/29/1986

BACHEM AMERICAS,INC

SALMON CALCITONIN (SCT) MANUFACTURED IN TORRANCE, CALIFORNIA.

6505

II

7/23/1986

DIPHARMA FRANCIS SRL

NIFEDIPINE USP AS MFG. IN MILAN, ITALY

6506

II

7/11/1986

ROHM AND HAAS CO

CHOLESTYRAMINE RESIN, USP-AMBERLITE IRP-276 MFG IN ITALY

6507

II

7/22/1986

ASPEN OSS BV

ARGININE VASOPRESSIN AS MFG. IN THE NETHERLANDS

6508

7/17/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

VALIDATION REPORT ON FLURAZEPAM AND IT'S MAJOR METABOLITES

6509

7/23/1986

CAROLINA MEDICAL PRODUCTS CO

FACILITIES, PERSONNEL AND GENERAL OPER. PROC. IN N. CAROLINA

6510

7/17/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

DETERMINATION OF HALOPERIDOL IN HUMAN PLASMA USING GC-MS

6511

II

7/30/1986

SCHERING CHEMICALS LTD

ULTRALANUM CREAM PLAIN MANUFACTURED IN ENGLAND.

6512

IV

7/31/1986

GATTEFOSSE ESTABLISSEMENTS

PRECIFAC AS MFG. IN SAINT PRIEST, FRANCE

6513

II

7/30/1986

FISONS PHARM LTD

NEDOCROMIL SODIUM MANUFACTURED IN CHESHIRE, ENGLAND.

6514

7/31/1986

RAYLO CHEMICALS

FACILITIES, PERSONNEL AND OPERATING PROCED. IN ALBERTA, CANADA

6515

7/9/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

VALIDATION REPORT ON NITROGLYCERIN METABOLITES

6516

7/17/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

VALIDATION REPORT ON PRAZEPAM AND IT'S MAJOR METABOLITES

6517

8/1/1986

HELSINN CHEMICALS SA

6518

II

4/11/1986

HELSINN CHEMICALS SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SWITZERLAND.
CHLORZOXAZONE DRUG SUBSTANCE AS MFG. IN BIASCA, SWITZERLAND

6519

II

8/1/1986

SELOC FRANCE

SODIUM VALPROATE MANUFACTURED BY SIFA LTD IN IRELAND.

6520

III

8/6/1985

MILLIKEN & CO

MILLAD 3905 (DIBENZYLIDENE SORBITOL) AS MFG. IN S.CAROLINA

6521

II

6/19/1986

CUNO INC

ZETAPOR 0.45 UM SP MEMBRANE CARTRIDGES MANUFACTURED INMERIDEN,CT

6522

II

8/7/1986

CAMBREX PROFARMACO MILANO SRL

ALBUTEROL SULPHATE AS MFG. IN MILAN, ITALY

6523

II

8/6/1986

PCAS

TRIMIPRAMINE MALEATE MANUFACTURED BY SIFA LTD IN IRELAND.

6524

II

8/7/1986

CAMBREX PROFARMACO MILANO SRL

ALBUTEROL BASE AS MFG. IN MILAN, ITALY

6525

II

8/11/1986

PHARMACIA AND UPJOHN SUB PFIZER INC

DEXAMETHASONE SODIUM PHOSPHATE MANUFACTURED IN KALAMAZOO, MICHIGAN.

6526

II

8/12/1986

ORGANICHEM CORP

AMINOBISAMIDE HYDROCHLORIDE AS MFG. IN RENSSELAER, NEW YORK

BUPIVACAINE HYDROCHLORIDE AS MFG. IN FIRENZE, ITALY


RIBAVIRIN AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY

Page 181

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6527 I
II
7/24/1986
BOEHRINGER INGELHEIM KG

SUBJECT
PHYSOSTIGMINE SALICYLATE MANUFACTURED IN GERMANY.

6528

III

8/8/1986

30030 HEAT SEAL FOR FOIL TO FOIL, POLYCARBONATE, PVC & OTHER

6529

II

8/8/1986

TECHNICAL COATINGS CO SUB OF BENJAMIN


MOORE & CO
LABORATOIRE CHOAY

6530

II

7/25/1986

BOEHRINGER INGELHEIM CHEMICALS INC

METAXALONE MANUFACTURED IN PETERSBUG, VIRGINIA.

6531

II

6/9/1986

ANTIBIOTICOS SPA

IBUPROFEN MANUFACTURED IN MILANO, ITALY.

6532

8/11/1986

RICHARDSON-VICKS INC

6533

II

8/12/1986

NIPPON KAYAKU CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NORTH CAROLINA.
DEOXYSPERGUALIN HYDROCHLORIDE FOR INJECTION MANUFACTURED INJAPAN

6534

II

7/31/1986

NORDION CANADA INC

MOLYBDENUM-99 (FISSON) AS MFG. IN ONTARIO, CANADA

6535

II

8/15/1986

IROPHARM LTD

IMIPRAMINE HYDROCHLORIDE AS MFG. IN IRELAND

6536

II

8/9/1986

RHONE-POULENC SANTE

GADOLINIUM OXIDE 99.99 (PHOSPHOR GRADE) AS MFG. IN FRANCE

6537

II

8/12/1986

NIPPON KAYAKU CO LTD

DEOXYSPERGUALIN HYDROCHLORIDE AS MFG. IN SHIGA-KEN, JAPAN

6538

IV

8/14/1986

HERCULES INC

HYDROXYPROPYL CELLULOSE AS MFG. IN HOPEWELL, VIRGINIA

6539

II

8/6/1986

BERK PHARMACEUTICALS LTD

ACTIVE & PLACEBO FUROSEMIDE (FRUSEMIDE TABS) 40MG MFG ENGLAND

6540

III

8/7/1986

PCI SERVICES

PACKAGING PROCEDURES A ESSEX, UK

6541

III

8/15/1986

HELVOET PHARMA MARYLAND

6542

IV

7/9/1986

LUBRIZOL ADVANCED MATERIALS INC

RUBBER CLOSURE FORMULATION B5001-45 GRAY MANUFACTURED IN SALISBURY,


MARYLAND.
NOVEON CA-1/NOVEON CA-2 (CALCIUM POLYCARBOPHIL USP)

6543

8/15/1986

PFIZER CHEMICAL CORP

6544

II

8/19/1986

PFIZER S/A

6545

8/15/1986

JM HUBER POLYMER SERVICES GRP

6546

II

8/19/1986

WHITBY RESEARCH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ORANGE, TEXAS.
N-0437 SYNTHESIS AND NON-CLINICAL STUDIES A IRVINE, CALIF.

6547

II

8/25/1986

DUPHAR BV

CALCITRIOL AS MANUFACTURED AND PACKED IN THE NETHERLANDS

6548

III

7/30/1986

BENVIC PEB 02 P/0546 AS MFG. IN QUETIGNY, FRANCE

6549

III

7/30/1986

6550

III

7/30/1986

6551

III

7/30/1986

6552

8/18/1986

SOCIETE BOURGUIGNONNE D'APPLICATIONS


PLASTIQUES
SOCIETE BOURGUIGNONNE D'APPLICATIONS
PLASTIQUES
SOCIETE BOURGUIGNONNE D'APPLICATIONS
PLASTIQUES
SOCIETE BOURGUIGNONNE D'APPLICATIONS
PLASTIQUES
EXTAL PTY LTD DIV JOHNSON AND JOHNSON

6553

II

8/13/1986

QUATRUM

6554

8/18/1986

SYNERGY HEALTH STERILISATION UK LTD

6555

8/18/1986

SYNERGY HEALTH STERILISATION UK LTD

6556

7/14/1986

6557

III

8/25/1986

PROCTER AND GAMBLE PHARMACEUTICALS


GERMANY GMBH
STATOIL

6558

II

9/1/1986

ORGANICHEM CORP

AMIODARONE HYDROCHLORIDE INJECTION AS MFG. IN MAROMME, FRANCE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RINGASKIDDY, IRELAND.
TINIDAZOLE MANUFACTURED IN SSAO PAULO, BRAZIL.

BENVIC PEB 02 P/0102 AS MFG. IN QUETIGNY, FRANCE


BENVIC PEB 01 P/0546 (A PVC CMPD) AS MFG IN QUETIGNY,FRANCE
BENVIC PEB 01 P/0102 MANUFACTURED IN QUETIGNY, FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TASMANIA, AUSTRALIA.
TRIAMCINOLONE BASE AS MFG. IN SACAVEM, PORTUGAL
COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN READING,
BERKSHIRE, ENGLAND
COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN
BRADFORD, WEST YORKSHIRE, ENGLAND
FACILITIES, PERSONNEL AND OPER. PROC. AT WEITERSTADT, GERMANY
POLYETHYLENE RESIN L500 AS MFG. IN STAHELLE, NORWAY
SR-2508, HYPOXIC CELL RADIOSENSITIZER MANUFACTURED IN LINZ, AUSTRIA.

Page 182

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6559 I
II
8/29/1986
ETHYL CORP

SUBJECT
TOLRESTA MANUFACTURED IN BATON ROUGE, LOUISIANA.

6560

II

8/29/1986

DIOSYNTH BV

6-ALPHA-METHYLPREDNISOLONE SODIUM SUCCINATE MFG. NETHERLANDS

6561

II

8/7/1986

TSUJIMOTO KAGAKU KOGYO CO LTD

DEXTROMETHORPHAN PHENOLPHTHALINATE AS MFG. IN OSAKA, JAPAN

6562

II

8/22/1986

CYCLOTRON-PRODUCED RADIOPHARMACEUTICALS AS MFG. IN TEXAS

6563

II

8/30/1986

UNIVERSITY OF TEXAS MD ANDERSON CANCER


CENTER
TOKUYAMA CORP

6564

9/5/1986

ZENITH LABORATORIES INC

FACIL. AND OPER. PROC. A PRALEX CORP. IN ST. CROIX,VIRGIN ISL

6565

III

9/3/1986

3M PHARMS

SCOTCHPAK BRAND HEAT SEALABLE POLYESTER FILM NO. 6

6566

8/28/1986

ASTA PHARMA AG

PRODUCTION PLANT AT KUNSEBECK, GERMANY

6567

III

8/18/1986

BENVIC IB 56C/0102 AS MFG. IN QUETIGNY, FRANCE

6568

II

9/4/1986

SOCIETE BOURGUIGNONNE D'APPLICATIONS


PLASTIQUES
EGIS PHARMACEUTICALS

6569

II

8/2/1982

CONTINENTAL PHARMA SA

CP 751 S TABLETS MANUFACTURED IN BRUSSELS, BELGIUM.

6570

II

8/28/1986

UNIBIOS SPA

NALIDIXIC ACID MANUFACTURED IN TRECAE, ITALY.

6571

II

8/28/1986

HEXAGON LABORATORIES INC

BROMPHENIRAMINE MALEATE USP MANUFACTURED IN BRONX, NEW YORK.

6572

II

9/10/1986

ACETAMINOPHEN D.C. PVP AS MFG. IN THE UNITED KINGDOM

6573

II

9/10/1986

6574

III

5/10/1985

HARTINGTON CHEMICALS DIV STAVELEY


CHEMICALS LTD
HARTINGTON CHEMICALS DIV STAVELEY
CHEMICALS LTD
DOW CORNING CORP

6575

II

9/11/1986

JOHNSON MATTHEY PLC

SOTRADECOL GEL MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

6576

II

9/12/1986

ASACOL (5-AMINOSALICYLIC ACID) TABLETS MANUFACTURED IN NORWICH, NEW YORK.

6577

II

9/12/1986

NORWICH EATON PHARMACEUTICALS INC SUB


PROCTOR AND GAMBLE CO
ROHM PHARMA GMBH

6578

III

9/5/1986

MITSUI CHEMICALS INC

TAFMER A 4085 RESIN COMPOUNDS MANUFACTURED IN TOKYO, JAPAN.

6579

II

9/9/1986

LABOCHIM

FLUPHENAZINE DECANOATE AS MFG. IN MILAN, ITALY

6580

II

12/24/1985

ICI AMERICAS INC

METHYLENE CHLORIDE MANUFACTURED IN CHESHIRE, ENGLAND.

6581

II

8/28/1986

BASF SE

VITAMIN A PALMITATE AS MFG.IN GERMANY

6582

II

9/8/1986

HOFFMANN LA ROCHE INC

RIBOFLAVIN 5'-PHOSPHATE SODIUM AS MFG.IN VILLIAGE-NEUF,FRANCE

6583

II

9/12/1986

ATOMIC ENERGY OF CANADA LTD

CP-VCR 807 GA-67 MANUFACTURED IN VANCOUVER, CANADA.

6584

IV

8/20/1986

MIKART INC

LORTAB LIQUID AS MFG. IN ALANTA, GEORGIA

6585

9/17/1986

KNOLL AG

FACILITIES, PERSONNEL AND PROCEDURES IN LIESTAL, SWITZERLAND

6586

II

2/6/1986

EURAND AMERICA INC

MICROENCAPSULATED ASPIRIN AS MFG. IN VANDALIA, OHIO

6587

II

9/19/1986

HEXAGON LABORATORIES INC

CHLORPROMAZINE HCL USP MANUFACTURED IN BRONX, NEW YORK.

6588

II

9/19/1986

HEXAGON LABORATORIES INC

IBUPROFEN USP MANUFACTURED IN BRONX, NEW YORK.

6589

II

9/18/1986

HEXAGON LABORATORIES INC

AMANTIDINE HYDROCHLORIDE MANUFACTURED IN BRONX, NEW YORK.

6590

II

9/19/1986

HEXAGON LABORATORIES INC

DISOPYRAMIDE PHOSPHATE USP AS MFG. IN BRONX, NEW YORK

6591

III

9/23/1986

VERTELLUS PERFORMANCE MATERIALS INC

CITROFLEX(R) B-6 AS MFG. IN GREENSBORO, NC

6592

9/17/1986

RHONE POULENC PHARMACY INC

FACILITIES, PERSONNEL AND PROCEDURES AT MONTREAL, CANADA

6593

IV

8/8/1986

DRAGOCO RIECH UND GESCHMACK STOFFE


GMBH

NATURAL PEPPERMINT POWDER FLAVOR AND MENTHOL CRYSTALIZED

CHLORZOXAZONE USP AS MFG. A THE IBARAKI PREFECTURE JAPAN FAC

CLOMIPHENE CITRATE USP AS MFG. IN BUDAPEST, HUNGARY

ACETAMINOPHEN D.C. 90 PVP MANUFACTURED IN UNITED KINGDOM.


SILASTIC QCF7-2856 ELASTOMER AS MFG. IN MIDLAND, MICHIGAN

ASACOL TABLETS MANUFACTURED IN WEITERSTADT, GERMANY.

Page 183

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6594 I
II
9/25/1986
FINE CHEMICALS CORPORATION

SUBJECT
SILVER SULPHADIAZINE MICRONIZED AS MFG. IN SOUTH AFRICA

6595

III

9/23/1986

WITTEN MANUFACTURING CO

PURIFIED COTTON USP AS MFG. IN GASTONIA, NORTH CAROLINA

6596

III

9/15/1986

WITTEN MANUFACTURING CO

PURIFIED RAYON AS MFG. IN GASTONIA, NORTH CAROLINA

6597

II

9/22/1986

METAPROTERENOL SULPHATE USP AS MFG. IN NIMIS (UDINE) ITALY

6598

II

9/24/1986

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
SANDOZ PHARMS CORP DIV SANDOZ INC

6599

II

10/29/1986

CIPLA LTD

METOPROLOL TARTRATE AS MFG. IN INDIA

6600

IV

9/23/1986

JRS PHARMA LP

EMCOCEL 90M MICROCRYSTALLINE CELLULOSE USP MANUFACTURED IN FINLAND.

6601

II

9/24/1986

NOVARTIS PHARMACEUTICALS CORP

PYRILAMINE BASE AS MFG. IN EAST HANOVER, NEW JERSEY

6602

II

9/23/1986

KV PHARMACEUTICAL CO

IBUPROFEN DIHYDROCODEINE F.C. TABLETS AS MFG. IN ST. LOUIS MO

6603

II

9/22/1986

MOEHS IBERICA SL

TRIAMTERENE AS MFG. IN RUBI (BARCELONA) SPAIN

6604

II

9/24/1986

NOVARTIS PHARMACEUTICALS CORP

PYRILAMINE MALEATE AS MFG. IN EAST HANOVER, NEW JERSEY

6605

II

9/23/1986

CILAG CHEMIE AG

MESALAZINE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

6606

II

9/24/1986

NOBEL CHEMICALS AB DIV FINE CHEMICALS INC

N,N'-BIS(2,3-DIHYDROXYPROPYL)-5-AMINO-ISOPHTHAMALIMIDE HCL

6607

III

9/16/1986

SWISSPACK CORP

TUBES AND CLOSURES MANUFACTURED IN LINCOLN PARK, NEW JERSEY.

6608

II

9/24/1986

HEXACHIMIE SA

1-(3-CHLOROPHENYL) PIPERAZINE HYDROCHLORIDE MANUFACTURED IN FRANCE.

6609

III

10/1/1986

COMAR UNICON PUERTO RICO LLC

PLASTIC PACKAGING COMPONENTS MANUFACTURED AT CAYEY, PR

6610

9/29/1986

AMEND RUGER CHEMICAL CO

FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN NJ

6611

IV

10/2/1986

ROQUETTE CORPORATION

LYCASIN BRAND OF HYDROGENATED GLUCOSE SYRUP MFG. IN ILL

6612

III

9/26/1986

PPG PACKAGING AND COATINGS

INTERNAL PROTECTIVE LACQUER COATINGS AS MFG. IN GERMANY

6613

II

9/29/1986

DIOSYNTH BV

NORGESTOMET AS MFG. IN THE NETHERLANDS

6614

2/18/1985

RP SCHERER CORP

6615

IV

9/29/1986

INDUSTRIAS CAPSUVAR SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ONTARIO, CANADA.
EMPTY HARD GELATIN CAPSULES AS MFG. IN CARACUS, VENEZUELA

6616

10/3/1986

LABORATORY FOR ANALYTICAL BIOLOGY INC

EFFECTS OF BIPERIDEN ON THE PHARMOKINETICS OF HALOPERIDOL

6617

III

9/26/1986

BASF CORP

SANTICIZER 711 MFG. IN TEXAS CITY, TEXAS

6618

II

10/2/1986

TEVA PHARMACEUTICALS INDUSTRIES LTD

ALBUTEROL BASE AND SULPHATE (SALBUTAMOL) MANUFACTURED IN ITALY.

6619

10/9/1986

ZENITH LABORATORIES INC

FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN NJ

6620

III

10/2/1986

HOSPIRA INC

BLOW/FILL/SEAL (B/F/S) SEMI-RIGID CONTAINER AS MFG. IN N.C.

6621

IV

10/2/1986

VEB GELATINE UND LEIMWERKE

EMPTY HARD GELATIN CAPSULES MFG. IN GERMANY

6622

II

10/8/1986

ZOLPIDEM TARTRATE MFG. IN GARGENVILLE, FRANCE

6623

III

9/30/1986

LABORATOIRES D'ETUDES ET DE RECHERCHES


SYNTHELABO
ALLPACK LTD

6624

III

6/3/1986

ADRIAPLAST SPA

ALKORPACK-P PLASTIC SHEET PACKAGING AS MFG. IN ITALY

6625

III

6/3/1986

ADRIAPLAST SPA

VENIPAK-P PLASTIC SHEET PACKAGING AS MFG. IN ITALY

6626

II

10/15/1986

SCHERING PLOUGH CORP

LORATADINE AS MFG. IN COUNTY WICKLOW, IRELAND

6627

III

9/22/1986

IDEMITSU PETROCHEMICAL COMPANY LTD

IDEMITSU POLYPROPYLENE FILM AS MFG. IN TOKYO, JAPAN

6628

III

10/15/1986

WYETH AYERST LABORATORIES INC

PROTOCOLS FOR EQUIVALENCY OF PACKAGING COMPONENTS

6629

II

10/14/1986

DR REDDY'S LABORATORIES LTD

L-METHYL DOPA AS MFG. IN INDIA

6630

III

10/15/1986

A SCHULMAN INC

COLORANTS FOR PLASTICS MANUFACTURED IN STRYKER, OHIO.

CHLORPHENIRAMINE BASE MANUFACTURED IN EAST HANOVER, NEW JERSEY.

PACKAGING OPERATIONS IN WAIBLINGEN, GERMANY.

Page 184

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6631 I
II
10/13/1986
CUNO INC

SUBJECT
ZETAPOR 0.20 UM AND 0.45 SP FLAT STOCK MEMBRANE AS MFG.IN CT

6632

III

9/30/1986

WILLIAM WARNE LTD

RUBBER SEALING GASKET PART #300H 42P AS MFG. IN ENGLAND

6633

10/14/1986

TOKUYAMA CORP

FACILITIES PRODUCING PROPANTHELINE BROMIDE

6634

7/18/1986

FERRING AB

6635

10/21/1986

AMERICAN CUSTOM DRYING COMPANY INC

6636

II

10/22/1986

RELIABLE CHEMICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MALMO, SWEDEN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BURLINGTON, NEW JERSEY.
PROTAMINE SULFATE (BULK) MANUFACTURED IN ST. LOUIS, MISSOURI.

6637

III

10/20/1986

ADVANCED ELASTOMER SYSTEMS

VYRAM THERMOPLASTIC RUBBER, GRADE 1055 MANUFACTURED IN ST. LOUIS, MISSOURI.

6638

II

10/21/1986

MIKART INC

LORCET PLUS TABLETS AS MFG. IN ALANTA, GEORGIA

6639

II

10/2/1986

GEDEON RICHTER

NORETHINDRONE 1 MG. AND MESTRANOL 0.05 MG. TABLETS IN BULK

6640

IV

10/2/1986

GEDEON RICHTER

FINISHED DOSAGE FORM OF PLACEBO TABLETS AS MFG. IN HUNGARY

6641

II

10/20/1986

FABBRICA ITALIANA SINTETICI SPA

CARBAMAZEPINE AS MFG. IN ITALY

6642

II

10/6/1986

LASA LABORATORIOS SA

METHOCARBAMOL MANUFACTURED IN BARCELONA, SPAIN.

6643

II

10/21/1986

IRISH FINE CHEMICALS LIMITED

DESIPRAMINE HYDROCHLORIDE AS MFG. IN WICKLOW, IRELAND

6644

II

9/10/1986

SIFAVITOR SRL

TIMOLOL MALEATE AS MFG. IN ITALY

6645

II

10/17/1986

PERPHENAZINE AS MFG. IN PITHIVIERS, FRANCE

6646

II

10/27/1986

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
QUATRUM

6647

10/22/1986

SPRAY TEK INC

6648

II

10/17/1986

HOKURIKU SEIYAKU CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NEW JERSEY.
TULOBUTEROL BASE AS MFG. BY YODOGAWA PHARMACEUTICAL CO.,LTD.

6649

10/27/1986

LENNON LTD

6650

II

10/29/1986

ROQUETTE FRERES

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PORT ELIZABETH, SOUTH AFRICA.
MANNITOL GRANULAR G.G. AS MFG. IN LESTREM, FRANCE

6651

III

10/21/1986

SAFET EMBAMET LETHIAS

SAFET MONOBLOC ALUMINUM CAN AS MFG. IN ST FLORENTIN, FRANCE

6652

II

8/8/1986

FERMION OY

TOREMIFENE CITRATE AS MFG. IN OULU, FINLAND

6653

10/30/1986

MY K LABORATORIES INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ILL.

6654

II

10/31/1986

NIACET CORP

SODIUM ACETATE ANHYDROUS, USP GRADE MANUFACTURED IN NIAGARA FALLS, CANADA.

6655

II

10/28/1986

EMERY CHEMICALS

EMTHOX 6946 (NONOXYNOL-9) MANUFACTURED IN SOUTH CAROLINA.

6656

II

9/30/1986

FINE CHEMICALS CORP PTY LTD

THIOTHIXENE HYDROCHLORIDE AS MFG. IN CAPE PROVINCE, S AFRICA

6657

10/29/1986

NEO MICRO AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6658

II

10/29/1986

EUTICALS SPA

SULFAPYRIDINE AS MFG. IN ITALY

6659

II

10/28/1986

ZENECA INC

COSMOCIL CQ (POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE)

6660

II

10/2/1986

GEDEON RICHTER

NORETHINDRONE 1 MG. AND ETHINYL ESTRADIOL 0.035 MG. USP TABS.

6661

II

11/6/1986

PINDOLOL AS MFG. IN MILAN, ITALY

6662

II

11/1/1986

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
HERAEUS PRECIOUS METALS GMBH AND CO KG

6663

II

11/5/1986

ACF CHEMIEFARMA NV

DESIPRAMINE HYDROCHLORIDE MANUFACTURED IN MAARSSEN, HOLLAND.

6664

11/7/1986

INTERNATIONAL MEDICINES EXCHANGE &


DEVELOPMENT

EMORFAZONE, CLINICAL AND PRE-CLINICAL STUDIES

HYDROCORTISONE HEMISUCCINATE MANUFACTURED IN LISBON, PORTUGAL.

CISPLATIN USP AS MANUFACTURED IN GERMANY

Page 185

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6665 I
II
11/10/1986
EGIS PHARMACEUTICALS

SUBJECT
DIETHYLCARBAMAZINE CITRATE USP AS MFG. IN BUDAPEST, HUNGARY

6666

II

11/10/1986

CUNO INC

ZETA PLUS 90 LP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED IN CONNECTICUT.

6667

II

11/5/1986

NV ORGANON

HUMAN MENOPAUSAL GONADOTROPHIN 100 AS MFG. IN THE NETHERLANDS

6668

II

11/7/1986

CYTARABINE AS MFG. IN PITHIVIERS, FRANCE

6669

II

11/10/1986

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
DOCTOR REDDYS LABORATORIES LTD

6670

II

11/12/1986

CUNO INC

ZETA PLUS 60 LP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT.

6671

III

11/5/1986

DUMA PACKAGING AS

DUMA TAMPER-EVIDENT CONTAINERS AND DUMACAPS MFG. IN DENMARK

6672

8/27/1986

STERIGENICS INTERNATIONAL

6673

II

11/12/1986

SOCIETA ITALIANA CORTICOSTEROIDI SPA

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN FORT


WORTH, TEXAS
MEGESTROL ACETATE MANUFACTURED IN MILAN, ITALY.

6674

II

11/11/1986

SOL PHARMACEUTICALS LIMITED

SULFAMETHOXAZOLE AND TRIMETHOPRIM AS MFG. IN INDIA.

6675

II

11/20/1986

SHIONOGI AND CO LTD

MOXALACTAM DIACID MANUFACTURED IN JAPAN.

6676

III

10/17/1986

EXXONMOBIL CHEMICAL CO

ESCORENE POLYPROPYLENE RESINS (1000 SERIES) MFG. IN TEXAS.

6677

III

10/22/1986

EXXONMOBIL CHEMICAL CO

ESCORENE POLYPROPYLENE RESINS (9000 SERIES) MANUFACTURED IN TEXAS.

6678

11/7/1986

PHARMACIA SPA

6679

II

11/12/1986

SYNTEX USA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MILAN, ITALY.
METHYLTESTOSTERONE MANUFACTURED IN MORELOS, MEXICO.

6680

II

11/20/1986

PENICK CORP

MORPHINE SULFATE AS MFG. IN NEWMARK, NEW JERSEY

6681

11/21/1986

SOLVAY PHARMACEUTICALS

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN GA

6682

II

11/18/1986

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

HALOPERIDOL DECANOATE AS MFG. IN MILAN, ITALY

6683

II

11/21/1986

HAARMANN & REIMER GMBH

DIBENZOSUBERONE AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY

6684

III

11/17/1986

AMCOR FLEXIBLES SHELBYVILLE

FLEXIBLE PACKAGING MATERIALS MANUFACTURED IN KENTUCKY.

6685

II

11/18/1986

GANES CHEMICALS INC

4-N,N-BIS(2-HYDROXYETHYL)-AMINOACETOPHENONE AS MFG. IN NJ

6686

II

11/14/1986

LUSOCHIMICA SPA

DILTIAZEM HYDROCHLORIDE AS MFG. IN MILAN, ITALY

6687

II

11/18/1986

HOVIONE FARMACIENCIA SA

BETAMETHASONE SODIUM PHOSPHATE AS MFG. IN PORTUGAL

6688

11/20/1986

TEVA PHARM & CHEMICAL WORKS

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN JERUSALEM

6689

II

11/20/1986

DIPHARMA FRANCIS SRL

DICLOFENAC SODIUM AS MFG. IN MILAN, ITALY

6690

II

11/20/1986

KV PHARMACEUTICAL CO

DISOPYRAMIDE S.R. CAPSULES (100 MG) MANUFACTYRED IN ST. LOUIS, MISSOURI.

6691

II

11/18/1986

EMERY CHEMICALS

EMEREST 2703 (PEG-4 LAURATE) AS MFG. IN MAULDIN, SC

6692

11/25/1986

RIVOPHARM SA

FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6693

II

11/25/1986

OLON SPA

MINOXIDIL MANUFACTURED IN MILAN, ITALY.

6694

II

11/26/1986

CUNO INC

ZETA PLUS 90 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT.

6695

IV

11/26/1986

LONZA RIVERSIDE

FILM COATING SOLUTION AS MFG. IN CONSHOHOCKEN, PENNSYLVANIA

6696

II

11/28/1986

TOKUYAMA CORP

SULFAMETHIZOLE AS MFG. IN JAPAN

6697

II

11/19/1986

BASF WYANDOTTE CORP

HDO 1,6-HEXANEDIOL MANUFACTURED IN FREEPORT, TEXAS.

6698

II

11/25/1986

PENNISULA LABORATORIES INC

BRADYKININ (A PEPTIDE) MANUFACTURED IN BELMONT, CALIFORNIA.

6699

II

12/2/1986

DIOSYNTH BV

ORGOTEIN MANUFACTURED IN OSS, HOLLAND.

6700

II

11/6/1986

STERLING CHEMS INC

LACTIC ACID 88% USP AND LACTIC ACID 88% LOW AMMONIA

6701

IV

12/17/1986

SHANDONG ENTERPRISES LTD

EMPTY HARD GELATIN CAPSULES AS MFG. IN PEOPLES REP. OF CHINA

IBUPROFEN AS MFG. IN INDIA

Page 186

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6702 I
I
11/24/1986
LEDERLE LABORATORIES DIV AMERICAN
CYANAMID CO
6703 I
V
12/3/1986
EASTMAN CHEMICAL CO

SUBJECT
FACILITIES, PERSONNEL AND GENERAL OPER. PROCEDURES IN GERMANY

6704

II

12/3/1986

EASTMAN CHEMICAL CO

5-AMINOSALICYLIC ACID DOSAGE FORM FOR CLINICAL RESEARCH

6705

II

12/5/1986

CIPLA LTD

METHOCARBAMOL AS MFG. IN INDIA

6706

II

12/4/1986

LINOLEIC ACID AS MFG. IN CANADA

6707

II

12/3/1986

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD
SALK INST BIOLOGICAL STUDIES

6708

II

11/26/1986

SIBEFAT SPA

VERAPAMIL HYDROCHLORIDE AS MFG. IN ITALY

6709

12/5/1986

PACKAGING COORDINATORS INC

6710

12/3/1986

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RICHMOND, VIRGINIA.
STERILE PROCESSING FACILITY FOR CEPHALOSPORIN IN JERUSALEM, ISRAEL

6711

II

12/2/1986

MEDICHEM SA

CHLORHEXIDINE BASE

6712

II

12/5/1986

CAMBREX PROFARMACO MILANO SRL

NAPROXEN SODIUM AS MFG. IN MILAN, ITALY

6713

II

11/28/1986

HOVIONE FARMACIENCIA SA

BETAMETHASONE 21-ACETATE AS MFG. IN LISBON, PORTUGAL

6714

II

12/3/1986

LERS CHEM DEVELOPMENT

CICLOPROLOL HYDROCHLORIDE AS MFG. IN FRANCE

6715

II

12/5/1986

FLUPHENAZINE HYDROCHLORIDE AS MFG. IN FRANCE

6716

II

12/11/1986

ORCHIMIE SA (PRODUITS CHIMIQUES ET


BIOCHIMIQUES)
CHUGAI PHARMACEUTICAL CO LTD

6717

12/5/1986

ROCHE AG

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

6718

11/26/1986

MARIETTA CORP

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

6719

II

12/8/1986

DAIICHI PURE CHEMICALS CO LTD

METHIONINE-ENKEPHALIN AS MFG. IN JAPAN

6720

II

12/5/1986

BORREGAARD INDUSTRIES LTD

5-AMINO-N,N'-BIS(2,3-DIHYDROXYPROPYL)-ISOPHTALAMIDE-HYDROCHLORIDE

6721

II

12/1/1986

EXCELLA GMBH

TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY

6722

12/15/1986

ROYCE LABORATORIES

FACILITIES, PERSONNEL AND CONTROLS IN FLORIDA

6723

12/8/1986

ATOMIC ENERGY OF CANADA LTD

FACILITIES AND GENERAL OPERATING PROCEDURES AT KANATA, CANADA

6724

II

11/25/1986

UNION CARBIDE AND CARBON CORP

CARBON DIOXIDE, XENON AND OXYGEN MIXTURE AS MFG. IN INDIANA

6725

II

12/15/1986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

6-ALPHA METHYLPREDNISOLONE AS MFG IN MADRID

6726

II

11/26/1986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

BETAMETHASONE DIPROPIONATE AS MFG. IN MADRID, SPAIN

6727

II

11/26/1986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

BETAMETHASONE SODIUM PHOSPHATE AS MFG. IN MADRID, SPAIN

6728

11/26/1986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

6729

II

12/17/1986

CUTTER BIOL DIV MILES LABS INC

CLOTRIMAZOLE AS MFG. IN CLAYTON, NC

6730

II

12/15/1986

BALENCO ENTERPRISES INC

MAPROTILINE HYDROCHLORIDE USP AS MFG. IN COMPTON, CA

6731

II

12/15/1986

CUNO INC

ZETA PLUS 50 LP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED INMERIDEN,CT

6732

II

12/15/1986

CUNO INC

ZETA PLUS 30 LP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED INMERIDEN,CT

6733

II

12/15/1986

CUNO INC

ZETA PLUS 60 SP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED INMERIDEN,CT

6734

12/1/1986

SOCIETA ITALIANA MEDICINAL SCANDICCI

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

6735

II

12/15/1986

OLON SPA

TAMOXIFEN CITRATE AS MFG. IN MILAN, ITALY

6736

II

12/15/1986

MAY AND BAKER LTD

KETOPROFEN AS MFG. IN DAGENHAM, ENGLAND.

6737

II

12/16/1986

GEDEON RICHTER LTD

BROMOCRIPTINE MESYLATE USP AS MFG. IN BUDAPEST, HUNGARY

5-AMINOSALICYLIC ACID TOXICOLOGY AND CLINICAL INFORMATION

[N-METYR1,NLE27,ASN28]-HGRF(1-29)-NHET AS MFG. IN CALIFORNIA

SG-75 (NICORANDIL) BULK DRUG PRODUCT AS MFG. IN JAPAN

Page 187

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6738 A
II
12/22/1986
GE HEALTHCARE

SUBJECT
SODIUM IODIDE I 123 PRODUCED VIA XENON XE 123

6739

III

11/19/1986

BETHAM CORP

1510C FOAM PAD AS MFG. IN NEW JERSEY

6740

II

12/26/1986

OKAMI CHEMICAL INDUSTRY CO LTD

TIOPRONIN AS MFG. IN JAPAN

6741

II

12/22/1986

DSM ANDENO

CARBASALATE CALCIUM AS MFG. IN HOLLAND.

6742

II

12/23/1986

CARBAMAZEPINE AS MFG. IN MILAN, ITALY.

6743

12/19/1986

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
PRIME EUROPEAN THERAPEUTICALS S P A

6744

II

12/22/1986

L-LEUCINE-ISOPROPYLAMINOCYCLOL HYDROCHLORIDE AS MFG IN SWITZ.

6745

IV

12/22/1986

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
BASF SE

6746

12/29/1986

ANAQUEST DIV BOC INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN OHIO

6747

II

12/29/1986

ANAQUEST DIV BOC INC

ENDROPHONIUM CHLORIDE USP AS MFG. IN CLEVELAND, OHIO.

6748

II

12/22/1986

HEXAGON LABORATORIES INC

CARBAMAZEPINE USP AS MFG. IN BRONX, NEW YORK.

6749

III

12/29/1986

DARTO MANUFACTURING INC

DARTCO XYDAR RESINS AS MFG. IN AUGUSTA, GEORGIA

6750

II

12/24/1986

BASF AKTIENGESELLSCHAFT

43915-BASF AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY

6751

II

12/24/1986

BASF AKTIENGESELLSCHAFT

47011-BASF AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY

6752

III

12/30/1986

SETCO

HIGH DENSITY POLYETHYLENE BOTTLES MANUFACTURED IN BROOKLYN, NEW YORK.

6753

II

11/26/1986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

HYDROCORTISONE HEMISUCCINATE AS MFG. IN MADRID, SPAIN

6754

II

12/30/1986

CUNO INC

ZETA PLUS 50 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT.

6755

II

12/30/1986

CUNO INC

ZETA PLUS 10 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT.

6756

III

12/15/1986

ALCAN CANADA FOILS

PUSH-THRU FOIL AS MFG. IN ONTARIO, CANADA

6757

II

12/31/1986

ALDRICH CHEMICAL COMPANY INC

AMINOGUANIDINE HYDROCHLORIDE (W176-2) AS MFG. IN WISCONSIN

6758

II

12/30/1986

CUNO INC

ZETA PLUS 30 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT.

6759

II

12/19/1986

PHARMECO LABORATORIES INC

CYCLOPENTOLATE HYDROCHLORIDE (P-637) AS MFG. IN CALIFORNIA

6760

II

12/29/1986

6761

II

1/5/1987

AYERST LABORATORIES INC DIV AMERICAN HOME INTRANASAL INSULIN AS MFG. IN NEW YORK
PRODUCTS CORP
CAMBREX PROFARMACO MILANO SRL
DILTIAZEM HCL AS MFG. IN MILAN, ITALY

6762

IV

1/2/1987

6763

II

6764

6765

6766

FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

KOLLIDON VA 64 AS MFG. IN GERMANY.

EMPTY HARD GELATIN CAPSULES AS MFG. IN PEOPLES REP. OF CHINA

12/23/1986

GUANGZHOU PHARMACEUTICAL PACKAGING


MATERIAL FACTORY
SELOC AG

II

1/5/1987

ACF CHEMIEFARMA NV

IMIPRAMINE HYDROCHLORIDE AS MFG. IN MAARSSEN, HOLLAND

III

1/6/1987

CONPLEX INC

THERMOPLASTIC SHEET AS MFG. IN FLORIDA

II

1/7/1987

GE SILICONES

BAYSILONE FLUID M 1000 S AS MFG IN GERMANY

6767

II

12/29/1986

MEDICHEM SA

LOXAPINE SUCCINATE AS MFG IN GERONA, SPAIN

6768

II

1/9/1987

PENICK CORP

OXYCODONE HYDROCHLORIDE AS MFG. IN NJ

6769

II

1/7/1987

GE SILICONES

BAYSILONE ANTIFOAM100% DIMETHYLPOLYSILOXANE MFG IN GERMANY

6770

II

10/6/1986

SODIUM HEPARIN.

6771

II

1/15/1987

SUZHOU BIOCHEMICAL PHARMACEUTICAL


MANUFACTURING CO
BAYER PHARMA AG

6772

II

1/13/1987

SELOC FRANCE

NIFEDIPINE AS MFG IN IRELAND

6773

II

1/15/1987

PENCO OF LYNDHURST INC

METHOCARBAMOL MANUFACTURED IN NEW JERSEY.

IMIPRAMINE PAMOATE AS MFG. BY SIFA LTD. IN IRELAND.

CLOTRIMAZOLE MANUFACTURED IN ASTURIAS, SPAIN AND WUPPERTAL, GERMANY.

Page 188

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6774 I
I
1/15/1987
CHELSEA LABORATORIES INC

SUBJECT
FACILITIES, PERSONNEL, & GENL OPERATING PROCEDURES IN NC.

6775

12/10/1986

ERCI FACILITIES SERVICES CORP

SOP'S FOR DRUG STORAGE AND DISTRIBUTION OF NCI DRUGS.

6776

II

1/12/1987

THIOTHIXENE BASE AND HC1 AS MFG. IN MILAN, ITALY

6777

II

1/9/1987

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
DINAMITE DIPHARMA SPA

6778

II

1/9/1987

DIPHARMA FRANCIS SRL

ISOSORBIDE-5-MONONITRATE (5-ISMN) AS MFG. IN ITALY.

6779

III

1/21/1987

ALPHA PACKAGING

HDPE & LDPE BOTTLES AS MFG. IN ST. LOUIS, MO.

6780

II

1/15/1987

PHARM ECO LABORATORIES INC

N,N'-BIS (2-CHLOROETHYL)-N-NITROSOUREA (CARMUSTINE) MFG IN CA

6781

III

1/16/1987

MOBAY CHEMICAL CORP

MERLON M 40(H)F-3291 MANUFACTURED IN BAYTOWN, TEXAS.

6782

II

1/19/1987

CUNO INC

ZETA PLUS 01A MEDIA CARTRIDGES AND FLA STOCKMANUFACTURED INMERIDEN,CT

6783

II

12/19/1986

ORION CORPORATION FERMION OULU PLANT

TOLMETIN SODIUM AS MFG. IN FINLAND.

6784

II

1/19/1987

HOECHST AG

CEFAZOLIN SODIUM INJECTION (STERILE FILLING), MFG. GERMANY.

6785

II

1/19/1987

CUNO INC

ZETA PLUS 30 CP MEDIA CARTRIDGES & FLA STOCK AS MFG. IN CT.

6786

II

1/8/1987

QUATRUM

HYDROCORTISONE ACETATE AS MFG. IN PORTUGAL.

6787

IV

1/23/1987

SHIONOGI AND CO LTD

CAPSULES 7432-S AS MFG. IN JAPAN

6788

II

1/27/1987

PFIZER INC

TRIAMCINOLONE 21-ACETATE AS MFG. IN MI.

6789

II

1/23/1987

DOTTIKON EXCLUSIVE SYNTHESIS AG

ISOSORBIDE-5-NITRATE-LACTOSE 20:80 BLEND MFG. IN SWITZERLAND.

6790

II

1/19/1987

CUNO INC

ZETA PLUS 70 CP MEDIA CARTRIDGES & FLA STOCK MANUFACTURED IN CONNECTICUT.

6791

II

1/19/1987

CUNO INC

ZETA PLUS 60 CP MEDIA CARTRIDGES & FLA STOCK AS MFG. IN CT.

6792

IV

1/14/1987

PHARMACIA AB

SEPHADEX GEL FILTRATION MEDIA AS MFG. IN SWEDEN

6793

II

1/20/1987

SULFAMETHOXAZOLE USP AS MFG. IN PEOPLES REPUBLIC OF CHINA.

6794

IV

1/19/1987

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD
PHARMACIA AB

6795

II

1/20/1987

TRIMETHOPRIM USP MANUFACTURED IN PEOPLE'S REPUBLIC OF CHINA.

6796

II

1/22/1987

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD
PURDUE UNIVERSITY

6797

1/26/1987

ORION CORP LTD

6798

II

1/28/1987

ANAQUEST INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MANKKAA PLANT.
METHOXYFLURANE MANUFACTURED IN OHIO.

6799

II

1/30/1987

ISOSORBIDE DINITRITE (ISDN), 2-ISMN AND 5-ISMN

6800

II

2/2/1987

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
IMHAUSEN CHEMIE GMBH

6801

II

1/27/1987

KV PHARMACEUTICAL CO

BROMPHENIRAMINE MALEATE/PHENYLPROPANOLAMINE C.R. TABLET

6802

1/30/1987

UCB BIOPRODUCTS SA

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

6803

II

2/5/1987

GRAESSER LABORATORIES LTD

ISOSORBIDE-2-MONONITRATE AS MFG. IN THE UNITED KINGDOM

6804

II

2/2/1987

UPJOHN CO

U-62,840 AS MFG. IN KALAMAZOO, MICHIGAN

6805

II

1/28/1987

RAYLO CHEMICALS

2',3'-DIDEOXYCYTIDINE AS MFG. IN CANADA

6806

II

2/2/1987

SELOC AG

IMIPRAMINE HYDROCHLORIDE AS MFG. BY SIFA LTD IN IRELAND

6807

IV

1/27/1987

PHARMACIA AB

SEPHADEX ION EXCHANGE MEDIA AS MFG. IN SWEDEN

6808

II

2/4/1987

SANOFI CHEMIE SAPCHIM

FLURAZEPAM HYDROCHLORIDE AS MFG. IN ARAMON, FRANCE

6809

II

2/5/1987

KYOWA HAKKO KOGYO CO LTD

ALPHA-MERCAPTOPROPIONYLGLYCINE AS MFG. IN JAPAN

ISOSORBIDE-2-MONONITRATE (2-ISMN) AS MFG. IN ITALY.

SEPHACRYL GEL FILTRATION MEDIA AS MFG. IN SWEDEN

3,4-METHYLENEDIOXYMETHAMPHETAMINE MDMA AS MFG. IN INDIANA

HALOPERIDOL MANUFACTURED IN LAHR, GERMANY.

Page 189

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6810 I
II
1/19/1987
CUNO INC

SUBJECT
ZETA PLUS 50 CP MEDIA CARTRIDGES AND FLA STOCK

6811

II

1/23/1987

SOCIETA ITALIANA CORTICOSTEROIDI SPA

FLUNISOLIDE AS MFG. IN MILAN, ITALY

6812

II

1/19/1987

CHEMINOVA AS

FYFANON TECHNICAL AS MANUFACTURED IN DENMARK

6813

II

1/19/1987

CUNO INC

ZETA PLUS 05 SP MEDIA CARTRIDGES AND FLA STOCK

6814

II

1/23/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

CLOBETASOL PROPIONATE AS MFG. IN MILAN, ITALY

6815

II

2/4/1987

SIBEFAT SPA

SODIUM CROMOGLYCATE AS MFG. IN ITALY

6816

II

1/19/1987

CUNO INC

ZETA PLUS 10 CP MEDIA CARTRIDGES AND FLA STOCK

6817

II

1/23/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

PANCURONIUM BROMIDE AS MFG. IN MILAN, ITALY

6818

II

2/11/1987

ALTANA LOMBERG CHEMISCHE FABRIK

THEOPHYLLINE SUSTAINED RELEASE CAPSULES (BY-158)

6819

II

1/6/1987

KYOWA HAKKO KOGYO CO LTD

DACARBAZINE AS MFG. IN JAPAN

6820

III

2/4/1987

WINN PACKAGING CO

HIGH DENSITY POLYETHYLENE PLASTIC CONTAINERS MANUFACTURED IN OHIO.

6821

II

12/16/1986

RELIANCE CELLULOSE PRODUCTS LTD

MICROCRYSTALLINE CELLULOSE AS MFG. IN INDIA

6822

2/12/1987

ASTA PHARMA AG

PHARMACEUTICAL PRODUCTION PLANT IN KUNSEBECK, GERMANY

6823

II

2/6/1987

PENINSULA LABS

D-ALA-8-THR-NH2 AS MFG. IN BELMONT, CALIFORNIA

6824

2/10/1987

SOUTH FLORIDA BIOAVAILABILITY CLINIC INC

EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL

6825

II

2/13/1987

DIOSYNTH BV

BETAMETHASONE MICRO AS MFG. IN HOLLAND

6826

2/10/1987

MEPHA AG

FACILITIES, PERSONNEL AND GENERAL OPER. PROC. IN SWITZERLAND

6827

II

2/13/1987

LEK PHARMACEUTICALS DD

BROMOCRIPTINE MESYLATE USP AS MFG. IN MENGES, SLOVENIA

6828

IV

2/11/1987

EMERY CHEMICALS

EMERWAX 1266 EMULSIFYING WAX AS MFG. IN SOUTH CAROLINA

6829

II

2/19/1987

ELAN PHARMA LTD

NIFEDIPINE 50 MG. TABLETS AS MFG IN IRELAND

6830

II

1/23/1987

QUATRUM

METHYLPREDNISOLONE HEMISUCCINATE AS MFG. IN PORTUGAL

6831

III

2/23/1987

SPARTECH PLASTICS

COMPOSITE THERMOPLASTIC SHEET TYPE GTE/MTE/FTE MFG. IN MASS

6832

II

1/19/1987

QUATRUM

METHYLPREDNISOLONE BASE MANUFACTURED IN PORTUGAL.

6833

III

2/24/1987

TECHNICAL PLASTIC EXTRUDERS INC

PHARMACEUTICAL GRADE POLYVINYL CHLORIDE FILM AND SHEETING

6834

2/13/1987

SUPERIOR INC

FACILITIES, PERSONNEL AND PROCEDURES IN FELTON, PA

6835

II

2/23/1987

LABOCHIM

METAPROTERENOL SULFATE USP AS MFG. IN MILAN, ITALY

6836

II

2/26/1987

ORGANICHEM CORP

AMINOBISAMIDE HYDROCHLORIDE AS MFG. IN NORTHUMBERLAND, ENGLAND

6837

III

2/23/1987

ALUMINUM COMPANY OF AMERICA

PHAR 9423 AS MFG IN PITTSBURGH, PA

6838

II

2/27/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

METOPROLOL TARTRATE USP AS MFG. IN ISREAL

6839

III

3/6/1987

HOSPIRA INC

ADD-VANTAGE FLEXIBLE DILUENT CONTAINER AS MFG. IN TX & IL

6840

II

2/18/1987

ORION CORP LTD

PRAZOSIN HCL DELTA-FORM AS MFG. IN MANKKA, FINLAND

6841

II

2/18/1987

ORION CORP LTD

PRAZOSIN HCL ALPHA-FORM AS MFG. IN MANKKA, FINLAND

6842

III

3/3/1987

JAMES RIVER CORPORATION

MANU OF CELESTRA X 1.00 LLP-T090 AND V090 NONWOVEN FABRICS IN WA.

6843

II

3/3/1987

ALBEMARLE CORP

FENOPROFEN CALCIUM, USP+BP AS MFG. IN SOUTH HAVEN, MICHIGAN

6844

III

2/24/1987

WACHUSETT MOLDING CORP

PACKAGING MATERIALS AS MFG. IN MASS.

6845

II

2/26/1987

PHARM ECO LABORATORIES INC

2,6-DICHLORO-N-(4,5-DIHYDRO-IH-IMIDAZOL-2-YL)-1,4-BEZENEDIAMINE MONO

6846

3/3/1987

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN VARESE,ITALY

6847

II

3/6/1987

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
DYNAMIT NOBEL AKTIENGESELLESCHAFT

NITROGLYCERIN 5% IN MIGLYOL 829 AS MFG. IN GERMANY

Page 190

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6848 I
II
3/9/1987
HOECHST MARION ROUSSEL SA

SUBJECT
TRIAMCINOLONE 21-ACETATE AS MFG. IN FRANCE

6849

II

2/26/1987

PHARM ECO LABORATORIES INC

XYLAZINE HYDROCHLORIDE MANUFACTURED IN SIMI VALLEY, CALIFORNIA.

6850

II

3/11/1987

FINE CHEMICALS CORPORATION

FLUPHENAZINE ENANTHATE AS MFG. IN SOUTH AFRICA

6851

2/27/1987

CYANAMID GREAT BRITAIN LTD

FACILITY AT GOSPORT HANTS, ENGLAND

6852

III

2/25/1987

SILGAN PLASTICS CORP

PACKAGING MATERIALS MANUFACTURED IN LYONS, NEW YORK

6853

II

3/10/1987

UCB PHARMA SA

CETIRIZINE HYDROCHLORIDE AS MFG. IN BELGIUM

6854

3/3/1987

ORION CORP LTD

6855

III

3/10/1987

BARNHARDT MANUFACTURING CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FINLAND.
PHARMACEUTICAL COIL PRODUCTS MANUFACTURED IN NORTH CAROLINA.

6856

II

3/10/1987

GANES CHEMICALS INC

DOXEPIN HYDROCHLORIDE MANUFACTURED IN NEW JERSEY.

6857

II

3/9/1987

CAMBREX PROFARMACO MILANO SRL

MECLOFENAMATE SODIUM AS MFG. IN ITALY

6858

II

3/10/1987

CUNO INC

50 TSM MEDIA CARTRIDGES AS MFG. IN MERIDEN, CONNECTICUT

6859

II

3/13/1987

DIOSYNTH BV

STABILIZED ESTRONE SODIUM SULPHATE AS MFG. IN THE NETHERLANDS

6860

II

2/27/1987

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

NIFEDIPINE MANUFACTURED IN ITALY.

6861

II

3/13/1987

DIOSYNTH BV

EQUILIN SODIUM SULPHATE STABILIZED AS MFG. IN THE NETHERLANDS .

6862

II

3/2/1987

DAITO PHARMACEUTICAL CO LTD

CLEMASTINE FUMARATE

6863

II

3/10/1987

CUNO INC

100 TSM MEDIA CARTRIDGES AS MFG. IN MERIDEN, CONNECTICUT

6864

III

3/4/1987

HELVOET PHARMA ITALIA SPA

RUBBER STOPPERS IN GREY CHLOROBUTYL COMPOUND 464.04

6865

III

3/4/1987

HELVOET PHARMA ITALIA SPA

RUBBER STOPPERS IN GREY BROMOBUTYL COMPOUND 544.04

6866

III

3/6/1987

TOP SEAL CORP

INJECTION MOLDED CLOSURES MANUFACTURED A PHOENIX, ARIZONA.

6867

III

3/4/1987

HELVOET PHARMA ITALIA SPA

EPR COPOLYMER RUBBER COMPOUND 056.04 AS MFG. IN ITALY

6868

II

1/20/1987

FINORGA SAS

ESMOLOL HYDROCHLORIDE AS MFG. IN FRANCE

6869

II

3/5/1987

ERREGIERRE SPA

ECONAZOLE NITRATE AS MFG. IN ITALY.

6870

II

3/5/1987

ERREGIERRE SPA

MICONAZOLE NITRATE AS MFG. IN ITALY

6871

II

3/13/1987

QUIMICA SINTETICA SA

MECLOFENAMATE SODIUM USP AS MFG. IN SPAIN

6872

II

3/13/1987

ZAMBON SPA

NAPROXEN USP MANUFACTURED IN ITALY.

6873

II

3/16/1987

HILLESTAD CORP

COUMARIN TABLETS 100 MG. MANUFACTURED IN SAN JOSE, CALIFORNIA.

6874

II

3/9/1987

SIBEFAT SPA

GEMFIBROZIL USP AS MFG. IN ITALY

6875

II

3/19/1987

KANEKA AMERICA CORP

N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANINE (ALE)

6876

III

3/13/1987

LLOYD MANUFACTURING COMPANY INC

GUM RUBBER FORMULATION #3141-71 MANUFACTURED IN RHODE ISLAND.

6877

II

3/6/1987

SEKISUI MEDICAL CO LTD

CLEMASTINE FUMARATE MANUFACTURED IN JAPAN.

6878

II

3/20/1987

DAIICHI PURE CHEMICALS CO LTD

MIX-RR MANUFACTURED IN TOKYO, JAPAN.

6879

II

3/10/1987

SANKYO CHEMICAL INDUSTRIES INC

FLAVOXATE HYDROCHLORIDE AS MFG. IN TOKYO, JAPAN.

6880

II

3/20/1987

MOEHS SA DIV OF SANOF

TRIMETHOPRIM AS MFG. IN SPAIN

6881

II

3/23/1987

NOVA PHARMACEUTICAL CORP

NPC-567 PRECLINICAL STUDIES & MFG. PROCEDURES IN BALTIMORE

6882

II

3/16/1987

PROSINTEX INDUSTRIE CHIMICHE ITALIANE SRL

MICONAZOLE NITRATE AS MFG. IN ITALY

6883

II

3/18/1987

SHIONOGI AND CO LTD

COMPOUND 7432-S AS MFG. IN JAPAN

6884

II

3/23/1987

LEO PHARMACEUTICAL PRODUCTS LTD

SODIUM TAURO-24,25-DIHYDROFUSIDATE BULK SUBSTANCE AS MFG. IN DENMARK

6885

II

1/20/1987

CIPLA LTD

ALBUTEROL SULFATE USP MANUFACTURED IN BOMBAY, INDIA.

Page 191

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6886 I
II
1/21/1987
CIPLA LTD

SUBJECT
ALBUTEROL AS MFG IN BOMBAY, INDIA

6887

II

3/16/1987

MEDICHEM SA

AMOXAPINE AS MFG. IN SPAIN

6888

II

3/13/1987

QUATRUM

METHYLPREDNISOLONE ACETATE AS MFG. IN PORTUGAL

6889

3/25/1987

ICI PHARMACEUTICALS PR INC

6890

II

3/27/1987

AMERSHAM CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CAROLINA, PUERTO RICO.
IN-113M GENERATOR AS MFG. IN ENGLAND

6891

IV

3/26/1987

DOW CORNING CORP

TRIMETHYLSILOXY ENDBLOCKED POLYMETHYLHYDROGEN SILOXANE

6892

II

3/25/1987

LONZA AG

L-CARNITINE (VIT. BT) AS MFG. IN SWITZERLAND

6893

III

3/23/1987

NORWOOD INDUSTRIES INC

NORWOOD KM-1392-00 AND IT'S COMPONENTS AS MFG. IN PA.

6894

3/16/1987

STERIGENICS US LLC

6895

II

3/26/1987

NOVARTIS PHARMA AG

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN HAW


RIVER, NC
POLY (DL-LACTIDE-CO-GLYCOLIDE) MANUFACTURED IN SWITZERLAND.

6896

2/28/1987

HOVIONE MACAU SOCIEDADE QUIMICA LDA

6897

4/1/1987

AUTOMATIC LIQUID PACKAGING

6898

II

3/25/1987

ISP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MACAU.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN WOODSTOCK, ILLINOIS.
SODIUM HYDROGEN VALPROATE AS MFG. IN CA

6899

II

3/31/1987

ORION CORP FARMOS CHEMICAL PLANT

METHOTREXATE 2,5 MG TABLET MANUFACTURED IN FINLAND.

6900

II

3/25/1987

POLYARYLSULFONE RESIN RADEL A-400

6901

3/30/1987

AMOCO CHEMS CORP AFFILIATE AMERICAN OIL


CO
POYTHRESS & CO

6902

III

4/2/1987

BCL LTD

REGENERATED CELLULOSE FILM AS MFG. IN SOMERSET, EMGLAND

6903

III

4/2/1987

BCL LTD

REGENERATED CELLULOSE FILM MANUFACTURED IN CUMBRIA, ENGLAND.

6904

II

4/3/1987

BLASCHIM SPA

FENOPROFEN CALCIUM MANUFACTURED IN MILANO, ITALY.

6905

II

3/30/1987

ZENECA PHARMACEUTICALS

ATENOLOL AS MANUFACTURED IN GERMANY

6906

3/31/1987

QUIMICA SINTETICA SA

FACIL, PERSONNEL AND GENL OPERATING PROCEDURES AT MADRID,SPAIN

6907

3/26/1987

INJECTRONICS INC

6908

II

4/7/1987

SIGMA ALDRICH IRELAND LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CLINTON, MA
DOXYLAMINE SUCCINATE USP

6909

II

4/3/1987

ZEELAND CHEMICALS INC

PARA-AMINOSALICYLIC ACID, SODIUM AS MFG. IN MICHIGAN

6910

II

3/26/1987

CIBA GEIGY LTD

CHLORTHALIDONE USP MANUFACTURED IN SWITZERLAND.

6911

II

4/8/1987

ZENECA PHARMACEUTICALS

ZESTRIL (LISINOPRIL) TABLETS AS MFG. IN DELAWARE

6912

3/30/1987

CELLTECH LTD

FACILITIES FOR PRODUCTION OF BULK RECOMBINANT HUMAN GROWTH HORMONE

6913

3/16/1987

STERIGENICS INTERNATIONAL

6914

II

4/9/1987

FINE CHEMICALS CORP PTY LTD

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN SALEM,


NEW JERSEY
BENZTROPINE MESYLATE AS MFG. IN SOUTH AFRICA

6915

3/16/1987

PROCESS TECHNOLOGY INC

FACILITIES, PERSONNEL AND PROCEDURES IN WEST MEMPHIS, ARIZONA

6916

III

3/4/1987

BUNDER GLAS GMBH

PACKAGING MATERIALS/BRONCHOLATOR AND RHINOLATOR AS MFG. IN GERMANY

6917

4/10/1987

AL HIKMA PHARMACEUTICALS

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMMAN JORDON

6918

II

4/7/1987

L-651,392-00N,4-BROMO-2,7-DIMETHOXY-3H-PHENOTHIAZIN-3-ONE

6919

4/9/1987

MERCK SHARP & DOHME RESEARCH LABS DIV


MERCK & CO INC
VOKES LTD

FACIL, PERSONNEL & CONTROLS A RICHMOND, VA

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ENGLAND

Page 192

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6920 I
II
4/7/1987
MERCK SHARP & DOHME DIV MERCK & CO INC

SUBJECT
APRINOCID AS MFG IN NEW JERSEY AND ENGLAND

6921

II

4/10/1987

SIBEFAT SPA

ATENOLOL-MFG IN MILANO,ITALY(FORMERLY B.T.B. INDUSTRIA CHIMICA

6922

II

4/10/1987

HEXAGON LABORATORIES INC

DEXCHLORPHENIRAMINE MALEATE AS MFG IN NEW YORK

6923

III

4/3/1987

COOPER FLEXIBLE PACKAGING, INC.

FLEXOGRAPHIC PRINTED INNERSEAL MATERIAL AS MFG IN ILLINOIS

6924

II

4/8/1987

MOEHS IBERICA SL

AMANTADINE HYDROCHLORIDE AS MFG IN SPAIN

6925

II

4/14/1987

ORION CORP FARMOS CHEMICAL PLANT

LEUCOVORIN CALCIUM 15MG TABLET AS MFG IN FINLAND

6926

II

4/6/1987

DIGOXIN AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY

6927

II

4/3/1987

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
ETHYL CHEMICALS GROUPS

6928

4/6/1987

GABRIEL CONSULTING INC

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MASS

6929

III

4/15/1987

CLP INDUSTRIES LTD

FLEXIBLE PACKAGING MATERIALS MANUFACTURED IN ISRAEL

6930

II

4/7/1987

MALLINCKRODT INC

OXYCODONE HYDROCHLORIDE USP (D) AS MANUFACTURED IN ST LOUIS MISSOURI

6931

4/15/1987

KNOLL AG

6932

II

4/14/1987

CAMBREX PROFARMACO MILANO SRL

MANUFACTURING SITE, FACILITES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MINDEN, GERMANY.
FENOPROFEN CALCIUM MANUFACTURED IN MILAN, ITALY.

6933

II

4/2/1987

DAIICHI PURE CHEMICALS CO LTD

L-VALINE AS MFG IN JAPAN

6934

II

4/2/1987

DAIICHI PURE CHEMICALS CO LTD

L-PHENYLALANINE AS MFG IN JAPAN

6935

III

4/13/1987

BOCKO INC

MANUFACTURE OF PLASTIC CONTAINERS FOR MEDICINE

6936

II

4/8/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE AS MFG IN MILAN ITALY

6937

II

4/15/1987

SANKYO CO LTD

CS-807 TABLETS AS MFG IN JAPAN

6938

II

4/20/1987

TOKUYAMA CORP

HYDRALAZINE HYDRCHLORIDE AS MFG IN JAPAN

6939

II

4/20/1987

HOFFMANN LA ROCHE INC

PYRIDOSTIGMINE BROMIDE AS MFG IN NEW JERSEY

6940

II

4/23/1987

SUMITOMO CHEMICAL CO LTD

CEFPIRAMIDE AS MFG IN JAPAN

6941

II

4/20/1987

HOFFMANN LA ROCHE INC

NEOSTIGMINE METHYLSULFATE AS MFG IN NEW JERSEY

6942

II

4/21/1987

MILES INC

EX-CYTE I (BOVINE ORIGIN) GROWTH ENHANCEMENT MEDIA SUPPLEMENT

6943

IV

4/21/1987

MILES INC

EX-CYTE III (BOVINE ORIGIN) GROWTH ENHANCEMENT MEDIA SUPPLEMENT

6944

II

4/22/1987

E MERCK

SODIUM DIETHYLDITHIOCARBAMATE TRIHYDRATE-EXTRA PURE AS MFG IN GERMANY

6945

4/24/1987

ANTI-INFECTIVE FACILITIES AT CONSHOHOKEN, PENNSYLVANIA

6946

II

4/15/1987

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
DR REDDY'S LABORATORIES LIMITED

6947

II

4/7/1987

BK GIULINI GMBH

PHOSKADENT NA 211 (SODIUMMONOFLUOROPHOSPHATE) AS MFG IN GERMANY

6948

4/28/1987

STELLA KG

6949

III

4/30/1987

GEORGIA PACKAGING INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ELTVILLE, GERMANY.
41737-30 PACKAGING MATERIAL AS MFG. IN COLUMBUS, GEORGIA

6950

4/28/1987

STELLA KG

6951

III

4/27/1987

HYGENIC CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KASTELLAUN, GERMANY.
PROCESSING OF LATEX SHEETING FOR COMPOUND FORMULA TR200

6952

II

4/16/1987

LABORATOIRES FOURNIER SA

FENOFIBRATE CAPSULES AS MFG IN FRANCE AND SWITZERLAND

6953

4/16/1987

SYNKEM DIV PLASTO SA

6954

4/16/1987

LABORATOIRES FOURNIER SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CHENOVE, FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN FONTAINE-LES-DIJON FRANCE.

IBUPROFEN AS MFG IN ORANGEBURG, SOUTH CAROLINA

ESTRADIOL AS MFG BY SYNTEX S.A IN MORELOS, MEXICO

Page 193

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6955 A
II
5/11/1987
EUTICALS SPA

SUBJECT
BROMOCRIPTINE MESYLATE AS MFG IN MILAN ITALY;

6956

III

5/4/1987

BRISTOL-MYERS PRODS DIV BRISTOL-MYERS CO

PACKAGING MATERIALS

6957

4/30/1987

SOUTH FLORIDA BIOAVAILABILITY CLINIC INC

DETERMINATION OF ERYTHROMYCIN IN HUMAN SERUM BY BIOLUMINOMETRY ASSAY

6958

II

4/30/1987

SOCIETA ITALIANA CORTICOSTEROIDI SPA

TRIAMCINOLONE HEXACETONIDE AS MFG IN ITALY;

6959

5/11/1987

POLI INDUSTRIA CHIMA SPA

FACILITIES PERSONNEL AND GENERAL OPERATING PROCEDURES IN MILAN, ITALY

6960

II

5/8/1987

FARMABOIS

BETAMETHASONE 17 VALERATE AS MFG IN ITALY

6961

II

5/8/1987

FARMABOIS

BETAMETHASONE AS MFG IN ITALY

6962

II

5/8/1987

HEXAGON LABORATORIES INC

BENZPHETAMINE HYDROCHLORIDE AS MFG IN BRONX, NEW YORK

6963

III

4/29/1987

SCANDIA PLASTICS INC

HDPE PILL BOTTLES AS MFG IN SHEBOYGAN, WISCONSIN.

6964

4/28/1987

FOREST LABORATORIES INC

FACILITIES AND PERSONNEL IN RIO PIEDRAS, PUERTO RICO

6965

5/8/1987

PARTICLE SIZE TECHNOLOGY INC

6966

II

5/8/1987

SIGMA F AND D DIV LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PENNSYLVANIA.
APOMORPHINE HCL AS MFG. IN SAINT LOUIS, MISSOURI.

6967

II

5/8/1987

NORAMCO INC

MORPHINE SULFATE AS MFG. IN WILMINGTON, DELAWARE

6968

5/12/1987

JOHNSON MATTHEY PLC

6969

II

4/30/1987

DIAMALT AG

MANUFACTURING SITE, FACILTIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN READING, ENGLAND
ENCAINIDE HYDROCHLORIDE AS MFG IN GERMANY

6970

II

4/14/1987

NOVO NORDISK AS

NORDITROPIN (BIOSYNTHETIC HUMAN GROWTH HORMONE, SOMAROPIN)

6971

II

5/12/1987

AVATAR CORP

SOYBEAN OIL, USP MANUFACTURED IN HICKORY HILLS, ILLINOIS.

6972

II

5/13/1987

MALLINCKRODT INC

IOVERSOL AS MANUFACTURED IN ST. LOUIS, MISSOURI

6973

5/15/1987

PACO PHARMACEUTICAL SERVICES INC

TRANSDERMAL MANUFACTURING FACILITY AT LAKEWOOD, NEW JERSEY

6974

5/2/1987

CONTRAPAK CORP

CONTRACT PACKAGING FACILITY IN WAYNE, PENNSYLVANIA

6975

II

5/12/1987

MCGAW INC

CYOCTOL PURIFIED AS MFG IN IRVINE, CALIFORNIA

6976

II

5/5/1987

NATL INST HLTH CONTRACEPTIVE DEV BRANCH

[D-TRP6, PRO9-NHET] GNRH

6977

II

4/10/1987

MALLINCKRODT CHEMICAL INC

OXYCODONE TEREPHTHALATE-D MANUFACTURED IN SAINT LOUIS,MISSOURI.

6978

5/19/1987

PROGRAPHARM LABS

FACILITES AND PERSONNEL AT CHATEAUNEUF-EN-THYMERAIS, FRANCE

6979

II

5/5/1987

ATENOLOL AS MFG IN FIRENZE, ITALY.

6980

5/7/1987

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
AMILCO CORP PR

6981

II

5/27/1987

YUNG ZIP CHEMICAL IND CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF GLASS CONTAINERS IN PUERTO RICO.
DICLOFENAC SODIUM MANUFACTURED IN TAIWAN.

6982

II

5/27/1987

YUNG ZIP CHEMICAL IND CO LTD

MICONAZOLE NITRATE AS MFG. IN TAIWAN

6983

II

5/22/1987

PCAS

TIMOLOL MALEATE MANUFACTURED IN FINLAND.

6984

II

5/8/1987

CHEMAPOL LTD

BROMOCRIPTINE MESYLATE MANUFACTURED BY GALENA IN CZECHOSLOVAKIA.

6985

5/1/1987

TIM PLASTICS INC

FACILITIES FOR MANUFACTURING HIGH DENSITY POLYETHYLENE BOTTLES

6986

5/26/1987

BAUSCH AND LOMB INC

6987

II

5/19/1987

ALCOLAC INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GREENVILLE, SOUTH CAROLINA.
CHLORHEXIDINE GLUCONATE MANUFACTURED IN BALTIMORE AND SEDALIA, MARYLAND.

6988

II

5/27/1987

SANDOZ GMBH

SACA SODIUM SALT AS MFG IN AUSTRIA

6989

II

5/29/1987

COPPERHEAD INVESTMENTS INC

SDM 77 (10% NITROGLYCERIN IN SOLVATED ACRYLATE BASED ADHESIVE) MANUFACTURED


IN TAMAQUA, PA.

Page 194

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
6990 I
I
5/27/1987
MEDEA RESEARCH LABS
6991

II

5/28/1987

ROHM AND HAAS CO

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN PORT JEFFERSON STATION, NEW YORK.
BIOCRYL BPA-5050PMN MANUFACTURED IN BRISTOL, PENNSYLVANIA.

6992

II

5/28/1987

ELAN PHARM RES CORP

THEOPHYLLINE CONTROLLED RELEASE BEADS MANUFACTURED IN GAINESVILLE, GEORGIA.

6993

5/27/1987

3M PHARMS

FACILITIES FOR MFG OF TRANSDERMAL DELIVERY DRUG PRODUCTS

6994

II

5/20/1987

SIEGFRIED AG

PHENPROBAMATE AS MFG IN SWITZERLAND

6995

IV

5/22/1987

TEK PRODUCTS AND SERVICES INC

IMPRINTING INKS FOR MARKING PHARMACEUTICAL DOSAGE FORMS

6996

IV

5/29/1987

WAKO PURE CHEMICAL INDUSTRIES LTD

COPOLY (DL-LACTIC ACID/GLYCOLIC ACID) MANUFACTURED IN JAPAN.

6997

II

5/22/1987

SIMS SRL

KETOPROFEN MANUFACTURED IN ITALY.

6998

IV

5/29/1987

GATTEFOSSE ESTABLISSEMENTS

SUPERPOLYSTATE MANUFACTURED IN FRANCE.

6999

5/29/1987

GRANUTEC INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN NC

7000

II

6/4/1987

ABBOTT LABORATORIES

VERAPAMIL HYDROCHLORIDE AS MANUFACTURED IN LIESTAL, SWITZERLAND

7001

IV

6/1/1987

BORDEN INC

#8743P NATURAL AND ARTIFICIAL SPRAY DRIED FRUIT PUNCH FLAVOR

7002

II

6/1/1987

GUANGZHOU PHARMACEUTICAL FACTORY

LINCOMYCIN HCL MANUFACTURED IN PEOPLES REPUBLIC OF CHINA.

7003

6/4/1987

FERRING GMBH

FACILITIES AND OPERATING PROCEDURES IN GERMANY

7004

II

6/4/1987

FERRING GMBH

GONADORELIN ACETATE AS MFG IN GERMANY

7005

II

5/29/1987

SIBEFAT SPA

SULINDAC USP XXI AS MFG IN ITALY

7006

III

6/5/1987

EXXONMOBIL CHEMICAL CO

LOW DENSITY POLYETHYLENE AND ETHYLENE-VINYL ACETATE COPOLYMERS

7007

II

6/8/1987

DIOSYNTH BV

17-ALPHA DIHYDROEQUILIN SODIUM SULPHATE

7008

III

6/1/1987

GEORGIA PACKAGING INC

41132-22 PACKAGING MATERIAL AS MFG. IN GEORGIA

7009

6/4/1987

ASSIA CHEMICAL INDUSTRIES LTD

FACILITIES AND PERSONNEL IN PETAH TIKVA, ISRAEL

7010

II

5/13/1987

JVL CORP

METAPROTERENOL SULFATE AS MFG IN GERMANY.

7011

II

6/9/1987

DIOSYNTH BV

HYDROMORPHONE HYDROCHLORIDE AS MFG. IN THE NETHERLANDS

7012

II

6/9/1987

DIOSYNTH BV

MEGESTROL ACETATE FROM GRANULATE

7013

II

6/2/1987

ALDRICH CHEMICAL COMPANY INC

AMMONIUM TETRATHIOMOLYBATE AS MFG. IN MILWAUKEE, WISCONSIN

7014

6/9/1987

ORGANON INC

FACIL, PERSONNEL AND OPER. PROCEDURES AT WEST ORANGE, NJ

7015

6/10/1987

INPHARZAM SA

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN SWITZERLAND

7016

II

6/10/1987

SUMIKA FINE CHEMICALS CO LTD

TRAZODONE HYDROCHLORIDE AS MFG IN GIFU PREFECTURE, JAPAN

7017

II

6/15/1987

STREM CHEMICALS INC

CIS-PLATIN AS MFG IN NEWBURYPORT, MASS.

7018

II

6/10/1987

MAPROTILINE HYDROCHLORIDE AS MFG IN CHICAGO IL

7019

II

6/15/1987

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
ROHM AND HAAS CO

7020

II

6/15/1987

ROHM AND HAAS CO

AMBERLITE IR-120 AS MFG IN PHILADELPHIA, PA

7021

II

6/9/1987

TAKEDA PHARMACEUTICAL CO LTD

LUPRON DEPOT AND LUPRON DEPOT VEHICLE AS MFG IN JAPAN

7022

III

6/9/1987

ALCAN RORSCHACH AG

COMPOSITION AND MANUFACTURING PROCEDURES OF PACKAGING MATERIALS

7023

II

6/15/1987

ROHM AND HAAS CO

AMBERLITE IRA-958 AS MFG IN PENNSYLVANIA

7024

II

6/18/1987

FDC PRIVATE LTD

METRONIDAZOLE U.S.P. XXI AS MFG IN INDIA

7025

II

6/18/1987

FDC PRIVATE LTD

DIAZEPAM U.S.P. XXI AS MFG IN INDIA

7026

6/15/1987

APOTEX INC

FACILITIES, PERSONNEL AND CONTROLS IN WESTON, ONTARIO

AMBERLITE IRA-68 AS MFG IN ENGLAND

Page 195

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7027 A
IV
6/17/1987
DOW CORNING CORP

SUBJECT
BIO-PSA MEDICAL GRADE SILICONE ADHESIVE XCF7-4354, QCF7-4354,XCF7-3355

7028

IV

6/15/1987

UNGERER AND CO

ARTIFICIAL BITTERMASKING FLAVOR #14078

7029

6/23/1987

BIOCHEMIC GESELLSCHAFT MBH

MANUFACTURE OF PENICILLIN PRODUCTS IN KUNDL, AUSTRIA

7030

6/18/1987

LEJUS PHARMACEUTICAL PRODUCT

FACILITIES, PERSONNEL AND PROCEDURES IN MOLNDAL, SWEDEN

7031

II

6/22/1987

LUNDBECK PHARMACEUTICALS ITALY SPA

DIAZOXIDE MANUFACTURED IN PADOVA, ITALY.

7032

II

6/17/1987

EURAND AMERICA INC

PRAZOSIN HYDROCHLORIDE CONTROLLED RELEASE TABLETS

7033

II

6/18/1987

DR REDDYS LABORATORIES LTD

BENZTROPINE MESYLATE

7034

II

6/16/1987

COSMA SPA

ACETOHEXAMIDE AS MFG IN CISERANO, ITALY.

7035

IV

6/29/1987

RELIABLE CHEMICAL CO

POLYHESIVE PBS SYRUPS AS MFG IN ST LOUIS, MISSOURI.

7036

II

6/26/1987

FARMABOIS

BETAMETHASONE 17,21 DIPROPIONATE AS MFG IN GROPELLO CAIROLI ITALY

7037

II

6/22/1987

BIOTECHNOLOGY GENERAL CORP

RECOMBINANT HUMAN GROWTH HORMONE

7038

II

7/1/1987

QUATRUM

BETAMETHASONE BASE AS MFG. IN SACAVEM, PORTUGAL

7039

II

6/24/1987

ERREGIERRE SPA

ECONAZOLE BASE MANUFACTURED IN SAN PAOLO D'ARGON, ITALY.

7040

II

6/24/1987

ERREGIERRE SPA

MICONAZOLE BASE AS MFG. IN SAN PAOLO D'ARGON, ITALY

7041

II

6/30/1987

FARMOS GROUP LTD MEDIPOLAR

FENOPROFEN CALCIUM AS MFG. IN OULU, FINLAND

7042

II

6/29/1987

GIST-BROCADES NV

6-APA AS MFG. IN STRANGAS, SWEDEN

7043

6/30/1987

WADDINGTON JAYCARE LTD

7044

III

6/30/1987

WADDINGTON JAYCARE LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF INJECTION MOULDED PLASTIC PACKAGING
TRACER PACK AS MFG. IN LONDON, ENGLAND

7045

III

6/30/1987

NOLATO JAYCARE LTD

SECURITAINERS, SECURITAINER CAPS AND JAYFILLA

7046

II

7/7/1987

RELIABLE CHEMICAL CO

PHOSPHATE BUFFERED SALINE (PBS) POLYHESIVE HYDROCORTISONE SYRUP

7047

II

6/29/1987

MALLINCKRODT INC

ACETOXYACETYL CHLORIDE AS MFG. IN ST. LOUIS, MISSOURI

7048

II

7/9/1987

GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE

CLAVULANATE POTASSIUM AS MFG. IN AYSHIRE, SCOTLAND

7049

II

7/8/1987

QUATRUM

BETAMETHASONE VALERATE AS MFG. IN SACAVEM, PORTUGAL

7050

II

7/6/1987

MALLINCKRODT INC

INDIUM CHLORIDE IN-111 AS MANUFACTURED. IN MARYLAND HEIGHTS, MO

7051

II

7/2/1987

MALLINCKRODT CHEMICAL INC

FENTANYL CITRATE USP AS MFG. IN ST. LOUIS, MISSOURI

7052

7/7/1987

ASTA PHARMA AG

PRODUCTION OF DRUG SUBSTANCES AT THE BIELEFELD PLANT,GERMANY

7053

II

7/3/1987

SHASUN PHARMACEUTICALS LTD

IBUPROFEN USP AS MFG. IN PONDICHERRY, INDIA

7054

II

6/18/1987

CUNO INC

MANUFACTURE OF ZETAPREP DEAE MODULAR CARTRIDGES IN CONN.

7055

II

7/7/1987

INTERFALK US INC

URSODEOXYCHOLIC ACID 250 MG TABLETS

7056

II

6/29/1987

MALLINCKRODT INC

ACETOXYACETYL CHLORIDE AS MFG. IN RALEIGH, NC

7057

7/14/1987

DANBURY PHARMACAL INC

7058

11/26/1986

CHEMINOVA AS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CARMEL, NEW YORK.
HAZARD EVALUATION: HUMAN & DOMESTIC ANIMALS

7059

II

7/17/1987

EGIS PHARMACEUTICALS

AMITRIPTYLINE HYDROCHLORIDE AS MFG IN BUDAPEST, HUNGARY

7060

7/6/1987

ECOLOCHEM, INC

MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF WATER TREAMENT IN FONTANA, CALIFORNIA, HOUSTON, TEXAS, AND ST. LOUIS,
MISSOURI.

7061

II

7/17/1987

EGIS PHARMACEUTICALS

PERPHENAZIN BASE AS MFG IN BUDAPEST, HUNGARY

7062

7/17/1987

YAMANOUCHI PHARMACEUTICAL COMPANY LTD

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SHIZUOKA-KEN

Page 196

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7063 I
II
6/22/1987
NIPPON KAYAKU COMPANY LTD

SUBJECT
CARBIDOPA AS MFG IN TOKYO, JAPAN

7064

II

6/22/1987

NIPPON KAYAKU COMPANY LTD

SULINDAC AS MFG IN TOKYO, JAPAN

7065

II

7/13/1987

PHARM ECO LABORATORIES INC

PRALIDOXIME CHLORIDE USP AS MFG IN SIMI VALLEY, CALIFORNIA

7066

7/15/1987

SIEGFRIED AG

FACILITIES, EQUIPMENT AND OPERATING CONTROLS IN ZOFINGEN, SWITZERLAND

7067

II

7/20/1987

RELIABLE CHEMICAL CO

PHOSPHATE BUFFER SALINE (PBS) POLYHESIVE HYDROCORTISONE ACETATE SYRUP

7068

IV

7/17/1987

PIERCE CHEM CO

DETOXI-GEL ENDOTOXIN REMOVING GEL FOR THE MANU OF DRUGS & DRUG PRODUCT

7069

IV

7/9/1987

MISSION PHARMACAL CO

SODIUM CELLULOSE PHOSPHATE AS MFG. IN SAN ANTONIO, TEXAS

7070

II

7/14/1987

H REISMAN CORP

PSEUDOEPHEDRINE HYDROCHLORIDE AS MFG. IN ORANGE, NEW JERSEY

7071

II

7/13/1987

TAKEDA PHARMACEUTICAL CO LTD

HYDROMORPHONE HYDROCHLORIDE AS MFG. IN NEWARK, NEW JERSEY

7072

7/20/1987

BIOCHEMIC GESELLSCHAFT MBH

STERILE PRECIPITATION PLANT IN KUNDL, TYROL, AUSTRIA

7073

II

7/15/1987

EI DUPONT DE NEMOURS AND CO

RECOMBINANT INTERLEUKIN-2, HUMAN (RIL-) MFG IN DELAWARE

7074

II

6/30/1987

B BRAUN MEDICAL INC

HYDROXYETHYL STARCH MANUFACTURED IN SABANA GRANDE, PR

7075

II

7/20/1987

MALLINCKRODT CHEMICAL INC

IBUPROFEN DCI-63 AS MFG. BY GLAT AIR TECHNIQUES, INC. IN RAMSEY, N.J.

7076

II

7/13/1987

JT BAKER CHEMICAL CO

DOXYLAMINE SUCCINATE AS MFG. IN PHILLIPSBURG, NEW JERSEY

7077

II

7/14/1987

PCAS

BACLOFEN AS MFG. IN IN TURKU, FINLAND

7078

II

7/24/1987

NORAMCO INC

HYDROCODONE BITARTRATE AS MFG. IN WILMINGTON, DELAWARE

7079

II

7/20/1987

SIGMA F AND D DIV LTD

OROTIC ACID AS MFG IN ST. LOUIS, MO

7080

II

6/25/1987

SPOFA UNITED PHARM WORKS

TERGURIDE AS MFG BY GALENA, N.P. IN CZECHOSLOVAKIA

7081

7/10/1987

LABORATORI GUIDOTTI SPA

FACIL, PERSONNEL & GENL OPERATING PROCEDURES IN PISA, ITALY

7082

II

6/15/1987

HUHTAMAKI OY LEIRAS PHARMACEUTICALS

SALBUTAMOL SULFATE BULK MANUFACTURED IN TURKU, FINLAND.

7083

II

7/27/1987

HUHTAMAKI OY LEIRAS PHARMACEUTICALS

SALBUTAMOL BASE BULK AS MFG IN TURKU, FINLAND

7084

II

7/20/1987

EI DUPONT DE NEMOURS AND CO

IRON-59 AS FERRIC CHLORIDE AND FERROUS CITRATE MFG IN MA -

7085

III

7/28/1987

GRAPHIC PACKAGING CORP

PRINTED & LAMIN ROLL STOCK FLEXIBLE PACK MATL & PREF BAGS -

7086

IV

7/28/1987

VERTELLUS PERFORMANCE MATERIALS INC

TRIETHYL CITRATE FCC AS MFG IN GREENSBORO, NORTH CAROLINA;

7087

III

7/27/1987

HERCULES INC

NC-603R POLYPROPYLENE RESIN AS MFG IN WILMINGTON, DELAWARE

7088

II

7/24/1987

LABOCHIM

BROMOCRIPTINE MESYLATE AS MFG IN MILAN, ITALY

7089

II

7/29/1987

NIPPON GOHSEI CO LTD

ALUMINUM SUCROSE SULFATE AS MFG IN KUMAMOTO JAPAN

7090

II

7/28/1987

NORDMARK ARZNEIMITTEL GMBH CO KG

PANCRELIPASE AS MFG. IN UETERSEN, GERMANY

7091

7/28/1987

KNOLL AG

NORDMARK PHARMACEUTICAL PROD. FACIL. IN UETERSEN, W. GERMANY

7092

III

7/31/1987

MULTISORB TECHNOLOGIES INC

MINIPAX DESSICANT PACKETS MANUFACTURED IN BUFFALO, NEW YORK.

7093

8/7/1987

RORER PHARM CORP SUB RORER GROUP

FACILITIES, PERSONNEL AND PROCEDURES IN FORT WASHINGTON, PA

7094

II

8/4/1987

CAMBREX PROFARMACO MILANO SRL

ALPRAZOLAM AS MFG. IN MILAN, ITALY -

7095

II

8/4/1987

PHARMACIA AND UPJOHN SUB PFIZER INC

BETAMETHASONE DIPROPIONATE AS MFG. IN KALAMAZOO, MICHIGAN -

7096

II

8/4/1987

SIFAVITOR SRL

MAPROTILINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY

7097

8/7/1987

ALCAN FOLIEN GMBH

FACILITIES FOR THE MFG. OF PACKAGING MATERIALS IN GERMANY

7098

8/7/1987

ADVANCED MAGNETICS INC

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN CAMBRIDGE,MA

7099

II

8/6/1987

ASPEN OSS BV

BUPRENORPHINE HYDROCHLORIDE AS MFG. IN OSS HOLLAND -

7100

II

8/4/1987

3M PHARMS

METHENAMINE HIPPURATE AS MFG. IN THE UK

7101

II

8/6/1987

ASTRAZENECA PHARMACEUTICALS LP

ATENOLOL ACETATE AS MANUFACTURED IN THE UNITED KINGDOM

Page 197

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7102 I
I
8/7/1987
FDC PRIVATE LTD

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MAHARASHTRA STATE, INDIA.
MICROCRYSTALLINE CELLULOSE POWDER MANUFACTURED IN NANDESARI, INDIA.

7103

II

8/10/1987

ASHOK ORGANIC INDUSTRIES LTD

7104

8/6/1987

WARNER LAMBERT CO

7105

7/27/1987

PHARMACIA AND UPJOHN SUB PFIZER INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BROCKVILLE, ONTARIO, CANADA.
PUURS ASEPTIC MANUFACTURING FACILITY

7106

III

8/14/1987

MULTISORB TECHNOLOGIES INC

DRICAP MANUFACTURED IN BUFFALO, NEW YORK.

7107

II

8/10/1987

DETERMINATION OF PSEUDOEPHEDRINE IN HUMAN PLASMA

7108

II

8/11/1987

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
3M PHARMS

7109

II

8/11/1987

HUNTINGTON LABS INC

20% CHLORHEXIDINE GLUCONATE AS MFG IN HUNTINGTON, INDIANA

7110

II

8/18/1987

SANDOZ GMBH

LIOTHYRONINE SODIUM AS MFG IN TYROL, AUSTRIA

7111

8/17/1987

MYLAN INC

7112

II

4/30/1987

7113

III

8/14/1987

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
POLYCON INDUSTRIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PUERTO RICO.
MCN-5691 AS MFG IN ST. PETERSBURG, FL

7114

IV

8/17/1987

DOW CORNING CORP

7115

II

8/24/1987

SANDOZ GMBH

DOW CORNING R BIOPSA AMINE-COMPATATIBLE SILICONE ADHESIVE MANUFACTURED IN


HEMLOCK, MI
CTAZ-TBE (CEFTAZIDIME-TERT.-BUTYLESTER) AS MFG IN KUNDL, AUSTRIA

7116

III

8/19/1987

COURTESY MEDTEK

PACKAGING FOR HUMAN DRUGS AND BIOLOGICS MANUFACTURED INWHEELING ILLINOIS

7117

8/18/1987

RORER PHARM CORP

FACILITIES, PERSONNEL AND PROCEDURES IN MANATI, PUERTO RICO

7118

II

8/20/1987

ALLIED SIGNAL INC

FLUOROCARBON AS MFG. IN BUFFALO, NEW YORK

7119

II

8/28/1987

FOREST LABORATORIES INC

7120

II

8/27/1987

ISOCHEM SA

SODIUM MONOFLUOROPHOSPHATE 76 MG. C.R. TABLETS MANUFACTURED IN INWOOD, NEW


YORK.
FENOPROFEN CALCIUM USP AS MFG. IN PITHIVIERS AND GENNEVILLIERS, FRANCE

7121

II

8/26/1987

SCHERING AG

PANCURONIUM BROMIDE AS MFG. IN BERGKAMEN, GERMANY

7122

II

8/24/1987

BACHEM FEINCHEMIKALIEN AG

BOC-THR(BZL)-D-GLU(OBZL)-NH2 AS MFG. IN BUBENDORF, SWITZERLAND

7123

III

8/25/1987

NORTON PERFORMANCE PLASTICS

TFE/PU LAMINATE AS MFG. IN GRANVILLE, N.Y AND WAYNE, N.J.

7124

II

8/27/1987

TANABE SEIYAKU CO LTD

TA-3090 AS MFG. IN OSAKA, JAPAN

7125

II

8/31/1987

QUATRUM

BETAMETHASONE DIPROPIONATE MANUFACTURED IN SACAVEM, PORTUGAL.

7126

II

8/21/1987

AVATAR CORP

SAFFLOWER OIL AS MFG. IN HICKORY HILLS, ILLINOIS

7127

II

8/17/1987

IFP INC

SULFASALAZINE STARCH POWDER AS MFG. IN HAYFIELD, MINNESOTA

7128

8/28/1987

WARNER LAMBERT CO

MANUFACTURING FACILITY IN PONTYPOOL, GWENT, UNITED KINGDOM

7129

III

9/3/1987

DAIICHI GLASS CO LTD

GLASS BOTTLES AS MFG. IN TOKYO, JAPAN

7130

II

8/25/1987

FABBRICA ITALIANI SINTETICI SPA

PIROXICAM AS MFG. IN VICENZA, ITALY

7131

II

9/4/1987

NOBEL CHEMICALS AB DIV FINE CHEMICALS INC

NAPROXEN SODIUM USP AS MFG. IN MILAN, ITALY

7132

II

9/4/1987

ALCHYMARS

TRANYLCYPROMINE SULFATE USP MANUFACTURED IN MILAN, ITALY.

7133

II

9/4/1987

BLASCHIM SPA

ATENOLOL AS MFG. IN MILAN, ITALY

7134

8/31/1987

ERCI FACILITIES SERVICES CORP

FACILITIES IN ROCKVILLE, MD FOR STORAGE-NCI CONTRACT #N01-CN-65002

7135

II

8/31/1987

RALLIS INDIA LTD

NAPROXEN AS MFG. IN GUJARA, INDIA

7136

8/31/1987

CHEMAPOL LTD

GALENA N.P., A CO. OF SPOFA-FACILITIES, OPAVA-KOMAROV, CZECHOSLOVAKIA

ORPHENADRINE CITRATE AS MFG. IN LEICESTERSHIRE, ENGLAND

PLASTIC BOTTLES AS MFG IN MERRILLVILLE, INDIANA

Page 198

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7137 I
II
9/4/1987
DELMAR CHEMICALS INC

SUBJECT
TACRINE HYDROCHLORIDE MONOHYDRATE AS MFG. QUEBEC, CANADA

7138

II

9/4/1987

EXTAL PTY LTD DIV JOHNSON AND JOHNSON

NALOXONE HYDROCHLORIDE AS MFG. IN WESTBURY, TASMANIA, AUSTRALIA

7139

II

9/10/1987

TUBOCURARINE CHLORIDE AS MFG. IN NORTH CHICAGO, ILLINOIS

7140

III

9/14/1987

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
NAN YA PLASTICS CORPORATION USA

7141

II

9/14/1987

ZENECA PHARMACEUTICALS

LISINOPRIL DIHYDRATE AS MFG. IN CHESHIRE, ENGLAND

7142

II

9/3/1987

UNILEVER UNITED STATES INC

ENCAPSULATED CALCIUM CARBONATE MFG. IN JOLIET & CHICAGO, IL.

7143

II

9/10/1987

BACHEM FEINCHEMIKALIEN AG

MANUFACTURE OF ANARITIDE ACETATE IN BUBENDORF, SWITZERLAND

7144

9/14/1987

STROLLE RESEARCH & DEVELOPMENT CORP

FACILITIES AND PROCEDURES IN CINCINNATI, OHIO

7145

II

9/17/1987

JOHNSON MATTHEY INC

CARBOPLATIN

7146

II

9/8/1987

LUSOCHIMICA S P A

PRODUCTION AND CONTROL METHODS FOR THE MFG. OF NIFEDIPINE

7147

II

9/17/1987

PFANSTIEHL LABORATORIES INC

L-RHAMNOSE AS MFG. IN WAUKEGAN, ILLINOIS

7148

9/16/1987

VIS FARMACEUTICA

FACILITIES, PERSONNEL AND CONTROLS IN PADOVA

7149

IV

9/14/1987

ALDRICH CHEMICAL COMPANY INC

ROSE BENGAL AS MFG. IN MILWAUKEE, WISCONSIN

7150

9/17/1987

SEKISUI CHEMICAL COMPANY LTD

7151

II

9/22/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN YAMAGUCHI, JAPAN.
METOPROLOL TARTRATE AS MFG. IN MILAN, ITALY

7152

II

9/24/1987

FRANCIS SPA

FENOPROFEN CALCIUM AS MFG. IN CARONNO PERTUSELLA, ITALY

7153

II

9/24/1987

SYLATEC GROUPE SYNTHELABO

KETO ACID MIXTURE EE FORMULA MB 235G06

7154

II

9/25/1987

SUMITOMO CHEMICAL CO LTD

PRAZOSIN HYDROCHLORIDE AS MFG. IN GIFU PREFECTURE & OSAKA, JAPAN

7155

III

9/1/1987

DAIKYO SEIKO LTD

PHARMACEUTICAL RUBBER ITEMS MANUFACTURED IN TOCHIGI, JAPAN.

7156

II

9/29/1987

EZ PAP INC

DIRECTLY COMPRESSIBLE ACETAMINOPHEN 73% (E-Z 180) MFG. IN NJ

7157

II

9/25/1987

GD SEARLE PHARMACEUTICALS INC

HALOPERIDOL AS MFG. IN NORTHUMBERLAND, ENG. & CAGUAS, P.R.

7158

II

9/23/1987

PFANSTIEHL LABORATORIES INC

UREA PEROXIDE, U-102 AS MFG. IN WAUKEGAN, ILLINOIS

7159

9/29/1987

CURRICULUM VITAES

7160

II

9/25/1987

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY INFECTIOUS DISEASES
NISSEI CHEMICAL INDUSTRY COMPANY LTD

7161

II

9/25/1987

SA AJINOMOTO OMNICHEM NV

PRAZOSIN HYDROCHLORIDE AS MFG. IN WETTEREN, BELGIUM

7162

9/30/1987

VETTER PHARMA FERTIGUNG GMBH

PREPARATION OF PRE-FILLED SYRINGES, MFG. IN RAVENSBURG, W.G.

7163

II

10/8/1987

SHANGHAI NO 2 PHARMACEUTICAL FACTORY

CARBAMAZEPINE AS MFG. IN SHANGHAI, CHINA

7164

9/25/1987

HOECHST ITALIA SUD SPA

STERILE POWDER FILLING OF STERILE CEPHALOSPORINS-SCOPPITO,ITAL

7165

II

9/25/1987

SIGMA F AND D DIV LTD

CORTICOSTERONE AS MFG. IN ST. LOUIS, MISSOURI

7166

IV

9/23/1987

FELTON WORLDWIDE INC

ARTIFICIAL TOASTED COCONUT FLAVOR #1323 P.G.

7167

9/22/1987

ABLE MANUFACTURING CORP

FACILITIES, PERSONNEL & PROCEDURES IN VEGA ALTA, PUERTO RICO

7168

II

10/5/1987

HOSPIRA

INTRAVENOUS FA EMULSION PRODUCT 4501 AS MFG. STOCKHOLM, SWE.

7169

II

9/14/1987

PENNISULA LABORATORIES INC

SALMON CALCITONIN AS MFG. IN BELMONT, CALIFORNIA

7170

IV

10/2/1987

LUBRIZOL ADVANCED MATERIALS INC

CARBOPOL 974P AND 971P AS MFG. AT CALVERT CITY, KENTUCKY

7171

II

10/12/1987

CIPLA LTD

MEBENDAZOLE USP AS MANUFACTURED. IN INDIA

7172

II

9/14/1987

PENINSULA LABS

DYNORPHIN A (1-13, PORCINE) AS MFG. IN BELMONT, CA

7173

IV

10/5/1987

STERLING ORGANICS

MACROSORB TYPE I MATERIALS AS MFG. IN ENGLAND

XAH FILM AND SHEET MATERIAL AS MFG. IN WHARTON, TEXAS

FACILITIES, PRODUCTION AND CONTROLS FOR MFG. OF SUCRALFATE

Page 199

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7174 I
II
10/12/1987
CIPLA LTD

SUBJECT
PROPANALOL HYDROCHLORIDE AS MFG. IN INDIA

7175

II

10/13/1987

PRODESFARMA QUIMICA SL

ATENOLOL AS MFG. IN BARCELONA, SPAIN

7176

III

10/8/1987

MULTISORB TECHNOLOGIES, INC

DRICAP PLUS AS MFG. IN BUFFALO, NEW YORK

7177

II

10/2/1987

NAPP TECHNOLOGIES INC

SULFAMETHOXAZOLE MANUFACTURIED IN LODI, NEW JERSEY.

7178

II

10/6/1987

ERREGIERRE SPA

METOPROLOL BASE AS MFG. IN SAN PAOLO D'ARGON, ITALY.

7179

II

10/8/1987

TEIKOKU CHEM INDUSTRY

FLUOROURACIL AS MFG. IN OSAKA, JAPAN

7180

III

10/9/1987

NUODEX INC

ADMEX 760 POLYMERIC PLASTICIZER AS MFG. IN CHESTERTOWN, MD

7181

10/9/1987

PFIZER CENTRAL RESEARCH

FACILITIES, PERSONNEL & EQUIPMENT IN SANDWICH, KENT, ENGLAND

7182

10/9/1987

7183

II

10/14/1987

AMSA ANONIMA MEDICINALI SINTETICI & AFFINI


SPA
WYCKOFF CHEMICAL CO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MILANO, ITALY.
DOXAPRAM HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

7184

10/12/1987

GIVAUDAN CORPORATION

CLINICAL STUDIES REGARDING THE USE OF PARSOL MCX

7185

10/16/1987

FISONS CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

7186

II

11/3/1987

ISTITUTO CHEMICOTHERAPICO ITALIANO

SUCRALFATE MANUFACTUED IN SAN GRATO DI LODI, ITALY.

7187

II

8/17/1987

AVANTI POLAR LIPIDS INC

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MANUFACTURED IN ALABAMA.

7188

II

10/13/1987

PCAS

PINDOLOL MANUFACTURED IN LIMAY, FRANCE.

7189

II

10/20/1987

INNOVATIVE FOOD PROCESSORS INC

DIETHYLCARBAMAZINE CITRATE AS MFG. IN HAYFIELD, MINNESOTA

7190

II

10/18/1987

ARCHIMICA SPA

IMIPRAMINE HYDROCHLORIDE AS MFG. IN ORRIGIO, ITALY

7191

III

10/16/1987

PHARMA ELASTOMERE

RUBBER PARTS PHE 401/60 GREY AS MFG. IN SIMMERAH, W. GERM.

7192

II

10/19/1987

RAYLO CHEMICALS

MFG. METHODS AND PROPERTIES OF 2'-3'-DIDEOXYADENOSINE

7193

II

10/26/1987

DELMAR CHEMS LTD

CLINDAMYCIN PHOSPHATE AS MFG. IN QUEBEC, CANADA

7194

10/26/1987

ORGANON INC

ORGANIZATION, FACILITIES AND PROCEDURES IN WEST ORANGE, N.J.

7195

II

10/16/1987

CADILA LABORATORIES PVT LTD

TRIMETHOPRIM AS MFG. IN GUJARAT STATE, INDIA

7196

10/28/1987

HEUMANN

7197

II

10/28/1987

ASPEN OSS BV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FEUCHT, GERMANY.
DESOGESTREL AS MFG. IN OSS, HOLLAND

7198

10/22/1987

A&I LABORATORY

7199

II

7/1/1987

FINE CHEMICALS CORPORATION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ARLINGTON, TEXAS.
MINOCYCLINE HYDROCHLORIDE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

7200

II

10/21/1987

IMPERIAL CHEMICAL INDUSTRIES PLC

ATENOLOL BULK DRUG MANUFACTURED IN GUAYAMA, PUERTO RICO.

7201

II

10/23/1987

UNILEVER UNITED STATES INC

ENCAPSULATED CIMETIDINE DURKOTE 130M-50 AND DURKOTE 145-50

7202

III

10/5/1987

ALUMINUM COMPANY OF AMERICA

PACKAGING STRUCTURES PHAR 9424 & 9425 AS MFG. PITTSBURGH,PA

7203

II

10/22/1987

PRAZOSIN HYDROCHLORIDE USP&PRAZOSIN HYDROCHLORIDE,POLYHYDRATE

7204

II

11/2/1987

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
CHUGAI PHARMACEUTICAL CO LTD

7205

10/21/1987

LEBERCO-CELSIS TESTING

7206

III

9/30/1987

ALUMINUM COMPANY OF AMERICA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROSELLE PARK, NEW JERSEY.
28 MM & 38 MM PP DROP-LOCK CLOSURES AS MFG. IN PITTSBURGH,PA

7207

II

11/2/1987

CHUGAI PHARMACEUTICAL CO LTD

CCA (LOBENZARIT SODIUM) BULK DRUG AS MFG. IN SHIZUOKA, JAPAN

7208

10/26/1987

MEGAS MANUFACTURING INC

FACILITIES, PERSONNEL & PRODUACTION CONTROLS IN CLEVELAND, OH

CCA (LOBENZARIT SODIUM) TABLETS AS MFG. IN TOKYO, JAPAN

Page 200

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7209 I
III
10/27/1987
TECH SEAL PRODUCTS INC

SUBJECT
LINER MATERIALS & TAMPER EVIDENCE INNERSEALS MFG ROSELLE, IL

7210

11/5/1987

BRANTFORD CHEMICALS INC

7211

II

11/4/1987

AMERICAN TOYKO KASEI INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ONTARIO, CANADA.
TRANS-1,2-CYCLOHEXANEDIAMINETETRAACETIC ACID MFG. PORTLAND OR

7212

II

10/26/1987

BLASCHIM SPA

GEMFIBROZIL USP AS MFG. IN MILANO, ITALY

7213

11/4/1987

TCI AMERICA

FACILITIES, PERSONNEL & GENERAL PROCEDURES IN PORTLAND, OR

7214

II

10/29/1987

BASF PHARMA EVIONNAZ SA

OXYBUTININ CHLORIDE AS MFG. IN EVIONNAZ, SWITZERLAND

7215

II

10/28/1987

ARCHIMICA SPA

DOXYLAMINE SUCCINATE USP AS MFG. IN VARESE, ITALY

7216

II

10/28/1987

ARCHIMICA SPA

DESIPRAMINE HYDROCHLORIDE USP AS MFG. IN VARESE, ITALY

7217

II

11/6/1987

SOUTHERN RESEARCH INSTITUTE

[D-TRPS6, DES-GLY10] - LHRH ETHYLMIDE AS MFG. BIRMINGHAM, AL.

7218

11/10/1987

PACO LABORATORIES INC

FACILITIES AND GENERAL OPERATING PROCEDURES IN PENNSAUKEN, NJ

7219

II

11/10/1987

ORION CORPORATION FERMION OULU PLANT

SELENIUM SULFIDE AS MFG. IN OULU, FINLAND

7220

II

9/18/1987

ASHOK ORGANIC INDUSTRIES LTD

PARACETAMOL AS MFG. IN BOMBAY, INDIA

7221

II

10/13/1987

SIGMA F AND D DIV LTD

ACETYLCHOLINE CHLORIDE AS MFG. IN SAINT LOUIS, MISSOURI

7222

11/13/1987

CAPSULE TECHNOLOGY INTERNATIONAL LTD

FACILITIES, EQUIPMENT AND PROCEDURES IN WINDSOR, ONTARIO, CN.

7223

II

10/19/1987

SEKISUI MEDICAL CO LTD

L-LEUCINE AS MFG. IN CHUO-KU, TOKYO, JAPAN

7224

II

11/9/1987

PHARMACIA AND UPJOHN

ETHINYL ESTRADIOL AS MFG. IN CUERNAVACA, MORELOS, MEXICO

7225

II

10/28/1987

QUATRUM

DEXAMETHASONE SODIUM PHOSPHATE AS MFG. IN SACAVEM, PORTUGAL

7226

II

11/19/1987

EMS DOTTIKON AG

DILUTED PENTAERYTHRITOL TETRANITRATE AS MFG. IN DOTTIKON, SZ.

7227

II

11/20/1987

ICN RADIOCHEMICALS

SODIUM IODIDE-131 AS MFG. IN IRVINE, CALIFORNIA

7228

II

11/30/1987

QUATRUM

BETMETHASONE SODIUM PHOSPHATE AS MFG IN SACAVEM, PORTUGAL -

7229

II

11/20/1987

WARNER LAMBERT CO DIV PARKE DAVIS

PHENYTOIN USP & PHENYTOIN SODIUM USP AS MFG. IN HOLLAND, MI

7230

III

11/25/1987

REXAM MEDICAL PACKAGING INC

MFG. OF FLEXIBLE P.V.C. PARENTERAL BAGS

7231

II

11/25/1987

ELAN CORP PLC

SPECIFIC DRUG SUBSTANCE PN-200-110 TABLETS AS MFG IN IRELAND

7232

11/16/1987

BEECHAM PHARMACEUTICALS

FACIL, PERSONNEL & GENL OPER PROCED IN GREA BURGH, EPSOM, U.K.

7233

11/16/1987

BEECHAM PHARMACEUTICALS

FACIL, PERSONNEL AND GENERAL OPERATING PROCEDURES IN HARLOW, ESSEX.

7234

II

11/17/1987

EURAND AMERICA INC

CIMETIDINE BASE MICROCAPSULES AS MFG. IN VANDALIA, OHIO.

7235

III

11/13/1987

EQUISTAR CHEMICALS LP SUB LYONDELLBASELL

ALATHON POLYETHYLENE RESIN COMPOUNDS MANUFACTURED IN TEXAS.

7236

11/16/1987

LISAC SA

FACIL, PERSONNEL, EQUIP & PROCEDURES IN BARCELONA, SPAIN

7237

II

11/20/1987

MALLINCKRODT INC

HYDROMORPHONE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO

7238

II

11/19/1987

SIPSY

TRIMEBUTINE BASE & TRIMEBUTINE MALEATE AS MFG IN FRANCE

7239

II

11/30/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

DILTIAZEM HCL MFG IN NATAWANYA,ISREAL

7240

II

10/26/1987

TORCAN CHEMICAL LTD

DILTIAZEM HYDROCHLORIDE AS MFG IN LASALLE, QUEBEC, CANADA

7241

II

11/27/1987

ISOCHEM SA

3-(PHOSPHORYLOXMETHYL)-5,5-DIPHENYL HYDANTOIN DISODIUM SALT

7242

II

11/9/1987

PROQUINA SA

SALAZOSULFAPYRIDINE AS MFG IN IXTACZOQUITLAN, VER., MEXICO

7243

II

12/4/1987

ALLERGAN OPTICAL INC DIV ALLERGAN INC

MIOGAN (ACETYLCHOLINE CHLORIDE FOR OPTHALMIC SOLUTION)

7244

II

11/7/1987

ALFA CHEMICALS ITALIANA SPA

VERAPAMIL HYDROCHLORIDE AS MFG. IN PONTECCHIO MARCONI, ITALY

7245

II

12/3/1987

DELMAR CHEMICALS INC

NIFEDIPINE AS MFG. IN LASALLE, QUEBEC, CANADA

7246

II

12/7/1987

CORN PRODUCTS BRASIL INGREDIENTS


INDUSTRIAIS LTDA

MANNITOL AS MFG. IN SAO GONCALO-RJ, BRAZIL.

Page 201

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7247 A
II
12/9/1987
YUNG ZIP CHEMICAL IND CO LTD

SUBJECT
SODIUM STARCH GLYCOLATE AS MFG. IN TAICHUNG HSIEN, TAIWAN

7248

II

12/7/1987

DEGUSSA AG

CHLORHEXIDINE ACETATE AS MFG. IN HANAU, GERMANY

7249

II

12/11/1987

APOTEX PHARMACHEM INC

GAMMA-HYDROXYBUTYRATE AS MFG. IN ONTARIO, CANADA

7250

12/10/1987

BORREGAARD INDUSTRIES LTD

FACILITIES, PERSONNEL & PROCEDURES IN SARPSBORG, NORWAY

7251

IV

12/7/1987

UNGERER AND CO

ARTIFICIAL GRAPE FLAVOR #18176 AS MFG. IN LINCOLN PARK, NJ

7252

II

12/9/1987

DAINIPPON PHARMACEUTICAL CO LTD

ENOXACIN SESQUIHYDRATE AS MFG. IN SUZUKA, MIE, JAPAN

7253

12/9/1988

NATIONAL O RINGS

7254

12/11/1987

WADDINGTON JAYCARE LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DOWNEY, CALIFORNIA
PRODUCTION OF JAYCAPS IN LONDON, ENGLAND

7255

II

12/14/1987

QUATRUM

TRIAMCINOLONE HEXACETONIDE AS MFG. IN SACAVEM, PORTUGAL

7256

III

12/16/1987

PRO GRAM PLASTICS INC

POLYETHYLENE AND POLYPROPYLENE CONTAINERS AS MFG. IN OHIO

7257

III

12/2/1987

COURTESY PLASTICS

INJECTION MOLDED PARTS AS MFG. IN WHEELING, ILLINOIS

7258

12/8/1987

ACCRA PAC INC

7259

12/21/1987

JOHNSON MATTHEY PLC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ELKHART, INDIANA.
FACILITIES, EQUIPMENT & PROCEDURES IN BUCKHAVEN,FIFE,SCOTLAND

7260

IV

12/7/1987

NATIONAL STARCH LLC

7261

III

10/15/1987

ANDERSON TOOL & DIE CORP

7262

II

12/16/1987

CLORAZEPATE AS MFG. IN MADISON, WISCONSIN

7263

II

12/23/1987

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
VERTELLUS PERFORMANCE MATERIALS INC

7264

II

12/22/1987

TEVA PHARMACEUTICAL INDUSTRIES LTD

TIMOLOL MALEATE AS MFG. IN SETTIMO

7265

II

12/23/1987

ATENOLOL AS MFG. IN COMO, ITALY

7266

III

12/7/1987

AMSA ANONIMA MEDICINALI SINTETICI & AFFINI


SPA
ZIMMER PAPER PRODUCTS INC

7267

II

12/29/1987

DIOSYNTH BV

2-PHENYL-1,3-PROPANEDIOL DICARBAMATE AS MFG. IN OSS, HOLLAND

7268

II

12/12/1987

YUKI GOSEI KOGYO CO LTD

2' DEOXYCYTIDINE HYDROCHLORIDE (BULK) AS MFG. IN TOKYO,JAPAN

7269

II

12/10/1987

COMPANIA ESPANOLA DE SINTESIS QUIMICA SA

BETAMETHASONE ACETATE AS MFG. IN MADRID, SPAIN

7270

II

12/18/1987

ALFA CHEMICAL ITALIANA

TOLMETIN SODIUM DIHYDRATE AS MFG. IN BOLOGNA, ITALY

7271

III

12/28/1987

BF ASCHER AND CO INC

PACKAGING MATERIALS AS MFG. IN LENEXA, KANSAS

7272

II

12/31/1987

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

CYCLOPENTOLATE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN

7273

III

1/7/1988

CONSTANTIA HUECK FOLIEN GMBH AND CO KG

FLEXIBLE PACKAGING MATERIALS

7274

II

12/21/1987

PLAISTOW LTD

FENOFIBRATE AS MFG. IN LITTLE ISLAND, CORK, IRELAND

7275

II

1/4/1988

SELOC FRANCE

XYLAZINE HYDROCHLORIDE AS MFG. BY SIFA LTD. IN IRELAND

7276

II

10/20/1987

NIPPON RIKAGAKUYAKUHIN CO LTD

CARBOCYSTEINE (S-CARBOXYMETHYL-L-CYSTEINE) AS MFG. IN TOKYO

7277

II

1/4/1988

GUANGDONG PHARMACEUTICAL FACTORY

TRIMETHOPRIM AND SULFAMETHOXAZOLE AS MFG, IN GUANGZHOU, CHINA

7278

II

1/1/1988

SIGMA F AND D DIV LTD

L-TRYPTOPHAN ETHYL ESTER HCL AS MFG. IN SAINT LOUIS, MISSOURI

7279

II

10/20/1987

NIPPON RIKAGAKUYAKUHIN CO LTD

L-2-OXOTHIAZOLIZINE-4-CARBOXYLIC ACID AS MFG. IN TOKYO, JAPAN

7280

II

1/4/1988

GUANGDONG PHARMACEUTICAL FACTORY

SULFAMETHAZINE MANUFACTURED IN GUANGZHOU, CHINA.

7281

II

1/5/1988

CHEMWERTH

DOXYCYCLINE MONOHYDRATE MANUFACTURED BY CHANGZHOU PHARMACEUTICAL.

7282

II

1/13/1988

NANJING PHARMACEUTICAL FACTORY CO LTD

SUCRALFATE MANUFACTURED IN NANJING, CHINA.

MODIFIED FOOD STARCHES FOR USE AS PHARMACEUTICAL EXCIPIENTS AS MFG. IN


BRIDGEWATER, NEW JERSEY
DRY SCRUB BRUSH AS MFG. IN LINDEN, NEW JERSEY

TRIBUTYL CITRATE AS MFG. IN GREENSBORO, NORTH CAROLINA

INNERSEALS MANUFACTURED IN INDIANAPOLIS, INDIANA.

Page 202

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7283 I
II
1/8/1988
PHARM ECO LABORATORIES INC

SUBJECT
N,N-BIS-(PYRIDOXAL-5-PHOSPHATE)ETHYLENEDIAMINE-N,N-DIACETIC ACID

7284

II

1/14/1988

LION CORPORATION

GLYCERIDE OF PENTADECANOIC ACID (PDG) DRUG SUBSTANCE

7285

II

1/14/1988

LION CORPORATION

LKF DRUG PRODUCT AS MFG, IN KASHIMA-GUN, JAPAN

7286

12/18/1987

MERCK SHARP & DOHME CAGUAS

7287

II

1/6/1988

BLASCHIM SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CAGUAS, PUERTO RICO.
TRAZODONE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY.

7288

II

1/5/1988

AMERICAN CHEMICAL INDUSTRIAL CORP

CARBAMAZEPINE MANUFACTURED IN RICHMOND, CALIFORNIA.

7289

II

1/5/1988

AMERICAN CHEMICAL INDUSTRIAL CORP

CLINDAMYCIN HYDROCHLORIDE AS MFG. IN RICHMOND, CALIFORNIA

7290

1/6/1988

MINNTECH CORP

WATER FILTER AS MFG, IN MINNEAPOLIS, MINNESOTA

7291

II

1/8/1988

NORAMCO INC

CHLORZOXAZONE AS MFG. IN ATHENS, GEORGIA

7292

II

1/15/1988

LEJUS PHARMACEUTICAL PRODUCT

QUINIDINE GLUCONATE EXTENDED RELEASE GRANULES AS MFG. IN SWEDEN

7293

II

12/1/1987

SIGMA F AND D DIV LTD

(+) - AMETHOPTERIN (METHOTREXATE) AS MFG. IN SAINT LOUIS, MISSOURI

7294

1/19/1988

IMAGENTS INC

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HOUSTON, TX

7295

II

2/2/1988

PFANSTIEHL LABORATORIES INC

D-GALACTOSE AS MFG. IN WAUKEGAN, IL.

7296

II

12/29/1987

RALLIS INDIA LTD

IBUPROFEN U.S.P. AS MFG, IN GUJARA, INDIA

7297

II

1/22/1988

CUNO INC

ZETAPREP SP MEDIA AS MFG. IN CONNECTICUT

7298

II

11/1/1987

FINE CHEMICALS CORPORATION

TOLAZOLINE HYDROCHLORIDE AS MFG. IN CAPE PROVINCE, S. AFRICA

7299

II

1/25/1988

SIFAVITOR SPA

7300

II

1/22/1988

CUNO INC

LOPERAMIDE HYDROCHLORIDE AS MFG. A CASALETTO LODIGIANO (FRAZ. MAIRANO) MILAN,


ITALY BY SIFAVITOR S.P.A.
ZETAPREP DEAE MEDIA AS MFG. IN CONNECTICUT

7301

II

1/6/1988

BOEHRINGER INGELHEIM KG

THEOPHYLLINE MONOHYDRATE AS MFG. IN INGELHEIM, GERMANY

7302

II

1/2/1988

CUNO INC

ZETAPREP QEA MEDIA AS MFG. IN CONNECTICUT

7303

12/30/1987

MOVA PHARMACEUTICAL CORP

7304

II

1/22/1988

EASTMAN KODAK CO

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN


CAGUAS, PUERTO RICO
3-(PHOSPHORYLOXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM SALT

7305

1/26/1988

MITCHELL COTTS CHEMICALS LTD

FACILITY AT MIRFIELD, UK

7306

II

1/27/1988

MOEHS IBERICA SL

METOPROLOL TARTRATE AS MFG. IN BARCELONA, SPAIN

7307

II

1/29/1988

BASF CORP

BIS-2-ETHYLHEXYL PHTHALATE AS MFG. IN KEARNY, NEW JERSEY

7308

12/17/1987

SIPHARM SUB OF SELOC AG

FACILITIES, PERSONNEL AND PROCEDURES IN SISSELN, SWITZERLAND

7309

2/1/1988

FORMULATION DEVELOPMENT CO

FACILITIES, PERSONNEL AND PROCEDURES IN WILMINGTON, N.CAROLINA

7310

II

2/2/1988

HOECHST MARION ROUSSEL SA

BETAMETHASONE VALERATE USP, BP AS MFG. IN VERTOLAYE, FRANCE

7311

II

2/2/1988

EXCELLA GMBH

BACLOFEN AS MANUFACTURED IN NUREMBERG,GERMANY

7312

1/27/1988

SWISS CAPS

FACILITIES, PERSONNEL AND PROCEDURES IN KIRCHBERG, SWITZERLAND

7313

II

2/1/1988

CHEMISCHE FABRIK WEYL GMBH

ACETYLSALICYLIC ACID AS MFG. IN MANNHEIM, GERMANY

7314

II

2/2/1988

REXIM SA DIV DEGUSSA

L-AMINO ACIDS AS MFG. IN HAM FRANCE

7315

2/1/1988

STERIS LABORATORIES INC

FACILITIES & STANDARD OPERATING PROCEDURES IN ARIZONA

7316

II

2/2/1988

REXIM SA DIV DEGUSSA AG

N-ACETYL L-TYROSINE AS MFG. IN HAM, FRANCE

7317

II

2/4/1988

DETERMINATION OF OXAZEPAM IN HUMAN PLASMA

7318

1/15/1988

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
BRADY ENTERPRISES INC

MANUFACTURING FACILITIES AND PROCEDURES IN E. WEYMOUTH, MA.

Page 203

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7319 I
I
1/28/1987
THERMO PAK COMPANY LTD

SUBJECT
FACILITIES AND PROCEDURES IN WOOD DALE, ILLINOIS

7320

2/5/1988

3M PHARMS

FACILITIES, PERSONNEL AND PROCED. IN PITHIVIERS, CEDEX, FRANCE

7321

2/10/1988

SOLOPAK LABORATORIES

FACILITIES, PERSONNEL AND PROCEDURES IN ELK GROVE VILLAGE, IL.

7322

II

2/9/1988

RESEARCH BIOCHMICALS INC

SKF-38393 HCL AS ENCAPSULATED A NORTHEASTERN UNIV.,BOSTON,MA

7323

II

2/10/1988

DIOSYNTH BV

5',8-DIMETHOXYLAUDANOSINE HCL AS MFG. IN OSS, HOLLAND

7324

II

2/5/1988

PUROLITE CORPORATION

CHOLESTYRAMINE RESIN USP AS MFG. IN VICTORIA, RUMANIA

7325

III

1/25/1988

HUNTSMAN CHEMICAL CORP

POLYPROPYLENE MANUFACTURED IN WOODBURY, NEW JERSEY.

7326

III

2/16/1988

4P VERPACKUNGEN RONSBERG GMBH

FLEXIBLE FOIL LAMINATE AS MFG. IN RONSBERG, GERMANY

7327

II

2/16/1988

IMAGENTS INC

RADIOCHEMICAL INDIUM CHLORIDE IN-111 AS MFG. IN HOUSTON, TEX.

7328

II

2/9/1988

ORGANICS DIV LA GRANGE INC

CONJUGATED ESTROGENS FOR INJECTION USP POWDER - CHICAGO, IL.

7329

II

2/12/1988

BASF PHARMA EVIONNAZ SA

CHOLINE-SALICYLATE 80% AS MFG. IN EVIONNAZ, SWITZERLAND

7330

2/8/1988

HOECHST CELANESE CORP

7331

II

1/20/1988

NIPPON KAYAKU COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BISHOP, TEXAS.
BUTADIAMUPLATIN AS MFG. IN TOKYO, JAPAN

7332

II

2/16/1988

GEDEON RICHTER

NORETHINDRONE 0.5 MG. AND ETHINYL ESTRADIOL 0.035

7333

II

2/8/1988

BASF PHARMA EVIONNAZ SA

METHENAMINE HIPPURATE AS MFG. IN EVIONNAZ, SWITZERLAND

7334

II

2/9/1988

BOEHRINGER INGELHEIM PHARMA KG

AROPINE METHYLNITRATE AS MFG, IN INGELHEIM, GERMANY

7335

2/18/1988

GLAXO WELLCOME INC

FACILITY LOCATED IN EDINBURG, SCOTLAND

7336

II

2/5/1988

COSMA SPA

TOLMETIN SODIUM AS MFG. IN CISERANO (BG) ITALY

7337

II

2/19/1988

NANTONG GENERAL PHARMACEUTICAL FACTORY

5-FLUOROURACIL AS MFG, IN NANTONG, JIANGSU PROVINCE, CHINA

7338

II

2/19/1988

HEXACHIMIE

CIBENZOLINE SUCCINATE INN. OR CIFENLINE SUCCINATE USAN

7339

2/17/1988

GREAT LAKES CHEMICAL KONSTANZ GMBH

L-AMINO ACID AS MFG. IN KONSTANZ, GERMANY

7340

II

2/17/1988

TEVA PHARMACEUTICAL INDUSTRIES LTD

LOPERAMIDE HYDROCHLORIDE AS MFG. IN MILAN, ITALY

7341

II

2/25/1988

ORION CORP FARMOS CHEMICAL PLANT

CYCLOPHOSPHAMIDE 50 MG. TABL. AS MFG, IN TURKU, FINLAND

7342

II

2/17/1988

GREAT LAKES CHEMICAL KONSTANZ GMBH

L-METHIONINE AS MFG. IN KONSTANZ, GERMANY

7343

II

2/18/1988

MACFARLAN SMITH

BUPRENORPHINE HYDROCHLORIDE MFG. IN EDINBURG, SCOTLAND

7344

II

2/10/1988

FABBRICA ITALIANI SINTETICI SPA

TRIAMTERENE MFG. IN VICENZA - ITALY

7345

2/12/1988

SCHERING AG

MFG. AND CONTROL OF CLINICAL SUPPLIES IN BERLIN,GERMANY

7346

II

2/16/1988

NITSON LABORATORIES

SULPHAMETHOXAZOLE USP AS MFG. IN THANE AND VAPI, INDIA

7347

II

2/17/1988

JAPAN CHEMICAL RESEARCH CO LTD

UROKINASE (BULK) AS MFG. IN KOBE, JAPAN

7348

II

2/25/1988

CADILA LABORATORIES PVT LTD

PHENYTOIN USP & PHENYTOIN SODIUM USP MFG. IN GUJARA, INDIA

7349

2/18/1988

LIPOID KG

FACILITIES, AND PERSONNEL LOCATED IN LUDWIGSHAFEN GERMANY

7350

II

2/25/1988

CADILA LABORATORIES PVT LTD

SULFAMETHOXAZOLE USP MFG. IN GUJARA, INDIA

7351

IV

2/18/1988

LIPOID GMBH

7352

2/23/1988

FORTUNE PLASTICS

7353

II

2/10/1988

CHEMISCHE FABRIK WEYL GMBH

LIPOID E 80 AND LIPOID E 80 S AS MANUFACTURED IN LUDWIGSHAFEN OR COLOGNE,


GERMANY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN RICHMOND, VIRGINIA.
5.7-DICHLORO-8-HYDROXYQUINOLINE MFG. IN MANNHEIM, GERMANY

7354

II

2/17/1988

ROHM PHARMA GMBH

THEOPHYLLINE R 85 D/02 MFG. IN WEITERSTADT, W. GERMANY

7355

III

2/29/1988

SPECIALTY PACKAGING PRODUCTS INC

DESCRIPTION OF LOTION PUMP SYSTEM LOCATED IN BRIDGEPORT, CT

Page 204

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7356 A
II
2/29/1988
ASTELLAS IRELAND CO LTD

SUBJECT
FAMOTIDINE MFG. IN DUBLIN, IRELAND

7357

II

3/2/1988

TRANSPHARMA LTD

ENCAPSULATED POTASSIUM CHLORIDE MFG. IN VANDALIA, OH

7358

2/23/1988

SILGAN PLASTICS CORPORATION

FACILITIES LOCATED IN FRANKLIN, KY

7359

II

2/29/1988

AMERICAN CHEMICAL INDUSTRIAL CORP

CLINDAMYCIN PHOSPHATE MFG. IN RICHMOND, CA

7360

II

2/25/1988

ALBUTEROL 8 MG, LOT E-14274 MFG. IN CLEARWATER, FL

7361

II

2/29/1988

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
AMERICAN CHEMICAL INDUSTRIAL CORP

7362

III

3/3/1988

FIRESTONE SYNTHETIC RUBBER AND LATEX CO

STEREON 840 AND 881 AS MFG. IN AKRON, OH.

7363

3/3/1988

SILGAN PLASTICS CORPORATION

FACILITIES LOCATED IN LOUISVILLE, KY.

7364

II

3/4/1988

APOTEX PHARMACHEM INC

CYTARABINE USP XXI MFG. IN BRANTFORD & MISSISSAUGA, CANADA

7365

II

2/28/1988

NYCOMED AUSTRIA GMBH

SUXAMETHONIUM CHLORIDE AS MFG. IN LINZ, AUSTRIA

7366

II

3/4/1988

ASPEN OSS BV

ETHYNODIOL DIACETATE AS MFG. IN OSS, THE NETHERLANDS

7367

IV

3/7/1988

AVANTI POLAR LIPIDS INC

1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MFG. PELHAM, AL.

7368

II

3/8/1988

RESOLUTION CHEMICALS LTD

BACLOFEN AS MFG. BY MITCHELL COTTS-CHEMICALS

7369

IV

3/7/1988

AVANTI POLAR LIPIDS INC

1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL MFG. PELHAM, AL

7370

II

3/1/1988

SIGMA F AND D DIV LTD

DL-3,4- DIHYDROXYPHENYLGLYCOL #D9753FD MFG. IN ST LOUIS, MO

7371

II

3/1/1988

HOECHST AG

EBIRAIDE (HOE 427) BULK DRUG AS MFG. IN FRANFURT, GERMANY

7372

2/26/1988

SANOFI PHARMACEUTICALS INC

CONTRACT PACKAGING OPERATIONS ONLY, LOCATED IN FENTON, MO

7373

III

2/25/1988

MITSUBISHI POLYSTER FILM GMBH

PACKAGING MATERIAL AS MFG. IN WIESBADEN, GERMANY

7374

II

3/7/1988

AZEO PROCESSING INC

THYROGLOBULIN, USP MFG. IN WAUTOMA, WI

7375

II

3/4/1988

SCHERING AG

ZK 112 119(6-BOCIP) AS MFG. IN BERLIN OR BERGKAMEN GERMANY

7376

II

3/4/1988

FDC LTD

MICONAZOLE NITRATE AS MFG. IN ROHA, INDIA

7377

III

3/17/1988

MULTISORB TECHNOLOGIES INC

ACTIVATED, BAGGED DESICCANT AS MFG. IN BUFFALO, NY

7378

II

3/7/1988

PENINSULA LABS

CORTICOTROPIN RELEASING FACTORAS MFG. IN BELMONT, CA.

7379

II

3/3/1988

ALDRICH CHEMICAL COMPANY INC

POLYBRENE, PRODUCT# 10,768-9 AS MFG. IN MILWAUKEE, WI

7380

II

3/11/1988

NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD

VALPROIC ACID AS MFG. IN OGAKI AND MIZUSHIMA, JAPAN

7381

III

2/4/1988

COMAR INC

PACKAGING MATERIALS (SEALS) AS MFG. IN BUENA, NJ

7382

III

3/10/1988

MALLINCKRODT INC

DAA ON 890 GREY (28 MM STOPPER) AS MFG. BY WEST CO.

7383

II

3/8/1988

CREATIVE BIOMOLECULES

EPIDERMAL GROWTH FACTOR, HEGF AS MFG. IN HOPKINTON, MA

7384

II

2/19/1988

CESQUISA SA

FLUOCINONIDE AS MFG. IN SEGOVIA, SPAIN

7385

3/12/1988

HAUSER CHEMICAL RESEARCH INC

FACILITIES AND PERSONNEL IN BOULDER COLORADO

7386

II

3/18/1988

QUATRUM

FLUOCINOLONE ACETONIDE AS MFG. IN SACAVEM, PORTUGAL

7387

II

3/21/1988

DAN DONG PHARMACEUTICALS

THEOPHYLLINE AS MFG. IN LIAONING, CHINA

7388

II

3/18/1988

CI-925 AND CI-929 AS DETERMINDE IN HUMAN PLASMA

7389

II

2/2/1988

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
HOECHST MARION ROUSSEL SA

7390

3/15/1988

PHILLIPS MANUFACTURING CO

MANUFACTURING SITE AND FACILITIES LOCATED IN CANTON, MA

7391

II

3/22/1988

FARMABOIS

FLUOCINONIDE MFG. IN PAVIA, ITALY

7392

3/22/1988

VESTAR RESEARCH INC

MANUFACTURING SITE, FACILITIES, AND CONTROLS LOCATED IN PASADENA, CA

7393

II

3/11/1988

SIGMA F AND D DIV LTD

D (-)-RIBOSE PRODUCT # R 7500 FD MFG. IN ST. LOUIS, MO.

CARBIDOPA MFG. IN RICHMOND, CA

BETAMETHASONE DIPROPIONATE AS MFG. IN VERTOLAYE, FRANCE

Page 205

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7394 I
IV
3/16/1988
HENRY H OTTENS MANUFACTURING CO INC

SUBJECT
EXCIPIENTS, COLORANTS, FLAVORS, ESSENCES AS MFG. IN PHILA. PA

7395

III

3/23/1988

AC MOLDING COMPOUNDS

UREA RESINS MANUFACTURED IN DALLAS, TEXAS.

7396

3/29/1988

BLISPAK INC

CONTRACT PACKAGING FACILITY LOCATED IN FAIRFIELD, NEW JERSEY

7397

IV

3/25/1988

CAPSUGEL

GELATIN CAPSULES MANUFACTURED IN SAGAMIHARA, JAPAN

7398

II

3/3/1988

ISOCHEM SA

QUINIDINE BISULPHATE AS MFG. IN GENNEVILLIERS, FRANCE

7399

3/24/1988

HICKSON PHARMACHEM LTD

FACILITIES AND PERSONNEL IN RINGASKIDDY, COUNTY CORK, IRELAND

7400

2/29/1988

WOCKHARDT LTD

FACILITIES A ANKLESHWAR, INDIA

7401

II

3/22/1988

FABBRICA ITALIANI SINTETICI SPA

DESIPRAMINE HYDROCHLORIDE AS MFG. IN VICENZA, ITALY

7402

II

2/29/1988

WOCKHARDT LTD

D-OXYPHEN BASE AS MFG. IN ANKLESHWAR, INDIA

7403

II

3/21/1988

SIGMA F AND D DIV LTD

OLEIC ACID SODIUM 95% AS MFG. IN ST. LOUIS, MISSOURI

7404

III

3/29/1988

FILTER PRODUCTS INC

PHARMACEUTICAL-GRADE FILTER MEDIA AS MFG. IN SACRAMENTO, CA.

7405

II

3/26/1988

MEDEA RESEARCH LABS

PHOSPHOCYSTEAMINE AS MFG. IN WESTHAMPTON BEACH, NEW YORK

7406

3/30/1988

PHYTEX AUSTRALIA PTY LTD

SITE, FACILITIES AND PERSONNEL LOCATED IN PERKHURST, AUSTRALIA

7407

III

3/22/1988

PRESSPART MANUFACTURING LTD

PKG. MATERIAL FOR PHARM. AEROSOL AS MFG. IN LANCASHIRE, UK

7408

II

3/30/1988

PHYTEX AUSTRALIA PARTY LTD

SCOPOLAMINE BASE AS MFG. IN PERKHURST, AUSTRALIA

7409

II

3/28/1988

CAMBREX PROFARMACO MILANO SRL

AMILORIDE HCL AS MFG. IN MILAN, ITALY

7410

II

3/30/1988

PHYTEX AUSTRALIA PARTY LTD

METHSCOPOLAMINE BROMIDE MANUFACTURED IN PERKHURST, AUSTRALIA.

7411

II

3/30/1988

EGIS PHARMACEUTICALS

ETHACRYNIC ACID MANUFACTURED IN BUDAPEST AND DORMEND, HUNGARY.

7412

4/5/1988

LUITPOLD PHARMACEUTICALS INC

STERILE PROCESSING FACILITY LOCATED IN SHIRLEY, NEW YORK

7413

II

3/31/1988

JACOBUS PHARMACEUTICAL CO

DAPSONE (FINAL DOSAGE FORMS) AS MFG. IN PLAINSBORO, N.J.

7414

II

3/30/1988

SIGMA ALDRICH IRELAND LTD

NORTRIPTYLINE HYDROCHLORIDE AS MFG. IN ARKLOW, IRELAND

7415

II

3/30/1988

PHYTEX AUSTRALIA PARTY LTD

SCOPOLAMINE HYDROBROMIDE MANUFACTURED IN PERKHURST, AUSTRALIA.

7416

II

4/4/1988

ROUSSEL-UCLAF

HYDROCORTISONE SODIUM PHOSPHATE AS MFG. IN VERTOLAYE, FRANCE

7417

II

3/30/1988

PHYTEX AUSTRALIA PARTY LTD

HYOSCINE METHONITRATE AS MFG. IN PERKHURST, AUSTRALIA

7418

4/6/1988

EXPANSIA

MANUFACTURING FACILITIES LOCATED IN ISLE-SUR-SORGUE, FRANCE

7419

II

4/6/1988

BIOCHEMIC GESELLSCHAFT MBH

THIOPENTAL SODIUM AS MFG. IN KUFSTIEN-SCHAFTENAU, AUSTRIA

7420

IV

3/18/1988

GUJARAT THEMIS BIOSYN LTD

ERYTHROMYCIN THIOCYANATE AS MFG. IN VAPI, GUJARAT STATE,INDIA

7421

4/6/1988

BIOCHEMIC GESELLSCHAFT MBH

PENICILLIN RECOVERY PLANT IN KUNDL, TYROL, AUSTRIAL

7422

II

4/7/1988

ISOCHEM SA

DILTIAZEM HCL AS MFG. IN GENNEVILLIERS, FRANCE

7423

II

4/12/1988

IMAGENTS INC

RADIOCHEMICAL STRONTIUM CHLORIDE SR-82 AS MFG. IN HOUSTON, TX

7424

II

4/5/1988

SOCIETA ITALIANA CORTICOSTEROIDI SPA

DESOXIMETASONE AS MFG. IN MILAN, ITALY

7425

II

4/11/1988

VERTELLUS PERFORMANCE MATERIALS INC

ACETYLTRI-N-BUTYL CITRATE AS MFG. IN GREENSBORO, N. CAROLINA

7426

II

4/11/1988

SIGNA SA DE CV

NADOLOL AS MFG. IN ONTARIO, CANADA

7427

II

4/12/1988

PHARM ECO LABORATORIES INC

TRICAINE AS MFG. IN SIMI VALLEY, CALIFORNIA

7428

II

4/18/1988

SERONO INC

LH ENRICHED FRACTION AS MFG. IN (ROMA) ITALY

7429

III

4/15/1988

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5002-45 - SALISBURY, MD.

7430

II

4/12/1988

DINAMITE DIPHARMA SPA

GEMFIBROZIL AS MFG. IN MILAN, ITALY

7431

III

4/15/1988

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5002-50 GRAY MANUFACTURED IN SALISBURY,


MARYLAND.

Page 206

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7432 I
II
4/18/1988
QUATRUM

SUBJECT
FLUOCINONIDE AS MFG. IN LISBON, PORTUGAL

7433

II

4/11/1988

WASHINGTON BIOLAB INC

HUMAN CHORIONIC GONADOTROPIN AS MFG. IN AMES, IOWA

7434

III

4/15/1988

HELVOET PHARMA MARYLAND

7435

IV

4/14/1988

PHARMATEC INC

IPC RUBBER CLOSURE FORMULATION B5002-60 GRAY MANUFACTURED IN SALISBURY,


MARYLAND.
2-HYDROXYPROPYL-B-CYCLODEXTRIN AS MFG. IN ALACHUA, FLORIDA

7436

II

3/30/1988

NATL INST HLTH ADAMHA DOC

INFORMATION ON FISH OILS AS SUBMITTED ON BEHALF OF FOTMAC

7437

IV

4/15/1988

GRAIN PROCESSING CORP

MALTRIN MALTODEXTRIN AND MALTRIN CORN SYRUP SOLIDS

7438

4/14/1988

SEPPIC DIV AIR LIQUIDE

LACAZE-BASSE FACTORY LOCATED IN CASTRES, FRANCE

7439

III

4/14/1988

FORTUNE PLASTICS

BLOW MOLDING OF PVC, LDPE, MDPE, HDPE PLASTICS BOTTLES

7440

4/12/1988

BIRMINGHAM POLYMERS INC

FAC. PERSONNEL, AND GEN. OPERATING PROCEDURES AS MFG.IN AL.

7441

III

4/20/1988

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION LZ514 MANUFACTURED IN SALISBURY, MARYLAND.

7442

4/22/1988

SILARX PHARMACEUTICALS INC

MFG. AND PROCESSING FAC. LOC'N IN SPRING VALLEY, N.Y.

7443

4/18/1988

HEALTH CARE INC

FACILITIES LOCATED IN ELKHART, INDIANA

7444

II

4/22/1988

WYCKOFF CHEMICAL CO INC

AMOXAPINE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

7445

II

4/22/1988

TEVA PHARMACEUTICAL INDUSTRIES LTD

GEMFIBROZIL MANUFACTURED IN NETANYA, ISRAEL.

7446

II

4/18/1988

SIGMA F AND D DIV LTD

NICOTINE #3876 FD MANUFACTURED IN ST. LOUIS, MISSOURI.

7447

II

3/15/1988

WOCKHARDT LTD

PIROXICAM AS MFG. IN ANKLESHWAR, INDIA

7448

II

4/15/1988

SOCIETA ITALIANA CORTICOSTEROIDI SPA

HALCINONIDE AS MFG. IN MILAN, ITALY

7449

4/22/1988

BIOCHEMIC GESELLSCHAFT MBH

MULTIPURPOSE SYNTHESIS PLANT LOCATED IN KUNDL, TYROL, AUSTRIA

7450

4/22/1988

REPLIGEN CORPORATION

FACILITIES LOCATED IN CAMBRIDGE, MA

7451

II

4/28/1988

DIOSYNTH INC

OXYMORPHONE HYDROCHLORIDE AS MFG. IN APELDOORN, NETHERLANDS

7452

4/28/1988

BIOCHEMIC GESELLSCHAFT MBH

FERMENTATION PLANT LOCATED IN KUNDL, TYROL, AUSTRIA

7453

II

4/28/1988

ISOCHEM SAS

LOPERAMIDE HYDROCHLORIDE AS MFG. IN GENNEVILLIERS, FRANCE

7454

II

4/19/1988

GREAT LAKES CHEMICAL KONSTANZ GMBH

L-VALINE AS MFG. IN KONSTANZ, GERMANY

7455

II

4/25/1988

CHEMISCHE FABRIK WEYL GMBH

VERAPAMIL HYDROCHLORIDE AS MFG. IN MANNHEIM, GERMANY

7456

II

4/21/1988

ZAMBON SPA

NAPROXEN SODIUM AS MFG. IN VICENZA, ITALY

7457

III

5/2/1988

WEST PHARMACEUTICAL SERVICES INC

PURCOAT MANUFACTURED IN PHOENIXVILLE, PENNSYLVANIA.

7458

II

4/23/1988

FARMABOIS

FLUOCINOLONE ACETONIDE MFG. IN PAVIA, ITALY

7459

II

5/5/1988

TEVA PHARMACEUTICAL INC

TRAZODONE HYDROCHLORIDE AS MFG. BY PLANTEX IN NETANYA, ISRAEL

7460

III

4/18/1988

WITTEN MANUFACTURING CO

POLYESTER COIL FIBRE AS MFG. IN GASTONIA, NORTH CAROLINA

7461

II

5/2/1988

SIGMA F AND D DIV LTD

MESO-2,3-DIMERCAPTOSUCCINIC ACID AS MFG. IN SAINT LOUIS, MO.

7462

II

5/5/1988

BASF CORPORATION

ACETAMINOPHEN AS MFG. IN BISHOP, TEXAS

7463

II

5/1/1988

SYLATEC GROUPE SYNTHELABO

KETO ACID TABLETS CODE CSW20-4 AS MFG. IN FRANCE

7464

II

5/5/1988

ORGAMOL SA

AMSACRINE AS MFG. IN EVIONNAZ SWITZERLAND

7465

II

5/3/1988

MEDEA RESEARCH LABS

EDROPHONIUM CHLORIDE AS MFG. IN WESTHAMPTON BEACH, NEW YORK

7466

II

5/11/1988

GEDEON RICHTER

NORETHINDRONE 0.75 MG. AND ETHINYL ESTRADIOL 0.035 MG. TABLET

7467

5/5/1988

JUSTE SAQF

FACILITIES, PERSONNEL AND OPERATING PROCEDURES-MADRID, SPAIN

7468

II

5/12/1988

BACHEM FINE CHEMICALS INC

ARIAL NARIURETIC PEPTIDE (1-28) HUMAN AS MFG.-TORRANCE, CA

7469

5/10/1988

KNOLL PHARMA CHEMICALS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CRAMLINGTON, ENGLAND.

Page 207

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7470 I
II
5/13/1988
GD SEARLE PHARMACEUTICALS INC

SUBJECT
DISOPYRAMIDE PHOSPHATE AS MFG. IN AUGUSTA, GA. AND CAGUAS, PR

7471

IV

5/9/1988

CARRUBBA INC

PINEAPPLE FLAVOR FORMULA #23297 AS MFG. IN MILFORD, CT.

7472

II

5/11/1988

DIPHARMA FRANCIS SRL

PIROXICAM AS MFG. IN MILAN, ITALY

7473

II

5/13/1988

MOEHS SA DIV OF SANOF

PIROXICAM AS MFG. IN BARCELONA, SPAIN

7474

II

5/11/1988

OLON SPA

TRETINOIN AS MFG. IN MILAN, ITALY

7475

5/11/1988

EGIS PHARMACEUTICALS

LACTA FACTORY LOCATED IN KORMEND, HUNGARY

7476

IV

5/10/1988

JM HUBER CORP

CALCIUM SILICATE AS MFG. IN HAVRE DE GRACE, MD.

7477

IV

5/5/1988

HENKEL CORP

DURO-TAK 280-2516 AS MFG. IN THE NETHERLANDS

7478

III

5/12/1988

FLINT HILLS RESOURCES LP

POLYPROPYLENE MANUFACTIRED IN LONGVIEW, TX

7479

IV

5/2/1988

NORWOOD INDUSTRIES INC

SEMEX MD-0129 AS MFG. IN FRAZER, PA

7480

II

5/16/1988

DEGUSSA GMBH

CHLORHEXIDINE HYDROCHLORIDE AS MFG. IN HANAU, GERMANY

7481

II

5/18/1988

GEDEON RICHTER

RGH-2957 AS MFG. IN BUDAPEST HUNGARY

7482

II

5/18/1988

SIGMA F AND D DIV LTD

TES(N-TRIS[ HYRDOXYMETHYL ] METHY 2-AMINOETHANESULFONIC ACID)

7483

II

5/18/1988

KV PHARMACEUTICAL CO

PSEUDOEPHEDRINE HCL CONTROLLED BEADS AS MFG. IN ST. LOUIS, MO

7484

II

5/10/1988

AVENTIS BEHRING

HPLC PURIFIED CALCITONIN-SALMON DRUG SUBSTANCE MFG. IN PA

7485

II

5/16/1988

OLON SPA

ISOTRETINOIN AS MFG. IN MILAN, ITALY

7486

II

5/17/1988

HEUMANN

HALOPERIDOL AS MFG. IN FEUCHT, GERMANY

7487

II

5/20/1988

REPLIGEN CORPORATION

ULTRAPURE RECOMBINANT PROTEIN A AS MFG. IN CAMBRIDGE, MA

7488

II

5/16/1988

SIGMA F AND D DIV LTD

SUCCINIC ACID,DISODIUM HEXAHYDRATE AS MFG.IN SAINT LOUIS, MI

7489

II

5/20/1988

REPLIGEN CORPORATION

IMMOBILIZED RECOMBINANT PROTEIN A AS MFG. IN CAMBRIDGE, MA

7490

II

5/20/1988

FINORGA

6-METHOXY-2-NAPHTHALDEHYDE AS MFG. IN CHASSE-SUR-RHONE FRANCE

7491

II

5/20/1988

REPLIGEN CORPORATION

THERAPEUTIC RECOMBINANT PROTEIN A AS MFG. IN CAMBRIDGE, MA

7492

II

5/22/1988

CHEMI SPA

DIFLUNISAL AS MFG. IN FROSINONE, ITALY

7493

II

4/30/1988

LONZA BRAINE SA

DESMOPRESSIN ACETATE AS MFG. IN BRAINE-L'ALLEUD BELGIUM

7494

II

5/26/1988

SHANGHAI NO 17 PHARMACEUTICAL FACTORY

INDOMETHACIN AS MFG. IN SHANGHAI, CHINA

7495

II

5/30/1988

SIFAVITOR SRL

PYRANTEL PAMOATE AS MFG. IN MILAN, ITALY

7496

IV

5/25/1988

MICROCRYSTALLINE CELLULOSE AS MFG. IN TAIPEI, TAIWAN, R.O.C.

7497

II

5/31/1988

WEI MING PHARMACEUTICAL MANUFACTURING


CO LTD
BIOGLUCONICS INC

7498

II

5/27/1988

FARMABOIS

DESOXIMETHASONE AS MFG. IN PAVIA, ITALY

7499

II

5/26/1988

ICFI SPA

BACLOFEN AS MFG. IN (VA) ITALY

7500

II

5/16/1988

PENINSULA LABS

BETA-HUMAN CHORIONIC-GONADOTROPIN (109-145) IN BELMONT, CA

7501

II

6/2/1988

QUATRUM

BECLOMETHASONE DIPROPIONATE AS MFG. IN LISBON, PORTUGAL

7502

II

6/1/1988

TESTOSTERONE INJECTABLE MICROSPHERES MFG. IN CINCINNATI, OH

7503

II

5/30/1988

MEDISORB TECHNOLOGIES INTERNATIONAL LTD


PARTNERSHIP
NOBEL CHEMICALS AB DIV FINE CHEMICALS INC

7504

II

6/3/1988

MOEHS IBERICA SL

NIFEDIPINE AS MFG. IN BARCELONA, SPAIN

7505

II

6/1/1988

FABBRICA ITALIANA SINTETICI SPA

CLONAZEPAM AS MFG. IN VICENZA, ITALY

7506

III

5/31/1988

SILGAN PLASTICS CORPORATION

PLASTIC BOTTLES MANUFACTURED IN FRANKLIN, KENTUCKY.

7507

IV

6/2/1988

SHIN-ETSU CHEM IND CO LTD

HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE

FERROUS GLUCONATE AS MFG. IN CARLSTADT, NEW JERSEY

FLUOCINONIDE AS MFG. IN MILAN, ITALY

Page 208

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7508 I
II
6/1/1988
EXPANSIA

SUBJECT
CICLETANINE AS MFG. IN ARAMON, FRANCE

7509

IV

6/1/1988

ABITEC CORP

BBS, BAKER'S BEST SHORTENING AS MFG. IN COLUMBUS, OHIO

7510

6/3/1988

PENCO OF LYNDHURST INC

FACILITY, PERSONNEL AND PROCEDURES IN LYNDHURST, NEW JERSEY

7511

III

6/9/1988

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMUATION B5001-55 GRAY, SALISBURY, MD

7512

6/6/1988

ERCI FACILITIES SERVICES CORP

STORAGE OF CHEMICALS AND DRUGS FOR NCI CONTRACT (N01-CM-73721)

7513

II

6/7/1988

NOVARTIS PHARMACEUTICALS CORP

STARTING MATERIALS 1 & 3, IN NEW JERSEY AND SWITZERLAND

7514

II

6/3/1988

ER SQUIBB AND SONS INC

FUNGILIN (AMPHOTERICIN B) ORAL SUSPENSION MFG. IN MORETON,UK

7515

II

5/19/1988

FARCHEMIA

N-METHYL-1-METHYLTHIO-2-NITRO ETHENAMINE, TREVIGLIO, ITALY

7516

6/6/1988

BOSTON ANALYTICAL

7517

II

6/8/1988

BACHEM FEINCHEMIKALIEN AG

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN EVERETT, MA.
H-PHE-0ME HYDROCHLORIDE AS MFG. IN BUDENDORF, SWITZERLAND

7518

II

6/10/1988

SOGO PHARMACEUTICAL COMPANY LTD

THIOTEPA AS MFG. IN SAGAMIHARA, JAPAN

7519

III

6/9/1988

AMPAC FLEXIBLES

PACKAGING MATERIALS AS MFG. IN CARY, IL

7520

II

6/8/1988

BIORESEARCH SPA

7521

IV

6/6/1988

UNILEVER UNITED STATES INC

S-ADENOSYL METHIONINE SULFATE P-TOLUENESULFONATE BULK DRUG AND ENTERIC


COATED 400 MG TABLET MFG. IN SWITZERLAND AND ITALY
EXCIPIENTS FOR CREAMTEX MANUFACTURED IN JOLIET, ILLINOIS.

7522

II

6/6/1988

OMNICHEM SA

5-AMINO-SALICYLIC ACID AS MFG. IN WETTEREN, BELGIUM

7523

II

6/8/1988

CHEMISCHE FABRIK BERG GMBH

METHENAMINE HIPPURATE AS MFG. IN LUDENSCHEID, GERMANY

7524

II

6/13/1988

DIOSYNTH BV

DEHYDRO ISOANDROSTERONE ACETATE AS MFG. OSS THE NETHERLANDS

7525

II

6/12/1988

STEROGENE BIOSEPARATIONS INC

7526

II

6/13/1988

SIGMA F AND D DIV LTD

PURIFICATION CHROMATOGRAPHY MEDIA USED IN THE PREPARATION OF PROTEINS AS MFG


IN CARLSBAD, CA.
DEXTROMETHORPHAN HYDROBROMIDE AS MFG. IN ST. LOUIS , MO.

7527

II

6/14/1988

JOHNSON MATTHEY INC

GALLIUM NITRATE AS MFG. IN WEST DEPTFORD, NEW JERSEY

7528

II

6/14/1988

SHANGHAI NO 6 PHARMACEUTICAL FACTORY

RANITIDINE HYDROCHLORIDE MFG. IN SHANGHAI (CHINA)

7529

II

6/13/1988

DIOSYNTH BV

METOLAZONE AS MFG. IN OSS THE NETHERLANDS

7530

III

6/8/1988

SILGAN PET CORP

PACKAGING MATERIALS MFG. IN LOUISVILLE, KY.

7531

II

6/13/1988

IMAGENTS INC

RADIOCHEMICAL GALLIUM CITRATE GA-67 AS MFG. IN HOUSTON, TEXAS

7532

II

6/13/1988

DIOSYNTH BV

DEHYDRO ISOANDROSTERONE SODIUM SULPHATE AS MFG. IN HOLLAND

7533

II

5/23/1988

ANTIBIOTICOS SPA

CABERGOLINE ACTIVE DRUG SUBSTANCE AS MFG. IN MILANO, ITALY

7534

II

5/23/1988

ANTIBIOTICOS SPA

CABERGOLINE FINISHED DOSAGE AS MFG. IN MILANO ITALY

7535

II

6/13/1988

DIOSYNTH BV

DEHYDRO ISOANDROSTERONE AS MFG. IN OSS THE NETHERLANDS

7536

II

5/17/1988

LINNEA PHYTOCHEMICALS

PILOCARPINE HYDROCHLORIDE AS MFG. IN RIAZZINO, SWITZERLAND

7537

III

4/28/1988

REEMAY INC

SPUNBONDED POLYESTER AS MFG. IN OLD HICKORY, TENNESSEE

7538

6/6/1988

ANGELINI FRANCESCO ACR

MFG. SITE AND FACILITIES LOCATED IN APRILIA (LT) ITALY

7539

II

6/9/1988

DROPERIDOL AS MFG. IN CARONNO PERTUSELLA (VA) ITALY

7540

II

6/16/1988

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
SIEGFRIED AG

7541

II

6/21/1988

SHANGHAI NO 6 PHARMACEUTICAL FACTORY

CIMETIDINE AS MFG. IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA

7542

II

6/2/1988

ANTIBIOTICOS SPA

THYMIC HUMORAL FACTOR GAMMA 2 ACTIVE DRUG SUBS. - MILAN,ITALY

7543

II

6/2/1988

ANTIBIOTICOS SPA

THYMIC HUMORAL FACTOR GAMMA 2 FINISHED DOSAGE, MILAN ITALY

DILTIAZEN HYDROCHLORIDE AS MFG. IN ZOFINREN, SWITZERLAND

Page 209

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7544 I
II
6/15/1988
FARMOS GROUP LTD MEDIPOLAR

SUBJECT
CYTARABINE MFG. IN OULU, FINLAND

7545

II

6/21/1988

SHOWA DENKO KK

L-5-HYDROXYTRYPTOPHAN AS MFG. IN OITA, JAPAN

7546

III

6/9/1988

AIR PRODUCTS AND CHEMICALS INC

AIRFLEX 416 EMULSION AS MFG. IN CALVERT CITY, KY.

7547

II

6/22/1988

ECONAZOLE NITRATE AS MFG. IN SETTIMO MILANESE, ITALY

7548

II

6/21/1988

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
FIS FABBRICA ITALIANA SINTETICI SPA

7549

II

6/21/1988

KNOLL AG

MEFLOQUINE HYDROCHLORIDE AS MFG. IN LUDWIGSHAFEN, GERMANY

7550

III

6/22/1988

DYMAX CORP

PACKAGING MATERIALS ADHESIVES MFG. IN TORRINGTON,CT.

7551

6/21/1988

7552

II

6/21/1988

NORTHEAST GENERAL PHARMACEUTICAL


FACTORY
NORTHEAST PHARMACEUTICALS GROUP CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SHENYANG, PEOPLE'S REP. OF CHINA (#2 AFFILIATED PLANT).
SUCRALFATE AS MFG. IN SHENYANG, PEOPLE'S REPUBLIC OF CHINA

7553

II

6/24/1988

SELOC FRNCE

DIVALPROEX SODIUM AS MFG. IN SHANNON CO. CLARE, IRELAND

7554

6/27/1988

CONTENSIO CHEMICALS GMBH

FACILITY LOCATED AT WITTEN/RUHR, GERMANY

7555

II

6/29/1988

EASTMAN KODAK CO

(ETHYLENEDINITRILO) TETRAACETIC ACID COPPER DISODIUM SALT

7556

II

6/30/1988

HOECHST MARION ROUSSEL SA

BETAMETHASONE AS MFG. IN VERTOLAYE, FRANCE

7557

II

6/22/1988

TCI AMERICA

DICHLOROACETIC ACID SODIUM SALT AS MFG. IN PORTLAND, OREGON

7558

III

6/28/1988

EXXONMOBIL CHEMICAL CO

LOW DENSITY POLYETHYLENEAS MFG. IN MONT BELVIEU, TEXAS

7559

IV

6/8/1988

JAY FLAVORS

ARTIFICIAL FLAVOR FOR ANTIBIOTIC SPRAY DRIED NV-7757

7560

6/29/1988

AB COWLES CO INC

FACILITIES AND OPERATING PROCEDURES AT THE WAYLAND PLANT, N.Y.

7561

7/4/1988

IROPHARM LTD

7562

II

6/28/1988

PENICK CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ARKLOW, IRELAND.
OPIUM TINCTURE SOLUTION AS MFG. IN NEWARK, NEW JERSEY

7563

II

7/4/1988

IROPHARM LTD

NIFEDIPINE AS MFG. IN ARKLOW CO. WICKLOW, REPUBLIC OF IRELAND

7564

II

7/1/1988

PARKER HANNIFIN MANUFACTURING LTD


MICROPORUS FILTERS MFG. IN BIRTLEY CO. DURHAM, ENGLAND
DOMNICK HUNTER PROCESS FILTRATION EUROPE

7565

II

7/4/1988

CD271 AS MFG. IN GARGENVILLE, FRANCE

7566

5/9/1988

LABORATOIRES D'ETUDES ET DE RECHERCHES


SYNTHELABO
FILTRON TECHNOLOGY CORP

7567

II

7/1/1988

ANGUS BIOTECH INC

ERYTHROMYCIN AS MFG. IN WILMINGTON, CALIFORNIA

7568

II

7/11/1988

DAIICHI SANKYO CO LTD

PRAVASTATIN SODIUM (CS-514) - ONAHAMA, IWAKI CITY, JAPAN

7569

II

7/13/1988

RALLIS INDIA LTD

NAPROXEN SODIUM AS MFG. IN GUJARA, INDIA

7570

III

7/7/1988

MAGENTA CORP

POP-LOK CAPS AS MFG. IN CHICAGO, IL

7571

II

7/6/1988

PAUL SCHERRER INSTITUTE

STRONTIUM SR-82 CONCENTRATE MFG. IN WURENLINGEN, SWITZERLAND

7572

7/6/1988

PAUL SCHERRER INSTITUTE

FACILITIES LOCATED IN WURENLINGEN, SWITZERLAND

7573

7/6/1988

SMITHKLINE BEECHAM PHARMACEUTICALS

PENN CHEMICALS PRODUCTION FACILITY IN COUNTY CORK, IRELAND

7574

II

7/6/1988

POLYPEPTIDE LABS INC

ANTOCIN AS MFG. IN MALMO SWEDEN

7575

II

7/12/1988

RESOLUTION CHEMICALS LTD

AZATHIOPRINE AS MFG. IN WEST YORKSHIRE, UNITED KINGDOM

7576

II

7/19/1988

REXIM SA DIV DEGUSSA

GLYCINE HYDROCHLORIDE AS MFG. IN HAM, FRANCE

7577

II

7/11/1988

MIKAH PHARMA LLC

LOXAPINE SUCCINATE AS MFG. IN SOUTH HAVEN, MICHIGAN

7578

II

7/7/1988

PHARMACHIM ECONOMIC CORP

TOBRAMYCIN BASE AS MFG. IN SOFIA, BULGARIA

CLOTRIMAZOLE MANUFACTURED IN VICENZA, ITALY.

FACILITIES LOCATED IN CLINTON, MASSACHUSETTS

Page 210

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7579 I
II
7/18/1988
MEDICHEM SA

SUBJECT
PROBUCOL AS MFG. IN CELRA (GERONA) SPAIN

7580

7/15/1988

IPCA LABORATORIES PVT LTD

FACILITY IBD-D IN PIN., INDIA

7581

II

7/15/1988

IPCA LABORATORIES LTD

METOCLOPRAMIDE HCL AS MFG. IN RATLAM, MADHYA PRADESH, INDIA

7582

7/18/1988

OWENS ILLINOIS CLOSURE INC

FACILITY LOCATED IN FORT WORTH, TEXAS

7583

II

7/19/1988

INSTITUTO MASSONE S A

MENOTROPIN MANUFACTURED IN BUENOS AIRES, ARGENTINA.

7584

II

6/29/1988

SCHERING AG

DANAZOL AS MFG. IN BERKAKAMEN, GERMANY

7585

II

7/14/1988

EGIS PHARMACEUTICALS PUBLIC LTD CO

PIROXICAM AS MFG. IN BUDAPEST, HUNGARY

7586

II

7/12/1988

SINTENOVA SA

ATENOLOL AS MFG. IN BARCELONA, SPAIN

7587

II

6/27/1988

RHONE POULENC PHARMACEUTICALS RP INC

SPIRAMYCIN SYRUP AS MFG. IN SAINT-GENIS-LAVAL, FRANCE

7588

II

7/6/1988

STOLLE RESEARCH & DEVELOPMENT CORP

NORETHINDRONE INJECTABLE MICROSPHERES - CINCINNATI, OHIO

7589

7/13/1988

DS INDUSTRIE APS

FACILITY FOR THE PRODUCTION OF LIPID ESTERS,COPENHAGEN,DENMARK

7590

II

7/18/1988

EXCELLA GMBH

CLOMIPHENE-CITRATE AS MANUFACTURED IN FEUCHT,GERMANY

7591

II

7/22/1988

FRANCIS SPA

ATENOLOL AS MFG. IN CARONNO, PERTUSELLA (VA) ITALY

7592

II

7/18/1988

THIETHYLPERAZINE MALEATE AS MFG. IN BASLE, SWITZERLAND

7593

II

7/13/1988

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
TANABE SEIYAKU CO LTD

7594

7/20/1988

PHARMACEUTICAL DELIVERY SYSTEMS INC

BENZYL S-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLATE P-TOLUENESULFONIC ACID


SALT (THIQ) AS MFG. IN ONODA CITY, YAMAGUCHI PREFECTURE, JAPAN
MFG. SITE, PERSONNEL AND PROCEDURES IN CHESTERFIELD, MO

7595

7/12/1988

BAXTER HEALTHCARE CORP

FACILITIES IN MORTON GROVE, IL AND BRIDGEPORT, NJ

7596

IV

7/14/1988

SCHER CHEMICALS INC

DIISOPROPYL DIMERATE AS MFG. IN CLIFTON, NJ

7597

II

6/27/1988

AJINOMOTO CO INC

INTRAVENOUS LENTINAN AS MFG. IN YOKKAICHI, JAPAN

7598

II

7/29/1988

FINE CHEMICALS CORP PTY LTD

PROCHLORPERAZINE DIMALEATE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

7599

II

7/21/1988

COSMA SPA

KETOPROFEN AS MANUFACTURED IN CISERANO (BERGAMO) ITALY

7600

II

7/18/1988

ZACH SYSTEM SPA

DILTIAZEM HYDROCHLORIDE AS MFG. IN (VICENZA) ITALY

7601

II

7/29/1988

FUJISAWA PHARMACEUTICAL COMPANY LTD

FK506 (FK900506) DOSAGE FORMS MFG. IN AICHI-KEN & OSAKA JAPAN

7602

7/28/1988

SYNTHO RIFA PVT LTD

7603

II

7/28/1988

SYNTHO RIFA PVT LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GUJARA, INDIA.
RIFAMPIN AS MFG. IN GUJARA, INDIA

7604

II

6/30/1988

PROQUINA SA

DANAZOL AS MFG. IN IXTACZOQITLAN, VER. MEXICO

7605

II

7/27/1988

SANDOZ PHARMS CORP DIV SANDOZ INC

THIAMYLAL SODIUM MFG. IN TYROL, AUSTRIA

7606

II

7/28/1988

LINZ INSTITUTE INC

IMINODIBENZYL AS MFG. IN LINZ, AUSTRIA

7607

7/29/1988

BIOMEASURE INC

MANUFACTURING FACILITIES LOCATED IN HOPKINTON, MASSACHUSETTS

7608

II

7/28/1988

CHEMDEX INC

IRON DEXTRAN SOLUTION 5% (50 MG/ML) AS MFG. IN LENEXA, KS

7609

II

8/2/1988

TEVA PHARMACEUTICAL INC

CO-POLYMER-1 (COP-1) AS MFG. IN NETANYA, ISRAEL

7610

III

8/3/1988

LOPAREX LLC

10976 S 63# BL KFT L/00 4D/000

7611

II

8/2/1988

BASF AKTIENGESELLSCHAFT

46928-BASF, BENZOIC ACID AS MFG. IN LUDWIGSHAFEN GERMANY

7612

II

8/3/1988

HEINRICH MACK NACHF

ALEXAN 1000 MG/20 ML VIAL (5% CYTARABINE SOLUTION) W. GERMANY

7613

II

8/2/1988

DETERMINATION OF HYDROCHLOROTHIAZIDE IN HUMAN URINE

7614

II

8/8/1988

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
CHANTAL PHARMACEUTICAL CORP

ETHOCYN AS MFG. IN CAROLINA, PUERTO RICO

Page 211

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7615 I
II
7/29/1988
LABORATOIRES D'ETUDES ET DE RECHERCHES
SYNTHELABO
7616 I
II
8/8/1988
BENZEX LABS LTD

SUBJECT
(S)-BETAXOLOL HYDROCHLORIDE INFO TRANS. TO D5464 ON 9/2/88

7617

II

8/2/1988

ISOCHEM SAS

AMIODARONE HYDROCHLORIDE AS MFG. IN GENNEVILLIERS, FRANCE

7618

IV

8/1/1988

LUBRIZOL ADVANCED MATERIALS INC

NOVEON AA-1 (R) FORMERLY CARBOPOL 976) AS MANUFACTURED IN CALVERT CITY, KY

7619

7/19/1988

WIPF AG

7620

II

8/9/1988

KABI PHARMACIA AB

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CH-8604 VOLKETSWIL, SWITZERLAND
MICTURO (TERODILINE HYDROCHLORIDE) 12.5MG TABS MANUFACTURED IN SWEDEN.

7621

II

7/29/1988

IRFI SPA

EASFOSFINA MANUFACTURED IN ROMA, ITALY.

7622

II

8/11/1988

ASAHI CHEM INDUSTRY CO LTD

1-(2,4-DIFLUOROPHENYL)-6, 7 DIFLUORO-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARB

7623

7/25/1988

PYUNGHWA SPECIAL RUBBER CO LTD

7624

III

7/25/1988

PYUNGHWA MEDICAL PRECISION CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KYUNGKI-DO, KOREA.
ELASTOMERIC CLOSURES MFG. IN KYUNGKI-DO, KOREA

7625

II

8/9/1988

MALLINCKRODT PHARMS DIV MALLINCKRODT INC

LEVORPHANOL TARTRATE AS MFG. IN ST. LOUIS, MISSOURI

7626

8/12/1988

PHARMACIA HEPAR INC

NUCLEIC ACIDS MANUFACTURED IN FRANKLIN, OHIO.

7627

II

8/15/1988

BACHEM FINE CHEMICALS INC

BIOMEASURE SOMATOSTATIN ANALOG AS MFG. IN TORRANCE, CA

7628

IV

8/3/1988

JAY FLAVORS

FLAVOR FOR ANTIBIOTIC SPRAY DRIED NV-7759, S. PLAINFIELD, NJ.

7629

II

8/12/1988

FUJISAWA PHARMACEUTICAL COMANY LTD

FK973 DRUG SUBSTANCE AND DRUG PRODUCT IN AICHI & OSAKA, JAPAN

7630

7/29/1988

ATOMIC ENERGY OF CANADA LTD

ISOTOPE PRODUCTION DEPARTMENT FACILITY IN KANATA, CANADA

7631

II

8/5/1988

KV PHARMACEUTICAL CO

CLONIDINE HYDROCHLORIDE CONTROLLED RELEASE CAPSULES 0.2 MG.

7632

III

8/10/1988

LAWSON MARDON GROUP LTD

FOIL LIDDING AS MFG. IN TORONTO, ONTARIO, CANADA

7633

III

8/16/1988

MAR CO INDUSTRIES CORP

PACKAGING MATERIALS AS MFG. IN PUERTO REAL, FAJARDO, PUERTO RICO

7634

II

8/15/1988

ALDRICH CHEMICAL COMPANY INC

1(2PHENYLETHYL)4(N(2PYRAZYL)2(FUROYLAMIDO)PIPERIDINE HCL

7635

II

8/23/1988

WM WRIGLEY JR CO

EXTRA SUGARFREE CHEWING GUM CONTAINING FLOURIDE - CHICAGO, IL

7636

8/25/1988

ZENECA PHARMACEUTICALS

FACILITY LOCATED IN NEWARK, DELAWARE

7637

III

8/17/1988

ZAPPA PLASTICS INC

PACKAGING MATERIALS MANUFACTURED IN PHILLIPSBURG, NJ.

7638

II

8/15/1988

FARMOS GROUP LTD MEDIPOLAR

GLYBURIDE AS MFG. IN OULU, FINLAND

7639

II

8/17/1988

DINAMITE DIPHARMA SPA

PENTOXIFYLLINE AS MFG. IN MILAN, ITALY

7640

8/22/1988

IODENT CO

7641

III

8/26/1988

SPA SAFTA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN RANTOUL, ILLINOIS.
ALUMINUM FOIL PACKAGING MATERIALS AS MFG. IN PIACENZA, ITALY

7642

II

8/23/1988

WOCKHARDT LTD

NIACIN AS MFG. IN ANKLESHWAR, INDIA

7643

II

8/17/1988

7644

III

8/25/1988

INSTITUTO BIOLOGICO CHEMIOTERAPICO SPA DIV DOXOFYLLINE AS MFG. IN TRECATE, ITALY


UNIBIOS
COMAR INC
PACKAGING MATERIALS MFG. IN VINELAND, NEW JERSEY.

7645

II

8/22/1988

ALDRICH CHEMICAL COMPANY INC

Q1196-9 AS MFG. IN MILWAUKEE, WISCONSIN

7646

II

8/23/1988

MALLINCKRODT CHEMICAL INC

DEXTROCET-N2000 AS MFG. IN ST. LOUIS, MO

7647

III

3/10/1988

MALLINCKRODT INC

WEST COMPANY'S 20MM 890 GREY STOPPER

7648

8/25/1988

ALPHA ONE BIOMEDICALS INC

FACILITIES UTILLIZED AT THE FOSTER CITY, CA LOCATION

7649

6/30/1988

PHARMACIA LEO PHARMACEUTICALS

FACILITIES, PERSONNEL AND PROCEDURES IN HELSINGBORG, SWEDEN

7650

II

8/23/1988

REXOLIN CHEMS AB

PIPERANZINE PHOSPHATE AS MFG. IN HELSINGBORG, SWEDEN

NAPROXEN AS MFG. IN BOLLARAM NARSAPUR T.Q MEDAK, INDIA

Page 212

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7651 A
II
8/22/1988
BLANVER FARMOQUIMICA LTDA

SUBJECT
TABLO (SODIUM STARCH GLYCOLATE NF/BP) MANUFACTURED IN COTIA, BRAZIL.

7652

II

8/26/1988

GANES CHEMICALS INC

7653

II

8/24/1988

BETATENE LTD

DEXBROMPHENIRAMINE MALEATE MANUFACTURED IN PENNSVILLE, CARLSADT, NEW


JERSEY.
BETA CAROTENE MANUFACTURED IN VICTORIA AND WHYALLA AUSTRALIA.

7654

II

9/2/1988

WYCKOFF CHEMICAL CO INC

NICOTINE POLACRILEX AS MFG. IN SOUTH HAVEN, MI

7655

II

9/1/1988

CAMBREX CHARLES CITY INC

5-AMINOSALICYLIC ACID MANUFACTURED IN CHARLES CITY, IOWA.

7656

8/31/1988

BARRE NATIONAL INC

FACILITIES, PERSONNEL AND PROCEDURES IN BALTIMORE, MD

7657

8/24/1988

VENTURE MOLDED PRODUCTS INC

FACILITIES FOR PACKAGING MATERIALS MFG. IN WEST TRENTON, NJ

7658

II

9/6/1988

PFANSTIEHL INC

SODIUM LACTATE MANUFACTURED I WAUKEGAN, ILLINOIS.

7659

II

9/6/1988

QP CORP

EGG YOLK PHOSPHATIDYL CHOLINE AS MFG. IN TOYKO, JAPAN

7660

II

8/31/1988

SIBEFAT SPA

PIROXICAM AS MFG. IN TRIBIANO (MILANO) ITALY

7661

II

9/12/1988

UNICHEM LABORATORIES LTD

DIPHENHYDRAMINE HYDROCHLORIDE AS MFG. IN BOMBAY, INDIA

7662

II

9/7/1988

SIGMA F AND D DIV LTD

BRADYKININ ACETATE SALT AS MFG. IN ST. LOUIS, MO

7663

III

9/6/1988

3M PHARMS

SCOTCHPAK BRAND FILM NO. X-443 AS MFG. IN ST. PAUL, MN

7664

III

9/8/1988

B BRAUN MEDICAL INC

MCGAW 4 LITER PLASTIC CONTAINER AS MFG. IN IRVINE, CA

7665

8/22/1988

BEA FILTRI S P A

7666

III

9/14/1988

ALPHAGARY CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PERO (MILANO) ITALY.
PACKAGING MATERIALS MFG. IN NEWARK, NJ

7667

II

9/12/1988

DIOSYNTH BV

BETAMETHASONE DIPRIONATE AS MFG. IN OSS, HOLLAND

7668

II

9/6/1988

ALDRICH CHEMICAL COMPANY INC

6- HYDROXYDOPAMINE HYDROBROMIDE MANUFACTURED IN MILWAUKEE, WISCONSIN.

7669

II

9/9/1988

COSMA SPA

PYRANTEL PAMOATE AS MANUFACTURED. IN CISERANO (BERGAMO) ITALY

7670

9/12/1988

FACILITIES, SITE AND PERSONNEL UTILLIZED IN IRVINE, CA

7671

9/14/1988

HERBERT LABORATORIES DIV SMITH KLINE &


FRENCH CO
FAULDING HOSPITAL PRODUCTS INC

7672

III

9/13/1988

ROBERTS & CARLSON INC

7673

9/21/1988

BEIERSDORF - LILLY GMBH

7674

9/14/1988

HR CENCI LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HAMBURG, GERMANY FOR MOXONIDINE.
FACILITIES, PERSONNEL AND PROCEDURES UTILLIZED IN FRESNO, CA

7675

II

9/16/1988

CAMBREX PROFARMACO MILANO SRL

GLYBURIDE AS MFG. IN PAULLO (MILANO) ITALY

7676

II

9/15/1988

REINO CHEMICAL INDUSTRIAL CORP

ACETAMINOPHEN AS MFG. IN TAIWAN, REPUBLIC OF CHINA

7677

II

10/21/1988

BOMBAY DRUG HOUSE LTD

TRIMETHOPRIM AS MFG. IN BOMBAY, INDIA

7678

II

9/16/1988

DIPHARMA FRANCIS SRL

GLYBURIDE AS MFG. IN MILANO, ITALY

7679

II

9/15/1988

SIGMA F AND D DIV LTD

INSULIN FROM BOVINE PANCREAS AS MFG. IN ST. LOUIS, MO

7680

II

9/23/1988

RAYLO CHEMICALS

2',3'-DIDEOXYINOSINE AS MFG. IN EDMONTON ALBERTA, CANADA

7681

9/15/1988

DIBRA SPA

FACILITIES UTILIZED IN MILANO, ITALY

7682

II

9/20/1988

INALCO SPA

PURIFIED LACTULOSE SYRUP AS MFG. IN PISTOIA, ITALY

7683

9/16/1988

SALARS SPA

FACILITIES UTILIZED IN COMO, ITALY

7684

II

9/16/1988

SALARS SPA

BUPRENORPHINE HYDROCHLORIDE MANUFACTURED IN COMO, ITALY.

7685

III

9/16/1988

SOUTHERN RESEARCH INSTITUTE

INTRA-ORAL FLUORIDE-RELEASING DEVICES - BIRMINGHAM, ALABAMA

7686

II

9/22/1988

CU CHEMIE UETIKON GMBH

KETAMINE HYDROCHLORIDE AS MFG. IN LAHR, GERMANY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AGUADILLA, PUERTO RICO.
LOKFLEX II PRIMER AS MFG. IN CLIFTON, NJ

Page 213

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7687 I
II
9/15/1988
SIGMA F AND D DIV LTD

SUBJECT
INOSINE AS MFG. IN ST. LOUIS, MO

7688

8/18/1988

RORER HLTH CARE UK LTD

FACILITIES UTILIZED IN EASTBOURNE, EAST SUSSEX, UK

7689

II

9/21/1988

SIGMA F AND D DIV LTD

ISONICOTINIC ACID HYDRAZIDE AS MFG. IN ST. LOUIS, MO

7690

II

9/21/1988

SIGMA F AND D DIV LTD

D (-) PENICILLAMINE AS MFG IN ST. LOUIS,MO

7691

II

9/26/1988

CHEMWERTH

PROPANTHELINE BROMIDE AS MFG. BY PENCO IN LYNDHURST, NJ

7692

III

9/23/1988

REXAM CLOSURES SYSTEMS INC

CONTAINER/CLOSURE SYSTEMS AS MFG IN MAUMEE PLANT

7693

IV

9/23/1988

B BRAUN MEDICAL INC

STERILIZATION OF GLASS MFG. IN IRVINE, CA

7694

II

9/30/1988

AJINOMOTO PHARMACEUTICALS CO LTD

2'3'-DIDEOXYINOSINE AS IN MIE-PREFECTURE AND KANAGAWA, JAPAN

7695

II

9/29/1988

PHARMECO LABS INC

DTPA BIS (METHYLAMIDE) AND ITS SALTS MFG. IN SIMI VALLEY, CA

7696

IV

9/29/1988

DS INDUSTRIE APS

ESTARAM'S INACTIVE DRUG INGREDIENTS MFG. IN COPENHAGEN, DK

7697

II

9/29/1988

ESTEVE QUIMICA SA

PIROXICAM AS MFG. IN BARCELONA, SPAIN

7698

II

9/29/1988

TEIKOKU CHEM INDUSTRY

THYMIDINE AS MFG. IN OSAKA, JAPAN

7699

II

10/3/1988

DIOSYNTH BV

PRAZEPAM AS MFG. IN OSS, HOLLAND

7700

II

10/1/1988

APPLIED LABORATORIES INC

BLAIREX BRONCHO SALINE AS MFG. IN COLUMBUS, INDIANA

7701

II

10/5/1988

STOLLE RESEARCH & DEVELOPMENT CORP

TETRACYCLINE BIODEGRADABLE MICROSPHERES MANUFACTURED IN CINCINNATI, OHIO.

7702

II

10/11/1988

BEIERSDORF GMBH

MOXONIDINE AS MFG. IN HAMBURG, GERMANY

7703

II

10/4/1988

ORION CORP LTD FERMION

PENTOXIFYLLINE AS MFG. IN ESPOO AND HANKO, FINLAND

7704

II

10/12/1988

VICTREX USA INC

POLYETHERETHERKETONE (PEEK) AS MFG. IN LANCASHIRE, ENGLAND

7705

IV

9/30/1988

CREMER OLEO GMBH AND CO KG

SOFTIGEN 767 EXCIPIENTS AS MFG. IN WITTEN/RUHR, GERMANY

7706

10/13/1988

CYGNUS RESEARCH CORP

FACILITIES AND MFG. SITE UTILIZED IN REDWOOD CITY, CA

7707

II

10/12/1988

INDUSTRIAS QUIMICAS TAUBATE SA

ISOSORBIDE DINITRATE AS MFG. IN SSAO PAULO. BRASIL

7708

10/11/1988

FACILITY LOCATED IN GUAYAMA, PUERTO RICO

7709

II

10/13/1988

WHITEHALL LABS DIV AMERICAN HOME PRODS


CORP
LINNEA PHYTOCHEMICALS

7710

II

10/13/1988

CAMBREX PROFARMACO MILANO SRL

GLIPIZIDE AS MFG. IN PAULLO (MILANO) ITALY

7711

II

10/7/1988

MITSUBISHI KASEI CORP

REPIRINAST (MY-5116) DRUG SUBSTANCE, KASHIMA-GUN, JAPAN

7712

II

10/12/1988

NIFEDIPINE SOFTGELS 20 MG AS MFG. IN CLEARWATER, FL

7713

II

10/12/1988

7714

10/11/1988

7715

III

10/7/1988

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
RP SCHERER NORTH AMERICA DIV RP SCHERER
CORP
WAITAKI INTERNATIONAL BIOSCIENCES SUB
WAITAKI CANADA LTD
TEKNI PLEX INC

7716

II

10/18/1988

ROUSSEL-UCLAF

BETAMETHASONE ACETATE AS MFG. IN VERTOLAYE, FRANCE

7717

II

10/18/1988

CIPLA LTD

METAPROTERENOL SULFATE AS MFG. IN VARIOUS SITES IN INDIA

7718

10/17/1988

SANOFI CHIMIE

FACILITIES LOCATED IN SISTERON, FRNACE

7719

II

10/17/1988

FRANCIS SPA

CROMOLYN SODIUM AS MFG. IN VARESE, ITALY

7720

II

10/17/1988

RP SCHERER CORP

MAXEPA OIL MFG. IN MARFLEET, ENGLAND

7721

II

10/20/1988

FABBRICA ITALIANI SINTETICI SPA

TRIMETHOBENZAMIDE HYDROCHLORIDE AS MFG. IN VICENZA, ITALY

7722

II

10/20/1988

SUMIKA FINE CHEMICALS CO LTD

PRAZOSIN HYDROCHLORIDE (POLYHYDRATE) MFG. IN GIFU, JAPAN

PILOCARPINE NITRATE MANUFACTURED IN RIAZZINO (LOCARNO) SWITZERLAND.

NIFEDIPINE SOFTGELS 10 MG AS MFG. IN CLEARWATER, FL


FACILITIES UTILIZED IN TORONTO, ONTARIO, CANADA
PVC COMPOUNDS AS MFG. IN RIDGEFIELD, NEW JERSEY

Page 214

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7723 I
IV
10/27/1988
AIR PRODUCTS AND CHEMICALS INC

SUBJECT
PERFLUOROPERHYDROPHENANTHRENE EXCIPIENT MFG. IN ALLENTOWN, PA

7724

II

10/25/1988

RESOLUTION CHEMICALS LTD

BACLOFEN RAW MATERIAL AS MFG. IN SUFFOLK, UK

7725

III

10/21/1988

LOPAREX INC

10420, 3 MIL CL PET 4N/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD, ILLINOIS.

7726

II

10/6/1988

SIMS

AMILORIDE HCL AS MFG. IN FIRENZE, ITALY

7727

III

10/13/1988

MEDICAL MOLDING CORP AMERICA

PLASTIC MATERIALS AND COLORANTS AS MFG. IN COSTA MESA, CA

7728

II

10/25/1988

PHARMA WALDHOF GMBH

ADENOSINE AS MFG. IN MANNHEIM, GERMANY

7729

III

10/28/1988

NATIONAL LABEL CO

NONPARENTERAL METAL PCAKAGING AS MFG. IN LAFAYETTE HILL, PA

7730

III

10/18/1988

EXXONMOBIL CHEMICAL CO

7731

9/1/1988

FERROSAN A/S

SANTOPRENE THERMOPLASTIC RUBBER 180 & 280 GRADE SERIES MFG. IN PENSACOLA FL,
WADSWORTH OH AND NEWPORT WALES UK
FACILITES AND GENERAL OPERATING PROCEDURES IN SOEBORG, DENMARK

7732

IV

10/31/1988

CAPSULE TECHNOLOGY PUERTO RICO INC

EMPTY HARD GELATIN CAPSULES AS MFG. IN PUERTO RICO

7733

IV

10/27/1988

DS INDUSTRIE APS

ESTARAM 299 AS MFG. IN COPENHAGEN, DENMARK

7734

II

10/31/1988

DSM NUTRITIONAL PRODUCTS LTD

TRETINOIN (ALL-TRANS-RETINDE, ACID) AS MFG IN BASLE, SWITZERLAND.

7735

III

10/11/1988

SCHUBERT SEALS A/S

RUBBER SHEET LAMINATE FROM COUMPOUND 6377 MFG. IN DENMARK

7736

III

10/11/1988

SCHUBERT SEALS A/S

RUBBER SHEET LAMINATE FROM COMPOUND 6377/42022 IN DENMARK

7737

10/21/1988

GIVAUDAN CORPORATION

FACILITIES AND PROCEDURES IN VERNIER, SWITZERLAND

7738

II

10/21/1988

GIVAUDAN CORPORATION

PARSOL MCX AS MFG. IN VERNIER, SWITZERLAND

7739

II

10/18/1988

AMINO GMBH

BETAINE HCL AS MFG. IN HELMSTEDT, F.R. GERMANY

7740

11/1/1988

NOVARTIS

7741

II

11/1/1988

7742

II

11/1/1988

7743

11/3/1988

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
RP SCHERER NORTH AMERICA DIV RP SCHERER
CORP
SIGNA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GRIMSBY, UK
NIFEDIPINE SOFTGELS 10 MG, TO SUPPORT CHELSEA LABS. ANDA

7744

II

10/25/1988

FREEDOM CHEMICAL DIAMALT GMBH

CARBAMAZEPINE AS MFG.. IN RAUBLING, F.R. GERMANY

7745

II

10/31/1988

PENINSULA LABS

BETA-ENDORPHIN MFG. IN BELMONT, CA

7746

II

11/8/1988

PHARMACIA AND UPJOHN INC

NICOTINE TRANSDERMAL DELIVERY SYSTEM MFG. IN REDWOOD CITY, CA

7747

IV

11/9/1988

DS INDUSTRIE APS

Z-ESTARAM AS MFG. IN COPENHAGEN, DENMARK

7748

II

10/25/1988

KOREA STEEL CHEMICAL COMPANY LTD

YELLOW PHENOLPHTHALEIN AS MFG. IN KYUNGSANGBUK-DO, KOREA

7749

II

11/8/1988

EASTMAN KODAK CO

RHODAMINE 123 AS MFG. IN ROCHESTER, NY

7750

II

10/28/1988

SOL PHARMACEUTICALS LIMITED

ALBUTEROL SULPHATE AS MFG. IN ANDHRA PRADESH, INDIA

7751

11/4/1988

GOODWIN INST

7752

II

11/7/1988

7753

11/15/1988

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
CELLTEC LABS LTD

MANUFACTURING SITE, FACILITES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PLAATION, FLORIDA.
NIFEDIPINE SOFTGELS 20 MG, KALIPHARMA, INC. MFG. IN FLORIDA

7754

II

11/7/1988

7755

II

7756

II

NIFEDIPINE SOFTGELS 20 MG, TO SUPPORT CHELSEA LABS. ANDA


MFG. SITE, FACILITIES AND PERSONNEL UTILIZED IN TOLUCA, MEXICO

FACILITIES UTILIZED IN MADRAS, INDIA


NIFEDIPINE SOFTGELS 10 MG MANUFACTURED BY KALIPHARMA INC IN FLORIDA.

11/14/1988

RP SCHERER NORTH AMERICA DIV RP SCHERER


CORP
SIEGFRIED AG

10/28/1988

PCAS

DILTIAZEM HYDROCHLORIDE MANUFACTURED IN LONGJUMEAU FRANCE

DIBENZOSUBERENONE AS MFG. IN ZOFINGEN, SWITZERLAND

Page 215

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7757 A
IV
11/9/1988
LUBRIZOL ADVANCED MATERIALS INC
7758

III

11/4/1988

AUTOMATIC INJECTION MOLDING INC

SUBJECT
CARBOPOLS 1342 AND 1382 AND PEMULEN BASE TR-1 AND TR-1 MANUFACTURED IN
CALVERT CITY, KY
PACKAGING MATERIALS AS MFG. IN BECKELEY HEIGHTS, NJ

7759

II

10/28/1988

FERMION OY

CYCLOBENZAPRINE HCL AS MFG. IN ESPOO AND HANKO, FINLAND

7760

III

10/5/1984

DUPONT TEIJIN FILMS US LP

7761

II

11/22/1988

SUMIKA FINE CHEMICALS CO LTD

POLYESTER FILMS AS MANUFACTURED IN DUMFREES,SCOTLAND, HOPEWELL VA,


RICHMOND VA, FLORENCE SC, AND GIFU, JAPAN
PROBUCOL AS MFG. IN GIFU PREFECTURE, JAPAN

7762

II

11/21/1988

SUMIKA FINE CHEMICALS CO LTD

PRAZOSIN HCL (BETA-FORM) AS MFG. IN THE GIFU PREFECTURE,JAPAN

7763

II

11/15/1988

ACETAMINOPHEN DC-PGS AS MFG. IN DEESIDE, CLWYD, U. K.

7764

II

11/22/1988

HARTINGTON CHEMICALS DIV STAVELEY


CHEMICALS LTD
FRANCIS SPA

7765

IV

11/18/1988

HERCULES INC

HERCULES RS, AS AND SS NITROCELLULOSE AS MFG. IN PARLIN, NJ

7766

II

11/18/1988

SIEGFRIED LTD

NICOTINE MANUFACTURED IN ZOFINGEN, SWITZERLAND.

7767

III

11/17/1988

GLASS CORP AMERICA

AMPULES AS MFG. IN AMADORA, PORTUGAL

7768

11/16/1988

PRODUITS ROCHE SA

7769

11/16/1988

ROCHE PRODUCTS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FONTENAY-SOUS-BOIS, FRANCE.
FACILITIES UTILIZED IN DALRY, SCOTLAND

7770

II

11/21/1988

LINNEA PHYTOCHEMICALS

CYTARABINE AS MFG. IN RIAZZINO (LOCARNO) SWITZERLAND

7771

II

11/8/1988

SIGMA F AND D DIV LTD

A-KETOISOCAPROIC ACID, SODIUM SALT AS MFG. IN ST.LOUIS, MO

7772

III

11/21/1988

FRESENIUS USA INC

PACKAGING OF SVP AND LVP PRODUCTS IN OGDEN, UTAH

7773

II

10/31/1988

IAF BIOCHEM INTERNATIONAL INC

SYNTHETIC GLUCAGON HYDROCHLORIDE HUMAN MFG. IN CANADA

7774

IV

11/15/1988

CAPSUGEL

GELATIN CAPSULES MANUFACTURED IN SUZHOU, PEOPLE'S REPUBLIC OF CHINA.

7775

IV

11/16/1988

NIPPON FINE CHEMICAL COMPANY LTD

PHOSPHOLIPID DPPC AS MFG. IN HYOGO, JAPAN

7776

II

11/4/1988

REXOLIN CHEMS AB

PIPERAZINE ADIPATE AS MFG. IN HELSINGBORG, SWEDEN

7777

II

11/18/1988

MEDEA RESEARCH LABS

POLYTHIAZIDE MANUFACTURED IN WESTHAMPTON BEACH, NEW YORK.

7778

II

11/16/1988

SIEGFRIED USA INC

OMOCONAZOLE NITRATE MANUFACTURED IN ZOFINGEN, SWITZERLAND.

7779

II

11/4/1988

NATL INST HLTH ADAMHA DOC

OMEGA-3 FATY ACID ETHYL ESTERS SUBMITTED FOR FOTMAC

7780

III

10/31/1988

REXHAM CORP

PACKAGING MATERIALS AS MFG. IN WESTFIELD, MASSACHUSETTS

7781

II

11/21/1988

RAYLO CHEMICALS

3-DEOXYTHYMIDIN-2-ENE AS MFG. IN EDMONTON, ALBERTA, CANADA

7782

IV

11/17/1988

BASF CORPORATION

BUTOFAN NS 222 AS MFG. IN CHATNOOGA, TN

7783

IV

11/17/1988

BASF CORPORATION

STYROFAN ND 487 MANUFACTURED IN CHATTANOOGA, TENNESSEE.

7784

11/25/1988

GRIFFITH MICRO SCI LTD

FACILITIES LOCATED IN DERBYSHIRE, ENGLAND

7785

II

12/6/1988

ORGANICHEM CORP

PHENYLEPHIRINE OXAZOLIDINE AS MFG. IN RENSSELAER, NY

7786

II

11/18/1988

SIGMA F AND D DIV LTD

D (+) GALACTOSE PRODUCT NO. G 0750 FD AS MFG. IN ST. LOIUS,MO

7787

II

11/7/1988

SIGMA F AND D DIV LTD

L-ALPHA-PHOSPHATIDYLCHOLINE TYPE XIII-E MDG. IN MISSOURI

7788

II

11/23/1988

CHANDRA PHARMACEUTICALS LTD

IBUPROFEN MANUFACTURED IN ANDHRA PRADESH, INDIA.

7789

IV

11/30/1988

DS INDUSTRIE APS

MCT OILS MANUFACTURED IN COPENHAGEN, DENMARK.

7790

II

11/28/1988

BASF PHARMA EVIONNAZ SA

PHENELZINE SULFATE MANUFACTURED IN EVIONNAZ, SWITZERLAND.

7791

11/23/1988

STERLING DRUG LTD

FACILITIES UTILIZED IN AURORA, ONTARIO, CANADA

7792

II

11/28/1988

CYGNUS INC

FEMPACH ESTRADIOL TRANSDERMAL SYSTEM

GEMFIBROZIL AS MFG. IN CARONNO PERTUSELLA (VA) ITALY

Page 216

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7793 I
II
11/28/1988
CYTEC INDUSTRIES INC

SUBJECT
SPECTRA-SORB UV-9 (OXYBENZONE) - WILLOW ISLAND, WEST VIRGINIA

7794

II

11/29/1988

KATSURA CHEMICAL CO LTD

PINDOLOL AS MFG. IN ZAMA-CITY, KANAGAWA PREF. JAPAN

7795

II

11/23/1988

PROSINTEX INDUSTRIE CHIMICHE ITALIANE S.R.L

PRAZOSIN HYDROCHLORIDE AS MFG. IN MILANO, ITALY

7796

12/5/1988

SANOFI RECHERCHE

FACILITIES UTILIZED IN MONTPELLIER, FRANCE

7797

12/15/1988

SANDOZ INDIA LTD

MFG. SITE AND FACILITIES UTILIZED IN BOMBAY, INDIA

7798

II

1/10/1989

PCR INC

FLOXURIDINE MANUFACTURED IN GAINESVILLE, FLORIDA.

7799

II

12/2/1988

KYOWA HAKKO BIO CO LTD

MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE OXIDIZED

7800

III

11/22/1988

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION LZ516 AS MFG. IN SALISBURY, MD

7801

II

12/8/1988

MITSUBISHI TANABE PHARMA CORP

MCI-9038 ARGATROBAN DRUG SUB.- IBRAKI PREFECTURE, JAPAN

7802

II

11/28/1988

IROPHARM LTD

AMITRIPTYLINE HCL B.P. 88/USP AS MFG. IN WICKLOW, IRELAND

7803

II

11/28/1988

IROPHARM LTD

ACEPROMAZINE MALEATE B.P. VET. AS MFG. IN WICLKOW, IRELAND

7804

II

12/6/1988

CADILA LABORATORIES PVT LTD

MEBENDAZOLE AS MFG. IN GUJARA, INDIA

7805

11/25/1988

MICRON MILLS LTD

7806

II

12/5/1988

SIGMA F AND D DIV LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KENT, ENGLAND.
B-NICOTINAMIDE ADENINE DINUCLEOTIDE MANUFACTURED IN ST. LOUIS, MO

7807

III

10/31/1988

ALMEXA ALUMINIO SA

PHAR 2000 (PHAR 9425) AS MFG. IN MEXICO

7808

12/13/1988

MINIPAK AEROSOLS LIMITED

FACILITY LOCATED IN CHESHIRE, UNITED KINGDOM

7809

II

12/12/1988

FDC LTD

ALBUTEROL SULFATE MANUFACTURED IN MAHARASHTRA STATE, INDIA.

7810

II

12/20/1988

CIBA GEIGY CORP PHARMACEUTICAL DIVISION

3-CHLOROIMINODIBENZYL AS MFG. IN GRIMSBY, THE UK

7811

II

12/8/1988

ORION COPORATION FERMION OULU PLANT

TERFENADINE AS MFG. IN OULU, FINLAND

7812

II

12/9/1988

PENTIGETIDE MANUFACTURED IN CHICAGO, ILLINOIS.

7813

II

12/20/1988

ABBOTT LABORATORIES PHARMACEUTICAL


PRODUCTS DIV
SUMIKA FINE CHEMICALS CO LTD

7814

II

12/15/1988

SANDOZ INDIA LTD

SULFAMETHOXAZOLE AS MFG. IN BOMBAY, INDIA

7815

II

12/19/1988

CL PHARMA AG

CARBAMAZEPINE AS MFG. IN LINZ, AUSTRIA

7816

II

12/15/1988

NIPPON PROTEIN CO INC

N-ACETYL-L-CYSTEINE AS MFG. IN KANAGAWA-KEN JAPAN

7817

II

12/15/1988

ERREGIERRE SPA

BACLOFEN AS MFG. IN BERGAMO, ITALY

7818

IV

12/9/1988

GATTESFOSSE SA

LAUROGLYCOL AS MFG. IN SAINT-PRIEST, FRANCE

7819

II

12/15/1988

PLAISTOW LTD

XYLAZINE BASE AS MFG. IN CORK, IRELAND

7820

II

12/19/1988

CAMBREX PROFARMACO MILANO SRL

CINOXACIN MANUFACTURED IN MILAN, ITALY.

7821

II

12/15/1988

IPCA LABORATORIES PVT LTD

ATENOLOL AS MFG. IN BOMBAY, INDIA

7822

II

12/15/1988

IPCA LABORATORIES LTD

PYRANTEL PAMOATE USP AS MFG. IN BOMBAY, INDIA

7823

III

12/13/1988

OWENS ILLINOIS INC

THERMOPLASTIC CLOSURES AND PACKAGING MFG. IN CHATTANOOGA, TN

7824

III

12/16/1988

UCB FILMS INC

CELLOPHANE PRODUCTS MFG. IN COVINGTON, IN AND TECUMSEH, KS

7825

11/21/1988

NATCO PHARMS PVT LTD

FACILITY LOCATED IN ANDRHA PRADESH, INDIA

7826

12/12/1988

SEPRACOR INC

PRODUCTION FACILITY IN VILLENEUVE LA GARENNE, FRANCE

7827

II

12/13/1988

VIS-INSTITUTO SCIENTIFICO DELLE VENEZIE SPA

CARBAMAZEPINE AS MFG. IN PADOVA, ITALY

7828

II

12/8/1988

NATL INST HLTH NCI

NSC321803

7829

II

12/12/1988

PRODUCTOS QUIMICOS NATURALES SA DE CV


PROQUINA

D.H.A. PURE PRASTERONE AS MFG. IN IXTACZOQUITLAN, MEXICO

THIETHYLPERAZONE MALATE AS MFG. A THE GIFU PLANT IN JAPAN

Page 217

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7830 I
II
12/12/1988
SEPRACOR INC

SUBJECT
DEAE-TRISACRYL M OR LS AS MFG. IN LA GARENNE, FRANCE

7831

III

12/14/1988

SPRUHVENTILE GMBH

AEROSOL VALVES AS MFG. IN GERMANY

7832

12/28/1988

ZENECA PHARMACEUTICALS DIV ZENECA INC

FACILITIES AND PERSONNEL LOCATED IN REIMS CEDEX, FRANCE

7833

II

12/20/1988

ZAMBON SPA

LACTULOSE MANUFACTURED IN VICENZA, ITALY.

7834

II

12/15/1988

GIVAUDAN CORPORATION

PARSOL MCX AS MFG. IN CLIFTON, NJ

7835

12/15/1988

GIVAUDAN CORPORATION

FACILITIES, PERSONNEL AND GEN. PROC. IN CLIFTON, NEW JERSEY

7836

II

12/20/1988

IROPHARM LTD

ORPHENADRINE HYDROCHLORIDE MFG. IN ARKLOW, WICKLOW, IRELAND

7837

II

12/20/1988

IROPHARM LTD

ORPHENADRINE CITRATE AS MFG. IN ARKLOW, WICKLOW, IRELAND

7838

II

12/22/1988

SUCRALFATE AS MFG. IN CONSHOHOCKEN, PA

7839

12/22/1988

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
DYNAMIT NOBEL AKTIENGESELLESCHAFT

7840

II

12/22/1988

DYNAMIT NOBEL AKTIENGESELLESCHAFT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LEVERKUSEN, GERMANY
NITROGLYCERINE AS MFG. IN LEVERKUSEN,GERMANY

7841

II

12/19/1988

PENINSULA LABS

HISTIDINYL-6-LYSINE-AMIDE MFG. IN BELMONT, CA

7842

II

12/19/1988

PROSINTEX INDUSTRIE CHIMICHE ITALIANE SRL

GUANABENZ ACETATE AS MFG. IN MILANO, ITALY

7843

II

12/19/1988

BASF PHARMA EVIONNAZ SA

BENZONATATE AS MFG. IN EVIONNAZ, SWITZERLAND

7844

III

1/23/1989

COMAR LLC

PLASTIC PACKAGING MATERIALS MANUFACTURED IN BUENA, NEW JERSEY.

7845

II

12/30/1988

BACHEM FEINCHEMIKALIEN AG

H-GLY-TYR-LYS-(DTPA)-0H. HCL MFG. IN BUBENDORF, SWITZERLAND

7846

II

12/29/1988

DIPHARMA FRANCIS SRL

NORTRIPTYLINE HCL AS MFG. IN MILANO, ITALY

7847

12/29/1988

ROUSSEL-UCLAF

MFG. PROCESS AND CONTROL AT USIPHAR IN COMPIEGNE, FRANCE

7848

II

12/28/1988

EXPANSIA

THIANAPHTEN CARBOXYLIC ACID AS MFG. IN ARAMON, FRANCE

7849

II

1/4/1989

KYOWA HAKKO KOGYO CO LTD

MINOCYCLINE HYDOCHLORIDE, SAKAI PLANT, OSAKA PREFECTURE JAPAN

7850

II

12/9/1988

NORDION INT INC

I-123 MYOPURE AS MFG. IN KANTA, ONTARIO, CANADA

7851

III

12/12/1988

JOHN L ARMITAGE AND CO

EH-22395-H PIGMENTED LINER AS MFG. IN BRIDGEPORT, CT

7852

III

12/19/1988

LOPAREX LLC

7853

III

12/19/1988

LOPAREX INC

10127, S 42# SB SCK 6Z/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD PARK,
ILLINOIS.
10699, S 5 MIL NT HDP 4N/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD, ILLINOIS.

7854

1/3/1989

FOREST LABORATORIES INC

FACILITIES UTILIZED IN ST. LOUIS, MO

7855

II

12/30/1988

PHARMECO LABS INC

ALTRETRAMINE AS MFG. IN SIMI VALLEY, CALIFORNIA

7856

II

1/25/1989

CHEMISCHE FABRIK WEYL GMBH

METHAZOLAMIDE MFG. IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY

7857

II

9/23/1988

EPHEDRINE HYDROCHLORIDE, TONG LIAO CITY PLANT, INNER MONGOLIA

7858

1/9/1989

INNER MONGOLIA PHARMACEUTICAL GENERAL


CORP
IROTEC LABORATORIES LTD

7859

II

1/9/1989

IRISH FHER LABORATORIES

AZAADINE MALEATE MFG. IN LITTLE ISLAND, CORK, IRELAND

7860

II

1/13/1989

SICOR SPA

BETAMETHASONE BENZOATE AS MFG. IN MILAN, ITALY

7861

II

12/29/1988

EASTMAN KODAK CO

POTASSIUM TETRATOXALATE DIHYDRATE MFG. IN ROCHESTER, NY

7862

III

1/16/1989

FOLIENWALZWERK BRUEDER TECHNOLOGY AG

LACQUERED ALUMINUM FOIL, IN OBERGRAFENDORF-MUHLOFEN, AUSTRIA

7863

II

12/13/1988

LEK PHARMACEUTICAL & CHEMICAL WORKS

CIMETIDINE MANUFACTURED IN MENGES, SLOVENIA

7864

II

1/13/1989

RECORDATI INDUSTRIA CHIMICA SPA

FENTICONAZOLE NITRATE AS MFG. IN LATINA, ITALY

7865

II

1/9/1989

BAYER AG

ACEMETACIN AS MFG. IN WUPPERTAL 1 & LEVERKUSEN, GERMANY

FACILITIES UTILIZED IN LITTLE ISLAND, CORK, IRELAND

Page 218

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7866 N
NOT AN ASSIGNED NUMBER

SUBJECT

7867

II

1/16/1989

ORION CORP LTD

FAVOXATE HCL AS MFG. IN ESPOO AND HANKO, FINLAND

7868

II

1/11/1989

7869

II

1/5/1989

BAXTER HEALTHCARE CORP BURDICK & JACKSON METHYL-T-BUTYL ETHER (MTBE) AS MFG. IN MUSKEGON, MI
DIV
REGIS TECHNOLOGIES INC
MELATONIN MANUFACTURED IN MORTON GROVE, ILLINOIS.

7870

7871

II

1/23/1989

SYNTHELABO PHARMACIE

4-(2-CYCLOPROPYLMETHOXYETHYL) PHENOL MFG. IN MOURENX, FRANCE

7872

II

1/20/1989

DAITO KOEKI KK

PINDOLOL AS MFG. IN TOYAMA-SHI, TOYAMA 939, JAPAN

7873

III

1/12/1989

MONTELL CANADA INC

POLYPROPYLENE AS MFG. IN CORUNNA, ONTARIO, CANADA

7874

III

1/12/1989

KLOCKNER PENTAPLAST OF AMERICA INC

PACKAGING MATERIALS AS MFG. IN SOUTH HACKENSACK, NJ

7875

II

1/23/1989

OREX PHARMA PVT LTD

TRIMETHOPRIM AS MFG. IN DOMBIVLI (EAST) MAHARASHTRA, INDIA

7876

1/12/1989

SEITZ FILTER WERKE

MICROFILTRATION MEMBRANE PLANT A BOSENHEIMER STR., GERMANY

7877

IV

1/24/1989

DS INDUSTRIE APS

ESTASAN PR AS MFG. IN COPENHAGEN, DENMARK

7878

1/10/1989

SCIENTIFIC PROTEIN LABORATORIES INC

FACILITIES (BOVINE LUNG HEPARIN SODIUM) IN WAUNAKEE, WI

7879

II

1/20/1989

PENCO OF LYNDHURST INC

CHLORPHENIRAMINE MALEATE AS MFG. IN LYNDHURST, NJ

7880

II

1/20/1989

PENCO OF LYNDHURST INC

BROMPHENIRAMINE MALEATE AS MFG. IN LYNDHURST, NJ

7881

1/10/1989

SCIENTIFIC PROTEIN LABORATORIES INC

FACILITIES FOR THE MFG. OF HEPARIN CLACIUM IN WAUNAKEE, WI

7882

II

1/24/1989

EGIS PHARMACEUTICALS PLC

PROMETHAZINE HCL MANUFACTURED IN BUDAPEST, HUNGARY.

7883

II

1/20/1989

5-FLUOROURACIL MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA.

7884

II

1/21/1989

SHANGHAI NUMBER 12 PHARMACEUTICAL


FACTORY
NICOBRAND LTD

7885

1/25/1989

GLAXO WELLCOME INC

MFG. SITE FACILITIES UTILIZED IN SPEKE LIVERPOOL (UK)

7886

1/25/1989

GLAXO WELLCOME INC

FACILITIES UTILIZED IN WARE HERTS, UNITED KINGDOM

7887

II

2/7/1989

MAPRIMED SA

DILTIAZEM HCL AS MFG. IN BUENOS ARIES, ARGENTINA

7888

II

1/30/1989

BIOCHEMIC GESELLSCHAFT MBH

OXYTOCIN ACETATE LYOPHILIZED MANUFACTURED IN TYROL, AUSTRIA.

7889

II

1/30/1989

MALLINCKRODT BAKER INC

7890

II

1/25/1989

MALLINCKRODT INC

ABX AND CBX BONDED PHASE SILICA GELS MANUFACTURED IN PHILLIPSBURG, NEW
JERSEY.
NICOTINE AS MANUFACTURED IN CO. LONDONDERRY, NORTH IRELAND

7891

II

1/31/1989

DYNAMIT NOBEL AKTIENGESELLESCHAFT

AZUD (CS-87) AS MFG. IN LEVERKUSEN, GERMANY

7892

IV

1/27/1989

ALBAMED INC

MONTANIDE 103 AS MFG. IN CASTRES, FRANCE

7893

IV

1/27/1989

SEPPIC DIV AIR LIQUIDE

MONTANIDE 888 AS MFG. IN CASTRES, FRANCE

7894

III

1/25/1989

ARLON INC

SELF ADHESIVE FOAM PRODUCT AS MFG IN SANTA, CA 92704

7895

1/25/1989

ALPHA PHARM PTY LTD

7896

II

1/28/1989

WYCKOFF CHEMICAL CO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN QUEENSLAND, AUSTRALIA.
PROTRIPTYLINE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

7897

IV

1/27/1989

ALBAMED INC

MONTANIDE 80 AS MFG. IN CASTRES, FRANCE

7898

II

1/30/1989

HEINRICH MACK NACHF

ALEXAN 100MG/5ML VIAL(2% CYTARABINE SOLUTION) AS MFG. GERMANY

7899

II

1/18/1989

TCI AMERICA

METHAZOLAMIDE MANUFACTURED IN PORTLAND, OREGON.

7900

III

1/20/1989

MEGAS MANUFACTURING INC

FACILITIES FOR PACKAGING IN CLEVELAND, OHIO

7901

II

1/26/1989

3M PURIFICATION INC

NYLON MEMBRANE CARTRIDGE PRODUCTS MANUFACTURED IN MERIDEN, CONNECTICUT.

NOT AN ASSIGNED NUMBER

NICOTINE AS MANUFACTURED IN CO. LONDONDERRY, NORTH IRELAND

Page 219

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7902 I
IV
2/1/1989
RHONE POULENC

SUBJECT
IGEPAL CO-730 AS MFG. IN LINDEN, NJ

7903

IV

2/1/1989

RHONE POULENC

ALKAMID CDO MANUFACTURED IN WINDER, GEORGIA.

7904

II

2/1/1989

CHEMWERTH

CARBAMAZEPINE AS MFG. BY NEPRA, INC. IN HARRIMAN, NEW YORK

7905

II

2/3/1989

LISAC SA

DIPYRIDAMOLEAS MFG. IN BARCELONA, SPAIN

7906

II

2/2/1989

SUMIKA FINE CHEMICALS CO LTD

KETOPROFEN AS MFG. IN OSAKA, JAPAN

7907

III

1/29/1989

SOLVAY & CIE SA

HD-PE HOMOPOLYMER ELTEX B3002 AS MFG. IN SOLVAY LI, ITALY

7908

II

1/26/1989

FABBRICA ITALIANI SINTETICI SPA

DILTIAZEM HYDROCHLORIDE AS MFG. IN VICENZA, ITALY

7909

1/3/1989

PHARMA HAMEIN GMBH

STERILE PROCESSING FACILITY IN HAMELN, GERMANY

7910

2/8/1989

BIOCHEMIC GESELLSCHAFT MBH

STERILE PENICILLIN PRODUCTS FACILITY IN KUNDL, TYROL, AUSTRIA

7911

2/8/1989

BIOCHEMIC GESELLSCHAFT MBH

FACILITIES FOR ORAL PENICILLIN PRODUCTS IN KUNDL TYROL,AUSTRIA

7912

III

2/8/1989

GEORGIA PACKAGING INC

4113-14 PRODUCTAS MFG. IN COLUMBUS, GA

7913

II

2/13/1989

RESOLUTION CHEMICALS LTD

PRAZEPAM AS MFG. IN MIRFIELD, WEST YORKSHIRE, UK

7914

1/31/1989

SCHOTT PHARMACEUTICAL PACKAGING INC

7915

2/3/1989

SERONO LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PHONIXVILLE, PENNSYLVANIA.
CELL CULTURE AND PROTEIN PURIFICATION FACILITY, IN RANDOLPH, MA

7916

II

1/27/1989

ERIMOS TECHNOLOGIES LLC

EXTRACTION OF M-NDGA BULK FORM IN EL PASO, TEXAS

7917

III

2/1/1989

SUN CHEMICALS CORP

PRIMER COATING P76-1182 AS MFG. IN PHILADELPHIA, PA

7918

12/14/1988

LABORATOIRES MXM

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ANTIBES, FRANCE.

7919

NOT AN ASSIGNED NUMBER

7920

NOT AN ASSIGNED NUMBER

7921

7922

III

2/7/1989

PMS CONSOLIDATED

COLORANTS AND FORMULATIONS MANUFACTURED IN FLORENCE, KENTUCKY.

7923

II

1/23/1989

UNICHEM LABORATORIES LTD

BUPRENORPHINE HYDROCHLORIDE MANUFACTURED IN BOMBAY, INDIA.

7924

II

2/7/1989

PENINSULA LABS

LYSINYL-13-CYSTEINE AS MFG. IN BELMONT, CA

7925

2/20/1989

LUPIN LABORATORIES LTD

7926

2/21/1989

SU HEUNG CAPSULE CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ANKLESHWAR (GUJARA) INDIA.
MFG. SITE, FACILITIES AND PERSONNEL UTILIZED IN SEOUL, KOREA

7927

IV

2/21/1989

SU HEUNG CAPSULE CO LTD

EMPTY GELATIN CAPSULES MANUFACTURED IN SEOUL, KOREA.

7928

II

2/16/1989

WYCKOFF CHEMICAL CO INC

MEFENAMIC ACID AS MFG. IN SOUTH HAVEN, MI

7929

III

2/14/1989

INJECTRON CORP

PACKAGING MATERIALS AS MFG. IN PLAINFIELD, NJ

7930

II

2/16/1989

LABORATORIO CHIMICO INTERNATIONAL SPA

M F 201 TARTRATE AS MFG. IN SEGRATE/MILAN, ITALY

7931

III

2/24/1989

DOUBLE LAMINATED FOIL AS MFG. IN AUSTRIA

7932

III

2/28/1989

7933

II

2/20/1989

FOLIENWALZWERK BRUEDER TECH


AKTIENGESELLSCHAFT
FOLIENWALZWERK BRUEDER TECH
AKTIENGESELLSCHAFT
COSMA SPA

7934

II

2/28/1989

CADILA LABORATORIES PVT LTD

NIFEDIPINE AS MFG. IN GUJARA, INDIA

7935

3/12/1989

BACHEM FINE CHEMICALS INC

7936

II

2/21/1989

TAMAG BASEL AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAN DIEGO, CALIFORNIA.
NICOTINE AS MFG. IN MENZIKEN, SWITZERLAND

NOT AN ASSIGNED NUMBER

SINGLE LAMINATED FOIL (FOIL, POLYETHYLENE) MFG. IN AUSTRIA


ATENOLOL MANUFACTURED IN CISERANO, ITALY.

Page 220

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7937 A
II
2/16/1989
KATWIJK CHEMIE BV

SUBJECT
ETHOSUXIMIDE AS MFG. IN KATWIJK ANN ZEE IN THE NETHERLANDS

7938

II

2/17/1989

TANABE SEIYAKU CO LTD

TA-5707F AS MFG. IN OSAKA, JAPAN

7939

II

2/8/1989

LUPIN LTD

7ADCA AS MFG. IN BOMBAY, INDIA

7940

IV

2/21/1989

PUROLITE CORPORATION

7941

III

3/3/1989

TEICH AG

7942

II

3/1/1989

ASTRA PHARMACEUTICAL PRODUCTS

TERBUTALINE SULPHATE AS MFG. IN SODERTALJE, SWEDEN

7943

II

3/1/1989

IMAGENTS INC

RADIOCHEMICAL GALLIUM CHLORIDE GA-67 AS MFG. IN HOUSTON, TX

7944

II

3/2/1989

CELSUS LABORATORIES INC

HEPARIN SODIUM MANUFACTURED IN CINCINNATI, OHIO.

7945

II

3/1/1989

TANABE SEIYAKU CO LTD

PROTIRELIN AS MFG. IN OSAKA, JAPAN

7946

II

3/2/1989

EGIS PHARMACEUTICALS

IMIPRAMINE HYDROCHLORIDE AS MFG. IN BUDAPEST, HUNGARY

7947

II

2/24/1989

CILAG AG

SUCCIMER AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

7948

II

3/1/1989

XTTRIUM LABS INC

4.0% CHLORHEXIDINE GLUCONATE SOLUTION 1101 MFG. IN CHICAGO IL

7949

II

3/1/1989

CYGNUS INC

FENTANYL TRANSDERMAL SYSTEM (FENTANYL TS) MFD IN REDWOOD CITY, CA

7950

IV

2/16/1989

LIQUID QUIMICA MEXICANA SA DE CV

CALCIUM CARBONATE MANUFACTURED IN NAUCALPAN DE JUAREZ, MEXICO.

7951

II

3/6/1989

CELSUS LABORATORIES INC

HEPARIN CALCIUM MANUFACTURED IN CINCINNATI, OHIO.

7952

II

3/6/1989

CELSUS LABORATORIES INC

LMW HEPARIN SODIUM AS MFG. IN CINCINNATI, OH

7953

II

3/7/1989

GUANGZHOU ZHUJIANG MEDICINE CO INC

MINOXIDIL AS MFG. IN DONG PU, GUANGZHOU, CHINA

7954

II

3/8/1989

UNICORN ORGANICS LTD

SORBITOL AS MFG. IN SECUNDERABAD, INDIA

7955

2/23/1989

7956

3/1/1989

COVANCE PHARMACEUTICAL PACKAGING


SERVICES INC
ABBOTT LABORATORIES LTD

7957

II

3/7/1989

CILAG CHEMIE AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALLENTOWN, PA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN QUEENBOURGH, KENT, UNITED KINGDOM.
GUANABENZ ACETATE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

7958

III

2/22/1989

APEX PLASTIC INC

PACKAGING MATERIALS MANUFACTURED IN BROOKFIELD, MO

7959

II

3/21/1989

EASTMAN KODAK CO

2-AMINO-N-(1-METHYL-1,2-DIPHENULETHYL) ACETAMIDE MONOHCL

7960

3/9/1989

GENERICS LTD

FACILITY UTILIZED IN POTTERS BAR, HERTS, ENGLAND

7961

II

3/7/1989

OMNICHEM NV (PRB)

PENTAMIDINE ISETHIONATE AS MFG. IN WETTERN, BELGIUM

7962

3/8/1989

UNICORN ORGANICS LTD

7963

IV

2/27/1989

JOGUE CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SECUNDERABAD, INDIA.
VARIOUS FLAVOR FORMULATIONS MANUFACTURED IN DETROIT, MICHIGAN AND INDIA.

7964

3/13/1989

TAMILNADU DADHA PHARMACEUTICAL

7965

II

3/13/1989

TAMILNADU DADHA PHARMACEUTICAL

7966

II

3/14/1989

RX77368 ORAL SOLUTION (FREEZE DRIED)

7967

3/8/1989

RECKITT & COLMAN PRODUCTS LTD


PHARMACEUTICAL DIV
TAMILNADU DADHA PHARMACEUTICAL

7968

II

3/14/1989

RX77368 INTRAVENOUS INJECTION (FREEZE DRIED)

7969

3/16/1989

RECKITT & COLMAN PRODUCTS LTD


PHARMACEUTICAL DIV
PHARMPAC CO INC DIV OF CARDIO PHARM

7970

II

3/14/1989

RX77368 AS MFG. IN N. HUMBERSIDE, UK AND LANCASTER, UK

7971

II

3/8/1989

RECKITT & COLMAN PRODUCTS LTD


PHARMACEUTICAL DIV
RECORDATI CORP

POLACRILIN POTASSIUM AS MFG AT PUROLITE SRL VICTORIA, ROMANIA


SCHAFT

SINGLE LAMINATED FOIL (PAPER, FOIL) AS MFG. IN AUSTRIA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF CISPLATIN IN MADRAS, INDIA.
CISPLATIN AS MFG. IN MADRAS, INDIA

MFG. SITE AND FACILITIES UTILIZED IN MADRAS, INDIA

MFG. SITE AND FACILITIES UTILIZED IN BAAVIA, NY

DANAZOL AS MFG. IN MADRAS, INDIA

Page 221

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
7972 I
IV
2/28/1989
AIR PRODUCTS AND CHEMICALS INC

SUBJECT
OCTADECAFLUORODECAHYDRONAPHTHALENE (PERFLUORODECALIN)

7973

II

3/16/1989

ISP

4-(METHYLTHIO) BENZOIC ACID MANUFACTURED IN COLUMBUS, OHIO.

7974

III

3/10/1989

SETCO INC

PACKAGING MATERIALS AS MFG. IN CRANBURY, NJ

7975

II

1/17/1989

SANOFI SYNTHELABO INC.

TICLOPIDINE HYDROCHLORIDE AS MFG. IN EVIONNAZ/VS, SWITZERLAND

7976

3/17/1989

GENPHARM INC

FACILITIES LOCATED IN ETOBICKE, ONTARIO, CANADA

7977

IV

2/14/1989

NOF CORP

DIMYRISTOYL PHOSPHATIDYL CHOLINE AS MFG. IN HYOGO, JAPAN

7978

2/13/1989

LIPOSOME CO INC

7979

II

3/17/1989

BOEHRINGER MANNHEIM GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HYOGO, JAPAN.
NITROFURANTOIN MACROCRYSTALLINE AS MFG. IN MANNHEIM, FRG

7980

II

3/16/1989

HEINRICH MACK NACHF

BROXURIDINE AS MFG. IN BAVARIA, FRG

7981

II

2/14/1989

ORGANON OSS

ORGABOLIN TABLETS 2 MG. AS MFG. IN OSS, THE NETHERLANDS

7982

II

3/22/1989

FINE CHEMICALS CORP PTY LTD

METHAZOLAMIDE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

7983

III

3/7/1989

SPARTECH PLASTICS

THERMOPLASTIC SHEET TYPE H-S-H AS MFG. IN PORTAGE, WI

7984

II

3/17/1989

TAKEDA CHEMICAL INDUSTRIES LTD

PYRIDOXINE HYDROCHLORIDE AS MFG. IN HIKARI-CITY, JAPAN

7985

III

3/7/1989

SPARTECH PLASTICS

THERMOPLASTIC SHEET TYPE PP-E-PP MANUFACTURED IN PORTAGE, WI

7986

II

3/22/1989

JOHNSON MATTHEY INC

PENTAMIDINE GLUCONATE AS MFG. IN WEST DEPTFORD, NJ

7987

II

3/29/1989

VULCAN CHEMICALS

SODIUM CHLORITE MANUFACTURED IN STAMFORD, CONNECTICUT.

7988

II

2/14/1989

BACHEM FEINCHEMIKALIEN AG

HUMAN ALPHA CALCITONIN GENE RELATED PEPIDE, SWITZERLAND

7989

II

3/29/1989

CADILA LABORATORIES PVT LTD

GLYBURIDE BP'88 (GLIBENCLAMIDE) AS MFG. IN GUJARA, INDIA

7990

II

3/28/1989

ERREGIERRE SPA

ACEBUTOLOL HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY.

7991

3/23/1989

GLAXO WELLCOME INC

MFG. FACILITIES LOCATED IN JURONG, SINGAPORE

7992

II

3/21/1989

CILAG AG

MOLINDONE HYDROCHLORIDE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

7993

IV

3/22/1989

SPECIALTY PRODUCTS INTERNATIONAL, INC.

CO-CRYSTALLIZED MANNITOL/SORBITOL MFG. IN MEW CASTLE, DE

7994

II

3/13/1989

DINAMITE DIPHARMA SPA

PROTRIPTYLINE HCL AS MFG. IN MILANO, ITALY

7995

II

3/22/1989

KANEKA CORP

N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANYL-N-CARBOXY ANHYDRIDE

7996

II

4/4/1989

SHANGHAI NO 6 PHARMACEUTICAL FACTORY

TRETINOIN AS MFG. IN SHANGHAI, PRC

7997

IV

3/28/1989

UNGERER AND CO

MOUTHWASH FLAVOR #16390 IN LINCOLN PARK, NEW JERSEY

7998

II

3/28/1989

SIBEFAT SPA

KETOPROFEN AS MFG. IN TRIBIANO (MILANO) ITALY

7999

3/23/1989

MARTEC PHARMACEUTICALS INC

LABORATORY, PACKAGING, LABELING FACILITIES IN KANSAS CITY, MO

8000

II

3/31/1989

VERTELLUS PERFORMANCE MATERIALS INC

ACETYLTRIETHYL CITRATE MANUFACTURED IN GREENSBORO, NORTH CAROLINA.

8001

II

3/20/1989

VIS-INSTITUTO SCIENTIFICO DELLE VENEZIE SPA

BENZTHIAZIDE AS MFG. IN PADOVA, ITALY

8002

II

3/23/1989

BASF PHARMA EVIONNAZ SA

CHLOROPROCAINE HYDROCHLORIDE MFG. IN EVIONNAZ/VS, SWITZERLAND

8003

II

4/5/1989

CELSUS LABORATORIES INC

AMMONIUM HEPARIN AS MFG. IN CINCINNATI, OH

8004

II

4/4/1989

EISAI CO LTD

EPERISONE AS MFG. IN TOKYO, JAPAN

8005

III

3/31/1989

KANE INTL CORP

STYSOLAC AW AS MFG. IN HETERENE CHEMICAL CO. IN NEW JERSEY

8006

4/4/1989

LYPHOMED INC

MFG. FACILITIES LOCATED IN CANOVANAS, PUERTO RICO

8007

4/6/1989

DHL LABORATORIES INC

FACILITIES UTILIZED IN UNION, SC

8008

IV

4/1/1989

WILD FLAVORS INC

MASKING FLAVOR #076932 AS MFG. IN CINCINNATI, OH

8009

II

4/6/1989

NATL INST HLTH NCI

PENTAMIDINE ISETHIONATE AS MFG. IN PHARM-ECO, SIMI VALLEY, CA

Page 222

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8010 I
II
4/3/1989
RHONE-POULENC

SUBJECT
ETHIONAMIDE SUPPOSITORIES, 500 MG, THERAPLIX SA, PARIS, FR

8011

II

4/17/1989

MORTON THIOKOL INC

MAGNESIUM HYDROXIDE AS MFG. IN MANISTEE, MI

8012

III

4/5/1989

A FRADAGRADA AND A PETTENATI SRL

PHARMACEUTICAL RUBBER CLOSURES AS MFG. IN MILAN, ITALY

8013

II

4/13/1989

UCB BIOPRODUCTS SA

SALCATONIN ACETATE AS MFG. IN BRAINE-L'ALLEUD, BELGIUM

8014

3/20/1989

ETHYPHARM

FACILITIES, PERSONNEL AND PROCEDURES LOCATED IN HOUDAN, FRANCE

8015

II

3/2/1989

FREEDOM CHEMICAL DIAMALT GMBH

ATENOLOL AS MFG. IN RAUBLING, FEDERAL REPUBLIC OF GERMANY

8016

4/8/1989

NAGASE AMERIKA CORP

FACILITIES LOCATED IN TOKYO, JAPAN

8017

II

4/8/1989

YUKI GOSEI KOGYO CO LTD

2,3,-DIDEOXYINOSINE AS MFG. IN TOKYO, JAPAN

8018

II

4/24/1989

LABORATOIRES DELAGRANGE

LAD 2691 AS MFG. IN ARPAJON, FRANCE

8019

II

3/31/1989

MALLINCKRODT CHEMICAL INC

POTASSIUM CHLORIDE AS MFG. IN ST. LOUIS, MISSOURI

8020

II

4/10/1989

CHEMIE LINZ GES MBH

L-NORADRENALINE BITARATE MONOHYDRATE AS MFG. IN LINZ, AUSTRIA

8021

II

4/20/1989

APOTEX PHARMACHEM INC

CIMETIDINE AS MFG. IN TOLUCA, ESTADO DE MEXICO, MEXICO

8022

II

4/4/1989

ROCHE PRODUCTS INC

FLUOROLACTAM AS MFG. IN MANATI, PUERTO RICO

8023

III

4/6/1989

PREJECT PRODUCTS SA

PREJECT PREFILLED SYRINGES AS MFG. IN GLAND, SWITZERLAND

8024

II

4/12/1989

MERCK KGAA

BISOPROLOL FUMARATE 2:1 AS MFG. BY VON GLENCK & CIE

8025

III

4/7/1989

ARIZONA CHEMICAL CO

AQUAIC 6025 AS MFG. BY ARIZONA CHEM AND HI-TEK POLYMERS

8026

4/3/1989

DELCOR LABORATORIES INC

PACKAGING FACILITY LOCATED IN E. STROUDSBURG, PA

8027

III

5/1/1989

COILLIR MANUFACTURING INC

MATERIALS MFG. BY AUTEX FIBERS AND COURTAEUDIS FIBERS

8028

II

4/24/1989

WOCKHARDT LTD

CAPTOPRIL AS MFG. IN DIST. BHARUCH GUJARAT STATE, INDIA

8029

II

4/19/1989

CETYLPYRIDINIUM CHLORIDE AS MFG. IN ZEELAND, MI

8030

II

4/24/1989

VERTELLUS HEALTH AND SPECIALTY PRODUCTS


LLC
BIOSOURCE TECHNOLOGIES INC

8031

4/20/1989

GYNOPHARMA INC

FACILITIES, METHODS AND CONTROLS IN SOMERVILLE, NJ

8032

4/28/1989

DAIICHI SEIYAKU CO LTD

PRODUCTION TECHNOLOGY RESEARCH LABS., EDOGAWA-KU, TOKYO, JAPAN

8033

IV

4/27/1989

ADVANCED POLYMER SYSTEMS

MMA/EGDMA MICROSPONGES AS MFG. IN LAFAYETTE, LOUISIANA

8034

II

4/25/1989

DINAMITE DIPHARMA SPA

FENBUFEN MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES

8035

II

4/27/1989

IMAGENTS INC

RADIOCHEMICAL THALLOUS CHLORIDE TL-201 AS MFG. IN HOUSTON, TX

8036

II

4/28/1989

ROUSSEL-UCLAF

BECLOMETHASONE DIPROPIONATE USP AS MFG. IN VERTOLAYE, FRANCE

8037

II

4/26/1989

SEPRACOR INC

HA-ULTROGEL AS MFG. IN VILLENEUVE LA GARENNE, FRANCE

8038

8039

II

4/26/1989

SEPRACOR INC

SP-TRISACRYL M OR LS AS MFG. IN VILLENEUVE LA GARENNE, FRANCE

8040

II

4/18/1989

ZACH SYSTEM

PAROXETINE STAGE 2 DL-AMINO ALCOHOL MFG. IN AVRILLE, FRANCE

8041

II

4/14/1989

LONZA AG

NIACIN (NICOTINIC ACID) AS MFG. IN VISP, SWITZERLAND

8042

II

4/21/1989

ORGAMOL SA

MEBEVERINE HYDROCHLORIDE AS MFG. IN EVIONNAZ, SWITZERLAND

8043

II

4/21/1989

NORDIC SYNTHESIS AB

NIFEDIPINE AS MFG. IN KARLSKOGA, SWEDEN

8044

II

4/26/1989

IAF BIOCHEM INTERNATIONAL INC

DESMOPRESSIN AS MFG. IN MONTREAL, QUEBEC, CANADA

8045

II

4/27/1989

REGIS CHEM CO

AMINOGUANIDINE HYDROCHLORIDE AS MFG. IN MORTON GROVE, IL

8046

II

5/1/1989

IMAGENTS INC

TUNGSTEN W-178 RADIOCHEMICAL AS MFG. IN HOUSTON, TEXAS

8047

II

4/25/1989

IROPHARM LTD

CLOMIPRAMINE HYDROCHLORIDE AS MFG. IN ARKLOW, IRELAND

MELANIN AS MFG. IN VACAVILLE AND MORGAN HILL, CA

NOT AN ASSIGNED NUMBER

Page 223

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8048 I
III
4/25/1989
RELEASE INTL

SUBJECT
8 POINT SBS POLY SLIK -IOWA CITY, IOWA AND BEDFORD PARK, ILL

8049

III

4/25/1989

MOORE & MUNGER MARKETING INC

TEMPORARY ADHESIVE MADE FROM A BLEND OF WAXES

8050

III

4/25/1989

LOPAREX INC

8051

II

5/1/1989

SIPSY

11504 S 94# BL KFT L/HP 4D/000 MANUFACTURED IN BEDFORD PARK AND WEST CHICAGO,
ILLINOIS, IOWA CITY, IOWA, AND EDEN, NORTH CAROLINA.
LOPERAMIDE HYDROCHLORIDE AS MFG. IN AVRILLE, FRANCE

8052

II

3/26/1989

PLAISTOW LTD

N,N-,BIS(PYRIDOXAL-5-PHOSPHATE) ETHYLENE-DIAMINE-N,N-DIACETIC

8053

II

5/5/1989

EURAND AMERICA INC

ASPIRIN EC-2 (MICROENCAPSULATED) AS MFG. IN VANDALIA, OH

8054

II

4/28/1989

JANSSEN PHARMACEUTICA NV

CLAZURIL TABLETS 2.5 MG (R 62690) AS MFG. IN BEERSE, BELGIUM

8055

II

5/4/1989

KRKA PHARMACEUTICAL & CHEMICAL WORKS

PIROXICAM AS MFG. IN NOVO MESTO, YUGOSLAVIA

8056

II

5/4/1989

SUMITOMO CHEMICAL CO LTD

SC-26480 (INTERMEDIATE) AS MANUFACTURED IN GIFU PREFECTURE, JAPAN

8057

II

5/11/1989

VALEAS SPA

BRONCOVALEAS INHALER (ALBUTEROL INHALER) MFG. IN MILAN, ITALY

8058

III

3/21/1989

PHE PHARMA ELASTOMERE GMBH CO KG

RUBBER FORMULATIONS AS MFG. IN SUMMERAH, FRG

8059

IV

4/25/1989

SIMETRY COMPANY

HYDROPHOBIC CARRIER FOR CONTROLLED RELEASE DOSAGE FORMS

8060

II

5/6/1989

CIPLA LTD

ALPRAZOLAM AS MANUFACTURED IN BANGALORE, INDIA

8061

4/24/1989

ANAQUEST INC

FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GUAYAMA, PR

8062

II

5/6/1989

CIPLA LTD

TERBUTALINE SULFATE AS MANUFACTURED IN BOMBAY AND BANGALORE, INDIA

8063

II

4/28/1989

JANSSEN PHARMACEUTICA NV

CLAZURIL - R 62690 AS MANUFACTURED IN BEERSE AND GEEL, BELGIUM

8064

II

5/5/1989

MALLINCKRODT INC

SODIUM IODIDE I-123 AS MANUFACTURED IN MARYLAND HEIGHTS, MO FACILITY

8065

II

4/28/1989

SUMIKA FINE CHEMICALS CO LTD

CYCLOBENZAPRINE HYDROCHLORIDE MFG. IN GIFU PREFECTURE, JAPAN

8066

II

5/16/1989

FUJISAWA PHARMACEUTICAL COMANY LTD

FK366 ALDOSE REDUCTASE INHIBITOR AS MFG. IN OSAKA, JAPAN

8067

III

5/9/1989

GRAHAM PACKAGING COMPANY L.P.

CONTAINER/CLOSURE SYSTEMS AS MFG IN NORTH KANSAS CITY MO

8068

IV

5/9/1989

TAKASAGO INTERNATIONAL CORP

TAK 80128 NATURAL ORANGE FLAVOR AS MFG. IN TETERBORO, NJ

8069

5/26/1989

SAFEPHARM LABORATORIES LTD

FACILITIES LOCATED IN SHARDLOW, ENGLAND

8070

II

5/9/1989

PHARMAZELL GMBH

5-AMINOSALICYLIC ACID AS MFG. IN RAUBLING, FRG

8071

II

5/10/1989

BRADYKININ ACETATE NPC-567 AS MFG. IN NORTH CHICAGO, IL

8072

IV

8/17/1988

ABBOTT LABS CHEM AND AGRICULTURAL PRODS


DIV
UNILEVER UNITED STATES INC

8073

5/15/1989

ERBA BIOCHIMICA SPA

FACILITIES LOCATED IN MILANO, ITALY

8074

II

5/11/1989

MALLINCKRODT CHEMICAL INC

FENTANYL ALKALOID AS MFG. IN ST. LOUIS, MO

8075

II

5/18/1989

SEPRACOR INC

S-(+)- IBUPROFEN AS MFG. IN MARLBOROUGH, MA

8076

II

4/18/1989

FARMABOIS

BECLOMETHASONE DIPROPIONATE MFG. IN GROPELLO CAIROLI, ITALY

8077

II

5/15/1989

GANTAX NV PHARMACEUTICA

PANCRUONIUM BROMIDE AS MFG. IN BRUSSEL, BELGIUM

8078

II

5/17/1989

PENICK CORP

MEPERIDINE HYDROCHLORIDE AS MFG. IN NEWARK, NEW JERSEY

8079

IV

5/30/1989

AVANTI POLAR LIPIDS INC

1-STEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (PTDCHO-MONO180)

8080

5/17/1989

WHEATON APPLICATOR CO

FACILITIES LOCATED IN MILLVILLE, NJ

8081

II

5/11/1989

WACKER CHEMIE GMBH

PHTALIMIDOACETONE AS MFG. IN BURGHAUSEN, FED. REP. OF GERMANY

8082

IV

5/19/1989

B BRAUN MEDICAL INC

STERILIZATION, SOLUTION PRODUCTS AS MFG. IN IRVINE, CA

8083

III

5/24/1989

AIR PRODUCTS & CHEMICALS INC

FLEXCRYL 1653 EMULSION AS MFG. IN SOUTH BRUNSWICK, NJ

8084

III

5/23/1989

ABBOTT BIOLOGICALS BV

PREFILLED BD READYFILL SYRINGE AS MFG. IN OLST, THE NETHERLANDS

DURKEE 07 EXCIPIENT AS MFG. IN JOLIET, IL

Page 224

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8085 I
I
5/26/1989
TRANS CONTAINER CORP
8086

5/16/1989

ABBOTT LABORATORIES LTD

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN UPLAND, CALIFORNIA.
FACILITIES LOCATED IN QUEENBOROUGH, KENT, UK

8087

5/8/1989

KM LEE LABORATORIES

MFG. SITE AND FACILITIES LOCATED IN SANTA FE SPRINGS, CA

8088

II

5/19/1989

DOW CORNING CORP

BIO-RELEASE SILICONE RELEASE COATING SYSTEM, HEMLOCK, MI

8089

8090

III

5/24/1989

AIR PRODUCTS & CHEMICALS INC

FLEXCRYL 1614 EMULSION AS MFG. IN SOUTH BRUNSWICK, NJ

8091

II

6/1/1989

CAMBREX PROFARMACO MILANO SRL

AMOXAPINE AS MFG. IN MILAN, ITALY

8092

II

6/1/1989

ROCHE PALO ALTO LLC

TICLOPIDINE HCL- BOULDER, CO, SPRINGFIELD, MO, EVIONNAZ,SWITZ

8093

II

6/7/1989

DIOSYNTH BV

DESMOPRESSIN AS MFG. IN OSS, HOLLAND

8094

III

6/1/1989

UACJ FOIL CORP

PACKAGING MATERIALS AS MFG. IN KUSATSU-CITY, SHIGA, JAPAN

8095

II

6/7/1989

SIBEFAT SPA

MICONAZOLE NITRATE AS MFG. IN MILAN, ITALY

8096

II

4/25/1989

CESQUISA SA

CLOBETASOL PROPIONATE AS MFG. IN PEROGORDO, SEGOVIA, SPAIN

8097

II

6/8/1989

HOECHST MARION ROUSSEL SA

VINORELBINE DITARTRATE AS MFG. IN ROMAINVILLE, FRANCE

8098

5/30/1989

STERILE PROCESSING FACILITY IN JAPAN

8099

II

6/13/1989

BRISTOL MYERS PRODUCTS DIV BRISTOL MYERS


CO
ZENECA INC

8100

II

4/27/1989

RESEARCH BIOCHMICALS INC

(HIPDM) AS MFG. IN NATICK, MA

8101

II

6/8/1989

CILAG AG

CYCLOBENZAPRINE HCL AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

8102

III

5/31/1989

SCHUBERT SEALS A/S

7.2 MM PLUNGER AS MFG. IN HORSENS, DENMARK

8103

III

5/31/1989

SCHUBERT SEALS A/S

RUBBER SHEET LAMINATE FOR DISCS MFG. IN HORSENS, DENMARK

8104

III

6/2/1989

GERRESHEIMER BUNDE GMBH

STAKED NEEDLE DISPOSABLE SYRINGE MFG. IN BUNDE/WESTFALEN FRG

8105

6/16/1989

HAYDEN MANUFACTURING CO INC

FACILITIES FORHAYDEN MOLDING LTD. IN BRANTFOR, ONTARIO, CANADA

8106

II

6/12/1989

BOEHRINGER MANNHEIM GMBH

CATALASE THERAPEUTIC GRADE AS MFG. IN PENZBERG, FRG

8107

II

6/15/1989

CUNO INC

ZETA PLUS LA MEDIA AND CARTRIDGES IN STAFFORD SPRINGS, CT

8108

II

6/15/1989

CUNO INC

ZETA PLUS SA MEDIA AND CARTRIDGES IN STAFFORD SPRINGS, CT

8109

II

6/15/1989

BAYER AG

AMPICILLIN SODIUM STERILE MFG. IN WUPPERTAL, GERMANY

8110

II

6/23/1989

UNILEVER UNITED STATES INC

DURKOTE CALCIUM CARBONATE 1551-95 (P), JOLIET & CHICHAGO, IL

8111

II

6/26/1989

CUNO INC

8112

II

6/20/1989

ASPEN OSS BV

ZETA PLUS CA MEDIA AND CARTRIDGES MANUFACTURED IN STAFFORD SPRINGS,


CONNECTICUT.
RIMEXOLONE MICRO AS MFG. IN OSS THE NETHERLANDS

8113

III

6/22/1989

BAXTER HEALTHCARE CORP

8114

IV

6/28/1989

JM HUBER CORP

PRODUCTION OF TERMINALLY STERILIZED PARENTERAL SOLUTIONS IN SEAL/FILL/SEAL


CONTAINERS IN ROUND LAKE, IL AND CLEVELAND,MS.
AMORPHOUS PRECIPITATED SILICON DIOXIDE MFG. IN MD AND TN

8115

II

6/20/1989

HEUMANN

CYCLOBENZAPRINE-HCL AS MFG. IN NUREMBERG, FRG

8116

II

6/26/1989

SANOFI AVENTIS DEUTSCHLAND GMBH

LEFLUNOMIDE (HWA 486) AS MFG. IN WIESBADEN, GERMANY

8117

II

6/26/1989

LUSOCHIMICA S P A

TERBUTALINE SULPHATE AS MFG. IN MILAN, ITALY

8118

II

7/15/1989

DIOSYNTH BV

HUMAN MENOPAUSAL GONADOTROPHIN NATURAL - OSS, THE NETHERLANDS

8119

II

6/28/1989

OCCIDENTAL CHEM CORP

ETHYLENE DICHLORIDE AS MFG. IN DEER PARK, TEXAS

8120

II

7/7/1989

CIPLA LTD

PROPANOLOL HCL AS MFG. IN BOMBAY, INDIA

NOT AN ASSIGNED NUMBER

SDM 70 AS MFG. BY ALAS POWER CO. IN TAMAQUA, PA

Page 225

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8121 I
II
6/13/1989
HEUMANN

SUBJECT
DICLOFENAC SODIUM AS MFG. IN FEUCHT, GERMANY

8122

7/6/1989

TEKKOTE CORP

FACILITIES LOCATED IN MOONACHIE, NJ

8123

7/6/1989

BOREALIS AB

FACILITIES LOCATED IN STENUNGSUND, SWEDEN

8124

III

7/19/1989

BOREALIS AG

BORMED LE6601-PH AND BORMED LE6607-PH AS MANUFACTURED IN PORVOO, FINLAND

8125

7/3/1989

NPBI B V

FACILITIESLOCATED IN EMMEN, THE NETHERLANDS

8126

7/3/1989

NPBI B V

8127

II

7/5/1989

DAITO KOEKI KK

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERALOPERATING PROCEDURES


IN EMMER-COMPASCUUM, THE NETHERLANDS
CARBIDOPA AS MFG, BY DAITO KOOEKI KK IN TOYAMA, JAPAN.

8128

7/10/1989

VALPHARMA S A

8129

II

7/10/1989

CAMBREX PROFARMACO MILANO SRL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN REPUBLIC SAN MARINO.
METAPROTERENOL SULFATE AS MFG. IN MILAN, ITALY

8130

6/30/1989

AID PACK INC

FACILITIES LOCATED IN GLOUCESTER, MASSACHUSETTS

8131

II

7/10/1989

NASAL NICOTINE SOLUTION (NNS) AS MFG. IN HELSINGBORG, SWEDEN

8132

II

7/13/1989

MCNEIL CONSUMER HEALTHCARE DIV MCNEIL


PPC INC
EASTMAN KODAK CO

8133

II

7/14/1989

NOVO NORDISK AS

SUBTILISIN A AS MFG. IN BAGSVATERD, DENMARK

8134

II

7/14/1989

BAYER SCHERING PHARMA AG

CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN WUPPERTAL, GERMANY

8135

II

7/12/1989

BIOCHEMIC GESELLSCHAFT MBH

TDA AS MFG. IN KUNDL, TYROL, AUSTRIA

8136

II

7/12/1989

BIOCHEMIC GESELLSCHAFT MBH

TET-ACA AS MFG. IN KUNDL, TYROL, AUSTRIA

8137

II

7/12/1989

GEMA SA

CEFAZOLIN AS MFG. IN STA. PERPETUA DE MOGUDA, SPAIN

8138

6/30/1989

SYNTEX SA

FACILITIES LOCATED IN MEXICO CITY, MEXICO

8139

7/7/1989

AKROSIL

8140

II

7/7/1989

IWAKI SEIYAKU CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MENASHA, WISCONSIN.
PHENYLEPHRINE HCL AS MDF. IN SHIZUOKA, JAPAN

8141

7/25/1989

BRISTOL MYERS SQUIBB COMPANY

8142

II

7/26/1989

NEWPORT PHARMACEUTICALS (IRELAND)

FACILITIES FOR PARENTERAL MANUFACTURING (BUILDING 115) LOCATED IN NEW


BRUNSWICK, NJ
METOPROLOL TARTRATE AS MFG. IN DUBLIN, IRELAND

8143

II

7/26/1989

SELOC AG

NORTRIPTYLINE HCL AS MFG. BY SIFA LTD., CLARE, IRELAND

8144

II

7/26/1989

WARNER LAMBERT CO

MECLOFENAMATE SODIUM AS MFG. IN HOLLAND, MI

8145

IV

7/26/1989

INNOPHOS INC

DIBASIC CALCIUM PHOSPHATE, ANHYDROUS GRANULAR, CHICAGO HTS IL

8146

III

7/19/1989

FRIEDRICH SANNER GMBH CO KG

PACKAGING MATERIALS MANUFACTURED IN AUERBACH, FEDERAL REPUBLIC OF GERMANY

8147

II

7/20/1989

SIGMA F AND D DIV LTD

N,N-DIMETHYLTRYPTAMINE AS MFG. IN ST. LOUIS, MO

8148

III

7/31/1989

EXXONMOBIL CHEMICAL CO

8149

III

7/11/1989

STYROLUTION GMBH

SANTOPRENE THERMOPLASTIC RUBBER GRADE 171-55-W199 AS MFG. IN PENSACOLA


FLAND WADSWORTH OH
LURAN 358 N AS MFG. IN LUDWIGSHAFEN, GERMANY

8150

IV

7/26/1989

HENRY H OTTENS MANUFACTURING CO INC

NATURAL & ARTIFICIAL CHERRY MINT #5095-A MFG. IN PHILA., PA

8151

II

7/25/1989

GALLOPAMIL HCL AS MFG. IN LATINA, ITALY

8152

II

8/1/1989

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
SOGO PHARMACEUTICAL CO LTD

8153

7/27/1989

CIMA LABORATORIES INC

FACILITIES LOCATED IN MINNEAPOLIS, MN

8154

III

7/31/1989

SCHUBERT SEALS A/S

RUBBER COMPOUND 6404 AS MFG. IN HORSENS, DENMARK

A-(2-AMINO-3-P-BROMOBENZOYLPHENYL) ACETIC ACID SODIUM SALT

SULFADIMETHOXINE MFG. AT THE FUKUOKA, JAPAN PLANT

Page 226

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8155 I
III
7/31/1989
SCHUBERT SEALS A/S

SUBJECT
RUBBER COMPOUND 41003 AS MFG. IN HORSENS, DENMARK

8156

III

7/31/1989

SCHUBERT SEALS A/S

RUBBER COMPOUND 42038 AS MFG. IN HORSENS, DENMARK

8157

III

7/31/1989

SCHUBERT SEALS A/S

RUBBER COMPOUND 42022 AS MFG. IN HORSENS, DENMARK

8158

III

7/31/1989

SCHUBERT SEALS A/S

RUBBER COMPOUND 41002, HORSENS, DENMARK

8159

III

7/31/1989

SCHUBERT SEALS A/S

PTFE FILM AS MFG. IN HORSENS, DENMARK

8160

II

8/8/1989

GADOLINIUM DIETHYLENETRIAMINEPENTAACETIC ACID, N. CHICAGO, IL

8161

II

8/2/1989

ABBOTT LABS CHEM AND AGRICULTURAL PRODS


DIV
DELMAR CHEMICALS INC

8162

II

7/27/1989

SEPRACOR INC

DEAE SPHERODEX M/LS AS MFG. IN VILLENEUVE-LA-GARENNE, FRANCE

8163

II

8/2/1989

CAMBREX PROFARMACO MILANO SRL

DIFLUNISAL AS MFG. IN MILAN, ITALY

8164

II

8/2/1989

CAMBREX PROFARMACO MILANO SRL

CROMOLYN SODIUM MANUFACTURED IN MILAN, ITALY.

8165

III

8/10/1989

PHARMASCIENCES INC

HIMEDICS DISPENSER AS MFG. IN HOLLYWOOD, FL

8166

8/15/1989

BRISTOL MYERS CO INTERNATIONAL DIV

FACILITIES LOCATED IN MAYAGUEZ, PUERTO RICO

8167

II

8/15/1989

RHONE POULENC

LINDANE AS MFG. IN LE PONT DE CLAIX, FRANCE

8168

7/25/1989

IRONWOOD INDUSTRIES

FACILITIES LOCATED IN LIBERTYVILLE, IL

8169

III

8/7/1989

LOPAREX LLC

8170

III

8/9/1989

HAZEN PAPER CO

10694, S 5 MIL CL PET 4N/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD PARK,
ILLINOIS.
DRUG PACK H-130 AS MFG. IN HOLYOKE, MA

8171

II

8/9/1989

BASF PHARMA EVIONNAZ SA

CINCHOCAINE BASE AND HCL AS MFG. IN EVIONNAZ, SWITZERLAND

8172

II

8/11/1989

PHARM ECO LABORATORIES INC

PENTAMIDINE ISETHIONATE AS MFG. IN SIMI VALLEY, CA

8173

IV

8/17/1989

IMAJE INK JET PRINTING CO

ED-1112-H2 BLUE INK AS MFG. IN SMYRNA, GA

8174

III

8/18/1989

DOW DERMATOLOGICS INC

VOID

8175

II

7/19/1989

PHARMECO LABORATORIES INC

DIPIVEFRIN HCL AS MFG. IN SIMI VALLEY, CA

8176

II

8/15/1989

ABBOTT LABORATORIES

PENTAMIDINE ISETHIONATE AS MFG. IN NORTH CHICAGO, IL

8177

II

8/30/1989

DELMAR CHEMICALS INC

FAMOTIDINE AS MFG. IN LASALLE, QUEBEC, CANADA

8178

II

8/15/1989

BAYER SCHERING PHARMA AG

IOPROMIDE AS MFG. IN BERGKAMEN, FRG

8179

8/18/1989

LUMELITE PLASTICS

FACILITIES AND PERSONNEL LOCATED IN PAWLING, NY

8180

II

8/21/1989

NATL INST HLTH CONTRACEPTIVE DEV BRANCH

ANTIDE, CONTRACTED MANUFACTURER SALK INSTITUTE, SAN DIEGO, CA

8181

III

8/24/1989

EI DUPONT DE NEMOURS AND CO

TEFLON FEP FLUROCARBON RESINS, TYPES 100, 140, 160

8182

IV

8/22/1989

AVATAR CORP

LIGHT MINERAL OIL NF AS MFG. IN HICKORY HILLS, IL

8183

II

8/24/1989

POTASSIUM NITRATE AS MFG. IN WARREN, NJ

8184

II

8/28/1989

NANTONG PHARMACEUTICAL FACTORY

PIROXICAM AS MFG. IN NANTONG, JIANGSU PROVINCE, CHINA

8185

II

8/25/1989

SUMIKA FINE CHEMICALS CO LTD

METHOTREXATE AS MFG. IN ANPACHINGUN AND OSAKA, JAPAN

8186

IV

8/18/1989

FLAVOR POTENTIATOR #3096-E AS MFG. IN PHILADELPHIA, PA

8187

II

8/9/1989

FINE CHEMICALS CORPORATION

GUANABENZ ACETATE AS MFG. IN EPPINDUST, SOUTH AFRICA

8188

II

8/25/1989

CREATIVE BIOMOLECULES

EPIDERMAL GROWTH FACTOR-51 AS MFG. IN HOPKINTON, MA

8189

II

8/28/1989

EGIS PHARMACEUTICALS PUBLIC LTD CO

CARBIDOPA AS MFG. IN BUDAPEST, HUNGARY

8190

8/31/1989

GRUPPO LEPETIT SPA

FACILITIES LOCATED IN GARESSIO (CUNEO) ITALY

8191

II

8/10/1989

KOEI CHEMICAL CO LTD

PYRMETHYLALCOHOL AS MFG. KIN OSAKA, JAPAN

8192

II

8/28/1989

CHENG FONG CHEMICAL CO LTD

DICLOFENAC SODIUM AS MFG. IN TA YUAN HISANG, TAIWAN, CHINA

AMIODARONE HCL AS MFG. IN LASALLE, QUEBEC, CANADA

Page 227

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8193 I
I
9/7/1989
HIMEDICS INC

SUBJECT
R&D PLANT 1 LOCATED IN HOLLYWOOD, FL

8194

9/8/1989

CG SMITH CHEMICALS DIV CG SMITH SUGAR LTD

FACILITIES LOCATED IN DURBAN, SOUTH AFRICA

8195

II

9/8/1989

RELAX LTD

LACTULOSE CONCENTRATE MANUFACTURED BY NATAL CANE IN DURBAN, SOUTH AFRICA.

8196

II

9/5/1989

MEIJI SEIKA KAISHA LTD

PIRARUBICIN BASE AS MFG. IN KANAGAWA, JAPAN

8197

II

9/5/1989

MEIJI SEIKA KAISHA LTD

PIRARUBICIN HCL FOR INJECTION AS MFG. IN KANAGAWA, JAPAN

8198

9/5/1989

MEIJI SEIKA KAISHA LTD

ODAWARA PLANT LOCATED IN KANAGAWA, JAPAN

8199

9/11/1989

SEITZ FILTER WERKE

8200

II

9/8/1989

DSM PHARMA CHEMICALS SOUTH HAVEN INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BAD KREUZNACH, FRG.
KETOPROFEN AS MFG. IN SOUTH HAVEN, MI

8201

III

5/3/1989

CLEARPLASS CONTAINER INC

CONTAINERS MANUFACTURED IN SHEFFIELD, ALABAMA.

8202

9/1/1989

YUKI GOSEI KOGYO CO LTD

8203

9/7/1989

CHEMI SPA

8204

II

8/11/1989

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF 2-DEOXYCYTIDINE HYDROCHLORIDE IN TOKYO, JAPAN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN PARICA (FROSINONE)ITALY.
CHLORTHALIDONE AS MFG. IN LOUGHBOROUGH, LEICES, UK

8205

II

9/6/1989

QUIMICA SINTETICA SA

MICONAZOLE NITRATE AS MFG. IN MADRID, SPAIN

8206

II

9/6/1989

QUIMICA SINTETICA SA

LOPERAMIDE HCL AS MFG. IN MADRID, SPAIN

8207

9/8/1989

UNISYN TECHNOLOGIES CORP

FACILITIES LOCATED IN TUSTIN, CA

8208

II

9/15/1989

RALLIS INDIA LTD

CROMOLYN SODIUM AS MFG. IN ANKLESHWAR, GUJARA, INDIA

8209

III

9/15/1989

ASAHI CHEM INDUSTRY CO LTD

BARRIALON UB-6 AS MFG. IN TOKYO, JAPAN

8210

II

9/18/1989

SUMITOMO CHEMICAL CO LTD

SM-8668 AS MFG. IN OSAKA, JAPAN

8211

II

9/1/1989

EURAND AMERICA INC

MICROENCAPSULATED SULFAMETHOXAZOLE MANUFACTURED IN VANDALIA, OHIO.

8212

II

9/19/1989

SMITH AND NEPHEW RES LTD

APRACLONIDINE HCL AS MFG. IN HARLOW & ROMFORD, ESSEX, UK

8213

9/19/1989

SMITH AND NEPHEW RES LTD

8214

9/19/1989

SMITH & NEPHEW PHARMACEUTICALS LTD

8215

II

9/20/1989

RHONE POULENC INSTITUTE DE BIOPHARMACIE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HARLOW, ESSEX, UNITED KINGDOM.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN ROMFORD, ESSEX, UNITED KINGDOM
UREA-CALCIUM ACETYLSALICYLATE, VITRY SUR SEINE CEDEX, FRANCE

8216

II

9/19/1989

GANES CHEMICALS INC

NORTRIPTYLINE CARBAMATE MFG. IN CARLSTADT OR PENNSVILLE, NJ

8217

9/19/1989

NORTHVIEW LABS INC

8218

II

8/18/1989

ELANCO ANIMAL HEALTH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NORTHBROOK, ILLINOIS.
DICLAZURIL AS MFG. IN BEERSE AND GEEL, BELGIUM

8219

II

9/7/1989

FDC LTD

FLURBIPROFEN AS MFG. IN ROHA, MAHARASHTRA STATE, INDIA

8220

III

9/18/1989

LOPAREX LLC

11117, S 72# BL KFT L/L 4D/000 MANUFACTURED IN IOWA CITY, IOWA

8221

II

9/21/1989

ALBEMARLE CORP

TETRACAINE HCL AS MFG. IN SOUTH HAVEN, MI

8222

II

9/20/1989

TOMITA PHARM CO LTD

ALUMINUM HYDROXIDE GEL MANUFACTURED IN TOKUSHIMA, JAPAN.

8223

III

9/25/1989

BETTS MEXICO SA DE CV

PACKAGING MATERIALS MFG. IN FLORENCE, KY

8224

9/26/1989

NP IND

FACILITIES LOCATED IN ST. LOUIS, MO

8225

II

9/21/1989

ROCHE DIAGNOSTICS GMBH

ADENOSINE DEAMINASE THERAPEUTIC GRADE MFG. IN PENZBERG, FRG

8226

II

9/29/1989

SUMITOMO CHEMICAL CO LTD

TIMOLOL MALEATE AS MFG. IN ANPACHI-GUM, GIFU AND OSAKA, JAPAN

8227

9/26/1989

HAMPSHIRE CHEMICAL CORP.

FACILITIES LOCATED IN DEER PARK, TEXAS

Page 228

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8228 I
II
9/26/1989
ICI COLOURS & FINE CHEMS

SUBJECT
THIOTEPA AS MFG. IN MANCHESTER, ENGLAND

8229

III

9/18/1989

ADVANCED ELASTOMER SYSTEMS

8230

II

9/25/1989

AVATAR CORP

TREFSIN THERMOPLASTIC RUBBER AS MFG. IN WADSWORTH, OHIO AND PENSACOLA,


FLORIDA.
PROPYLENE GLYCOL AS MFG. IN HICKORY HILLS, ILLINOIS

8231

II

10/3/1989

MEDICHEM SA

PIROXICAM AS MFG. IN GERONA, SPAIN

8232

II

9/29/1989

DISCOVERY THERAPEUTICS INC

N-0923 AS MFG. IN IOWA CITY, IOWA

8233

9/29/1989

DISCOVERY THERAPEUTICS INC

PHARMACOLOGY & TOXICOLOGY DATA ON N-0923

8234

II

10/1/1989

SIFAVITOR SRL

CROMOLYN SODIUM AS MFG. IN MILAN, ITALY

8235

II

10/5/1989

IAF BIOCHEM INTERNATIONAL INC

CALCITONIN AS MFG. IN MONTREAL, QUEBEC, CANADA

8236

9/29/1989

KNOLL PHARMACEUTICAL CO

FACILITIES LOCATED IN NOTTINGHAM, ENGLAND

8237

10/3/1989

KANEGAFUCHI CHEMICAL INDUSTRY CO LTD

FACILITIES LOCATED IN TAKASAGO CITY, HYOGO PREFECTURE, JAPAN

8238

II

10/5/1989

ERREGIERRE SPA

TERFENADINE MANUFACTURED IN SAN PAOLO D'ARGON BERGAMO, ITALY.

8239

II

10/5/1989

ROUSSEL-UCLAF

NORETHINDRONE AS MFG. IN VERTOLAYE, FRANCE

8240

10/4/1989

IVERS LEE LTD

FACILITIES LOCATED IN BRAMPTON, ONTARIO, CANADA

8241

II

10/6/1989

ASH STEVENS INC

FLUDARABINE PHOSPHATE AS MFG. IN DETROIT, MICHIGAN

8242

9/12/1989

FINE GRINDING CORP

FACILITIES LOCATED IN CONSHOHOCKEN, PENNSYLVANIA

8243

II

10/11/1989

TAKEDA GMBH

PANTOPRAZOLE SODIUM SESQUIHYDRATE

8244

10/12/1989

FACILITIES LOCATED IN SINGEN AND KONSTANZ, GERMANY

8245

10/10/1989

BYK GULDEN LOMBERG CHEMISCHE FABRIK


GMBH
GREENWICH PHARMACEUTICALS INC

8246

III

10/16/1989

MITSUBISHI PLASTICS INC

VINYFOIL RIGID PVC CALENDERED FILM AS MFG. IN TOKYO, JAPAN

8247

II

10/17/1989

DSM PHARMA CHEMICALS NETHERLANDS BV

3-T-BUTYLAMINO-1,2-PROPANEDIOL AS MFG. IN VENLO, NETHERLANDS

8248

III

10/12/1989

CKS PACKAGING

EXTRUSION BLOWN PLASTIC BOTTLES AS MFG. IN NAUGATUCK, CT.

8249

II

10/12/1989

SMITH KLINE CONSUMER PRODUCTS

BANDING OF PSEUDOEPHEDRINE HCL AND CHLORPHENIRAMINE MALEATE

8250

IV

10/11/1989

HENRY H OTTENS MANUFACTURING CO INC

NATURAL/ARTIFICIAL CHERRY MINT FLAVOR #5073A - PHILA., PA.

8251

III

10/9/1989

GRAFCO

PET PLASTIC CONTAINERS AS MFG. IN JONESBORO, GEORGIA

8252

II

10/3/1989

SEPRACOR INC

QMA SPHEROSIL M/LS AS MFG. IN VILLENEUVE-LA-GARENNE, FRANCE

8253

II

10/19/1989

BACHEM FINE CHEMICALS INC

GLUCAGON (1-29), HUMAN HCL SALT - TORRANCE AND SAN DIEGO, CA.

8254

10/20/1989

BAYER AG

FACILITY AND OPERATING PROCEDURES IN DORMAGEN, GERMANY

8255

II

10/17/1989

PROFARMACO SRL

ETHYL ESTER 3-(2-CHLORO-4,5-DIFLUOROPHENYL)-3-OXO PROPIONIC

8256

10/17/1989

EASTMAN CHEMICAL CO

8257

IV

10/12/1989

LIPOID KG

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN ROCHESTER, NEW YORK.
LIPOID PG 18:0/18:0-L-A-DISTEAROYLPHOSPHATIDYLGLYCEROL-NA

8258

II

10/20/1989

WYCKOFF CHEMICAL CO INC

PROBUCOL AS MFG. IN SOUTH HAVEN, MICHIGAN

8259

II

10/17/1989

NIACIN AS MFG. IN ANTWERPEN, BELGIUM

8260

III

10/16/1989

VERTELLUS AGRICULTURE NUTRITION


SPECIALTIES LLC
ANCHOR HOCKING PACKAGING

8261

II

10/12/1989

ARCHIMICA SPA

2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER (SOL.) - VARESE,ITALY

8262

II

10/12/1989

ARCHIMICA SPA

2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER -VARESE, ITALY

8263

II

10/27/1989

ANDRULIS PHARMACEUTICALS CORP

THALIDOMIDE AS MFG. IN BELTSVILLE, MARYLAND

FACILITIES LOCATED IN HORSHAM, PENNSYLVANIA

CONTINUOUS THREAD METAL CLOSURES MANUFACTURED IN GLASSBORO, NEW JERSEY.

Page 229

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8264 I
II
11/22/1989
SIPSY SNC

SUBJECT
HYDROCORTISONE-17-BUTYRATE AS MFG. IN AVRILLE, FRANCE

8265

II

10/27/1989

AMERSHAM CORP

SODIUM IOTHALAMATE I-125 INJECTION AS MFG. IN AMERSHAM, UK

8266

II

10/17/1989

RHONE-POULENC SANTE

NICERGOLINE AS MFG. IN VITRY SUR SEINE, CEDEX, FRANCE

8267

10/25/1989

GRAIN PROCESSING CORP

FACILITY FOR WATER LOCK(R) SUPERABSORBENT POLYMERS IN IOWA

8268

10/31/1989

TOKYO KASEI KOGYO CO LTD

8269

II

10/27/1989

TIANJIN PHARMACEUTICAL PLANT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FUKAYA, JAPAN.
HYDROCORTISONE AS MFG. IN TIANJIN, CHINA

8270

II

10/31/1989

TOKYO KASEI KOGYO CO LTD

2,7-DIFLUORO-5-METHOXYSPIRO(9H-FLUORENE-9,4'-IMIDAZOLIDINE

8271

III

10/2/1989

CALIGEN FOAM LTD

POLYESTER POLYURETHANE FOAM 5100A MFG. IN LANCASHIRE, UK

8272

II

10/24/1989

CHEMI SPA

OXIRACETAM AS MFG. IN FORSINONE, ITALY

8273

10/27/1989

EISAI CO LTD

FACILITY IN GIFU-KEN, JAPAN FOR THE MFG. OF E3810 DRUG PRODUCT

8274

10/27/1989

EISAI CO LTD

FACILITY IN IBARAKI-KEN, JAPAN MFG. OF E3810 DRUG SUBSTANCE

8275

III

10/26/1989

KEY INTERNATIONAL INC

POLYETHYLENE FILM AS MFG. IN ENGLISHTOWN, NEW JERSEY

8276

III

10/23/1989

SCHUBERT SEALS A/S

RUBBER COMPOUND 6374B2 AS MFG. IN HORSENS, DENMARK

8277

II

10/31/1989

SUMIKA FINE CHEMICALS CO LTD

MESORIDAZINE BESYLATE AS MFG. IN GIFU, ANPACHIGUN, JAPAN

8278

II

10/3/1989

FREEDOM CHEMICAL DIAMALT GMBH

6-PROPYL-2-THIOURACIL AS MFG. IN MUNICH, GERMANY

8279

II

11/2/1989

ABBOTT PHARMS INC

FENTANYL CITRATE AS MFG. IN CHICAGO, ILLINOIS

8280

II

11/2/1989

AVATAR CORP

WHITE MINERAL OIL AS MFG. IN HICKORY HILLS, ILLINOIS

8281

II

11/2/1989

MALLINCKRODT BAKER INC

SODIUM FLUORIDE AS MFG. IN PHILLIPSBURG, NEW JERSEY

8282

II

10/24/1989

AMINO GMBH

L-TRYPTOPHAN AS MFG. IN HELMSTEDT, GERMANY

8283

II

11/6/1989

PENINSULA LABS

HISTIDINYL-31-GLYCINE AS MFG. IN BELMONT, CALIFORNIA

8284

11/10/1989

THERATECH INC

FACILITY LOCATED IN SALT LAKE CITY, UTAH

8285

II

11/15/1989

MEDICHEM SA

KETOPROFEN AS MFG. IN GERONA, SPAIN

8286

II

11/14/1989

ZAMBON SPA

PROBUCOL USP AS MFG. IN VIA DOVARO, ITALY

8287

III

11/17/1989

SPA SAFTA

POLYESTER, ALUMINUM FOIL , POLYETHYLENE AS MFG. IN ITALY

8288

II

11/17/1989

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

RANITIDINE HCL AS MANUFACTURED IN BARCELONA SPAIN

8289

11/17/1989

SIMIREX INC

8290

II

11/15/1989

GUANGDONG PHARMACEUTICAL FACTORY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MT. LAUREL, NEW JERSEY.
SULFADIAZINE AND SULFADIAZINE SODIUM AS MFG. IN CHINA

8291

II

11/24/1989

MEDICHEM SA

GUANABENZ ACETATE AS MFG. IN GERONA, SPAIN

8292

II

11/16/1989

LEK PHARMACEUTICAL & CHEMICAL WORKS

AURANOFIN AS MFG. IN LJUBLJANA, YUGOSLAVIA

8293

11/21/1989

DR MADAUS GMBH

8294

II

11/16/1989

CHEMAPOL LTD

NON-PRODUCT SPECIFIC DOCUMENTATION FOR STERILIZATION PROCESS VALIDATION


APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS
SULFAMETHAZINE AS MFG. IN USTI AND LABEM, CZECHOSLOVAKIA

8295

II

11/10/1989

CHEMAPOL LTD

SULFANILAMIDE AS MFG. IN USTI AND LABEM, CZECHOSLOVAKIA

8296

II

11/14/1989

TEVA PHARMACEUTICAL INDUSTRIES LTD

CARBIDOPA AS MFG. BY ASSIA LTD. IN PETAH-TIQVA ISRAEL

8297

II

11/13/1989

RECORDATI INDUSTRIA CHIMICA SPA

MEBEVERINE HYDROCHLORIDE AS MFG. IN MILANO, ITALY

8298

II

11/17/1989

TEVA WOMENS HEALTH INC

COPPER T MODEL TCU 380A INTRAUTERINE CONTRACEPTIVE -NEW YORK

8299

III

11/27/1989

TICONA LLC

RITEFLEX POLYESTER ELASTOMER AS MFG. IN SHELBY, N. CAROLINA

8300

III

10/1/1989

ROSSENDALE COMBINING CO LTD

POLYETHYLENE FILM FOAM LAMINATE AS MFG. IN LANCS, ENGLAND

Page 230

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8301 I
I
11/16/1989
GRIFFITH MICRO SCIENCE INC

SUBJECT
ETO STERILIZATION PROCESS IN WILLOWBROOK, ILLINOIS

8302

11/22/1989

SOUTHERN RESEARCH INSTITUTE

FACILITY LOCATED IN BIRMINGHAM, ALABAMA

8303

III

11/3/1989

HOFFMANN NEOPAC AG

LAMINATE COLLAPSIBLE TUBING AS MFG. IN OBERDIESSBACH, SWITZ.

8304

II

11/24/1989

BASF PHARMA EVIONNAZ SA

FELBAMATE (W-554) AS MFG. IN EVIONNAZ, SWITZERLAND

8305

II

11/17/1989

SEPRACOR INC

SP-SPHERODEX M/LS AS MFG. IN VILLENEUVE-LA-GARENNE, FRANCE

8306

12/4/1989

SANOFI CHIMIE

FACILITY LOCATED IN SISTERON, FRANCE

8307

II

12/4/1989

BIOCHEMICAL FACTORY NANJING UNIV

CHINESE CRUDE HMG AS MFG. IN NANJING, CHINA

8308

II

11/1/1989

LEO PHARMA AS

CALCIPOTRIOL DRUG SUBSTANCE AS MFG. IN BALLERUP, DENMARK

8309

II

11/10/1989

BOEHRINGER KNOLL LTD

PROPRANOLOL HYDROCHLORIDE AS MFG. IN THANE, INDIA

8310

II

11/27/1989

WHATMAN

WHAMAN DE52 (DIETHYLAMINOETHYL CELLULOSE) AS MFG-KENT, UK

8311

II

11/27/1989

ORGAMOL SA

PROPAFENONE HYDROCHLORIDE AS MFG. IN EVIONNAZ, SWITZERLAND

8312

II

11/27/1989

LEO PHARMA AS

CALCIPOTRIOL OINTMENT AS MFG. IN BALLERUP, DENMARK

8313

11/27/1989

LEO PHARMACEUTICAL PRODUCTS LTD

FACILITIES AND OPERATING PROCEDURES IN BALLERUP, DENMARK

8314

II

12/1/1989

LANZ LABORATORIES

LOPERAMIDE HYDROCHLORIDE AS MFG. IN MAHARASHTRA, INDIA

8315

12/7/1989

XYROFIN AG

FACILITIES AND OPERATING PROCEDURES AS MFG. IN KOTKA, FINLAND

8316

II

12/7/1989

XYROFIN AG

XYLITOL AS MFG. IN KOTKA, FINLAND

8317

II

12/1/1989

FINE ORGANICS LTD

N,N-DIMETHYLAMINOTHIOACETAMIDE HYDROCHLORIDE

8318

II

12/8/1989

FERMENTECH LIMITED

PROTEIN A AS MFG. IN EDINBURGH, SCOTLAND

8319

II

12/11/1989

MITSUBISHI CHEMICAL CORP

MCI-196 DRUG SUBSTANCE AS MFG. IN JAPAN

8320

III

12/7/1989

(FILE IS RETIRED)

ZELTUBE AS MFG. IN ZELL/MOSEL GERMANY

8321

II

12/5/1989

CUNO INC

ZETAFFINITY UNCOUPLED MEDIA MANUFACTURED IN MERIDEN, CONNECTICUT.

8322

11/27/1989

LEO PHARMACEUTICAL PRODUCTS LTD

FACILITIES AND OPERATING PROCEDURES AS MFG. IN DUBLIN, IRELAND

8323

6/11/1985

BRISTOL MYERS CO INTERNATIONAL DIV

FACILITIES LOCATED IN BARCELONETA, PUERTO RICO - PREVIOUSLY AN ANTIBIOTIC FILE

8324

II

12/18/1989

POLI INDUSTRIA CHIMA SPA

PENTOXIFYLLINE AS MFG. IN MILAN, ITALY

8325

IV

11/30/1989

AKZO NOBEL CHEMICALS BV

AKUCELL AF2781 AS MFG. IN ARNHEM, THE NETHERLANDS

8326

8327

IV

12/6/1989

SELTZER CHEMS INC

DL-LEUCINE FCC III AS MFG. IN CARLSBAD, CALIFORNIA

8328

II

12/13/1989

MACFARLAN SMITH LTD

MORPHINE SULFATE AS MFG. IN EDINBURGH, SCOTLAND

8329

II

12/12/1989

ROUSSEL-UCLAF

TRIAMCINOLONE HEXACETONIDE AS MFG. IN VERTOLAYE, FRANCE

8330

II

12/11/1989

CUNO INC

ZETA PLUS ZA MEDIA AND CARTRIDGES AS MFG. IN MERIDEN, CT

8331

IV

12/12/1989

INTERNATIONAL SPECIALTY PRODUCTS

GANEX V-216 AS MFG. IN LINDEN, NJ AND SPARTANBURG, SC

8332

12/19/1989

IOLAB PHARMACEUTICALS

FACILITIES AND OPERATING PROCEDURES IN SAN GERMAN, PUERTO RICO - BUILDING 2

8333

12/20/1989

FACILITIES AND OPERATING PROCEDURES IN CLERMONT-FERRAND,FRANCE

8334

II

12/19/1989

MERCK SHARP & DOHME LABS CHIBRET


RESEARCH CTR
ACF CHEMIEFARMA NV

8335

II

12/9/1989

FARMABOIS

HALCINONIDE AS MFG. IN PAVIA, ITALY

8336

II

12/9/1989

FARMABIOS S P A

CLOBETHASOL-17-PROPIONATE AS MFG. IN PAVIA, ITALY

8337

12/18/1989

COURTAULDS CHEMS

FACILITIES AND OPERATING PROCEDURES IN MANCHESTER, ENGLAND

8338

II

12/18/1989

COURTAULDS CHEMS

N,N-DIAMETHYLAMINOTHIOACETAMIDE HCL - MANCHESTER, ENGLAND

NOT AN ASSIGNED NUMBER

SULFADIAZINE SODIUM AS MFG. IN MAARSSEN, HOLLAND

Page 231

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8339 I
II
12/19/1989
PENNISULA LABORATORIES INC

SUBJECT
DYNORPHIN A 1-10 AMIDE AS MFG. IN BELMONT, CALIFORNIA

8340

III

12/7/1989

SOLVAY & CIE SA

(HDPE) ELTEX B 5920 UM AS MFG. IN SARRALBE, FRANCE

8341

12/14/1989

IONISOS

FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION IN DAGNEUX FRANCE

8342

II

12/21/1989

NORDION INT INC

YTTRIUM 90 AS REVIALLED IN ONTARIO, CANADA

8343

II

12/21/1989

PHYSOSTIGMINE SALICYLATE AS MFG. IN BASLE, SWITZERLAND

8344

III

11/30/1989

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
BESPAK PLC

8345

II

12/14/1989

1ST SOUTHWEST PHARMACEUTICAL FACTORY

CIMETIDINE AS MFG. IN XINAN, CHINA

8346

III

12/26/1989

SEITZ FILTER WERKE

SUPRADISC (R) DEPTH FILTER MODULES, BAD KREUZNACH, FRG

8347

II

12/15/1989

NEPERA INC

ESTROPIPATE AS MFG. IN HARRIMAN, NY

8348

II

11/10/1989

NEORX INC

RHENIUM RE 186 AS MFG. IN SEATTLE, WA AND COLUMBIA, MO

8349

II

12/29/1989

CHLORHEXIDINE BASE AS MFG. IN ZAGREB, CROATIA

8350

III

12/31/1989

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
ADVANCED MONOBLOC INC

8351

III

12/15/1989

AMPACET CORP

11147 CAMEL WHITE PEMB AS MFG. IN MOUNT VERNON, NY

8352

II

11/19/1989

NOBEL CHEMS SPA

KETOPROFEN AS MFG. IN MILAN, ITALY

8353

II

12/26/1989

SUMIKA FINE CHEMICALS CO LTD

PIROXICAM AS MFG. IN OSAKA AND GIFU PREFECTURE, JAPAN

8354

III

12/14/1989

AMPACET CORP

11078 WHITE PEMB AS MFG. IN MOUNT VERNON, NY

8355

II

12/29/1989

BACHEM FEINCHEMIKALIEN AG

THYMORALIN AS MFG. IN BUBENDORF, SWITZERLAND

8356

III

12/20/1989

CELANESE EVA PERFORMANCE POLYMERS

AT 1070 AND 1070C AS MFG. IN ONTARIO AND ALBERTA, CANADA

8357

II

8/21/1989

DIOSYNTH BV

MIRTAZAPINE AS MFG. IN OSS, THE NETHERLANDS

8358

12/22/1989

MERRELL DOW PHARMS CANADA INC

FACILITIES AND OPERATING PROCEDURES IN ONTARIO, CANADA

8359

12/28/1989

TROPONWERKE GMBH CO KG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

8360

12/28/1989

WYETH AYERST RESEARCH

FACILITIES AND OPERATING PROCEDURES IN QUEBEC, CANADA

8361

II

12/27/1989

SQUIBB MARK DIV ER SQUIBB & SONS INC

HYDROXYUREA LYOPHILIZED POWDER AS MFG. IN NEW BRUNSWICK, NJ

8362

III

11/13/1989

IRONWOOD INDUSTRIES

JAYCAPS AS MFG. IN LIBERTYVILLE, ILLINOIS

8363

II

12/18/1989

CHLORHEXIDINE GLUCONATE SOLUTION AS MFG. IN ZAGREB, CROATIA

8364

II

12/29/1989

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
PHARMACOSMOS AS

8365

II

3/28/1989

HYBRITECH INC

YTTRIUM-90 CHLORIDE AS MFG. IN SAN DIEGO, CALIFORNIA

8366

12/21/1989

RISDON PHARMA

8367

12/22/1989

LABORATOIRE PEROUSE STERILISATION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DIEPPE, FRANCE.
FACILITIES LOCATED IN RANTIGNY, FRANCE

8368

II

12/19/1989

VIATRIS GMBH AND COMPANY KG

AZELASTINE HCL AS MFG. IN VARIOUS LOCATIONS IN GERMANY

8369

II

1/11/1990

QUIMICA SINTETICA SA

TERFENADINE AS MFG. IN MADRID, SPAIN

8370

II

1/11/1990

KNOLL PHARMA CHEMICALS

FLOSEQUINAN AS MFG. IN NEWCASTLE-UPON-TYNE AND NOTTINGHAM, UK

8371

II

12/25/1989

TAISHO PHARMACEUTICAL CO LTD

HYDROCORTISONE BUTEPRATE AS MFG. IN OHMIYA-SHI, JAPAN

8372

II

11/22/1989

AZIENDE CHIMICHE RIUNITE

ETOPERIDONE HYDROCHLORIDE AS MFG. IN APRILIA, ITALY

8373

II

1/11/1990

KYOWA HAKKO KOGYO CO LTD

SODIUM HYALURONATE AS MFG. IN THE HOFU PLANT

TIMPILO VIAL SUB-ASSEMBLY IN NORFOLK, UK

EIANLAKK IA-1001A MANUFACTURED IN HERMITAGE, PENNSYLVANIA AND ONTARIO, CANADA.

IRON DEXTRAN POWDER AS MANUFACTURED IN VIBY SJ., DENMARK

Page 232

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8374 I
I
1/15/1990
MEDISOL LABORATORIES INC

SUBJECT
FACILITIES LOCATED IN EAST HANOVER, NJ

8375

II

1/16/1990

DAINIPPON PHARMACEUTICAL CO LTD

A-4140 AS MFG. IN OSAKA, JAPAN

8376

III

1/26/1990

FERRO CORP

THERMOPLASTIC COMPOUNDS AS MFG IN HOUSTON, TEXAS

8377

II

1/15/1990

ROCHE DIAGNOSTICS GMBH

PROPYLTHIOURACIL, AS MFG. IN MANNHEIM, GERMANY

8378

II

1/12/1990

SALK INST BIOLOGICAL STUDIES

ANITIDE AS MFG. IN SAN DIEGO, CA.

8379

II

1/19/1990

EVONIK TECHNOCHEMIE GMBH

CHLORHEXIDINE GLUCONATE AS MFG. IN HANAU, GERMANY

8380

II

1/22/1990

MALLINCKRODT INC

SODIUM PERRHENATE RE 186 INJECTION, MARYLAND HEIGHTS, MO

8381

II

11/23/1989

SIFAVITOR SRL

PROTRIPTYLINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY

8382

II

1/24/1990

MARION MERRELL DOW INC

SUDAFED 12-HOUR CAPSULES AS MFG. IN KANSAS CITY, MO

8383

II

1/22/1990

STOLLE RES & DEV CORP

90 DAY PROGESTERONE AS MFG. IN CINCINNATI, OH

8384

IV

1/23/1990

SEPPIC DIV AIR LIQUIDE

SEPIFILM 752 AS MFG. IN CASTRES, FRANCE

8385

IV

1/23/1990

SEPPIC DIV AIR LIQUIDE

SEPIFILM 003 AS MFG. IN CASTRES, FRANCE

8386

1/18/1990

CLINICAL PACKAGING SERVICES INC

FACILITIES AND OPERATING PROCEDURES IN WATERBURY, CT

8387

II

1/23/1990

SHANGHAI NO 2 PHARMACEUTICAL FACTORY

SULFATHIAZOLE AS MFG. IN SHANGHAI, CHINA

8388

II

1/22/1990

DSM PHARMA CHEMICALS SOUTH HAVEN INC

NORTRIPTYLINE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

8389

II

1/18/1990

PFANSTIEHL LABORATORIES INC

AURANOFIN AS MFG. IN WAUKEGAN, IL

8390

II

1/19/1990

THERAKOS INC

UVADEX (METHOXSALEN), STERILE SOLUTION, NUTLEY, NJ

8391

II

1/25/1990

PAREKH CHEMICALS ITALIA SPA

CEFADROXIL AS MFG IN BORGO SAN GIOVANNI (MI) ITALIA

8392

1/25/1990

PAREKH CHEMICALS ITALIA SPA

FACILITIES IN BORGO SAN GIOVANNI, MILAN, ITALY

8393

II

1/15/1990

ORGAMOL SA

ESERINE BASE AND SALICYLATE AS MFG. IN EVIONNAZ, SWITZERLAND

8394

III

1/4/1990

AMPACET CORP

11585 WHITE MANUFACTURED IN DERIDDER, LOUISIANA.

8395

III

1/4/1990

AMPACET CORP

11560 WHITE AS MFG. IN TERRE HAUTE, IN

8396

II

1/26/1990

POLYPEPTIDE LABORATORIES SWEDEN AB

DESMOPRESSIN AS MFG. IN MALMO, SWEDEN

8397

III

1/15/1990

VETREIA PARMENSE BROMIOLI ROCCO SPA

GLASS CONTAINERS AS MFG, PARMA AND BERGANTINO, ITALY

8398

II

1/25/1990

CILAG AG

TERFENADINE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

8399

III

1/26/1990

EXXEL CONTAINER LP

PACKAGING MATERIALS AS MFG. IN SOMERSET, N.J.

8400

II

1/26/1990

INFAR INDIA LTD

VINCRISTINE SULPHATE (USP) AS MFG. IN WEST BENGAL, INDIA

8401

1/26/1990

INFAR INDIA LTD

FACILITIES AND OPERATING PROCEDURES AS MFG IN W. BENGAL, INDIA

8402

III

1/30/1990

ALFA CHEMICALS ITALIANA SRL

NAPROXEN AS MFG. IN BOLOGNA, ITALY

8403

IV

1/27/1990

NOF CORP

(DPPC) AS MFG. IN HYOGO, JAPAN

8404

1/24/1990

KORSCH PROCESSING LABORATORIES INC

FACILITIES AND OPERATING PROCEDURES AS MFG IN SOMERVILLE, N.J.

8405

II

1/25/1990

KYOWA HAKKO KOGYO CO LTD

AICA-RIBOSIDE AS MFG. IN HOFU CITY, JAPAN

8406

II

1/30/1990

NANTONG GENERAL PHARMACEUTICAL FACTORY

PRIMIDONE USP XXII; AS MFG. IN PEOPLES REPUBLIC OF CHINA

8407

2/2/1990

LABORATORIES PFIZER LIMITADA

8408

1/29/1990

PLIVA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SSAO PAULO, BRAZIL.
FACILITY FOR AZITHROMYCIN DIHYDRATE MFG. IN ZAGREB, CROATIA

8409

1/11/1990

PYMAH CORP ATI DIV

FACILITIES FOR MFG. STERILIZATION PROCESS INDICATORS

8410

III

2/6/1990

PURELL PE 1840 H AS MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

8411

III

9/17/1989

BASELL POLIOLEFINE ITALIA SRL SUB


LYONDELLBASELL
BASF AKTIENGESELLSCHAFT

LUPOLEN 1810 H AS MFG. IN WESSELING, GERMANY

Page 233

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8412 A
III
9/17/1989
BASELL POLYOLEFINE ITALIA SRL

SUBJECT
PURELL PE 1810 E

8413

III

9/17/1989

BASELL POLIOLEFINE ITALIA SRL

PURELL PE 3020 D

8414

IV

1/27/1990

NIPPON OIL & FATS CO LTD

DISTEAROYL PHOSPHATIDYL CHOLINE AS MFG. IN HYOGO, JAPAN

8415

II

2/6/1990

CIPLA LTD

NORFLOXACIN AS MFG. IN BANGALORE, INDIA

8416

II

2/1/1990

KETOPROFEN USP XXII AS MFG IN REPUBLIC OF CHINA

8417

II

1/30/1990

SOUTHWEST SYNTHETIC PHARMACEUTICAL


FACTORY
QUIMICA SINTETICA SA

8418

1/31/1990

WYETH PHARMA

FACILITIES AND OPERATING PROCEDURES IN MUENSTER, GERMANY

8419

2/5/1990

ZAMBON SPA

8420

IV

1/31/1990

PACO RESEARCH CORP

MANUFACTURINGS SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN VICENZA, ITALY.
GELATIN BASED OPTHALMIC VEHICLE AS MFG. IN LAKEWOOD, NJ

8421

II

2/6/1990

HOECHST MARION ROUSSEL SA

METOLAZONE AS MFG. IN VERTOLAYE, FRANCE

8422

III

2/1/1990

KOA GLASS CO LTD

PARENTERAL AND NON PARENTERAL FLINT GLASS CONTAINERS

8423

II

2/2/1990

SCHERING AG

NOCLOPROST BETA-CYCLODEXTRIN CLAHRATE MFG IN GERMANY

8424

II

1/1/1990

SIGMA F AND D DIV LTD

TRIOLEIN AS MFG. IN SAINT LOUIS, MO

8425

II

2/6/1990

SIGMA F AND D DIV LTD

3,3;5- TRIIODOTHYROACETIC ACID-PRODUCT NO. T7650FD

8426

II

2/1/1990

NV ORGANON

PIMOZIDE AS MFG. IN THE NETHERLANDS

8427

II

1/31/1990

BACHEM FEINCHEMIKALIEN AG

N-FMOC-L-LEUCINE AS MFG. IN SWITZERLAND

8428

2/6/1990

ROCHE QUIMICOS E FARMACEUTICOS SA

FACILITIES AND OPERATING PROCEDURES IN SAO PAULO, BRAZIL

8429

II

1/26/1990

FINORGA

8430

II

2/6/1990

ESTEVE QUIMICA SA

(-)-(R)-1,2,3,4,-TETRAHYDRO-6,7-DIMETHOXY-2-METHYL-1-(3,4,5-TRIMETHOXYBENZYL)
ISOQUINOLINE 2,3-DI-O-BENZOYL -L -TARTRATEAS MFG IN CHASSE-SUR-RHONE, FRANCE
METOPROLOL TATRATE AS MFG. IN BARCELONA, SPAIN

8431

II

2/6/1990

GUSMER ENTERPRISES INC

PHARMACEUTICAL GRADE FILTER MEDIA MFG. PROCEDURES

8432

III

2/21/1990

JSR LIFE SCIENCES CORP

SYNDIOTACTIC 1, 2 POLYBUTADIENE AS MFG. IN TOKYO

8433

II

2/14/1990

PHENYLALANINE-METHYLAMINOCYCLOL HCL AS MFG IN BASLE, SWITZ.

8434

2/13/1990

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
GENSIA PHARMACEUTICAL INC

8435

II

2/20/1990

QUIMICA SINTETICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN IRVINE, CALIFORNIA.
BUMETANIDE AS MFG. IN MADRID, SPAIN

8436

II

2/19/1990

ALFA WASSERMANN SPA

NAPROXEN SODIUM AS MFG. IN BOLOGNA, ITALY

8437

2/22/1990

PHARMAKAPSEL PRODUKTIONS GMBH & CO. KG

FACILITIES AND OPERATING PROCEDURES AS MFG. IN GERMANY

8438

II

2/5/1990

PURAC BIOCHEM BV

CALCIUM GLUCONATE AS MFG. IN TER APELKANAAL, THE NEDERLANDS

8439

II

2/21/1990

PENNISULA LABORATORIES INC

C- PEPTIDE ( 31 AMINO ACIDS) CODE # 7309 LOT # 020524

8440

III

2/19/1990

LOPAREX LLC

10917, S 80# SB SCK 4Z/000 MANUFACTURED IN IOWA CITY, IOWA.

8441

III

2/19/1990

LOPAREX INC

10625, S 44# NT KFT H/00 4D/000 MANUFACTURED IN IOWA CITY, IOWA.

8442

III

2/19/1990

LOPAREX LLC

11430 S 92# BL KFT L/L 4D/000 MANUFACTURED IN IOWA CITY, IOWA.

8443

II

2/28/1990

SUMIKA FINE CHEMICALS CO LTD

FLAVOXATE HYDROCHLORIDE AS MFG. IN GIFU PLANT, JAPAN

8444

II

10/20/1989

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

LEVODOPA AS MFG. IN BULCIAGO, ITALY

8445

III

4/27/1990

DOW CORNING CORP

SILASTIC MDF-0372 AND MDF-0373 MEDICAL GRADE TUBING -JAPAN

8446

II

2/26/1990

PENINSULA LABS

SUBSTANCE P CODE #7451 LOT #020973 AS MFG IN BELMONT, CA

8447

II

3/2/1990

RESOLUTION CHEMICALS LIMITED

BUMETAMIDE USP AS MFG IN THE UNITED KINGDOM

CIMETIDINE USP XXII AS MFG. IN SPAIN

Page 234

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8448 I
II
2/27/1990
BIOCHEMIC GESELLSCHAFT MBH

SUBJECT
AMPICILLIN ANHYDRATE AS MFG. IN KUNDL, AUSTRIA

8449

II

3/2/1990

ASAHI CHEM INDUSTRY CO LTD

PHOSPHATIDYLGLYCEROL AS MFG. IN MIYAZAKI-KEN, JAPAN

8450

2/15/1990

DEGUSSA AG

FACILITIES AND PROCEDURES FOR CHLORHEXIDINE AS MFG. IN KONSTANZ, GERMANY

8451

II

2/15/1990

DEGUSSA AG

CHLORHEXIDINE AS MFG. IN KONSTANZ,GERMANY

8452

2/28/1990

MERCK SA INDUSTRIA QUIMICAS

MFG. FACILITIES IN PARNAIBA-PD-BRAZIL

8453

II

3/2/1990

VEGEFLORA EXTRACOES DO NORDESTE LTDA

PILOCARPINE HYDROCHLORIDE AS MFG. IN PARNAIBA, BRAZIL

8454

2/28/1990

GRIFFITH MICRO SCI LTD

ETO STERILIZATION MFG. IN BOUND BROOK, NEW JERSEY

8455

II

2/15/1990

GANES CHEMICALS INC

TERFENADINE AS MFG. IN CARLSTADT, NEW JERSEY

8456

III

3/7/1990

THOROUGHBRED PLASTICS CORP

POLYETHYLENE TEREPHTHALATE MFG. IN LOUISVILLE, KENTUCKY

8457

II

3/2/1990

EASTMAN KODAK CO

FURIL DIOXIME AS MFG. IN ROCHESTER, NY

8458

II

2/28/1990

PENINSULA LABS

DERMORPHIN CODE #8801, LOT # 020746 AS MFG IN BELMONT, CA

8459

II

2/27/1990

NOBEL CHEMS SPA

FLUNISOLIDE AS MFG. IN MILAN, ITALY

8460

II

3/5/1990

QUIMICA SINTETICA SA

CAPTOPRIL AS MFG. IN MADRID SPAIN

8461

3/5/1990

JANSSEN PHARMACEUTICA INC

FACILITIES FOR PARENTERAL FACILITY AS MFG. FORT WASHINGTON, PA

8462

II

2/22/1990

WACKER CHEMIE GMBH

1,3-DICHLOROACETONE AS MFG. IN BURGHAUSEN,GERMANY

8463

IV

3/5/1990

LIPOID GMBH

L-A-DIMYRISTOYLPHOSPHATIDYLGLYCEROL-NA AS MFG. GERMANY

8464

III

3/8/1990

TICONA LLC

VECTRA LIQUID CRYSTAL POLYMERS AS MFG. IN SHELBY, NC

8465

II

2/23/1990

IG SPRUHTECHNIK GMBH

ALBUTEROL INHALER 90 MCG. AS MFG. IN GERMANY

8466

II

3/12/1990

SYNTHELABO BP

L-LYSINE ALPHA KETO BETA METHYLVALERATE - MONTARGIS CEDEX,FR

8467

II

3/12/1990

SYNTHELABO BP

L-ORNITHINE ALPHA KETO ISOCAPROATE AS MFG. IN MONTARGIS, FR.

8468

II

3/12/1990

SYNTHELABO BP

DL-LYSINE ACETYLSALICYLATE MFG. IN MONTARGIS CEDEX, FRANCE

8469

II

2/14/1990

BROCADES PHARMA BV DIV YAMANOUCHI GROUP DRIED BISMUTHSUBCITRATE SOL AS MFG. IN THE NETHERLANDS

8470

3/8/1990

BIOCHEMIC GESELLSCHAFT MBH

CYCLOSPORIN RECOVERY PLANT AS MFG. IN KUNDL, TYROL AUSTRIA

8471

II

3/21/1990

SUMIKA FINE CHEMICALS CO LTD

MICONAZOLE NITRATE AS MFG IN GIFU PERFECTURE AND OSAKA, JAPAN

8472

II

3/12/1990

SUMIKA FINE CHEMICALS CO LTD

SULINDAC AS MFG. IN GIFU PERFECTURE AND OSAKA, JAPAN

8473

II

3/15/1990

SAFC BIOSCIENCES INC

93% DME (HG)/5% NCTC (CAT. NO. 52-589) AS MFG. IN DENVER, PA

8474

II

3/15/1990

SAFC BIOSCIENCES INC

BIOTAIN-MPS TM CONCENTRATE (100X) AS MFG. IN LENEXA, KS

8475

II

3/15/1990

SAFC BIOSCIENCES INC

DMS-12 (100X) CONCENTRATE AS MFG. IN LENEXA, KS

8476

3/20/1990

BIOKEN SEPARATIONS INC

MFG. OF ULTRAFILTRATION MEMBRANE CARTRIDGES IN NORWOOD, MASS

8477

3/20/1990

CURRICULUM VITAE OF THE PEDIATRIC INVESTIGATORS FOR AIDS (CTG)

8478

II

3/16/1990

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY INFECTIOUS DISEASES
EXPANSIA

8479

3/9/1990

PFIZER PHARMS INC

FACILITY IN NAGOYA, JAPAN

8480

II

3/14/1990

PENNISULA LABORATORIES INC

ANGIOTENSIN II AS MFG. IN BELMONT, CA

8481

IV

3/15/1990

ALKERMES INC

MEDISORB AS MANUFACTURED IN CINCINNATI, OHIO

8482

II

3/13/1990

MALLINCKRODT INC

D-PROPOXYPHENE NAPSYLATE USP CRYSTALS AS MANUFACTURED IN MO.

8483

III

3/14/1990

SPARTECH PLASTICS

H-S-LD AS MFG. IN PORTAGE, WISCONSIN

8484

II

3/20/1990

MALLINCKRODT BAKER INC

PEI BONDED PHASE SILICA GEL AS MFG. IN PHILIPSBURG, N.J.

8485

3/22/1990

MARSAM PHARMACEUTICALS INC

FACILITIES FOR STERILE FILLING OPERATION IN CHERRY HILL, NJ.

5-METHYL-2-(2-THIAZOLYLAMINO) PHENOL MONOHYDROCHLORIDE

Page 235

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8486 I
II
3/19/1990
INTEROX CHEMICALS LTD

SUBJECT
MMPP AS MFG. IN CHESHIRE, ENGLAND

8487

II

3/22/1990

ABBOTT LABS

HYROCHLOROQUINE SULFATE AS MFG. IN NORTH CHICAGO, IL

8488

3/19/1990

BIOPRODUCTS FOR SCIENCE INC

8489

II

3/28/1990

ASTELLAS PHARMA INC

MANUFACTURING SITE, FACILITY, PERSONEL AND OPREAING PROCEDURES IN MADISON,


WISCONSIN
CEPHALOSPORIN (ORAL) (FK482 CEFDINIR, CI-983) MANUFACTURED IN JAPAN.

8490

II

3/20/1990

QUIMICA SINTETICA SA

NORFLOXACIN USP XXII AS MFG. IN SPAIN

8491

II

3/23/1990

EASTMAN KODAK CO

CIS-4-METHOXYCYCLOHEXYL P-TOLUNESSULFONATE AS MFG. IN N.Y.

8492

II

3/20/1990

BASF AKTIENGESELLSCHAFT

N-[1-(5,6,7,8-TETRAHYDRO-5,5,8,8-TETRAMETHYL 2-NAPHTHALENYL)

8493

4/2/1990

AVTECH LABS

FACILITIES AND PROCEDURES IN KALAMAZOO, MICHIGAN

8494

II

3/27/1990

QUIMICA SINTETICA S A

RANITIDINE HYDROCHLORIDE MFG. IN MADRID, SPAIN

8495

II

3/27/1990

SIBEFAT SPA

LABETALOL HYDROCHLORIDE AS MFG. IN MILAN, ITALY

8496

II

3/29/1990

EURAND AMERICA INC

DIFFUTAB SIMETRY BASE AS MFG. IN VANDALIA, OHIO

8497

III

3/26/1990

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5001-60 GRAY MFG.-SALISBURY, MD.

8498

II

3/26/1990

BORON BIOLOGICALS INC

10B-ENRICHED D,L-P-BORONO-PHENYLALANINE MFG. IN PITTSBURGH,PA

8499

3/23/1990

ELF ATOCHEM

FACILITIES AND PROCEDURES IN PIERRE BENITE AND JARRIE, FRANCE

8500

3/28/1990

DAIICHI PHARMACEUTICAL CO LTD

8501

3/28/1990

ESTEVE QUIMICA SA

8502

II

4/2/1990

PAREKH CHEMICALS ITALIA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EDOGAWA-KU, TOKYO, JAPAN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BARCELONA, SPAIN.
CEFOPERAZONE ACID MANUFACTURED IN MILAN, ITALY.

8503

II

3/23/1990

ATOCHEM

PERFLUOROOCTYLBROMIDE C8F17BR MANUFACTURED IN PIERRE BENITE AND JARRIE.

8504

3/28/1990

DAIICHI PHARMACEUTICAL CO

8505

III

3/23/1990

FERRO CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EDOGAWA-KU, TOKYO, JAPAN.
THERMAL PLASTIC COMPOUNDS MANUFACTURED IN HOUSTON, TEXAS.

8506

3/23/1990

DIMENSIONAL MERCHANDISING INC

8507

II

3/30/1990

TASMANIAN ALKALOIDS PROPRIETARY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEST CALDWELL, NEW JERSEY.
NALMEFENE HYDROCHLORIDE MANUFACTURED IN TASMANIA, AUSTRALIA.

8508

II

4/5/1990

DIOSYNTH BV

2'-DEOXY-5-AZACYTIDINE MANUFACTURED IN OSS, THE NETHERLANDS.

8509

II

4/4/1990

BACHEM AMERICAS INC

PARATHYROID HORMONE (1-34) HUMAN AS MANUFACTURED IN TORRANCE, CA.

8510

II

4/4/1990

BRANTFORD CHEMICALS INC

ASTEMIZOLE MANUFACTURED IN ONTARIO, CANADA.

8511

IV

4/5/1990

CIMA LABORATORIES INC

EXCIPIENT COMPONENTS MANUFACTURED IN MINNEAPOLIS, MINNESOTA.

8512

II

4/2/1990

BORON BIOLOGICALS INC

10B-ENRICHED L-P-BORONO-PHENYLALANINE MFG. IN PITTSBURGH, PA.

8513

II

4/5/1990

JOHNSON MATTHEY INC

FENTANYL CITRATE AS MFG. IN WEST DEPTFORD, NEW JERSEY

8514

III

3/30/1990

PLASTIPAK PACKAGING

PET PLASTIC CONTAINERS AS MFG. IN PLYMOUTH, MICHIGAN

8515

IV

4/5/1990

ORION CORP FARMOS CHEMICAL PLANT

1,2-DIPALMITOYL-SN-GLYCEROL-3-PHOSPHORYLCHOLINE (DPPC),

8516

III

3/28/1990

EXXONMOBIL CHEMICAL CO

8517

II

4/5/1990

QUIMICA SINTETICA SA

BROMINATED ISOBUBATON ROUGE, LOUISIANA, KASHIMA-GUN IBARAKI-KEN, JAPAN,


SOUTHHAMPTON, ENGLAND, BAYTOWN, TEXASTYLENE - ISOPRENE RUBBER IN
CIPROFLOXACIN HYDROCHLORIDE MFG. IN MADRID, SPAIN

8518

III

4/3/1990

FPC FLEXIBLE PACKAGING CORP

PACKAGING MATERIAL MFG. IN SCARBOROUGH, CANADA

8519

II

4/4/1990

SOL PHARMACEUTICALS LIMITED

ALBUTEROL BASE MFG. IN ANDHRA PRADESH, INDIA

8520

III

3/27/1990

EXXON CHEMICAL CO

PACKAGING MATERIAL XPP-323 AND XPP-626 MANUFACTURED IN MARLIN, PENNSYLVANIA.

Page 236

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8521 I
IV
4/9/1990
HENRY H OTTENS MANUFACTURING CO INC

SUBJECT
ARTIFICIAL SWEET CHERRY FLAVOR #5244 IN PHILADELPHIA, PA

8522

IV

4/9/1990

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICAL SWEET CHERRY FLAVOR #5243

8523

II

3/30/1990

FINE CHEMICALS CORP LTD

AZAADINE MALEATE

8524

II

4/10/1990

DYNAMIT NOBEL GMBH

NITROGLYCERIN MFG. IN LEVERKUSEN, GERMANY

8525

II

4/10/1990

FREEDOM CHEMICAL DIAMALT GMBH

DIETHYLENETRIAMINEPENTAACETIC ACID MFG. IN MUNICH, GERMANY

8526

II

4/16/1990

LEO PHARMACEUTICAL PRODUCTS LTD

FUSIDIC ACID AS MFG. IN BALLERUP, DENMARK

8527

II

4/16/1990

LEO PHARMACEUTICAL PRODUCTS LTD

SODIUM FUSIDATE MFG. IN BALLERUP, DENMARK

8528

II

4/16/1990

LEO PHARMACEUTICAL PRODUCTS LTD

FUCIDIN CREAM MFG. IN DUBLIN, IRELAND

8529

II

4/16/1990

LEO PHARMACEUTICAL PRODUCTS LTD

FUCIDIN OINTMENT MFG. IN DUBLIN, IRELAND

8530

3/23/1990

BANN LABS INC

FACILITIES AND PROCEDURES IN RAHWAY, NEW JERSEY

8531

II

4/17/1990

FINE ORGANICS LTD

1,3-DICHLOROACETONE AS MFG. IN MIDDLEBROUGH CLEVELAND,ENGLAND

8532

4/17/1990

GLAXO WELLCOME INC

BUILDINGS AND FACILITIES IN SEALS SANDS, ENGLAND

8533

III

3/12/1990

ST GOBAIN DESJONQUERES SA SGD

GLASS CONTAINERS AS MFG IN COURBEVOIE, FRANCE

8534

4/12/1990

GLOBAL PHARMACEUTICALS INC

8535

II

4/12/1990

BILCHEM LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DON MILLS, ONTARIO, CANADA.
DEXTROMETHORPHAN HYDROBROMIDE USP AS MFG. IN PONCE, P.R.

8536

II

4/3/1990

IND ESQUIMEX SA KM 396 CARRETERA MEX

CIMETIDINE AS MFG IN ZACAPU, MICHOACAN, MEXICO

8537

II

4/17/1990

BIOSURFACE AB

DELMOPINOL HYDROCHLORIDE AS MFG. IN MALMO, SWEDEN

8538

II

4/26/1990

LOFTUS BRYAN CHEMICALS LTD

PHENIRAMINE MALEATE AS MFG RAHDRUM,COUNTY WICKLOW,IRELAND

8539

II

4/23/1990

BAYER SCHERING PHARMA AG

ACARBOSE MFG WUPPERTAL, GERMANY

8540

III

4/23/1990

SEITZ FILTER WERKE

SEITZ MEMBRACART (R) NYLON 66 MEMBRANE MFG. BAD KREUZNACH WG

8541

II

4/24/1990

YONEZAWA HAMARI CHEMICALS LTD

[(S)-1,2,3,4-TETRAHYDRO-3-ISO-QUINOLINECARBOXYLIC MFG JAPAN

8542

II

4/27/1990

DIOSYNTH BV

BUPRENORPHINE AS MFG AK APELDOORN HOLLAND

8543

II

4/11/1990

MEDGENIX GROUP

TIRARICOL 3,5,3 TRIIODOTHYROACETIC ACID MFG, MULHOUSE FRANCE

8544

4/20/1990

MANDEVILLE MEDICINES

8545

II

2/21/1990

IPCA LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AYLESBURY, ENGLAND.
TRIMETHOPRIM USP MFG.IN TATLAM,MADHYA PRADESH, INDIA

8546

II

3/2/1990

NATURAL-SOURCE VITAMIN E ASSOCIATION

8547

II

4/19/1990

LUSOCHIMICA S P A

NATURAL SOURCE VITAMIN E MANUFACTURED BY HENKEL CORP IN EXCELSIOR,


MINNESOTA, EISAI U.S.A., INC.
PINDOLOL MANUFACTURED IN MILANO, ITALY.

8548

II

5/1/1990

HAMARI COMPANY LTD

DILTIAZEM HYDROCHLORIDE MFG YONEZAWA JAPAN

8549

II

5/1/1990

NIPPON MEKTRON LTD

PERFLUOROOCTYLBROMIDE (PFOB), C8F17BR MANUFACTURED IN KITAIBARAKI, JAPAN.

8550

5/1/1990

NIPPON MEKTRON LTD

FACILITIES AND OPERATING PROCEDURES IN KAAIBARAK, JAPAN

8551

II

4/23/1990

KETOPROFEN MFG IN ZAGREB, CROATIA

8552

II

5/3/1990

PLIVA PHARMACEUTICAL CHEMICAL FOOD &


COSMETIC INDUSTRY
IMAGENTS INC

8553

II

5/2/1990

YAKULT HONSHA CO LTD

CPT-11 MFG IN CHIBA AND SHIZUOKA, JAPAN

8554

4/27/1990

8555

III

5/5/1990

SMITH KLINE & FRENCH LABS DIV SMITHKLINE


BECKMAN CORP
HELVOET PHARMA MARYLAND

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GERMANY.
RUBBER CLOSURE FORMULATION B-5300-50 GRAY MANUFACTURED IN MARYLAND.

8556

II

4/25/1990

FINE CHEMICALS CORPORATION

PERPHENAZINE MFG IN CAPE TOWN, SOUTH AFRICA

RADIOCHEMICAL GALLIUM CHLORIDE GA-67 MANUFACTURED IN HOUSTON, TEXAS.

Page 237

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8557 I
III
5/7/1990
COVALENCE COATED PRODUCTS

SUBJECT
PRODUCTS 41748-30 MFG IN COLUMBUS, GEORGIA

8558

III

4/30/1990

TREND PLASTICS

SINGLE -DOSE POLYETHYLENE CONTAINER MFG IN ALAMEDA, CA

8559

4/19/1990

ESQUIRE PHARMACEUTICAL

8560

II

3/17/1990

IPCA LABORATORIES PVT LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WESTMONT, ILLINOIS.
ERTHROMYCIN ESTOLATE MANUFACTURED IN BOMBAY, INDIA.

8561

4/27/1990

SURGICAL TECHNOLOGIES

8562

5/9/1990

ISOCHEM SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAINT PAUL, MINNESOTA.
FACILITIES AND OPERATING PROCEDURES IN GENNEVILLER, FRANCE

8563

II

5/7/1990

AJINOMOTO CO INC

CURDLAN SULFATE SODIUM INTRAVENOUS AS MFG. IN TOKYO, JAPAN

8564

II

5/14/1990

MITSUBISHI KASEI

CRUDE REPIRINAST (MY-5116) MANUFACTURED IN KUROSAKI, JAPAN.

8565

II

5/14/1990

DAIICHI PHARMACEUTICAL CO

DR-3355 BULK SUBSTANCE AS MFG IN TOKYO, JAPAN

8566

II

4/9/1990

FARMABOIS

FLUNISOLIDE AS MFG. IN GROPELLO CAIROLI, ITALY

8567

5/9/1990

BIOINDUSTRIA FARMACEUTICI SPA

8568

II

5/9/1990

EXXONMOBIL CHEMICAL COMPANY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FRESONARA, ITALY.
AMILORIDE AS MFG. IN NOVI LIGURE AND FRESONARA, ITALY

8569

III

5/14/1990

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B-5300-50 CREAM MFG SALISBURY,MD

8570

5/14/1990

SYNERGY HEALTH EDE BV

GAMMA IRRADIATION FACILITY LOCATED IN EDE, THE NETHERLANDS

8571

5/17/1990

RAPID SPRAY GMBH CO KG

FACILITY FOR THE MFG OF AEROSOL SPRAY CONTAINER IN WEST GERMAN

8572

II

4/10/1990

CELLIANCE A SEROLOGICALS CO

PENTEX BOVINE EXCYTE VLE GROWTH ENHANCEMENT MFG IN ILLINIOS

8573

II

5/11/1990

QUIMICA SINTETICA S A

CINOXACIN USP XXII AS MFG IN MADRID, SPAIN

8574

III

5/22/1990

TOKAI ALUMINUM FOIL CO LTD

ALUMINUM FOR PHARMACEUTICAL PACKING PTP MFG YOKOHAMA,JAPAN

8575

III

3/2/1990

TOKAI METALS CO LTD

E PL-11 FILM MFG. IN KANAGAWA, JAPAN

8576

5/21/1990

ORIL INDUSTRIE

FACILITIES AND OPERATING PROCEDURES IN BOLBEC, FRANCE

8577

II

5/21/1990

ORIL

INDAPAMIDE AS MFG. IN BOLBEC, FRANCE

8578

4/19/1990

UNITED COCONUT CHEMICALS

FACILITIES AND PROCEDURES IN MAKAI, N.M., PHILIPPINES

8579

II

5/22/1990

DOW CHEMICAL CO MICHIGAN DIV

POLYGLYCOL E-3350 NF MFG. IN FREEPORT, TEXAS

8580

II

5/11/1990

RASCHIG GMBH

BENZYLAMINOPYRIDINE AS MFG. IN RHEIN, GERMANY

8581

II

5/15/1990

GUANGDONG PHARMACEUTICAL FACTORY

INDOMETHACIN AS MFG. IN GUANGZHOU, THE REPUBLIC OF CHINA

8582

II

5/28/1990

DELMAR CHEMICALS INC

ETHAMBUTOL DIHYDROCHLORIDE MANUFACTURED IN CANADA.

8583

II

5/28/1990

PROSINTEX SPA

DICLOFENAC SODIUM AS MFG. IN VILLANTERIO, ITALY

8584

II

5/25/1990

QUIMICA SINTETICA SA

ACYCLOVIR AS MFG. IN MADRID, SPAIN

8585

II

5/29/1990

DAISO CO LTD

PINDOLOL MANUFACTURED IN MASUYAMA CITY, JAPAN.

8586

III

5/29/1990

EXXONMOBIL CHEMICAL CO

ISOBUTYLENE ISOPRENE RUBBER, EXXON CHEMICAL 065

8587

III

6/1/1990

NATIONAL STARCH & CHEMICAL CORP

28-4979 (DERMACYL-79) AS MFG. IN BRIDGEWATER, NEW JERSEY

8588

III

6/4/1990

PACKAGING MATERIALS MANUFACTURED IN NEWBURYPORT, MASSACHUSETTS.

8589

II

6/5/1990

OWENS BROCKWAY INC PLASTICS AND


CLOSURES DIV
ABBOTT LABORATORIES

8590

II

6/12/1990

MEDICHEM SA

GUANFACINE HYDROCHLORIDE AS MFG. IN GERONA, SPAIN

8591

III

6/6/1990

FPC FLEXIBLE PACKAGING CORP

SUPPOSITORY AND PILLOW PACKAGING MFG. IN ONTARIO, CANADA

8592

II

6/8/1990

HOFFMANN LA ROCHE INC

TRETINOIN CAPSULES AS MFG IN N.J. AND FL.

DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN NORTH CHICAGO, ILLINOIS.

Page 238

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8593 I
III
6/7/1990
KALLE PENTAPLAST GMBH

SUBJECT
GENOTHERM POLYVINYL CHLORIDE FILM-GERMANY & THE NETHERLANDS

8594

5/30/1990

DE VONQUE INC

FACILITY AND OPERATING PROCEDURES IN RICHMOND HILL, NEW YORK

8595

III

6/11/1990

ANGSTROM TECHOLOGIES INC

NON-VISIBLE MATRIX OF PRINTING INKS MFG. IN ERLANGER, KY.

8596

II

6/15/1990

KLINGE PHARMA GMBH

DROLOXIFENE CITRATE IN TABLET DOSAGE FORM AS MFG. IN GERMANY

8597

II

6/12/1990

PENINSULA LABS

ADRENOCORTICOTROPIC HORMONE MANUFACTURED IN BELMONT, CALIFORNIA.

8598

II

6/15/1990

SHANGHAI NO 2 PHARMACEUTICAL FACTORY

ATENOLOL USP AS MFG. IN SHANGHAI, PEOPLES REPUBLIC OF CHINA

8599

6/18/1990

KURARAY CO LTD

FACILITIES AND OPERATING PROCEDURES IN NIIGATA, JAPAN.

8600

II

6/18/1990

KURARAY CO LTD

(-) -HPBE AS MFG. IN NIIGATA, JAPAN

8601

III

6/11/1990

LOPAREX INC

8602

IV

6/7/1990

NOF CORP

11005, S 66 #BL KFT L/L 4D/4D MANUFACTURED IN IOWA CITY, IOWA AND WEST CHICAGO,
ILLINOIS.
PURIFIED EGG YOLK PHOSPHATIDYL CHOLINE AS MFG. IN HYOGO, JAPAN

8603

III

6/11/1990

GW PLASTICS INC

ORAL INHALER DEVICE AS MFG. IN PLEASENT ST. BETHEL, VT.

8604

II

6/20/1990

NORISTON LTD

PYRAZINAMIDE AS MFG. IN WALTOO, PRETORIA.

8605

IV

4/4/1990

GATTESFOSSE SA

COMPRITO HD5 ATO (GELUCIRE 63/05) LUBRIFIANT WL 3284 ATO

8606

II

6/21/1990

IMIPRAMINE & DESIPRAMINE IN HUMAN PLASMA

8607

II

6/22/1990

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
ALBEMARLE CORP

8608

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 42046 AS MFG. HORSENS, DENMARK

8609

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 42018 AS MFG. IN HORSENS, DENMARK

8610

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6247 AS MFG. IN HORSENS, DENMARK

8611

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6424 AS MFG IN HORSENS, DENMARK

8612

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6432 AS MFG. IN HORSENS, DENMARK

8613

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6433 AS MFG. IN HORSENS, DENMARK

8614

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6425 AS MFG. IN HORSENS, DENMARK

8615

III

4/4/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6426 AS MFG IN HORSENS, DENMARK

8616

II

6/25/1990

ISOCHEM

3-TRIFLUOROMETHYL-4-NITROPHENYL ISOCYANATE MFG. FRANCE

8617

III

6/22/1990

3M PHARMS

AUTOHALER DEVICE AS MFG. IN GERMANY & ENGLAND

8618

II

6/25/1990

EGIS PHARMACEUTICALS

SODIUM CROMOGLYCATE MFG. IN BUDAPEST, HUNGARY

8619

II

6/27/1990

SCI PHARMTECH INC

HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN TAOYUAN, TAIWAN.

8620

III

6/18/1990

VALSPAR KOLACK CORPORATION AG

INTERIOR COATING J 3121 PIGMENTED MANUFACTURED IN KALTBRUNN, SWITZERLAND.

8621

IV

6/26/1990

F AND C INTERNATIONAL INC

PUNCH FLAVOR #103543 AS MFG. IN CINCINNATI, OHIO

8622

III

6/21/1990

LOPAREX INC

10688, S 5 MIL BU HDP 4N/000 MANUFACTURE IN IOWA CITY, IOWA.

8623

II

6/25/1990

BASF AKTIENGESELLSCHAFT

5-ETHENYL-PYRROLIDIN-2-ONE AS MFG. IN LUDWIGSHAFEN, GERMANY

8624

II

6/29/1990

DIOSYNTH BV

TRIAZOLAM AS MFG. IN APELDOORN, THE NETHERLANDS

8625

II

6/28/1990

DEXBROMPHENIRAMINE MALEATE AS MFG. IN TAIWAN, REPUB. OF CHINA

8626

II

6/22/1990

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
ISOCHEM SA

8627

II

7/2/1990

CIPLA LTD

CIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA

8628

III

6/26/1990

EXXON CHEMICAL CO

ELASTOMERIC MODIFERS, CHEMICAL GRADES PA23, PA30, PA50

8629

7/3/1990

GLAXO WELLCOME INC

FACILITY IN BUCKHAVEN, UNITED KINGDOM

S (+) IBUPROFEN AS MFG. IN ORANGEBURG, SOUTH CAROLINA.

TERFENADINE AS MFG. IN GENNEVILLIERS, FRANCE

Page 239

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8630 I
II
7/3/1990
COURTAULDS FIBRES LTD

SUBJECT
BISULPHATE ADDUCT AS MFG. IN BUCKHAVEN, UNITED KINGDOM

8631

II

6/27/1990

SHASUN PHARMA SOLUTIONS LTD

SULPHONAMIDO ANILINE GR 40917A AS MFG. IN NORTHUMBERLAND, ENG

8632

IV

7/6/1990

GATTESFOSSE SA

OCTYLDODECYL MYRISTATE (M.O.D.) MFG. IN CEDEX FRANCE

8633

IV

6/29/1990

LANXESS CORPORATION

MACROLEX FLUORESCENT YELLOW 10 GN AS MFG. IN BAYERWERK, WG

8634

II

7/2/1990

BIOCHEMIC GESELLSCHAFT MBH

CEFAZOLIN AS MFG. IN TYROL, AUSTRIA

8635

II

7/2/1990

BIOCHEMIC GESELLSCHAFT MBH

CEFAZOLIN CRUDE AS MFG. IN TYROL, AUSTRIA

8636

IV

6/21/1990

JWS DELAVAU CO INC

DELA-COAT CLEAR AS MFG. IN PHILADELPHIA, PENNSYLVANIA

8637

II

7/11/1990

HOFFMANN LA ROCHE INC

HIVID DIDEOXYCYTIDINE SYRUP AS MFG. IN NUTLEY, NEW JERSEY

8638

II

7/13/1990

PHARMACEUTICAL WORKS POLPHARMA S.A

SULFANILAMIDE AS MFG. IN STAROGARD, GDANSKI, POLAND

8639

7/13/1990

PHARMACEUTICAL WORKS POLPHARMA S.A

FACILITIES AND PROCEDURES AT 19 PELPLINSKA STR., POLAND

8640

7/13/1990

PHARMACEUTICAL WORKS POLPHARMA S.A

FACILITY AND OPERATING PROCEDURES IN 24-26 STAROGARD, POLAND

8641

II

7/13/1990

PHARMACEUTICAL WORKS POLPHARMA SA

SULFADIMETHOXINE AS MFG. IN STAROGARD, GDANSKI, POLAND

8642

II

7/13/1990

PHARMACEUTICALS WORKS POLPHARMA S.A.

SULFAQUINOXALINE AS MFG. IN STAROGARD, GDANSKI, POLAND

8643

II

7/13/1990

PHARMACEUTICAL WORKS POLPHARMA S.A.

SULFATHIAZOLE AS MFG IN STAROGARD, GDANSKI, POLAND

8644

II

7/12/1990

NEORX INC

RHENIUM RE 188 AS MFG. IN SEATTLE, WASHINGTON AND MISSOURI

8645

II

7/10/1990

SANKYO CO LTD

CS-622 DRUG SUBSTANCE AS MFG. IN TOKYO, JAPAN

8646

II

7/10/1990

SANKYO CO LTD

CS-622 FINISHED DOSAGE FORM AS MFG. IN TOKYO, JAPAN

8647

II

7/2/1990

JIANGSU HENGRUI MEDICINE CO LTD

ETOPOSIDE USP AS MFG. IN LIANYUNGANG CITY, REPUBLIC OF CHINA

8648

II

7/13/1990

MEDICHEM SA

AURANOFIN AS MFG. IN CELRA (GERONA), SPAIN

8649

II

7/9/1990

SUZHOU #1 PHARMACEUTICAL FACTORY

TIMOLOL MALEATE USP AS MFG. IN SUZHOU, JIANGSU PROVINCE CHINA

8650

II

7/3/1990

ROCHE DIAGNOSTICS GMBH

GALACTOSE, THERAPEUTIC GRADE MANUFACTURED IN GERMANY.

8651

7/9/1990

LABORATOIRES EOLLIEZ SA

FACILITY AND OPERATING PROCEDURES IN COURGEVAUX, SWITZERLAND

8652

II

7/10/1990

PHARMACIA AND UPJOHN INC

NICOTINE INHALER AS MFG. IN HELSINGBORG, SWEDEN

8653

IV

6/30/1990

CHITOSAN SALTS AS MFG. IN SHIZUOKA, JAPAN

8654

7/12/1990

PROMEDICS HEALTH CARE TOPICALS DIV UNION


CARBIDE CORP
NEW ZEALAND PHARMACEUTICAL LTD

8655

II

7/12/1990

NEW ZEALAND PHARMACEUTICAL LTD

SODIUM CHOLATE (INTERMEDIATE) AS MFG. IN LINTON, NEW ZEALAND

8656

II

7/11/1990

TEVA PHARMACEUTICAL INDUSTRIES LTD

CARBIDOPA AS MFG. IN BULCIAGO, ITALY

8657

II

7/16/1990

LIPOID GMBH

LIPOID E PC (EGG PHOSPHATIDYLCHOLINE) AS MFG. IN F.R.G.

8658

IV

7/17/1990

MOBAY CHEMICAL CORP

TEXIN 480A NATURAL MANUFACTURED IN NEW MARTINSVILLE, WEST VIRGINIA.

8659

III

6/18/1990

VALSPAR KOLACK CORPORATION AG

INTERIOR COATING J 3121 GOLD TRANSPARENT AS MFG. IN ITINGEN

8660

II

7/2/1990

(FILE IS RETIRED)

AMPEROZIDE HYDROCHLORIDE AS MFG. IN MALMO, SWEDEN

8661

II

7/12/1990

QUIMICA SINTETICA SA

GUANFACINE HYDROCHLORIDE AS MFG. IN MADRID, SPAIN

8662

II

7/19/1990

SMITH AND NEPHEW RES LTD

BETAXOLOL HCL (NODS) AS MFG. IN HARLOW, ESSEX, UK

8663

II

7/9/1990

ROHM AND HAAS CO

BIOCRYL, BPA-1050 AS MFG. IN PHILADELPHIA, AND BRISTOL, PA

8664

II

7/9/1990

ROHM AND HAAS CO

BIOCRYL, BPA-1000 AS MFG. IN PHILADELPHIA, AND BRISTOL, PA

8665

II

7/23/1990

DIOSYNTH BV

PANCURONIUM BROMIDE AS MFG. IN OSS, THE NETHERLANDS

8666

IV

7/20/1990

MCGAW INC

STERILIZATION OF SOLUTION PRODUCTS IN THE (PAB)

8667

II

7/19/1990

DOW CORNING CORP

X7-2837/Q7-2837 SILICONE EMULSION AND REINFORCING AGENT

FACILITY AND OPERATING PROCEDURES IN LINTON, NEW ZEALAND

Page 240

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8668 A
III
7/20/1990
PUREPLAST INC

SUBJECT
GENOTHERM 1001C PVC FILM MFG. IN CAMBRIDGE, ONTARIO, CANADA

8669

III

7/25/1990

EXXONMOBIL CHEMICAL COMPANY

HIGH DENSITY POLYETHYLENE AS MFG. IN MONT BELVIEU, TEXAS

8670

7/18/1990

SCHERING AG

STERILE PROCESSING OF PHARMACEUTICAL PRODUCTS IN VELTEN AND BERLIN, GERMANY

8671

II

7/24/1990

TEVA PHARMACEUTICAL INDUSTRIES LTD

VERAPAMIL HYDROCHLORIDE AS MFG. IN BULCIAGO (COMO) ITALY

8672

II

10/16/1989

EGIS PHARMACEUTICALS

CLOMIPHENE CITRATE TABLETS AS MFG. IN BUDAPEST, HUNGARY

8673

II

7/25/1990

HEINRICH MACK NACHF

DIMERCAPTOSUCCINIC ACID AS MFG. IN ILLERTISSEN/BAVARIA, FRG

8674

II

7/31/1990

ALCHYMARS

GLIBENCLAMIDE/GLYBURIDE AS MFG. IN MILAN, ITALY

8675

II

7/30/1990

EGIS PHARMACEUTICALS

CHLORPROMAZINE BASE AS MFG. IN BUDAPEST, HUNGARY

8676

II

8/1/1990

DELMAR CHEMICALS INC

METHAZOLAMIDE AS MFG. IN LASALLE, QUEBEC, CANADA

8677

II

7/26/1990

KV PHARMACEUTICAL CO

ADENOSINE SUBLINGUAL TABLETS, 25 MG. AS MFG. IN ST. LOUIS, MO

8678

II

7/27/1990

DIOSYNTH BV

CLONAZEPAM AS MFG. IN APELDOORN, THE NETHERLANDS

8679

II

8/2/1990

FINE CHEMICALS CORP LTD

FLUTAMIDE AS MFG. IN CAPE PROVINCE, SOUTH AFRICA

8680

III

8/2/1990

MITSUI CHEMICALS INC

HZ2200J, HZ3000B AND MITSUI POLYPRO F401 - CHIBA, JAPAN

8681

II

7/30/1990

BACHEM FINE CHEMICALS INC

ANTIDE (LH-RH ANTAGONIST) AS MFG. IN TORRANCE & SAN DIEGO, CA

8682

II

7/31/1990

GUILIN PHARMACEUTICAL CO LTD

BUMETANIDE USP AS MFG. IN GUILIN, GUANGXI, PEOPLES REP. CHINA

8683

II

7/31/1990

BACHEM FEINCHEMIKALIEN AG

BULK DRUG INSULINOTROPIN AS MFG. IN BUBENDORF, SWITZERLAND

8684

7/23/1990

CHEMDEX INC

FACILITY FOR GENERAL DRUM DRYING OF PRODUCTS-BOYNTON BEACH,FLA

8685

II

7/17/1990

BOEHRINGER INGELHEIM KG

PHYSOSTIGMINE SALICYLATE (SYNTHETIC MFG.) IN INGELHEIM, FRG

8686

III

8/10/1990

MARSHALL PLASTIC FILM INC

POLYETHYLENE FILM AS MFG. IN MARTIN, MICHIGAN

8687

II

8/3/1990

HEINRICH MACK NACHF

CARBINOXAMINE MALEATE AS MFG. IN ILLERTISSEN/BAVARIA, GERMANY

8688

II

8/8/1990

YONEZAWA HAMARI CHEMICALS LTD

DICLOFENAC SODIUM AS MFG. IN YAMAGATA, JAPAN

8689

II

8/8/1990

PVP SOCIEDADE ANONIMA

L-DOPA OR LEVODOPA AS MFG. IN PARNAIBA, BRAZIL

8690

II

8/3/1990

RHONE POULENC RORER GMBH

PHOSPHOLIPON MC (DMPC) AS MFG. IN COLOGNE, GERMANY

8691

II

8/3/1990

PHOSPHOLIPID GMBH

PHOSPHOLIPON 90 G AS MFG. IN COLOGNE, GERMANY

8692

II

8/3/1990

RHONE POULENC RORER GMBH

PHOSPHOLIPON 80 MANUFACTURED IN COLOGNE, GERMANY.

8693

II

8/3/1990

RHONE POULENC RORER GMBH

PHOSPHOLIPON 90 AS MFG. IN COLOGNE, GERMANY

8694

II

8/3/1990

RHONE POULENC RORER GMBH

PHOSPHOLIPON MG-NH4 AS MFG. IN COLOGNE, GERMANY

8695

II

8/7/1990

OLON SPA

FLUOXETINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY

8696

II

8/6/1990

OMNICHEM NV

ETOPOSIDE AS MFG. IN LOUVAIN-LA-NEUVE, BELGIUM

8697

8/7/1990

LABORATOR MAG VIA MILANO

FACILITY AND OPERATING PROCEDURES IN MILAN, ITALY

8698

II

8/2/1990

SCHERING AG

AAMESTANE AS MFG. IN BERLIN, FEDERAL REPUBLIC OF GERMANY

8699

II

8/8/1990

SULFADIAZINE AS MFG. IN SHANGHAI, THE PEOPLE REPUBLIC OF CHINA

8700

III

8/1/1990

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
BASELL POLIOLEFINE ITALIA SRL

8701

7/27/1990

OREGON FREEZE DRY INC

FACILITY AND PROCEDURES IN ALBANY, OREGON

8702

8/14/1990

KALBE FARMA

FACILITY AND PROCEDURES IN JAKARAA, INDONESIA

8703

III

8/7/1990

PLASTEK GROUP

PACKAGING MATERIALS AS MFG. IN ERIE, PENNSYLVANIA

8704

II

8/6/1990

CAMBREX PROFARMACO MILANO SRL

TRIAZOLAM AS MFG. IN MILANO. ITALY

8705

8/17/1990

INTERPHARM LABORATORIES LTD

FACILITY FOR MFG. HUMAN INTERFERON, BETA IN NESS-ZIONA, ISRAEL

LUPOLEN 3040 D AS MFG. IN WESSLING, FEDERAL REPUBLIC OF GERMANY

Page 241

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8706 I
II
8/7/1990
ICHIKAWA LAB CO LTD

SUBJECT
DILTIAZEM HYDROCHLORIDE AS MFG. IN OBAMA CITY, JAPAN

8707

II

8/17/1990

APROTININ AS MFG. IN AESCH, SWITZERLAND

8708

III

8/15/1990

DSM NUTRITIONAL PRODUCTS LTD BRANCH


PENTAPHARM
AERNI LEUCH

8709

II

9/10/1990

BASF CORP

IBUPROFEN MANUFACTURED IN CORPUS CHRISTI, TEXAS.

8710

II

9/6/1990

KONGO CHEMICAL CO LTD

D-BROMPHENIRAMINE MALEATE AS MFG. IN TOYAMA-KEN, JAPAN

8711

II

8/10/1990

LIVRON INC

L-TYROSINE TABLETS MANUFACTURED IN WEST NEW YORK, NEW JERSEY.

8712

III

8/22/1990

EPSILON PRODUCTS CO

POLYPROPYLENE RESINS AS MFG. IN MARCUS HOOK, PENNSYLVANIA

8713

II

8/17/1990

PHARMA-WALDHOF GMBH

N6-(2-ISOPENTENYL)-ADENOSINE AS MFG IN MANNHEIM, GERMANY

8714

II

8/24/1990

LEO PHARMACEUTICAL PRODUCTS LTD

CALCIPOTRIOL SOLUTION CREAM DRUG PRODUCT AS MFG. IN IRELAND

8715

II

8/24/1990

LEO PHARMACEUTICAL PRODUCTS LTD

CALCIPOTRIOL SUSPENSION CREAM DRUG PRODUCT AS MFG. IN IRELAND

8716

III

8/20/1990

FILTER PRODUCTS INC

PHARMACEUTICAL SERIES PLEATED CARTRIDGES - SACRAMENTO, CA.

8717

III

8/16/1990

BASF CORPORATION

OPPANOL B80 AS MFG. IN CHARLOTTE, NORTH CAROLINA

8718

III

8/21/1990

PHILLIPS PETROLEUM CO

CRYSTALOR POLYMETHYLPENTENE RESINS AS MFG. IN OKLAHOMA

8719

8/31/1990

BIOVAIL TECHNOLOGIES LTD

FACILITIES AND OPERATING PROCEDURES IN COSTA RICA

8720

III

8/27/1990

REXAM CLOSURE SYSTEMS INC

8721

9/13/1990

RD LABORATORIES

THERMOPLASTIC CLOSURES AND PACKAGING MANUFACTURED IN HAMLET, NORTH


CAROLINA.
FACILITIES AND OPERATING PROCEDURES IN COLLINSVILLE, ILLINOIS

8722

9/6/1990

METSA SPECIALTY CHEMICALS BV

FACILITY AND OPERATING PROCEDURES IN NIJMEGEN, NETHERLANDS

8723

II

8/31/1990

SCOPOLAMINE AS MFG. IN INGELHEIM, GERMANY

8724

II

9/7/1990

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
RAYLO CHEMICALS

8725

II

9/11/1990

E MERCK

EUSOLEX 6300 OIL SOLUBLE UV-B-FILTER MFG.-GERNSHEIM, GERMANY

8726

9/11/1990

E MERCK

FACILITIES AND PROCEDURES IN GERNSHEIM, FED. REP. OF GERMANY

8727

II

9/14/1990

DM GRAHAM LABORATORIES INC

IBUPROFEN S (+) TABLETS AS MFG. IN HOBART, NEW YORK

8728

II

9/7/1990

HEUMANN

E-CLOMIPHENE-CITRATE AS MFG. IN FEUCHT, GERMANY

8729

II

9/12/1990

MENOTROPINS AS MFG. IN SHANGHAI, PEOPLE'S REP. OF CHINA

8730

8/29/1990

SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL


LABORATORIES
SHAKLEE USA INC

8731

9/12/1990

ESTEVE QUIMICA SA

FACILITY AND OPERATING PROCEDURES AS MFG. CELRA, SPAIN

8732

III

8/29/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 36141 AS MFG. IN HORSENS, DENMARK

8733

IV

9/17/1990

ACESULFAME POTASSIUM MANUFACTURED IN GERMANY.

8734

III

8/29/1990

NUTRINOVA NUTRITION SPECIALITIES AND FOOD


INGREDIENTS GMBH
SCHUBERT SEALS A/S

8735

II

9/13/1990

PACIFIC NORTHWEST NATIONAL LABORATORY

YTTRIUM-90 (Y-90) AS MFG. IN RICHLAND, WASHINGTON

8736

II

9/13/1990

SYN TECH CHEM AND PHARM CO LTD

CHLORZOXAZONE USPXXII AS MFG. IN HSIN YING, TAIWAN

8737

9/12/1990

NORTHVIEW PACIFIC LABORATORIES INC

8738

III

9/6/1990

SOLVIN SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BERKELEY, CALIFORNIA.
DIOFAN 193 D AS MANUFACTURED IN TAVAUX, FRANCE

8739

III

9/4/1990

BASF AKTIENGESELLSCHAFT

DIOFAN 185 D AS MFG. IN LUDWIGSHAFEN, GERMANY

8740

III

9/4/1990

SOLVIN S.A.

DIOFAN 233 D AS MFG. IN LUDWIGSHAFEN, GERMANY

ALFOIL FILMS AS MFG. IN BERN, SWITZERLAND AND GORDONSVILLE,VIRGINIA

ACONIAZIDE AS MFG. IN EDMONTON, ALBERTA, CANADA

FACILITY AND OPERATING PROCEDURES MFG. IN NORMAN, OKLAHOMA

RUBBER COMPOUND 36140 AS MFG. IN HORSENS, DEMARK

Page 242

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8741 I
III
9/4/1990
BASF AKTIENGESELLSCHAFT

SUBJECT
DIOFAN A 735 AS MFG. IN LUDWIGSHAFEN, GERMANY

8742

III

9/10/1990

BASF AKTIENGESELLSCHAFT

TERLUX 2802 TR AS MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

8743

III

9/3/1990

BASF AKTIENGESELLSCHAFT

DIOFAN A 710 AS MFG. IN LUDWIGSHAFEN, GERMANY

8744

9/20/1990

KYOWA HAKKO KOGYO CO LTD

FACILITIES AND PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN

8745

II

9/20/1990

KYOWA HAKKO KOGYO CO LTD

CI-920 (FOSTRIECIN) BULK FORM AS MFG. IN TOKYO, JAPAN

8746

II

9/18/1990

TEVA PHARMACEUTICAL INDUSTRIES LTD

NAPROXEN SODIUM AS MFG. IN BULCIAGO (COMO), ITALY

8747

9/19/1990

AVANTI POLAR LIPIDS INC

FACILITIES AND OPERATING PROCEDURES IN ALABASTER, ALABAMA

8748

II

6/19/1990

TEVA PHARMACEUTICAL INDUSTRIES LTD

NAPROXEN AS MFG. IN BULCIAGO (COMO), ITALY

8749

II

8/30/1990

ASHWOOD CHEMICALS LTD

DIMETHYLAMINOETHYLCHLORIDE HCL MFG. IN BALEY, ENGLAND

8750

II

9/17/1990

DUPHAR MEDICAL DEVICES

AROPINE/PRALIDOXIME CHLORIDE INJECTION (PERFORATED NEEDLE)

8751

II

9/17/1990

DUPHAR MEDICAL DEVICES

AROPINE/PRALIDOXIME CHLORIDE INJECTION (RETRACTION NEEDLE)

8752

IV

9/17/1990

BOEHRINGER INGELHEIM KG

POLY-(D,L-LACTIDE-CO-GLYCOLIDE) 50:50 MANUFACTURED IN GERMANY.

8753

II

9/18/1990

SIGMA F AND D DIV LTD

D-ARGININE HYDROCHLORIDE MANUFACTURED IN ST. LOUIS, MISSOURI.

8754

9/26/1990

FACILITIES AND OPERATING PROCEDURES IN ANDHRA PRADESH, INDIA

8755

II

9/26/1990

8756

9/26/1990

SUMITRA PHARMACEUTICALS AND CHEMICALS


LTD
SUMITRA PHARMACEUTICALS AND CHEMICALS
LTD
TATEISHI SEIYAKU CO LTD

8757

II

9/25/1990

SANDOZ GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERALOPERATING PROCEDURES


IN TOKYO, JAPAN
6-APA (6 AMINOPENICILLANIC ACID) AS MFG. IN KUNDL, AUSTRIA

8758

II

10/2/1990

EASTMAN KODAK CO

4-(ACETYLAMINO)PHENYL ALL-TRANS-RETINOATE AS MFG., NEW YORK

8759

II

10/2/1990

WATSON LABORATORIES INC

TRANSDERMAL ESTRADIOL PACH AS MFG. IN CORONA, CALIFORNIA

8760

II

9/20/1990

DANIPHARM APS

LACTULOSE SYRUP AS MFG. IN NIBE, DENMARK

8761

III

9/28/1990

ALUMINUM COMPANY OF AMERICA

PHAR 9300 AS MFG. IN PITTSBURGH, PENNSYLVANIA

8762

III

10/1/1990

AVANTI POLAR LIPIDS INC

PACKAGING MATERIALS AS MFG. IN ALABASTER, ALABAMA

8763

III

10/1/1990

AMPACET CORP

11447 WHITE PE/MB MANUFACTURED IN TERRE HAUTE, INDIANA AND DERIDDER, LA.

8764

II

9/26/1990

TEVA PHARMACEUTICAL INC

TERFENADINE AS MFG. IN PETAH TIQVA, ISRAEL

8765

III

9/24/1990

ARKEMA INC

8766

III

9/17/1990

SCHUBERT SEALS A/S

PLEXIGLAS DR AS MFG. IN PHILADELPHIA, PENNSYLVANIA ALTOGLAS DIVISION, 2000 MARKET


STREET PHILADELPHIA, PA19103-3222
RUBBER COMPOUND 42047 AS MFG. IN HORSENS, DENMARK

8767

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 42045 AS MFG. IN HORSENS, DENMARK

8768

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 42044 AS MFG. IN HORSENS, DENMARK

8769

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 42043 AS MFG. IN HORSENS, DENMARK

8770

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 41010 AS MFG. IN HORSENS, DENMARK

8771

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 41008 AS MFG. IN HORSENS, DENMARK

8772

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6446 MANUFACTURED IN HORSENS, DENMARK.

8773

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6445 MANUFACTURED IN HORSENS, DENMARK.

8774

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6443 MANUFACTURED IN HORSENS, DENMARK.

8775

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6442 AS MFG. IN HORSENS, DENMARK

8776

III

9/17/1990

SCHUBERT SEALS A/S

RUBBER COMPOUND 6427 AS MFG. IN HORSENS, DENMARK

IBUPROFEN AS MFG. IN ANDHRA PRADESH, INDIA

Page 243

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8777 A
III
9/28/1990
ST GOBAIN PERFORMANCE PLASTICS
8778

III

9/24/1990

BASF CORP

8779

III

10/5/1990

DUPONT PERFORMANCE POLYMERS

SUBJECT
RIGID PVC C/1/S #7000 SILICONE RELEASE COATING MANUFACTURED IN WORCESTER,
MASSACHUSETTS.
EMULDUR PR 8381 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
HYTREL 8238 POLYESTER ELASTOMER MANUFACTURED IN WILMINGTON, DELAWARE.

8780

10/15/1990

PEPTISYNTHA

FACILITIES AND OPERATING PROCEDURES IN BRUSSELS, BELGIUM

8781

10/19/1990

REFERENCE INFORMATION (CURRICULA VITAE)

8782

II

10/11/1990

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY INFECTIOUS DISEASES
LUBRIZOL ADVANCED MATERIALS INC

8783

III

10/17/1990

LOPAREX LLC

10929, S 53# SB SCK 6X/000 MANUFACTURED IN NEENAH, WISCONSIN.

8784

II

10/12/1990

FINORGA

ADAPALENE AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE

8785

10/10/1990

MADIS LABORATORY

FACILITIES AND OPERATING PROCEDURES IN SOUTH HACKENSACK, NJ

8786

10/16/1990

PHARMACHEMIE BV

STERILE MANUFACTURING FACILITY IN HAARLEM,NETHERLANDS

8787

II

10/10/1990

BIOSPECIA LTD

HUMAN CHORIONIC GONADOTROPHIN MANUFACTURED IN KENT, ENGLAND.

8788

III

10/21/1990

FIBERSORB SUPERABSORBENT MATERIALS 7000, 7200 AND 7500 IN PA

8789

IV

10/9/1990

ARCO CHEMICAL COMPANY DIV OF ATLANTIC


RICHFIELD CO
HERCULES INC

8790

III

10/1/1990

BASF AKTIENGESELLSCHAFT

LUPOLEN 3025 K MANUFACTURED IN WESSLING, FEDERAL REPUBLIC OF GERMANY.

8791

III

10/5/1990

LOPAREX LLC

SILICONE RELEASE LINERS MANUFACTURED IN IOWA CITY, IA AND EDEN, NC

8792

II

10/22/1990

NIPPON STEEL CHEMICALS CO LTD

(S)-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACID-JAPAN

8793

II

10/19/1990

BACHEM FEINCHEMIKALIEN AG

CYT-379 AS MFG. IN BUBENDORF, SWITZERLAND

8794

II

10/18/1990

EGIS PHARMACEUTICALS

NIFEDIPINE AS MFG. IN BUDAPEST, HUNGARY

8795

10/25/1990

GLAXO OPERATIONS UK LTD

FACILITIES AND OPERATING PROCEDURES AT BARNARD CASTLE, UK

8796

III

9/7/1990

TOYO ALUMINUM

PAPER/LDPE/AL FOIL/ADHESIVE/ACRYLONITRILE FILM IN JAPAN

8797

10/10/1990

KLINGE PHARMA GMBH

MANUFACTURING FACILITY IN KILLORGLIN, IRELAND

8798

III

10/17/1990

LOPAREX BV

GELROLEASE 111/80, PS 29.701 AS MFG. IN THE NETHERLANDS

8799

II

10/23/1990

TATEISHI SEIYAKU CO LTD

DILTIAZEM HYDROCHLORIDE AS MFG. IN TOKYO, JAPAN

8800

II

10/25/1990

DELMAR CHEMICALS INC

PYRIDOSTIGMINE BROMIDE AS MFG. IN VILLE LASALLE,QUEBEC,CANADA

8801

II

10/29/1990

HAUSER CHEMICAL RESEARCH INC

TAXOL MANUFACTURED IN BOULDER, COLORADO.

8802

II

10/24/1990

GEDEON RICHTER LTD

DIHYDROLYSERGOL AS MFG. IN BUDAPEST, HUNGARY

8803

III

10/24/1990

B LAUFENBERG GMBH

POLYESTERFILM MANUFACTURED IN HULS, FEDERAL REPUBLIC OF GERMANY.

8804

II

11/1/1990

MALLADI DRUGS AND PHARMACEUTICALS LTD

EPHEDRINE HYDROCHLORIDE AS MFG. IN TAMIL NADU, INDIA

8805

II

10/31/1990

SUMITOMO CHEMICAL CO LTD

GLIPIZIDE AS MFG. IN GIFU PREFECTURE AND OSAKA, JAPAN

8806

II

10/30/1990

GEDEON RICHTER PLC

LEVONORGESTREL AS MFG. IN BUDAPEST, HUNGARY

8807

III

11/2/1990

NYPRO CAROLINA

MOLDED MEMBRANE PORT #03-20-16-422 AS MFG. IN BURLINGTON, NC

8808

II

10/31/1990

WATSON LABORATORIES INC

IRON DEXTRAN, 5% SOLUTION AS MFG. IN NORTH CHICAGO, ILLINOIS

8809

II

10/31/1990

CILAG AG

2-BENZYLAMINO-PYRIDINE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

8810

II

11/6/1990

AMERSHAM CORP

YTTRIUM CHLORIDE (Y-90) AS MFG. IN BUCKS, ENGLAND

8811

II

9/18/1990

PIONEER PHARMACEUTICALS CO INC

ELMIRON (PENTOSAN POLYSULFATE SODIUM)CAPSULES 100MG, NJ

8812

II

11/5/1990

PROFARMACO SRL

LOXAPINE SUCCINATE AS MFG. IN MILAN, ITALY

CARBOPOL SALTS AS MFG. BY BFGOODRICH COMPANY

PENTALYN H SYNTHETIC RESIN AS MFG. IN BURLINGTON, NJ

Page 244

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8813 I
I
11/5/1990
FAR RESEARCH INC

SUBJECT
FACILITY IN PALM BAY, FLORIDA

8814

II

11/5/1990

FAR RESEARCH INC

MONOBENZONE AS MFG. IN PALM BAY, FLORIDA

8815

II

11/9/1990

ASAHI GLASS CO LTD

PERFLUOROOCTYLBROMIDE AS MFG. IN CHIBA, JAPAN

8816

11/9/1990

ASAHI GLASS CO LTD

FACILITES AND OPERATING PROCEDURES IN CHIBA, JAPAN

8817

II

11/6/1990

AVANTI POLAR LIPIDS INC

GLYCEROPHOSPHOCHOLINE.CDC12.CELITE AS MFG. IN ALABASTER, AL

8818

II

11/7/1990

SIGNA SA DE CV

AZT AS MFG. IN BRANTFORD, ONTARIO, CANADA

8819

II

11/9/1990

ROUSSEL-UCLAF

ESTRADIOL AS MFG. BY DIOSYNTH BV IN OSS, HOLLAND

8820

II

11/9/1990

CYCLO PRODUCTS INC

BIOTIN AS MFG. IN LOS ANGELES, CALIFORNIA

8821

II

10/31/1990

PFIZER INC

TRIAMCINOLONE ACETONIDE AS MFG. IN KALAMAZOO, MICHIGAN

8822

III

10/11/1990

SCHOELLER AND HOESCH GMBH

GEFOLUX TDS/HF

8823

II

10/11/1990

SCHOELLER AND HOESCH GMBH

GEFOLUX TDS/M AS MANUFACTURED IN GERNSBACH, REPUBLIC OF GERMANY.

8824

NOT AN ASSIGNED NUMBER

8825

NOT AN ASSIGNED NUMBER

8826

8827

II

11/9/1990

HASHIMOTO CHEMICAL INDUSTRIES CO LTD

SODIUM FLUORIDE AS MFG. IN OSAKA, JAPAN

8828

II

11/20/1990

KYOWA HAKKO KOGYO CO LTD

ADENOSINE MANUFACTURED A HOFU CITY PLANT, JAPAN

8829

II

11/16/1990

HAIMEN PHARM FACTORY

DAUNORUBICIN HYDROCHLORIDE AS MFG. IN JIAOJIANG CITY, CHINA

8830

IV

11/8/1990

SC JOHNSON & SON INC

PRIMAFRESH HS AS MFG. IN STURTEVANT, WISCONSIN

8831

II

11/15/1990

IAF BIOCHEM INTERNATIONAL INC

ACONIAZIDE TABLETS 650 MG. AS MFG. BY PFIZER - CANADA

8832

11/15/1990

CREATIVE PRODUCTS INC

FACILITIES AND OPERATING PROCEDURES IN ROSSVILLE, ILLINOIS

8833

III

11/5/1990

DANAPAK FLEXIBLES AS

COMPOUND PACKAGING MATERIAL AS MFG. IN ODENSE S., DENMARK

8834

II

10/10/1990

ARCHIMICA SPA

ATENOLOL AS MFG. IN VARESE, ITALY

8835

III

10/31/1990

LOHMANN GMBH & CO KG

PARATEX III/40 AS MFG. IN NEUWIED AND DIERDOEF, GERMANY

8836

11/16/1990

STERIS ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN SPARTANBURG, SOUTH CAROLINA.

8837

III

11/19/1990

HEUCK FOLIEN GESELLSCHAFT MBH

METALLIZED POLYESTER FILMS AS MFG. IN BAUMGARTENBERG, AUSTRI

8838

II

11/9/1990

RECORDATI INDUSTRIA CHIMICA SPA

METOPROLOL TARTRATE AS MFG. IN LATINA, ITALY

8839

11/12/1990

KYOWA HAKKO USA INC

8840

II

11/16/1990

SIPSY SNC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ASHIKAGA-SHI, JAPAN.
TRICAINE METHANE SULFONATE AS MFG. IN AVRILLE, FRANCE

8841

11/21/1990

KINERTON LTD

FACILITY AND OPERATING PROCEDURES IN BLANCHARDSTOWN, IRELAND

8842

11/16/1990

MALLINCKRODT CANADA INC

FACILITIES AND OPERATING PROCEDURES IN POINTE CLAIRE, CANADA

8843

II

11/15/1990

KOPRAN LTD

AMPICILLIN TRIHYDRATE MFG. IN MAHARASHTRA, INDIA

8844

II

11/15/1990

KOPRAN LTD

CLOXACILLIN SODIUM MANUFACTURED IN MAHARASHTRA, INDIA.

8845

II

11/15/1990

KOPRAN LTD

AMOXYCILLIN TRIHYDRATE MFG. IN MAHARASHTRA, INDIA

8846

11/15/1990

KOPRAN LTD

FACILITIES AND OPERATIONS IN MAHARASHTRA, INDIA

8847

II

11/16/1990

MALLINCKRODT CANADA INC

X-RAY CONTRAST MEDIA AS MFG. IN POINTE CLAIRE, QUEBEC, CANADA

8848

II

8/10/1990

3M HEALTH CARE LTD

SALSALATE AS MFG. IN LEICESTERSHIRE, ENGLAND

8849

II

8/10/1990

3M HEALTH CARE LTD

MANUFACTURE OF FLECAINIDE ACETATE

8850

II

11/16/1990

MALLINCKRODT CANADA INC

HEXABRIX X-RAY CONTRAST MEDIA MANUFACTURED IN POINTE CLAIRE,CANADA

NOT AN ASSIGNED NUMBER

Page 245

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8851 I
II
11/21/1990
BACHEM INC

SUBJECT
EEL CALCITONIN MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA.

8852

II

11/21/1990

ACS DOBFAR SPA

7-AMINO-3-CHLORO CEPHEM ESTER AS MFG. IN TRIBIANO (MI), ITALY

8853

II

11/21/1990

QUIMICA SINTETICA S A

CHLORAMPHENICOL PALMITATE AS MFG. IN MADRID, SPAIN

8854

11/27/1990

NIPPON FINE CHEMICAL COMPANY LTD

8855

II

11/26/1990

ASPEN OSS BV

MANUFACTURTING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HYOGO, JAPAN.
16-ALPHA-HYDROXYPREDNISOLONE MANUFACTURED IN OSS, THE NETHERLANDS.

8856

II

11/20/1990

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD

DOBUTAMINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA

8857

11/4/1990

GENZYME FINE CHEMICALS

8858

II

11/29/1990

PERRIGO API LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HAVERHILL, ENGLAND.
PENTOXYFYLLINE AS MFG. IN BE'ER SHEVA, ISRAEL

8859

II

11/26/1990

ZAMBON SPA

TRIAZOLAM AS MFG. IN VICENZA, ITALY

8860

II

11/26/1990

ZAMBON SPA

ALPRAZOLAM AS MFG. IN VICENZA, ITALY

8861

II

11/29/1990

RIEDEL DEHAEN AG

BENZOPHENONE -3 (OXYBENZONE) AS MFG. IN SEELZE, GERMANY

8862

11/20/1990

PHARMACONSULTANT INC

DRUG INTERACTION STUDY ON BROMOCRIPTINE AND TORECAN

8863

8864

II

11/19/1990

LUNDBECK PHARMACEUTICALS ITALY SPA

CLOMIPRAMINE HYDROCHLORIDE MANUFACTURED IN PADOVA, ITALY.

8865

11/30/1990

TAENAKA KOGYO CO LTD

FACILITIES AND OPERATING PROCEDURES IN MOBARA CITY, JAPAN

8866

II

11/30/1990

TAENAKA KOGYO CO LTD

L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE MFG. IN JAPAN

8867

III

11/11/1990

FRANTSCHACH INNCOAT GMBH

AZETIN SILAZET MANUFACTURED IN RAUBLING, GERMANY.

8868

11/30/1990

ORLOVE GROUP

FACILITIES AND OPERATING PROCEDURES IN FORT LAUDERDALE, FLA.

8869

II

12/3/1990

BIOCHEMIE S.A.

ANHYDROUS AMPICILLIN INTERMEDIATE NON-STERILE BULK MFG. SPAIN

8870

III

12/4/1990

AMCOR FLEXIBLES ITALIA SRL

PAPER/ALUMINUM/POLYETHYLENE LAMINATE DRUG MFG. IN ITALY

8871

IV

11/30/1990

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL BING CHERRY AND CHERRY RASPBERRY FLAVORS MFG. P.A.

8872

II

12/4/1990

TRI-BUFFERED BUFFERIN AS MFG. IN MORRISVILLE, NORTH CAROLINA

8873

III

12/6/1990

BRISTOL MYERS PRODUCTS DIV BRISTOL MYERS


CO
OWENS ILLINOIS INC

8874

II

12/4/1990

QUIMICA SINTETICA S A

ACEBUTOLOL HYDROCHLORIDE AS MFG. IN MADRID, SPAIN

8875

II

11/28/1990

DENKA PHARMCEUTICAL CO LTD

MENOTROPIN AS MFG. IN KANAGAWA, JAPAN

8876

II

12/14/1990

AVECIA INC.

8877

12/10/1990

IMHAUSEN CHEMIE GMBH

SDM-75 (20 % NITROGLYCERIN IN SOLVATED ACRYLATE POLYMER) MANUFACTURED IN


TAMAQUA, PA
FACILITIES AND GENERAL OPERATING PROCEDURES IN LAHR, GERMANY

8878

III

12/6/1990

4P FOLIE FORCHHEIM GMBH

PVC RIGID FILM TYPE 41121 AS MFG. IN FORCHHEIM, GERMANY

8879

III

12/6/1990

4P FOLIE FORCHHEIM GMBH

PVC RIGID FILM TYPE 51520 MANUFACTURED IN FORCHHEIM, GERMANY.

8880

II

12/7/1990

FINE ORGANICS LTD

S-1,2,3,4-TETRAHYDROISOQUINOLINE-3- ACID SALT MFG. IN ENGLAND

8881

III

12/10/1990

TAISEI KAKO CO LTD

VIALS AND AMPULES AS MFG. IN KITA-KU, OSAKA, JAPAN

8882

III

12/10/1990

TAISEI KAKO CO LTD

CONTAINERS FOR CARTELOL EYE DROPS AS MFG. IN GIFU, JAPAN

8883

III

12/10/1990

TAISEI KAKO CO LTD

TAS-SHEETS FOR PKG. TABLETS AND CAPSULES MFG. GIFU, JAPAN

8884

III

12/10/1990

TAISEI KAKO CO LTD

PLASTIC BOTTLES AS MFG. IN GIFU AND OSAKA, JAPAN

8885

II

12/7/1990

REPLIGEN CORPORATION

FAST FLOW IMMOBILIZED RECOMBINANT PROTEIN A IN MASSACHUSETTS

8886

II

12/10/1990

FINE ORGANICS LTD

SULPHAZINE AS MFG. IN CLEVELAND, ENGLAND

NOT AN ASSIGNED NUMBER

PACKAGING MATERIALS AS MFG IN BALTIMORE MD PLANT

Page 246

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8887 I
II
12/11/1990
DAIICHI PHARMACEUTICAL CO LTD

SUBJECT
PANTETHINE BULK SUBSTANCE AS MFG. IN AKITA, JAPAN

8888

II

12/13/1990

VERTELLUS PERFORMANCE MATERIALS INC

ACETYLTRI-N-HEXYL CITRATE (ATHC) MANUFACTURED IN NORTH CAROLINA.

8889

III

12/11/1990

DOUBLE LAMINATED FOIL OPA/ALU/PVC AS MFG. IN AUSTRIA

8890

II

6/28/1990

FOLIENWALZWERK BRUEDER TECH


AKTIENGESELLSCHAFT
DAIICHI PHARMACEUTICAL CO LTD

8891

12/12/1990

SUN CHEMICAL CO

8892

II

12/13/1990

BACHEM AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAITAMA, JAPAN.
CALCITONIN (SALMON) (BULK) MANUFACTURED IN SWITZERLAND.

8893

II

12/17/1990

KYOWA HAKKO BIO CO LTD

MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE REDUCED

8894

12/10/1990

MIDWEST RES INST

8895

II

12/10/1990

AMICON DIV WR GRACE AND CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MISSOURI.
MAREX SILICA PAE MEDIA MANUFACTURED IN DANVERS, MASACHUSETTS.

8896

II

12/18/1990

LEO PHARMACEUTICAL PRODUCTS LTD

FUCIDIN GEL DRUG PRODUCT MANUFACTURED IN DUBLIN, IRELAND.

8897

II

12/17/1990

SUN CHEMICAL CO LTD

TIAZEPN AS MFG. IN SAITAMA, JAPAN

8898

II

12/21/1990

BAXTER HEALTHCARE CORP

ANTI-PROTEIN C AFFINITY MATRIX AS MFG. IN HAYWARD, CALIFORNIA

8899

III

12/19/1990

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION MANUFACTURED IN SALISBURY, MARYLAND.

8900

12/19/1990

TAKEDA CHEMICAL INDUSTRIES LTD

8901

II

12/13/1990

BOEHRINGER INGELHEIM PHARMA KG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SHONAN PLANT.
ISOPROTERENOL HYDROCHLORIDE AS MFG. IN INGELHEIM

8902

II

12/11/1990

CHATTEM CHEMICALS

ALUMINATE (1-),[CARBONATO(2-)-0] DIHYDROXY-SODIUM IN TENN.

8903

12/30/1990

UNION CARBIDE CORP

FACILITIES IN SHIZOUKA, JAPAN

8904

II

12/20/1990

ABBVIE INC

BUTORPHANOL TARTRATE AS MANUFACTURED IN CHICAGO, ILLINOIS

8905

12/20/1990

CHEMIE LINZ GES MBH

FACILITIES AND OPERATING PROCEDURES IN LINZ, AUSTRIA

8906

IV

11/2/1990

FLAVOR NORTH AMERICA INC

ARTIFICIAL RASPBERRY FLAVOR #906.014/WC AS MFG. IN ILLINOIS

8907

IV

12/27/1990

LIPOID GMBH

LIPOID S PC-3 AS MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

8908

12/31/1990

LEBSA CTRA DE LHOSPITALET 30

8909

II

12/31/1990

LEBSA LABORATORIOS ESPINOSY BOFILL SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BARCELONA, SPAIN.
OXODIPINE AS MFG. IN BARCELONA, SPAIN.

8910

II

12/27/1990

LIPHA PHARMACEUTICALS INC

5% HYDROXOCOBALAMIN INJECTION AS MFG. IN ALBUQUERQUE, NM

8911

12/27/1990

KING PHARMACEUTICALS INC

8912

III

12/18/1990

SOLVAY & CIE SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BRISTOL, TENNESSEE.
ELTEX P HP 200 AS MFG. IN SARRALBE, FRANCE

8913

1/3/1991

AMAGASAKI CHEMICAL INDUSTRIES CO LTD

FACILITIES AND PROCEDURES IN AMAGASAKI CITY, HYOGO, JAPAN

8914

II

1/3/1991

FUJIMOTO CHEMICALS CO LTD

DACARBAZINE (BULK) AS MFG. IN HYOGO, JAPAN

8915

II

1/4/1991

ZENECA PHARMACEUTICALS

DIPRIVAN AS MFG. IN MILAN, ITALY

8916

II

1/3/1991

MEDICHEM SA

DICLOFENAC SODIUM AS MFG. IN GERONA, SPAIN

8917

II

1/2/1991

ABBOTT LABS

RAPAMYCIN CRUDE OIL AS MFG. IN NORTH CHICAGO, ILLINOIS

8918

II

1/9/1991

PHARMACIA AND UPJOHN INC

3-OXO-4-AZAANDROST-5-ENE-17 BETA-CARBOXYLIC ACID, IN MICHIGAN

8919

II

1/10/1991

MAPRIMED SA

NICARDIPINE HYDROCHLORIDE AS MFG. IN BUENOS AIRES, ARGENTINA

8920

1/3/1991

RECHERCHE SYNTEX FRANCE SA

8921

1/24/1991

BOEHRINGER MANNHEIM GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LEUVILLE-SUR-ORGE, FRANCE.
FACILITIES AND OPERATING PROCEDURES IN MANNHEIM, GERMANY

PANTOSIN 200 MG TABLETS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN.

Page 247

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8922 A
III
1/9/1991
ST GOBAIN DESJONQUERES SA SGD

SUBJECT
GLASS PACKAGING MATERIAL MANUFACTURED IN FRANCE AND GERMANY.

8923

II

1/16/1991

SOCIETA ITALIANA CORTICOSTEROIDI SPA

FLUMETHASONE PIVALATE AS MFG. IN RHO, ITALY

8924

II

1/16/1991

LABORATORIO CHIMICO INTERNAZIONALE SPA

DICLOFENAC SODIUM AS MFG. IN MILAN , ITALY

8925

III

1/7/1991

SOLVIN SA

DIOFAN 3193 AS MANUFACTURED IN TAVAUX, FRANCE.

8926

1/2/1991

RELIABLE CHEMICAL CO

FACILITIES AND OPERATING PROCEDURES IN ST. LOUIS, MISSOURI

8927

II

1/9/1991

CAMBREX PROFARMACO MILANO SRL

LOXAPINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY

8928

II

1/11/1991

APOTEX PHARMACHEM INC

BUSPIRONE HYDROCHLORIDE AS MFG. IN BRANTFORD, ONTARIO, CANADA

8929

II

1/15/1991

3M PHARMS

TRANSDERMAL PACH LY188035 AS MFG. IN ST. PAUL, MINNESOTA

8930

1/17/1991

GATTESFOSSE SA

8931

III

1/14/1991

PRETIUM PACKAGING

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAINT-PRIEST, FRANCE
PACKAGING MATERIALS AS MFG. IN GRAIN VALLEY, MO, SEYMOUR, IN

8932

10/25/1990

BOEHRINGER MANNHEIM ITALIA SPA

8933

III

1/17/1991

4P VERPACKUNGEN RONSBERG GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MONZA, ITALY.
FLEXIBLE FILM LAMINATE PVC/PE/PVDC AS MFG. IN GERMANY

8934

II

10/31/1990

SIBEFAT SRL

SULINDAC AS MFG. IN LAHR, GERMANY BY IMHAUSEN CHEMIE GMBH

8935

II

11/21/1990

QUIMICA SINTETICA SA

CHLORAMPHENICOL AS MFG. IN MADRID, SPAIN

8936

III

1/3/1991

MOBAY CHEMICAL CORP

MAKROLON FRC 2458-8227 AS MFG. IN PITTSBURGH, PENNSYLVANIA

8937

IV

12/28/1990

WILD FLAVORS INC

CHERRY RASPBERRY FLAVOR #257691T AS MFG. IN CINCINNATI, OHIO

8938

III

1/7/1991

PMS CONSOLIDATED

COLORANT #56429 CMB AS MFG. IN CORALSPRINGS, FLORIDA

8939

IV

12/4/1990

GUANDONG PING KANG PHARM

EMPTY HARD GELATIN CAPSULES AS MFG. IN KAIPING, CHINA

8940

II

1/18/1991

BASF PHARMACHEMIKALIEN GMBH CO KG

OXYMETAZOLINE HYROCHLORIDE AS MFG. IN MINDEN, GERMANY

8941

III

1/25/1991

HERRMANN AG

RAW MATERIALS IN THE PRODUCTION OF HDPE SCREW CAPS FOR DRUG PACKAGING

8942

II

1/17/1991

RHONE POULENC RORER INC

PROMAZINE HYDROCHLORIDE AS MFG. IN FRANCE

8943

III

1/18/1991

AMPACET CORP

11656 WHITE PE/MB AS MFG. IN DERIDDER LA.

8944

II

1/21/1991

SCHERING PHARMACEUTICAL CORPORATION

ALCLOMETASONE DIPROPIONATE, USP AS MFG. MANATI, PUERTO RICO

8945

IV

1/22/1991

SEPPIC

MONTANIDE ISA 70 AS MFG. IN CASTRES, FRANCE

8946

II

1/22/1991

NIPPON KAYAKU CO LTD

ETOPOSIDE AS MFG. IN TOKYO, JAPAN

8947

II

1/25/1991

SUMIKA FINE CHEMICALS CO LTD

TRIPROLIDINE HYDROCHLORIDE AS MFG. IN THE GIFU, JAPAN

8948

II

1/24/1991

MALLINCKRODT CHEMICAL INC

NALTREXONE METHOBROMIDE AS MFG. IN ST. LOUIS, MISSOURI

8949

II

2/8/1991

STERLING DRUG INC

PLACEBO TABLETS TO MACH PRIMAQUINE PHOSPHATE TABLETS IN N.Y.

8950

II

1/22/1991

SEPPIC

INTERMEDIATE FOR MONTANIDE ISA 50 AS MFG. IN CASTRES, FRANCE

8951

II

1/30/1991

HENKEL CORP

DELIOS MEDIUM CHAIN TRIGLYCERIDES AS MFG. IN LAGRANGE, IL

8952

II

1/28/1991

UNICHEM LABORATORIES LTD

PYRIDOSTIGMINE BROMIDE AS MFG. IN BOMBAY, INDIA

8953

II

1/29/1991

PHARMAGLOBE LABS LTD

RANITIDINE HYDROCHLORIDE AS MFG. IN REXDALE, ONTARIO, CANADA

8954

II

1/30/1991

DIOSYNTH BV

STANOLONE AS MFG. IN THE NETHERLANDS

8955

II

1/29/1991

PHARMECO LABS INC

2-(2,6-DIOXO-3-PIPERIDINYL)1H-ISOINDOLE-1,3(2H)-DIONE IN CA

8956

II

1/28/1991

PENINSULA LABS

VASOACTIVE INTESTINAL PEPTIDE AS MFG. IN BELMONT, CALIFORNIA

8957

II

2/5/1991

RENAL KETO ACID PRODUCT AS MFG. IN NORTH CHICAGO, ILLINOIS

8958

III

1/25/1991

ABBOTT LABS CHEM AND AGRICULTURAL PRODS


DIV
BASF AKTIENGESELLSCHAFT

NOVOLEN 1300 L AS MFG. IN WESSELING, GERMANY

Page 248

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8959 I
I
1/31/1991
QP CORP

SUBJECT
MANUFACTURING SITE IN SASHIMA-GUN, IBARAKI, JAPAN

8960

II

2/4/1991

KONGO CHEMICAL CO LTD

PHENIRAMINE MALEATE AS MFG. IN JAPAN

8961

1/30/1991

RP SCHERER

8962

III

1/16/1991

BASF AKTIENGESELLSCHAFT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BEINHEIM, FRANCE.
NOVOLEN 1300 H MANUFACTURED IN WESSELING, GERMANY.

8963

III

1/16/1991

BASF AKTIENGESELLSCHAFT

NOVOLEN 2500 HX MANUFACTURED IN WESSELING, GERMANY.

8964

II

2/4/1991

CALBIOCHEM-BEHRING CORP

DODECYL-B-D-MALTOSIDE AS MFG. IN LA JOLLA, CALIFORNIA

8965

II

2/5/1991

ATENOLOL MANUFACTURED IN LATINA, ITALY.

8966

III

2/4/1991

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
VALSPAR KOLACK CORPORATION AG

8967

II

2/15/1991

SIEGFRIED USA LLC

VENLAFAXINE HYDROCHLORIDE AS MFG. IN PENNSVILLE, NEW JERSEY

8968

III

2/11/1991

LUDWIG HEUMANN AND CO GMBH

LAQUERED ALUMINUM FOIL PACKAGING MANUFACTURED IN GERMANY.

8969

II

2/15/1991

ORGANICHEM CORP

PODOPHYLLOTOXIN AS MFG. IN HERLEV, DENMARK

8970

II

2/21/1991

ARCHIMICA LTD

ETHYL-4-N(N-BUTYLAMINO) BENZOATE AS MFG. IN ENGLAND

8971

II

2/5/1991

SIEGFRIED LTD

VENLAFAXINE HYDROCHLORIDE AS MFG. IN ZOFINGEN, SWITZERLAND

8972

II

2/14/1991

HELVOET PHARMA MARYLAND

CALCIUM LACTOBIONATE AS MFG. IN THANE, INDIA

8973

II

2/18/1991

SIFAVITOR SRL

IPRATROPIUM BROMIDE MANUFACTURED IN MILAN, ITALY.

8974

II

2/22/1991

IPSEN MANUFACTURING IRELAND LTD

SOMATULINE (BIM 23014C) AS MFG. IN DUBLIN, IRELAND

8975

II

2/1/1991

QUIMICA SINTETICA SA

FLUCONAZOLE AS MFG. IN MADRID, SPAIN

8976

III

2/15/1991

HELVOET PHARMA MARYLAND

RUBBER CLOSURE LZ412 AS MFG. IN SALISBURY, MARYLAND

8977

III

2/15/1991

LAWSON MARDON WHEATON PHARMATECH

RUBBER CLOSURE B5310-55 GRAY MANUFACTURED IN SALISBURY, MARYLAND.

8978

II

2/20/1991

DETERMINATION OF BROMPHENIRAMINE IN HUMAN PLASMA BY GAS LIQUI

8979

II

2/15/1991

WISCONSIN ANALYTICAL & RESEARCH SERVICES


LTD
LUSOCHIMICA SPA

8980

III

2/11/1991

BASF AKTIENGESELLSCHAFT

LUPOLEN 5041 H AS MFG. IN WESSLING, REPUBLIC OF GERMANY

8981

III

2/4/1991

GLAXO WELLCOME INC

PLASTIC PACKAGING COMPONENTS AS MFG. IN GREENVILLE, NC

8982

2/18/1991

FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY

8983

2/18/1991

GRUPPO LEPETIT SPA SUB MERRELL DOW


PHARMACEUTICALS INC
BIOCHIMICA DEL SALENTO SPA

8984

II

2/21/1991

FIRST SOUTHWEST PHARMACEUTICAL FACTORY

CIMETIDINE AS MFG. IN CHONGQING CITY, REPUBLIC OF CHINA

8985

II

2/26/1991

NORDION INT INC

INDIUM CHLORIDE (IN-111) AS MFG. IN KANATA, ONTARIO, CANADA

8986

II

2/25/1991

ENZYMATIX LTD

1,2-DIPALMITOYL-SN-GLYCEROL-3-PHOSPHOCOLINE DPPC AS MFG. UK

8987

II

1/7/1991

CHISSO CORP

CELLUFINE GC GEL FILTRATION CHROMATOGRAPHY MEDIA MFG. JAPAN

8988

1/7/1991

CHISSO CORP

FACILITIES AND OPERATING PROCEDURES IN MINAMAA, JAPAN

8989

II

1/7/1991

CHISSO CORP

CELLUFINE SULFATE AS MFG. IN MINAMAA, JAPAN

8990

II

2/27/1991

INDUSTRIE CHIMICHE ITALIANE SPA

TERFENADINE MANUFACTURED IN MILAN, ITALY.

8991

IV

2/26/1991

MATRIX PHARMACEUTICAL INC

COLLAGEN IN SYRINGES AS MFG. IN MENLO PARK, CALIFORNIA

8992

II

2/28/1991

MATRIX PHARMACEUTICAL INC

5-FU THERAPEUTIC IMPLANT AS MFG. IN MENLO PARK, CALIFORNIA

8993

II

2/28/1991

BAYER SCHERING PHARMA AG

CIPROFLOXACIN AS MANUFACTURED IN WUPPERTAL, FEDERAL REPUBLIC OF GERMANY

8994

3/1/1991

DANIPHARM APS

FACILITIES AND OPERATING PROCEDURES IN NIBE, DENMARK

INTERIOR COATING J 3092 AS MFG. IN KALTBRUNN, SWITZERLAND

IPRATROPIUM BROMIDE AS MFG. IN LOMAGNA (CO), ITALY

FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY

Page 249

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
8995 I
III
2/22/1991
SPECIALTY PACKAGING PRODUCTS INC

SUBJECT
LPA-19 PUMP AS MFG. IN BRIDGEPORT, CT. AND EL PASO, TEXAS

8996

II

2/25/1991

EURAND AMERICA INC

POTASSIUM CHLORIDE MICROCAPS COMPRESSIBLE AS MFG.-VANDALIA,OH

8997

IV

3/1/1991

NIPPON FINE CHEMICAL CO LTD

PHOSPHOLIPID PGE (L-A-PHOSPHATIDYL GLYCEROL) AS MFG. IN HYOGO, JAPAN

8998

II

3/26/1991

MARINE BIO CO LTD

PROTAMINE SULFATE (BULK) AS MFG. IN KAMAISHI, JAPAN

8999

II

3/4/1991

DIOSYNTH BV

APOMORPHINE HYDROCHLORIDE AS MFG. IN OSS, THE NETHERLANDS

9000

II

3/4/1991

ASPEN OSS BV

GONADERELIN DIACETATE TETRAHYDRATE MANUFACTURED IN OSS, HOLLAND.

9001

III

3/1/1991

HUHTAMAKI FORCHHEIM

HDPE FILM, QUALITY 24000, WHITE 71000 IN FORCHHEIM, GERMANY

9002

2/27/1991

KNOLL AG LUDWIGSHAFEN

9003

III

2/28/1991

SPECIALTY PACKAGING PRODUCTS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN UETERSEN, GERMANY.
PLP-20 PUMP MANUFACTURED IN BRIDGEPORT CONNECTICUT AND EL PASO, TEXSA.

9004

II

2/28/1991

PHOSPHOROUS-32 AS MFG. IN NORTH BILLERICA, MASSACHUSETTS

9005

IV

3/7/1991

PERKIN ELMER LIFE AND ANALYTICAL SCIENCES


INC
NIPPON FINE CHEMICAL CO LTD

9006

II

2/25/1991

BASF PHARMA (EVIONNAZ) SA

4-CHLORBUTANAL SODIUM BISULPHATE ADDUCT MFG. IN SWITZERLAND

9007

II

3/7/1991

ISP CHEMICALS LLC

SYNTHETIC PROCEDURE FOR MITOTANE MANUFACTURED IN COLUMBUS, OHIO.

9008

II

3/5/1991

BACHEM FEINCHEMIKALIEN AG

N-FMOC-L-LEUCINE SODIUM SALT MANUFACTURED IN BUBENDORF, SWITZERLAND.

9009

II

3/14/1991

EASTMAN CHEMICAL CO

VITAMIN E TPGS AS MFG. IN ROCHESTER, NEW YORK

9010

IV

3/28/1991

ROHM AND HAAS CO

AMBERLITE IRP-64 AS MFG. IN PHILADELPHIA, PENNSYLVANIA

9011

II

2/25/1991

GEO SPECIALTY CHEMICALS

GLYCINE AS MFG. IN DEER PARK, TEXAS

9012

III

2/28/1991

PHILLIPS PLASTICS CORP

GENTLE HAIR ACTUATORS MANUFACTURED IN EAU CLAIRE, WISCONSIN.

9013

3/13/1991

DUPONT MERCK PHARMACEUTICAL CO

9014

IV

3/13/1991

FRESENIUS KABI DEUTSCHLAND GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GENEVA, SWITZERLAND.
EGG YOLK PHOSPHOLIPID (EYP) MFG. IN KUNGSANGEN & STOCKHOLM

9015

IV

3/13/1991

NIPPON FINE CHEMICAL CO LTD

PHOSPHOLIPID DSPG (DISTEAROYL-L-A-PHOSPHATIDYL GLYCEROL)

9016

II

3/12/1991

TOMITA PHARMACEUTICAL CO LTD

MAGALDRATE AS MFG. IN NARUTO-CITY AND TOKUSHIMA-CITY, JAPAN

9017

II

3/13/1991

NOVARTIS PHARMACEUTICALS CORP

TESSALON DRUG SUBSTANCE AS MFG. IN SUMMIT, NEW JERSEY

9018

3/12/1991

SMITHKLINE BEECHAM PHARMACEUTICALS

FACILITIES AND OPERATING PROCEDURES IN TIANJIN, CHINA

9019

II

3/15/1991

FRESENIUS KABI CLAYTON L P

MCT LIPID EMULSION MANUFACTURED IN CLAYTON, NORTH CAROLINA.

9020

3/13/1991

SCICLONE PHARMACEUTICALS INC

PRECLINICAL STUDIES FOR THYMOSIN ALPHA 1 INJECTION

9021

II

3/8/1991

SIGMA F AND D DIV LTD

MYO-INOSITOL AS MFG. IN ST. LOUIS, MISSOURI

9022

III

3/4/1991

INTEGRATED PLASTIC TECHNOLOGIES

POLYPROPYLENE CLOSURES AS MFG. IN HOLYOKE, MASSACHUSETTS

9023

3/11/1991

MERCK PHARMACEUTICAL MANUFACTURING DIV

FACILITIES AND OPERATING PROCEDURES IN NORTHUMBERLAND, UK

9024

II

3/13/1991

RAYLO CHEMICALS

DOBUTAMINE HYDROCHLORIDE AS MFG. IN EDMONTON, ALBERTA, CANADA

9025

III

3/12/1991

MONTEBELLO PACKAGING

COLLAPSIBLE ALUMINUM TUBES AS MFG. IN HAWKESBURY, ONTARIO

9026

II

3/28/1991

BIOINDUSTRIA FARMACEUTICI SPA

INDAPAMIDE AS MFG. IN NOVI LIGURE, ITALY

9027

II

3/25/1991

AMERICAN BIO SYNTHETICS CORP

CAFFEINE AS MFG. IN MILWAUKEE, WISCONSIN

9028

II

3/28/1991

JOHNSON MATTHEY INC

DMP LACTATE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

9029

II

3/25/1991

CILAG CHEMIE AG

PYRIDOSTIGMINE BROMIDE MFG. IN SCHAFFHAUSEN, SWITZERLAND

9030

II

3/20/1991

GLUCONA BV

MAGNESIUM GLUCONATE AS MFG. IN TER APELKANATAL, NETHERLANDS

9031

III

3/18/1991

B BRAUN CO

DISPENSER SET 1 ML. AND 4 ML. MANUFACTURED IN MELSUNGEN, GERMANY.

PHOSPHOLIPID DMPC AS MFG. IN HYOGO, JAPAN

Page 250

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9032 I
II
3/27/1991
FARMITALIA CARLO ERBA SPA

SUBJECT
FCE 25913 (BAU) FINISHED DOSAGE FORM AS MFG. IN MILAN, ITALY

9033

II

3/27/1991

FARMITALIA CARLO ERBA SPA

FCE 25913 (BAU) ACTIVE DRUG SUBSTANCE AS MFG. IN MILAN, ITALY

9034

IV

3/25/1991

AMCOL HEALTH AND BEAUTY SOLUTIONS INC

9035

II

3/18/1991

ABBOTT LABS

METHYL METHACRYLATE/ETHYLENEGLYCOL DIMETHACRYLATE COPOLYMER MICROSPONGE


PRODUCT CODE E140.06
FENTANYL MANUFACTURED IN NORTH CHICAGO, ILLINOIS.

9036

III

3/27/1991

BRYCE CORP

FLEXIBLE PACKAGING LAMINATION MANUFACTURED IN MEMPHIS, TENNESSEE.

9037

II

3/29/1991

OMNICHEM NV

PANCURONIUM BROMIDE MANUFACTURED IN BELGIUM.

9038

II

3/29/1991

PROCOS SPA

TERFENADINE AS MFG. IN CAMERI (NOVARA), ITALY

9039

3/27/1991

NESTE CHEMICALS

9040

III

3/27/1991

BOREALIS AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BERINGEN, BELGIUM.
BORMED HD810MO AND BORMED HF840MO

9041

III

4/5/1991

MOBIL CHEMICAL CO

BICOR OPPALYATE TWL AS MFG. IN SHAWNEE, OKLAHOMA

9042

II

4/2/1991

ISOCHEM SAS

FLAVOXATE HYDROCHLORIDE AS MFG. IN GENNEVILLERS, FRANCE

9043

II

4/4/1991

FERMION OY

ALPRAZOLAM AS MFG. IN ESPOO AND HANKO, FINLAND

9044

II

4/2/1991

CHEMIE LINZ GES MBH

FIDOL, 3-(4-FLUORPHENYL)-1(METHLETHYL)-1H-INDOL IN AUSTRIA

9045

4/9/1991

SCIENCE LABORATORIES INC

9046

3/29/1991

SIEGFRIED CHEMICALS INC

9047

4/9/1991

SANKYO CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MINNEAPOLIS, MINNESOTA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TAIPEI, TAIWAN.
FACILITIES AND OPERATING PROCEDURES IN HIRASUKA-SHI, JAPAN

9048

II

4/9/1991

SANKYO CO LTD

BULK CS-045 ORAL HYPOGLYCEMIC AS MFG. IN HIRASUKA-SHI, JAPAN

9049

II

4/3/1991

UNITED GUARDIAN INC

IDOSENE SURGICAL SCRUB AS MFG. IN HAPPAUGE, NEW YORK

9050

II

4/10/1991

SUMIKA FINE CHEMICALS CO LTD

CHLORPHENESIN CARBAMATE AS MFG. IN ANPACHIGUN, JAPAN

9051

II

4/11/1991

CHISSO CORP

CELLUFINE GH-25 AS MFG. IN MINAMAA, JAPAN

9052

IV

4/12/1991

GATTESFOSSE SA

GELEOL STEARATE 4000(STEARATE 4000 SD) AND GELOT 64(GELOT SD)

9053

II

4/11/1991

CARLBIOTECH LTD AS

DESMOPRESSIN ACETATE AS MFG. IN COPENHAGEN, DENMARK

9054

IV

4/10/1991

LYONDELLBASELL INDUSTRIES

1200 GRADE AND 1250 GRADE ALCOHOL AS MFG. IN TUSCOLA,ILLINOIS

9055

II

3/4/1991

ULTRADENT PRODUCTS INC

5% SANQUANARINE CHLORIDE (PERIOGARD) AS MFG. IN SANDY, UTAH

9056

4/9/1991

INSTITUTE FOR CLINICAL PET

CLINICAL AND PRECLINCAL DATA ON FLUDEOXYGLUCOSE F-18 INJECTION

9057

II

4/9/1991

INSTITUTE FOR CLINICAL PET

FLUDEOXYGLUCOSE F-18 INJECTION

9058

II

4/5/1991

GEMFIBROZIL AS MFG. IN FIRENZE, ITALY

9059

II

4/17/1991

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
ROUSSEL LABORATORIES LTD

9060

II

4/15/1991

ZAMBON GROUP SPA

DIFLUNISAL AS MFG. IN VICENZA, ITALY

9061

II

4/15/1991

ESTEVE QUIMICA SA

CARBIDOPA AS MFG. IN BARCELONA, SPAIN

9062

4/11/1991

QUALIS INC

9063

4/16/1991

ALMU SA

9064

II

3/25/1991

QUIMICA SINTETICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DES MOINES, IOWA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN ZENETA (MURCIA) SPAIN.
INDAPAMIDE AS MFG. IN MADRID, SPAIN

9065

II

4/18/1991

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA

PENTAMIDINE ISETHIONATE AS MFG. IN WILTSHIRE, ENGLAND

TERBUTALINE SULFATE AS MFG. IN CARONNO PERTUSELLA, ITALY

Page 251

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9066 I
I
4/12/1991
KAWAKEN FINE CHEMICALS CO LTD
9067

II

4/12/1991

KAWAKEN FINE CHEMICALS CO LTD

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN KAWAGOE CITY, JAPAN.
DIHYDROLYSERGIC ACID AS MFG. IN SAITAMA, JAPAN

9068

II

4/12/1991

KAWAKEN FINE CHEMICALS CO LTD

DIHYDROELYMOCLAVINE AS MFG. IN SAITAMA, JAPAN

9069

4/17/1991

AZIENDE CHIMICHE RIUNITE

FACILITIES AND OPERATING PROCEDURES IN ANCONA, ITALY

9070

II

3/29/1991

FINE CHEMICALS CORP PTY LTD

GLIPIZIDE AS MFG. IN CAPE PROVINCE, SOUTH AFRICA

9071

II

4/17/1991

SIEGFRIED AG

GEMFIBROZIL AS MFG. IN ZOFINGEN, SWITZERLAND

9072

III

4/19/1991

AC FOLIEN GMBH

PVC FILM AS MFG. IN MULLHEIM, GERMANY

9073

II

4/19/1991

GIST BROCADES

EXOMETHYLENE CEPH V SULFOXIDE ESTER AS MFG. IN NETHERLANDS

9074

II

4/19/1991

ZACH SYSTEM

MILNACIPRAN AS MFG. IN AVRILLE, FRANCE

9075

4/22/1991

SANOFI WINTHROP LTD.

9076

II

4/23/1991

CLARIANT LIFE SCIENCE MOLECULES UK LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MANCHESTER, ENGLAND.
AMINOBENZOATE POTASSIUM AS MFG. IN SANDYCROFT, ENGLAND

9077

4/26/1991

GUIDELINES ANALYTICAL LABORATORIES INC

9078

II

4/20/1991

ATUL PRODUCTS LTD

9079

4/20/1991

ATUL PRODUCTS LTD

9080

II

4/26/1991

FIRST SOUTHWEST PHARMACEUTICAL FACTORY

9081

II

4/30/1991

TIPREDANE AS MFG. BY LINSON LTD./SWORDS IN DUBLIN, IRELAND

9082

II

4/15/1991

BRISTOL MYERS SQUIBB PHARMACEUTICAL


RESEARCH INSTITUTE
BASF AKTIENGESELLSCHAFT

9083

5/1/1991

SOLCHEM ITALIANA SPA

9084

II

3/25/1991

QUIMICA SINTETICA S A

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MILAN, ITALY.
FAMOTIDINE AS MFG. IN MADRID, SPAIN

9085

III

4/30/1991

CUSTOM PACK INC

CUSTOM THERMOFORMING AND FOAM FABRICATION IN PENNSYLVANIA

9086

III

4/17/1991

CEBAL

BLISTER FOIL AS MFG. IN BRIGNOUD, FRANCE

9087

II

4/29/1991

AESICA QUEENBOROUGH LTD

ISOFLURANE MANUFACTURED IN QUEENBOROUGH, KENT, ENGLAND.

9088

4/29/1991

ABBOTT LABORATORIES LTD

FACILITIES AND OPERATING PROCEDURES IN QUEENBOROUGH, ENGLAND

9089

III

4/4/1991

AT PLASTICS

PACKAGING MATERIALS A 910 AND A 720 MB MFG. IN CANADA

9090

III

5/1/1991

HEINKE TECHNOLOGY INC

PACKAGING MATERIAL FOR DISPOSABLE VAGINAL CREAM APPLICATOR

9091

II

5/1/1991

LEBSA LABORATORIOS ESPINOSY BOFILL SA

ELGODIPINE HYDROCHLORIDE AS MFG. IN BARCELONA, SPAIN

9092

II

5/1/1991

LIFECORE BIOMEDICAL

SODIUM HYALURONATE MANUFACTURED IN MINNEAPOLIS, MINNESOTA.

9093

II

4/29/1991

GANES CHEMICALS INC

ETHYL 4-(BUTYLAMINO) BENZOATE - CARLSTADT AND PENNSVILLE, NJ

9094

II

5/3/1991

EASTMAN KODAK CO

FLUORESCEIN MFG. IN ROCHESTER, NEW YORK

9095

II

4/18/1991

NORDION CANADA INC

STRONTIUM-82 AS MFG. IN VANCOUVER, B.C., CANADA

9096

II

5/1/1991

WHATMAN

D322 DIETHYLAMINOETHYL CELLULOSE MFG. IN KENT, ENGLAND

9097

4/11/1991

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HODDESDON, HERTFORD, UNITED KINGDOM.

9098

MERCK SHARP & DOHME RESEARCH LABS,


DEVELOPMENT LABS
NOT AN ASSIGNED NUMBER

9099

II

4/30/1991

KERFOOT PHARMACEUTICALS

KETOPROFEN MANUFACTURED IN LANCANSHIRE, ENGLAND.

9100

II

5/6/1991

HOECHST MARION ROUSSEL SA

HYDROXOCOBALAMIN BASE MANUFACTURED IN FRANCE.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MIAMI, FLORIDA.
CLIOQUINOL AS MFG. IN GUJARA, INDIA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN GUJARA, INDIA.
RANITIDINE AS MFG. IN CHOGQING CITY, REPUBLIC OF CHINA

VITAMIN A ACETATE, 1.0 MIO I.U./GRAM AS MFG. IN GERMANY

Page 252

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9101 N
NOT AN ASSIGNED NUMBER

SUBJECT

9102

II

5/2/1991

SIPSY

BUTOXOCORT PROPIONATE AS MFG. IN AVRILLE CEDEX, FRANCE

9103

II

4/30/1991

SIPSY SNC

AMIFOSTINE AS MFG. IN AVRILLE CEDEX, FRANCE

9104

II

5/15/1991

BASF PHARMACHEMIKALIEN GMBH CO KG

XYLOMETAZOLINE HYDROCHLORIDE MFG. IN MINDEN, GERMANY

9105

4/3/1991

VITA TECH INTERNATIONAL INC

9106

II

5/6/1991

FARMITALIA CARLO ERBA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TUSTIN, CALIFORNIA.
FCE 23884 ACTIVE DRUG SUBSTANCE AS MFG. IN MILAN, ITALY

9107

5/6/1991

FARMITALIA CARLO ERBA SPA

9108

II

5/6/1991

FARMITALIA CARLO ERBA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF FCE 23884 IN MILAN, ITALY.
FCE 23884 0.20 AND 0.50 MG TABLETS MFG. IN MILAN, ITALY

9109

II

5/7/1991

MALLINCKRODT CHEMICAL INC

OXYMORPHONE HYDROCHLORIDE AS MFG. IN ST. LOUIS, MISSOURI

9110

II

5/6/1991

SIEGFRIED AG

METOPROLOL TARTRATE MANUFACTURED IN ZOFINGEN, SWITZERLAND.

9111

5/14/1991

YUKI GOSEI KOGYO CO LTD

9112

II

5/14/1991

YUKI GOSEI KOGYO CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF SULFADIAZINE SILVER IN JAPAN.
SULFADIAZINE SILVER MFG. IN JOBAN, JAPAN

9113

II

4/30/1991

MERCK AG

4-DIMETHYLAMINOPHENOL HYDROCHLORIDE AS MFG. SWITZERLAND

9114

4/22/1991

FINAF 92 SA

9115

II

4/22/1991

ESTEVE QUIMICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TARRAGONA, SPAIN.
SODIUM DICLOFENAC MANUFACTURED IN TARRAGONA, SPAIN.

9116

5/7/1991

PHARMA TECH INDUSTRIES INC

9117

III

5/7/1991

NATIONAL WAX CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN UNION, MISSOURI.
CEREPLAX 4628 WAX COATING MFG. IN SKOKIE, ILLINOIS

9118

II

5/13/1991

ARCH PHARMALABS LTD

PIROXICAM MANUFACTURED IN THANE, MAHARASHTRA, INDIA.

9119

II

5/13/1991

ARCH PHARMALABS LTD

IBUPROFEN MANUFACTURED IN THANE, MAHARSHTRA, INDIA.

9120

5/13/1991

SEKHSARIA CHEMICALS PRIVATE LTD

9121

4/30/1991

9122

5/16/1991

YUNG SHIN PHARMACEUTICAL INDUSTRIES CO


LTD
PHARMACIA AND UPJOHN INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN THANE, INDIA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TAIWAN, CHINA.
MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN
JOHANNESHOV, SWEDEN.

9123

NOT AN ASSIGNED NUMBER

9124

NOT AN ASSIGNED NUMBER

9125

9126

III

5/13/1991

STYROLUTION GMBH

LURAN 368 R MFG. IN LUDWIGSHAFEN, GERMANY

9127

II

5/20/1991

NV ORGANON

BUTORPHANOL TARTRATE MFG. IN APELDOORN, THE NETHERLANDS

9128

II

5/20/1991

DIOSYNTH BV

ALPRAZOLAM MFG. IN AK APELDOORN, THE NETHERLANDS

9129

II

5/15/1991

PFANSTIEHL LABORATORIES INC

SUCROSE, N.F. (HIGH PURITY) MFG. IN WAUKEGAN, ILLINOIS

9130

III

5/17/1991

HELVOET PHARMA MARYLAND

RUBBER CLOSURE R2502-50 TAN MANUFACTURED IN SALISBURY, MARYLAND.

9131

II

5/9/1991

ASPEN OSS BV

HEPARIN SODIUM (PEROXIDE PURIFICATION PROCESS)-OSS, NETHERLANDS

9132

II

4/30/1991

ONY INC

INFASURF MFG. IN AMHERST, NEW YORK

9133

5/20/1991

ELDER PHARMACEUTICALS LTD

9134

III

5/22/1991

CONSOLIDATED CONTAINER CO LLC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NEW BOMBAY, INDIA.
CONTAINERS MANUFACTURED IN VERONA, PENNSYLVANIA

NOT AN ASSIGNED NUMBER

Page 253

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9135 I
III
5/15/1991
BASF AKTIENGESELLSCHAFT

SUBJECT
NOVOLEN 1100 N MFG. IN WESSLING, REPUBLIC OF GERMANY

9136

II

5/20/1991

GEDEON RICHTER USA INC

NORGESTREL MANUFACTURED IN BUDAPEST, HUNGARY.

9137

III

5/22/1991

CROWN CORK AND SEAL COMPANY INC

PILFER PROOF CAP MANUFACTURED BY CROWN BENDER IN GERMANY.

9138

III

5/15/1991

UNION CAMP CORP

PAPER/LOW DENSITY POLYETHYLENE MFG. IN NORTH CAROLINA

9139

II

5/29/1991

FRONTIER SCIENTIFIC INC

NPE6 DRUG SUBSTANCE MFG. IN LOGAN, UTAH

9140

II

5/21/1991

SCHERING AG

ILOPROST MFG. IN BERLIN, FEDERAL REPUBLIC OF GERMANY

9141

II

5/16/1991

INSTITUTE FOR CLINICAL PET

F-18 FLUDEOXYGLUCOSE (MICHIGAN SYNTHESIS)

9142

IV

5/24/1991

DS INDUSTRIE APS

ESTARAM T SUPPOSITORY BASES MFG. IN COPENHAGEN, DENMARK

9143

II

5/31/1991

ABBOTT LABS

ARBUTAMINE MFG. IN NORTH, CHICAGO, ILLINOIS

9144

II

5/30/1991

EGIS PHARMACEUTICALS

SULFAMETHOXAZOLE MFG. IN BUDAPEST, HUNGARY

9145

III

5/23/1991

MITSUI CHEMICALS INC

TPX MFG. IN YAMAGUCHI, JAPAN

9146

III

5/29/1991

BOREALIS AG

BORMED DM55PHARM AS MANUFACTURED IN BURGHAUSEN, GERMANY

9147

II

5/31/1991

PFANSTIEHL, INC

SODIUM GLUCONATE MFG. IN WAUKEGAN, ILLINOIS

9148

5/21/1991

YUKI GOSEI KOGYO CO LTD

9149

II

6/5/1991

FINE CHEMICALS CORP LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF PROTAMINE SULFATE IN TOKYO, JAPAN.
INDAPAMIDE MFG. IN CAPE PROVINCE, SOUTH AFRICA

9150

6/3/1991

MICRA BIOTECHNOLOGIES INC

9151

II

6/5/1991

NIPPON FINE CHEMICAL COMPANY LTD

9152

5/21/1991

DIACEL CHEMICAL INDUSTRIES LTD

9153

III

5/24/1991

UNITED CLOSURES AND PLASTICS PLC

9154

6/4/1991

GATTEFOSSE AG

9155

IV

6/10/1991

ROQUETTE FRERES

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LUCERNE, SWITZERLAND.
BETA CYCLODEXTRIN MFG. IN LESTREM, FRANCE

9156

II

6/7/1991

RASCHIG GMBH

3-ACETYLPRYIDINE MFG. IN LUDWIGSHAFEN, GERMANY

9157

II

6/6/1991

SUMITOMO CHEMICAL CO LTD

TERAZOSIN HYDROCHLORIDE MFG. IN GIFU AND OSAKA, JAPAN

9158

II

5/3/1991

ZACH SYSTEM

4-METHOXY-2,3,6-TRIMETHYLBENZALDEHYDE MFG. IN CEDEX, FRANCE

9159

II

6/4/1991

SYNTHELABO BP

ZOLPIDEM TARTRATE MANUFACTURED IN MOURENX, FRANCE.

9160

II

6/10/1991

PENNISULA LABORATORIES INC

PEPTIDE E MFG. IN BELMONT, CALIFORNIA

9161

6/11/1991

FARMHISPANIA SA

9162

II

6/12/1991

PHARMACEUTICAL WORKS POLPHARMA S.A

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BARCELONA, SPAIN.
NIFEDIPINE MFG. IN STAROGARD GDANSKI, POLAND

9163

IV

2/25/1991

POLIOLES SA DE CV

POLYETHYLENE GLYCOLS (PEG'S) MFG. IN LERMA ESTADO DE MEXICO

9164

IV

2/25/1991

POLIOLES SA DE CV

PROPYLENE GLYCOL (MPG) AND DYPROPYLENE GLYCOL IN MEXICO

9165

II

6/13/1991

NORAMCO OF DELAWARE INC

PERINDOPRIL ERBUMINE MANUFACTURED IN WILMINGTON, DELAWARE.

9166

II

4/4/1991

FERSINSA GIST BROCADES SA DE CV

7-ADCA MANUFACTURED IN COAHUILA, MEXICO.

9167

II

6/11/1991

EXCELLA GMBH

BUSPIRONE HYDROCHLORIDE MANUFACTURED IN NURNBERG, GERMANY.

9168

6/13/1991

JB LABS

FACILITY AND OPERATING PROCEDURES IN HOLLAND, MICHIGAN

9169

II

6/12/1991

ROMAN INDUSTRIES COMPANY LTD

UROFOLLITROPIN MANUFACTURED IN KANAGAWA-KEN, JAPAN.

9170

II

6/12/1991

ROMAN INDUSTRIES COMPANY LTD

MENOTROPINS MFG. IN KANAGAWA-KEN, JAPAN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FORT LEE, NEW JERSEY.
PHOSPHOLOPID DMPG MFG. IN HYOGO, JAPAN
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN AARI-CITY, JAPAN.
X825 PLASTIC CLOSURE MATERIAL MFG. IN NORWICH, ENGLAND

Page 254

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9171 A
II
6/10/1991
ORIL INDUSTRIE

SUBJECT
PERINDOPRIL ERBUMINE MFG. IN BOLBEC, FRANCE

9172

II

6/14/1991

BAYER AG

METRIFONATE DRUG SUBSTANCE MFG. IN GERMANY

9173

II

6/14/1991

BAYER AG

METRIFONATE DRUG PRODUCT MFG. IN GERMANY

9174

III

5/23/1991

COSTAR NUCLEPORE

QMC CARTRIDGE MEDIA FILTERS MFG. IN PLEASANTON, CALIFORNIA

9175

III

5/23/1991

COSTAR NUCLEPORE

QR2 CARTRIDGE FILTERS MFG. IN PLEASANTON, CALIFORNIA

9176

III

5/23/1991

COSTAR NUCLEPORE

QS CARTRIDGE FILTERS MFG. IN PLEASANTON, CALIFORNIA

9177

II

6/13/1991

GIULINI CHEMIE GMBH

DIHYDROXY ALUMINUM SODIUM CARBONATE - LUDWIGSHAFEN, GERMANY

9178

6/17/1991

VAN DEN BERGH FOODS CO

FACILITIES AND OPERATING PROCEDURES IN JOLIET, ILLINOIS

9179

II

6/11/1991

ZACH SYSTEM

1,3 PROPANEDIOL 2 PHENYL MFG. IN AVRILLE CEDEX, FRANCE

9180

III

6/11/1991

SPARTECH PLASTICS

THERMOPLASTIC SHEET TYPE PES-HD-PES MFG. IN PORTAGE, WI

9181

III

6/11/1991

SPARTECH PLASTICS

THERMOPLASTIC SHEET TYPE PES-PP-PES MFG IN PORTAGE, WI

9182

III

6/11/1991

AMPACET CORP

11246 BLUE-WHITE PEMB MFG. IN TARRYTOWN, NEW YORK

9183

IV

6/12/1991

ALZA CORP

GITS MFG. IN VACAVILLE AND MOUNTAIN VIEW, CALIFORNIA

9184

6/25/1991

ABIC LTD

9185

II

6/14/1991

QUIMICA SINTETICA S A

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NETANYA, ISRAEL.
MEFENAMIC ACID MFG. IN MADRID, SPAIN

9186

6/21/1991

PERIMMUNE INC

9187

II

6/17/1991

PFANSTIEHL LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF LAK CELLS.
PODOPHYLLOTOXIN MFG. IN WAUKEGAN, ILLINOIS

9188

II

6/25/1991

FERMION OY

PRAZOSIN HYDROCHLORIDE MFG. IN ESPOO AND HANKO, FINLAND

9189

II

6/14/1991

QUIMICA SINTETICA S A

BUSPIRONE MFG. IN IN MADRID, SPAIN

9190

III

7/30/1991

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5002-45 RED MANUFACTURD IN MARYLAND.

9191

II

6/17/1991

IRE

SODIUM MOLYBDATE MO-99 (FISSON) PURIFICATION IN BELGIUM

9192

II

6/24/1991

AVANTI POLAR LIPIDS INC

1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE MFG. IN ALABAMA

9193

6/25/1991

KNOLL PHARMA CHEMICALS

9194

II

6/13/1991

APPLIED BIOSYSTEMS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NOTTINGHAM, ENGLAND.
ISIS 1082 MFG. IN FOSTER CITY, CA. (TRANS. TO BIOL. 7/10/91)

9195

6/13/1991

APPLIED BIOSYSTEMS

FACILITIES IN FOSTER CITY, CA. (TRANS. TO BIOLOGICS-7/10/91)

9196

II

6/26/1991

PERIMMUNE INC

ATENOLOL MFG. IN KARNATAKA, INDIA

9197

III

6/26/1991

AMPACET CORP

11171 WHITE PE MB MFG. IN TARRYTOWN, NEW YORK

9198

6/26/1991

B P R L FINE CHEMICALS P LTD

9199

III

6/20/1991

TRICON

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KARNATAKA, INDIA.
HOSTAPHAN RN 100 MFG. IN FREIBURG, REPUBLIC OF GERMANY

9200

II

6/26/1991

ORION CORP LTD FERMION

TRIAZOLAM MANUFACTURED IN ESPOO AND HANKO, FINLAND.

9201

IV

6/17/1991

BLANVER FARMOQUIMICA LTDA

TABULOSE AND TABULOSE-FG MFG. IN COTIA, BRAZIL

9202

6/28/1991

SOCHINAZ SA

FACILITIES AND OPERATING PROCEDURES IN VIONNAZ, SWITZERLAND

9203

6/27/1991

ASTA MEDICA AG

FACILITIES AND OPERATING PROCEDURES IN CARINTHIA, AUSTRIA

9204

6/24/1991

LIBBY LABS

9205

III

6/24/1991

SCHWEIZ SCHOTT AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BERKELEY, CALIFORNIA.
PRIMARY PACKAGING MATERIAL (VIALS, CARTRIDGES) MANUFACTURED IN ST. GALLEN
SWITZERLAND

Page 255

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9206 A
III
6/24/1991
SCHOTT DE MEXICO SA DE CV
9207

II

7/1/1991

CHISSO CORP

SUBJECT
PRIMARY PACKAGING MATERIAL (VIALS, AMPULS, SYRINGES, CARTRIDGES) MANUFACTURED
IN VERA CRUZ MEXICO
CM CELLUFINE C - 200 MFG. IN MINAA, JAPAN

9208

II

7/1/1991

CHISSO CORP

DEAE CELLUFINE A - 200 MANUFACTURED IN MINAA, JAPAN.

9209

II

7/1/1991

CHISSO CORP

CM CELLUFINE C - 500 MFG. IN MINAA, JAPAN

9210

II

7/1/1991

CHISSO CORP

CM CELLUFINE C - 40 MFG. IN MINAA, JAPAN

9211

II

7/1/1991

CHISSO CORP

DEAE CELLUFINE A - 800 MFG. IN MINAA, JAPAN

9212

II

7/1/1991

CHISSO CORP

DEAE CELLUFINE A - 500 MFG. IN MINAA, JAPAN

9213

II

6/25/1991

NEN LIFE SCIENCE PRODUCTS

YTTRIUM-90 (YTTRIUM CHLORIDE) AS MFG. IN MASSACHUSETTS

9214

II

6/25/1991

EI DUPONT DE NEMOURS & CO

RHENIUM-186 AS SODIUM PERRHENATE (NARE04) MFG. MASSACHUSETTS

9215

III

7/3/1991

4P FOLIE FORCHHEIM GMBH

EUROPHAN FILM QUALITY 89014 MFG. IN FORCHHEIM GMBH

9216

II

6/21/1991

NV ORGANON

PYRIDOSTIGMINE BROMIDE MFG. IN APELDOORN, THE NETHERLANDS

9217

III

5/31/1991

UNITED CLOSURES AND PLASTICS PLC

CLICLOC CLOSURES MFG. IN NORWICH, ENGLAND

9218

II

5/15/1991

OMNICHEM SA

NEFAZODONE II MFG. IN WETTERN, BELGIUM

9219

II

7/3/1991

CIPLA LTD

PODOPHYLLOTOXIN MFG. IN INDIA

9220

IV

5/12/1991

EMPTY HARD GELATIN CAPSULES MANUFACTURED IN JERUSALEM, ISRAEL.

9221

II

7/3/1991

CAPSPHARMA ENTERPRISE LTD SCIENCE BASED


INDUSTRIES CAMPUS
EGIS PHARMACEUTICALS PUBLIC LTD CO

9222

7/16/1991

CHEMIE LINZ AG

FACILITY IN LINZ, AUSTRIA

9223

IV

6/26/1991

GIVAUDAN ROURE CORP

FRAGRANCE PA-71038 MFG. IN CLIFTON, NEW JERSEY

9224

III

7/9/1991

NESTE CHEMICALS

POLYPROPYLENE PRODUCT XB18 66MN MFG. IN PORVOO, FINLAND

9225

II

6/28/1991

VEGEFLORA EXTRACOES DO NORDESTE LTDA

PILOCARPINE NITRATE MANUFACTURED IN PARNAIBA, BRAZIL.

9226

7/9/1991

NESTE CHEMICALS

FACILITIES AND OPERATING PROCEDURES IN PORVOO, FINLAND

9227

6/10/1991

ANTIVIRAL STUDY GROUP INFORMATION TO SUPPORT CLINICAL STUDIES

9228

II

7/11/1991

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY AND INFECTIOUS DISEASES
UCB MANUFACTURING IRELAND LIMITED

9229

II

7/9/1991

MDS NORDION

SODIUM IODIDE I-131 MFG. IN FLEURUS, BELGIUM

9230

II

7/10/1991

WYCKOFF CHEMICAL CO INC

SELEGILINE HYDROCHLORIDE MFG. IN SOUTH HAVEN, MICHIGAN

9231

II

7/11/1991

BACHEM SA

CARBIDOPA MANUFACTURED IN VIONNAZ, SWITZERLAND.

9232

II

8/1/1991

DIOSYNTH BV

NOMEGESTROL ACETATE MFG. IN OSS, THE NETHERLANDS

9233

III

7/29/1991

3M PHARMS

PHARMACEUTICAL GRADE TRANSFER ADHESIVE MFG. IN MINNESOTA

9234

7/2/1991

E MERCK (INDIA) LTD

9235

II

7/2/1991

IPCA LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF CHLOROQUIN PHOSPATE IN INDORE, INDIA
CHLOROQUINE PHOSPHATE MFG. IN INDORE, INDIA

9236

7/2/1991

IPCA LABORATORIES LTD

FACILITY FOR BULK DRUG PRODUCTION IN INDORE INDIA

9237

II

7/2/1991

IPCA LABORATORIES LTD

PROBENECID USP AS MFG. IN RATLAM, MADHYA PRADESH, INDIA

9238

II

7/2/1991

BDH PHARMACEUTICALS LTD

IBUPROFEN BULK DRUG SUBSTANCES MFG. IN IN INDORE, INDIA

9239

7/10/1991

GLAXO WELLCOME INC

9240

II

7/10/1991

BURROUGHS WELLCOME (INDIA) LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BOMBAY, INDIA.
TRIMETHOPRIM BULK DRUG PRODUCT MFG. IN BOMBAY, INDIA

9241

II

7/15/1991

MEDEA RESEARCH LABORATORIES INC

HYDROXYUREA MFG. IN PORT JEFFERSON STATION, NEW YORK

CAPTOPRIL MANUFACTURED IN BUDAPEST, HUNGARY.

ISOSORBIDE DINITRATE DILUTED MFG IN SHANNON, IRELAND

Page 256

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9242 I
II
7/16/1991
SANDOZ PHARMA LTD

SUBJECT
TIZANIDINE HYDROCHLORIDE MFG IN BASLE, SWITZERLAND

9243

7/16/1991

HISAMITSU PHARMACEUTICAL CO INC

9244

7/15/1991

KOS PHARMACEUTICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TOKYO, JAPAN.
FACILITIES AND PROCEDURES IN HOLLYWOOD, FLORIDA AND AKRON,OHIO

9245

III

7/11/1991

AMPACET CORP

11418-F WHITE HDPE MB MFG. IN TARRYTOWN, NEW YORK

9246

III

7/10/1991

BASF AKTIENGESELLSCHAFT

ULTRAPEK KR 4175, 4176, 4177 AND 4178 MFG.-LUDWIGSHAFEN, FRG

9247

III

7/16/1991

AMPACET CORP

11912 WHITE PE MB MFG. IN TARRYTOWN, NEW YORK

9248

II

7/3/1991

SIGMA F AND D DIV LTD

N-DODECYL B-D-MALTOSIDE, PRODUCT NO. D 4641 IN ST.LOUIS, MO.

9249

6/19/1991

CHEDOKE MCMASTER HOSP

9250

II

6/19/1991

CHEDOKE MCMASTER HOSP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HAMILTON, ONTARIO, CANADA.
18F 2-FLUORO-2-DEOXYGLUCOSE MFG. IN HAMILTON, ONTARIO, CANADA

9251

II

7/18/1991

ORION CORPORATION FERMION OULU PLANT

DEXMEDETOMIDINE MFG IN OULU, FINLAND

9252

7/19/1991

GRUPPO LEPETIT SPA

FACILITIES AND PROCEDURES IN GERENZANO (VARESE), ITALY

9253

III

7/22/1991

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B-5001-55 PEARL GRAY-SALISBURY,MD

9254

III

9/6/1988

3M

SCOTCHPAK BRAND HEAT SEALABLE POLYESTER FILM NO. 113

9255

7/22/1991

9256

II

7/24/1991

DRAXIMAGE DIV DRAXIS SPECIALTY


PHARMACEUTICALS INC
MILES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KIRKLAND, QUEBEC, CANADA.
PENTEX HUMAN TRANSFERRIN, IRON SAURATED MFG. IN KANKAKEE, IL

9257

II

7/26/1991

MEDICHEM SA

MEXILETINE HYDROCHLORIDE MFG. IN GERONA, SPAIN

9258

7/23/1991

MERCKLE GMBH

FACILITIES AND PROCEDURES IN BLAUBEUREN, GERMANY

9259

II

7/23/1991

HOFFMANN LA ROCHE INC

FLUCYTOSINE CAPSULES AND MACHING PLACEBO MFG. IN NEW JERSEY

9260

II

7/22/1991

PHARMAGLOBE LABS LTD

LINOLENIC ACID MFG. IN WINDSOR, NOVA SCOTIA, CANADA

9261

II

7/26/1991

PROSTINEX

GLIPIZIDE MFG. IN VILLANTERIO (PAVIA), ITALY

9262

II

7/23/1991

CHEMSPEC CHEMICALS PRIVATE LTD

GUAIFENESIN MFG. IN BOMBAY, INDIA

9263

II

7/30/1991

NOF CORP

DIPALMITOYL PHOSPHATIDYL CHOLINE (DPPC) MFG. IN HYOGO, JAPAN

9264

II

7/26/1991

ROHM AND HAAS CO

AMBERLITE IRP-88 POLACRILIN POTASSIUM NF AS MANUFACTURED IN CHAUNY, FRANCE

9265

II

7/31/1991

7-AMINOCEPHALOSPORANIC ACID BULK INTERMEDIATE MFG. IN KOREA

9266

II

7/30/1991

CHEIL FOODS AND CHEMICALS INC


PHARMACEUTICAL DIV
ABBOTT LABORATORIES

9267

II

7/31/1991

NORDION CANADA INC

YTTRIUM-90 CHLORIDE RADIOCHEMICAL MFG. IN CANADA

9268

II

7/17/1991

ZACH SYSTEM

FELBAMATE MFG. IN AVRILLE CEDEX, FRANCE

9269

II

7/31/1991

FARMHISPANIA SA

CAPTOPRIL MFG. IN BARCELONA, SPAIN

9270

II

8/5/1991

MEDICHEM SA

ETIDRONATE DISODIUM MFG. IN CELRA (GERONA), SPAIN

9271

III

6/4/1991

HEAT SEAL PACKAGING

FOILGUARD # W***BF10V MFG. IN QUEBEC, CANADA

9272

II

8/1/1991

BPRL FINE CHEMICALS PRIVATE LTD

NIFEDIPINE BULK DRUG SUBSTANCE MFG. IN BANGALORE, INDIA

9273

8/5/1991

STRATHMANN BIOTECH HANOVER

9274

8/1/1991

PENN PHARMACEUTICALS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HANNOVER, GERMANY.
FACILITIES AND OPERATING PROCEDURES IN TREDEGAR, ENGLAND

9275

II

8/5/1991

DIPHARMA FRANCIS SRL

SELEGILINE HYDROCHLORIDE MFG. IN MILAN, ITALY

9276

II

8/9/1991

PENINSULA LABS

ARG-9-ARG(RMP-7 DRUG SUBSTANCE) MFG. IN BELMONT, CALIFORNIA

9277

II

8/6/1991

PHARMECO LABS INC

DIPIVEFRIN MFG. IN SIMI VALLEY, CALIFORNIA

9-(S)-ERYTHROMYCYLAMINE MFG. IN NORTH CHICAGO, ILLINOIS

Page 257

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9278 A
II
8/9/1991
EMBIO LTD

SUBJECT
L-EPHEDRINE HYDROCHLORIDE MFG. IN MAHARASHTRA, INDIA

9279

8/7/1991

E MERCK

FACILITIES AND PROCEDURES IN DARMSTADT, GERMANY FOR SODIUM FLUORIDE

9280

II

8/7/1991

E MERCK

SODIUM FLUORIDE MFG. IN DARMSTADT, GERMANY

9281

II

8/7/1991

GLOBE ORGANICS LTD

1,1 METHYLAMINO METHYLTHIO 2-NITROTHENE AS MFG. IN INDIA

9282

II

8/13/1991

FINE CHEMICALS CORPORATION

FLUPHENAZINE ENANTHATE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

9283

II

8/13/1991

ASAHI OPTICAL CO LTD

PENTAX HYDROXYAPAITE MFG. IN TOKYO, JAPAN

9284

II

8/12/1991

AVANTI POLAR LIPIDS INC

1,2-DIMYRISTOYL-SN-GLYCERO-3[PHOSPHO-RAC-(1-GLYCEROL)] ALABASTER, AL

9285

II

8/12/1991

AVANTI POLAR LIPIDS INC

CHOLESTEROL MFG. IN ALABASTER, ALABAMA

9286

III

8/8/1991

SPARTECH PLASTICS

THERMOPLASTIC SHEET TYPE PP SHEET MFG. IN PORTAGE, WISCONSIN

9287

8/16/1991

AESCULAPIUS-PHARMA SA

FACILITIES AND PROCEDURES IN MEZZOVICO, SWITZERLAND

9288

II

8/13/1991

PHARMAGLOBE LABS LTD

LINOLEIC ACID MFG. IN WINDSOR, NOVA SCOTIA, CANADA

9289

II

8/7/1991

BAYER PHARMA AG

AZELAIC ACID MFG. IN BERLIN, GERMANY

9290

IV

8/15/1991

NUTRI LITE PRODS INC

CALCIUM CARBONATE GRANULAR L13-075 MFG. IN LAKEVIEW, CA.

9291

II

8/27/1991

UROKINASE MFG. IN SHANGHAI, CHINA

9292

II

8/2/1991

SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL


LABORATORIES
PHARMAGLOBE LABS LTD

9293

III

8/2/1991

SPARTECH PLASTICS

HDPE PLASTIC SHEET MFG. IN PORTAGE, WISCONSIN

9294

II

8/20/1991

PHARMACEUTICAL WORKS POLPHARMA SA

METRONIDAZOLE MFG. IN GDANSKI, POLAND

9295

III

8/21/1991

MEGAS BEAUTY CARE INC

RAYON AND COTTON BOTTLE FILLING MATERIAL MANUFACTURED IN POMFRET,


CONNECTICUT.

9296

9297

8/20/1991

SHIONOGI AND CO LTD

9298

8/20/1991

KATSURA CHEMICAL CO LTD

9299

II

8/21/1991

PENINSULA LABS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KANEGASAKI, JAPAN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN YAMAGATA, JAPAN.
SECRETIN (PORCINE) MANUFACTURED IN BELMONT, CALIFORNIA.

9300

III

8/14/1991

EXXONMOBIL CHEMICAL CANADA

ESCORENE POLYETHYLENE MANUFACTURED IN SARNIA, ONTARIO, CANADA.

9301

II

8/16/1991

ISHIHARA SANGYO KAISHA LTD

QUINUCLIDINE HYDROCHLORIDE HEMIHYDRATE MANUFACTURED IN YOKKAICHI, JAPAN.

9302

8/16/1991

ISHIHARA SANGYO KAISHA LTD

9303

II

8/23/1991

CYGNUS THERAPEUTIC SYSTEMS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN YOKKAICHI CITY, JAPAN.
DEXMEDETOMIDINE TRANSDERMAL SYSTEM (DEXMED TX) REDWOOD CITY, CA.

9304

II

8/26/1991

BEST MEDICAL BELGIUM SA

XENON XE-133 MFG. IN FRANCE, BELGIUM AND THE NETHERLANDS

9305

8/1/1991

XTTRIUM LABS INC

FACILITIES FOR THE MANUFACTURING OF ANTIMICROBIAL PRODUCTS

9306

II

8/26/1991

DOW CHEMICAL CO MICHIGAN DIV

AMINOGUANIDINE HYDROCHLORIDE MANUFACTURED IN MIDLAND, MICHIGAN.

9307

II

8/22/1991

PFIZER INC

PREDNISOLONE SODIUM PHOSPHATE MFG. IN KALAMAZOO, MICHIGAN

9308

II

8/29/1991

CHISSO CORP

OCTYL-CELLUFINE HYDROPHOBIC INTERACTION CHROMATOGRAPHY MEDIA

9309

II

8/29/1991

CHISSO CORP

PHENYL-CELLUFINE HYDROPHOBIC INTERACTION CHROMATOGRAPHY MEDIA

9310

II

8/29/1991

CHISSO CORP

FORMYL-CELLUFINE AN AFFINITY CHROMATOGRAPHY MEDIA MFG. JAPAN

9311

II

8/29/1991

CHISSO CORP

HYDROPHOBIC INTERACTION CHROMATOGRAPHY MEDIA MANUFACTURD IN JAPAN.

9312

II

8/30/1991

CYANAMID UK LTD

PROPRANOLOL HYDROCHLORIDE MFG. IN GOSSPORT, HANTS, ENGLAND

TERFENADINE MFG. IN REXDALE, ONTARIO, CANADA

NOT AN ASSIGNED NUMBER

Page 258

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9313 I
I
8/27/1991
SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL
LABORATORIES
9314 I
I
8/30/1991
REXAM CLOSURES

SUBJECT
MANUFACTURING FACILITIES FOR CHORIONIC GONADOTROPIN IN CHINA

9315

III

8/27/1991

BASF AKTIENGESELLSCHAFT

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN EVANSVILLE AND PRINCETON, INDIANA
POLYSTYROL 436C MFG. IN LUDWIGSHAFEN, GERMANY

9316

III

8/27/1991

BASF AKTIENGESELLSCHAFT

ULTRAFORM W2320 007 MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

9317

II

9/2/1991

SUMIKA FINE CHEMICALS CO LTD

NIFEDIPINE MANUFACTURED IN OKAYAMA, JAPAN.

9318

9/4/1991

TILLOTTS PHARMA AG

9319

III

8/26/1991

WATSON STANDARD CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ZIEFEN, SWITZERLAND.
JVHS-157-1 VINYL ACRYLIC HEAT SEAL COATING, MANUFACTURED IN HARWICK, PA

9320

II

8/30/1991

BIOSPECIA LTD

9321

III

9/3/1991

OWENS ILLINOIS INC

MENOTROPIN MANUFACTURED BY ANACLIN LIMITED IN SITTINGBOURNE, KENT, UNITED


KINGDOM.
THERMOPLASTIC CLOSURES AND PACKAGING MANUFACTURED IN CONSTANTINE, MI

9322

II

9/3/1991

THATCHER CHEMICAL COMPANY

HEXACHLOROPHENE SOAP SOLUTION MANUFACTURED IN SALT LAKE CITY, UTAH.

9323

IV

9/5/1991

EASTMAN CHEMICAL CO

EASTMAN CELLULOSE ACETATE (CA-398-10NF)

9324

9/5/1991

SAUTER LABORATORIES LTD

FACILITIES AND OPERATING PROCEDURES IN GENEVA, SWITZERLAND

9325

9/3/1991

ALPS PHARMACEUTICAL IND CO LTD

9326

9/3/1991

ALPS PHARMACEUTICAL IND CO LTD

9327

III

9/6/1991

AMPACET CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KAMINO, JAPAN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MUKAIMACHI, JAPAN.
10358-F SLIP PE MB MFG. IN TARRYTOWN, NEW YORK

9328

III

9/6/1991

AMPACET CORP

10477-F ANTIBLOCK PE MB MFG. IN TARRYTOWN, NEW YORK

9329

II

9/4/1991

BACHEM FEINCHEMIKALIEN AG

H-LEU-LEU-OME HYDROCHLORIDE MFG. IN BUBENDORF, SWITZERLAND

9330

III

9/6/1991

LEIDEL CORP

INJECTION MOLDED PRODUCTS MFG. IN FARMINGDALE, NEW YORK

9331

9/5/1991

GEN THERAPEUTICA VERTRIEBS GMBH AND CO

FACILITIES AND OPERATING PROCEDURES IN BAD ZWISCHENAHN,GERMANY

9332

II

9/5/1991

BOEHRINGEER INGELHEIM PHARMA KG

PILOCARPINE HYDROCHLORIDE MFG. IN BRAZIL BY MERCK/VEGETEX

9333

II

9/5/1991

TECHNOCHEMIE GMBH

METHOXYCARBONYL-METHYLENE-TRIPHENYL-PHOSPHORANEYLID-ESTER

9334

III

9/10/1991

HELVOET PHARMA MARYLAND

RUBBER FORMULATION B5310-55 BLACK MFG. IN SALISBURY,MARYLAND

9335

II

9/6/1991

ISOCHEM SA

1,4-DITHIA-7-AZASPIRO[4,4]NONANE-8-(S)CARBOXYLIC ACID-HYDROBR

9336

II

9/6/1991

APOMORPHINE MFG. IN LYON, FRANCE

9337

III

9/9/1991

LABORATOIRE AGUETTANT PARC SCIENTIFIC


TONY GARNIER RUE ALEXANDER FLEMMING
HELVOET PHARMA MARYLAND

9338

9/6/1991

FACILITIES AND PROCEDURES FOR THE MFG. OF APOMORPHINE, FRANCE

9339

IV

9/10/1991

LABORATOIRE AGUETTANT PARC SCIENTIFIC


TONY GARNIER RUE ALEXANDER FLEMMING
HENRY H OTTENS MANUFACTURING CO INC

9340

IV

9/10/1991

HENRY H OTTENS MANUFACTURING CO INC

POWDERED NATURAL/ARTIFICAL LEMON JUICE FLAVOR #4968 IN PENNSY

9341

IV

9/10/1991

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL CHERRY RASPBERRY FLAVOR #5091(ALCOHOL FREE)

9342

II

8/31/1991

FINE CHEMICALS CORPORATION

TRIAZOLAM MFG. IN CAPE PROVINCE, SOUTH AFRICA

9343

II

8/31/1991

FINE CHEMICALS CORPORATION

ALPRAZOLAM MFG. IN CAPE PROVINCE, SOUTH AFRICA

9344

II

9/16/1991

WHATMAN

SODIUM CELLULOSE PHOSPHATE MFG. IN SPRINGFIELD MILL, ENGLAND

9345

III

9/18/1991

FUJI PHOTO FILM CO LTD

ASTRO PORE PSM CARTRIDGE MFG. IN MINAMIASHIGARA CITY, JAPAN

9346

9/5/1991

TAIHO PHARMACEUTICAL CO INC

FACILITIES AND PROCEDURES FOR TAZOBACTAM BULK DRUG

RUBBER FORMULATION B5011-55 BLACK MFG. IN SALISBURY,MARYLAND

SPRAY DRIED ARTIFICIAL VANILLA CREAM FLAVOR S-208,PENNSYLVANI

Page 259

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9347 I
I
9/19/1991
GUJARAT DRUGS AND CHEMICALS LTD

SUBJECT
FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES - INDIA

9348

II

9/19/1991

INFAR INDIA LTD

METOCLOPRAMIDE AND ITS RELATED HYDROCHLORIDE SALT MFG. INDIA

9349

9/19/1991

AMUCHINA SPA

FACILITY FOR THE MFG. OF AMUCHINA 10% IN CASELLA(GENOVA) ITALY

9350

IV

9/18/1991

GATTESFOSSE SA

SUPPOCIRE P SERIES EXCIPIENTS MFG. IN SAINT-PRIEST FRANCE

9351

II

9/6/1991

HYOSCYAMINE SULFATE MFG. IN INGELHEIM, GERMANY

9352

II

9/16/1991

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
GANES CHEMICALS INC

9353

III

9/18/1991

PUBLIC STOCK CORPORATION OYJ

NASAL ADAPTER MFG. IN NURMIJARVI, FINLAND

9354

III

9/24/1991

HELVOET PHARMA MARYLAND

RUBBER FORMULATION N4003-45 RED MFG. IN SALISBURY, MARYLAND

9355

II

9/27/1991

AMICON DIV WR GRACE AND CO

AMICON MATRIX SILICA REVERSED PHASE CHROMATOGRAPHY MEDIA

9356

II

10/1/1991

HUMAN CHORIONIC GONADOTROPIN MFG. IN SHANGHAI, CHINA

9357

9/20/1991

SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL


LABORATORIES
HIGHLAND PACKAGING CO

9358

II

9/26/1991

PANTETHINE MFG. IN IBARAGI-KEN, JAPAN BY DAINIPPON INK

9359

II

9/23/1991

DAINIPPON INK AND CHEMICAL INC BIOCHEMICAL


DIV
SA AJINOMOTO OMNICHEM NV

9360

II

10/2/1991

CHINA CHEMICAL SYNTHESIS IND CO LTD

NORFLOXACIN MFG. IN TAIWAN, THE REPUBLIC OF CHINA

9361

III

9/25/1991

UNITED STATES COTTON INC

100% COTTON COIL MFG. IN RIO RANCHO, NEW MEXICO

9362

IV

8/27/1991

BLANVER FARMOQUIMICA LTDA

SOLUTAB CROSCARMELLOSE SODIUM MFG. IN ITAPEVI - SP - BRAZIL

9363

9/7/1991

YUKI GOSEI KOGYO CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF ISONAZID IN JOBAN FACTORY, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.

9364

II

10/1/1991

EGIS PHARMACEUTICALS

PROCHLORPERAZINE MALEATE MFG. IN BUDAPEST, HUNGARY

9365

II

9/30/1991

TAKEDA PHARMACEUTICAL CO LTD

TAP-144-SR (3M) (22.5MG.) MANUFACTURED IN OSAKA AND FUJISAWA, JAPAN.

9366

II

10/2/1991

PENICK CORP

CODEINE MFG. IN NEWARK, NEW JERSEY

9367

II

10/3/1991

REGIS CHEM CO

4'-CARBETHOXYPHENYL-4-GUANIDINOBENZOATE HCL MFG. ILLINOIS

9368

II

10/2/1991

PENICK CORP

CODEINE SULFATE MFG. IN NEWARK, NEW JERSEY

9369

II

9/30/1991

SUMIKA FINE CHEMICALS CO LTD

DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN ANPACHIGUN, JAPAN.

9370

III

10/7/1991

HEAT SEAL PACKAGING

FOILGUARD #W***LP150V MFG. IN VAUDREUIL, QUEBEC, CANADA

9371

II

10/8/1991

DIOSYNTH BV

UROFOLLITROPHIN MFG. IN OSS AND BOXTEL, THE NETHERLANDS

9372

10/7/1991

FACILITIES AND OPERATING PROCEDURES IN OSAKA, JAPAN

9373

II

10/7/1991

HARIMA FACTORY OF TEIKOKU CHEMICAL


INDUSTRIES
NAGASE FINE CHEMICALS LTD

9374

II

10/4/1991

SYNTEX PHARMACEUTICALS INTERNATIONAL LTD

AMIPRILOSE HYDROCHLORIDE MFG. IN FREEPORT, BAHAMA ISLAND

9375

10/14/1991

RESOLUTION CHEMICALS LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF AZATHIPRINE UPS MANUFACTURED BY MITCHELL COTTS CHEMICALS IN WEDGEWOOD
WAY, ENGLAND.

9376

II

10/9/1991

CAMBREX PROFARMACO MILANO SRL

ACEBUTOLOL HYDROCHLORIDE MFG. IN MILAN, ITALY

9377

III

10/8/1991

ALUMINUM COMPANY OF AMERICA

PHAR 9101 MFG. IN PITTSBURGH, PENNSYLVANIA

9378

III

10/8/1991

ALUMINUM COMPANY OF AMERICA

PHAR 9100 MFG. IN PITTSBURGH, PENNSYLVANIA

9379

III

10/10/1991

JAPAN GLASS INDUSTRY CO LTD

GLASS AMPULES, VIALS AND CARTRIDGES MFG. IN SHIZUOKA, JAPAN

9380

II

10/18/1991

DIASPA

DEMECLOCYCLINE HYDROCHLORIDE MFG. IN MILAN, ITALY

FELBAMATE MFG. IN CARLSTADT AND PENNSVILLE, NEW JERSEY

FACILITY IN BRANCHBURG TOWNSHIP, NEW JERSEY

6-MERCAPTOPURINE MFG. IN WETTERN, BELGIUM

S-(+)-2-(4`-ISOBUTYLPHENYL) PROPIONIC ACID (S-(+)-IBUPROFEN

Page 260

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9381 I
I
10/2/1991
BLIS TECH CORP
9382

II

10/23/1991

SANOFI CHIMIE

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN FAIRFIELD, NEW JERSEY.
ACEBUTOLOL HYDROCHLORIDE MFG. IN VITRY, FRANCE

9383

II

10/24/1991

TAENAKA KOGYO CO LTD

L-TYROSINE MFG. IN THE MOBARA PLANT, JAPAN

9384

II

10/24/1991

TAENAKA KOGYO CO LTD

L-GLUTAMIC ACID MANUFACTURED IN MOBARA, JAPAN.

9385

IV

10/24/1991

DOW CHEMICAL CO

CARBOWAX SENTRY METHOXYPOLYETHYLENE GLYCOL MFG. NEW YORK

9386

II

10/24/1991

MALLINCKRODT INC

DESMOPRESSIN MANUFACTURED IN ST. LOUIS, MISSOURI

9387

II

10/25/1991

WEST GRAND CORP

THEOPHYLLINE MFG. IN MILWAUKEE, WISCONSIN

9388

10/28/1991

SYNPAC CHEMICALS LTD

FACILITIES AND OPERATING PROCEDURES IN CAMBOIS, ENGLAND

9389

10/16/1991

YONEYAMA YAKUHIN KOGYO CO LTD

FACILITIES AND OPERATING PROCEDURES A THE MIKUNI PLANT

9390

III

10/25/1991

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 6031 M MFG. IN WESSLING, GERMANY

9391

III

9/24/1991

BASF AKTIENGESELLSCHAFT

NOVOLEN 3204 PCX MFG. IN E-TARRAGONA, SPAIN

9392

III

9/24/1991

BASF AKTIENGESELLSCHAFT

NOVOLEN 3200 H MFG. IN E-TARRAGONA, SPAIN

9393

II

10/18/1991

DAICEL CHEMICAL INDUSTRIES LTD

9394

III

10/21/1991

CREST FLEXIBLE PACKAGING LTD

N-{1-(S)-ETHOXYCARBONYL-3-PHENYLPROPYL}-(S)-ALANINE MANUFACTURED IN NIGATA,


JAPAN.
SACCHET OVERWRAP MFG. IN GILLINGHAM, KENT, ENGLAND

9395

III

10/21/1991

CREST FLEXIBLE PACKAGING LTD

BLISTER PACK PEELABLE LIDDING MATERIAL MFG. IN KENT, ENGLAND

9396

10/18/1991

TORAY INDUSTRIES INC

FACILITIES FOR THE MFG. OF BERAPROST SODIUM IN NAGOYA, JAPAN

9397

11/5/1991

CHEMAGIS LTD

MANUFACTURING SITE FOR PENTOXIFYLLINE MFG. IN BEER SHEVA, ISRAEL

9398

III

11/1/1991

SOCIETE ALSACIENE D' ALUMINUM

DRUG PHARMACEUTICAL BLISTER MFG.IN SELESTA CEDEX, FRANCE

9399

II

10/31/1991

JOHNSON MATTHEY INC

SUFENTANIL CITRATE (GENERIC) MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

9400

II

11/1/1991

MALLADI DRUGS AND PHARMACEUTICALS LTD

PSEUDOEPHEDRINE BASE MFG. IN THEIR PLANT LOCATED IN TAMILNADU, INDIA

9401

III

11/5/1991

BESPAK DIV CONSORT MEDICAL PLC

BESPAK BK 681 VALVE MFG. IN NORFOLK, ENGLAND

9402

11/5/1991

BIOKINE TECHNOLOGY LTD

FACILITIES FOR THE MFG. OF GLUCOSAMINYLMURAMYL PEPTIDES

9403

IV

10/21/1991

CERESTAR USA INC

BETA-CYCLODEXTRIN MFG. IN HAMMOND, INDIANA

9404

10/21/1991

AMERICAN MAIZE-PRODUCTS COMPANY

FACILITIES AND OPERATING PROCEDURES IN HAMMOND, INDIANA

9405

II

11/8/1991

MAY AND BAKER LTD

PROMETHAZINE HYDROCHLORIDE MFG. IN DAGENHAM, ESSEX, ENGLAND

9406

II

11/14/1991

SIFAVITOR SRL

METRONIDAZOLE BENZOATE MFG. IN MILAN, ITALY

9407

III

11/19/1991

KAITO CHEMICAL INDUSTRY CO LTD

PORTION PACK A, B, AND C MFG. IN NODA (CHIBA) JAPAN

9408

II

11/11/1991

SANDOZ GMBH

9409

III

11/5/1991

ROLLPRINT PACKAGING PRODUCTS INC

PYCA.HI (PYRIDINIUM-7-AMINOCEPHALOSPORANIC ACID HYDROIODIDE) MFG. IN KUNDL,


TYROL, AUSTRIA
RPP #36-1054 PACKAGING MATERIAL MFG. IN ADDISON, ILLINOIS

9410

11/5/1991

BIRCHWOOD LABORATORIES INC

FACILITY IN EDEN PRAIRIE, MINNESOTA

9411

II

11/15/1991

BIO RAD LABORATORIES INC

BIO-GEL HTP (HYDROXYAPATITE) MANUFACTURED IN RICHMOND, CALIFORNIA.

9412

II

11/15/1991

BACHEM FEINCHEMIKALIEN AG

AC-ARG-PRO-ASP-PRO-PHE-NH2 CITRATE MFG. IN BUBENDORF, SWITZERLAND

9413

11/20/1991

H LUNDBECK & CO AS

FACILITY IN NYKOBING SJ., DENMARK

9414

II

11/20/1991

H LUNDBECK & CO AS

SERTINDOLE BULK DRUG SUBSTANCE MFG. IN NYKOBING SJ., DENMARK

9415

II

11/14/1991

TERFENADINE MFG. IN CARONNO, PERTUSELLA (VA), ITALY

9416

11/21/1991

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE


SPA
SQUIBB MANUFACTURING INC

FACILITIES FOR THE MFG. OF SEMISOLIDS IN HUMACAO, PUERTO RICO

Page 261

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9417 I
II
11/15/1991
ALDRICH CHEMICAL COMPANY INC

SUBJECT
COPPER (II) CHLORIDE DIHYDRATE MFG. IN MILWAUKEE, WISCONSIN

9418

II

11/22/1991

CMIC CMO CO LTD

TRANEXAMIC ACID MFG. IN SHIZUOKA PREFECTURE, JAPAN

9419

II

11/25/1991

KYOWA HAKKO KOGYO CO LTD

L-ASPARAGINASE MFG. IN HOFU CITY, JAPAN

9420

IV

11/22/1991

ROQUETTE FRERES

HYDROXY-PROPYL BETA-CYCLODEXTRIN MFG. IN LESTREM, FRANCE

9421

II

10/22/1991

ABBOTT LABS

GLIPIZIDE MFG. IN NORTH CHICAGO, ILLINOIS

9422

II

11/29/1991

TANABE SEIYAKU CO LTD

L-ISOLEUCINE MFG. IN OSAKA, JAPAN

9423

III

11/21/1991

CREST FLEXIBLE PACKAGING LTD

CHILD-RESISTANT SACHET OVERWRAP MFG. IN GILLINGHAM, KENT, ENGLAND

9424

III

11/21/1991

CREST FLEXIBLE PACKAGING LTD

EASI-TEAR OVERWRAP MFG. IN GILLINGHAM, KENT, ENGLAND

9425

11/25/1991

CARBOGEN LABORATORIES AG

FACILITIES AND OPERATING PROCEDURES IN ZURICH, SWITZERLAND

9426

IV

11/27/1991

AQUALON CO

CMC CARBOXYMETHYLCELLULOSE SODIUM MFG. IN HOPEWELL, VIRGINIA

9427

11/8/1991

PROMETIC BIOSCIENCES LIMITED

9428

12/2/1991

9429

IV

11/1/1991

JOHNSON AND JOHNSON PHARMACEUTICAL


RESEARCH AND DEVELOPMENT LLC
WILD FLAVORS INC

9430

II

12/3/1991

LUSOCHIMICA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FREEPORT, BRITISH ISLES.
NON-CLINICAL PHARMACOLOGY TOXICOLOGY STUDIES ON HYDROXYPROPYL-BETACYCLODEXTRIN (ENCAPSIN HPB)
ARTIFICIAL SWEETNESS FLAVOR (284) #409284 AND/OR ARTIFICIAL SWEETNESS FLAVOR
#40928T
GLIBENCLAMIDE MANUFACTURED IN PISA, ITALY.

9431

II

11/1/1991

MEISSNER FILTRATION PRODUCTS INC

ALPHA AND VANGUARD FILTER CARTRIDGES MFG. IN CAMARILLO CALIFORNIA

9432

II

11/1/1991

MEISSNER FILTRATION PRODUCTS INC

9433

II

11/27/1991

JUZEN CHEMICAL CO., LTD.

NYLUX, CHEMDYNE, ULTRADYNE AND STYLUX FILTER CARTRIDGES MFG IN CAMARILLO,


CALIFORNIA
CARBIDOPA AS MFG. BY JUZEN CHEMICAL CO., LTD. IN TOYAMA-CITY, JAPAN

9434

II

11/25/1991

GANES CHEMICALS INC

SODIUM DIETHYLDITHIOCARBAMATE MFG. IN CARLSTADT, NEW JERSEY

9435

II

11/14/1991

FETUIN (PEDERSEN) MFG. IN TORONTO, ONTARIO, CANADA

9436

II

10/28/1991

WAITAKI INTERNATIONAL BIOSCIENCES SUB


WAITAKI CANADA LTD
PTI ADVANCED FILRATION INC

9437

II

12/2/1991

SANDOZ GMBH

CEPHALOSPORIN C SODIUM MFG. IN KUNDL, AUSTRIA

9438

II

11/15/1991

BIO-RAD LABORATORIES

BIO-GEL HT (HYDROXYAPAITE) MANUFACTURERD IN RICHMOND, CALIFORNIA.

9439

III

12/3/1991

VETROPACK LTD.

RAW MATERIALS AND MFG. OF GLASS BOTTLES IN WAUWIL, SWITZERLAND

9440

II

11/11/1991

QUIMICA SINTETICA S A

KETOTIFEN FUMERATE MFG. IN MADRID, SPAIN

9441

II

11/27/1991

PENICK CORP

OXYCODONE TEREPHTHALATE MFG. IN NEWARK, NEW JERSEY

9442

II

11/27/1991

LUSOCHIMICA S P A

ACEBUTOLOL HYDROCHLORIDE MFG. IN LOMAGNA, ITALY

9443

II

11/11/1991

QUIMICA SINTETICA S A

ASTEMIZOLE MFG. IN MADRID, SPAIN

9444

12/10/1991

DERIVADOS QUIMICOS S A

FACILITIES AND OEPRAING PROCEDURES IN MURCIA, SPAIN

9445

II

12/10/1991

DSM ANDENO

9446

12/10/1991

DSM ANDENO

9447

II

12/5/1991

PHARMACHEM CORP

METHYL (2R,3S)-(-)-3-(4-METHOXYPHENYL) OXIRANE-2-CARBOXYLATE (MEFA) MFG. IN


VENLO, THE NETHERLANDS
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN VENLO, THE NETHERLANDS.
DEXTRAN SULFATE MFG. IN BETHLEHEM, PENNSYLVANIA

9448

II

11/12/1991

EXPANSIA

POLY A. POLY U BULK DRUG MFG. IN ARAMON, FRANCE

9449

II

12/12/1991

MEISEI CHEMICAL WORKS LTD

POLY(ETHYLENE OXIDE) ALKOX R-400 PF MFG. IN TSU-CITY, JAPAN

9450

II

12/12/1991

MEISEI CHEMICAL WORKS LTD

POLY(ETHYLENE OXIDE) ALKOX E-160 PF MFG. IN TSU-CITY, JAPAN

POLYFLOW AND POLYFLOW PROTECTOR MANUFACTURED IN NEWBURY PARK, CALIFORNIA.

Page 262

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9451 I
I
12/12/1991
MEISEI CHEMICAL WORKS LTD

SUBJECT
FACILITIES AND OPERATING PROCEDURES IN TSU-CITY, JAPAN

9452

III

12/12/1991

HEINKE TECHNOLOGY INC

VCA-3 VAGINAL CREAM APPLICATOR MFG. IN LINCOLN, NEBRASKA

9453

12/16/1991

SIMAFEX

FACILITY IN MARANS, FRANCE

9454

II

12/9/1991

CHEMI SPA

5-AMINOSALICYLIC ACID (MESALAZINE) MFG. IN PARICA (FROSINONE), ITALY

9455

12/5/1991

BOEHRINGER MANNHEIM GMBH

PRODUCTION PLANT HC-B 4 AND EXTRACTION PLANT HC-B 10 IN MANNHEIM, GERMANY

9456

12/7/1991

FUJISAWA PHARMACEUTICAL COMPANY LTD

FACILITY LOCATED IN NAGOYA, JAPAN

9457

12/10/1991

FUJISAWA PHARMACEUTICAL COMPANY LTD

FACILITY LOCATED IN OSAKA, JAPAN

9458

II

12/13/1991

NORISTAN LTD

DICYCLOMINE HYDROCHLORIDE MFG. IN WALTLOO, PRETORIA, REP. OF SOUTH AFRICA

9459

12/11/1991

UNION QUIMICO FARMACEUTICA SA

9460

12/12/1991

9461

12/13/1991

MARION MERRELL DOW RESEARCH AND


DEVELOPMENT CENTRE
MITSUBISHI KASEI CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF CIMETIDINE USP IN BARCELONA, SPAIN.
FACILITIES LOCATED IN WINNERSH, BERKSHIRE, THE UNITED KINGDOM

9462

II

12/13/1991

BOEHRINGER MANNHEIM GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MIE PREFECTURE, JAPAN.
QUININE SULFATE MFG. IN MANNHEIM, GERMANY

9463

II

12/18/1991

MALLINCKRODT CHEMICAL INC

CALCITONIN, SALMON MANUFACTURED IN ST. LOUIS, MISSOURI.

9464

II

12/12/1991

CAMBRIDGE CHEMICAL INC

2,7-DIMETHYL-FMOC-L-LEUCINE MFG. IN MILWAUKEE, WISCONSIN

9465

II

12/19/1991

DOW CORNING CORP

SILASTIC MDF-0108 MEDICAL GRADE TUBING MANUFACTURD IN HEMLOCK, MICHIGAN.

9466

III

12/13/1991

SIEGWERK DRUCKFARBEN AG AND CO KGAA

9467

III

12/17/1991

TECH SEAL PRODUCTS INC

9468

II

12/18/1991

ROCHE DIAGNOSTICS GMBH

EPOXY AMINE TWO COMPONENT INKS FOR PRINTING POLYESTER FILMS, BARGEN BE,
SWITZERLAND
LINER MATERIALS AND TAMPER EVIDENCE INNERSEALS MANUFACTURED IN WHEELING,
WEST VIRGINIA.
CYTOSINE - ARABINOFURANOSIDE MFG. IN MANNHEIM, GERMANY

9469

II

12/19/1991

SCIENTIFIC PROTEIN LABORATORIES

DERMATAN SULFATE MFG. IN WAUNAKEE, WISCONSIN

9470

12/26/1991

KYORIN PHARMACEUTICAL CO LTD

9471

12/20/1991

LIPHA SA

FACILITIES FOR THE MFG. OF FLEROXACIN BULK DRUG SUBSTANCE AT THE OKAYA PLANT IN
NAGANO, JAPAN
FACILITIES AND PROCEDURES IN HERTFORDSHIRE AND MIDDLESEX, ENGLAND

9472

II

12/23/1991

SANOFI CHIMIE

HEPARIN SODIUM MFG. IN PLOERMEL, FRANCE

9473

IV

12/19/1991

MITSUBISHI KASEI CORP

SUCROSE STEARATE RYOTO MFG. IN MIE PREFECTURE, JAPAN

9474

II

12/26/1991

CYGNUS INC

FENTANYL TRANSDERMAL SYSTEM (FENTANYL TS)

9475

II

1/2/1992

APPLIED ANALYTICAL INDUSTRIES

SUCROSE OCTASULFATE, AMMONIUM SALT MFG. IN WILMINGTON, NORTH CAROLINA

9476

II

12/31/1991

DM GRAHAM LABORATORIES INC

ACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG. AS MFG. IN HOBART, NEW YORK

9477

II

11/25/1991

PIERRE FABRE MEDICAMENT

VINORELBINE DITARTRATE MFG. IN GAILLAC CEDEX, FRANCE

9478

II

12/31/1991

ASTELLAS PHARMA INC

CEFIXIME MFG. IN TAKAOKA, JAPAN

9479

II

12/16/1991

ASTELLAS PHARMA INC

7 ACA-A48 MFG. IN OSAKA, JAPAN

9480

II

12/16/1991

FUJISAWA PHARMACEUTICAL COMANY LTD

STERILE CEFAZOLIN SODIUM MFG. IN THE FUJI PLANT, JAPAN

9481

II

12/17/1991

PHARMECO LABORATORIES INC

LEVOBUNOLOL HYDROCHLORIDE MFG. IN SIMI VALLEY, CALIFORNIA

9482

II

1/8/1992

MEDICHEM SA

LEVOBUNOLOL HYDROCHLORIDE MFG. IN GERONA, SPAIN

9483

II

1/10/1992

BIOCHIMICA OPOS 2 SPA

9484

II

1/6/1992

BURROUGHS WELLCOME (INDIA) LTD

DOBUTAMINE HYDROCHLORIDE, BULK, NON STERILE PYROGEN FREE AS MFG. IN MILAN,


ITALY
PSEUDOEPHEDRINE HYDROCHLORIDE MANUFACTURED IN BOMBAY, INDIA.

Page 263

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9485 A
II
1/3/1992
EVONIK CORP

SUBJECT
GLYCYL-L-TYROSINE DIHYDRATE MFG. IN HAM, FRANCE

9486

II

1/3/1992

EVONIK COPORATION

L-ALANYL-L-GLUTAMINE MFG. IN HAM, FRANCE

9487

II

1/3/1992

EVONIK CORP

GLYCYL-L-GLUTAMINE MONOHYDRATE MFG. IN HAM, FRANCE

9488

II

1/6/1992

YONEYAMA YAKUHIN KOGYO CO LTD

L-LEUCINE MFG. AT THE MIKUNI PLANT, JAPAN

9489

II

1/7/1992

5N PLUS LUBECK GMBH

BISMUTH CITRATE MFG. IN LUBECK, GERMANY

9490

II

12/6/1991

SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD

HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN SHANGHAI, CHINA

9491

II

12/31/1991

AMRINONE MFG. IN CHONGQING SICHUAN, PEOPLE'S REPUBLIC OF CHINA

9492

IV

1/7/1992

CHONGQING PHARMACEUTICAL RESEARCH


INSTITUTE
SHAW MUDGE AND CO

9493

II

1/8/1992

LUSOCHIMICA SPA

NICARDIPINE HYDROCHLORIDE MFG. IN LOMAGNA, (C0), ITALY

9494

12/30/1991

EMS DOTTIKON AG

9495

II

1/14/1992

GIST BROCADES

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DOTTIKON, SWITZERLAND.
6-AMINOPENICILLANIC ACID (6-APA) MFG. IN DELFT, THE NETHERLANDS

9496

II

1/10/1992

SYNTHELABO RECHERCHE

ALPIDEM MFG. IN GARGENVILLE, FRANCE

9497

II

12/11/1991

RENKER GMBH AND CO KG

HOSTAPHAN RN 15 MFG. IN FREIBURG, GERMANY

9498

1/3/1992

OGDDEN BIOSERVICES CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

9499

III

12/20/1991

WEST CO INC

FASPAK ANTIBIOTIC CONTAINERS MFG. IN JERSEY SHORE, PENNSYLVANIA

9500

1/7/1992

FLEXCON CO

9501

II

1/10/1992

BASF SE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SPENCER, MASSACHUSETTS.
SOLUTOL HS 15 MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

9502

1/13/1992

BOEHRINGER MANNHEIM GMBH

CHEMICAL PLANT HC-B 21 LOCATED IN MANNHEIM, GERMANY

9503

IV

1/14/1992

ATOCHEM

ETHYLENE-VINYL ACETATE COPOLYMERS PELLETS MANUFACTURD IN ORTHEZ, FRANCE

9504

IV

1/14/1992

AMERICAN MAIZE PRODUCTS CO

HIGH FRUCTOSE CORN SYRUP MFG. IN DECATUR, ALABAMA AND DIMMITT, TEXAS

9505

II

1/17/1992

EVONIK DEGUSSA GMBH

GLYCYL-L-TYROSINE MANUFACTURED IN HANAU, FEDERAL REPUBLIC OF GERMANY.

9506

II

1/17/1992

EVONIK DEGUSSA GMBH

GLYCYL-L-GLUTAMINE MANUFACTURED IN HANAU, FEDERAL REPUBLIC OF GERMANY.

9507

1/17/1992

DEGUSSA AG

FACILITY FOR THE MANUFACTURING OF DIPEPTIDE IN HANAU, GERMANY

9508

II

10/16/1991

NATIONAL STARCH AND CHEMICAL CORP

OCTYL DIMETHYL AMINOBENZOATE

9509

III

1/13/1992

FERRO CORP

THERMOPLASTIC COMPOUNDS MFG. IN EVANSVILLE, INDIANA

9510

II

1/20/1992

SIFAVITOR SRL

CYCLOBENZAPRINE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY.

9511

II

4/30/1992

DEGUSSA CORP

ELCEMA MANUFACTURED IN ELLWANGEN-HOLZMUHLE, GERMANY

9512

III

1/17/1992

FINDLEY ADHESIVES, INC.

WATERBASED HEASEAL COATING C4408-01 MFG. IN WISCONSIN AND MICHIGAN

9513

II

1/17/1992

SASOL GERMANY GMBH

1-DOCOSANOL (BEHENYL ALCOHOL) MFG. IN BRUNSBUTTEL, GERMANY

9514

1/17/1992

SASOL NORTH AMERICA INC.

9515

III

1/24/1992

HELVOET PHARMA MARYLAND

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF 1-DOCOSANOL (BEHENYL ALCOHOL) IN BRUNSBUTTEL, GERMANY.
RUBBER CLOSURE FORMULATION B5015-50 GRAY

9516

1/22/1992

PHARMAGLOBE LABS LTD

FACILITIES AND PROCEDURES IN WINDSOR, NOVA SCOTIA, CANADA

9517

II

1/31/1992

RAYLO CHEMICALS

2',3',5'-TRI-O-ACETYLURIDINE MFG. IN EDMONTON, ALBERTA, CANADA

9518

II

1/27/1992

JOHNSON MATTHEY INC

ORMAPLATIN MFG. IN WEST DEPTFORD, NEW JERSEY

9519

1/27/1992

SCHERING PLOUGH INTERNATIONAL


PHARMACEUTICAL DEVELOPMENT LABORATORY

FACILITY IN DARDILLY, FRANCE

FRAGRANCE FORMULATIONS M-4600 AND U-8571 MFG. IN STAMFORD, CONNECTICUT

Page 264

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9520 I
II
1/23/1992
NATIONAL INSTITUTE CHILD HEALTH AND HUMAN
DEVELOPMENT
9521 I
II
1/15/1992
PROMETIC BIOSCIENCES LTD

SUBJECT
GONADOTROPIN RELEASING HORMONE (GNRH)

9522

III

1/20/1992

WESTLAKE LONGVIEW CORP

MIMETIC BLUE 1 A6XL CHROMATOGRAPHIC MEDIA MFG. IN THE FREEPORT, BALLASALLA,


ISLE OF MAN, BRITISH ISLES
LOW-DENSITY POLYETHYLENE (LDPE) AS MANUFACTURED IN LONGVIEW, TEXAS

9523

II

2/7/1992

HAARMANN AND REIMER CORP

NEO HELIOPAN OS (2-ETHYLHEXYL SALICYLATE) MFG. IN GOOSE CREEK, SOUTH CAROLINA

9524

III

1/8/1992

RHONE POULENC INC

9525

II

2/3/1992

9526

II

1/3/1992

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
LACHEMA BRNO

COLLOID 581B MFG. IN NEWARK, NEW JERSEY, MISSISSAUGA, ONTARIO AND LOS ANGELES,
CALIFORNIA
TERFENADINE MFG. IN LATINA, ITALY

9527

III

11/28/1991

ST GOBAIN DESJONQUERES SA SGD

AMBER TYPE 1 GLASS VIALS MANUFACTURED IN MERS LES BAINS, FRANCE.

9528

1/31/1992

RIEDEL DEHAEN AG

9529

II

1/29/1992

QUIMICA SINTETICA S A

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF PERFLUOROOCTYLBROMIDE MANUFACTURED IN SEELZE, GERMANY.
ETODOLAC MFG. IN MADRID, SPAIN

9530

II

1/3/1992

LACHEMA BRNO

ACYCLOVIR MFG. IN BRNO, CZECHOSLOVAKIA

9531

II

1/3/1992

LACHEMA BRNO

TAMOXIFEN CITRATE MFG. IN BRNO, CZECHOSLOVAKIA

9532

II

2/6/1992

ROCHE DIAGNOSTICS GMBH

GUAIACOL-O-ETHYLTOSYLATE MFG. IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY

9533

II

2/3/1992

ROCHE DIAGNOSTICS GMBH

4-HYDROXYCARBAZOLE MFG. IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY

9534

1/10/1992

OTSUKA PHARMACEUTICAL CO LTD

9535

II

1/29/1992

PROMETIC BIOSCIENCES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TOKUSHIMA, JAPAN.
LYSINE AGAROSE 6XL MFG. IN FREEPORT, BALLASALLA, ISLE OF MAN, BRITISH ISLES

9536

III

2/14/1992

MWV SLATERSVILLE LLC

POLYTOP AND POLYCAM CLOSURES MFG. IN SLATERSVILLE, RHODE ISLAND

9537

II

1/30/1992

INALCO SPA

LACTULOSE CRYSTALS MFG. IN PISTOIA, ITALY

9538

2/19/1992

TECH POULSON INC

9539

II

2/13/1992

PLIVA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SCOTTSDALE, ARIZONA.
METOPROLOL TARTRATE MFG. IN ZAGREB AND SAVSKI MAROF, CROATIA

9540

II

2/10/1992

CHEMI SPA

MICONAZOLE NITRATE MFG. IN PATRICA (FROSINONE), ITALY

9541

II

1/3/1992

LACHEMA BRNO

CARBOPLATIN MFG. IN BRNO, CZECHOSLOVAKIA

9542

2/7/1992

OGDEN BIOSERVICES CORP

9543

III

2/7/1992

GERRESHEIMER GLASS INC

9544

II

2/18/1992

SYNTHELABO PHARMACIE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROCKIVILLE, MARYLAND.
TUBULAR GLASS PACKAGING MATERIAL AS MANUFACTURED IN VINELAND, NJ;MORGANTON,
NC;FOREST GROVE, NJ;QUERETARO, MEXICO AND PISA, ITALY
THIAZEPIN MFG. IN MONTARGIS CEDEX, FRANCE

9545

II

2/10/1992

SELTZER CHEMS INC

9546

II

2/17/1992

PLANTEX LTD CHEM AND PHARM WORKS

9547

IV

2/13/1992

PHARMACEUTICAL INGREDIENTS LTD

9548

2/10/1992

VEREIN FUR KREBSFORSCHUNG

9549

II

2/10/1992

VEREIN FUR KREBSFORSCHUNG

FIBROSOL (MODIFIED CARBOXYMETHYLCELLULOSE SODIUM) MFG. IN ROCKY HILL, NEW


JERSEY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN ARLESHEIM, SWITZERLAND
ISCADOR MFG. IN ARLESHEIM, SWITZERLAND

9550

III

2/7/1992

SILGAN PLASTICS CANADA INC

PLASTIC CONTAINERS MFG. IN BRAMPTON AND MISSISSAUGA, ONTARIO, CANADA

9551

III

2/11/1992

HIGH POINT PACKAGING CORP

PACKAGING MATERIALS FOR BOTTLE MANUFACTURING

METHOTREXATE SODIUM MFG. IN BRNO, CZECHOSLOVAKIA

UBIDECARENONE (COENZYME Q 10) MFG. IN TOKYO, JAPAN BY DAINIPPON INK &


CHEMICALS, INC.
ETOPOSIDE MANUFACTURED IN NETANYA, ISRAEL.

Page 265

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9552 I
II
2/20/1992
SUMITOMO CHEMICAL CO LTD

SUBJECT
DIPIVEFRIN HYDROCHLORIDE MANUFACTURED IN GIGU-PREFECTURE AND OSAKA, JAPAN.

9553

II

12/11/1991

SEPRAGEN CORP

SUPERFLOW CHROMATOGRAPHY COLUMN MFG. IN SAN LEANDRO, CALIFORNIA

9554

III

2/10/1992

ALCO CHEMICAL

ALCOGUM 9710-P MANUFACTURED IN CHATTANOOGA, TENNESSEE.

9555

III

1/23/1992

PRODUCT HM-0777 MFG. IN VADNAIS HEIGHTS, MINNESOTA

9556

2/21/1992

HB FULLER CO RESEARCH AND DEVELOPMENT


LABORATORY
ASAHI CHEMICAL INDUSTRY CO LTD

9557

IV

2/21/1992

ASAHI KASEI CHEMICALS CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NOBEOKA, JAPAN.
PREGELATINIZED STARCH PCS MANUFACTURED IN NOBEOKA ANDKASHIHARA CITY, JAPAN

9558

II

2/21/1992

SEPPIC

MONTANIDE ISA 740 MANUFACTURED IN CASTRES, FRANCE.

9559

II

2/21/1992

SEPPIC

MONTANIDE ISA 206 MFG. IN CASTRES, FRANCE

9560

II

2/21/1992

SEPPIC

MONTANIDE ISA 25 MFG. IN CASTRES, FRANCE

9561

II

2/21/1992

SEPPIC

MONTANIDE ISA 720 MANUFACTURED IN CASTRES, FRANCE.

9562

II

11/22/1991

INTERFALK CANADA INC

9563

II

2/12/1992

INTERFALK CANADA INC

9564

II

3/6/1992

GILEAD SCIENCES INC

SALOFALK 250MG MESALAMINE ENTERIC COATED TABLETS MANUFACTURED BY SCHERING


CANADA, INC.
4G/240ML ENTERAL SUSPENSION 5-AMINOSALICYLIC ACID (MESALAMINE) MFG. BY
BIOPHARM INC.
AMBISOME, LIPOSOMAL AMPHOTERICIN B MANUFACTURED IN SAN DIMAS, CALIFORNIA.

9565

III

2/8/1992

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION R5001-55 RED MFG. IN SALISBURY, MARYLAND

9566

III

2/18/1992

SCHUBERT SEALS A/S

RUBBER COMPOUND NO. 6449 MFG. IN HORSENS, DENMARK

9567

III

2/18/1992

SCHUBERT SEALS A/S

RUBBER COMPOUND 6454 MANUFACTURED IN HORSENS, DENMARK.

9568

III

2/18/1992

SCHUBERT SEALS A/S

RUBBER COMPOUND NO. 41013 MANUFACTURED IN HORSENS, DENMARK.

9569

II

3/2/1992

KYOWA HAKKO KOGYO CO LTD

ADENOSINE TRIPHOSPHATE DISODIUM MANUFACTURED IN UBE, JAPAN.

9570

II

2/29/1992

PENINSULA LABS

[ASN1, VAL5] ANGIOTENSIN II MANUFACTURED IN BELMONT, CALIFORNIA.

9571

II

3/4/1992

PCR INC

ISOFLURANE MFG. IN GAINESVILLE, FLORIDA

9572

II

3/3/1992

MALLINCKRODT INC

NALTREXONE BASE AS MANUFACTURED IN ST. LOUIS, MISSOURI

9573

II

3/10/1992

MEDICHEM SA

CHLORHEXIDINE ACETATE MFG. IN GERONA, SPAIN

9574

2/28/1992

YUKI GOSEI KOGYO CO LTD

9575

III

3/5/1992

HELVOET PHARMA MARYLAND

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF GLYCINE IN IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.
RUBBER CLOSURE FORMULATION R2502-50 GRAY MFG. IN SALISBURY, MARYLAND

9576

III

3/2/1992

EVONIK INDUSTRIES

DEGALAN LP AL 23 MANUFACTURED IN WESSLING, GERMANY.

9577

II

2/25/1992

FUJI CHEMICAL INDUSTRIES CO LTD

L-LYSINE 50% SOLUTION MANUFACTURED IN TOYAMA, JAPAN.

9578

IV

2/21/1992

NOF CORP

9579

II

3/4/1992

SOUTHERN RESEARCH INSTITUTE

DIMYRISTOYL PHOSPHATIDYL GLYCEROL SODIUM SALT MFG. IN AMAGASAKI-CITY, HYOGO,


JAPAN
INFLUENZA MICROSPHERES MFG. IN BIRMINGHAM, ALABAMA

9580

3/3/1992

CATAZYME DRUGS AND PHARMACEUTICALS LTD

9581

2/28/1992

KIPPGROUP

9582

III

3/4/1992

MITSUI CHEMICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TAMILNADU, INDIA
MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF PLASTIC MOLDED COMPONENTS IN ONTARIO, CANADA.
TAFMER-A4085X RESIN COMPOUND MFG. IN ICHIHARA-CITY, CHIBA, JAPAN

9583

III

2/21/1992

MITSUI CHEMICALS INC

TAFMER P RESIN COMPOUND MFG. IN ICHIHARA-CITY, CHIBA, JAPAN

9584

3/12/1992

PATHEON INC TORONTO REGION OPERATIONS

MANUFACTURING SITE, FACILITIES AND PERSONNEL IN FORT ERIE, ONTARIO, CANADA

9585

II

3/19/1992

KV PHARMACEUTICAL CO

BUTOCONAZOLE NITRATE 2% VAGINAL CREAM MFG. IN ST. LOUIS, MISSOURI

Page 266

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9586 I
IV
3/2/1992
MILLIKEN AND CO
9587

3/15/1992

PRO.BIO SINT, S.R.L.

SUBJECT
REACTINT YELLOW X15, BLUE X3LV, RED X52 AND ORANGE X38 MFG. IN BLACKSBURG,
SOUTH CAROLINA
FACILITY AND OPERATING PROCEDURES IN VARESE, ITALY

9588

II

3/2/1992

KNOLL PHARMACEUTICAL CO

BTS 67 582 MFG. IN NOTTINGHAM, ENGLAND

9589

II

3/19/1992

SANTEN PHARMACEUTICAL CO LTD

RIMAIL MANUFACTURED IN OSAKA, JAPAN.

9590

3/19/1992

TAIHO PHARMACEUTICAL CO INC

FACILITIES FOR THE MFG. OF TEGAFUR IN SAITAMA, JAPAN

9591

3/19/1992

TAIHO PHARMACEUTICAL CO INC

FACILITIES IN TOKUSHIMA, JAPAN

9592

3/16/1992

DAISO CO LTD

FACILITY FOR THE MFG. OF PINDOLOL IN MASUYAMA-CITY, JAPAN

9593

3/10/1992

MERCK PHARMACEUTICAL MANUFACTURING DIV

9594

II

3/16/1992

PLENUM SCIENTIFIC RESEARCH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SABANA HOYOS, PUERTO RICO.
URIDINE TRIPHOSPHATE MFG. IN HACKENSACK, NEW JERSEY

9595

3/13/1992

9596

II

2/28/1992

BOEHRINGER INGELHEIM PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN RIDGEFIELD, CONNECTICUT.
STREM CHEMICALS INC
GALLIUM NITRATE HYDRATE MFG. IN NEWBURY, MA.

9597

3/16/1992

SYNTEX LABS

FACILITIES AND CONTROLS IN BUENOS AIRES, ARGENTINA

9598

4/17/1992

SAITAMA DAIICHI PHARMACEUTICAL CO., LTD

FACITLITIES AND PROCEDURES IN ONUMA, HANYU-SHI, SAITAMA PREFECTURE, JAPAN

9599

II

3/4/1992

TRIDENT ORGANICS PRIVATE LTD

ASTEMIZOLE INTERMEDIATES MANUFACTURED IN ANDHRA PRADESH, INDIA

9600

IV

3/10/1992

LIPOID GMBH

LIPOID S 75 MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

9601

II

3/26/1992

JOHNSON MATTHEY INC

CISPLATIN MFG. IN WEST DEPTFORD, NEW JERSEY

9602

III

3/19/1992

SILGAN PLASTICS CORP

9603

II

3/18/1992

TOMITA PHARMACEUTICAL CO LTD

PLASTIC TUBES MANUFACTURED IN MUSCATINE, IOWA AND WASHINGTON COURT HOUSE,


OHIO
FERRIC AMMONIUM CITRATE, BROWN MFG. IN NARUTO-CITY, JAPAN

9604

II

3/24/1992

CARLBIOTECH LTD AS

OXYTOCIN MFG. IN COPENHAGEN, DENMARK

9605

IV

3/23/1992

LIPOID GMBH

LIPOID S 100 MFG. IN LUDWIGSHAFEN, GERMANY

9606

II

3/25/1992

WACKER CHEMIE GMBH

9607

III

3/16/1992

3M DRUG DELIVERY SYSTEMS

2-(2-METHOXYETHOXY) ACETALDEHYDE DIMETHYL ACETAL AS MANUFACTURED IN


BURGHAUSEN, GERMANY
9720 POLYETHYLENE FILM MFG. IN BROOKINGS, SOUTH DAKOTA

9608

III

3/20/1992

ROLLPRINT PACKAGING PRODUCTS INC

RPP # 26-1054 MFG. IN ADDISON, ILLINOIS

9609

III

3/6/1992

DSM THERMOPLASTIC ELASTOMERS, INC.

9610

III

2/13/1992

RHONE POULENC INC

SARLINK 2400 SERIES OF THERMOPLASTICS ELASTOMERS MANUFACTURED IN


LEOMINSTER, MASSACHUSETTS
COLLOID 999 MANUFACTURED IN KENNESAW, GEORGIA.

9611

IV

3/16/1992

METSA SPECIALTY CHEMICALS BV

SODIUM CARBOXYMETHYLCELLULOSE MFG. IN NIJMEGEN, THE NETHERLANDS

9612

III

3/5/1992

AMPACET CORP

11171-101 WHITE PE/MB MFG. IN TARRYTOWN, NEW YORK

9613

II

5/15/1991

PROCYTE CORP

GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE AS MANUFACTURED IN KIRKLAND, WASHINGTON

9614

II

12/14/1988

BACHEM FEINCHEMIKALIEN AG

9615

II

10/1/1990

HAMARI CHEMICALS LTD

GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE AS MANUFACTURED IN BUBENDORF,


SWITZERLAND
GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE AS MANUFACTURED IN OSAKA, JAPAN

9616

II

5/7/1969

PHARMACIA PL BIOCHEMICALS INC

POLYCYTIDYLIC ACID (POLY 1) AS MANUFACTURED IN MILWAUKEE, WISCONSIN

9617

II

5/7/1969

PHARMACIA PL BIOCHEMICALS INC

POLYCYTIDYLIC ACID (POLY C) AS MANUFACTURED IN MILWAUKEE, WISCONSIN

9618

II

10/19/1990

CARLBIOTECH LTD AS

(D-ALA1)-PEPTIDE-T AMIDE AS MANUFACTURED IN COPENHAGEN, DENMARK

9619

II

9/30/1992

CAMBREX PROFARMACO MILANO SRL

CYSTEAMINE BITARTRATE MANUFACTURED IN MILAN, ITALY.

Page 267

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9620 I
II
3/16/1992
SYNTEX SA

SUBJECT
HEPARIN SODIUM MANUFACTURED IN BUENOS AIRES, ARGENTINA.

9621

II

4/2/1992

PLAISTOW LTD

PROPIRAM FUMERATE MANUFACTURED IN LITTLE ISLAND, COUNTY CORK, IRELAND.

9622

3/30/1992

HAMARI CHEMICALS LTD

9623

III

4/1/1992

TUREX INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OSAKA, JAPAN.
PACKAGING MATERIAL MFG. IN HARRISVILLE, RHODE ISLAND

9624

II

3/30/1992

HAMARI CHEMICALS LTD

9625

II

4/1/1992

NEWPORT PHARMACEUTICALS (IRELAND)

(3S)-1,2,3,4-TETRAHYDRO-3-ISOQUINOLINECARBOXYLIC ACID BENZYL ESTER PTOLUENESULFONIC ACID SALT THIQ-B MFG. IN OSAKA, JAPAN
PENTAMIDINE ISETHIONATE MFG. IN DUBLIN, IRELAND

9626

II

3/30/1992

BIO RAD LABORATORIES

MACRO-PREP S STRONG CATION EXCHANGE SUPPORT MFG. IN RICHMOND, CALIFORNIA

9627

IV

3/30/1992

BIO RAD LABORATORIES INC

MACRO-PREP CM WEAK CATION EXCHANGE SUPPORT MFG. IN RICHMOND, CALIFORNIA

9628

II

3/30/1992

BIO RAD LABORATORIES

MACRO-PREP Q STRONG ANION EXCHAGE SUPPORT MFG. IN RICHMOND, CALIFORNIA

9629

4/1/1992

FUJISAWA PHARMACEUTICAL CO LTD

FACILITY IN TOYOMA, JAPAN

9630

III

3/24/1992

COLOR CONVERTING INDUSTRIES

PRINTING INK FOR PACKAGING MATERIALS AS MANUFACTURED IN DES MOINES, IOWA

9631

3/30/1992

PT SINKONA INDONESIA LESTARI

9632

II

3/30/1992

PT SINKONA INDONESIA LESTARI

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CIATER, INDONESIA.
QUINIDINE SULFATE MANUFACTURED IN CIATER, INDONESIA.

9633

III

3/23/1992

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-1066 MANUFACTURED IN ADDISON, ILLINOIS.

9634

3/23/1992

BIHOKU FUNKA KOGYO CO LTD

9635

4/3/1992

TAYLOR PHARMACAL CO

9636

II

4/6/1992

HONEYWELL IROPHARM PLC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF CALCIUM CARBONATE IN OKAYAMA, JAPAN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN DECATUR, ILLINOIS.
BROMPHENIRAMINE BASE MFG. IN WICKLOW, IRELAND

9637

II

4/9/1992

GEDEON RICHTER LTD

CIMETIDINE AS MFG. IN BUDAPEST, HUNGARY

9638

II

4/9/1992

SANOFI SYNTHELABO INC.

TICLOPIDINE HYDROCHLORIDE MANUFACTURED IN SISTERON, FRANCE.

9639

II

4/3/1992

MALLINCKRODT INC

GASTROMARK (FERUMOXSIL) BOWEL MARKER AS MANUFACTURED IN RALEIGH, NC

9640

III

4/7/1992

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION N4005-40 RED MFG. IN SALISBURY, MARYLAND

9641

II

4/8/1992

ERREGIERRE SPA

FLURBIPROFEN MANUFACTURED IN BERGAMO, ITALY.

9642

3/27/1992

PIERRE FABRE MEDICAMENT PRODUCTION 2

STERILE MANUFACTURING FACILITY IN PAU IDRON, FRANCE

9643

II

4/15/1992

NOVARTIS PHARMACEUTICALS CORP

LIORESAL INTRATHECAL AMPULS/BACLOFEN MANUFACTURED IN SUMMIT, NEW JERSEY

9644

III

4/13/1992

MEDIPLAST CO

PACKAGING MATERIAL MFG. IN ETOBICOKE, ONTARIO CANADA

9645

III

4/1/1992

LAWSON MARDON WHEATON INC

MOLDED GLASS CONTAINERS MFG. IN MILLVILLE, NEW JERSEY

9646

III

4/8/1992

COMPLEX TOOLING AND MOLDING

PACKAGING MATERIAL MG. IN RANDLEMAN, NORTH CAROLINA

9647

3/31/1992

CLINICAL TRIAL SERVICES

9648

II

4/16/1992

CHEMI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CRAIGAVON, NORTH IRELAND.
MICONAZOLE BASE AS MFG. IN FROSINONE, ITALY

9649

II

4/9/1992

SCIENTIFIC PROTEIN LABORATORIES LLC

PANCREATIN/ PANCRELIPASE MFG. IN WAUNAKEE, WISCONSIN

9650

II

4/20/1992

POPULATION COUNCIL

9651

5/11/1992

RHONE POULENC CHEMICALS

9652

II

5/11/1992

SUMITOMO CHEMICAL CO LTD

17-(ACETYOXY)-16- METHYLENE -19-NONPREGN-4-ENE-3,20-DIONE MFG. IN BUDAPEST AND


DOROG, HUNGARY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN AVONMOUTH, BRISTOL, ENGLAND.
LEVOBUNOLOL HYDROCHLORIDE MFG. IN OSAKA AND ANPACHIGUN, JAPAN

9653

II

4/23/1992

PHARMACIA AND UPJOHN SUB PFIZER INC

16A-HYDROXYPREDNISOLONE MANUFACTURED IN KALAMAZOO, MICHIGAN.

Page 268

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9654 A
IV
4/16/1992
DUPONT FLUOROPRODUCTS

SUBJECT
HFC134A (TETRAFLUOROETHANE) MANUFACTURED IN INGELSIDE, TEXAS.

9655

II

4/28/1992

GUILIN PHARMACEUTICAL FACTORY

MEBENDAZOLE MANUFACTURED IN GUILIN, GUANGXI, PEOPLE'S REPUBLIC OF CHINA.

9656

II

4/10/1992

EVONIK DEGUSSA GMBH

L-ALANYL-L-GLUTAMINE MANUFACTURED IN HANAU, FEDERAL REPUBLIC OF GERMANY.

9657

4/10/1992

FBG TRIDENT LTD

9658

II

4/30/1992

JOHNSON MATTHEY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERTAING PROCEDURES


OF GLASS CONTAINERS IN UNITED KINGDOM.
AURANOFIN MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

9659

II

4/24/1992

SPI PHARMA INC

CALCIUM CARBONATE/STARCH GRANULATION MFG. IN JOLIET, ILLINOIS

9660

II

4/20/1992

5N PLUS LUBECK GMBH

BISMUTH SUBSALICYLATE MFG. IN LUBECK, GERMANY

9661

4/20/1992

DETERMINATION OF IBUPROFEN IN HUMAN PLASMA IN MADISON, WISCONSIN

9662

IV

4/21/1992

WISCONSIN ANALYTICAL AND RESEARCH


SERVICES LTD
DMV FONTERRA EXCIPIENTS GMBH CO KG

9663

4/30/1992

SS PHARMACEUTICAL CO LTD

9664

II

4/30/1992

SOLCHEM ITALIANA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN IVX-E-59 IN TOKYO, JAPAN.
ACEBUTOLOL HYDROCHLORIDE MFG. IN MILAN, ITALY

9665

II

4/28/1992

AMANTADINE HYDROCHLORIDE MFG. IN SHENYANG, PEOPLE'S REPUBLIC OF CHINA

9666

II

5/4/1992

NORTHEAST GENERAL PHARMACEUTICAL


FACTORY
LIANYUNGANG PHARMACEUTICAL FACTORY

9667

IV

4/20/1992

FLAVOR NORTH AMERICA INC

NATURAL & ARTIFICIAL LIME AND LEMON FLAVORS

9668

4/22/1992

DIAGNOSTIC CHEMICALS LTD

9669

III

4/21/1992

ALUMINUM COMPANY OF AMERICA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CHARLOTTETOWN, P.E.I. , CANADA.
PHAR 9500 (MEDICAL BLISTER PACK)

9670

III

4/21/1992

ALUMINUM COMPANY OF AMERICA

PHAR 9501 (MEDICAL BLISTER PACK)

9671

III

1/29/1992

ODENSE FLEXIBLE APS

COMPOUND PACKAGING MATERIAL MANUFACTURED IN ODENSE S. DENMARK.

9672

II

5/8/1992

SALK INSTITUTE

AZALINE B MFG. IN LA JOLLA, CALIFORNIA

9673

II

5/1/1992

WHATMAN

CM-CELLULOSE/D5001 (CARBOXYMETHYL CELLULOSE) MANUFACTURED IN KENT, ENGLAND.

9674

III

5/14/1992

PRETIUM PACKAGING

POLYETHYLENE BOTTLES MANUFACTURED IN MONTREAL, QUEBEC, CANADA.

9675

5/13/1992

TORCAN CHEMICAL LTD

9676

IV

5/2/1992

REXAM RELEASE BV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AURORA, ONTARIO, CANADA.
FL2000 OPP 60 MFG. IN APELDOORN AND PERLEN, THE NETHERLANDS.

9677

II

5/7/1992

RIEDEL DEHAEN AG

4-CHLOROBENZYLIDENEPHTHALIDE AS MFG. IN SEELZE, GERMANY

9678

III

5/6/1992

TOYO ALUMINUM KK

9679

4/30/1992

PROCTER AND GAMBLE CO

9680

II

5/7/1992

AVANTI POLAR LIPIDS INC

PROCESSED ALUMINUM FOILS FOR BLISTER (PTP)/STRIP PACKAGE OF PHARMACEUTICAL


TABLETS/CAPSULES
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN LONGJUMEAU CEDEX, FRANCE.
1,2-DILAUROYL-SN-GLYCERO-3-PHOSPHOCHOLINE AS MFG. IN ALABASTER, ALABAMA

9681

II

5/7/1992

AVANTI POLAR LIPIDS INC

PALMITIC ACID AS MFG. IN ALABASTER, ALABAMA

9682

III

5/6/1992

TOYO ALUMINUM

9683

II

5/13/1992

9684

5/13/1992

9685

II

5/13/1992

SHANGHAI NUMBER 16 PHARMACEUTICAL


FACTORY
SHANGHAI NUMBER 16 PHARMACEUTICAL
FACTORY
SHANGHAI WANDAI PHARMACEUTICAL CO LTD

ALUMINUM FOIL FOR BLISTER(PIP)/STRIP PACKAGING OF PHARMACEUTICAL TABLETS AS


LOCATED A THE GUMMA PLANT, JAPAN
1,3-DIMETHYL-4-AMINO-5-FORMYLAMINOURACIL MANUFACTURED IN SHANGHAI, CHINA.

PRIMELLOSE (CROSCARMELLOSE SODIUM) MFG. IN FOXHOL, THE NETHERLANDS

VALPROIC ACID MANUFACTURED IN LIANYUNGANG CITY, PEOPLES'S REPUBLIC OF CHINA.

FACILITY ON QU-XI ROAD, SHANGHAI, CHINA


THEOPHYLLINE (ANHYDROUS) AS MFG. IN SHANGHAI, CHINA

Page 269

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9686 A
V
5/19/1992
STERIS-ISOMEDIX SERVICES

SUBJECT
CONTRACT STERILIZATION FACILITY IN EL PASO, TX

9687

5/7/1992

REXAM CONTAINERS LTD

9688

II

5/13/1992

CAYMAN PHARMA SRO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HAMPSHIRE, UNITED KINGDOM.
ALPROSTADIL (PGE1) AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC

9689

5/11/1992

9690

5/13/1992

9691

5/19/1992

PROMIX LABORATORIES DIV PATHEON GROUP INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BURLINGTON, ONTARIO, CANADA.
SHANGHAI WANDAI PHARMACEUTICAL CO LTD
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SHANGHAI, CHINA.
R P SCHERER LTD
FACILITIES AND PERSONNEL IN SWINDON, WILTSHIRE, ENGLAND

9692

II

5/20/1992

RIEDEL DEHAEN AG

PERFLUOROOCTYLBROMIDE AS MFG. IN SEELZE, GERMANY

9693

II

5/21/1992

ALBEMARLE CORP

S(+)-IBUPROFEN AS MFG. IN ORANGEBURG, SOUTH CAROLINA

9694

5/8/1992

BANYU PHARMACEUTICAL CO LTD

9695

III

5/28/1992

SPARTECH POLYCOM

9696

5/29/1992

ABBOTT LABORATORIES

9697

5/29/1992

NIPPON ROCHE KK

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OKAZAKI CITY, JAPAN.
PP5140 K3 NATURAL TALC-FILLED POLYPROPYLENE 40% AS MFG. IN DONORA,
PENNSYLVANIA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN NORTH CHICAGO, ILLINOIS.
FACILITIES AND OPERATING PROCEDURES IN FUKUROI CITY, JAPAN

9698

II

5/27/1992

FUJISAWA PHARMACEUTICAL CO LTD

9699

II

5/29/1992

NITROCLOR PRODUCTS QUIMICOS SA

FK-037 DRUG SUBSTANCE (INJECTABLE CEPHALOSPORIN) MANUFACTURED IN OSAKA,


JAPAN.
PARA-ACETAMINOPHEN MANUFACTURED IN BRAZIL.

9700

5/26/1992

9701

II

5/27/1992

MJ AGRO CHEMICALS PRIVATE LTD


MANUFACTURERS EXPORTERS
MEDICHEM SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ANKLESHWAR, INDIA.
CHLORHEXIDINE GLUCONATE MANUFACTURED IN GERONA, SPAIN.

9702

II

5/22/1992

ZAMBON GROUP SPA

FLUBIPROFEN AS MFG. IN VICENZA, ITALY

9703

II

5/29/1992

CHEMSYN SCIENCE LABORATORIES

ALTRETAMINE MFG. IN HARRISONVILLE, MISSOURI

9704

II

5/21/1992

FABBRICA ITALIANI SINTETICI SPA

CALCIUM CHANNEL BLOCKER - RO 40-5967/001 AS MFG. IN VICENZA, ITALY

9705

III

5/29/1992

SEALED AIR CORP

9706

II

5/18/1992

SIGMA F AND D DIV LTD

9707

6/5/1992

SUMIKA FINE CHEMICALS CO LTD

M310 AND M530 SERIES OF MEDICAL PACKAGING MANUFACTURED IN DUNCAN, SOUTH


CAROLINA
N-HYDROXYSUCCINIMIDOBIOTIN - PRODUCT NO. H 1759 FD MANUFACTURED IN SAINT LOUIS,
MISSOURI
FACILITIES AND PROCEDURES IN OSAKA, JAPAN

9708

III

6/3/1992

HELVOET PHARMA MARYLAND

LZ 519 RUBBER CLOSURE FORMULATION MFG. IN SALISBURY, MARYLAND

9709

II

6/4/1992

CIBA GEIGY CORP PHARMACEUTICAL DIV

NAPHAZOLINE HYDROCHLORIDE MANUFACTURED IN SUMMIT, NEW JERSEY.

9710

II

6/4/1992

HOECHST ROUSSEL PHARMACEUTICALS INC

9711

II

5/29/1992

NIPPON JUNRYO CHEMICALS CO LTD

HP 290 MANUFACTURE, ISOLATION, PURIFICATION AND TESTING IN SOMERVILLE, NEW


JERSEY
5-AMINOSALICYLIC ACID AS MFG. IN NIIGATA, JAPAN

9712

II

6/2/1992

HOUBA INC

ZIDOVUDINE MANUFACTURED IN CULVER, INDIANA.

9713

6/5/1992

SUMIKA FINE CHEMICALS CO LTD

FACILITIES AND PROCEDURES A THE GIFU PLANT, JAPAN

9714

6/5/1992

SUMIKA FINE CHEMICALS CO LTD

FACILITIES AND PROCEDURES A THE OKAYAMA PLANT IN JAPAN

9715

6/4/1992

ASTRA HASSLE A.B.

STUDIES CONDUCTED WITH ALMOKALANT

9716

II

6/8/1992

CU CHEMIE UETIKON GMBH

4-PHENYLBUTYRIC ACID SODIUM SALT MANUFACTURED IN LAHR, GERMANY.

9717

II

6/5/1992

AVANTI POLAR LIPIDS INC

1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)] AS MFG. IN
ALABASTER, ALABAMA

Page 270

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9718 I
II
5/19/1992
QUIMICA SINTETICA SA

SUBJECT
KETOCONAZOLE AS MFG. IN MADRID, SPAIN

9719

II

5/20/1983

HEM RESEARCH INC

ADMINISTRATIVE RESPONSIBILITY FOR YOUR BIOLOGICS MASTER FILE IS BEING


TRANSFERRED FROM THE CENTER OF BIOLOGICS EVALUATION AND RESEARCH TO THE
CENTER FOR DRUG EVALUATION AND RESEARCH. THERE IS ONLY ONE COPY OF THIS FILE
IN CDR.

9720

III

1/20/1992

81463 ADHESIVE AS MFG. IN DOWNERS GROVE, ILLINOIS

9721

II

6/12/1992

SWIFT ADHESIVES DIV REICHHOLD CHEMICALS


INC
CHISSO CORP

9722

II

6/12/1992

CHISSO CORP

CELLUFINE GCL-25 AND GCL-90 GEL FILTRATION CHROMATOGRAPHY MEDIA AS MFG. IN


MINAMAA, JAPAN
CELLUFINE GCL-1000 CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN

9723

II

6/12/1992

CHISSO CORP

CELLUFINE GCL-300 CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN

9724

II

6/12/1992

CHISSO CORP

9725

II

6/12/1992

CHISSO CORP

9726

II

6/12/1992

CHISSO CORP

FMP ACTIVATED CELLUFINE AFFINITY CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA,


JAPAN
CELLUFINE GCL-2000 GEL FILTRATION CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA,
JAPAN
CHELATE CELLUFINE AFFINITY CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN

9727

II

6/9/1992

AVANTI POLAR LIPIDS INC

9728

III

6/10/1992

HEINKE TECHNOLOGY INC

1,2-DIPALMITOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)] AS MFG. IN ALABASTER,


ALABAMA
VCA-6CC VAGINAL CREAM APPLICATOR AS MFG. IN LINCOLN, NEBRASKA

9729

II

6/17/1992

DSM PHARMA CHEMICALS NETHERLANDS BV

ETHYL 4-PHENYL-2-OXO-BUTANOATE (FOBES) AS MFG. IN VENLO, THE NETHERLANDS

9730

IV

6/15/1992

NIPPON FINE CHEMICAL LTD

PALMITIC ACID MANUFACTURED IN HYOGO, JAPAN.

9731

IV

6/15/1992

NIPPON FINE CHEMICAL LTD

TRIPALMITIN AS MFG. IN HYOGO, JAPAN

9732

II

6/8/1992

SIGMA F AND D DIV LTD

2,2'-(ETHYLENEDIIMINO) DIBUTYRIC ACID AS MFG. IN SAINT LOUIS, MISSOURI

9733

9734

II

6/23/1992

ALCHYMARS

SELEGILINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY

9735

6/11/1992

APPLIED ANALYTICAL INDUSTRIES

9736

6/23/1992

9737

II

6/17/1992

DAINIPPON INK AND CHEMICAL INC BIOCHEMICAL


DIV
TAKEDA CHEMICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WILMINGTON, NORTH CAROLINA.
FACILITY FOR THE MANUFACTURE OF PANTHETHINE IN TOKYO, JAPAN

9738

II

6/23/1992

DAIICHI PHARMACEUTICAL CO LTD

DT-5621 DRUG SUBSTANCE AS MFG. IN AKITA, JAPAN

9739

II

6/12/1992

JOHNSON MATTHEY INC

CNS-1044 MFG. IN WEST DEPTFORD, NEW JERSEY

9740

IV

6/18/1992

F AND C INTERNATIONAL INC

COCOANUT BASE 41 (#11706T) MFG. IN CINCINNATI, OHIO

9741

III

6/19/1992

EXXONMOBIL CHEMICAL CO

ETHYLENE-BUTENE COPOLYMERS

9742

6/24/1992

SOUTHERN RESEARCH INSTITUTE

FACILITIES AND PROCEDURES ON N. 4OTH STREET IN BIRMINGHAM, ALABAMA

9743

II

6/23/1992

DSN ANTI-INFECTIVES INDIA LIMITED

6-APA ANTIBIOTIC INTERMEDIATE AS MFG. IN HOSHIARPUR, PUNJAB, INDIA

9744

II

9/8/1987

MAX GB LTD

7-ADCA ANTIBIOTIC INTERMEDIATE AS MFG. IN HOSHIAPUR, PUNJAB, INDIA

9745

II

6/23/1992

SHANDONG WEI FANG PHARM FACTORY

CAPTOPRIL AS MFG. IN SHANDONG, PEOPLE'S REPUBLIC OF CHINA

9746

III

6/19/1992

HPG INTERNATIONAL INCORPORATED

MEDICAL GRADE PACKAGING MATERIAL MANUFACTURED IN MOUNTAINTOP, PENNSYLVANIA.

9747

6/23/1992

HEINRICH MACK NACHFOLGER

FACILITIES, PERSONNEL AND EQUIPMENT IN ILLERTISSEN, GERMANY

9748

II

6/29/1992

SMITHKLINE BEECHAM PHARMACEUTICALS

AURANOFIN AS MFG. CARRIGALINE, CO. CORK, IRELAND BY PENN CHEMICALS

9749

6/26/1992

SANTEN OY

FACILITIES AND PROCEDURES IN TAMPERE, FINLAND

NOT AN ASSIGNED NUMBER

TNP-470 AS MFG. IN OSAKA, JAPAN

Page 271

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9750 I
I
6/15/1992
RICERCA INC

SUBJECT
FACILITIES FOR ANALYSES OF DRUGS IN PAINESVILLE OHIO

9751

III

7/1/1992

MARVAL INDUSTRIES INC

MARVAL M-PE 51 NATURAL AS MFG IN MAMARONECK, NEW YORK

9752

6/30/1992

DAIICHI PURE CHEMICALS CO LTD

9753

II

6/29/1992

HOSPIRA

9754

II

6/26/1992

KNOLL PHARMA CHEMICALS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN IWATE PREFECTURE, JAPAN.
TIN ETHYL ETIOPURPURIN (TEP) EMULSION PROCESSING IN KUNGSANGEN AND
STOCKHOLM, SWEDEN
DOTHIEPIN HYDROCHLORIDE AS MFG IN CRAMLINGTON, NORTHUMBERLAND,ENGLAND

9755

II

6/24/1992

SEPPIC DIV AIR LIQUIDE

MONTANIDE ISA 708 AS MFG IN CASTRES, FRANCE

9756

IV

6/24/1992

SEPPIC SA

MONTANIDE ISA 51 VG

9757

II

7/11/1990

BIOCRAFT LABORATORIES INC

7-AMINODESACETOXY CEPHALOSPORANIC ACID (7-ADCA) MFG IN MEXICO, MISSOURI

9758

II

7/11/1990

TEVA PHARMACEUTICALS USA INC

CEPHALOSPORIN G MFG IN MEXICO, MISSOURI

9759

II

7/11/1990

TEVA PHARMACEUTICAL INDUSTRIES LTD

PENICILLIN G SULFOXIDE MFG IN MEXICO, MISSOURI

9760

6/26/1992

NOBEL CHEMICALS AB DIV FINE CHEMICALS INC

9761

II

6/30/1992

9762

II

7/2/1992

9763

III

6/25/1992

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF LIDOCAINE AND LIDOCAINE BASE.
KOEI CHEMICAL CO LTD
HYD [2-HYDROXYMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY PYRIDINE] MFG IN OSAKA,
JAPAN
RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA DOBUTAMINE HYDROCHLORIDE MFG. IN LATINA, ITALY
SPA
DOW CHEMICAL CO
DFDB-1085 NATURAL 7 MFG IN BOUND BROOK, NEW JERSEY

9764

7/6/1992

CHIRON BV

9765

II

7/7/1992

HAUSER CHEMICAL RESEARCH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN AMSTERDAM , THE NETHERLANDS.
TAXOL MANUFACTURED IN BOULDER, COLORADO.

9766

II

6/23/1992

EVONIK TECHNOCHEMIE GMBH

LISINOPRIL (TFA)-ETHYLESTER MANUFACTURED IN HANAU, GERMANY.

9767

II

6/23/1992

DEGUSSA AG

LISINOPRIL (TFA)-ETHYLESTER AS MANUFACTURED IN HANAU, GERMANY.

9768

II

6/23/1992

PEDIATRIC PHARMACEUTICALS INC

9769

II

7/8/1992

GEDEON RICHTER LTD

THALIDOMIDE TABLETS MANUFACTURED IN LEXINGTON, MA AND IOWA CITY, IA FOR


PEDIATRIC PHARMACEUTICALS INC.
CIMETIDINE HYDROCHLORIDE AS MFG. IN DOROG AND BUDAPEST, HUNGARY

9770

II

7/15/1992

MEDICHEM SA

CAPTOPRIL AS MFG IN GERONA, SPAIN

9771

III

3/6/1992

BASF AKTIENGESELLSCHAFT

TERLUX KR 2804 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

9772

II

7/13/1992

SCHERING AG

HYDROXY ACID MANUFACTURED IN BERLIN, GERMANY.

9773

II

7/13/1992

PFIZER INC

HYDROXY ACID AS MANUFACTURED IN KALAMAZOO

9774

7/10/1992

SANOFI CHIMIE

MANUFACTURING FACILITIES AT NOTRE DAME DE BONDEVILLE, FRANCE

9775

III

7/8/1992

MOLD-RITE PLASTICS INC

PACKAGING MATERIALS MANUFACTURED IN PLATTSBURGH, NEW YORK.

9776

7/10/1992

YAMASA CORP

FACILITIES FOR THE MANUFACTURE OF ADENOSINE

9777

II

7/10/1992

YAMASA SHOYU CO LTD

ADENOSINE AS MFG IN CHIBA-KEN, JAPAN

9778

III

7/17/1992

SFC34-ON AS MFG. IN BEEK, THE NETHERLANDS.

9779

III

6/15/1992

DSM MARKETING CENTRE CHEMICALS AND


POLYMERS
BASF AKTIENGESELLSCHAFT

9780

III

6/15/1992

BASF AKTIENGESELLSCHAFT

LUPOLEN 2424 F AS MFG IN WESSLING GERMANY

9781

II

7/14/1992

HOVIONE FARMACIENCIA SA

CLOBETASOL 17-PROPIONATE MFG. IN LISBON PORTUGAL

9782

II

7/15/1992

HOVIONE SOCIEDADE QUIMICA SA

BECLOMETHASONE 17,21-DIPROPIONATE MONOHYDRATE MFG IN LISBON, PORTUGAL

9783

6/19/1992

CHANGZHOU PHARMACEUTICAL FACTORY

FACILITY FOR THE MANUFACTURE OF METHACYCLINE

LUPOLEN 2414 F AS MFG IN WESSLING, GERMANY

Page 272

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9784 I
III
7/14/1992
CORNING INC SCIENCE PRODUCTS DIVISION

SUBJECT
PYREX BOROSILICATE GLASSES FOR LABORATORY AND PHARMACEUTICAL APPLICATIONS

9785

II

7/21/1992

SANOFI CHIMIE

HYDROXY ACID AS MANUFACTURED IN VERTOLAYE, FRANCE

9786

II

6/30/1992

FINE CHEMICALS CORPORATION

MEXILETINE HYDROCHLORIDE AS MANUFACTURED A CAPE PROVINCE, SOUTH AFRICA

9787

II

7/21/1992

HAARMANN AND REIMER GMBH

NEO HELIOPAN TYPE 303 (OCTOCRYLENE) MANUFACTURED IN HOLZMINDEN, GERMANY

9788

7/17/1992

YAMANOUCHI PHARMACEUTICAL CO LTD

9789

II

3/20/1992

TOYO KASEI KOGYO CO LTD

9790

II

7/20/1992

BIOVECTRA INC

MANUFACTURE, PROCESSING, PACKAGING, AND STORING OF BULK DRUG SUBSTANCE A


TAKAHAGI IBARAKI 318, JAPAN
DIMETHYLAMINOTHIOACETAMIDE HYDROCHLORIDE MANUFACTURED IN TAKASAGO-CITY,
HYOGO, JAPAN
ENZYME ADENOSINE DEAMINASE AS MANUFACTURED IN CHARLOTTETOWN, P.E.I. CANADA

9791

II

7/22/1992

PIRAMAL ENTERPRISES LTD

ISOFLURANE AS MANUFACTURED IN ANDHRA PRADESH INDIA

9792

III

7/23/1992

3M PHARMACEUTICALS

#9831 POLYURETHANE LAMINATE AS MANUFACTURED IN BROOKINGS, SD

9793

II

6/24/1992

ISOCHEM SA

MICONAZOLE NITRATE AS MFG. IN GENNEVILLIERS, FRANCE

9794

II

7/22/1992

RHONE-POULENC INCORPORATED

ORUVAIL 200 MG. CAPSULES AS MFG. IN DAGENHAM, ESSEX, ENGLAND

9795

II

7/14/1992

FINE CHEMICALS CORP LTD

PROCHLORPERAZINE MESYLATE AS MFG. IN CAPE PROVINCE, SOUTH AFRICA

9796

II

7/29/1992

GEMFIBROZIL AS MFG. IN LATINA, ITALY

9797

7/30/1992

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
SYNTEX FP INC

9798

II

7/11/1990

TEVA PHARMACEUTICALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GROVE CITY, OHIO.
PARAHYDROXY DANE SALT MANUFACTURED IN MEXICO, MISSOURI

9799

II

7/11/1990

BIOCRAFT LABORATORIES INC

6-AMINOPENICILLANIC ACID MANUFACTURED IN MEXICO, MISSOURI

9800

II

7/11/1990

BIOCRAFT LABORATORIES INC

D-(ALPHA)-DANE SALT MANUFACTURED IN MEXICO, MISSOURI

9801

7/22/1992

BIOCHIMICA OPOS 2 SPA

9802

II

7/22/1992

BIOCHIMICA OPOS 2 SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF BUSPIRONE HYDROCHLORIDE IN MILAN, ITALY.
BUSPIRONE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY.

9803

III

8/10/1992

AVERY DENNISON CHEMICAL DIV

AS-2533 ADHESIVE MANUFACTURED IN MILL HALL, PENNSYLVANIA.

9804

II

8/6/1992

BIO RAD LABORATORIES INC

MP50 EPOXIDE, UNDISTILLED, SIZED AS MFG. IN RICHMOND, CALIFORNIA

9805

II

5/7/1992

CRUDE BLEOMYCIN (INTERMEDIATE) AS MFG IN PARKVILLE, VICTORIA, AUSTRALIA.

9806

II

8/3/1992

BUNGE PARTY LTD SCIENTIFIC TECHNICAL


SERVICES DIV
SIFAVITOR SRL

9807

II

8/7/1992

NORAMCO DELAWARE INC

TRAMADOL HYDROCHLORIDE AS MFG. IN WILMINGTON, DELAWARE

9808

8/13/1992

DR FRANZ KOHLER CHEMIE GMBH

9809

II

8/3/1992

K-V PHARMACEUTICAL COMPANY

9810

II

8/14/1992

ELEOS INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES LOCATED IN ALSBACKHAHNLEIN, FEDERAL REPUBLIC OF GERMANY
CETIRIZINE HYDROCHLORIDE/PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES, 10MG/240MG AS MANUFACTURED IN ST. LOUIS MISSOURI.
NUMBER OL(1)P53 AS MANUFACTURED IN FOSTER CITY,CA.

9811

II

8/5/1992

GRUNENTHAL GMBH

9812

8/5/1992

GRUENTHAL

9813

III

8/3/1992

BASELL POLIOLEFINE ITALIA SPA

9814

II

8/10/1992

NIPPON KAYAKU CO LTD

CLOTRIMAZOLE AS MFG. IN MILAN, ITALY

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN AACHEN, FEDERAL REPUBLIC OF


GERMANY.
FACILITY FOR THE MANUFACTURE OF TRAMADOL HYDROCHLORIDE IN AACHEN, FEDERAL
REPUBLIC OF GERMANY
LUPOLEN 1840 D AS MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY.
BOC-AHPBA-OH, INTERMEDIATE OF DRUG SUBSTANCE AS MANUFACTURED IN KITA-KU,
TOKYO, JAPAN.

Page 273

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9815 I
II
8/25/1992
SIANG TA PHARMACEUTICAL CO LTD
9816

II

8/14/1992

SYNTHELABO PHARMACIE

9817

III

8/10/1992

AMOCO CHEMICAL SA

SUBJECT
SODIUM STARCH GLYCOLATE AS MANUFACTURED IN HU-KUO HSINCHU, TAIWAN, THE
REPUBLIC OF CHINA.
40% AQUEOUS SOLUTION OF L-ORNITHINE AS MANUFACTURED IN MONTARGIS CEDEX
FRANCE.
POLYPROPYLENE AMOCO PP 128-50109 AS MANUFACTURED IN GENEVA SWITZERLAND.

9818

III

8/10/1992

AMOCO CHEMICAL SA

POLYPROPYLENE AMOCO PP 110-50109 AS MANUFACTURED IN GENEVA SWITZERLAND.

9819

8/17/1992

YAMANOUCHI PHARMACEUTICAL CO LTD

MANUFACTURING FACILITIES LOCATED IN IWATE-KEN 028-71, JAPAN.

9820

8/11/1992

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP MANUFACTURING FACILITIES LOCATED IN HORSHAM, ENGLAND.

9821

II

8/14/1992

WYCKOFF CHEMICAL CO INC

PSEUDOEPHEDRINE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

9822

IV

8/14/1992

COLORCON

9823

III

8/7/1992

AMPACET CORP

ETHYLCELLULOSE DISPERSIONS FOR DRUG APPLICATIONS AS MANUFACTURED IN


INDIANAPOLIS, INDIANA.
10781 PE AS MANUFACTURED IN TARRYTOWN, N.Y.

9824

8/14/1992

LYNX THERAPEUTICS INC

9825

III

8/7/1992

AMPACET CORP

9826

8/25/1992

ALBEMARLE CORP

9827

II

8/25/1992

ALBEMARLE CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN THANN, FRANCE.
2-BROMO-6-METHOXYNAPHTHALENE AS MFG. IN THANN, FRANCE

9828

III

8/17/1992

AMPACET CORP

16666 BLUE PEMB AS MFG. IN TARRYTOWN, NEW YORK.

9829

II

8/14/1992

BAYER PHARMA AG

TRASYLOL (APROTININ) DRUG PRODUCT AS MANUFACTURED IN LEVERKUSEN, GERMANY

9830

II

7/22/1992

QUIMICA SINTETICA SA

LORATIDINE AS MFG. IN MADRID, SPAIN.

9831

II

8/19/1992

MILLIPORE CORP

VIRESOLVE FILTER MEMBRANE AS MFG. IN BEDFORD MASSACHUSETTS.

9832

III

8/4/1992

SOLVAY AND CIE SA

ELTEX P KS 400 AS MFG. IN SARRALBE, FRANCE

9833

III

8/4/1992

SOLVAY SA

ELTEX P KL 104 AS MANUFACTURED IN SARRALBE, FRANCE

9834

IV

8/24/1992

SUDZUCKER AG

ISOMALT AS MFG. IN OBRIGHEIM/PFALZ GERMANY.

9835

8/15/1992

SYNCHEM CHEMICALS PVT LTD

9836

8/24/1992

MEIJI SEIKA KAISHA LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ANKLESHWAR GUJARA, INDIA.
FACILITY AND PROCEDURES AT THE KITAKAMI PLANT.

9837

II

8/20/1992

RESOLUTION CHEMICALS LIMITED

BACLOFEN AS MFG IN HERTS ENGLAND.

9838

II

8/15/1992

SYNCHEM CHEMICALS PVT LTD

METOPROLOL TARTRATE AS MFG IN ANKLESHWAR GUJARATINDIA

9839

II

7/27/1992

FDC LTD

TIMOLOL MALEATE AS MFG. IN MAHARASHTRA STATE, INDIA

9840

II

8/21/1992

WYCKOFF CHEMICAL CO INC

FLURBIPROFEN AS MFG. IN SOUTH HAVEN, MICHIGAN

9841

II

8/31/1992

3M DRUG DELIVERY SYSTEMS

9842

IV

7/28/1992

ROBERTET FLAVORS

ESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM AS MFG. IN ST. PAUL, MINNESOTA AND
NORTHRIDGE, CALIFORNIA
SPRAY DRIED ARTIFICIAL CHERRY FLAVOR AS MFG. IN SOUTH PLAINFIELD, NEW JERSEY

9843

8/31/1992

WACKER CHEMIE GMBH

FACILITIES AND PROCEDURES IN BURGHAUSEN, GERMANY

9844

II

8/28/1992

KONGO CHEMICAL CO LTD

CARBINOXAMINE MALEATE AS MANUFACTURED IN TOYAMA-KEN, JAPAN

9845

II

8/31/1992

CELSUS LABORATORIES INC

HEPARIN PEPTIDOGLYCAN AS MFG. IN CINCINNATI, OHIO

9846

III

8/28/1992

BOSTIK INC

HOT MELT ADHESIVE 235-334

9847

II

8/28/1992

BRISTOL MYERS SQUIBB COMPANY

TRIAMCINOLONE HEXACETONIDE AS MFG. IN HUMACAO, PUERTO RICO

9848

II

9/3/1992

PENTAPHARM LTD BASLE

PEFABLOC SC AS MFG. IN BASLE, SWITZERLAND

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN FOSTER CIY, CALIFORNIA.
10007 PEMB AS MANUFACTURED IN TARRYTOWN, N.Y.

Page 274

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9849 I
II
9/1/1992
BACHEM INC

SUBJECT
MSI-78 AS MFG. IN TORRANCE AND SAN DIEGO, CALIFORNIA

9850

II

9/4/1992

DSM PHARMA CHEMICALS SOUTH HAVEN INC

HYDROXYUREA AS MFG. IN SOUTH HAVEN, MICHIGAN

9851

III

8/24/1992

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 5261 ZQ 445 AS MFG. IN WESSELING, FEDERAL REPUBLIC OF GERMANY

9852

II

8/31/1992

ANDRULIS RESEARCH CORP

CIS-PLATIN (NSC-119875) AS MFG. IN BELTSVILLE, MARYLAND

9853

9/1/1992

SMITHKLINE BEECHAM PHARMACEUTICALS

9854

II

9/1/1992

ASPEN OSS BV

MANUFACTURING SITE, FACILITIES, PESONNEL, AND GENERAL OPERATING PROCEDURES IN


WEST SUSSEX, ENGLAND.
ROCURONIUM BROMIDE AS MFG. IN OSS, THE NETHERLANDS

9855

9/2/1992

CHANTAL PHARMACEUTICAL CORP

FACILITIES AND PROCEDURES IN KAISERSLAUTERN, GERMANY

9856

III

9/2/1992

3M PHARMACEUTICALS

9857

III

9/2/1992

3M DRUG DELIVERY SYSTEMS

#MSP 082592P DOUBLE COATED POLYETHYLENE TAPE AS MFG. IN BROOKINGS, SOUTH


DAKOTA
#MSP 082492P POLYETHYLENE TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA.

9858

III

9/2/1992

3M DRUG DELIVERY SYSTEMS

#1777 POLYOLEFIN FOAM TAPE AS MFG. IN BROOKINGS, SOUTH DAKOTA

9859

9/3/1992

TOXICOLOGY AND PHARMACOKINETICS DATA ON THE HYDROFLUOROALKANE HFA-134A.

9860

III

9/11/1992

INTERNATIONAL PHARMACEUTICAL AEROSOL


CONSORTIUM TOXICOLOGY TESTING
JL CLARK DIV ATLAS TUBE

9861

II

9/8/1992

BAYER AG

BAY Y 3118 DRUG SUBSTANCE AS MFG. IN WUPPERTAL, FEDERAL REPUBLIC OF GERMANY.

9862

III

9/3/1992

WALTER DRAKE INC

THERMFORMED PLASTIC STRIPS AS MFG IN HOLYOKE MASSACHUSETTS.

9863

III

8/31/1992

FINDLEY ADHESIVES INC

HOT MELT ADHESIVE 694-373

9864

III

9/3/1992

PRENT CORP

24 UNIT RU-TUSS DE ARRAY MANUFACTURED IN JANESVILLE, WISCONSIN.

9865

II

9/14/1992

JAPAN ENERGY CORP

KNI-272 AS MFG BY BIOSCIENCE RESEARCH LABORATORIES IN SAITAMA, JAPAN.

9866

9/14/1992

JAPAN ENERGY CORP

9867

II

8/8/1992

JOHNSON MATTHEY INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAITAMA, JAPAN.
BAHNH (CYTOGEN LINKER) MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

9868

III

9/9/1992

ST GOBAIN DESJONQUERES SA SGD

AMBER GLASS CONTAINERS AS MFG IN FRANCE.

9869

III

9/8/1992

9870

II

9/7/1992

BPREX HEALTHCARE PACKAGING INC DBA BERRY


PLASTICS
FERMTEC PROCHIM SA

THERMOPLASTIC CLOSURES & SPECIALTY ITEMS MANUFACTURED IN BROOKVILLE,


PENNSYLVANIA
METHACYCYLINE HYDROCHLORIDE MANUFACTURED IN VARESE, ITALY.

9871

9/11/1992

UNION QUIMICO FARMACEUTICA SA

9872

III

9/18/1992

KOLACK AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BARCELONA, SPAIN.
INTERNAL COATING 3123 MANUFACTURED IN KALTBRUNN, SWITZERLAND.

9873

II

9/14/1992

ROHNER AG

PHENAZOPYRIDIINE HYDROCHLORIDE MANUFACTURED IN PRATEIN,SWITZERLAND.

9874

II

9/15/1992

PHARMAZELL GMBH

9875

II

9/24/1992

NIPPON KAYAKU CO LTD

L-LYSINE-N-ACETYLCYSTEINATE MANUFACTURED IN RAUBLING, FEDERAL REPUBLIC OF


GERMANY.
AUREOBASIDIN A AS MFG.. IN TAKASAKI AND IN TOKYO, JAPAN.

9876

II

9/22/1992

ACS DOBFAR SPA

O-FORMYL CEFAMANDOLE ACETONITRILE SOLVATE MANUFACTURED INTRIBIANO, ITALY.

9877

III

9/29/1992

SPARTECH POLYCOM

9878

III

9/25/1992

NOVA CHEMICALS CORP

D19971 WHITE POLYPROPYLENE CONCENTRATE MANUFACTURED IN DONORA,


PENNSYLVANIA.
POLYETHYLENE RESINS AS MFG. IN ONTARIO, CANADA

9879

9/4/1992

SOLVAY FLUOR AND DERIVATE GMBH

9880

II

9/25/1992

GANES CHEMICALS INC

MANUFACTURING SITE, FACLITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF 1,1,2,3,3,3-HEPTAFLUOROPROPANE IN FRANKFURT, GERMANY.
GEMFIBROZIL MANUFACTURED IN CARLSTADT AND PENNSVILLE, NEW JERSEY.

9881

II

9/18/1992

SCICLONE PHARMACEUTICALS

THYMOSIN ALPHA 1 INJECTION FINAL DOSAGE FORM AS MFG. IN FOSTER CITY, CALIFORNIA

COLLAPSIBLE ALUMINUM TUBES MANUFACTURED IN DOWNERS GROVE, ILLINOIS.

Page 275

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9882 I
IV
9/28/1992
INTERCAPS SPOL SRO

SUBJECT
EMPTY HARD GELATIN CAPSULES AS MFG IN ZLIN, CZECH REPUBLIC

9883

II

9/25/1992

VIOBIN CORP

VIOKASE AS MFG. IN MONTICELLO, ILLINOIS

9884

III

10/1/1992

3M PHARMACEUTICALS

#MSP 081792P POLYOLEFIN FOAM TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA.

9885

III

10/1/1992

3M PHARMACEUTICALS

#9751 POLYOLEFIN FOAM TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA.

9886

II

4/15/1987

DAIICHI SANKYO PROPHARMA CO LTD

9887

II

9/3/1982

SANKYO CO LTD

9888

II

10/2/1992

HUHTAMAKI OY LEIRAS PHARMACEUTICALS

CS-807 CEFPODOXIME PROXETIL DRUG SUBSTANCE MANUFACTURED IN ODAWARA, JAPAN


(PREVIOUSLY ANTIBIOTIC FILE).
CEFMETAZOLE (FREE ACID) MANUFACTURED IN ODAWARA, JAPAN. PREVIOUSLY AN
ANTIBIOTIC FILE
DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN TURKU, FINLAND.

9889

II

9/21/1992

ELANCO QUIMICA LIMITADA

CEPHALEXIN DISOLVATE MANUFACTURED IN SAO PAULO, BRAZIL.

9890

II

9/30/1992

LIFE TECHNOLOGIES INC

CHO-S-SFM AND CHO-S-SFMII AS MFG. IN GRAND ISLAND, NEW YORK

9891

II

9/19/1992

FREEDOM CHEMICAL DIAMALT GMBH

METOPROLOL TARTRATE AS MFG. IN RAUBLING, THE FEDERAL REPUBLIC OF GERMANY

9892

II

9/30/1992

LIFE TECHNOLOGIES INC

HYBRIDOMA SFM AS MFG. IN GRAND ISLAND, NEW YORK

9893

II

9/30/1992

LIFE TECHNOLOGIES INC

SF-900 SERUM-FREE INSECT CELL CULTURE MEDIUM AS MFG. IN GRAND ISLAND, NEW YORK

9894

8/21/1992

OTSUKA PHARMACEUTICAL CO., LTD.

FACILITIES AND OPERATING PROCEDURES AT THE SAGA FACTORY, JAPAN

9895

II

9/25/1992

ATI DIV PYMAH CORP

9896

10/5/1992

OTSUKA PHARMACEUTICAL CO., LTD.

POTASSIUM DICHROMATE, POTASSIUM HYDROFIDE, UREA (STERILIZATION PROCESS


INDICATORS
COMMERCIAL BULK PLANT OF SECOND TOKUSHIMA FACTORY IN TOKUSHIMA, JAPAN

9897

9/30/1992

9898

II

10/5/1992

CHEMICAL PHARMACEUTICAL RESEARCH


INSTITUTE LTD.
STAVO INDUSTRIES INC

9899

II

10/5/1992

SYN TECH CHEM AND PHARM CO LTD

PHARMACEUTICAL GRADE DEPTH TYPE FILTER MEDIA MANUFACTURED IN KINGSTON, NEW


YORK.
DICLOFENAC SODIUM MANUFACTURED IN HSIN YING, TAIWAN, REPUBLIC OF CHINA.

9900

III

10/8/1992

3M DRUG DELIVERY SYSTEMS

#1779 POLYOLEFIN FOAM TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA.

9901

III

10/5/1992

WEST PENN PLASTIC INC

25 TABLET DISPENSER AS MFG. IN NEW CASTLE PENNSYLVANIA.

9902

III

10/5/1992

WEST PENN PLASTIC INC

DOSAGE CUP PP FOR TRIAMINIC LIQUIDS AS MFG. IN NEW CASTLE, PENNSYLVANIA.

9903

III

10/5/1992

WEST PENN PLASTIC INC

28 TABLET DISPENSER MANUFACTURED IN NEW CASTLE, PENNSYLVANIA.

9904

III

10/5/1992

WEST PENN PLASTIC INC

21 TABLET DISPENSER AS MFG. IN NEW CASTLE, PENNSYLVANIA.

9905

III

10/1/1992

ST GOBAIN DESJONQUERES SA SGD

TITAN 300 TREATED CONTAINERS AS MFG. IN FRANCE.

9906

II

10/9/1992

NOVARTIS PHARMA AG

PENTETREOTIDE AS MFG. IN SWITZERLAND

9907

10/14/1992

ASAHI CHEMICAL INDUSTRY CO LTD

9908

II

10/14/1992

ASAHI KASEI FINECHEM CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF ORACIL IN NOBEOKA CITY, JAPAN.
URACIL AS MFG. IN NOBEOKA CITY, JAPAN.

9909

III

10/14/1992

TENAX CORP

9910

II

10/13/1992

LAPORTE INDUSTRIES LTD

9911

II

9/24/1992

PHARMACIE CENTRALE DE FRANCE

9912

II

10/16/1992

3M PHARMACEUTICALS

BISMUTH SUBSALICYLATE AND SODIUM BICARBONATE 2 PER THOUSAND AS MFG. IN LA


VOULTE SUR RHONE, FRANCE.
PERFLUORODICHLOROOCTANE AS MFG. IN ST. PAUL, MINNESOTA

9913

II

9/29/1992

HYDRO MED SCIENCES

HISTRELIN (LHRH AGONIST) IMPLANTS AS MFG. IN NEW BRUNSWICK, NEW JERSEY.

9914

10/8/1992

VALOIS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LE VAUDREUIL, FRANCE.

FACILITY FOR THE MANUFACTURE OF GALANTHAMINE HYDROBROMIDE IN SOFIA, BULGARIA

PACKAGING MATERIALS MANUFACTURED IN YOUNGSVILLE AND CARY, NORTH CAROLINA


AND DANBURY, CONNECTICUT.
LAPONITE D, DS, XLG, XLS, AND DF PRODUCTS AS MFG. IN CHESHIRE, UNITED KINGDOM.

Page 276

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9915 A
II
10/21/1992
PEPTISYNTHA SA

SUBJECT
EPTIFIBATIDE (BULK) AS MFG. IN BRUSSELS BELGIUM.

9916

II

10/12/1992

IPCA LABORATORIES LTD

PYRANTEL TARTRATE AS MFG. IN BOMBAY, INDIA

9917

II

10/21/1992

MALLINCKRODT INC

9918

II

10/21/1992

MALLINCKRODT INC

OCTREOSCAN REACTION VIAL, PENETREOTIDE LYPHOLIZED AS MFG. IN THE PETTEN


FACILITY IN THE NETHERLANDS.
OCTREOSCAN REACTION VIAL MANUFACTURED IN MARYLAND HEIGHTS, MISSOURI.

9919

II

10/21/1992

MALLINCKRODT INC

9920

III

9/28/1992

ROLLPRINT PACKAGING PRODUCTS INC

INDIUM IN-111 CHLORIDE STERILE SOLUTION AS MANUFACTURED IN MARYLAND HEIGHTS,


MISSOURI.
RPP #31-1003 PACKAGING MATERIAL AS MFG. IN ADDISON ILLINOIS.

9921

III

10/23/1992

HAENDLER AND NATERMANN GMBH

FORMABLE FILM FOIL COMBINATIONS AS MFG. IN GERMANY.

9922

9/24/1992

PHARMACIE CENTRALE DE FRANCE

FACILITY IN LA VOULTE SUR RHONE, FRANCE

9923

II

10/23/1992

SEKISUI MEDICAL CO LTD

N-ACETYL-DL-TRYPTOPHAN AS MFG. IN IWATE PREFECTURE, JAPAN.

9924

III

10/23/1992

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-1072 PACKAGING MATERIAL AS MFG. IN ADDISON, ILLINOIS.

9925

II

10/27/1992

TEVA PHARMACEUTICAL INDUSTRIES LTD

VECURONIUM BROMIDE AS MFG. IN RHO, ITALY

9926

II

10/28/1992

E BEGEROW GMBH AND CO

9927

II

10/27/1992

ERREGIERRE SPA

FILTRATION MEDIA FOR PURIFICATION OF PHARMACEUTICAL PRODUCTS AS MFG IN


LANGENLONSHEIM, GERMANY
LABETALOL HYDROCHLORIDE AS MFG. IN BERGAMO, ITALY.

9928

II

10/23/1992

LIFE TECHNOLOGIES INC

SF-900 II SFM (OPTIMIZED SERUM-FREE MEDIUM FOR INSECT CELL CULTURE, COMPLETE)

9929

10/24/1992

CARACO PHARMACEUTICAL LABORATORIES LTD

FACILITY IN DETROIT, MICHIGAN.

9930

II

10/30/1992

SANDOZ PHARMACEUTICALS CORP

SDZ PSC 833 AS MFG. IN BASLE, SWITZERLAND

9931

II

11/2/1992

SIGMA F AND D DIV LTD

TESTOSTERONE AS MFG. IN ST. LOUIS, MISSOURI

9932

II

10/28/1992

NIHON SURFACTANT KOGYO KK

HCO-60 MANUFACTURED IN UTSUOMIYA, JAPAN.

9933

II

11/2/1992

MILLIPORE CORPORATION

MILLIPAK 20 FILTER UNIT MANUFACTURED IN JAFFREY, NEW HAMPSHIRE.

9934

II

10/30/1992

FUKUZYU PHARMACEUTICAL CO LTD

NAPHAZOLINE HYDROCHLORIDE MANUFACTURED IN TOYAMA CITY, JAPAN.

9935

II

10/29/1992

CHONGQING NO. 5 PHARM. FACTORY

METHAZOLAMIDE AS MFG. IN CHONGQING, SICHUAN, PEOPLE'S REPUBLIC OF CHINA.

9936

10/28/1992

EASTMAN CHEMICAL CO

9937

III

11/3/1992

SHIN ETSU CHEMICAL IND CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF HOT MELT ADHESIVES IN LONGVIEW, TEXAS.
X-70-201 FLUOROSILICONE RELEASE MATERIAL AS MFG. IN TOKYO JAPAN.

9938

III

11/2/1992

TUSA SA

ALUMINUM TUBES PACKAGING MATERIAL AS MFG. IN VEVEY SWITZERLAND.

9939

II

11/2/1992

SANOFI SYNTHELABO INC.

NADROPARIN CALCIUM AS MFG. IN NOTRE-DAME DE BONDEVILLE, FRANCE.

9940

II

10/28/1992

BIORAD CHEMICAL DIV

9941

II

10/28/1992

BIO RAD LABORATORIES INC

9942

II

11/6/1992

PCAS

MACRO-PREP HIGH S STRONG CATION EXCHANGE SUPPORT AS MFG. IN RICHMOND


CALIFORNIA.
MACRO-PREP HIGH Q STRONG ANION EXCHANGE SUPPORT AS MFG. IN RICHMOND,
CALIFORNIA.
MOEXIPRIL HYDROCHLORIDE AS MFG. IN SWITZERLAND AND IRELAND.

9943

III

10/13/1992

BASF AKTIENGESELLSCHAFT

SICOLEN BROWN 32-1315 AS MFG. IN STUTTGART, GERMANY.

9944

III

10/13/1992

BASF AKTIENGESELLSCHAFT

SICOLEN BLUE 65-0475 AS MFG. IN STUTTGART, GERMANY.

9945

III

10/13/1992

BASF AKTIENGESELLSCHAFT

SICOLEN BLUE 66-0185 AS MFG. IN STUTTGART, GERMANY.

9946

III

10/13/1992

BASF AKTIENGESELLSCHAFT

SICOLEN BROWN 23-1195 MANUFACTURED IN STUTTGART, GERMANY.

9947

III

10/13/1992

BASF AKTIENGESELLSCHAFT

SICOLEN BROWN 32-1855 AS MFG. IN STUTTGART, GERMANY.

9948

III

10/12/1992

STYROLUTION EUROPE GMBH

NOVODUR R HD 877 M GREY AS MFG IN LUDWIGSHAFEN AND SCHWARZHEIDE, GERMANY

9949

III

10/12/1992

STYROLUTION EUROPE GMBH

NOVODUR R HD 877M WHITE AS MFG IN LUDWIGSHAFEN AND SCHWARZHEIDE, GERMANY.

Page 277

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9950 A
III
10/13/1992
BASF PIGMENT GMBH

SUBJECT
SICOSTYREN WHITE 00-2105 AS MFG. IN STUTTGART, GERMANY.

9951

II

11/5/1992

BACHEM AMERICAS INC

DES-AMINO(1)-D-ARGININE(8)-VASOPRESSIN (DDAVP) AS MFG. IN TORRANCE, CALIFORNIA

9952

III

11/2/1992

ROLLPRINT PACKAGING PRODUCTS INC

RPP #21-1046 PACKAGING MATERIAL MANUFACTURED IN ADDISON ,ILLINOIS.

9953

III

11/6/1992

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-3009 PACKAGING MATERIAL AS MFG. IN ADDISON, ILLINOIS.

9954

11/9/1992

URQUIMA SA

FACILITIES AND OPERATING PROCEDURES IN BARCELONA, SPAIN.

9955

III

11/6/1992

AMERICAN RENOLIT CORPORATION LAPORTE

SOLMED 100 FILM AS MFG. IN LAPORTE, INDIANA

9956

IV

10/22/1992

FLAVORS NORTH AMERICA INC

#827.052/EN NOR-CAP ARTIFICIAL CINNAMON FLAVOR AS MFG. IN NORTHFIELD ILLINOIS.

9957

II

11/10/1992

GENZYME FINE CHEMICALS

ACEBUTOLOL HYDROCHLORIDE AS MFG. IN SUFFOLK, ENGLAND.

9958

II

11/13/1992

DAIICHI PURE CHEMICALS CO LTD

DF-4639 INTERMEDIATE AS MFG. IN TOKYO, JAPAN.

9959

II

11/13/1992

DAIICHI PHARMACEUTICAL CO LTD

DS-4152 DRUG SUBSTANCE AS MFG. IN TOKYO, JAPAN.

9960

11/13/1992

DAIICHI PHARMACEUTICAL CO LTD

PARENTERAL FORMULATION FACILITY IN OSAKA, JAPAN.

9961

IV

11/9/1992

AMERICAN MAIZE PRODUCTS CO

MALTODEXTRIN AS MFG. IN HAMMOND, INDIANA.

9962

II

11/2/1992

BIHOKU FUNKA KOGYO CO LTD

PRECIPITATED CALCIUM CARBONATE AS MFG. IN OKAYAMA, JAPAN.

9963

11/13/1992

HAMILTON PHARMACEUTICAL LTD

9964

II

11/17/1992

HOSPIRA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN HUMACAO, PUERTO RICO.
PFC EMULSION MANUFACTURED IN CLAYTON, NORTH CAROLINA.

9965

IV

11/16/1992

AMERICAN MAIZE PRODUCTS CO

TABLETING STARCH MANUFACTURED IN HAMMOND, INDIANA.

9966

II

11/20/1992

TEVA PHARMACEUTICAL INDUSTRIES LTD

ETOPOSIDE MANUFACTURED IN RHO, ITALY.

9967

II

11/19/1992

FARCHEMIA SRL

CARBAMAZEPINE AS MFG. IN BERGAMO ITALY.

9968

II

11/13/1992

MALLINCKRODT INC

LEVORPHANOL TARTRATE MANUFACTURED IN ST. LOUIS, MISSOURI.

9969

II

11/13/1992

ALDRICH CHEMICAL CO INC

1-HEXADECANOL MANUFACTURED IN MILWAUKEE, WISCONSIN.

9970

II

11/6/1992

FAR RESEARCH INC

WAY-125,174 CRUDE AS MFG. IN PALM BAY, FLORIDA.

9971

II

11/19/1992

WHATMAN PAPER LTD

DE52/D461 ANION EXCHANGE CELLULOSE AS MFG. AND TESTED IN KENT, ENGLAND

9972

II

11/25/1992

BACHEM SA

5-AMINOLEVULINIC ACID HYDROCHLORIDE MANUFACTURED IN VIONNAZ, SWITZERLAND.

9973

II

11/23/1992

NAVELBINE FOR INJECTION MANUFACTURED IN IDRON, FRANCE.

9974

11/25/1992

PIERRE FABRE MEDICAMENT


PRODUCTION/AQUITAINE PHARM INTERNATIONAL
LABORATORIO BP SRL

9975

11/17/1992

LIPHA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SIDERNO, ITALY.
FACILITY AND OPERATING PROCEDURES IN SURESNES, FRANCE.

9976

II

11/19/1992

BASF CORP

UVINUL N539 SG AS MFG. IN RESSELATER, NEW YORK.

9977

II

11/18/1992

ALDRICH CHEMICAL CO INC

PERCORTEN PIVALATE MANUFACTURED IN MILWAUKEE, WISCONSIN.

9978

II

11/20/1992

PARTICLE DYNAMICS INC

DESTAB CALCIUM CARBONATE 95% MANUFACTURED IN ST. LOUIS, MISSOURI.

9979

II

11/19/1992

SIGMA F AND D DIV LTD

L-ARGININE HYDROCHLORIDE MANUFACTURED IN SAINT LOUIS, MISSOURI.

9980

II

11/6/1992

SHIN ETSU CHEMICAL IND CO LTD

GADOLINIUM OXIDE MANUFACTURED IN TAKEFU, JAPAN.

9981

III

11/30/1992

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION 35004-50 RED AS MFG. IN SALISBURY MARYLAND.

9982

II

8/7/1972

ASTELLAS PHARMA INC

CEPHALOSPRIN C FERMENTATION AND RECOVERY INOSAKA, JAPAN.

9983

II

3/20/1975

OLON SPA

7 AMINO CEPHALOSPORANIC ACID AS MFG. IN CORREZZANA, ITALY

9984

II

12/1/1992

TRITON LABORATORIES PRIVATE LTD

ACETAMINOPHEN MANUFACTURED IN HYDERABAD, INDIA.

9985

11/17/1992

LIPHA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CALAIS, FRANCE.

Page 278

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
9986 I
I
11/24/1992
BRECON PHARMACEUTICALS LTD
9987

III

7/10/1992

EASTMAN CHEMICAL CO

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN HAY-ON-WYE, HEREFORD, ENGLAND.
EASTAR AND VORIDIAN POLYMER PRODUCTION AT TENNESSEE EASTMAN DIVISION

9988

III

11/26/1992

FLINT HILLS RESOURCES LP

POLYPROPYLENE MANUFACTURED IN LONGVIEW, TX

9989

II

11/25/1992

SIGMA CHEMICAL CO

L-METHIONINE AS MFG. IN SAINT LOUIS, MISSOURI.

9990

II

11/25/1992

SIGMA F AND D DIV LTD

L-CYSTEINE MANUFACTURED IN SAINT LOUIS, MISSOURI.

9991

II

11/25/1992

SIGMA F AND D DIV LTD

L-ISOLEUCINE MANUFACTURED IN ST. LOIUS, MISSOURI.

9992

II

11/25/1992

SIGMA F AND D DIV LTD

L-THREONINE MANUFACTURED IN SAINT LOUIS, MISSOURI.

9993

II

11/25/1992

SIGMA F AND D DIV LTD

L-PHENYLALANINE AS MFG. IN SAINT LOUIS, MISSOURI.

9994

II

12/3/1992

ALZA CORP

9995

II

12/10/1992

FERRING LABORATORIES INC

CONTROLLED RELEASE FORMULATIONOF THE AMORPHOUS ERYTHROMYCIN


ETHYLSUCCINATE MFG. IN MOUTAIN VIEW, CALIFORNIA.
TERLIPRESSIN DRUG SUBSTANCE AS MFG. IN MALMO, SWEDEN.

9996

II

12/4/1992

BECTON DICKINSON PHARMACEUTICAL SYSTEMS IONTOPHORETIC DELIVERY SYSTEM MANUFACTURED IN WEST CALDWELL, NEW JERSEY.

9997

11/30/1992

JUZEN CHEMICAL COMPANY LTD

FACILITIES AND OPERATING PROCEDURES IN TOYAMA CITY, JAPAN.

9998

II

11/26/1992

FUKUZYU PHARMACEUTICAL CO LTD

PYRIMETHAMINE MANUFACTURED IN TOYAMA CITY, JAPAN.

9999

IV

12/2/1992

FLAVOR NORTH AMERICA INC

#862.170/EM NATURAL & ARTIFICIAL LEMON FLAVOR EMULSION.

10000 I

II

12/9/1992

AMAGASAKI CHEMICAL INDUSTRIES CO LTD

FR084078 AS MFG. IN AMAGASAKI-CITY, HYOGO, JAPAN.

10001 I

II

12/8/1992

OLON SPA

MYCOPHENOLIC ACID AS MFG. IN TURIN, ITALY.

10002 I

12/10/1992

BOOTS COMPANY LTD

D95 MANUFACTURING FACILITY AND OPERATING PROCEDURES IN NOTTINGHAM, ENGLAND.

10003 A

II

11/25/1992

ACS DOBFAR SPA

SODIUM CARBONATE STERILE AS MFG. IN MILAN, ITALY.

10004 I

II

12/15/1992

SAFC BIOSCIENCES INC

PF-11 MANUFACTURED IN DENVER, PENNSYLVANIA.

10005 I

II

12/15/1992

ALZA CORP

GITS (VENLAFAXINE HYDROCHLORIDE) MFG. IN MOUNTAIN VIEW, CALIFORNIA

10006 A

II

12/15/1992

FERMION OY

CROMOLYN SODIUM MFG. IN ESPOO AND HANKO, FINLAND

10007 I

II

12/10/1992

BIO RAD LABORATORIES INC

MACRO PREP METHYL HIC SUPPORT MFG. IN RICHMOND, CALIFORNIA

10008 I

12/6/1992

TATEYAMA KASEI CO LTD

KYUSYU PLANT IN TAGAWA CITY, JAPAN

10009 I

7/30/1990

ASTELLAS PHARMA INC

10010 I

12/16/1992

ADVANCE BIOFACTURES CORP

STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN


TAKAOKA, JAPAN
BIO-SPECIFIC N.V. FACILITY IN CURACAO, NETHERLANDS

10011 I

II

12/14/1992

HEUMANN PHARMA GMBH AND COMPANY

TRIMETREXATE BASE MFG. IN FEUCHT, GERMANY

10012 I

II

12/16/1992

HOSPIRA INC

SPC-100270 EMULSION MFG. IN CLAYTON, NORTH CAROLINA

10013 I

II

12/14/1992

CHISSO CORP

HEPARIN - CELLUFINE B MFG. IN CHIBA, JAPAN

10014 I

II

12/14/1992

CHISSO CORP

AMINO - CELLUFINE MFG. IN CHIBA, JAPAN

10015 I

II

12/14/1992

CHISSO CORP

HEPARIN - CELLUFINE MFG. IN CHIBA, JAPAN

10017 I

12/20/1992

BIOCHIMICA OPOS 2 SPA

FACILITIES AND PROCEDURES IN MILAN, ITALY

10018 I

12/10/1992

CYTOSOL LABORATORIES INC

FACILITY IN BRAINTREE, MASSACHUSETTS

10019 I

12/28/1992

LABORATORIOS SENOSIAIN SA DE CV

10020 I

II

7/29/1992

JACOBUS PHARMACEUTICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CELAYA, GUANAJUATO, MEXICO.
PYRIDOXAL ISONICOTINOYL HYDRAZONE DIHYDROCHLORIDE MFG. IN PLAINSBORO, NEW
JERSEY

10016 N

NOT AN ASSIGNED NUMBER

Page 279

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10021 I
III
12/29/1992
NALGE CO

SUBJECT
INJECTION BLOW MOLDING FACILITY IN ROCHESTER, NEW YORK

10022 I

II

12/16/1992

JACOBUS PHARMACEUTICAL CO

3,4-DIAMINOPYRIDINE MFG. IN PLAINSBORO, NEW JERSEY

10023 I

III

12/18/1992

RICHARDS PACKAGING INC

PACKAGING MATERIALS AS MFG IN WOODBRIDGE ONTARIO CANADA

10024 I

IV

12/21/1992

ALEX FRIES

ARTIFICIAL CONCORD GRAPE FLAVOR 69-974 LIQUID MFG. IN CINCINNATI, OHIO

10025 A

II

12/28/1992

ANIDRO DO BRASIL EXTRACOES SA

PILOCARPINE HYDROCHLORIDE USP ORAL GRADE MANUFACTURED IN PARNAIBA, BRAZIL

10026 I

12/30/1992

GENESIS INDUSTRIES INC

MANUFACTURING FACILITY IN ELMWOOD, WISCONSIN

10027 I

II

12/30/1992

SOLCHEM ITALIANA S P A

RIFAMPIN AS MFG. IN MULAZZANO (MI), ITALY

10028 A

II

12/30/1992

OLON SPA

LOPERAMIDE HYDROCHLORIDE AS MFG. IN MULAZZANO, (MI), ITALY

10029 I

II

1/4/1993

LABORATORIO BP SRL

CIMETIDINE AS MFG. IN SIDERNO, ITALY

10030 I

II

1/5/1993

ARES SERONO SA

10031 I

12/11/1992

SPAN CONTRACT PACKAGING INC

SODIUM CHLORIDE FOR INJECTION AS MFG. IN HAMELN, FEDERAL REPUBLIC OF GERMANY


AND AUBONNE, SWITZERLAND
MANUFACTURING FACILITIES IN GREENVILLE, SOUTH CAROLINA

10033 A

III

1/11/1993

TICONA GMBH

10034 I

III

10/14/1993

MULTISORB TECHNOLOGIES INC

CELANEX PRODUCTS AS MANUFACTURED IN KELSTERBACH AND NIEDERZISSEN, GERMANY,


FLORENCE, KENTUCKY, AND SHELBY, NORTH CAROLINA
DESICCANT CARTRIDGES FINAL ASSEMBLY IN BUFFALO, NEW YORK

10035 A

II

1/11/1993

CU CHEMIE UETIKON GMBH

TERAZOSIN HYDROCHLORIDE MANUFACTURED IN LAHR, GERMANY

10036 I

II

12/30/1992

ARENOL CHEMICAL CORP

SELEGILINE (DEPRENYL) HYDROCHLORIDE AS MFG. IN SOMERVILLE, NEW JERSEY

10037 A

II

1/15/1993

JANSSEN PHARMACEUTICA NV

KETOCONAZOLE DRUG SUBSTANCE AS MANUFACTURED IN GURABO, PUERTO RICO

10038 I

II

1/15/1993

JANSSEN RESEARCH FOUNDATION

INTERMEDIATES OF KETOCONAZOLE AS MFG. IN GEEL, BELGIUM

10039 I

1/15/1993

TANAKA KIKINZOKU KOGYO

10040 A

II

1/15/1993

TANAKA KIKINZOKU KOGYO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF OXALIPLAIN IN KANAGAWA, JAPAN.
OXALIPLATIN AS MFG. IN KANAGAWA, JAPAN

10041 I

II

1/13/1993

PHARMACIA AND UPJOHN INC

DEFEROXAMINE MESYLATE AS MFG. IN KALAMAZOO, MICHIGAN

10042 I

II

1/22/1993

NIPPON KAYAKU CO LTD

UBINIMEX AS MFG. IN TOKYO, JAPAN

10043 I

III

1/12/1993

BOREALIS GROUP

PACKAGING MATERIAL NCPE 7003 AND NCPE 7007 AS MFG. IN STENUNGSUND, SWEDEN

10044 A

II

1/12/1993

10045 I

II

1/13/1993

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA ACYCLOVIR AS MFG. IN LATINA, ITALY


SPA
NORDIC SYNTHESIS AB
KETOPROFEN AS MFG. IN KARLSKOGA, SWEDEN

10046 A

II

1/19/1993

URQUIMA SA

GLIPIZIDE AS MFG. IN BARCELONA, SPAIN

10047 A

III

1/8/1993

TICONA LLC

10048 I

1/21/1993

ARCHIMICA SPA

CELANEX POLYBUTYLENE TEREPHTHALATE AS MANUFACTURED IN KELSTERBACH AND


NIEDERZISSEN, GERMANY, FLORENCE, KENTUCKY, AND SHELBY, NORTH CAROLINA
FACILITY IN ORIGGIO (VARESE), ITALY

10049 A

III

2/12/1993

LANXESS CORP

POCAN B1501 NATURAL AS MFG. IN LEVERKUSEN, GERMANY

10050 I

III

1/19/1993

ABSORBENT COTTON CO

10051 I

III

1/18/1993

10052 I

II

12/9/1992

GETTIG PHARMACEUTICAL INSTRUMENT CO DIV


GETTIG TECHNOLOGIES INC
DIOSYNTH B V

COTTON AND RAYLON COILER MANUFACTURED IN VALLEY PARK, MISSOURI AND SPARKS,
NEVADA
GETTIG BLUNT ASSEMBLY AS MFG. IN SPRING MILLS, PENNSYLVANIA

10053 I

III

1/20/1993

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-1010B AS MFG. IN ADDISON, ILLINOIS

10054 I

II

1/21/1993

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

TERAZOSIN HYDROCHLORIDE AS MFG. IN VARESE, ITALY

10055 I

1/25/1993

GLAXO WELLCOME INC

MANUFACTURING PRODUCTION FACILITY IN TORONTO, CANADA

10032 N

NOT AN ASSIGNED NUMBER

HEPARIN SODIUM AS MFG. IN OSS, THE NETHERLANDS

Page 280

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10056 I
I
1/25/1993
ASAHI GLASS CO LTD

SUBJECT
MANUFACTURING FACILITIES IN HIRAKAA CITY, OSAKA, JAPAN

10057 I

II

1/25/1993

ASAHI GLASS CO LTD

RO 09-1168 AS MFG. IN HIRAKAA CITY, OSAKA, JAPAN

10058 A

II

1/29/1993

COPPERHEAD INVESTMENTS INC

SDM-71 NITROGLYCERIN TRANSDERMAL PATCH AS MFG. IN TAMAQUA, PENNSYLVANIA

10059 I

III

1/25/1993

OLACK AG

SEALING LACQUER LO 7505 GRAU AS MFG. IN KALTBRUNN, SWITZERLAND

10060 I

II

1/26/1993

MALG

BOTULINAL ANTITOXIN AS MFG. IN ST. PAUL, MINNESOTA

10061 I

II

1/26/1993

TANABE SEIYAKU CO LTD

L-THREONINE AS MFG. IN OSAKA, JAPAN

10062 I

II

1/26/1993

TANABE SEIYAKU CO LTD

L-LYSINE AS MFG. IN OSAKA, JAPAN

10063 I

II

1/26/1993

TANABE SEIYAKU CO LTD

L-PROLINE AS MFG. IN OSAKA, JAPAN

10064 N

NOT AN ASSIGNED NUMBER

10065 I

1/27/1993

MERCIAN CORP

10066 I

II

2/1/1993

ZENECA INC

10067 I

II

1/31/1993

DIGOXIN DRUG SUBSTANCE AS MFG. IN LONGJUMEAU, FRANCE

10068 A

II

2/4/1993

PROCTER AND GAMBLE PHARMACEUTICALS INC


SUB PROCTER AND GAMBLE CO
BACHEM AMERICAS INC

10069 I

II

2/1/1993

COSMA SPA

PANTETHINE AS MFG. IN CISERANO (BERGAMO), ITALY

10070 I

2/2/1993

ZENECA PHARMACEUTICALS DIV ZENECA INC

10071 A

IV

2/3/1993

LUBRIZOL ADVANCED MATERIALS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CAROLINA, PUERTO RICO.
CARBOPOL 981 NF AS MFG. IN CALVERT CITY, KENTUCKY

10072 A

IV

2/3/1993

LUBRIZOL ADVANCED MATERIALS INC

CARBOPOL 980 NF AS MFG. IN CALVERT CITY, KENTUCKY

10073 I

III

12/11/1992

BOREALIS AG

BOREALIS POLYPROPYLENE HC115MO AS MFG. IN STATHELLE, NORWAY

10074 I

III

12/12/1992

STATOIL

STATOIL POLYETHYLENE LDPE, L610 AS MFG. IN STAHELLE, NORWAY

10075 I

II

2/5/1993

PHARMACHEM CORP

IRON DEXTRAN AS MFG. IN BETHLEHEM, PENNSYLVANIA

10076

12/18/1986

ACS DOBFAR SPA

10077 A

8/27/1991

ACS DOBFAR SPA

10078 I

8/27/1991

ACS DOBFAR SPA

10079 I

2/15/1993

CASCADE BIOCHEM LTD

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE


ADDETTA PLANT IN MILANO, ITALY
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE
ROSSINI PLANT IN MILANO, ITALY
FACILITY AND OPERATING PROCEDURES IN VIA MARZABOTTO, VIMERCATE, MILANO, ITALY
(PREVIOUSLY AN ANTIBIOTIC FILE)
MANUFACTURING FACILITY IN READING, BERKSHIRE, ENGLAND

10080 I

II

2/15/1993

CASCADE BIOCHEM LTD

LEUKOTRIENE D4 IN ETHANOL MANUFACTURED IN READING, BERKSHIRE, ENGLAND

10081 A

III

1/26/1993

SHIOTANI GLASS CO LTD

AMPULES, VIALS AND CARTRIDGES MANUFACTURED IN TOYAMA, JAPAN

10082 A

III

2/8/1993

DAIKYO SEIKO LTD

PACKAGING MATERIALS MANUFACTURED IN TOCHIGI PREFECTURE, JAPAN

10083 I

IV

2/10/1993

UNGERER AND CO

ARTIFICIAL FRUIT FLAVOR #25288 MANUFACTURED IN BETHLEHEM, PENNSYLVANIA

10084 I

II

11/30/1992

KYOWA HAKKO KOGYO CO LTD

URACIL AS MFG. IN OSAKA, JAPAN

10085 I

2/5/1993

DHP LTD

10086 I

2/10/1993

MEGA BLOW MOULDING LTD

10087 I

II

4/11/1991

PHARMACIA AND UPJOHN INC

10088 A

II

2/10/1993

INDENA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN POWYS, THE UNITED KINGDOM
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MISSISSAUGA, ONTARIO, CANADA
ERYTHROMYCIN ENTERIC-COATED TABLETS MANUFACTURED IN KALAMAZOO, MICHIGANPREVIOUSLY AN ANTIBIOTIC FILE
COLCHICINE USP AS MANUFACTURED IN MILAN, ITALY

10089 I

II

1/29/1993

AJINOMOTO USA INC

M-HES AS MFG. IN KAWASAKI, KANAGAWA, JAPAN.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KUMAMOTO, JAPAN.
SDM-70 NITROGLYCERIN/POLYMER MIXTURE AS MFG. IN TAMAQUA, PENNSYLVANIA

AC-137 AS MFG. IN TORRANCE, CALIFORNIA

Page 281

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10090 I
II
2/10/1993
SIGMA F AND D DIV LTD
10091 I

IV

2/11/1993

QP CORP

SUBJECT
HEPES, SODIUM SALT (N-2-HYDROXYETHYLPIPERAZINE-N'-2-ETHANESULFONIC ACID) AS
MFG. IN SAINT LOUIS, MISSOURI
SODIUM HYALURONATE AS MFG. IN TOKYO, JAPAN.

10092 I

III

2/18/1993

SABIC PETROCHEMICALS BV

SABIC LDPE 2100TN00 AS MFG. IN BEEK, THE NETHERLANDS.

10093 I

III

2/18/1993

SABIC PETROCHEMICALS BV

SABIC LDPE 2200TC00 AS MFG. IN BEEK, THE NETHERLANDS.

10094 I

III

2/18/1993

SABIC PETROCHEMICALS BV

SABIC LDPE 2200TC12 AS MFG. IN BEEK, THE NETHERLANDS.

10095 A

III

2/12/1993

NIPRO GLASS AMERICAS CORP

TUBING GLASS CONTAINERS MANUFACTURED IN MILLVILLE, NEW JERSEY.

10096 I

2/9/1993

NATIONAL INSTITUTES OF HEALTH

ANTI-FUNGAL DRUGS

10097 I

II

2/11/1993

EGIS PHARMACEUTICALS

DOBUTAMINE HYDROCHLORIDE AS MFG. IN BUDAPEST, HUNGARY.

10098 I

III

2/4/1993

H AND N CHEMICAL CO

10099 A

IV

2/1/1993

SOLVAY FLUOR GMBH

10100 I

II

2/22/1993

WHATMAN PAPER LTD

10101 I

II

2/25/1993

GENZYME CORP

PRESSURE SENSITIVE ADHESIVE CODED POLYTAC 212X26 AS MANUFACTURED IN TOTOWA,


NEW JERSEY
1,1,1,2,3,3,3-HEPTAFLUOROPROPANE (R-227) PROPELLANT GAS AS MFG. IN FRANKFURT,
FEDERAL REPUBLIC OF GERMANY
DE52/D774 ANION EXCHANGE CELLULOSE AS MANUFACTURED AND TESTED IN MAIDSTONE,
KENT, ENGLAND
CERAMIDETRIHEXOSIDASE AS MFG. IN FRAMINGHAM, MASSACHUSSETTS

10102 A

II

2/26/1993

DAIICHI SANKYO CO LTD

LEVOFLOXACIN DRUG SUBSTANCE MANUFACTURED IN AKITA, JAPAN.

10103 A

II

2/22/1993

SAFC INC

MECHLORETHAMINE HYDROCHLORIDE AS MANUFACTURED IN MILWAUKEE, WISCONSIN

10104 A

II

2/19/1993

SIFAVITOR SRL

NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN MILANO, ITALY

10105 I

II

2/22/1993

SEPPIC DIV AIR LIQUIDE

MONTANOX 80DF AS MANUFACTURED IN CASTRES, FRANCE

10106 I

II

2/26/1993

ORIL

DEXFENFLURAMINE HYDROCHLORIDE AS MANUFACTURED IN BOLBEC, FRANCE

10107 I

II

2/26/1993

WATSON LABORATORIES INC

10108 I

IV

2/16/1993

MILES INC

PROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG. MANUFACTURED IN STATE
COLLEGE, PENNSYLVANIA
LEWATIT S 5428 A AS MANUFACTURED IN LEVERKUSEN, GERMANY BY BAYER AG

10109 A

II

2/23/1993

IPCA LABORATORIES LTD

FUROSEMIDE USP AS MANUFACTURED IN PIN, INDIA

10110 A

II

2/26/1993

COPPERHEAD INVESTMENTS INC

10111 I

III

2/22/1993

SCHUBERT SEALS A/S

SDM-74 (20/80 NITROGLYCERIN-SOLVATED ADHESIVE POLYMER) MANUFACTURED IN


TAMAQUA, PA
RUBBER COMPOUND NO. 6457 MANUFACTURED IN HORSENS, DENMARK

10112 I

II

4/30/1980

10113 I

III

2/22/1993

LEDERLE LABORATORIES DIV AMERICAN


CYANAMID CO
AMPACET CORP

10114 I

II

3/1/1993

KURARAY CO LTD

10115 I

II

3/3/1993

PHARMACO LSR

10116 I

II

3/3/1993

FUJISAWA PHARMACEUTICAL CO LTD

10117 I

2/17/1993

EUROPLAZ LIMITED

10118 A

III

3/8/1993

AMCOR FLEXIBLES ITALIA SRL

10119 A

II

2/19/1993

FINE CHEMICALS CORP PTY LTD

10120 I

II

12/4/1989

BIOCHIMICA OPOS 2 SPA

10121 I

II

3/5/1993

GUERBET CHIMIE AULNAY

PIPERACILLIN MONOHYDRATE MANUFACTURED IN STAMFORD, CONNECTICUT (PREVIOUSLY


AN ANTIBIOTIC FILE)
100267 AS MB MANUFACTURED IN BELGIUM, TERRE HAUTE, INDIANA AND DE RIDDER,
LOUISIANA
1S,3S,4R-3-(2-PROPENYL)-BICYCLO[2,2,1] HEPTAN-2-ONE MANUFACTURED IN NIIGATA, JAPAN.
METHOD VALIDATION REPORT, METHOD 29, GC/MS ANALYSIS OF UNCONJUGATED ESTRONE
AND 17B-ESTRADIOL IN HUMAN PLASMA
ZOTEPINE DRUG SUBSTANCE MANUFACTURED IN OSAKA AND FUJI, JAPAN
MANUFACTURING FACILITIES, OPERATING PROCEDURES AND PERSONNEL LOCATED AT
ESSEX, ENGLAND.
PAPER / ALUMINUM / POLYETHYLENE LAMINATE DRUG WRAPPER PRODUCT WITH GLUE AND
ADHESIVE MANUFACTURED IN VICENZA, ITALY.
AZATHIOPRINE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.
ACT, BULK, NON-STERILE MANUFACTURED IN AGRATE BRIANZA, MILAN, ITALY. (PREVIOUSLY
AN ANTIBIOTIC FILE)
SYNTHESIS OF P607 IN AULNAY SOUS BOIS, FRANCE.

Page 282

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10122 I
I
3/5/1993
MARION MERRELL DOW S/A
10123 A

II

3/9/1993

MALLINCKRODT INC

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BOURGOIN-JALLIEU CEDEX, FRANCE.
ZICONOTIDE, MALLINCKRODT INC. CODE 8068 AS MANUFACTURED IN ST. LOUIS, MISSOURI.

10124 I

II

3/2/1993

OMNICHEM S A

ACYCLOVIR AS MFG IN WETTEREN, BELGIUM.

10125 N
10126 I

NOT AN ASSIGNED NUMBER


II

6/26/1987

10128 A

II

3/15/1993

MALLINCKRODT INC

FENTANYL CITRATE (NEW PROCESS) MANUFACTURED IN SAINT LOUIS, MISSOURI

10129 I

II

11/18/1988

BIOCHIMICA OPOS 2 SPA

10130 I

II

7/31/1986

BIOCHIMICA OPOS 2 SPA

10131 A

II

4/7/1989

CORDEN PHARMA LATINA SPA

CEFAZOLIN FREE ACID AS MFG. IN AGRATE BRIANZA, MILAN, ITALY. (PREVIOUSLY AN


ANTIBIOTIC FILE)
CEFAZOLIN SODIUM, BULK AS MFG. IN AGRATE BRIANZA, MILAN, ITALY. (PREVIOUSLY AN
ANTIBIOTIC FILE)
L-ARGININE AS MANUFACTURED IN BARCELONETA, PUERTO RICO.

10132 I

II

6/20/1989

BRISTOL-MYERS SQUIBB COMPANY

10133 I

II

2/2/1982

BRISTOL-MYERS SQUIBB COMPANY

10134 I

3/12/1993

MIDDLESEX SCIENCES INC

7-AMINO CEPHALOSPORANIC ACID (7-ACA) AS MFG. IN SYRACUSE, NEW YORK. (PREVIOUSLY


AN ANTIBIOTIC FILE)
PIPERACILLIN MONOHYDRATE AS MFG. IN SYRACUSE, NEW YORK. (PREVIOUSLY AN
ANTIBIOTIC FILE)
FACILITY AND PROCEDURES IN MANSFIELD, MASSACHUSETTS.

10135 I

III

2/25/1993

BASF AKTIENGESELLSCHAFT

ULTRAFORM H 2320 AS MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY.

10136 A

III

2/25/1993

BASF SE

ULTRAFORM S 2320 AS MFG. IN LUDWIGSHAFEN, GERMANY.

10137 A

II

3/5/1993

JOHNSON MATTHEY INC

METHYLPHENIDATE HYDROCHLORIDE AS MFG. IN WEST DEPTFORD, NEW JERSEY.

10138 A

IV

3/5/1993

MANTROSE HAEUSER CO INC

CRYSTALAC GLAZE FORMULA C MFG. ATTLEBORO, MASSACHUSETTS

10139 I

II

6/10/1968

BRISTOL-MYERS SQUIBB COMPANY

6-APA MANUFACTURED IN SYRACUSE, NEW YORK. (PREVIOUSLY AN ANTIBIOTIC FILE)

10140 I

II

3/16/1993

ENZYME DEVELOPMENT CORP

ENZECO PURIFIED PROTEOLYTIC ENZYME POWDER MFG. IN SCRANTON, PENNSYLVANIA

10141 I

III

3/1/1993

MITSUI PETROCHEMICAL AMERICA LTD

ADMER Q F 500 A MFG. IN LAPROTE, TEXAS

10142 I

III

3/2/1993

MITSUI PETROCHEMICAL AMERICA LTD

ADMER A689A, A820A, NB550A AND NF530A MFG. IN LAPROTE, TEXAS

10143 I

II

3/19/1993

WITCO CORP

WITCONATE NONOXYNOL 9 MANUFACTURED IN HARAHAN, LOUISIANA

10144 I

3/19/1993

CANLAC CORP

10145 A

II

3/19/1993

CANLAC GROUP ABBOTT PRODUCTS INC

MANUFACTURING FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


VICTORIAVILLE, PQ, CANADA
LACTULOSE CONCENTRATE AS MANUFACTURED IN VICTORIAVILLE, PQ, CANADA

10146 I

III

3/5/1993

BASF AKTIENGESELLSCHAFT

10147 I

III

2/17/1993

BASF AKTIENGESELLSCHAFT

10148 I

III

2/17/1993

BASELL POLIOLEFINE ITALIA SPA

10149 I

III

3/24/1993

SOLVAY AND CIE SA

10150 I

III

3/24/1993

SOLVAY AND CIE SA

10151 I

II

3/30/1993

RIEDEL DE HAEN

10152 I

8/7/1972

ASTELLAS PHARMA INC

10153 I

II

5/8/1991

ASTELLAS PHARMA INC

10127 N

BRISTOL MYERS SQUIBB COMPANY

CRUDE AMPHOTERICIN SLURRY MANUFACTURED IN ANAGNI, FROSINONE, ITALY


(PREVIOUSLY AN ANTIBIOTIC FILE)

NOT AN ASSIGNED NUMBER

LUPOLEN KNOZ. SL 02 OA MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF


GERMANY
LUPOLEN 1810 S WHITE 99950 MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF
GERMANY
LUPOLEN 1800 S MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY
HD POLYETHYLENE ELTEX A 4019 MANUFACTURED IN SARRALBE, FRANCE AND ROSIGNANOSOLVAY LI, ITALY
POLYPROPYLENE ELTEX P RP 210 MANUFACTURING IN SARRALBE, FRANCE
2-(2-METHOXYPHENOXY)-ETHYL TOLUENE-4-SULFONATE MANUFACTURED IN SEELZE,
GERMANY.
STERILE PROCESSING FACILITIES FOR CEFAZOLIN SODIUM STERILE, (BULK) ASLOCATED IN
FUJI, JAPAN
OXY-COMPOUND AN INTERMEDIATE TO PURIFIED CEFTIZOXIME AS MANUFACTURED IN
TAKAOKA, JAPAN. (PREVIOUSLY AN ANTIBIOTIC FILE)

Page 283

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10154 A
II
3/1/1991
ACS DOBFAR SPA

SUBJECT
ACID CEFUROXIME AS MFG. IN VIALE ADDETTA, TRIBIANO, MILAN ITALY. (PREVIOUSLY AN
ANTIBIOTIC FILE)
7-ADCA MANUFACTURED BY SQUIBB S.P.A. IN ANAGNI, ITALY (PREVIOUSLY AN ANTIBIOTIC
FILE)
CEFAZOLIN AS MANUFACTURED AT THE FUJI PLANT, JAPAN.

10155 I

II

8/27/1974

BRISTOL MYERS SQUIBB COMPANY

10156 I

II

10/8/1991

ASTELLAS PHARMA INC

10157 I

IV

3/24/1993

UNGERER AND CO

10158 I

3/26/1993

INTERNATIONAL TOLLERS INC

FLAVOLOPE NATURAL BANANA TYPE FLAVOR #21724 MANUFACTURED IN LINCOLN PARK,


NEW JERSEY.
FACILITY LOCATED IN GRAND HAVEN, MICHIGAN.

10159 I

II

3/24/1993

NORAMCO DELAWARE INC

CODEINE SULFATE MANUFACTURED IN WILMINGTON, DELAWARE.

10160 I

III

3/23/1993

RAGE CORP

PACKAGING MATERIALS (PLASTIC BOTTLES) MANUFACTURED IN HILLIARD OHIO.

10161 I

II

3/23/1993

PERKIN ELMER LIFE SCIENCES

[14C]-UREA MANUFACTURED IN BOSTON, MASSACHUSETTS

10162 I

II

3/24/1993

NORAMCO DELAWARE INC

CODEINE MANUFACTURED IN WILMINGTON, DELAWARE.

10163 A

III

3/25/1993

COIM USA INC

10164 A

III

3/25/1993

COIM USA INC

10165 A

II

3/26/1993

APTALIS PHARMATECH INC

NOVACOTE ADH22, CROSS LINKED WITH NOVACOTE CR 12 MANUFACTURED BY C.E.L. IN


NEW CASTLE, DELAWARE AND IN HAMBURG, GERMANY.
NOVACOTE ADH250, CROSS LINKED WITH NOVACOTE CR 30 OR CR 32 MANUFACTURED NY
C.E.L. IN NEW CASTLE, DELAWARE AND IN HAMBURG, GERMANY
IBUPROFEN GELATIN/CAP MICROCAPSULES, AS MANUFACTURED IN VANDALIA, OH.

10166 I

III

3/30/1993

BAYER AG

10167 A

II

3/31/1993

BAYER SCHERING PHARMA AG

MAKROLON 2458 90/110 MANUFACTURED IN KREFELD-VERDINGEN, FEDERAL REPUBLIC OF


GERMANY.
NISOLDIPINE AS MANUFACTURED IN WUPPERTAL, FEDERAL REPUBLIC OF GERMANY.

10168 A

III

2/11/1993

UACJ FOIL CORP

PTP FOIL P-125 MANUFACTURED IN THE ISESAKI PLANT, JAPAN

10169 I

II

3/26/1993

TANABE SEIYAKU CO LTD

HER.TIAZEPN MANUFACTURED AT THE ONADA PLANT, JAPAN

10170 I

3/31/1993

10171 I

III

3/24/1993

PHARMACEUTICAL FACTORY SHANGHAI


INSTITUTE PHARMACEUTICAL INDUSTRY
COLORS FOR PLASTICS

FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN THE PUDONG NEW DISTRICT,


SHANGHAI, P.R. CHINA
COLORANT, ACPP 10001 MANUFACTURED IN HUNTLEY, ILLINOIS

10172 I

II

12/14/1987

JOHNS HOPKINS UNIV

10173 I

3/8/1993

YUKI GOSEI KOGYO CO LTD

10174 I

II

3/31/1993

LIFE TECHNOLOGIES INC

10175 A

II

3/30/1993

ASPEN OSS BV

POLY I: POLY C12U MANUFACTURED IN BALTIMORE, MARYLAND (PREVIOUSLY BIOLOGICS


FILE #2789)
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF NIACINAMIDE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.
KERAINOCYTE-SFM (SERUM FREE KERAINOCYTE MEDIUM) PRODUCED IN GRAND ISLAND,
NEW YORK.
DESMOPRESSIN (NEW PROCESS) MANUFACTURED IN OSS, THE NETHERLANDS.

10176 I

II

5/6/1974

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
NOT AN ASSIGNED NUMBER

10179 I

II

6/8/1989

GLAXOCHEM LIMITED

10180 I

II

12/6/1983

ACS DOBFAR UK LTD

10181 I

4/6/1993

BESPAK PLC

10182 I

II

4/7/1993

XIAN PHARMACEUTICAL FACTORY

10183 I

11/4/1992

LABORATOIRES STERILYO

10177 N
10178 N

7-ADCA MANUFACTURED IN DELFT, THE NETHERLANDS\

NOT AN ASSIGNED NUMBER


PENICILLIN G INTERMEDIATES MANUFACTURED IN THE ULVERSON PLANT, ENGLAND
(PREVIOUSLY AN ANTIBIOTIC FILE)
PENICILLIN G INTERMEDIATES MANUFACTURED IN CAMBOIS, ENGLAND (PREVIOUSLY AN
ANTIBIOTIC FILE)
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN NORFOLK, ENGLAND.
PODOFILOX MANUFACTURED IN XIJIAO, XI'AN, SHAANXI PROVINCE, CHINA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SAINT-AMAND-LES-EAUX CEDEX, FRANCE.

Page 284

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10184 I
III
3/22/1993
H AND N CHEMICAL CO

SUBJECT
POLYTAC 221R MANUFACTURED IN TOTOWA, NEW JERSEY

10185 A

II

4/12/1993

ASPEN OSS BV

NORETHINDRONE ACETATE PROCESS II MANUFACTURED IN OSS, THE NETHERLANDS

10186 I

3/23/1993

ABBOTT LABORATORIES LTD

10187 I

4/12/1993

10188 I

II

4/8/1993

JOHNSON AND JOHNSON/MERCK AND COMPANY


INC
SIGMA F AND D DIV LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ETHRANE IN QUEENBOUROUGH, KENT, ENGLAND.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN LANCASTER, PENNSYLVANIA.
SOMATOSTATIN (PRODUCT NO. S 9129 FD) MANUFACTURED IN SAINT LOUIS, MISSOURI

10189 I

4/8/1993

TAKASAGO INTERNATIONAL CORP

10190 I

II

4/8/1993

TAKASAGO INTERNATIONAL CORP

10191 I

II

4/13/1993

ETOPOSIDE MANUFACTURED IN PUDONG NEW DISTRICT, SHANGHAI

10192 I

III

4/7/1993

SHANGHAI INSTITUTE PHARMACEUTICAL


INDUSTRY
SUN COAST CLOSURES INC

10193 I

III

4/7/1993

SUN COAST CLOSURES INC

53-400 LINERLESS CLOSURE MANUFACTURED IN SARASOTA, FLORIDA

10194 I

III

4/7/1993

SUN COAST CLOSURES INC

89-400 M/D LINED CAP MANUFACTURED IN SARASOTA, FLORIDA

10195 I

II

4/13/1993

ACS DOBFAR SPA

PHOSPHATE SODIUM DIBASIC STERILE MANUFACTURED IN TRIBIANO, MILAN, ITALY

10196 I

IV

4/10/1993

MARUTI LABORATORIES PRIVATE LTD

10197 I

4/17/1993

ABBOTT LABORATORIES

MICROCRYSTALLINE CELLULOSE (MCC) PH 101/102 MANUFACTURED IN CUDDALORE,


TAMILNADU, INDIA
FACILITIES AND OPERATING PROCEDURES IN LATINA, ITALY (LABORATORI ABBOTT S.P.A.)

10198 I

III

1/27/1993

CROWN CORK AND SEAL CO INC

PILFER PROOF CAPS MANUFACTURED BY CROWN BENDER IN FRANKENTHAL, W. GERMANY

10199 A

III

4/19/1993

3M PHARMACEUTICALS

10200 I

III

4/19/1993

3M PHARMACEUTICALS

10201 A

III

4/19/1993

3M DRUG DELIVERY SYSTEMS

10202 I

II

4/22/1993

PENINSULA LABORATORIES

10203 I

4/21/1993

INTERNATIONAL LABORATORIES INC

10204 A

III

4/5/1993

ABLE PACKAGING GROUP LTD

3M SCOTCHPAK 9723 POLYESTER FILM LAMINATE MANUFACTURED IN COTTAGE GROVE,


MINNESOTA
3M SCOTCHPAK 9721 POLYESTER FILM LAMINATE MANUFACTURED IN COTTAGE GROVE,
MINNESOTA
3M COTRAN 9722 POLYOLEFIN FILM LAMINATE MANUFACTURED IN COTTAGE GROVE,
MINNESOTA
CHOLECYSTOKININ TETRAPEPTIDE (30-33) (CCK-4, PL #7185) MANUFACTURED IN BELMONT,
CALIFORNIA
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
IN ST. PETERSBURG, FLORIDA.
PACKAGING MATERIALS ANTI-STATIC MANUFACTURED IN BYLEY, CHESHIRE, ENGLAND

10205 I

III

4/15/1993

MAUSER WERKE GMBH

PACKAGING MATERIAL MANUFACTURED IN BAMMENTAL AND BRUHL, GERMANY

10206 N

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN IWAA, JAPAN.
4-AA, OR [3R-[3A(R*),4B]]-4-(ACETYLOXY)-3-[[91,1-DIMETHYLETHYL)DIMETHYLSILYL]OXY]ETHYL]-2-AZETIDINONE MANUFACTURED A THE ITAWA PLANT AND THE
HARIMA PLANT IN JAPAN

120MM LINED CAP MANUFACTURED IN SARASOTA, FLORIDA

NOT AN ASSIGNED NUMBER

10207 I

III

4/19/1993

COLORS FOR PLASTICS

ACPP-60167 MANUFACTURED IN HUNTLEY, ILLINOIS

10208 I

III

4/19/1993

COLORS FOR PLASTICS

ACPP-60166 MANUFACTURED IN HUNTLEY, ILLINOIS

10209 I

III

4/19/1993

COLORS FOR PLASTICS

ACPP-30070 MANUFACTURED IN HUNTLEY, ILLINOIS

10210 I

III

4/19/1993

ACTION COLOR INC

ACPP-60207 MANUFACTURED IN HUNTLEY, ILLINOIS

10211 I

II

4/22/1993

WHATMAN PAPER LTD

10212 I

IV

4/26/1993

CRODA INC

DEAE-CELLULOSE/D617 ANION EXCHANGE CELLULOSE MANUFACTURED IN MAIDSTONE,


KENT, ENGLAND
SUPER REFINED SOYBEAN OIL MANUFACTURED IN PARSIPPANY, NEW JERSEY

10213 I

II

4/22/1993

JOHNSON MATTHEY INC

PROCHLORPERAZINE EDISYLATE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

Page 285

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10214 I
I
4/8/1993
LANCASTER SYNTHESIS DIV MTM RESEARCH
CHEMICALS LTD
10215 I
II
4/8/1993
LANCASTER SYNTHESIS DIV MTM RESEARCH
CHEMICALS LTD
10216 I
IV
4/27/1993
UNION CARBIDE CHEMICALS AND PLASTICS CO
INC
10217 I
II
4/27/1993
DSM PHARMA CHEMICALS SOUTH HAVEN INC

SUBJECT
FACILITIES AND PROCEDURES IN LANCASTER, ENGLAND

10218 A

II

5/4/1993

BAYER OY

NORPLANT (LEVONORGESTREL IMPLANTS) MANUFACTURED IN TURKU, FINLAND

10219 I

II

4/30/1993

THATCHER CO

IODOPHOR 241 FORMULA 47D MANUFACTURED IN SALT LAKE CITY, UTAH

10220 A

II

5/4/1993

ASPEN OSS BV

GONADORELIN DIACETATE MANUFACTURED IN OSS, THE NETHERLANDS

10221 A

IV

5/3/1993

MANTROSE HAEUSER CO INC

AQUEOUS GLAZE SB-1/P MANUFACTURED IN ATTLEBORO, MASSACHUSETTS

10222 I

III

5/7/1993

HELVOET PHARMA MARYLAND

10223 I

II

5/5/1993

PRODUCTOS QUIMICOS NATURALES S A

RUBBER CLOSURE FORMULATION B5301-45 GRAY MANUFACTURED IN SALISBURY,


MARYLAND
FLUORANDROSTENONE MANUFACTURED IN IXTACZOQUITLAN, VER. MEXICO

10224 I

II

5/5/1993

JOHNSON MATTHEY INC

AUROTHIOGLUCOSE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

10225 I

II

4/30/1993

TAKEDA CHEMICAL INDUSTRIES LTD

TAK-536 DRUG SUBSTANCE MANUFACTURED IN OSAKA, JAPAN

10226 I

II

4/23/1993

ALDRICH CHEMICAL CO INC

ISOBUTYRAMIDE MANUFACTURED IN MILWAUKEE, WISCONSIN

10227 I

II

4/23/1993

ALDRICH CHEMICAL CO INC

BUTYRIC ACID MANUFACTURED IN MILWAUKEE, WISCONSIN

10228 A

III

5/5/1993

3M DRUG DELIVERY SYSTEMS

10229 I

IV

4/22/1993

AQUALON CO

3M SCOTCHPAK 9742 RELEASE LINER MANUFACTURED IN ST. PAUL, MN., COTTAGE GROVE,
MN. AND NEVADA, MO.
HYDROXYETHYL CELLULOSE MANUFACTURED IN WILMINGTON, DELAWARE

10230 A

III

4/26/1993

BECTON DICKINSON AND CO

10231 I

II

5/7/1993

JOHNSON MATTHEY INC

MONOVIAL-INF. NG (DRUG CONTAINER AND CLOSURE) MANUFACTURED IN GLAND,


SWITZERLAND
GOLD SODIUM THIOMALATE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

10232 I

II

3/6/1993

LABOCHIM SPA

LEUCOVORIN CALCIUM MANUFACTURED IN MILAN, ITALY

10233 A

II

5/5/1993

CILAG AG

RIMANTADINE HYDROCHLORIDE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

10234 I

II

5/4/1993

NORTH CHINA PHARMACEUTICAL CORP

10235 I

II

5/5/1993

TEVA PHARMACEUTICAL INDUSTRIES LTD

PENICILLIN G POTASSIUM CRUDE MANUFACTURED IN SHIJIAZHUANG, PEOPLE'S REPUBLIC


OF CHINA
SELEGILINE HYDROCHLORIDE MANUFACTURED IN PETAH TIQVA, ISRAEL

10236 I

II

4/14/1993

BK LADENBURG GMBH

PHOSKADENT SF (SODIUM FLUORIDE) MANUFACTURED IN HANNOVER-SEELZE, GERMANY

10237 I

II

4/14/1993

BK LADENBURG GMBH

10238 I

II

4/14/1993

BK LADENBURG GMBH

PHOSKADENT TM (SODIUM TRIMETAPHOSPHATE) MANUFACTURED IN LADENBURG,


GERMANY
DENTPHOS C (CALCIUM HYDROXYLAPAITE) MANUFACTURED IN LADENBURG, GERMANY

10239 I

4/22/1993

PRIMA PHARM INC

FACILITY AND OPERATING PROCEDURES IN SAN DIEGO, CALIFORNIA

10240 I

5/10/1993

TATEYAMA KASEI CO LTD

TOYAMA PLANT IN TOYAMA PREF., JAPAN

10241 I

5/7/1993

NV ORGANON

FACILITY AND PROCEDURES IN OSS, THE NETHERLANDS - MOLENSTRAA 110

10242 A

II

4/26/1993

DIHYDROERGOTAMINE MESYLATE MANUFACTURED IN INGELHEIM, GERMANY

10243 A

4/30/1993

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
IONISOS

10244 I

5/7/1993

WILLIAM RANSON AND SON LTD

10245 A

III

5/6/1993

HENKEL AG AND CO KGAA

METHYLENE DIPHOSPHONIC ACID MANUFACTURED IN LANCASTER, ENGLAND


TONE P-767E AND TONE P-787 MANUFACTURED IN SOUTH CHARLESTON, WEST VIRGINIA
3M ORPHENADRINE CITRATE MANUFACTURED IN SOUTH HAVEN, MICHIGAN

FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION IN SABLE SUR SARTHE,
FRANCE
FACILITY FOR THE MANUFACTURED OF LIQUID PHARMACEUTICALS IN HERTFORDSHIRE,
ENGLAND
LIOFOL, LAMINATING ADHESIVE,MANUFACTURED IN DUSSELDORF, FEDERAL REPUBLIC OF
GERMANY

Page 286

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10246 I
III
5/12/1993
MITSUI PETROCHEMICAL AMERICA LTD

SUBJECT
ADMER QF551E MANUFACTURED IN LAPROTE, TEXAS

10247 I

II

5/17/1993

DIOSYNTH BV

PANCURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS

10248 I

II

5/17/1993

WYCKOFF CHEMICAL CO INC

FLURBIPROFEN SODIUM MANUFACTURED IN SOUTH HAVEN, MICHIGAN

10249 I

III

5/14/1993

OMV WERKSTOFF PCD POLYMERE GMBH

DAPLEN KS101 MANUFACTURED IN LINZ, AUSTRIA

10250 I

II

5/18/1993

SYNKEM DIV PLASTO SA

B.P. 102 MANUFACTURED IN CHENOVE CEDEX, FRANCE

10251 I

II

5/14/1993

ABBOTT LABORATORIES

PROTIRELIN (TRH) MANUFACTURED IN NORTH CHICAGO, ILLINOIS

10252 I

III

5/21/1993

HELVOET PHARMA MARYLAND

10253 A

II

5/12/1993

NEULAND LABORATORIES LTD

10254 I

II

5/12/1993

NEULAND LABORATORIES LTD

10255 A

5/18/1993

SYNERGY HEALTH WESTPORT LTD

10256 I

II

5/24/1993

KAKEN PHARMACEUTICAL CO LTD

RUBBER CLOSURE FORMULATION V 7000-55 BLACK MANUFACTURED IN SALISBURY,


MARYLAND
BENZYL ALBUTEROL,INTERMEDIATE MANUFACTURED IN BONTHAPALLI VILLAGE, JINNARAM
MANDAL, TELANGANA, INDIA
ALBUTEROL SULFATE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL,
ANDHRA PRADESH, INDIA
COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN
WESTPORT, CO. MAYO, IRELAND
KP-102 MANUFACTURED IN SHIZOUKA PREFECTURE, JAPAN

10257 I

5/20/1993

OTSUKA PHARMACEUTICAL CO LTD

FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN

10258 I

III

5/3/1993

10259 A

III

5/21/1993

GETTIG PHARMACEUTICAL INSTRUMENT CO DIV


GETTIG TECHNOLOGIES INC
OWENS BROCKWAY GLASS CONTAINER INC

GETTIG NEEDLE ASSEMBLY MANUFACTURED IN SPRING MILLS, PENNSYLVANIA, ANGOLA AND


KNOX INDIANA
GLASS CONTAINERS (FLINT AND AMBER)

10260 I

IV

5/17/1993

BENTLEY PHARMACEUTICALS INC

CYCLOPENTADECANOLIDE MANUFACTURED BY FIRMENICH S.A. IN GENEVA, SWITZERLAND

10261 I

II

5/26/1993

BIOREX RESEARCH DEVELOPMENT CO

MOLINDONE HYDROCHLORIDE MANUFACTURED IN BUDAPEST, HUNGARY.

10262 I

II

5/25/1993

JETPHARMA SA

CONTRACT MICRONIZATION SERVICES LOCATED IN BALERNA, SWITZERLAND

10263 I

II

5/27/1993

TAKEDA CHEMICAL INDUSTRIES LTD

TAP-144-SR(N) 7.5 AND 3.75 MG. MANUFACTURED IN OSAKA, JAPAN.

10264 I

II

5/24/1993

LONZA INC

DEXTROMETHORPHAN BASE MANUFACTURED IN LOS ANGELES, CALIFORNIA

10265 I

II

5/17/1993

ZAMBON GROUP SPA

WAY-125,147 CRUDE MANUFACTURED IN VICENZA, ITALY

10266 I

II

6/3/1993

SMITHKLINE BEECHAM PHARMACEUTICALS

10267 I

II

6/3/1993

SMITHKLINE BEECHAM PHARMACEUTICALS

10268 A

II

6/3/1993

WELLSPRING PHARMACEUTICAL CORP

10269 I

IV

6/2/1993

PARKE DAVIS DIV WARNER LAMBERT CO

BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE) MANUFACTURED IN IRVINE,


AYRSHIRE, UNITED KINGDOM.
BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE) MANUFACTURED IN WORTHING,
WEST SUSSEX, UNITED KINGDOM.
DIBENZYLINE (SK&F 688-A) SOLUTION FOR INJECTION MANUFACTURED IN SWEDELAND,
PENNSYLVANIA.
CAPILL MANUFACTURED IN GREENWOOD, SOUTH CAROLINA

10270 I

II

5/26/1993

LONZA LTD

DEBMEB MANUFACTURED IN VISP, SWITZERLAND

10271 I

III

5/25/1993

TEMPIL DIV BIG THREE INDUSTRIES INC

10272 I

5/28/1993

ABBOTT LABORATORIES LTD

SERIES 200 POLYMER ACTIVATED INKS MANUFACTURED IN SOUTH PLAINFIELD, NEW


JERSEY
SEMI-WORKS AREA IN QUEENBOROUGH, KENT, UNITED KINGDOM

10273 A

II

5/27/1993

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM) MANUFACTURED IN BARCELONA, SPAIN

10274 A

II

6/4/1993

CU CHEMIE UETIKON GMBH

PHENYLACETIC ACID SODIUM SALT MANUFACTURED IN LAHR, GERMANY.

10275 I

II

6/4/1993

PENINSULA LABORATORIES

TJN-135 MANUFACTURED IN BELMONT, CALIFORNIA.

10276 I

III

5/28/1993

HELVOET PHARMA MARYLAND

10277 A

III

5/31/1993

FUJIMORI KOGYO CO LTD

RUBBER CLOSURE FORMULATION B5004-50 GRAY MANUFACTURED IN SALISBURY,


MARYLAND.
RELEASE LINER FILM MANUFACTURED IN, SHIZUOKA PREF., JAPAN.

Page 287

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10278 I
II
6/3/1993
BIO RAD

SUBJECT
BIO-GEL A-5M, MEDIUM MANUFACTURED IN RICHMOND, CALIFORNIA.

10279 I

II

6/3/1993

BIO RAD

PC CROSSLINKED BIO-GEL A-5M, MEDIUM MANUFACTURED IN RICHMOND, CALIFORNIA.

10280 I

II

6/7/1993

UNIQUE CHEMICALS

NIFEDIPINE MANUFACTURED IN BOMBAY, INDIA.

10281 I

II

6/8/1993

NORTH CHINA PHARMACEUTICAL CORP

CYCLOSPORINE, USP (BULK, NON-STERILE) MANUFACTURED IN SHIJIAZHUANG, CHINA.

10282 I

II

6/3/1993

JUZEN CHEMICAL CO LTD

10283 I

II

6/10/1993

BACHEM FEINCHEMIKALIEN AG

METHYL (2R,3S)-3-(4-METHOXYPHENYL)-2,3-EPOXYPROPIONATE MANUFACTURED IN


TOYOMA CITY, JAPAN.
DESMOPRESSIN ACETATE MANUFACTURED IN BUBENDORF, SWITZERLAND.

10284 I

III

6/11/1993

HELVOET PHARMA MARYLAND

10285 N

RUBBER CLOSURE FORMULATION B5002-50 RED MANUFACTURED IN SALISBURY,


MARYLAND.

NOT AN ASSIGNED NUMBER

10286 N

NOT AN ASSIGNED NUMBER

10287 I

III

6/7/1993

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 5261 ZS MANUFACTURED IN WESSELING, GERMANY.

10288 I

III

6/9/1993

TEKNI PLEX INC

F93SR-1 MANUFACTURED IN EXTON, PENNSYLVANIA

10289 I

II

6/14/1993

BIO RAD

AG 1-X2 RESIN, 200-400 MESH, ACETATE MANUFACTURED IN RICHMOND, CALIFORNIA

10290 A

II

6/14/1993

CARMUSTINE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

10291 A

III

6/9/1993

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
MULTISORB TECHNOLOGIES INC

10292 I

6/12/1993

FUJISAWA PHARMACEUTICAL CO LTD

10293 I

II

6/11/1993

LABORATOIRES SERONO SA

10294 A

II

6/14/1993

ASPEN OSS BV

STERILE PROCESSING FACILITIES FOR PROGRAF (TACOLIMUS) AMPOULES AS LOCATED IN


BANSAGH, KILLOGLIN, CO. KERRY, IRELAND.
BULK GRF (1-29) NH2 (SERMORELIN ACETATE DRUG SUBSTANCE) MANUFACTURED IN
AUBONNE, SWITZERLAND.
OXYTOCIN PURIFIED MANUFACTURED IN OSS, THE NETHERLANDS

10295 I

II

6/17/1993

ZENECA PHARMACEUTICALS DIV ZENECA INC

HALOTHANE MANUFACTURED AT ROCKSAVAGE WORKS, UNITED KINGDOM

10296 I

II

6/14/1993

CHEMSYN SCIENCE LABORATORIES

DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN HARRISONVILLE, MISSOURI

10297 I

II

6/17/1993

CHINOIN PHARMACEUTICAL CHEMICAL WORKS

GLIBENCLAMIDE BP88 (GLYBURIDE) MANUFACTURED IN BUDAPEST, HUNGARY

10298 I

II

6/14/1993

ROFERM SPA

7-AMINOCEPHALOSPORANIC ACID MANUFACTURED IN TRENTO, ITALY

10299 I

II

6/15/1993

BRACCO IND CHIMICA SPA

IOMEPROL MANUFACTURED IN MILAN, ITALY

10300 I

III

6/18/1993

HELVOET PHARMA MARYLAND

10301 I

II

6/11/1993

ARCHER DANIELS MIDLAND CO

RUBBER CLOSURE FORMULATION B5005-45 GRAY MANUFACTURED IN SALISBURY,


MARYLAND
POTASSIUM CITRATE MONOHYDRATE MANUFACTURED IN SOUTHPORT, NORTH CAROLINA

10302 I

6/18/1993

UNIQUE CHEMICALS

FACILITY AND PROCEDURES IN ANKLESHWAR, INDIA

10303 A

II

4/1/1987

ACS DOBFAR SPA

ACID CEFAZOLIN (INTERMEDIATE GRADE) MANUFACTURED IN MILAN, ITALY

10304 A

6/24/1993

BAXTER PHARMACEUTICALS SOLUTIONS LLC

STERILE PROCESSING FACILITY IN BLOOMINGTON, INDIANA.

10305 I

6/29/1993

ONO PHARMACEUTICAL CO., LTD

FACILITY AND OPERATING PROCEDURES IN OSAKA, JAPAN

10307 I

III

6/16/1993

ACTION COLOR INC

ACPP-80071 COLORANT MANUFACTURED IN HUNTLEY, ILLINOIS

10308 I

6/29/1993

CREAPHARM SA

FACILITY AND OPERATING PROCEDURES IN LE HAILLAN, FRANCE

10309 I

II

6/29/1993

3M BIOAPPLICATIONS

3M EMPHAZE AB 1 SUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MINNESOTA

10310 A

II

6/30/1993

SANOFI AVENTIS CHIMIE

10311 I

II

6/28/1993

BURZYNSKI RESEARCH INSTITUTE INC

SR 47436 DRUG SUBSTANCE MANUFACTURED IN ARAMON, SISTERON AND MONTPELLIER


CEDEX, FRANCE
ANTINEOPLASTON A10 INJECTIONS MANUFACTURED IN STAFFORD AND HOUSTON, TEXAS

10312 I

6/25/1993

LIPHA SA

FACILITY AND PROCEDURES IN SEMOY, FRANCE

10306 N

DESIMAX MANUFACTURED IN BUFFALO, NEW YORK

NOT AN ASSIGNED NUMBER

Page 288

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10313 I
III
6/14/1993
BASF AKTIENGESELLSCHAFT

SUBJECT
NOVOLEN 1125 N MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

10314 I

III

6/14/1993

BASF AKTIENGESELLSCHAFT

NOVOLEN 1325 M MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

10315 I

II

6/16/1993

LUSOCHIMICA SPA

RITODRINE HYDROCHLORIDE MANUFACTURED IN LOMAGNA, ITALY

10316 I

II

6/25/1993

SIPSY

PENTAMIDINE ISETHIONATE MANUFACTURED IN AVRILLE CEDEX, FRANCE

10317 I

II

6/25/1993

LONZA RIVERSIDE

TRANYLCYPROMINE SULFATE MANUFACTURED IN CONSHOHOCKEN, PENNSYLVANIA

10318 A

III

6/29/1993

TOTAL PETROCHEMICALS AND REFINING USA INC

10319 I

II

6/24/1993

CATALENT PHARMA SOLUTIONS LLC

FINA GF7740F2 AND 8183 HIGH DENSITY POLYETHYLENE RESINS MANUFACTURED IN


PASADENA, TEXAS
HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL

10320 A

II

6/24/1993

MALLADI DRUGS AND PHARMACEUTICALS LTD

D-PSEUDO EPHEDRINE HYDROCHLORIDE MANUFACTURED IN TAMILNADU, INDIA

10321 I

II

6/25/1993

DAINIPPON SUMITOMO PHARMA CO LTD

MEROPENEM/SODIUM CARBONATE MFG IN OSAKA, JAPAN

10322 A

II

6/25/1993

DAINIPPON SUMITOMO PHARMA CO LTD

MEROPENEM MFG IN TSURUSAKI, JAPAN.

10323 I

II

6/17/1993

NAGASE FINE CHEMICALS LTD

10324 I

6/24/1993

CCL INDUSTRIES LTD

METHYL (2R,3S)-(4-METHOXYPHENYL)-2,3-EPOXYPROPIONATE MANUFACTURED IN TASUNO


CITY, JAPAN
FACILITY AND OPERATING PROCEDURES IN RUNCORN, UNITED KINGDOM

10325 I

III

6/24/1993

BASF AKTIENGESELLSCHAFT

ULTRAPEK A 1000 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

10326 I

III

6/24/1993

BASF AKTIENGESELLSCHAFT

ULTRAPEK A 2000 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

10327 I

III

6/24/1993

BASF AKTIENGESELLSCHAFT

ULTRAPEK A 3000 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

10328 I

IV

6/14/1993

NOVILLE ESSENTIAL OIL CO INC

FLAVOR AN106248 MANUFACTURED IN SOUTH PLAINFIELD, NEW JERSEY

10329 A

III

6/10/1993

PHILLIPS PLASTICS CORP

DUST CAP, ACTUATOR AND HOUSING MANUFACTURED IN MENOMONIE, WISCONSIN

10330 I

III

7/1/1993

WHEATON PHARMATECH

N4003-45 PINK MANUFACTURED IN SALISBURY, MARYLAND

10331 I

III

6/26/1991

SCHUPBACH AG

10332 I

III

3/30/1989

SCHUPBACH AG

COMPOUND PACKAGING MATERIAL FOR NICOTIN-TTS MANUFACTURED IN BURGDORF,


SWITZERLAND
TRANSDERM-NITRO TTS BACKING FILM MANUFACTURED IN BURGDORF, SWITZERLAND

10333 A

III

6/29/1993

OY PREMIX LTD

10334 A

II

7/6/1993

CHATTEM CHEMICALS INC

PREWHITE PE 10-50,PREWHITE PP 22-50 AND PREWHITE PE 16-50 MANUFACTURED IN


RAJAMAKI, FINLAND
HYDROXYAMPHETAMINE HYDROBROMIDE MANUFACTURED IN SOMERVILLE, NEW JERSEY

10335 A

II

6/29/1993

ASAHI GLASS CO LTD

CARBOXYLIC ACID MANUFACTURED IN HIARAKATA CITY, OSAKA, JAPAN

10336 I

II

7/12/1993

HAFSLUND NYCOMED PHARMA AG

AMINOBISAMIDE-HYDROCHLORIDE MANUFACTURED IN LINZ, AUSTRIA

10337 I

7/12/1993

PHARMACIA AND UPJOHN INC

FACILITY AND OPERATING PROCEDURES IN STOCKHOLM, SWEDEN

10338 I

7/12/1993

PHARMACIA AND UPJOHN INC

10339 I

7/12/1993

PHARMACIA AND UPJOHN COMPANY

FACILITY AND OPERATING PROCEDURES AT THE BRUNNA FACILITY IN KUNGSANGEN,


SWEDEN
FACILITY AND OPERATING PROCEDURES IN STRANGNAS, SWEDEN

10340 A

II

6/28/1993

BASF PHARMACHEMIKALIEN GMBH CO KG

SELEGILINE HYDROCHLORIDE MANUFACTURED IN MINDEN, GERMANY

10341 I

III

7/6/1993

AMPACET CORP

10342 I

III

7/6/1993

AMPACET CORP

10343 I

III

6/29/1993

BASF AKTIENGESELLSCHAFT

10344 I

III

6/29/1993

BASF AKTIENGESELLSCHAFT

10345 I

III

6/29/1993

BASF AKTIENGESELLSCHAFT

100319 AS MB MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND


MESSANCY, BELGIUM
100320 AS MB MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND
MESSANCY, BELGIUM
SICOLEN BLUE 69-0964 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
RAKUSOL WHITE 00-2207 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
RAKUSOL BLUE 62-9607 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY

Page 289

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10346 I
III
6/29/1993
BASF AKTIENGESELLSCHAFT
10347 I

III

5/22/1993

PRESSPART MANUFACTURING LTD

SUBJECT
RAKUSOL BLUE 70-9007 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
PHARMACEUTICAL AEROSOL CANS MANUFACTURED IN CARY, NORTH CAROLINA

10348 A

III

7/8/1993

ALBEA AMERICAS INC

GLAMINATE TUBES GS-1004-11 MANUFACTURED IN NEENAH, WISCONSIN

10349 I

II

7/12/1993

BURZYNSKI RESEARCH INSTITUTE INC

ANTINEOPLASTON AS2-1 INJECTIONS MANUFACTURED IN STAFFORD, TEXAS

10350 A

II

6/23/1993

PHARMACEUTICAL WORKS POLPHARMA SA

TINIDAZOLE MANUFACTURED IN STAROGARD GDANSKI, POLAND

10351 A

III

7/9/1993

GERRESHEIMER LOHR GMBH

GLASS CONTAINERS MANUFACTURED IN LOHR A. MAIN, GERMANY

10352 A

III

7/6/1993

CLARIANT MASTERBATCHES NORDEN AB

MASTERBATCH PE-10993 MANUFACTURED IN MALMO, SWEDEN

10353 A

II

7/13/1993

BAYER SCHERING PHARMA AG

10354 I

III

7/6/1993

MARVAL

CIPROFLOXACIN ORAL NEW DRUG SUBSTANCE AS MANUFACTURED IN WUPPERTAL,


GERMANY
MARVAL M-800 NATURAL MANUFACTURED IN MAMARONECK, NEW YORK

10355 I

III

6/8/1993

H AND N CHEMICAL CO

PRESSURE SENSITIVE CODED POLYTAC 5135-1 MANUFACTURED IN TOTOWA, NEW JERSEY

10356 I

III

7/9/1993

TECHNICOTE

10357 A

III

5/12/1993

TIM PLASTICS INC

10358 I

7/12/1993

DIOSYNTH BV

10359 I

III

5/24/1993

ADRIAPLAST SPA

PACKAGING MATERIALS MANUFACTURED IN MIAMISBURG, OHIO, TERRE HAUTE, INDIANA,


CUYAHOGA FALLS, OHIO AND CORONA, CALIFORNIA
HIGH DENSITY PLASTICS BOTTLES FOR DRUG PACKAGING MANUFACTURED IN NORTH EAST,
MARYLAND
FACILITIES AND OPERATING PROCEDURES A DIOSYNTH FRANCE S.A. IN USINE SAINTCHARLES ERAGNY-SUR-EPTE, FRANCE
ALKORPACK P/S MANUFACTURED IN MONFALCONE, ITALY

10360 I

II

7/14/1993

IROTEC LABORATORIES LTD

DICLOFENAC SODIUM MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND

10361 I

IV

7/8/1993

VAN GELDER COATING BV

10362 I

II

7/15/1993

10363 I

II

7/19/1993

UNIVERSITY OF PENNSYLVANIA SCHOOL OF


MEDECINE
GREAT LAKES CHEMICAL CORP

GELROFLEX ALU-PET 100 MICRONS-2S REF: 154/155 MANUFACTURED IN APELDOORN, THE


NETHERLANDS.
LR-3001 MANUFACTURED IN FOSTER CITY, CALIFORNIA

10364 I

7/19/1993

GREAT LAKES CHEMICAL CORP

FACILITY FOR THE MANUFACTURE OF ISOFLURANE IN WEST LAFAYETTE, INDIANA.

10365 I

II

7/16/1993

ISO TEX DIAGNOSTICS

IODINE-125 MANUFACTURED IN FRIENDSWOOD, TEXAS.

10366 A

III

7/21/1993

KURARAY AMERICA INC

ETHYLENE/VINYL ALCOHOL COPOLYMERS MANUFACTURED IN PASADENA, TEXAS.

10367 I

III

7/16/1993

AMPACET CORP

10005 AS MB MANUFACTURED IN TARRYTOWN, NEW YORK.

10368 I

7/20/1993

CRODA UNIVERSAL LTD

MANUFACTURING FACILITIES AND OPERATING PROCEDURES IN LEEK, GREA BRITIAN.

10369 I

II

7/20/1993

CRODA UNIVERSAL LTD

CROSSENTIAL LF100 MANUFACTURED IN LEEK, GREA BRITIAN.

10370 I

III

7/14/1993

COURTESY MED TEK

10371 I

II

6/28/1993

SCICLONE PHARMACEUTICALS

PLASTIC INJECTION MOLDED COMPONENTS FOR HUMAN DRUGS AND BIOLOGICS AS MFG IN
BUFFALO GROVE, IL
THYMOSIN ALPHA I (BULK DRUG) MANUFACTURED IN FOSTER CITY, CALIFORNIA.

10372 I

II

11/2/1993

SYNCHEM CHEMICALS PRIVATE LTD

KETOROLAC TROMETHAMINE MANUFACTURED IN ANKLESHWAR, GUJARA, INDIA.

10373 I

7/15/1993

ALTAIRE PHARMACEUTICALS INC

FACILITIES AND OPERATING PROCEDURES IN HOLBROOK, NEW YORK.

10374 I

II

7/21/1993

ZENTIVA, S.A.

PENTOXIFYLLINE MANUFACTURED IN HLOHOVEC, SLOVAKIA.

10375 I

7/26/1993

GENZYME CORP

10376 I

II

7/26/1993

ICN HUNGARY COMPANY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LIESTAL, SWITZERLAND.
MEXILETINE HYDROCHLORIDE USP BULK MANUFACTURED IN TISZAVASVARI, HUNGARY.

10377 I

7/21/1993

TOKUYAMA SODA CO LTD

ISOFLURANE MANUFACTURED IN WEST LAFAYETTE, INDIANA.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF SILICA (AMORPHOUS, FUMED) IN TOKUYAMA, YAMAGUCHI, JAPAN.

Page 290

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10378 A
V
7/29/1993
INTERNATIONAL PHARMACEUTICAL AEROSOL
CONSORTIUM TOXICOLOGY TESTING
10379 I
II
7/23/1993
BIO RAD LABORATORIES INC

SUBJECT
SAFETY DATA ON HFA-227 (1,1,1,2,3,3,3 HEPTAFLUOROPROPANE).

10380 I

7/13/1993

OMJ PHARMACEUTICALS INC

STERILE MFG PROCESSES AS PRODUCED IN SAN GERMAN,PUERTO RICO

10381 A

II

7/9/1993

MITSUBISHI TANABE PHARMA CORP

10382 I

II

7/22/1993

PEPTOSYN INC

DILTIAZEM HYDROCHLORIDE (PROCESS C) MANUFACTURED IN ONODA CITY, YAMAGUCHI,


JAPAN
TOLONIUM CHLORIDE (TOLUIDINE BLUE-O) MANUFACTURED IN TUCKAHOE, NEW YORK

10383 A

II

7/30/1993

PHARMACEUTICAL WORKS POLPHARMA SA

ACETAZOLAMIDE MANUFACTURED IN STAROGARD GDANSKI, POLAND

10384 I

II

7/30/1993

PHARMACEUTICAL WORKS POLPHARMA SA

CHLORPROPAMIDE MANUFACTUERED IN STAROGARD GDANSKI, POLAND

10385 A

II

8/2/1993

TEVA PHARMACEUTICAL INDUSTRIES LTD

BUTORPHANOL TARTRATE MANUFACTURED IN OPAVA, CZECH REPUBLIC

10386 I

II

7/30/1993

PHARMACEUTICAL WORKS POLPHARMA SA

ACETYLSALICYLIC ACID MANUFACTURED IN STAROGARD GDANSKI, POLAND

10387 I

II

7/28/1993

PHARMACIA AND UPJOHN INC

17-DESOXY OXIDO MANUFACTURED IN KALAMAZOO, MICHIGAN

10388 I

II

7/30/1993

PHARMACEUTICAL WORKS POLPHARMA SA

TOLBUTAMIDE MANUFACTURED IN STAROGARD GDANSKI, POLAND

10389 I

II

7/29/1993

LONZA RIVERSIDE

PROPYLHEXEDRINE MANUFACTURED IN CONSHOHOCKEN, PENNSYLVANIA

10390 I

IV

7/29/1993

TAKASAGO INTERNATIONAL CORP

10391 I

III

8/2/1993

SABIC PETROCHEMICALS BV

10392 A

III

7/19/1993

NOLATO JAYCARE LTD

TAK-90516 SOLID EXTRACT TAMARIND FLAVOR MANUFACTURED IN TETERBORO, NEW


JERSEY
SABIC LDPE 2304AN00, STAMYLAN 1808AN00, AND STAMLEX 9089F MANUFACTURED IN BEEK,
THE NETHERLANDS
JAYSQUARE CONTAINERS MANUFACTURED IN NORTH SHIELDS, TYNE AND WEAR, ENGLAND

10393 I

7/21/1993

MERCK AND CO INC

10394 I

8/2/1993

CIBA GEIGY MEXICANA SA DE CV

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LE PUY CEDEX, FRANCE.
FACILITY AND OPERATING PROCEDURES IN PUEBLA, MEXICO

10395 I

III

7/16/1993

EUROPLAZ LTD

PLASTIC PACKAGING MATERIAL MANUFACTURED IN SOUTHMINSTER, ESSEX, ENGLAND

10396 A

II

6/17/1993

TAIHO PHARMACEUTICAL CO LTD

TEGAFUR AS MANUFACTURED IN SAITAMA, JAPAN

10397 I

III

8/3/1993

HELVOET PHARMA MARYLAND

10398 I

III

8/3/1993

PMS CONSOLIDATED

RUBBER CLOSURE FORMULATION C6201-45 GREEN MANUFACTURED IN SALSBURY,


MARYLAND
COLORANTS FOR PACKAGING, 042098 JPMB AND 07663 JFFD AS MANUFACTURED IN
SOMERSET, NEW JERSEY

10399 N

DEAE BIO-GEL A GEL MANUFACTURED IN RICHMOND, CALIFORNIA

NOT AN ASSIGNED NUMBER

10400 I

II

6/17/1993

TAIHO PHARMACEUTICAL CO INC

UFT CAPSULES (TEGAFUR AND URACIL) MANUFACTURED IN TOKUSHIMA, JAPAN

10401 I

8/3/1993

SINTENOVO SA DE CV

10402 I

II

8/4/1993

GANES CHEMICALS INC

FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE NAUCALPAN (MEXICO)


PLANT
IODINATED GLYCEROL AZEO MANUFACTURED IN CARLSTADT, NEW JERSEY

10403 I

II

8/4/1993

GANES CHEMICALS INC

IODINATED GLYCEROL SOLUTION MANUFACTURED IN CARLSTADT, NEW JERSEY

10404 I

II

8/4/1993

GANES CHEMICALS INC

IODINATED GLYCEROL CONCENTRATE MANUFACTURED IN CARLSTADT, NEW JERSEY

10405 I

II

8/6/1992

HUMATECH

IBOGAINE HYDROCHLORIDE MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM

10406 I

III

8/9/1993

HEINKE TECHNOLOGY INC

VCA5 VAGINAL CREAM APPLICATOR MANUFACTURED IN LINCOLN, NEBRASKA

10407 I

III

8/9/1993

10408 I

IV

8/10/1993

PAPIERFABRIK DIV SCHOELLER AND HOESCH


GMBH
RESOURCES INDUSTRY INC

GEFOLUX TDS/M 50, 75, 10UM (ONE SIDE ALUMINIZED) AS MANUFACTURED IN GERNSBACH,
GERMANY
MICROCRYSTALLINE CELLULOSE MANUFACTURED IN LAFAYETTE, INDIANA

10409 I

IV

8/6/1993

TAKASAGO INTERNATIONAL CORP

TAK-920471 NATURAL AND ARTIFICIAL TAMARIND FLAVOR MANUFACTURED IN TETERBORO,


NEW JERSEY

Page 291

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10410 A
II
8/13/1993
SYNTHOKEM LABS PRIVATE LTD
10411 I

III

8/6/1993

PMS CONSOLIDATED

SUBJECT
METHOCARBAMOL MANUFACTURED IN SANATHNAGAR, HYDERABAD, ANDHRA PRADESH,
INDIA
152 LFD COLORANT MANUFACTURED IN GARDENA, CALIFORNIA

10412 A

III

8/16/1993

WESTLAKE POLYMERS CORP

LOW DENSITY POLYETHYLENE (LDPE) RESINS MANUFACTURED IN SULPHUR, LOUISIANA

10413 A

II

8/13/1993

SYNTHOKEM LABS PRIVATE LTD

GUAIFENESIN MANUFACTURED IN SANATHNAGAR, HYDERABAD, ANDHRA PRADESH, INDIA

10414 I

II

8/9/1993

ARCHIMICA SPA

BUSPIRONE HYDROCHLORIDE MANUFACTURED IN VARESE, ITALY

10415 I

II

8/10/1993

ONO PHARMACEUTICAL CO LTD

ALPROSTADIL ALFADEX I.V. MANUFACTURED IN JOTO, JAPAN

10416 A

II

8/13/1993

TAKEDA PHARMACEUTICAL CO LTD

LEUPROLIDE ACETATE MANUFACTURED IN HIKARI-CITY, YAMAGUCHI, JAPAN

10417 A

II

8/16/1993

SAFC BIOSCIENCES INC

EX-CELL 301 MANUFACTURED IN DENVER, PENNSYLVANIA

10418 I

8/13/1993

TAKEDA CHEMICAL INDUSTRIES LTD

FACILITIES AND OPERATING PROCEDURES IN HIKARI-CITY, YAMAGUCHI, JAPAN

10419 I

6/2/1993

GALEN LTD

FACILITY AND OPERATING PROCEDURES IN CRAIGAVON, NORTHERN IRELAND

10420 I

7/30/1993

PHARMACIA AND UPJOHN INC

FACILITY, PERSONNEL AND OPERATING PROCEDURES IN STOCKHOLM, SWEDEN

10421 I

IV

8/3/1993

10422 I

III

3/11/1993

QUEST INTERNATIONAL FLAVORS AND FOOD


INGREDIENTS CO
TICONA GMBH

ARTIFICIAL BANANA FLAVOR 81.605P, DY-02041 MANUFACTURED IN OWINGS MILLS,


MARYLAND
NYLON 6,6 MANUFACTURED IN BISHOP, TEXAS AND FLORENCE, KENTUCKY

10423 I

II

8/11/1993

HOECHST MARION ROUSSEL SA

BETAMETHASONE SODIUM PHOSPHATE MANUFACTURED IN VERTOLAYE, FRANCE

10424 I

IV

8/12/1993

TAKASAGO INTERNATIONAL CORP

10425 I

III

8/16/1993

DCP-LOHJA INC

TAK-920444 NATURAL ORANGE EXTRACT WONF MANUFACTURED IN TETERBORO, NEW


JERSEY.
RELEASE FILMS MANUFACTURED IN DIXON, ILLINOIS

10426 I

III

8/17/1993

DSM POLYMERS

PACKAGING MATERIAL STAMYLAN HD 7058Z MANUFACTURED IN BEEK, THE NETHERLANDS

10427 I

III

8/5/1993

CREST FLEXIBLE PACKAGING LTD

10428 I

III

8/5/1993

CREST FLEXIBLE PACKAGING LTD

10429 A

III

8/18/1993

MYLAN TECHNOLOGIES INC

PACKAGING MATERIAL FOR PEPCIDIN 20 MG AND 40 MG AS MANUFACTURED IN GILLINGHAM,


KENT, ENGLAND
18779-010-010 PAPER/PE/FOIL/PE BASE 10000 PACKING MATERIAL AS MANUFACTURED IN
GILLINGHAM, KENT, ENGLAND
2226 LINER AS MANUFACTURED IN ST. ALBANS, VERMONT

10430 I

II

8/18/1993

IMUTEC CORP

PREMIX A FOR VIRULIZIN-2B MANUFACTURED IN SCARBOROUGH, ONTARIO, CANADA

10431 I

III

8/20/1993

BESPAK PLC

BESPAK BK636 PHARMACEUTICAL ORAL ACTUATOR MANUFACTURED IN NORFOLK, ENGLAND

10432 I

II

8/17/1993

ANDRULIS RESEARCH CORP

10433 I

III

8/11/1993

BASF AKTIENGESELLSCHAFT

10434 I

III

8/17/1993

PMS CONSOLIDATED

10435 A

III

8/6/1993

BASF COLOR SOLUTIONS GERMANY GMBH

10436 I

III

8/26/1993

GEON CO

BIS-ETHYL NORSPERMINE TETRAHYDROCHLORIDE (BENS.4HCL) MANUFACTURED IN


BELTSVILLE, MARYLAND
SICOLEN BLUE 69-1625 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
COLORANTS 502617 JPMBC, 502622 JPMBC, 503986 JPMBC, 504240 JPMBC, 41P997 CMB AND
21P5030 CMB MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS
EUTHYLEN WHITE 00-1905 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
GEON 87781-003, 87781-005 AND 87781-007 MANUFACTURED IN CLEVELAND, OHIO

10437 I

8/26/1993

FUJI GLASS CO LTD

FACILITY AND OPERATING PROCEDURES IN TOKYO, JAPAN.

10438 A

III

8/26/1993

FUJI GLASS CO LTD

GLASS TUBULAR VIALS MANUFACTURED IN TOKYO, JAPAN.

10439 A

III

8/26/1993

FUJI GLASS CO LTD

AMPULES MANUFACTURED IN TOKYO, JAPAN

10440 I

II

8/24/1993

WYCKOFF CHEMICAL CO INC

PSEUDOEPHEDRINE SULFATE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

10441 I

IV

8/27/1993

PHARMECO LABORATORIES INC

ZONYL FSO 100 MANUFACTURED IN LEXINGTON, MASSACHUSETTS.

10442 I

II

8/17/1993

SIGMA F AND D DIV LTD

2-DEOXYCYTIDINE MANUFACTURED IN SAINT LOUIS, MISSOURI.

Page 292

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10443 A
II
8/25/1993
ISOCHEM SAS

SUBJECT
METHYL-3-FLAVONE-8-CARBOXYLIC ACID MANUFACTURED IN GENNEVILLIERS, FRANCE.

10444 I

8/23/1993

FACILITY AND PROEDURES IN LLANGEFNI, ENGLAND.

10445 I

III

8/16/1993

PEBOC DIVISION OF EASTMAN CHEMICAL (UK)


LIMITED
SOLVAY AND CIE SA

10446 I

III

8/25/1993

SAM SEMCO

PACKAGING MATERIAL MANUFACTURED IN MONTE CARLO, MONACO.

10447 I

II

8/26/1993

PHARMACIA AND UPJOHN SUB PFIZER INC

HYDROCORTISONE BUTYRATE MANUFACTURED IN KALAMAZOO, MICHIGAN

10448 I

9/1/1993

NIPPON GOHSEI CO LTD

FACILITY AND OPERATING PROCEDURES IN UTO, KUNAMOTO PREFECTURE, JAPAN.

10449 I

8/26/1993

ORGANICHEM CORP

10450 A

II

8/30/1993

KANEKA CORP

10451 A

III

8/4/1993

DANAPAK FLEXIBLES AS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OSLO, NORWAY.
(4S,6S)-5, 6-DIHYDRO-4-HYDROXY-6-METHYL-4H-THIENO[2,3-B]THIOPYRAN 7,7-DIOXIDE
(HSOT) MANUFACTURED IN HYOGO, JAPAN
COMPOUND PACKAGING MATERIAL MANUFACTURED IN ODENSE, DENMARK

10452 I

III

8/16/1993

SOLVAY AND CIE SA

POLYPROPYLENE ELTEX A 4019-X1869 MANUFACTURED IN SARRALBE, FRANCE.

10453 I

III

8/16/1993

SOLVAY AND CIE SA

POLYPROPYLENE ELTEX P HS 250 MANUFACTURED IN SARRALBE, FRANCE

10454 I

III

8/16/1993

SOLVAY AND CIE SA

POLYPROPYLENE ELTEX P HV 252 MANUFACTURED IN SARRALBE, FRANCE

10455 A

III

9/21/1994

DR REDDYS LABORATORIES INC

HDPE BOTTLES MANUFACTURED IN BRISTOL, TENNESSEE

10456 A

II

8/9/1993

FDC LTD

10457 A

II

8/30/1993

ASPEN OSS BV

ECONAZOLE NITRATE MANUFACTURED IN ROHA, DIST. RAIGAD, MAHARASHTRA STATE,


INDIA.
MIRTAZAPINE MANUFACTURED IN OSS, THE NETHERLANDS

10458 I

II

9/7/1993

FLUORO SEAL INC

APF-30M (DODECAFLOUROPENTANE) MANUFACTURED IN ALLENTOWN, PENNSYLVANIA

10459 I

II

9/3/1993

PCR INC

MEDICAL GRADE DODECAFLUOROPENTANE MANUFACTURED IN GAINESVILLE, FLORIDA

10460 A

II

9/8/1993

PCAS

DICYCLOMINE HYDROCHLORIDE MANUFACTURED IN LIMAY, FRANCE FOR PCAS

10461 A

II

9/8/1993

PCAS

DESIPRAMINE HYDROCHLORIDE MANUFACTURED IN LIMAY, FRANCE FOR PCAS

10462 A

II

8/25/1993

INDENA SPA

10-DEACETYLBACCATIN III MANUFACTURED IN SETTALA, (MI), ITALY

10463 I

8/25/1993

INDENA GRUPPO INVERNI DELLA BEFFA

FACILITY AND OPERATING PROCEDURES IN SETTALA (MI), ITALY

10464 I

2/19/1993

VINTAGE PHARMACEUTICAL INC

FACILITY AND OPERATING PROCEDURES IN CHARLOTTE, NORTH CAROLINA

10465 A

III

9/2/1993

FUJIMORI KOGYO CO LTD

PLASTIC FILM BAG MANUFACTURED IN NABARI-CITY, JAPAN

10466 I

II

6/2/1993

DILTIAZEM HYDROCHLORIDE MANUFACTURED IN ANDHRA PRADESH, INDIA

10467 I

II

9/13/1993

SUMITRA PHARMACEUTICALS AND CHEMICALS


LTD
NIPPON GOHSEI

10468 I

II

8/27/1993

FINORGA SA

10469 I

9/10/1993

YUHAN CORP

2-N-BUTYL-4-CHLORO-1H-IMIDAZOLE-5-CARBOXALDEHYDE MANUFACTURED IN KUNAMOTO,


JAPAN
2-BUTYL-4(5)-CHLORO-1H-IMIDAZOLE-5(4)-CARBOXALDEHYDE MANUFACTURED IN CHASSESUR-RHONE, FRANCE
FACILITY AND OPERATING PROCEDURES IN ANSANSHI, KYONGGI-DO, SOUTH KOREA

10470 I

II

9/4/1993

CLARIANT LIFE SCIENCE MOLECULES UK LTD

BENZOCAINE MANUFACTURED IN MANCHESTER, UNITED KINGDOM

10471 I

III

9/2/1993

ECP ENICHEM POLYMERES FRANCE

ERACLENE MP94 MANUFACTURED IN PORTO TORRES, ITALY

10472 I

II

9/10/1993

ICN HUNGARY COMPANY LIMITED

CHLOROQUINE PHOSPHATE MANUFACTURED IN TISZAVASVARI, HUNGARY

10473 I

II

9/14/1993

LABORATOIRES SERONO SA

STERILE WATER FOR INJECTION MANUFACTURED BY PHARMA HAMELN GMBH IN HAMELN,


FEDERAL REPUBLIC OF GERMANY AND PACKAGED BY LABORATOIRES SERONO SA IN
AUBONNE, SWITZERLAND

10474 I

8/28/1993

NIPPON PHARMACEUTICAL CHEMICALS CO LTD

FACILITIES AND OPERATING PROCEDURES IN HIGASHIOSAKA CITY, OSAKA, JAPAN

10475 I

9/3/1993

NIPPON TERPENE CHEMICAL CO LTD

FACILITY AND OPERATING PROCEDURES IN KOBE, JAPAN

10476 A

II

9/17/1993

NIPPON KAYAKU CO LTD

ETOPOSIDE PHOSPHATE AS MFG. IN TOKYO, JAPAN

POLYPROPYLENE ELTEX P HS 200 MANUFACTURED IN SARRALBE, FRANCE.

Page 293

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10477 I
I
9/3/1993
LEO PHARMACEUTICAL PRODUCTS LTD

SUBJECT
WEXPORT LTD. FACILITIES IN LITTLE ISLAND, CORK, IRELAND FOR THE MANUFACTURE OF
HEPARIN SODIUM
FRUCTOSE-1.6-BISPHOSPHATE MANUFACTURED IN PENZBERG, FEDERAL REPUBLIC OF
GERMANY
(D-ALA1)-PEPTIDE T AMIDE, HYDROCHLORIDE MANUFACTURED IN COPENHAGEN, DENMARK

10478 I

II

9/17/1993

ROCHE DIAGNOSTICS GMBH

10479 I

II

9/20/1993

PEPTECH EUROPE A/S

10480 I

9/2/1993

NOVO NORDISK A/S

10481 I

9/17/1993

HOFFMANN LA ROCHE INC

10482 I

III

9/8/1993

BASF AKTIENGESELLSCHAFT

FACILITIES IN BAGSVATERD, KALUNDBORG, COPENHAGEN, SOEBERG, HILLEROED AND


VATERLOESE, DENMARK
FACILITY AND OPERATING PROCEDURES IN WELWYN GARDEN CITY, HERTFORDSHIRE,
ENGLAND
NOVOLEN 1100 RC MANUFACTURED IN LUDWIGSHAFEN, GERMANY

10483 I

III

9/8/1993

BASF AKTIENGESELLSCHAFT

TERLUX 2802 TR TRANSPARENT 27768 MANUFACTURED IN LUDWIGSHAFEN, GERMANY

10484 I

III

9/8/1993

BASF AKTIENGESELLSCHAFT

TERLUX 2802 TR TRANSPARENT 28348 MANUFACTURED IN LUDWIGSHAFEN, GERMANY

10485 I

II

9/21/1993

HAFSLUND NYCOMED PHARMA AG

PODOPHYLLOTOXIN MANUFACTURED IN LINZ, AUSTRIA

10486 I

III

9/15/1993

SWIFT 2H041 ADHESIVE MANUFACTURED IN DOWNERS GROVE, ILLINOIS

10487 I

III

9/20/1993

SWIFT ADHESIVES DIV REICHHOLD CHEMICALS


INC
AMPACET CORP

10488 I

III

9/17/1993

ROLLPRINT PACKAGING PRODUCTS INC

10489 I

II

9/21/1993

SEPRACOR INC

10490 I

III

9/13/1993

HELVOET PHARMA MARYLAND

10491 I

9/24/1993

QUALITY CHEMICALS INC

10492 A

II

9/15/1993

TICLOPIDINE HYDROCHLORIDE MANUFACTURED IN FLORENCE, ITALY

10493 A

II

9/23/1993

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
ASPEN OSS BV

10494 I

9/27/1993

CTRC RESEARCH FDN

FACILITIES, SITE AND PERSONNEL IN SAN ANTONIO, TEXAS

10495 A

IV

9/23/1993

CREMER OLEO GMBH AND CO KG

MIGLYOL 829 MANUFACTURED IN WITTEN, GERMANY

10496 I

II

9/24/1993

HOFFMANN LA ROCHE INC

10497 I

II

9/24/1993

GEDEON RICHTER USA INC

NITOMAN (TETRABENAZINE) TABLETS MANUFACTURED IN DALRY, SCOTLAND AND WELWYN


GARDEN CITY, ENGLAND
FLUTAMIDE MANUFACTURED IN BUDAPEST, HUNGARY

10498 A

II

9/28/1993

GRAIN PROCESSING CORP

ETHYL ALCOHOL PRODUCTS MANUFACTURED IN MUSCATINE, IOWA

10499 A

II

9/29/1993

CATALENT PHARMA SOLUTIONS LLC

IBUPROFEN SOFTGELS, 200 MG. MANUFACTURED IN ST. PETERSBURG, FLORIDA

10500 A

III

9/23/1993

BEATSON CLARK PLC

AMBER GLASS CONTAINERS MANUFACTURED IN ROTHERHAM, ENGLAND

10501 I

III

9/23/1993

BEATSON CLARK PLC

WHITE FLINT GLASS CONTAINERS MANUFACTURED IN ROTHERHAM, ENGLAND

10502 I

IV

9/21/1993

J MANHEIMER INC

NATURAL CHERRY WONF 606948 MANUFACTURED IN LONG ISLAND CITY, NEW YORK

10503 I

IV

9/21/1993

J MANHEIMER INC

10504 I

II

9/29/1993

NAPRO BIOTHERAPEUTICS INC

NATURAL AND ARTIFICIAL CHERRY FLAVOR 606947 MANUFACTURED IN LONG ISLAND CITY,
NEW YORK
PACLITAXEL DRUG SUBSTANCE MANUFACTURED IN BOULDER, COLORADO

10505 I

II

9/29/1993

LONZA LTD

10506 I

III

9/7/1993

FERRO CORP

10507 I

II

9/30/1993

BTR SEPARATIONS

180132 SKIN TONE POLYETHYLENE MASTERBACH MANUFACTURED IN TARRYTOWN, NEW


YORK
RPP #26-1067 PACKAGING MATERIAL MANUFACTURED IN ADDISON, ILLINOIS
BLUE TRISACRYL AND BLUE TRISACRYL PLUS MANUFACTURED IN VILLENEUVE LA GARENNE,
FRANCE
RUBBER CLOSURE FORMULATION B5021-45 GRAY MANUFACTURED IN SALISBURY,
MARYLAND
FACILITY AND OPERATING PROCEDURES IN DAYTON, OHIO

BUDESONIDE MANUFACTURED IN OSS, THE NETHERLANDS

2-BUTYL-5-CHLORO-1H-IMIDAZOLE-4-CARBOXALDEHYDE MANUFACTURED IN VISP,


SWITZERLAND
NPPOONPO4NA (ALTERNATIVELY X53-041 OR CPC27-4555) MANUFACTURED IN EVANSVILLE,
INDIANA
ZORBAX MANUFACTURED IN DEEPWATER, NEW JERSEY.

Page 294

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10508 I
IV
9/23/1993
CREMER OLEO GMBH AND CO KG

SUBJECT
IMWITOR 742 MANUFACTURED IN WITTEN, GERMANY

10509 I

9/21/1993

LONZA LTD

FACILITY AND OPERATING PROCEDURES IN VISP, SWITZERLAND

10510 I

II

9/27/1993

NITRIC OXIDE IN NITROGEN GAS MIXTURE PRODUCED IN OAK BROOK, ILLINOIS

10511 I

9/24/1993

LIQUID CARBONIC INDUSTRIES CORP BULK


GASES
BTR SEPARATIONS

10512 I

II

10/4/1993

LABORATORIOS SERONO SA

10513 A

II

10/5/1993

MEDICIS PHARMACEUTICAL CORP

BACTERIOSTATIC SODIUM CHLORIDE INJECTION MANUFACTURED IN AUBONNE,


SWITZERLAND
PIRBUTEROL ACETATE MANUFACTURED IN PITHIVIERS, CEDEX, FRANCE

10514 A

II

10/8/1993

LEO PHARMA AS

CALCIPOTRIENE HYDRATE DRUG SUBSTANCE MANUFACTURED IN BALLERUP, DENMARK

10515 A

II

10/8/1993

LEO PHARMA AS

CALCIPOTRIENE CREAM DRUG PRODUCT MANUFACTURED IN BALLERUP, DENMARK

10516 I

II

10/5/1993

RANBAXY LABORATORIES LTD

RANITIDINE HYDROCHLORIDE MANUFACTURED IN DISTT. ROPAR, PUNJAB, INDIA

10517 A

II

9/30/1993

SIFAVITOR SRL

LOPERAMIDE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY

10518 A

II

9/30/1993

SIFAVITOR SRL

MICONAZOLE NITRATE MANUFACTURED IN MILAN, ITALY

10519 I

II

10/8/1993

NV ORGANON

DANAPAROID SODIUM MANUFACTURED IN OSS, THE NETHERLANDS

10520 I

II

9/30/1993

ORGAMOL SA

MOEXIPRIL HYDROCHLORIDE MANUFACTURED IN EVIONNAZ, SWITZERLAND

10521 I

10/5/1993

SANDOZ AG

FACILITIES AND PROCEDURES IN NUREMBERG, GERMANY

10522 I

III

10/8/1993

INTERNATIONAL TRADING CORP

10523 I

II

10/7/1993

UPSHER SMITH LABORATORIES INC

10524 A

IV

10/12/1993

CREMER OLEO GMBH AND CO KG

PROLEN XM6150K, HY6100, AND SM6100K MANUFACTURED BY POLIBRASIL S.A. IN RIO DE


JANEIRO, BRAZIL
NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS) MANUFACTURED IN MINNEAPOLIS,
MINNESOTA
SOFTISAN 649 MANUFACTURED IN WITTEN, GERMANY

10525 I

10/14/1993

NOVARTIS PHARMA AG

FACILITY AND OPERATING PROCEDURES IN DORVAL, QUEBEC, CANADA

10526 I

III

10/6/1993

HELVOET PHARMA MARYLAND

10527 I

II

8/31/1993

FINE CHEMICALS CORP LTD

RUBBER CLOSURE FORMULATION B5301-50 GRAY MANUFACTURED IN SALISBURY,


MARYLAND
NICOTINE POLACRILEX MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA

10528 I

II

10/13/1993

SIGMA F AND D DIV LTD

DEOXYRIBONUCLEASE I (PROD. NO. D 5025) MANUFACTURED IN ST. LOUIS, MISSOURI

10529 I

II

10/14/1993

IROTEC LABORATORIES LTD

SELEGILINE HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND

10530 I

II

8/14/1993

MEDEA RESEARCH LABORATORIES INC

WARFARIN SODIUM MANUFACTURED IN PORT JEFFERSON STATION, NEW YORK

10531 I

II

10/19/1993

ARCHIMICA SPA

NITRO-THIAZOLINEBULK MANUFACTURED IN ORIGGIO, ITALY.

10532 A

II

10/15/1993

DEAD SEA BROMINE CO LTD

MAGNESIUM HYDROXIDE MANUFACTURED IN D.N. ARAVA, ISRAEL

10533 I

9/30/1993

VANCHEM INC

FACILITY AND OPERATING PROCEDURES IN LOCKPORT, NEW YORK

10534 A

II

10/21/1993

MEDICHEM SA

CLOZAPINE MANUFACTURED IN CELRA (GERONA), SPAIN

10535 I

10/15/1993

WEST GRAND DE MEXICO S DE RL DE CV

10536 A

II

10/18/1993

PHARMACIA AND UPJOHN SUB PFIZER INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN VERACRUZ, MEXICO.
ESTRADIOL MANUFACTURED IN KALAMAZOO, MICHIGAN

10537 I

III

10/25/1993

DSM POLYMERS

STAMYLAN P 112MN40 MANUFACTURED IN BEEK, THE NETHERLANDS

10538 I

III

10/25/1993

DSM POLYMERS

STAMYLAN HD 8621 MANUFACTURED IN BEEK, THE NETHERLANDS

10539 I

III

10/25/1993

DSM POLYMERS

STAMYLAN LD 2102T MANUFACTURED IN BEEK, THE NETHERLANDS

10540 I

10/25/1993

3M PHARMACEUTICALS

10541 I

II

10/25/1993

3M PHARMACEUTICALS

PRECLINICAL SAFETY OF THE ADHESIVE SYSTEM FOR THE TRANSDERMAL DRUG


PRODUCTS A-81418
TRANSDERMAL PACH A-81418 MANUFACTURED IN ST. PAUL, MINNESOTA

FACILITIES AND OPERATING PROCEDURES IN MILAN, ITALY.

Page 295

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10542 I
II
10/25/1993
CYGNUS INC
10543 I

II

10/26/1993

MALLINCKRODT CHEMICAL INC

SUBJECT
ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM MANUFACTURED IN
REDWOOD, CALIFORNIA
BRAIN NARIURETIC PEPTIDE MANUFACTURED IN ST. LOUIS, MISSOURI

10544 I

II

10/22/1993

KYOWA HAKKO KOGYO CO LTD

L-GLUTAHIONE REDUCED (ORAL GRADE) MANUFACTURED IN HOFU CITY, JAPAN

10545 I

III

10/20/1993

AMPACET CORP

LT-70279 PEACH POLYETHYLENE MASTERBACH.

10546 I

II

10/25/1993

ESTEVE QUIMICA SA

METOPROLOL FUMARATE MANUFACTURED IN CELRA (GIRONA), SPAIN.

10547 A

II

10/25/1993

ESTEVE QUIMICA SA

METOPROLOL SUCCINATE MANUFACTURED IN CELRA (GIRONA), SPAIN.

10548 I

II

10/26/1993

SELOC AG

CHLOROTRIANISENE MANUFACTURED IN LIMAY, FRANCE

10549 A

II

10/26/1993

PCAS

MEPENZOLATE BROMIDE MANUFACTURED IN LIMAY, FRANCE

10550 I

10/22/1993

VALOIS

10551 I

9/29/1993

SYNBIOTICS LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LE NEUBOURG, FRANCE.
FACILITIES AND OPERATING PROCEDURES IN VADODARA (GUJARA), INDIA.

10552 I

10/28/1993

REGIS CHEMICAL CO

FACILITY AND OPERATING PROCEDURES IN MORTON GROVE, ILLINOIS.

10553 I

III

10/21/1993

DANAPAK FLEXIBLES

COMPOUND PACKAGING MATERIAL MANUFACTURED IN ODENSE, DENMARK.

10554 I

III

10/29/1993

SILGAN PLASTICS CANADA INC

10555 I

III

10/29/1993

REXHAM CONTAINERS

10556 I

II

9/30/1993

GENZYME FINE CHEMICALS

100-300 R PHARMACEUTICAL BOTTLES MANUFACTURED IN SCARBOROUGH, ONTARIO,


CANADA.
100-250 OB PHARMACEUTICAL BOTTLES MANUFACTURED IN SCARBOROUGH, ONTARIO,
CANADA.
SODIUM CHOLESTERYL SULPHATE MANUFACTURED IN HAVERHILL, SUFFOLK, ENGLAND

10557 I

III

10/18/1993

HARGRO PACKAGING

10558 N

PACKAGING MATERIAL CODE E-93PS-1 MANUFACTURED IN EDINBURGH, IN OR FLEMINGTON,


NJ

NOT AN ASSIGNED NUMBER

10559 A

III

10/27/1993

UNITED CLOSURES AND PLASTICS PLC

CLOSURES MANUFACTURED IN NORWICH, ENGLAND

10560 I

11/3/1993

SENN CHEMICALS

10561 A

III

11/3/1993

LOPAREX LLC

MANUFACTURING SITE, FACILITIES AND OPERATING PROCEDURES AND PERSONNEL IN


DIELSDORF, SWITZERLAND
BIORELEASE FILM LINER MANUFACTURED IN BEDFORD PARK, IL, IOWA CITY, IA

10562 A

III

11/4/1993

PHILLIPS SUMIKA POLYPROPYLENE CO

MARLEX POLYPROPYLENE MANUFACTURED IN PASADANA, TEXAS

10563 I

III

10/22/1993

ROWO COATING GMBH FUR BESCHICHTUNG

10564 I

II

10/29/1993

ZAMBON GROUP SPA

POLYESTER FILM 100 MICRON (ONE SIDE ALUMINIZED) MANUFACTURED IN HERBOLZHEIM,


GERMANY
IOPAMIDOL MANUFACTURED IN VICENZA, ITALY

10565 A

II

11/12/1993

SAFC BIOSCIENCES INC

10566 I

11/8/1993

ALBERT DAVID LTD

EX-CELL 300 (MBS) W/L-GLUTAMINE, HEPES, NAHC03, GALACTOSE W/O PHENOL RED (CAT.
NO. 14035)
FACILITY AND OPERATING PROCEDURES IN CALCUTTA, INDIA

10567 I

11/5/1993

MAROPACK AG

FACILITIES AND OPERATING PROCEDURES IN ZELL/LUCERNE, SWITZERLAND.

10568 I

II

11/9/1993

PHARMACIA AND UPJOHN INC

BIZELESIN (U-77779) DRUG SUBSTANCE MANUFACTURED IN KALAMAZOO, MICHIGAN

10569 I

II

11/12/1993

RANBAXY LABORATORIES LTD

TERFENADINE MANUFACTURED IN DISTT. ROPAR, PUNJAB, INDIA

10570 I

II

11/4/1993

DAIICHI ASUBIO PHARMA CO LTD

SUN A0026 DRUG SUBSTANCE MANUFACTURED IN CHIBA-CITY, CHIBA, JAPAN

10571 I

11/4/1993

SUNTORY BIO PHARMA TECH CENTER

MANUFACTURING SITE A THE CHIBA PLANT IN CHIBA-CITY, CHIBA, JAPAN

10572 I

IV

11/10/1993

ENCAPSULATION SYSTEMS INC

DELTA STARCH 901 MANUFACTURED IN DARBY, PENNSYLVANIA

10573 I

II

11/11/1993

3V PARTECIPAZIONI INDUSTRIALI SPA

UVASORB MET/C MANUFACTURED IN MOZZO, ITALY

10574 I

11/11/1993

3V PARTECIPAZIONI INDUSTRIALI SPA

MANUFACTURING FACILITY IN MOZZO, ITALY

10575 I

II

11/17/1993

BACHEM INC

DESLORELIN PAMOATE MANUFACTURED IN TORRANCE, CALIFORNIA

Page 296

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10576 A
II
11/18/1993
INTERPHARMA PRAHA A S

SUBJECT
IODIPAMIDE DRUG SUBSTANCE MANUFACTURED IN PRAGUE, MODRANY, CZECH REPUBLIC.

10577 I

II

11/8/1993

ALDRICH CHEMICAL CO INC

2,5-DIHYDROXYBENZOIC ACID MANUFACTURED IN MILWAUKEE, WISCONSIN.

10578 I

IV

11/5/1993

CARRUBBA INC

FLAVOR CONCENTRATE # 48119 MANUFACTURED IN MILFORD, CONNECTICUT.

10579 I

II

11/16/1993

KV PHARMACEUTICAL CO

MICONAZOLE VAGINAL CREAM MANUFACTURED IN ST. LOUIS, MISSOURI

10580 A

IV

11/17/1993

CREMER OLEO GMBH AND CO KG

SOFTISAN 378 MANUFACTURED IN WITTEN, GERMANY

10581 A

11/19/1993

NERPHARMA SRL

STERILE AND NON-STERILE FACILITIES LOCATED IN MILAN, ITALY

10582 I

II

11/19/1993

SCHUTZ AND CO

TRIPELENNAMINE HYDROCHLORIDE MANUFACTURED IN RAHDRUM, CO. WICKLOW, IRELAND

10583 I

III

10/27/1993

BASF AKTIENGESELLSCHAFT

NOVOLEN 1100 L MANUFACTURED IN LUDIWIGSHAFEN, GERMANY.

10584 I

III

10/27/1993

BASF SE

ULTRADUR B 4520 MANUFACTURED IN LUDWIGSHAFEN, GERMANY

10585 I

III

12/1/1993

INTRAPAC CORP

10586 I

II

11/22/1993

BOEHRINGER INGELHEIM PHARMA KG

COLLAPSIBLE ALUMINUM TUBES MANUFACTURED IN CHESTER, PA, CARROLTON, KY AND


VEGA ALTA, PR
LOBELINE SULFATE MANUFACTURED IN INGELHEIM, GERMANY.

10587 I

III

11/9/1993

CEBAL VERPACKUNGEN GMBH AND CO KG

ALUMINUM TUBES, CAPS AND AEROSOL CANS MANUFACTURED IN SCHESSLITZ, GERMANY.

10588 A

III

11/18/1993

FAULKNER EXPORT PACKAGING LTD

STATPAK (TM) FP MANUFACTURED IN DUBLIN, IRELAND.

10589 I

II

11/22/1993

LEO PHARMACEUTICAL PRODUCTS

10590 I

II

11/22/1993

10591 I

II

11/24/1993

10592 I

11/24/1993

HEPARIN SODIUM DRUG SUBSTANCE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND BY


WEXPORT LTD.
LONZA RIVERSIDE
BROMFENAC SODIUM SESQUIHYDRATE MANUFACTURED IN CONSHOHOCKEN,
PENNSYLVANIA.
CYGNUS INC
ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM MANUFACTURED IN REDWOOD CITY,
CALIFORNIA.
LABORATORIOS APPLICACIONES FARMACEUTICAS FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MEXICO CITY, DF MEXICO.

10593 A

II

11/30/1993

DPX FINE CHEMICALS AUSTRIA GMBH & CO KG

PYRIDOSTIGMINE BROMIDE MANUFACTURED IN LINZ, AUSTRIA.

10594 I

III

11/19/1993

PERLOS OYJ

MAIN ASSEMBLY TURBUHALER MANUFACTURED IN LEHMO, FINLAND.

10595 I

11/29/1993

PVC CONTAINER CORP

FACILITY AND OPERATING PROCEDURES IN EATONTOWN, NEW JERSEY

10596 I

II

12/7/1993

LEO PHARMACEUTICAL PRODUCTS

TINZAPARIN SODIUM DRUG SUBSTANCE MANUFACTURED IN BALLERUP, DENMARK

10597 I

II

12/7/1993

LEO PHARMACEUTICAL PRODUCTS

INNOHEP INJECTION 20,000 ANTI-XA IR/ML MANUFACTURED IN BALLERUP, DENMARK

10598 I

II

12/2/1993

GENZYME PHARMACEUTICALS

10599 I

II

11/29/1993

ANGUS CHEMICAL CO

SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC) MANUFACTURED IN SUFFOLK,


ENGLAND
TROMETHAMINE (TRIS AMINO) MANUFACTURED IN IBBENBUREN, GERMANY

10600 I

II

12/7/1993

JANSSEN PHARMACEUTICA NV

MEBENDAZOLE POLYMORPH B DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM

10601 A

II

12/8/1993

SAFC BIOSCIENCES INC

EX-CELL 400 MANUFACTURED IN DENVER, PENNSLYVANIA

10602 I

II

11/23/1993

BIOCHEMICA OPOS SPA

10603 I

11/29/1993

NOVO NORDISK PHARMACEUTICALS INC

7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID, 4-NITROBENZYL ESTER HC1


MANUFACTURED IN AGRATE BRIANZA (MI), ITALY
FACILITIES AND PROCEDURES IN DENMARK

10604 I

12/13/1993

NOVOCOL PHARMACEUTICAL CANADA INC

FACILITY AND PROCEDURES IN CAMBRIDGE, ONTARIO

10605 I

IV

12/9/1993

ALEX FRIES

10606 I

III

11/30/1993

BASF AKTIENGESELLSCHAFT

NATURAL LEMON-LIME FLAVOR WONF 79-337 SD POWDER MANUFACTURED IN CINCINNATI,


OHIO
TERLUX KR 2812 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

10607 I

12/9/1993

OWENS ILLINOIS INC

FACILITY AND PROCEDURES IN FINDLAY, OHIO

10608 I

II

12/8/1993

BIO-RAD LABORATORIES, INC.

BIO-GEL DNA HTP (HYDROXYLAPAITE) MANUFACTURED IN RICHMOND, CALIFORNIA

Page 297

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10609 I
II
12/8/1993
BIO-RAD LABORATORIES, INC.

SUBJECT
MACRO-PREP DEAE SUPPORT MANUFACTURED IN RICHMOND, CALIFORNIA

10610 I

II

12/8/1993

BIO RAD LABORATORIES INC

MACRO-PREP T-BUTYL HIC SUPPORT MANUFACTURED IN RICHMOND, CALIFORNIA

10611 A

IV

12/6/1993

ASAHI KASEI CHEMICALS CORP

10612 I

II

12/6/1993

SIPSY

MICROCRYSTALLINE CELLULOSE SPHERES, CELPHERE MANUFACTURED IN NOBEOKA CITY,


JAPAN
FEDOTOZINE TARTRATE MANUFACTURED IN AVRILLE CEDEX, FRANCE

10613 I

II

12/10/1993

PENINSULA LABORATORIES INC

GLUCAGON-LIKE PEPTIDE 1 (7-36), MANUFACTURED IN BELMONT, CALIFORNIA

10614 I

12/6/1993

ASAHI CHEMICAL INDUSTRY CO LTD

10615 I

12/9/1993

HIKMACHEM BPC

10616 I

II

12/9/1993

3M PHARMACEUTICALS

MANUFACTURING SITE, FACILITIES, PROCEDURES AND PERSONNEL IN NOBEOKA CITY,


JAPAN
MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN AMMAN,
JORDAN
PIRBUTEROL ACETATE MANUFACTURED IN GROTON, CONNECTICUT AND KENT, ENGLAND

10617 I

II

10/8/1993

TANABE SEIYAKU CO LTD

L-ALANINE MANUFACTURED IN OSAKA, JAPAN

10618 I

12/15/1993

FUJI PHOTO FILM CO LTD

MANUFACTURING FACILITY IN ODAWARA CITY, JAPAN

10619 I

12/15/1993

MAX GB LTD

MANUFACTURING FACILITIES IN TOANSA, INDIA

10620 I

II

12/15/1993

FUJI PHOTO FILM CO LTD

FJ-776 MANUFACTURED IN ODAWARA CITY, JAPAN

10621 I

II

12/15/1993

CAYMAN PHARMA SRO

PROSTAGLANDIN E2 (DINOPROSTONE) MANUFACTURED IN NERATOVICE, CZECH REPUBLIC

10622 I

12/17/1993

PHARMACO LSR

HPLC ANALYSIS OF GLIPIZIDE IN HUMAN PLASMA IN RICHMOND, VIRGINIA

10623 A

II

12/18/1993

JM-216 MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

10624 I

IV

12/17/1993

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
WARNER JENKINSON CO

10625 I

12/15/1993

LTS LOHMANN THERAPIE SYSTEME GMBH

10626 I

12/15/1993

MING TAI CHEMICAL CO LTD

10627 I

10/20/1993

APPRYL

10628 I

III

12/21/1993

AMPACET CORP

10629 A

IV

12/21/1993

NOF CORP

11495-S POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA,


DERIDDER, LOUISIANA AND BY AMPACET EUROPE S.A. IN MESSANCY, BELGIUM
1,2-DIMYRISTOL-SN-GLYCEROL AMMONIUM/SODIUM SALT MANUFACTURED IN HYOGO, JAPAN

10630 I

III

12/2/1993

FERRO CORP

THERMOPLASTIC COMPOUNDS (NEVOONSO1NA), MANUFACTURED IN EVANSVILLE, IN

10631 A

III

12/13/1993

WHINK PRODUCTS CO

HDPE PLASTIC BOTTLES AS MFG IN ELDORA,IOWA

10632 I

12/22/1993

HAMNMI FINE CHEMICAL CO LTD

10633 I

II

11/9/1993

PVP SOCIEDADE ANONIMA

BULK PHARMACEUTICAL CHEMICAL FACILITY AND QUALITY CONTROL LABORATORIES IN


SOUTH KOREA
QUERCETIN MANUFACTURED IN PARNAIBA, BRAZIL

10634 I

12/15/1993

PHARMACIA AND UPJOHN INC

10635 I

II

12/17/1993

JANSSEN PHARMACEUTICA NV

MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES


OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN.
ETOMIDATE MANUFACTURED IN GEEL, BELGIUM

10636 A

III

12/20/1993

INTRAPAC

COLLAPSIBLE TIN TUBES MANUFACTURED IN CHESTER, PENNSYLVANIA

10637 I

12/13/1993

SEAL LINE SPA

MANUFACTURING PLANT IN MONTEGALDELLA (VI) ITALY

10638 A

II

12/13/1993

BRACCO IMAGING SPA

IOPAMIDOL MANUFACTURED IN CERIANO LAGHETTO, ITALY

10639 I

II

12/28/1993

RANBAXY LABORATORIES LTD

10640 A

III

12/1/1993

CLARIANT CORP

7-AMINO-3-DESACETOXY CEPHALOSPORANIC ACID DRUG SUBSTANCE INTERMEDIATE


MANUFACTURED IN ROPAR, PUNJAB, INDIA
PACKAGING MATERIALS MANUFACTURED IN HOLDEN, MA; ALBION, MI; MINNEAPOLIS, MN;
LAWRENCEVILLE, GA

NO. 62060 SYNTHETIC RED IRON OXIDE, NO. 82150 SYNTHETIC BLACK IRON OXIDE AND NO.
35070 SYNTHETIC YELLOW IRON OXIDE MANUFACTURED IN ST. LOUIS, MISSOURI
MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN
ANDERNACH, GERMANY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TAOYUAN HSIEN, TAIWAN REPUBLIC OF CHINA.
MANUFACTURING FACILITY LOCATED IN LAVERA

Page 298

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10641 A
II
12/16/1993
PHARMAZELL GMBH

SUBJECT
PROPAFENONE HYDROCHLORIDE MANUFACTURED IN RAUBLING, GERMANY

10642 A

II

12/30/1993

CIPLA LTD

ETOPOSIDE AS MANUFACTURED IN BANGALORE, INDIA

10643 I

II

12/30/1993

EURAND AMERICA INC

CAFFEINE MICROCAPS MANUFACTURED IN VANDALIA, OHIO

10644 I

II

12/28/1993

ELF ATOCHEM NORTH AMERICA INC

PERFLUORODECYL BROMIDE C10F21BR MANUFACTURED IN PIERRE-BENITE, FRANCE

10645 I

II

1/3/1993

PLIVA

MESALAZINE MANUFACTURED IN SAVSKI MAROF, CROATIA

10646 I

III

12/20/1993

PUREPLAST INC

RIGID POLY VINYL CHLORIDE FILM MANUFACTURED IN CAMBRIDGE, ONTARIO, CANADA

10647 I

II

10/28/1993

ADHESIVES RESEARCH INC

10648 I

II

12/20/1993

LONZA INC

PRESSURE SENSITIVE ADHESIVES USED AS DRUG MATRIXES MANUFACTURED IN GLEN


ROCK, PENNSYLVANIA
TRIPROLIDINE HYDROCHLORIDE MANUFACTURED IN LOS ANGELES, CA

10649 I

12/30/1993

PHARMA TEK INC

MANUFACTURING FACILITIES IN ELMIRA, NEW YORK

10650 I

12/10/1993

RELIABLE BIOPHARMACEUTICAL CORP

10651 I

II

12/9/1993

CYGNUS INC

10652 I

II

1/10/1994

GADOR SA

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SAINT LOUIS,


MISSOURI
ESTRADIOL TRANSDERMAL DELIVERY SYSTEM (E2 III TDS) MANUFACTURED IN REDWOOD
CITY, CALIFORNIA
ZOLPIDEM HEMITARTRATE MANUFACTURED IN PROVINCIA DE BUENOS AIRES, ARGENTINA

10653 I

12/28/1993

KATAYAMA SEIYAKUSYO CO LTD

10654 I

II

12/28/1993

KATAYAMA SEIYAKUSYO CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OSAKA, JAPAN.
GLYCL-L-GLUTAMINE MANUFACTURED IN OSAKA, JAPAN

10655 I

II

12/6/1993

PHARMACIE CENTRALE DE FRANCE

BISMUTH CITRATE MANUFACTURED IN LA VOULTE SUR RHONE, FRANCE

10656 A

II

1/7/1994

SIGMA ALDRICH MANUFACTURING LLC

GLYCYLGLYCINE (PRODUCT NO. W 5310-8) MANUFACTURED IN SAINT LOUIS, MISSOURI

10657 I

III

12/23/1993

BASF AKTIENGESELLSCHAFT

RAKUSOL BLUE 68-5647 MANUFACTURED IN THE FEDERAL REPUBLIC OF GERMANY

10658 I

II

1/6/1994

SIGMA F AND D DIV LTD

COLLAGEN(PRODUCT NO. C 9301) MANUFACTURED IN SAINT LOUIS, MISSOURI

10659 I

III

2/14/1994

DSM POLYMERS

STAMYLAN HD 9630 MANUFACTURED IN BEEK, THE NETHERLANDS

10660 I

II

1/6/1994

CELOX CORP

SERUM-FREE CELL GROWTH MEDIUM MANUFACTURED IN HOPKINS, MINNESOTA

10661 I

1/5/1994

GLAXO WELLCOME INC

MANUFACTURING FACILITY AT VERONA, ITALY.

10662 I

III

12/1/1993

LOPAREX BV

GELROFLEX ALU-PET 100 M - 25 MANUFACTURED IN APELDOORN, THE NETHERLANDS

10663 I

II

12/1/1993

SEPRACOR INC

HYPER - D ION EXCHANGERS MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE

10664 I

II

1/5/1994

PFIZER IRELAND PHARMACEUTICALS

FEDOTOZINE TARTRATE MANUFACTURED IN CO. CORK, IRELAND

10665 I

12/6/1993

PHARMACIE CENTRALE DE FRANCE

MANUFACTURING FACILITY FOR BISMUTH CITRATE AT LA VOULTE SUR RHONE

10666 A

III

1/18/1994

MEDISIZE SCHWEIZ AG

10667 A

II

1/12/1994

LOBA FEINCHEMIE AG

RAW MATERIALS AND MANUFACTURING CONTROLS UTILIZED IN PRODUCTION OF PLASTIC


BOTTLES IN NUERENSDORF, SWITERLAND
NAPHAZOLINE HYDROCHLORIDE MFG IN FISCHAMEND, AUSTRIA

10668 I

III

1/4/1994

HELVOET PHARMA MARYLAND

SIL FREE COATED STOPPERS FOR DRUG PACKAGING MANUFACTURED IN SALISBURY MD

10669 I

III

1/6/1994

ECP ENICHEM POLYMERES FRANCE

RIBLENE MP30 MANUFACTURED IN DUNKIRK, FRANCE.

10670 I

III

1/10/1994

COIM USA INC

NOVACOTE ADH260-805 MANUFACTURED IN HAMBURG, GERMANY

10671 A

II

1/10/1994

EXCELLA GMBH

ACICLOVIR MANUFACTURED IN FEUCHT, GERMANY

10672 I

II

12/22/1993

SCHERING AG

ONAPRISTONE MANUFACTURED IN THE BERLIN WEDDING PLANT.

10673 I

12/15/1993

FACILITY AND PROCEDURES IN SOFIA, BULGARIA

10674 I

II

12/15/1993

CHEMICAL PHARMACEUTICAL RESEARCH


INSTITUTE NIHFI LTD
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD

FENOFIBRATE MANUFACTURED IN SOFIA, BULGARIA.

Page 299

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10675 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10676 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10677 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10678 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10679 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10680 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10681 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10682 I
II
12/15/1993
CHEMICAL PHARMACEUTICAL RESEARCH
INSTITUTE NIHFI LTD
10683 I
III
1/19/1994
WINPAK TECHNOLOGIES INC

SUBJECT
PROPANOLOL HYDROCHLORIDE MANUFACTURED IN SOFIA, BULGARIA.

10684 I

III

1/19/1994

WINPAK TECHNOLOGIES INC

10685 A

II

1/12/1994

OLON SPA

NON FORMING LIDDING FOR PILL PACKAGE MANUFACTURED IN TORONTO, ONTARIO,


CANADA.
ACYCLOVIR MANUFACTURED IN MULAZZANO (MI), ITALY

10686 A

III

1/21/1994

PERLEN CONVERTING AG

PERLALUX BLISTER FILMS, TWO AND THREE LAYER.

10687 I

II

1/17/1994

CHINA SUZHOU NO 5 PHARMACEUTICAL FACTORY METHACYCLINE HYDROCHLORIDE MANUFACTURED IN SUZHOU, JIANGSU.

10688 A

II

1/24/1994

MAPRIMED SA

10689 I

III

1/20/1994

COVALENCE COATED PRODUCTS

FLECAINIDE ACETATE PROCESS I (CODE 50064) MANUFACTURED IN BUENOS AIRES,


ARGENTINA.
PRODUCT 41727-34 MANUFACTURED IN COLUMBUS, GEORGIA.

10690 A

II

1/25/1994

PCAS

TIMOLOL HEMIHYDRATE MANUFACTURED IN TURKU, FINLAND

10691 I

II

1/24/1994

NV ORGANON

DEHYDROISOANDROSTERONE MANUFACTURED IN OSS, THE NETHERLANDS.

10692 I

1/17/1994

10693 I

1/25/1994

CHINA SUZHOU NO 5 PHARMACEUTICAL FACTORY MANUFACTURING FACILITIES GENERAL OPERATING PROCEDURES IN JIANGSU, PEOPLES
REPUBLIC OF CHINA.
KONICA CHEMICAL CORP
FACILITIES AND PROCEDURES IN SHIZUOKA, JAPAN

10694 I

III

1/7/1994

ROBB CONTAINER

10695 I

II

12/15/1993

10696 I

II

1/25/1994

CHEMICAL PHARMACEUTICAL RESEARCH


INSTITUTE NIHFI LTD
GENSIA LABORATORIES LTD

10697 I

III

1/28/1994

SABIC PETROCHEMICALS BV

SABIC HDPE MI00053 MANUFACTURED IN BEEK, THE NETHERLANDS.

10698 I

III

1/28/1994

DSM POLYMERS

STAMYLAN HD 7625 MANUFACTURED IN BEEK, THE NETHERLANDS.

10699 I

III

1/18/1994

C AND J INDUSTRIES INC

PLASTIC OCUMETER TIPS MANUFACTURED IN MEADVILLE, PA

10700 I

III

1/24/1994

POLYCOM HUNTSMAN INC

D55006 WHITE POLYETHYLENE CONCENTRATE MANUFACTURED IN DONORA, PA

10701 I

III

1/24/1994

SPARTECH POLYCOM

D23980 WHITE POLYETHYLENE CONCENTRATE MANUFACTURED IN DONORA, PA.

10702 I

II

1/25/1994

MITSUBISHI CORP

10703 I

II

1/31/1994

SCHERING AG

10704 A

II

2/7/1994

JANSSEN PHARMACEUTICA NV

NICARDIPINE HYDROCHLORIDE MANUFACTURED BY DAITO CORPORATION IN TOYAMA,


JAPAN
ELTANOLONE MANUFACTURED IN BERLIN AND CHARLOTTENBURG, FEDERAL REPUBLIC OF
GERMANY
INTERMEDIATE T001333 MANUFACTURED IN GEEL, BELGIUM

KETOTIFEN HYDROGEN MANUFACTURED IN SOFIA, BULGARIA.


FLUNARIZINE HYDROCHLORIDE MANUFACTURED IN SOFIA, BULGARIA.
PRAZOSIN HYDROCHLORIDE MANUFACTURED IN SOFIA, BULGARIA.
BROMOCRIPTINE MESYLATE MANUFACTURED IN SOFIA, BULGARIA.
AMIKACIN SULFATE MANUFACTURED IN SOFIA, BULGARIA.
TAMOXIFEN CITRATE MANUFACTURED IN SOFIA, BULGARIA.
RANITIDINE HYDROCHLORIDE MANUFACTURED IN SOFIA AND DUPNITZA, BULGARIA.
POUCH FOR POWDERED DRUGS MANUFACTURED IN TORONTO, ONTARIO, CANADA.

PHARMACEUTICAL CONTAINERS MANUFACTURED IN PERU, ILLINOIS, OMAHA, NEBRASKA,


AND LE CENTER, MINNESOTA
PIROXICAM MANUFACTURED IN SOFIA, BULGARIA.
STERILE WATER FOR INJECTION MANUFACTURED IN IRVINE, CA

Page 300

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10705 A
II
2/8/1994
JANSSEN PHARMACEUTICA NV

SUBJECT
INTERMEDIATE T001330 MANUFACTURED IN GEEL, BELGIUM

10706 I

II

1/28/1994

IROTEC LABORATORIES

DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND

10707 I

II

2/1/1994

HYCLONE LABORATORIES

HYQ-CCM 1 WITH AND WITHOUT PHENOL RED MANUFACTURED IN LOGAN, UTAH

10708 I

II

2/7/1994

KINERTON LTD

TETRAPEPTIDE (BIM 32001) MANUFACTURED IN DUBLIN, IRELAND

10709 I

II

2/2/1994

IPCA LABORATORIES LTD

FLUMEQUINE MANUFACTURED IN RATLAM, PIN, INDIA

10710 I

II

2/7/1994

CIPLA LTD

10711 I

2/1/1994

ORGAMOL FRANCE SA

10712 I

2/4/1994

CHENG FONG CHEMICALS CO LTD

ACYCLOVIR MANUFACTURED IN BANGALORE, BOMBAY AND VIKHROLI AND PATALGANGA,


INDIA
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN ST. VULBAS, FRANCE.
FACILITY AND OPERATING PROCEDURES IN TAO YUAN HSIEN, TAIWAN, R.O.C.

10713 A

II

2/4/1994

FARCHEMIA SRL

CLOTRIMAZOLE MANUFACTURED IN TREVIGLIO, ITALY

10714 I

IV

2/2/1994

ICI KLEA

1,1,1,2-TETRAFLUOROETHANE MANUFACTURED IN RUNCORN, CHESHIRE, UNITED KINGDOM

10715 I

2/2/1994

ICI AMERICAS INC

FACILITY AND PROCEDURES IN ST. GABRIEL, LOUISIANA

10716 I

2/2/1994

ICI LTD

FACILITY AND OPERATING PROCEDURES IN RUNCORN, CHESHIRE, UNITED KINGDOM

10717 I

II

2/7/1994

ESTEVE QUIMICA SA

LESOPITRON DIHYDROCHLORIDE MANUFACTURED IN BARCELONA, SPAIN

10718 I

III

2/14/1994

DSM POLYMERS

STAMYLEX 1016LF MANUFACTURED IN BEEK, THE NETHERLANDS

10719 I

1/20/1994

10720 I

2/7/1994

SHANDONG XIN-HUA PHARMACEUTICAL COMPANY FACILITY AND PROCEDURES IN ZIBO, SHANDONG, THE PEOPLE'S REPUBLIC OF CHINA.
LTD
CHEMINOR DRUGS PVT LTD
FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN ANDHRA PRADESH, INDIA

10721 A

III

1/28/1994

CHEVRON PHILLIPS CHEMICAL CO LP

POLYETHYLENE COPOLYMER RESIN 6109 MANUFACTURED IN ORANGE, TEXAS

10722 A

III

1/31/1994

GRUPPO MOSSI AND GHISOLFI

POLYESTER RESINS MANUFACTURED IN APPLE GROVE, WEST VIRGINIA

10723 I

1/25/1994

KONICA CHEMICAL CORP

FACILITIES AND PROCEDURES IN FUKUSHIMA, JAPAN

10724 I

IV

2/2/1994

ICI KLEA

1,1,1,2-TETRAFLUORETHANE MANUFACTURED IN ST. GABRIEL, LOUISIANA

10725 A

II

2/18/1994

JANSSEN PHARMACEUTICA NV

ITRACONAZOLE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM

10726 A

III

2/7/1994

BPREX HEALTHCARE OFFRANVILLE SAS

EYE-DROPPER 5 AND 11 ML, PLUG, CAPS MANUFACTURED IN TAMPERE, FINLAND

10727 A

II

2/4/1994

LUSOCHIMICA SPA

BETAXOLOL HYDROCHLORIDE MANUFACTURED IN LOMAGNA, ITALY

10728 I

III

2/2/1994

ALCOGUM 926 W MANUFACTURED IN CHATTANOOGA, TENNESSEE

10729 A

2/23/1994

ALCO CHEMICAL DIV NATIONAL STARCH AND


CHEMICAL CO
GLAXOSMITHKLINE LLC

10730 A

II

1/20/1994

SHANDONG XINHUA PHARMACEUTICAL CO LTD

PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A


(GR106642X)
ASPIRIN MANUFACTURED IN ZIBO, SHANDONG, THE PEOPLE'S REPUBLIC OF CHINA

10731 A

II

11/1/1993

OLON SPA

CEFAZOLIN ACID MANUFACTURED IN MILAN, ITALY

10732 I

11/29/1993

ALLERGAN INC

10733 A

2/15/1994

SYNERGY HEALTH MARSEILLE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PUERTO RICO.
STERILE PROCESSING FACILITY LOCATED IN MARSEILES, FRANCE

10734 I

2/17/1994

SAMCHULLY PHARMACEUTICAL CO LTD

10735 I

2/9/1994

PLASTINVENT I KARLSKOGA AB

10736 I

II

2/18/1994

SOCIETA ITALIANA MEDICINAL SCANDICCI

10737 I

2/24/1994

CENTRAL GLASS CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KYONGGI-DO, SOUTH KOREA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN KARLSKOGA, SWEDEN.
CROMOLYN SODIUM MANUFACTURED IN FILARONE, REGGELLO, ITALY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN UBE-CITY, JAPAN.

Page 301

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10738 I
II
2/25/1994
EASTMAN CHEMICAL CO
10739 A

II

2/1/1994

NICOBRAND LTD

SUBJECT
[5-METHYL-2-[(2-NITROPHENYL)AMINO]-3-THIOPHENECARBONITRILE](COMMONLY KNOWN AS
TCN, STEP 2) MANUFACTURED IN BATESVILLE, ARKANSAS
NICOTINE POLACRILEX RESIN MANUFACTURED IN COLERAINE, N. IRELAND

10740 I

II

2/23/1994

DELMAR CHEMICALS INC

KETOROLAC TROMETHAMINE MANUFACTURED IN LASALLE, QUEBEC, CANADA

10741 I

II

2/28/1994

NIPPON RIKAGAKUYAKUHIN CO LTD

CYSTEINE HYDROCHLORIDE MANUFACTURED IN ASHIKAGA, JAPAN

10742 I

2/25/1994

FERRING AB

FACILITY AND OPERATING PROCEDURES IN MALMO, SWEDEN

10743 I

III

2/25/1994

BILCARE INC

PACKAGING SERVICES IN PHOENIXVILLE, PENNSYLVANIA

10744 A

III

10/18/1993

TEKNOR APEX CO

MD-12243 NAT MANUFACTURED IN ST. ALBANS, VERMONT

10745 I

III

2/8/1994

EDISON PLASTICS CO

PACKAGING MATERIALS MANUFACTURED IN NEWPORT NEWS, VIRGINIA

10746 I

III

2/21/1994

NESTE CHEMICALS

POLYETHYLENE PRODUCT NCPE2224 MANUFACTURED IN FINLAND

10747 I

2/25/1994

ARZNEIMITTELWERK DRESDEN GMBH

FACILITY AND OPERATING PROCEDURES IN RADEBEUL, GERMANY

10748 I

II

3/3/1994

SOLVAY DUPHAR BV

CHOLECALCIFEROL (VITAMIN D3) MANUFACTURED IN WEESP, THE NETHERLANDS

10749 I

II

3/1/1994

SUMIKA FINE CHEMICALS CO LTD

5MACA (INTERMEDIATE) MANUFACTURED IN THE OKAYAMA PLANT, JAPAN

10750 I

II

1/25/1994

BACHEM INC

PEPTIDE AL-204 MANUFACTURED IN TORRANCE, CALIFORNIA

10751 A

II

3/4/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000034 MANUFACTURED IN GEEL, BELGIUM

10752 I

II

3/4/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000015 MANUFACTURED IN GEEL, BELGIUM

10753 I

II

3/4/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000506 MANUFACTURED IN GEEL, BELGIUM

10754 I

II

3/4/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000509 MANUFACTURED IN GEEL, BELGIUM

10755 I

IV

2/18/1994

TIMERX TECHNOLOGIES

CONTROLLED RELEASE EXCIPIENT MANUFACTURED IN DANBURY, CONNETICUT

10756 I

II

2/28/1994

RAYLO CHEMICALS

10757 I

2/21/1994

NESTE CHEMICALS

INTERMEDIATE FOR ACA-147, 4-(2,2-DIMETHYLPROPYL)-N-HEXYLBENZENEMETHANAMINE


HYDROCHLORIDE MANUFACTURED IN EDMONTON, ALBERTA, CANADA
FACILITY AND MANUFACTURING PROCEDURES IN PORVOO, FINLAND

10758 I

II

3/8/1994

PEPTISYNTHA

LY297141 MANUFACTURED IN BRUSSELS, BELGIUM

10759 I

II

3/3/1994

AKZO NOBEL CHEMICALS BV

10760 I

II

3/3/1994

AKZO NOBEL CHEMICALS BV

10761 I

IV

3/4/1994

LIPOID GMBH

10762 A

II

2/28/1994

COPPERHEAD INVESTMENTS INC

DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP) MANUFACTURED IN


HERKENBOSCH, THE NETHERLANDS
DISSOLVINE NA-2-P (EDETATE DISODIUM USP) MANUFACTURED IN HERKENBOSCH, THE
NETHERLANDS
LIPOID S 75-MIGLYOL MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
SDM-78 MFG. IN TAMAQUA, PA

10763 I

II

2/28/1994

SYNTHELABO RECHERCHE

ELIPRODIL HYDROCHLORIDE MANUFACTURED IN GARGENVILLE, FRANCE

10764 I

III

2/15/1994

BASF AKTIENGESELLSCHAFT

NOVOLEN 2600 PCX MANUFACTURED IN WESSELING, GERMANY

10765 I

II

3/10/1994

SELOC FRANCE

FLUNIXIN MEGLUMINE MANUFACTURED IN SHANNON, IRELAND AND LEMAY, FRANCE

10766 A

III

3/8/1994

GERRESHEIMER BUNDE GMBH

DISPOSABLE SYRINGE SYSTEM MANUFACTURED IN BUNDE, GERMANY

10767 A

III

3/7/1994

RESCO COLOURS INC

10768 I

2/18/1994

IPCA LABORATORIES LTD

01EHD-225 MANUFACTURED IN MISSISSAUGA, ONTARIO, CANADA AND COVENTRY, RHODE


ISLAND
IBD-IV MANUFACTURING FACILITY IN RATLAM, INDIA

10769 I

II

3/14/1994

FUJISAWA PHARMACEUTICAL CO LTD

RHIZOXIN MANUFACTURED IN AICHI-PREFECTURE, JAPAN.

10770 I

II

3/11/1994

NIPPON PROTEIN CO LTD

N-ACETYL-D-GLUCOSAMINE MANUFACTURED IN TOCHIGI-KEN, JAPAN

10771 I

3/10/1994

CERESTAR, USA, INC.

FACILITIES AND OPERATING PROCEDURES IN WAUKEGAN, ILLINOIS

10772

IV

3/10/1994

WACKER CHEMICAL CORP

HYDROXYPROPYL BETA CYCLODEXTRIN (HPBCD) MANUFACTURED IN WAUKEGAN, ILLINOIS.

Page 302

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10773 I
III
3/1/1994
GERRESHEIMER GLAS AG

SUBJECT
KIMBLE ITALIANA KI101 GLASS, KI201 GLASS MANUFACTURED IN PISA, ITALY.

10774 A

III

1/31/1994

CODING PRODUCTS

SV-19811 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10775 I

III

1/31/1994

CODING PRODUCTS

10776 A

III

1/31/1994

CODING PRODUCTS

TTR-5903 AND TTR-7903 THERMAL TRANSFER INK RIBBONS MANUFACTURED IN KALKASKA,


MICHIGAN
SV-19154 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10777 I

III

1/31/1994

CODING PRODUCTS

SV-16391 HOT STAMP INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN

10778 I

III

1/31/1994

CODING PRODUCTS

DOI-1A AND DOI-1A 3/4 HOT STAMP INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN

10779 A

III

1/31/1994

CODING PRODUCTS

DOI-6 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10780 A

III

1/31/1994

CODING PRODUCTS

SV-16810 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10781 A

III

1/31/1994

CODING PRODUCTS

SV-17805 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10782 I

III

1/31/1994

CODING PRODUCTS

10783 I

III

1/31/1994

CODING PRODUCTS

10784 A

III

1/31/1994

CODING PRODUCTS

TTR-5907, TTR-5908, TTR-7907 AND TTR-7908 THERMAL TRANSFER IN RIBBONS


MANUFACTURED IN KALKASKA, MICHIGAN
TTR-5901, TTR-5902, TTR-7901 AND TTR-7902 THERMAL TRANSFER INK RIBBONS
MANUFACTURED IN KALKASKA, MICHIGAN
SV-16356 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10785 A

III

1/31/1994

CODING PRODUCTS

SV-14808 HOT STAMP INK RIBBON MANUFACTRUED IN KALKASKA, MICHIGAN

10786 A

III

1/31/1994

CODING PRODUCTS

SV-13807 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10787 I

III

1/31/1994

CODING PRODUCTS

TTR-7909 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10788 I

III

1/31/1994

CODING PRODUCTS

DOI-6A HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10789 I

III

1/31/1994

CODING PRODUCTS

DOI-9 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10790 I

III

1/31/1994

CODING PRODUCTS

DS-1 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10791 I

III

1/31/1994

CODING PRODUCTS

FOI-3 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10792 I

III

1/31/1994

CODING PRODUCTS

FOI-4 HOT STAMP INK KRIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10793 I

III

1/31/1994

CODING PRODUCTS

TTR-5900 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10794 A

III

1/31/1994

CODING PRODUCTS

CDF-1 AND CDF-1 3/4 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10795 I

III

1/31/1994

CODING PRODUCTS

CDF-4P HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10796 A

III

1/31/1994

CODING PRODUCTS

CDF-6 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10797 A

III

1/31/1994

CODING PRODUCTS

CDF-9 AND CDF-9 3/4 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10798 I

III

1/31/1994

CODING PRODUCTS

CDF-634 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10799 I

III

1/31/1994

CODING PRODUCTS

CDF-63 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10800 I

III

1/31/1994

CODING PRODUCTS

CDF-14 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10801 A

III

1/31/1994

CODING PRODUCTS

CDF-98 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10802 I

III

1/31/1994

CODING PRODUCTS

DB-1 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10803 I

III

1/31/1994

CODING PRODUCTS

DB-14 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10804 A

III

1/31/1994

CODING PRODUCTS

DOI-1 AND DOI-1 3/4 HOT STAMP INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN

10805 I

III

1/31/1994

CODING PRODUCTS

CDF-33 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10806 I

III

1/31/1994

CODING PRODUCTS

CDF-96 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10807 I

III

1/31/1994

CODING

CDF-95 HOT STAMP INK RIBBON MANUFACUTRED IN KALKASKA, MICHIGAN

10808 I

III

1/31/1994

CODING PRODUCTS

CDF-93 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10809 I

III

1/31/1994

CODING PRODUCTS

CDF-94 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

Page 303

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10810 I
III
1/31/1994
CODING PRODUCTS

SUBJECT
CDF-92 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10811 I

III

1/31/1994

CODING PRODUCTS

CDF-37 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

10812 A

II

3/15/1994

ALBEMARLE CORP

10813 I

II

3/15/1994

JANSSEN PHARMACEUTICA NV

MACA (5-METHANESULFONYLAMINOINDOLE-2-CARBOXYLIC ACID) MANUFACTURED IN


SOUTH HAVEN, MICHIGAN
INTERMEDIATE T000743 MANUFACTURED IN GEEL, BELGIUM

10814 I

II

3/16/1994

LABORATOIRES SERONO SA

STERILE DILUENT (0.3% M-CRESOL) MANUFACTURED IN AUBONNE, SWITZERLAND

10815 I

III

3/16/1994

SCHUPBACH AG

10816 I

III

3/9/1994

PACUR INC

COMPOUND PACKAGING MATERIAL #SOP 25255 PAPER/PE/ALU/LONOMER MANUFACTURED


IN BURGDORF, SWITZERLAND.
PETG COPOLYESTER 6763 MATERIAL MANUFACTURED IN OSHKOSH, WISCONSIN

10817 I

II

3/15/1994

BACHEM FEINCHEMIKALIEN AG

10818 I

II

3/18/1994

CHEMOX CHEMICAL INDUSTRIES LTD

10819 I

III

3/10/1994

MORGAN ADHESIVES CO ROLL PRODUCTS DIV

10820 I

3/17/1994

BIOVAIL CORP INTERNATIONAL

PHARMACEUTICAL LABEL PRODUCT LINE MANUFACTURED IN STOW, OHIO AND NELLIS,


NEVADA.
MANUFACTURING FACILITIES IN STEINBACH, CANADA.

10821 I

4/12/1994

10822 I

3/18/1994

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS LTD
CHEMOX CHEMICAL INDUSTRIES LTD

FACILITY FOR THE MANUFACTURE OF SELEGILINE HYDROCHLORIDE IN BUDAPEST,


HUNGARY
FACILITIES AND PROCEDURES IN GUJARA, INDIA.

10823 I

II

3/18/1994

DOTTIKON EXCLUSIVE SYNTHESIS AG

10824 A

III

3/20/1994

10825 I

II

3/25/1994

POLYONE CORP GLS THERMOPLASTIC


ELASTOMERS
JICHENG PHARMACEUTICAL FACTORY

ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2% MANUFACTURED IN


DOTTIKON, SWITZERLAND.
THERMOPLASTIC ELASTOMER COMPOUNDS MANUFACTURED IN CARY, ILLINOIS.

10826 I

III

3/1/1994

GERRESHEIMER GLAS AG

10827 I

III

3/23/1994

LABORATORIOS DR ESTEVE SA

KIMBLE N51A GLASS, KIMBLE AMBER 203 GLASS AND KIMBLE KG-33 GLASS MANUFACTURED
IN VINELAND, NEW JERSEY.
FACILITIES AND PERSONNEL IN MARTORELLAS (BARCELONA), SPAIN.

10828 I

3/24/1994

JANSSEN PHARMACEUTICA NV

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BEERSE, BELGIUM.

10829 I

II

3/22/1994

DOCTOR REDDYS LABORATORIES LTD

2,6-DIISOPROPYLPHENOL MFG. IN ANDHRA PRADESH, INDIA.

10830 A

II

3/24/1994

YUNG ZIP CHEMICAL IND CO LTD

ACYCLOVIR MANUFACTURED IN TACHIA, TAIWAN, REPUBLIC OF CHINA.

10831 A

II

3/24/1994

YUNG ZIP CHEMICAL IND CO LTD

DICLOFENAC POTASSIUM MANUFACTURED IN TACHIA, TAIWAN, REPUBLIC OF CHINA.

10832 I

III

3/21/1994

MILLIKEN AND CO

PC COLORANTS MANUFACTURED IN BLACKSBURG, SOUTH CAROLINA.

10833 I

II

3/25/1994

SIANG TA PHARMACEUTICAL CO LTD

METHOCARBAMOL MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

10834 I

3/25/1994

SANDOZ CANADA INC

FACILITIES AND PROCEDURES IN WHITBY, ONTARIO, CANADA.

10835 I

3/24/1994

HANJIANG PHARMACEUTICAL FACTORY

FACILITY AND PROCEDURES IN HANZHONG CITY, SHAANXI PROVINCE, CHINA.

10836 A

II

3/30/1994

KYOWA HAKKO KOGYO CO LTD

SODIUM HYALURONATE MANUFACTURED IN UBE-SHI, JAPAN.

10837 A

II

3/28/1994

ERREGIERRE SPA

FLUOXETINE HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY.

10838 A

II

3/29/1994

SANDOZ GMBH

10839 I

II

3/30/1994

LEO PHARMA AS

7-PACA (7-AMINO-3-PROPENYL-CEPHALOSPORANIC ACID) MANUFACTURED IN KUNDL,


TYROL, AUSTRIA.
CALCIPOTRIENE SCALP SOLUTION MANUFACTURED IN BALLERUP, DENMARK.

10840 I

II

3/30/1994

LEO PHARMACEUTICAL PRODUCTS LTD

EB 1089 MANUFACTURED IN BALLERUP, DENMARK.

10841 I

3/25/1994

BACHEM FEINCHEMIKALIEN AG

10842 I

3/30/1994

LEO PHARMACEUTICAL PRODUCTS LTD

MANUFACTURING FACILITY FOR AC-ARG-PRO-ASP-ISOBUTYLAMIDE CITRATE


MANUFACTURED IN BUBENDORF, SWITZERLAND.
FACILITY FOR THE MANUFACTURE OF EB 1089 IN BALLERUP, DENMARK.

1-HYDROXY-2-NAPHTHOYL-ARG-PRO-NH2 HYDROCHLORIDE MANUFACTURED IN


BUBENDORF, SWITZERLAND
SULFAMETHOXAZOLE MANUFACTURED IN GUJARA, INDIA.

MINOXIDIL MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA.

Page 304

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10843 I
I
3/30/1994
LEO PHARMACEUTICAL PRODUCTS LTD

SUBJECT
FACILITY FOR THE MANUFACTURE OF CALCIPOTRIENE SCALP SOLUTION IN BALLERUP,
DENMARK.
AC-ARG-PRO-ASP-ISOBUTYLAMIDE CITRATE MANUFACTURED IN BUBENDORF,
SWITZERLAND.
HOSTAPET AMORPHOUS POLYESTER FILM MANUFACTURED IN WEERT, THE NETHERLANDS.

10844 I

II

3/25/1994

BACHEM FEINCHEMIKALIEN AG

10845 I

III

3/14/1994

KALLE PENTAPLAST GMBH

10846 I

IV

3/15/1994

MOTHER MURPHYS LABORATORIES INC

10847 I

III

3/31/1994

BASF CORPORATION

10848 I

II

3/30/1994

GANES CHEMICALS INC

N & A CINNAMON MINT FLAVOR NO. 6244 MANUFACTURED IN GREENSBORO, NORTH


CAROLINA.
LAROSTA FPE AND LAROSTA FPE-S, ANTISTAIC AGENTS MANUFACTURED IN GURNEE,
ILLINOIS.
SPARFOSATE SODIUM MANUFACTURED IN CARLSTADT, NEW JERSEY.

10849 I

II

4/11/1994

PIERCE CHEMICAL CO

EMPHAZE PROTEIN A BIOSUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MINNESOTA

10850 I

3/31/1994

10851 I

3/29/1994

10852 I

II

4/7/1994

MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB


INC
MERCK AND CO INC DIV MERCK SHARP AND
DOHME
3M BIOAPPLICATIONS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ROUND ROCK, TEXAS.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BOLLATE (MILAN) ITALY.
3M EMPHAZE HYDRAZIDE BIOSUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MINNESOTA.

10853 I

II

4/8/1994

ASTRAZENECA PHARMACEUTICALS LP

LISINOPRIL BULK DRUG MANUFACTURED IN GUAYAMA, PUERTO RICO.

10854 A

IV

4/8/1994

CRODA EUROPE LTD

SUPER REFINED SESAME OIL MANUFACTURED IN MILL HILL, PENNSYLVANIA.

10855 I

4/7/1994

SPOLANA NERATOVICE

FACILITIES AND OPERATING PROCEDURES IN NERATOVICE, CZECH REPUBLIC.

10856 A

II

4/4/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000824 MANUFACTURED IN BEERSE AND GEEL, BELGIUM.

10857 A

II

4/5/1994

CU CHEMIE UETIKON GMBH

AZELAIC ACID MANUFACTURED IN LAHR, GERMANY.

10858 I

II

4/11/1994

CIPLA LTD

10859 I

II

4/8/1994

JANSSEN PHARMACEUTICA NV

MITOXANTRONE HYDROCHLORIDE MANUFACTURED IN BANGALORE, BOMBAY AND


MAHARASHTRA, INDIA
AZAPERONE MANUFACTURED IN GEEL, BELGIUM

10860 I

II

4/11/1994

JANSSEN PHARMACEUTICA NV

MEBENDAZOLE POLYMORH C MANUFACTURED IN GEEL, BELGIUM

10861 I

II

2/28/1994

PVP SOCIEDADE ANONIMA

PILOCARPINE HYDROCHLORIDE MANUFACTTURED IN PARNAIBA, BRAZIL

10862 A

II

4/5/1994

AREVIPHARMA GMBH

CLOZAPINE MANUFACTURED IN RADEBEUL, GERMANY

10863 I

II

4/5/1994

HEINRICH MACK NACHFOLGER

DISODIUM METHOTREXATE MANUFACTURED IN ILLERTISSEN, GERMANY

10864 I

II

4/11/1994

FERMENTACIONES Y SINTESIS ESPANOLAS SA

NITRO-THIAZOLINE MANUFACTURED IN COAHUILA, MEXICO

10865 I

III

4/14/1994

CURWOOD INC

PACKAGING MATERIALS MANUFACTURED IN OSHKOSH AND NEW LONDON, WISCONSIN

10866 I

II

4/7/1994

ESTEVE QUIMICA SA

AZT (ZIDOVUDINE) MANUFACTURED IN BARCELONA, SPAIN

10867 A

II

4/12/1994

APOTEX PHARMACHEM INDIA PVT LTD

DEFERIPRONE MANUFACTURED IN BRANTFORD, ONTARIO, CANADA

10868 A

II

4/20/1994

PROPOFOL MANUFACTURED IN VARESE, ITALY

10869 I

III

4/20/1994

PRIME EUROPEAN THERAPEUTICALS SPA


EUTICALS SPA
RENOLIT NEDERLAND BV

10870 A

IV

4/14/1994

SEPPIC SA

MONTANIDE ISA 51 VG STERILE

10871 I

II

4/14/1994

LAKESIDE CHEMICAL

EXFENFLURAMINE HYDROCHLORIDE MANUFACTURED IN ST. FRANCIS, WISCONSIN

10872 I

II

4/18/1994

PIMOZIDE MANUFACTURED IN BEERSE AND GEEL, BELGIUM

10873 I

II

4/14/1994

JANSSEN RESEARCH FDN DIV JOHNSON AND


JOHNSON
LABORATORIOS SERVIER SA

10874 I

4/13/1994

PHARMACO LIFE SCIENCE RESEARCH

METHOD VALIDATION NITOGLYCERIN AND ITS DINITROGLYCERIN METABOLITES IN HUMAN


PLASMA

POLYETHYLENE FILMS AND BAGS MANUFACTURED IN BURGDORF, SWITZERLAND

DEXFENFLURAMINE BASE MANUFACTURED IN TOLEDO, SPAIN

Page 305

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10875 I
I
4/14/1994
LABORATORIOS SERVIER SA

SUBJECT
FACILITIES AND PERSONNEL IN TOLEDO, SPAIN

10876 A

II

4/7/1994

BIO RAD LABORATORIES INC

MACRO-PREP 50 EPOXIDE, DISTILLED SIZED SUPPORT

10877 A

II

4/11/1994

HELSINN HEALTHCARE SA

PYRIDOSTIGMINE BROMIDE MANUFACTURED IN BIASCA, SWITZERLAND

10878 I

II

4/26/1994

PEPTECH EUROPE A/S

GONADORELIN ACETATE MANUFACTURED IN COPENHAGEN, DENMARK

10879 I

IV

4/15/1994

ROQUETTE AMERICA INC

NEOSORB 70/20 SORBITOL SOLUTION MANUFACTURED IN GURNEE, ILLINOIS

10880 A

II

4/25/1994

PHYTEX AUSTRALIA PARTY LTD

CASTANOSPERMINE MANUFACTURED IN PEAKHURST, AUSTRALIA

10881 A

II

4/22/1994

HOYA CORP

PENTAX HIGH CAPACITY CERAMIC HYDROXYAPATITE MANUFACTURED IN TOKYO, JAPAN

10882 I

III

4/14/1994

RESCO COLOURS INC

10883 I

II

4/19/1994

EURAND SPA

WHITE CONCENTRATE (01EHD-371) MANUFACTURED IN MISSISSAUGA, ONTARIO, CANADA


AND COVENTRY, RHODE ISLAND
PANCRELIPASE (ULTRASE) MINITABS MANUFACTURED IN CINISELLO BALSAMO, (MI) ITALY

10884 I

II

4/21/1994

AJINOMOTO CO INC

GLYCYL-L-GLUTAMINE HYDRATE MANUFACTURED IN KANAGAWA, JAPAN

10885 A

II

4/25/1994

NOVOPHARM LTD

10886 I

4/26/1994

SERIPHARM SA

RANITIDINE HYDROCHLORIDE USP MANUFACTURED IN CELRA (GERONA) SPAIN FOR


NOVOPHARM LTD
FACILITIES AND PROCEDURES IN LE MANS, FRANCE

10887 I

III

4/26/1994

ALCOGUM 9710 MANUFACTURED IN CHATTANOOGA, TENNESSEE

10888 I

4/2/1994

ALCO CHEMICAL DIV NATIONAL STARCH AND


CHEMICAL CO
SEAC

10889 I

II

5/3/1994

WYCKOFF CHEMICAL CO INC

ASTEMIZOLE MANUFACTURED IN SOUTH HAVEN, MICHIGAN

10890 I

4/29/1994

JANSSEN PHARMACEUTICA NV

10891 A

II

4/28/1994

ZACH SYSTEM SPA

FACILITIES AND OPERATING PROCEDURES IN THE CHEMICAL PILOT PLANT, BEERSE,


BELGIUM
FOSFOMYCIN TROMETAMOL MANUFACTURED IN VICENZA, ITALY

10892 I

4/19/1994

DOWTY SEALS LTD

FACILITY AND MANUFACTURING PROCEDURES IN GLOUCESTERSHIRE, UNITED KINGDOM

10893 I

4/22/1994

CARIC AUBE CHAMPAGNE

FACILITIES AND OPERATING PROCEDURES IN BRIENNE LE CHATEAU, FRANCE

10894 I

III

5/2/1994

AMPACET CORP

10895 A

III

5/2/1994

AMPACET CORP

10896 I

5/3/1994

RHONE POULENC RORER SA

150206 RED POLYETHYLENE MASTERBACH MANUFACTURED LOUISIANA OR MESSANCY,


BELGIUM
170207 GREEN POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA,
DERIDDER, LOUISIANA OR MESSANCY, BELGIUM
FACILITY AND OPERATING PROCEDURES IN VILLENEUVE-LA-GARENNE CEDEX, FRANCE

10897 I

II

5/10/1994

KNOLL AG

10898 I

II

5/13/1994

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD

10899 I

5/11/1994

SYRINGE ASEPTIC FILL PROGRAM IN GRAND ISLAND, NEW YORK.

10900 I

II

5/12/1994

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
VIALE FULVIO TESTI

10901 I

II

5/18/1994

TEVA PHARMACEUTICAL INDUSTRIES LTD

LABETALOL HYDROCHLORIDE MANUFACTURED IN MILANO, ITALY

10902 N

FACILITY AND OPERATING PROCEDURES IN BEUVRY-LA-FORET, FRANCE

S-ADENOSYL-L-METHIONINE 1, 4-BUTANEDISULFONATE MANUFACTURED IN SAN ANTONIO,


SWITZERLAND
CISPLATIN DRUG SUBSTANCE MANUFACTURED IN BORONIA, VICTORIA, AUSTRALIA

TIMOLOL MALEATE MANUFACTURED IN FROSININE, ITALY

NOT AN ASSIGNED NUMBER

10903 I

III

4/25/1994

BASF AKTIENGESELLSCHAFT

NOVOLEN 1040 RC MANUFACTURED IN E-TARRAGONA, SPAIN

10904 A

III

5/11/1994

TICONA LLC

GUR AND GHR POLYETHYLENES MANUFACTURED IN PASADENA, TEXAS

10905 I

5/5/1994

RHONE POULENC RORER GMBH

10906 I

III

5/19/1994

ZELLER PLASTIK INC

FACILITIES AND OPERATING PROCEDURES FOR THE MANUFACTURE OF 10-DAB IN KOLN,


GERMANY
PLASTIC PACKAGING COMPONENTS MANUFACTURED IN LIBERTYVILLE, IL

10907 I

5/13/1994

KELCO INTERNATIONAL LTD

MANUFACTURING FACILITY AND PROCEDURES AT KNOWSLEY, UNITED KINGDOM

10908 I

5/17/1994

VECTOR CORP EAST COAST LABORATORY

FACILITIES AND OPERATING PROCEDURES IN CRANBURY, NEW JERSEY

Page 306

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10909 I
I
5/17/1994
MEDISORB TECHNOLOGIES INTERNATIONAL LTD
PARTNERSHIP
10910 I
II
5/17/1994
SUMITOMO CHEMICAL CO LTD

SUBJECT
FACILITY AND OPERATING PROCEDURES IN WILMINGTON, OHIO

10911 A

IV

5/13/1994

INGREDION INC

PURITY 21 (45-0821) MANUFACTURED IN BRIDGEWATER, NEW JERSEY

10912 I

II

5/20/1994

JANSSEN PHARMACEUTICA NV

MICONAZOLE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM

10913 A

II

5/20/1994

JANSSEN PHARMACEUTICA NV

MICONAZOLE NITRATE MANUFACTURED IN GEEL, BELGIUM

10914 A

II

4/22/1994

HOYA CORP

10915 I

III

4/29/1994

ECP ENICHEM POLYMERES FRANCE

PENTAX STANDARD CAPACITY CERAMIC HYDROXYAPATITE MANUFACTURED IN TOKYO,


JAPAN
FLEXIRENE MS40 MANUFACTURED IN DUNKIRK, FRANCE

10916 I

III

5/11/1994

TICONA LLC

10917 I

III

5/24/1994

SARNATECH XIRO AG

GUR AND GHR POLYETHYLENES MANUFACTURED IN OBERHAUSEN, FEDERAL REPUBLIC OF


GERMANY
XIRO ADHESIVE FILM V -300 MANUFACTURED IN SCHMITTEN, SWITZERLAND

10918 A

II

6/8/1994

PROCOS SPA

LABETALOL MANUFACTURED IN CAMERI, ITALY

10919 A

II

5/27/1994

NORAMCO INC

TOPIRAMATE DRUG SUBSTANCE MANUFACTURED IN ATHENS, GEORGIA

10920 I

5/24/1994

RHONE POULENC RORER GMBH

MANUFACTURING FACILITY A VITRY-SUR-SEINE CEDEX, FRANCE

10921 I

5/31/1994

NICHOLAS PIRAMAL INDIA LTD

MANUFACTURING FACILITY AT MADHYA PRADESH, INDIA

10922 I

II

5/25/1994

NORAMCO INC

OFLOXACIN MANUFACTURED IN AHENS, GEORGIA

10923 I

II

5/25/1994

GENZYME CORP

10924 I

II

5/24/1994

PROSINTEX INDUSTRIE CHIMICHE ITALIANE S.R.L.

SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)


MANUFACTURED IN SUFFOLK, ENGLAND
PIRENZEPINE DIHYDROCHLORIDE MANUFACTURED IN MILANO, ITALY

10925 A

IV

5/25/1994

BRISTOL MYERS SQUIBB CO

10926 I

III

5/26/1994

BASF SE

10927 I

6/3/1994

SANTEN PHARMACEUTICAL CO LTD

PLASTIBASE 50W (PLASTICIZED HYDROCARBON GEL) MANUFACTURED IN HUMACO, PUERTO


RICO AND BUFFALO, NY
ULTRAFORM W 2320 003 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY
MANUFACTURING PLANT AT NOTO, JAPAN

10928 I

6/1/1994

UNISYN TECHNOLOGIES INC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES A SAN DIEGO, CA

10929 I

II

6/2/1994

ORGAPHARM SAS

10930 A

6/1/1994

STERIGENICS INTERNATIONAL

10931 A

6/1/1994

STERIGENICS INTERNATIONAL

10932 I

II

6/6/1994

ELF ATOCHEM NORTH AMERICA INC

METHYL SULFONAMIDE INDOLE-2- CAROXYLIC ACID MANUFACTURED IN PITHIVIERS,


FRANCE
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN
CHARLOTTE, NC.
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN
CORONA, CA
FORALKYL BR 8 NP, C8F17BR MANUFACTURED IN CEDEX, FRANCE

10933 I

6/8/1994

SINTESIS QUIMICA SA

MANUFACTURING FACILITIES OPERATING PROCEDURES AND PERSONNEL AT LIMU, PERU

10934 I

III

5/18/1994

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 2420 F MANUFACTURED IN WESSELING, (FEDERAL REPUBLIC OF GERMANY)

10935 I

III

5/30/1994

SCHUBERT SEALS A S

RUBBER COMPOUND NO. 6460 MANUFACTURED IN HORSENS, DENMARK

10936 I

5/20/1994

TECHNOCHEMIE GMBH

10937 I

IV

6/8/1994

MICROCELLULOSE WEIBENBORN GMBH CO

10938 I

III

5/18/1994

AMPACET CORP

10939 I

III

6/9/1994

3M PHARMACEUTICALS INC

10940 I

II

6/9/1994

TAIWAN BIOTECH CO LTD

MANUFACTURING SITE, OPERATING PROCEDURE AND PERSONNEL A DOSSENHEIM,


GERMANY
OMNICEL, MICROCRYSTALLINE CELLULOSE USP N.F. MANUFACTURED IN WEIBENBORN,
GERMANY
100327 UV BARRIER PE MB MANUFACTURED IN TERRE HAUTE, INDIANA; DERIDDER,
LOUISIANA; MESSANCY, BELGIUM
CONTAINER-CLOSURE SYSTEM FOR NON-CFC INHALATION AEROSOLS ASSEMBLED IN
NORTHRIDGE, CA. & LOUGHBOROUGH, LEICESTERSHIRE, ENGLAND
7 - AMINO CEPHALOSPORANIC ACID MANUFACTURED IN TAIWAN, ROC

SB210272 MANUFACTURED IN ANPACHI-GUN, GIFU PREFECTURE, JAPAN

Page 307

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10941 I
II
6/17/1994
JANSSEN PHARMACEUTICA NV

SUBJECT
INTERMEDIATE T001001 MANUFACTURED IN GEEL, BELGIUM

10942 I

II

6/17/1994

JANSSEN PHARMACEUTICA NV

LOPERAMIDE HYDROCHLORIDE MANUFACTURED IN GEEL, BELGIUM

10943 I

6/20/1994

WOCKHARDT LTD

10944 A

II

6/17/1994

AVENTIS PHARMA MANUFACTURING PTE LTD

FACILITY AND OPERATING PROCEDURES IN CHIKALTHANA, AURANGABAD, MAHARASHTRA


STATE INDIA
NEDOCROMIL SODIUM MANUFACTURED IN SINGAPORE

10945 A

II

6/9/1994

EXCELLA GMBH

ACYCLOVIR SODIUM MANUFACTURED IN FEUCHT, GERMANY

10946 A

II

6/13/1994

JANSSEN PHARMACEUTICA NV

HALOPERIDOL, MANUFACTURED IN GEEL, BELGIUM

10947 A

II

6/13/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000263, MANUFACTURED IN GEEL, BELGIUM

10948 A

II

6/20/1994

ALPROSTADIL, MANUFACTURED IN BUDAPEST, HUNGARY

10949 A

II

6/2/1994

CHINOIN PHARMACEUTCIAL AND CHEMICAL


WORKS CO LTD
SIGMA ALDRICH IRELAND LTD

10950 A

III

6/17/1994

MITSUI CHEMICALS INC

MILLION AND MIPELON RESINS.MANUFACTURED IN YAMAGUGUCHI INDUSTRIES

10951 I

III

6/16/1994

HOBA LACKE UND FARBEN GMBHIK

LACQQUERS IL-320-0136 & IL-320-1528, MANUFACTURED IN NUREMBERG, GERMANY

10952 I

III

6/16/1994

UCB TRANSPAC NV

RAYOPEEL P AND ITS MEDIFLEX LAMINATES MANUFACTURED IN GENT, BELGIUM

10953 A

III

6/17/1994

DATWYLER PHARMA PACKAGING BELGIUM NV

10954 A

II

6/23/1994

JANSSEN PHARMACEUTICA NV

RUBBER COMPOUNDS MANUFACTURED IN PENNSAUKEN, NEW JERSEY, ALKEN, BELGIUM


AND PREGNANA MILANESE, ITALY
HALOPERIDOL DECANOATE, MANUFACTURED IN GEEL, BELGIUM

10955 I

6/21/1994

SANKYO KASEI CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING


PROCEDURESFOR MANUFACTURE OF OXYBENZONE USP XXII, MANUFACTURED IN
HIROSHIMA, JAPAN

10956 I

II

6/21/1994

SANKYO KASEI CO LTD

OXYBENZONE USP XXII, MANUFACTURED IN HIROSHIMA, JAPAN

10957 I

6/24/1994

HOECHST CANADA INC

10958 A

IV

6/24/1994

GRAIN PROCESSING CORP

MANUFACTURING SITES, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN


QUEBEC, CANADA
PHARMACEUTICAL STARCHES MANUFACTURED IN MUSCATINE, IOWA.

10959 A

III

6/21/1994

BERRY PLASTICS CORP

936.1 FILM AS MANUFACTURED IN CHIPPEWA FALLS, WI

10960 I

IV

6/24/1994

HULS AKTIENGESELLSCHAFT

DEHYDRATED ALCOHOL (ETHANOL) USP MANUFACTURED IN HERNE, GERMANY

10961 I

III

6/24/1994

BESPAK DIV CONSORT MEDICAL PLC

BK357 PHARMACEUTICAL METERING VALVE, MANUFACTURED IN NORFOLK, ENGLAND

10962 I

II

6/21/1994

NORDIC SYNTHESIS AB

TACRINE HYDROCHLORIDE MONOHYDRATE, MANUFACTURED IN KARLSKOGA, SWEDEN

10963 A

II

6/24/1994

MILLIPORE CORP

DURAPORE FILTER MEMBRANE MANUFACTURED IN CORK, IRELAND

10964 A

III

6/15/1994

AMPACET CORP

10965 I

IV

8/16/1994

ACCESS PHARMACEUTICALS INC

10053 ANTISTA POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, INDIANA,


DERIDDER, LOUISIANA AND BELGIUM
SEPA 0009 (2-NONYL-1,3-DIOXACYCLOPENTANE),MFG. IN SCOTLAND ,UK

10966 I

II

6/24/1994

TEVA PHARMACEUTICALS INC

DIHYDRO DANE SALT, MANUFACTURED IN MEXICO, MISSOURI

10967 I

6/15/1994

RAYLO CHEMICALS

10968 A

III

6/22/1994

B LAUFENBERG GMBH

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN EDMONTON, ALBERTA, CANADA.
SILICONE COATING ON ALUMINIZED POLYESTER FILM MANUFACTURED IN HULS, GERMANY

10969 I

6/28/1994

CHIFENG PHARMACEUTICAL FACTORY

MANUFACTURING SITE, FACILITIES AND PERSONNEL AT INNER MONGOLIA, P.R. CHINA

10970 I

II

6/28/1994

GUANGDONG PHARMACEUTICAL FACTORY

MICONAZOLE NITRATE MANUFACTURED IN GUANGZHOU, CHINA

10971 I

6/29/1994

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT BUDAPEST, HUNGARY

10972 I

II

6/28/1994

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS LTD
CATALENT PHARMA SOLUTIONS LLC

10973 I

IV

7/8/1994

GOLDSCHMIDT CHEMICAL DIV WILSON PHARMA


AND CHEMICAL CORP

PEG-25 GLYCERYL TRIOLEATE, (TAGAT TO) MANUFACTURED IN ESSEN, GERMANY

CLOMIPRAMINE HYDROCHLORIDE, MANUFACTURED IN ARKLOW, IRELAND

VESANOID, 10MG SOFTGELS MANUFACTURED IN ST. PETERSBURG, FLORIDA

Page 308

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
10974 I
I
7/1/1994
CHEMOSWED AB
10975 I

III

7/1/1994

ISHIDA PRESS KOGYO CO LTD

SUBJECT
MANUFACTURING FACILITIES, PERSONNEL AND GENERAL PROCEDURES AT MALMO,
SWEDEN
ALUMINIUM CAPS FOR VIALS MANUFACTURED A SAITAMA, JAPAN

10976 A

II

7/11/1994

TEVA PHARMACEUTICAL INDUSTRIES LTD

BUDESONIDE, MFG. IN MILANO, ITALY

10977 I

III

7/8/1994

ACI BLOWPAK

POLYPROPYLENE VIALS MFG. IN KINGSGROVE, AUSTRALIA

10978 I

II

7/8/1994

CILAG AG

TOPIRAMATE, MFG. IN SCHAFFHAUSEN, SWITZERLAND

10979 I

IV

7/7/1994

SANDOZ PHARMA LTD

CORN OIL-MONO-DI-TRIGLYCERIDES MFG. IN BASLE, SWITZERLAND.

10980 I

7/1/1994

ZELLER PLASTIK GMBH

10981 A

II

7/8/1994

TOKYO KASEI KOGYO CO LTD

MFG SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL A ZELL/MOSEL, FEDERAL


REPUBLIC OF GERMANY
TROPICAMIDE USP, MFG. IN SAITAMA, JAPAN

10982 A

II

7/11/1994

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

CIMETIDINE USP MANUFACTURED IN BARCELONA, SPAIN.

10983 I

7/12/1994

ACCUCAPS INDUSTRIES LTD

10984 A

III

6/27/1994

AKCROS CHEMICALS INC

MFG. FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT WINDSOR,


ONTARIO
INTERSTAB HEAT AND LIGHT STABILIZERS MFG. IN NEW BRUNSWICK, NJ

10985 I

III

7/8/1994

KARL HOLL GMBH AND CO KG

10986 I

II

7/18/1994

JANSSEN PHARMACEUTICA NV

ALUMINIUM AND LAMINATE TUBES MANUFACTURED IN LANGENFELD AND


KIRCHHEIMBOLANDEN, FEDERAL REPUBLIC OF GERMANY.
INTERMEDIATE T001349, MANUFACTURED IN GEEL, BELGIUM.

10987 I

II

7/18/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T000425 MANUFACTURED IN GEEL, BELGIUM.

10988 I

II

7/19/1994

SIANG TA PHARMACEUTICAL CO LTD

GUAIFENESIN MANUFACTURED IN HU-KUO HSINCHU, TAIWAN, THE REPUBLIC OF CHINA

10989 I

II

7/15/1994

HEUMANN PHARMA GMBH AND CO

RANITIDINE HYDROCHLORIDE-FORM 1 MANUFACTURED IN FEUCHT, GERMANY

10990 I

7/20/1994

SPIRIG AG

10991 A

II

7/14/1994

PHOSPHOLIPID GMBH

MANUFACTURING FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN


EGERKINGEN, SWITZERLAND
PHOSPHOLIPON 90 H MANUFACTURED BY CU CHEMIE UETIKON GMBH IN LAHR, GERMANY.

10992 I

II

7/14/1994

PHOSPHOLIPID GMBH

PHOSAL 50 PG MANUFACTURED IN COLOGNE, GERMANY.

10993 I

III

7/15/1994

CARCANO ANRONIO S.P.A.

PACKAGING MATERIALS FOR SUPPOSITORIES MFG. IN MANDELLO DEL LARIO, ITALY

10994 A

II

7/19/1994

OLON SPA

BUMETANIDE MFG. IN MILAN, ITALY

10995 I

II

7/21/1994

JANSSEN PHARMACEUTICA NV

LEVAMISOLE HYDROCHLORIDE CRUDE MFG. IN GEEL, BELGIUM

10996 I

II

7/21/1994

GENZYME LTD

5-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC ACID MGF. IN SUFFOLK, ENGLAND

10997 I

III

7/22/1994

TUBENFABRIK BISCHOFSZELL

ALUMINUM DRUG PACKAGE MATERIALS MFG. IN BISCHOFSZELL, SWITZERLAND

10998 A

II

8/25/1994

APOTEX PHARMACHEM INC

RANITIDINE HCL MFG. IN TOLUCA, ESTADO DE MEXICO, MEXICO

10999 I

III

5/9/1994

BASF AKTIENGESELLSCHAFT

STYROLUX 637 D MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

11000 I

7/25/1994

SANOFI RECHERCHE

11001 A

III

7/26/1994

NIPRO GLASS GERMANY AG

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TOULOUSE, FRANCE.
ARTICLES OF TUBULAR GLASS MFG. IN MUNNERSTADT, GERMANY

11002 I

7/22/1994

SANDOZ LTD

11003 I

III

7/25/1994

DSM POLYMERS

MANUFACTURING FACILITIES, PERSONENEL, AND GENERAL OPERATING PROCEDURES IN


CO. CORK, IRELAND.
STAMYLEX 2H 438 MFG. IN AA BEEK, THE NETHERLANDS.

11004 A

II

7/21/1994

PROCOS SPA

EMBUTRAMIDE MFG. IN NOVARA, ITALY

11005 I

III

7/1/1994

TOYO ALUMINUM KK

11006 I

III

7/29/1994

REXAM MEDICAL PACKAGING INC

FILM PACKAGING MATERIAL: PET, LDPE REVERSE PRINTED WHITE, ALUMINUM FOIL,
ADHESIVE AND ACRYLONITRILE FILM MFG. IN GUMA & OSAKA, JAPAN
ECDEL LAYFLA FILM MANUFACTURED IN BRISTOL, ENGLAND

11007 I

7/28/1994

BIO PHARMACEUTICAL PHARMACEUTICS


SERVICES INC DIV IBAH INC

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL AT FORT


WASHINGTON, PA

Page 309

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11008 A
II
7/26/1994
ORGAPHARM

SUBJECT
HEMATOPORPHYRIN DIHYDROCHLORIDE MANUFACTURED IN PITHIVIERS, FRANCE

11009 I

III

8/2/1994

PMS CONSOLIDATED

11010 A

III

7/25/1994

ST GOBAIN DESJONQUERES SA SGD

COLORANT-061233CMBR,USED IN PLASTIC PACKAGING MATERIALS MANUFACTURED IN ELK


GROVE VILLAGE,ILLINOIS
GLASS TYPE II CONTAINERS, MFG. IN MERS-LES BAINS, FRANCE

11011 I

7/28/1994

VERDUGT B V

11012 I

III

7/27/1994

RESCO COLOURS INC

11013 I

II

8/2/1994

JRH BIOSCIENCES

11014 I

II

7/28/1994

BIOSYNTH AG

11015 I

II

8/2/1994

JANSSEN PHARMACEUTICA NV

MANUFACTURING FACILITIES OPERATING PROCEDURES AND PERSONNEL IN TIEL,


NETHERLAND
BLUE WHITE MASTERBACH 01EHD-261 MFG IM MISSISSAUGA, ONTARIO, CANADA AND
COVENTRY, RHODE ISLAND
RPMI 1640 MEDIUM, W/O L-GLUTAMINE AND W/O PHENOL RED (PROD. NO. 52773), MFG IN
WOODLAND, CA
MELATONIN AND A STABILITY INDICATION ASSAY METHOD FOR MELATONIN MFG. IN ES
DUIVEN (GLD.), THE NETHERLANDS
LEVAMISOLE DRUG SUBSTANCE MFG IN GEEL, BELGIUM

11016 I

II

8/1/1994

BYK GULDEN LOMBERG CHEMISCHE FABRIK

ELTENAC/B 7808-020 DRUG SUBSTANCE MFG. IN SINGEN, FEDERAL REPUBLIC OF GERMANY

11017 I

II

8/2/1994

ESTEVE QUIMICA SA

OMEPRAZOLE MFG. IN BARCELONA, SPAIN

11018 I

II

8/4/1994

TARO PHARMACEUTICAL INDUSTRIES LTD

DESOXIMETASONE MFG. IN HAIFA BAY, ISRAEL

11019 A

II

8/1/1994

BAYER SCHERING PHARMA AG

ESTRONE MFG IN BERLIN AND BERGKAMEN, GERMANY

11020 I

II

7/31/1994

DERETIL SA

D(-) ALPHA PHENYLGLYCINE DANE SALT ETHYL NPOTASSIUM MFG. IN ALMERIA, SPAIN

11021 A

II

7/31/1994

DERETIL SA

11022 I

II

7/31/1994

DERETIL SA

D(-) ALPHA PARAHYDROXY PHENYLGLYCINE DANE SALT METHYL POTASSIUM MFG. IN


ALMERIA, SPAIN
D(-) ALPHA DIHYDRO PHENYLGLYCINE DANE SALT METHYL SODIUM MFG. IN ALMERIA, SPAIN

11023 A

II

8/2/1994

BASF PHARMACHEMIKALIEN GMBH CO KG

DOBUTAMINE HYDROCHLORIDE MFG. IN MINDEN, GERMANY

11024 I

II

8/5/1994

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD

GLIPIZIDE MFG. IN TAIWAN, THE REPUBLIC OF CHINA

11025 I

II

8/4/1994

PHARM ECO LABORATORIES INC

3,4,5-TRIMETHOXYBENZOYLFORMIC ACID MFG. IN LEXINGTON, MA

11026 I

7/21/1994

MERIND LTD

11027 I

II

7/21/1994

MERIND LTD

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL A BOMBAY,


INDIA
AMITRIPTYLINE HYDROCHLORIDE USP, MFG IN BOMBAY, INDIA

11028 I

III

8/10/1994

MITSUI CHEMICALS INC

APEL RESINS FOR DRUG PACKAGING MFG. IN YAMAGUGUCHI, JAPAN

11029 I

II

8/10/1994

PVP SOCIEDADE ANONIMA

PILOCARPINE NITRATE MFG. IN PARNAIBA, BRAZIL

11030 I

II

7/27/1994

AVENTIS PHARMA SA

HEMATOROPHYRINE DIHYDROCHLORIDE,PACKAGED AND TESTED IN VERTOLAYE,FRANCE

11031 I

8/6/1994

TAKASAGO INTERNATIONAL CORP

11032 I

II

8/6/1994

TAKASAGO INTERNATIONAL CORP

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN


SHIZUOKA PREFECTURE, JAPAN
A88820.605 MFG IN SHIZUOKA PREFECTURE, JAPAN

11033 I

III

8/15/1994

MULLER PACKAGING LTD

11034 I

III

8/11/1994

EK PACK FOLIEN GMBH

COATED METAL CONTAINERS, CONICAL STEEL DRUMS MFG. IN RHEINFELDEN, FEDERAL


REPUBLIC OF GERMANY
EK-MINIUM S PAP 50 GMS - PE 12 MY - ALU 12 MY - SURLYN 30 GMS; PHARMACEUTICAL
COMPONENT/PHARMACEUTICAL INTERMEDIATE MFG. IN ERMENGERST-WIGGENSBATCH,
GERMANY

11035 I

II

8/16/1994

JANSSEN PHARMACEUTICA NV

VOROZOLE DRUG SUBSTANCE MFG IN GEEL, BELGIUM

11036 I

8/16/1994

NIELS CLAUSON-KAAS AS

11037 A

II

7/29/1994

SONAC LOENEN BV

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN FARUM, DENMARK
HEMIN,MANUFACTURED IN GD LOENEN,THE NETHERLANDS

Page 310

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11038 I
I
8/18/1994
SYNTECH CHEMICAL AND PHARMACEUTICAL CO
11039 I

III

7/14/1994

LIFOCOLOR FARBEN GMBH

SUBJECT
MANUFACTURING SITE,FACILITIES,OPERATING PROCEDURES AND PERSONNEL A HSINYING,TAIWAN
LIFOCOLOR RED 30858 PP,MANUFACTURED IN LICHTENFELS,GERMANY

11040 A

8/15/1994

SYNERGY HEALTH STERILISATION UK LTD

STERILE PROCESSING PROCEDURES AS LOCATEDIN DAVENTRY, ENGLAND

11041 I

II

6/24/1994

SMITHKLINE BEECHAM PHARMACEUTICALS CO

11042 I

III

8/15/1994

BASELL POLIOLEFINE ITALIA SPA

PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE MANUFACTURED IRVINE,


AYRSHIRE, SCOTLAND.
LUPOLEN 3020 F MANUFACTURED IN WESSELING, (FEDERAL REPUBLIC OF GERMANY).

11043 I

II

8/22/1994

ASAHI CHEMICAL CO LTD

2-ISOPROPL-4-(N-METHYL) AMINO-METHYL THIAZOLE MFG. IN FUKUI PREFECTURE, JAPAN

11044 I

8/22/1994

ASAHI CHEMICAL INDUSTRY CO LTD

11045 A

II

8/23/1994

DEAD SEA BROMINE CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN FUKUI PREFECTURE, JAPAN
MAGNESIUM OXIDE GRADE HA5 MANUFACTURED IN MISHOR ROTEM, D.N. ARAVA, ISRAEL

11046 A

II

8/23/1994

DEAD SEA BROMINE CO LTD

MAGNESIUM OXIDE GRADE HA4 MANUFACTURED IN MISHOR ROTEM,D.N. ARAVA,ISRAEL

11047 A

II

8/23/1994

DEAD SEA BROMINE CO LTD

BASIC MAGNESIUM CARBONATE MANUFACTURED IN MISHOR ROTEM,D.N. ARAVA,ISRAEL

11048 I

8/17/1994

TECH PLASTICS INC

MANUFACTURING SITE,FACILITIES,PERSONNELAND GENERAL OPERATING PROCEDURES


MANUFACTURED IN TEMPE,ARIZONA

11050 I

II

8/26/1994

FARMHISPANIA SA

CROMOLYN SODIUM MANUFACTURED IN BARCELONA,SPAIN

11051 A

IV

8/1/1994

JRS PHARMA LP

DEXTRATES, N.F. (HYDRATED), EMDEX MANUFACTURED IN CEDAR RAPIDS, IOWA

11052 I

8/26/1994

SANOFI WINTHROP INC

11053 A

III

8/25/1994

PRETIUM PACKAGING

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


AT COLLEGEVIEW, PA
PACKAGING MATERIAL AS MANUFACTURED IN POINTE CLAIRE, QUEBEC, CANADA

11054 A

II

8/30/1994

ERREGIERRE SPA

BUPROPION HYDROCHLORIDE USP MANUFACTURED IN BERGAMO, ITALY

11055 I

II

9/1/1994

SELOC FRANCE

GLYBURIDE MANUFACTURED IN SHANNON, IRELAND AND LIMAY, FRANCE

11056 A

9/2/1994

MEDIMMUNE LLC

STERILE PROCESSING FACILITY (E SUB) LOCATED IN NIJMEGEN THE NETHERLANDS

11057 I

II

9/1/1994

PIERCE CHEMICAL CO

EMPHAZE HEPARIN BIOSUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MN

11058 I

II

8/8/1994

FINE CHEMICALS CORP

MESORIDAZINE BESYLATE MANUFACTURED IN CAPE PROVINCE,SOUTH AFRICA

11059 I

II

9/1/1994

ROQUETTE AMERICA INC

DEXTROSE MONOHYDRATE, USP GRADE MANUFACTURED IN KEOKUK, IOWA

11060 I

II

9/2/1994

SUD CHEMIE GROUP BUSINESS UNIT RHEOLOGY

QUATERNIUM-18 BENTONITE (BULK) MANUFACTURED IN LOUISVILLE, KY

11061 I

IV

9/2/1994

PFANSTIEHL LABORATORIES INC

11062 A

III

9/2/1994

OBRIST OVERSEAS LTD

11063 I

II

9/2/1994

PHARM ECO LABORATORIES INC

11064 I

III

8/29/1994

WINPAK TECHNOLOGIES INC

ALPHA, ALPHA-TREHALOSE DIHYDRATE, LOW ENDOTOXIN MANUFACTURED IN WAUKEGAN,


IL
COLLAPSIBLE ALUMINUM TUBES FOR CREAM & OINTMENTS MANUFACTURED IN REINACH,
SWITZERLAND
(S)-N-[2-OXO-2-(3,4,5-TRIMETHOXYPHENYL) ACETYL]PIPERIDINE-2-CARBOXYLIC ACID 1,7BIS(3-PYRIDYL)-4-HEPTYL ESTER DICITRATE SALT MANUFACTURED IN LEXINGTON, INC.
TRANSDERMAL PACH PRODUCT MANUFACTURED IN TORONTO, CANADA

II

9/2/1994

11068 I

III

9/2/1994

MITSUI PETROCHEMICAL AMERICA LTD

ADMER QF550E AND SF710 MANUFACTURED IN LAPROTE, TX

11069 I

II

9/8/1994

AMINO GMBH

BETAINE, MONOHYDRATE MANUFACTURED IN FRELLSTEDT, GERMANY

11070 I

IV

8/30/1994

BASF SE

KOLLIDON 17 PF MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

11071 I

III

8/18/1994

BASF AKTIENGESELLSCHAFT

TERLURAN 967 K MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

11049 N

NOT AN ASSIGNED NUMBER

11065 N
11066 I

NOT AN ASSIGNED NUMBER

11067 N

JOHNSON MATTHEY INC

NAPHAZOLINE HYDROCHLORIDE MANUFACTURED IN WEST DEPTFORD,NEW JERSEY

NOT AN ASSIGNED NUMBER

Page 311

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11072 I
IV
9/2/1994
NP PHARMACEUTICAL SA

SUBJECT
SUGAR SPHERES (NEUTRAL PELLETS) MANUFACTURED IN BAZAINVILLE, FRANCE

11073 I

IV

9/7/1994

ELF ATOCHEM NORTH AMERICA INC

11074 I

III

8/24/1994

CREST FLEXIBLE PACKAGING LTD

11075 I

II

9/13/1994

PURAC BIOCHEM BV

FORANES, F11, F12, AND F114 MANUFACTURED IN VIZCAYA, SPAIN AND PIERRE BENITE,
FRANCE
PACKAGING MATERIALS FOR MEDICAL PACKAGING (PAPER/PE/FOIL/MEL 850) 40.0G/M2
PAPER MANUFACTURED IN KENT, ENGLAND.
AMMONIUM LACTATE, PURASAL NH 70 MANUFACTURED IN GORINCHEM, THE NETHERLANDS

11076 I

II

9/13/1994

LAEVOSAN GMBH AND CO KG

HETASTARCH FOR INJECTION MANUFACTURED IN LINZ, AUSTRIA

11077 I

II

9/9/1994

TANABE SEIYAKU CO LTD

DILTIAZEM MALATE MANUFACTURED IN YAMAGUCHI JAPAN

11078 A

II

9/10/1994

BACHEM AMERICAS INC

11079 A

II

9/8/1994

AMINO GMBH

OVINE CORTICOTROPIN RELEASING FACTOR (0CRF) MANUFACTURED IN TORRANCE


CALIFORNIA
BETAINE MANUFACTURED IN FRELLSTEDT, GERMANY.

11080 I

II

9/14/1994

7-AMINOCEPHALOSPORANIC ACID (7-ACA) MANUFACTURED IN HOKKAIDO, JAPAN.

11081 I

II

9/3/1994

ASAHI CHEMICAL INDUSTRY CO LTD FINE


CHEMICALS DIV
SUMIKA FINE CHEMICALS CO LTD

11082 I

II

9/1/1994

KANEKA CORP

11083 I

II

9/15/1994

SOCHINAZ SA

N2-[1-(S)-ETHOXYCARBONYL 1-3-PHENYLPROPYL]-N6-TRIFLUOROACETYL-L-LYSYL-LPROLINE.
DOBUTAMINE HCL MANUFACTURED IN VIONNAZ, SWITZERLAND.

11084 A

III

8/26/1994

VISCOUNT PLASTICS AUSTRALIA

POLYPROPYLENE VIALS MANUFACTURED IN CANNING VALE, WESTERN AUSTRALIA.

11085 I

II

9/14/1994

ABBOTT LABORATORIES

AMRINONE MANUFACTURED IN NORTH CHICAGO, ILLINOIS.

11086 I

9/16/1994

ALLERGAN INC

11087 I

II

9/16/1994

FINE ORGANICS LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN WACO, TEXAS.
TVA MANUFACTURED IN CLEVELAND, ENGLAND.

11088 I

II

9/16/1994

WYCKOFF CHEMICAL CO INC

11089 I

II

9/16/1994

SANOFI SYNTHELABO INC.

11090 A

IV

9/19/1994

QUALICAPS EUROPE SA

5-HYDROXYMETHYLTHIAZOLE-4-NITROPHENYLCARBONATE HYDROCHLORIDE
MANUFACTURED IN SOUTH HAVEN, MI.
ISOETHARINE MESYLATE AND ISOETHARINE HYDROCHLORIDE MANUFACTURED IN NEW
CASTLE UPON TYNE, UNITED KINGDOM AND RENSSELAER, NEW YORK..
EMPTY GELATIN CAPSULES MANUFACTURED IN ALCOBENDAS, SPAIN.

11091 I

II

9/13/1994

CHEMIE LINZ GMBH

N-(PHENOXYCARBONYL)-L-VALINE METHYL ESTER MANUFACTURED IN LINZ, AUSTRIA.

11092 I

9/20/1994

SOCIETE INDUSTRIELLE DES OLEAGINEUX

11093 I

III

9/9/1994

HELVOET PHARMA MARYLAND

11094 A

III

9/12/1994

UNITED CLOSURES AND PLASTICS PLC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


MANUFACTURED IN SAINT LAURENT BLANGY CEDEX, FRANCE.
RUBBER CLOSURE FORMULATION N4013-45 RED MANUFACTURED IN SALISBURY,
MARYLAND.
PP28 TAMPER-EVIDENT CLICLOC III CLOSURE MANUFACTURED IN NORWICH, ENGLAND.

11095 I

9/14/1994

ASAHI CHEMICAL INDUSTRY CO LTD

11096 I

III

9/22/1994

3M PHARMACEUTICALS INC

11097 A

II

9/23/1994

ALBEMARLE CORP

11098 I

II

9/26/1994

CLOZAPINE MANUFACTURED IN BASLE SWITZERLAND.

11099 I

II

9/28/1994

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL


DEVELOPMENT
SEPRACOR INC

11100 I

II

9/8/1994

WHATMAN

11101 I

II

9/8/1994

WHATMAN

EXPRESS-ION EXCHANGER C (CARBOXYETHYL CELLULOSE)MANUFACTURED IN KENT,


ENGLAND.
EXPRESS-ION EXCHANGER S (SULPHOXYETHYL CELLULOSE) MANUFACTURED IN KENT,
ENGLAND.

CHLORPHENESIN CARBAMATE MANUFACTURED IN OKAYAMA PREFECTURE,JAPAN.

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURE IN


HOKKAIDO, JAPAN.
MSX 1154P 28% EVA COTRAN CONTROLLED CALIPER FILM MANUFACTURED IN ST. PAUL,
MINNESOTA.
DIPHENHYDRAMINE CITRATE, USP MANUFACTURED IN SOUTH HAVEN, MI.

(S)-KETOPROFEN MANUFACTYRED IN MARLBOROUGH, MA

Page 312

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11102 I
II
9/8/1994
WHATMAN
11103 I

II

9/8/1994

WHATMAN

11104 A

II

9/28/1994

SIEGFRIED LTD

SUBJECT
EXPRESS-ION EXCHANGER D (DIETHYLAMINOETHYL CELLULOSE) MANUFACTURED IN KENT,
ENGLAND.
EXPRESS-ION EXCHANGER Q (QUATERNARY AMMONIUM CELLULOSE) MANUFACTURED IN
KENT, ENGLAND.
SELEGILINE HYDROCHLORIDE MANUFACTURED IN ZOFINGEN, SWITZERLAND

11105 A

II

9/26/1994

ZACH SYSTEM SA

LOTEPREDNOL ETABONATE MANUFACTURED IN ARVILLE CEDEX, FRANCE.

11106 I

IV

9/30/1994

3M PHARMACEUTICALS

11107 I

IV

9/30/1994

3M PHARMACEUTICALS

11108 I

IV

9/30/1994

3M PHARMACEUTICALS

CHLOROFLUOROCARBON PROPELLANT P-11 (TRICHLOROFLUOROMETHANE, NF)


MANUFACTURED IN VIZCAYA, SPAIN FOR 3M PHARMACEUTICALS INC
CHLOROFLUOROCARBON PROPELLANT P-12 (DICHLOROFLUOROMETHANE,NF)
MANUFACTURED IN VIZCAYA, SPAIN FOR 3M PHARMACEUTICALS INC
CHLOROFLUOROCARBON PROPELLANT P-114 (1,2DICHLOROTETRAFLUOROETHAN,NF)MANUFACTURED IN PIERRE BENITE, FRANCE FOR 3M
PHARMACEUTICALS INC

11109 I

II

9/29/1994

FINE ORGANICS LTD

ATOC (ACETOXY ACID GR148460X)MANUFACTURED IN CLEVELAND,UK.

11110 I

II

9/30/1994

BACHEM INC

GLUCAGON-LIKE PEPTIDE (7-37) MANUFACTURED IN TORRANCE, CALIFORNIA.

11111

III

9/29/1994

DOW CORNING CORP

SILASTIC QCF7-4910 UNFILLED ELASTOMER MANUFACTURED IN HEMLOCK, MI.

III

10/3/1994

BELL FIBRE PRODUCTS CORP

41713-34 MANUFACTURED IN COLUMBUS, GA.

11112 I
11113 N

NOT AN ASSIGNED NUMBER

11114 I

III

8/31/1994

ALUMINUM CO AMERICA

PHARM 9502 MANUFACTURED IN RIVERDALE, IA.

11115 I

II

9/30/1994

WYCKOFF CHEMICAL CO INC

SELEGIINE MANUFACTURED IN SOUTH HAVEN, MI.

11116 I

III

8/27/1994

VANLEER VERPACKUNGEN GMBH

FIBRE DRUMS MANUFACTURED IN COLOGNE, GERMANY.

11117 I

III

9/20/1994

REXHAM CONTAINERS

P&G 100CT HDPE BOTTLES MANUFACTURED IN FLORA,IL.

11118 I

III

9/21/1994

LOCTITE INTERNATIONAL

11119 I

II

9/21/1994

LONZA LTD

LOCTITE 408 MANUFACTURED IN WHITESTOWN, DUBLIN 24 AND BALLYFERMOT, DUBLIN 10,


IRELAND
NIACINAMIDE MANUFACTURED IN VISP, SWITZERLAND

11120 I

9/29/1994

ZENECA PHARMACEUTICALS DIV ZENECA INC

11121 A

III

9/28/1994

APTAR FRANCE SAS

11122 I

II

9/30/1994

DSM ANDENO

11123 I

II

9/30/1994

DSM ANDENO

11124 A

IV

9/23/1994

AKZO NOBEL SURFACE CHEMISTRY LLC

11125 I

III

10/5/1994

ELF ATOCHEM

11126 I

III

10/5/1994

ELF ATOCHEM

11127 I

III

10/5/1994

ELF ATOCHEM

11128 I

II

10/5/1994

NORISTAN LTD

11129 I

9/30/1994

NUOVA OMPI SRL

11130 A

III

7/18/1994

KEY INTERNATIONAL INC

MFG. SITE, FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN PLANKSTADT,


GERMANY
APTAR GASKETS MANUFACTURED IN VAL-DE-REUIL, FRANCE
R(-)-2-PHENYLGLYCINE DANE SALT (POTASSIUM, ETHYL) (KE) MANUFACTURED IN GENEVA,
SWITZERLAND
R (-)-2-4-HYDROXY-PHENYLGLYCINE DANE SALT (POTASSIUM , METHYL) (DP)
MANUFACTURED IN GENEVA, SWITZERLAND
ALCOGUM SP MANUFACTURED IN CHATTANOOGA TENNESSEE
HIGH DENSITY POLYETHYLENE QUALITY LACQTENE HD 2040 MN 55 MANUFACTURED IN
HARFLEUR, FRANCE.
HIGH DENSITY POLYETHYLENE QUALITY LACQTENE HD 2003 SN 53 MANUFACTURED IN
HARFLEUR, FRANCE.
LOW DENSITY POLYETHYLENE QUALITY LACQTENE BD 1020 FN MANUFACTURED IN
HARFLEUR, FRANCE.
ACETYLSALICYLIC ACID (ASA) MANUFACTURED IN WALTLOO, PRETORIA, REPUBLIC OF
SOUTH AFRICA.
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
MANUFACTURED IN VIA MOLINELLA,ITALY.
EMPTY MOLDED SHELLS FABRICATED FROM PLASTIC FILM MANUFACTURED IN
ENGLISHTOWN, NEW JERSEY.

Page 313

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11131 I
I
10/5/1994
GLAXO SPA
11132 A

II

10/5/1994

CENTRAL GLASS CO LTD

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
IN S. POLO DI TORRILLE PR,ITALY.
SEVOFLURANE MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN.

11133 A

IV

10/7/1994

WAKO PURE CHEMICAL INDUSTRIES LTD

POLYLACTIC ACID (PLA) MANUFACTURED IN SAITAMA PREFECTURE, JAPAN.

11134 I

II

10/3/1994

SYNCHEM CHEMICALS PRIVATE LTD

ATENOLOL MANUFACTURED IN GUJARA, INDIA.

11135 I

III

10/11/1994

SUN CHEMICALS CO LTD

SUNFAST PIGMENTS MANUFACTURED IN CINCINNATI, OHIO

11136 I

II

10/13/1994

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T001168 MANUFACTURED IN GEEL AND BEERSE,BELGIUM.

11137 I

10/13/1994

KLINGE PHARMACAL GMBH

11138 I

II

10/13/1994

SANOFI RECHERCHE

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY
SR 27417A MANUFACTURED IN TOULOUSE CEDEX, FRANCE.

11139 I

II

10/13/1994

WYCKOFF CHEMICAL CO INC

NORFLOXACIN MANUFACTURED IN SOUTH HAVEN MI

11140 A

II

10/14/1994

YUNG ZIP CHEMICAL IND CO LTD

ECONAZOLE NITRATE MANUFACTURED IN TACHIA,TAIWAN,REPUBLIC OF CHINA.

11141 I

III

10/16/1994

CAPTIVE PLASTICS INC

EXTRUSION BLOWN PLASTIC CONTAINERS MANUFACTURED IN RICHMOND,VIRGINIA.

11142 A

II

10/18/1994

SYNTHESIA AS

ERGOCALCIFEROL USP, MANUFACTURED IN SEMTIN, CZECH REPUBLIC

11143 I

10/20/1994

PURETEK CORP

11144 I

II

10/21/1994

ABBOTT LABORATORIES

MANUFACTURING SITE, FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN


SAN FERNANDO,CA.
ATRACURIUM BESYLATE, MANUFACTURED IN NORTH CHICAGO,IL.

11145 I

III

10/13/1994

JAMES RIVER CORP DIV BERLIN GORHAM GROUP

DUNCOTE II HG 605/260 MANUFACTURED IN PORT HURON, MI.

11146 A

III

10/7/1994

CODING PRODUCTS

TTR-5640 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA,MI.

11147 A

III

10/7/1994

CODING PRODUCTS

TTR-5940 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA, MI.

11148 A

II

10/21/1994

FERMION OY

BUSPIRONE HYDROCHLORIDE MANUFACTURED IN ESPOO AND HANKO, FINLAND.

11149 I

II

10/19/1994

KOKEN CO LTD

CERAMIC HYDROXYAPAITE MANUFACTURED IN YAMAGATA-KEN,JAPAN.

11150 I

II

10/20/1994

ARENOL CHEMICAL CORP

MAGNESIUM SALICYLATE USP,MANUFACTURED IN SOMERVILLE,NEW JERSEY.

11151 I

II

10/14/1994

MITSUI PETROCHEMICAL INDUSTRIES LTD

PP J858T MANUFACTURED IN ICHIHARA-CITY, CHIBA, JAPAN

11152 I

III

10/17/1994

COLORS FOR PLASTICS

ACPP-10371 COLORANT MANUFACTURED IN HUNTLEY,ILLINOIS.

11153 I

III

10/17/1994

COLORS FOR PLASTICS

ACPP-10378 COLORANT MANUFACTURED IN HUNTLEY,IL.

11154 I

III

10/17/1994

COLORS FOR PLASTICS

ACPP-40544 COLORANT MANUFACTURED IN HUNTLEY,ILLINOIS.

11155 A

II

10/24/1994

AJINOMOTO PHARMACEUTICALS CO LTD

A-4166 MANUFACTURED IN MIE PREFECTURE, JAPAN

11156 I

II

10/24/1994

DSM PHARMA CHEMICALS SOUTH HAVEN INC

OXAPROZIN MANUFACTURED IN SOUTH HAVEN,MI.

11157 A

III

10/15/1994

ARTE CORP

DUAL CHAMBER PREFILLABLE SYRINGE MANUFACTURED IN IBARAKI PREFECTURE,JAPAN.

11158 I

10/15/1994

ARTE CORP

11159 A

III

9/1/1994

NIPRO CORP

MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN


IBARAKI PREFECTURE, JAPAN.
ELASTOMERIC CLOSURES MANUFACTURED IN OHDATE-SHI AKITA, JAPAN

11160 I

III

10/17/1994

EI DUPONT DENEMOURS AND CO INC

ZYTEL 101L NC010 MANUFACTURED IN WILMINGTON,DELAWARE.

11161 I

II

10/24/1994

DILTIAZEM ER TABLETS MANUFACTURED IN WEST POINT, PA & KIRKLAND CANADA

11162 I

III

10/11/1994

MERCK RESEARCH LABORATORIES DIV MERCK


AND CO INC
MITSUI CHEMICALS INC

11163 A

II

10/26/1994

FARCHEMIA SRL

SULFASALAZINE MANUFACTURED IN BERGAMO,ITALY.

11164 I

III

10/19/1994

AMPACET CORP

11165 A

IV

10/26/1994

QUALICAPS INC

11416 WHITE POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE


HAUTE,INDIANA,DERIDDER,LOUISIANA AND MESSANCY,BELGIUM.
EMPTY GELATIN CAPSULES MANUFACTURED IN WHITSETT,NORTH CAROLINA.

HZ 1300J MANUFACTURED IN ICHIHARA-CITY CHIBA,JAPAN.

Page 314

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11166 I
II
10/12/1994
ZAMBON GROUP SPA

SUBJECT
ANA 756 MANUFACTURED IN VICENZA,ITALY.

11167 I

II

10/26/1994

SINTESIS QUIMICA SA

6-AMINOPENICILLANIC ACID MANUFACTURED IN LIMA,PERU.

11168 I

III

10/21/1994

ECP ENICHEM POLYMERES FRANCE

FLEXIRENE MS20 MANUFACTURED IN DUNKIRK, FRANCE

11169 I

10/28/1994

ZENECA LTD

11170 I

II

10/28/1994

MERCK RESEARCH LABORATORIES DIV MERCK


AND CO INC

MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES OF


THE PARENTERAL MANUFACTURING FACILITY IN MACCLESFIELD,CHESHIRE,U.K.
ENALAPRIL MALEATE & DILTIAZEM ER TABLETS MFG. IN WEST POINT, PA, BALLYDINE,
IRELAND BARCELONETA, PR, WILSON, NC, MERCK FROSST FACILITIES IN KIRKLAND,
QUEBEC, CA, MARION MERRELL DOW FACILITIES IN KANSAS CITY,MO & PACO PACKAGING,
LAKEWOOD NJ.

11171 A

II

10/31/1994

CADILA PHARMACEUTICALS LTD

ETHAMBUTOL HC1 MANUFACTURED IN GUJARAT,INDIA.

11172 I

10/28/1994

ZENECA LTD

11173 I

III

10/14/1994

WHEATON PHARMATECH

MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES OF


THE GOSERELIN BULK DRUG PLANT IN MACCLESFIELD, CHESHIRE, U.K.
RUBBER CLOSURE FORMULATION B5006-50 BLACK MANUFACTURED IN SALISBURY,MD.

11174 I

10/28/1994

ZENECA LTD

11175 A

III

11/2/1994

NASHUA CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


FOR THE STERILE PRODUCT PLANT IN MACCLESFIELD, CHESHIRE UK.
PBL-3 MANUFACTURED IN MERRIMACK,NH.

11176 I

10/31/1994

11177 I

II

10/31/1994

PHARMACEUTICAL MANUFACTURING RESEARCH


SERVICES
ARENOL CHEMICAL CORP

MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES IN


HORSHAM, PA.
COPPER GLYCINATE MONOHYDRATE MANUFACTURED IN SOMERVILLE, NJ.

11178 I

III

10/28/1994

BASF AKTIENGESELLSCHAFT

STYROLUX KR 2691 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY.

11179 I

II

11/4/1994

HOECHST CELANESE CORP

GLYBURIDE MANUFACTURED IN COVENTRY, RHODE ISLAND

11180 I

II

10/28/1994

KANEKA AMERICA LLC

UBIDECARENONE MANUFACTURED IN TAKASAGOSHI, HYOGO, JAPAN

11181 I

10/28/1994

KANEKA CORP

11182 I

II

11/4/1994

PFANSTIEHL LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


AT TAKASAGO-SHI HYOGO, JAPAN
PHOSPHOLIPIDS, EGG MANUFACTURED IN WAUKEGAN, IL

11183 I

II

11/8/1994

CILAG AG

IRI -695 MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

11184 I

III

10/27/1994

INDUSTRIAL GOMERA SA DE CV

BUTYL STOPPER COMPOUND MANUFACTURED IN ESTADO DE MEXICO, MEXICO

11185 A

III

11/11/1994

DAK AMERICAS MISSISSIPPI INC

PERMACLEAR POLYETHYLENE TEREPHTHALATE MANUFACTURED IN DARLINGTON, SC

11186 A

III

10/12/1994

CLARIANT MASTERBATCHES NORDEN AB

PP 12455 MANUFACTURED IN JARNYXEGATAN 7, MALMO, SWEDEN

11187 I

III

11/4/1994

ELM PLASTIC GMBH

DOSING PIPETTES MANUFACTURED IN GEWERBEGEBIET, DUSSELDORF

11188 A

III

11/5/1994

TAISEI KAKO CO LTD

11189 A

III

10/31/1994

INTRAPAC INDIANA INC

CONTAINERS FOR PULMONARY,NASAL,ORAL, THROAT,SUBLINGUAL OR EAR MANUFACTURED


IN GIFU AND OSAKA, JAPAN
LAMINATE TUBES MANUFACTURED IN SWEDESBORO, NEW JERSEY

11190 I

III

11/4/1994

ALUMINUM CO AMERICA

PHAR 9503 MANUFACTURED IN PITTSBURGH, PENNSYLVANIA

11191 I

11/14/1994

BURROUGHS WELLCOME CO

11192 I

II

11/12/1994

SYNCHEM CHEMICALS PRIVATE LTD

MANUFACTURING SITE, FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN


GREENVILLE, NORTH CAROLINA.
NADOLOL MANUFACTURED IN GUJARARA, INDIA

11193 I

III

11/7/1994

VALSPAR CORP

TPL-301 CLEAR COATING MANUFACTURED IN KOTO-KU, TOKYO,JAPAN.

11194 A

II

11/9/1994

PERRIGO API LTD

FENOFIBRATE MANUFACTURED IN BE'ER SHEVA, ISREAL.

11195 A

II

11/16/1994

CLOZAPINE MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA.

11196 I

II

11/14/1994

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
NORDIC SYNTHESIS AB

BUPROPION HYDROCHLORIDE MANUFACTURED IN KARLSKOGA, SWEDEN.

Page 315

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11197 I
I
11/11/1994
DEGUSSA AG

SUBJECT
MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN
WEISSENBORN, GERMANY.
UNITAB, MICROCRYSTALLINE CELLULOSE MANUFACTURED IN WEISSENBORN, GERMANY.

11198 A

IV

11/11/1994

JRS PHARMA GMBH AND CO KG

11199 I

10/24/1994

INPAC AB

11200 A

II

11/15/1994

JOHNSON MATTHEY INC

11201 I

III

11/11/1994

AMPACET CORP

11202 I

II

11/15/1994

UNITED BREWERIES LTD

11203 I

11/15/1994

UNITED BREWERIES LTD

11204 A

II

11/22/1994

BACHEM SA

MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES A


TUMKUR,INDIA.
PROPOFOL MANUFACTURED IN VIONNAZ,SWITZERLAND.

11205 I

III

11/10/1994

KUHN KUNSTSTOFFWERK

PLASTIC CAPS (MOULDED),MANUFACTURED IN BIETIGHEM/BADEN, GERMANY

11206 A

III

11/7/1994

BORMIOLI ROCCO E FIGLIO SPA BU PLASTICA

CHILD-PROOF CAP. 0 28 MM MANUFACTURED IN CASTELGUELFO,ITALY.

11207 I

II

11/15/1994

SENN CHEMICALS

THYROTROPIN RELEASING HORMONE MANUFACTURED IN DIELSFDORF,SWITZERLAND.

11208 I

II

11/23/1994

ASH STEVENS INC

P-BORONO-L-PHENYLALANINE (B-10 ENRICHED) MANUFACTURED IN RIVERVIEW,MI.

11209 I

11/23/1994

INTERQUIM SA

11210 I

II

11/23/1994

INTERQUIM SA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN BARCELONA, SPAIN
DOTARIZINE MANUFACTURED IN BARCELONA, SPAIN

11211 I

IV

11/15/1994

DEXTER NONWOVENS DIV

TRANSDERMAL MEDICATION FABRIC MANUFACTURED IN WINDSOR LOCKS, CT

11212 I

II

11/21/1994

TOAGOSEI CO LTD

TOAGOSEI GIGAPITE (HYDROXY APAITE MANUFACTURED IN NAGOYA, JAPAN

11213 I

11/22/1994

ZENECA LTD

11214 A

IV

11/30/1994

STEPAN SPECIALTY PRODUCTS LLC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


OF GROUP NO.1 PLANT IN MACCLESFIELD, CHESHIRE, U.K.
WECOBEE SS, HYDROGENATED VEGETABLE OIL MANUFACTURED IN PORT NEWARK, NJ

11215 I

II

11/30/1994

HALOTHANE MANUFACTURED IN NORTH AUGUSTA,S.C.

11216 I

III

11/30/1994

11217 I

II

11/30/1994

HALOCARBON LABORATORIES DIV HALOCARBON


PRODUCTS CORP
HALOCARBON LABORATORIES DIV HALOCARBON
PRODUCTS CORP
SANOFI SYNTHELABO INC.

11218 I

II

10/7/1994

TIANJIN PHARMACEUTICAL CORP

PREDNISOLONE MANUFACTURED IN TIANJIN,CHINA.

11219 I

11/21/1994

11220 A

III

10/28/1994

PAPIERFABRIK DIV SCHOELLER AND HOESCH


GMBH
TAKEUCHI PRESS INDUSTRIES CO LTD

MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES IN


GERNSBACH,GERMANY.
ALUMINIUM COLLAPSIBLE TUBES MANUFACTURED IN TOYAMA,JAPAN.

11221 A

III

11/18/1994

KITANO CO LTD

POLYETHYLENE CAPS MANUFACTURED IN TOYAMA,JAPAN.

11222 I

11/7/1994

PHARMASOL LTD

11223 I

12/5/1994

ROQUETTE FRERES SA

11224 I

IV

11/30/1994

HENRY H OTTENS MANUFACTURING CO INC

11225 I

II

11/29/1994

PHARM ECO LABORATORIES INC

11226 I

11/28/1994

BAUSCH AND LOMB PHARMACEUTICALS INC

11227 I

II

12/1/1994

MALLINCKRODT CHEMICAL INC

MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN


ANDOVER HAMPSHRE,UNITED KINGDOM.
MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN
LESTREM,FRANCE.
SPRAY DRIED ARTIFICIAL STRAWBERRY OIL S-464 MANUFACTURED IN
PHILADELPHIA,PENNSYLVANIA.
(3)-TETRAHYDRO-3-FURYL-N-[91S,2R)-3-2-HYDROSYPROPYL]CARBAMATE MESYLATE
MANUFACTURED IN N.ANDOVER,MA.
MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN
TAMPA,FLORIDA.
SODIUM HYDROGEN L-TARTRATE MANUFACTURED IN ST. LOUIS, MISSOURI

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN LUND, SWEDEN.
FENTANYL HYDROCHLORIDE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY
110406 WHITE POLYPROPYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA,
DERIDDER, LOUISANA, OR MESSANCY, BELGIUM
IBUPROFEN USP MANUFACTURED IN TUMKUR, INDIA.

HALOTHANE PACKAGING MATERIAL MANUFACTURED IN NORTH AUGUSTA,SC.


BEFLOXATONE MANUFACTURED BY FINORGA SA IN CHASSE SUR RHONE, FRANCE.

Page 316

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11228 I
II
12/16/1994
BORYUNG PHARMACEUTICAL CO LTD

SUBJECT
CAPTOPRIL MANUFACTURED IN KYONGGI-DO, KOREA.

11229 A

II

11/15/1994

RELIABLE BIOPHARMACEUTICAL CORP

ETOMIDATE MANUFACTURED IN ST. LOUIS, MISSOURI

11230 I

II

11/28/1994

ECP ENICHEM POLYMERES FRANCE

RIBLENE MR10 MANUFACTURED IN DUNKIRK, FRANCE

11231 I

11/29/1994

METRICS INC

11232 I

II

12/1/1994

RHONE POULENC CHIMIE

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN GREENVILLE, NORTH CAROLINA
SALICYLIC ACID MANUFACTURED IN ROUSSILLON, FRANCE

11233 A

II

12/5/1994

DS PHARMA ANIMAL HEALTH CO LTD

ORBIFLOXACIN MANUFACTURED IN SUZUKA-SHI,MIE, JAPAN

11234 A

III

11/28/1994

BPREX HEALTHCARE OFFRANVILLE SAS

THERMO-PLASTIC MATERIALS MANUFACTURED IN DIEPPE CEDEX,FRANCE.

11235 I

III

11/15/1994

PARM PRECISION PLASTICS

PACKAGING MATERIALS MANUFACTURED IN ERIE,PA.

11236 A

II

12/8/1994

BACHEM AMERICAS INC

LEUPROLIDE ACETATE, MANUFACTURED IN TORRANCE, CALIFORNIA

11237 I

12/9/1994

LEIRAS OY

11238 I

III

12/1/1994

AMERICAN POLYMERS INC

MANUFACTURING SITE, FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN


TURKU,FINLAND.
PACKAGING MATERIALS MANUFACTURED IN OXFORD,MA.

11239 I

12/8/1994

INTERNATIONAL PROCESSING CORP

11240 A

12/7/1994

AMERICAN PHARMACEUTICAL PARTNERS INC

MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN


WINCHESTER,KY.
MANUFACTURING FACILITY IN GRAND ISLAND, NY.

11241 I

II

12/13/1994

NAGASE FINE CHEMICALS LTD

2',3',5' TRI-O-ACETYLURIDINE MANUFACTURED IN HYOGO-PREFECTURE,JAPAN.

11242 I

III

12/8/1994

AMPACET CORP

11243 I

II

11/29/1994

SHANDONG XINHUA PHARMACEUTICAL FACTORY

10761 AB/AS POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE


HAUTE,INDIANA,DERIDDER,LOUISIANA,AND MESSANCY, BELGIUM.
IBUPROFEN BP 88/USP XXII MANUFACTURED IN SHANDONG,CHINA.

11244 I

III

12/6/1994

FPC FLEXIBLE PACKAGING CORP

11245 I

II

12/13/1994

HOVIONE SOCIEDADE QUIMICA SA

PAPER/FOIL/POLYETHYLENE POUCH, FPC SPECIFICATION NUMBER 43521X MANUFACTURED


IN ONTARIO,CANADA.
IOPAMIDOL MANUFACTURED IN LOURES, PORTUGAL.

11246 I

II

12/8/1994

KNOLL AG

CARBIDOPA MANUFACTURED IN LIESTAL,SWITZERLAND.

11247 A

IV

12/12/1994

LIPOID GMBH

11248 I

II

9/5/1995

HAUSER CHEMICAL RESEARCH INC

LIPOID PC 14:/14:0,1.2-DIMYRISTOYLSN-GLYCERO-3-PHOSPHO CHOLINE MANUFACTURED IN


LUDWIGSHAFEN,FEDERAL REPUBLIC OF GERMANY.
PACLITAXEL MANUFACTURED IN BOULDER, COLORADO.

11249 A

III

12/19/1994

AL CHEM & CY US ACQUICO INC

AEROTEX 3730 RESIN MANUFACTURED IN WALLINGFORD,CONNECTICUT.

11250 I

12/15/1994

MERCIAN CORP

11251 I

12/27/1994

SKW BIOTECHNOLOGICAL CO LTD

11252 I

II

12/16/1994

JANSSEN PHARMACEUTICA NV

MANUFACTURING SITE,FACILITIES,PERSONNEL,AND GENERAL OPERATING PROCEDURES IN


SHIZUOKA, JAPNA.
MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES
MANUFACTURED IN BUDAPEST, HUNGARY.
DRAFLAZINE MANUFACTURED IN GEEL,BELGIUM.

11253 I

III

12/12/1994

RENKER GMBH AND CO KG

11254 I

III

12/19/1994

SOLVAY DRAKA INC

11255 I

III

12/19/1994

LILLY FRANCE SA

11256 I

II

12/21/1994

DERETIL SA

11257 I

II

12/21/1994

PHARM ECO LABORATORIES INC

11258 I

12/19/1994

CREATIVE PRODUCTS INC

2-NSA-FORMALDEHYDE CONDENSATE, SODIUM SALT-FRACTIONATED MANUFACTURED IN


LEXINGTON, MA
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES

11259 I

III

12/16/1994

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5320-45 BLACK MANUFACTURED IN SALISBURY, MD

11260 I

III

12/16/1994

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5311-55 BLACK MANUFACTURED IN SALISBURY, MD

BIAXIALLY ORIENTED POLYPROPYLENE 40 MICRON COATED ON THE PRETREATED SIDE


WITH A HAZY COATING MANUFACTURED IN FREIBURG, GERMANY.
SOLMED 100 WHITE FILM MANUFACTURED IN LAPORTE, IN.
QUALITY CONTROL PROCEDURES FOR IN-COMING INSPECTION OF PACKAGING
COMPONENTS USED IN FEGERSHEIM FRANCE
D (-) ALPHA PHENYLGLYCINE MANUFACTURED IN ALMERIA, SPAIN.

Page 317

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11261 I
I
11/25/1994
INALCO SPA

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
IN PISTOIA, ITALY
LACTULOSE CRYSTALS MANUFACTURED IN PISTOIA, ITALY

11262 I

II

12/25/1994

INALCO SPA

11263 I

III

12/16/1994

VARI SPA

11264 I

II

12/16/1994

FINE ORGANICS LTD

11265 I

II

12/16/1994

FINE ORGANICS LTD

11266 I

II

12/19/1994

CHIREX LTD

2-ISOPROPYL-4-(N-METHYLAMINO)METHL-THIAZOLE MANUFACTURED IN CLEVELAND,


ENGLAND
ACETOXY ACID GR 148460X MANUFACTURED IN NORTHUMBERLAND, ENGLAND.

11267 A

II

12/23/1994

LABORATORIO CHIMICO INTERNAZIONALE SPA

DICLOFENAC POTASSIUM MANUFACTURED IN SEGRATE (MILAN), ITALY

11268 I

II

12/28/1994

HAUSER CHEMICAL RESEARCH INC

MX-DTPA KEY INTERMEDIATE MANUFACTURED IN BOULDER, COLORADO.

11269 I

III

12/7/1994

SEAL LINE SPA

RUBBER STOPPERS MANUFACTURED IN MONTEGALDELLA, ITALY.

11270 I

II

12/27/1994

GUERBET CHIMIE AULNAY SA

IOXITOL MANUFACTURED IN LANESTER, FRANCE.

11271 I

12/30/1994

CIPLA LTD

11272 I

12/30/1994

ONO PHARMACEUTICAL CO LTD

11273 I

II

12/28/1994

KANEKA SINGAPORE CO PTE LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KURKUMBH, INDIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN FUKUI, JAPAN.
HPG DANE SALT MANUFACTURED IN GUL CRESCENT SINGAPORE.

11274 A

II

12/27/1994

DAIICHI FINE CHEMICAL CO LTD

DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN TOYAMA, JAPAN.

11275 I

12/29/1994

TAKASAGO INTERNATIONAL CORP

11276 I

II

12/29/1994

TAKASAGO INTERNATIONAL CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERTAING PROCEDURES


IN SHIZUOKA, JAPAN.
A-87172.0 MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN.

11277 A

III

12/20/1994

LEXINGTON RUBBER GROUP INC

PACKAGING MATERIAL MANUFACTURED IN VIENNA, OH.

11278 I

III

1/5/1995

DSM POLYMERS

STAMYLAN LD 2102TN26 MANUFACTURED IN BECK, THE NETHERLANDS.

11279 I

1/6/1995

VITRO ENVASES NORTEAMERICA

11280 A

II

1/4/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN MONTERREY, MEXICO.D.F., TLANEPANTLA AND GUADALAJARA, MEXICO.
MESALAZINE N MANUFACTURED IN SAVSKI MAROF, CROATIA

11281 I

III

3/1/1995

ECP ENICHEM POLYMERES FRANCE

FLEXIRENE CM30 MANUFACTURED IN DUNKIRK, FRANCE.

11282 I

II

1/5/1995

KANEKA CORP

KPM-1648 MANUFACTURED IN HYOGO, JAPAN

11283 I

III

12/23/1994

CARCANO ANTONIO S.P.A

ALUMINIUM FOIL FOR BLISTERS COVER MANUFACTURED IN MANDELLO DEL LARIO-CO-ITALY

11284 I

II

1/3/1995

ADITHYA ALKALOIDS LTD

11285 I

II

1/3/1995

ADITHYA ALKALOIDS LTD

VINBLASTINE SULFATE MANUFACTURED IN MEHBOOB NAGAR DISTRICT NEAR HYDERABAD,


INDIA.
VINCRISTINE SULFATE MANUFACTURED IN MEHBOOB NAGAR NEAR HYDERABAD, INDIA.

11286 I

1/3/1995

ADITHYA ALKALOIDS LTD

11287 I

II

12/29/1994

DOW CHEMICAL CO

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MAHABOONAGAR DISTRICT NEAR HYDERABAD,INDIA.
VERSENE NA CHELAING AGENT MANUFACTURED IN FREEPORT, TX

11288 I

III

12/20/1994

CEBAL ITALIANA

ALUMINIUM TUBES MANUFACTURED IN CIVIDATE AL PIANO BG AND TORTONA AL, ITALY

11289 A

II

10/7/1994

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

PREDNISONE MANUFACTURED IN TIANJIN, CHINA.

11290 A

II

1/11/1995

JIANGSU HENGRUI MEDICINE CO LTD

IFOSFAMIDE USP MANUFACTURED IN LIANYUNGANG CITY, PEOPLE'S REPUBLIC OF CHINA.

11291 A

II

1/9/1995

LUPIN LTD

RIFAMYCIN-S (BULK SUBSTANCE) AS MANUFACTURED IN TARAPUR, MAHARASHTRA, INDIA.

11292 I

IV

1/5/1995

EASTMAN CHEMICAL CO

TRIACETIN (PLASTICIZER) USP MANUFACTURED IN KINGSPORT, TENNESSEE.

11293 I

III

1/6/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN TOP SEAL MANUFACTURED IN LINZ,AUSTRIA.

AEROSOL VALVES, METERED DOSE AEROSOL VALVES, ORAL ADAPTERS-MOUTHPIECE,


MANUFACTURED IN OLGINATE(LC) ITALY
LO287 (CRUDE LOTEPREDNOL ETABONATE) MANUFACTURED IN CLEVELAND, ENGLAND

Page 318

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11294 I
III
1/6/1995
PCD POLYMERE GMBH

SUBJECT
DAPLEN KF 201 T 50 PHARM MANUFACTURED IN LINZ, AUSTRIA.

11295 I

III

12/21/1994

BOREALIS AG

POLYPROPYLENE GRADE HF320FBP MANUFACTURED IN LINZ, AUSTRIA.

11296 A

II

1/9/1995

KAKEN PHARMACEUTICAL CO LTD

11297 I

1/9/1995

KAKEN PHARMACEUTICAL CO LTD

11298 I

IV

1/6/1995

UNION CARBIDE CORPORATION

KP-363 BUTENEAFINE HYDROCHLORIDE MANUFACTURED IN SHIZUOKA PREFECTURE,


JAPAN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SHIZUOKA PREFECTURE, JAPAN.
SENTRY PLUS POLYVINYL ACETATE MANUFACTURED IN SOUTH CAROLINA, WEST VIRGINIA.

11299 I

1/9/1995

LUPIN CHEMICALS LTD

11300 A

II

1/16/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TARAPUR, INDIA.
TERAZOSIN HYDROCHLORIDE MANUFACTURED IN MILANO, ITALY.

11301 I

II

12/7/1994

SYNTHELABO PHARMACIE

L-LYSINE AQUEOUS SOLUTION MANUFACTURED IN AMILLY, FRANCE.

11302 I

II

1/16/1995

CHIRON MIMOTOPES PEPTIDE SYSTEMS

CT-112 MANUFACTURED IN SAN DIEGO, CALIFORNIA.

11303 I

II

12/30/1994

GUANGDONG PHARMACEUTICAL FACTORY

ECONAZOLE NITRATE MANUFACTURED IN FUNGCUN DADAO, GUANGZHOUG, CHINA.

11304 I

IV

1/12/1995

F AND C WILD FLAVORS INC

ARTIFICIAL PUNCH FLAVOR #FAAF896 MANUFACTURED IN CINCINNATI, OHIO.

11305 I

1/17/1995

SAMHWA LUBE OIL CO LTD

11306 I

III

1/19/1995

WINPAK TECHNOLOGIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KANGWON PROVINCE, SOUTH KOREA.
VAGISTA POUCHES MANUFACTURED IN TORONTO, ONTARIO.

11307 A

12/7/1994

APP PHARMACEUTICALS LLC

TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK.

11308 A

II

1/18/1995

KATWIJK CHEMIE BV

OXAPROZIN MANUFACTRUED IN KATWIJK AAN ZEE, THE NETHERLANDS.

11309 I

1/11/1995

BRECON PHARMACEUTICALS LTD

11310 I

III

1/20/1995

HENKEL CORP

MANUFACTURING SITE, FACILITIES, PERESONNEL, AND GENERAL OPERATING PROCEDURES


IN HEREFORD, ENGLAND.
TPX 16-159 MANUFACTURED IN KANKAKEE, ILLINOIS.

11311 I

IV

1/25/1995

GENZYME PHARMACEUTICALS LLC

N-(CARBAMONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3PHOSPHOETHANOLAMINE SODIUM SALT (MPEG-DSPE) AS MANUFACTURED IN LIESTAL,


SWITZERLAND.

11312 I

III

1/9/1995

SONOCO PRODUCTS CO

SPC-TM-506 MANUFACTURED IN DAYTON, NEW JERSEY.

11313 I

III

1/20/1995

RESCO COLOURS INC

11314 A

II

12/31/1994

SAFC BIOSCIENCES INC

O6EHD-895 (AMBER CONCENTRATE) MANUFACTURED IN ONTARIO, CANADA AND


CONVENTRY, RHODE ISLAND.
EX-CELL 405 WITH L-GLUTAMINE MANUFACTURED IN DENVER, PENNSYLVANIA.

11315 A

II

1/26/1995

FERMION OY

FLUOXETINE HYDROCHLORIDE MANUFACTURED IN HANKO, FINLAND.

11316 I

1/25/1995

FUJI PHOTO FILM CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

11317 I

II

1/25/1995

FUJI PHOTO FILM CO LTD

FP-21399 MANUFACTURED IN KANAGAWA PREFECTURE, JAPAN.

11318 I

1/13/1995

SUPERFOS PACKAGING A/S

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

11319 A

II

1/20/1995

KYOWA HAKKO KIRIN CO LTD

UCN-01 (KW-2401) BULK SUBSTANCE MANUFACTURED IN TOKYO, JAPAN

11320 I

IV

1/20/1995

DAVID MICHAEL AND CO INC

ARTIFICIAL CHERRY FLAVOR 13233 MANUFACTURED IN PHILADEPHIA, PA

11321 A

III

1/15/1995

STEVANATO GROUP SPA

11322 A

III

2/2/1995

ALUBERG SPA

11323 I

1/31/1995

SM ORGANICS PRIVATE LTD

GLASSWARE CONTAINERS FOR PHARMACETUICAL USAGE MANUFACTURED IN PIOMBINO


DESE, ITALY
LACQUERED ALUMINUM FOIL DRUG PACKAGING MATERIALS MANUFACTURED IN BERGAMO,
ITALY.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN HARYANA, INDIA.

Page 319

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11324 I
I
1/26/1995
CALBIOCHEM NOVABIOCHEM AG
11325 A

III

1/24/1995

CODING PRODUCTS

SUBJECT
MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN LAUFELFINGEN, SWITZERLAND.
SV-11618, A HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MI.

11326 A

III

1/24/1995

CODING PRODUCTS

SV-11521 A HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MI.

11327 I

II

2/6/1995

JANSSEN PHARMACEUTICA NV

SUFENTANIL CITRATE MANUFACTURED IN GEEL, BELGIUM.

11328 I

II

2/7/1995

SP PHARMACEUTICALS LLC

11329 I

III

1/31/1995

CREST FLEXIBLE PACKAGING LTD

11330 I

III

1/27/1995

PCD POLYMERE GES MBH

9-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION AND DILUENT MANUFACTURED IN


ALBUQUERQUE, NEW MEXICO.
PACKAGING MATERIALS FOR MEDICAL PACKAGING (PET/FOIL/PE) MANUFACTURED IN KENT,
ENGLAND.
POLYPROPYLENE GRADE DAPLEN MSC 3006 A MANUFACTURED IN LINZ, AUSTRIA.

11331 I

II

1/16/1995

BK LADENBURG GMBH

11332 I

III

1/27/1995

PCD POLYMERE GES MBH

PHOSKADENT SF-SODIUM FLUORIDE MANUFACTURED BY BAYER AG IN LEVERKUSENBAYERWERK, GERMANY.


POLYPROPYLENE GRADE DAPLEN CHC 3007 MANUFACTURED IN LINZ, AUSTRIA.

11333 I

III

1/27/1995

PCD POLYMERE GES MBH

POLYPROPLYENE GRADE DAPLEN COD 9007 MANUFACTURED IN LINZ, AUSTRIA.

11334 I

III

1/27/1995

PCD POLYMERE GES MBH

POLYPROPYLENE GRADE DAPLEN MOC 9006 A MANUFACTURED IN LINZ, AUSTRIA.

11335 I

II

2/7/1995

PHARMACIA AND UPJOHN INC

9-AMINOCAMPTOTHECIN ACTIVE DRUG SUBSTANCE MANUFACTURED IN MILAN, ITALY.

11336 I

II

12/2/1996

ANTIBIOTIC CO

LOVASTATIN, MANUFACTURED IN RAZGARD, BULGARIA

11337 I

II

2/3/1995

JANSSEN PHARMACEUTICA NV

ALFENTANIL HYDROCHLORIDE MANUFACTURED IN GEEL, BELGIUM.

11338 A

II

2/10/1995

DELTA SYNTHETIC CO LTD

LIDOCAINE HYDROCHLORIDE MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

11339 A

II

2/10/1995

DELTA SYNTHETIC CO LTD

LIDOCAINE MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

11340 A

II

2/9/1995

SAFC INC

19-NOR-1A, 25-DIHYDROXY VITAMIN D2 MANUFACTURED IN MADISON WI

11341 I

2/9/1995

TETRIONICS INC

11342 A

2/13/1995

FRESENIUS KABI USA LLC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MADISON, WI.
MANUFACTURING FACILITY IN MELROSE PARK, IL.

11343 I

2/14/1995

ELF ATOCHEM

11344 I

2/14/1995

ELF ATOCHEM

11345 A

II

2/10/1995

MALLINCKRODT INC

11346 I

2/13/1995

ARAB MEDICAL CONTAINERS CO LTD

11347 I

2/10/1995

HEUMANN PHARMA GMBH AND CO

11348 I

II

2/13/1995

PROMETIC BIOSCIENCES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN SAHAB, JORDAN.
MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES
IN FEUCHT, GERMANY.
MIMETIC GREEN 1 A6XL MANUFACTURED IN ISLE OF MAN, GREAT BRITAIN.

11349 I

II

2/14/1995

BRISTOL MYERS SQUIBB COMPANY

TRIAMCINOLONE DIACETATE, STERILE MANUFACTURED IN HUMACAO, PUERTO RICO.

11350 I

III

2/10/1995

AMPACET CORP

11351 A

II

2/17/1995

CAMBREX PROFARMACO MILANO SRL

11898 WHITE POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA,


DERIDDER, LOUISIANA AND AMPACET EUROPE S.A. IN MESSANCY, BELGIUM.
CLONAZEPAM MANUFACTURED IN MILANO, ITALY.

11352 I

II

2/20/1995

11353 I

III

2/21/1995

LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL ACYCLOVIR ACTIVE SUBSTANCE MANUFACTURED IN KOLODVORSKA, SLOVENIA.
CO
WATSON LABORATORIES INC
PACKAGING MATERIALS AS MANFACTURED IN COPIAGUE, NY.

11354 I

2/15/1995

SA ALCON COUVREUR NV

11355 I

2/22/1995

RTI INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ALONSOTEGUI, SPAIN.
MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN PIERRE-BENITE, FRANCE.
MEPERIDINE HYDROCHLORIDE, USP MANUFACTURED IN ST. LOUIS, MISSOURI.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PUURS, BELGIUM.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SALEM, NEW JERSEY.

Page 320

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11356 A
II
2/20/1995
RESOLUTION CHEMICALS LIMITED

SUBJECT
SELEGILINE HYDROCHLORIDE MANUFACTURED IN HERTFORSHIRE, UNITED KINGDOM.

11357 I

III

2/13/1995

SOLVAY AND CIE SA

HIGH DENSITY POLYETHYNE ELTEX B3002/33 MANUFACTURED IN SARRALBE, FRANCE.

11358 I

2/23/1995

BIO INTERMEDIAIR BV

11359 A

II

2/20/1995

AMSA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GRONINGEN, THE NETHERLANDS.
ETODOLAC AS MANUFACTURED IN COMO, ITALY.

11360 I

III

2/22/1995

ELM PLASTIC GMBH

MEASURING DISHES MANUFCTURED IN DUDELDORF, GEWERBEGEBIET.

11361 I

III

2/9/1995

SENSORMATIC ELECTRONICS CORP

OUTLOOK FILM #71WX38 MANUFACTURED BY OUTLOOK GRAPHICS IN NEENAH, WISCONSIN.

11362 I

III

2/22/1995

TUREX INC

LD-640N MANUFACTURED IN NASONVILLE, RHODE ISLAND

11363 I

II

2/27/1995

BIOSEPRA INC

PROTEIN A-HYPER D. MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE.

11364 A

IV

3/2/1995

SYMRISE INC

11365 I

II

2/23/1995

HOSPIRA INC

MICROSEAL NATURAL AND ARTIFICIAL ORANGE FLAVOR 9/79J839 MANUFACTURED IN


TOTOWA, NEW JERSEY
H324/38 EMULSION FOR INFUSION MANUFACTURED IN CLAYTON, NORTH CAROLINA

11366 I

IV

2/28/1995

KYOWA HAKKO KOGYO CO LTD

SODIUM HYALURONATE MANUFACTURED IN UBESHI YAMAGUCHI-KEN JAPAN

11367 I

II

3/1/1995

POWDERSIZE INC

CONTRACT MICRONIZATION SERVICES LOCATED IN QUAKERTOWN, PA.

11368 A

III

2/24/1995

AMPACET CORP

11369 A

III

2/15/1995

PLASTIQUES MICRON INC

110080 WHITE POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA,


DERIDDER, LOUISIANA, OR AMPACET EUROPE, S.A. MESSANCY, BELGIUM.
PLASTIC CONTAINERS MANUFACTURED IN QUEBEC CANADA

11370 I

IV

2/28/1995

J MANHEIMER INC

11371 I

3/9/1995

TORPHARM INC

11372 I

3/9/1995

PHARMACO LIFE SCIENCE RESEARCH

11373 A

II

3/6/1995

NOVACYL SAS

ASPIRIN MANUFACTURED IN SAINT-FONS, FRANCE

11374 I

II

3/3/1995

OMNICHEM SA

BOC CORE SUCCINATE A88820.605 MANUFACTURED IN WETTEN, BELGIUM

11375 A

IV

3/9/1995

WACKER CHEMIE AG

GAMMA CYCLODEXTRIN MANUFACTURED IN MUNCHEN, GERMANY

11376 I

3/10/1995

BUNDER GLAS GMBH

11377 I

3/12/1995

FERMIC SA DE CV

11378 A

II

3/16/1995

CAMBRIDGE ISOTOPE LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN BUNDE, GERMANY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN MEXICO, D.F., MEXICO.
C-13 UREA MANUFACTURED IN ANDOOVER, MASSACHUSETTS.

11379 A

II

3/13/1995

DIPHARMA FRANCIS SRL

URSODEOXYCHOLIC ACID MANUFACTURED IN CARONNO PERTUSELLA (VA), ITALY

11380 I

3/7/1995

DIXIE CHEMICAL CO INC

11381 I

3/15/1995

SS ORGANICS LTD

11382 I

III

3/6/1995

SOLVIN S.A.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN PASADENA, TEXAS.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SADASIVAPET MANDIA, INDIA.
DIOFAN DS 2319 X MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY.

11383 A

III

3/6/1995

SOLVIN SA

DIOFAN A-736 MANUFACTURED IN TAVAUX, FRANCE

11384 A

III

3/6/1995

SOLVIN SA

DIOFAN A-716 MANUFACTURED IN TAVAUX, FRANCE

11385 I

II

3/15/1995

JIANGSU TIANQING PHARMACEUTICAL FACTORY

11386 I

IV

3/8/1995

J MANHEIMER INC

FOSCARNET SODIUM MANUFACTURED IN XINU, LIANYUNGANG CITY, PEOPLE'S REPUBLIC OF


CHINA.
NATURAL ORANGE WONF 608352 MANUFACTURED IN LONG ISLAND CITY, NEW YORK.

NATURAL AND ARTIFICIAL GRAPE FLAVOR 522463 MANUFACTURED IN LONG ISLAND CITY,
NEW YORK
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN ONTARIO, CANADA.
METHOD VALIDATION, GC/MS ANALYSIS OF TRINITROGLYCERIN, 1,2, DINITROGLYCERIN AND
1,3 DINITROGLYCERIN IN HUMAN PLASMA, METHOD MS42.1 MANUFACTURED IN RICHMOND,
VIRGINIA.

Page 321

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11387 A
II
3/15/1995
APOTEX PHARMACHEM INC

SUBJECT
WARFARIN SODIUM MANUFACTURED IN ONTARIO, CANADA.

11388 I

3/15/1995

MW ENCAP LTD

11389 A

II

3/17/1995

SIFAVITOR SRL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN WEST LOTHIAN, UNITED KINGDOM.
CICLOPIROX OLAMINE MANUFACTURED IN MILANO, ITALY.

11390 I

II

3/15/1995

JANSSEN PHARMACEUTICA NV

INTERMEDIATE T001310 MANUFACTURED IN GEEL, BELGIUM

11391 I

II

3/15/1995

BACHEM FEINCHEMIKALIEN AG

TEMURTIDE MANUFACTURED IN BUBENDORF, SWITZERLAND.

11392 A

III

2/1/1995

NUSSBAUM KESSWIL AG

11393 I

II

3/15/1995

BOEHRINGER INGELHEIM PHARMA KG

COLLAPSIBLE ALUMINUM TUBES AND PLASTIC CLOSURES MANUFACTURED IN KESSWIL,


SWITZERLAND.
CROTAMITON MANUFACTURED IN INGELHEIM/RHEIN.

11394 I

II

3/22/1995

RANBAXY LABORATORIES LTD

11395 A

II

3/24/1995

TAKEDA PHARMACEUTICAL CO LTD

7-AMINO-3-CHLORO-3-CEPHEM-4-CARBONXYLIC ACID-DRUG SUBSTANCE INTERMEDIATE


MANUFACTURED IN PUNJAB, INDIA.
TAP-144-SR (C-LINE) MANUFACTURED IN OSAKA, JAPAN.

11396 I

III

1/16/1995

MYLAN TECHNOLOGIES INC

2229 PEELABLE RELEASE LINER MANUFACTURED IN ST. ALBANS, VERMONT.

11397 A

III

3/20/1995

NASHUA CORP

BM-4 (LABEL ADHESIVE) MANUFACTURED IN MERIMACK, NEW HAMPSHIRE.

11398 A

IV

3/22/1995

AMCOL HEALTH AND BEAUTY SOLUTIONS INC

11399 I

II

3/13/1995

PURITAN BENNETT CORP

METHYL METHACRYLATE/ETHYLENE GLYCOL DIMETHACRYLATE COPOLYMER


MICROSPONGE (APS PRODUCT CODE: E101-04) MANUFACTURED IN LAFAYETTE, LA
NITRIC OXIDE IN NITROGEN GAS MIXTURE MANUFACTURED IN OVERLAND PARK, KANSAS.

11400 I

3/24/1995

SMITHKLINE BEECHAM PHARMACEUTICALS

11401 I

3/23/1995

UPJOHN FARMOQUIMICA SA

11402 A

III

3/23/1995

BAYER MATERIALSCIENCE LLC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CUERNAVACA, MEXICO.
MANUFACTURING SITE, FACILITIES, PERSONNNEL, AND GENERAL OPERATING PROCEDURES
IN MADRID, SPAIN.
MAKROLON 2658-1112 MANUFACTURED IN BAYTOWN, TEXAS.

11403 A

3/27/1995

APP PHARMACEUTICALS LLC

TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS.

11404 A

III

3/15/1995

MYLAN TECHNOLOGIES INC

MEDIFLEX 1200 and MEDIFLEX 1501 MANUFACTURED IN ST. ALBANS, VERMONT.

11405 A

II

3/29/1995

PHARMACEUTICAL WORKS POLPHARMA SA

ETODOLAC MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

11406 A

II

3/29/1995

PORTON FINE CHEMICALS LTD

PROPOFOL MANUFCTURED IN SCHAFFHAUSEN, SWITZERLAND.

11407 I

II

3/28/1995

AVANTI POLAR LIPIDS INC

11408 I

3/24/1995

SAUREFABRIK SCHWEIZERHALL

11409 I

II

3/29/1995

DSM ANDENO BV

11410 I

3/29/1995

DSM ANDENO GMBH

11411 I

II

3/28/1995

11412 I

3/28/1995

ZENECA SPECIALITIES SUB NOVACOTE


INTERNATIONAL
PHARMACO LIFE SCIENCE RESEARCH

1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MANUFACTURED IN ALABASTER,


ALABAMA.
MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES I
SCHWEIZERHALLE, SWITZERLAND.
L-VALINE-N-(PHENOXYCARBONYL)-METHYLESTER (VAPOX-M) MANUFACTURED IN VENLO,
THE NETHERLANDS.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN REGENSBURG, GERMANY.
HYDROXYSULPHONE FC4010 MANUFACTURED IN MANCHESTER, UNITED KINGDOM.

11413 I

II

3/28/1995

SANOFI AVENTIS US INC

MDL 101,731 MANUFACTURED IN MIDLAND, MICHIGAN.

11414 I

IV

3/13/1995

ARTIFICIAL RASPBERRY DYO4447 MANUFACTURED IN OWINGS MILLS, MARYLAND.

11415 I

IV

3/22/1995

11416 I

III

3/24/1995

QUEST INTERNATIONAL FLAVORS AND FOOD


INGREDIENTS CO
QUEST INTERNATIONAL FLAVORS AND FOOD
INGREDIENTS CO
GERRESHEIMER BUNDE GMBH

METHOD GC32,GC ANALYSIS OF SELEGILINE IN HUMAN PLASMA AND METHOD GC33


REVISION 1, GC ANALYSIS OF AMPHETAMINE METHAPHETAMINE AND DESMETHYSELEGILINE
IN HUMAN PLASMA MANUFACTURED IN RICHMOND, VIRGINIA.

ARTIFICIAL STRAWBERRY FLAVOR DY04359 MANUFACTURED IN OWINGS MILLS, MARYLAND.


PRIMARY PACKAGING MATERIAL FOR PHARMACEUTICAL PRODUCTS MADE FROM TUBULAR
GLASS MANUFACTURED IN BUNDE, FEDERAL REPUBLIC OF GERMANY.

Page 322

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11417 I
V
4/3/1995
KOLMI SET OY

SUBJECT
GAMMA STERILIZATION AS CARRIED OUT BY MOLNLYCKE HEALTH CARE OY IN ILOMANTSI,
FINLAND
ORANGE CONCENTRATE (90PPP-158) MANUFACTURED IN ONTARIO, CANADA AND
COVENTRY, RHODE ISLAND.
PHENYLOXYCARBONYL-(L)-VALINE METHYL ESTER MANUFACTURED IN CHASSE-SURRHONE, FRANCE.
1,4-BIS[5-(2-IMIDAZOLINYL)-2-BENZIMIDAZOLYL]BUTANE TETRAHYDROCHLORIDE
MANUFACTURED IN LEXINGTON, MASSACHUSETTS.
NALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310 MANUFACTURED IN ST.
LOUIS, MONTANA
2,6-DIISOPROPYPHENOL(DIP) MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA.

11418 I

III

3/27/1995

RESCO COLOURS INC

11419 I

II

3/30/1995

FINORGA SA

11420 I

II

3/31/1995

PHARM ECO LABORATORIES INC

11421 A

II

3/31/1995

MALLINCKRODT INC

11422 A

II

4/4/1995

SI GROUP

11423 I

III

3/27/1995

RESCO COLOURS INC

11424 I

III

3/27/1995

RESCO COLOURS INC

11425 I

III

3/27/1995

RESCO COLOURS INC

11426 A

II

4/3/1995

PROCOS SPA

GREEN CONCENTRATE (50PPP-488) MANUFACTURED IN ONTARIO, CANADA AND


CONVENTRY, RHODE ISLAND.
YELLOW CONCENTRATE (30PPP-260)MANUFACTURED IN ONTARIO, CANADA AND
CONVENTRY, RHODE ISLAND.
ORANGE CONCENTRATE (90PPP-160)MANUFACTURED IN ONTARIO, CANADA AND
CONVENTRY, RHODE ISLAND
PROPAFENONE HYDROCHLORIDE MANUFACTURED IN CAMERI-NOVARA, ITALY.

11427 A

III

3/28/1995

NASHUA CORP

PC-79 HEAT SEAL ADHESIVE MANUFACTURED IN MERRIMACK, NEW HAMPSHIRE.

11428 I

4/3/1995

JANSSEN PHARMACEUTICA NV

11429 I

II

4/7/1995

BIOSEPRA INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN OLEN, BELGIUM.
LYSINE-HYPER D MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE.

11430 I

IV

4/6/1995

DRAGOCO GERBERDING AND CO AG

BLOOD ORANGE FLAVORING 9/028658 MANUFACTURED IN HOLZMINDEN, GERMANY.

11431 A

III

3/31/1995

MONDI KORNEUBURG GMBH

11432 I

II

4/7/1995

SANKYO CO LTD

ALUMINUM LAMINATE & ALUMINUM LAMINATE POUCH MANUFACTURED IN KORNEUBURG,


AUSTRIA
CS-866 DRUG PRODUCT MANUFACTURED IN TOKYO, JAPAN.

11433 I

II

4/7/1995

SANKYO CO LTD

CS-866 DRUG SUBSTANCE MANUFACTURED IN TOKYO, JAPAN.

11434 I

III

4/10/1995

DUOPAC PACKAGING INC

ROUND AND OBLONG HDPE BOTTLES MANUFACTURED IN LAVAL, CANADA

11435 A

II

4/5/1995

NTP RADIOISOTOPES LTD

MOLYBDENUM-99 (FISSION) MANUFACTURED IN PRETORIA, REPUBLIC OF SOUTH AFRICA.

11436 I

II

4/5/1995

GRANULES INDIA LTD

11437 I

4/6/1995

YONEZAWA HAMARI CHEMICALS CO LTD

11438 A

II

4/11/1995

JANSSEN PHARMACEUTICA NV

COMPRESSO-90-P (ACETAMINOPHEN GRANULES 90%) MANUFACTURED IN HYDERABAD,


INDIA
MANUFACTURING SITE, FACILITY PERSONNEL AND GENERAL OPERATING PROCEDURES IN
YAMAGATA, JAPAN.
RISPERIDONE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM

11439 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN KFC 2004 SB MANUFACTURED IN LINZ, AUSTRIA.

11440 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN KFC 2208 SB MANUFACTURED IN LINZ, AUSTRIA.

11441 I

III

4/11/1995

BOREALIS AG

POLYPROPYLEN GRADE DAPLEN KFC 2104 SB MANUFACTURED IN LINZ, AUSTRIA.

11442 I

III

4/11/1995

BOREALIS AB

POLYPROPYLENE GRADE DAPLEN USC 1012A MANUFACTURED IN LINZ, AUSTRIA.

11443 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN DH 5973 MANUFACTURED IN LINZ, AUSTRIA.

11444 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN CF 501 MANUFACTURED IN LINZ, AUSTRIA.

11445 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN PT 551 S MANUFACTURED IN LINZ, AUSTRIA.

11446 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN KFC 2008 MANUFACTURED IN LINZ, AUSTRIA.

11447 I

III

4/11/1995

PCD POLYMERE GMBH

POLYPROPYLENE GRADE DAPLEN DH 5273 MANUFACTURED IN LINZ, AUSTRIA.

11448 I

II

4/11/1995

SOLVAY DUPHAR BV

LACTULOSE CONCENTRATE MANUFACTURED IN WEESP, THE NETHERLANDS.

Page 323

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11449 A
II
4/17/1995
CIPLA LTD

SUBJECT
FELODIPINE MANUFACTURED IN CIPLA-VIKHROLI, BOMBAY, INDIA.

11450 I

II

4/14/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

AMPICILLIN TRIHYDRATE BPC MANUFACTURED IN BALTIMORE, MARYLAND.

11451 I

II

4/14/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

AMOXICILLIN TRIHYDRATE BPC MANUFACTURED IN BALTIMORE, MARYLAND.

11452 I

II

3/24/1995

KYOWA HAKKO KOGYO CO LTD

DX-52-1 BULK MATERIAL MANUFACTURED IN TOKYO, JAPAN.

11453 I

III

3/20/1995

11454 A

IV

4/17/1995

KNIGHT ENGINEERING AND PLASTICS DIV


COURTAULDS PACKAGING
BAYER SCHERING PHARMA AG

PLASTIC CONTAINERS MANUFACTURED IN ARLINGTON HEIGHTS, ILLINOIS AND


WOODSTOCK, ILLINOIS.
PDMS 373 TW MANUFACTURED IN TURKU, FINLAND.

11455 A

II

4/17/1995

ALDRICH CHEMICAL CO ISOTEC FACILITY

UREA-13 C MANUFACTURED IN MIAMISBURG, OHIO.

11456 I

II

4/17/1995

SAFC BIOSCIENCES INC

67210 MANUFACTURED IN DENVER, PENNSYLVANIA.

11457 I

II

4/17/1995

SAFC BIOSCIENCES INC

62180 MANUFACTURED IN DENVER, PENNSYLVANIA.

11458 I

II

4/17/1995

JRH BIOSCIENCES

11459 I

III

4/11/1995

PCD POLYMERE GMBH

PHOSPHATE BUFFERED SALINE (PRODUCT 62137) MANUFACTURED IN DENVER,


PENNSYLVANIA.
POLYPROPYLENE GRADE DAPLEN KFC 2004 MANUFACTURED IN LINZ, AUSTRIA.

11460 I

III

4/10/1995

ECP ENICHEM POLYMERES FRANCE

RIBLENE FF20 MANUFACTURED IN DUNKIRK, FRANCE.

11461 I

3/23/1995

SCIPAC LTD

11462 I

IV

4/21/1995

ROQUETTE FRERES SA

MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES


IN SITTINGBOURNE, KENT.
MALTODEXTRIN FOR PERITONEAL DIALYSIS MANUFACTURED IN LESTREM, FRANCE.

11463 A

II

4/12/1995

NOF CORP

11464 A

II

4/12/1995

NOF CORP

DIMYRISTOYLPHOSPHATIDYLGLYCEROL AMMONIUM/SODIUM SALT MANUFACTURED IN


HYOGO, JAPAN.
DIMYRISTOYL PHOSPHATIDYL CHOLINE MANUFACTURED IN HYOGO, JAPAN.

11465 I

II

4/19/1995

ARZNEIMITTELWERK DRESDEN GMBH

CHLORHEXIDINE (BASE) MANUFACTURED IN RADEBEUL, GERMANY.

11466 I

III

12/13/1995

KERPLAS SNC

11467 A

III

1/24/1995

DANAPAK FLEXIBLES

PLASTIC BOTTLE 15, 20, 30, 60, 100 AND 160ML PEHD WHITE MANUFACTURED IN DIEPPE,
FRANCE.
COMPOUND PACKAGING MATERIAL 3RCUXXXX MANUFACTURED IN ODENSE S. DENMARK.

11468 I

IV

4/20/1995

BRISTOL MYERS SQUIBB COMPANY

11469 I

II

4/12/1995

MEDICHEM SA

PLASTIBASE 10W (PLASTICIZED HYDROCARBON GEL) MANUFACTURED IN HUMACAO,


PUERTO, RICO.
BUSPIRONE HYDROCHLORIDE MANUFACTURED IN CELRA (GERONA) SPAIN

11470 I

III

4/19/1995

COLORS FOR PLASTICS

ACPP-40581 MANUFACTURED IN HUNTLEY, ILLINOIS.

11471 I

III

4/19/1995

COLORS FOR PLASTICS

ACPP-10397 MANUFACTURED IN HUNTLEY, ILLINOIS.

11472 I

II

4/19/1995

DSM ANDENO GMBH

11473 I

4/5/1995

KLINGE PHARMACAL GMBH

11474 I

II

4/26/1995

11475 I

III

4/25/1995

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
GRUPPO MOSSI AND GHISOLFI

L-VALINE, N-(PHENOXYCARBONYL)-METHYLESTER (VAPOX-M) MANUFACTURED IN


REGENSBURG, GERMANY.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
FOR ZOTEPINE SUGAR-COATED TABLETS IN MUNCHEN, GERMANY.
PROPOFOL MANUFACTURED IN NORTH CHICAGO, ILLINOIS

11476 I

4/20/1995

PERLOS OYJ

11477 I

III

4/25/1995

REXAM CLOSURE SYSTEMS INC

11478 I

II

4/27/1995

SELOC AG

11479 I

4/26/1995

JANSSEN CILAG SPA

POLYETHYLENE NAPHTHALATE RESINS MANUFACTURED IN APPLE GROVE, WEST VIRGINIA.


MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN
LEHMO, FINLAND.
PLASTIC LINING MATERIALS MANUFACTURED BY OWNES-BROCKWAY SPECIALTY PRODUCTS
IN ERIE, PA.
OXYBUTYNIN BASE MANUFACTURED A SIFA LTD. IN CO. CLARE IRELAND AND SICOR S.A. IN
LIMAY, FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BORGO SAN MICHELE, ITALY

Page 324

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11480 I
II
4/28/1995
BOEHRINGER INGELHEIM CHEMICALS INC

SUBJECT
RANITIDINE HYDROCHLORIDE USP MANUFACTURED IN PETERSBURG, VIRGINIA.

11481 I

II

4/28/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

AMOXICILLIN TRIHYDRATE CAPSULES MANUFACTURED IN BALTIMORE, MARYLAND.

11482 I

II

4/28/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

11483 I

II

4/28/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

11484 I

II

4/28/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

AMPICILLIN TRIHYDRATE FOR ORAL SUSPENSION MANUFACTURED IN BALTIMORE,


MARYLAND.
AMOXICILLIN TRIHYDRATE FOR ORAL SUSPENSION MANUFACTURED IN BALTIMORE,
MARYLAND.
AMPICILLIN TRIHYDRATE CAPSULES MANUFACTURED IN BALTIMORE, MARYLAND.

11485 A

III

4/26/1995

SELIG SEALING PRODUCTS INC

BOTTLE CAP LINING MATERIALS MANUFACTURED IN AURORA, ONTARIO, CANADA.

11486 I

II

5/12/1995

NAGASE FINE CHEMICALS LTD

S-KETOPROFEN MANUFACTURED IN HYOGO , JAPAN.

11487 I

II

5/1/1995

ASTRA MERCK INC

TCV-116 MANUFACTURED IN OSAKA, JAPAN.

11488 I

IV

5/1/1995

ANDREA AROMATICS INC

FRAGRANCE FORMULATION L-93-12514 MANUFACTURED IN TRENTON, NEW JERSEY.

11489 I

5/5/1995

SOREBIO

11490 I

4/25/1995

FLUKA CHEMICAL CO

11491 I

IV

2/27/1995

DAVID MICHAEL AND CO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MARITILLAC, FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BUCHS, SWITZERLAND.
NATURAL AND ARTIFICIAL ORANGE FLAVOR #12728 MANUFACTURED IN PHILADEPHIA, PA.

11492 I

II

4/26/1995

SIGMA CHEMICAL CO

CHOLESTREROL, PRODUCT NUMBER W 5179-2 MANUFACTURED IN ST. LOUIS, MISSOURI.

11493 I

5/3/1995

INDUSTRIE CHIMIQUE MULHOUSE DORNACH

11494 I

II

5/8/1995

BIOSEPRA INC

11495 A

IV

4/28/1995

MANTROSE HAEUSER CO INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MULHOUSE, FRANCE.
OCTYL AT SPHERODEX M MANUFACTURED AT BIOSEPRA SA, VILLENEUVE-LA-GARENNE,
FRANCE.
25% AMMONIATED SHELLAC SOLUTION MANUFACTURED IN ATTLEBORO, MASSACHUSETTS.

11496 I

IV

5/5/1995

FLAVORS NORTH AMERICA INC

11497 I

III

5/1/1995

CREST PLASTICS

11498 A

II

5/8/1995

SERONO INC

11499 I

II

5/11/1995

ASSIA CHEMICAL INDUSTRIES LTD

11500 I

III

4/10/1995

ROWO COATING GMBH FUR BESCHICHTUNG

11501 A

II

5/11/1995

PIERRE FABRE MEDICAMENT

POLYESTER FILM 15 MICRON ONE SIDE ALUMINIZED) MANUFACTURED IN HERBOLZHEIM,


GERMANY.
MILNACIPRAN HYDROCHLORIDE MANUFACTURED IN GAILLAC, FRANCE.

11502 A

II

5/12/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

LOVASTATIN USP BULK MANUFACTURED I DEBRECEN, HUNGARY.

11503 A

III

5/8/1995

TICONA GMBH

KEMATAL ACETAL COPOLYMER MANUFACTURED IN KELSTERBACH, GERMANY.

11504 I

II

5/11/1995

DOCTOR REDDYS LABORATORIES LTD

DILTIAZEM HYDROCHLORIDE MANUFACTURED IN ANDHRA PRADESH, INDIA.

11505 I

II

5/12/1995

LEO PHARMACEUTICAL PRODUCTS LTD

EB 1089 EC-CAPSULES DRUG PRODUCT MANUFACTURED IN BALLERUP, DENMARK.

11506 I

III

5/9/1995

POLYMER COLOR INC

WLC-12486, 25/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS.

11507 I

II

5/15/1995

MAPRIMED SA

KETOROLAC TROMETHAMINE MANUFACTURED IN BUENOS AIRES, ARGENTINA.

11508 I

II

5/12/1995

LYNX THERAPEUTICS INC

LR-3280 MANUFACTURED IN HAYWARD, CALIFORNIA.

11509 I

III

5/8/1995

11510 I

III

5/8/1995

CLARIANT MASTERBATCHES DIVISION CLARIANT


CANADA INC
RESCO COLOURS INC

11511 A

III

5/9/1995

SONOCO FLEXIBLE PACKAGING

WHITE CONCENTRATE (01PPP-072) MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY,


RHODE ISLAND.
WHITE CONCENTRATE (01EHD-260) MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY,
RHODE ISLAND.
MPE953M-1 MANUFACTURED IN ENDINBURGH, INDIANA.

884.114 NOR-CAP NATURAL AND ARTIFICIAL ORANGE FLAVOR MANUFACTURED IN CAROL


STREAM, ILLINOIS.
PLASTIC CONTAINERS MANUFACTURED IN SCARBOROUGH, CANADA.
MURINE MONOCLONAL ANTI-FSH ANTIBODY 9/14 MANUFACTURED BY SOREBIO SA IN
MARTILLAC, FRANCE.
DICLOFENAC SODIUM MANUFACTURED IN PETAH TIQVA, ISRAEL.

Page 325

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11512 I
III
5/9/1995
SONOCO FLEXIBLE PACKAGING

SUBJECT
MPE95WA-1 MANUFACTURED IN ENDINBURGH, INDIANA.

11513 I

II

5/11/1995

GRANULES INDIA LTD

11514 A

III

5/12/1995

MAC CLOSURES INC

11515 I

II

5/2/1995

3V INC

COMPRESSO-90-CP(F) (ACETAMINOPHEN GRANULES 90%) MANUFACTURED IN HYDERABAD,


INDIA.
KERR CR-1 CONTINUOUS THREADED CHILD-RESISTANT CLOSURE MANUFACTURED IN
WATERLOO, QUEBEC, CANADA.
UVASORB MET/C MANUFACTURED IN GEORGETOWN, SOUTH CAROLINA.

11516 I

II

5/19/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

11517 I

II

5/19/1995

CONSOLIDATED PHARMACEUTICAL GROUP INC

11518 I

5/19/1995

TIANJIN XIN XIN PHARMACEUTICAL CORP

11519 I

II

5/19/1995

PLAISTOW LTD

11520 A

III

5/19/1995

PACKAGING COORDINATORS LLC

11521 I

III

5/22/1995

SCHUEPBACH AG

11522 A

II

5/23/1995

FERMION OY

11523 I

5/15/1995

RHONE POULENC RORER SA

11524 A

II

5/24/1995

CIPLA LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN VITRY-SUR-SEINE CEDEX, FRANCE.
FLUCONAZOLE AS MANUFACTURED IN VIKHROLI BOMBAY, INDIA, AND PATALGANGA, INDIA.

11525 A

II

5/19/1995

FARMHISPANIA SA

ENALAPRIL MALEATE MANUFACTURED IN BARCELONA, SPAIN.

11526 I

II

5/19/1995

IROTEC LABORATORIES

TRAMADOL HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND.

11527 I

5/11/1995

PIERRE FABRE SANTE

11528 I

5/19/1995

LYNX THERAPEUTICS INC

11529 I

II

7/6/1995

MALLINCKRODT INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GAILLAC, FRANCE.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN HAYWARD, CA.
MORPHINE SULFATE INJECTION USP AS MANUFACTURED IN RALEIGH, NORTH CAROLINA.

11530 I

IV

5/25/1995

HENRY H OTTENS MANUFACTURING CO INC

11531 A

IV

5/25/1995

HENRY H OTTENS MANUFACTURING CO INC

11532 I

III

5/19/1995

AMPACET CORP

11533 I

II

5/25/1995

TORONTO RESEARCH CHEMICALS INC

11534 I

II

5/31/1995

ONO PHARMACEUTICAL CO LTD

11535 A

II

5/26/1995

FARMHISPANIA SA

11536 I

III

5/30/1995

SABIC PETROCHEMICALS BV

1-[N2-[(S)-1-CARBOXY-3-PHENYLPROPYL]-L-LYSYL]-L-PROLINE DIHYDRATE MANUFACTURED


IN BARCELONA, SPAIN.
SABIC HDPE B5309 MANUFACTURED IN AA BEEK, THE NETHERLANDS.

11537 A

II

6/5/1995

GEDEON RICHTER PLC

FAMOTIDINE MANUFACTURED IN BUDAPEST, HUNGARY.

11538 I

II

5/26/1995

BORON BIOLOGICALS INC

11539 I

III

5/23/1995

AMPACET CORP

11540 I

II

5/22/1995

ALDRICH CHEMICAL CO INC

10B-ENRICHED L-P-BORONOPHENYLALANINE MANUFACTURED IN RALEIGH, NORTH


CAROLINA.
100221-A ANTISTAT POLYETHYLEN MASTERBATCH MANUFACTURED IN TERRE HAUTE,
INDIANA, DERIDDER, LOUISIANA OR AMPACET EUROPE S.A., MESSANCY, BELGIUM.
POLYGALACTURONIC ACID MANUFACTURED IN SHEBOYGAN FALLS, WI.

PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP MANUFACTURED IN BALTIMORE,


MARYLAND.
PENICILLIN V POTASSIUM TABLETS, USP MANUFACTURED IN BALTIMORE, MARYLAND.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TIANJIN, CHINA.
LEVOBUNOLOL HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND.
MANUFACTURING SITE, FACILTIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN PHILADELPHIA, PA.TYPE I CONVERSION TO TYPE III
COMPOUND PACKAGING MATERIAL PAPER/ALUMINUM/OPA/PAN-BAREX MATERIAL SOP 50962
MANUFACTURED IN BURGDORF, SWITZERLAND.
FLUTAMIDE MANUFACTURED IN ESPOO, FINLAND.

SPRAY DRIED NATURAL/ARTIFICIAL KIWI FLAVOR S-718 MANUFACTURED IN PHILADELPHIA,


PA.
SPRAY DRIED NATURAL ORANGE FLAVOR WONF S-261 MANUFACTURED IN PHILADEPHIA, PA.
100102 ANTISTAT POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE,
INDIANA, DERIDDER, LOUISIANA, OR AMPACET EUROPE, S.A., MESSANCY, BELGIUM.
SUCROSE OCTASULFATE, POTASSIUM SALT MANUFACTURED IN DOWNSVIEW, ONTARIO,
CANADA.
PROSTAGLANDIN E1 MANUFACTURED IN FUKUI, JAPAN.

Page 326

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11541 I
I
5/31/1995
E PHARMA SPA
11542 I

II

5/31/1995

DSM ANDENO GMBH

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN VIA PROVINA, ITALY.
MBT-ESTER MANUFACTURED IN REGENSBURG, GERMANY.

11543 I

II

6/1/1995

MAPRIMED SA

RANITIDINE HYDROCHLORIDE MANUFACTURED IN BUENOS AIRES, ARGENTINA.

11544 I

II

6/2/1995

MAHARISHI AYUR VED PRODUCTS INTL INC

MAHARISHI MARIT KALASH (MAK-4 AND MAK-5) MANUFACTURED IN NOIDA, UP INDIA.

11545 I

6/1/1995

GREAT LAKES CHEMICAL KONSTANZ GMBH

11546 I

II

5/31/1995

DOCTOR REDDYS LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN KONSTANZ, GERMANY.
RANITIDINE MANUFACTURED IN ANDHRA PRADESH, INDIA.

11547 I

III

6/1/1995

RESCO COLOURS INC

11548 I

III

6/5/1995

POLYMER COLOR INC

AMBER CONCENTRATE (06EDH-950) MANUFACTURED IN MISSISSAUGA,ONTARIO, CANADA,


AND COVENTRY, RHODE ISLAND.
RLC-14321, 25/1 PINK COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS

11549 I

II

6/9/1995

PLANTEX LTD

PENTOXIFYLLINE MANUFACTURED BY PLANTEX LTD IN NETANYA, ISRAEL.

11550 I

II

6/1/1995

XIAN PHARMACEUTICAL FACTORY

DEMETHYLEPIPODOFILOX MANUFACTURED IN SHAANXI PROVINCE, CHINA.

11551 A

II

6/9/1995

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

OMEPRAZOLE MANUFACTURED IN BARCELONA, SPAIN

11552 I

II

6/12/1995

AVANTI POLAR LIPIDS INC

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPATE MANUFACTURED IN ALABASTER, ALABAMA.

11553 I

II

6/12/1995

AVANTI POLAR LIPIDS INC

11554 I

II

6/12/1995

AVANTI POLAR LIPIDS INC

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-(POLYETHYLENE GLYCOL
5000) MANUFACTURED IN ALABASTER, ALABAMA.
IMARX SYNTHETIC PHOSPHOLIPID BLEND MANUFACTURED IN ALABASTER, ALABAMA

11555 I

II

6/12/1995

ORGANON NV

DESOGESTREL TABLETS (75UG AND 150UG) MANUFACTURED IN OSS, THE NETHERLANDS

11556 I

6/13/1995

SANOFI RECHERCHE

11557 I

III

6/9/1995

CLARIANT CORPORATION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN LABEGE CEDEX, FRANCE
WPC-116, 33/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINIOS

11558 I

III

6/12/1995

SCHUEPBACH AG

11559 A

III

6/8/1995

TICONA GMBH

COMPOUND PACKING MATERIAL PAPER/ALUMINIUN/POLYETHYENE MATERIAL #SOP 25330


MANUFACTURED IN BURGDORF, SWITZERLAND
HOSTAFORM ACETAL COPOLYMER MANUFACTURED IN KELSTERBACH, GERMANY.

11560 A

III

6/12/1995

CLARIANT CORP

WPA-116B, 25/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS.

11561 A

II

5/31/1995

NOF CORP

PURIFIED EGG YOLK PHOSPHATIDYLCHOLINE MANUFACTURED IN HYOGO JAPAN.

11562 A

II

6/20/1995

FARCHEMIA SRL

MICONAZOLE NITRATE MANUFACTURED IN TREVIGLIO, ITALY.

11563 A

II

7/6/1995

DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN BUDAPEST, HUNGARY.

11564 A

II

6/5/1995

CHINOIN PHARMACEUTCIAL AND CHEMICAL


WORKS CO LTD
ALBEMARLE CORP

11565 A

III

6/16/1995

STYROLUTION GMBH

11566 I

6/8/1995

SEITZ FILTER WERKE

POLYSTYROL 158 K KO 21 GK 00013 MANUFACTURED IN LUDWIGSHAFEN, GERMANY AND


ANTWERPEN 4, BELGIUM.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
FOR SEITZ MEMBRACART PS MEMBERANE FILTER CARTRIDGES IN BAD KREUZNACH,
FEDERAL REPUBLIC OF GERMANY.

11567 A

IV

6/28/1995

GATTEFOSSE SA

PECEOL ISOTEARIQUE MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE.

11568 A

II

6/29/1995

FERMION OY

PROPAFENONE HCL MANUFACTURED IN ESPOO, ENGLAND.

11569 I

III

6/27/1995

SCHUEPBACH AG

11570 I

III

6/27/1995

AMPACET CORP

11571 I

II

6/25/1995

TECHCO CHEMICAL CO LTD

COMPOUND PACKAGING MATERIAL ACLAR FLUROPOLYMER/POLYVINYLCHORIDE FILM (PVC)


MATERIAL #SOP 56019 MANUFACTURED IN BURGDORF, SWITZERLAND.
LR-86344 ANTISTA POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE,
INDIANA, DERIDDER, LOUISIANA OR AMPACET EUROPE, S.A., MESSANCY, BELGIUM.
7-ADCA MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

11572 I

II

7/7/1995

ABBOTT LABORATORIES

MSI-78 MANUFACTURED IN NORTH CHICAGO, ILLINOIS.

LIDOCAINE USP MANUFACTURED IN SOUTH HAVEN, MI.

Page 327

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11573 I
I
6/29/1995
3M HEALTH CARE LTD
11574 A

II

7/7/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
BY 3M NEOTECHNIC LIMITED IN LEICESTERSHIRE, ENGLAND.
FLUNISOLIDE ANHYDROUS MANUFACTURED IN RHO (MILAN)ITALY.

11575 I

II

7/4/1995

HELSINN CHEMICALS SA

MELATONIN MANUFACTURED IN BIASCA, SWITZERLAND

11576 A

IV

7/6/1995

LYDALL PERFORMANCE MATERIALS BV

SOLUPOR (UHWM-PE) MANUFACTURED IN HEERLEN, THE NETHERLANDS.

11577 I

II

7/3/1995

SIGMA CHEMICAL CO

11578 A

II

7/5/1995

11579 A

II

7/13/1995

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
ESTEVE QUIMICA SA

N-DODECYL B-D-MALTOSIDE (PRODUCT NO.D5795/STOCK NO. W 5309-4) MANUFACTURED A


SIGMA CHEMICALS AND SIGMA DIAGNOSTICS IN ST. LOUIS, MO.
KETOENAMINE MANUFACTURED IN VARESE, ITALY.

11580 I

II

7/13/1995

CILAG AG

RETINAMIDIC ACID MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

11581 I

7/13/1995

BAYER SPA

11582 A

II

7/10/1995

ERCROS SA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GARBAGNATE MILANESE ITALY.
FOSFOMYCIN PHENETHYL AMMONIUM SALT MANUFACTURED IN ARANJUEZ (MADRID) SPAIN.

11583 A

II

7/11/1995

FARCHEMIA SRL

CIMETIDINE HYDROCHLORIDE MANUFACTURED IN TRVIGLIO, ITALY.

11584 I

II

7/13/1995

ESTEVE QUIMICA SA

ASTEMIZOLE MANUFACTURED IN BARCELONA, SPAIN.

11585 I

7/14/1995

LEO PHARMACEUTICAL PRODUCTS LTD

11586 I

II

7/12/1995

BASF SE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR EB 1089 EC CAPSULES IN BALLERUP, DENMARK.
RETINOL 50 P MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

11587 I

II

7/17/1995

HOECHST MARION ROUSSEL SA

11588 I

II

7/19/1995

MITSUBISHI CHEMICAL CORP

DEXAMETHASONE ACETATE USP MONOHYDRATE MANUFACTURED IN AUVERGNE,


VERTOLAYE, FRANCE.
MCI-154 MANUFACTURED IN IBARAKI PREFECTURE, JAPAN.

11589 I

III

4/20/1995

AB VAXJOPLAST

PLASTIC MATERIAL FOR PLASTIC CAPS MANUFACTURED IN VAXJO, SWEDEN.

11590 I

II

7/19/1995

BOMBAY DRUGS AND PHARMACEUTICALS LTD

ETIDRONATE DISODIUM MANUFACTURED IN MAHARASHTRA STATE AND GUJARAH, INDIA.

11591 I

II

8/14/1995

NV ORGANON

ORG 32489 RECOMBINANT FSH MANUFACTURED IN OSS, THE NETHERLANDS.

11592 I

II

7/20/1995

LOHMANN THERAPIE SYSTEME GMBH AND CO KG

11593 I

II

7/20/1995

NV ORGANON

CHOLINERGIC CHANNEL ACTIVATOR-TRANSDERMAL DELIVERY SYSTEM MANUFACTURED IN


ANDERNACH AND NEUWIED, FEDERAL REPUBLIC OF GERMANY.
HYALURONIC ACID LMW MANUFACTURED IN OSS, THE NETHERLANDS.

11594 I

7/20/1995

ANTIBIOTICOS

11595 A

II

7/21/1995

COPPERHEAD INVESTMENTS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


FOR BULK PROCESS DEVELOPMENT IN RODANO, ITALY.
NITROGLYCERIN MANUFACTURED IN TAMAQUA, PA.

11596 I

II

7/25/1995

ARCHIMICA SPA

BULK CRUDE PROPOFOL MANUFACTURED IN VARESE, ITALY.

11597 I

II

7/6/1995

PALMER RESEARCH

11598 I

III

7/18/1995

CARCANO ANTONIO S.P.A.

11599 I

III

8/15/1995

MONTELL SDK SUNRISE LTD

TRIETHYL 3-BROMOPROPANE-1, 1, 1-TRICARBOXYLATE MANUFACTURED IN CLWYD, UNITED


KINGDOM.
PACKAGING MATERIAL ALUMINUM FOIL SMOOTH, HARD TEMPER, .020, .025 AND .030 MM
MANUFACTURED IN MANDELLO DEL LARIO-CO-ITALY.
SHOLEX 6002B AND SHO-ALLOMER MA 411 AND MA 422 MANUFACTURED IN OITA
PREFECTURE, JAPAN AND BY JAPAN POLYPROPYLENE CO., LTD. IN OKAYAMA PREFECTURE,
JAPAN.

11600 I

II

8/15/1995

ZENTIVA KS

METOPROLOL SUCCINATE MANUFACTURED IN HLOHOVEC, SLOVAKIA.

11601 A

IV

7/27/1995

CFC CONSORTIUM

CHLOROFLUOROCARBON 11, 12, AND 114.

11602 I

II

2/5/1996

UNION QUIMICO FARMAEUTICA, S.A. (UQUIFA)

CIPROFLOXACIN HYDROCHLORIDE MANUFACTURED IN BARCELONA, SPAIN.

11603 I

II

7/25/1995

SHANGHAI INDUSTRIAL CHEMICAL CO LTD

D-(-)-PHENYGLYCINE DANE SALT MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF


CHINA.

KETOCONAZOLE MANUFACTURED IN CELRA (GIRONA) SPAIN.

Page 328

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11604 I
III
7/18/1995
CARCANO ANTONIO S.P.A.
11605 I

II

7/28/1995

HELSINN CHEMICALS SA

SUBJECT
PACKAGING MATERIAL ALUMINUM FOIL, SMOOTH, SOFT TEMPER, .045 AND .048MM
MANUFACTURED IN MANDELLO DEL LARIO-CO-ITALY.
TRAMADOL HYDROCHLORIDE MANUFACTURED IN BIASCA, SWITZERLAND.

11606 A

II

7/27/1995

SHANDONG XINHUA PHARMACEUTICAL CO LTD

HYDROCORTISONE BASE MANUFACTURED IN ZIBO, PEOPLE'S REPUBLIC OF CHINA.

11607 A

II

7/31/1995

FARMHISPANIA SA

ATRACURIUM BESYLATE USP MANUFACTURED IN BARCELONA, SPAIN.

11608 I

III

7/25/1995

SUPERFOS PHARMA

11609 I

II

7/25/1995

LIFECORE BIOMEDICAL INC

HD POLYETHYLENE COLOURED WHITE BOTTLES MANUFACTURED IN VAERLOESE,


DENMARK.
HY-50 HYALURONATE SODIUM STERILE INJECTION MANUFACTURED IN CHASKA, MINNESOTA.

11610 I

II

7/28/1995

AIR LIQUIDE AMERICA CORP

11611 I

III

8/2/1995

KANEKA TEXAS CORP

2200 PPM NITRIC OXIDE/BALANCE NITROGEN GAS MIXTURE MANUFACTURED IN LONG


BEACH, CALIFORNIA.
KANE ACE B-22, B-52, B-56, AND B-522 MANUFACTURED IN WESTERLO-OEVEL, BELGIUM.

11612 I

III

8/2/1995

KANEKA TEXAS CORP

KANE ACE B-22, B-52, B-56, AND B-522 MANUFACTURED IN PASADENA, TEXAS.

11613 I

III

8/2/1995

KANEKA TEXAS CORP

KANE ACE B-22, B-52, B-56, AND B-522 MANUFACTURED IN HYOGO, JAPAN.

11614 A

II

7/28/1995

VETTER PHARMA FERTIGUNG GMBH AND CO KG

STERILE WATER FOR INJECTION MANUFACTURED IN LANGENARGEN, GERMANY

11615 A

II

8/4/1995

BASF SE

DERMAZ 88 (AZELAIC ACID) AS MANUFACTURED IN CINCINNATI, OHIO FOR BASF SE

11616 I

III

9/1/1995

SONOCO FLEXIBLE PACKAGING

MPE953M-3 MANUFACTURED IN EDINBURGH, INDIANA.

11617 I

III

8/3/1995

DSM POLYMERS

STAMYLAN LD 2304A MANUFACTURED IN BEEK, THE NETHERLANDS.

11618 I

II

8/7/1995

SANDOZ PHARMA LTD

CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.

11619 I

II

8/9/1995

UNION QUIMICO FARMACEUTICA SA

11620 I

IV

8/8/1995

CYTRX CORP

11621 I

III

8/7/1995

HARTFORD PLASTICS

2-ISOPROPYL-4-(N-METHYL) AMNINOMETHYLTHIAZOLE MANUFACTURED IN BARCELONA,


SPAIN.
CRL-1005 (POE-POP-POE BLOCK COPOLYMER 120.5) MANUFACTURED IN NORCROSS,
GEORGIA.
HIGH-DENSITY POLYETHYLENE MANUFACTURED IN WINDSOR, CONNECTICUT.

11622 I

7/20/1995

PHARMACO LIFE SCIENCE RESEARCH

11623 I

7/20/1995

PHARMACO LIFE SCIENCE RESEARCH

11624 I

III

8/4/1995

REXENE CORP

11625 I

8/14/1995

LABORATORIOS SERONO SA

11626 I

III

8/14/1995

SAMHWA LUBE OIL CO LTD

11627 I

II

6/4/1996

FARCHEMIA SRL DIV TESSENDERLO CHEMIE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TRES CANTOS, SPAIN.
LUBRICATION OILS FOR COLD ROLLING OF ALUMINUM FOIL MANUFACTURED IN KANGWONPROVINCE, KOREA.
NAPROXEN SODIUM USP MANUFACTURED IN TREVILGLIO (BERGAMO) ITALY

11628 I

IV

8/11/1995

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL COOLING COMPOUND #6883 MANUFACTURED IN PHILADELPHIA, PA.

11629 I

8/17/1995

DEGUSSA AG

11630 I

II

8/15/1995

SLOVAKOFARMA LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN CISPLATIN USP IN HANAU, GERMANY.
METOPROLOL TARTRATE MANUFACTURED IN HLOHOVEC, SLOVAKIA.

11631 I

II

8/23/1995

11632 I

8/23/1995

SHANGHAI NUMBER 6 PHARMACEUTICAL


FACTORY
TIANJIN HEBEI PHARMACEUTICAL FACTORY

11633 I

8/25/1995

CALAIRE CHIMIE SA

11634 I

III

8/7/1995

FLINT HILLS RESOURCES LP

METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILA IN HUMAN URINE


MANUFACTURED IN RICHMOND, VIRGINIA.
METHOD MS23 REVISION 1 GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILA IN HUMAN
PLASMA MANUFACTURED IN RICHMOND, VIRGINIA.
POLYETHYLENE RESIN PE 1403 MANUFACTURED IN ODESSA, TEXAS.

PRAZIQUANTEL MANUFACTURED IN SHANGHAI PROVINCE, PEOPLE'S REPUBLIC OF CHINA.


MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN TIANJIN, CHINA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN CEDEX, FRANCE.
POLYPROPYLENE RESIN PP 6310 MANUFACTURED IN ODESSA, TEXAS.

Page 329

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11635 I
II
8/31/1995
UCB INC

SUBJECT
METHYLPHENIDATE HYDROCHLORIDE, USP MANUFACTURED IN SANTA ANA, CALIFORNIA.

11636 I

II

8/30/1995

MALLINCKRODT INC

11637 I

II

8/28/1995

ZENTIVA, A.S.

MEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML AS MANUFACTURED IN RALEIGH,


NORTH CAROLINA.
D,L-METIPRANOLOL MANUFACTURED IN HLOHOVEC, SLOVAKIA.

11638 A

II

9/1/1995

ROCHE DIAGNOSTICS GMBH

D,L-METIPRANOLOL MANUFACTURED IN MANNHEIM, GERMANY

11639 A

II

8/28/1995

NORBROOK SRO

PROCAINE HYDROCHLORIDE USP MANUFACTURED IN SEMTIN, CZECH REPUBLIC.

11640 A

III

10/9/1995

BPREX HEALTHCARE OFFRANVILLE SAS

11641 I

II

9/1/1995

CELSUS LABORATORIES INC

PLASTIC BOTTLE 10ML PEHD WHITE, PLASTIC NOZZLE PELD WHITE, AND PLASTIC CAP
PELD/HD MIXING 50/50 MANUFACTURED IN DIEPPE, FRANCE.
PERIODATE-OXIDIZED HEPARIN MANUFACTURED IN CINCINNATI, OHIO.

11642 I

III

8/16/1995

REXENE CORP

POLYPROPYLENE RESIN PP 13T10A CS-276 MANUFACTURED IN ODESSA, TEXAS.

11643 I

II

9/13/1995

MERCK AND CO INC

STERILE DILUENT MANUFACTURED IN WEST POINT, PENNSYLVANIA.

11644 I

III

9/5/1995

3M HEALTH CARE LTD

11645 I

II

9/7/1995

DSM ANDENO BV

11646 I

III

9/8/1995

AMPACET CORP

MSX 1174P NONWOVEN TAPE MANUFACTURED IN BROOKINGS, SD AND ST. PAUL,


MINNESOTA.
3,H-1,2,4-TRIAZOL-3-ONE, 5-ETHYL-2-4-DIHYDRO-4-(2-PHENOXYETHYL)TRIAZOLON
MANUFACTURED IN VENLO, THE NETHERLANDS.
10061 SLIP POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE, INDIANA,
DERIDDER, LOUISIANA, CARTERSVILLE, GEORGIA AND AMPACET EUROPE, S.A., MESSANCY,
BELGIUM.

11647 I

III

9/6/1995

WEST PHARMACEUTICAL SERVICES INC

COUNTER CAP MANUFACTURED IN WILLIAMSPORT, PA

11648 A

9/6/1995

WEST PHARMACEUTICAL SERVICES INC

11649 I

II

9/12/1995

JANSSEN PHARMACEUTICA NV

WESTAR MANUFACTURED IN JERSEY SHORE, PA, SINGAPORE, ESCHWEILER, GERMANY, AND


LE NOUVION-EN-THIERACHE, FRANCE.
R093877 MANUFACTURED IN GEEL, BELGIUM.

11650 A

II

9/8/1995

HUASHU PHARMACEUTICAL CORP

11651 I

IV

1/3/1996

SPI PHARMA INC

OXYTETRACYCLINE BASE MANUFACTURED IN SHIJIAZHUANG, PEOPLE'S REPUBLIC OF


CHINA.
SORBITOL SPECIAL (PLASTICIZER) MANUFACTURED IN NEW CASTLE, DELAWARE.

11652 I

II

9/4/1995

CELSUS LABORATORIES INC

DERMATAN SULFATE MANUFACTURED IN CINCINNATI, OHIO.

11653 I

III

9/13/1995

PROMEXMEDICAL INC

11654 I

III

9/11/1995

FOLIENWALZWERK BRUDER TEICH AG

11655 I

9/15/1995

GULF PHARMACEUTICAL INUSTRIES

11656 I

II

9/18/1995

MAPRIMED SA

SECONDARY PACKAGING OF ZOSTRIX CREAM .025% CAPSAICIN AND ZOSTRIX HP CREAM, .


075% CAPSAICIN MANUFACTURED IN WEST CALDWELL, NEW JERSEY.
LACQUERED ALUMINUM FOIL FOR PACKAGING OF CONDOMS MANUFACTURED IN
OBERGRAFENDORF-MUHLHOFEN, AUSTRIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN RAS AL KHAIMAH, UNITED ARAB EMIRATES.
ENALAPRIL MALEATE MANUFACTURED IN BUENOS AIRES, ARGENTINA.

11657 A

II

8/18/1995

ACS DOBFAR SPA

7-ZACA MANUFACTURED IN MILANO, ITALY.

11658 I

III

9/15/1995

11659 A

III

9/15/1995

CLARIANT CORPORATION MASTERBATCHES


DIVISION
EASTMAN CHEMICAL CO

11660 I

IV

9/11/1995

GLIDCO INC

WLA-12486-A 25/1 WHITE ANTI-STAT COLOR CONCENTRATE MANUFACTURED IN MCHENRY,


ILLINOIS.
EASTAR POLYMERS DN003 AND DN004 AND EASTALLOY POLYMER DA003-8999K
MANUFACTURED IN KINGSPORT,TENNESSEE OR COLUMBIA,SOUTH CAROLINA
PEPPERMINT OIL 540 MANUFACTURED IN JACKSONVILLE, FLORIDA.

11661 I

9/15/1995

LABORATORIOS ARGENOL SL

11662 A

II

9/15/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN ZARAGOZA, SPAIN.
SILVER SULFADIAZINE MANUFACTURED IN ZARAGOZA, SPAIN.

11663 I

II

9/20/1995

TAKEDA CHEMICAL INDUSTRIES LTD

EM574 MANUFACTURED IN OSAKA, JAPAN.

11664 A

II

9/21/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

TICLOPIDINE HCL MANUFACTURED IN CARONOO PERTUSELLA (VARESE) AND BULCIAGO


(LECCON), ITALY.

Page 330

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11665 I
II
9/15/1995
EURAND AMERICA INC

SUBJECT
MICROCAPS PSEUDOEPHEDRINE HCL MANUFACTURED IN VANDALIA, OHIO.

11666 I

II

9/11/1995

FINORGA SA

RITONAVIR MANUFACTURED IN CHASSE SUR RHONE, FRANCE.

11667 I

II

9/19/1995

QUIMICA SINTETICA SA

RANITIDINE HCL FORM 1 MANUFACTURED IN MADRID, SPAIN.

11668 I

II

9/19/1995

ASH STEVENS INC

WR 242511 MANUFACTURED IN RIVERVIEW, MICHIGAN.

11669 I

II

10/2/1995

SIGMA CHEMICAL CO

11670 I

II

9/23/1995

UNION QUIMICO FARMACEUTICA SA

11671 I

III

9/15/1995

KERPLAS SNC

11672 A

II

9/22/1995

11673 A

II

9/22/1995

11674 A

II

9/22/1995

11675 I

II

9/18/1995

PRIME EUROPEAN THERAPEUTICALS SPA


EUTICALS SPA
PRIME EUROPEAN THERAPEUTICALS SPA
EUTICALS SPA
PRIME EUROPEAN THERAPEUTICALS SPA
EUTICALS SPA
KURITA WATER INDUSTRIES LTD

POLYGALACTURONIC ACID SIGMA STOCK NUMBER (W 5356-6) MANUFACTURED BY SIGMA


CHEMICALS CO. AND SIGMA DIAGONSTICS IN ST. LOUIS, MISOURI.
2-ISOPROPYL-4-(N-METHYL) AMINOMETHYLTHIAZOYLCARBONYL-(L)-VALINE MANUFACTURED
IN BARCELONA, SPAIN.
PLASTIC BOTTLE PEHD WHITE (20, 35, 50ML) AND PLASTIC LID PP WHITE MANUFACTURED IN
DIEPPE, FRANCE.
A-84538.0 (RITONAVIR) MANUFACTURED IN ORIGGIO, VARESE, ITALY.

11676 I

II

9/26/1995

AMOLI ORGANICS LTD

KURIMOVER II MANUFACTURED IN KANAGAWA, JAPAN, AND BY YMC CO., LTD IN KYOTO,


JAPAN.
DICLOFENAC SODIUM MANUFACTURED IN GUJARAT STATE, INDIA.

11677 I

II

9/25/1995

AJINOMOTO CO INC

A-84538.0 (RITONAVIR) MANUFACTURED IN HINAGA YOKKAICHI, MIE PREFECTURE, JAPAN.

11678 A

IV

9/13/1995

FMC CORP FMC BIOPOLYMER DIV

MARINE COLLOIDS CARRAGEENAN MANUFACTURED IN ROCKLAND, MAINE.

11679 I

II

9/20/1995

BOEHRINGER INGELHEIM PHARMA KG

11680 I

9/27/1995

DURA PHARMACEUTICALS INC

11681 I

9/26/1995

AMOLI ORGANICS LTD

11682 A

II

9/19/1995

ISOCHEM SA

11683 A

II

9/25/1995

COPPERHEAD INVESTMENTS INC

SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN) MANUFACTURED IN INGELHEIM/RHEIN,


GERMANY.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SAN DIEGO, CALIFORNIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN GUJARA, INDIA.
TERTIOBUTYL-4'-CHLORO-4-BUTYROPHENONE MANUFACTURED IN GENNEVILLIERS CEDEX,
FRANCE.
SDM 26 (NITROGLYCERIN ON LACTOSE MIXTURE) MANUFACTURED IN TAMAQUA, PA.

11684 I

III

9/22/1995

PROMEXMEDICAL INC

11685 I

II

4/20/1995

SYNTHELABO PHARMACIE

11686 I

9/27/1995

VETTER PHARMA FERTIGUNG GMBH

11687 A

III

9/18/1995

AMILCO SA

PRODUCTION OF PRE-FILLED SYRINGES AND LIQUID PRODUCTS AS MFG IN RAVENSBURG,


FEDERAL REPUBLIC OF GERMANY
GLASS TUBULAR CONTAINERS MANUFACTURED IN MADRID, SPAIN.

11688 I

II

9/29/1995

DELMAR CHEMICALS INC

KETOROLAC DERIVAIVE MANUFACTURED IN LASALLE, QUEBEC, CANADA.

11689 I

9/12/1995

EORTC NEW DRUG DEVELOPMENT OFFICE

11690 I

III

9/29/1995

CREST FLEXIBLE PACKAGING LTD

11691 A

III

9/29/1995

BAXTER HEALTHCARE CORP

11692 A

II

10/3/1995

CAMBREX PROFARMACO MILANO SRL

STANDARD OPERATING PROCEDURES OF EARLY CLINICAL RESEARCH OF NEW ANTICANCER


AGENTS.
PACKAGING MATERIALS FOR MEDICAL PACKAGING (PAPER/PE/FOIL/MEL 850 45.0G/M2
PAPER) MANUFACTURED IN KENT, ENGLAND.
TERMINALLY STERILIZED INJECTIONS IN PL 2408 PLASTIC CONTAINER MANUFACTURED IN
MARION, NORTH CAROLINA.
CLOZAPINE MANUFACTURED IN PAULLO (MILANO) ITALY.

11693 I

9/29/1995

ALMEDICA EUROPE LTD

BOC CORE SUCCINATE MANUFACTURED IN ORIGGIO, VARESE, ITALY.


5-THIAZOLE WING MANUFACTURED IN ORIGGIO, VARESE, ITALY.

SECONDARY PACKAGING OF BIAXIN FILMTABS CLAIRTHROMYCIN 500MG TABLETS,


MEDISCRIPTS STARTER MANUFACTURED IN WEST CALDWELL, NEW JERSEY.
UREA-CALCIUM ACETYLSALICYLATE MANUFACTURED IN AMILLY, FRANCE.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DEESIDE, UNITED KINGDOM.

Page 331

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11694 I
III
10/4/1995
COVALENCE COATED PRODUCTS

SUBJECT
41706-40 MANUFACTURED IN COLUMBUS, GEORGIA.

11695 I

II

9/28/1995

AIR PRODUCTS AND CHEMICALS INC

APF-N30 (PERFLUOROPROPANE) MANUFACTURED IN ALLENTOWN, PENNSYLVANIA.

11696 I

IV

9/28/1995

GATTEFOSSE SA

PLUROL DIISOSTEARIQUE MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE.

11697 I

II

10/3/1995

JACOBUS PHARMACEUTICAL CO

AMINOSALICYLATE SODIUM USP MANUFACTURED IN PLAINSBORO, NEW JERSEY.

11698 I

III

10/5/1995

YOSHINO KOUGYOUSHO CO LTD

11699 I

II

10/4/1995

SIMS

PLASTIC CONTAINER FOR WRAPPING TABLETS MANUFACTURED IN TOCHIGI-KEN AND


GUNMA-KEN, JAPAN.
FLUOXETINE HCL MANUFACTURED IN REGGELLO (FLORENCE) ITALY.

11700 I

II

9/30/1995

FARCHEMIA SRL

DICLOFENAC SODIUM MANUFACTURED IN TREVIGLIO (BERGAMO) ITALY.

11701 I

9/28/1995

PHARMACIA AND UPJOHN INC

11702 A

II

10/10/1995

DR REDDYS LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN NERVIANO MILAN, ITALY.
PERMETHRIN MANUFACTURED IN WEST YORKSHIRE, ENGLAND.

11703 I

10/6/1995

CLINETICS CORP

11704 A

II

10/5/1995

EXCELLA GMBH

11705 I

II

10/4/1995

AVECIA INC

11706 I

II

10/12/1995

BAYER SCHERING PHARMA AG

SDM-79 (25% NITROGLYCERIN IN SOLVATED ADHESIVE POLYMER) MANUFACTURED IN


TAMAQUA, PA.
ILOPROST B-CYCLODEXRIN CLATHRATE MANUFACTURED IN BERLIN, GERMANY.

11707 A

III

10/13/1995

3M DRUG DELIVERY SYSTEMS

A66210 SPRAYMISER MK2 VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN.

11708 I

III

10/11/1995

11709 I

II

10/2/1995

CLARIANT CORPORATION - MASTERBATCHES


DIVISION
TERRY MESON TECHNOLOGY LTC

MLC-15194 25/1 SILVER METALLIC COLOR CONCENTRATE MANUFACTURED IN MCHENRY,


ILLINOIS.
STRONTIUM-82 (P:4N, 6N) MANUFACTURED IN TROITSK, MOSCOW, RUSSIA AND BY
CYCLOTRON (INSTITUTE FOR PHYSICS AND POWER ENGINNERING) IN OBNINSK, KALUGA,
RUSSIA.

11710 A

III

10/10/1995

TUBED PRODUCTS LLC

11711 A

III

9/27/1995

TRIVENI POLYMERS PRIVATE LTD

POLYETHYLENE AND POLYPROPYLENE SQUEEZE TUBES IN NATURAL OR WHITE RESIN


MANUFACTURED IN EASTHAMPTON, MASSACHUSETTS.
PLASTIC CONTAINERS MANUFACTURED IN NEW DELHI, INDIA.

11712 I

III

10/16/1995

11713 A

10/20/1995

CLARIANT CORPORATION - MASTERBATCHES


DIVISION
AMERICAN PHARMACEUTICAL PARTNERS INC

11714 I

II

10/18/1995

BOEHRINGER INGELHEIM PHARMA KG

11715 I

III

10/18/1995

MAC CLOSURES INC

YLC-15218 25/1 PEARL YELLOW COLOR CONCENTRATE MANUFACTURED IN MCHENRY,


ILLINOIS.
POWDER DRUGS IN VIALS STERILIZATION PROCESS VALIDATION DOCUMENTATION (ASEPTIC
FILL) IN GRAND ISLAND, NEW YORK.
CAMPTOTHECIN MANUFACTURED BY BOEHRINGER INGELHEIM ESPANA, S.A. IN FABRICA
MALGRATE DE MAR, SPAIN.
13-425 LINERLESS CLOSURE MANUFACTURED IN WATERLOO, QUEBEC, CANADA.

11716 I

III

10/16/1995

AIR PRODUCTS AND CHEMICALS INC

FLEXCRYL GP5 EMULSION MANUFACTURED IN PIEDMONT AND LANGLEY, SOUTH CAROLINA.

11717 I

IV

10/16/1995

TECHNOLOGY FLAVORS & FRAGRANCES INC

ARTIFICIAL STRAWBERRY FLAVOR 844-149 MANUFACTURED IN AMITYVILLE, NEW YORK.

11718 I

IV

10/16/1995

TECHNOLOGY FLAVORS & FRAGRANCES INC

NATURAL CHERRY WONF 544-412 MANUFACTURED IN AMITYVILLE, NEW YORK.

11719 I

IV

10/16/1995

TECHNOLOGY FLAVORS & FRAGRANCES INC

NATURAL CHERRY TYPE FLAVOR 544-411 MANUFACTURED IN AMITYVILLE, NEW YORK.

11720 I

III

10/30/1995

TENAX CORP

RECTAL DELIVERY SYSTEM COMPONENT MANUFACTURED IN DANBURY, CONNECTICUT.

11721 I

10/20/1995

NOVARTIS PHARMACEUTICALS CORPORATION

11722 A

III

10/16/1995

COLORS FOR PLASTICS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE IN


ORLEANS-LA SOURCE, FRANCE.
R27188 MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS.

11723 I

III

10/16/1995

COLORS FOR PLASTICS

W06221 MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS.

11724 I

II

10/26/1995

LIPHA SA

CROMOLYN SODIUM MANUFACTURED IN PITHIVIERS, FRANCE.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN TUSTIN, CALIFORNIA.
METHOTREXATE MANUFACTURED IN FEUCHT, GERMANY.

Page 332

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11725 I
II
10/27/1995
MERCIAN CORP

SUBJECT
RAPAMYCIN CRUDE OIL MANUFACTURED IN SHIZUOKA, JAPAN.

11726 I

IV

10/27/1995

WESTERN FLAVORS AND FRAGRANCES INC

11727 A

II

10/31/1995

KOEI CHEMICAL CO LTD

11728 I

II

1/30/1996

TAMA KAGAKU KOGYO CO LTD

CHERRY FLAVOR ARTIFICIAL WILD W.S. #501237 MANUFACTURED IN LIVERMORE,


CALIFORNIA.
(S)-3-[[(1,1-DIMETHYLETHYL) AMINO] CARBONYL] -1- PIPERAZINECARBOXYLIC ACID 1,1DIMETHYLETHYL ESTER MANUFACTURED IN OSAKA, JAPAN.
(-)-CIS-1-AMINOINDAN-2-01 MANUFACTURED IN SAITAMA, JAPAN.

11729 I

9/1/1995

CAULDRON INC

11730 I

II

10/26/1995

LONZA LTD

11731 A

III

10/31/1995

BERRY PLASTICS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MALVERN, PENNSYLVANIA.
TERT-BUTYL (S)-3-(TERT-BUTYLCARBAMOYL) PIPERAZINE-1-CARBOXYLATE MANUFACTURED
IN VISP, SWITZERLAND.
PLASTIC CONTAINERS MANUFACTURED IN WASHINGTON, NEW JERSEY.

11732 A

III

10/31/1995

3M DRUG DELIVERY SYSTEMS

ALUMINIUM CAN MANUFACTURED IN LANCASHIRE, GREAT BRITAIN.

11733 A

III

11/1/1995

3M DRUG DELIVERY SYSTEMS

A66139 50UL SPRAYMISER VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN.

11734 I

II

11/16/1995

MEDEA RESEARCH LABORATORIES INC

11735 I

10/20/1995

LABORATOIRES SANDOZ SA

11736 I

II

11/3/1995

11737 A

III

11/3/1995

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
3M DRUG DELIVERY SYSTEMS

2,5-DIMETHOXY-2-METHYL-5H-DIHYDROFURAN MANUFACTURED IN PORT JEFFERSON


STATION, NEW YORK.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN RUEIL-MALMAISON, FRANCE.
KETOROLAC TROMETHAMINE MANUFACTURED IN NORTH CHICAGO, ILLINOIS.

11738 I

III

11/2/1995

3M PHARMACEUTICALS INC

11739 I

III

10/31/1995

PECHINEY EMBALLACE ALIMENTAIRE

11740 I

II

11/6/1995

CHEMI SPA

BLISTER FOIL A LACQURED ANNEALED ALUMINIUM FOIL MANUFACTURED IN BRIGNOUD


CEDEX, FRANCE.
ETODOLAC MANUFACTURED IN PATRICIA (FROSINONE) ITALY.

11741 I

III

11/8/1995

MITSUI CHEMICALS INC

HZ 5195B AND MIRASON 50 MANUFACTURED IN CHIBA, JAPAN.

11742 A

II

11/14/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

ATRACURIUM BESYLATE MANUFACTURED IN RHO (MILAN) ITALY.

11743 I

II

11/9/1995

SIGMA CHEMICAL CO

CHOLESTERYL ACETATE (W 5388-4) MANUFACTURED IN ST. LOUIS, MISSOURI.

11744 A

II

11/14/1995

DSM ANDENO BV

(-)-CIS-1-AMINOINDAN-2-OL(AMINDA) MANUFACTURED IN VENLO, THE NETHERLANDS.

11745 I

II

11/9/1995

11746 I

II

11/14/1995

MORTON INTERNATIONAL INC SPECIALTY


CHEMICAL GROUP
PHARM ECO LABORATORIES INC

MAGNESIUM OXIDE USP HEAVY (PRODUCT CODE 6010-9)MANUFACTURED IN MANISTEE,


MICHIGAN.
(S)-N-BENZYL-N-[1,5,-BIS(4-PYRIDYL)-3-PENTYL]-3-(4CHLOROPHENYL)-2-{METHYL-[2-OXO-2(3,4,5 TRIMETHOXYPHENYL) ACETYL]AMINO} PROPIONAMIDE DIMETHANESULONATE
MANUFACTURED IN LEXINGTON AND NORTH ANDOVER , MASSACHUSETTS.

11747 A

II

11/13/1995

ZACH SYSTEM SPA

ZALEPLON MANUFACTURED IN ALMISANO DI LONIGO (VICENZA) ITALY

11748 I

II

11/20/1995

SUMITOMO CHEMICAL CO LTD

OXAPROZIN MANUFACTURED IN GIFU PREFECTURE, JAPAN.

11749 I

II

11/17/1995

HOECHST AG

11750 A

II

11/16/1995

CKD BIO CORP

BULK MEPERIDINE HYDROCHLORIDE USP (PETHIDINE HYDROCHLORIDE EP) DRUG


SUBSTANCE MANUFACTURED IN FRANKFURT, (MAIN) FEDERAL REPUBLIC OF GERMANY.
RIFAMYCIN-S MANUFACTURED IN ANSAN-CITY, KYEONGKI-DO, KOREA.

11751 A

III

8/15/1996

3M DRUG DELIVERY SYSTEMS

11752 I

III

11/20/1995

WHEATON WORLDWIDE INC

CONTAINER CLOSURE COMPONENTS FOR HFA-134A FLUNISOLIDE METERED DOSE INHALER


(MDI) MANUFACTURED IN GREAT BRITAIN, FINLAND, LEXINGTON, KENTUCKY
PLASTIC CONTAINERS MANUFACTURED IN MILLVILLE, NEW JERSEY.

11753 I

III

11/14/1995

OY PREMIX LTD

PREADD SL 101 MANUFACTURED IN RAJAMAKI, FINLAND.

11754 I

III

11/14/1995

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 5021 D MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY.

11755 I

II

11/27/1995

ALDRICH PHARMACEUTICALS LTD

FENBENDAZOLE MANUFACTURED IN GUJARA, INDIA.

3M SCOTCH PAK 9724 POLYESTER FILM LAMINATE MANUFACTURED IN COTTAGE GROVE,


MINNESOTA.
66203 63UL SPRAYMISER MK1 VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN.

Page 333

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11756 I
I
11/16/1995
CHONG KUN DANG CORP
11757 A

II

11/9/1995

ACS DOBFAR SPA

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN KYEONGKI-DO, KOREA.
CEPHAPIRIN ACID MANUFACTURED IN MILANO, ITALY.

11758 A

II

11/28/1995

APOTEX PHARMACHEM INC

METHACHOLINE CHLORIDE USP MANUFACTURED IN ONTARIO, CANADA.

11759 A

II

11/29/1995

SHIRATORI PHARMCEUTICAL CO LTD

EMESDASTINE DIFUMARATE MANUFACTURED IN OSAKA, JAPAN.

11760 I

II

11/28/1995

ARCHIMICA SPA

OP 3300/15 MANUFACTURED IN ORIGGIO, VARESE, ITALY.

11761 A

II

12/1/1995

ASTELLAS PHARMA INC

TAMSULOSIN HYDROCHLORIDE MANUFACTURED IN IBARAKI-KEN, JAPAN.

11762 I

III

11/27/1995

PROMEXMEDICAL INC

11763 A

III

11/23/1995

BESPAK DIV CONSORT MEDICAL PLC

11764 A

II

12/5/1995

FINORGA SAS

SECONDARY PACKAGING OF PREVACID 15MG & 30MG CAPSULES OF LANSOPRAZOLE,


MEDISCRIPTS STARTER MANUFACTURED IN WEST CALDWELL, NEW JERSEY.
BK 600 SERIES PHARMACEUTICAL ORAL ACTUATOR AND DUSTCAPS MANUFACTURED IN
NORFOLK, ENGLAND.
ZOLPIDEM TARTRATE MODIFIED SYNTHESIS MANUFACTURED IN MOURENX, FRANCE.

11765 I

III

12/4/1995

MAC CLOSURES INC

CONTINUOUS THREADED CLOSURES (CTC) MANUFACTURED IN QUEBEC, CANADA.

11766 A

II

12/11/1995

TEVA PHARMACEUTICAL INDUSTRIES LTD

ETODOLAC MANUFACTURED IN NETANYA, ISRAEL.

11767 A

II

12/6/1995

NORBROOK SRO

BENZOCAINE USP MANUFACTURED IN SEMTIN, CZECH REPUBLIC.

11768 A

II

12/7/1995

JANSSEN PHARMACEUTICA NV

CISAPRIDE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM.

11769 I

II

12/5/1995

BORON BIOLOGICALS INC

DISODIUM 1-MERCAPTO-UNDECAHYDRODODECABORATE, 10B-ERICHED AND 1-MERCAPTOUNDECAHYDRODODECABORATE, NATURAL ABUNDANCE MANUFACTURED IN RALEIGH,


NORTH CAROLINA.

11770 I

IV

11/30/1995

CUSTOM ESSENCE INC

FRAGRANCE CE-26101 MANUFACTURED IN SOMERSET, NEW JERSEY.

11771 I

II

12/12/1995

SM ORGANICS PRIVATE LTD

COLCHICINE MANUFACTURED IN HARYANA, INDIA.

11772 I

III

12/15/1995

SABIC PETROCHEMICALS BV

SABIC LDPE 2308A MANUFACTURED IN BEEK, THE NETHERLANDS.

11773 I

III

12/15/1995

SABIC PETROCHEMICALS BV

SABIC LDPE 1922T MANUFACTURED IN BEEK, THE NETHERLANDS.

11774 I

III

12/15/1995

DSM POLYMERS

STAMYLEX 9089 MANUFACTURED IN BEEK, THE NETHERLANDS.

11775 I

III

12/15/1995

DSM POLYMERS

STAMYLAN HD 9089U MANUFACTURED IN BEEK, THE NETHERLANDS.

11776 I

IV

11/28/1995

GRAIN PROCESSING CORP

11777 A

II

12/8/1995

SI GROUP

SUPERABSORBENT ADDITIVES USED IN DRUG DOSAGE FORMS MANUFACTURED IN


MUSCATINE, IOWA.
PROPOFOL MANUFACTURED IN ORANGEBURG,SOUTH CAROLINA

11778 I

III

12/11/1995

VERATEC CANADA

RAYON AND COTTON PHARMACEUTICAL COIL MANUFACTURED IN ONTARIO, CANADA.

11779 A

II

12/22/1995

SIFAVITOR SRL

LABETALOL HYDROCHLORIDE MANUFACTURED IN FRAZIONE MAIRANO (MILANO) ITALY.

11780 A

II

12/24/1995

KATWIJK CHEMIE BV

PEMOLINE MANUFACTURED IN KATWIJK, THE NETHERLANDS.

11781 I

II

12/19/1995

WYCKOFF CHEMICAL CO INC

BUTAMBEN USP MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

11782 I

12/26/1995

CHISSO CORP

11783 I

III

12/20/1995

FLINT HILLS RESOURCES LP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MINAMAA, JAPAN.
POLYPROPYLENE RESIN PP 12N25A MANUFACTURED IN ODESSA, TEXAS.

11784 A

II

12/20/1995

FIS FABBRICA ITALIANA SINTETICI SPA

ESTAZOLAM MANUFACTURED IN VINCENZA, ITALY.

11785 A

II

12/18/1995

SANOFI AVENTIS DEUTSCHLAND GMBH

FUROSEMIDE (BULK) MANUFACTURED IN FRANKFURT (MAIN), GERMANY.

11786 A

II

12/24/1995

KATWIJK CHEMIE BV

SODIUM VALPROATE MANUFACTURED IN KATWIJK, THE NETHERLANDS.

11787 I

III

12/7/1995

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 5031 L MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY.

11788 I

III

12/18/1995

SOLVAY SA

POLYPROPYLENE ELTEX P HF100 MANUFACTURED IN SARRALBE, FRANCE.

11789 I

III

12/18/1995

SOLVAY SA

B55-20N0047 MANUFACTURED IN ANTWERPEN, BELGIUM.

11790 I

III

12/18/1995

SOLVAY SA

HIGH DENSITY POLYETHYLENE ELTEX B3015LG MANUFACTURED IN SARRALBE, FRANCE.

Page 334

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11791 I
III
12/18/1995
SOLVAY SA

SUBJECT
HIGH DENSITY POLYETHYLENE ELTEX B4020LG MANUFACTURED IN SARRALBE, FRANCE AND
ROSIGNANO, ITALY.
HIGH DENSITY POLYETHYLENE ELTEX A4009MANUFACTURED IN ROSIGNANO, ITALY.

11792 I

III

12/18/1995

SOLVAY SA

11793 A

III

12/18/1995

SCHOTT HUNGARY KFT

11794 A

II

12/21/1995

ESTEVE QUIMICA SA

11795 A

III

12/27/1995

TAISEI KAKO CO LTD

11796 I

II

1/22/1996

DIASPA SPA

11797 A

IV

10/27/1995

JRS PHARMA LP

11798 I

IV

12/29/1995

MISSISSIPPI BLENDING CO INC

NONPAREILS (SUGAR SPHERES NF) MANUFACTURED IN ROBBINSVILLE, NEW JERSEY FOR


JRS PHARMA LP.
DIRECTO PRESS NF (CORNSTARCH BLEND) MANUFACTURED IN KEOKUK, IOWA.

11799 I

II

1/4/1996

CILAG AG

KETOROLAC TROMETHAMINE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

11800 I

IV

12/21/1995

SENN CHEMICALS AG

AA-D-TREHALOSE DIHYDRATE MANUFACTURED IN DIELSDORF, SWITZERLAND.

11801 A

II

1/10/1996

KYOWA HAKKO KIRIN CO LTD

OLOPATADINE HYDROCHLORIDE (KW 4679) MANUFACTURED IN OSAKA, JAPAN.

11802 I

II

1/5/1996

INHALE THERAPEUTICS SYSTEMS

11803 A

II

12/19/1995

QUIMICA SINTETICA SA

DRY POWDER AEROSOL PARAHYROID HORMONE (PTH) DRUG PRODUCT MANUFACTURED IN


PALO ALTO, CALIFORNIA.
LORATADINE MANUFACTURED IN MADRID, SPAIN.

11804 I

III

1/10/1996

3M PHARMACEUTICALS INC

A66154 50UL SPRAYMISER VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN.

11805 I

II

1/11/1996

SMITHKLINE BEECHAM PHARMACEUTICALS

CIMETIDINE MANUFACTURED IN CAMACARI-BAHIA, BRAZIL.

11806 I

1/15/1996

ORSYMONDE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF MODAFINIL DRUG SUBSTANCE IN MITRY-MORY MITRY-MORY CEDEX FRANCE.

11807 A

II

1/15/1996

FARCHEMIA SRL

MESALAMINE MANUFACTURED IN TREVIGLIO (BERGAMO) ITALY.

11808 A

II

1/9/1996

INTERQUIM SA

SERTACONAZOLE NITRATE MANUFACTURED IN BARCELONA, SPAIN.

11809 A

II

1/15/1996

ACS DOBFAR SPA

TRISODIUM CITRATE DIHYDRATE (STERILE) MANUFACTURED IN TRIBIANO MILANO, ITALY.

11810 A

II

1/16/1996

CHENG FONG CHEMICAL CO LTD

11811 A

II

1/15/1996

CIPLA LTD

PHENYLPROPANOLAMINE HYDROCHLORIDE MANUFACTURED IN TAIWAN, REPUBLIC OF


CHINA.
NORFLOXACIN USP MANUFACTURED IN KURKUMBH, INDIA.

11812 I

III

1/11/1996

CARCANO ANTONIO S.P.A.

11813 I

IV

1/15/1996

TIMERX TECHNOLOGIES

ALUMINIUM FOIL, SMOOTH, HARD TEMPER, .020 AND .025 MM LACQUERED MANUFACTURED
IN MANDELLO DEL LARIO-CO-ITALY.
TIMERX-O CONTROLLED RELEASE SYSTEM MANUFACTURED BY BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC. AND GLAXO WELLCOME INC. IN DANBURY, CONNECTICUT AND
QUEBEC, CANADA.

11814 I

II

1/17/1996

JANSSEN PHARMACEUTICA NV

RIDOGREL DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM.

11815 I

IV

12/20/1995

DAVID MICHAEL AND CO INC

11816 I

II

1/12/1996

SIGMA CHEMICAL CO

11817 A

III

1/18/1996

APTAR FRANCE SAS

MICHAELOK NATURAL LEMON-LIME FLAVOR WONF #1296 MANUFACTURED IN PHILADELPHIA,


PENNSYLVANIA.
CHOLESTERYL BENZOATE, STOCK NUMBER W 5389-2 MANUFACTURED BY SIGMA CHEMICAL
AND SIGMA DIAGNOSTICS IN ST. LOUIS, MISSOURI.
METERED DOSE VALVES MANUFACTURED BY APTAR IN LE VAUDREUIL, FRANCE

11818 I

1/17/1996

MITSUI CHEMICALS INC

11819 A

IV

1/17/1996

MITSUI CHEMICALS INC

11820 A

III

12/22/1995

SCHOTT AG PHARMACEUTICAL SYSTEMS


MULLHEIM

PRIMARY PACKAGING MATERIAL (VIALS, AMPULS, SYRINGES, CARTRIDGES) MANUFACTURED


IN LUKACSHAZA HUNGARY
OMEPRAZOLE MANUFACTURED IN CELRA (GIRONA) SPAIN.
PLASTIC AND METAL TUBES FOR NONPARENTERAL CONTAINERS MANUFACTURED IN OSAKA
AND KANAGAWA, JAPAN.
RIFAMYCIN S BULK MANUFACTURED IN CORANA (PAVIA) ITALY.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF PLGA5 IN NAGOYA, JAPAN.
PLGA5, POLY 9DL-LACTIDE-O(O-GLYCOLIDE), MANUFACTURED IN NAGOYA, JAPAN.
GLASS VIALS MANUFACTURED IN MULLHEIM, GERMANY.

Page 335

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11821 A
II
1/23/1996
SANOFI CHIMIE

SUBJECT
TILUDRONATE DISODIUM DRUG SUBSTANCE MANUFACTURED IN ARAMON, FRANCE.

11822 I

1/15/1996

11823 A

II

1/23/1996

RANQ PHARMACEUTICALS AND EXCIPIENTS PVT


LTD
ACS DOBFAR SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN MAHARASHTRA STATE INDIA.
CEFOXITIN ACID MANUFACTURED IN MILANO, ITALY.

11824 I

II

1/25/1996

HOECHST MARION ROUSSEL INC

11825 I

II

1/24/1996

PTI ADVANCED FILTRATION INC

RANITIDINE HYDROCHLORIDE USP, FORM 1 MANUFACTURED BY DOW CHEMICAL COMPANY


IN MIDLAND, MICHIGAN.
CLARIFLOW PRODUCT LINE MANUFACTURED IN NEWBURY PARK, CALIFORNIA.

11826 A

II

1/3/1996

ASPEN OSS BV

TESTOSTERONE MANUFACTURED IN OSS, THE NETHERLANDS.

11827 I

II

1/25/1996

CHEMICA

11828 A

II

1/26/1996

FARCHEMIA SRL

A-PHENYL-A-(2-PYRIDYL) ACETIC ACID METHYL ESTER MANUFACTURED IN LOS ANGELES,


CALIFORNIA.
NAPROXEN USP MANUFACTURED IN TREVIGLIO (BERGAMO) ITALY.

11829 I

II

1/24/1996

FIDIA FARMACEUTICI SPA

ACYCLOVIR SODIUM SALT MANUFACTURED IN MULAZZANO (MI), ITALY.

11830 I

II

1/24/1996

CU-67 BULK RADIOISOTOPIC PRODUCT MANUFACTURED IN LOS ALAMOS, NEW MEXICO.

11831 I

II

1/19/1996

LOS ALAMOS NATIONAL LABORATORY DEPT


ENERGY
VEREIN FUR KREBSFORSCHUNG

11832 I

1/19/1996

VEREIN FUR KREBSFORSCHUNG

11833 I

IV

1/19/1996

COURTAULDS CHEMICALS

11834 A

II

1/29/1996

CHEMI SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF ISCADOR QU SPEZIAL IN ARLESHEIM, SWITZERLAND.
SEPA 0009 (2-MONYL-1,3-DIOXACYCLOPENTANE) MANUFACTURED IN SCOTLAND, UNITED
KINGDOM.
BUPROPION HYDROCHLORIDE MANUFACTURED IN PATRICA (FROSINONE) ITALY.

11835 I

1/29/1996

ASAHI GLASS CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF BFBB MANUFACTURED BY SEIMI CHEMICAL CO., LTD. IN KANAGAWA, JAPAN.

11836 I

II

1/29/1996

ASAHI GLASS CO LTD

BFBB MANUFACTURED BY SEIMI CHEMICAL CO., LTD. IN KANAGAWA, JAPAN.

11837 A

III

1/18/1996

AMPACET CORP

19571 BLACK POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA,


DERIDDER, LOUISIANA, CARTERSVILLE, GEORGIA OR BY AMPACET EUROPE S.A., IN
MESSANCY, BELGIUM.

11838 I

II

1/30/1996

YAMAKAWA CHEMICAL INDUSTRY CO LTD

BOC-PIPERAZINE MANUFACTURED IN IBARAKI, JAPAN.

11839 I

II

1/17/1996

GENPHARM INC

11840 I

1/15/1996

11841 I

II

1/29/1996

COVANCE PHARMACEUTICAL PACKAGING


SERVICES INC
NAPRO BIOTHERAPEUTICS INC

RANITIDINE HYDROCHLORIDE USP FORM 1 MANUFACTURED IN LLICA DE VALL AND SAINT


CELONI BARCELONA, SPAIN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
OF PACKAGING OF CLILNICAL TRIALS SUPPLIES IN BASEL, SWITZERLAND.
PACLITAXEL DRUG SUBSTANCE MANUFACTURED IN BRITISH COLUMBIA, CANADA.

11842 I

II

1/26/1996

ARCHIMICA SPA

SANCYCLINE MANUFACTURED IN ORIGGIO VARESE, ITALY.

11843 I

II

2/5/1996

EURAND INTERNATIONAL SPA

11844 I

III

10/12/1995

POLIMERI EUROPA

11845 I

II

2/6/1996

NISSAN CHEMICAL INDUSTRIES LTD

DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS MANUFACTURED IN CINISELLO


BALSAMO (MI) ITALY.
GREENFLEX FF 55 M (MEDICAL GRADE) MANUFACTURED BY POLIMERI EUROPA GMBH IN
OBERHAUSEN, GERMANY.
ALPROSTADIL MANUFACTURED IN YAMAGUCHI, JAPAN.

11846 I

IV

2/5/1996

EASTMAN CHEMICAL CO

DIETHYL PHTHALATE, NF MANUFACTURED IN KINGSPORT, TENNESSEE.

11847 I

II

2/8/1996

NORDION INTERNATIONAL INC

DOPASCAN INJECTION MANUFACTURED IN VANCOVER, B.C. CANADA.

11848 A

II

2/8/1996

BETAMETHYL EPOXIDE MANUFACTURED IN KALAMAZOO, MICHIGAN.

11849 I

II

2/13/1996

PHARMACIA & UPJOHN (A WHOLLY OWNED


SUBSIDIARY OF PFIZER, INC.)
PHARM ECO LABORATORIES INC

ISCADOR QU SPEZIAL MANUFACTURED IN ARLESHEIM, SWITZERLAND.

2(R)-HYDROXY-3(S) BOC-AMINO-4-PHENYL-1-AMINOBUTANE MANUFACTURED IN NORTH


ANDOVER, MASSACHUSETTS.

Page 336

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11850 I
I
2/5/1996
CIBA GEIGY CORP PHARMACEUTICALS DIV

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
BY CIBA-GEIGY SPA IN TORRE ANNUNIAA (NAPLES) ITALY.
41121-22 MANUFACTURED IN COLUMBUS, GEORGIA.

11851 A

III

2/16/1996

BERRY PLASTICS CORP

11852 I

III

2/14/1996

11853 I

3/4/1996

CLARIANT CORPORATION - MASTERBATCHES


DIVISION
SEPPIC DIV AIR LIQUIDE

11854 I

IV

2/13/1996

SYMRISE INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN GIVAUDAN LAVIROTTE, LYON, FRANCE.
CHERRY FLAVORING 9/021529 MANUFACTURED IN HOLZMINDEN, GERMANY.

11855 I

IV

2/13/1996

SYMRISE INC

CHERRY FLAVORING 9/021935 MANUFACTURED IN HOLZMINDEN, GERMANY.

11856 I

II

2/19/1996

BIOSEPRA SA

11857 I

II

2/9/1996

WOODWARD IODINE CORP

CM-HYPERD (10U, 20U, F AND M GRADES) MANUFACTURED IN VILLENEUVE-LA GARENNE,


FRANCE.
IODINE (USP IODINE) MANUFACTURED IN WOODWARD, OKLAHOMA.

11858 I

III

2/14/1996

11859 A

IV

2/16/1996

CLARIANT CORPORATION - MASTERBATCHES


DIVISION
MERCK SHARP AND DOHME CORP

11860 I

II

2/19/1996

TASMANIAN ALKALOIDS PARTY LTD

POLYVINYL ACETATE-CROTONIC ACID COPOLYMER MANUFACTURED IN EAST PALO ALTO,


CALIFORNIA. FOR MERCK AND CO INC
BUPRENORPHINE BASE MANUFACTURED IN TASMANIA, AUSTRALIA.

11861 I

III

2/26/1996

GRAND POLYMER CO LTD

GRANDPOLYPRO F300(I) AND F305(I) MANUFACTURED IN CHIBA, JAPAN.

11862 I

II

2/8/1996

MEDICHEM SA

OXAPROZIN MANUFACTURED IN CELRA (GERONA) SPAIN.

11863 I

II

2/14/1996

BROOKHAVEN NATIONAL LAB

CU-67 BULK RADIOISOTOPIC PRODUCT MANUFACTURED IN UPTON, NEW YORK.

11864 I

II

1/1/1996

DSM DERETIL

11865 I

2/19/1996

DUDEK PLAST AS

11866 A

II

2/27/1996

ESTEVE QUIMICA SA

D-(-) ALPHA PHENYLGLYCINE CHLORIDE HYDROCHLORIDE MANUFACTURED IN ALMERIA,


SPAIN.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN JONSTRUP, DENMARK.
ENALAPRIL MALEATE MANUFACTURED IN BARCELONA, SPAIN.

11867 I

II

2/28/1996

CILAG AG

OXAPROZIN MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

11868 A

IV

2/27/1996

ENDO PHARMACEUTICALS INC

11869 I

2/21/1996

PLASRO PLASTICS LTD

11870 A

III

2/29/1996

BERRY PLASTICS CORP

TIMERX CONTROLLED RELEASE SYSTEMS MANUFACTURED IN KIRKLAND, QUEBEC, CANADA


FOR PENWEST PHARMACEUTICALS CO
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN SURREY, UNITED KINGDOM.
41708-34 MANUFACTURED IN COLUMBUS, GEORGIA.

11871 A

III

2/28/1996

DESICCARE INC

PACKAGING MATERIALS PILLOW PAKS MANUFACTURED IN SANTA FE SPRINGS, CALIFORNIA.

11872 I

III

2/19/1996

MITSUI CHEMICALS INC

MIRASON 14P MANUFACTURED IN CHIBA, JAPAN.

11873 I

III

2/27/1996

B BRAUN MEDICAL INC

11874 I

2/28/1996

BOEHRINGER MANNHEIM SA

11875 I

IV

2/28/1996

MARUTI INDUSTRIAL CARBOHYDRATES LTD

QUALIFICATION AND MANUFACTURING OF EXCEL PLASTIC IV CONTAINER MANUFACTURED


IN IRVINE, CALIFORNIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN BARCELONA, SPAIN.
MICROCRYSTALLINE CELLULOSE (MCC) MANUFAURED IN TAMILNADU, INDIA.

11876 A

II

2/28/1996

BK GIULINI GMBH

SUCRALFATE POWDER MANUFACTURED IN LUDWIGSHAFEN/RHEIN, GERMANY.

11877 A

II

3/4/1996

SCI PHARMTECH INC

ARTICAINE HYDROCHLORIDE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

11878 I

2/27/1996

MCGAW INC

11879 A

II

2/29/1996

MICROBIOPHARM JAPAN CO LTD

STERILIZATION AND MICROBIOLOGY PROGRAM FOR EXCEL PLASTIC IV CONTAINER


MANUFACTURED IN IRVINE, CALIFORNIA.
DAUNORUBICIN HYDROCHLORIDE (CRUDE) MANUFACTURED IN KUMAMOTO AND SHIZUOKA,
JAPAN.

GLC-16004 25/1 LIME COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS.

BLC-16005 25/1 PEARL BLUE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS.

Page 337

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11880 I
III
3/5/1996
TUBEX LTD IRELAND

SUBJECT
COLLAPSIBLE ALUMINIUM TUBES MANUFACTURED IN TIPPERARY, IRELAND.

11881 A

III

3/5/1996

AMCOR FLEXIBLES BURGDORF GMBH

11882 I

II

3/13/1996

ORION CORP FERMION

COMPOUND PACKAGING MATERIAL PAPER/OPA/ALUMINIUM/PAN-BAREX MATERIAL #SOP


50963 MANUFACTURED IN BURGDORF, SWITZERLAND.
TERAZOSIN HYDROCHLORIDE DIHYDRATE MANUFACTURED IN ESPOO, FINLAND.

11883 I

II

3/8/1996

EAGLE PICHER INDUSTRIES INC

CEP-2563 DIHYDROCHLORIDE MANUFACTURED IN LENEXA, KANSAS.

11884 I

IV

3/4/1996

MYLAN TECHNOLOGIES INC

BERTEK CODE 44119 MEDILAM 3600 MANUFACTURED IN ST. ALBANS, VERMONT.

11885 I

II

2/28/1996

UCB SA PHARMACEUTIQUE SECTEUR

PIRACETAM MANUFACTURED IN BRAINE L'ALLEUD, BELGIUM.

11886 I

II

2/28/1996

UCB SA PHARMA SECTOR

PIRACETAM TABLETS 80 MG AND 1200 MG MANUFACTURED IN BRAINE L'ALLEUD, BELGIUM.

11887 I

II

3/6/1996

IROTEC LABORATORIES

SOTALOL HYDROCHLORIDE MANUFACTURED IN CORK, IRELAND.

11888 A

II

3/8/1996

SIGMA ALDRICH IRELAND LTD

PROMETHAZINE HYDROCHLORIDE MANUFACTURED IN WICKLOW, IRELAND.

11889 A

II

3/11/1996

OMICRON QUIMICA SA

BISMUTH SUBSALICYLATE MANUFACTURED IN CANOVELLES, SPAIN.

11890 I

II

2/22/1996

ISOCHEM SA

FLUMECINOL MANUFACTURED IN GENNEVILILERS, FRANCE.

11891 I

II

2/28/1996

MARUTI INDUSTRIAL CARBOHYDRATES LTD

SODIUM CARBOXYMETHYL CELLULOSE (CMC) MANUFACTURED IN TAMILNADU, INDIA.

11892 I

II

3/14/1996

PHARM ECO LABORATORIES INC

3(S)-N-(3-FURANOXYCARBONYL)AMINO-1-(N,N-ISOBUTYLAMINO, 4AMINOBENZENESULFONYL)AMINO-2(S)-HYDROXY-4-PHENYLBUTANE MANUFACTURED IN


NORTH ANDOVER, MASSACHUSETTS.

11893 A

II

3/18/1996

BORREGAARD AS, BORREGAARD SYNTHESIS

IOXILAN BULK DRUG SUBSTANCE MANUFACTURED IN SARPSBORG, NORWAY.

11894 I

II

3/15/1996

FINE CHEMICALS CORP

ASTEMIZOLE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

11895 I

3/11/1996

FOREST LABORATORIES IRELAND LTD

11896 A

II

3/18/1996

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN DUBLIN, IRELAND.
ACYCLOVIR MANUFACTURED IN LLICA DE VALL AND SAINT CELONI BARCELONA, SPAIN.

11897 I

II

3/21/1996

HOECHST CELANESE CORP

CLONAZEPAM MANUFACTURED IN CORPUS CHRISTI, TEXAS.

11898 I

II

3/11/1996

CIS US INC

11899 A

II

3/25/1996

OLON SPA

META-IODOBENZYLGUANIDINE SULFATE (MIBG-S) MANUFACTURED IN BEDFORD,


MASSACHUSETTS.
HYDROXYUREA MANUFACTURED IN MULAZZANO, (MI) ITALY.

11900 A

II

3/22/1996

MEITO SANGYO CO LTD

IRON OXIDE/CARBOXYDEXTRAN SOL MANUFACTURED IN AICHI, JAPAN.

11901 I

II

3/26/1996

ARZNEIMITTELWERK DRESDEN GMBH

CARBAMAZEPINE MANUFACTURED IN RADEBEUL, GERMANY.

11902 A

II

3/26/1996

ALBEMARLE CORP

FLURBIPROFEN USP & BP MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

11903 I

II

3/29/1996

AARON INDUSTRIES INC

ZINC GLUCONATE USP MANUFACTURD IN CLINTON, SOUTH CAROLINA.

11904 I

3/29/1996

11905 A

II

3/29/1996

SHANDONG WEI FANG PHARMACEUTICAL


FACTORY
SHANDONG WEIFANG PHARMACEUTICAL
FACTORY CO LTD
NOT AN ASSIGNED NUMBER

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF CAPTOPRIL USP IN SHANDONG, PEOPLES REPUBLIC OF CHINA.
CAPTOPRIL USP MANUFACTURED IN SHANDONG, THE PEOPLES REPUBLIC OF CHINA.

11907 A

II

3/31/1996

KOEI CHEMICAL CO LTD

11908 I

II

3/29/1996

KOEI CHEMICAL CO LTD

2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE MANUFACTURED IN
OSAKA, JAPAN.
(3-N-ISOPROPYLAMINO-2-PIPERAZINYL) PYRIDINE MANUFACTURED IN OSAKA, JAPAN.

11909 A

II

3/29/1996

YUNNAN HANDE BIO TECH CO LTD

11910 A

II

3/28/1996

SUNLIT FLUO AND CHEMICAL CO LTD

11911 I

II

3/29/1996

MILLIPORE CORP

11906 N

PACLITAXEL DRUG SUBSTANCE MANUFACTURED IN KUNMING, PEOPLES REPUBLIC OF


CHINA.
SODIUM FLUORIDE USP MANUFACTURED IN TAIWAN, PEOPLES REPUBLIC OF CHINA AND BY
HASHIMOTO CHEMICAL CORPORATION IN OSAKA, JAPAN.
PROSEP A HIGH CAPACITY MANUFACTURED IN COUNTY DURHAM, UNITED KINGDOM.

Page 338

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11912 I
III
4/2/1996
NALGE NUNC INTL

SUBJECT
NALGENE PETG MEDIA AND SERUM BOTTLES MANUFACTURED IN ROCHESTER, NEW YORK.

11913 I

IV

3/28/1996

DAVID MICHAEL AND CO INC

ARTIFICIAL TUTTI FLAVOR #16007 MANUFACTURED IN PHILADELPHIA, PENNSYLVANIA.

11914 I

III

3/21/1996

BASF AKTIENGESELLSCHAFT

NOVOLEN 3245 PC MANUFACTURED BY BASF ESPANOLA S.A. IN TARAGONA, SPAIN.

11915 I

III

4/8/1996

DSM RESEARCH

RONFALIN SFC34-** MANUFACTURED IN BEEK, THE NETHERLANDS.

11916 I

4/3/1996

SCHERING PLOUGH PRODUCTS INC

11917 I

II

4/9/1996

BOEHRINGER MANNHEIM SA

STERILE PRODUCTS MANUFACTURING UPGRADE MANUFACTURED IN MANATI, PUERTO


RICO.
4-EPITETRACYCLINE HYDROCHLORIDE MANUFACTURED IN BARCELONA, SPAIN.

11918 I

II

4/9/1996

BOEHRINGER MANNHEIM SA

N-DECYLMETHYLSULFOXIDE MANUFACTURED IN BARCELONA, SPAIN.

11919 I

II

4/9/1996

BOEHRINGER MANNHEIM SA

TOPICYCLINE MANUFACTURED IN BARCELONA, SPAIN.

11920 A

II

4/9/1996

PHARM ECO LABORATORIES INC

11921 I

III

4/9/1996

EXXON CHEMICAL CO

11922 I

II

4/15/1996

11923 I

IV

4/10/1996

R.W JOHNSON PHARMACEUTICAL RESEARCH


INSTITUTE
F AND C WILD FLAVORS INC

L-2'[2-1-METHYL-2-PIPERIDYL)ETHYL] CINNAMANILIDE MANUFACTURED IN LEXINGTON AND


NORTH ANDOVER, MASSACHUSETTS.
ESCORENE PP 1385 H1 MANUFACTURED BY EXXON CHEMICAL FRANCE IN NOTRE-DAME-DEGRAVENCHON, FRANCE.
17-DEACETYLNORGESTIMATE/ETHINYL ESTRADIOL TRANSDERMAL CONTRACEPTIVE
SYSTEM MANUFACTURED IN REDWOOD CITY, CALIFORNIA.
ARTIFICIAL TOASTED COCONUT FLAVOR #18408T MANUFACTURED IN CINCINNATI, OHIO

11924 I

II

4/17/1996

GROUPE LIPHA

11925 I

II

4/17/1996

CATALYTICA PHARMACEUTICALS INC

11926 I

IV

4/16/1996

ALEX FRIES AND BROTHERS INC

11927 A

II

4/17/1996

CAMBREX PROFARMACO MILANO SRL

11928 I

III

4/17/1996

CATALENT PHARMA SOLUTIONS LLC

11929 A

IV

4/15/1996

PAULAUR CORP

11930 I

III

4/11/1996

AMPACET CORP

11931 I

3/20/1996

EASTERN COOPERATIVE ONCOLOGY GROUP

11932 A

II

4/17/1996

LONZA AG

11933 I

IV

5/17/1996

WORTHEN INDS

11934 I

II

4/16/1996

STANDARD ORGANICS LTD

DL-2-(DIFLUOROMETHYL) ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE


MANUFACTURED IN VISP, SWITZERLAND.
TWO-PART POLYURETHANE LAMINAING ADHESIVES SYSTEM SW 042/SW-043
MANUFACTURED IN NASHUA, NEW HAMPSHIRE.
TRIMETHOPRIM USP (NON-STERILE BULK) MANUFACTURED IN ANDHRA PRADESH, INDIA.

11935 A

II

4/18/1996

WOCKHARDT LTD

DEXTROMETHORPHAN HYDROBROMIDE USP MANUFACTURED IN GUJARAT STATE, INDIA.

11936 I

II

4/19/1996

SYNKEM DIV PLASTO SA

PHENTOLAMINE MESYLATE MANUFACTURED IN CHENOVE, FRANCE.

11937 I

II

6/12/1996

MOUNT SINAI MEDCTR

INDIUM-111 CHLORIDE STERILE SOLUTION, MANUFACTURED IN MIAMI, FLORIDA.

11938 A

II

4/18/1996

BASF PHARMA EVIONNAZ SA

11939 I

II

4/23/1996

ALBEMARLE CORP

BUPIVACAINE BASE MANUFACTURED IN EVIONNAZ, SWITZERLAND OR BY ORGAMOL FRANCE


IN ST-VULBAS, FRANCE.
NAPROXEN (RACEMIC) MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA.

11940 I

II

4/25/1996

ALBEMARLE CORP

NAPROXEN SODIUM MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA.

11941 I

II

4/25/1996

ALBEMARLE CORP

NAPROXEN MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA.

11942 I

II

4/24/1996

YAMASA CORP

2'-DEOXYADENOSINE MONOHYDRATE MANUFACTURED IN CHIBA-KEN, JAPAN.

11943 I

II

4/24/1996

YAMASA CORP

2'-DEOXYCYTIDINE HYDROCHLORIDE MANUFACTURED IN CHIBA-KEN, JAPAN.

METFORMIN HYDROCHLORIDEMANUFACTURED BY LIPHA SEMOY IN SEMOY CEDEX,


FRANCE.
N-ISOPROPYL-2(1-PIPERAZINYL)-3-PYRIDINAMINE MANUFACTURED IN EAST PALO ALTO,
CALIFORNIA.
ARTIFICIAL STRAWBERRY ICE CREAM FLAVOR 84-192 W/S LIQUID MANUFACTURED IN
CINCINNATI, OHIO.
TERBUTALINE SULFATE MANUFACTURED IN PAULLO (MILANO) ITALY.
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
IN HUMACAO, PUERTO RICO.TYPE I CONVERSION TO TYPE III
NONPAREIL SEEDS (SUGAR SPHERES, N.F.) MANUFATURED IN CRANBURY, NEW JERSEY.
100600 UV POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE, INDIANA,
DERIDDER, LOUISIANA, CARTERSVILLE, GEORGIA, AND MESSANCY, BELGIUM.
CLINICAL TRIALS BY ECOG IN BROOKLINE, MASSACHUSETTS.

Page 339

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11944 I
II
4/24/1996
YAMASA CORP

SUBJECT
2'-DEOXYGUANOSINE MONOHYDRATE MANUFACTURED IN CHIBA-KEN, JAPAN.

11945 I

II

4/24/1996

YAMASA CORP

THYMIDINE MANUFACTURED IN CHIBA-KEN, JAPAN.

11946 I

II

4/25/1996

LABORATORI MAG SPA

FENFLURAMINE HYDROCHLORIDE MANUFACTURED IN GARBAGNATE, MILANESE, ITALY.

11947 A

II

4/26/1996

BASF PHARMA EVIONNAZ SA

11948 A

II

4/24/1996

EVONIK TECHNOCHEMIE GMBH

OXYBUTYNIN BASE MANUFACTURED IN EVIONNAZ, SWITZERLAND OR BY ORGAMOL FRANCE


S.A. IN ST-VULBAS, FRANCE.
NIFEDIPINE MANUFACTURED IN RADEBEUL, GERMANY.

11949 A

IV

4/23/1996

F AND C WILD FLAVORS INC

11950 I

II

5/1/1996

MOUNT SINAI MEDCTR

11951 A

II

4/29/1996

CHEMI SPA

ARTIFICIAL CHERRY RASPBERRY FLAVORS #101253 AND 10125T MANUFACTURED IN


CINCINNATI, OHIO.
BULK RADIOCHEMICAL THALLIUM-201 CHLORIDE AND THALLIUM-201 STERILE SOLUTION
MANUFACTURED IN MIAMI BEACH, FLORIDA.
5-ASA MANUFACTURED IN PATRICA (FROSINONE) ITALY.

11952 I

II

5/2/1996

CHEMI SPA

5-ASA CRYSTALLIZED MANUFACTURED IN PATRICA (FROSINONE) ITALY.

11953 I

II

5/3/1996

MOUNT SINAI MEDCTR

BULK RADIOCHEMICAL GALLIUM-67 CHLORIDE MANUFACTURED IN MIAMI BEACH, FLORIDA.

11954 I

II

5/3/1996

DSM ANDENO BV

R-SETRON-S MANUFACTURED IN VENLO, THE NETHERLANDS.

11955 I

5/6/1996

LUKIAN PLASTIC CLOSURES LTD

11956 I

II

5/9/1996

MITSUBISHI CHEMICAL CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF PLASTIC CAPS IN ONTARIO, CANADA.
MKC-442 DRUG SUBSTANCE MANUFACTURED IN IBARAKI PREFECTURE, JAPAN.

11957 I

IV

5/8/1996

KERRY INC DBA MASTERTASTE INC

11958 A

II

5/2/1996

AMRI RENSSELAER INC

NATURAL AND ARTIFICIAL RASPBERRY FLAVOR FOR MASKING 650008 MANUFACTURED IN


TETERBORO, NEW JERSEY.
METOLAZONE, USP MANUFACTURED IN RENSSELAER, NEW YORK.

11959 A

II

5/6/1996

PERRIGO API LTD

TRAMADOL HYDROCHLORIDE MANUFACTURED IN BE'ER SHEVA, ISRAEL.

11960 I

IV

5/9/1996

LACTOSE NEW ZEALAND LTD

LACTOSE MONOHYDRATE SPRAY DRIED NF, USP MANUFACTURED IN KAPUNI, NEW ZEALAND.

11961 I

III

5/6/1996

BOREALIS AS

PACKAGING MATERIAL HH315P MANUFACTURED IN STATHELLE, NORWAY.

11962 I

5/3/1996

3M PHARMACEUTICALS PARTY LTD

11963 A

IV

5/9/1996

JRS PHARMA GMBH AND CO KG

11964 I

5/9/1996

J RETTENMAIER & SOHNE GMBH + CO**

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN THRONLEIGH NSW, AUSTRALIA.
MICROCRYSTALLINE CELLULOSE USP NF VIVAPUR(TM) - VARIOUS GRADES (CAS NO.9004-346) MANUFACTURED IN WEISSENBORN, GERMANY
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE
OF MICROCRYSTALLINE CELLULOSE USP NF BY MICROCELLULOSE WEISSENBORN GMBH +
CO IN WEISSENBORN, GERMANY.

11965 I

III

5/8/1996

CLARIANT CORPORATION

CLC-16645 25/1 LIGHT GREY COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS.

11966 A

II

2/21/1996

QUIMICA SINTETICA SA

11967 I

IV

5/9/1996

WILLETT SYSTEMS LTD

CIPROFLOXACIN HYDROCHLORIDE (NEW SYNTHETIC PATHWAY) MANUFACTURED IN


MADRID, SPAIN.
CIJ ETHANOL MICRO PILL CODING BLUE PART201-0001-220,FG SF TOP-UP PART201-0001221,ET 3920E BLUE & TOP-UP PART201-0001-620 &201-0001-720 AND CIJ ET 3912F
WASHDOWN PART 201-0001-721 MANUFACTURED BY WARNER JENKINSON EUROPE IN
NORFOLK,UK

11968 A

II

5/17/1996

ERREGIERRE SPA

TICLOPIDINE HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY.

11969 I

5/14/1996

BACHEM FEINCHEMIKALIEN AG

11970 A

II

5/15/1996

CEPHALON FRANCE

11971 I

II

5/13/1996

GALENA AS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF BULK DRUG IN BUBENDORF, SWITZERLAND.
MODAFINIL DRUG SUBSTANCE MANUFACTURED IN MITRY-MORY CEDEX, FRANCE AND BY
ISOCHEM IN GENNEVILLIERS CEDEX, FRANCE.
CYCLOSPORINE MANUFACTURED IN OPAVA, CZECH REPUBLIC.

11972 I

II

5/10/1996

ROCHE PRODUCTS LTD

PYRIDOSTIGMINE BROMIDE TABLETS USP 30MG MANUFACTURED IN NUTLEY NJ

Page 340

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
11973 I
II
5/6/1996
GALENA AS

SUBJECT
BROMOCRIPTINE MESYLATE MANUFACTURED IN OPAVA, CZECH REPUBLIC.

11974 I

II

5/8/1996

MALLINCKRODT CHEMICAL INC

ACYCLOVIR, USP MANUFACTURED IN ST. LOUIS, MISSOURI.

11975 I

II

5/21/1996

CATALYTICA PHARMACEUTICALS

11976 I

II

5/14/1996

SANOFI SYNTHELABO INC.

11977 I

5/24/1996

HIKMA FARMACEUTICA PORTUGAL LDA

11978 I

II

5/24/1996

BACHEM INC

11979 I

III

5/13/1996

BASF AKTIENGESELLSCHAFT

5-METHANESULFONAMIDOINDOLE-2-CARBOXYLIC ACID (MACA) MANUFACTURED IN EAST


PALO ALTO, CALIFORNIA.
ALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE MANUFACTURED IN GARGENVILLE,
FRANCE.
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN
SINTRA, PORTUGAL
CORTICORTROPIN RELEASING FACTOR, HUMAN , ACETATE SALT MANUFACTURED IN
TORRANCE AND SAN DIEGO, CALIFORNIA.
STYROLUX 656 C MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY.

11980 A

II

5/24/1996

QUIMICA SINTETICA SA

KETOROLAC TROMETHAMINE MANUFACTURED IN MADRID, SPAIN.

11981 I

II

5/29/1996

ACYCLOVIR MANUFACTURED IN TRECATE AND SORBOLO, ITALY.

11982 I

II

5/31/1996

ISTITUTO BIOLOGICO CHEMIOTERAPICO SPA


DIVISIONE UNIBIOS
YAMANOUCHI PHARMACEUTICAL CO LTD

11983 I

II

5/31/1996

TAIHO PHARMACEUTICAL CO LTD

TAS-103 MANUFACTURED IN SAITAMA, JAPAN.

11984 A

II

6/3/1996

ESTEVE QUIMICA SA

NABUMETONE MANUFACTURED IN BARCELONA, SPAIN.

11985 I

II

6/3/1996

LABORATORI MAG SPA

DEXFENFLURAMINE HYDROCHLORIDE MANUFACTURED IN GARBAGNATE MILANESE, ITALY.

11986 I

6/1/1996

11987 I

II

6/4/1996

NORTHEAST GENERAL PHARMACEUTICAL


FACTORY
LANXESS CORPORATION

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


IN BEI ST., TIEXI DISTRICT OF SHENYANG, P.R. CHINA.
PREVENTOL SB MANUFACTURED BY BAYER AG IN LEVERKUSEN AND DORMAGEN, GERMANY.

11988 I

III

6/7/1996

REXAM PHARMA SAS

11989 I

IV

5/10/1996

TRICON VEREDLUNGS GMBH

11990 I

II

6/6/1996

CHENG FONG CHEMICAL CO LTD

PLASTIC CHILDPROOF INNER LID PP WHITE WITH NEW MASTERBACH MANUFACTURED IN


OFFRANVILLE, FRANCE.
PET FILM 15U ONE SIDE ALUMINIZED AND PRIMERED, SECOND SIDE OCHER COLOUR
PRINTING MANUFACTURED IN FREIBURG, GERMANY.
DICLOFENAC POTASSIUM MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

11991 I

II

6/3/1996

GEDEON RICHTER LTD

VINCA ROSEA EXTRACT MANUFACTURED IN BUDAPEST, HUNGARY.

11992 I

II

6/7/1996

NATCO PHARMA LTD CHEMICAL DIV

FLUOXETINE HYDROCHLORIDE MANUFACTURED IN ANDHRA PRADESH, INDIA.

11993 I

6/4/1996

SANYO FINE CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF 5,6-DIMETHOXY-1-INDANONE MANUFACTURED IN HYOGO PREFECTURE, JAPAN.

11994 A

II

6/4/1996

SANYO FINE CO LTD

5,6-DIMETHOXY-1-INDANONE MANUFACTURED IN HYOGO PREFECTURE, JAPAN.

11995 A

II

6/10/1996

MERCK SANTE SAS

CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE MANUFACTURED IN MEYZIEU, FRANCE.

11996 A

IV

6/5/1996

LIPOID GMBH

11997 A

II

6/10/1996

GEDEON RICHTER PLC

LIPOID PC 18:0/18:0, 1, 2-DISTEAROYL-SN-GLYCERO-3-PHOSPHO CHOLINE MANUFACTURED


IN LUDWIGSHAFEN, GERMANY
3-KETODESOGESTREL MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY.

11998 A

III

5/24/1996

NIPRO CORP

VIALS MANUFACTURED IN SHIGA, JAPAN.

11999 I

II

6/12/1996

MOUNT SINAI MEDCTR

BULK RADIOCHEMICAL INDIUM-111 CHLORIDE MANUFACTURED IN MIAMI BEACH, FLORIDA.

12000 A

III

6/18/1996

12001 A

III

6/18/1996

12002 I

II

6/17/1996

CCC PLASTICS CANADA COLORS AND CHEMICALS WHITE MB 20-902 POLYETHELENE COLOUR CONCENTRATE MANUFACTURED IN COLBORNE,
LTD
ONTARIO, CANADA.
CANADA COLORS AND CHEMICALS LTD
WHITE WB 20-960 POLYETHELENE COLOUR CONCENTRATE MANUFACTURED IN COLBORNE,
ONTARIO, CANADA.
DIOSYNTH BV
VECURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS.

12003 A

II

6/17/1996

PERRIGO API LTD

YM435 MANUFACTURED IN IBARAKI-KEN, JAPAN.

AMMONIUM LACTATE MANUFACTURED IN BE'ER SHEVA, ISRAEL.

Page 341

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12004 I
IV
6/3/1996
TECHNOLOGY FLAVORS & FRAGRANCES INC

SUBJECT
ARTIFICIAL BLUEBERRY FLAVOR 844-443 MANUFACTURED IN AMITYVILLE, NEW YORK.

12005 I

IV

6/3/1996

TECHNOLOGY FLAVORS & FRAGRANCES INC

ARTIFICIAL BOYSENBERRY FLAVOR 844-509 MANUFACTURED IN AMITYVILLE, NEW YORK.

12006 I

IV

6/3/1996

TECHNOLOGY FLAVORS & FRAGRANCES INC

ARTIFICIAL BLUEBERRY FLAVOR 844-112 MANUFACTURED IN AMITYVILLE, NEW YORK.

12007 I

III

6/19/1996

3M PHARMACEUTICALS INC

COTRAN EVA FILM, MSP050994P MANUFACTURED BY 3M MEDICAL/SURGICAL DIVISION


PLANT AND 3M COMMERICAL GRAPHICS PILOT PLANT IN BROOKINGS, SOUTH DAKOTA AND
ST. PAUL, MINNESOTA.

12008 I

III

6/17/1996

DEBIO RECHERCHE PHARMACEUTIQUE SA

DEBIOJECT SINGLE DOSE DELIVERY SYSTEM

12009 A

II

6/19/1996

SIFAVITOR SRL

FLUOXETINE HYDROCHLORIDE MANUFACTURED IN FRAZIONE MAIRANO (MILANO) ITALY.

12010 A

II

6/20/1996

YUKI GOSEI KOGYO CO LTD

TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN

12011 I

6/20/1996

MYLAN INC

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES


OF TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.

12012 I

II

6/24/1996

DEGUSSA AG

CISPLATIN MANUFACTURED IN HANAU, GERMANY.

12013 I

III

6/25/1996

HYGENIC CORP

TUBING GAR1030 MANUFACTURED IN CUYAHOGA FALLS, OHIO.

12014 I

6/24/1996

PPD WARS DIV PPD CRV INC

12015 A

II

6/25/1996

PFANSTIEHL INC

METHODS WARS-P317.01 DETERMINATION OF CLOZAPINE AND NORMETHYLCLOZAPINE IN


HUMAN PLASMA BY GAS LIQUID CHROMATOGRAPHY
MALTOSE HIGH PURITY HYDRATE (LOW ENDOTOXIN)

12016 A

III

6/25/1996

BD MEDICAL PHARMACEUTICAL SYSTEMS

PLASTIC PRE-FILLABLE STERILE SYRINGE SYSTEM

12017 I

II

6/27/1996

ICN CZECH REPUBLIC AS

L-EPHEDRINE HYDROCHLORIDE, MANUFACTURED IN ROZTOKY, CZECH REPUBLIC

12018 I

II

6/28/1996

AVANTI POLAR LIPIDS INC

TETRAMYRISTOYL CARDIOLIPIN (14:0 CA) MANUFACTURED IN ALABASTER, ALABAMA

12019 I

II

6/28/1996

ABBOTT LABORATORIES

D-CHIRO-INOSITOL, MANUFACTURED IN NORTH CHICAGO, IL

12020 I

II

6/25/1996

CHIREX LTD

KETOPROFEN MANUFACTURED IN DUDLEY ENGLAND

12021 A

II

6/27/1996

ESTEVE QUIMICA SA

DICLOFENAC POTASSIUM MANUFACTURED IN TARRAGONA SPAIN

12022 I

II

7/3/1996

GE SILICONES

12023 A

II

6/25/1996

QUIMICA SINTETICA SA

BAYSILONE FLUID M PH 300, 350, 500, 1000, 1500, MANUFACTURED IN BAYERWERK,


GERMANY
KETOCONAZOLE MANUFACTURED IN MADRID SPAIN

12024 I

7/1/1996

PPD WARS DIV PPD CRV INC

12025 I

II

7/3/1996

WATSON LABORATORIES

12026 I

II

7/2/1996

TAKEDA CHEMICAL INDUSTRIES LTD

DETERMINATION OF N-0923 IN HUMAN PLASMA BY GC/MS (WARS-P333.00) AND BY LC/MS/MS


(WARS P380.00)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG
MANUFACTURED IN CORONA, CA 91720
TAK-603,MANUFACTURED IN OSAKA, JAPAN

12027 I

III

6/18/1996

DRYCOLOR AB

MASTER BACH PE 192214 MANUFACTURED IN MALMO, SWEDEN

12028 I

II

7/8/1996

MICROBIOPHARM JAPAN CO LTD

12029 I

II

7/3/1996

WATSON LABORATORIES

(1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLSILYLOXY) ANDROST-5-EN-17-ONE (SI-HDEA)


MANUFACTURED IN KANAGAWA 251, JAPAN
HYDROCODONE BITARTRATE TABLETS, 10 MG MANUFACTURED IN CORONA, CALIFORINA

12030 I

II

7/2/1996

ASH STEVENS INC

2',3'-DIDEOXY-2'-B-FLUORO-ADENOSINE MANUFACTURED IN RIVERVIEW, MI

12031 I

III

7/11/1996

POLYFIL CORP

AMC-0500-50 AND AMC-0500-95 MANUFACTURED IN DOVER, NEW JERSEY

12032 I

II

7/5/1996

NORDMARK ARZNEIMITTEL GMBH

12033 I

7/30/1996

GROUPE LIPHA

12034 I

6/25/1996

GENELABS DIAGNOSTICS PTE LTD

12035 I

II

7/3/1996

BRITISH BIOTECHNOLOGY PLC

PANCRELIPASE ENTERIC COATED MICROTABLETS MANUFACTURED IN UETERSEN,


GERMANY
LIPHA LACASSAGNE; MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND
PERSONNEL
MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN
SINGAPORE
LEXIPAFANT (BB-882) TABLETS MANUFACTURED IN EDINBURG, SCOTLAND

Page 342

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12036 A
II
7/3/1996
SHASUN PHARMACEUTICALS LTD

SUBJECT
S-IBUPROFEN MANUFACTURED IN PONDICHERRY, INDIA

12037 A

II

7/10/1996

CAMBREX PROFARMACO MILANO SRL

12038 I

7/12/1996

ORGANICHEM CORP

NOREPINEPHRINE BITARTRATE OR NORADRENALINE ACID TARTRATE, MANUFACTURED IN


MILANO, ITALY
LINDESNES PLANT IN SPANGEREID NORWAY

12039 I

III

7/2/1996

ADVANCED ELASTOMER SYSTEM

ADVANCED ELASTOMER SYSTEMS PRODUCT BM62 MANUFACTURED IN AKRON, OHIO

12040 I

III

6/13/1996

BASF AKTIENGESELLSCHAFT

STYROFAN N 920 MANUFACTURED IN LUDWIGSHAFEN, (FEDERAL REPUBLIC OF GERMANY)

12041 A

III

7/5/1996

AMPAC FLEXIBLES AG

BOTTOM GUSSET BAGS MANUFACTURED IN KIRCHBERG, SWITZERLAND

12042 A

III

6/4/1996

INEOS OLEFINS AND POLYMERS USA

POLYPROPYLENE RESINS-GENERAL FORMULATIONS MANUFACTURED IN CHICAGO, ILLINOIS

12043 A

III

7/11/1996

LOPAREX BV

12044 I

III

7/10/1996

ISHIDA PRESS KOGYO CO LTD

FL2000TM 100 UM PET EASY\EASY (PRODUCT CODE 78G101) MANUFACTURED IN


APELDOORN, THE NETHERLANDS
STORAGE OF ALUMINUM CAPS FOR VIALS SAITAMA, JAPAN

12045 I

II

7/15/1996

GREAT LAKES CHEMICAL CORP INC

ISOFLURANE,MANUFACTURED IN EL DORADO, ARKANSAS

12046 A

II

7/19/1996

SYNTHESIA AS

MITOXANTRONE HYDROCHLORIDE USP MANUFACTURED IN SEMTIN, CZECH REPUBLIC

12047 A

III

7/16/1996

ALLTUB FRANCE SAS

ALUMINUM COLLAPSIBLE TUBES MANUFACTURED IN SAUMUR, FRANCE

12048 A

II

6/30/1996

FUJIAN FUKANG PHARMACEUTICAL CO LTD

GENTAMICIN SULFATE MANUFACTURED IN FUZHOU, CHINA

12049 I

II

7/19/1996

CUNO INC

ZETA PLUS DELIPID FILTER MEDIUM, MANUFACTURED IN STAFFORD SPRINGS, CT

12050 A

II

7/23/1996

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

VECURONIUM BROMIDE MANUFACTURED IN ZHEJIANG, CHINA

12051 I

III

7/19/1996

MYLAN TECHNOLOGIES INC

MEDIDERM 3800, MANUFACTURED IN ST. ALBANS, VT 05478

12052 A

II

7/18/1996

MALLINCKRODT INC

LEUPROLIDE ACETATE, MANUFACTURED IN ST. LOUIS, MISSOURI

12053 I

III

7/17/1996

TEUSCHER KUNSTSTOFF-TECHNIK AG

VETTER LYO-JECT MANUFACTURED IN GRECHEN, SWITZERLAND

12054 I

7/12/1996

TEUSCHER KUNSTSTOFF-TECHNIK AG

THE VETTER LYO-JECT MANUFACURED IN GRECHEN, SWITZERLAND

12055 I

II

7/19/1996

GENZYME PHARMACEUTICALS

12056 I

II

7/22/1996

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

N-[2-(5-METHOXYINDOL-3-YL)ETHYL] ACETAMIDE (MELATONIN) MANUFACTURED IN SUFFOLK,


ENGLAND
FENFLURAMINE HYDROCHLORIDE, MANUFACTURED IN VARESE, ITALY

12057 I

7/11/1996

KERPLAS NEUENBURG GMBH

12058 I

7/17/1996

ADVANCED MATERIAL RESOURCES

12059 A

II

7/26/1996

3M PURIFICATION INC

12060 I

II

7/26/1996

CUNO INC

ZETA PLUS CA, LA, SA, SERIES. MANUFACTURED A STAFFORD SPRINGS, CT.

12061 I

II

7/26/1996

CUNO INC

ZETA PLUS AP AND CP SERIES, MANUFACTURED IN STAFFORD SPRINGS, CT

12062 I

II

7/26/1996

CUNO INC

ZETA PLUS LP SERIES, MANUFACTURED IN STAFFORD SPRINGS, CT

12063 A

II

7/26/1996

EUTICALS SPA

VECURONIUM BROMIDE (P 3038), MANUFACTURED IN ROZZANO, ITALY

12064 A

II

7/30/1996

BORREGAARD AS, BORREGAARD SYNTHESIS

TAI I BULK INTERMEDIATE, MANUFACTURED IN SARPSBORG, NORWAY

12065 I

II

7/26/1996

LONZA LTD

SB 217063 AND SK&F 109077 MANUFACTURED IN VISP, SWITZERLAND.

12066 I

II

7/26/1996

LONZA LTD

SB 201999, MANUFACTURED IN VISP, SWITZERLAND

12067 I

II

7/23/1996

HOMATROPINE HYDROBROMIDE, MANUFACTURED IN INGELHIEM/RHEIN, GERMANY

12068 I

II

7/31/1996

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
MULTIPLE PEPTIDE SYSTEMS

12069 I

II

7/18/1996

GREEN SPRINGS BIOCHEMISTRY

PACLITAXEL, MANUFACTURED IN KUNMING AND LIJIANG, YUNNAN, PEOPLE'S REPUBLIC OF


CHINA

MANUFACTURING AND CONTROL PROCEDURES FOR PACKAGING. MANUFACTURING AT


NEUENBURG AM RHEIN/GERMANY
RAW MATERIAL MANUFACTURING SITE, FACILITIES, PROCESSED IN JIANYIN, JIONGSU
PROVINCE, CHINA.
ZETA PLUS FOR AP, CA, CP HP, HTP, HTM, LA, LP, LPM, M, SA, SP, VR, Z, ZA, ZB AND DEL
PRODUCT SERIES

P-113 SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA

Page 343

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12070 I
III
7/25/1996
XTP INC

SUBJECT
PACKAGING MATERIAL, MANUFACTURED IN BROOKLYN, NY

12071 I

II

8/2/1996

ORION CORP FERMION

DILTIAZEM HCL PROCESS II, MANUFACTURED IN HANKO, FINLAND

12072 I

II

8/5/1996

LIANYUNGANG PHARMACEUTICAL FACTORY

MESNA, MANUFACTURED IN JIANGSU PROVINCE, PEOPLE'S REPUBLIC OF CHINA

12073 I

II

8/6/1996

BACHEM CALIFORNIA

ANGIOTENSIN II HUMAN, MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA

12074 I

II

8/6/1996

PTI ADVANCED FILTRATION INC

PROFLOW II, MANUFACTURED IN NEWBURY, CALIFORNIA

12075 I

III

8/7/1996

SABIC PETROCHEMICALS BV

12076 I

8/7/1996

12077 A

III

8/2/1996

KINGS COLLEGE SCH OF MEDICINE AND


DENTISTRY
GERRESHEIMER VAERLOESE AS

SABIC LDPE 2602TH00 LOW DENSITY POLYETHYLENE, MANUFACTURED IN THE


NETHERLANDS
PROPRIETARY CLINICAL STUDY RECORDS IN LONDON, UNITED KINGDOM

12078 A

II

8/5/1996

SYNKEM SAS

PACKAGING MATERIAL, MANUFACTURED IN VAERLOSE AND FREDRIKSSUND, DENMARK,


GISLAVED, AND VAXJO, SWEDEN, AND KENT, ENGLAND
FENOFIBRATE MANUFACTURED IN CHENOVE FRANCE

12079 A

II

8/7/1996

CELGENE CORP

FR901228 MANUFACTURED IN AICHI JAPAN

12080 I

II

8/6/1996

SUMITOMO CHEMICAL CO LTD

SB-210272 (INTERMEDIATE) MANUFACTURED IN OITA, JAPAN

12081 I

8/8/1996

GROUPE LIPHA

12082 I

IV

8/9/1996

SONUS PHARMACEUTICALS

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL LIPHA


MEYZIEU, MEYZIEU, FRANCE
MEDICAL GRADE PEG TELOMAR B MANUFACTURED IN BOTHELL WA

12083 I

8/8/1996

ACS DOBFAR SPA

MANUFACTURING FACILITIES, PERSONNEL, AND GENERAL OPERATIONS IN BERGAMO, ITALY

12084 I

8/13/1996

KREBS BIOCHEMICALS LTD

12085 I

II

8/13/1996

KREBS BIOCHEMICALS LTD

EPHEDRINE AND PSEUDOEPHEDRINE MANUFACTURING FACILITIES IN ANDHRA PRADESH,


INDIA
D-PSEUDOEPHEDRINE HYDROCHLORIDE, U.S.P., MANUFACTURED IN ANDHRA, INDIA

12086 A

II

8/2/1996

LUPIN LTD

7-ACCA AN INTERMEDIATE FOR CEFACLOR MANUFACTURED IN ANKLESHWAR, INDIA

12087 A

III

8/13/1996

TEKNI PLEX EUROPE NV

12088 I

II

8/9/1996

POLFA TARCHOMIN

PE-BUTYL PLASTIC STRIP FORMULA, FORMULA S8501, MANUFACTURED IN EREMBODEGEM,


BELGIUM
6AP ACID, MANUFACTURED IN WARSAW, POLAND

12089 I

II

8/12/1996

CILAG AG

BUPROPION HYDROCHLORIDE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

12090 I

II

8/13/1996

LOHMANN LTS

ASPIRIN-TTS (ACETYLSALICYLIC ACID - TRANSDERMAL THERAPEUTIC SYSTEM)

12091 I

II

8/13/1996

DINAMITE DIPHARMA SPA

NABUMETONE MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES

12092 A

II

8/1/1996

NOVACYL SAS

ASPIRIN USP (RHODINE (TM)) MANUFACTURED IN THAILAND

12093 I

II

8/20/1996

ABBOTT LABORATORIES

SIMETHICONE COATED CELLULOSE (SONORX); MANFACTURED IN NORTH CHICAGO, IL

12094 A

II

8/20/1996

JIANGXI DONGFENG PHARMACEUTICAL LLC

12095 I

III

8/5/1996

CKS PACKAGING, INC.

PENICILLIN G POTASSIUM (INDUSTRY GRADE), MANUFACTURED IN JIANGXI PROVINCE,


PEOPLE'S REPUBLIC OF CHINA
CLEAR AND WHITE PVC CYLINDER, MANFACTURED IN MOORESVILLE, NORTH CAROLINA

12096 I

III

8/20/1996

12097 A

II

8/23/1996

CLARIANT CORPORATION - MASTERBATCHES


DIVISION
BASF GRENZACH GMBH

CLC-16645-A 25/1 LIGHT GREY COLOR CONCENTRATE, MANUFACTURED IN MCHENRY,


ILLINOIS
TRICLOSAN MANUFACTURED IN GRENZACH-WYHLEN, GERMANY

12098 A

II

8/20/1996

HYDROMORPHONE HCL, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

12099 I

8/26/1996

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
SHANDONG LUKANG PHARMACEUTICAL CO LTD

12100 A

III

8/1/1996

MYLAN TECHNOLOGIES INC

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL AT JINING


CITY, SHANDONG PROVINCE, CHINA
BERTEK CODE 44127 MEDIFLEX 1000 MANUFACTURED IN ST ALBANS, VERMONT

12101 I

IV

8/19/1996

CARGILL FLAVOR SYSTEMS

WATERMELON F-11420, MANFACTURED IN LANGHORNE PENNSYLVANIA

12102 A

IV

8/21/1996

EVONIK ROHM GMBH

PLASTOID B, MANUFACTURED IN DARMSTADT, GERMANY

Page 344

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12103 A
II
8/28/1996
MALLINCKRODT INC

SUBJECT
SODIUM MOLYBDATE (99MO) AS MANUFACTURED IN PETTEN, HOLLAND

12104 A

II

8/28/1996

AVANTI POLAR LIPIDS INC

TRIOLEIN, MANUFACTURED IN ALABASTER, ALABAMA

12105 A

II

8/28/1996

AVANTI POLAR LIPIDS INC

12106 I

7/10/1996

LUKIAN PLASTIC CLOSURES LTD

1, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC), MANUFACTURED IN ALABASTER,


ALABAMA
PLASTIC CAP MANUFACTURING SITE IN POINTE CLAIRE, QUEBEC

12107 I

II

8/29/1996

DIOSYNTH BV

AC/2 OXALATE; MANUFACTURED IN OSS, THE NETHERLANDS

12108 A

III

8/12/1996

LOPAREX LLC

12109 A

III

8/22/1996

LOPAREX LLC

12110 I

III

8/22/1996

LOPAREX INC

12111 I

III

8/22/1996

LOPAREX INC

12112 I

III

8/22/1996

LOPAREX INC

12113 A

III

8/22/1996

LOPAREX LLC

12114 I

9/3/1996

SHOWA KAKO CORP

12115 I

II

8/29/1996

SICOR SPA

GRADE 15462, 10 MIL NT STY 92A/000 SILICONE COATED RELEASE LINER, MANUFACTURED IN
IOWA CITY, IA; BEDFORD PARK, IL; EDEN, NC
GRADE 15020, 3 MIL CL PET B22/000 SILICONE COATED RELEASE LINER; MANUFACTURED IN
IOWA CITY, IA; BEDFORD PARK, IL; AND EDEN, NC
GRADE 15835, 7 MIL NT HDP 92A/92A SILICONE COATED RELEASE LINER; MANUFACTURED IN
IOWA CITY, IA; BEDFORD PARK, IL; EDEN, NC
GRADE 15827, 10 MIL NT PVC 92A/000 SILICONE COATED RELEASE LINER, MANUFACTURED
IN WEST CHICAGO, IL; IOWA CITY, IA; BEDFORD PARK, IL AND EDEN, NC
GRADE 13361, 1.5 MIL CL PET 85A/86B SILICONE COATED RELEASE LINER; MANUFACTURED
IN WEST CHICAGO, IL; IOWA CITY, IA; BEDFORD PARK, IL; AND EDEN, NC
GRADE 15719, 6 MIL NT STY 92A/000 SILICONE COATED RELEASE LINER; MANUFACTURED IN
IOWA CITY, IA; BEDFORD PARK, IL; AND EDEN, NC
FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES, MANUFACTURED IN
OSAKA, JAPAN
PORFIROMYCIN, MANUFACTURED IN ITALY

12116 I

II

9/3/1996

B I CHEMICALS INC

ISOETHARINE HYDROCHLORIDE, MANUFACTURED IN PETERSBURG, VIRGINIA

12117 I

II

8/27/1996

NAPP TECHNOLOGIES INC

WARFARIN SODIUM CLAHRATE; MANUFACTURED IN COVENTRY, RHODE ISLAND

12118 I

IV

8/21/1996

MEYERS COLOUR COMPOUNDS LIMITED

MMB-3479 GREY & MMB-7366 MAUVE; MANUFACTURED IN OAKVILLE, ONTARIO

12119 I

II

9/3/1996

TASMANIAN ALKALOIDS PARTY LTD

BUTORPHANOL TARTRATE; MANUFACTURED IN TASMANIA, AUSTRALIA

12120 I

II

9/5/1996

QUIMICA ESTEROIDAL SA DE CV

ARACURIUM BESYLATE; MANUFACTURED IN TLALNEPANTLA, STATE OF MEXICO, MEXICO

12121 I

II

9/6/1996

EMMELLEN BIOTECH PHARMACEUTICALS LTD

D-PSEUDOEPHEDRINE HYDROCHLORIDE, MANUFACTURED IN TAMIL NADU, INDIA

12122 I

II

9/3/1996

SHANDONG LUKANG PHARMACEUTICAL CO LTD

12123 A

III

8/30/1996

BOREALIS AG

12124 A

II

9/4/1996

LAPICOR NV

PENICILLIN G POTASSIUM BULK NON-STERILE INTERMEDIATE FOR FURTHER PROCESSING,


MANUFACTURED IN JINING CITY, SHANDONG PROVINCE, CHINA
BORMED RF825MO, BORMED RF830MO AND BORMED RG835MO AS MANUFACTURED IN
BERINGEN, BELGIUM
NITAZOXANIDE, MANUFACTURED IN LANDEN, BELGIUM

12125 I

IV

8/30/1996

RESCO COLOURS

BLUE CONCENTRATE (04VFV-415), MANUFACTURED IN ONTARIO, CANADA

12126 I

9/11/1996

FERRING PEPTIDE PRODUCTION AB

12127 A

II

9/11/1996

PFIZER INC

FACILITIES, PERSONNEL, QUALITY ASSURANCE, QUALITY CONTROL, MANFACTURING AND


GENERAL OPERATING PROCEDURES
ALPHAMETHYL EPOXIDE, MANUFACTURED IN KALAMAZOO, MICHIGAN

12128 I

II

9/12/1996

TOBRAMYCIN, MANUFACTURED IN GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA

12129 I

III

8/21/1996

GUANGDONG QINGYUAN NEW NORTH RIVER


PHARMACEUTICALS CO
BASF CORP

12130 I

II

8/6/1996

PHYTOGEN LIFE SCIENCES INC

PACLITAXEL, MANUFACTURED IN DELTA, BC, CANADA

12131 A

III

8/27/1996

3M DRUG DELIVERY SYSTEMS

A66010 25U SPRAYMISER, VALVE ASSEMBLY LOCATED AT LANCASHIRE, GREAT BRITAIN

12132 A

III

9/6/1996

TOPAS ADVANCED POLYMERS GMBH

TOPAS CYCLIC OLEFIN COPOLYMERS, MANUFACTURED IN OBERHAUSEN, GERMANY

12133 A

II

9/17/1996

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

12134 I

II

9/13/1996

EURAND AMERICA INC

LOVASTATIN USP, NONSTERILE BULK DRUG, JIOJIANG, ZHEJIANG PROVINCE, PEOPLE'S


REPUBLIC OF CHINA
PSEUDOEPHEDRINE HCL (MICROCAP), MANUFACTURED IN VANDALIA, OHIO

LUPHEN DDS 3459, MANUFACTURED IN SCHWARZHEIDE, GERMANY

Page 345

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12135 A
II
9/16/1996
ICN HUNGARY COMPANY LIMITED

SUBJECT
BUSPIRONE BASE, MANUFACTURED IN TISZAVASVARI, HUNGARY

12136 I

II

9/12/1996

AVENTIS PHARMA DEUTSCHLAND GMBH

12137 I

II

9/16/1996

LONZA LTD

GLYBURIDE [MILLED (GROUND)], MANUFACTURED IN FRANKFURT, FEDERAL REPUBLIC OF


GERMANY
1-(MERCAPTOMETHYL) CYCLOPROPYLACETIC ACID, MANUFACTURED IN VISP, SWITZERLAND

12138 A

II

9/9/1996

BAYER PHARMA AG

DROSPIRENONE, MANUFACTURED IN BERLIN, GERMANY

12139 I

II

9/23/1996

CELSIS INTERNATIONAL PLC

CELSIS DIGITAL SYSTEM, MANUFACTURED IN CAMBRIDGE, UNITED KINGDOM

12140 I

II

9/20/1996

PHARM WALDHOF GMBH

12141 A

II

9/23/1996

ASPEN OSS BV

URIDINE-5'-TRIPHOSPHATE (UTP), THERAPEUTIC GRADE; MANUFACTURED IN PENZBERG,


GERMANY
ESTRIOL, MANUFACTURED IN OSS, THE NETHERLANDS

12142 I

9/19/1996

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL

12143 I

III

9/26/1996

NORTON GELKAPS GELATINE KASPEL


PRODUKTION GMBH
RESCO COLOURS INC

12144 I

III

9/26/1996

RESCO COLOURS INC

WHITE CONCENTRATE (10PPP-200), MANUFACTURED IN ONTARIO, CANADA

12145 I

II

10/9/1996

FMC CORP

PERMETHRIN, MANUFACTURED IN CONSHOHOCKEN, PA

12146 A

II

10/2/1996

TEVA PHARMACEUTICAL INDUSTRIES LTD

12147 A

II

9/26/1996

JOHNSON MATTHEY INC

FLUOXETINE HCI, MANUFACTURED IN PETAH TIQVA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
DIFENOXIN HCL, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

12148 A

IV

10/1/1996

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL GRAPE FLAVOR #6175, MANUFACTURED IN PHILADELPHIA, PA

12149 I

II

10/7/1996

IPR PHARMACEUTICALS INC

ATENOLOL BULK DRUG, MANUFACTURED IN GUAYAMA, PR

12150 A

IV

10/4/1996

JRS PHARMA LP

12151 I

10/1/1996

12152 A

II

10/2/1996

GUANGDONG QINGYUAN NEW NORTH RIVER


PHARMACEUTICAL CO LTD
AVECIA BIOTECHNOLOGY INC

PROSOLVE SMCC (MICROCRYSTALLINE CELLULOSE, NF, JP, PH.EUR., BP AND COLLOIDAL


SILICON DIOXIDE, NF, PH.EUR., BP), MANUFACTURED IN NASTOLA, FINLAND
MANUFACTURING FACILITIES FOR TOBRAMYCIN PHARMACEUTICAL CO., LTD.

12153 I

III

9/24/1996

3M PHARMACEUTICALS INC

COTRAN 9720 FILM, MANUFACTURED IN BROOKINGS, SD

12154 I

10/7/1996

PHYTOGEN LIFE SCIENCES INC

MANUFACTURING FACILITIES IN DELTA, BRITISH COLUMBIA, CANADA

12155 I

II

10/3/1996

TOYAMA CHEMICAL CO LTD

TKY-93 (INTERMEDIATE), MANUFACTURED IN GIFU, JAPAN

12156 A

II

9/30/1996

BASF PHARMA EVIONNAZ SA

RIBAVIRIN, MANUFACTURED IN EVIONNAZ, SWITZERLAND AND ST-VULBAS, FRANCE

12157 I

II

10/2/1996

NV ORGANON

MEGESTROL ACETATE, MANUFACTURED IN OSS, THE NETHERLANDS

12158 I

II

10/8/1996

BACHEM INC

NBI-5788, MANUFACTURED IN TORRANCE, CALIFORNIA

12159 I

II

10/8/1996

RANBAXY INC

ACYCLOVIR DRUG SUBSTANCE, MANUFACTURED IN MADHYA PRADESH INDIA

12160 I

III

10/3/1996

ASAHI CHEMICAL INDUSTRY CO LTD

BARRIALON CX #24S, MANUFACTURED IN MIEPREFECTURE 513, JAPAN

12161 I

III

11/1/1996

WEDTECH INC

12162 A

II

10/8/1996

SUGAI CHEMICAL INDUSTRY CO LTD

12163 I

II

10/9/1996

CORTEX PHARMACEUTICALS INC

12164 I

IV

9/24/1996

BOEHRINGER INGELHEIM KG

12165 I

II

10/7/1996

AVENTIS PHARMA DEUTSCHLAND GMBH

12166 A

II

10/9/1996

DR REDDYS LABORATORIES LTD

PRODUCT CODE 1006 WHITE FOR USE IN PACKAGING MATERIALS, MANUFACTURED IN


ALBERTA AND ONTARIO, CANADA
MONAL, 3-[2-(7-CHLOROQUINOLINY) ETHENYL]-BENZALDEHYDE, MANUFACTURED IN FUKUI,
JAPAN
AMPALEX, BULK PHARMACEUTICAL CHEMICAL (BPC), MANUFACTURED IN LAWRENCE,
KANSAS
COPOLYMERS OF TRIMETHYLENE CARBONATE WITHL- OR D,L-LACTIDE, MANUFACTURED IN
INGELHEIM, GERMANY
GLYBURIDE (MICRONIZED) BULK DRUG SUBSTANCE, MANUFACTURED IN FRANKFURT/MAIN
FEDERAL REPUBLIC OF GERMAN
RANITIDINE HDROCHLORIDE (FORM I), MANUFACTURED IN ANDHRA PRADESH , INDIA

RED CONCENTRATE (20PPP-681), MANUFACTURED IN ONTARIO, CANADA

OLIGONUCLEOTIDES, MANUFACTURED IN MILFORD, MA

Page 346

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12167 I
IV
10/11/1996
ICI KLEA

SUBJECT
1,1,1,2-TETRAFLUOROETHANE (ZEPHEX MDI), MANUFACTURED IN UNITED KINGDOM

12168 I

10/11/1996

AIRSEC SA

12169 A

III

10/11/1996

AIRSEC SA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN ROMORANTIN, FRANCE
DESICCATOR CAPSULES IN PE MANUFACTURED IN ROMORANTIN, FRANCE

12170 I

II

10/8/1996

SIGMA CHEMICAL CO

12171 A

II

10/11/1996

ALBEMARLE CORP

POLY-L-LYSINE HYDROCHLORIDE, SIGMA PRODUCT NUMBER P6837, MANUFACTURED IN ST.


LOUIS, MISSOURI
KETOCONAZOLE, MANUFACTURED IN SOUTH HAVEN, MI

12172 A

II

10/16/1996

ALKALOIDA CHEMICAL CO ZRT

BUSPIRONE HYDROCHLORIDE; MANUFACTURED IN HUNGRY

12173 I

III

10/9/1996

RESCO COLOURS INC

WHITE CONCENTRATE (O1EHD-415), MANUFACTURED IN ONTARIO, CANADA

12174 I

II

10/17/1996

SCHERING PLOUGH AVONDALE CO

5-(N,N-DIBENZYLGLYCYL) SALICYLAMIDE, MANUFACTURED IN CO WICKLOW, IRELAND

12175 A

II

10/8/1996

ISOCHEM

DOMIPHEN BROMIDE, MANUFACTURED IN GENNEVILLIERS, FRANCE

12176 A

IV

10/16/1996

CORDEN PHARMA SWITZERLAND LLC

12177 I

10/17/1996

FUZHOU ANTIBIOTIC GENERAL FACTORY

1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DMPC), MANUFACTURED IN LIESTAL,


SWITZERLAND
MANUFACTURING FACILITIES FOR GENTAMICIN SULFATE IN FUZHOU, P.R. CHINA

12178 I

II

10/22/1996

GANES CHEMICALS INC

NELFINAVIR, MANUFACTURED IN PENNSVILLE, NJ

12179 I

II

10/22/1996

FARMHISPANIA SA

ASTEMIZOLE, MANUFACTURED IN BARCELONA, SPAIN

12180 A

III

10/9/1996

MINNESOTA RUBBER AND PLASTICS

C2512EJ ANFD C2512FV RUBBER COMPOUNDS, MANUFACTURED IN LITCHFIELD, MN

12181 I

II

10/24/1996

NANOSYSTEMS

12182 I

II

10/23/1996

METABOLIC SOLUTIONS INC

TRIAMCINOLONE ACETONIDE NANOCRYSTAL COLLOIDAL DISPERSION, MANUFACTURED


RESEARCH SERVICES, INC. IN HORSHAM, PA
ERYTHROMYCIN BREATH TEST DOSE, MANUFACTURED IN MERRIMACK, NH

12183 A

II

10/21/1996

MALLINCKRODT INC

SUFENTANIAL BASE CODE 0310 AS MANUFACTURED IN ST. LOUIS, MISSOURI

12184 I

10/21/1996

NOVOPHARM QUEBEC

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN QUEBEC, CANADA

12185 A

II

10/22/1996

AVANTI POLAR LIPIDS INC

TRIOCTANOIN, MANUFACTURED IN ALABASTER, ALABAMA

12186 I

II

10/24/1996

BACHEM CALIFORNIA

T-20, MANUFACTURED IN TORRANCE, CALIFORNIA

12187 I

10/28/1996

FUJI CHEMICAL INDUSTRIES LTD

12188 I

III

10/18/1996

AMPACET CORP

12189 I

III

10/14/1996

AMPACET CORP

12190 I

III

10/21/1996

AMPACET CORP

12191 I

II

10/25/1996

LIPOID GMBH

MANUFACTURING, FACILITIES AND CONTROLS FOR GOHKAKIZAWA FACTORY IN TOYAMA,


JAPAN
110409 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,
DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE
110505 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,
DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE
110375 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,
DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE
LIPOID PG 16:0/16:0, MANUFACTURED IN LUDWIGSHAFEN

12192 I

II

10/25/1996

LIPOID GMBH

LIPOID PC 18:1/18:1, MANUFACTURED IN LUDWIGSHAFEN

12193 I

III

10/22/1996

PHARMATUBE LTD

12194 I

10/31/1996

TAYCA CORP

12195 A

II

10/31/1996

TAYCA CORP

COLLAPSIBLE ALUMINIUM TUBE FOR PHARMACEUTICALS, MANUFACTURED IN MANCHESTER


ENGLAND
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATINGPROCEDURES, A THE
OKAYAMA PLANT IN OKAYAMA, JAPAN
MICRO TITANIUM DIOXIDE MT SERIES, MANUFACTURED IN OKAYAMA, JAPAN

12196 A

III

10/29/1996

MULTISORB TECHNOLOGIES INC

SORBICAP, MANUFACTURED IN BUFFALO, NEW YORK

12197 I

10/30/1996

NOVOPHARM BIOTECH INC

12198 A

II

11/1/1996

DAINIPPON SUMITOMO PHARMA CO LTD

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN


WINNIPEG MANITOBA, CANADA
ZONISAMIDE DRUG SUBSTANCE, MANUFACTURED AT IT'S SUZUKA FACTORY IN MIE, JAPAN

Page 347

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12199 I
I
10/30/1996
INALCO SPA
12200 I

II

10/30/1996

INALCO SPA

12201 A

II

11/1/1996

KANEKA CORP

SUBJECT
MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT R S M
S.R.L. IN PISTOIA, ITALY
2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-GLUCOPYRANOSIDE (DBEG), MANUFACTURED BY
RICERCHE SPERIMENTALI MONTALE IN MONTALE, ITALY
PCE, MANUFACTURED IN OSAKA, JAPAN

12202 I

II

10/25/1996

EURAND AMERICA INC

MICROCAPS PHENYLPROPANOLAMINE HC1, USP MANUFACTURED IN VANDALIA, OHIO

12203 I

IV

5/5/1996

TRICON VEREDLUNGS GMBH

PET FILM 100 MICRON WITH LOGO PRINTING, MANUFACTURED IN FREIBURG, GERMANY

12204 A

III

10/28/1996

FLINT HILLS RESOURCES LP

12205 I

11/1/1996

CORTEX PHARMACEUTICALS INC

12206 I

11/4/1996

CORTEX PHARMACEUTICALS INC

12207 A

II

11/6/1996

RANBAXY LABORATORIES LTD

POLYPROPYLENE AS A PACKAGING MATERIAL, MANUFACTURED IN LONGVIEW, TX,


MARYSVILLE, MI AND WOODBURY, NJ
AMPALEX TM, PRIOR CLINICAL STUDIES, BY CORTEX PHARMACEUTICALS, INC. IN IRVINE,
CALIFORNIA
AMPALEX TM, PRE-CLINICAL STUDIES , BY CORTEX PHARMACEUTICALS, INC. IN IRVINE,
CALIFORNIA
RANITIDINE HYDROCHLORIDE (FORM I), MANUFACTURED IN PUNJAB, INDIA

12208 I

11/1/1996

12209 I

II

11/8/1996

SHANGHAI NUMBER 16 PHARMACEUTICAL


FACTORY
TEVA GROUP

MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


SHANGHAI, P.R. CHINA
ACYCLOVIR USP, MANUFACTURED A ASSIA CHEMICAL INDUSTRIES LTD. IN TIQVA, ISRAEL

12210 I

II

11/12/1996

PG AMIDE

D-(-)-PHENYLGLYCINAMIDE (FG-AMIIDE), MANUFACTURED IN VENLO, THE NETHERLANDS

12211 I

II

11/11/1996

IOPAMIDOL, MANUFACTURED IN LATINA, ITALY

12212 I

III

11/5/1996

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
CKS PACKAGING INC

12213 I

III

11/6/1996

OY PREMIX LTD

PRE-ELEC PP 1381, MANUFACTURED IN RAJAMAKI, FINLAND

12214 A

II

10/25/1996

CKD BIO CORP

CYCLOSPORINE, NON-STERILE BULK, USP MANUFACTURED IN SEOUL, KOREA

12215 I

III

10/28/1996

CODING PRODUCTS

SV-59122, HOT STAMP INK RIBBON, MANUFACTURED IN KALKASKA, MI

12216 A

III

10/28/1996

CODING PRODUCTS

SV-16848, HOT STAMP INK RIBBON, MANUFACTURED IN KALKASKA, MI

12217 I

II

11/14/1996

FARCHEMIA SRL DIV TESSENDERLO CHEMIE

DICLOFENAC POTASSIUM, MANUFACTURED IN BERGAMO, ITALY

12218 I

II

11/12/1996

NIPPON SODA CO LTD

4-NITROBENZYL (4R,5R,6S)-3-DIPHENYLPHOSPHORYLOXY-6-[(R)-1-HYDROXYETHYL]-4METHYL-7-OXO-1-AZABICYCLO[3.2.0.] HEPT-2-ENE-2-CARBOXYLATE (CODE NAME MAP), A


BULK CHEMICAL DRUG SUBSTANCE INTERMEDIATE, MANUFACTURED IN TOYAMA, JAPAN

12219 I

III

11/11/1996

AMPACET CORP

12220 A

IV

10/31/1996

DOW CORNING CORP

12221 I

II

11/15/1996

CILAG AG

11233 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, GE
BIO-PSA STANDARD SILICONE PRESSURE SENSITIVE ADHESIVES, MANUFACTURED IN
HEMLOCK, MI 48626
FLUOXETINE HYDROCHORIDE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

12222 I

11/16/1996

CALMAR ALBERT GMBH

12223 A

III

11/16/1996

MWV CALMAR GMBH

12224 A

II

11/15/1996

SIFAVITOR SRL

MANUFACTURING FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HEMER,


GERMANY
MISTETTE MARK II AND MK SPRAYER MEDICAL DEVICE MANUFACTURED IN HEMER,
GERMANY
SULINDAC, ACCORDING TO USP 23 AND BP 1993, MANUFACTURED IN LODI, ITALY

12225 I

III

11/13/1996

DUPONT CO

TEFLON TOPCOAT 3200-100, MANUFACTURED IN PARLIN, NJ

12226 I

III

11/5/1996

NEVEETI INDUSTRIES LLC

COTTON, RAYON, POLYESTER COILER, MANUFACTURED IN RENO, NV

12227 I

II

5/17/1996

KAWAKEN FINE CHEMICALS CO LTD

N-BENZYL-4-FORMYLPIPERIDINE, MANUFACTURED IN SAITAMA, JAPAN

12228 A

II

11/18/1996

CAMBREX PROFARMACO MILANO SRL

ESTAZOLAM, MANUFACTURED IN MILAN, ITALY

12229 I

II

11/13/1996

CHEMI SPA

PENTAACETYLIOPAMIDOL INTERMEDIATE, MANUFACTURED IN FROSINONE, ITALY

HIGH DENSITY POLYETHLENE PLASTIC CONTAINERS, MANUFACTURED IN ALANTA, GA

Page 348

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12230 I
II
11/18/1996
XINJIANG HESHUO PHARMACEUTICAL COMPLEX
12231 I

II

11/21/1996

CILAG AG

SUBJECT
PSEUDOEPHEDRINE HYDROCHLORIDE, MANFACTURED A XINJIANG HESHUO EPHEDRINE
FACTORY IN HESHUO XINJIANG, CHINA
CLADRIBINE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

12232 I

III

11/19/1996

VALOIS DISPRAY

MICROPUMPS, MANUFACTURED IN MEZZOVICO, SWITZERLAND

12233 A

IV

11/22/1996

CORDEN PHARMA SWITZERLAND LLC

12234 I

II

11/22/1996

DEGUSSA AG WERK RADEBEUL

1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, SODIUM SALT (DSPG, NA),


MANUFACTURED IN LIESTAL, SWITZERLAND
TIMOLOL MALEATE, MANUFACTURED IN RADEBEUL, GERMANY

12235 I

II

11/20/1996

ALDRICH CHEMICAL CO INC

PEG TELOMER B, MANUFACTURED IN SHEBOYGEN FALLS, WI

12236 I

III

11/25/1996

WEDTECH INC

PRODUCT CODE 1004 WHITE, MANUFACTURED IN ALBERTA AND ONTARIO, CANADA

12237 A

II

11/18/1996

MALLINCKRODT INC

COMPAP WSE, CODE 2907 AS MANUFACTURED IN GREENVILLE, ILLINOIS

12238 I

II

12/5/1996

HOECHST CELANESE CORP

PEMOLINE, MANUFACTURED IN CORPUS CHRISTI, TEXAS

12239 I

III

11/11/1996

A KIENZLE GMBH AND CO KG

COLLAPSIBLE ALUMINIUM TUBES, MANUFACTURED IN BISSINGEN, GERMANY

12240 I

II

11/20/1996

BOEHRINGER INGELHEIM ESPANA SA

ESERETHOL, MANUFACTURED IN BARCELONA, SPAIN

12241 A

II

12/2/1996

TEVA PHARMACEUTICAL INDUSTRIES LTD

12242 I

II

12/2/1996

PCAS FINLAND OY

DEFEROXAMINE MESYLATE, MANUFACTURED AT BIOGAL PHARMACEUTICAL WORKS LTD IN


DEBRECEN, HUNGARY
DIPIVEFRIN HYDROCHLORIDE, MANUFACTURED IN TURKU, FINLAND

12243 A

IV

12/6/1996

MITSUI CHEMICALS INC

12244 I

II

11/25/1996

BASF PHARMACHEMIKALIEN GMBH CO KG

PLGA75, POLY(DL-LACTIDE-CO-GLYCOLIDE), MANUFACTURED AT NAGOYA FACTORY IN


NAGOYA CITY, JAPAN
TERAZOSIN HYDROCHLORIDE, MANUFACTURED IN LUDWIGSHAFEN, GERMANY

12245 I

III

11/25/1996

PET PARTNERS BV

CLEAR PET BOTTLES AND AMBER PET BOTTLES, MANUFACTURED IN THE NETHERLANDS

12246 I

11/25/1996

PET PARTNERS BV

MANUFACTURING SITES, PERSONNEL AND GENERAL OPERATING PROCEDURES

12247 I

II

12/3/1996

GUANDONG PHARMACEUTICAL FACTORY

SULFADIMETHOXINE SODIUM, MANUFACTURED IN GUANGZHOU, CHINA

12248 A

II

12/4/1996

ESTEVE QUIMICA SA

FELODIPINE, MANUFACTURED IN BARCELONA SPAIN

12249 A

III

8/14/1996

COLORS FOR PLASTICS INC

B18196, MANUFACTURED IN ELK GROVE, IL

12250 I

III

8/14/1996

COLORS FOR PLASTICS

B18215, MANUFACTURED IN ELK GROVE, IL

12251 I

III

9/27/1996

COLORS FOR PLASTICS

E11690, MANUFACTURED IN ELK GROVE, IL

12252 I

III

8/14/1996

COLORS FOR PLASTICS

E11757, MANUFACTURED IN ELK GROVE, IL

12253 I

III

8/14/1996

COLORS FOR PLASTICS

E11706,MANUFACTURED IN ELK GROVE, IL

12254 I

III

8/14/1996

COLORS FOR PLASTICS

N04859, MANUFACTURED IN ELK GROVE, IL

12255 I

III

8/14/1996

COLORS FOR PLASTICS

N04841, MANUFACTURED IN ELK GROVE, IL

12256 I

III

8/14/1996

COLORS FOR PLASTICS

W06219, MANUFACTURED IN ELK GROVE, IL

12257 I

II

12/9/1996

H LUNDBECK AS

12258 I

12/6/1996

MALLINCKRODT MEDICAL IMAGING IRELAND

12259 A

II

12/6/1996

MALLINCKRODT INC

LU-25-109-M DRUG SUBSTANCE, MANUFACTURED IN LEVERKUSEN, GERMANY AND


ZOFINGEN, SWITZERLAND
MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN DUBLIN,
IRELAND
IOVERSOL, DRUG SUBSTANCE FOR OPTIRAY AS MANUFACTURED IN DUBLIN, IRELAND

12260 A

II

12/11/1996

RELIABLE BIOPHARMACEUTICAL CORP

12261 I

III

12/10/1996

BOSTIK INC

12262 A

II

12/11/1996

12263 A

II

9/24/1996

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD
WUXI KAILI PHARMACEUTICAL CO LTD

PHENTOLAMINE MESYLATE, USP A BULK PHARMACEUTICAL, MANUFACTURED IN ST. LOUIS,


MISSOURI
POLYMERIC ADHESIVE, MANUFACTURED IN MIDDLETON, MA
MITOXANTRONE HYDROCHLORIDE USP, MANUFACTURED IN SICHUAN, CHINA
CIMETIDINE, MANUFACTURED IN JIANGSU PROVINCE, CHINA

Page 349

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12264 N
NOT AN ASSIGNED NUMBER

SUBJECT

12265 I

12/11/1996

RP SCHERER

12266 I

IV

12/3/1996

JANSSEN BIOTECH NV

12267 A

II

12/11/1996

SANOFI CHIMIE

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEIHEM,


FRANCE
HYDROXYPROPYL-BETA-CYCLODEXTRIN, (ENCAPSIN HPB), MANUFACTURED IN OLEN,
BELGIUM
TRIMEGESTONE, MANUFACTURED IN NEUVILLE, FRANCE

12268 A

II

12/16/1996

ASPEN OSS BV

ESTRADIOL VALERATE, MANUFACTURED IN OSS, THE NETHERLANDS

12269 A

II

12/16/1996

TEVA PHARMACEUTICAL INDUSTRIES LTD

WARFARIN SODIUM CLATHRATE, MANUFACTURED IN BRNO, CZECH REPUBLIC

12270 I

II

11/22/1996

KYOWA HAKKO KOGYO CO LTD

BUCILLAMINE BULK SUBSTANCE, MANUFACTURED IN OSAKA PREFECTURE, JAPAN

12271 I

II

12/16/1996

AKZO NOBEL CHEMICALS BV

HALAMID PHARMA GRADE, MANUFACTURED IN AMSTERDAM, THE NETHERLANDS

12272 I

II

12/6/1996

AVENTIS PHARMA DEUTSCHLAND GMBH

12273 A

II

12/17/1996

CAMBREX PROFARMACO MILANO SRL

BULK PROTIRELIN (THYROID RELEASING HORMONE; TRH) DRUG SUBSTANCE,


MANUFACTURED IN FRANKFURT, GERMANY
SOTALOL HCL, MANUFACTURED IN MILANO, ITALY

12274 I

II

12/13/1996

SANKYO CO LTD

CS-834 DRUG SUBSTANCE, MANUFACTURED IN KANAGAWA, JAPAN

12275 I

II

12/17/1996

JANSSEN PHARMACEUTICA NV

LIAROZOLE FUMERATE DRUG SUBSTANCE, MANUFACTURED IN GEEL, BELGIUM

12276 I

II

12/13/1996

SANKYO CO LTD

CS-834 DRUG PRODUCT, MANUFACTURED IN TOKYO, JAPAN

12277 I

II

12/16/1996

ROCHE DIAGNOSTICS GMBH

5-BROMO-2'-DEOXYURIDINE, MANUFACTURED IN MANNHEIM, GERMANY

12278 I

12/13/1996

12279 I

II

12/12/1996

SHANGHAI NUMBER 1 PHARMACEUTICAL


FACTORY
UNION QUIMICO FARMACEUTICA SA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


SHANGHAI, CHINA
PENTAACETYLIOPAMIDOL, MANUFACTURED IN BARCELONA, SPAIN

12280 I

II

12/12/1996

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

IOPAMIDOL STEP #1, MANUFACTURED IN BARCELONA, SPAIN

12281 A

II

8/28/1996

HEPARIN SODIUM, MANUFACTURED IN SHANGHAI, CHINA

12282 I

III

12/10/1996

SHANGHAI NUMBER 1 BIOCHEMICAL AND


PHARMACEUTICAL CO
CARCANO ANTONIO S.P.A.

12283 I

II

12/20/1996

NANOSYSTEMS

MK-639 NANOCRYSTAL, MANUFACTURED BY PMRS IN HORSHAM, PA

12284 I

12/19/1996

BIODOME

MANUFACTURING SITES, FACILITIES, AND PERSONNEL IN CEDEX, FRANCE

12285 I

12/23/1996

BAYER DE MEXICO SA DE CV

12286 I

II

12/19/1996

EXCELLA GMBH

MANUFACTURING SITES, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN


DELEGACION MIGUEL HIDALGO, MEXICO
FLUNIXIN MEGLUMINE, MANUFACTURED IN FEUCHT, GERMANY

12287 A

II

12/20/1996

SA AJINOMOTO OMNICHEM NV

BALSALAZIDE DISODIUM, MANUFACTURED IN WETTEREN, BELGIUM

12288 I

II

12/23/1996

BACHEM CALIFORNIA

IB-367, MANUFACTURED IN SAN DIEGO, CALIFORNIA

12289 I

II

12/18/1996

COURTAULDS CHEMICALS

BALSALAZIDE DISODIUM, MANUFACTURED IN FIFE SCOTLAND

12290 I

12/19/1996

BIODOME

BIOSET INFUSION, IN CEDEX, FRANCE

12291 A

II

12/18/1996

QUIMICA SINTETICA SA

FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN MADRID, SPAIN

12292 I

II

12/23/1996

INDUSTRIALE CHIMICA SRL

FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN SARONNO, ITALY

12293 A

II

12/24/1996

ASPEN OSS BV

ETONOGESTREL, MANUFACTURED IN OSS, THE NETHERLANDS

12294 A

II

12/27/1996

SERIPHARM SA

PACLITAXEL, MANUFACTURED IN LE MANS, FRANCE

12295 A

II

12/30/1996

VIFOR INTERNATIONAL INC

12296 A

II

12/23/1996

CHEMI SPA

DEXFER HUMAN USA (IRON DEXTRAN POWDER), MANUFACTURED IN ST. GALLEN,


SWITZERLAND
NABUMETONE, MANUFACTURED IN FROSINONE, ITALY

12297 I

II

12/27/1996

BACHEM CALIFORNIA

GLUCAGON (1-29), HUMAN, MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA

ALUMINIUM FOIL, SMOOTH, SOFT TEMPER, 0.045 MM, LACQUERED FOR PRINTING ON ONE
SIDE AND LAMINATED WITHADHESIVE TO POLYETHYLENE FILM 0.020 MM ON THE OTHER
SIDE, MANUFACTURED IN DEL LARIO-LC-ITALY

Page 350

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12298 I
III
12/10/1996
OWENS ILLINOIS INC

SUBJECT
COMPRESSION MOLDED CLOSURES, MANUFACTURED IN ERIE, PA

12299 A

IV

12/20/1996

BLANVER FARMOQUIMICA LTDA

12300 I

III

12/24/1996

ALVEO AG

CELLULOSE, MICROCRYSTALLINE AND CARBOXYMETHYLCELLULOSE SODIUM NF,


MANUFACTURED IN ITAPEVI-SP-BRAZIL
ALVEOLIT TEE 0500 WHITE, MANUFACTURED IN LUZERN, SWITZERLAND

12301 I

III

12/31/1996

BAG PACK INC

BOTTOM SEAL POLY BAGS, MANUFACTURED IN CINCINNATI, OHIO

12302 I

1/2/1997

12303 I

IV

12/16/1996

DRUG DEVELOPMENT OFFICE CANCER


RESEARCH CAMPAIGN
RHONE POULENC INC

12304 I

II

1/3/1997

SIGMA CHEMICAL CO

BACKGROUND, PERSONNEL AND PROCEDURES FOR DEVELOPMENT OF NEW ANTI-CANCER


AGENTS IN UNITED KINGDOM
IGEPAL CA 630 SPECIAL (OCTOXYNOL-9), MANUFACTURED IN SPARTANBURG, SOUTH
CAROLINA
PHLORIDZIN FROM APPLE SIGMA PRODUCT NO. P0289, MANUFACTURED IN ST. LOUIS, MO

12305 I

IV

12/27/1996

BOC GROUP INC THE BOC GASES

EXCIPIENT, LIQUEFIED NITROGEN, MANUFACTURED IN TERRELL, TEXAS

12306 I

III

8/31/1996

IRIS LTD DIV ARCO BEAUTY LTD

12307 I

1/6/1997

TAKASAGO INTL CORP

SURGICAL COIL 100% COTTON AND 100% RAYON-PHARMACEUTICAL GRADE,


MANUFACTURED IN MONTREAL, QUEBEC, CANADA
MANUFACTURING SITES, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES
A FINE CHEM CO., LTD. IN OGASA-GUN, JAPAN FOR (R)-4-MERCAPTOPYRROLIDIN-2-ONE, OR
(R)

12308 I

II

1/10/1997

CHANGZOU SYNTHETIC MATERIAL PLANT

ALBENDAZOLE, MANUFACTURED IN NIUTANG TOEN CHANGZOU CITY JIIANGSU, CHINA

12309 A

II

1/9/1997

SYNKEM SAS

OXYBUTYNIN HYDROCHLORIDE, MANUFACTURED IN CEDEX, FRANCE

12310 I

II

1/6/1997

TAKASAGO INTL CORP

12311 I

III

12/16/1996

BASELL POLIOLEFINE ITALIA SPA

(R)-4-MERCAPTOPYRROLIDIN-2-ONE, OR (R)-MPD, MANUFACTURED BY FINE CHEM CO., LTD.


AT OGASA-GUN, JAPAN
LUPOLEN 2426 F, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

12312 I

III

12/16/1996

BASF AKTIENGESELLSCHAFT

LUPOLEN 1804 H, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

12313 I

II

1/13/1997

ANTIBIOTIC CO

STERILE SULBACTAM SODIUM, MANUFACTURED IN RAZGRAD, BULGARIA

12314 I

III

12/11/1996

SOLVIN SA

IXAN PVDC WA 36, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12315 I

III

12/11/1996

SOLVAY SA

IXAN PVDC PA 120, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12316 I

III

12/11/1996

SOLVIN SA

IXAN PVDC WA 63, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12317 I

III

11/21/1996

SOLVAY SA

IXAN PVDC PA 344, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12318 I

III

12/10/1996

SOLVAY SA

IXAN PVDC PA 331, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12319 I

III

12/10/1996

SOLVIN SA

IXAN PVDC WA 50, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12320 I

II

12/30/1996

DOTTIKON EXCLUSIVE SUNTHESIS AG

12321 A

III

1/16/1997

BAYER MATERIALSCIENCE LLC

6.7-DIHYDRO-3-ETHYL-2-METHYLINDOL-4-ONE (EMOTI), MANUFACTURED IN DOTTIKON,


SWITZERLAND
MAKROLON 2458-FBL, MANUFACTURED IN KREFELD-VERDINGEN, GERMANY

12322 A

IV

1/7/1997

DOW CORNING CORP

12323 A

III

12/4/1996

12324 I

III

1/17/1997

BIO-PSA AMINE-COMPATIBLE HOT MELT SILICONE PRESSURE SENSITIVE ADHESIVES,


MANUFACTURED IN HEMLOCK, MI
NAN YA PLASTICS CORPORATION AMERICA SOUTH TAIRILIU COPOLYMER PET, MANUFACTURED IN LAKE CITY, SOUTH CAROLINA
CAROLINA PLANT
BASF AKTIENGESELLSCHAFT
BASONA F DS 3425, MANUFACTURED IN SCHWARZHEIDE, FEDERAL REPUBLIC OF GERMANY

12325 I

III

1/15/1997

TUBCOR SA

COLLAPSIBLE ALUMINIUM TUBE, MANUFACTURED IN VILAFRANCA DEL PENEDES, SPAIN

12326 I

II

1/14/1997

UNION QUIMICO FARMACEUTICA SA

AG 1346, MANUFACTURED IN BARCELONA, SPAIN

12327 A

II

1/21/1997

CATALENT PHARMA SOLUTIONS LLC

12328 A

II

1/20/1997

IDT AUSTRALIA LTD

BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES AS MANUFACTURED IN ST.


PETERSBURG FL
MITOXANTRONE HYDROCHLORIDE USP, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA

Page 351

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12329 A
IV
1/16/1997
FMC CORP FMC BIOPOLYMER DIV

1/23/1997

PRECISE PRODUCTS AND DEVELOPMENT


CORPORATION
GANES CHEMICALS INC

SUBJECT
AVICEL RC/CL MICROCRYSTALLINE CELLULOSE AND CARBOXYMETHLCELLULOSE SODIUM,
MANUFACTURED IN NEWARK, DELAWARE AND CORK, IRELAND
BOTTLE PLUG AND DIP TUBE ASSEMBLY DWG NO. P9601-05 REV. A., MANUFACTURED IN
MIDDLESEX, NJ
R-NORSELEGILINE BASE AND HYDROCHLORIDE, MANUFACTURED IN PENNSVILLE, NJ

1/23/1997

NV ORGANON

NORGESTOMET, MANUFACTURED IN OSS, THE NETHERLANDS

1/23/1997

TAYLOR WHARTON

SEAMLESS STEEL COMPRESSED GAS CYLINDERS, MANUFACTURED IN HARRISBURG, PA

II

1/24/1997

PT SIKONA INDONESIA LESTARI

QUINIDINE GLUCONATE, MANUFACTURED IN CIATER, WEST JAVA, INDONESIA

III

1/27/1997

THE WEST COMPANY INC

MERCURY BOTTLE ASSEMBLY, MANUFACTURED IN LIONVILLE, PA

12336 I

III

1/27/1997

TETRAFLUOR INC

12337 A

III

1/23/1997

LUXFER GAS CYLINDERS

12338 I

IV

1/23/1997

ARYLESSENCE INC

TEFLON O-RING GASKET FOR COMPRESSED GAS CYLINDER, MANUFACTURED IN EL


SEGUNDO, CA
HIGH PRESSURE ALUMINUM COMPRESSED GAS CYLINDERS, MANUFACTURED IN RIVERSIDE,
CA
ARYLESSENCE 00798 N AND A CHERRY FLAVOR, MANFACTURED IN MARIETTA, GA

12339 I

III

1/7/1997

GEORGIA GULF CHEMICALS AND VINYLS LLC

PVC COMPOUND, 8272 WHITE 344, MANUFACTURED IN TIPTONVILLE, TN

12340 A

II

1/24/1997

FARCHEMIA SRL

OXAPROZIN, MANUFACTURED IN TREVIGLIO (BERGAMO), ITALY

12341 A

II

1/28/1997

DR REDDYS LABORATORIES LTD

NAPROXEN, MANUFACTURED IN ANDHRA PRADESH, INDIA

12342 A

II

1/28/1997

DR REDDYS LABORATORIES LTD

NAPROXEN SODIUM, MANUFACTURED IN ANDHRA PRADESH, INDIA

12343 A

1/2/1997

APTAR STELMI SAS

ULTRACLEAN-6 WASHING PROCESS, MANUFACTURED IN GRANVILLE, FRANCE

12344 I

1/27/1997

12345 I

III

1/8/1997

12346 A

II

1/29/1997

NATIONAL INSTITUTES HEALTH NATIONAL CANCER PRECLINICAL TOXICOLOGY DATA FOR THE AGENT ECTEINASCIDIN 743 IN BETHESDA, MD
INSTITUTE
CREST FLEXIBLE PACKAGING LTD
PACKAGING MATERIALS AND MEDICAL PACKAGING (POLYESTER/ADHESIVE/ALUMINIUM
FOIL/ADHESIVE/POLYETHYLENE), MANUFACTURED IN KENT, ENGLAND
ZACH SYSTEM
VENLAFAXINE HYDROCHLORIDE, MANUFACTURED IN AVRILLE CEDEX, FRANCE

12347 I

III

1/16/1997

3M

3M SCOTCHPAK 96 FILM, MANUFACTURED IN ST. PAUL, MN

12348 A

II

1/31/1997

ANTIBIOTICOS SA

6-AMINO PENICILLANIC ACID, MANUFACTURED IN LEON, SPAIN

12349 I

II

2/5/1997

TASMANIAN ALKALOIDS PARTY LTD

NALTREXONE BENZOATE, MANUFACTURED IN WESTBURY, TASMANIA, AUSTRALIA

12350 I

II

2/3/1997

EGIS PHARMACEUTICALS PUBLIC LTD CO

BUSPIRONE HYDROCHLORIDE USP BULK, MANUFACTURED IN BUDAPEST, HUNGARY

12351 I

2/2/1997

ROLABO SL

12352 I

II

2/6/1997

PHARMACEUTICAL FINE CHEMICALS BAHAMAS

MANUFACTURING SITES, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN ZARAGOZA, SPAIN
RIFAXIMIN, MANUFACTURED IN FREEPORT, GRAND BAHAMA ISLAND

12353 I

II

2/4/1997

FLUVOXAMINE MALEATE, MANUFACTURED IN PADOVA, ITALY

12354 I

II

2/3/1997

12355 A

II

1/31/1997

VIS FARMACEUTICI INSTITUTO SCIENTIFICO


VINEZIE SPA
VIS FARMACEUTICI INSTITUTO SCIENTIFICO
VINEZIE SPA
ROHM AND HAAS CO

12356 A

II

2/4/1997

DIVIS LABORATORIES LTD

DEXTROMETHORPHAN HYDROBROMIDE USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

12357 I

II

2/11/1997

VICKSBURG CHEMICAL CO

POTASSIUM NITRATE USP GRADE, MANUFACTURED IN VICKSBURG, MS

12358 A

III

1/30/1997

SHERWOOD VALVE LLC

COMPRESSED CYLINDER GAS VALVES, SERIES 6074X, MANUFACTURED IN WASHINGTON, PA

12359 I

III

2/11/1997

AMPACET CORP

12360 I

II

1/31/1997

EURAND AMERICA INC

160325 BLUE UV POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE
MICROCAPS DIPHENHYDRAMINE CITRATE, MANUFACTURED IN VANDALIA, OHIO

12330 I

III

1/6/1997

12331 I

II

12332 I

II

12333 I

III

12334 I
12335 I

ETIDRONATE DISODIUM, MANUFACTURED IN PADOVA, ITALY


AMBERLITE IRP69, MANUFACTURED IN CHAUNY CEDEX, FRANCE

Page 352

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12361 I
II
1/31/1997
EURAND AMERICA INC

SUBJECT
MICROCAPS CIMETIDINE, USP, MANUFACTURED IN VANDALIA, OH

12362 A

III

2/10/1997

SOLVIN SA

SOLVIN 257 RF MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

12363 I

2/10/1997

INDUSTRIALE CHIMICA SRL

12364 I

II

2/13/1997

OMAN CHEMICALS AND PHARMACEUTICALS LLC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN SARONNO, ITALY
6-AMINO PENICILLANIC ACID, MANUFACTURED IN AL BURAIMI, SULTANATE OF OMAN

12365 I

III

2/11/1997

FLEX INDUSTRIES LIMITED

POLYESTER FILM (BIAXIALLY ORIENTED), MANUFACTURED IN GHAZIABAD, INDIA

12366 I

II

2/5/1997

MATERIALS PROCESSING TECHNOLOGY INC

DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90B, MANUFACTURED IN PATERSON, NJ

12367 I

II

2/5/1997

MATERIALS PROCESSING TECHNOLOGY INC

DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90A, MANUFACTURED IN PATERSON, NJ

12368 A

II

2/18/1997

GEDEON RICHTER PLC

DESOGESTREL, MANUFACTURED IN BUDAPEST, HUNGARAY

12369 I

II

2/21/1997

DEGUSSA AG

CARBOPLATIN, USP, MANUFACTURED IN HANAU, GERMANY

12370 I

III

2/18/1997

POLYMER COLOR INC

GLC-18713 25/1 TURQUOISE COLOR CONCENTRATE, MANUFACTURED IN MCHENRY, ILLINOIS

12371 I

2/24/1997

NOVOCOL PHARMACEUTICAL CANADA INC

AUTOINJECTOR PRODUCTION, MANUFACTURED IN CAMBRIDGE, ONTARIO

12372 A

IV

2/11/1997

MANTROSE HAEUSER CO INC

CERTISEAL FC-300A, MANUFACTURED IN ATTLEBORO, MA

12373 I

2/24/1997

USV LTD

12374 A

II

2/24/1997

USV LIMITED

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


MAHARASHTRA, INDIA
GLIPIZIDE, MANUFACTURED IN MAHARASHTRA, INDIA

12375 I

III

2/18/1997

BASF CORP

GLEITMITTELDISPERSION 8645, MANUFACTURED IN LUDWIGSHAFEN, GERMANY

12376 I

III

2/12/1997

DANAPAK FLEXIBLES

PHARMACEUTICAL COMPONENT, MANUFACTURED IN ODENSE, DENMARK

12377 A

2/24/1997

12378 I

III

3/3/1997

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY AND INFECTIOUS DISEASES
4P VERPACKUNGEN RONSBERG GMBH

12379 A

II

2/19/1997

AJINOMOTO CO INC

DAIDS POLICIES AND PROCEDURES PERTAINING TO CLINICAL TRIALS CONDUCTED UNDER


DAIDS-SPONSORED INDS
FLEXIBLE LAMINATE FOR TUBE PRODUCTION, MANUFACTURED IN RONSBERG, FEDERAL
REPUBLIC OF GERMANY
LEVODOPA, MANUFACTURED IN KANAGAWA, JAPAN

12380 A

II

2/24/1997

ASTELLAS PHARMA INC

FORMOTEROL FUMARATE, MANUFACTURED IN IBARAKI-KEN, JAPAN

12381 I

2/24/1997

H LUNDBECK AS

12382 I

2/24/1997

H LUNDBECK AS

12383 I

2/24/1997

H LUNDBECK AS

12384 A

II

2/24/1997

H LUNDBECK AS

12385 A

II

2/21/1997

BASF PHARMACHEMIKALIEN GMBH CO KG

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN VALBY, DENMARK
MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
IN SEAL SANDS, UNITED KINGDOM
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LAMSAS,
DENMARK
CITALOPRAM HYDROBROMIDE, MANUFACTURED IN LUMSAS AND VALBY, DENMARK AND
SEAL SANDS, UNITED KINGDOM
SELEGILINE, MANUFACTURED IN MINDEN, GERMANY

12386 I

II

2/27/1997

SOLVAY DUPHAR BV

CALCIFEDIOL, MANUFACTURED IN WEESP, THE NETHERLANDS

12387 I

2/21/1997

IWAKI SEIYAKU CO

12388 A

II

2/21/1997

IWAKI SEIYAKU CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE


SHIZUOKA FACTORY IN SHIZUOKA, JAPAN
PILOCARPINE HYDROCHLORIDE, MANUFACTURED IN SHIZUOKA, JAPAN

12389 I

II

2/26/1997

SHANDONG LUKANG PHARMACEUTICAL CO LTD

PENICILLIN G POTASSIUM (CRUDE), MANUFACTURED IN SHANDONG PROVINCE, CHINA

12390 I

II

2/26/1997

CUNO EUROPE SA

ZETA-PLUS LP AND LPM SERIES, MANUFACTURED IN MAZERES SUR SALA, FRANCE

12391 I

II

2/26/1997

CUNO EUROPE SA

ZETACARBON R.1SP AND SLP SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE

12392 I

II

2/26/1997

CUNO EUROPE SA

ZETACARBON R.2SP AND SLP SERIES, MANUAFCTURED IN MAZERES SUR SALAT, FRANCE

12393 I

II

2/26/1997

CUNO EUROPE SA

ZETACARBON R.3SP AND SLP SERIES, MANUAFCTURED IN MAZERES SUR SALAT, FRANCE

Page 353

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12394 I
II
2/26/1997
CUNO EUROPE SA

SUBJECT
ZETA PLUS SP SERIES, MANUFACTURED IN MAZERES SUR SALA, FRANCE

12395 I

2/26/1997

CUNO EUROPE SA

12396 I

II

2/26/1997

CUNO EUROPE SA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


MAZERES SUR SALA, FRANCE
ZETACARBON R.4 SP AND SLP SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE

12397 I

II

2/26/1997

CUNO EUROPE SA

ZETA-PLUS CP SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE

12398 I

II

2/26/1997

CUNO EUROPE SA

12399 I

II

2/26/1997

CUNO EUROPE SA

ZETA-PLUS DELIPID DEL 1 AND DEL 1 LP SERIES, MANUFACTURED IN MAZERES SUR SALA,
FRANCE
ZETA-PLUS HTP AND HTM SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE

12400 I

II

3/2/1997

ZHEJIANG RUIBANG LABORATORIES

LOVASTATIN, MANUFACTURED IN ZHEJIANG, CHINA

12401 I

II

3/5/1997

SELOC FRANCE

CLOZAPINE, MANUFACTURED BY SICOR SA IN LIMAY, FRANCE

12402 I

3/5/1997

AJANTA PHARMA LIMITED

12403 I

II

3/4/1997

YAMASA CORP

12404 I

II

2/28/1997

ZENTIVA, A.S.

MANUFACTURED SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


MAHARASHTRA, INDIA
URIDINE 5'-TRIPHOSPHATE, TRISODIUM SALT (UTP, 3NA), MANUFACTURED IN CHIBA-KEN,
JAPAN
TRAMADOL HYDROCHLORIDE, MANUFACTURED IN HLOHOVEC, SLOVAKIA

12405 A

II

3/5/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

AD-32 BULK DRUG SUBSTANCE, MANUFACTURED IN MILAN, ITALY

12406 A

IV

3/5/1997

FMC CORP FMC BIOPOLYMER DIV

12407 I

III

2/26/1997

INTERNATIONAL GROUP INC

AQUACOAT CPD CELLULOSE ACETATE PHTHALATE AQUEOUS DISPERSION, MANUFACTURED


IN NEWARK, DELAWARE
IGI 1239, MANUFACTURED IN AGINCOURT, ONTARIO, CANADA

12408 I

III

3/6/1997

AMPACET CORP

12409 I

III

3/6/1997

AMPACET CORP

12410 I

2/28/1997

CIBA VISION STERILE MANUFACTURING

12411 I

II

3/10/1997

BACHEM CALIFORNIA

100488 AB POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,


LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM
10437 SLIP POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,
DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM
STERILE MFG IN FACILITIES FOR THE PRODUCTION OF OPHTHALMIC AND CONTACT LENS
SOLUTIONS
PEPTIDE P280, MANUFACTURED IN TORRANCE, CALIFARNIA

12412 A

II

3/10/1997

RECKITT BENCKISER HEALTHCARE UK LTD

BUPRENORPHINE HCI, MANUFACTURED IN DANSOM LANE, UK

12413 I

III

2/7/1997

VALSPAR CORP

PHENOLIC SPRAY COATING AS MFG IN BIRMINGHAM, ALABAMA

12414 I

III

2/7/1997

VALSPAR CORP

PHENOLIC SPRAY COATING AS MFG IN WAUKEGAN, ILLINOIS

12415 I

III

1/31/1997

BASF AKTIENGESELLSCHAFT

NOVOLEN 3248 TC, MANUFACTURED IN TARAGONA, SPAIN

12416 I

II

3/14/1997

JANSSEN PHARMACEUTICA NV

12417 A

II

3/14/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

12418 I

II

3/1/1997

OTSUKA PHARMACEUTICAL CO LTD

LOVIRIDE DRUG SUBSTANCE, MANUFACTURED IN BEERSE AND GEEL, BELGIUM AND CALAIS
CEDEX, FRANCE
CALCITRIOL, MANUFACTURED IN PETAH TIQVA, ISRAEL FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
NADIFLOXACIN DRUG SUBSTANCE, MANUFACTURED IN TOKUSHIMA, JAPAN

12419 A

II

3/17/1997

AMRI RENSSELAER INC

SULFAMYLON (MAFENIDE) ACETATE, MANUFACTURED IN RENSSELAER, N.Y.

12420 I

II

3/18/1997

KYOWA HAKKO KOGYO CO LTD

KW-2189 DRUG SUBSTANCE, MANUFACTURED IN TOKYO, JAPAN

12421 A

II

3/14/1997

NOVARTIS PHARMACEUTICALS CORP

12422 A

3/7/1997

STERIGENICS INTERNATIONAL INC

TESSALON DRUG SUBSTANCE, (BENZONATATE, USP), MANUFACTURED IN GRIMSBY,


ENGLAND
STERILIZATION FACILITY IN GURNEE, IL

12423 I

II

2/15/1997

CKD BIO CORPORATION

7-AMINOCEPHALOSPORANIC ACID, (7-ACA), MANUFACTURED IN KYEONGKI-DO, KOREA

12424 I

II

3/17/1997

BIOINDUSTRIA

TERAZOSIN HCI. 2H20 BULK SUBSTANCE, MANUFACTURED IN FRESONARA (AL)-ITALY

12425 I

II

3/20/1997

PROMETIC BIOSCIENCES LTD

MIMETIC ORANGE 1-6XL, MANUFACTURED IN ISLE OF MAN, GREAT BRITAIN

Page 354

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12426 I
II
3/19/1997
YAMANOUCHI IRELAND CO LTD

SUBJECT
FORMOTEROL FUMERATE, MANUFACTURED IN DUBLIN, IRELAND

12427 I

3/19/1997

YMC CO LTD

12428 I

III

2/11/1997

ASPELL POLYMERES

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


ISHIKAWA, JAPAN
LACQTENE 2003 SN 53 U, MANUFACTURED IN GONFREVILLE L'ORCHER, HARFLEUR

12429 I

III

3/27/1997

DSM PERFORMANCE POLYMERS

STAMYLAN P 17M10, MANUFACTURED IN GELEEN, THE NETHERLANDS

12430 I

III

3/27/1997

DSM POLYETHYLENES

STAMYLAN HD 7625, MANUFACTURED IN BEEK, THE NETHERLANDS

12431 I

III

3/12/1997

ALBIS PLASTIC GMBH

LUPOLEN 1810 S WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY

12432 A

III

3/12/1997

ALBIS PLASTIC GMBH

LUPOLEN 1810 E WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY

12433 A

III

3/12/1997

ALBIS PLASTIC GMBH

LUPOLEN 3020 D WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY

12434 I

III

3/12/1997

ALBIS PLASTIC GMBH

LUPOLEN 5021 D WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY

12435 I

III

3/12/1997

ALBIS PLASTIC GMBH

LUPOLEN 5031 L WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY

12436 A

III

3/12/1997

ALBIS PLASTIC GMBH

LUPOLEN KONZENTRAT SL 02 OA, MANUFACTURED IN HAMBURG, GERMANY

12437 I

II

3/26/1997

SIEGFRIED LTD

FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN ZOFINGEN, SWITZERLAND

12438 I

II

3/12/1997

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

BACLOFEN, MANUFACTURED IN VARESE, ITALY

12439 I

II

3/6/1997

SANOFI AVENTIS CHIMIE

CLOPIDOGREL BISULFATE, MANUFACTURED IN SISTERON, FRANCE

12440 A

II

3/24/1997

SANDOZ INDUSTRIAL PRODUCTS GMBH

7-AMINOCEPHALOSPORANIC ACID, ENZYMATIC, MANUFACTURED IN FRANKFURT, GERMANY

12441 A

II

3/31/1997

MALLINCKRODT INC

DIPHENOXYLATE HYDROCHLORIDE USP, MANUFACTURED IN ST. LOUIS, MISSOURI

12442 I

II

3/31/1997

IOPAMIDOL, USP, MANUFACTURED IN NORTH CHICAGO, IL

12443 I

II

3/28/1997

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
SCHERING PLOUGH PRODUCTS INC

12444 A

II

3/26/1997

FERMION OY

ENTACAPONE, MANUFACTURED IN HANKO AND ESPOO, FINLAND

12445 I

II

3/18/1997

NAPP TECHNOLOGIES INC

NABUMETONE, MANUFACTURED IN COVENTRY, RHODE ISLAND

12446 I

III

3/21/1997

CREST FLEXIBLE PACKAGING LTD

PAPER/PE/FOIL/PE, MANUFACTURED IN KENT, ENGLAND

12447 I

3/24/1997

BEA FILTRI SPA

12448 I

III

4/2/1997

AMPACET CORP

12449 I

II

4/3/1997

PHARM ECO LABORATORIES INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MILANO,


ITALY
100652 ANTIBLOCK SLIP POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE,
IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM
2-AMINO-5-PHENYL-4(5H)-OXAZOLONE-(PEMOLINE), MANUFACURED IN LEXINGTON, MA

12450 A

III

4/1/1997

CODING PRODUCTS

SV-54258, MANUFACTURED IN KALKASKA, MI

12451 A

III

4/1/1997

CODING PRODUCTS

SV-14258NT, MANUFACTURED IN KALKASKA, MI

12452 I

III

4/1/1997

CODING PRODUCTS

SV-14157NNT, MANUFACTURED IN KALKASKA, MI

12453 I

III

4/4/1997

SAFTA SPA

STERIFOIL 121235, MANUFACTURED IN PIACENZA, ITALY

12454 I

4/2/1997

SCHENK FILTERBAU GMBH

12455 A

II

4/7/1997

GUFIC BIOSCIENCES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


WALDSTETTEN, GERMANY
MICONAZOLE NITRATE USP, MANUFACTURED IN GUJARAT STATE, INDIA

12456 I

III

4/2/1997

AMPACET CORP

12457 I

III

3/13/1997

BASF AKTIENGESELLSCHAFT

12458 A

III

4/8/1997

LOPAREX BV

12459 A

III

4/4/1997

FUJIMORI KOGYO CO LTD

STERILE WATER FOR INJECTION, MANUFACTURED IN MANATI, PUERTO RICO

109982 ANTIBLOCK POLYETHYENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM
NOVOLEN 110 H Q651, MANUFACTURED IN WESSELING, GERMANY
FL2000 175UM HDPE EASY/EASY (PRODUCT CODE 78D171), MANUFACTURED IN APELDORN,
THE NETHERLANDS
PLASTIC FILM AND BAG, MANUFACTURED IN MIE PREFECTURE, JAPAN

Page 355

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12460 I
II
4/8/1997
SANOFI SYNTHELABO INC.

SUBJECT
CLOPIDOGREL BISULFATE, MANUFACTURED IN EVIONNAZ, SWITZERLAND

12461 I

II

4/9/1997

DAIICHI PHARMACEUTICAL CO LTD

12462 I

II

3/6/1997

SAMYANG GENEX RESEARCH CORP

12463 I

II

4/9/1997

ADVANCED CHEMTECH INC

12464 A

III

4/10/1997

3M DRUG DELIVERY SYSTEMS

12465 A

III

4/17/1997

WIPF AG

12466 I

III

4/11/1997

LUBRIZOL ADVANCED MATERIALS INC

DX-8951F DRUG SUBSTANCE, MANUFACTURED BY CHEMSYN SCIENCE LABORATORIES IN


LENEXA, KANSAS
BULK PHARMACEUTICAL CHEMICAL GENEXOL, PLANT A, MANUFACTURED IN TAEJEON,
KOREA
GONADERELIN ACETATE BULK PHARMACEUTICAL CHEMICAL, MANUFACTURED IN
LOUISVILLE, KY
PACKAGING MATERIAL FOR THE CICLESONIDE HFA METERED DOSE INHALER
MANUFACTURED IN ST. PAUL, MN
POLYESTER-ALUMINIUM-POLYACRYLONITRILE LAMINATE, MANUFACTURED IN VOLKETSWIL,
SWITZERLAND
STAT-RITE E-1150, MANUFACTURED IN CLEVELAND, OHIO

12467 I

II

4/15/1997

DOCTOR REDDYS LABORATORIES LTD

DEXTROMETHORPHAN HYDROBROMIDE, MANUFACTURED IN SRIKAKOLAM DISTRICT

12468 I

III

3/25/1997

DRYCOLOR AB

MASTERBACH PE 192301, MANUFACTURED IN MALMO, SWEDEN

12469 A

II

4/14/1997

UNIQUE CHEMICALS

DICLOFENAC SODIUM, MANUFACTURED IN GUJARAT, INDIA

12470 A

III

4/11/1997

CLARIANT MASTERBATCHES NORDEN AB

MASTERBATCH PE 192183, MANUFACTURED IN MALMO, SWEEDEN

12471 A

II

4/14/1997

ESTEVE QUIMICA SA

QUINAPRIL HCL, MANUFACTURED IN BARCELONA, SPAIN

12472 A

II

4/11/1997

EXCELLA GMBH

METHOTREXATE DISODIUM SALT MANUFACTURED IN FEUCHT, GERMANY

12473 I

4/14/1997

DOCTORS ORGANIC CHEMICALS LTD

12474 I

IV

4/10/1997

ADHESIVES RESEARCH INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN K.


ILLINDALAPARRU, TANUKU, ANDHRA PRADESH, INDIA
MEDICAL GRADE ADHESIVES, MANUFACTURED IN GLEN ROCK, PENNSYLVANIA

12475 A

II

4/17/1997

RANKE QUIMICA SA

ALMOTRIPTAN, LAS 31416 D,L HYDROGEN MALATE, MANUFACTURED IN BARCELONA, SPAIN

12476 I

II

4/18/1997

PROQUINA SA

ESTRIOL, MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO

12477 I

II

4/22/1997

CARA PARTNERS WALLINGSTOWN LTD

GINKGO BILOBA EXTRACT, MANUFACTURED IN IN CO. CORK, IRELAND

12478 A

III

4/18/1997

SCHOTT FRANCE PHARMA SYSTEM SAS

GLASS AMPOULES, MANUFACTURED IN PONT-SUR-YONNE, FRANCE

12479 I

III

4/15/1997

POLYMER COLOR INC

12480 I

II

3/4/1997

POLFA TARCHOMIN

BLC-19380 25/1 PROCESS BLUE COLOR CONCENTRATE, MANUFACTURED IN MCHENRY,


ILLINOIS
7-ADC ACID, MANUFACTURED IN WARSAW, POLAND

12481 I

II

4/25/1997

STANDARD CHEM AND PHARM CO LTD

LOVASTATIN, MANUFACTURED IN TAIWAN, R.O.C.

12482 I

IV

4/10/1997

CERESTAR USA INC

HYDROXYPROPYL BETA CYCLODEXTRIN, MANUFACTURED IN WAUKEGAN, IL

12483 I

IV

4/24/1997

LA DREYFUS CO

DREYCO CHEWING GUM BASE, MANUFACTURED IN EDISON, NEW JERSEY

12484 I

4/21/1997

SCHERING GMBH UND CO PRODUKTIONS KG

MANUFACTURING SITE, FACILITIES, PERSONNEL AND PROCEDURES IN WEIMAR, GERMANY

12485 A

II

4/8/1997

12486 A

4/24/1997

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND


SYSTEMECHNIK
STERIGENICS INTERNATIONAL

GLYCEROLTRINITRATE-DUROTAK 387-2516 SOLUTION, MANUFACTURED IN LEVERKUSEN,


GERMANY
CONTRACT STERILIZATION FACILITY IN HAYWARD, CA

12487 I

III

2/24/1997

ALVEO AG

ALVEOLIT TEE 3000 WHITE, MANUFACTURED IN LUZERN, SWITZERLAND

12488 I

III

2/24/1997

ALVEO AG

ALVEOLIT TEE 1000 WHITE, MANUFACTURED IN LUZERN, SWITZERLAND

12489 I

II

4/30/1997

REHEIS INC

ALUMINUM NITRATO HYDRATE, MANUFACTURED IN BERKELEY HEIGHTS, NJ

12490 I

II

3/27/1997

HARBIN PHARMACEUTICAL FACTORY

PENICILLIN G POTASSIUM CRUDE, MANUFACTURED IN HARBIN, CHINA

12491 I

II

4/28/1997

NANOSYSTEMS

12492 I

II

4/21/1997

THATCHER CO

RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-JAR MILLING PROCESS,


MANUFACTURED IN HORSHAM, PA
CHLORHEXIDINE GLUCONATE, 20% (W/V), MANUFACTURED IN SALT LAKE CITY, UTAH

Page 356

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12493 A
III
3/27/1997
LANXESS CORP

SUBJECT
PERBUNAN, MANUFACTURED IN LEVERKUSEN, GERMANY

12494 I

IV

4/30/1997

ROUGIER INC

CONTRAMID, MANUFACTURED IN QUEBEC, CANADA

12495 I

III

4/30/1997

BECTON DICKINSON AND CO

BD AUTO-INJECTOR CARTRIDGE, MANUFACTURED IN LE PONT-DE-CLAIX, FRANCE

12496 I

II

5/8/1997

CHONGQING DAXIN PHARMACEUTICAL CO LTD

LOVASTATIN, USP, MANUFACTURED IN SICHUAN, CHINA

12497 A

III

5/5/1997

BD MEDICAL PHARMACEUTICAL SYSTEMS

BD READYFILL, MANUFACTURED IN LE PONT-DE-CLAIX, FRANCE

12498 I

4/28/1997

PLASTIAPE SPA

12499 A

III

4/28/1997

PLASTIAPE SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OSNAGO,


ITLAY
AEROLISER INHALATION DEVICE, MANUFACTURED IN OSNAGO, ITALY

12500 I

IV

5/8/1997

HENKEL CORP

GLUCOPON 625 UP, MANUFACTURED IN CINCINNATI, OHIO

12501 I

II

5/8/1997

VERA LABS LTD

RANITIDINE BULK DRUG, MANUFACTURED IN ANDHRA PRADESH, INDIA

12502 I

5/8/1997

VERA LABS LTD

12503 A

II

5/13/1997

NEULAND LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ANDHRA


PRADESH, INDIA
RANITIDINE, MANUFACTURED IN TELANGANA, INDIA

12504 I

III

5/8/1997

AMPACET CORP

12505 I

II

5/15/1997

EGIS PHARMACEUTICALS PUBLIC LTD CO

10562 PROCESS AID POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN


DERIDDER, LA CARTERSVILLE, GA AND MESSANCY, BELGIUM
LEVODOPA USP BULK, MANUFACTURED IN BUDAPEST, HUNGARY

12506 A

III

4/24/1997

A SCHULMAN INC

POLYETHYLENE PACKAGING COMPONENTS, MANUFACTURED IN AKRON OHIO

12507 I

III

5/5/1997

BASF AKTIENGESELLSCHAFT

NOVOLEN 1100 H, MANUFACTURED IN TARAGONA, SPAIN

12508 I

5/16/1997

RENTSCHLER BIOTECHNOLOGIE GMBH

STERILE PROCESSING FACILITY LOCATED IN LAUPHEIM, GERMANY

12509 A

II

5/15/1997

LUSOCHIMICA SPA

CARTEOLOL HYDROCHLORIDE, MANUFACTURED IN LOMAGNA, ITALY

12510 I

III

5/15/1997

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-3027, MANUFACTURED IN ADDISON, ILLINOIS

12511 I

II

5/19/1997

ERREGIERRE SPA

ISOXSUPRINE HYDROCHLORIDE USP, MANUFACTURED IN BERGAMO, ITALY

12512 I

II

5/21/1997

MAX INDIA LTD

CARBAMAZEPINE BULK DRUG SUBSTANCE, MANUFACTURED IN KARNATAKA, INDIA

12513 I

II

5/23/1997

CYCLACEL LTD

CS-682, MANUFACTURED IN KANAGAWA, JAPAN

12514 A

IV

4/25/1997

CHP CARBOHYDRATE PIRNA GMBH CO KG

SODIUM STARCH GLYCOLATE USP/NF, MANUFACTURED IN PIRNA, GERMANY

12515 I

II

5/23/1997

ALDRICH CHEMICAL CO INC

SQUALENE, MANUFACTURED IN SHEBOYGAN FALLS, WI

12516 I

III

5/20/1997

BASF CORP

LUTONAL A 50, 50% IN ETHYL ALCOHOL MANUFACTURED IN LUDWIGSHAFEN, GERMANY

12517 I

5/23/1997

POLYPEPTIDE LABORATORIES AS

12518 I

5/20/1997

12519 I

IV

5/5/1997

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY INFECTIOUS DISEASES
MARUTI INDUSTRIAL CARBOHYDRATES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


HILLEROD, DENMARK
PLASMA HIV-RNA IN CLINICAL TRIALS SUPPORTING TRADITIONAL APPROVAL OF AN
ANTIRETROVIRAL DRUG:DATA ANALYSIS ISSUES
SODIUM STARCH GLYCOLATE, MANUFACTURED IN TAMILNADU, INDIA

12520 I

III

4/10/1997

DRYCOLOR AB

MASTERBACH PE 142365, MANUFACTURED IN MALMO, SWEDON

12521 A

III

3/25/1997

CLARIANT MASTERBATCHES NORDEN AB

MASTERBATCH PE 192300, MANUFACTURED IN MALMO, SWEDEN

12522 A

II

5/12/1997

NEOMPS INC

ACYLINE, MANUFACTURED IN SAN DIEGO, CA

12523 A

II

5/23/1997

JIANGXI DONGFENG PHARMACEUTICAL LLC

PENICILLIN G POTASSIUM USP23, MANUFACTURED IN LEPING, JIANGXI, CHINA

12524 A

IV

6/2/1997

SEPPIC SA

SEPIFILM LP-WHITE RANGE(761 AND 770)

12525 A

III

5/5/1997

APTAR FRANCE SAS

APTAR VP3 PUMPS, MANUFACTURED IN LE VAUDREUIL, FRANCE AND CONGERS, NY

12526 I

II

5/23/1997

PROTEIN TECHNOLOGIES INTERNATIONAL INC

PTI G-4660, MANUFACTURED IN ST. LOUIS, MO

12527 I

III

5/26/1997

AMPHABEL SA

GLASS VAILS, MANUFACTURED IN LESSINES, BELGIUM

12528 I

II

5/30/1997

HOECHST MARION ROUSSEL SA

DOBUTAMINE ISONICOTINATE/ OFF-0358-A-01-1, MANUFACTURED IN VERTOLAYE, FRANCE

Page 357

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12529 I
II
5/30/1997
HOECHST MARION ROUSSEL SA

SUBJECT
DOBUTAMINE HYDROCHLORIDE/STE 443-A-01-1, MANUFACTURED IN NEUVILLE SUR SAONE,
FRANCE
HALOPERIDOL DECANOATE, MANUFACTURED IN VARESE, ITALY

12530 A

II

5/28/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

12531 I

6/3/1997

BRISTOL MYERS SQUIBB CARIBBEAN CO

12532 A

II

6/2/1997

NEULAND LABORATORIES LTD

PARENTERAL MANUFACTURING FACILITY DESCRIPTION AND PROCESSVALIDATION


SUMMARY AS PERFORMED IN MAYAGUEZ, PUERTO RICO
RANITIDINE HYDROCHLORIDE (FORM I), MANUFACTURED IN TELANGANA, INDIA

12533 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 20 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12534 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 20 UM ANNEALED FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12535 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 25 UM ANNEALED FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12536 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 25 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12537 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 30 UM ANNEALED FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12538 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 30 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12539 I

III

5/20/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 15 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12540 I

II

6/9/1997

STAR TOBACCO PHARMACEUTICALS INC

TOBACCO GOLD, MANUFACTURED IN KEYSVILLE, VIRGINIA

12541 A

II

4/17/1997

FINE CHEMICALS CORP PTY LTD

(R)-(-)-BACLOFEN, MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA

12542 I

II

6/5/1997

JANSSEN PHARMACEUTICA NV

LUBELUZOLE, MANUFACTURED IN BEERSE AND GEEL, BELGIUM

12543 A

II

6/11/1997

SHASUN PHARMACEUTICALS LTD

RANITIDINE, MANUFACTURED IN CUDDALORE, INDIA

12544 I

II

6/10/1997

XECHEM INC

PACLITAXEL BULK DRUG SUBSTANCE, MANUFACTURED IN NEW BRUNSWICK, NJ

12545 I

II

5/23/1997

PROTEIN TECHNOLOGIES INTERNATIONAL INC

12546 A

II

6/3/1997

FINORGA

12547 I

III

6/12/1997

3M DRUG DELIVERY SYSTEMS

PTI G-2535 (UNCONJUGATED ISOFLAVONES-70), MANUFACTURED BY SIGMA CHEMICLAL


COMPANY IN ST. LOUIS, MO
ALFUZOSIN HYDROCHLORIDE (INN), SL77-0499-10, MANUFACTURED IN CHASSE SUR RHONE,
FRANCE
A66000 25UL SPRAYMISER VALVE, MANUFACTURED IN GLOUCESTERSHIRE, GREAT BRITAIN

12548 A

III

6/18/1997

MYLAN TECHNOLOGIES INC

MEDIDERM 3500, MANUFACTURED IN ST. ALBANS, VT

12549 A

IV

6/7/1997

JRS PHARMA LP

LUBRITAB, MANUFACTURED IN JACKSON, IL

12550 I

II

6/17/1997

GENZYME PHARMACEUTICALS

12551 I

II

6/17/1997

12552 A

II

6/19/1997

FAULDING PHARMACEUTICALS SUB FH FAULDING


AND CO LTD
WOCKHARDT LTD

1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, AMMONIUM SALT (POPG, NH4)


MANUFACTURED IN LIETAL, SWITZERLAND
COATED CIMETIDINE POWDER, MANUFACTURED IN SALISBURY SOUTH, SOUTH AUSTRALIA

12553 A

II

6/18/1997

PERRIGO API LTD

MIDAZOLAM, MANUFACTURED IN BE'ER SHEVA, ISRAEL

12554 A

II

6/18/1997

TAIHO PHARMACEUTICAL CO LTD

CDHP, MANUFACTURED IN SAITAMA, JAPAN

12555 A

II

6/23/1997

CORDEN PHARMA SWITZERLAND LLC

12556 I

5/6/1997

IVEX PHARMACEUTICALS

12557 I

II

6/19/1997

SHAOXING PHARMACEUTICAL FACTORY

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC), MANUFACTURED IN LIESTAL,


SWITZERLAND
MANUFACTURING SITE, FACILITIES AND PERSONNEL IN COUNTY ANTRIM, NORTHERN
IRELAND
NYSTATIN, MANUFACTURED IN ZHEJIANG, CHINA

12558 A

II

6/17/1997

FARMAK AS

KETOROLAC TROMETHAMINE, MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

12559 I

II

6/25/1997

VERA LABORATORIES LTD

NAPROXEN SODIUM, MANUFACTURED IN ANDHRA PRADESH, INDIA

12560 I

III

5/23/1997

GEORGIA PACKAGING INC

PRODUCT 41722-35, MANUFACTURED IN COLUMBUS, GA

12561 I

III

6/27/1997

ISHIDA PRESS KOGYO CO LTD

ALUMINUM CAPS FOR MEDICAL VIALS, MANUFACTURED IN SAITAMA, JAPAN

12562 A

II

6/26/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

PENTOXIFYLLINE, MANUFACTURED IN NETANYA, ISRAEL

RANITIDINE HYDROCHLORIDE, MANUFACTURED IN GUJARAT STATE, INDIA

Page 358

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12563 I
I
7/2/1997
SEPRACOR CANADA LTD

SUBJECT
MANUFACTURING SITE, FACILITIES, AND PERSONNEL IN NONA SCOTIA, CANADA

12564 I

II

6/25/1997

SELOC AG

ISOSORBIDE CONCENTRATE, MANUFACTURED BY SIFA LTD. IN CO. CLARE, IRELAND

12565 A

III

6/25/1997

STYROLUTION GMBH

12566 I

III

6/18/1997

SOLVAY DRAKA INC.

POLYSTYROL 143 E, MANUFACTURED IN LUDWIGSHAFEN, GERMANY AND ANTWERPEN,


BELGIUM
SOLMED 91 FILM, MANUFACTURED IN LAPORTE, INDIANA

12567 I

IV

6/23/1997

INTERNATIONAL SPECIALTY PRODUCTS

12568 I

II

6/30/1997

SUMIKA FINE CHEMICALS CO LTD

CELEX 101, MICROCRYSTALLINE CELLULOSE, NF, MANUFACTURED BY ISP-CHEMFEILDS IN


DIST. NAGPUR, INDIA
OXONIC ACID POTASSIUM SALT, MANUFACTURED A OSAKA PLANT IN OSAKA CITY, JAPAN

12569 I

II

7/2/1997

CASCADE BIOCHEMICAL LTD

ALPROSTADIL, MANUFACTURED IN BERKSHIRE, UNITED KINGDOM

12570 I

III

6/19/1997

CARCANO ANTONIO S.P.A.

ALUMINIUM FOIL, SMOOTH, SOFT TEMPER, 0.040MM, LACQUERED FOR PRINTING OR WITH
TEXT IN BLACK COLOUR ON ONE SIDE AND LAMINATED ADHESIVE TO POLYETHYLENE FILM
0.025MM ON THE OTHER SIDE, MANUFACTURED IN MANDELLO DEL LARIO-LC-ITALY

12571 A

II

7/9/1997

ALKERMES GAINESVILLE LLC

12572 I

III

6/12/1997

ROLLPRINT PACKAGING PRODUCTS INC

RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS,


MANUFACTURED IN ATHLONE, IRELAND
RPP #26-3028, MANUFACTURED IN ADDISON, ILLINOIS AND BLOOMFIELD, CT

12573 I

III

7/8/1997

STEDIM SA

STEDIM 5 BAGS, MANUFACTURED IN AUBAGNE CEDEX, FRANCE

12574 I

III

6/25/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 30 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12575 I

III

6/25/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 15 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12576 I

III

6/25/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 20 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12577 I

III

6/25/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

LID 20 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

12578 I

III

6/25/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

12579 I

III

6/25/1997

PECHINEY EMBALLAGE ALIMENTAIRE

12580 I

III

6/25/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

12581 I

II

7/8/1997

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA

LID 20 UM ANNEALED FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX,


FRANCE
LID 25 UM ANNEALED FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX,
FRANCE
LID 30 UM ANNEALED FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX,
FRANCE
TERAZOSIN HCL-FORM 1, MANUFACTURED IN VARESE, ITALY

12582 I

IV

7/7/1997

SYMRISE INC

PINEAPPLE FLAVOR 9/H04395, CHOCOLATE FLAVOR SPRAY DRIED 9/H07215, STRAWBERRY


FLAVOR ARTIFICIAL TYPE 9/H04832, AND VANILLA FLAVOR 9/H00625, MANUFACTURED IN
PANDON LOOP, SINGAPORE

12583 I

II

6/17/1997

THERATECH INC

ALORA ESTRADIOL TRANSDERMAL SYSTEM, MANUFACTURED IN SALT LAKE CITY, UTAH

12584 A

II

7/11/1997

NICOBRAND LTD

12585 A

II

7/9/1997

ACS DOBFAR SPA

NICOTINE BITARTRATE DIHYDRATE, MANUFACTURED IN CO. LONDONDERRY, NORTHERN


IRELAND
SODIUM BICARBONATE, STERILE, MANUFACTURED IN MILANO, ITALY

12586 A

II

7/9/1997

ACS DOBFAR SPA

CEPHALOTHIN SODIUM, ORAL GRADE, MANUFACTURED IN MILANO, ITALY

12587 I

III

7/7/1997

GRAND POLYMER CO LTD

GRANDPOLYPRO J216, MANUFACTURED IN CHIBA, JAPAN

12588 A

III

7/7/1997

ST GOBAIN DESJONQUERES SA SGD

12589 I

II

7/11/1997

FERMION OY

SILICONIZATION PROCEDURE FOR GLASS PACKAGING MATERIAL IN MERS LES BAINS,


FRANCE
AZATHIOPRINE, MANUFACTURED IN OULU, FINLAND

12590 I

IV

7/8/1997

MITSUBISHI CHEMICAL CORP

SUCROSE STEARIC ACID ESTERS AND SUCROSE PALMITIC ACID ESTERS, MANUFACTURED
IN MIE PREFECTURE, JAPAN

Page 359

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12591 I
V
7/11/1997
NATIONAL INSTITUTES HEALTH NATIONAL CANCER
INSTITUTE
12592 A
III
7/22/1997
LAMP S PROSPERO SPA
12593 I

III

7/15/1997

HELVOET PHARMA MARYLAND

SUBJECT
PRECLINICAL PHARMACOLOGY AND TOXICOLOGY AGENT ISIS 5320 (NSC 665353), IN
BETHESDA, MARYLAND
PVC FOIL DRUG PACKAGING MATERIAL LAMINATED TO PE FILM, MANUFACTURED IN MODENA
(ITALY)
RUBBER CLOSURE FORMULATION B5310-45 N GRAY, MANUFACTURED IN SALISBURY, MD

12594 I

II

7/18/1997

TORRENT GUJARAT BIOTECH LTD.

6-AMINO PENICILLANIC ACID, MANUFACTURED IN VADODARA, INDIA

12595 I

II

7/18/1997

TORRENT GUJARAT BIOTECH LTD.

PENICILLANIC G POTASSIUM, MANUFACTURED IN VADODARA, INDIA

12596 A

II

7/18/1997

CARBOGEN AMCIS AG

TROPICAMIDE, MANUFACTURED IN BUDENDORF, SWITZERLAND

12597 I

III

7/11/1997

SKILLPACK PET TECHNOLOGIES BV

12598 I

7/23/1997

NORDEN PACK INTERNATIONAL AB

12599 I

II

7/18/1997

LONZO LTD

POLYETHYLENE TEREPHTHALATE PACKAGING MATERIALS MANUFACTURED IN ETTEN-LEUR,


NETHERLANDS
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN
HELSINGBORG AND ASTORP, SWEDEN
IMEOL, MANUFACTURED IN VISP, SWITZERLAND

12600 A

II

7/17/1997

BASF SE

UVINUL N 539 T, MANUFACTURED IN LUDWIGSHAFEN, GERMANY

12601 I

III

7/9/1997

DUDEK PLAST AS

12602 A

III

7/9/1997

LINHARDT GMBH AND CO KG

12603 A

III

7/24/1997

BRASKEM AMERICA INC

TABLET CONTAINER AND CAPS IN FIVE SIZES 150ML, 250ML, 300ML, 400ML AND 500ML,
MANUFACTURED IN JONSTRUP, DENMARK
ALUMINIUM TUBES FOR THE COSMETIC, THE PHARMACEUTICAL AND THE FOOD SECTOR,
MANUFACTURED IN VIECHTACH, HAMBRUCKEN, AND PAUSA, GERMANY
POLYPROPYLENE 5E88S, MANUFACTURED IN NORCO, LA AND NORTH SEADRIFT, TX

12604 I

II

7/24/1997

NANOSYSTEMS

12605 A

II

7/23/1997

QUIMICA SINTETICA SA

12606 A

III

7/21/1997

SUD CHEMIE PERFORMANCE PACKAGING

12607 A

II

7/25/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

12608 I

III

7/28/1997

ERACO AS

12609 I

7/24/1997

NEMO SA

12610 I

III

7/30/1997

3M DRUG DELIVERY SYSTEMS

CHILD RESISTANCE AND TAMPER EVIDENCE CLOSURES, MANUFACTURED IN


FREDERIKSSUND, DENMARK
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN
BARCELONA, SPAIN
METERED DOSE AEROSOL VALVE, MANUFACTURED IN LEICESTERSHIRE, GREAT BRITAIN

12611 I

IV

6/18/1997

SHANGHAI GUANG DE LI CAPSULES CO LTD

GELATIN CAPSULES MANUFACTURED IN SHANGHAI CHINA

12612 A

II

8/5/1997

PFANSTIEHL INC

AMMONIUM LACTATE MANUFACTURED IN WAUKEGAN, IL.

12613 A

II

8/4/1997

ERREGIERRE SPA

TIOCONAZOLE, MANUFACTURED IN BERGAMO, ITALY.

12614 I

II

8/5/1997

DIOSYNTH BV

12615 I

II

7/29/1997

ESTEVE QUIMICA SA

DEHYDROISOANDROSTERONE SODIUM SULPHATE, MANUFACTURED IN IN TLALNEPANTLA,


STATE OF MEXICO, MEXICO.
VPA-985, MANUFACTURED IN CELRA (GIRONA) SPAIN

12616 I

II

6/9/1997

GEDEON RICHTER LTD

GLUTETHIMIDE, MANUFACTURED IN BUDAPEST, HUNGARY

12617 I

IV

8/6/1997

EASTMAN DENTAL CENTER

SAIB SPECIAL GRADE (SG), MANUFACTURED IN KINGSPORT, TN.

12618 I

II

8/8/1997

RANBAXY PHARMACEUTICALS

ETODOLAC DRUG SUBSTANCE, MANUFACTURED IN MADHYA PRADESH, INDIA

12619 I

8/5/1997

ORGANICHEM CORP

12620 A

II

8/11/1997

BACHEM AMERICAS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURE IN CORK,


IRELAND.
VASOACTIVE INTESTINAL PEPTIDE (VIP), HUMAN, MANUFACTURED IN TORRANCE, CA.

12621 I

II

8/12/1997

MALLINCKRODT CHEMICAL INC

L-754,030 NANOCRYSTAL COLLOIDAL DISPERSION-JAR MILLING PROCESS, MANFACTURED IN


HORSHAM, PA
OMEPRAZOLE, MANUFACTURED IN MADRID, SPAIN
AIRSEC DRI-PAX POLY TUBES, DESICCANT PLUGS, AND DESICCANT STOPPERS,
MANUFACTURED IN BELEN, NEW MEXICO
DIFLORASONE DIACETATE BULK DRUG, MANUFACTURED IN MILAN, ITALY

ACYCLOVIR USP (MICRONIZED), CODED 2524, MANUFACTURED BY POWDERSIZE, INC. IN


QUAKERTOWN PA.

Page 360

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12622 I
II
8/14/1997
FINORGA SA

SUBJECT
6-BENZYL-1-ETHOXYMETHYL-5-ISOPROPYLURACIL, MANUFACTURED IN CHASSE-SURRHONE, FRANCE.
NABUMETONE, MANUFACTURED IN FREEPORT GRAND BAHAMAS ISLAND, BAHAMAS

12623 I

II

8/14/1997

PHARMACEUTICAL FINE CHEMICALS,BAHAMAS

12624 A

III

3/27/1997

NOLATO JAYCARE LTD

12625 I

III

8/14/1997

AMPACET CORP

12626 I

II

8/21/1997

HANA BIOSCIENCES, INC

12627 A

IV

8/21/1997

FMC CORP FMC BIOPOLYMER DIV

12628 I

8/22/1997

PHARMA BIOTECH

12629 I

II

8/15/1997

VEGEFLORA EXTRACOES DO NORDESTE LTDA

AVICEL CE-15 MICROCRYSTALLINE CELLULOSE AND GUAR GUM, MANUFACTURED IN


NEWARK, DE
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN SIGNES,
FRANCE.
PILOCARPINE USP, MANUFACTURED IN PARNAIBA-PI-BRASIL

12630 I

II

8/25/1997

HUBEI PHARMACEUTICAL FACTORY

NAPROXEN USP, MANUFACTURED IN HUBEI, P.R. CHINA.

12631 I

II

8/27/1997

UNION QUIMICO FARMACEUTICA SA

FLUOXETINE HYDROCHLORIDE, USP, MANUFACTURED IN BARCELONA, SPAIN.

12632 I

II

8/27/1997

HAMNMI FINE CHEMICAL CO LTD

CEFOTAXIME ACID, MANUFACTURED IN KYONGGI-DO, REPUBLIC OF KOREA.

12633 I

III

8/26/1997

STEDIM SA

EVA BAGS MANUFACTURED IN AUBAGNE CEDEX, FRANCE.

12634 A

II

8/27/1997

EXCELLA GMBH

DOXAZOSIN MESYLATE AS MANUFACTURED IN FEUCHT, GERMANY

12635 I

II

8/29/1997

ABBOTT LABORATORIES

TROMETHAMINE,USP, MANUFACTURED IN NORTH CHICAGO, IL

12636 I

II

8/29/1997

SUMITOMO CHEMICAL CO LTD

BMCB(INERMEDIATE) MANUFACTURED IN OKAYAMA PREFECTURE, JAPAN

12637 A

II

8/28/1997

FLUOROMED LP

APF-N40M, MANUFACTURED IN ROUND ROCK, TX.

12638 I

II

8/29/1997

BETAXOLOL HYDROCHLORIDE, USP MANUFACTURED IN NORTH CHICAGO, IL.

12639 I

II

9/2/1997

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
NATURAL BIOLOGICS

12640 A

IV

9/3/1997

ACG ASSOCIATED CAPSULES PRIVATE LTD

EMPTY GELATIN CAPSULES, MANUFACTURED IN MUMBAI, INDIA

12641 I

IV

8/21/1997

12642 I

8/18/1997

PAPIERFABRIK DIV SCHOELLER AND HOESCH


GEFOLUX BOPP/ML, MANUFACTURED IN GERNSBACH, GERMANY.
GMBH
NATIONAL INSTITUTES HEALTH NATIONAL CANCER OVERSIGHT, REVIEW, MONITORING, AND AUDITING PROCEDURES OF NATIONAL CANCER
INSTITUTE DIV CANCER PREVENTION AND
INSITUTE, DIVISION OF CANCER PREVENTION.
CONTROL

12643 A

II

9/4/1997

EUTICALS SPA

TICLOPIDINE HYDROCHLORIDE, MANUFACTURED IN ROZZANO-(MI)

12644 I

9/8/1997

SUMITOMO SEIKA CHEMICALS

12645 A

II

9/8/1997

SUMITOMO SEIKA CHEMICALS CO LTD

MANUFACTURING SITE , FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HYOGO,


JAPAN.
2,4-THIAZOLE WING ACID HOSU ACTIVE ESTER, MANUFACTURED IN HYOGO, JAPAN.

12646 I

II

9/5/1997

MALLINCKRODT CHEMICAL INC

PRAMLINTIDE STD AMYLIN, MANUFACTURED IN ST, LOUIS MO.

12647 A

II

9/8/1997

USV LIMITED

METFORMIN HCL BP, MANUFACTURED IN MAHARASHTRA, INDIA.

12648 I

III

7/10/1997

APTAR FRANCE SAS

VP3 PUMPS, MANUFACTURED IN CONGERS, NY

12649 I

II

9/8/1997

CILAG AG

12650 A

II

9/11/1997

MOREPEN LABORATORIES LTD

TERAZOSIN HYDROCHLORIDE MONOHYDRATE, MANUFACTURED IN SCHAFFHAUSEN,


SWITZERLAND.
LORATADINE, MANUFACTURED IN HIMACHAL PRADESH, INDIA.

12651 I

III

8/28/1997

LOPAREX BV

12652 I

II

9/15/1997

DSM ANDENO GMBH

SECURIPAC, VITAPAC CONTAINER WITH JAYCAP CLOSURE, MANUFACTURED IN LONDON,


ENGLAND
11200 WHITE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, AND
CARTERSVILLE, GA
VINCRISTINE SULFATE LIPOSOME INJECTION, MANUFACTURED IN VANCOUVER CANADA

NATURAL CONJUGATED ESTROGEN-BULK INGREDIENT, MANUFACTURED IN AUSTIN, MN

FL2000TM 80UM HDPE (PRODUCT CODE 78-080-A-020-B), MANUFACTURED IN APELDOORN,


THE NETHERLANDS
TRIAZOLON, MANUFACTURED IN REGENSBURG, GERMANY

Page 361

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12653 A
III
8/6/1997
WEBER INTERNATIONAL PACKAGING
CORPORATION
12654 I
III
8/9/1997
ELM PLASTIC GMBH

SUBJECT
PHARMACEUTICAL PLASTIC BOTTLES, MANUFACTURED IN QUEBEC, CANADA

12655 I

II

9/11/1997

FINE CHEMICALS CORPORATION LTD

CODEINE PHOSPHATE, MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

12656 A

II

9/10/1997

SYN TECH CHEM AND PHARM CO LTD

DICLOFENAC POTASSIUM, MANUFACTURED IN TAIWAN, R.O.C.

12657 A

III

9/22/1997

BPREX HEALTHCARE OFFRANVILLE SAS

12658 I

III

9/19/1997

SABIC PETROCHEMICALS BV

EYE-DROPPER 5, 11 AND 15ML, DROPPERS, CAPS, MANUFACTURED IN OFFRANVILLE,


FRANCE.
SABIC LDPE 2102TC32;, MANUFACTURED IN AA BEEK, THE NETHERLANDS.

12659 A

II

9/18/1997

AMRI RENSSELAER INC

TRIENTINE HCL, MANUFACTURED IN RENSSELAER, N.Y.

12660 I

III

8/8/1997

DANAPAK FLEXIBLES

PHARMACEUTICAL COMPONENT, MANUFACTURED IN ODENSE S., DENMARK.

12661 A

II

9/19/1997

ALFENTANIL HCL, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

12662 A

II

9/20/1997

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
FARMABIOS S P A

12663 A

III

9/1/1997

3M DRUG DELIVERY SYSTEMS

METERED DOSE AEROSOL VALVE, MANUFACTURED IN LEICESTERSHIRE, GREAT BRITAIN.

12664 A

III

9/19/1997

GEORGIA GULF CHEMICALS AND VINYLS LLC

PVC COMPOUND, 8271 CLEAR 36, MANUFACTURED IN TIPTONVILLE, TENNESSEE.

12665 I

II

9/23/1997

SHASUN CHEMICALS AND DRUGS LTD

RANITIDINE HYDROCHLORIDE, MANUFACTURED IN CUDDALORE, INDIA.

12666 A

III

9/26/1997

INEOS CHLORVINYLS BELGIUM NV

12667 I

II

9/26/1997

FINE ORGANICS LTD

MARVYLAN S 5702,MANUFACTURED AT DSM POLYMERS IN BEEK, THE NETHERLANDS AND


SAV MAZINGARBE IN BULLY LES MINES, FRANCE.
TVSE, MANUFACTURED IN CLEVELAND, ENGLAND.

12668 I

III

9/10/1997

PLASTICOS ARCO IRIS SA DE CV

PLASTIC MATERIALS, MANUFACTURED IN JALISCO, MEXICO.

12669 A

II

9/22/1997

WANBURY LTD

IBUPROFEN BULK DRUG, MANUFACTURED IN ANDHRA PRADESH, INDIA.

12670 A

II

9/30/1997

MERCK SANTE SAS

METFORMIN HYDROCHLORIDE DRUG SUBSTANCE, MANUFACTURED IN MEYZIEU, FRANCE.

12671 I

II

9/29/1997

YAMASA CORP

SODIUM CITICOLINE, MANUFACTURED IN CHIBA-KEN, JAPAN.

12672 I

II

9/23/1997

SINOVA PHARMACEUTICALS CO PTE LTD

CAPTOPRIL, MANUFACTURED IN SINGAPORE, REPUBLIC OF SINGAPORE.

12673 I

10/1/1997

KIBUN FOOD CHEMIFA CO LTD

12674 A

II

10/1/1997

KIKKOMAN BIOCHEMIFA CO

PLANT FACILITIES AND ORGANIZATION FOR MANUFACTURING SODIUMHYALURONATE OF


PHARMACEUTICAL GRADE IN TOKYO, JAPAN.
SODIUM HYALURONATE OF PHARMACEUTICS GRADE IN TOKYO, JAPAN.

12675 I

III

9/30/1997

DRYCOLOR AB

MASTERBACH PE 142306, MANUFACTURED IN MALMO, SWEDEN.

12676 I

II

10/1/1997

PRODOTTI CHIMICI DOTTORI RE

CHENODIOL, (CHENODEOXYCHOLIC ACID), MANUFACTURED IN BASALUZZO, ITALY.

12677 I

III

10/3/1997

SCHOTT PARENTA SYSTEMS

12678 I

III

9/29/1997

POLYMER COLOR INC

PACKAGING MATERIAL, PREFILL SYRINGE, A COMBINATION PRODUCT, MANUFACTURED IN


CLEONA, PA .
WPC-116-P 33/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS.

12679 I

II

10/2/1997

CAMBREX KARLSKOGA AB

ISOSORBIDE-5-MONONITRATE/LACTOSE MANUFACTURED IN KARLSKOGA, SWEEDEN.

12680 I

II

10/2/1997

SIFAVITOR SRL

BETAXOLOL HYDROCHLORIDE, MANUFACTURED IN MILANO, ITALY.

12681 I

III

9/30/1997

3M PHARMACEUTICALS INC

3MVA15378 50 MCL SOLUTION VALVE, MANUFACTURED IN LOUGHBOROUGH, GREAT BRITAIN.

12682 I

6/16/1997

BRISTOL MYERS SQUIBB COMPANY

FACILITIES FOR PARENTERAL MANUFACTURING (BUILDING D) LOCATED IN MAYAGUEZ, PR.

12683 A

III

10/7/1997

SCHOTT PHARMACEUTICAL PACKAGING INC

GLASS PRODUCTS, MANUFACTURED IN CLEONA, PENNSYLVANIA

12684 I

II

9/30/1997

INDUSTRIALE CHIMICA SRL

BUSPIRONE HYDROCHLORIDE, MANUFACTURED IN SARANNO, ITALY

12685 I

10/3/1997

TOKUYAMA CORP

12686 A

II

10/6/1997

CAMBREX PROFARMACO MILANO SRL

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN IBARAKI,


JAPAN
MIDAZOLAM BASE MANUFACTURED IN MILAN ITALY.

DOSING PIPETTE, MANUFACTURED IN DUDELDORF, GERMANY

MEGESTROL ACETATE, MANUFACTURED IN PAVIA-ITALY.

Page 362

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12687 A
II
10/8/1997
TEVA PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
MEGESTROL ACETATE, MANUFACTURED IN LERMA, EDO. MEXICO.

12688 I

II

10/7/1997

GILEAD SCIENCES INC

PMPA GEL, MANUFACTURED AT DPT LABS, SAN ANTONIO, TEXAS.

12689 I

III

9/26/1997

BASF AKTIENGESELLSCHAFT

LURAN 388 S, MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

12690 I

III

9/26/1997

BASF AKTIENGESELLSCHAFT

TERLURAN 958 I WHITE 00260, MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

12691 I

II

10/9/1997

SIEGFRIED CHEMIE AG LTD

PROPAFENONE HYDROCHLORIDE, MANUFACTURED IN ZOLFINGEN,SWITZERLAND

12692 A

IV

10/8/1997

FUJI CHEMICAL INDUSTRY CO LTD

FUJICALIN, MANUFACTURED IN TOYAMA, JAPAN

12693 A

III

10/8/1997

BAYER MATERIALSCIENCE LLC

TEXIN 5286, 5290, 5250, 6265, 5270, 5590, 5370, MANUFACTURED IN NEW MARTINSVILLE, WV.
TEXIN 5370, MANUFACTURED IN ONTARIO, CANADA. TEXIN 5275, MANUFACTURED IN
DORMAGEN, GERMANY.

12694 A

II

10/9/1997

ASTRAZENECA AB

12695 A

II

10/15/1997

FARMABIOS S P A

PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM) , AS MANUFACTURED IN


SODERTALJE, SWEDEN.
MEDROXYPROGESTERONE ACETATE, MANUFACTURED IN PAVIA, ITALY.

12696 I

II

10/15/1997

INTERQUIM SA

SODIUM CITICOLINE, MANUFACTURED IN BARCELONA SPAIN.

12697 A

II

10/16/1997

ALBEMARLE CORP

ITRACONAZOLE, MANUFACTURED IN SOUTH HAVEN, MI

12698 I

II

10/15/1997

DOCTOR REDDYS LABORATORIES LTD

DOMPERIDONE MALEATE, MANUFACTURED IN SRIKAKULAM DISTRICT, INDIA.

12699 I

II

10/14/1997

SOLVAY DUPHAR BV

LACTULOSE CRYSTALLINE, MANUFACTURED IN AMSTERDAM, THE NETHERLANDS.

12700 I

III

10/10/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

COLD-FORMED BLISTER; CEF60, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE.

12701 A

II

10/17/1997

BACHEM AMERICAS INC

PEPTIDE KL4, ACETATE, MANUFACTURED IN TORRANCE, CALIFORNIA.

12702 I

II

10/15/1997

LEO PHARMACEUTICAL PRODUCTS LTD

BUMETANIDE PURE MICRONISED, MANUFACTURED IN DUBLIN, IRELAND.

12703 A

II

10/20/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

MEDROXYPROGESTERONE ACETATE, MANUFACTURED IN LERMA, EDO MEXICO

12704 I

II

10/21/1997

WARFARIN SODIUM, USP, MANUFACTURED IN SHANGHAI, CHINA

12705 I

III

10/11/1997

SHANGHAI SHEN XING PHARMACEUTICAL


FACTORY
PECHINEY EMBALLAGE ALIMENTAIRE

12706 A

II

10/20/1997

GAYLORD CHEMICAL CO LLC

DIMETHYL SULFOXIDE (DMSO), USP GRADE, MANUFACTURED IN SLIDELL, LOUISIANA

12707 A

III

10/20/1997

ALFATHERM SPA

ALFAFORM K072, MANUFACTURED IN VARESE-ITALY.

12708 A

III

10/20/1997

ALFATHERM SPA

ALFAFORM K206, MANUFACTURED IN VARESE-ITALY

12709 A

III

10/20/1997

ALFATHERM SPA

ALFACLEAR OR K263, MANUFACTURED IN VARESE-ITALY

12710 I

III

10/22/1997

CRODA ADHESIVES LTD

CRODALAM 29-208/25-011, MANUFACTURED IN NEWARK, ENGLAND

12711 A

II

10/21/1997

ESTEVE QUIMICA SA

ENANAPRILAT, MANUFACTURED IN BARCELONA SPAIN

12712 I

III

10/24/1997

SABIC PETROCHEMICALS BV

SABIC LDPE 2201TH00; MANUFACTURED IN AA BEEK, THE NETHERLANDS

12713 I

II

10/24/1997

PFANSTIEHL LABORATORIES INC

INULIN, USP,MANUFACTURED IN WAUKEGAN, IL.

12714 I

II

10/23/1997

EDMOND PHARMA

CARTEOLOL HYDROCHLORIDE, MANUFACTURED IN PADERNO DUGNANO (MI), ITALY

12715 I

IV

10/20/1997

PEBOC DIVISION EASTMAN CHEMICAL (UK) LTD

EASTMAN VITAMIN E TPGS 1000 MANUFACTURED IN NORTH WALES, UNITED KINGDOM

12716 I

II

10/23/1997

EXCELLA GMBH

BISOPROLOL HEMIFUMARATE, MANUFACTURED IN FEUCHT, GERMANY.

12717 I

II

10/21/1997

CHEMI SPA

DPPC (DIPALMITOYL-PHOSPHATATIDYLCHOLINE) MANUFACTURED IN FROSINONE, ITALY.

12718 I

III

10/22/1997

G AND A PRINTERS LTD

PHARMACEUTICAL PACKAGING MATERIALS, MANUFACTURED IN KENT, ENGLAND

12719 A

III

10/22/1997

EXXONMOBIL CHEMICAL CO

12720 I

II

10/29/1997

AMINO GMBH

SANTOPRENE THERMOPLASTIC RUBBER 8280 GRADE SERIES, MANUFACTURED IN AKRON


OH, PENSACOLA FL, WADSWORTH OH, AND NEWPORT WALES UK
L-VALINE, MANUFACTURED IN FRELLSTEDT, GERMANY

12721 I

II

10/29/1997

AMINO GMBH

N-ACETYL-L-TYROSINE, MANUFACTURED IN FRELLSTEDT, GERMANY

12722 I

II

11/5/1997

JOHNSON MATTHEY INC

LANTHANUM CARBONATE, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

PHARMACEUTICAL STRIP, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

Page 363

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12723 A
II
10/29/1997
OMICRON QUIMICA SA

SUBJECT
BISMUTH SUBCITRATE, MANUFACTURED IN BARCELONA, SPAIN.

12724 I

II

10/20/1997

KYOWA HAKKO KOGYO CO LTD

CITICOLINE MONOSODIUM SALT, MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN.

12725 A

II

10/29/1997

OMICRON QUIMICA SA

BISMUTH SUBCARBONATE, MANUFACTURED IN BARCELONA, SPAIN.

12726 A

II

10/31/1997

ASTRAZENECA AB

OMEPRAZOLE MAGNESIUM,(DRUG SUBSTANCE) MANUFACTURED IN SODERTALJE, SWEDEN.

12727 I

11/4/1997

VISTA PHARMACEUTICALS INC

12728 I

11/6/1997

CONTI BPC NVSA

12729 A

II

11/7/1997

PHARMATECH INTERNATIONAL INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PRO-CEDURES IN ANDHRA


PRADESH, INDIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LANDEN,
BELGIUM.
MISOPROSTOL, MANUFACTURED IN FAIRFIELD, NEW JERSEY.

12730 A

IV

10/27/1997

CAPSUGEL

GELATIN CAPSULES, MANUFACTURED IN PATHUMTHANI, THAILAND

12731 A

IV

10/27/1997

CAPSUGEL

GELATIN CAPSULES MANUFACTURED IN WEST JAVA, INDONESIA.

12732 A

II

11/3/1997

UNION QUIMICO FARMACEUTICA SA

2,4-WING ACTIVE ESTER, MANUFACTURED IN BARCELONA, SPAIN.

12733 I

11/11/1997

JANSSEN PHARMACEUTICA INC

12734 I

II

11/7/1997

WYCKOFF CHEMICAL CO INC

12735 I

11/10/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

12736 A

II

11/12/1997

TEVA PHARMACEUTICAL INDUSTRIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN CORK,


IRELAND.
TRIMETHOPRIM, MANUFACTURED IN SOUTH HAVEN, MI AND BY THE PHARMACEUTICAL
PRODUCTS OF INDIA LTD IN BOMBAY, INDIA.
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEER
SHEVA, ISREAL.
GABAPENTIN, MANUFACTURED IN BE'ER SHEVA, ISREAL.

12737 I

II

11/12/1997

SYLACHIM

AMISULPRIDE, MANUFACTURED IN MOURENX, FRANCE.

12738 A

II

11/11/1997

AMCOL HEALTH AND BEAUTY SOLUTIONS INC

FLUOROURACIL IN ACRYLATES COPOLYMER, MANUFACTURED IN LAFAYETTE, LA.

12739 I

III

10/29/1997

DUPONT POLYESTER FILMS

12740 I

II

11/13/1997

FINORGA SA

12741 I

II

10/10/1997

ORPHARM INC

12742 A

III

11/12/1997

CENTER PACKAGING INC

MELINEX 813, MANUFACTURED IN DUMFRIES, UNITED KINGDOM, ROZENBURG, THE


NETHERLANDS AND WILMINGTON, USA
N-(2-DEOXY-2-L-LEUCYLAMINO-B-D-GLUCOPYRANOSYL)-N-OCTADECYL-DODECANAMIDE,
MANUFACTURED IN CHASS SUR RHONE, FRANCE.
LEVOMETHADYL ACETATE HYDROCHLORIDE (LAAM HCL), MANUFACTURED IN HOUSTON
TEXAS
CP 20 PRESSURE SENSITIVE INNERSEAL LINER, MANUFACTURED IN BROOKLYN, NY.

12743 I

III

11/12/1997

COURTALDS PACKAGING LIMITED

OPHTHALMIC BOTTLES, MANUFACTURED IN WREXAM, UNITED KINGDOM.

12744 A

IV

11/14/1997

ACG ASSOCIATED CAPSULES PRIVATE LTD

EXCIPIENT HARD GELATIN CAPSULES SHELLS, MANUFACTURED IN MAHARASHTRA, INDIA

12745 I

II

11/14/1997

ABBOTT LABORATORIES HOSP PRODUCTS DIV

MIDAZOLAM, MANUFACTURED IN NORTH CHICAGO,IL.

12746 A

II

11/18/1997

TARO PHARMACEUTICAL INDUSTRIES LTD

WARFARIN SODIUM CLATHRATE, MANUFACTURED IN HAIFA BAY, ISRAEL

12747 A

II

11/17/1997

CATALENT PHARMA SOLUTIONS LLC

12748 A

III

11/12/1997

CENTER PACKAGING INC

RITONAVIR, 100MG NAD 200MG SOFT-GELATIN CAPSULE, MANUFACTURED IN


ST.PETERSBURG, FL.
CP 40 PRESSURE SENSITIVE INNERSEAL LINER, MANUFACTURED IN BROOKLYN NY.

12749 A

II

11/18/1997

FARMABIOS S P A

BETAMETHASONE VALERATE, MANUFACTURED IN PAVIR, ITALY.

12750 A

II

11/14/1997

DR REDDYS LABORATORIES LTD

DOXAZOSIN MESYLATE, MANUFACTURED IN ANDHRA PRADESH, INDIA.

12751 I

III

10/10/1997

PECHINEY SOPLARIL FLEXIBLE EUROPE

COLD-FORMED BLISTER: CEF 100, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE.

12752 I

II

11/17/1997

DSM PHARMA CHEMICALS NORTH AMERICA INC

R-FLURBIPROFEN, MANUFACTURED IN SOUTH HAVEN, MI

12753 I

III

11/6/1997

BASF AKTIENGESELLSCHAFT

LUPOLEN 3220 F Q285, MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

12754 A

II

11/14/1997

EUTICALS SPA

HYDROXYUREA, MANUFACTURED IN LODI, ITALY.

12755 I

II

11/21/1997

HAIMEN PHARMACEUTICAL FACTORY

IVERMECTIN, NON-STERILE BULK DRUG, MANUFACTURED IN ZHIJIANG PROVINCE, CHINA.

Page 364

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12756 N
NOT AN ASSIGNED NUMBER

SUBJECT

12757 I

II

11/20/1997

INDENA UK LTD

PACLITAXEL, DRUG SUBSTANCE, MANUFACTURED IN HERTFORDSHIRE, ENGLAND

12758 A

II

11/24/1997

CAMBREX PROFARMACO MILANO SRL

LABETALOL HCL, MANUFACTURED IN MILANO, ITALY

12760 I

II

11/25/1997

AVANTI POLAR LIPIDS INC

L-ALPHA-PHOSPHATIDYLCHOLINE (EGG, 95%), MANUFACTURED IN ALABASTER, ALABAMA.

12761 I

II

11/20/1997

RHODIA CHIREX INC.

CEP-701, MANUFACTURED IN MALVERN, PA.

12762 A

II

11/12/1997

ICN HUNGARY COMPANY LIMITED

HYDROXYCHLOROQUINE SULFATE, MANUFACTURED IN KABAY J., HUNGARY

12763 I

III

11/26/1997

MYLAN TECHNOLOGIES INC

MEDIIRELEASE 2500, RELEASE LINER MATERIAL, MANUFACTURED IN ST. ALBANS, VT.

12764 I

III

12/1/1997

LOPAREX BV

FL2000 PET 75U-1S, MANUFACTURED IN APELDOORN, THE NETHER- LANDS.

12765 I

IV

10/20/1997

TECHNOLOGY FLAVORS AND FRAGRANCES INC

NATURAL MASKING FLAVOR 777-185, MANUFACTURED IN AMITYVILLE, NEW YORK.

12766 A

II

11/27/1997

YAMASA CORP

RIBAVIRIN, MANUFACTURED IN CHIBA-KEN, JAPAN.

12767 A

III

12/3/1997

PLASTICS COLOR CORP

APEC 17530 COLOR CONCENTRATE

12768 I

III

11/25/1997

3M PHARMACEUTICALS INC

M3647 25MCL COLD FILL VALVE, MANUFACTURED IN LOUGHBOROUGH, GREAT BRITAIN.

12769 A

II

11/25/1997

MALLINCKRODT INC

METHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO.

12770 A

II

12/3/1997

APOTEX PHARMACHEM INC

PAROXETINE HYDROCHLORIDE (ANHYDROUS), MANUFACTURED IN ONTARIO, CANADA.

12771 I

III

12/1/1997

CAP LINER INC

POLYETHYLENE CAP LINER (CL-101), MANUFACTURED IN FREEPORT, NY.

12772 I

II

12/1/1997

LONZA INC

12773 I

II

12/5/1997

MALLINCKRODT INC

[3-(4-BROMOBENZYL)-2-BUTYL-5-CHLORO-3H-IMIDAZOL-4-YL]METHANOL, (MEOL),
MANUFACTURED IN CONSHOHOCKEN, PA.
CT50034, MANUFACTURED IN ST.LOUIS, MO.

12774 I

II

12/5/1997

FLUOXETINE HCL USP, MANUFACTURED IN LATINA, ITALY.

12775 I

II

12/2/1997

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
POLYPEPTIDE LABORATORIES AS

12776 I

12/2/1997

UNIV BRITISH COLUMBIA

TECHNIQUES TO EVALUATE MAGNETIC RESONANCE IMAGING (MRI) IN VANCOUVER CANADA.

12777 I

II

12/8/1997

FLURA CORPORATION

PERFLUOROPROPANE (OCTAFLUOROPROPANE) GAS, MANUFACTURED IN NEWPORT, TN.

12778 I

II

12/10/1997

ORGANICS LAGRANGE INC

12779 A

III

12/5/1997

CLARIANT PRODUCTION FRANCE

ACTIVE PHARMACEUTICAL INGREDIENT-ESTERIFIIED ESTROGENS USP, MANUFACTURED IN


CHICAGO,ILLINOIS.
STANDARD DESICCATOR CAPSULES, MANUFACTURED IN ROMORANTIN, FRANCE.

12780 A

II

12/10/1997

WOCKHARDT LTD

ENALAPRIL MALEATE, MANUFACTURED IN GUJARAT STATE , INDIA.

12781 I

II

12/12/1997

NIKKOMYCIN Z HYDROCHLORIDE, MANUFACTURED IN NORTH CHICAGO, IL.

12782 I

II

12/12/1997

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
VIRCO BVBA

12783 A

12/12/1997

MALLINCKRODT INC

12784 A

II

12/12/1997

CIPLA LTD

DESCRIBING THE QUALIFICATIONS OF AN EXPANDED ASEPTIC PROCESSING AREA IN


MARYLAND HEIGHTS, MISSOURI
DOXAZOSIN MESYLATE MANUFACTURED IN MAHARASHTRA, INDIA.

12785 I

12/9/1997

SUMITOMO SEIKA CHEMICALS CO LTD

12786 I

II

12/9/1997

SUMITOMO SEIKA CHEMICALS CO LTD

12787 A

IV

12/9/1997

MINGTAI CHEMICAL CO LTD

12788 A

III

12/15/1997

3M DRUG DELIVERY SYSTEMS

12789 I

IV

12/17/1997

RITA CORP

12759 N

NOT AN ASSIGNED NUMBER

CALCITONIN (SALMON), PH.EUR.,MANUFACTURED IN HILLEROD, DENMARK.

KETOROLAC TROMETHAMINE, MANUFACTURED BY SICOR SA IN LAMAY, FRANCE.

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES A BEFU


WORKS IN HYOGO, JAPAN.
2-BROMO-1-[(4-METHYL SULFONYL) PHENYL] ETHANONE, MANUFACTURED IN HYOGO,
JAPAN.
CROSCARMELLOSE SODIUM NF (PROCESS I) ,MANUFACTURED IN TAIWAN, R O C.
ACTUATORS AND DUST CAPS FOR CFC INHALATION AEROSOLS, MANUFACTURED IN CHINO
AND CORONA, CALIFORNIA. FOR 3M PHARMACEUTICALS INC
LANOLIN, MANUFACTURED IN CHICAGO, IL.

Page 365

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12790 I
II
12/11/1997
TRIQUIM SA

SUBJECT
FLUTAMIDE, MANUFACTURED IN MUNRO, ARGENTINA.

12791 A

IV

12/17/1997

PFIZER INC

12792 I

II

12/15/1997

SCHERING AG

SULPHOBUTYLETHER BETA-CYCLODEXTRIN (SBECD), MANUFACTURED BY ABBOTT


LABORATORIES IN NORTH CHICAGO,IL.
EOB-DTPA, MANUFACTURED IN BERLIN,GERMANY

12793 I

II

12/17/1997

ARENOL CHEMICAL CORP

4-HYDROXYANISOLE, MANUFACTURED IN SOMERVILLE, NJ

12794 I

II

12/9/1997

QUIMICA FINA FARMEX SA DE CV

KETOCONAZOLE, MANUFACTRRED IN QUERETARO, MEXICO

12795 I

II

12/18/1997

AVENTIS PHARMA DEUTSCHLAND GMBH

HMR 1275, MANUFACTURED IN FRANKFURT, GERMANY.

12796 I

II

12/15/1997

ORGAMOL SA

PEMOLINE, MANUFACTURED IN EVIONNAZ, SWITZERLAND.

12797 A

II

12/22/1997

LONZA AG

12798 I

II

12/22/1997

LA JOLLA PHARMACEUTICAL CO

HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT, MANUFACTURED IN


BRAINE-L' ALLEUD (BELGIUM).
LJP 394 DRUG SUBSTANCE, MANUFACTURED IN SAN DIEGO, CALIFORNIA.

12799 A

II

12/22/1997

GUFIC BIOSCIENCES LTD

ECONAZOLE NITRATE USP, MANUFACTURED IN GUJARAT STATE, INDIA

12800 I

III

11/7/1997

RISDON SA

12801 I

III

12/23/1997

ROHM AND HAAS CO

CAPS (BLUE AND TAN BROWN COLORS) FOR EYE-DROPPERS BOTTLES, MANUFACTURED IN
OFFRANVILLE, FRANCE.
EMULSION E-2920 (7-1946), MANUFACTURED IN PHILADELPHIA, PA.

12802 I

II

12/22/1997

12803 A

II

12/22/1997

BIOINDUSTRIA LABORATORIO ITALIANO


MEDICINALI SPA
CHEMWERTH INC

12804 I

12/16/1997

NOVARTIS PHARMACEUTICALS CORP

12805 A

IV

12/15/1997

STEPAN SPECIALTY PRODUCTS LLC

12806 I

II

12/24/1997

URQUIMA SA

12807 A

II

12/17/1997

FLUTAMIDE USP, MANUFACTURED IN ORRIGIO, ITALY.

12808 I

II

12/23/1997

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
ELAN PHARMA LTD

12809 A

II

12/29/1997

KRKA DD NOVA MESTO

ENALAPRIL MALEATE, MANUFACTURED IN SLOVENIA, EUROPE.

12810 I

III

12/19/1997

MICHELMAN INC

MICHEM LUBE 160, MANUFACTURED IN CINCINNATI, OH.

12811 I

III

12/18/1997

RAKU GMBH

EXTRUSION MOLD BOTTLE 3097 (R), MANUFACTURED IN RASTATT, GERMANY.

12812 A

III

12/30/1997

BERRY PLASTICS CORPORATION

PLASTIC PACKAGING PRODUCTS, MANUFACTURED IN HOT SPRINGS, ARKANSAS.

12813 A

II

1/5/1998

FARMABIOS S P A

BECLOMETHASONE DIPROPIONATE, MANUFACTURED IN PAVIA, ITALY.

12814 I

II

1/6/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

12815 I

1/7/1998

HALCYON LABS PRIVATE LTD

12816 I

II

1/7/1998

HALCYON LABS PVT LTD

BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE,


MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERANING PROCEDURES IN
AHMEDABAD, INDIA.
TRIMETHOPRIM USP, MANUFACTURED IN AHMEDABAD, INDIA

12817 I

III

1/9/1998

DUDEK PLAST AS

DUDEK CONTAINERS, MANUFACTURED IN JONSTRUP, DENMARK.

12818 A

II

1/7/1998

SANOFI AVENTIS CHIMIE

APOMORPHINE HYDROCHLORIDE, MANUFACTURED IN ARAMON, FRANCE

12819 I

II

2/5/1997

KURARAY CO LTD

12820 I

II

1/16/1998

ESTEVE QUIMICA SA

(1S,3R,20S)-20-(3-HYDROXY-3-METHYLBUTLOXY) PREGNA-5,7-DIENE-1,3-DIOL,
MANUFACTURED IN NIIGATA, JAPAN
CIZOLIRTINE CITRATE, MANUFACTURED IN BARCELONA SPAIN.

12821 I

III

1/9/1998

ROLLPRINT PACKAGING PRODUCTS INC

RPPP #36-1080A, MANUFACTURED IN ADDISON, ILLINOIS

TERAZOSIN HCL 2H20, MANUFACTURED IN FRESONARA (AL)-ITALY.


DISODIUM PAMIDRONATE (ANHYDROUS FORM), MANUFACTURED IN NEWBURYPORT, MA FOR
CHEMWERTH INC
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN STEIN,
SWITZERLAND.
NEOBEE M-20, PROPYLENE GLYCOL DI(CAPRYLATE/CAPRATE), MANUFACTURED IN
MAYWOOD, NJ.
FLUTRIMAZOLE, MANUFACTURED IN BARCELONA, SPAIN.

MORPHINE SULFATE, MANUFACTURED IN COUNTY WESTMEATH, IRELAND

Page 366

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12822 I
III
1/19/1998
3M PHARMACEUTICALS INC
12823 I

1/19/1998

MATRIX PACKAGING INC

12824 I

IV

1/19/1998

FONA INTERNATIONAL INC

12825 I

1/21/1998

ANALYTICON AG

12826 I

II

1/20/1998

JANSSEN PHARMACEUTICA NV

SUBJECT
CP-325,366 METERED DOSE INHALER CONTAINER CLOSURE SYSTEM, MANUFACTURED IN
LEICESTERSHIRE, ENGLAND.
MANUFACTURING SITE, FACILITIES, PERSONNEL, OPERATING PROCEDURES IN ONTARIO,
CANADA.
#815.089 N-C BUBBLEGUM FLAVOR (A NATURAL FLAVOR),MANUFACTURED IN CAROLSTREAM,
ILLINOIS.
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN
POTSDAM, GERMANY.
R108512 DRUG SUBSTANCE, MANUFACTURED IN BEERSE,BELGIUM.

12827 A

II

1/21/1998

CIPLA LTD

OMEPRAZOLE USP MANUFACTURED IN BANGALORE,INDIA.

12828 A

10/31/1997

GREER LABORATORIES INC

STERILE PRODUCTS FACILITY IN LENOIR, NC.

12829 A

II

1/23/1998

CORDEN PHARMA LATINA SPA

PIPERACILLIN MONOHYDRATE AS MANUFACTURED IN SERMONETA, LATINA, ITALY.

12830 I

II

1/23/1998

WYCKOFF CHEMICAL CO INC

TRAMADOL HYDROCHLORIDE, MANUFACTURED IN SOUTH HAVEN, MI.

12831 A

III

12/22/1997

JS PLASTICS INC

EXTRUSIONS AND COEXTRUSIONS, MANUFACTURED IN NAPERVILLE, IL.

12832 I

II

1/29/1998

HOSPIRA INC

LAMISIL EMULSION, MANUFACTURED IN CLAYTON, NC

12833 I

II

1/30/1998

LIANYUNGANG PHARMACEUTICAL FACTORY

12834 I

II

1/30/1998

KISSEI PHARMACEUTICAL CO LTD

METHOTREXATE USP, NON-STERILE BULK DRUG, MANUFACTURED IN JIANGSU PROVINCE,


CHINA
KAD-1229, MANUFACTURED IN HYOGO PREFECTURE, JAPAN

12835 I

II

1/16/1998

BIOCLONES PTY LTD

POLY RIBOINOSINIC ACID (POLY [I]), MANUFACURED IN CAPE TOWN, SOUTH AFRICA

12836 I

II

1/16/1998

BIOCLONES PTY LTD

12837 I

III

1/21/1998

PET TECHNOLOGIES LTD

12838 A

II

1/29/1998

CATALENT PHARMA SOLUTIONS LLC

12839 I

III

1/23/1998

VIANOVA RESINS GMBH

12840 I

II

2/2/1998

SANOFI AVENTIS SPA

POLY RIBOCYTIDYLIC/URIDYLIC ACID (POLY [C12U]), MANUFACTURED IN CAPE TOWN, SOUTH


AFRICA
POLYETHYLENE TEREPHTHALATE PACKAGING MATERIALS MANUFACTURED IN OXFORD,
ENGLAND
1-ALPHA-HYDROXYVITAMIN D2 2.5-UG SOFT-GELATIN CAPSULES MANUFACTURED IN ST.
PETERSBURG, FL
COATINGS FOR PHARMACEUTICAL PACKAGING ALRESEN PA 101, MANUFACTURED IN
WIESBADEN, GERMANY
OXYBUTYNIN CHLORIDE, MANUFACTURED IN GARESSIO,ITALY

12841 I

IV

1/27/1998

MONA INDUSTRIES INC

MONAMID 150-LWA, MANUFACTURED IN PATERSON, NEW JERSEY

12842 I

III

1/29/1998

AMPACET CORP

12843 I

III

1/29/1998

AMPACET CORP

12844 I

III

1/29/1998

AMPACET CORP

12845 I

III

1/30/1998

OWENS ILLINOIS CLOSURE INC

12846 I

III

2/2/1998

POLIMERI EUROPA

10407 UV POLYETHELYNE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN,


CARTERSVILLLE, GA, AND DERIDDER LA.
16027 BLUE UV POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE,IN,
CARTERSVILLE,GA, AND DERIDDER.LA.
19699 BLACK POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE,IN,
CATERSVILLE,GA, AND DERIDDER,LA.
INJECTION MOLDING OPERATION MED-TIME CLOSURES, MAN UFACTURED IN EL PASO,
TEXAS.
CLEARGLEX FH 50, MANUFACTURED IN MILAN,ITALY.

12847 I

III

1/27/1998

BASF AKTIENGESELLSCHAFT

ULTRAFORM S1320 003, MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

12848 A

II

2/5/1998

HYDROCODONE BITARTRATE, USP MANUFACTURED IN WEST DEPTFORD, NEW JERSEY.

12849 I

II

2/6/1998

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
ROBERTS LABORATORIES INC

12850 I

III

1/27/1998

SOLVIN SA

IXAN PA 350 PVDC AQUEOUS DISPERSION, MANUFACTURED IN TAVAUX CEDEX,FRANCE.

12851 I

II

2/5/1998

FERRO PFANSTIEHL INC

DECITABINE, MANUFACTURED IN WAUKEGAN,IL.

12852 I

IV

2/4/1998

KERRY INC DBA MASTERTASTE INC

NA CHERRY WONF 606007, MANUFACTURED IN TETERBORO, NEW JERSEY.

STANATE (STANNSOPORFIN) INJECTION, MANUFACTURED IN BEDFORD,OH.

Page 367

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12853 A
III
2/11/1998
SHOWA DENKO PACKAGING CORP

SUBJECT
HARD PACK, MANUFACTURED IN SHIGA, JAPAN

12854 I

II

2/10/1998

ASTELLAS PHARMA INC

YM087 DRUG SUBSTANCE, MANUFACTURED IN IBARAKI-KEN, JAPAN.

12855 I

II

2/6/1998

PHARMA ECO LABORATORIES INC

5-(2,3-DICHLOROBENZOYLAMINO)-3-[4-(N-{5-(2,4-DICHLOROBENZOYLAMINO)-4-OXO-3,4DIHYDRO-2,7-DISULFONAPHTHALENE-3-YLIDENE}HYDRAZINO)-2,5-DIMETHOXYPHENYLHDYRAZONO]-4-OXO-3,4-DIHYDRONAPHTHALENE-2,7-DISULFONIC ACID TETRASODIUM SALT.

12856 A

II

2/11/1998

ASTELLAS PHARMA INC

FK463, MANUFACTURED IN NISHIKASUGAIGUN,JAPAN

12857 A

II

2/17/1998

SIFAVITOR SRL

ECONAZOLE NITRATE, MANUFACTURED IN LODI, ITALY.

12858 I

II

2/11/1998

J K PHARMACHEN LIMITED

PENICILLIN G POTASSIUM, MANUFACTURED IN TAMIL NADU, INDIA.

12859 A

IV

2/15/1998

FARMACAPSULAS DE COLUMBIA SA

12860 I

III

2/11/1998

TARGOR GMBH F 206

EXCIPIENT EMPTY HARD GELATIN CAPSULES SHELLS, MANUFACTURED IN BARRANQUILLA,


COLUMBIA
NOVOLEN 1170 L, MANUFACTURED IN LILLEBONNE,FRANCE.

12861 I

III

2/11/1998

TARGOR GMBH

NOVOLEN 1170 PC, MANUFACTURED IN LILLEBONNE, FRANCE.

12862 A

II

2/13/1998

HERAEUS PRECIOUS METALS GMBH AND CO KG

DACARBAZINE, USP MANUFACTURED IN HANAU, GERMANY.

12863 I

II

2/13/1998

BOEHRINGER INGELHEIM PHARMA KG

MOXONIDINE, MANUFACTURED IN INGELHEIM/RHEIN GERMANY.

12864 I

II

2/17/1998

HENAN KAIFENG PHARMACEUTICAL FACTORY

DOXYCYCLINE HYDROCHLORIDE, MANUFACTURED IN HENAN, CHINA.

12865 A

III

1/1/1998

UNITED CLOSURES AND PLASTICS PLC

12866 A

II

2/9/1998

12867 I

II

2/13/1998

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS


SRL
KATSURA CHEMICAL CO LTD

28MM AND 33MM STANDARD TAMPER-EVIDENT CLIC-LOC III CLOSURE, MANUFACTURED IN


NORWICH, ENGLAND.
CLONIDINE BASE, MANUFACTURED IN REGGELLO, ITALY.

12868 I

II

2/17/1998

PARTICLE DYNAMICS CO

DESTAB MAGNESIUM CARBONATE 90, MANUFACTURED IN MIDDLESEX, NEW JERSEY.

12869 I

II

2/18/1998

EXCELLA GMBH

12870 I

II

2/20/1998

SA AJINOMOTO OMNICHEM NV

TRAMADOL HYDROCHLORIDE, MANUFACTURED IN FEUCHT, FEDERAL REPUBLIC OF


GERMANY.
IRBESARTAN CRUDE, MANUFACTURED IN WETTEREN, BELGIUM.

12871 I

II

2/20/1998

MALLINCKRODT INC

PENTAZOCINE HYDROCHLORIDE USP, MANUFACTURED IN ST. LOUIS, MO.

12872 A

1/28/1998

JANSSEN DIAGNOSTICS BVBA

ANTIVIROGRAM (DOCUMENT IDENTIFICATION: VIRCO/FDA/98001) IN MECHELEN, BELGIUM.

12873 I

II

2/22/1998

CLOZAPINE, USP, MANUFACTURED IN GUANGDONG PROVINCE, CHINA.

12874 I

II

2/23/1998

HUIZHOU DONGJIANG PHARMACEUTICAL


FACTORY GUANGDONG
REPLIGEN CORP

12875 I

III

2/20/1998

RIFLEX FILM AS

NON-SOFTENED PVC FILMS (RIFLEX), MANUFACTURED IN HALDEN, NORWAY.

12876 A

II

2/23/1998

INDENA SPA

PACLITAXEL, MANUFACTURED IN SETTALA (MI)- ITALY

12877 A

III

2/23/1998

DRUG PLASTICS CLOSURES INC

PLASTIC CLOSURES, MANUFACTURED IN PHOENIX, AZ AND EDINBURG, IN.

12878 I

III

12/8/1997

POWDERJECT TECHNOLOGIES INC

DERMAL POWDERJECT DELIVERY SYSTEM, MANUFACTURED IN BURLINGAME, CA.

12879 A

II

2/26/1998

ROQUETTE FRERES

MANNITOL USP GRADE, MANUFACTURED IN LESTREM, FRANCE.

12880 I

II

12/17/1997

MILLIPORE CORP

12881 I

II

2/25/1998

FUJIMOTO CHEMICALS CO LTD

STERISCREEN RAPID MICRO SCREENING SYSTEM, MANUFACTURED BY CELSIS LUMAC BV IN


LANDGRAAF, THE NETHERLAND.
BIS-THP PGE1, MANUFACTURED IN HYOGO, JAPAN

12882 I

II

2/27/1998

BRISTOL MYERS SQUIBB COMPANY

IRBESARTAN, MANUFACTURED IN HUMACAO, PUERTO RICO

12883 I

II

3/2/1998

JAPAN TOBACCO INC

12884 A

III

2/27/1998

HB FULLER CO

JTE-522 DRUG SUBSTANCE, A NEW CYCLOOXYGENASE-2 (COX-2) INHIBITOR,


MANUFACTURED A FUJI CHEMICALINDUSTRY, CO., LTD IN TOYAMA, JAPAN
HL-0916-S, MANUFACTURED IN QUEBEC, CANADA

12885 A

II

2/4/1998

INDUSTRIAS QUIMICAS KIMITSU CHILE Y CIA LTDA

SODIUM ALGINATE, ALGINIC ACID, MANUFACTURED IN LAS COLONIAS PAINE, CHILE

BTA, MANUFACTURED IN KANAGWA, JAPAN.

IMMOBILIZED PROTEIN A IPA-400HC, MANUFACTURED IN NEEDHAM, MASSACHUSETTS.

Page 368

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12886 A
II
2/28/1998
SUZHOU NUMBER 4 PHARMACUTICAL FACTORY
12887 A

II

2/19/1998

ALBEMARLE CORP

SUBJECT
CLINDAMYCIN HYDROCHLORIDE ETHANOLATE INTERMEDIATE, MANUFACTURED IN JIANSGU
PROVINCE, CHINA
TERCONAZOLE, MANUFACTURED IN SOUTH HAVEN, MI

12888 A

III

3/6/1998

3M DRUG DELIVERY SYSTEMS

M3659 50 MCL COLD FILL VALVE, MANUFACTURED IN LEICESTERSHIRE, ENGLAND.

12889 A

III

3/5/1998

3M DRUG DELIVERY SYSTEMS

M3665 50 MCL COLD FILL VALVE, MANUFACTURED IN LEICESTERSHIRE, ENGLAND.

12890 I

II

3/6/1998

ARCHER DANIELS MIDLAND CO

TOCOPHEROL, MANUFACTURED IN DECATUR, IL

12891 I

II

3/6/1998

NATCO PHARMA LTD

NAPROXEN, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

12892 I

II

3/6/1998

NATCO PHARMA LTD

NAPROXEN SODIUM, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

12893 A

IV

3/9/1998

FUJI CHEMICAL INDUSTRY CO LTD

NEUSILIN MAGNESIUM ALUMINOMETASILICATE, MANUFACTURED IN TOYAMA PREF., JAPAN

12894 I

II

3/11/1998

RANBAXY LABORATORIES LTD

CEFADROXIL USP, HEMIHYDRATE, (NON-STERILE BULK), MANUFACTURED IN PUNJAB, INDIA

12895 A

II

3/11/1998

RANBAXY LABORATORIES LTD

AMOXICILLIN USP, TRIHYDRATE, (NON-STERILE BULK), MANUFACTURED IN PUNJAB, INDIA

12896 A

II

3/12/1998

TRIFARMA SPA

FUROSEMIDE, MANUFACTURED IN MILANO-ITALY

12897 I

III

3/16/1998

MOLDEX PRODUCTS INC

MONO PVC FILMS, MANUFACTURED IN QUEZON CITY, PHILIPPINES

12898 I

IV

3/19/1998

FONA INTERNATIONAL INC

12899 A

II

3/16/1998

PIERRE FABRE MEDICAMENT

#918.005 SWEET-AM POWDER (A NATURAL FLAVOR), MANUFACTURED IN CAROL STREAM,


ILLINOIS
IDAZOXAN HYDROCHLORIDE, MANUFACTURED IN GAILLAC CEDEX, FRANCE

12900 A

IV

3/17/1998

QUALICAPS CO LTD

12901 I

II

3/17/1998

SANDOZ PRIVATE LTD

HYDROXYPROPYL METHYCELLULOSE CAPSULE (HPMC CAPSULE), MANUFACTURED IN


NARA, JAPAN
PYRILAMINE MALEATE USP, MANUFACTURED IN MUMBAI, INDIA

12902 I

II

3/18/1998

PENINSULA LABORATORIES INC

MET-ENKEPHALIN DRUG SUBSTANCE, MANUFACTURED IN SAN CARLOS, CALIFORNIA

12903 A

II

3/10/1998

ROHM AND HAAS CO

AMBERLITE IRP64, MANUFACTURED IN CHAUNY CEDEX, FRANCE

12904 I

II

3/18/1998

TORRENT GUJARAT BIOTECH LTD

AMOXICILLIN, USP, MANUFACTURED IN GUJARA, INDIA

12905 A

III

3/18/1998

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 60ML, MANUFACTURED IN CASTELGUELFO, ITALY

12906 A

III

3/18/1998

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 80ML, MANUFACTURED IN CASTELGUELFO, ITALY

12907 A

III

3/18/1998

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 120ML, MANUFACTURED IN CASTELGUELFO, ITALY

12908 A

III

3/18/1998

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 150ML, MANUFACTURED IN CASTELGUELFO, ITALY

12909 I

IV

3/19/1998

FONA INTERNATIONAL INC

12910 I

II

3/23/1998

DIOSYNTH BV

#884.010 N-C NATURAL & ARTIFICIAL ORANGE FLAVOR, MANUFACTURED IN CAROL STREAM,
ILLINOIS
MIDAZOLAM, MANUFACTURED IN APELDOORN, THE NETHERLAND

12911 A

II

3/6/1998

OLON SPA

OXAPROZIN, MANUFACTURED IN MULAZZANO, ITALY

12912 I

II

1/26/1998

GEDEON RICHTER LTD

LISINOPRIL, MANUFACTURED IN BUDAPEST, HUNGARY

12913 A

II

3/10/1998

MALLINCKRODT INC

OPTISON MANUFACTURED IN MARYLAND HEIGHTS, MO

12914 A

II

3/17/1998

TREOSULFAN MANUFACTURED BY DYNAMIT NOBEL GMBH ES LEVERKUSEN, GERMANY

12915 I

II

3/25/1998

MEDAC GESELLSCHAFT FUR KLINISCHE


SPEZIALPRAPARATE MBH
LUBRIZOL ADVANCED MATERIALS INC

12916 I

II

3/26/1998

SANOFI SYNTHELABO INC.

R-ZACOPRIDE, MANUFACTURED IN GARGENVILLE, FRANCE

12917 A

II

3/25/1998

DR REDDYS LABORATORIES LTD

OMEPRAZOLE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

12918 I

II

3/26/1998

CHUGAI PHARMACEUTICAL CO LTD

OCT (MAXACALCITOL), MANUFACTURED IN SHIZUOKE PREFECT, JAPAN

12919 I

II

3/27/1998

ASAHI GLASS CO LTD

4'-BROMOMETHY1-2-CYANOBIPHENYL (CPB-2), MANUFACTURED IN KANAGAWA, JAPAN

12920 I

II

4/7/1998

GEDEON RICHTER LTD

CDB-2914, MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY

12921 I

II

3/27/1998

ABBOTT LABORATORIES LTD

BUTORPHANOL TARTRATE USP, MANUFACTURED IN KENT, UNITED KINGDOM

CARBOPOL ETD 2050, MANUFACTURED IN CALVERT CITY,KY

Page 369

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12922 A
II
4/2/1998
TRIFARMA SPA

SUBJECT
CLINDAMYCIN PHOSPHATE USP, MANUFACTURED IN MILANO, ITALY

12923 I

III

3/16/1998

SOLVAY SA

IXAN PVDC PA 121, MANUFACTURED IN TAVAUX CEDEX, FRANCE

12924 A

IV

3/26/1998

LUBRIZOL ADVANCED MATERIALS INC

CARBOPOL ETD 2020, MANUFACTURED IN CALVERT CITY, KY

12925 I

3/31/1998

HONG KONG INSTITUTE BIOTECHNOLOGY LTD

STERILE PROCESSING FACILITY LOCATED IN HONG KONG, CHINA

12926 I

II

3/2/1998

GLYCINE (AMINO ACETIC ACID), MANUFACTURED IN TAMIL NADU, INDIA

12927 I

II

3/31/1998

MARUTI SYNTHETICS AND PHARMACEUTICALS


LTD
GUILFORD PHARMACEUTICALS INC

12928 I

3/23/1998

BANYON CHEMICALS PRIVATE LIMITED

12929 I

II

3/30/1998

PCAS

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GUJARA,


INDIA
MIDAZOLAM BASE, MANUFACTURED IN LIMAY, FRANCE

12930 I

III

3/23/1998

RESCO COLOURS INC

CUSTOM COLOR/ADDITIVE CONCENTRATE, MANUFACTURED IN ONTARIO, CANADA

12931 I

II

4/1/1998

ASH STEVENS INC

12932 A

II

4/2/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

SS-2'-DEOXY-5-FLUOROURIDINE ACTIVE PHARMACEUTICAL INGREDIENT, MANUFACTURED IN


DETROIT AND RIVERVIEW, MI
CYCLOSPORINE, MANUFACTURED IN OPAVA, CZECH REPUBLIC

12933 I

II

3/31/1998

SMITHKLINE BEECHAM

6-AMINOPENICILLANIC ACID [6-APA], MANUFACTURED IN SCOTLAND,UK

12934 I

II

3/20/1998

YANGZHOU PHARMACEUTICAL FACTORY

LEVONORGESTREL USP 23, MANUFACTURED IN JIANGSY PROVINCE, CHINA

12935 I

4/3/1998

MIPHARM SPA

12936 I

III

3/24/1998

RESCO COLOURS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MILANO,


ITALY
78MPT-466, MANUFACTURED IN OMTARIO, CANADA

12937 A

II

4/3/1998

SCHERING CORP

BETAMETHASONE, USP, MANUFACTURED IN SINGAPORE

12938 A

II

4/8/1998

CATALENT PHARMA SOLUTIONS LLC

12939 I

II

4/8/1998

GEDEON RICHTER LTD

MICONAZOLE NITRATE (1,200MG) VAGINAL OVULE SOFT-GELATIN CAPSULE, MANUFACTURED


IN ST. PETERSBURG, FL
ENALAPRIL MALEATE, MANUFACTURED IN BUDAPEST, HUNGARY

12940 I

III

4/9/1998

DSM RESINS US INCORPORATED

URAVER FB120 B-60, MANUFACTURED BY DSM KUNSTHARZE GMBH IN MEPPEN, GERMANY

12941 I

III

4/8/1998

WEST PHARMACEUTICAL SERVICES INC

LYODRY DESICANT STOPPER, MANUFACTURED IN LIONVILLE, PA

12942 I

II

4/7/1998

CHEMSOURCE CORP

RANITIDINE HCI FORM 1 DRUG SUBSTANCE MANUFACTURED IN GUAYAMA, P.R.

12943 I

III

4/8/1998

COURTESY MED TEK

12944 I

II

4/9/1998

JOHNSON MATTHEY INC

PART NUMBER D12001AA, LYO-CAP ASSEMBLY, MANUFACTURED IN BUFFALO GROVE,


ILLINOIS
MEPERIDINE HCI, USP, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

12945 A

IV

4/6/1998

LUBRIZOL ADVANCED MATERIALS INC

CARBOPOL ULTREZ 10, MANUFACTURED IN CALVERT CITY, KY

12946 A

II

4/7/1998

YMC CO LTD

YMC*GEL, MANUFACTURED IN ISHIKAWA 923, JAPAN

12947 I

II

4/13/1998

ADVANCED CHEMTECH INC

802-2 SYNTHETIC PEPTIDE STERILE POWDER, MANUFACTURED IN LOUISVILLE, KY

12948 N

GPI 202, MANUFACTURED IN BALTIMORE, MARYLAND

NOT AN ASSIGNED NUMBER

12949 A

II

4/13/1998

EUTICALS SPA

CYCLOSPORINE, MANUFACTURED IN MILAN, ITALY

12950 A

III

4/8/1998

CODING PRODUCTS

SV-13916, A HOT STAMP INK RIBBON, MANUFACTURED IN MILAN, ITALY

12951 I

II

4/17/1998

HAMILTON PHARMACEUTICALS, INC.

NEFIRACETAM DRUG SUBSTANCE, MANUFACTURED IN AKITA-SHI AKITA, JAPAN

12952 A

III

4/16/1998

3M DRUG DELIVERY SYSTEMS

12953 I

III

4/15/1998

12954 I

II

4/21/1998

CONTAINER-CLOSURE SYSTEM FOR NON-CFC INHALATION AEROSOLS, MANUFACTURED IN


CLITHEROE, UK
TECHNICAL COATINGS CO SUB BENJAMIN MOORE 7GZ216 TUBE SEALANT, MANUFACTURED IN NUTLEY, N.J.
AND CO
GUILFORD PHARMACEUTICALS INC
P(DAPG-EOP), MANUFACTURED IN BALTIMORE, MD

Page 370

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12955 A
III
4/17/1998
BPREX HEALTHCARE PACKAGING INC DBA BERRY
PLASTICS
12956 I
I
4/9/1998
VIVIMED LABS LTD

SUBJECT
SRB II CONTAINERS, MANUFACTURED IN BATTLBORO, NC
MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN (STATE
OF KARNATAKA), INDIA
MAKROLON 2458-1112 AND 1117, MANUFACTURED IN PITTSBURGH, PA

12957 A

III

4/22/1998

BAYER MATERIALSCIENCE LLC

12958 I

4/22/1998

PPD PHARMACO INC

12959 I

II

4/20/1998

CUNO INC

12960 A

II

4/24/1998

FERMION OY

DETERMINATION OF ISDN, 2-ISMN AND 5-ISMN IN HUMAN PLASMA BY GAS LIQUID


CHROMATOGRAPHY IN MIDDLETON, WI
ZETA PLUS DELIPID FILTER MEDIUM (DEL3 FORMULATION), MANUFACTURED IN STAFFORD
SPRINGS, CT
LEVOSIMENDAN, MANUFACTURED IN OULU,FINLAND

12961 I

IV

4/21/1998

EASTMAN CHEMICAL CO

EASTMAN VITAMIN E TPGS 1000, MANUFACTURED IN ROCHESTER, NY

12962 A

II

4/24/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

12963 I

III

4/20/1998

AMPACET CORP

12964 A

II

4/27/1998

PCAS

BLEOMYCIN SULFATE USP, NON-STERILE BULK DRUG, MANUFACTURED IN ZHEJIANG


PROVINCE, CHINA
160638-A BLUE PA POLYETHLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN,
CARTERSVILLE, GA AND DERIDDER, LA
CLONIDINE BASE, MANUFACTURED IN TURKU, FINLAND

12965 I

III

4/22/1998

ZELLER PLASTIK GMBH

SCREW CLOSURE ND 20 WITH ZELSNAP SNAP HINGE, MANUFACTURED IN ZELL, GERMANY

12966 A

IV

2/3/1998

MINGTAI CHEMICAL CO LTD

12967 A

IV

2/3/1998

MINGTAI CHEMICAL CO LTD

12968 A

II

4/24/1998

ESTEVE QUIMICA SA

COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M101, M102 ,M112, M113, M112D+ &
M113D+, MANUFACTURED IN TAIWAN, ROC
COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M101D+, M102+, M103D+ & M105D+,
MANUFACTURED IN TAIWAN, ROC.
LISINOPRIL, MANUFACTURED IN BARCELONA, SPAIN

12969 I

II

5/4/1998

FUJISAWA PHARMACEUTICAL CO LTD

FK317, MANUFACTURED IN NISHIKAKASUGAIGUN AICHI PREFECTURE, JAPAN

12970 I

IV

4/29/1998

FONA INTERNATIONAL INC

12971 I

III

4/21/1998

GEORGIA PACKAGING INC

#815.087 BUBBLEMINT FLAVOR (A NA. & ART. FLAVOR), MANUFACTURED IN CAROL STREAM,
IL
15803-10, MANUFACTURED IN COLUMBUS, GA

12972 I

II

4/30/1998

NANOSYSTEMS

MK-869 ORAL NANOCRYSTAL COLLOIDAL DISPERSION, MANUFACTURED IN HORSHAM, PA

12973 I

III

4/28/1998

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-1108 (PACKAGING MATERIAL), MANUFACTURED IN ADDISON, ILLINOIS

12974 A

II

4/24/1998

ROHM AND HAAS CO

AMBERLITE IRP70, MANUFACTURED IN CHAUNY CEDEX, FRANCE

12975 I

II

4/22/1998

CUNO INC

12976 A

II

4/30/1998

ACS DOBFAR SPA

ZETA PLUS DELIPID FILTER MEDIUM (DEL2 FORMULATION), MANUFACTURED IN STAFFORD


SPRINGS, CT
CEFOXITIN SODIUM (STERILE BULK), MANUFACTURED IN MILANO, ITALY

12977 A

II

5/2/1998

CADILA HEALTHCARE LTD

WARFARIN SODIUM, MANUFACTURED IN GUJARAT, INDIA

12978 I

4/30/1998

JENAPHARM GMBH CO KG

12979 I

III

3/26/1998

SHIOTANI GLASS CO LTD

12980 I

III

5/8/1998

DSM RESINS BV

12981 I

5/4/1998

MUSASHINO CHEMICAL LABORATORY LTD

12982 I

II

5/4/1998

MUSASHINO CHEMICAL LABORATORY LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN JENA,


GERMANY
MANUFACTURING METHODS OF AMPULES AND SYRINGES, MANUFACTURED IN OSAKA,
JAPAN
URAVAR FB209 BT-57, MANUFACTURED BY SCHENECTADY EUROPE S.A. IN BETHUNE CEDEX,
FRANCE
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN IBARAKI,
JAPAN
SODIUM PYRUVATE, MANUFACTURED IN IBARAKI, JAPAN

12983 I

II

4/27/1998

12984 I

IV

5/7/1998

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
AMPACET CORP

POLY(D,L-LACTIDE) AND ITS COPOLYMERS, MANUFACTURED IN INGELHEIM/RHEIN, FEDERAL


REPUBLIC OF GERMANY
11151-T WHITE PE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA,
CARTERSVILLE, GA AND BELGIUM, FEDERAL REPUBLIC OF GERMANY

Page 371

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
12985 I
II
5/7/1998
CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD

SUBJECT
CHLORAMPHENICAL USP XXIII. MANUFACTURED IN TAIWAN, CHINA

12986 I

II

5/11/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

CLONAZEPAM, USP, MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

12987 I

II

5/11/1998

LONZA LTD

12988 A

II

5/15/1998

SUZHOU NUMBER 4 PHARMACUTICAL FACTORY

12989 A

II

5/15/1998

SIEGFRIED USA LLC

2-BUTYL-3-H-IMIDAZOL-4-CARBALDEHYDE (IMALOC SB 202783), MANUFACTURED IN VISP,


SWITZERLAND
CLINDAMYCIN ISOPROPYLIDENE, INTERMEDIATE, MANUFACTURED IN JIANGSU PROVINCE,
CHINA
METHYLPHENIDATE HCI USP, MANUFACTURED IN PENNSVILLE, NJ

12990 A

II

5/5/1998

12991 I

II

5/18/1998

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
SANOFI SYNTHELABO INC.

12992 A

II

5/15/1998

ISOCHEM SAS

SUCCIMER (MESO-2,3-DIMERCAPTOSUCCINIC ACID), MANUFACTURED IN SCHAFFHAUSEN,


SWITZERLAND
AMINOPYRROLAMIDE, MANUFACTURED IN GENNEVILLIERS AND PITHIVIERS, FRANCE

12993 A

III

4/30/1998

KUTTERER MAUER AG

CAPS MADE FROM PLASTIC MATERIAL/RESINS

12994 I

II

5/18/1998

HUBEI PHARMACEUTICAL FACTORY

LEVONORGESTREL, USP, MANUFACTURED IN HUBEI, CHINA

12995 I

II

5/15/1998

BACHEM AG

12996 I

5/19/1998

12997 A

II

5/21/1998

SHANGHAI SHEN XING PHARMACEUTICAL


FACTORY
IDT AUSTRALIA LTD

PEPTIDE P829 (DEPREOTIDE) TRIFLUOROACETATE, MANUFACTURED IN BUBENDORF,


SWITZERLAND
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN
SHANGHAI, CHINA
ACETAZOLAMIDE, USP, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA

12998 I

II

5/22/1998

CHEMI SPA

DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLINE), MANUFACTURED IN FROSINONE, ITALY

12999 A

II

5/21/1998

COSMA SPA

OXAPROZIN, MANUFACTURED IN BERGAMO, ITALY

13000 A

IV

5/19/1998

LIPOID GMBH

13001 I

II

5/19/1998

LIPOID GMBH

13002 I

II

5/26/1998

JOHNSON MATTHEY INC

LIPOID PC 16:0/16:0 (1.2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO CHOLINE), MANUFACTURED


IN LUDWIGSHAFEN, GERMANY
LIPOID PC 16:0/16:0 (1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO CHOLINE), MANUFACTURED
IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY
AMD 3100, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

13003 A

II

5/26/1998

BORREGAARD AS, BORREGAARD SYNTHESIS

BFI BULK INTERMEDIATE, MANUFACTURED IN SARPSBORG, NORWAY

13004 A

II

5/27/1998

SR 47436 (CRUDE) MANUFACTURED IN LEVERKUSEN, GERMANY

13005 I

II

5/28/1998

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND


SYSTEMECHNIK
NEW CONCEPT THERAPEUTICS INC

13006 A

II

5/28/1998

RELIABLE BIOPHARMACEUTICAL CORP

CLADRIBINE, MANUFACTURED IN ST. LOUIS, MISSOURI

13007 I

II

5/28/1998

NEW CONCEPT THERAPEUTICS INC

10B ENRICHED P-BORONOPHENYLALANINE, MANUFACTURED IN CARY, NC

13008 I

II

5/29/1998

PHARMACIA AND UPJOHN SPA

9-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION, MANUFACTURED IN NERVIANO-MI-ITALY

13009 A

II

5/25/1998

SANDOZ GMBH

CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE), MANUFACTURED IN TYROL, AUSTRIA

13010 A

II

6/1/1998

ERREGIERRE SPA

PROPAFENONE HYDROCHLORIDE USP, MANUFACTURED IN BERGAMO, ITALY

13011 I

II

5/26/1998

FUJISAWA PHARMACEUTICAL CO LTD

FK 960, MANUFACTURED IN OSAKA, JAPAN

13012 A

II

5/28/1998

QUIMICA SINTETICA SA

ITRACONAZOLE, MANUFACTURED IN MADRID, SPAIN

13013 I

II

6/5/1998

FARMABIOS SRL

BUDESONIDE, MANUFACTURED IN PAVIA, ITALY

13014 A

III

6/2/1998

SARTORIUS STEDIM BIOTECH FMT SAS

13015 I

II

6/10/1998

MCNEIL CONSUMER HEALTHCARE

STEDIM 71 BAGS FOR HUMAN DRUGS AND BIOLOGICS PACKAGING, MANUFACTURED IN


AUBAGNE CEDEX, FRANCE
NICOTINE PURIFICATION PROCESS, MANUFACTURED IN CORK, IRELAND

13016 I

II

6/11/1998

CSF BIOTECH

PACLITAXEL, MANUFACTURED IN SAINTE-FOY, CANADA AND CORK, IRELAND

13017 I

II

6/11/1998

NEXTRAN INC

TRISACCHARIDE FREE ACID (TRFA), MANUFACTURED IN LA JOLLA AND SAN DIEGO, CA

31/AC HCI, MANUFACTURED IN ORIGGIO, ITALY

10B-ENRICHED L-P-BORONOPHENYLALANINE, MANUFACTUREDIN CARY, NC

Page 372

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13018 I
II
6/10/1998
ZACH SYSTEM SPA

SUBJECT
SULINDAC SULFONE, MANUFACTURED IN VICENZA, ITALY

13019 A

II

6/12/1998

EUTICALS SPA

MECAMYLAMINE BASE, MANUFACTURED IN ROZZANO-(MI), ITALY

13020 I

III

6/11/1998

AMPACET CORP

13021 A

II

6/15/1998

TARO PHARMACEUTICAL INDUSTRIES LTD

110849 WHITE HD POLYETHYLENE MASTERBATCH, MANUFACTURED INTERRE HAUTE, IN,


CARTERSVILLE, GA AND DERIDDER, LA
CLOMIPRAMINE HYDROCHLORIDE, MANUFACTURED IN HAIFA BAY, ISRAEL

13022 A

II

6/11/1998

SAFC BIOSCIENCES INC

EX-CELL 301 COMPLETE MEDIUM (MODIFIED), MANUFACTURED IN DENVER, PENNSYVANIA

13023 I

II

6/12/1998

WUJING CHANGXIN BIOCHEMISTRY FACTORY

HUMAN MENOPAUSAL GONADOTROPIN, MANUFACTURED IN CHANGZHOU, CHINA

13024 I

II

6/12/1998

NANJING CHENGHONG BIOCHEMICAL FACTORY

HUMAN CHORIONIC GONADOTROPIN, MANUFACTURED IN JIANGSU, CHINA

13025 I

II

6/17/1998

GEDEON RICHTER PLC

17-DEACETYL NORGESTIMATE, MANUFACTURED IN BUDAPEST, HUNGARY

13026 I

II

6/16/1998

BASF PHARMACHEMIKALIEN GMBH AND CO KG

FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN MINDEN, GERMANY

13027 I

II

6/17/1998

TACONIC BIOTECHNOLOGY

ANTIBODY RELATED REAGENTS, MANUFACTURED IN RENNSELAER, N.Y.

13028 I

III

6/15/1998

TENNECO PACKAGING FILMS LTD

MONO PVC FILMS, MANUFACTURED IN SOUTH WALES, GREAT BRITAIN

13029 I

II

6/15/1998

AUSIMONT USA INC

13030 A

II

6/18/1998

KISSEI PHARMACEUTICAL CO LTD

13031 I

IV

6/17/1998

BORCULO WHEY PRODUCTS R AND D

POLYMIST F5A TSP, MANUFACTURED IN ORANGE, TX; BELLE MEAD & CRANBURY, NJ (TOLL
PROCESSORS)
KMD-3213 DRUG SUBSTANCE, MANUFACTURED IN SAN LUIS OBISPO, CALIFORNIA FOR
KISSEI PHARMACEUTICAL CO LTD
LACTOCHEM, MANUFACTURED IN AB BORCULO, THE NETHERLANDS

13032 A

II

6/18/1998

MSD INTERNATIONAL GMBH

LORATADINE, MANUFACTURED IN SINGAPORE

13033 I

III

6/17/1998

HELVOET PHARMA MARYLAND

RUBBER CLOSURE FORMULATION B5001-BLUE 3XD, MANUFACTURED IN SALISBURY, MD

13034 I

II

6/16/1998

CUNO INC

ZETAPOR 020ST, MANUFACTURED IN MERIDEN, CT

13035 I

II

6/17/1998

JIN ZHOU FIRST PHARMACEUTICAL FACTORY

PARACETAMOL, MANUFACTURED IN JINZOU, CHINA

13036 A

II

6/17/1998

QUIMICA SINTETICA SA

FAMOTIDINE, MANUFACTURED IN MADRID, SPAIN

13037 I

II

6/15/1998

SHANGHAI TONGREN PHARMACEUTICAL CO LTD

IVERMECTIN, MANUFACTURED IN SHANGHAI, PEOPLES REPUBLIC OF CHINA

13038 A

III

6/11/1998

BASELL POLIOLEFINE ITALIA SRL

POLYPROPYLENES HOMOPOLYMERS, COPOLYMERS AND TERPOLYMERS, MANUFACTURED


IN FERRARA, BRINDISI AND TERNI, ITALY, WESSELING, GERMANY, ROTTERDAM,
NETHERLANDS AND MANCHESTER, UNITED KINGDOM

13039 A

II

6/22/1998

APOTEX PHARMACHEM INDIA PVT LTD

DOXAZOSIN MESYLATE, MANUFACTURED IN ONTARIO, CANADA

13040 A

II

6/25/1998

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD

13041 I

III

6/10/1998

POLIMERI EUROPA SPA

DOXYCYCLINE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE,


CHINA
FLEXIRENE CM50, MANUFACTURED IN DUNKIRK, FRANCE

13042 A

II

6/24/1998

13043 I

III

6/22/1998

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
SHELL CHEMICAL CO

1-(MERCAPTOMETHYL)CYCLOPROPYL ACETIC ACID (TAD), MANUFACTURED IN


CONSHOHOCKEN, PA
SOLID EPOXY RESINS, MANUFACTURED IN WESSELING, GERMANY AND DEER PARK, TEXAS

13044 A

6/24/1998

PATHEON MANUFACTURING SERVICES LLC

STERILE PRODUCT OPERATION-SOUTH(SPO-SOUTH) IN GREENVILLE NORTH CAROLINA

13045 A

II

6/26/1998

DIPHARMA FRANCIS SRL

DICLOFENAC POTASSIUM, MANUFACTURED IN MILAN, ITALY

13046 I

III

7/28/1998

TARGOR UK LIMITED SPECIALITIES

HOSTACOM D1124 NATURAL 001, MANUFACTURED IN MIDDLESBROUGH, UNITED KINGDOM

13047 I

II

6/28/1998

ALDRICH CHEMICAL CO INC

RHODAMINE 123, MANUFACTURED IN SHEBOYGEN FALLS, WI

13048 A

III

6/29/1998

INEOS ABS USA CORP

LUSTRAN ABS 348-VARIOUS, MANUFACTURED IN ADDYSTON, OH

13049 I

II

6/30/1998

AVECIA BIOTECHNOLOGY, INC.

13050 I

II

7/2/1998

LIANYUNGANG PHARMACEUTICAL FACTORY

OLIGONUCLEOTIDE 2006 ACTIVE PHARMACEUTICAL INGREDIENT, MANUFACTURED IN


MILFORD, MASSACHUSETTS
CYCLOPHOSPHAMIDE USP,NON-STERILE BULK DRUG, MANUFACTURED IN JIANGSU
PROVINCE, PEOPLE'S REPUBLIC OF CHINA

Page 373

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13051 I
III
7/2/1998
ISHIDA PRESS KOGYO CO LTD

SUBJECT
ALUMINUM CAPS FOR MEDICAL VIALS, MANUFACTURED IN SAITAMA, JAPAN

13052 I

II

7/2/1998

H. LUNDBECK A/S

LU 28-179-C, DRUG SUBSTANCE, MANUFACTURED IN NYKOBING SJ. AND VALBY, DENMARK

13053 I

II

7/2/1998

H. LUNDBECK A/S

LU 28-179-CAPSULES, MANUFACTURED IN VALBY, DENMARK

13054 I

III

7/2/1998

INGE SPA

PLASTIC PACKAGING, MANUFACTURED IN MILAN, ITALY

13055 A

II

6/29/1998

MEDICHEM SA

ENALAPRIL MALEATE, MANUFACTURED IN GERONA, SPAIN

13056 I

IV

7/7/1998

MITSUBISHI CHEMICAL CORP

13057 I

7/6/1998

TAKASAGO INTERNATIONAL CORP

13058 A

II

7/6/1998

TAKASAGO INTERNATIONAL CORP

SUCROSE FATY ACID ESTERS-SUCROSE STEARIC ACID ESTERS AND SUCROSE PALMITIC
ACID ESTERS, MANUFACTURED IN YOKKAICHI, MIE PREFECTURE, JAPAN
MANUFACTURING SITE, FACILTIES, PERSONNEL AND OPERATIONAL PROCEDURES IN
SHIZUOKA PREFECTURE, JAPAN
[2R-[2A,5A,6A(R*)]]-6-(L-HYDROXYETHYL)-3,7-DIOXO-L-AZABICYCLO [3.2.0]HEPTANE-2CARBOXYYLIC ACID, (4-NITROPHENYL) METHYL ESTER, OR TRADE NAME OF ADC-13 OR
BICYCLIC KETONE, MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN

13059 I

6/23/1998

13060 I

II

7/7/1998

EUROPEAN ORGANIZATION FOR RESEARCH AND


TREATMENT OF CANCER (EORTC)
CATALENT FRANCE BEINHEIM S.A

13061 A

II

7/7/1998

BAYER PHARMA AG

13062 I

III

3/24/1998

POLIMERI EUROPA FRANCE SA

PERSONNEL AND PROCEDURES FOR THE DEVELOPMENT OF ANTI-CANCER AGENTS AND


OTHER MODALITES IN CLINICAL TRIALS IN BRUSSELS, BELGIUM
AMPRENAVIR 50 AND 150 MG SOFT GELATIN CAPSULES, MANUFACTURED IN BEINHEIM,
FRANCE
GADOBUTROL AS MANUFACTURED IN BERLIN AND BERGKAMEN, FEDERAL REPUBLIC OF
GERMANY
RIBLENE FL24, MANUFACTURED IN DUNKIRK, FRANCE

13063 A

IV

7/7/1998

BAYER PHARMA AG

CALCIUMBUTROL AS MANUFACTURED IN BERLIN, FEDERAL REPUBLIC OF GERMANY

13064 A

III

6/26/1998

FUJIMORI KOGYO CO LTD

13065 A

IV

7/15/1998

MINGTAI CHEMICAL CO LTD

13066 A

III

7/9/1998

PRINTAL OY

13067 A

IV

7/7/1998

MEXICHEM UK LTD

13068 I

II

6/26/1998

13069 A

II

7/9/1998

LANZHOU CHEMISTRY NATRUAL PRODUCTS


FACTORY
DR REDDYS LABORATORIES LTD

PLASTIC FILM FOR USE IN DRUG SUBSTANCE AND PRODUCT CONTAINERS, MANUFACTURED
IN MIE PREFECTURE, JAPAN
COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M200D+ M200 & M212
MANUFACTURED IN TAIWAN, R.O.C.
ONE-PIECE ALUMINIUM CANS, BOTTLES AND RIGID CONTAINERS, MANUFACTURED IN
HANKO, FINLAND
INHALATION GRADE 1,1,1,2-TETRAFLUOROETHANE, MANUFACTURED IN RUNCORN
CHESHIRE, UNITED KINGDOM
4'-DEMETHYL-EPIPODOPHYLLOTOXIN, MANUFACTURED IN GANSU PROVINCE, CHINA

13070 I

II

7/15/1998

MITSUBISHI TANABE PHARMA CORP

MCC-135 (BULK DRUG SUBSTANCE), MANUFACTURED IN IBARAKI-KEN, JAPAN

13071 I

II

7/1/1998

BASF AKTIENGESELLSCHAFT

9-Z-ISOTRETINOIN, MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

13072 A

II

7/13/1998

RANBAXY LABORATORIES LTD

CIPROFLOXACIN HYDROCHLORIDE, MANUFACTURED IN MADHYA PRADESH, INDIA

13073 A

II

7/7/1998

13074 A

II

7/17/1998

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
ISHIHARA SANGYO KAISHA LTD

SULFADIMETHOXINE (PHARMACEUTICAL RAW MATERIAL), MANUFACTURED IN SHANGHAI,


CHINA
CEVIMELINE HYDROCHLORIDE, MANUFACTURED IN YOKKAICHI, MIE, JAPAN

13075 A

III

7/16/1998

INTRAPAC CORP

13076 A

III

7/20/1998

BORMIOLI ROCCO SPA BU PLASTICS

METERED DOSE INHALER CANS INTERNALLY COATED WITH FLUOROPOLYMER,


MANUFACTURED IN HARRISONBURG, VIRGINIA
HDPE BOTTLE 40 ML, MANUFACTURED IN CASTALGUELFO (PR) ITALY

13077 I

III

7/10/1998

POLIMERI EUROPA FRANCE SA

ERACLENE MM 74, MANUFACTURED IN MILANO-ITALY

13078 I

III

7/10/1998

POLIMERI EUROPA FRANCE SA

RIBLENE FC 40, MANUFACTURED IN MILANO-ITALY

13079 A

III

7/15/1998

ILC DOVER INC

13080 A

II

7/17/1998

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD

FLEIBLE CONTAINMENT DEVICE USED TO STORE ACTIVE PHARMACEUTICAL INGREDIENTS


(BULK DRUG SUBSTANCE), MANUFACTURED IN FREDERICA, DE
METHOCARBAMOL USP (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANUFACTURED IN
TAIWAN, THE R.O.C.

FLUOXETINE HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 374

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13081 I
IV
7/21/1998
CERESTAR USA INC

SUBJECT
HYDROXYPROPYL BETA CYCLODEXTRIN, MANUFACTURED IN WAUKEGAN, IL

13082 A

II

7/8/1998

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD

13083 I

II

7/21/1998

ERREGIERRE SPA

CLINDAMYCIN PHOSPHATE U.S.P., MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S


REPUBLIC OF CHINA
SOTALOL HYDROCHLORIDE, MANUFACTURED IN BERGAMO, ITALY

13084 A

II

7/22/1998

PCAS

OXYBUTYNIN BASE, MANUFACTURED IN LIMAY, FRANCE

13085 I

II

7/20/1998

CUNO INC

ZETA PLUS DELIPID PLUS, MANUFACTURED IN STAFFORD SPRINGS, CT

13086 A

II

7/21/1998

ERCROS SA

FAMOTIDINE, MANUFACTURED IN MADRID, SPAIN

13087 A

II

7/24/1998

CHEMWERTH INC

13088 A

III

7/22/1998

NOLATO JAYCARE LTD

AMRINONE USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE MANUFACTURED IN
ZHEJIANG PROVINCE, CHINA FOR CHEMWERTH INC
500ML/750ML ROUND HDPE BOTTLE, MANUFACTURED IN LONDON, ENGLAND

13089 I

II

7/21/1998

DIPHARMA SPA

SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY

13090 A

II

7/27/1998

PURESYN INC

POLYFLO RESIN, MANUFACTURED IN MALVERN, PA

13091 A

IV

7/23/1998

CLARIANT PRODUKTE DEUTSCHLAND GMBH

13092 A

II

7/10/1998

SHANDONG XINHUA PHARMACEUTICAL CO LTD

MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF), MANUFACTURED IN BURGKIRCHEN,


GERMANY
CAFFEINE ANHYDROUS, MANUFACTURED IN SHANDONG, CHINA

13093 I

II

7/27/1998

NV ORGANON

PORCINE INSULIN HIGHLY PURIFIED, MANUFACTURED IN SERFONTAINE, FRANCE

13094 I

II

7/28/1998

DIOSYNTH BV

ORG 9487, MANUFACTURED IN BH OSS, THE NETHERLANDS

13095 I

III

7/22/1998

INEOS ABS USA CORP

LUSTRAN SAN 32 20010, LUSTRAN SAN 29 20029, MANUFACTURED IN ADDYSTON, OH

13096 A

III

7/22/1998

INEOS ABS USA CORP

LUSTRAN SAN 29-2040 LUB TINTED, LUSTRAN SAN 31-2060 LUB CRYSTAL, LUSTRAN SAN 311000 LUB NATURAL, LUSTRAN SAN SPARKLE 2090 UNL CRYSTAL, LUSTRAN SAN SPARKLE
2090 LUB CRYSTAL, MANUFACTURED IN ADDYSTON, OH

13097 I

III

7/27/1998

PHARMACEUTICAL AND MEDICAL PLASTICS INC

HIGH DENSITY POLYETHLENE RESIN (165770), MANUFACTURED IN VICKSBURG, MI

13098 I

II

7/24/1998

SF-CHEM

13099 I

II

7/31/1998

RANBAXY LABORATORIES LTD

2-BROMO-4'-(METHLSULFONYL) ACETOPHENONE, (BROMOSULFONE), MANUFACTURED IN


PRATELN, SWITZERLAND
7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID, MANUFACTURED IN PUNJAB, INDIA

13100 I

II

7/30/1998

BIONEBRASKA INC

13101 A

II

7/30/1998

AMSA SPA

13102 A

IV

7/29/1998

DMV FONTERRA EXCIPIENTS GMBH CO KG

13103 I

II

7/26/1998

CHAICHEM PHARMACEUTICALS INTERNATIONAL

HMS LACTOSE DT AND PHARMATOSE(R) DCL 15 AS MANUFACTURED IN VEGHEL, THE


NETHERLANDS
PACITAXELINE, MANUFACTURED IN QUEBEC, CANADA

13104 I

II

7/31/1998

CHEMI SPA

DMPG. NA (DIMYRISTOYL-PHOSPHATIDYLGLYCEROL), MANUFACTURED IN FROSINONE, ITALY

13105 I

II

7/30/1998

NABUMETONE, MANUFACTURED IN LATINA, ITLAY

13106 I

II

7/6/1998

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
QUIMICA SINTETICA SA

13107 A

II

8/5/1998

BIOIBERICA SA

CHONDROITIN SULFATE, MANUFACTURED IN BARCELONA, SPAIN

13108 A

II

8/3/1998

NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD

'TBHI', MANUFACTURED IN KUMAMOTO, JAPAN

13109 I

III

8/3/1998

LOPAREX BV

13110 I

III

8/3/1998

BASELL POLIOLEFINE ITALIA SPA

FL20000 100 MICRON PET EASY/EASY PRODUCT CODE 78-100-A-320-B OR 7CF


MANUFACTURED IN APELDOORN THE NETHERLANDS
LUPOLEN 2420 K, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

13111 I

II

8/5/1998

AVANTI POLAR LIPIDS INC

13112 A

II

8/5/1998

KYOWA HAKKO KIRIN CO LTD

RECOMBINANT HUMAN GROWTH HORMONE RELEASING FACTOR (RGRF), MANUFACTURED


IN LINCOLN, NEBRASKA
GLIPIZIDE MANUFACTURED IN COMO, ITALY

BUTOCONAZOLE NITRATE, MANUFACTURED IN MADRID, SPAIN

1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-GLUTARYL, MANUFACTURED IN
ALABASTER, AL
KRN5500 DRUG SUBSTANCE, MANUFACTURED IN TAKASKI-SHI GUNMA, JAPAN

Page 375

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13113 I
II
8/4/1998
APTE AMALGAMATIONS LTD

SUBJECT
SULFAMETHOXAZOLE, MANUFACTURED IN MAHARASHTRA STATE INDIA

13114 I

II

8/6/1998

LEK PHARMACEUTICALS DD

ENALAPRIL MALEATE, ACTIVE SUBSTANCE, MANUFACTURED IN KOLODVORSKA, SLOVENIA

13115 I

II

8/7/1998

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD

13116 A

III

8/3/1998

13117 I

III

8/6/1998

ISO GESELLSCHAFT FUR ARZNEIVERPACKUNGEN


MBH
WEDTECH INC

NIFEDIPINE USP, (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN,


THE REPUBLIC OF CHINA
PACKAGING MATERIAL, MANUFACTURED IN BAD KONIGSHOFEN, GERMANY

13118 I

III

8/6/1998

INGENIA POLYMERS CORP

13119 I

II

8/11/1998

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD

13120 I

IV

8/11/1998

FONA INTERNATIONAL INC

13121 I

IV

8/11/1998

FONA INTERNATIONAL INC

13122 I

IV

8/11/1998

FONA INTERNATIONAL INC

884.114 N-C NATURAL & ARTIFICIAL ORANGE FLAVOR, MANUFACTURED IN CAROL STREAM,
ILLINOIS
877.038 N-C NATURAL MINT FLAVOR, MANUFACTURED IN CAROL STREAM, ILLINOIS

13123 I

IV

8/11/1998

FONA INTERNATIONAL INC

894.037 N-C NATURAL PEPPERMINT FLAVOR, MANUFACTURED IN CAROL STREAM, ILLINOIS

13124 I

II

7/27/1998

JINZHOU JIUTAI PHARMACEUTICAL CO LTD

CHLORHEXIDINE ACETATE, MANUFACTURED IN JINZHOU, CHINA

13125 I

II

8/11/1998

TEVA GROUP

CARBAMAZEPINE USP, MANUFACTURED IN NETANYA, ISRAEL

13126 I

II

8/11/1998

LIPOMED AG

AG14-35 (VICUREX), MANUFACTURED IN ARLESHEIM, SWITZERLAND

13127 I

II

8/12/1998

EVONIK TECHNOCHEMIE GMBH

CLOMIPRAMINE HYDROCHLORIDE, MANUFACTURED IN HANAU, GERMANY

13128 I

8/12/1998

ASTA MEDICA INC

TOXICOLOGY INFORMATION FOR PERIFOSINE (D-21266)

13129 A

IV

8/13/1998

SANWA STARCH CO LTD

CRYSTALLINE MALTOSE, MANUFACTURED IN KASHIHARA CITY, NARA PREFECTURE, JAPAN

13130 I

II

8/12/1998

NATCO PHARMA LTD CHEMICAL DIV

DILTIAZEM HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

13131 I

III

8/7/1998

ARTSANA SPA

PACKAGING MATERIAL, MANUFACTURED IN COMO, ITALY

13132 A

II

8/12/1998

MALLINCKRODT INC

METHYLPHENIDATE BASE MANUFACTURED IN ST. LOUIS, MISSOURI

13133 I

II

8/14/1998

ELAN DRUG DELIVERY INC

13134 A

8/17/1998

FRESENIUS KABI NORGE AS

RITALIN QD (METHYLPHENIDATE) ONCE DAILY CAPSULES, MANUFACTURED IN IN


GAINSVILLE, GA (PRIMARY) AND ATHLONE, COUNTY WESTMEATH, IRELAND (ALTERNATE)
STERILE MANUFACTURING OPERATIONS IN HALDON, NORWAY

13135 I

II

8/14/1998

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD

LOXAPINE BASE, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA

13136 I

10/9/1998

PHARMACIA AND UPJOHN INC

TOXICOLOGY INFORMATION FOR IODODOXORUBICIN HCL

13137 I

II

8/7/1998

ENDURA SPA

PIPERONYL BUTOXIDE, MANUFACTURED IN BOLOGNA, ITALY

13138 I

III

8/6/1998

INGENIA POLYMERS CORP

13139 I

III

8/6/1998

INGENIA POLYMERS CORP

13140 I

III

8/14/1998

B BRAUN MEDICAL INC

13141 I

II

8/18/1998

DEGUSSA AG WERK RADEBEUL

WT-152 WHITE (WHITE COLOUR CONCENTRATE), MANUFACTURED IN ALBERTA AND


ONTARIO, CANADA
WT-153 WHITE (WHITE COLOUR CONCENTRATE), MANUFACTURED IN ALBERTA AND
ONTARIO, CANADA
250 ML STERILE FLEXIBLE I.V. CONTAINER, PART NUMBER 80-203, MANUFACTURED IN IRVINE,
CA
KETAMINE HYDROCHLORIDE, MANUFACTURED IN RADEUL, GERMANY

13142 I

II

8/18/1998

ASH STEVENS INC

13143 I

III

7/13/1998

MUNNERSTADTER GLASWARENFABRIK GMBH

WEDTECH 1005 WHITE FOR USE IN PACKAGING MATERIALS, MANUFACTURED IN ALBERTA &
ONTARIO, CANADA
WEDTECH WT-157 WHITE FOR USE IN PACKAGING MATERIALS, MANUFACTURED IN ALBERTA
& ONTARIO, CANADA
OXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANUFACTURED IN TAIWAN,
THE REPUBLIC OF CHINA
840.042 NATURAL FLAVOR (CREAM TYPE), MANUFACTURED IN CAROL STREAM, ILLINOIS

N-(2-PYRAZINECARBONYL)-L-PHENYLALANINE-L-LEUCINE BORONIC ACID BULK DRUG


SUBSTANCE, MANUFACTURED IN RIVERVIEW, MI
ARTICLES OF TUBULAR GLASS USED AS CONTAINERS, MANUFACTURED IN BAD BOCKLETHOHN, FEDERAL REPUBLIC OF GERMANY

Page 376

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13144 A
II
8/18/1998
SHANDONG XINHUA PHARMACEUTICAL CO LTD

SUBJECT
TRIMETHOPRIM USP, MANUFACTURED IN ZIBO, SHANDONG, PEOPLE'S REPUBLIC OF CHINA

13145 I

II

8/20/1998

PFANSTIEHL LABORATORIES INC

D-GLUCOSAMINE HYDROCHLORIDE, HIGH PURITY, MANUFACTURED IN WAUKEGAN, IL

13146 I

II

8/18/1998

NEOMPS INC

MBI 226, A SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA

13147 I

II

8/18/1998

MULTIPLE PEPTIDE SYSTEMS

MPS-35, A SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA

13148 I

II

8/21/1998

13149 A

IV

8/25/1998

CHONGQING UNIT MODERN TECHNOLOGY CO LTD PACLITAXEL, MANUFACTURED IN NANQIAOSI, DASHIBA, JIANGBEI DISTRICT, CHONGQUING,
P.R. CHINA
ROTEM AMFERT NEGEV LTD
EXCIPIENT, WHITE PHOSPHORIC ACID, MANUFACTURED IN M.P. ARAVA, ISRAEL

13150 A

II

8/21/1998

POLYPEPTIDE LABORATORIES INC

LEUPROLIDE, MANUFACTURED IN TORRANCE, CA

13151 I

II

8/24/1998

VALEANT PHARMACEUTICALS NORTH AMERICA

MOGADON (NITRAZEPAM) TABLETS, MANUFACTURED IN BASEL, SWITZERLAND

13152 A

II

8/25/1998

ISO TEX DIAGNOSTICS INC

INDIUM-111, MANUFACTURED IN FRIENDSWOOD, TEXAS

13153 A

III

8/21/1998

NEMERA LE TREPORT

13154 I

III

8/26/1998

POLYTECH KUNSTSTOFF GMBH

13155 I

II

8/26/1998

REPLIGEN CORP

PACKAGING MATERIALS, PHARMACEUTICALS SPRAY PUMPS, MANUFACTURED IN LE


TREPORT, FRANCE
PACKAGING MATERIALS FOR HDPE BOTTLE 950 ML, MANUFACTURED IN TETTAUKLEINTETTAU, GERMANY
IMMOBLIZED (R) PROTEIN (A) TM, IPA-500, MANUFACTURED IN NEEDHAM, MASSACHUSETTS

13156 A

IV

8/15/1998

MINGTAI CHEMICAL CO LTD

13157 I

II

8/27/1998

AMYLIN PHARMACEUTICALS INC

13158 I

6/23/1998

AJINOMOTO CO INC

13159 I

III

8/28/1998

SABIC PETROCHEMICALS BV

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


YOKKAICHI, MIE PREFECTURE, JAPAN
SABIC LDPE 2101TN47 POLYETHYLENE, MANUFACTURED IN BEEK, THE NETHERLANDS

13160 A

II

8/27/1998

ISO TEX DIAGNOSTICS INC

PLATINUM-195M (PT-195M), MANUFACTURED IN FRIENDSWOOD, TEXAS

13161 I

II

8/26/1998

SIEGFRIED CHEMICALS INC

VALPROIC ACID, MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

13162 A

IV

9/1/1998

SIGMA ALDRICH MANUFACTURING LLC

L-A-PHOSPHATIDYLCHOLINE DIPALMITOYL, MANUFACTURED IN ST. LOUIS, MO

13163 A

IV

8/31/1998

LIPOID GMBH

13164 A

III

9/1/1998

BOXMORE PLASTICS LTD

LIPOID PA 16:0/16:0 (1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHATIDIC ACID MONOSODIUM


SALT), MANUFACTURED IN LUDWIGSHAFEN, GERMANY
PLASTIC CONTAINERS, MANUFACTURED IN COUNTY CAVAN, IRELAND

13165 I

9/2/1998

APTE AMALGAMATIONS LTD

13166 A

II

9/2/1998

APOTEX PHARMACHEM INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


MAHARASHTRA STATE INDIA
TERAZOSIN HCI DIHYDRATE, MANUFACTURED IN ONTARIO, CANADA

13167 A

III

8/31/1998

LAGEEN TUBOBLAST LTD

ALUMINUM TUBES AND CAPS, MANUFACTURED IN HOLON, ISRAEL

13168 A

III

9/2/1998

SARTORIUS STEDIM BIOTECH SA

13169 A

II

9/1/1998

AEROJET FINE CHEMICALS LLC

STEDIM 40 BAGS FOR HUMAN DRUGS AND BIOLOGICS, MANUFACTURED IN AUBAGNE


CEDEX, FRANCE
CARMUSTINE (BCNU), MANUFACTURED IN RANCHO CORDOVA, CA

13170 A

III

8/27/1998

ALBIS PLASTIC GMBH

LUPOLEN 1840 H WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY

13171 I

III

9/4/1998

ABBOTT LABORATORIES

13172 A

II

9/4/1998

AVANTI POLAR LIPIDS INC

13173 A

II

8/6/1998

CRYSTAL PHARMA SAU

FORM FILL SEAL FLEXIBLE CONTAINER, MANUFACTURED IN ROCKY MOUNTAIN, NORTH


CAROLINA
1,2-DIOLEOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)](DOPG), MANUFACTURED IN
ALABASTER, AL
PREDNISONE ANHYDROUS USP, MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN

13174 A

II

9/10/1998

YANGZHOU PHARMACEUTICAL CO LTD

DOXYCYCLINE HYCLATE, MANUFACTURED IN JIANGSU PROVINCE, CHINA

13175 I

IV

8/25/1998

FONA INTERNATIONAL INC

#862.378 LEMON FLAVOR, NATURAL (WONF), MANUFACTURED IN CAROL STREAM, IL

13176 I

IV

7/30/1998

KERRY INC DBA MASTERTASTE INC

NA & ART VANILLA FLAVOR 601444, MANUFACTURED IN TETERBORO, NEW JERSEY

COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M301D+ M302D+M301 & M302, AS


MANUFACTURED IN TAIWAN, ROC
EXENDIN-4 INJECTION DRUG PRODUCT, MANUFACTURED IN SAN DIEGO, CA

Page 377

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13177 I
I
9/10/1998
ADVANCED SYTHESIS TECHNOLOGIES SADE CV
13178 I

II

9/4/1998

MEDICHEM SA

SUBJECT
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN TIJUANA,
MEXICO
GABAPENTIN, DRUG SUBSTANCE, MANUFACTURED IN CELRA (GERONA), SPAIN

13179 I

II

9/8/1998

YAMAMOTO CHEMICAL INDUSTRIES CO LTD

FLAVOXATE HYDROCHLORIDE JP XIII, MANUFACTURED IN WAKAYAMA CITY, JAPAN

13180 I

II

9/9/1998

PROMETIC BIOSCIENCES LTD

DECYL AGAROSE 6XL, MANUFACTURED IN ISLE OF MAN, GREAT BRITAIN

13181 A

II

9/10/1998

ST PHARM CO LTD

ZIDOVUDINE DRUG SUBSTANCE, MANUFACTURED IN SHIHEUNG-SHI KYUNGGI-DO, KOREA

13182 I

II

9/17/1998

DAIICHI PHARMACEUTICAL CO LTD

DX-9065A, MANUFACTURED IN TOKYO, JAPAN

13183 I

II

9/10/1998

YANGZHOU PHARMACEUTICAL FACTORY

METHACYCLINE, MANUFACTURED IN JIANGSU PROVINCE, CHINA

9/14/1998

VIRCHOW LABORATORIES LIMITED

13184 I
13185 A

II

9/14/1998

VIRCHOW LABORATORIES LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


HYDERBAD, INDIA
SULPHAMETHOXAZOLE-USP, MANUFACTURED IN HYDERABAD, INDIA

13186 I

II

9/14/1998

HEUMANN PHARMA GMBH

SOTALOL HYDROCHLORIDE, MANUFACTURED IN FEUCHT, GERMANY

13187 I

III

9/15/1998

GRAHAM PACKAGING CO LP

PLASTIC CONTAINERS, MANUFACTURED IN CHICAGO, IL

13188 A

II

9/11/1998

MACFARLAN SMITH LTD

APOMORPHINE HYDROCHLORIDE, MANUFACTURED IN EDINBURGH, SCOTLAND

13189 A

II

9/8/1998

CORDEN PHARMA SWITZERLAND LLC

13190 A

IV

8/25/1998

ROTEM AMFERT NEGEV LTD

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOPHAIDIC ACID SODIUM SALT (DPPA,NA),


MANUFACTURED IN LIESTAL, SWITZERLAND
MONOBASIC POTASSIUM PHOSPHATE, MANUFACTURED IN M.P. ARAVA, ISRAEL

13191 I

II

9/18/1998

NIPPON SYNTHETIC CHEMICAL INDUSTRIES

13192 A

II

9/21/1998

SHASUN PHARMACEUTICALS LTD

2-N-BUTYL-1H-IMIDAZOLE-4-CARBOXALDEHYDE (BFI), MANUFACTURED IN KUMAMOTO,


JAPAN
NIZATIDINE, MANUFACTURED IN CUDDALORE, INDIA

13193 I

II

9/22/1998

ARCHIMICA SPA

AMRINONE, USP, MANUFACTURED IN ORIGGIO (VA), ITALY

13194 I

II

9/23/1998

TEVA PHARMACEUTICAL FINE CHEMICALS SRL

TERAZOSIN HCL 2H20, MANUFACTURED IN VARESE, ITALY

13195 A

II

9/23/1998

CHEMWERTH INC

13196 A

9/21/1998

STERIS ISOMEDIX SERVICES

MILRINONE, NON-STERILE BULK DRUG MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR


CHEMWERTH INC
CONTRACT STERILIZATION FACILITY IN GROVEPORT OHIO

13197 A

II

4/30/1998

ABBVIE INC

ERYTHROMYCIN

13198 I

II

4/30/1998

GIST BROCADES

PENICILLIN G PROCAINE

13199 I

II

4/30/1998

CULTOR FOOD SCI

POLYMYXIN B SULFATE

13200 I

II

4/30/1998

OXYTETRACYCLINE

13201 I

II

4/30/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
SMITHKLINE BEECHAM

13202 I

II

4/30/1998

HOUBA INC

DOXYCYCLINE HYCLATE

13203 I

II

4/30/1998

BIOCHEMIE DEUTSCHLAND GMBH

PENICILLIN G PROCAINE STERILE

13204 I

II

4/30/1998

LILLY RES LABS

ERYTHROMYCIN ESTOLATE

13205 A

II

4/30/1998

ACS DOBFAR SPA

CEFUROXIME SODIUM (STERILE)

13206 A

II

4/30/1998

ACS DOBFAR SPA

CEPHALOTHIN SODIUM

13207 A

II

4/30/1998

AMOXICILLIN

13208 A

II

4/30/1998

SMITHKLINE BEECHAM CORP DBA


GLAXOSMITHKLINE
ACS DOBFAR SPA

13209 A

II

4/30/1998

MEIJI SEIKA PHARMA CO LTD

DOXORUBICIN HYDROCHLORIDE

13210 A

II

4/30/1998

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV

CEPHALEXIN MONOHYDRATE AS MANUFACTURED IN BARCELONA, SPAIN

AMOXICILLIN TRIHYDRATE

CEFAZOLIN SODIUM LYOPHILIZED (STERILE BULK)

Page 378

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13211 A
II
4/30/1998
MICROBIOPHARM JAPAN CO LTD

SUBJECT
DOXORUBICIN HYDROCHLORIDE

13212 A

II

4/30/1998

SANDOZ INDUSTRIAL PRODUCTS SA

AMPICILLIN

13213 I

II

4/30/1998

TEVA PHARMACEUTICALS USA, INC. API DIVISION

PENICILLIN V POTASSIUM MFG IN MEXICO, MISSOURI

13214 A

II

4/30/1998

LUPIN LTD

RIFAMPIN

13215 I

II

4/30/1998

SINTESIS QUIMICA

AMOXICILLIN TRIHYDRATE

13216 A

II

4/30/1998

SANDOZ INDUSTRIAL PRODUCTS SA

OXACILLIN SODIUM

13217 I

II

4/30/1998

LUPIN LTD

CEFACLOR

13218 I

II

4/30/1998

BRISTOL MYERS SQUIBB COMPANY

CEFACLOR

13219 A

II

4/30/1998

LUPIN LTD

CEFOTAXIME SODIUM USP (STERILE) AS MANUFACTURED IN RAISEN, INDIA

13220 I

II

4/30/1998

HIKMACHEM

CEFADROXIL MONOHYDRATE

13221 I

II

4/30/1998

CONSOLIDATED PHARM

DICLOXACILLIN SODIUM

13222 A

II

4/30/1998

SPIC

PENICILLIN G POTASSIUM

13223 I

II

4/30/1998

LEK PHARM

VANCOMYCIN HYDROCHLORIDE

13224 A

II

4/30/1998

SHANGHAI ASIA PIONEER CO LTD

AMPHOTERICIN B

13225 A

II

4/30/1998

ACS DOBFAR SPA

CEFADROXIL MONOHYDRATE

13226 I

II

4/30/1998

MIWON

CEFACLOR MONOHYDRATE USP, NON-STERILE BULK

13227 I

II

9/21/1998

ZAMBON GROUP SPA

OXAPROZIN, MANUFACTURED IN VICENZE, ITALY

13228 A

II

9/21/1998

SIEGFRIED USA LLC

DEXMETHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN PENNSVILLE, NJ

13229 I

II

9/22/1998

PHARM ECO LABORATORIES INC

13230 A

II

9/24/1998

ALBEMARLE CORP

2-NSA-FORMALDEHYDE CONDENSATE, SODIUM SALT-FRACTIONED, MANUFACTURED IN


LEXINGTON AND N.ANDOVER, MA
PRAMOXINE HYDROCHLORIDE, MANUFACTURED IN SOUTH HAVEN, MI

13231 A

IV

9/23/1998

NEKTAR THERAPEUTICS

MPEG5000, MANUFACTURED IN HUNTSVILLE, AL

13232 I

III

9/22/1998

AMPACET CORP

13233 I

IV

9/10/1998

SOLUTIA INC

13234 I

II

9/22/1998

FLUROMED LP FMLP

816030-P WHITE POLYETHYLENE MASTERBACH, MANUFACTURED IN KITCHENER, ONTARIO,


CANADA
DEQUEST 2010 DEFLOCCULANT AND SEQUESTRANT, MANUFACTURED IN NEW PORT,
WALES, UNITED KINGDOM
PERFLUOROHEXANES, 99.0% (APF-60M), MANUFACTURED IN ROUND ROCK, TEXAS

13235 A

II

9/25/1998

MOEHS IBERICA SL

LIDOCAINE, MANUFACTURED RUBI, SPAIN

13236 I

II

9/1/1998

13237 I

9/28/1998

HEBEI ZHONGKANG PHARMACEUTICAL COMPANY


LTD
STERIS-ISOMEDIX SERVICES

PENICILLIN G POTASSIUM CRUDE, MANUFACTURED IN HEBEI PROVINCE, PEOPLE'S


REPUBLIC OF CHINA
CONTRACT STERILIZATION FACILITY IN TEMECULA,CALIFORNIA

13238 A

9/28/1998

STERIS ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN CHESTER NY

13239 I

II

9/27/1998

AVANTI POLAR LIPIDS INC

1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE, MANUFACTURED IN ALABASTER, AL

13240 I

II

9/25/1998

ARADIGM CORP

AER INSULIN DIABETES MANAGMENT SYSTEM, MANUFACTURED IN HAYWARD, CA

13241 I

II

9/28/1998

BIOSEPRA SA

13242 I

II

9/28/1998

BIOSEPRA SA

13243 A

II

10/1/1998

13244 I

II

10/1/1998

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
SPI PHARMA

Q/S CERAMIC HYPERD ION EXCHANGERS, MANUFACTURED IN VILLENEUVE LA GARENNE


(FRANCE)
DEAE CERAMIC HYPERD ION EXCHANGERS, MANUFACTURED IN VILLENEUVE LA GARENNE
(FRANCE)
NAPROXEN SODIUM, USP (BULK), MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

13245 A

II

9/30/1998

VIFOR INTERNATIONAL INC

DRIED ALUMINUM HYDROXIDE GEL, USP, MANUFACTURED IN LEWES, DE


VENOFER CONCENTRATE USA, MANUFACTURED IN ST. GALLEN, SWITZERLAND

Page 379

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13246 A
III
10/1/1998
BAXTER PHARMACEUTICALS SOLUTIONS LLC

SUBJECT
PACKAGING MATERIALS OF VIAL DRUG PRODUCTS, MANUFACTURED IN BLOOMINGTON,
INDIANA
AMGRAN, MANUFACTURED BY ERIE FOODS INTERNATIONAL, INC. IN ROCHELLE, ILLINOIS

13247 A

II

9/28/1998

AMERICAN INGREDIENTS INC

13248 I

II

9/30/1998

LOVASTATIN, USP, MANUFACTURED IN NORTH CHICAGO, IL

13249 A

II

9/30/1998

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
EVOTEC OAI

13250 A

II

9/29/1998

NEULAND LABORATORIES LTD

CIPROFLOXACIN HYDROCHLORIDE, USP, MANUFACTURED IN TELANGANA, INDIA

13251 A

III

9/16/1998

BERRY PLASTICS CORP

PRODUCT 11173-40, MANUFACTURED IN COLUMBUS, GA

13252 A

III

9/16/1998

BERRY PLASTICS CORP

PRODUCT 41713-34, MANUFACTURED IN COLUMBUS, GA

13253 I

III

9/16/1998

GEORGIA PACKAGING INC

PRODUCT 41762-34, MANUFACTURED IN COLUMBUS, GA

13254 I

II

10/2/1998

MAYNE PHARMA (USA) INC

BLEOMYCIN SULFATE, MANUFACTURED IN VICTORIA, AUSTRALIA

13255 A

II

10/2/1998

WOCKHARDT LTD

FELODIPINE, MANUFACTURED IN GUJARAT STATE, INDIA

13256 A

10/1/1998

STERIS-ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN VEGA ALTA, PUERTO RICO

13257 A

III

10/1/1998

BAXTER PHARMACEUTICALS SOLUTIONS LLC

13258 I

III

9/30/1998

HOSPIRA INC

PACKAGING MATERIALS OF SYRINGE DRUG PRODUCTS, MANUFACTURED IN BLOOMINGTON,


INDIANA
ALUER VIAL SUBASSEMBLY, MANUFACTURED IN ABBOTT, ILLNOIS

13259 I

III

10/7/1998

DSM RESEARCH

ARNITAL E EM400, MANUFACTURED IN EMMEN, THE NETHERLNDS

13260 I

III

10/7/1998

DSM RESEARCH

ARNITEL P PM380, MANUFACTURED IN EMMEN, THE NETHERLANDS

13261 I

III

10/7/1998

DSM RESEARCH

ARNITEL P PL380, MANUFACTURED IN EMMEN, THE NETHERLANDS

13262 I

III

10/7/1998

DSM RESEARCH

ARNITEL E EM460, MANUFACTURED IN EMMEN, THE NETHERLANDS

13263 I

III

10/7/1998

DSM RESEARCH

ARNITEL P P-X6179, MANUFACTURED IN EMMEN, THE NETHERLANDS

13264 I

III

10/7/1998

DSM RESEARCH

ARNITEL P PL460, MANUFACTURED IN EMMEN, THE NETHERLANDS

13265 A

II

10/8/1998

BRISTOL MYERS SQUIBB CO

13266 A

II

10/5/1998

FABBRICA ITALIANA SINTETICI SPA

IRBESARTAN, MANUFACTURED AT SWORDS LABORATORIES IN COUNTYDUBLIN, REP. OF


IRELAND
NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY

13267 I

9/30/1998

13268 I

II

6/4/1998

OSAKA WORKS OF KOIE CHEMICAL COMPANY


LIMITED
GENERAL ELECTRIC MEDICAL SYSTEM

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN OSAKA, JAPAN
FLUDEOXYGLUCOSE F-18 INJECTION, MANUFACTURED IN UPPSALA, SWEEDEN

13269 A

III

10/14/1998

SEKISUI FILM CO LTD

POLYLON TUBE, MANUFACTURED IN HIROSHIMA, JAPAN

13270 A

III

10/7/1998

ST GOBAIN PERFORMANCE PLASTICS

POLYESTER C1S 6022 SILICONE RELEASE COATING, MANUFACTURED IN WORCESTER, MA

13271 A

III

10/7/1998

ST GOBAIN PERFORMANCE PLASTICS

13272 A

III

10/7/1998

ST GOBAIN PERFORMANCE PLASTICS

13273 I

II

10/14/1998

UBE INDUSTRIES LTD

NATURAL HIGH DENSITY POLYETHYLENE C1S 7015 SILICONE RELEASE COATING,


MANUFACTURED IN WORCESTER, MA
POLYETHYLENE C1S 6113 SILICONE RELEASE COATING, MANUFACTURED IN WORCESTER,
MA
CS-615 DRUG SUBSTANCE, MANUFACTURED IN YAMAGUCHI, JAPAN

13274 I

II

9/23/1998

MENLA TIBETAN MEDICAL INSTITUTE

13275 I

III

10/14/1998

BASELL POLIOLEFINE ITALIA SPA

13276 A

III

10/20/1998

FUJIMORI KOGYO CO LTD

13277 A

II

10/22/1998

MYLAN LABORATORIES LTD

13278 A

IV

10/5/1998

NOF CORP

PROSTAGLANDIN E, MANUFACTURED IN OXEN, UNITED KINGDOM

TIBETAN HERBAL FORMULAS, MANUFACTURED AT TIBETAN HERBAL CLINIC FOR DR. YESHI
DHONDEN IN DHARAMSALA, INDIA
LUPOLEN 5231 HX, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY
PLASTIC FILM AND BAG FOR USE IN DRUG SUBSTANCE AND PRODUCT CONTAINERS,
MANUFACTURED IN MIE PREFECTURE, JAPAN
ACYCLOVIR USP AS MANUFACTURED IN TELANGANA, INDIA
EXCIPIENT, DIPALMITOYL PHOSPHATIDIC ACID SODIUM SALT (DPPA-NA), MANUFACTURED IN
HYOGO, JAPAN

Page 380

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13279 I
II
10/19/1998
FINORGA SA

SUBJECT
LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE

13280 I

II

10/19/1998

SANKYO CO LTD

CS-615 DRUG PRODUCT, MANUFACTURED IN TOKYO, JAPAN

13281 I

10/15/1998

DAICEL CHEMICAL INDUSTRIES LTD

13282 I

II

10/15/1998

DAICEL CHEMICAL INDUSTRIES LTD

13283 I

III

10/16/1998

PHYSIOR SA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN NIIGATA,


JAPAN
CHIRALPAK AD CSP (20UM) FOR LIQUID CHROMATOGRAPHIC RESOLUTION, MANUFACTURED
IN NIIGATA, JAPAN
IZZO SYSTEM CARTRIDGE, MANUFACTURED IN NANTERRE, FRANCE

13284 I

II

10/20/1998

CHEMI SPA

DMPC STANDARD, MANUFACTURED IN FROSINONE, ITALY

13285 I

II

10/15/1998

OTSUKA PHARMACEUTICAL CO LTD

NO-1886 DRUG SUBSTANCE, MANUFACTURED IN TOKUSHIMA, JAPAN

13286 I

II

9/1/1998

PENICK

NEOMYCIN SULFATE

13287 I

II

9/1/1998

SQUIBB

PENICILLIN V POTASSIUM

13288 I

II

9/1/1998

SQUIBB

TETRACYCLINE HYDROCHLORIDE

13289 I

II

9/1/1998

KAYAKU CO LTD

COLISTIN SULFATE

13290 I

II

9/1/1998

PFIZER

CARBENICILLIN INDANYL SODIUM

13291 I

II

9/1/1998

ELI LILLY

PENICILLIN G PROCAINE

13292 A

II

9/1/1998

PHARMACIA AND UPJOHN SUB PFIZER INC

LINCOMYCIN HYDROCHLORIDE

13293 I

II

9/1/1998

ABBOTT

ERYTHROMYCIN ETHYLSUCCINATE

13294 A

II

9/1/1998

SANDOZ GMBH

PENICILLIN G BENZATHINE

13295 A

II

9/1/1998

SANDOZ GMBH

PENICILLIN V POTASSIUM, MANUFACTURED IN KUNDL, AUSTRIA

13296 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

AMPICILLIN TRIHYDRATE

13297 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

AMPICILLIN

13298 I

II

9/1/1998

E R SQUIBB

NYSTATIN

13299 I

II

9/1/1998

GLAXOCHEM LTD

AMPICILLIN TRIHYDRATE

13300 I

II

9/1/1998

PFIZER

TETRACYCLINE

13301 I

II

9/1/1998

KAYAKU

COLISTIN SULFATE

13302 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE

13303 I

II

9/1/1998

DOW CHEM

TETRACYCLINE

13304 I

II

9/1/1998

PIERREL AMERICA

CHLORTETRACYCLINE HYDROCHLORIDE

13305 I

II

9/1/1998

IBI

OXYTETRACYCLINE

13306 I

II

9/1/1998

RACHELLE LABS

TETRACYCLINE

13307 I

II

9/1/1998

RACHELLE LABS

TETRACYCLINE

13308 I

II

9/1/1998

RACHELLE LABS

CHLORAMPHENICOL

13309 I

II

9/1/1998

ANGUS BIOTECH

CHLORTETRACYCLINE HYDROCHLORIDE

13310 I

II

9/1/1998

DIASPA

TETRACYCLINE HYDROCHLORIDE

13311 I

II

9/1/1998

DIASPA

TETRACYCLINE

13312 I

II

9/1/1998

DIASPA

OXYTETRACYCLINE HYDROCHLORIDE

13313 I

II

9/1/1998

DIASPA

OXYTETRACYCLINE

13314 I

II

9/1/1998

DIASPA

ERYTHROMYCIN

13315 I

II

9/1/1998

DIASPA

ERYTHROMYCIN STEARATE

13316 I

II

9/1/1998

DIASPA

ERYTHROMYCIN ESTOLATE

Page 381

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13317 I
II
9/1/1998
PITMAN-MOORE

SUBJECT
CYCLOSERINE

13318 I

II

9/1/1998

PFIZER

PENICILLIN G BENZATHINE

13319 I

II

9/1/1998

PFIZER

PENICILLIN G PROCAINE

13320 I

II

9/1/1998

PFIZER

METHACYCLINE HYDROCHLORIDE

13321 I

II

9/1/1998

PFIZER

DOXYCYCLINE HYCLATE

13322 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE

13323 I

II

9/1/1998

PFIZER LABS

BACITRACIN

13324 I

II

9/1/1998

ABBOTT

ERYTHROMYCIN STEARATE

13325 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

KANAMYCIN SULFATE

13326 I

II

9/1/1998

FERMENTA PRODS

PENICILLIN G POTASSIUM

13327 I

II

9/1/1998

WYETH AYERST LABS

PENICILLIN G PROCAINE

13328 I

II

9/1/1998

WYETH AYERST LABS

PENICILLIN G BENZATHINE

13329 I

II

9/1/1998

FERMENTA PRODS

AMPICILLIN

13330 I

II

9/1/1998

WYETH PHARMACEUTICALS

DEMECLOCYCLINE HYDROCHLORIDE

13331 I

II

9/1/1998

LILLY RES LABS

ERYTHROMYCIN ESTOLATE

13332 I

II

9/1/1998

LILLY RES LABS

PENICILLIN V POTASSIUM

13333 I

II

9/1/1998

LILLY RES LABS

ERYTHROMYCIN ESTOLATE

13334 A

II

9/1/1998

PHARMACIA AND UPJOHN SUB PFIZER INC

NOVOBIOCIN SODIUM

13335 I

II

9/1/1998

PARKE DAVIS DIV WL

CHLORAMPHENICOL

13336 I

II

9/1/1998

PHARMACIA AND UPJOHN

ERYTHROMYCIN

13337 I

II

9/1/1998

GIST BROCADES

GRAMICIDIN

13338 I

II

9/1/1998

GLAXOSMITHKLINE LLC

GRISEOFULVIN

13339 A

II

9/1/1998

TETRACYCLINE HYDROCHLORIDE

13340 I

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SA
ALPHARMA

13341 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

BACITRACIN STERILE USP AS MANUFACTURED IN OSLO NORWAY

13342 I

II

9/1/1998

WYETH

GRISEOFULVIN

13343 I

II

9/1/1998

WYETH

GRISEOFULVIN

13344 I

II

9/1/1998

ALPHARMA

BACITRACIN ZINC

13345 I

II

9/1/1998

GIST BROCADES

TYROTHRICIN

13346 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

PENICILLIN V POTASSIUM

13347 I

II

9/1/1998

LEDERLE LABS

CHLORTETRACYCLINE HYDROCHLORIDE

13348 I

II

9/1/1998

ISF

TETRACYCLINE HYDROCHLORIDE

13349 I

II

9/1/1998

PLIVA

OXYTETRACYCLINE HYDROCHLORIDE

13350 I

II

9/1/1998

PLIVA

OXYTETRACYCLINE

13351 I

II

9/1/1998

PARKE DAVIS DIV WL

CHLORAMPHENICOL PALMITATE

13352 I

II

9/1/1998

FERMENTA PRODS

DICLOXACILLIN SODIUM

13353 I

II

9/1/1998

FARMITALIA CES

CHLORTETRACYCLINE HYDROCHLORIDE

13354 I

II

9/1/1998

GIST BROCADES

PENICILLIN G SODIUM

BACITRACIN

Page 382

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13355 I
II
9/1/1998
GIST BROCADES

SUBJECT
PENICILLIN V POTASSIUM

13356 I

II

9/1/1998

GIST BROCADES

PENICILLIN G POTASSIUM

13357 I

II

9/1/1998

ICN CHIMICA

TETRACYCLINE HYDROCHLORIDE

13358 I

II

9/1/1998

ICN RADIOCHEMICALS

TETRACYCLINE

13359 I

II

9/1/1998

ERYTHROMYCIN ESTOLATE

13360 A

II

9/1/1998

13361 I

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
COMPANHIA INDUSTRIAL PRODUTORA DE
ANTIBIOTICOS SA
PHARMACIA AND UPJOHN

13362 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

COLISTIN SULFATE AS MANUFACTURED IN COPENHAGEN, DENMARK

13363 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

COLISTIMETHATE SODIUM AS MANUFACTURED IN COPENHAGEN, DENMARK

13364 I

II

9/1/1998

PIERREL AMERICA

AMPICILLIN TRIHYDRATE

13365 I

II

9/1/1998

PFIZER

TETRACYCLINE HYDROCHLORIDE

13366 I

II

9/1/1998

PFIZER

TETRACYCLINE

13367 I

II

9/1/1998

PFIZER PHARMACETUICALS GROUP

OXYTETRACYCLINE

13368 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE HYDROCHLORIDE

13369 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE CALCIUM

13370 I

II

9/1/1998

PFIZER

DOXYCYCLINE HYCLATE

13371 A

II

9/1/1998

PFIZER INC

CLINDAMYCIN HYDROCHLORIDE

13372 A

II

9/1/1998

ABBVIE INC

ERYTHROMYCIN STEARATE

13373 I

II

9/1/1998

LEDERLE LABS

TETRACYCLINE HYDROCHLORIDE

13374 I

II

9/1/1998

PFIZER

PLICAMYCIN

13375 I

II

9/1/1998

PFIZER

PENICILLIN V POTASSIUM

13376 I

II

9/1/1998

PFIZER

STREPTOMYCIN SULFATE

13377 I

II

9/1/1998

PFIZER

TETRACYCLINE HYDROCHLORIDE

13378 A

II

9/1/1998

PHARMACIA AND UPJOHN CO

NEOMYCIN SULFATE

13379 I

II

9/1/1998

WYETH AYERST LABS

AMPICILLIN SODIUM

13380 I

II

9/1/1998

PFIZER

VIOMYCIN SULFATE

13381 I

II

9/1/1998

IBI

ERYTHROMYCIN STEARATE

13382 I

II

9/1/1998

AMPICILLIN TRIHYDRATE

13383 A

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
SANOFI AVENTIS SPA

13384 I

II

9/1/1998

LILLY RES LABS

CEPHALOTHIN SODIUM

13385 I

II

9/1/1998

LILLY RES LABS

CEPHALEXIN MONOHYDRATE

13386 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

OXACILLIN SODIUM MONOHYDRATE

13387 I

II

9/1/1998

FERMENTA PRODS

NAFCILLIN SODIUM

13388 A

II

9/1/1998

XELLIA PHARMACEUTICALS AS

BACITRACIN ZINC MANUFACTURED IN OSLO NORWAY

13389 A

II

9/1/1998

OXYTETRACYCLINE CALCIUM

13390 A

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
COMPANHIA INDUSTRIAL PRODUTORA DE
ANTIBIOTICOS SA

TETRACYCLINE
ERYTHROMYCIN STEARATE

RIFAMPIN

OXYTETRACYCLINE HYDROCHLORIDE

Page 383

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13391 I
II
9/1/1998
COMPANHIA INDUSTRIAL PRODUTORA DE
ANTIBIOTICOS SARL
13392 I
II
9/1/1998
MEIJI SEIKA PHARMACEUTICALS

SUBJECT
CHLORTETRACYCLINE HYDROCHLORIDE

13393 I

II

9/1/1998

POLFA

ERYTHROMYCIN STEARATE

13394 I

II

9/1/1998

DIAMOND SHAMROCK

TETRACYCLINE HYDROCHLORIDE

13395 I

II

9/1/1998

DIASPA

TETRACYCLINE

13396 I

II

9/1/1998

FERMENTACIONES

TETRACYCLINE

13397 I

II

9/1/1998

GYMA LABS

TETRACYCLINE HYDROCHLORIDE

13398 I

II

9/1/1998

NOVARTIS PHARM

RIFAMPIN

13399 I

II

9/1/1998

FARMITALIA CES

TETRACYCLINE

13400 I

II

9/1/1998

PFIZER

CARBENICILLIN INDANYL SODIUM

13401 I

II

9/1/1998

GLAXO

STREPTOMYCIN SULFATE

13402 I

II

9/1/1998

GLAXO GROUP RESEARCH

DIHYDROSTREPTOMYCIN SULFATE

13403 I

II

9/1/1998

FERMIC SA

DEMECLOCYCLINE HYDROCHLORIDE

13404 I

II

9/1/1998

LEDERLE LABS

MINOCYCLINE HYDROCHLORIDE

13405 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

METHICILLIN SODIUM

13406 I

II

9/1/1998

ERYTHROMYCIN

13407 A

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
PFIZER INC

13408 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

AMPICILLIN TRIHYDRATE

13409 A

II

9/1/1998

POLFA TARCHOMIN

ERYTHROMYCIN

13410 I

II

9/1/1998

POLFA

OXYTETRACYCLINE

13411 I

II

9/1/1998

DIAMOND SHAMROCK

CHLORTETRACYCLINE HYDROCHLORIDE

13412 A

II

9/1/1998

PHARMACIA AND UPJOHN SUB PFIZER INC

CLINDAMYCIN PALMITATE HYDROCHLORIDE

13413 A

II

9/1/1998

PHARMACIA AND UPJOHN SUB PFIZER INC

CLINDAMYCIN PHOSPHATE

13414 I

II

9/1/1998

FARMITALIA CARLO ERBA SPA

CHLORAMPHENICOL

13415 I

II

9/1/1998

FARMITALIA CARLO ERBA SPA

CHLORAMPHENICOL PALMITATE

13416 I

II

9/1/1998

FARMITALIA CARLO ERBA SPA

CYCLOSERINE

13417 I

II

9/1/1998

DISTA

PENICILLIN V POTASSIUM

13418 I

II

9/1/1998

ISF

PENICILLIN G POTASSIUM

13419 I

II

9/1/1998

ISF

PENICILLIN V

13420 I

II

9/1/1998

ISF

CHLORTETRACYCLINE HYDROCHLORIDE

13421 I

II

9/1/1998

PHARMACHIM

TETRACYCLINE HYDROCHLORIDE

13422 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

HETACILLIN ACID

13423 I

II

9/1/1998

TEVA PHARMACEUTICALS INDUSTRIES LTD

AMPICILLIN TRIHYDRATE MFG IN MEXICO, MISSOURI

13424 I

II

9/1/1998

PFIZER

PENICILLIN V POTASSIUM

13425 I

II

9/1/1998

PHARMACIA AND UPJOHN

AMPICILLIN SODIUM

13426 A

II

9/1/1998

FERSINSA GB SA DE CV

AMPICILLIN TRIHYDRATE

13427 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

HETACILLIN

13428 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

HETACILLIN POTASSIUM

KANAMYCIN SULFATE

SPECTINOMYCIN HYDROCHLORIDE

Page 384

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13429 I
II
9/1/1998
BRISTOL MYERS SQUIBB COMPANY

SUBJECT
DICLOXACILLIN SODIUM

13430 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

HETACILLIN POTASSIUM

13431 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

DICLOXACILLIN SODIUM

13432 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

OXACILLIN SODIUM

13433 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

OXACILLIN SODIUM

13434 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

CLOXACILLIN SODIUM

13435 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

AMPICILLIN

13436 I

II

9/1/1998

GEORGE UHE CO

ERYTHROMYCIN

13437 I

II

9/1/1998

SCHERING PHARMACEUTI

GENTAMICIN SULFATE

13438 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

AMPICILLIN TRIHYDRATE

13439 A

II

9/1/1998

ANTIBIOTICOS SA

PENICILLIN G POTASSIUM

13440 A

II

9/1/1998

ANTIBIOTICOS SA

AMPICILLIN TRIHYDRATE

13441 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

NYSTATIN

13442 I

II

9/1/1998

RHONE POULENC

DIHYDROSTREPTOMYCIN SULFATE

13443 A

II

9/1/1998

ABBVIE INC

ERYTHROMYCIN ETHYLSUCCINATE AS MANUFACTURED IN BARCELONETA, PUERTO RICO

13444 I

II

9/1/1998

IND DIV-B-M-S

PENICILLIN G POTASSIUM

13445 I

II

9/1/1998

DSM CAPUA SPA

ERYTHROMYCIN STEARATE

13446 I

II

9/1/1998

DSM CAPUA SPA

ERYTHROMYCIN

13447 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CARBENICILLIN INDANYL SODIUM

13448 I

II

9/1/1998

GIST BROCADES

AMPICILLIN

13449 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

PENICILLIN G POTASSIUM

13450 I

II

9/1/1998

ANKERMAN SPA

DOXYCYCLINE

13451 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE

13452 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE HYDROCHLORIDE

13453 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE CALCIUM

13454 I

II

9/1/1998

PFIZER

METHACYCLINE HYDROCHLORIDE

13455 I

II

9/1/1998

PFIZER

DOXYCYCLINE HYCLATE

13456 I

II

9/1/1998

ARCHIFAR LAB

TETRACYCLINE HYDROCHLORIDE

13457 I

II

9/1/1998

FERMIC SA

ERYTHROMYCIN

13458 I

II

9/1/1998

FERMIC SA

ERYTHROMYCIN ESTOLATE

13459 I

II

9/1/1998

FERMIC SA

ERYTHROMYCIN STEARATE

13460 I

II

9/1/1998

FERMIC SA

TETRACYCLINE HYDROCHLORIDE

13461 I

II

9/1/1998

FERMIC SA

TETRACYCLINE HYDROCHLORIDE

13462 I

II

9/1/1998

FERMIC SA

TETRACYCLINE PHOSPHATE COMPLEX

13463 I

II

9/1/1998

FERMIC

OXYTETRACYCLINE

13464 I

II

9/1/1998

FERMIC SA

OXYTETRACYCLINE HYDROCHLORIDE

13465 I

II

9/1/1998

ARCHIFAR LAB

TETRACYCLINE

13466 A

II

9/1/1998

ERCROS SA

ERYTHROMYCIN

13467 I

II

9/1/1998

ERCROS INDUSTRIAL SA

ERYTHROMYCIN STEARATE

Page 385

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13468 A
II
9/1/1998
ERCROS SA

SUBJECT
ERYTHROMYCIN ESTOLATE

13469 I

II

9/1/1998

ROFERM SPA

ERYTHROMYCIN ESTOLATE

13470 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

METHICILLIN SODIUM

13471 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE HYDROCHLORIDE

13472 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE

13473 I

II

9/1/1998

SOCIEDAD

PENICILLIN G POTASSIUM

13474 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CLOXACILLIN SODIUM

13475 I

II

9/1/1998

GLAXO GROUP RESEARCH

PENICILLIN G POTASSIUM

13476 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CLOXACILLIN BENZATHINE

13477 I

II

9/1/1998

SANDOZ INDUSTRIAL PRODUCTS SPA

ERYTHROMYCIN

13478 I

II

9/1/1998

ARCHIFAR LAB

ERYTHROMYCIN STEARATE

13479 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

AMPICILLIN TRIHYDRATE

13480 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

AMPICILLIN SODIUM

13481 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

AMOXICILLIN TRIHYDRATE

13482 I

II

9/1/1998

MEIJI SEIKA KAISHA L

PENICILLIN G POTASSIUM

13483 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

CEPHAPIRIN SODIUM

13484 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

METHICILLIN SODIUM

13485 I

II

9/1/1998

RHONE POULENC

STREPTOMYCIN SULFATE

13486 I

II

9/1/1998

PFIZER

TETRACYCLINE

13487 I

II

9/1/1998

PFIZER

TETRACYCLINE HYDROCHLORIDE

13488 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE

13489 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE HYDROCHLORIDE

13490 I

II

9/1/1998

PFIZER

OXYTETRACYCLINE HYDROCHLORIDE

13491 I

II

9/1/1998

PFIZER

TROLEANDOMYCIN

13492 I

II

9/1/1998

PFIZER

DOXYCYCLINE HYCLATE

13493 I

II

9/1/1998

PFIZER

AMPICILLIN TRIHYDRATE

13494 I

II

9/1/1998

AXELLIA PHARMACEUTICALS AS

GRAMICIDIN

13495 I

II

9/1/1998

LEDERLE LABS

CHLORTETRACYCLINE HYDROCHLORIDE

13496 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

CEPHAPIRIN SODIUM

13497 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

DICLOXACILLIN SODIUM MONOHYDRATE

13498 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

AMOXICILLIN

13499 I

II

9/1/1998

PHARMACIA AND UPJOHN SUB PFIZER INC

CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ARECIBO PR

13500 I

II

9/1/1998

WATSON LABORATORIES INC

DOXYCYCLINE AS MANUFACTURED IN CULVER IN.

13501 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CEPHRADINE

13502 I

II

9/1/1998

BRISTOL MYERS SQUIBB INDUSTRIAL DIV

CEPHRADINE

13503 I

II

9/1/1998

RHONE POULENC

DAUNORUBICIN HYDROCHLORIDE

13504 I

II

9/1/1998

FERMENTA PRODS

PENICILLIN V POTASSIUM

13505 I

II

9/1/1998

WYETH LABS

PENICILLIN V

13506 I

II

9/1/1998

AMFAIR INC

OXYTETRACYCLINE HYDROCHLORIDE

Page 386

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13507 I
II
9/1/1998
KRKA DD NOVO MESTO

SUBJECT
OXYTETRACYCLINE

13508 I

II

9/1/1998

LEDERLE LABS

TETRACYCLINE HYDROCHLORIDE

13509 I

II

9/1/1998

ABBOTT

ERYTHROMYCIN

13510 I

II

9/1/1998

ABBOTT

ERYTHROMYCIN STEARATE

13511 I

II

9/1/1998

ABBOTT

ERYTHROMYCIN ETHYLSUCCINATE

13512 I

II

9/1/1998

GIST BROCADES

NAAMYCIN

13513 I

II

9/1/1998

LILLY RES LABS

TOBRAMYCIN SULFATE

13514 I

II

9/1/1998

SQUIBB

AMPICILLIN TRIHYDRATE

13515 I

II

9/1/1998

ELI LILLY

ERYTHROMYCIN

13516 I

II

9/1/1998

ANKERFARM SPA

AMPICILLIN

13517 I

II

9/1/1998

ANKERFARM SPA

PENICILLIN G PROCAINE

13518 A

II

9/1/1998

TEVA PHARMACEUTICALS INDUSTRIES LTD

AMOXICILLIN MFG IN MEXICO, MISSOURI

13519 I

II

9/1/1998

LARK

CEPHALEXIN MONOHYDRATE

13520 I

II

9/1/1998

ANTIBIOTICOS

TETRACYCLINE PHOSPHATE COMPLEX

13521 I

II

9/1/1998

KYOWA HAKKO

MITOMYCIN

13522 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CLOXACILLIN BENZATHINE

13523 A

II

9/1/1998

NYSTATIN

13524 I

II

9/1/1998

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
SMITHKLINE BEECHAM PHARMACEUTICALS

13525 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

AMOXICILLIN TRIHYDRATE

13526 I

II

9/1/1998

HOECHST MARION RSSL

TETRACYCLINE HYDROCHLORIDE

13527 I

II

9/1/1998

BRISTOL MYERS SQUIBB CO

AMIKACIN BASE

13528 I

II

9/1/1998

APOTHEKERNES

NEOMYCIN SULFATE

13529 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CLOXACILLIN SODIUM

13530 I

II

9/1/1998

PFIZER

ERYTHROMYCIN STEARATE

13531 I

II

9/1/1998

PFIZER

ERYTHROMYCIN

13532 I

II

9/1/1998

E R SQUIBB

AMPICILLIN SODIUM

13533 I

II

9/1/1998

E R SQUIBB

PENICILLIN G POTASSIUM

13534 I

II

9/1/1998

ISF

CEPHALEXIN MONOHYDRATE

13535 I

II

9/1/1998

MEIJI SEIKA KAISHA L

PENICILLIN G PROCAINE

13536 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

POLYMYXIN B SULFATE AS MANUFACTURED IN COPENHAGEN, DENMARK

13537 I

II

9/1/1998

SQUIBB

PENICILLIN G SODIUM

13538 I

II

9/1/1998

BRISTOL

TETRACYCLINE PHOSPHATE COMPLEX

13539 I

II

9/1/1998

GIST BROCADES

PENICILLIN G PROCAINE

13540 I

II

9/1/1998

CANADA PACKERS INC FINE CHEMICALS DIV

AMPICILLIN TRIHYDRATE

13541 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

CEPHRADINE

13542 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

CEPHRADINE

13543 I

II

9/1/1998

PFIZER

TETRACYCLINE HYDROCHLORIDE

13544 I

II

9/1/1998

PFIZER

AMPHOTERICIN B

CLOXACILLIN BENZATHINE

Page 387

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13545 I
II
9/1/1998
ANTIBIOTICOS INC

SUBJECT
CEPHALOTHIN SODIUM;SODIUM CHLORIDE

13546 I

II

9/1/1998

ANTIBIOTICOS INC

CEPHALOTHIN SODIUM;SODIUM CHLORIDE

13547 I

II

9/1/1998

PHARMACIA AND UPJOHN

TETRACYCLINE HYDROCHLORIDE

13548 I

II

9/1/1998

ANTIBIOTICOS

CLOXACILLIN SODIUM

13549 A

II

9/1/1998

ANTIBIOTICOS SA

AMOXICILLIN

13550 I

II

9/1/1998

FLAVINE INTL

CHLORAMPHENICOL

13551 I

II

9/1/1998

CANADA PACKERS INC FINE CHEMICALS DIV

AMOXICILLIN TRIHYDRATE

13552 I

II

9/1/1998

PIERREL AMERICA

AMOXICILLIN TRIHYDRATE

13553 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

OXACILLIN SODIUM

13554 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

NAFCILLIN SODIUM

13555 I

II

9/1/1998

GIST BROCADES

PENICILLIN V POTASSIUM

13556 I

II

9/1/1998

ANKERMAN SPA

AMOXICILLIN TRIHYDRATE

13557 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

CLOXACILLIN SODIUM

13558 I

II

9/1/1998

BRISTOL MEYERS BARCELONETA INC

DICLOXACILLIN SODIUM MONOHYDRATE

13559 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

CLOXACILLIN SODIUM

13560 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

AMOXICILLIN TRIHYDRATE

13561 I

II

9/1/1998

GLAXO WELLCOME

PENICILLIN G POTASSIUM

13562 I

II

9/1/1998

FERMENTA PRODS

CYCLACILLIN

13563 I

II

9/1/1998

DUMEX

BACITRACIN

13564 I

II

9/1/1998

ANTIBIOTICOS

CEPHALEXIN MONOHYDRATE

13565 I

II

9/1/1998

ELI LILLY

CEFAMANDOLE NAFATE

13566 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

CEFADROXIL

13567 I

II

9/1/1998

GIST BROCADES

AMPICILLIN TRIHYDRATE

13568 I

II

9/1/1998

DUMEX

BACITRACIN ZINC

13569 I

II

9/1/1998

GIST BROCADES

AMPICILLIN SODIUM

13570 I

II

9/1/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

TICARCILLIN DISODIUM

13571 I

II

9/1/1998

FERMENTA PRODS

CYCLOSERINE

13572 I

II

9/1/1998

CHEMIBIOTIC IRELAND LTD

TETRACYCLINE PHOSPHATE

13573 I

II

9/1/1998

CHEMIBIOTIC IRELAND LTD

OXYTETRACYCLINE

13574 I

II

9/1/1998

SANDOZ GMBH

OXYTETRACYCLINE HYDROCHLORIDE

13575 A

II

9/1/1998

SANDOZ GMBH

PENICILLIN G PROCAINE

13576 A

II

9/1/1998

OLON SPA

PAROMOMYCIN MANUFACTURED IN TURIN ITALY

13577 I

II

9/1/1998

BIOCHEMIE DEUTSCHLAND GMBH

PENICILLIN G POTASSIUM MANUFACTURED IN FRANKFURT, GERMANY

13578 I

II

9/1/1998

PFIZER

PENICILLIN G SODIUM

13579 I

II

9/1/1998

ROXANE

CHLORAMPHENICOL

13580 I

II

9/1/1998

POLFA

ERYTHROMYCIN ETHYLSUCCINATE

13581 I

II

9/1/1998

DSM ANDENO (SZ)

ERYTHROMYCIN ETHYLSUCCINATE

13582 I

II

9/1/1998

NIPPON KAYAKU CO LTD

GRISEOFULVIN

13583 I

II

9/1/1998

GIST BROCADES (IT)

ERYTHROMYCIN ETHYLSUCCINATE

Page 388

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13584 I
II
9/1/1998
DUMEX

SUBJECT
CANDICIDIN

13585 I

II

9/1/1998

PFIZER PHARM

MECLOCYCLINE SULFOSALICYLATE

13586 I

II

9/1/1998

AMOXICILLIN TRIHYDRATE

13587 I

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
ISF

13588 A

II

9/1/1998

ANTIBIOTICOS SA

CEPHALEXIN MONOHYDRATE

13589 I

II

9/1/1998

ERYTHROMYCIN ETHYLSUCCINATE

13590 I

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
ASTRA LAKEMEDEL

13591 I

II

9/1/1998

FERMENTA S A

PENICILLIN G POTASSIUM

13592 I

II

9/1/1998

FERMENTA S A

PENICILLIN G POTASSIUM

13593 I

II

9/1/1998

TRADE

AMOXICILLIN

13594 I

II

9/1/1998

ELI LILLY

CEFAMANDOLE NAFATE

13595 I

II

9/1/1998

LARK

CEPHRADINE

13596 I

II

9/1/1998

LARK

AMOXICILLIN

13597 I

II

9/1/1998

FERMENTACIONES

AMPICILLIN TRIHYDRATE

13598 I

II

9/1/1998

ELI LILLY

CEFACLOR

13599 I

II

9/1/1998

PIERREL AMERICA

KANAMYCIN SULFATE

13600 I

II

9/1/1998

ARCHIFAR LAB

ERYTHROMYCIN ETHYLSUCCINATE

13601 I

II

9/1/1998

BIOCHEMIE GMBH

PENICILLAMINE MANUFACTURED IN KUNDL, AUSTRIA

13602 I

II

9/1/1998

LEDERLE LABS

TETRACYCLINE HYDROCHLORIDE

13603 I

II

9/1/1998

LEDERLE LABS

TETRACYCLINE

13604 I

II

9/1/1998

LEDERLE LABS

DEMECLOCYCLINE HYDROCHLORIDE

13605 I

II

9/1/1998

LEDERLE LABS

DEMECLOCYCLINE

13606 I

II

9/1/1998

LEDERLE LABS

CHLORTETRACYCLINE HYDROCHLORIDE

13607 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

BACITRACIN NON-STERILE USP AS MFG IN OSLO NORWAY

13608 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

BACITRACIN ZINC NON-STERILE USP AS MANUFACTURED IN OSLO NORWAY

13609 I

II

9/1/1998

APOTHEKERNES

NEOMYCIN SULFATE

13610 I

II

9/1/1998

DISTA

CEPHALEXIN

13611 I

II

9/1/1998

PLANTEX USA INC

AMPICILLIN TRIHYDRATE

13612 A

II

9/1/1998

ACS DOBFAR SPA

CEPHALEXIN MONOHYDRATE

13613 I

II

9/1/1998

ACS DOBFAR S.P.A

CEPHRADINE MONOHYDRATE

13614 I

II

9/1/1998

ACS DOBFAR SPA

CEFADROXIL HEMIHYDRATE

13615 I

II

9/1/1998

ROUSSEL UCLAF

NEOMYCIN SULFATE

13616 I

II

9/1/1998

FERMENTA PRODS

AMOXICILLIN

13617 I

II

9/1/1998

TEVA PHARMACEUTICALS USA INC

OXACILLIN SODIUM MFG IN MEXICO, MISSOURI

13618 I

II

9/1/1998

PHILIPS ROXANE

CHLORAMPHENICOL

13619 I

II

9/1/1998

ELI LILLY

CEFAMANDOLE SODIUM

13620 I

II

9/1/1998

GIST BROCADES (IT)

GENTAMICIN SULFATE

13621 I

II

9/1/1998

TEVA PHARMACEUTICALS USA INC

CLOXACILLIN SODIUM MFG IN MEXICO, MISSOURI

AMOXICILLIN TRIHYDRATE

BACAMPICILLIN HYDROCHLORIDE

Page 389

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13622 I
II
9/1/1998
ELI LILLY

SUBJECT
CEFACLOR

13623 I

II

9/1/1998

CONSOLIDATED PHARM

AMPICILLIN TRIHYDRATE

13624 I

II

9/1/1998

CONSOLIDATED PHARM

AMOXICILLIN

13625 I

II

9/1/1998

PHARMACHIM

GENTAMICIN SULFATE

13626 I

II

9/1/1998

ERSANA

CEPHRADINE DIHYDRATE

13627 I

II

9/1/1998

BAYER AG

AMPICILLIN TRIHYDRATE

13628 I

II

9/1/1998

KANAMYCIN SULFATE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA

13629 I

II

9/1/1998

13630 A

II

9/1/1998

SHANGHAI ASIA PIONEER PHARMACEUTICAL


CORP
SHANGHAI ASIA PIONEER PHARMACEUTICAL
CORP
SHANGHAI ASIA PHARMACEUTICAL CO LTD

13631 I

II

9/1/1998

PFIZER

CEFOPERAZONE SODIUM

13632 I

II

9/1/1998

EGIS PHARM

CHLORAMPHENICOL

13633 I

II

9/1/1998

SIGMA CHEM

DACTINOMYCIN

13634 I

II

9/1/1998

ANTIBIOTICOS

CANDICIDIN

13635 I

II

9/1/1998

NANTONG PHARM

ERYTHROMYCIN

13636 I

II

9/1/1998

HOVIONE

DOXYCYCLINE HYCLATE AS MANUFACTURED IN LOURES, PORTUGAL.

13637 I

II

9/1/1998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTD GENTAMICIN SULFATE

13638 I

II

9/1/1998

BRISTOL MYERS SQUIBB LABORATORIES CO

CEFADROXIL MONOHYDRATE BULK MANUFACTURED IN BARCELONETA,PR

13639 I

II

9/1/1998

LEO PHARM

AMDINOCILLIN

13640 A

II

9/1/1998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTD OXYTETRACYCLINE HYDROCHLORIDE

13641 A

II

9/1/1998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTD OXYTETRACYCLINE

13642 I

II

9/1/1998

GIST BROCADES (IT)

13643 A

II

9/1/1998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTD STREPTOMYCIN SULFATE AS MANUFACTURED IN SICHUAN, CHINA

13644 I

II

9/1/1998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTD RIFAMPIN

13645 I

II

9/1/1998

CONSOLIDATED PHARM

AMPICILLIN

13646 I

II

9/1/1998

CELL PRODUCTS

AMPHOTERICIN B

13647 I

II

9/1/1998

DISTA PRODUCTS CO DIV ELI LILLY AND CO

CEFACLOR

13648 I

II

9/1/1998

CELL PRODUCTS

AMPHOTERICIN B

13649 I

II

9/1/1998

HOVIONE

METHACYCLINE HYDROCHLORIDE

13650 I

II

9/1/1998

GLAXO WELLCOME

CEFTAZIDIME

13651 I

II

9/1/1998

GIST BROCADES (IT)

AMIKACIN SULFATE

13652 I

II

9/1/1998

ELI LILLY

VANCOMYCIN HYDROCHLORIDE

13653 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

NAFCILLIN SODIUM

13654 A

II

9/1/1998

ERCROS SA

ERYTHROMYCIN ETHYLSUCCINATE

13655 I

II

9/1/1998

BRISTOL EUROPE

PENICILLIN G BENZATHINE

DIHYDROSTREPTOMYCIN SULFATE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC


OF CHINA
GENTAMICIN SULFATE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA

ERYTHROMYCIN ESTOLATE

Page 390

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13656 A
II
9/1/1998
ROCHE PHARMACEUTICALS DIV HOFFMANN
LAROCHE INC
13657 A
II
9/1/1998
TEVA PHARMACEUTICALS USA INC

SUBJECT
CEFTRIAXONE SODIUM

13658 I

II

9/1/1998

MEIJI SEIKA KAISHA L

GENTAMICIN SULFATE

13659 A

II

9/1/1998

XIAN LIJUN PHARMACEUTICAL CO LTD

TETRACYCLINE HYDROCHLORIDE

13660 I

II

9/1/1998

FARMITALIA CARLO ERBA SPA

CYCLOSERINE

13661 A

II

9/1/1998

ACS DOBFAR SPA

AMPICILLIN SODIUM

13662 I

II

9/1/1998

LEO PHARM

AMDINOCILLIN

13663 A

II

9/1/1998

CKD BIO CORP

RIFAMPIN

13664 I

II

9/1/1998

ALPHARMA

CALCIUM AMPHOMYCIN

13665 I

II

9/1/1998

CIBRAN

ERYTHROMYCIN

13666 I

II

9/1/1998

OXYTETRACYCLINE HYDROCHLORIDE

13667 I

II

9/1/1998

13668 I

II

9/1/1998

13669 I

II

9/1/1998

13670 I

II

9/1/1998

13671 I

II

9/1/1998

13672 I

II

9/1/1998

13673 I

II

9/1/1998

ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI


A/S
ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI
A/S
ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI
A/S
ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI
A/S
ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI
A/S
ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI
A/S
ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI
A/S
BRISTOL EUROPE

13674 I

II

9/1/1998

DSM ANDENO (SZ)

ERYTHROMYCIN ESTOLATE

13675 I

II

9/1/1998

ELI LILLY

CEFUROXIME SODIUM

13676 I

II

9/1/1998

ELI LILLY

ERYTHROMYCIN ESTOLATE

13677 I

II

9/1/1998

PRO CHIM RE SPA

AMOXICILLIN TRIHYDRATE

13678 I

II

9/1/1998

PRO CHIM RE SPA

AMPICILLIN TRIHYDRATE

13679 I

II

9/1/1998

PRO CHIM RE SPA

AMPICILLIN

13680 I

II

9/1/1998

TEVA PHARMS

CYCLACILLIN MFG IN MEXICO, MISSOURI

13681 I

II

9/1/1998

FERMENTA PRODS

AMPICILLIN TRIHYDRATE

13682 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

AMPHOTERICIN B AS MANUFACTURED IN COPENHAGEN, DENMARK

13683 A

II

9/1/1998

ACS DOBFAR SPA

CEFTAZIDIME FOR INJECTION (CEFTAZIDIME STERILE BUFFERED)

13684 I

II

9/1/1998

TAKEDA CHEM IND

STERILE CEFOTIAM

13685 I

II

9/1/1998

TAKEDA CHEM IND

STERILE CEFOTIAM

13686 I

II

9/1/1998

ELI LILLY

CYCLOSERINE

13687 I

II

9/1/1998

LEDERLE LABS

CEFIXIME

13688 I

II

9/1/1998

BAYER AG

AMPICILLIN

13689 I

II

9/1/1998

LEDERLE LABS

VANCOMYCIN HYDROCHLORIDE

DICLOXACILLIN SODIUM MFG IN MEXICO, MISSOURI

TETRACYCLINE PHOSPHATE COMPLEX


TETRACYCLINE
TETRACYCLINE HYDROCHLORIDE
OXYTETRACYCLINE CALCIUM
GENTAMICIN SULFATE
OXYTETRACYCLINE
CEFORANIDE

Page 391

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13690 I
II
9/1/1998
ACS

SUBJECT
CEFAZOLIN SODIUM

13691 A

II

9/1/1998

XELLIA PHARMACEUTICALS APS

VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN COPENHAGEN, DENMARK

13692 I

II

9/1/1998

CIBRAN

ERYTHROMYCIN STEARATE

13693 I

II

9/1/1998

CIBRAN

ERYTHROMYCIN ESTOLATE

13694 I

II

9/1/1998

FUJISAWA PHARM

VANCOMYCIN HYDROCHLORIDE

13695 A

II

9/1/1998

ACS DOBFAR SPA

NAFCILLIN SODIUM

13696 I

II

9/1/1998

ACS

OXACILLIN SODIUM

13697 I

II

9/1/1998

ACS

NAFCILLIN SODIUM

13698 A

II

9/1/1998

ACS DOBFAR SPA

CEPHAPIRIN SODIUM

13699 I

II

9/1/1998

CEPA

AMOXICILLIN

13700 I

II

9/1/1998

CIBRAN

LINCOMYCIN HYDROCHLORIDE

13701 I

II

9/1/1998

BRISTOL MYERS SQUIBB CO

AMPHOTERICIN B MANUFACTURED IN HUMACAO, PR

13702 I

II

9/1/1998

ABBOTT

CLINDAMYCIN HYDROCHLORIDE

13703 A

II

9/1/1998

ABBVIE INC

CLINDAMYCIN PHOSPHATE

13704 A

II

9/1/1998

LEK PHARMACEUTICALS DD

GENTAMICIN SULFATE

13705 I

II

9/1/1998

ROUSSEL UCLAF

CLINDAMYCIN PHOSPHATE

13706 A

II

9/1/1998

FUJIAN FUKANG PHARMACEUTICAL CO LTD

CHLORTETRACYCLINE HYDROCHLORIDE

13707 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

CEFAZOLIN SODIUM

13708 I

II

9/1/1998

PFIZER

TROLEANDOMYCIN

13709 A

II

9/1/1998

ABBVIE INC

VANCOMYCIN HYDROCHLORIDE

13710 A

II

9/1/1998

HOVIONE FARMACIENCIA SA

DOXYCYCLINE MONOHYDRATE AS MANUFACTURED IN PORTUGAL AND MACAU

13711 I

II

9/1/1998

FERMIC SA

ERYTHROMYCIN ETHYLSUCCINATE

13712 I

II

9/1/1998

RANBAXY LAB LTD

AMPICILLIN TRIHYDRATE

13713 A

II

9/1/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

TOBRAMYCIN

13714 A

II

9/1/1998

HOVIONE PHARMASCIENCE LTD

DOXYCYCLINE HYCLATE AS MANUFACTURED BY HOVIONE

13715 I

II

9/1/1998

YOSHITOMI PHARM

CEPHALEXIN

13716 A

II

9/1/1998

RANBAXY LABORATORIES LTD

DOXYCYCLINE HYCLATE

13717 I

II

9/1/1998

FERMIC SA

RIFAMPIN

13718 A

II

9/1/1998

SICHUAN PHARMACEUTICAL PLANT

TETRACYCLINE HYDROCHLORIDE

13719 A

II

9/1/1998

TEVA PHARMACEUTICALS INDUSTRIES LTD

CEPHALEXIN MFG IN MEXICO, MISSOURI

13720 I

II

9/1/1998

SQUIBB MFG

CEPHALEXIN

13721 I

II

9/1/1998

ANGUS BIOTECH

ERYTHROMYCIN

13722 I

II

9/1/1998

BRISTOL MYERS SQUIBB

AMIKACIN SULFATE

13723 I

II

9/1/1998

BRISTOL MYERS SQUIBB COMPANY

CEPHALEXIN

13724 A

II

9/1/1998

FERSINSA GB SA DE CV

PENICILLIN G POTASSIUM AS MANUFACTURED IN COAHUILA, MEXICO

13725 I

II

9/1/1998

GENZYME

CLINDAMYCIN PHOSPHATE

13726 A

II

9/1/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

DOXORUBICIN HYDROCHLORIDE

13727 A

II

9/1/1998

MEIJI SEIKA PHARMA CO LTD

DAUNORUBICIN HYDROCHLORIDE

13728 A

II

9/1/1998

CORDEN PHARMA LATINA SPA

AMPICILLIN TRIHYDRATE

Page 392

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13729 I
II
9/1/1998
DELMAR CHEMS

SUBJECT
CLINDAMYCIN PHOSPHATE

13730 I

II

9/1/1998

PHARMACIA AND UPJOHN

VIDARABINE

13731 I

II

9/1/1998

GIST BROCADES

AMOXICILLIN

13732 I

II

9/1/1998

GIST BROCADES

PENICILLIN G BENZATHINE

13733 I

II

9/1/1998

BENZEX LABORATORIES LTD

CEPHALEXIN

13734 I

II

9/1/1998

ANGUS BIOTECH

ERYTHROMYCIN STEARATE

13735 I

II

9/1/1998

ANGUS BIOTECH

ERYTHROMYCIN ESTOLATE

13736 I

II

9/1/1998

ANGUS BIOTECH

ERYTHROMYCIN ESTOLATE

13737 I

II

9/1/1998

ABBOTT

ERYTHROMYCIN ESTOLATE

13738 A

II

9/1/1998

HOVIONE FARMACIENCIA SA

MINOCYCLINE HYDROCHLORIDEAS MANUFACTURED INLOURES, PORTUGAL.

13739 I

II

9/1/1998

PHARMACHIM

TOBRAMYCIN

13740 I

II

9/1/1998

PHARMACHIM

TOBRAMYCIN

13741 I

II

9/1/1998

TEVA PHARMS

CEFAZOLIN SODIUM MFG IN MEXICO, MISSOURI

13742 A

II

9/1/1998

AMPICILLIN SODIUM

13743 A

II

9/1/1998

13744 A

II

9/1/1998

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI


LORENZINI
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI
LORENZINI
CKD BIO CORP

13745 I

II

9/1/1998

CHEMFERM

CEFADROXIL HEMIHYDRATE

13746 I

II

9/1/1998

CHEMFERM

CEPHRADINE

13747 I

II

9/1/1998

BIOCHEMIE

CEPHALEXIN

13748 I

II

9/1/1998

NIPPON KAYAKU

MINOCYCLINE HYDROCHLORIDE

13749 A

II

9/1/1998

CEFADROXIL MONOHYDRATE AS MANUFACTURED IN BARCELONA, SPAIN

13750 I

II

9/1/1998

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
BARCELONETA

13751 A

II

9/1/1998

SANDOZ GMBH

PENICILLIN G SODIUM (STERILE) MANUFACTURED IN KUNDL, AUSTRIA

13752 I

II

9/1/1998

LUPIN LAB LTD

CEPHALEXIN

13753 A

II

9/1/1998

JIANGXI GUOYAO PHARMACEUTICAL LLC

LINCOMYCIN HYDROCHLORIDE

13754 A

II

9/1/1998

SANDOZ GMBH

AMPICILLIN SODIUM (STERILE), MANUFACTURED IN KUNDL, AUSTRIA

13755 I

II

9/1/1998

KYOWA HAKKO KOGYO

MINOCYCLINE HYDROCHLORIDE

13756 I

II

9/1/1998

ABBOTT LABS

AMIKACIN SULFATE

13757 A

II

9/1/1998

SUZHOU NUMBER 4 PHARMACUTICAL FACTORY

LINCOMYCIN HYDROCHLORIDE MANUFACTURED IN SUZHOU, CHINA

13758 A

II

9/1/1998

MINOCYCLINE HYDROCHLORIDE

13759 A

II

9/1/1998

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SA
RANBAXY LABORATORIES LTD

13760 I

II

9/1/1998

CHONGQING DAXIN PHARMACEUTICAL CO., LTD

AMIKACIN BASE AS MANUFACTURED IN CHONGQING, CHINA

13761 I

II

9/1/1998

RANBAXY LAB LTD

CEFADROXIL MONOHYDRATE

13762 A

II

9/1/1998

ACS DOBFAR SPA

AMIKACIN BASE

13763 A

II

9/1/1998

ACS DOBFAR SPA

AMIKACIN SULFATE

13764 A

II

9/1/1998

SANDOZ INDUSTRIAL PRODUCTS SA

AMOXICILLIN TRIHYDRATE

OXACILLIN SODIUM
DEMECLOCYCLINE HYDROCHLORIDE

CEFAZOLIN SODIUM MANUFACTURED IN BARCELONETA, PR

CEPHALEXIN

Page 393

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13765 A
II
9/1/1998
SANDOZ INDUSTRIAL PRODUCTS SA

SUBJECT
AMPICILLIN TRIHYDRATE

13766 I

II

9/1/1998

SHAOGUAN PHARM

OXYTETRACYCLINE

13767 A

II

9/1/1998

SANDOZ GMBH

STERILE PENICILLIN G POTASSIUM BUFFERED AS MANUFACTURED IN TYROL, AUSTRIA

13768 I

II

9/1/1998

SANDOZ GMBH

PENICILLIN G SODIUM BUFFERED (STERILE)

13769 I

II

9/1/1998

SHENZHEN

CLINDAMYCIN HYDROCHLORIDE

13770 I

II

9/1/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

TOBRAMYCIN

13771 A

II

9/1/1998

CHONGZHOU PHARMACEUTICAL FACTORY

DOXYCYCLINE HYCLATE

13772 A

II

9/1/1998

DAEWOONG BIO INC

AMOXICILLIN

13773 A

II

9/1/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

13774 A

II

9/1/1998

CHONGQING DAXIN PHARMACEUTICAL CO LTD

DOXORUBICIN HYDROCHLORIDE AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE,


CHINA
TOBRAMYCIN AS MANUFACTURED IN CHONGQING, CHINA

13775 A

II

9/1/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

13776 A

II

9/1/1998

FERMENTACIONES Y SINTESIS SA DE CV

DAUNORUBICIN HYDROCHLORIDE AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE,


CHINA
AMOXICILLIN TRIHYDRATE

13777 A

II

9/1/1998

FERSINSA GB SA DE CV

AMPICILLIN

13778 I

II

9/1/1998

KDL BIOTECH LTD

AMOXICILLIN TRIHYDRATE

13779 I

II

9/1/1998

BRISTOL-MYERS

AMPICILLIN

13780 A

II

9/1/1998

ACS DOBFAR SPA

CEFACLOR MONOHYDRATE

13781 I

II

9/1/1998

TAIWAN BIOTECH

CEPHALEXIN

13782 I

II

9/1/1998

GIST BROCADES

PENICILLIN G POTASSIUM

13783 A

II

9/1/1998

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MITOMYCIN AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE, CHINA

13784 A

II

9/1/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

BLEOMYCIN SULFATE

13785 A

II

9/1/1998

MICROBIOPHARM JAPAN CO LTD

MITOMYCIN

13786 A

II

9/1/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

DAUNORUBICIN HYDROCHLORIDE

13787 A

II

9/1/1998

CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, CHINA

13788 A

II

9/1/1998

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD
CHONGQING DAXIN PHARMACEUTICAL CO LTD

13789 A

II

9/1/1998

CHEMWERTH INC

CYCLOSPORINE AS MANUFACTURED IN FUJIAN, CHINA FOR CHEMWERTH INC

13790 I

II

9/1/1998

RANBAXY LABORATORIES LTD

CEFACLOR

13791 A

II

9/1/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

MITOMYCIN

13792 A

II

9/1/1998

MYTHEN SPA

DEMECLOCYCLINE HYDROCHLORIDE

13793 I

II

9/1/1998

TEVA PHARMS

CEPHRADINE MFG IN MEXICO, MISSOURI

13794 A

II

9/1/1998

XELLIA PHARMACEUTICALS LTD

VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN BUDAPEST HUNGARY

13795 A

II

9/1/1998

SANDOZ INDUSTRIAL PRODUCTS SA

PENICILLIN V POTASSIUM,MANUFACTURED IN KUNDL, AUSTRIA

13796 A

II

9/1/1998

OLON SPA

RIFAMPIN

13797 I

II

9/1/1998

ASTELLAS PHARMA INC

CEFAZOLIN SODIUM (STERILE)

13798 A

II

9/1/1998

SANDOZ INDUSTRIAL PRODUCTS SA

DICLOXACILLIN SODIUM

13799 A

II

9/1/1998

TEVA PHARMACEUTICALS INDUSTRIES LTD

CYCLOSPORINE

13800 A

II

9/1/1998

ABBVIE INC

CYCLOSPORINE

13801 A

II

10/23/1998

LABORATORIO CHIMICO INTERNAZIONALE SPA

FENOFIBRATE, MANUFACTURED IN MILANO, ITALY

AMIKACIN SULFATE AS MANUFACTURED IN CHONGQING, CHINA

Page 394

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13802 I
II
10/21/1998
DIPHARMA SPA

SUBJECT
DIBENZOSUBERENONE, MANUFACTURED IN MERETO DI TOMBA (UD)-ITALY

13803 I

II

10/23/1998

AVECIA BIOTECHNOLOGY INC

OLIGONUCLEOTIDE MG98 API, MANUFACTURED IN MILFORD, MA

13804 I

10/23/1998

SKYEPHARMA PLC

13805 I

II

10/23/1998

SOLVAY SOLEXIS INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES


IN CEDEX, FRANCE
FOMBLIN Y25 TSP, MANUFACTURED IN SPINETTA MARENGO (AL), ITALY

13806 A

II

10/30/1998

APTUIT INC

MILRINONE DRUG SUBSTANCE, MANUFACTURED IN HARRISONVILLE, MISSOURI

13807 I

II

10/29/1998

BASF PHARMACHEMIKALIEN GMBH AND CO KG

DOXAZOSIN MESYLATE, MANUFACTURED BY QCI IN DAYTON OHIO

13808 I

9/30/1998

KOEI CHEMICAL CO LTD

13809 I

II

10/30/1998

BACHEM INC

13810 A

II

10/30/1998

FERMION OY

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OSAKA,


JAPAN
HUMAN GROWTH HORMONE RELEASING FACTOR (1-44), AMIDE, ACETATE (BULK),
MANUFACTURED IN SAN DIEGO, CALIFORNIA
DEXMEDETOMIDINE HYDROCHLORIDE, MANUFACTURED IN ESPOO, FINLAND

13811 I

II

10/20/1998

INKE SA

LORATIDINE, MANUFACTURED IN BARCELONA, SPAIN

13812 I

IV

11/2/1998

LIPOID GMBH

LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHATIDYL GLYCEROL


AMMONIUM SALT)MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

13813 A

III

10/26/1998

BERRY PLASTICS CORP

PRODUCT 24-3-090 AS MANUFACTURED IN HOMER, LA

13814 I

III

10/26/1998

MAC CLOSURES INC

13815 I

8/11/1998

STERIGENICS INTERNATIONAL

RECLOSABLE CONTINUOUS THREADED LE STYLE STRIPPED CLOSURE, MANUFACTURED IN


QUEBEC, CANADA
ELECTRON BEAM FACILITY IN SAN DIEGO, CA

13816 A

III

11/2/1998

NEMERA BUFFALO GROVE

PACKAGING COMPONENTS, MANUFACTURED IN BUFFALO GROVE, IL

13817 I

IV

11/4/1998

CENTRAL SOYA CO INC

SOY LECITHIN, ETC., MANUFACTURED IN DECATUR AND REMINGTON, IN AND BELLEVUE, OH

13818 A

III

10/30/1998

HONEYWELL

ACLAM LAMINATE STRUCTURES, MANUFACTURED IN MORRISTOWN, NJ

13819 I

II

11/5/1998

ASENCE PHARMA PVT LTD

AMPHOTERICIN B, MANUFACTURED IN GUJARAT, INDIA

13820 A

II

11/5/1998

RANBAXY LABORATORIES LTD

ENALAPRIL MALEATE, MANUFACTURED IN PUNJAB, INDIA

13821 I

III

11/2/1998

HENKEL CORP

MACROMELT 6900, MANUFACTURED IN KANKAKEE, IL

13822 A

II

11/6/1998

BACHEM AG

LEUPROLIDE ACETATE, MANUFACTURED IN BUBENDORF, SWITZERLAND

13823 I

III

11/5/1998

CFC INTERNATIONAL INC

PIGMENTED FOILS, MANUFACTURED IN CHICAGO HEIGHTS, IL

13824 A

IV

11/9/1998

WILD FLAVORS INC

NATURAL PEPPERMINT FLAVOR WONF #112136, MANUFACTURED IN ERLANGER, KY

13825 I

II

11/9/1998

PHARMACIA AND UPJOHN SPA

IODODOXORUBICIN HCI BULK DRUG SUBSTANCE MANUFACTURED IN MILAN, ITALY

13826 I

II

11/4/1998

PACLITAXEL, MANUFACTURED IN GUILIN, CHINA

13827 I

II

11/9/1998

HUIANG BIO CHEMICAL PRODUCT MANUFACTURE


COMPANY LTD
TAPI PUERTO RICO INC

13828 I

III

11/8/1998

ROPACK INC

METFORMIN HYDROCHLORIDE DRUG SUBSTANCE, MANUFACTURED IN GUAYAMA, PUERTO


RICO
BULK DRUG PACKAGING AS LOCATED IN QUEBEC, CANADA

13829 I

III

11/9/1998

3M PHARMACEUTICALS INC

D96171 SPRAYMISER VALVE, MANUFACTURED IN LANCASHIRE, GREAT BRITAIN

13830 I

III

11/11/1998

HUMPHREY COSBURN PLASTICS

PACKAGING FOR CYCLOSPORIN, MANUFACTURED IN ONTARIO, CANADA

13831 A

II

11/5/1998

EUTICALS SPA

PIRENZEPINE DIHYDROCHLORIDE, MANUFACTURED IN LODI, ITALY

13832 A

IV

11/19/1998

BAYER SCHERING PHARMA AG

PDMS 372 TUBING, MANUFACTURED IN TURKU, FINLAND

13833 I

11/9/1998

ASAHI CHEMICAL INDUSTRY CO LTD

13834 A

IV

11/9/1998

ASAHI KASEI CHEMICALS CORP

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATIONAL PROCEDURES IN


TOKYO, JAPAN
MICROCRYSTALLINE CELLULOSE, CEOLUS KG, MANUFACTURED IN TOKYO, JAPAN

Page 395

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13835 I
II
11/9/1998
DR REDDYS LABORATORIES LTD

SUBJECT
ENALAPRILAT, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

13836 A

II

11/9/1998

DR REDDYS LABORATORIES LTD

ENALAPRIL MALEATE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

13837 A

II

11/12/1998

ISO TEX DIAGNOSTICS INC

PT-195M CIS-PLATIN, MANUFACTURED IN FRIENDSWOOD, TEXAS

13838 A

II

11/12/1998

ISO TEX DIAGNOSTICS INC

PLATINUM-195M, MANUFACTURED IN FRIENDSWOOD, TEXAS

13839 I

II

11/11/1998

MALLINCKRODT INC

PROSAPTIDE TX 14(A), CODE 8200, MANUFACTURED IN ST. LOUIS, MO

13840 I

III

11/12/1998

COURTAULDS PACKAGING LTD

13841 A

III

11/11/1998

ST GOBAIN PERFORMANCE PLASTICS

13842 I

II

11/12/1998

MEDICHEM SA

ALBUTEROL 300 DOSE ACTUATOR PROJECT, MANUFACTURED IN WREXHAM, UNITED


KINGDOM
POLYESTER/9022 FLUOROSILICONE RELEASE COATING, MANUFACTURED IN WORCESTER,
MA
LORATIDINE, MANUFACTURED IN GERONA, SPAIN

13843 A

II

11/12/1998

CHATTEM CHEMICALS INC

AMMONIUM LACTATE, MANUFACTURED IN CHATTANOOGA, TN

13844 A

II

11/19/1998

PERRIGO API LTD

GRANISETRON HYDROCHLORIDE, MANUFACTURED IN BE'ER SHEVA, ISRAEL

13845 I

II

11/16/1998

ORGANICHEM CORP

4-METHOXYPHENOL, MANUFACTURED IN LINZ, AUSTRIA

13846 A

II

10/29/1998

BIDACHEM SPA

MELOXICAM, MANUFACTURED IN FOMOVO S GIOVANNI (BG), ITALY

13847 I

III

11/18/1998

KOHAP LTD

PAPET (TM) POLYESTER RESIN, MANUFACTURED IN ULSAN AND KYUNGGI-DO, KOREA

13848 I

II

11/18/1998

PENINSULA LABORATORIES INC

ALA-10-ASP, MANUFACTURED IN SAN CARLOS, CALIFORNIA

13849 I

II

11/18/1998

PENINSULA LABORATORIES INC

GLU-10-THR, MANUFACTURED IN SAN CARLOS, CALIFORNIA

13850 I

II

11/18/1998

PENINSULA LABORATORIES INC

ASP-10-GLU, MANUFACTURED IN SAN CARLOS, CALIFORNIA

13851 I

II

11/16/1998

SOLMAG SPA

BUPROPION HYDROCHLORIDE, MANUFACTURED IN GARBAGNATE MILANESE (MI), ITALY

13852 I

II

11/19/1998

UCB SA PHARMACEUTIQUE SECTEUR

13853 I

10/16/1998

STANDARD CHEM AND PHARM CO LTD

13854 A

II

10/16/1998

13855 A

IV

11/16/1998

STANDARD CHEMICAL AND PHARMACEUTICAL CO


LTD
LUBRIZOL ADVANCED MATERIALS INC

HYDROXYZINE HYDROCHLORIDE COMPACTED, MANUFACTURED IN BRAINE-L ALLEUD BELGIUM


MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN TAIWAN,
R.O.C.
DEXTROMETHORPHAN HYDROBROMIDE USP, MANUFACTURED IN TAIWAN, R.O.C.

13856 I

II

11/10/1998

ESTEVE QUIMICA SA

NEFAZODONE HYDRCHLORIDE, MANUFACTURED IN TARRAGONA, SPAIN

13857 I

II

11/23/1998

JACOBUS PHARMACEUTICAL CO INC

PROGUANIL HYDROCHLORIDE, MANUFACTURED IN PRINCETON, NEW JERSEY

13858 I

II

11/23/1998

RUIBANG LABORATORIES

CYCLOSPORINE, MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA

13859 I

III

11/19/1998

REXAM CONSUMER PLASTICS INC

13860 I

III

11/16/1998

AMPACET CORP

13861 A

II

11/25/1998

TARO PHARMACEUTICAL INDUSTRIES LTD

ACTUATOR AND/OR STRAPCAP COMPONENTS, MANUFACTURED IN BUFFALO GROVE,


ILLINOIS
WHITE POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE IN,DERIDDER, LA,
CARTERSVILLE, GA AND MESSANCY, BELGIUM
DESOXIMETASONE, MANUFACTURED IN HAIFA BAY, ISRAEL

13862 A

II

11/24/1998

DR REDDYS LABORATORIES LTD

CIPROFLOXACIN HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

13863 I

II

11/25/1998

13864 A

III

11/24/1998

UNIVERSITY OF WISCONSIN FOOD RESEARCH


INSTITUTE
ONGROPACK LTD

PREPARATION OF BOTULINUM TOXINS A THROUGH G FOR MOUSE NEUTRALIZATION ASSAYS,


MANUFACTURED IN MADISON, WISCONSIN
ONGROFOL KTE-101 RIGID PVC FILM, MANUFACTURED IN BOLYAI TER 1, HUNGARY

13865 I

II

11/24/1998

MALLINCKRODT INC

PEMOLINE MALLINCKRODT CODE 1500, MANUFACTURED IN ST. LOUIS, MISSOURI

13866 A

II

11/27/1998

DIVIS LABORATORIES LTD

NAPROXEN USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

13867 A

II

11/27/1998

DIVIS LABORATORIES LTD

NAPROXEN SODIUM USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

13868 I

11/25/1998

PROGEN INDUSTRIES LIMITED

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN DARRA,


AUSTRALIA

CARBOPOL 1984, 2984 AND 5984 RESINS, MANUFACTURED IN CALVERT CITY, KY

Page 396

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13869 A
II
11/24/1998
FARMHISPANIA SA

SUBJECT
METFORMIN HYDROCHLORIDE, MANUFACTURED IN BARCELONA, SPAIN

13870 A

II

11/27/1998

BOEHRINGER INGELHEIM ESPANA SA

DIPYRIDAMOLE API, MANUFACTURED IN MALGRAT DE MAR-SPAIN

13871 I

III

11/20/1998

POLIMERI EUROPA FRANCE SA

RIBLENE FL20, MANUFACTURED IN DUNKIRK, FRANCE AND FERRARA, ITALY

13872 I

III

11/25/1998

POLIMERI EUROPA

GREENFLEX FF 35, MANUFACTURED IN OBERHAUSEN, GERMANY

13873 I

II

11/30/1998

LIPOID GMBH

LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3- PHOSPHATIDYL GLYCEROL


AMMONIUM SALT)MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

13874 I

II

12/2/1998

FINORGA

TIAPRIDE HYDROCHLORIDE, MANUFACTURED IN MOURENX, FRANCE

13875 I

III

11/19/1998

13876 I

II

12/4/1998

LEXINGTON MEDICAL DIV LEXINGTON


COMPONENTS
SICOR SPA

PACKAGING MATERIALS USED IN SHORT TERM EXTERNALLY COMMUNICATING DEVICES,


MANUFACTURED IN ROCK HILL, SC
IDARUBICIN AGLYCONE (BULK CHEMICAL), MANUFACTURED ITALY

13877 I

II

12/4/1998

SICOR SPA

DAUNOSAMINE TFA ACETATE (BULK CHEMICAL), MANUFACTURED IN MILAN, ITALY

13878 I

II

12/3/1998

ASTELLAS IRELAND CO LTD

TAMSULOSIN HYDROCHLORIDE, MANUFACTURED IN DUBLIN, IRELAND

13879 I

IV

12/4/1998

DERIVADOS MACROQUIMICOS SA DE CV

HYDROPROPYL METHLCELLULOSE, MANUFACTURED IN ZACAPU, MICHOACAN, MEXICO

13880 I

II

11/19/1998

PROTEIN TECHNOLOGIES INTERNATIONAL INC

PTI G-2535 (UNCONJUGATED ISOFLAVONES-70) CAPSULES 150 MG GENISTEIN


ACTIVITY/CAPSULE, MANUFACTURED BY UNIVERSITY PHARMACEUTICALS OF MARYLAND
INC. IN BALTIMORE, MARYLAND

13881 I

II

11/19/1998

PROTEIN TECHNOLOGIES INTERNATIONAL INC

PTI G-4660 (UNCONJUGATED ISOFLAVONES - 100) CAPSULES 150 MG GENISTEIN


ACTIVITY/CAPSULE, MANUFACTURED BY UNIVERSITY PHARMACEUTICALS OF MARYLAND
INC. IN BALTIMORE, MARYLAND

13882 A

II

11/30/1998

SHASUN PHARMACEUTICALS LTD

NAPROXEN, USP, MANUFACTURED IN PONDICHERRY, INDIA

13883 A

II

12/3/1998

ERREGIERRE SPA

MESALAMINE, MANUFACTURED IN BERGAMO, ITALY

13884 A

II

12/7/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

IDARUBICIN HYDROCHLORIDE, MANUFACTURED IN MILAN, ITALY

13885 A

III

12/1/1998

ZEON CORP

CYCLOOLEFIN POLYMER (ZEONOR 1020R), MANUFACTURED IN OKAYAMA, JAPAN

13886 I

III

12/7/1998

DSM RESEARCH

VESTOLEN A 6016 L-O, MANUFACTURED IN GELSENKIRCHEN, GERMANY

13887 I

II

12/7/1998

CIPLA LTD

16A-BROMOEPIANDROSTERONE, MANUFACTURED IN MUMBAI, INDIA

13888 I

II

12/7/1998

SUMITOMO CHEMICAL CO LTD

13889 I

II

12/7/1998

PHARMACIA AND UPJOHN SPA

PAROXETINE HYDROCHLORIDE ANHYDRATE, MANUFACTURED IN ANPACHIGUN, GIFU


PREFECTURE, JAPAN
IODODOXORUBICIN HCI FOR INJECTION, MANUFACTURED IN MILAN, ITALY

13890 I

II

12/8/1998

ELI LILLY AND CO

13891 I

III

12/8/1998

AMPACET CORP

13892 I

II

12/10/1998

DIOSYNTH BV

DIPEPTIDYLAMINOPEPTIDASE (DDAP), MANUFACTURED IN LILLY FRANCE S.A. IN


FEGERSHEIM, FRANCE
100099 UV BARRIER, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE,
GA AND MESSANCY, BELGIUM
FLUVOXAMINE MALEATE, MANUFACTURED IN AK APELDOORN, THE NETHERLANDS

13893 A

II

12/14/1998

BAYER SCHERING PHARMA AG

PYNASUNATE, MANUFACTURED IN BERLIN, GERMANY

13894 I

II

12/14/1998

PENINSULA LABORATORIES INC

GLU-11-VAL, MANUFACTURED IN SAN CARLOS, CALIFORNIA

13895 I

II

12/14/1998

NV ORGANON

TIBOLONE, MANUFACTURED IN OSS, THE NETHERLANDS

13896 I

II

12/15/1998

PFANSTIEHL LABORATORIES INC

SODIUM DICHLOROACETATE, MANUFACTURED IN WAUKEGAN, IL

13897 I

II

12/16/1998

SHANXI HANCHENG PHARMACEUTICAL FACTORY

13898 A

II

12/18/1998

13899 A

II

12/18/1998

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
DSM SINOCHEM PHARMACEUTICALS
NETHERLANDS BV

DROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE, MANUFACTURED
IN SHANXI PROVINCE, CHINA
CLAVULANATE POTASSIUM MIXTURE WITH SILICONE DIOXIDE IN THE RATIO 1:1,
MANUFACTURED IN STRAGNAS,SWEDEN
CLAVULANATE POTASSIUM MIXTURE WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO
1:1, MANUFACTURED IN STRAGNAS, SWEDEN

Page 397

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13900 A
II
12/18/1998
DSM SINOCHEM PHARMACEUTICALS
NETHERLANDS BV
13901 A
III
12/10/1998
ST GOBAIN PERFORMANCE PLASTICS

SUBJECT
CLAVULANATE POTASSIUM, MANUFACTURED IN STRAGNAS, SWEDEN

13902 I

II

12/18/1998

KYORIN PHARMACEUTICAL CO LTD

53# BLEACHED KRAFT C1S 7015 SILICONE RELEASE COATING, MANUFACTURED IN


WORCESTER, MA
GATIFLOXACIN, MANUFACTURED IN OKAYA-SHI NAGANO, JAPAN

13903 I

III

12/18/1998

RHODIA FILTEC INDUSTRIAL YARNS

POLYESTER GRANULAT 74K40Z108, MANUFACTURED IN EMMENBRUCKE, SWITZERLAND

13904 A

II

12/17/1998

EXCELLA GMBH

ENALAPRILAT, MANUFACTURED IN FEUCHT, GERMANY

13905 I

II

12/21/1998

HOSPIRA INC

TEQUIN I.V. (GATIFLOXACIN), MANUFACTURED IN NORTH CHICAGO, ILLINOIS

13906 I

II

12/22/1998

RESTORAGEN INC

13907 I

II

12/17/1998

NEOMPS INC

13908 A

II

12/22/1998

SUMITOMO CHEMICAL CO LTD

RECOMBINANT GLUCAGON-LIKE PEPTIDE-1 (RGLP), MANUFACTURED IN LINCOLN,


NEBRASKA
SYNTHETIC PEPTIDES MPS-74, MPS-75, MPS-76, MPS-77, AND MPS-78, MANUFACTURED IN
SAN DIEGO, CA
POTASSIUM OTASTAT, MANUFACTURED IN GIFU PREFECTURE, JAPAN

13909 A

II

12/18/1998

UBE INDUSTRIES LTD

6,7-DIFLUOROESTER FORM, MANUFACTURED IN YAMAGUCHI, JAPAN

13910 A

II

12/22/1998

SYNKEM SAS

BISOPROLOL FUMARATE, MANUFACTURED IN CORK, IRELAND

13911 A

II

12/24/1998

HERAEUS PRECIOUS METALS GMBH AND CO KG

THIOTEPA USP, MANUFACTURED IN HANAU, GERMANY

13912 I

II

12/23/1998

CHEMI SPA

DSPC(1,2-DISTEAROYL-PHOPHAIDYCHLOINE), MANUFACTURED IN FROSINONE, ITALY

13913 A

II

12/23/1998

TEVA PHARMACEUTICAL INDUSTRIES LTD

FLUVOXAMINE MALEATE, MANUFACTURED IN GUAYAMA, PUERTO RICO

13914 I

III

12/29/1998

13915 I

1/8/1999

13916 I

III

12/22/1998

MARUTANI CHEMICAL PLANT & ENGINEERING CO., HI-DRYPACK FOR PACKAGING TABLETS & CAPLETS, MANUFACTURED IN IBARAGI
LTD
PREFECTURE, JAPAN
DEXCEL LTD
MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OR
AKIVA, ISRAEL
MY HEALTHCARE INTALY S.R.L.
PRINTED ALUMINUM FOIL, MANUFACTURED IN L CASONI-PODENZANO (PIACENZA)-ITALY

13917 I

II

12/23/1998

13918 I

III

13919 I

II

13920 I

LOVASTATIN, MANUFACTURED IN MILANO, ITALY

12/23/1998

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
ALVEO AG

12/29/1998

PLIVA DD

PEMOLINE, MANUFACTURED IN SAVSKI MAROF, CROTIA

II

12/24/1998

EURORESEARCH S.R.L.

BISKALCITRATE LYOPHILIZED, POTASSIUM SALT (ORAL), MANUFACTURED IN MILANO, ITALY

13921 A

II

12/30/1998

TARO PHARMACEUTICAL INDUSTRIES LTD

HYDROCORTISONE 17-VALERATE, USP, MANUFACTURED IN HAIFA BAY, ISRAEL

13922 I

II

12/29/1998

PENINSULA LABORATORIES INC

LEUPROLIDE, MANUFACTURED IN SAN CARLOS, CALIFORNIA

13923 I

II

8/15/1998

PYRETHRUM BOARD OF KENYA

PYRETHRUM, MANUFACTURED IN NAKURU, KENYA

13924 I

II

12/30/1998

ORGANICHEM CORP

HYPERPOLARIZED HELIUM-3 GAS (HP-3HE), MANUFACTURED IN SOUTH PLAINFIELD, NJ

13925 I

12/18/1998

VEREIN FUR KREBSFORSCHUNG

13926 I

II

12/21/1998

VEREIN FUR KREBSFORSCHUNG

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


ARLESHEIM, SWITZERLAND
CANNADOR MANUFACTURED IN ARLESHEIM, SWITZERLAND

13927 A

II

12/21/1998

SIFAVITOR SRL

BUPROPION HYDROCHLORIDE, MANUFACTURED IN LODI, ITALY

13928 I

III

12/29/1998

CRYOVAC

13929 A

II

1/4/1999

APOTEX PHARMACHEM INC

M371, OXYGEN BARRIER MEDICAL PACKAGING MATERIAL, MANUFACTURED IN DUNCAN,


SOUTH
CYCLOSPORINE USP (BULK) MANUFACTURED IN WINNIPEG, MANITOBA, CANADA

13930 I

III

12/28/1998

KERR SUN COAST FOOD AND BEVERAGE GROUP

13931 A

IV

1/4/1999

PHOSPHOLIPID GMBH

LINED PLASTIC INJECTION MOLDED CLOSURE (BOTTLE CAP), MANUFACTURED IN


SARASOTA, FL
PHOSOL 50 PG, MANUFACTURED IN COLOGNE, GERMANY

13932 I

II

1/8/1999

MALLINCKRODT INC

EXENDIN-4, MANUFACTURED IN TORRANCE, CA

ALVEOLIT TEE 0500 SKIN, MANUFACTURED IN LUZERN, SWITZERLAND

Page 398

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13933 I
IV
1/4/1999
WILD FLAVORS INC

SUBJECT
ARTIFICIAL STRAWBERRY FLAVOR #FACN402, MANUFACTURED IN ERLANGER, KY

13934 I

II

1/8/1999

CAMBREX PROFARMACO CORK LTD

DICLOFENAC POTASSIUM, MANUFACTURED INCORK, IRELAND

13935 I

II

1/12/1999

TOYAMA CHEMICAL CO LTD

T-3811ME DRUG SUBSTANCE, MANUFACTURED IN OSAKA, JAPAN

13936 A

III

1/6/1999

BERRY PLASTICS CORP

PRODUCT 24-5-081 AS MANUFACTURED IN HOMER LA

13937 A

III

1/13/1999

CCC PLASTICS

13938 I

III

1/12/1999

RICON COLORS

WHITE MB50-902 POLYPROPYLENE COLOUR CONCENTRATE, MANUFACTURED IN ONTARIO,


CANADA
WHITE, CPP-W368-1, MANUFACTURED IN ONTARIO, CANADA

13939 I

II

1/13/1999

PENINSULA LABORATORIES INC

DESLORELIN, MANUFACTURED IN SAN CARLOS, CALIFORNIA

13940 I

II

12/31/1998

AVANTI POLAR LIPIDS INC

L-A-PHOSPHATIDYL-DL-GLYCEROL (EGG), MANUFACTURED IN ALABASTER, AL

13941 A

IV

1/15/1999

EVONIK ROHM GMBH

EUDRAGIT FS 30 D, MANUFACTURED IN DARMSTADT, GERMANY

13942 A

II

1/18/1999

BOEHRINGER INGELHEIM CHEMICALS INC

METHADONE HYDROCHLORIDE USP, MANUFACTURED IN PETERSBURG, VA

13943 I

III

1/19/1999

PRETIUM PACKAGING

PACKAGING MATERIALS, MANUFACTURED IN EASTON, PA

13944 A

II

1/13/1999

YANGZHOU PHARMACEUTICAL CO LTD

DOXYCYCLINE MONOHYDRATE, MANUFACTURED IN JIANGSU PROVINCE, CHINA

13945 A

II

1/15/1999

SANOFI AVENTIS DEUTSCHLAND GMBH

HR1799, MANUFACTURED IN FRANKFURT, GERMANY

13946 A

II

1/18/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

PAMIDRONATE BULK CHEMICAL, MANUFACTURED IN MILAN, ITALY

13947 I

II

1/11/1999

LONZA LTD

L-CARNITINE USP, MANUFACTURED IN VISP, SWITZERLAND

13948 A

II

12/29/1998

EMBIO LTD

PSEUDOEPHEDRINE HYDROCHLORIDE, USP, MANUFACTURED IN MAHARASHTRA, INDIA

13949 A

1/13/1999

STERIS ISOMEDIX SERVICES

CONTRACT STERILIZATION FACILITY IN LIBERTYVILLE (SOUTH),IL

13950 A

II

1/19/1999

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

PREDNISONE ACETATE, MANUFACTURED IN TIANJIN, CHINA

13951 I

12/4/1998

CULTOR FOOD SCIENCE INC

13952 I

II

12/4/1998

CULTOR FOOD SCIENCE INC

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN KOTKA,


FINLAND
LACTITOL MONOHYDRATE, MANUFACTURED IN THOMPSON, IL

13953 I

III

1/20/1999

AMPACET CORP

13954 I

III

1/20/1999

LUBRIZOL ADVANCED MATERIALS INC

19699 BLACK POLYETHYLENE, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA AND


CARTERSVILLE, GA
STAT-RITE E-1150-001, MANUFACTURED IN CLEVELAND, OHIO

13955 A

II

1/21/1999

ANALYTECON SA

PODOPHYLLOTOXIN (CPH-86), MANUFACTURED IN COUVET, SWITZERLAND

13956 I

II

1/22/1999

3M PHARMACEUTICALS INC

R-848 DRUG SUBSTANCE AND DRUG PRODUCT (ORAL), MANUFACTURED IN ST. PAUL, MN

13957 A

II

1/22/1999

ALKERMES GAINESVILLE LLC

FLUVOXAMINE MALEATE CR CAPSULES, MANUFACTURED IN COUNTY WESTMEATH, IRELAND

13958 A

III

1/18/1999

ACCEL COLOR CORP

PACKAGING MATERIALS, MANUFACTURED IN NAPERVILLE, IL

13959 A

II

1/26/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

TERAZOSIN HCI DIHYDRATE, MANUFACTURED IN SHEVA, ISRAEL

13960 A

II

1/25/1999

PQ CORP

13961 A

II

1/29/1999

GLAXOSMITHKLINE LLC

13962 A

II

1/29/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

MAGNESIUM SULFATE HEPTAHYDRATE, USP (PARENTERAL GRADES), MANUFACTURED IN


UTICA, IL
MUPIROCIN FREE ACID AND MUPIROCIN CALCIUM, MANUFACTURED IN WORTHING, WEST
SUSSEX, ENGLAND
ESTROGENIC POWDERS, MANUFACTURED IN CHICAGO, ILLINOIS

13963 A

II

1/29/1999

BIOTIKA SA

PENICILLIN V POTASSIUM, MANUFACTURED IN SLOVENSKA LUPCA, SLOVAKIA

13964 I

III

1/29/1999

AMPACET CORP

13965 A

II

1/29/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

13966 A

II

1/29/1999

ENTERIS BIOPHARMA INC

100552-A AS POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM
BECLOMETHASONE DIPROPIONATE MONOHYDRATE, MANUFACTURED IN LERMA, EDO.
MEXICO
AMIDATING ENZYME, MANUFACTURED IN BOONTON, NEW JERSEY

Page 399

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
13967 A
II
1/22/1999
SIMAFEX SAS

SUBJECT
DOTA, MANUFACTURED IN MARANS, FRANCE

13968 I

III

2/3/1999

FINA RESEARCH SA

FINAHENE 6006, MANUFACTURED IN ANTWERPEN, BELGIUM

13969 A

II

1/29/1999

ASHLAND INC

PLASDONE S-630, MANUFACTURED IN TEXAS CITY, TEXAS

13970 I

II

12/4/1998

CULTOR FOOD SCIENCE INC

LACTITOL, DIRECTLY COMPRESSIBLE FORM,(FINLAC DC) MANUFACTURED IN THOMSON IL

13971 A

II

2/4/1999

ASPEN OSS BV

GANIRELIX, MANUFACTURED IN OSS, THE NETHERLANDS

13972 A

II

2/9/1999

PRODUCTOS QUIMICOS NATURALES SA DE CV

EQUILIN, USP, MANUFACTURED IN IXTACZOQUITLAN, VER.,MEXICO

13973 I

III

2/3/1999

AMPACET CORP

13974 I

2/8/1999

MEDI-CULT A/S

13975 I

II

2/8/1999

MEDI-CULT A/S

110021 WHITE PE MB POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,


CARTERSVILLE, GA AND DEERIDDER, LA
MANUFACTURING SITE, FACILTIES, PERSONNEL AND OPERATING PROCEDURES IN
COPENHAGEN, DENMARK
RENCYTE SYSTEM, MANUFACTURED IN COPENHAGEN, DENMARK

13976 I

II

2/9/1999

UNIVERSITY OF MICHIGAN

NGVL/NONVIRAL GMP VECTOR PRODUCTION FACILITY IN ANN ARBOR, MI

13977 A

II

2/16/1999

PRODUCTOS QUIMICOS NATURALES SA

DEHYDROESTRONE, MANUFACTURED IN IXTACZOQUITLAN, VER. MEXICO

13978 I

III

1/28/1999

SOLVAY POLYOLEFINS EUROPE SA

ELTEX A5006FN1285, MANUFACTURED IN ROSIGNANO, ITALY

13979 I

II

2/17/1999

MITSUBISHI TANABE PHARMA CORP

MCC-555, MANUFACTURED IN KASHIMA-GUN, IBARAKI-KEN, JAPAN

13980 I

II

2/10/1999

KUNMING INSTITUTE OF BOTANY

PACLITAXEL (TAXOL) AS MANUFACTURED IN KUNMING, YUNNAN, CHINA

13981 I

III

1/21/1999

SOLVIN SA

IXAN PVDC PA 345, MANUFACTURED IN TAVAUX CEDEX, FRANCE

13982 I

III

1/21/1999

SOLVAY SA

IXAN PVDC PA 910, MANUFACTURED IN TAVAUX CEDEX, FRANCE

13983 A

II

2/9/1999

INDUSTRIALE CHIMICA SRL

PENTAZOCINE HYDROCHLORIDE, MANUFACTURED IN SARONNO,ITALY

13984 I

2/19/1999

KOPALLE PHARMA CHEMICALS PVT LTD

13985 A

II

2/17/1999

LABORATOIRES BESINS INTERNATIONAL

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN


HYDERABAD, INDIA
ESTROGEL 0.06%, MANUFACTURED IN MONTROUGE, FRANCE

13986 I

II

2/17/1999

RP SCHERER CANADA INC

13987 I

II

2/17/1999

MONACHEM

ETOPOSIDE 50MG SOFT-GELATIN CAPSULE, MANUFACTURED IN WINDSOR, ONTARIO,


CANADA
NOMEGESTROL ACETATE, MANUFACTURED IN MC, MONACO

13988 I

II

2/8/1999

CONTI BPC NVSA

MEMANTIME HCI, MANUFACTURED IN LANDED, BELGIUM

13989 I

III

2/11/1999

MICHELMAN INC

MICHEM LUBE 160PFE, MANUFACTURED IN CINCINNATI, OH

13990 I

2/23/1999

ALPS PHARMACEUTICAL IND CO LTD

13991 I

II

2/23/1999

ALPS PHARMACEUTICAL IND CO LTD

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GIFU


PREF, JAPAN
SENNOSIDES USP, MANUFACTURED IN GIFU PREF., JAPAN

13992 A

II

2/22/1999

MOEHS IBERICA SL

SOTALOL HCI, MANUFACTURED IN RUBI, SPAIN

13993 A

II

2/19/1999

PRODUCTOS QUIMICOS NATURALES SA DE CV

SODIUM 17 -ESTRADIOL SULFATE, MANUFACTURED IN IXTACZOQUITLAN, VER. MEXICO

13994 A

II

2/19/1999

SAFC BIOSCIENCES INC

QBSF60 MEDIUM PRODUCT NO. 62520, MANUFACTURED IN DENVER, PENNSYLVANIA

13995 A

II

1/26/1999

AETERNA ZENTARIS GMBH

PERIFOSINE (D-21266), DRUG PRODUCT, MANUFACTURED IN BIELEFELD, GERMANY

13996 A

II

1/26/1999

AETERNA ZENTARIS GMBH

PERIFOSINE (D-21266), DRUG SUBSTANCE, MANUFACTURED IN RADEBEUL, GERMANY

13997 I

III

1/12/1999

BESPAK INC

PHARMACEUTICAL ORAL INHALER, MANUFACTURED IN YOUNGSVILLE, NC

13998 I

2/24/1999

BIODOME

BIO-SET INJECTION RCC & RCL, MANUFACTURED IN ISSOIRE CEDEX, FRANCE

13999 A

II

2/24/1999

PCAS

PRAZIQUANTEL, MANUFACTURED IN LIMAY, FRANCE

14000 I

II

2/23/1999

NIPPON SHINYAKU CO LTD

NS-49, MANUFACTURED IN KYOTO, JAPAN

14001 I

IV

2/14/1999

FONA INTERNATIONAL INC

877.117 N-C NATURAL MINT FLAVOR (WONF), MANUFACTURED IN CAROL STREAM, IL

14002 I

IV

2/14/1999

FONA INTERNATIONAL INC

827.161 CINNAMON FLAVOR NATURAL, MANUFACTURED IN CAROL STREAM, IL

Page 400

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14003 A
III
10/1/1998
BORMIOLI ROCCO AND FIGLIO SPA

SUBJECT
GLASS CONTAINERS FOR PACKAGING FOR HUMAN DRUG AND BIOLOGICS, MANUFACTURED
IN PARMA, BERGANTINO (RO), S. VITO AL TAGLIAMENTO (PN) & MONTERONI D'ARBIA (SI),
ITALY

14004 I

II

2/26/1999

MALLINCKRODT INC

PROPOXYPHENE HYDROCHLORIDE USP POWDER, MANUFACTURED IN ST. LOUIS, MISSOURI

14005 A

II

3/1/1999

PRODUCTOS QUIMICOS NATURALES SA DE CV

SODIUM-17 DIHYROEQUILIN SULFATE AS MANUFACTURED IN IXTACZOQUITLA VER MEXICO

14006 I

II

3/8/1999

ORGANICHEM CORP

FLOXURIDINE, MANUFACTURED IN LINZ, AUSTRIA

14007 I

II

3/5/1999

CHONGQING DAXIN PHARMACEUTICAL CO LTD

14008 I

IV

2/25/1999

MCCORMICK AND CO INC

14009 I

III

2/4/1999

AMPACET CORP

14010 I

II

3/4/1999

FARMABIOS SRL

AMIKACIN HYDROCHLORIDE, NON-STERILE BULK DRUG, MANUFACTURED IN SICHUAN


PROVINCE, CHINA
MINT FLAVOR, NATURAL & ARTIFICIAL, WATER SOLUBLE, F55003, MANUFACTURED IN HUNT
VALLEY, MD
110733 WHITE TALC POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN,
CARTERSVILLE, GA AND DERIDDER, LA
CEFUROXIME, MANUFACTURED IN PAVIA, ITALY

14011 A

III

2/23/1999

CANADA COLORS AND CHEMICALS LTD

14012 I

II

3/1/1999

LABORATORIES ARGENOI SL

ANTISTAT MB553-02 POLYPROPYLENE ADDITIVE CONCENTRATE, MANUFACTURED IN


ONTARIO, CANADA
METHOCARBAMOL, MAUFACTURED IN ZARAGOZA, SPAIN

14013 A

II

3/5/1999

CHEMI SPA

AICA.HCI, MANUFACTURED IN FROSINONE, ITALY

14014 A

II

2/26/1999

BAYER PHARMA AG

DIENOGEST, MANUFACTURED IN BERKAMEN, BERLIN AND JENA, GERMANY

14015 I

IV

3/11/1999

MANE INC

NATURAL & ARTIFICIAL PEPPERMINT FLAVOR S.D. F93125, MANUFACTURED IN WAYNE, NJ

14016 I

IV

3/11/1999

MANE

NATURAL PEPPERMINT FLAVOR F93554, MANUFACTURED IN WAYNE, NJ

14017 I

IV

3/11/1999

MANE

NATURAL ANISE FLAVOR W.O.N.F. NY11599, MANUFACTURED IN WAYNE, NJ

14018 A

III

2/20/1999

BORMIOLI ROCCO SPA BU PLASTICS

14019 A

III

2/20/1999

BORMIOLI ROCCO SPA BU PLASTICS

14020 A

III

2/20/1999

BORMIOLI ROCCO SPA BU PLASTICS

14021 A

III

2/20/1999

BORMIOLI ROCCO SPA BU PLASTICS

14022 I

II

3/1/1999

TAOKA CHEMICAL CO LTD

14023 I

II

3/9/1999

BOEHRINGER INGELHEIM CHEMICALS INC

HDPE BOTTLE 180ML, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT
SULPICE, FRANCE
HDPE BOTTLE 105ML, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT
SULPICE, FRANCE
HDPE BOTTLE 70 ML, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT
SULPICE, FRANCE
CHILD PROOF CAP 35MM, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND
SAINT SULPICE, FRANCE
TRANS-4-ISOPROPYLCYCLOHEXANECARBONYL CHLORIDE AS MANUFACTURED IN OSAKA,
JAPAN
MILRINONE AS MANUFACTURED IN PETERSBURG VA

14024 A

II

3/19/1999

ZACH SYSTEM SPA

GABAPENTIN AS MANUFACTURED IN VICENZA ITALY

14025 I

3/12/1999

NOVO NORDISK PHARMACEUTICAL INC

14026 I

II

3/9/1999

T HASEGAWA CO LTD

14027 I

3/11/1999

PHARMACIA AND UPJOHN SPA

14028 I

II

3/18/1999

ALKERMES INC

STERILIZATION PROCESS VALIDATION INFORMATION AT NOVO NORDISK PHARMACEUTICALS


IN CLAYTON, NC
TRANS-4-ISOPROPYLCYCLOHEXANECARBONYL CHLORIDE MANUFACTUREDIN SAITAMA
PREFECTURE, JAPAN
MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL OF THE
GS/API PROCESS R&D PLANT IN NERVIANO, ITALY
PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR
PRODUCT ADMINISTRATION AS MANUFACTURED AT COOK PHARMACEUTICAL SOLUTIONS IN
BLOOMINGTON IN

14029 A

III

3/17/1999

BORMIOLI ROCCO SPA BU PLASTICS

14030 A

III

3/17/1999

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 200 ML AS MANUFACTURED IN CASTELGUELFO ITALY RIVANAZZANO ITALY AND


SAINT SULPICE FRANCE
HDPE BOTTLE 125 ML AS MANUFACTURED IN CASTELGUELFO ITALY RIVANAZZANO ITALY AND
SAINT SULPICE FRANCE

Page 401

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14031 A
IV
3/8/1999
SEPPIC SA

SUBJECT
SEPIFILM LP- COLORLESS RANGE (007,010, 014 AND 030)

14032 A

II

3/10/1999

TORAY INDUSTRIES INC

BERAPROST SODIUM AS MANUFACTURED IN SHIZUOKA JAPAN

14033 I

II

3/19/1999

SP PHARMACEUTICALS LLC

IMMTHER DRUG PRODUCT AS MANUFACTURED IN ALBUQUERQUE, NEW MEXICO

14034 A

II

3/19/1999

ASPEN OSS BV

NALOXONE HYDROCHLORIDE AS MANUFACTURED IN APELDOORN THE NETHERLANDS

14035 I

II

3/19/1999

BASILDON CHEMICAL CO LTD

14036 A

II

3/16/1999

DR REDDYS LABORATORIES LTD

SIMETHICONE USP (BASILDON CHEMICALS SIMETHICONE ANTIFOAM C100F) AS


MANUFACTURED IN OXON, GREAT BRITAIN
NIZATIDINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

14037 I

II

3/13/1999

BACHEM CALIFORNIA

14038 I

II

3/19/1999

LEO PHARMA AS

14039 I

II

3/19/1999

LEO PHARMA AS

GROWTH HORMONE RELEASING FACTOR (1-44), AMIDE, HUMAN, TRIFLUOROACETATE


(BULK), MANUFACTURED IN SAN DIEGO AND TORRANCE, CALIFORNIA
HEPARIN SODIUM DRUG SUBSTANCE AS MANUFACTURED IN ESBJERG DENMARK
MIDDLESBROUGH UNITED KINGDOM AND CORK IRELAND
HEPARINASE DRUG SUBSTANCE AS MANUFACTURED IN BALLERUP DENMARK

14040 A

II

3/11/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

MUPIROCIN AS MANUFACTURED IN DEBRECEN HUNGARY

14041 I

III

3/26/1999

SHIOTANI GLASS CO LTD

14042 I

III

3/25/1999

BERRY PLASTICS CORPORATION

MANUFACTURING, INSPECTING, PACKAGING, LABELING, & STORING OF AMPULES,


SYRINGES, AND OTHER SPECIAL CONTAINERS
CLOSURES MANUFACTURED AT EVANSVILLE AND PRINCETON, INDIANA

14043 I

III

3/2/1999

FILLAB INC

POLYVINYL CHLORIDE (PVC) SUPPOSITORY SHELLS

14044 I

III

4/2/1999

LOGOTECH INC

LABEL STOCK, INK, AND VARNISH FOR PRINTING LABELS MANUFACTURED IN FAIRFIELD, NJ

14045 A

II

3/31/1999

ISO TEX DIAGNOSTICS INC

YTTRIUM-90 (Y-90) AS MANUFACTURED IN FRIENDSWOOD, TEXAS

14046 A

II

3/31/1999

PADDOCK LABORATORIES LLC

CONJUGATED ESTROGENS (F00022) AS MANUFACTURED IN CHICAGO, ILLINOIS

14047 I

II

3/29/1999

ERREGIERRE SPA

TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY

14048 I

3/29/1999

MANUFACTURING FACILITY IN TAIWAN, CHINA FOR THE PRODUCTION OF LOVASTATIN

14049 I

II

3/29/1999

14050 A

II

3/25/1999

YUNG SHIN PHARMACEUTICAL INDUSTRIES CO


LTD
YUNG SHIN PHARMACEUTICAL INDUSTRIES CO
LTD
SANYO FINE CO LTD

14051 I

IV

3/25/1999

FONA INTERNATIONAL INC

14052 A

IV

3/18/1999

14053 I

III

3/11/1999

MOLKEREI MEGGLE WASSERBURG GMBH AND CO MICROCELAC 100 AS MANUFACTURED IN WASSERBURG, GERMANY
KG
HENKEL KG AA
LOXIOL EP 728 AND 861 AS MANUFACTURED IN DUSSELDORF, GERMANY

14054 I

III

3/7/1999

RISDON SA

14055 A

II

3/19/1999

WANBURY LTD

THERMOPLASTICS FOR THE MANUFACTURE OF EYE DROPPERS AND ACCESSORIES AS


MADE IN OFFRANVILLE, FRANCE
METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTA, INDIA

14056 A

II

4/5/1999

VUAB PHARMA AS

NYSTATIN USP AS MANUFACTURED IN VLTAVSKA, CZECH REPUBLIC

14057 I

III

3/24/1999

INGENIA POLYMERS CORP

14058 A

II

4/7/1999

RANBAXY LABORATORIES LTD

WT170 WHITE FOR USE IN PACKAGING MATERIALS AS MANUFACTURED IN CALGARY,


ALBERTA AND BRANTFORD, ONTARIO, CANADA
CEFUROXIME AXETIL (CRYSTALLINE) AS MANUFACTURED IN PUNJAB INDIA

14059 I

II

4/5/1999

ERREGIERRE SPA

OXAPROZIN JP AS MANUFACTURED IN BERGAMO, ITALY

14060 I

III

3/30/1999

CANADA COLORS AND CHEMICALS LTD

14061 I

III

4/27/1999

WADDINGTON IP JAYCARE

14062 I

II

4/12/1999

ML LABORATORIES

WHITE MB20922 POLYETHYLENE COLOR CONCENTRATE AS MANUFACTURED IN COLBORNE,


ONTARIO
DESIGNS MATERIALS AND SPECIFICATIONS FOR 60ML WHITE OPAQUE HDPE BOTTLE AS
MANUFACTURED IN CARLSTADT NJ
DEXTRIN SULPHATE AS MANUFACTURED IN LIVERPOOL ENGLAND

LOVASTATIN AS MANUFACTURED IN TAIWAN, CHINA


HMMP [2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE] AS
MANUFACTURED IN HYOGO PREFECTURE, JAPAN
NATURAL AND ARTIFICIAL PEACH FLAVOR

Page 402

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14063 I
II
4/9/1999
UBE INDUSTRIES LTD

SUBJECT
6,7-DIFLUOROACID FORM INTERMEDIATE AS MANUFACTURED IN YAMAGUCHI, JAPAN

14064 A

III

4/12/1999

MEDISIZE IRELAND LTD

14065 I

II

4/7/1999

14066 I

4/9/1999

DEPA ILAC AKTIF MADDELERI SANAYI VE


PAZARLAMA A S
SPECIALTIES SEPTODONT

SADDLE PORT SYSTEM DESIGNED FOR USE IN MEDICAL FLUID CONTAINERS AS


MANUFACTURED IN CO DONEGAL, REPUBLIC OF IRELAND
CLAVULANATE POTASSIUM AS MANUFACTURED IN KOCAELI, TURKEY

14067 A

III

4/8/1999

3M DRUG DELIVERY SYSTEMS

14068 A

III

4/8/1999

3M DRUG DELIVERY SYSTEMS

14069 A

III

4/8/1999

3M DRUG DELIVERY SYSTEMS

14070 A

II

4/7/1999

SAFC BIOSCIENCES INC

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL AT


SPECIALITIES SEPTODONT LOCATED IN SAINT MAURDES FOSSES, FRANCE
COTRAN 9715, 9716, AND 9728 (19% ETHYLENE VINYL ACETATE (EVA) FILMS) MANUFACTURED
IN BROOKINGS, SOUTH DAKOTA
COTRAN 9726 (2% ETHYLENE VINYL ACETATE (EVA) FILM) AS MANUFACTURED IN
BROOKINGS, SOUTH DAKOTA
COTRAN 9702, 9705, AND 9706 (9% ETHYLENE VINYL ACETATE (EVA) FILMS) AS
MANUFACTURED IN BROOKINGS, SOUTH DAKOTA.
EXCELL PF CHO AS MANUFACTURED IN DENVER, PENNSYLVANIA

14071 I

II

3/30/1999

JUZEN CHEMICAL CO LTD

OXYBUTYNIN AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN

14072 A

II

4/7/1999

BAXTER HEALTHCARE CORP

ICODEXTRIN POWDER AS MANUFACTURED IN LIVERPOOL, ENGLAND

14073 I

II

4/7/1999

ML LABORATORIES

4% ICODEXTRIN SOLUTION AS MANUFACTURED IN LARNE CO, ANTRIM, NORTHERN IRELAND

14074 I

II

4/7/1999

RANBAXY LABORATORIES LTD

CEFUROXIME AXETIL AS MANUFACTURED IN PUNJAB, INDIA

14075 I

II

3/22/1999

WL GORE AND ASSOC INC

GORE PERISTALTIC PUMP TUBING AS MANUFACTURED IN ELKTON, MARYLAND

14076 I

3/23/1999

STERITEK INC

14077 A

II

3/29/1999

GEDEON RICHTER PLC

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, MAJOR EQUIPMENT, AND


KEY PERSONNEL FOR PACKAGING OF DRUG PRODUCTS IN MOONACHIE, NEW JERSEY.
SPIRONOLACTONE AS MANUFACTURED IN BUDAPEST, HUNGARY

14078 I

II

4/8/1999

SICOR DE MEXICO SA DE CV

CYPROTERONE ACETATE AS MANUFACTURED IN LERMA, EDO, MEXICO

14079 I

4/15/1999

PLIVA DD

14080 I

II

4/9/1999

14081 I

III

4/23/1999

CLARIANT GMBH GRIESHEIM WORKS DIVISION


FINE CHEMICALS
ALGROUP LAWSON MARDON

MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN


DIHYDRATE AS MANUFACTURED IN PRIGOJE BRDOVECKO, CROATIA
N-CARBOXYBENZYL-3-FLUORO-4-MORPHOLINOANILINE AS MANUFACTURED IN FRANKFURT
AM MAIN, GERMANY
LAMINATED ALUMINUM FOIL PACKAGES AS PRODUCED IN TORONTO, ONTARIO, CANADA

14082 A

III

4/23/1999

BERRY PLASTICS CORP

BPN6036 AS MANUFACTURED BY BERRY PLASTICS

14083 I

III

4/21/1999

AMPACET CORP

14084 A

III

4/19/1999

ZEON CORP

14085 A

III

4/12/1999

EXAL CORP

14086 A

II

4/19/1999

CATALENT PHARMA SOLUTIONS LLC

11989I WHITE PE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE, IN,


CARTERSVILLE, GA, DERIDDER, LA & MESSANCY, BELGIUM
CYCLOOLEFIN POLYMER (ZEONEX 690 R) AS MANUFACTURED IN KURASHIKI, OKLAYAMA,
JAPAN
PACKAGING MATERIALS AEROSOL ALUMINUM CONTAINERS AS AMNUFACTURED IN
YOUNGSTOWN OHIO
TARGRETIN 75 MG SOFT-GELATIN CAPSULE AS MANUFACTURED IN ST PETERSBURG FL

14087 A

II

4/17/1999

IPCA LABORATORIES LTD

HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN MADHYA PRADESH INDIA

14088 I

II

4/19/1999

CLARIANT GMBH

14089 A

II

4/20/1999

LONZA BIOTEC SRO

N-CARBOXYBENZYL-3-FLUORO-4-MORPHOLINOANILINE AS MANUFACTURED IN FRANKFURT


GERMANY
L-CARNITINE L-TARTATE AS MANUFACTURED IN KOURIM CZECH REPUBLIC

14090 I

III

4/21/1999

HUMPHREY COSBURN PLASTICS

PLASTIC APPLICATORS AS MANUFACTURED IN TORONTO CANADA

14091 A

II

4/22/1999

ALBEMARLE CORP

1LZD-LINEZOLID, STEP 1 AS MANUFACTURED IN SOUTH HAVEN MI

14092 I

III

4/6/1999

INTERGLASS INC

14093 A

II

4/16/1999

DISHMAN NETHERLANDS BV

TUBING GLASS CONTAINERS (AMPOULES & VIALS) AS MANUFACTURED IN WOODBRIDGE


ONTARIO CANADA
CALCITRIOL AS MANUFACTURED IN WEESP THE NETHERLANDS

Page 403

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14094 I
II
4/23/1999
CHEMI SPA
14095 A

III

3/1/1999

CANADA COLORS AND CHEMICALS LTD

14096 A

II

4/30/1999

SAFC BIOSCIENCES INC

14097 I

II

5/3/1999

AJINOMOTO CO INC

SUBJECT
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT AS
MANUFACTURED IN PATRICIA ITALY
ANTIBLOCK MB-155-13 POLYPROPYLENE ADDITIVE CONCENTRATE AS MANUFACTURED IN
COLBORNE ONTARIO CANADA
EX-CELL 525 FOR PER C6 CELLS, DEFINED SERUM FREE MEDIUM,AS MANUFACTURED IN
DENVER PENNSYLVANIA
AT-1015 A 5-HT2A ANTAGONIST AS MANUFACTURED IN MIE PREFECTURE JAPAN

14098 I

III

5/4/1999

WISTOFF GMBH & CO

PHARMACEUTICAL GLASS CONTAINERS AS MANUFACTURED IN ESSEN GERMANY

14099 A

II

5/3/1999

MEDICHEM SA

FELODIPINE AS MANUFACTURED IN CELRA SPAIN

14100 A

II

4/28/1999

YAMASA CORP

DIQUAFOSOL TETRASODIUM AS MANUFACTURED IN CHILBA-KEN JAPAN

14101 I

II

4/30/1999

EURO CHEMI INC

NIZATIDINE AS MANUFACTURED IN BARCELONA SPAIN

14102 I

III

4/26/1999

DOW CHEMICAL CO

POLYETHYLENE RESINS FOR PACKAGING AND MEDICAL APPLICATIONS AS MANUFACTURED


IN QUEBEC & ONTARIO CANADA TOLEDO OH PHILADELPHIAPA ST LOUIS IL AND HOUSTON TX

14103 A

II

4/29/1999

H LUNDBECK AS

S-CITALOPRAM OXALATE AS MANUFACTURED IN NYKOBING SI DENMARK COPENHAGENVALBY DENMARK MIDDLESBROUGH ENGLAND AND VANDOEUVRE-LES-NANCY CEDEX
FRANCE

14104 I

III

4/24/1999

CLARIANT SPA (ITALIA)

14105 I

III

5/3/1999

HUNTSMAN POLYPROPYLENE CORP

CUSTOM COLORING/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND


PACKAGING AS MFG IN MERATE ITALY
POLYPROPYLENE PRODUCTS AS MANUFACTURED IN ODESSA TEXAS

14106 A

III

4/19/1999

GERRESHEIMER GLASS INC

14107 I

III

2/23/1999

PECHINEY EMBALLAGE FLEXIBLE EUROPE

14108 I

III

2/23/1999

PECHINEY EMBALLAGE FLEXIBLE EUROPE

14109 A

II

5/10/1999

EUTICALS SPA

14110 A

III

5/10/1999

WEST PHARMACEUTICAL SERVICES INC

ELASTOMERIC COMPONENTS ALTERNATIVE FORMULATION 4588/40 GRAY TO FORMULATION


1888 GRAY

14111 I

IV

3/16/1999

FONA INTERNATIONAL INC

825.075 ARTIFICIAL WILD CHERRY FLAVOR AS MANUFACTURED IN CAROL STREAM IL

14112 I

IV

3/25/1999

FONA INTERNATIONAL INC

936.115 NATURAL BITTERING FLAVOR AS MANUFACUTRED IN CAROL STREAM IL

14113 I

IV

3/25/1999

FONA INTERNATIONAL INC

EU 936.115 NATURAL BITTERING FLAVOR AS MANUFACTURED IN CAROL STREAM IL

14114 I

IV

3/25/1999

FONA INTERNATIONAL INC

942.001 N-C NATURAL & ARTIFICIAL DAIRY FLAVOR AS MANUFACTURED IN CAROL STREAM IL

14115 I

IV

3/16/1999

FONA INTERNATIONAL INC

14116 I

IV

3/16/1999

FONA INTERNATIONAL INC

915.356 ARTIFICIAL STRAWBERRY FLAVOR (FRESH TYPE) AS MANUFACTURED IN CAROL


STREAM IL
918.004 SWEET AM (A NATURAL FLAVOR) AS MANUFACTURED IN CAROL STREAM IL

14117 I

IV

3/23/1999

FONA INTERNATIONAL INC

14118 I

IV

3/15/1999

FONA INTERNATIONAL INC

14119 I

IV

3/15/1999

FONA INTERNATIONAL INC

14120 I

III

5/7/1999

AMPACET CORP

14121 A

III

5/7/1999

AMPACET CORP

MOULDED GLASS PACKAGING MATERIAL AND CONTAINERS AS MANUFACTURED IN CHICAGO


HEIGHTS, IL AND MILLVILLE, NJ
FOIL FOR PHARMACEUTICAL WHITE(ONE SIDE) BLISTERFOIL AS MANUFACTURED IN
BRIGOUND FRANCE DIJON FRANCE BARCELONA SPAIN AND DARMSTADT GERMANY
FOIL FOR PHARMACEUTICAL WHITE(BOTH SIDES) BLISTERFOIL WITH PHTALATES AS MFG IN
BRIGOUND FRANCE DIJON FRANCE BARCELONA SPAIN AND DARMSTADT GERMANY
1-LZD AS MANUFACTURED IN ROZZANO ITALY

815.105 BUBBLEMINT FLAVOR (NATURAL AND ARTIFICIAL) AS MANUFACTURED IN CAROL


STREAM IL
827.183 N-C CINNAMON FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL
STREAM ILLINOIS
827.182 N-C CINNAMON FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL
STREAM ILLINOIS
11134 WHITE PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GA AND DERIDDER LA
190405 BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA

Page 404

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14122 I
III
5/7/1999
AMPACET CORP

SUBJECT
10561 UV PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
19909-T BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
190007-U BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
11303 WHITE UV PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE INCARTERSVILLE GAAND DERIDDER LA
10478-A UV PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
19909 BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
11376 WHITE HDPE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE INCARTERSVILLE GAAND DERIDDER LA
YTTRIUM-90 AS MANUFACTURED IN BOSTON MA

14123 I

III

5/7/1999

AMPACET CORP

14124 I

III

5/7/1999

AMPACET CORP

14125 I

III

5/7/1999

AMPACET CORP

14126 I

III

5/7/1999

AMPACET CORP

14127 I

III

5/7/1999

AMPACET CORP

14128 I

III

5/7/1999

AMPACET CORP

14129 A

II

5/5/1999

PERKINELMER

14130 I

4/30/1999

PUBLIC STOCK CORPORATION OYJ

14131 I

IV

5/7/1999

FONA INTERNATIONAL INC

DESCRIPTION OF FACILITIES PROCESS AND MATERIALS OF MFG PLANT LOCATED IN


NURMIJARU FINLAND
825.450 CHERRY MINT ARTIFICIAL FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS

14132 I

II

5/1/1999

ALPS PHARMACEUTICAL IND CO LTD

SENNOSIDES(60) AS MANUFACTURED IN THE GIFU PREFECTURE JAPAN

14133 A

II

5/3/1999

SANDOZ GMBH

CEFAZOLIN SODIUM(STERILE)AS MANUFACTURED IN TYROL AUSTRIA

14134 I

III

5/6/1999

AMPACET CORP

14135 I

III

5/6/1999

AMPACET CORP

14136 A

II

5/12/1999

FARMABIOS S P A

110532-I WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE


INCARTERSVILLE GAAND DERIDDER LA
110674 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
FLUDROCORTISONE ACETATE AS MANUFACTURED IN PAVIA ITALY

14137 I

II

5/12/1999

FARMABIOS SRL

CEFUROXIME SODIUM STERILE AS MANUFACTURED IN PAVIA ITALY

14138 A

II

5/10/1999

DOW CHEMICAL CO

POLYMILL POLYSTYRENE MILLING MEDIA AS MANUFACTURED IN MIDLAND MICHIGAN

14139 A

III

5/5/1999

RTP CO

14140 I

II

5/12/1999

THERMOPLASTIC COMPOUNDS FOR USE IN DRUG DELIVERY SYSTEMS AS MANUFACTURED


IN WINONA MN
NATIONAL INSTITUTES HEALTH NATIONAL CANCER PC-4 (SILICONE PHTHALOCYANINE) AS MANUFACTURED IN BUFFALO NY
INSTITUTE DIV CANCER TREATMENT AND
DIAGNOSIS

14141 A

5/17/1999

DSM PHARMACEUTICALS INC

STERILE PRODUCT OPERATION-NORTH (SPO-NORTH) IN GREENVILLE NORTH CAROLINA

14142 I

II

5/21/1999

SOLVAY PHARMA GMBH

CHOLECALCIFEROL AS MANUFACTURED IN WEESP THE NETHERLANDS

14143 A

III

5/14/1999

CO PLAST SRL

PLASTIC CAPS MANUFACTURED IN BEVERA DI BARZAGO ITALY

14144 A

II

5/12/1999

BASF PHARMA EVIONNAZ SA

14145 I

5/19/1999

PHARMACIA AND UPJOHN INC

14146 A

III

5/17/1999

AMPACET CORP

14147 I

III

5/13/1999

AMPACET CORP

14148 A

II

5/20/1999

PISGAH LABS INC

PRILOCAINE BASE AS MANUFACTURED IN EVIONNAZ SWITZERLAND AND ST VULBAS


FRANCE
REFERENCE INFORMATION FOR NEW STERILE MFG. FACILITY IN KALAMAZOO MI REFERRED
TO AS THE CENTER FOR ADVANCED STERILE TECHNOLOGY(CAST)
11070 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE
INCARTERSVILLE GAAND DERIDDER LA
11898-IT WHITE PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE
IN CARTERSVILLE GAAND DERIDDER LA
DISODIUM PAMOATE AS MANUFACTURED IN PISGAH FOREST NC

14149 I

II

5/21/1999

SCHWIEZERHALL MFG CO

SULFABENZAMIDE AS MANUFACTURED IN GREENVILLE SC

14150 I

II

5/21/1999

SCHWIEZERHALL DEVELOPMENT CO

IMIPRAMINE PAMOATE AS MANUFACTURED IN GREENVILLE SC

Page 405

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14151 A
II
5/14/1999
TARO PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
FLUOCINONIDE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL

14152 I

3/18/1999

PENINSULA LABORATORIES INC

14153 I

II

4/30/1999

SILICONATURE SPA

MANUFACTURING SITE FACILITIES PROCEDURES & PERSONNEL FOR DRUG SUBSTANCES


PRODUCED IN SAN CARLOS CA
SILFLU MED MD07 AS MANUFACTURED IN GODEGA DI S URBANO ITALY

14154 I

II

5/25/1999

INDUSTRIALE CHIMICA SRL

FORMOTEROL FUMARATE DIHYDRATE MICRONIZED AS MANUFACTURED IN SARRONO, ITALY.

14155 A

II

5/26/1999

ROLABO OUTSOURCING SL

LORATADINE AS MANUFACTURED IN ZARAGOZA SPAIN

14156 I

II

5/28/1999

DAICEL CHEMICAL INDUSTRIES LTD

FK614 DRUG SUBSTANCE AS MANUFACTURED IN NIIGATA JAPAN

14157 A

II

5/26/1999

ORGAPHARM

FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS FRANCE

14158 I

III

5/14/1999

BERRY PLASTICS CORP

PRODUCT 41727-34 AS MANUFACTURED IN COLUMBUS, GA

14159 I

III

5/21/1999

AKZO NOBLE INKS CORPORATION

14160 I

III

5/10/1999

POLIMERI EUROPA FRANCE SNC

WATER BASED PRINTING INK PRODUCTS UV CURABLE PRINTING INK PRODUCTS AS


MANUFACTURED IN PLYMOUTH MN
FLEXIRENE FG20F AS MANUFACTURED IN DUNKIRK FRANCE

14161 I

III

5/10/1999

POLIMERI EUROPA FRANCE SA

FLEXIRENE FG23F AS MANUFACTURED IN DUNKIRK FRANCE

14162 I

III

5/21/1999

VERRETUBEX

14163 I

IV

3/18/1999

FONA INTERNATIONAL INC

AMPOULES VIALS CARTRIDGES AS MANUFACTURED IN NOGENT LE ROI AND CHALON SUR


SAONE FRANCE
874.001 NOR CAP ART MELON FLAVOR AS MAUFACTURED IN CAROL STREAM ILLINOIS

14164 I

IV

3/18/1999

FONA INTERNATIONAL INC

14165 I

IV

3/18/1999

FONA INTERNATIONAL INC

14166 I

IV

3/18/1999

FONA INTERNATIONAL INC

14167 A

II

5/28/1999

MALLINCKRODT INC

14168 A

III

6/3/1999

MILLIKEN AND CO

852.035 N-C NATURAL AND ARTIFICIAL FLAVOR AS MANUFACTURED IN CAROL STREAM


ILLINOIS
895.032 NOR CAP ARTIFICIAL PINNEAPPLE FLAVOR AS MANUFACTURED IN CAROL STREAM
ILLINOIS
815.016 N-C BUBBLEGUM FLAVOR (A NATURAL AND ARTIFICIAL FLAVOR) AS MANUFACTURED
IN CAROL STREAM ILLINOIS
SODIUM PHOSPHATE MONOBASIC USP MONOHYDRATE GRANULAR FOOD GRADE AS
MANUFACTURED IN ST LOUIS MO
PC COLORANTS AS MANUFACTURED IN BLACKSBURG SOUTH CAROLINA

14169 A

II

6/2/1999

TARO PHARMACEUTICAL INDUSTRIES LTD

CLORAZEPATE DIPOTASSIUM USP AS MANUFACTURED IN HAIFA BAY ISRAEL

14170 A

II

6/1/1999

IDT AUSTRALIA LTD

THIOTEPA USP AS MANUFACTURED IN BORONA VICTORIA AUSTRALIA

14171 I

II

5/28/1999

SHANGHAI SHENLONG PHARMACEUTICAL CO LTD

14172 I

II

5/31/1999

HAUPT PHARMA GMBH

AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI PEOPLES REPULIC OF


CHINA
L-CARNITINE CAPSULES 500MG AS MANUFACTURED IN WOLFRAHAUSEN GERMANY

14173 I

II

6/3/1999

CILAG AG

DOXAZOSIN MESYLATE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

14174 I

II

6/4/1999

API INC

NABUMETONE DRUG SUBSTANCE AS MANUFACTURED IN GUAYAMA PUERTO RICO

14175 I

IV

5/31/1999

LTP LIPID TECHNOLOGIES PROVIDER AB

CPL-GALACTOLIPID AS MANUFACTURED IN KARLSHAMN SWEDEN

14176 I

III

5/24/1999

SOLVAY DRAKA INC.

SOLMED WRAPFLEX 5000 AS MANUFACTURED IN FRESNO CALIFORNIA

14177 I

IV

5/25/1999

FONA INTERNATIONAL INC

14178 A

III

5/21/1999

HEINKE TECHNOLOGY INC

14179 I

5/25/1999

SANOCHEMIA PHARMAZEUTIKA AG

14180 I

II

5/28/1999

14181 A

II

5/28/1999

NINGBO RENJIAN BIOCHEMICAL &


PHARMACEUTICAL CO LTD
HUNAN DONGTING PHARMACEUTICAL CO LTD

14182 I

II

6/1/1999

HIKAL LTD

'

915.236 N-C NATURAL STRAWBERRY FLAVOR(WONF) AS MANUFACTURED IN CAROL STREAM


ILLINOIS
PLASTIC CONTAINER AND APPLICATOR DEVICE AS MANUFACTURED IN LINCOLN NE
FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES IN THE CHEMICAL
PRODUCTION UNIT IN NEUFELD/LEITHA AUSTRIA
CHORIONIC GONADOTROPHIN AS MANUFACTURED IN CIXI NINGBO PEOPLES REPUBLIC OF
CHINA
TRANEXAMIC ACID AS MANUFACTURED IN THE HUNAN PROVINCE PEOPLES REPUBLIC OF
CHINA
PENTOXIFYLLINE AS MANUFACTURED IN BANGALORE INDIA

Page 406

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14183 I
II
5/25/1999
BASIC VEGETABLE PRODUCTS

SUBJECT
NUTRACEUTICAL GARLIC PRODUCT A10000 AS MANUFACTURED IN KING CITY CALIFORNIA

14184 A

II

5/28/1999

MALLINCKRODT INC

SODIUM PHOSPHATE DIBASIC USP POWDER (DRIED) AS MANUFACTURED IN ST LOUIS MO

14185 A

II

6/1/1999

SHASUN PHARMACEUTICALS LTD

NAPROXEN SODIUM USP AS MANUFACTURED IN PONDICHERRY INDIA

14186 A

III

6/7/1999

MITSUBISHI PLASTICS IND LTD

CASTING POLYPROPYLENE SHEET AS MANUFACTURED IN SHIGA PREFECTURE JAPAN

14187 A

II

6/10/1999

XELLIA PHARMACEUTICALS APS

POLYMYXIN B SULFATE AS MANUFACTURED IN COPENHAGEN DENMARK

14188 I

III

5/26/1999

SOLVAY SA

IXAN PA331 PVDC AS MANUFACTURED IN TAVUX CEDEX FRANCE

14189 I

III

5/25/1999

POLIMERI EUROPA SRL

RIBLENE FF34 AS MANUFACTURED IN GELA ITALY

14190 I

III

5/24/1999

POLIMERI EUROPA FRANCE SA

RIBLENE FC10 AS MANUFACTURED IN OBERHAUSEN DENMARK

14191 I

III

5/26/1999

POLIMERI EUROPA FRANCE SA

FLEXIRENE FG23U AS MANUFACTURED IN BRINDISI ITALY

14192 I

III

5/26/1999

POLIMERI EUROPA FRANCE SA

FLEXIRENE FG20U AS MANUFACTURED IN BRINDISI ITALY

14193 I

II

5/7/1999

SALSBURY CHEMICALS INC

NICOTINE POLACRILEX RESIN AS MANUFACTURED IN CHARLES CITY IA

14194 A

IV

6/9/1999

BANNER PHARMACAPS INC

14195 A

II

6/7/1999

SIFAVITOR SRL

GELATIN MASSES (SOFLET AND SOFTGEL FORMULATIONS) AS MANUFACTURED IN HIGH


POINT NORTH CAROLINA
LEVOBUNOLOL HYDROCHLORIDE AS MANUFACTURED IN FRAZIONE MAIRANO(LODI) ITALY

14196 A

II

4/15/1999

OMICRON QUIMICA SA

BISMUTH SUBGALLATE AS MANUFACTURED IN BARCELONA SPAIN

14197 A

II

4/14/1999

OMICRON QUIMICA SA

BISMUTH SUBNITRATE AS MANUFACTURED IN BARCELONA SPAIN

14198 I

III

6/11/1999

WINPAK HEAT SEAL PACKAGING

FOILGUARD BF10V AS MANUFACTURED IN VAUDREUIL-DORION QUEBEC CANADA

14199 I

III

6/14/1999

MOBIL CHEMICAL CO

14200 I

II

9/1/1998

ABBVIE INC

METALLIZED MULTILAYER POLYPROPYLENE FILM AS MANUFACTURED IN VIRTON BELGIUM


AND DAYVILLE CONNECTICUT
ERYTHROMYCIN BASE

14201 I

II

6/14/1999

AJANTA PHARMA LTD

CEFADROXIL USP AS MFG IN MAHARASHTRA INDIA

14202 I

II

6/15/1999

SANKYO CO LTD

CS-780 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA JAPAN

14203 I

III

6/7/1999

HUNTSMAN POLYPROPYLENE CORP

14204 A

II

6/11/1999

EUTICALS SPA

POLYPROPYLENES PP23M2 23M2CS38 23M2CS198 23M2CS219 23M2CS260 23M10


23M10CS259 41E4CS215 AND 31S4CS62 AS MANUFACTURED IN ODESSA TEXAS
DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN LODI ITALY

14205 I

II

6/15/1999

SANKYO CO LTD

CS-780 DRUG PRODUCT AS MANUFACTURED IN TOKYO JAPAN

14206 I

III

6/8/1999

WINPAK TECHNOLOGIES INC

14207 I

II

5/20/1999

KYOWA HAKKO KOGYO CO LTD

14208 A

II

6/14/1999

AMRI RENSSELAER INC

FLEXIBLE PACKAGING MATERIALS FOR VARIOUS PHARMACEUTICAL APPLICATIONS AS


MANUFACTURED IN ONTARIO CANADA
UBIDECARENONE BULK AS MANUFACTURED IN TAKASAGO-CITY HYOGO-PREFECTURE
JAPAN
PRALIDOXIME CHLORIDE AS MANUFACTURED IN RENSSELAER NY

14209 A

II

6/17/1999

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

KETOROLAC TROMETHAMINE USP AS MANUFACTURED IN BARCELONA SPAIN

14210 A

II

6/14/1999

CADILA HEALTHCARE LTD

ATENOLOL AS MANUFACTURED IN GUJARAT INDIA

14211 I

II

4/22/1997

YUHAN CORP

CEFACLOR BULK AS MANUFACTURED IN SEOUL KOREA

14212 I

II

9/1/1980

GLAXO PHARM

AMPICILLIN TRIHYDRATE

14213 I

II

4/5/1990

BRISTOL MYERS SQUIBB COMPANY

HETACILLIN POTASSIUM AS MANUFACTURED IN PUERTO RICO

14214 A

III

3/24/1999

AMPACET CORP

14215 A

III

6/16/1999

AMPACET CORP

14216 I

III

6/16/1999

AMPACET CORP

16180 BLUE PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN


DERIDDER LA AND CARTERSVILLE GA
7188335 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN
DERIDDER LA AND CARTERSVILLE GA
7182482 PEARLESCENT POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE IN DERIDDER LA AND CARTERSVILLE GA

Page 407

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14217 I
III
6/16/1999
AMPACET CORP
14218 I

III

6/16/1999

AMPACET CORP

14219 I

III

6/16/1999

AMPACET CORP

14220 I

III

6/21/1999

AKERLUND AND RAUSING GROUP

SUBJECT
7188680 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN
DERIDDER LA AND CARTERSVILLE GA
7188338 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN
DERIDDER LA AND CARTERSVILLE GA
7180674 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN
DERIDDER LA AND CARTERSVILLE GA
TRANSOFOIL LL-OPET/PE LAMINATE AS MANUFACTURED IN LUND SWEDEN

14221 I

III

6/15/1999

POLYVEL INC

ANTISTAIC ADDITIVE CONCENTRATE USED IN THE MFG OF FLEXIBLE CONTAINMENT DEVICES

14222 I

III

6/15/1999

POLYVEL INC

14223 I

6/18/1999

NINGXIA PHARMACEUTICAL FACTORY

ANTIBLOCK ADDITIVE CONCENTRATE ASED IN THE MFG OF FLEXIBLE CONTAINMENT


DEVICES
MANUFACTURING SITES FACILITIES OPERATION PROCEDURES AND PERSONNEL IN
YINCHUAN CITY NINGXIA HUI NATIONALITY AUTONOMOUS REGION PEOPLES REPUBLIC OF
CHINA

14224 A

II

6/23/1999

14225 I

III

6/21/1999

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
AMPACET CORP

14226 A

II

6/22/1999

EXCELLA GMBH

14227 I

IV

6/2/1999

FONA INTERNATIONAL INC

14228 I

IV

6/2/1999

FONA INTERNATIONAL INC

14229 I

IV

6/18/1999

FONA INTERNATIONAL INC

14230 I

IV

6/18/1999

FONA INTERNATIONAL INC

14231 I

III

6/18/1999

BERRY PLASTICS CORP

14232 I

III

6/18/1999

14233 I

III

6/18/1999

14234 A

II

6/24/1999

14235 A

II

6/24/1999

14236 A

II

6/7/1999

14237 I

II

6/24/1999

BERRY PLASTICS CORP TAPES AND COATINGS DIV 48 GAUGE PET FILM/MICA A-131-X/12# WHITE PE/0.00030 FOIL/MICA A-291/1.5 MIL LLDPE HI
(VF-58) AS MANUFACTURED IN HOMER LA
BERRY PLASTICS CORP TAPES AND COATINGS DIV 30# BLEACHED COATED ONE SIDE KRAFT PAPER/8# LDPE/0.00030 FOIL/MICA A-291/22# LLDPE
(VF-50) AS MANUFACTURED IN HOMER LA
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH GUAIFENESIN USP AS MANUFACTURED IN TAIWAN PRC
CO LTD
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH PRAVASTATIN SODIUM USP AS MANUFACTURED IN TAIWAN PRC
CO LTD
ROHNER LTD
4-AMINO-5-CHLORO2,1,3-BENZOTHIADIAZOLE DRUG SUBSTANCE AS MANUFACTURED IN
PRATTELN SWITZERLAND
SIFAVITOR SRL
ECONAZOLE AS MANUFACTURED IN LODI ITALY

14238 I

II

6/28/1999

ASUBIO PHARMA CO LTD

CARPERITIDE DRUG SUBSTANCE AS MANUFACTURED IN GUNMA JAPAN

14239 I

II

6/25/1999

PHARMASYNTHESE

4 HYDROXYTAMOXIFEN AS MANUFACTURED IN EVRY CEDEX FRANCE

14240 A

II

6/25/1999

RANBAXY LABORATORIES LTD

OFLOXACIN USP AS MANUFACTURED IN PUNJAB INDIA

14241 A

II

6/25/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

NORGESTIMATE BULK DRUG SUBSTANCE AS MANUFACTURED IN MILAN ITALY

14242 I

II

6/29/1999

MITSUBISHI TANABE PHARMA CORP

MKC-242 BULK DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI-KEN JAPAN

14243 I

II

7/1/1999

TETRACYCLINE PHOSPHATE AS MANUFACTURED IN ALENQUER, PORTUGAL

14244 A

II

7/1/1999

COMPANHIA INDUSTRIAL PRODUTORA DE


ANTIBIOTICOS SARL
COMPANHIA INDUSTRIAL PRODUTORA DE
ANTIBIOTICOS SARL

SULFAMETHAZINE SODIUM AS MANUFACTURED IN SHANGHAI CHINA


13920 YELLOW PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE
INDERIDDER LA ANDCARTERSVILLE GA
HALOPERIDOL AS MANUFACTURED IN FEUCHT GERMANY
915.354 N-C ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CAROL STREAM
ILLINOIS
831.002 N-C ARTIFICIAL PINA COLADA FLAVOR AS MANUFACTURED IN CAROL STREAM
ILLINOIS
825.476 ARTIFICIAL CHERRY FLAVOR
826.229 NATURAL AND ARTIFICIAL CHOCOLATE FLAVOR AS MANUFACTURED IN CAROL
STREAM ILLINOIS
PRODUCT 24-5-067 AS MANUFACTURED IN HOMER, LA

DEMECLOCYCLINE HCL AS MANUFACTURED IN ALENQUER PORTUGAL

Page 408

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14245 I
II
7/1/1999
COMPANHIA INDUSTRIAL PRODUTORA DE
ANTIBIOTICOS SARL
14246 I
II
7/6/1999
LEO LABORATORIES LTD
14247 N

SUBJECT
ERYTHROMYCIN STEARATE AS MANUFACTUREDIN ALENQUER PORTUGAL
AMDINOCILLIN PIVOXIL HCL

NOT AN ASSIGNED NUMBER

14248 I

5/25/1999

MEDIBRANDS LTD

14249 A

II

6/14/1999

SAFC BIOSCIENCES INC

MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR MEDIBRANDS LTD. IN
HAIFA ISRAEL
EX-CELL PF CHO MEDIUM(MODIFIED) AS MANUFACTURED IN DENVER PENNSYLVANIA

14250 A

II

5/26/1999

ECOLAB INC

20% CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN HUNTINGTON IN

14251 I

III

6/23/1999

ASTRA PLASTIQUE

14252 I

II

6/30/1999

PHIBRO ANIMAL HEALTH CORP

CONTAINER CLOSURES(CAPS) MFG FROM THERMO PLASTIC MATERIAL AS MANUFACTURED


IN SAINT GEORGES DE RENEINS FRANCE
POTASSIUM NITRATE USP AS MANUFACTURED IN NARUTO JAPAN

14253 A

II

6/29/1999

CADILA PHARMACEUTICALS LTD

FLUOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

14254 A

III

6/30/1999

ISHIDA PRESS KOGYO CO LTD

ALUMINUM CAPS FOR MEDICAL VIALS AS MANUFACTURED IN SAITAMA JAPAN

14255 A

II

5/25/1999

CARLSON FILTRATION LTD

ASBESTOS FREE DEPTH FILTER SHEETS AS MANUFACTURED INLANCASHIRE UK

14256 I

II

6/29/1999

LEVOTHYROXINE SODIUM USP AS MANUFACTURED IN MULHOUSSE FRANCE

14257 I

II

6/28/1999

RHODIA INDUSTRIE CHIMIQUE MULHOUSE


DORNACH
HOSPIRA INC

14258 A

II

6/25/1999

14259 A

II

6/25/1999

14260 I

II

7/3/1995

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
BOEHRINGER INGELHEIM PHARMA GMBH AND CO
KG
BIOCHEMICA OPOS SPA

ALBUTEROL SULFATE (UNMICRONIZED) AS MANUFACTURED IN INGLHEIM AM RHEIN,


GERMANY
IPRATROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGLEHEIM AM RHEIN,
GERMANY
CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN MILAN ITALY

14261 I

III

6/30/1999

ZIMMER CUSTOM-MADE PACKAGING

14262 A

III

6/25/1999

LAGEEN TUBOBLAST LTD

MOBIL OPPALYTE 35MU842/COMMEX CX1102 FILM LAMINATE AS MANUFACTURED IN


INDIANAPOLIS INDIANA
PLASTIC TUBES AND CAPS AS MFG IN KIBBUTZ YAGUR, ISRAEL

14263 I

III

6/29/1999

MEDIFIQ HEALTHCARE CORP

JADELLE (R) INSERTER SET AS MANUFACTURED IN LEHMO FINLAND

14264 I

6/29/1999

CADILA PHARMACEUTICALS LTD

14265 I

III

6/30/1999

TRANSFOBEL PLASTICS NV

14266 I

II

6/29/1999

J K DRUGS AND PHARMACEUTICALS LTD

MFG SITE FACILITIES PROCEDURES AND PERSONEL FOR ANKLESHWAR SITE IN


GUJARATINDIA
POLYPROPYLENE SCREWCAPS FOR LOCKING ALUMINUM TUBES AS MANUFACTURED IN
BRUSSELS BELGIUM
CEPHALEXIN USP AS MANUFACTURED IN UTTAR PRADESH INDIA

14267 A

II

7/6/1999

ASPEN OSS BV

EPTIFIBATIDE AS MANUFACTURED IN THE NETHERLANDS

14268 I

III

7/6/1999

HUMPHREY COSBURN PLASTICS

ELDER-FRIENDLY CAPS AS MANUFACTURED IN TORONTO ONTARIO CANADA

14269 A

II

7/6/1999

EUTICALS SPA

MECAMYLAMINE HYDROCHLORIDE AS MANUFACTURED IN MILAN ITALY

14270 A

IV

6/28/1999

FONA INTERNATIONAL INC

14271 I

II

6/30/1999

ONO PHARMACEUTICAL CO LTD

877.170 N-C MINT FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM
ILLINOIS
ONO-2506 DRUG SUBSTANCE AS MANUFACTURED IN KAISHIAI FUKAYA SAITAMA JAPAN

14272 A

IV

6/15/1999

SHIN ETSU CHEMICAL CO LTD

14274 I

II

7/8/1999

BRISTOL MYERS SQUIBB COMPANY

AMPHOTERICIN NON PARENTAL GRADE AS MANUFACTURED IN HUMACO PUERTO RICO

14275 I

III

7/6/1999

TUBES SOUPLES NV

14276 A

III

6/23/1999

DANAPAK FLEXIBLES AS

ALUMINUM COLLAPSIBLE TUBES AS PACKAGING MATERIAL AS MANUFACTURED IN TERNA


BELGIUM
KISI VERBUND PACKAGING MATERIAL AS MANUFACTURED IN SLAELSE DENMARK

14273 N

ROGOSIN EMULSION AS MANUFACTURED IN CLAYTON NC

SHIN-ETSU AQOAT (HYPROMELLOSE ACETATE SUCCINATE) MANUFACTURED IN NIIGATA


JAPAN

NOT AN ASSIGNED NUMBER

Page 409

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14277 A
III
7/6/1999
MICA CORP

SUBJECT
A-131-X AS MANUFACTURED IN SHELTON CONNETICUT

14278 A

III

7/6/1999

MICA CORP

A-251-A AS MANUFACTURED IN SHELTON CONNETICUT

14279 A

II

7/9/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

NEFAZODON HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA ISRAEL

14280 A

III

7/7/1999

ALFATHERM SPA

ALFAFORM K122 AS MANUFACTURED IN VARESE ITALY

14281 I

II

7/9/1999

14282 I

II

7/7/1999

PHARMACEUTICAL FINE CHEMICALS BAHAMAS


LTD
RANBAXY LABORATORIES LTD

DOXAZOSIN MESYLATE AS MANUFACTURED IN FREEPORT GRAND BAHAMA ISLAND


BAHAMAS
AMMONIUM SALT OF MEVINOLINIC ACID AS MANUFACTURED IN HIMACHAL PRADESH INDIA

14283 I

II

7/12/1999

NV ORGANON

14284 A

II

6/30/1999

MALLINCKRODT LLC

DEHYDROISOANDROSTERONE POLYMORPH I AS MANUFACTURED IN OSS THE


NETHERLANDS
FENTANYL HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS MISSOURI

14285 A

II

6/30/1999

MALLINCKRODT INC

FENTANYL ALKALOID AS MANUFACTURED IN ST LOUIS MISSOURI

14286 I

II

7/7/1999

WOCKHARDT LTD

OMEPRAZOLE AS MANUFACTURED IN ANKLESHWAR INDIA

14287 I

II

7/12/1999

FUJISAWA PHARMACEUTICAL CO LTD

NILVADIPINE AS MANUFACTURED IN OSAKA JAPAN

14288 I

II

7/12/1999

HOECHST MARION ROUSSEL

LEVONORGESTREL AS MANUFACTURED IN ROMAINVILLE AND VERTOLAYE FRANCE

14289 I

II

7/12/1999

WOCKHARDT LTD

FLUOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANKLESHWAR INDIA

14290 A

III

7/14/1999

3M DRUG DELIVERY SYSTEMS

14291 A

III

7/14/1999

3M DRUG DELIVERY SYSTEMS

14292 A

III

7/14/1999

3M DRUG DELIVERY SYSTEMS

14293 A

III

7/8/1999

PROMENS MEDICAL PACKAGING AS

2-MIL POLYESTER FILM LAMINATE SCOTCHPAK 9732 AS MANUFACTURED IN COTTAGE


GROVE MN
2MIL POLYESTER FILM LAMINATE SCOTCHPAK 9733 AS MANUFACTURED IN COTTAGE GROVE
MN
2MIL POLYESTER FILM LAMINATE SCOTCHPAK 9735 AS MANUFACTURED IN COTTAGE GROVE
MN
POLYPROPYLENE VIALS AS MANUFACTURED IN LANGESKOV DENMARK

14294 A

II

6/30/1999

CORN PRODUCTS INTERNATIONAL INC

ANHYDROUS DEXTROSE USP AS MANUFACTURED IN BEDFORD PARK IL

14295 A

II

7/14/1999

RANBAXY LABORATORIES LTD

DOXYCYCLINE USP AS MANUFACTURED IN PUNJAB INDIA

14296 A

III

5/28/1999

PHARMA GLAS GMBH KONIAKOWSKY AND KUEHR

14297 A

II

7/9/1999

ERREGIERRE SPA

PACKAGING MATERIAL AMPOULES MADE OF TUBULAR GLASS AS MANUFACTURED IN


SALBURG AUSTRIA
GEPIRONE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO ITALY

14298 I

II

7/16/1999

CHEM SOURCE CORP

ETODOLAC DRUG SUBSTANCE AS MANUFACTURED IN GUAYAMA PUERTO RICO

14299 I

III

10/18/1999

RHODIA FILTEC INDUSTRIAL YARNS

POLYESTER GRANULAT 74K40 AS MFG IN EMMENBRUKE SWITZERLAND

14300 I

III

7/19/1999

RXI PLASTICS INC

POLYETHYLENE CONTAINERS AND CLOSURES AS MANUFACTURED IN OTTAWA OHIO

14301 I

IV

7/19/1999

FONA INTERNATIONAL INC

937.108 MASKING AGENT (A NATURAL FLAVOR) AS MANUFACTURED IN CAROL STREAM IL

14302 I

IV

7/19/1999

FONA INTERNATIONAL INC

937.106 NATURAL FLAVOR FOR MOUTHFEEL AS MANUFACTURED IN CAROL STREAM IL

14303 A

II

7/14/1999

NTP RADIOISOTOPES LTD

IODINE-131 (FISSION) AS MANUFACTURED IN PRETORIA SOUTH AFRICA

14304 A

II

7/21/1999

MOEHS IBERICA SL

ACETYLCYSTEINE USP AS MANUFACTURED IN RUBI SPAIN

14305 I

IV

7/22/1999

FONA INTERNATIONAL INC

14306 I

IV

7/22/1999

FLAVORS NORTH AMERICA INC

884.064N-C NATURAL AND ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN CAROL


STREAM ILLINOIS
805.018 N-C ARTIFICIAL BANANA FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS

14307 A

II

7/16/1999

SAFC BIOSCIENCES INC

14308 I

II

7/22/1999

J K DRUGS AND PHARMACEUTICALS LTD

EX-CELL PF CHO MEDIUM (MODIFIED) DEFINED SERUM-FREE MEDIUM AS MANUFACTURED IN


DENVER PENNSYLVANIA
CEFADROXIL MONOHYDRATE AS MANUFACTURED IN UTTAR PRADESH INDIA

14309 A

II

7/22/1999

DR REDDYS LABORATORIES LTD

FAMOTIDINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

14310 A

III

7/16/1999

STOELZE OBERGLAS GMBH

GLASS PRIMARY PACKAGING AS MANUFACTURED INKOFLACH AUSTRIA

Page 410

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14311 A
II
7/22/1999
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

SUBJECT
CAPTOPRIL USP AS MANUFACTURED IN ZHEJIANG PEOPLES REPUBLIC OF CHINA

14312 I

III

7/16/1999

HEINKE TECHNOLOGY INC

VAGINAL FOAM APPLICATORS AS MANUFACTURED IN LINCOLN NE

14313 A

III

7/22/1999

LANXESS DEUTSCHLAND GMBH

LEVAPREN 500 HV (ETHYLENE AMD VINYL COPOLYMER) AS MANUFACTURED IN DORMAGEN,


GERMANY

14314 N

NOT AN ASSIGNED NUMBER

14315 I

II

7/1/1998

NORTH CHINA PHARMACEUTICAL CORP

CYCLOSPORINE, USP (NON STERILE BULK)AS MANUFACTURED IN SHIJIAZHUANG PRC

14316 I

II

7/29/1999

JIANGSU HENGRUI MEDICINE CO LTD

THIOTEPA USP NON STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PRC

14317 I

II

7/28/1999

BAYER CORP PHARMACEUTICAL DIV

CIPROFLOXACIN OD AS MANUFACTURED IN WUPPERTAL AND LEVERKUSEN GERMANY

14318 A

II

7/28/1999

3M DRUG DELIVERY SYSTEMS

CI-1017 TRANSDERMAL DELIVERY SYSTEM AS MANUFACTURED IN ST PAUL MN

14319 A

II

7/1/1999

FARMHISPANIA SA

ML-107 AS MANUFACTURED IN BARCELONA SPAIN

14320 A

II

7/29/1999

SANTEN PHARMACEUTICAL CO LTD

CS-011 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA JAPAN

14321 I

II

7/29/1999

DAIICHI SANKYO CO LTD

CS-011 DRUG PRODUCT AS MANUFACTURED IN TOKYO JAPAN

14322 A

II

7/15/1999

NUSIL TECHNOLOGY LLC

14323 I

II

7/25/1999

LIFEHEALTH LIMITED

14324 A

II

7/29/1999

COSMA SPA

SENTRY SIMETHICONE USP & SENTRY SIMETHICONE USP FORMULATIONS AS


MANUFACTURED IN FRIENDLY WVA AND DACULA GA
NITOMAN (TETRABENAZINE) TABLETS AS MANUFACTURED IN NEWCASTLE-UPON-TYNE
UNITED KINGDOM
METOPROLOL TARTRATE AS MANUFACTURED IN BERGAMO ITALY

14325 I

II

7/28/1999

SEITZ FILTER WERKE

14326 I

IV

8/2/1999

FONA INTERNATIONAL INC

SEITZ DEPTH FILTER MEDIA AS MANUFACTURED IN BAD KREUZNACH FEDERAL REPUBLIC OF


GERMANY
918.003 SWEET AM (AN ARTIFICIAL FLAVOR ) AS MANUFACTURED IN CAROL STREAM IL

14327 I

II

8/2/1999

SUMIKA FINE CHEMICALS CO LTD

SNK-860 AS MANUFACTURED IN OSAKA CITY JAPAN

14328 I

IV

8/3/1999

FONA INTERNATIONAL INC

906.265 N-C ARTIFICIAL RASPBERRY FLAVOR AS MANUFACTURED IN CAROL STREAM IL

14329 I

IV

8/3/1999

FONA INTERNATIONAL INC

14330 I

IV

8/3/1999

FONA INTERNATIONAL INC

14331 I

IV

8/3/1999

FONA INTERNATIONAL INC

913.047 DEEP GREEN SPEARMINT FLAVOR NATURAL(WONF) AS MANUFACTURED IN CAROL


STREAM IL
913.048 SWEET GREEN SPEARMINT FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED
IN CAROL STREAM IL
913.049 WINTERMINT (A NATURAL FLAVOR) AS MANUFACTURED IN CAROL STREAM IL

14332 I

IV

8/3/1999

FONA INTERNATIONAL INC

14333 I

II

6/22/1999

14334 A

II

8/6/1999

935.094 ORIENTAL SPICEMINT FLAVOR NATURAL & ARTIFICIAL AS MANUFACTURED IN CAROL


STREAM IL
SHIJIAZHUANG PHARMACEUTICAL GROUP CO LTD TRAMADOL HYDROCHLORIDE USP (BULK) AS MANUFACTURED IN SHIJIAZHUANG HEBEI
CHINA
CIPLA LTD
ALENDRONATE SODIUM USP AS MANUFACTURED IN MAHARASHTRA INDIA

14335 A

II

8/6/1999

KATWIJK CHEMIE BV

14336 A

II

8/6/1999

PARTICLE DYNAMICS INTERNATIONAL LLC

1,2-DIMETHYL-3-HYDROXY-PYRIDONE-4(DEFERIPONE) AS MANUFACTURED IN KATWIJK THE


NETHERLANDS
IBUPROFEN 70% AS MANUFACTURED IN ST LOUIS MO

14337 A

II

7/28/1999

LUSOCHIMICA SPA

NISOLDIPINE AS MANUFACTURED IN LOMAGNA ITALY

14338 A

II

8/4/1999

SAMYANG GENEXBIO CORP

GENEXOL AS MANUFACTURED IN TAEJON KOREA

14339 I

II

8/10/1999

USV LTD

GLYBURIDE AS MANUFACTURED IN MAHARASHTRA INDIA

14340 I

II

8/9/1999

DIVIS LABORATORIES LTD

KETOROLAC ACID AS MANUFACTURED IN ANDHRA PRADESH INDIA

14341 A

II

8/4/1999

ERCROS SA

FOSFOMYCIN SODIUM AS MANUFACTURED IN MADRID SPAIN

14342 I

IV

8/12/1999

FONA INTERNATIONAL INC

14343 I

IV

8/12/1999

FONA INTERNATIONAL INC

852.114 N-C NATURAL PUNCH FLAVOR(HAWAIIAN TYPE) AS MANUFACTURED IN CAROL


STREAM IL
865.001 N-C NATURAL LIME FLAVOR (WONF) AS MANUFACTURED IN CAROL STREAM IL

Page 411

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14344 I
IV
8/12/1999
FONA INTERNATIONAL INC

SUBJECT
894.068 N-C NATURAL PEPPERMINT FLAVOR(WONF) AS MANUFACTURED IN CAROL STREAM

14345 I

IV

8/12/1999

FONA INTERNATIONAL INC

14346 A

II

8/3/1999

DISHMAN NETHERLANDS BV

921.002 NOR-CAP NATURAL TANGERINE FLAVOR(WONF) AS MANUFACTURED IN CAROL


STREAM IL
CHOLESTEROL HP AS MANUFACTURED IN VEENENDAAL THE NETHERLANDS

14347 I

II

8/13/1999

LIPOID GMBH

LIPOID TRIOLEIN AS MANUFACTURED IN LUDWIGSHAFEN FEDERAL REPUBLIC OF GERMANY

14348 I

III

7/27/1999

RAYVEN INC

SILICONE COATED POLYESTER RELEASE LINER AS MANUFACTURED IN ST PAUL MN

14349 A

II

8/3/1999

ESSENTIAL PHYTOSTEROLINS INC

STERINOL AS MANUFACTURED IN MIDRAND SOUTH AFRICA

14350 I

II

8/18/1999

NAPRO BIOTHERAPEUTICS, INC.

PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN BOULDER COLORADO

14351 I

II

8/19/1999

MOLYBDENUM-99 OF U-235 (N,F) AS MANUFACTURED IN MOSCOW RUSSIA

14352 A

II

8/19/1999

TECHNOLOGY COMMERCIALIZATION
INTERNATIONAL INC
CIPLA LTD

14353 A

II

8/14/1999

PIRAMAL ENTERPRISES LTD

IBUPROFEN AS MANUFACTURED IN ANDHRA PRADESH INDIA

14354 I

II

8/16/1999

JAPAN TOBACCO INC

JTT-501 DRUG SUBSTANCE AS MANUFACTURED IN OSAKA JAPAN

14355 A

II

6/22/1999

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

ENALAPRIL MALEATE USP AS MANUFACTURED IN LINHAI CITY ZHEJIANG PROVINCE CHINA

14356 I

III

8/23/1999

SABIC PETROCHEMICALS BV

SABIC LDPE 2101TN00 AS MANUFACTURED IN BEEK THE NETHERLANDS

14357 I

III

8/2/1999

C AND H PACKAGING CO INC

UNIDOSE DRUG PACKAGING MATERIAL AS MANUFACTURED IN MERRILL WI

14358 A

III

8/18/1999

MICA CORP

MICA G-1092 AS MANUFACTURED IN SHELTON CONN

14359 A

III

8/20/1999

TOKAI CHEMICAL INDUSTRY CO LTD

14360 A

8/9/1999

JANSSEN DIAGNOSTICS BVBA

DESSICANT TYPE PACKAGING MATERIALS AS MANUFACTURED IN AICHI AND TOCHIGI


PREFECTURES JAPAN
GENOTYPIC RESISTANCE TESTING FOR HIV AS DEVELOPED IN MECHELEN BELGIUM

14361 A

III

8/24/1999

STYROLUTION AMERICA LLC

14362 I

II

8/24/1999

BACHEM INC

STYRENE METHYL METHACRYLATE COPOLYMER RESIN NAS30 AS MANUFACTURED IN


INDIAN ORCHARD MA
DESMOPRESSIN AS MANUFACTURED IN TORRANCE AND SAN DIEGO CA

14363 I

II

8/20/1999

ZONAGEN INC

CHITOSAN AS MANUFACTURED IN THE WOODLANDS TEXAS

14364 A

8/9/1999

CYDEX PHARMACEUTICALS INC

SULFOBUTYLETHER BETACYCLODEXTRIN(CAPTISOL) SAFETY STUDIES

14365 I

II

8/16/1999

14366 I

II

8/19/1999

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
MEDICHEM SA

D L-2(DIFLUOROMETHYL)ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE AS


MANUFACTURED IN CONSHOHOKEN PA
DOXAZOSIN MESYLATE AS MANUFACTURED IN GERONA SPAIN

14367 A

II

8/25/1999

ACS DOBFAR SPA

CEFOTAXIME SODIUMSTERILE AS MANUFACTURED IN MILANO ITALY

14368 A

8/30/1999

CANGENE BIOPHARMA INC

14369 I

III

8/25/1999

CONTINENTALAFA DISPENSING CO

MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR NEW


STERILE PROCESSING FACILITY IN BALTIMORE MD
LLD-500 PUMPS AS MANUFACTURED IN BRIDGEPORT CT

14370 I

II

8/30/1999

GRANULES INDIA LTD

COMPRESSO GGF 95P AS MANUFACTURED IN HYDERABAD INDIA

14371 I

II

8/30/1999

GRANULES INDIA LTD

COMPRESSO GGF95 AS MANUFACTURED IN HYDERABAD INDIA

14372 A

II

8/30/1999

GRANULES INDIA LTD

GUAIFENESIN USP 23 AS MANUFACTURED IN HYDERABAD INDIA

14373 I

II

8/26/1999

SIOUX PHARM INC

CHONDROITIN SULFATE TYPE A AS MANUFACTURED IN SIOUX CENTER IOWA

14374 A

II

8/30/1999

TARO PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL

14375 A

II

8/31/1999

ALBEMARLE CORP

MILRINONE AS MANUFACTURED IN SOUTH HAVEN MI

14376 A

III

7/9/1999

ECLATIN AG

14377 A

III

8/31/1999

POLYONE CORP

C-8820 INTERNAL LACQUER FOR TUBES AND AEROSOLS AS MANUFACTURED IN SOLOTHURN


SWITZERLAND
CC00022099WE AS MANUFACTURED IN VONORE, TN.

PRAZIQUANTEL USP AS MANUFACTURED IN BANGALORE & MAHARASHTRA INDIA

Page 412

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14378 A
III
8/31/1999
POLYONE CORP

SUBJECT
CC00001885D4/WE AS MANUFACTURED IN VONORE, TN.

14379 I

III

8/23/1999

ROHM AND HAAS CO

PACKAGING MATERIAL AS MANUFACTURED IN MONTREAL QUEBEC CANADA

14380 I

II

8/4/1999

MERCK KGAA

EMD 121974 AS MANUFACTURED IN LYON CEDEX FRANCE

14381 I

III

8/25/1999

CARCANO ANTONIO S.P.A.

PACKAGING MATERIAL AS MANUFACTURED IN MANDELLO DEL LARIO ITALY

14382 I

II

9/2/1999

DIOSYNTH BV

BOVINE INSULIN HIGHLY PURIFIED AS MANUFACTURED IN SERIFONTAINE FRANCE

14383 I

II

8/31/1999

HARLAN BIOSCIENCE FOR SCIENCE INC

CGMP MURINE ASCITES FLUID AS MANUFACTURED IN MADISON WISCONSIN

14384 I

II

8/31/1999

PROTOPORPHYRIN IX DIMETHYLESTER(PPME) AS MANUFACTURED IN CHIBA JAPAN

14385 I

II

8/31/1999

SATO PHARMACEUTICAL RESEARCH INSTITUTE


INC
NEOMPS INC

14386 I

II

8/30/1999

NINGXIA PHARMACEUTICAL FACTORY

14387 I

IV

9/1/1999

FONA INTERNATIONAL INC

14388 I

IV

9/7/1999

AARHUSKARLSHAMN AB

TETRACYCLINE HYDROCHLORIDE AS MFG IN YINCHUAN CITY NINGXIAHUI NATIONALITY


AUTONOMOUS REGION P.R. OF CHINA
815.109 BUBBLEGUM FLAVOR NATURAL & ARTIFICIAL AS MANUFACTURED IN CAROL STREAM
IL
AKOLINE A MEDIUM CHAIN MONO-DIGLYCERIDE AS MANUFACTURED IN KARLSHMN SWEDEN

14389 I

II

8/26/1999

CHROMADEX INC

PACLITAXEL AS MANUFACTURED IN XI'AN CHINA

14390 A

II

9/7/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

MISOPROSTOL AS MANUFACTURED IN CORK ISLAND IRELAND

14391 A

II

9/7/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

MISOPROSTOL HPMC DISPERSION 1:100 AS MANUFACTURED IN CORK IRELAND

14392 A

III

9/6/1999

MEDISIZE CORP

MIRENA INSERTER AS MANUFACTURED IN LEHMO FINLAND

14393 A

II

9/10/1999

TOYAMA CHEMICAL CO LTD

14394 I

9/8/1999

DABUR INDIA LTD

14395 A

II

9/8/1999

FRESENIUS KABI ONCOLOGY LTD

T-3811(BMS-284756-01) DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA CITY TOYAMA


JAPAN
MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR MFG OF
METAXALONE IN KALYANI DIST NADIA WEST BENGAL INDIA
METAXALONE AS MANUFACTURED IN KALYANI DIST NADIA WEST BENGAL INDIA

14396 I

III

8/23/1999

DSM RESEARCH

SABIC LDPE 2201TH12 AS MANUFACTURED IN BEEK THE NETHERLANDS

14397 A

III

9/17/1999

OWENSBORO SPECIALTY POLYMERS INC

DARAN SL155 AS MANUFACTURED INOWENSBORO KENTUCKY

14398 A

II

9/10/1999

NUVIEW LIFE SCIENCES

THALLIUM TL-201 RADIOCHEMICAL AS MANUFACTURED IN DENTON TEXAS

14399 A

II

9/13/1999

ASPEN OSS BV

WARFARIN SODIUM AS MANUFACTURED IN APELDORN THE NETHERLANDS

14400 I

II

9/10/1999

BIOTIKA AS

PENICILLIN G PROCAINE AS MANUFACTURED IN SLOVENSKA LUPCA

14401 I

III

9/7/1999

OWENS ILLINOIS CLOSURE INC

DISPENSING CLOSURES AS MANUFACTURED IN NEW CASTLE PA

14402 I

II

9/15/1999

LEK PHARMACEUTICAL AND CHEMICAL CO DD

LOVASTATIN ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN KOLODVORSKA SLOVENIA

14403 I

II

9/13/1999

LD PHARMACEUTICAL

PACLITAXEL AS MANUFACTURED IN OROMOCTO NEW BRUNSWICK CANADA

14404 A

III

9/16/1999

MEDISIZE CORP

LEVONOVA(=MIRENA) T-BODY AS MANUFACTURED IN NURMIJARVI FINLAND

14405 I

II

9/14/1999

SCOTT MEDICAL PRODUCTS

14406 A

III

9/18/1999

MICA CORP

PERFLUOROPROPANE(OCTAFLUOROPROPANE)GAS AS MANUFACTURED IN
PLUMSTEADVILLE PA
MICA M-1164 AS MANUFACTURED IN SHELTON CONN

14407 I

IV

9/21/1999

BIRMINGHAM POLYMERS INC

BIODEGRADEABLE POLYMERS AS MANUFACTURED IN BIRMINGHAM AL

14408 A

8/31/1999

GULF PHARMACEUTICAL INUSTRIES

STERILE MANUFACTURING FACILITIES LOCATED IN RAS-AL-KAIMAH, UNITED ARAB EMIRATES

14409 A

III

9/15/1999

C AND J INDUSTRIES INC

13MM FLAT TIP PLUG .006 ORIFICE AS MANUFACTURED IN MEADVILLE PA

14410 A

II

9/21/1999

JUBILANT GENERICS LTD

14411 A

II

9/17/1999

FINE CHEMICALS CORP PTY LTD

CARBAMAZEPINE DRUG SUBSTANCE AS MANUFACTURED IN NANJANGUD MYSORE


DISTRICT,KARNATAKA,INDIA.
PENBUTOLOL SULFATE AS MANUFACTURED IN EPPING SOUTH AFRICA

SYNTHETIC PEPTIDE MPS-93 AS MANUFACTURED IN SAN DIEGO CA

Page 413

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14412 A
II
9/23/1999
UNION QUIMICO FARMACEUTICA SA UQUIFA SA

SUBJECT
CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN MILAN ITALY

14413 A

IV

12/9/1998

SCIENTIFIC POLYMER PRODUCTS INC

POLY(2-HYDROXYMETHYL METHACRYLATE) AS MANUFACTURED IN ONTARIO NEW YORK

14414 A

IV

9/24/1999

LIPOID GMBH

LIPOID E SM AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

14415 I

II

10/6/1999

FAKO ILACLARI AS

RANITIDINE HYDROCHLORIDE FORM I BULK AS MFG IN ISTANBUL TURKEY

14416 I

II

9/23/1999

DOCTOR REDDYS LABORATORIES LTD

14417 I

III

9/14/1999

FRITZ GMBH AND CO KG

14418 I

IV

9/23/1999

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD

1-METHYLAMINO-1-METHYTHIO-2-NITROETHENE(NMSM) CHEMICAL INTERMEDIATE AS


MANUFACTURED IN ANDHRA PRADESH INDIA
GLASS TUBULAR AMPOULES FOR PHARMACEUTICAL AND COSMETICAL PACKAGING AS
MANUFACTURED IN WERTHEIM MAIN GERMANY
SODIUM STARCH GLYCOLATE NF18 AS MANUFACTURED IN TAIWAN ROC

14419 I

II

9/23/1999

FLUCONAZOLE AS MANUFACTURED IN TAIWAN ROC

14420 A

II

9/22/1999

CHUNGWA CHEMICAL SYNTHESIS & BIOTECH CO


LTD
MOEHS IBERICA SL

14421 I

II

10/4/1999

CALCIUM POLYCARBOPHIL USP 23 AS MANUFACTURED IN TAIWAN ROC

14422 I

II

9/30/1999

14423 I

9/3/1999

CHUNGHWA CHEMICAL SYNTHESIS & BIOTHCH


CO, LTD
INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA
LTD
NORDEN PAC PLASTIC AB

14424 I

II

10/21/1999

DUMEX ALPHARMA A S

14425 A

II

9/29/1999

JANSSEN PHARMACEUTICA NV

14426 A

II

9/30/1999

UGP THERAPEUTICS

14427 A

III

10/1/1999

B BRAUN MELSUNGEN AG

14428 A

II

9/30/1999

DR REDDYS LABORATORIES LTD

14429 A

II

9/28/1999

CORDEN PHARMA SWITZERLAND LLC

14430 I

II

9/28/1999

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
NOT AN ASSIGNED NUMBER

14432 I

II

9/30/1999

ASAHI GLASS CO LTD

14433 I

III

9/30/1999

MULTIFILM PACKAGING CORPORATION

14434 I

III

9/27/1999

AMPACET CORP

14435 I

III

9/27/1999

AMPACET CORP

14436 A

II

10/5/1999

FERMIC SA DE CV

110916 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN


DERIDDER LA CARTERSVILLE GA LATEXO TX AND HEATH OH
110869 WHITE COP CMPD POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE IN DERIDDER LA HEATH OH CARTERSVILLE GA AND LATEXO TX
CLAVULANATE POTASSIUM AS MANUFACTURED IN MEXICO CITY MEXICO

14437 A

II

10/5/1999

CIPLA LTD

SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

14438 A

II

10/4/1999

CHATTEM CHEMICALS INC

BUTABARBITAL SODIUM AS MANUFACTURED IN CHATTANOOGA TENNESSEE

14439 I

II

6/23/1999

SANYO FINE CO LTD

ELS(ELASTASE) AS MANUFACTURED IN HUKUI AND HYOGO PREFECTURES JAPAN

14440 I

II

10/8/1999

GENZYME CORP

LEUPROLIDE ACETATE AS MANUFACTURED IN LIESTAL SWITZERLAND

14441 I

II

10/7/1999

PFANSTIEHL LABORATORIES INC

N-ACETYL-D-GLUCOSAMINE AS MANUFACTURED IN WAUKEGAN IL

14442 I

II

10/7/1999

SLOVAKOFARMA AS

MEXILETINE HYDROCHLORIDE AS MANUFACTURED IN HLOHOVEC SLOVAKIA

14431 N

ACEBUTOLOL AS MANUFACTURED IN RUBI SPAIN

TIAZOFURIN AS MANUFACTURED IN BORONIA VICTORIA AUSTRALIA


MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR ASTORP SWEDEN
LOCATION
COLISTIN SULFATE MONOCOMPONENT AS MFG IN COPENHAGEN DENMARK
GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN EDINBURGH, SCOTLAND AND
WETTERN, BELGIUM FOR JANSSEN PHARMACEUTICA NV
E. COLI DIRECT EXPRESSION PRODUCTION SYSTEM FOR RECOMBINANT SALMON
CALCITONIN AS MANUFACTURED IN BOONTON, NJ
1ML AND 4ML DISPENSER SETS AND 120ML ASPIRATOR TUBES AS MANUFACTUREDIN BAD
AROLSEN, GERMANY
OXAPROZIN AS MANUFACTURED IN ANDHRA PRADESH INDIA
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL SODIUM SALT(POPG NA) AS
MANUFACTURED IN LIESTAL SWITZERLAND
MELOXICAM JETMILLED AS MFG IN BIBERACH/RIB GERMANY

PAROXETINE HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN ICHIHARA CITY CHIBA


JAPAN
CAST POLYPROPYLENE TWISTWRAP AS MANUFACTURED IN ELGIN IL

Page 414

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14443 A
IV
10/8/1999
PADDOCK LABORATORIES LLC
14444 I

IV

10/12/1999

FONA INTERNATIONAL INC

14445 I

IV

10/12/1999

FONA INTERNATIONAL INC

SUBJECT
ORA-BRAND OF ORAL PHARMACEUTICAL VEHICLES AS MANUFACTURED IN MINNEAPOLIS
MINNESOTA
826.397 N-C CHOCOLATE FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL
STREAM IL
840.136 ART CREAM FLAVOR POWDER AS MFG IN CAROL STREAM IL

14446 I

IV

10/12/1999

FONA INTERNATIONAL INC

852.263 N-C NA AND ART GOLDEN PUNCH FLAVOR AS MFG IN CAROL STREAM IL

14447 I

IV

10/12/1999

FONA INTERNATIONAL INC

884.044 NA ORANGE EXTRACT AS MFG IN CAROL STREAM IL

14448 I

IV

10/12/1999

FONA INTERNATIONAL INC

800.002 N-C NA ALMOND FLAVOR AS MFG IN CAROL STREAM IL

14449 I

IV

9/21/1999

FONA INTERNATIONAL INC

926.462 NA AND ART VANILLA FLAVOR AS MFG IN CAROL STREAM IL

14450 I

IV

9/21/1999

FONA INTERNATIONAL INC

906.243 N-C NA RASPBERRY FLAVOR WONF AS MFG IN CAROL STREAM IL

14451 I

IV

9/21/1999

FONA INTERNATIONAL INC

895.047 NA ART PINEAPPLE FLAVOR AS MFG IN CAROL STREAM IL

14452 I

IV

9/21/1999

FONA INTERNATIONAL INC

884.612 JUICY ORANGE FLAVOR NA AND ART AS MFG IN CAROL STREAM IL

14453 I

IV

9/21/1999

FONA INTERNATIONAL INC

884.611 JUICY ORANGE FLAVOR NA AND ART AS MFG IN CAROL STREAM IL

14454 I

IV

9/21/1999

FONA INTERNATIONAL INC

884.610 ORANGE CREME FLAVOR EMULSION NA AND ART AS MFG IN CAROL STREAM IL

14455 I

IV

9/21/1999

FONA INTERNATIONAL INC

884.011 ORANGE CREME FLAVOR NA AND ART FLAVOR AS MFG IN CAROL STREAM IL

14456 I

IV

9/21/1999

FONA INTERNATIONAL INC

861.057 N-C NATURAL LEMON HONEY FLAVOR(WONF) AS MFG IN CAROL STREAM IL

14457 I

IV

9/21/1999

FONA INTERNATIONAL INC

856.055 N-C NATURAL GRAPE FLAVOR(WONF) AS MFG CAROL STREAM IL

14458 I

IV

9/21/1999

FONA INTERNATIONAL INC

856.012 N-C NATURAL GRAPE FLAVOR AS MFG IN CAROL STREAM IL

14459 I

IV

9/12/1999

FONA INTERNATIONAL INC

856.003 NC ART GRAPE FLAVOR AS MFG IN CAROL STREAM IL

14460 I

IV

9/21/1999

FONA INTERNATIONAL INC

852.330 RED PUNCH FLAVOR NA AND ART(ALCOHOL FREE) AS MFG IN CAROL STREAM IL

14461 I

IV

9/21/1999

FONA INTERNATIONAL INC

839.099 N-C CRANBERRY FLAVOR NA(WONF) AS MFG IN CAROL STREAM IL

14462 I

IV

9/21/1999

FONA INTERNATIONAL INC

825.527 CHERRY FLAVOR NA AND ART(ALCOHOL FREE) ETOH AS MFG IN CAROL STREAM IL

14463 I

IV

10/6/1999

FONA INTERNATIONAL INC

915.192 ART STRAWBERRY FLAVOR AS MFG IN CAROL STREAM IL

14464 I

IV

10/7/1999

FLAVORS NORTH AMERICA INC

890.045 OS NATURAL MOCHA FLAVOR AS MFG IN CAROL STREAM IL

14465 I

IV

10/7/1999

FONA INTERNATIONAL INC

944.023 OS ART KIWI FLAVOR AS MFG IN CAROL STREAM IL

14466 A

III

10/1/1999

POLYONE CORP

CC10004850WE AS MANUFACTURED IN VONORE, TN.

14467 A

II

9/29/1999

3M PURIFICATION INC

POLYNET CARTRIDGE AS MFG IN ENFIELD CT

14468 A

II

10/6/1999

SHASUN PHARMACEUTICALS LTD

RANITIDINE HYDROCHLORIDE AS MFG IN CUDDALORE INDIA

14469 A

II

10/11/1999

LONZA BIOLOGICS PLC

HP67.6 ANTIBODY AS MFG IN BERKSHIRE UK

14470 I

II

10/14/1999

RANBAXY LABORATORIES LTD

LOVASTATIN USP AS MFG IN HIMACHAL PRADESH INDIA

14471 I

II

10/8/1999

SICOR SPA

N-ACETYL CALICHEAMICIN AS MFG IN MILAN AND PAVIA ITALY

14472 A

II

10/8/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

14473 I

III

10/13/1999

POLIMERI EUROPA SPA

NAC-GAMMA CALICHEAMICIN ACBUT OSU(PIVOTAL INTERMEDIATE) AS MFG IN MILAN AND


VERCELLI ITALY
RIBLENE FM53 AS MFG IN FERRARA ITALY

14474 A

II

10/19/1999

UQUIFA MEXICO SA DE CV

CIPROFLAXIN HCL AS MFG IN BARCELONA SPAIN

14475 I

II

10/13/1999

GLAXOSMITHKLINE

14476 A

III

10/8/1999

14477 A

II

10/15/1999

SOCIETA INDUSTRIA COMMERCIO APPLICAZIONI


TECNICHE E FARMACEUTICHE SPA
OLON SPA

PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MFG IN CARRIGALINE IRELAND AND


AYRSHIRE SCOTLAND
PACKAGING MATERIAL RELATED TO THE PRODUCTION OF GLASS AMPOULES AS MFG IN
TREVIGLIO(BG)ITALY
MYCOPHENOLIC ACID NS TECHNICAL GRADE AS MFG IN SETTIMO TORINESE(TO)ITALY

Page 415

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14478 I
III
10/18/1999
DONEGAL HEALTHCARE LTD

SUBJECT
TIP & CAP DROPPER SYSTEM AS MFG IN LETTERKENNY IRELAND

14479 I

II

10/20/1999

BOSTON BIOSYSTEMS

GTI-2040 DRUG SUBSTANCE AS MFG IN BEDFORD MA

14480 I

II

10/14/1999

WOCKHARDT LTD

AZITHROMYCIN USP AS MFG IN ANKLESHWAR INDIA

14481 I

IV

10/18/1999

FONA INTERNATIONAL INC

807.117 N-C MIXED BERRY FLAVOR NA(WONF) AS MFG IN CAROL STREAM IL

14482 I

IV

10/15/1999

FONA INTERNATIONAL INC

815.111 BUBBLEMINT FLAVOR NA & ART AS MFG IN CAROL STREAM IL

14483 I

IV

10/15/1999

FONA INTERNATIONAL INC

815.112 BUBBLEMINT FLAVOR NA & ART AS MFG IN CAROL STREAM IL

14484 I

IV

10/18/1999

FONA INTERNATIONAL INC

856.409 GRAPE FLAVOR ART AS MFG IN CAROL STREAM IL

14485 I

IV

10/18/1999

FONA INTERNATIONAL INC

926.336 N-C NA & ART VANILLA FLAVOR AS MFG IN CAROL STREAM IL

14486 I

IV

10/18/1999

FONA INTERNATIONAL INC

932.049 WINTERGREEN FLAVOR ART AS MFG IN CAROL STREAM IL

14487 I

IV

10/18/1999

FONA INTERNATIOANL INC

932.050 WINTERGREEN FLAVOR ART AS MFG IN CAROL STREAM IL

14488 I

IV

10/18/1999

FONA INTERNATIONAL INC

932.051 WINTERGREEN FLAVOR ART AS MFG IN CAROL STREAM IL

14489 I

IV

10/18/1999

FONA INTERNATIONAL INC

936.404 MASKING AGENT FLAVOR NA AS MFG IN CAROL STREAM IL

14490 N

NOT AN ASSIGNED NUMBER

14491 A

IV

10/10/1999

ZSCHIMMER AND SCHWARZ ITALIANA SPA

GM 9011/C AS MFG IN TRICERRO(VC)ITALY

14492 A

IV

10/10/1999

ZSCHIMMER AND SCHWARZ ITALIANA SPA

ZETESOL LES 2 AS MFG IN TRICERRO(VC)ITALY

14493 I

II

10/14/1999

RP SCHERER NORTH AMERICA

ACCUTANE (ISOTRETINOIN) AS MFG IN ST PETERSBURG FL

14494 I

II

10/5/1999

J K DRUGS AND PHARMACEUTICALS LTD

14495 I

10/11/1999

MEITO SANGYO CO LTD

7-AMINODESACETOXYCEPHALOSPORANIC ACID (7-ADCA) CHEMICAL INTERMEDIATE AS MFG


IN UTTAR PRADESH INDIA
MFG AND QUALITY CONTROL OF SUBSTANCES-NAGOYA-AS IN AICHI JAPAN

14496 I

III

10/22/1999

KANEKA TEXAS CORP

14497 I

III

10/20/1999

BOREALIS AG

14498 A

III

10/18/1999

LAJOVIC TUBA EMBALAZA, D.D.

14499 I

10/21/1999

EVERLIGHT CHEMICAL IND CORP

14500 I

II

10/21/1999

EVERLIGHT CHEMICAL IND CORP

14501 I

II

10/28/1999

HMR-4052 AS MFG IN KAWAGOE CITY SAITAMA JAPAN

14502 A

II

10/29/1999

HOECHST MARION ROUSSEL PHARMACEUTICALS


INC
MALLINCKRODT INC

14503 I

II

10/27/1999

BIOXEL PHARMA INC

PACLITAXEL AS MFG IN SAINTE-FOY QC CANADA

14504 A

II

10/22/1999

GADOR SA

14505 A

II

10/27/1999

MALLINCKRODT INC

PAMIDRONIC ACID ACTIVE PHARMACEUTICAL INGREDIENT AS MFG IN BUENOS ARIES


ARGENTINA
SUFENTANIL CITRATE USP AS MANUFACUTRED IN ST LOUIS MO

14506 I

III

9/29/1999

AGIFIN SRL

14507 I

II

11/9/1999

QUIMICA FINA FARMEX SA DE CV

SECURECLIK 5ML SAFETY SYRINGES WITH RETRACTABLE NEEDLE AS MFG IN


RENATE(MI)ITALY
ITRACONAZOLE AS MFG IN VILLA CORREGIDORA QUERETARO MEXICO

14508 I

IV

11/1/1999

FONA INTERNATIONAL INC

802.029 N-C ANISE FLAVOR NATURAL AS MFG IN CAROL STREAM IL

14509 I

11/5/1999

LA CALHENE

14510 I

III

10/27/1999

PRESSPART INC

MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR PHARMACEUTICAL


PACKAGE COMPONENT PROCESSING FACILITY LOCATED IN VENDOME FRANCE
EXTRUDED CANS MFG AND CLEANED IN CARY NC

14511 A

II

10/29/1999

MEDICHEM SA

FLUVOXAMINE MALEATE AS MFG IN CELRA(GIRONA)SPAIN

PA-10 PA-20 PA-30 PA-40 PA-50 PA-101 AND PA-110 AS MFG IN PASEDENA TX TAGASAGO JAPAN
AND WESTERIO-OEVEL BELGIUM
HE1903 AS MFG IN BERINGEN BELGIUM
ALUMINUM TUBES FOR USE IN THE PHARMACEUTICAL INDUSTRY AS MFG IN LJUBLJANA
SLOVENIA
MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR FACTORY LOCATED IN
TAOYUAN HSIEN TAIWAN
MISOPROSTOL AS MFG IN TAOYUAN HSIEN TAIWAN

OXYMORPHONE HYDROCHLORIDE USP AS MANUFACTURED IN ST LOUIS MO

Page 416

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14512 I
II
10/26/1999
TEVA PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
THIOTEPA AS MFG IN SANTHIA(VERCELLI)ITALY

14513 I

III

10/27/1999

AMPACET CORP

14514 I

11/5/1999

PRONOVA BIOMEDICAL AS

11976 WHITE PE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE INDERIDDER


LACARTERSVILLE GAHEATH OH AND LATEXO TX
MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR OSLO NORWAY

14515 A

IV

11/5/1999

FMC BIOPOLYMER AS

CHITOSAN CHLORIDE AND CHITOSAN GLUTAMATE AS MFG IN OSLO NORWAY

14516 A

III

10/1/1999

POLYONE CORP

CC00017246WE/D4 AS MANUFACTURED IN VONORE, TN.

14517 A

III

11/22/1999

ARDAGH GLASS GMBH

AMBER GLASS CONTAINERS AS MFG IN BAD MUNDER, GERMANY

14518 I

III

11/8/1999

DSM RESEARCH

STAMYLAN P 15M10 AS MFG IN GELEEN THE NETHERLANDS

14519 I

III

11/8/1999

DSM RESEARCH

STAMYLAN P 16M10 AS MFG IN GELEEN THE NETHERLANDS

14520 I

10/15/1999

DAICEL CHEMICAL INDUSTRIES LTD

14521 I

II

10/15/1999

DAICEL CHEMICAL INDUSTRIES LTD

FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES OF ARAI PLANT FOR MFG
OF CHIRAL PAK ADCSP FOR LIQUID CHROMAIC RESOLUTION IN NIIGATA JAPAN
CHIRALPAK AD CSP AS MFG IN NIIGATA JAPAN

14522 I

III

8/13/1999

POLIMERI EUROPA FRANCE SA

FLEXIRENE MR50 AS MFG IN DUNKIRK FRANCE

14523 I

III

10/15/1999

RISDON SA

14524 A

II

11/15/1999

LG LIFE SCIENCES LTD

35ML PILL JARS HDPE WHITE MOULD REFERENCE 1600 AS MFG IN OFFRANVILLE FRANCE
FOR AL HIKMA/ JORDAN
GEMIFLOXACIN MESYLATE AS MFG IN IKSAN CITY CHUNBUK-DO KOREA

14525 A

II

11/12/1999

SAFC BIOSCIENCES INC

EX-CELL 325 PF CHO PROTEIN FREE MEDIUM AS MFG IN DENVER PENNSYLVANIA

14526 I

III

11/10/1999

CANADA COLORS AND CHEMICALS LTD

PACKAGING MATERIAL AS MFG IN COLBORNE ONTARIO CANADA

14527 I

II

11/9/1999

CHEMI SPA

14528 I

II

11/10/1999

J K DRUGS AND PHARMACEUTICALS LTD

POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHORYLCHOLINE) AS MFG IN
PATRICA(FROSINONE)ITALY
CEPHRADINE USP AS MFG IN UTTAR PRADESH INDIA

14529 A

II

11/12/1999

APOTEX PHARMACHEM INDIA PVT LTD

FLUVOXAMINE MALEATE AS MFG IN BRANTFORD ONTARIO CANADA

14530 I

II

11/16/1999

WOCKHARDT LTD

FAMOTIDINE USP AS MFG IN ANKLESHWAR INDIA

14531 I

III

11/15/1999

BORMIOLI ROCCO E FIGLIO SPA PLASTIC DIV

14532 I

II

11/15/1999

14533 I

III

11/15/1999

PHARMACEUTICAL FINE CHEMICALS(PFC)


BAHAMAS LTD
HI TECH POLYMERS(INDIA) PVT LTD

14534 A

II

11/11/1999

DIPHARMA FRANCIS SRL

SPECIAL CHILD PROOF CAP 028MM AS MFG IN CASTLEGUELFO(PR) RIVANAZZANO(PV)ITALY


AND SAINT SUPICE FRANCE
TERAZOSIN HYDROCHLORIDE AS MFG IN RIVIERA BEACH FLORIDA AND FREEPORT GRAND
BAHAMAS
HDPE BOTTLES AND CLOSURES FOR PHARMACEUTICAL APPLICATIONS AS MFG IN
GUJARATINDIA
BUPROPION HCL AS MFG IN MILAN ITALY

14535 I

IV

11/11/1999

COLORS FOR PLASTICS INC

R28415 AS MFG IN ELK GROVE IL

14536 A

II

11/16/1999

EVONIK CORPORATION

LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE

14537 I

II

11/19/1999

FUJISAWA PHARMACEUTICAL CO LTD

FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN

14538 A

II

11/9/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE AS MFG IN LERMA MEXICO

14539 A

II

11/18/1999

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

CLINDAMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN BARCELONA SPAIN

14540 A

II

11/18/1999

ASPEN OSS BV

TESTOSTERONE UNDECANOATE AS MFG IN OSS THE NETHERLANDS

14541 I

II

11/22/1999

EVONIK TECHNOCHEMIE GMBH

TRAMADOL HYDROCHLORIDE AS MFG IN RADEBEUL, GERMANY

14542 I

IV

11/14/1999

FONA INTERNATIONAL INC

2050A TUTTI FRUTTI BASE OIL AS MFG IN CAROL STREAM IL

14543 I

IV

11/14/1999

FONA INTERNATIONAL INC

852.049 N-C NATURAL AND ARTIFICIAL FUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL

14544 I

IV

11/14/1999

FONA INTERNATIONAL INC

14545 I

IV

11/14/1999

FONA INTERNATIONAL INC

852.013 STRAW PUNCH FLAVOR(A NATURAL AND ARTIFICIAL FLAVOR) AS MFG IN CAROL
STREAM IL
2038A NATURAL AND ARTIFICIAL TROPICAL FRUIT PUNCH FLAVOR AS MFG IN CAROL STREAM
IL

Page 417

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14546 I
IV
11/14/1999
FONA INTERNATIONAL INC

SUBJECT
2038B INTERMEDIATE B AS MFG IN CAROL STREAM IL

14547 I

IV

11/14/1999

FONA INTERNATIONAL INC

856.039 N-C ARTIFICIAL CONCORD GRAPE FLAVOR AS MFG IN CAROL STREAM IL

14548 I

IV

11/14/1999

FONA INTERNATIONAL INC

856.316 N-C ARTIFICIAL CONCORD GRAPE FLAVOR AS MFG IN CAROL STREAM IL

14549 I

IV

11/14/1999

FONA INTERNATIONAL INC

856.107 N-C ARTIFICIAL CONCORD GRAPE FLAVOR AS MFG IN CAROL STREAM IL

14550 I

IV

11/14/1999

FONA INTERNATIONAL INC

884.596 N-C ORANGE CREME FLAVOR NATURAL(WONF) AS MFG IN CAROL STREAM IL

14551 I

IV

11/14/1999

FONA INTERNATIONAL INC

600.014 ACETALDEHYDE NATURAL 50% SOLN/TRIACETIN AS MFG IN CAROL STREAM IL

14552 I

IV

11/14/1999

FONA INTERNATIONAL INC

10252A ORANGE CREAM FLAVOR NATURAL(WONF) AS MFG IN CAROL STREAM IL

14553 I

IV

11/14/1999

FONA INTERNATIONAL INC

929.005 N-C ARTIFICIAL WATERMELON FLAVOR AS MFG IN CAROL STREAM IL

14554 I

IV

11/14/1999

FONA INTERNATIONAL INC

929.001 ARTIFICIAL WATERMELON FLAVOR AS MFG IN CAROL STREAM IL

14555 I

IV

11/14/1999

FONA INTERNATIONAL INC

807.216 N-C BERRY FLAVOR(AN ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL

14556 I

IV

11/15/1999

FONA INTERNATIONAL INC

906.423 RASPBERRY FLAVOR ARTIFICIAL AS MFG IN CAROL STREAM IL

14557 I

IV

11/15/1999

FONA INTERNATIONAL INC

6788D NATURAL AND ARTIFICIAL RASPBERRY CONC AS MFG IN CAROL STREAM IL

14558 I

IV

11/14/1999

FONA INTERNATIONAL INC

807.101 N-C NATURAL AND ARTIFICIAL BERRY FLAVOR AS MFG IN CAROL STREAM IL

14559 I

IV

11/14/1999

FONA INTERNATIONAL INC

6922B NATURAL AND ARTIFICIAL BERRY OIL AS MFG IN CAROL STREAM IL

14560 I

IV

11/14/1999

FONA INTERNATIONAL INC

6711C ARTIFICIAL IRISONE AS MFG IN CAROL STREAM IL

14561 I

IV

11/14/1999

FONA INTERNATIONAL INC

825.032 N-C ARTIFICIAL WILD CHERRY FLAVOR AS MFG IN CAROL STREAM IL

14562 I

IV

11/14/1999

FONA INTERNATIONAL INC

825.029 ARTIFICIAL WILD CHERRY FLAVOR AS MFG IN CAROL STREAM IL

14563 I

IV

11/14/1999

FONA INTERNATIONAL INC

852.002 N-C NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL

14564 I

IV

11/14/1999

FONA INTERNATIONAL INC

611B NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL

14565 I

IV

11/14/1999

FONA INTERNATIONAL INC

852.017 N-C TUTTI FRUTTI FLAVOR(A NATURAL FLAVOR) AS MFG IN CAROL STREAM IL

14566 I

IV

11/14/1999

FONA INTERNATIONAL INC

8539Z RUM FLAVOR (NATURAL) AS MFG IN CAROL STREAM IL

14567 I

IV

11/14/1999

FONA INTERNATIONAL INC

5839B COMPOUND 1036 NATURAL AS MFG IN CAROL STREAM IL

14568 I

IV

11/15/1999

FONA INTERNATIONAL INC

1837D ARTIFICIAL STRAWBERRY FLAVOR AS MFG IN CAROL STREAM IL

14569 I

IV

11/15/1999

FONA INTERNATIONAL INC

915.136 ARTIFICIAL STRAWBERRY BASE OIL AS MFG IN CAROL STREAM IL

14570 I

IV

11/15/1999

FONA INTERNATIONAL INC

258C ARTIFICIAL RUM ETHER AS MFG IN CAROL STREAM IL

14571 I

IV

11/15/1999

FONA INTERNATIONAL INC

915.697 N-C STRAWBERRY FLAVOR NATURAL AND ARTIFICIAL AS MFG IN CAROL STREAM IL

14572 I

IV

11/15/1999

FONA INTERNATIONAL INC

10257A ARTIFICIAL STRAWBERRY OIL AS MFG IN CAROL STREAM IL

14573 I

IV

11/15/1999

FONA INTERNATIONAL INC

612.600 METHYL THIOBUTYRATE 1% SOLN/ETOH(1208850) AS MFG IN CAROL STREAM IL

14574 I

IV

11/15/1999

FONA INTERNATIONAL INC

600.297 ALPHA AMYL CINNAMIC ALDEHYDE 1% SOLN.PG AS MFG IN CAROL STREAM IL

14575 I

IV

11/15/1999

FONA INTERNATIONAL INC

612.500 METHYL SULFIDE 1% SOLN/ETOH(1208750) AS MFG IN CAROL STREAM IL

14576 I

IV

11/15/1999

FONA INTERNATIONAL INC

612.401 2-ME-2-PENTENAL 1% SOLN/PG(1208420) AS MFG IN CAROL STREAM IL

14577 I

IV

11/15/1999

FONA INTERNATIONAL INC

906.300 N-C NATURAL AND ARTIFICIAL RASPBERRY FLAVOR AS MFG IN CAROL STREAM IL

14578 I

IV

11/15/1999

FONA INTERNATIONAL INC

6788A ARTIFICIAL RASPBERRY KEY AS MFG IN CAROL STREAM IL

14579 I

IV

11/15/1999

FONA INTERNATIONAL INC

5638B SOLVENT BASE (TEC) AS MFG IN CAROL STREAM IL

14580 I

IV

11/15/1999

FONA INTERNATIONAL INC

807.120 N-C TRIPLEBERRY FLAVOR ARTIFICIAL AS MFG IN CAROL STREAM IL

14581 I

IV

11/15/1999

FONA INTERNATIONAL INC

809.085 N-C NATURAL AND ARTIFICIAL BLUEBERRY FLAVOR AS MFG IN CAROL STREAM IL

14582 I

IV

11/15/1999

FONA INTERNATIONAL INC

2915C ARTIFICIAL BLUEBERRY FLAVOR AS MFG IN CAROL STREAM IL

14583 I

IV

11/15/1999

FONA INTERNATIONAL INC

856.054 ARTIFICIAL CONCORD GRAPE BASE OIL AS MFG IN CAROL STREAM IL

Page 418

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14584 I
IV
11/14/1999
FONA INTERNATIONAL INC

SUBJECT
981N NATURAL BLUEBERRY FLAVOR AS MFG IN CAROL STREAM IL

14585 I

IV

11/15/1999

FONA INTERNATIONAL INC

758A NATURAL BLUEBERRY FORTIFIER AS MFG IN CAROL STREAM IL

14586 I

IV

11/15/1999

FONA INTERNATIONAL INC

600.300 AMBRETTE SEED ABSOLUTE AS MFG IN CAROL STREAM IL

14587 I

IV

11/15/1999

FONA INTERNATIONAL INC

601.070 BORONIA ABSOLUTE 1% SOLN/ETOH(1003600) AS MFG IN CAROL STREAM IL

14588 I

IV

11/15/1999

FONA INTERNATIONAL INC

601.090 BUCHU LEAF OIL 1% SOLN/ETOH AS MFG IN CAROL STREAM IL

14589 I

IV

11/15/1999

FONA INTERNATIONAL INC

606.400 GALBANUM RESINOIDE 1% SOLN/ETOH(1013220) AS MFG IN CAROL STREAM IL

14590 I

IV

11/15/1999

FONA INTERNATIONAL INC

606.500 GERANIUM OIL CHINESE AS MFG IN CAROL STREAM IL

14591 I

IV

11/15/1999

FONA INTERNATIONAL INC

609.200 JASMIN ABSOLUTE 1% SOLN/ETOH(1014625) AS MFG IN CAROL STREAM IL

14592 I

IV

11/15/1999

FONA INTERNATIONAL INC

612.010 MANDARIN PETT TRPLS 1% SOLN/ETOH AS MFG IN CAROL STREAM IL

14593 I

IV

11/14/1999

FONA INTERNATIONAL INC

915.005 N-C ARTIFICIAL STRAWBERRY FLAVOR AS MFG IN CAROL STREAM IL

14594 I

IV

11/14/1999

FONA INTERNATIONAL INC

915.004 ARTIFICIAL STRAWBERRY BASE OIL AS MFG IN CAROL STREAM IL

14595 I

IV

11/15/1999

FONA INTERNATIONAL INC

915.747 STRAWBERRY FLAVOR(AN ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL

14596 I

IV

11/15/1999

FONA INTERNATIONAL INC

915.727 N-C STRAWBERRY FLAVOR NATURAL AND ARTIFICIAL AS MFG IN CAROL STREAM IL

14597 I

IV

11/15/1999

FONA INTERNATIONAL INC

1837R N-C STRAWBERRY FLAVOR ARTIFICIAL AS MFG IN CAROL STREAM IL

14598 I

III

11/18/1999

AMPACET CORP

14599 A

II

11/29/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

10799-A TALC POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE INDERIDDER


LACARTERSVILLE GAHEATH OH AND LATEXO TX
SIMVASTATIN AS MFG IN DEBRECCEN HUNGARY

14600 I

II

11/30/1999

ERREGIERRE SPA

NABUMETONE AS MFG IN BERGAMO ITALY

14601 A

III

11/25/1999

LOG PLASTIC PRODUCTS

PLASTIC BOTTLES AS MFG IN KIBBUTZ ASDOT YA'AKOV ICHUD ISRAEL

14602 I

II

11/23/1999

SCHERING AKTIENGESELLSCHAFT

ZK807834 AS MFG IN BERLIN GERMANY

14603 A

II

11/23/1999

DR REDDYS LABORATORIES LTD

KETOROLAC TROMETHAMINE AS MFG IN ANDHRA PRADESH INDIA

14604 A

II

12/1/1999

AVANTI POLAR LIPIDS INC

1,2-DIERUCOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DEPC) AS MFG IN ALABASTER AL

14605 I

II

11/19/1999

TEVA PHARMACEUTICALS USA INC

CEFACLOR USP AS MFG IN MEXICO MO

14606 I

11/3/1999

SIEGFRIED CHEMICALS INC

14607 I

II

11/5/1999

SIEGFRIED CHEMICALS INC

ORGANIZATION MFG SITE BUILDING FACILITIES AND OPERATION OF FACTORY IN TAOYUAN


TAIWAN ROC
VALPROIC ACID USP AS MFG IN TAOYUAN TAIWAN ROC

14608 I

III

11/29/1999

FLINT HILLS RESOURCES LP

PP11530V POLYPROPYLENE AS MFG IN ODESSA AND LONGVIEW TEXAS

14609 I

12/7/1999

S.C. ANTIBIOTICE S.A.

14610 I

III

11/19/1999

DEX-POLYMERS V O F

FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES FOR FACTORY IN IASI


ROMANIA
ETHYLENE OCTENE COPOLYMERS AS MFG IN HEERLEN THE NETHERLANDS

14611 A

II

12/7/1999

R TECH UENO LTD

UNOPROSTONE ISOPROPYL AS MFG IN SANDA HYOGO JAPAN

14612 A

II

12/9/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

METOPROLOL SUCCINATE AS MFG IN BE'ER SHEVA AND PETAH TIQVA ISRAEL

14613 I

11/30/1999

GLAND PHARMA LTD

14614 I

II

12/9/1999

DAIICHI ASUBIO PHARMA CO LTD

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN


AMEEPET AND DUNDIGAL, INDIA
SUN A0026 DRUG SUBSTANCE AS MFG IN TOKYO JAPAN

14615 I

II

12/9/1999

SAFC INC

2-METHOXYESTRA-3,17 B-DIOL AS MFG IN MADISON WI

14616 A

II

12/2/1999

SAFC BIOSCIENCES INC

EX-CELL PF CHO PART A(MODIFIED) AS MFG IN DENVER PENNSYLVANIA

14617 A

II

12/6/1999

SAFC BIOSCIENCES INC

EX-CELL PF CHO MEDIUM(MODIFIED)DEFICIENT AS MFG IN DENVER PENNSYLVANIA

II

12/13/1999

14618 N
14619 A

NOT AN ASSIGNED NUMBER


SA AJINOMOTO OMNICHEM NV

VINORELBINE TARTRATE AS MFG IN LOUVAIN-LA-NEUVE BELGIUM

Page 419

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14620 A
IV
12/8/1999
WACKER CHEMICAL CORPORATION, WACKER
BIOSOLUTIONS DIVISION
14621 A
V
11/26/1999
CHEMUNEX

SUBJECT
BETA-CYCLODEXTRIN AS MFG IN EDDYVILLE IOWA

14622 A

II

12/10/1999

QUIMICA SINTETICA SA

DESCRIPTION AND DATA TO SUPPORT USE OF SOLID PHASE CYTOMETER FOR THE
MEASUREMENT OF VIABLE MICRO-ORGANISMS IN PHARMACEUTICAL WATER SYSTEMS
TERCONAZOLE AS MFG IN MADRID SPAIN

14623 I

II

12/16/1999

AVENTIS PHARMA LTD

PYRAZINAMIDE AS MFG IN WALTLOO SOUTH AFRICA

14624 I

III

12/9/1999

COLOR MASTER INC

BN11107E CHOCOLATE BROWN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14625 I

III

12/9/1999

COLOR MASTER INC

RD1583E 187C RED COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14626 A

II

12/16/1999

MALLINCKRODT INC

14627 A

II

12/17/1999

SANOFI AVENTIS DEUTSCHLAND GMBH

NOSCAPINE USP SMALL CRYSTALS CODE 6040 AND NOSCAPINE HYDROCHLORIDE PURIFIED
CODE 6150 AS MANUFACTURED IN ST LOUIS MISSOURI
CICLOPIROX AS MFG IN FRANKFURT, GERMANY

14628 A

IV

12/15/1999

BAYER SCHERING PHARMA AG

PDMS 373MI TUBING AS MFG IN TURKU FINLAND

14629 A

IV

12/15/1999

BAYER SCHERING PHARMA AG

4910 UNFILLED ELASTOMER AS MFG IN TURKU FINLAND

14630 A

II

12/15/1999

XIAN LIJUN PHARMACEUTICAL CO LTD

ERYTHROMYCIN BASE USP 23 AS MFG IN XIAN SHAANXI PRC

14631 A

III

12/17/1999

GALLAZZI SPA

FLEXAPHARM PRODUCTS AS MFG IN TRADATE(VARESE)ITALY

14632 I

12/15/1999

LEIRAS OY

MFG FACILITY EQUIPMENT AND PERSONEL FOR SITE IN TURKU FINLAND

14633 A

II

12/17/1999

SANOFI AVENTIS DEUTSCHLAND GMBH

CICLOPIROX OLAMINE AS MFG IN FRANKFURT, GERMANY

14634 A

III

12/2/1999

LONSTROFF AG

BROMOBUTYL RUBBER COMPOUNDS AS MFG IN AARAU SWITZERLAND

14635 I

III

12/8/1999

SPARTECH COLOR

WH 18485 WHITE POLYETHYLENE CONCENTRATE AS MFG IN STRAFORD ONTARIO CANADA

14636 A

II

12/18/1999

CEDARBURG PHARMACEUTICALS INC

BUTABARBITAL SODIUM AS MFG IN GRAFTON WISCONSIN

14637 A

II

12/20/1999

CIPLA LTD

FLUTAMIDE AS MANUFACTURED IN BANGALORE AND MAHARASHTRA, INDIA

14638 I

II

12/16/1999

INDUSTRIAS MONFEL SA DE CV

ACETAMINOPHEN AS MFG IN SAN LUIS POTOSI SLP MEXICO

14639 A

II

12/16/1999

EASTMAN CHEMICAL CO

HYDROQUINONE USP AS MFG IN KINGSPORT TN

14640 A

II

12/22/1999

ABBVIE INC

5-DESOSAMINYL-6-0-METHYL ERYTHRONOLIDE AS MANUFACTURED IN KENT ENGLAND

14641 I

II

12/23/1999

ARADIGM CORP

14642 I

III

12/22/1999

MAC CLOSURES INC

AERX MORPHINE SULFATE PAIN MANAGEMENT SYSTEM AS MFG IN HAYWARD CA AND DES
PLAINES IL
PLASTIC DISPENSER AS MFG IN WATERLOO QUEBEC CANADA

14643 A

II

12/22/1999

CATALENT FRANCE BEINHEIM SA

DUTASTERIDE SOFT GELATIN CAPSULES .5MG AS MFG IN BEINHEIM FRANCE

14644 A

IV

12/23/1999

DMV FONTERRA EXCIPIENTS GMBH CO KG

RESPITOSE ML001 AS MFG IN VEGHEL, THE NETHERLANDS

14645 I

II

12/28/1999

TAIHO PHARMACEUTICAL CO LTD

GTS-21 AS MFG IN IBARAKI JAPAN

14646 A

II

12/27/1999

PCAS

DIVALPROEX SODIUM AS MFG IN LIMAY FRANCE

14647 I

II

12/28/1999

SUMITOMO CHEMICAL CO LTD

MCC-555 AS MFG IN GIFU PREFECTURE JAPAN

14648 A

II

12/28/1999

TARO PHARMACEUTICAL INDUSTRIES LTD

CLOBETASOL-17-PROPIONATE USP MICRONIZED AS MFG IN HAIFA BAY ISRAEL

14649 A

II

12/30/1999

MERCK AND CO INC

OMEPRAZOLE MAGNESIUM AS MFG IN ALBANY GA

14650 I

II

12/29/1999

SCHWEIZERHALL MANUFACTURING CO

METYRAPONE AS MFG IN GREENVILLE SC

14651 A

II

12/30/1999

TARO PHARMACEUTICAL INDUSTRIES LTD

BETAMETHASONE DIPROPIONATE AS MFG IN HAIFA BAY ISRAEL

14652 A

III

12/2/1999

MYLAN TECHNOLOGIES INC

MEDIRELEASE 2249 AS MANUFACTURED IN ST ALBANS VT

14653 I

II

1/3/2000

FAKO ILACLARIA AS

CEFUROXIME AXETIL AMORPHOUS AS MFG IN ISTANBUL TURKEY

14654 I

II

12/28/1999

TEVA GROUP API DIVISION

ACYCLOVIR USP AS MFG IN BEER SHEVA ISRAEL

Page 420

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14655 I
II
12/29/1999
NAPP TECHNOLOGIES INC

SUBJECT
SULFABENZAMIDE AS MFG IN GREENVILLE SC MICRONIZED IN KENT ENGLAND AND TESTED
IN RANDOLPH NJ
EMPTY GELATINCAPSULES AS MFG IN LA CIOTAT CEDEX FRANCE

14656 A

IV

12/7/1999

ROXLOR SA

14657 I

12/25/1999

GLENMARK PHARMACEUTICALS LTD

14658 I

II

1/7/2000

NANOSYSTEMS

MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR SAPUR NASIK INDIA
SITE
L-822,179 ORAL NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS

14659 A

II

1/6/2000

SYN TECH CHEM AND PHARM CO LTD

DILTIAZEM HYDROCHLORIDE USP AS MFG IN HSIN YING TAIWAN ROC

14660 A

II

1/11/2000

NISSAN CHEMICAL INDUSTRIES LTD

NK-104 DRUG SUBSTANCE AS MANUFACTURED IN ONODA YAMAGUCHI JAPAN

14661 A

II

1/3/2000

INDUSTRIALE CHIMICA SRL

ZOPICLONE AS MFG IN SARONNO(VARESE)ITALY

14662 I

II

1/10/2000

BEIJING SECOND PHARMACEUTICAL FACTORY

ISONIAZID USP23 AS MFG IN CHAOYANG DIST BEIJING PRC

14663 A

III

12/30/1999

POLYONE CORP

CC00016123WE AS MANUFACTURED IN VONORE, TN.

14664 A

III

12/30/1999

POLYONE CORP

CC10004846WE AS MANUFACTURED IN VONORE, TN.

14665 A

III

12/30/1999

POLYONE CORP

CC00017504DR AS MANUFACTURED IN VONORE, TN.

14666 A

III

12/30/1999

POLYONE CORP

CC00017506WE/DR AS MANUFACTURED IN VONORE, TN.

14667 I

III

12/30/1999

POLYONE CORP

CC10004836WE AS MANUFACTURED IN VONORE TN

14668 A

III

12/30/1999

POLYONE CORP

CC00015904WE AS MANUFACTURED IN VONORE, TN.

14669 A

III

12/30/1999

POLYONE CORP

CC00022347DR AS MANUFACTURED IN VONORE, TN.

14670 A

III

1/3/2000

ST GOBAIN PERFORMANCE PLASTICS FRANCE

14671 I

III

1/14/2000

WINPAK HEAT SEAL PACKAGING INC

ELASTOMERIC CLOSURES FOR ALUMINUM CONTAINERS & PHARMACEUTICAL VIALS AS MFG


IN CHARNY FRANCE
HEAT SEALABLE LIDDING AS MFG IN QUEBEC CANADA(FOILGUARD LF1512SP)

14672 A

III

1/14/2000

AMCOR FLEXIBLES ITALIA SRL

14673 I

III

12/30/1999

M A HANNA COLOR

14674 I

1/7/2000

BOOTS CO PLC

14675 A

II

1/13/2000

EUTICALS SPA

14676 I

III

1/12/2000

FBG ANCHOR

MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR D95 MFG FACILITY
LOCATED IN NOTTINGHAM ENGLAND
INTERMEDIATE PERG/9 D-6-N-(PROPIONYL)-8B-METHYLTHIOMETHYLERGOLINE AS MFG IN
ROZZANO(MI)ITALY
TUBULAR GLASS VIALS(TYPE I) AS MFG IN LONDON ENGLAND

14677 I

III

1/14/2000

WINPAK HEAT SEAL PACKAGING INC

FOILGUARD LF1515E2Z AS MFG IN QUEBEC CANADA

14678 I

II

1/21/2000

YAKULT HONSHA CO LTD

SN-38B-11 INTERMEDIATE COMPOUND AS MFG IN HYOGO SHIZUOKA JAPAN

14679 A

II

1/19/2000

SANDOZ INDUSTRIAL PRODUCTS SPA

CLAVULANATE POTASSIUM AS MFG IN ROVERETO(TRENTO) ITALY

14680 I

1/21/2000

14681 A

III

1/20/2000

CHLOPROPHAM TASK FORCE C/O MCDERMOTT


WILL AND EMERY
DANAPAK FLEXIBLES AS

14682 I

IV

1/24/2000

TAKASAGO INTERNATIONAL CORP

ONE YEAR CHRONIC STUDY OF CHLORPROPHAM IN DOGS AS PERFORMED BYTPS INC IN MT


VERNON INDIANA
COMPOUND PACKAGING MATERIAL FOR PHARMACEUTICAL USE AS MFG IN SLAGELSE
DENMARK
TAK-990020 ARTIFICIAL RASPBERRY FLAVOR AS MFG IN TETERBORO NJ

14683 I

IV

1/24/2000

TAKASAGO INTERNATIONAL CORP

TAK-990021 ARTIFICIAL CHERRY FLAVOR AS MFG IN TETERBORO NJ

14684 I

III

1/27/2000

SHINKONG SYNTHETIC FIBERS CORP

14685 A

II

1/26/2000

CATALENT PHARMA SOLUTIONS LLC

14686 A

II

1/26/2000

CIPLA LTD

SHINPET 5015W POLYETHYLENE TERPHTHALATE COPOLYESTER AS MFG IN TAOYUAN HSIEN


TAIWAN ROC
LOVAZA 1 G SOFT GELATIN CAPSULES(OMEGA-3-ACID ETHYL ESTERS, 1 GRAM) AS
MANUFACTURED IN ST. PETERSBURG, FL.
PAMIDRONIC ACID AS MANUFACTURED IN MUMBAI MAHARASHTRA AND BANGALORE INDIA

14687 I

II

1/24/2000

3M PHARMACEUTICALS INC

R-848 ORAL DRUG PRODUCT AS MFG IN ST PAUL MN AND PITHIVIERS CEDEX FRANCE

POLYESTER ALUMINUM/POLYETYLENE DRUG WRAPPER PRODUCT W/ADHESIVE AS MFG IN


LUGO DI VICENZA ITALY
COLORANT PRODUCT #506324JEMB AS MFG IN SOMERSET NJ

Page 421

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14688 I
II
1/17/2000
SALSBURY CHEMICALS INC

SUBJECT
SULFASALAZINE PVP AS MFG IN CHARLES CITY IA

14689 A

II

1/21/2000

QIAGEN GMBH

QIAGEN NI-NTA AGAROSE AS MFG IN HILDEN, GERMANY

14690 A

II

1/21/2000

QIAGEN GMBH

NI-NTA SUPERFLOW AS MFG IN HILDEN, GERMANY

14691 I

III

12/23/1999

ASPELL POLYMERES

LACQTENE HD2002SN58U AS MFG IN HARFLEUR FRANCE

14692 A

II

1/31/2000

SICOR DE MEXICO SA DE CV

ALCLOMETASONE DIPROPIONATE AS MFG IN LERMA ENDO MEXICO

14693 A

II

2/1/2000

FARMABIOS S P A

TRIAMCINOLONE ACETONIDE AS MFG IN PAVIA ITALY

14694 A

II

2/15/2000

CORDEN PHARMA SWITZERLAND LLC

14695 I

II

2/24/2000

DOW CHEMICAL CO

1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE(POPC) AS MFG IN LIESTAL


SWITZERLAND
SEVELAMER HYDROCHLORIDE AS MFG IN MIDLAND MICHIGAN

14696 I

II

2/2/2000

METAFLUX AG

METAFLUX 70-09 BIOLUB(SPRAY) AS MFG IN MOHLIN SWITZERLAND

14697 A

II

2/3/2000

EMISPHERE TECHNOLOGIES INC

5-CNAC AS MFG IN MORTON GROVE IL

14698 A

II

1/31/2000

EMBIO LTD

PSEUDOEPHEDRINE SULFATE AS MFG IN MAHARASHTRA INDIA

14699 A

II

2/2/2000

DR REDDYS LABORATORIES LTD

CIPROFLOXACIN USP AS MFG IN ANDHRA PRADESH INDIA

14700 A

II

2/2/2000

SUMITOMO SEIKA CHEMICALS CO LTD

B-WING AS MFG IN HYOGO JAPAN

14701 I

III

2/3/2000

COLOR MASTER INC

MT1161E FDA BRONZE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14702 A

II

2/4/2000

COSMA SPA

LABETALOL HYDROCHLORIDE AS MANUFACTURED IN CISERANO(BERGAMO) ITALY

14703 A

II

12/20/1999

TEVA PHARMACEUTICAL INDUSTRIES LTD

FLUDROCORTISONE ACETATE AS MFG IN MILAN ITALY

14704 I

II

2/2/2000

INTERNATIONAL ISOTOPES IDAHO INC

STRONTIUM SR-89 CHLORIDE AS MFG IN SCOVILLE IDAHO

14705 I

II

2/9/2000

EXCELLA GMBH

FLUTAMIDE AS MANUFACTURED IN FEUCHT GERMANY

14706 I

II

2/10/2000

NATURAL PHARMACEUTICALS INC

14707 I

III

1/28/2000

NORDEN PACK INTERNATIONAL AB

PACLITAXEL API, ISOLATION AND PURIFICATION FROM TAXUS BREVIFOLIA AS MFG IN


BOULDER CO
PACKAGING MATERIAL FOR NICOTROL INHALER AS MFG IN ASTORP SWEDEN

14708 A

III

2/14/2000

KLOCKNER PENTAPLAST GMBH

14709 A

II

2/11/2000

CIPLA LTD

14710 A

II

2/10/2000

WOCKHARDT LTD

CYCLOOLEFIN MULTILAYER PACKAGING FILMS AS MFG IN, GERMANY THE NETHERLANDS


USA AND SWITZERLAND
CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA BANGALORE
AND MUMBAI INDIA
NIZATIDINE USP AS MFG IN ANKLESHWAR INDIA

14711 A

II

2/15/2000

ERREGIERRE SPA

NAFTIFINE HYDROCHLORIDE AS MFG IN BERGAMO ITALY

14712 A

II

2/29/2000

SERIPHARM SA

10-DEACETYL BACCATIN III AS MFG IN LE MANS FRANCE

14713 A

II

1/27/2000

PIRAMAL ENTERPRISES LTD

DILTIAZEM HYDROCHLORIDE AS MFG ANDHRA PRADESH INDIA

14714 A

II

12/15/1999

INKE SA

FLUCONAZOLE AS MFG IN CASTELLBISBAL BARCELONA SPAIN

14715 A

II

2/1/2000

PEPTIDO GMBH

LEVOTHYROXINE SODIUM AS MFG IN BEXBACH, GERMANY

14716 I

III

2/18/2000

WINPAK TECHNOLOGIES INC

14717 A

III

2/10/2000

PRETIUM PACKAGING LLC

PACKAGING MATERIAL FOR PHARMACEUTICAL PRODUCTS AS MFG IN TORONTO ONTARIO


CANADA
PLASTIC PACKAGING MATERIALS AS MFG IN SEYMOUR IN

14718 A

II

2/18/2000

CERBIOS PHARMA SA

CALCITRIOL DRUG SUBSTANCE AS MFG IN BARBENGO SWITZERLAND

14719 I

II

2/18/2000

IROTEC LABORATORIES LTD

FLUTAMIDE AS MFG IN LITTLE ISLAND CORK IRELAND

14720 A

II

2/21/2000

ALBEMARLE CORP

BENAZEPRIL HYDROCHLORIDE AS MFG IN SOUTH HAVEN MI

14721 A

IV

2/22/2000

CP KELCO US INC

GELLAN GUM GELRITE MK AS MFG IN SAN DIEGO CA

14722 I

II

2/23/2000

NATIONAL INSTITUTES OF HEALTH/NATIONAL


CANCER INSTITUTE

PYROXAMIDECMC AND PRECLINICAL PHARMACOLOGY AND TOXICOLOGY DAA AS MFG IN


BUFFALO NY AND LEXINGTON MA

Page 422

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14723 I
III
3/2/2000
DSM RESEARCH

SUBJECT
STAMYLAN P11E10 AS MFG IN GELEEN THE NETHERLANDS

14724 A

II

2/23/2000

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

SULFASALAZINE AS MFG IN ZHEJIANG CHINA

14725 I

III

2/9/2000

POLIMERI EUROPA FRANCE SA

FLEXIRENE FG23F AS MFG IN DUNKIRK FRANCE

14726 I

III

2/9/2000

POLIMERI EUROPA FRANCE SA

FLEXIRENE FG20F AS MFG IN DUNKIRK FRANCE

14727 A

II

2/29/2000

KEWPIE CORP

SODIUM HYALURONATE AS MFG IN IBARAKI-KEN JAPAN

14728 I

II

2/21/2000

PCAS

CLOMIPHENE CITRATE AS MFG IN LIMAY FRANCE

14729 A

II

2/25/2000

TEVA PHARMACEUTICAL INDUSTRIES LTD

PRAVASTATIN SODIUM AS MFG IN DEBECCEN HUNGARY

14730 I

II

3/14/2000

AVENTIS PHARMACEUTICALS INC

MDL 105074 AS MFG IN MIDLAND MICHIGAN

14731 I

II

3/14/2000

AVENTIS PHARMACEUTICALS INC

MDL 104036 AS MFG IN MIDLAND MICHIGAN

14732 I

II

2/25/2000

SOCIETA ITALIANA MEDICINALI SCANDICCI

MESNA AS MFG IN FIRENZE ITALY

14733 I

III

3/3/2000

COLOR MASTER INC

BL1886E FDA282C DK BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14734 I

III

3/3/2000

COLOR MASTER INC

BN1114E FDA DK BROWN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14735 I

III

3/3/2000

COLOR MASTER INC

GR1579E FDA 332C GREEN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14736 I

III

3/3/2000

COLOR MASTER INC

RD1369E FDA 2365 PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14737 I

III

3/3/2000

COLOR MASTER INC

RD1640E FDA182C PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14738 I

III

2/25/2000

COLOR MASTER INC

RD1636E FDA PMS 182 PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14739 I

III

2/25/2000

COLOR MASTER INC

BL 1879E FDA PMS282 DK BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14740 I

III

2/25/2000

COLOR MASTER INC

GR1573E FDA PMS332 GREEN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14741 I

III

2/25/2000

COLOR MASTER INC

RD1635E FDA PMS2356 PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

14742 I

II

3/1/2000

MOLECULAR MEDICINE LLC

ADENOVIRUS AS MFG IN LA JOLLA CA

14743 A

II

2/15/2000

OKAMI CHEMICAL INDUSTRY CO LTD

TROPICAMIDE AS MFG IN KYOTO JAPAN

14744 A

III

3/1/2000

SOFFIERIA BERTOLINI SPA

GLASS VIALS AND GLASS AMPOULES AS MFG IN TORINO ITALY

14745 I

III

2/24/2000

AKZO NOBEL INKS CORP

14746 I

2/29/2000

MEDI-CULT A/S

14747 I

II

2/29/2000

MEDI CULT A/S

WATER BASED PRINTING INK AND UV CURABLE COATING PRODUCTS AS MFG IN PLYMOUTH
MN
MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL LOCATED IN JYLLINGE
DENMARK
RENCYTE SYSTEM MEDIA AS MFG IN JYLLINGE DENMARK

14748 I

II

3/2/2000

PROCOS SPA

MONOALDEHYDE AS MFG IN NOVARA ITALY

14749 A

II

2/29/2000

FLECAINIDE ACETATE AS MANUFACTURED IN COMO ITALY

14750 I

II

2/29/2000

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI


SPA
SIFAVITOR SPA

14751 I

II

3/8/2000

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

SULFASALAZINE-PVP AS MFG IN ZHEJIANG CHINA

14752 I

II

9/1/1998

ABBOTT INDUSTRIES INC

LINCOMYCIN HYDROCHLORIDE MONOHYDRATE BULK

14753 I

II

9/1/1998

FERMIC SA DE CV

GENTAMYCIN SULFATE

14754 I

II

9/1/1998

BIOCHEMICA OPOS SPA

CEFACLOR BULK NON STERILE

14755 I

II

9/1/1998

ERYTHROMYCIN ESTOLATE

14756 I

II

9/1/1998

14757 I

II

3/6/2000

ABBOTT LABORATORIES CHEMICAL AND


AGRICULTURAL PRODUCTS DIV
ABBOTT LABORATORIES CHEMICAL AND
AGRICULTURAL PRODUCTS DIV
DSM MINERA BV

TIMOLOL MALEATE AS MFG IN LODI ITALY

ERYTHROMYCIN ESTOLATE
SILVER SULFADIAZINE AS MFG IN MAARSSEN THE NETHERLANDS

Page 423

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14758 A
III
3/8/2000
STELLA KUNSTSTOFFTECHNIK GMBH

SUBJECT
CHILD PROOF PACKAGING MATERIAL AS MFG ELTVILLE, GERMANY

14759 A

II

3/7/2000

MIDORI KAGAKU CO LTD

A WINGS AS MFG IN FUKUSHIMA JAPAN

14760 A

III

2/24/2000

MULLER AND MULLER JOH GMBH CO KG

TUBULAR GLASS INJECTION VIALS AS MFG IN HOLMINDEN, GERMANY

14761 I

II

3/3/2000

14762 A

III

3/9/2000

14763 A

II

3/7/2000

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA TRAMADOL HYDROCHLORIDE AS MFG IN CAMPOVERDE DI APRILIA LATINA ITALY
SPA
TECH SEAL PRODUCTS INC
CLOSURE LINERS AND CONTAINER INNER INNER SEALS AS MANUFACTURED IN
TRIADELPHIA, WV
CHEMI SPA
LEUPROLIDE ACETATE AS MFG IN PATRICA(FROSINONE)ITALY

14764 I

III

2/22/2000

ARDAGH GLASS LIMMARED AB

AMBER GLASS CONTAINERS AS MFG IN LIMMARED SWEDEN

14765 A

IV

3/3/2000

QUALICAPS EUROPE SA

EMPTY HYPROMELLOSE CAPSULES ( HPMC)

14766 I

II

3/10/2000

XIAN PHARMACEUTICAL FACTORY

CLARITHROMYCIN AS MFG IN XIAN SHAANXI PR CHINA

14767 A

II

3/8/2000

QUIMICA SINTETICA SA

OFLOXACIN AS MFG IN MADRID SPAIN

14768 A

II

3/3/2000

TEVA PHARMACEUTICAL INDUSTRIES LTD

BROMOCRIPTINE MESYLATE AS MFG IN OPAVA CZECH REPUBLIC

14769 A

II

3/9/2000

LUPIN LTD

CEFUROXIME AXETIL CRYSTALLINE AS MFG IN INDIA THAILAND AND PUERTO RICO

14770 I

III

12/14/1999

TARGOR GMBH

NOVOLEN 3270H AS MFG IN GERMANY AND SPAIN

14771 I

III

1/28/2000

TARGOR GMBH

NOVOLEN 2670PC AS MFG IN GERMANY AND THE NETHERLANDS

14772 I

III

2/28/2000

TARGOR GMBH

NOVOLEN 3278TC AS MFG IN GERMANY AND SPAIN

14773 I

IV

2/3/2000

FONA INTERNATIONAL INC

926.016 LIQIUD NOR-VAN(AN ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL

14774 A

II

3/15/2000

TEVA PHARMACEUTICAL INDUSTRIES LTD

LISINOPRIL DRUG SUBSTANCE AS MFG IN GUAYAMA PUERTO RICO

14775 I

III

3/10/2000

ASTRA PLASTIQUE

PACKAGING MATERIAL ASW MFG IN SAINT-GEORGES DE RENEINS FRANCE

14776 A

II

3/14/2000

SHANGHAI MEDICINAL LTD

METFORMIN HYDROCHLORIDE AS MFG IN SHANGHAI CHINA

14777 A

III

3/13/2000

CANADA COLORS AND CHEMICALS LTD

14778 A

II

3/14/2000

DIVIS LABORATORIES LTD

AMBER MB 20-3731 POLYETHYLENE COLOR CONCENTRATE AS MFG IN COLBORNE ONTARIO


CANADA
A WINGS AS MFG IN ANDHRA PRADESH INDIA

14779 A

II

3/14/2000

DIVIS LABORATORIES LTD

B WINGS AS MFG IN ANDHRA PRADESH INDIA

14780 A

III

3/14/2000

LOPAREX BV

14781 A

II

2/29/2000

TEVA PHARMACEUTICAL INDUSTRIES LTD

FL2000 75MCG PET C1S WITH GRADE CODE 78BT AS MFG IN APELDOORN THE
NETHERLANDS
ERGOLOID MESYLATES AS MFG IN OPAVA CZECH REPUBLIC

14782 A

3/16/2000

BUILDING 41 ASEPTIC FACILITY UPGRADE

14783 A

II

3/17/2000

14784 I

II

3/15/2000

14785 I

IV

3/16/2000

PHARMACIA AND UPJOHN CO WHOLLY OWNED


SUB PFIZER INC
JOHNSON MATTHEY PHARMACEUTICAL
MATERIALS
RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA
SPA
MYLAN TECHNOLOGIES INC

14786 I

II

3/16/2000

YANGZHOU PHARMACEUTICAL FACTORY

FELODIPINE AS MFG IN YANGZHOU JIANGSU CHINA

14787 I

III

3/14/2000

CLARIANT(CANADA) INC

01PPP-14 WHITE MASTERBATCH AS MFG IN MISSISSAUGA ONTARIO CANADA

14788 I

II

4/4/2000

OXO CHEMIE INC

OXO-K993 AS MFG IN WANZLEBEN, GERMANY

14789 A

III

3/23/2000

CSP TECHNOLOGIES INC

MODIFIED THERMOPLASTIC PACKAGING PRODUCTS AS MFG IN AUBURN ALABAMA

14790 A

II

3/21/2000

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

FLOXURIDINE AS MFG IN ZHEJIANG PROVINCE CHINA

14791 I

II

3/3/2000

CHEMISCHE FABRIK BERG BITTERFELD GMBH

BUTABARBITAL SODIUM AS MFG IN BITTERFELD GERMANY

DEXTROAMPHETAMINE SULFATE AS MFG IN WEST DEPTFORD NJ


LOVASTATIN AS MFG IN LATINA ITALY
PIB ADHESIVE AS MFG IN ST ALBANS VT

Page 424

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14792 I
II
12/16/1999
MALLINCKRODT INC
14793 A

II

3/27/2000

ACS DOBFAR SPA

SUBJECT
NOSCAPINE USP SMALL CRYSTALS AND NOSCAPINE HYDROCHLORIDE PURIFIED AS MFG IN
ST LOUIS MISSOURI
CEFAMANDOLE NAFATE AS MFG IN MILAN ITALY

14794 A

II

1/19/2001

INFA SA

KETOCONAZOLE AS MFG IN ALCANTARILLA, MURCIA, SPAIN

14795 I

III

3/17/2000

ACLO COMPOUNDERS INC

14796 I

II

3/28/2000

DEGUSSA-HULS AG

40% MINERAL(TALC)FILLED ISOTATIC HOMOPOLYPROPYLENE PACKAGING MATERIAL AS MFG


IN CAMBRIDGE ONTARIO CANADA
IFOSFAMIDE CRUDE AS MFG IN RADEBEUL GERMANY

14797 I

II

3/27/2000

ZHEJIANG TAIZHOU HISOAR PHARM CHEM CO LTD CLINDAMYCIN PHOSPHATE AS MFG IN ZHEJIANG CHINA

14798 A

3/28/2000

MALLINCKRODT LLC

14799 I

III

3/27/2000

PREGIS CORPORATION

MALLINCKRODT INC-MARYLAND HEIGHTS PARAMETRIC RELEASE PROGRAM IN MARYLAND


HEIGHTS MISSOURI
PROPYFLEX AS MFG IN HALLE/WESTFALEN FEDERAL REPUBLIC OF GERMANY

14800 I

III

3/27/2000

PREGIS CORPORATION

FLAT PA175 CLOSED PART AS MFG IN HALLE/WESTFALEN FEDERAL REPUBLIC OF GERMANY

14801 A

II

3/24/2000

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LISINOPRIL DIHYDRATE(BULK) AS MFG IN ZHEJIANG PROVINCE PR OF CHINA

14802 A

II

3/22/2000

MINOCYCLINE HYDROCHLORIDE AS MFG IN ORIGGIO(VA)ITALY

14803 I

IV

3/29/2000

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
WILD FLAVORS INC

14804 I

II

3/23/2000

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD

NABUMETONE(BULK)AS MFG IN XIANJU ZHEJIANG PROVINCE PR OF CHINA

14805 A

III

3/29/2000

TOSOH CORP

PETROTHENE 175K PACKAGING MATERIAL AS MFG IN YOKKAICHISI MIE JAPAN

14806 A

III

3/27/2000

INEOS ABS USA CORP

LUSTRAN ABS 248FC PACKAGING MATERIAL AS MFG IN ADDYSTON & HEBRON OH

14807 A

II

3/29/2000

CATALENT PHARMA SOLUTIONS LLC

14808 A

IV

3/27/2000

UNGERER AND CO

LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES AS MFG IN ST PETERSBURG


FL
ART GRAPE FLVP FH-1035 AS MFG IN LINCOLN PARK NJ

14809 A

II

3/31/2000

SANOFI CHIMIE

CLOPIDOGREL BISULFATE FORM II AS MFG IN ARAMON FRANCE

14810 I

II

4/3/2000

TOYAMA CHEMICAL CO LTD

T-588 DRUG SUBSTANCE AS MFG IN OSAKA JAPAN

14811 I

II

3/31/2000

ASUBIO PHARMA CO LTD

SUN N4057 DRUG SUBSTANCE AS MFG IN GUNMA JAPAN

14812 I

II

3/31/2000

SHIONO FINESSE LTD

KAD-1229 DRUG SUBSTANCE AS MFG IN FUKUI JAPAN

14813 A

II

3/31/2000

ANTIBIOTICE SA

NYSTATIN AS MFG IN IASI ROMANIA

14814 A

III

3/29/2000

3M DRUG DELIVERY SYSTEMS

A66007 SPRAYMISER VALVE AS MFG IN GREAT BRITAIN

14815 A

III

3/29/2000

3M DRUG DELIVERY SYSTEMS

A66200 SPRAYMISER VALVE AS MFG IN GREAT BRITAIN

14816 I

II

4/4/2000

ASTELLAS PHARMA GMBH

FK-866 DRUG SUBSTANCE AS MFG IN OSAKA JAPAN

14817 I

II

3/31/2000

TORONTO RESEARCH CHEMICALS INC

L-METHIONINE SULFOXIMINE AS MFG IN TORONTO ONTARIO CANADA

14818 I

III

3/29/2000

AMPACET CORP

7012276 SLIP AB LDPE MB POLYETHYLENE MASTERBATCHAS MFG IN TERRE HAUTE,INDIANA;


DERIDDER,LOUISIANA; CARTERSVILLE,GEORGIA; HEATH,OHIO; LATEXO,TEXAS.

14819 A

IV

3/27/2000

UNGERER AND CO

ART GRAPE BASE 42483 AS MFG IN LINCOLN PARK NJ

14820 I

II

4/27/2000

NIDARIA TECHNOLOGY LTD

14821 I

III

4/7/2000

SKC INC

14822 A

III

3/5/2000

IMBC BLOWMOLDING 2014 INC

PLANKTON BLOCKING TECHNOLOGY (PBT) EXTRACT AS MFG IN KINAROT, ZEMACH, JORDAN


VALLEY, ISRAEL
SKYROL PET FILMS FOR PACKAGING DRUG PRODUCTS AS MFG IN COVINGTON GA AND
KYONGGI-DO KOREA
PLASTIC BOTTLES FOR PHARMACEUTICAL USE AS MFG IN ORANGEVILLE ONTARIO CANADA

14823 A

IV

4/11/2000

BASF CORP

ARTIFICIAL SWEETNESS FLAVOR #FADF421 AS MFG IN ERLANGER KY

KOLLICOAT MAE 30DP AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF


GERMANY

Page 425

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14824 A
III
4/5/2000
VETTER PHARMA FERTIGUNG GMBH AND CO KG

SUBJECT
V-OVS SYSTEM 10.6 DRUG PACKAGING MATERIAL AS MFG IN RAVENSBURG, GERMANY

14825 I

III

5/4/2000

KUREHA CHEMICAL INDUSTRY CO LTD

KREHALON LATEX DO702 & DO703 AS MFG IN FUKUSHIMA, JAPAN

14826 I

III

3/31/2000

AKZO NOBEL INKS CORP

UV CURABLE PRINTING INKS AS MFG IN PLYMOUTH MN

14827 I

III

4/10/2000

PACKAGING COORDINATORS, INC.

PHARMACEUTICAL PACKAGING PRODUCTS AS MFG IN PHILADELPHIA PA

14828 I

III

4/12/2000

REXAM PHARMA DIVISION

14829 I

III

3/30/2000

BESPAK PLC

PACKAGING FOR HUMAN DRUGS AND BIOLOGICS AS MFG IN WHEELING AND BUFFALO
GROVE IL
FOREST AEROBID HFA SPACER INHALER AS MFG IN APEX NC

14830 I

II

4/14/2000

DEGUSSA HULS AG WERK RADEBEUL

CYCLOPHOSPHAMIDE AS MFG IN RADEBEUL GERMANY

14831 A

II

4/10/2000

DICLOFENAC HYDROXY ETHYL PERROLIDINE AS MANUFACTURED IN COMO ITALY

14832 A

IV

4/12/2000

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI


SPA
GLATFELTER GERNSBACH GMBH AND CO KG

14833 I

II

4/14/2000

DIOSYNTH BV

BOVINE INSULIN HIGHLY PURIFIED AS MFG IN SERIFONTAINE FRANCE

14834 A

II

4/12/2000

FARCHEMIA SRL

HYDROUS BENZOYL PEROXIDE AS MFG IN TREVIGLIO(BERGAMO)ITALY

14835 A

II

4/14/2000

CATALENT PHARMA SOLUTIONS LLC

ZARONTIN 0.25G SOFT GELATIN CAPSULES AS MFG IN ST PETERSBURG FL

14836 A

IV

4/14/2000

KERRY INGREDIENTS AND FLAVOURS

NATURAL BANANA FLAVOR WONF 080-0029R LIQUID AS MFG IN CINCINNATI OH

14837 A

II

4/17/2000

CORDEN PHARMA SWITZERLAND LLC

14838 I

4/13/2000

MOUNT SINAI MEDICAL SCH

14839 A

II

4/24/2000

IDT AUSTRALIA LTD

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL,SODIUM SALT(DPPG,NA) AS MFG IN


LIESTAHL SWITZERLAND
MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL FOR THE
17TH FLOOR OF ANNENBERG BUILDING
HEMATOPORPHYRIN DIACETATE AS MFG IN BORONIA, VICTORIA, AUSTRALIA

14840 A

III

4/14/2000

LOPAREX LLC

14841 I

II

4/20/2000

SIFAVITOR SRL

GRADE 15787 3MIL CL PET 92A/000 SILICONE COATED RELEASE LINER AS MFG IN IOWA CITY,
IA; EDEN,NC.
SOTALOL HYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY

14842 A

II

4/20/2000

CEDARBURG PHARMACEUTICALS INC

BUTORPHANOL TARTRATE AS MFG IN GRAFTON, WISCONSIN

14843 I

3/10/2000

14844 A

III

3/10/2000

14845 A

II

5/8/2000

MEDIS LABORATORIES MEDICAMENTS STERLIES - STERILE PROCESSING FACILITY LOCATED IN NABEUL, TUNISIA
S.A.
TICONA LLC
FORTRON POLYPHENYLENE SULFIDE AS MFG IN WILMINGTON, NC; FLORENCE, KY;
SHELBY,NC; SHROPSHIRE, UK
NITTO DENKO CORP
AG-AS ACTIVE PHARMACEUTICAL INGREDIENT MANUFACTURED IN MILFORD, MA

14846 I

5/8/2000

JUNGBUNZLAUER LADENBURG GMBH

MANUFACTURING, FACILITIES, OPERATING PROCEDURES AND PERSONNAL

14847 A

II

5/5/2000

JUNGBUNZLAUER LADENBURG GMBH

TRIPOTASSIUM CITRATE AS MANUFACTURED IN LADENBURG GERMANY

14848 A

II

4/26/2000

ISP CHEMICALS LLC

BORONIC ACID INTERMEDIATE (BAI) AS MANUFACTURED IN COLUMBUS OHIO

14849 I

II

5/4/2000

CLOPIDOGREL BISULFATE FORM I

14850 A

II

4/25/2000

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS LTD
SAFC BIOSCIENCES INC

14851 I

II

4/28/2000

HOSPIRA INC

OFNE ADMIXTURE DRUG PRODUCTS

14852 A

II

4/28/2000

SANOFI CHIMIE

DESOXIMETASONE USP, MICRONIZED, MFG IN VERTOLAYE, FRANCE

14853 I

II

4/27/2000

MITSUI CHEMICALS,INC.

MS-275 (N-(2-AMINOPHENYL)-4-[N-(PYRIDIN-3-YLMETHOXYCARBONYL)AMINOMETHYL]BENZAMIDO) MANUFACTURED IN CHIYODAKU, TOKYO,


JAPAN

14854 A

II

4/25/2000

SAFC BIOSCIENCES INC

14855 I

II

4/28/2000

INFAR S.A.

EX-CELL 610 HSF HYBRIDOMA, SERUM-FREE MEDUIM. CATALOG NO. 14610 AS MFG IN
DENVER,PA.
5-AMINOSALICYLIC ACID

DYNAPORE LONG FIBRE PAPER 026 AS MFG GERNSBACH, GERMANY

EX-CELL PF CHO MEDUIM (MODIFIED), CATALOG NO. 62625 AS MFG IN DENVER,PA.

Page 426

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14856 I
IV
4/25/2000
FONA INTERNATIONAL INC

SUBJECT
#929.125 WATERMELON FLAVOR, ARTIFICIAL

14857 I

IV

4/25/2000

FONA INTERNATIONAL INC

#915.791 STRAWBERRY BANANA FLAVOR ARTIFICIAL

14858 I

IV

4/25/2000

FONA INTERNATIONAL INC

#906.440 BLUE RASPBERRY FLAVOR, ARTIFICIAL (ALCOHOL FREE)

14859 I

IV

4/25/2000

FONA INTERNATIONAL INC

#889.013 ARTIFICIALFRESH PEACH FLAVOR

14860 I

IV

4/25/2000

FONA INTERNATIONAL INC

#884.655 ORANGE CREME FLAVOR EMULSION, NATURAL & ARTIFICIAL

14861 I

IV

4/25/2000

FONA INTERNATIONAL INC

#936.589 COTTON CANDY FLAVOR, ARTIFICIAL (ALCOHOL FREE)

14862 I

IV

4/28/2000

FMC CORP SPECIALTY DIV

LUSTRECLEAR MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED COATING.

14863 I

II

5/2/2000

WOCKHARDT LTD

FLUCONAZOLE AS MFG IN GUJARAT STATE, INDIA

14864 I

II

3/31/2000

WORLD MINERALS INCORPORATED

CHROMOSORB P-AW 100/120 MANUFACTURED IN LOMPOC CA

14865 I

II

6/12/2000

SAMCHULLY PHARMACEUTICAL CO LTD

ACYCLOVIR DRUG SUBSTANCE AS MFG IN KYUNGGI-DO, KOREA

14866 I

II

5/4/2000

YANTAI NO.2 PHARMACEUTICAL FACTORY

GENTAMICIN SULFATE AS MFG IN SHANDONG PROVINCE, P.R. CHINA

14867 I

II

5/8/2000

R.P. SCHERER NORTH AMERICA

HECTOROL, 1.0 MICROG SOFT GELATIN CAPSULES MANUFACTURED IN ST. PETERSBURG, FL

14868 I

III

4/26/2000

AKZO NOBEL INKS CORP

WATER-BASED PRINTING INK PRODUCTS ; UV-CURABLE PRINTING INK PRODUCTS

14869 I

IV

5/8/2000

FONA INTERNATIONAL INC

#825.083 ARTIFICIAL BLACK CHERRY FLAVOR

14870 I

II

5/5/2000

AVIGEN INC

14871 I

IV

5/8/2000

FONA INTERNATIONAL INC

ADENO-ASSOCIATED VIRUS (AAV) VECTOR CONTAINING THE GENE FOR HUMAN BLOOD
COAGULATION FACTOR IX (COAGULIN-B) AS MFG IN ALMEDA CALIFORNIA
#856.150 ARTIFICIAL CONCORD GRAPE FLAVOR

14872 I

III

5/9/2000

SONOCO FLEXIBLE PACKAGING

SFP003M-4 LAMINATED PACKAGING MATERIAL AS MFG IN EDINBURGH, IN

14873 I

IV

5/8/2000

FONA INTERNATIONAL INC

#936.451 MOUTH SALVATION FLAVOR, ARTIFICIAL

14874 I

II

5/10/2000

OPOCRIN LABORATORIO FARMACOBIOLOGICA

SULODEXIDE AS MANUFACTURED IN CORLO (MODENA) ITALY

14875 I

III

5/3/2000

KUNSTSTOFFWERK MAUER GMBH

14876 I

IV

5/11/2000

METAROM CANADA INC.

14877 I

III

5/1/2000

COLOR MASTER, INC.

PLASTIC PACKAGING PRODUCTS AS MFG IN UBSTADT-WEIHER, FEDERAL REPUBLIC OF


GERMANY
COTTON CANDY ARTIFICIAL FLAVOR ; ORANGE CREAMSICLE N&A FLAVOR; BLUERASPBERRY
N&A FLAVOR ; WATERMELON N&A FLAVOR.
MT1164E, FDA SILVERCOLOR CONCENTRATE FOR PLASTICS

14878 I

III

5/1/2000

COLOR MASTER INC

BL1911 E, TRANSPARENT BLUECOLOR CONCENTRATE FOR PLASTICS

14879 I

III

5/1/2000

COLOR MASTER, INC.

BK1101E, FDA BLACKCOLOR CONCENTRATE FOR PLASTICS

14880 I

III

5/1/2000

COLOR MASTER, INC.

YL1322E, FDA V. YELLOW COLOR CONCENTRATE FOR PLASTICS

14881 A

III

5/14/2000

TOTAL PETROCHEMICALS RESEARCH FELUY SA

RANDOM COPOLYMER POLYPROPYLENE PPM R021

14882 A

II

5/19/2000

NIACINAMIDE USP AS MFG IN INDIANAPOLIS IN

14883 I

II

5/19/2000

VERTELLUS AGRICULTURE NUTRITION


SPECIALTIES LLC
NANOSYSTEMS

14884 A

II

5/15/2000

DAIICHI SANKYO EUROPE GMBH

CS-866(5 10 20 & 40MG) TABLETS AS MFG IN PFAFFENHOFEN, GERMANY

14885 A

III

5/10/2000

TOURNAIRE

ALUMINUM CONTAINER-CLOSURE SYSTEMS AS MFG IN GRASSE CEDEX FRANCE

14886 I

II

5/16/2000

OMNICHEM NV

DIPYRIDAMOLE USP AS MFG IN BALEN, BELGIUM

14887 I

III

5/5/2000

LUDLOW COATED PRODUCTS

#60063-58 PACKAGING PRODUCT AS MFG IN COLUMBUS OHIO

14888 I

II

11/5/1996

BILCARE INC

ENCAPSULATION PROCESS AS PERFORMED AT PHOENIXVILLE, PA

14889 A

III

5/10/2000

AMPACET CORP

14890 A

II

5/8/2000

DR REDDYS LABORATORIES EU LTD

11748-SP WHITE POLYETHYLENE MASTERBATCHAS MFG IN TERRE HAUTE,INDIANA;


DERIDDER,LOUISIANA; CARTERSVILLE,GEORGIA; HEATH,OHIO; LATEXO,TEXAS.
TRAVOPROST AS MFG IN STEVENAGE HERTS UNITED KINGDOM

N1106 (VX-745) ORAL NANOCRYSTAL CAPSULES (125MG) AS MFG IN HORSHAM PA

Page 427

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14891 A
IV
5/16/2000
ROQUETTE FRERES

SUBJECT
MANNITOL, SPRAY DRIED USP GRADE, (PEARLITOL(R) AS MGF IN LESTERM FRANCE

14892 I

II

5/12/2000

DAIICHI PHARMACEUTICAL CO LTD

DE-310 DRUG SUBSTANCE AS MFG IN EDOGAWA-KU TOKYO JAPAN

14893 A

II

5/19/2000

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

CARBAMAZEPINE USP MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

14894 I

II

5/26/2000

AVANTI POLAR LIPIDS INC

DIMETHYLDIOCTADECYLAMMONIUM BROMIDE AS MFG IN ALABASTER, ALABAMA

14895 I

II

5/15/2000

LONZA BIOTEC SRO

L-CARNITINE DIR AS MANUFACTURED IN KOURIM, CZECH REPUBLIC

14896 A

III

5/19/2000

STELLA KUNSTSTOFFTECHNIK GMBH

14897 I

III

5/19/2000

ALVEO AG

PROTECAP, CHILD-RESISTANT CLOSURE; STELLA-ARTICLE 6-5268-01-01 AS MFG IN ELTVILLA,


GERMANY
ALVEOLIT TA S WHITE AS MFG IN LUZERN, SWITZERLAND

14898 A

III

5/8/2000

SUMITOMO RUBBER INDUSTRIES LTD

RUBBER CLOSURE AS MFG IN OSAKA, JAPAN

14899 I

II

5/26/2000

FUJISAWA PHARMACEUTICAL CO., LTD.

FK 788 DRUG SUBSTANCE AS MFG IN OSAKA, JAPAN

14900 I

II

5/25/2000

TAMA KAGAKU KOGYO CO LTD

14901 I

III

5/19/2000

RADEMATE LTD.

14902 A

III

5/19/2000

TOTAL PETROCHEMICALS

2-HYDROXYMETHY1-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE AS MFG IN SAITAMA,


JAPAN
RAPID BIODEGRADABLE HYDROPHOBIC MATERIAL RBHM, MANUFACTURED IN TEIC, SCIENCE
PARK TECHNION, NESHER HAIFA, ISRAEL
PP HOMOPOLYMER APPRYL 3250 MR1 MANUFACTURED IN LAVERA, FRANCE

14903 A

III

5/19/2000

BERRY PLASTICS CORP TAPES AND COATINGS DIV ALVEOLIT TA AS MFG IN LUZERN, SWITZERLAND

14904 I

III

6/5/2000

JAPAN POLYOLEFINS CO., LTD.

14905 I

II

5/22/2000

WOCKHARDT LTD

POLYETHYLENE FOR USE IN DRUG PACKAGING AS MFG IN OITA PREFECTURE, AND


KANAGAWA PREFECTURE JAPAN
CIPROFLOXACIN HYDROCHLORIDE, USP AS MFG IN GUJARAT STATE, INDIA

14906 I

II

5/31/2000

BIDACHEM S.P.A.

METHOCARBAMOL AS MFG IN GLOVANNI, ITALY

14907 I

II

5/31/2000

MOEHS IBERICA SL

METOPROLOL TARTRATE USP AS MFG IN RUBI, SPAIN

14908 I

II

6/2/2000

IRVINE SCIENTIFIC SALES COMPANY

MODIFIED IS-CHO AS MFG IN SANTA ANA, CA.

14909 I

III

6/2/2000

VANGUARD PLASTICS

14910 A

II

6/1/2000

CADILA HEALTHCARE LTD

PLASTIC CONTAINERS UTILIZING THE EXTRUSION BLOW MOLDING PROCESS AS MFG IN


ALLENTOWN, PA
DEFERIPRONE AS MFG IN DABHASA, GUJARAT, INDIA

14911 A

III

5/25/2000

ECLATIN AG

14912 A

II

6/5/2000

BIOCON LTD

14913 A

II

6/1/2000

AESICA PHARMACEUTICALS LTD

14914 I

II

6/6/2000

MEIJI SEIKA KAISHA, LTD.

PAROXETINE HYDROCHLORIDE AS MFG IN NORTHUMBERLAND, GREAT BRITAIN;


LUDWIGSHAFEN, GERMANY
TAPORFIN SODIUM DRUG SUBSTANCE AS MFG IN TOKYO, JAPAN

14915 A

II

6/8/2000

CYALUME SPECIALTY PRODUCTS INC

GLUCOSAPURE (GLUCOSAMINE SULFATE) AS MFG IN BOUND BROOK, NJ; ALBANY, OREGON.

14916 A

II

6/12/2000

TERAZOSIN HCL. 2H2O AS MFG IN FRESONARA AL, ITALY

14917 I

III

6/5/2000

BIOINDUSTRIA LABORATORIO ITALIANO


MEDICINALI SPA
AMPACET CORP

14918 I

5/26/2000

14919 I

III

6/6/2000

14920 I

II

6/20/2000

14921 A

II

5/4/2000

INTERNAL LACQUERS FOR TUBES AND AIROSOLS V-5266 AND V-5266/A-2093 AS MFG IN
SOLOTHURN, AWITZERLAND
LOVASTATIN USP AS MFG IN BANGALORE, INDIA

100323 ANTISTAT POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,INDIANA;


DERIDDER,LOUISIANA; CARTERSVILLE,GEORGIA; HEATH,OHIO; LATEXO,TEXAS.
SHENZHAN (CHINA) NEPTUNUS PHARMACEUTICAL MFG FACILITIES, OPERATING PROCEDURES, AND PERSONEL FOR PRODUCTION FACILITY
CO., LTD.
LOCATED IN NANSHAN DISTRICT, SHENZHEN, GUANGDONG, CHINA
NATIONAL PAPER & PACKAGING INC.
GLASS CONTACTS: U-S-P TYPE 3 GLASS AS MFG IN SAN ANDRES ATOTO, NAUCALPAN,
MEXICO.
LILLY RESEARCH LABORATORIES DIV ELI LILLY
CEPHALEXIN MONOHYDRATE BULK AS MFG IN MAYAGUEZ, PUERTO RICO
AND CO
CKD BIO CORP
LOVASTATIN, NON-STERILE BULK, USP AS MFG IN ANSAN-CITY, KYEONGKI-DO, KOREA

Page 428

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14922 I
II
6/15/2000
SANKYO CO., LTD.

SUBJECT
CS-505 DRUG SUBSTANCE AS MFG IN KANAGAWA, JAPAN

14923 A

II

6/16/2000

3M DRUG DELIVERY SYSTEMS

ESTRADIOL/LEVONORGESTREL TRANSDERMAL DELIVERY SYSTEM AS MFG IN ST. PAUL, MN.

14924 I

II

6/15/2000

BAYER SCHERING PHARMA AG

FLUDARABINE PHOSPHATE AS MFG IN BERLIN, GERMANY

14925 I

II

6/18/2000

AVANTI POLAR LIPIDS INC

14926 I

II

6/18/2000

AVANTI POLAR LIPIDS INC

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE(DPPE) AS MFG IN ALABASTER,


AL.
DC-30 LIPID BLEND AS MFG IN ALABASTER, AL.

14927 A

III

6/15/2000

EAGLE STAINLESS CONTAINER

EAGLE STAINLESS CONTAINER AS MFG IN WARMINSTER, PA.

14928 A

II

6/19/2000

CAMBREX CHARLES CITY INC

OFLOXACIN USP AS MFG IN CHARLES CITY, IA

14929 I

II

6/20/2000

NANO SYSTEMS

14930 A

II

6/21/2000

SAFC BIOSCIENCES INC

CELECOXIB 200 MG FILM COATED TABLETS AS MFG IN HORSHAM, PA.; COUNTY WESTMEAH,
IRELAND
EX-CELL 302 MEDIUM (GS MODIFIED), CATALOG NO. 62639 AS MFG IN DENVER, PA.

14931 I

II

6/15/2000

HYBRIDON INC

G3139 ACTIVE PHARMACEUTICAL INGREDIENT AS MFG IN MILFORD MA

14932 A

III

6/26/2000

ZEON CORP

ZEONOR 750R (CYCLOOLEFIN POLYMER) AS MFG IN OKAYAMA, JAPAN

14933 I

IV

6/19/2000

TECHNOLOGY FLAVORS & FRAGRANCES, INC.

ARTIFICIAL CHERRY FLAVOR BRY-63 AS MFG IN AMITYVILLE, N.Y.

14934 I

III

6/19/2000

COLOR MASTER INC

14935 I

III

6/14/2000

COLOR MASTER INC

BN1025M, FDA TRANSPARENT AMBER COLOR CONCENTRATE FOR PLASTICS AS MFG IN


AVILLA, IN.
BL1918E, PEARL MAG BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA, IN.

14936 I

II

6/22/2000

14937 A

IV

6/20/2000

NORTHEAST GENERAL PHARMACEUTICAL


FACTORY
WACKER CHEMIE AG

14938 I

II

6/30/2000

CHEM SOURCE CORP

RIMANTADINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE CW-100 AS MFG IN


SHENYANG, CHINA
ALPHA-CYCLODEXTRIN.A DRUG SUBSTANCE INTERMEDIATE USED IN THE PREPARATION OF
A DRUG PRODUCT AS MFG IN EDDYVILLE, IOWA.
ENALAPRIL MALEATE DRUG SUBSTANCE AS MFG IN GUAYAMA, PR.

14939 A

IV

7/12/2000

HENRY H OTTENS MANUFACTURING CO INC

NATURAL & ARTIFICIAL CITRUS FLAVOR # 9185 AS MFG IN PHILADELPHIA, PA.

14940 I

II

7/3/2000

SHIONO FINESSE, LTD.

TROPICAMIDE AS MFG IN FUKUI, JAPAN

14941 A

II

7/3/2000

CATALENT PHARMA SOLUTIONS LLC

PROMETRIUM 100-MG AND 200-MG SOFT-GELATIN CAPSULE AS MFG IN ST. PETERSBURG, FL.

14942 A

II

6/26/2000

PYRIDOXAL-5-PHOSPHATE AS MFG IN CAMPOVERDE DI APRILIA-LT (ITALY)

14943 A

III

5/5/2000

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
BERRY PLASTICS CORP

14944 A

II

6/28/2000

TEVA PHARMACEUTICAL INDUSTRIES LTD

DIHYDROERGOTAMINE MESYLATE AS MFG IN CZECH REPUBLIC

14945 I

II

8/21/2000

TAKEHARA KAGAKU KOGYO CO LTD

U-CAL SSS CALCIUM CARBONATE AS MFG IN HIROSHIMA, JAPAN

14946 I

II

7/3/2000

A.M.S.A. S.P.A.

CARTEOLOL HYDROCHLORIDE AS MFG IN COMO, ITALY

14947 A

II

6/29/2000

ERREGIERRE SPA

BISACODYL USP- PH. EUR. AS MFG IN BERGAMO, ITALY

14948 I

II

6/30/2000

NAPP TECHNOLOGIES INC

KETOCONAZOLE USP AS MFG IN JALISCO, MEXICO

14949 A

III

7/7/2000

GERRESHEIMER BUNDE GMBH

DISPOSABLE ALL GLASS SYRINGE SYSTEMS READY TO FILL (RTF) AS MFG IN GERMANY.

14950 A

III

7/11/2000

ALVEO AG

ALVEOLIT TL S AS MFG IN LUZERN, SWITZERLAND

14951 A

II

7/13/2000

NEULAND LABORATORIES LTD

SOTALOL HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

14952 I

II

7/13/2000

HEALTH RESEARCH INC

HUMAN PARAHYROID HORMONE, SYNTHETIC [SPTH(1-34)] AS MFG IN TORRANCE, CA.

14953 A

II

7/14/2000

DAIICHI SANKYO PROPHARMA CO LTD

CS-866 DRUG SUBSTANCE AS MFG IN ODAWARA, KANAGAWA PREFECTURE, JAPAN.

14954 I

II

7/18/2000

DAIICHI PHARMACEUTICAL CO LTD

DX-8951F DRUG SUBSTANCE AS MFG IN HARRISONVILLE, MISSOURI

14955 A

II

9/19/2000

KANEKA AMERICA CORP

N-2-[1-(S)-ETHOXYCARBONYL]-N-6-TRIFLUOROACETYL-1-LYSYL-N-2-CARBOXY
ANHYDRIDE(EPTL) AS MFG IN FUKUSHIMA, JAPAN

11176-40 AS MFG IN COLUMBUS, GA.

Page 429

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14956 I
II
7/19/2000
DIOSYNTH BV

SUBJECT
HEPARIN SODIUM AS MFG IN OSS, THE NETHERLANDS

14957 A

III

7/18/2000

BILCARE LTD

BILCARE PVDC COATED PVC FILM AS MFG IN MAHARASHTRA, INDIA

14958 I

II

7/20/2000

WL GORE AND ASSOC INC

GORE FLUOROELASTOMER PERISTALTIC PUMP TUBE AS MANUFACTURED IN ELKTON, MD

14959 I

II

7/28/2000

TICARCILLIN DISODIUM AS MFG IN PISCATAWAY, NJ

14960 A

II

7/25/2000

SMITHKLINE BEECHAM PHARMACEUTICALS


FP1005
BAYER PHARMA AG

14961 I

II

7/27/2000

TICARCILLIN MONOSODIUM AS MFG IN PISCATAWAY, NJ

14962 I

II

8/2/2000

SMITHKLINE BEECHAM PHARMACEUTICALS


FP1005
SMLX TECHNOLOGIES INC

14963 I

II

7/19/2000

NINGBO RENJIAN PHARMACEUTICAL CO LTD

HMG (HUMAN MENOPAUSAL GONADOTROPHIN) AS MFG IN CIXI NINGBO, CHINA

14964 I

II

7/25/2000

BOSTON BIOSYSTEMS

EPI-2010 DRUG SUBSTANCE AS MFG IN BEDFORD, MA

14965 I

II

7/25/2000

DSM FINE CHEMICALS GERMANY GMBH

FLOXURIDINE AS MFG IN REGENSBURG, GERMANY

14966 A

II

7/25/2000

3M DRUG DELIVERY SYSTEMS

14967 I

II

7/20/2000

14968 A

III

8/2/2000

14969 I

II

7/31/2000

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
MARUTANI CHEMICAL PLANT ENGINEERING CO
LTD
SANYO FINE CO LTD

TRANSDERMAL DELIVERY SYSTEM CONTAINING FENTANYL AS MFG IN 3M CENTER, ST. PAUL,


MN
TROSPIUM CHLORIDE AS MFG IN INGELHEIM AM RHEIN, GERMANY

14970 A

II

7/31/2000

CORDEN PHARMA SWITZERLAND LLC

14971 A

II

7/19/2000

PROCOS SPA

1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC) AS MFG IN LIESTAL,


SWITZERLAND
ORPHENADRINE CITRATE AS MFG IN VIA LEONARDO DA VINCI, VIA MATTEOTTI, ITALY

14972 A

II

7/31/2000

ERREGIERRE SPA

SULCONAZOLE NITRATE USP AS MFG IN BERGAMO, ITALY

14973 A

II

7/27/2000

BIOCHEM CORP

PROTAMINE SULFATE AS MFG IN SAITAMA-KEN, JAPAN

14974 A

II

8/4/2000

FARMASTUR 2010 SL

SULBACTAM SODIUM USP AS MFG IN SILVOTA, ASTURIAS, SPAIN

14975 A

IV

7/31/2000

MITSUBISHI CHEMICAL CORP

EXCIPIENTS SUCROSE FATTY ACID ESTERS(SUCROSE STEARIC ACID ESTERS, SUCROSE


PALMITIC ACID ESTERS AND SUCROSE LAURIC ACID ESTERS) AS MFG IN YOKKAICHI, MIE
PREFECTURE, JAPAN

14976 I

II

7/28/2000

CHEMI SPA

14977 A

II

8/1/2000

CADILA HEALTHCARE LTD

1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT 95%


POSITIONAL PURITY AS MFG PATRICIA(FROSIONE), ITALY
HYDROXYCHLOROQUINE SULFATE AS MFG IN PADRA (GUJARAT), INDIA

14978 I

II

9/6/2000

ELAN PHARMACEUTICAL RESEARCH CORP

FAMPRIDINE SR TABLETS AS MFG IN COUNTY WESTMEATH, IRELAND

14979 A

II

7/26/2000

LUSOCHIMICA SPA

NIMODIPINE AS MFG IN LOMAGNA (LC), ITALY

14980 A

III

7/24/2000

POLYONE CORP

CC00012984D4/WE AS MANUFACTURED IN VONORE, TN.

14981 I

II

8/4/2000

PGE1 ETHYL ESTER AS MFG IN BUDAPEST, HUNGARY

14982 I

II

7/25/2000

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS LTD
TEVA GROUP

14983 I

II

8/2/2000

ALCHYMARS SPA

ALENDRONATE SODIUM AS MFG IN MILANO ITALY

14984 I

II

8/3/2000

PROLIGO LLC

GTI-2040 DRUG SUBSTANCE AS MFG IN BOULDER, COLORADO

14985 A

II

8/29/2000

CAMBREX PROFARMACO MILANO SRL

PROPAFENONE HYDROCHLORIDE AS MFG IN PAULLO (MILANO), ITALY

14986 I

III

7/31/2000

BETTS UK LTD

BETTS UK LTD LAMINATE TUBES AS MFG IN ESSEX, UNITED KINGDOM

14987 A

II

7/25/2000

SUN PHARMACEUTICAL INDUSTRIES LTD

PENTOXIFYLLINE E.P/B.P AS MFG IN MAHARASHTRA, INDIA

14988 I

II

8/8/2000

NIPPON SODA CO LTD

FAROPENEM DALOXATE AS MFG IN TOYAMA, JAPAN

ETHINYLESTRADIOL-B-CYCLODEXTRIN-CLATHRATE AS MFG IN BERLIN, GERMANY

INSULIN (HUMULIN) TRANSDERMAL PACHES AS MFG IN HOLLANDALE, FLORIDA

MK DESSICANT AS MFG IN IBARAKI-KEN, JAPAN


OMEPRAZOLE AS MFG IN HYOGO PREFECTURE, JAPAN

SULFAMETHOXAZOLE USP AS MANUFACTURED IN NETANYA, ISRAEL

Page 430

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
14989 A
IV
8/24/2000
QUALICAPS CO LTD

SUBJECT
EDIBLE INKS AS MFG IN NARA, JAPAN

14990 I

IV

8/10/2000

FMC CORP

14991 A

II

5/26/2000

HOVIONE FARMACIENCIA SA

LUSTRECLEAR N MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED COATING AS MFG


IN NEWARK, DELAWARE
MOMETASONE 17-FUROATE AS MFG IN LOURES, PORTUGAL

14992 I

II

8/10/2000

GLAXO WELLCOM INC.

CEFUROXIME AXETIL BULK DRUG SUBSTANCE

14993 A

IV

8/8/2000

FMC BIOPOLYMER AS

SODIUM ALGINATE AS MFG IN OSLO, NORWAY

14994 A

II

8/4/2000

POLYPEPTIDE LABORATORIES INC

OCTREOTIDE ACETATE DRUG SUBSTANCE AS MFG IN TORRANCE, CA.

14995 A

II

8/14/2000

RANBAXY LABORATORIES LTD

LISINOPRIL USP (NON-STERILE BULK) AS MFG IN PUNJAB, INDIA

14996 A

II

7/25/2000

MACCO ORGANIQUES SRO

CALCIUM CHLORIDE DIHYDRATE USP AS MFG IN BRUNTAL, CZECH REPUBLIC

14997 I

II

8/15/2000

SHANGHAI SINE PHARMACEUTICAL CORP., LTD.

BIFICO AS MFG IN SHANGHAI, P.R. CHINA

14998 I

III

8/3/2000

BASF AKTIENGESELLSCHAFT

TERLURAN GP-22NATURAL AS MFG IN TAMPS, MEXICO

14999 A

III

8/11/2000

INEOS ABS USA CORP

LUSTRAN ABS 308-1000 FOR PACKAGING AS MFG IN ADDYSTON, OHIO

15000 I

III

8/3/2000

BASF AKTIENGESELLSCHAFT

TERLURAN GP-35 NATURAL AS MFG IN TAMPS, MEXICO

15001 A

II

8/10/2000

OTSUKA PHARMACEUTICAL CO LTD

REBAMIPIDE(OPC-12759) DRUG SUBSTANCE AS MFG IN SAGA, JAPAN

15002 I

II

8/15/2000

CUNO INC

15003 A

II

9/11/2000

15004 A

II

8/18/2000

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
TARO PHARMACEUTICAL INDUSTRIES LTD

ZETA PLUS M SERIES GRADED DENSITY MEDIA AND CARTIDGE PRODUCTS AS MFG IN
STAFFORD SPRINGS, CT.
EPINASTINE HYDROCHLORIDE AS MFG IN INGELHEIM AM RHEIN, GERMANY

15005 I

II

8/21/2000

KRKA DD NOVO MESTO

ENALAPRILA USP AS MFG IN NOVO MESTO, SLOVENIA

15006 I

II

8/17/2000

IRVINE SCIENTIFIC SALES COMPANY

IS-CHO AS MFG IN SANTA ANA, CA

15007 I

II

8/22/2000

15008 A

III

8/17/2000

TECHNOLOGY COMMERCIALIZATION
INTERNATIONAL, INC.
AMPACET CORP

ACCELERATOR-PRODUCED PALLADIUM-103 (103 PD) MEDICAL RADIOISOTOPE AS MFG IN


TROITSK, RUSSIA
100664 MOLD RELEASE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN;
DERIDDER,LA; CARTERSVILLE,GA ; HEATH,OH; LATEXO,TX; MESSANCY,BELGIUM.

15010 A

II

8/18/2000

SAFC BIOSCIENCES INC

EX-CELL PF CHO MEDIUM (MODIFIED) CATALOG NO. 67480 AS MFG IN DENVER, PA

15011 I

II

8/22/2000

INTERNATIONAL ISOTOPES, INC.

SODIUM IODIDE I-123 RADIOCHEMICAL AS MFG IN DENTON, TEXAS

15012 A

III

9/20/2000

POLYFIL CORP

POLYFIL CONCENTRATES ABC5000 AND MT5000 AS MFG IN ROCKAWAY, NJ

15013 A

II

8/24/2000

BACHEM SA

PERGOLIDE MESYLATE AS MFG IN VIONNAZ, SWITZERLAND

15014 A

II

10/2/2000

IDT AUSTRALIA LTD

MINOCYCLINE HYDROCHLORIDE USP AS MFG IN VICTORIA, AUSTRALIA

15015 I

III

8/24/2000

AMPACET CORP

15016 I

II

8/25/2000

BECTON DICKINSON CO

190695 FDA BLACK POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE, IN;


CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OHIO; MESSANCY, BELGIUM
PROTEOSE PEPTONE N0.3 AS MFG IN DETROIT, MICHIGAN; SPARKS, MARYLAND

15017 A

II

8/17/2000

EVERLIGHT CHEMICAL INDUSTRIAL CORP

MISOPROSTOL AS MFG IN TAOYUAN HSIEN, TAIWAN

15018 I

II

8/28/2000

CADILA HEALTHCARE LTD

LORATIDINE AS MFG IN GUJARA, INDIA

15019 A

III

9/11/2000

SOLVIN SA

15020 I

III

8/25/2000

15021 A

II

9/12/2000

15022 A

II

9/12/2000

15009 N

BETAMETHASONE 17-VALERATE, USP MICRONIZED AS MFG IN HAIFA BAY, ISRAEL

NOT AN ASSIGNED NUMBER

SOLVIN 271GA AS MFG IN JEMEPPE-SUR-SAMBRE (BELGIUM); RHEINBERG (GERMANY);


SANTO ANDRE-SP (BRAZIL); TAVAUX (FRANCE); MARTORELL (SPAIN).
STELLA KUNSTSTOFFTECHNIK GMBH
PROTECAP, CHILD-RESISTANCE CLOSURE; STELLA-ARTICLE 6-4418-02-01 AS MFG IN
ELTVILLE, GERMANY
XELLIA PHARMACEUTICALS APS
TOBRAMYCIN SULPHATE, NON-STERILE BULK AS MANUFACTURED IN COPENHAGEN S,
DENMARK
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFAZOLIN, USP AS MFG IN KANCHEEPURAM DISTRICT, INDIA

Page 431

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15023 I
II
8/22/2000
COBRA THERAPEUTICS LIMITED

SUBJECT
PLASMID DNA PRODUCTION PROCESS AS MFG IN STAFFORDSHIRE, UNITED KINGDOM

15024 A

II

8/25/2000

HETERO DRUGS LTD

OMEPRAZOLE AS MFG IN ANDHRA PRADESH, INDIA

15025 A

II

8/31/2000

ZACH SYSTEM SPA

TSE 424 ACETATE AS MFG IN ALMISANO DI LONIGO (VICENZA), ITALY

15026 I

II

9/7/2000

LEK PHARMACEUTICALS DD

LISINOPRIL ACTIVE DRUG SUBSTANCE AS MFG IN KOLODVORSKA, SLOVENIA

15027 A

IV

9/7/2000

FREUND CORP

NONPARIEL-105T AS MFG IN HAMAMATSU CITY, JAPAN

15028 I

II

9/13/2000

LEDERLE LABORATORIES

NYSTATIN BULK POWDER AS MFG IN PEARL RIVER, NY

15029 I

II

9/13/2000

LEDERLE LABORATORIES

15030 I

II

9/13/2000

LEDERLE LABORATORIES

DECLOMYCIN(DEMECLOCYCLINE HYDROCHLORIDE) BULK POWDER AS MFG IN PEARL


RIVER, NY
ACHROMYCIN (TETRACYCLINE) BULK, AS MFG IN PEARL RIVER, NY

15031 A

II

9/4/2000

TATEYAMA KASEI CO LTD

QUAZEPAM AS MFG IN TOYAMA PREFECTURE, JAPAN

15032 I

III

8/21/2000

BASF AKTIENGESELLSCHAFT

15033 I

III

8/21/2000

BASF AKTIENGESELLSCHAFT

15034 A

III

8/24/2000

POLYONE CORP

LURAN S 757 R NATURAL AND WHITE 00260 AS MFG IN LUDWIGSHAFEN, FEDERAL REPUBLIC
OF GERMANY
LURAN S 777 K NATURAL AND WHITE 00260 AS MFG IN LUDWIGSCHAFEN, FEDERAL
REPUBLIC OF GERMANY
CC00022594WE AS MANUFACTURED IN VONORE, TN.

15035 A

III

8/24/2000

POLYONE CORP

CC00017674DF/DR/WE AS MANUFACTURED IN VONORE, TN.

15036 A

IV

9/14/2000

CARGILL INC

15037 A

II

9/8/2000

IPCA LABORATORIES LTD

CONTRAMID 92450 AS MANUFACTURED IN SAS VAN GENT, THE NETHERLANDS AND


HAUBOURDIN CEDEX, FRANCE
ATENOLOL AS MFG IN SEJAVTA DISTRICT, RATLAM, INDIA

15038 I

II

9/14/2000

BOEHRINGER INGELHEIM CHEMICALS INC

15039 A

II

9/15/2000

GLAXOSMITHKLINE LLC

LEVO-ALPHA-ACETYL-METHADOL (LAAM) HYDROCHLORIDE AS MANUFACTURED IN


PETERSBURG, VIRGINIA
PAROXETINE HYDROCHLORIDE AS MANUFACTURED IN COUNTY CORK, IRELAND

15040 I

III

9/8/2000

BASELL POLIOLEFINE ITALIA SRL

LUPOLEN 2003 H AS MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

15041 A

II

9/15/2000

FARCHEMIA SRL

DISULFIRAM AS MANUFACTURED IN TREVIGLIO(BERGAMO), ITALY

15042 I

III

9/12/2000

NEMO SA

PACKAGING MATERIALS AS MANUFACTURED IN BARCELONA, SPAIN

15043 A

II

9/28/2000

ACS DOBFAR SPA

DEFU(DECARBAMOYLCEFUROXINE) AS MFG IN VIMERCRATE (MILANO), ITALY

15044 I

II

9/13/2000

DAIICHI FINE CHEMICAL CO LTD

MISOPROSTOL DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN

15045 A

II

8/11/2000

MYLAN LABORATORIES LTD

FLUCONAZOLE USP AS MANUFACTURED IN TELANGANA, INDIA

15046 I

II

9/18/2000

ELI LILLY AND COMPANY

RECOMBINANT PORCINE CARBOXYPEPTIDASE B (RCPB) AS MFG IN FERGERSHEIM, FRANCE

15047 I

II

9/18/2000

ELI LILLY AND COMPANY

RECOMBINANT BOVINE TRYPSIN (RTRYPSIN) AS MFG IN FEGERSHEIM, FRANCE.

15048 I

III

9/15/2000

ASTRA PLASTIQUE

VISTOP 28 THERMO-PLASTIC CLOSURES AS MFG IN SAINT-GEORGES DE RENEINS, FRANCE

15049 A

III

9/15/2000

HOSPIRA INC

15050 A

III

9/15/2000

HOSPIRA INC

15051 I

II

9/18/2000

SANKYO CO LTD

FC97 POLYOLEFIN FLEXIBLE CONTAINER AS MFG IN NORTH CHICAGO, ILLINOIS AND AUSTIN,
TEXAS
STERILIZATION OF PORT ASSEMBLIES FOR THE FLEXIBLE CONTAINER AS MFG IN ROCKY
MOUNT, NC AND EL PASO, TEXAS
CS-505 DRUG PRODUCT AS MFG IN TOKYO, JAPAN

15052 A

II

9/18/2000

CIPLA LTD

15053 A

9/12/2000

SOUTHWEST ONCOLOGY GROUP

15054 I

II

9/18/2000

DSM MINERA BV

OLANZAPINE AS MANUFACTURED IN KURKUMBH, BANGALORE, PATALGANGA, VIKHROLI,


INDIA
CLINICAL INVESTIGATION METHODS TO ASSURE PATIENT SAFETY AND SCIENTIFIC
INTEGRITY AS PERFORMED AT SAN ANTONIO, TEXAS
KETONE BISULFITE ADDUCT(KBA) AS MFG IN MAARSSEN, THE NETHERLANDS

15055 A

IV

9/20/2000

BASF SE

KOLLICOAT SR 30 D AS MFG IN LUDWIGSHAFEN, GERMANY

Page 432

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15056 I
II
9/25/2000
AKZONOBEL SURFACE CHEMISTRY LLC

SUBJECT
DERMACRYL 79 (28-079P) AS MFG IN SALISBURY, NC

15057 A

II

8/15/2000

SAFC BIOSCIENCES INC

STEMMAX(TM), PRODUCT NO. 62647 AS MFG IN DENVER, PA

15058 I

II

9/22/2000

UBE INDUSTRIES LTD

CS-747 DRUG SUBSTANCE AS MFG IN YAMAGUCHI, JAPAN

15059 A

II

9/22/2000

D-THREO-METHYLPHENIDATE HYDROCHLORIDE AS MFG IN WEST DEPTFORD, NJ

15060 A

II

9/21/2000

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
EVONIK TECHNOCHEMIE GMBH

15061 A

III

9/25/2000

POLYONE CORP

CC00012694A2/D4/60 AS MANUFACTURED IN VONORE, TN.

15062 A

II

9/29/2000

NISSHIN PHARMA INC

EPA-E DRUG SUBSTANCE AS MANUFACTURED IN CHIYODA-KU, TOKYO, JAPAN

15063 A

II

9/29/2000

SICOR DE MEXICO SA DE CV

MOMETASONE FUROATE USP AS MANUFACTURED IN LERMA, EDO MEXICO

15064 A

II

9/29/2000

IFOTAM CO LTD

IFOSFAMIDE AS MANUFACTURED IN LODZ, POLAND

15065 A

II

9/29/2000

LUNDBECK PHARMACEUTICALS ITALY SPA

DAPSONE AS MFG IN PADOVA, ITALY

15066 I

III

9/27/2000

AMPACET CORP

15067 A

III

6/24/2000

AMCOR FLEXIBLES SINGEN GMBH

15068 I

II

9/28/2000

DAIICHI FINE CHEMICAL CO LTD

11078-DR WHITE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,


IN;CARTERSVILLE,GA;HEATH,OH;LATEXO,TX OR MESSANCY,BELGIUM.
PACKAGING MATERIALS AS MFG IN SHELBYVILLE, KY; KREUZLINGEN, SWITZERLAND; AND
SINGEN, GERMANY
MISOPROSTOL HPMC DISPERSION AS MFG IN OMIYA SAITAMA, JAPAN

15069 A

III

9/27/2000

POLYONE CORP

CC00014978WE AS MANUFACTURED IN VONORE, TN.

15070 A

III

9/29/2000

POLYONE CORP

CC00012674D4/DR AS MANUFACTURED IN VONORE, TN.

15071 A

III

9/28/2000

POLYONE CORP

CC00012975DR AS MANUFACTURED IN VONORE, TN.

15072 A

III

9/28/2000

POLYONE CORP

CC00016462DR AS MANUFACTURED IN VONORE, TN.

15073 A

III

9/28/2000

POLYONE CORP

CC00014448WE AS MANUFACTURED IN VONORE, TN.

15074 A

II

10/2/2000

UNIQUE CHEMICALS

DICLOFENAC POTASSIUM AS MFG IN GUJARAT, INDIA

15075 A

III

9/29/2000

POLYONE CORP

CC00002127WE AS MANUFACTURED IN VONORE, TN.

15076 A

III

9/11/2000

NAMICOS CORP

GLASS AMPOULES USED FOR PHARMACEUTICAL PACKAGING AS MFG IN SHINGA, JAPAN

15077 A

II

10/2/2000

BAYER PHARMA AG

TESTOSTERONE USP AS MFG IN IXTACZOQUITLAN, VER. MEXICO

15078 A

III

9/14/2000

PRESSPART GMBH CO KG

15079 A

II

10/6/2000

HOSPIRA BOULDER INC

ALUMINUM ALLOY METERED DOSE INHALER CONTAINERS INTERNALLY COATED WITH


FLUOROPOLYMER AS MFG IN MARSBERG, GERMANY
PACLITAXEL EXTRACT AS MFG IN BOULDER, COLORADO

15081 A

II

10/5/2000

PROCOS SPA

15082 I

II

10/6/2000

NORAC CO INC

THIAPROLINE-M-AMINO BENZOIC ACID HYRDOCHLORIDE CHEMICAL INTERMEDIATE FOR


MK826 AS MFG IN CAMERI(NOVARA), ITALY
DRONABINOL AS MANUFACTURED IN AZUSA, CALIFORNIA

15083 A

II

10/10/2000

MOEHS IBERICA SL

BISOPROLOL FUMARATE AS MFG IN RUBI SPAIN

15084 A

III

10/9/2000

AMPACET CORP

10919 PROCESS AID POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN;DERIDDER,


LA;CARTERSVILLE,GA;HEATH,OH;LATEXO,TX, OR MESSANCY, BELGIUM

15085 I

II

10/11/2000

NV ORGANON

ESTRADIOL BENZOATE AS MFG IN OSS, THE NETHERLANDS

15086 A

III

10/12/2000

DAIWA SPECIAL GLASS CO LTD

GLASS VIALS AS MFG IN YODOGAWA-KU, OSAKA, JAPAN

15087 A

II

10/11/2000

FARCHEMIA SRL

METAXALONE AS MFG IN TREVIGLIO(BERGAMO), ITALY

15088 A

II

10/13/2000

JOHNSON MATTHEY INC

AMPHETAMINE ASPARTATE AS MFG IN WEST DEPTFORD, NJ

15089 A

II

10/13/2000

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS

AMPHETAMINE SULFATE AS MFG IN WEST DEPTFORD, NJ.

15080 N

THIAPROLINE-M-AMINOBENZOIC ACID MONOHYDROCHLORIDE AS MFG IN HANAU, GERMANY

NOT AN ASSIGNED NUMBER

Page 433

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15090 A
II
10/13/2000
JOHNSON MATTHEY PHARMACEUTICAL
MATERIALS
15091 I
II
10/5/2000
CHINOIN PHARMACEUTICAL AND CHEMICAL
WORKS LTD
15092 A
II
10/11/2000
HOSPIRA BOULDER INC

SUBJECT
DEXTROAMPHETAMINE SACCHARATE AS MFG IN WEST DEPTFORD, NJ

15093 I

II

10/12/2000

FUJISAWA PHARMACEUTICAL CO LTD

FK117 AS MFG IN YODOGAWA-KU, OSAKA, JAPAN

15094 A

II

10/13/2000

AIR LIQUIDE HEALTHCARE AMERICA CORP

SULFUR HEXAFLUORIDE (SF6) GAS AS MFG IN PLUMSTEADVILLE, PA

15095 I

II

10/9/2000

15096 A

II

10/16/2000

BEIJING FRIENDSHIP HOSPITAL LIVER RESEARCH


CENTER
LONZA AG

15097 I

III

9/29/2000

BASF AKTIENGESELLSCHAFT

15098 A

II

10/18/2000

LUPIN LTD

WATER AND/OR ALCOHOL EXTRACTS OF HERBAL COMPOUND 861 AS MFG IN BEIJING,


PEOPLES REPUBLIC OF CHINA
PRAMLINTIDE (ACETATE) ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN
BELGIUM
EMULDER DS 2360 AS MANUFACTURED IN SCHWARTZHEIDE (FEDERAL REPUBLIC OF
GERMANY)
LISINOPRIL USP [BULK] AS MANUFACTURED IN MADHYA PRADESH, INDIA

15099 I

II

10/18/2000

ASTRA IDL LTD

ACYCLOVIR USP, BULK, AS MANUFACTURED IN BANGALORE, INDIA

15100 A

II

10/19/2000

ANGELINI ACRAF SPA

METAXALONE AS MANUFACTURED IN APRILIA (LT), ITALY

15101 A

III

10/12/2000

POLYONE CORP

CC00008063WE AS MANUFACTURED IN VONORE, TN.

15102 A

II

10/18/2000

ASPEN OSS BV

NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN APLEDOORN, THE NETHERLANDS

15103 I

III

10/16/2000

AMPACET CORP

15104 I

III

10/16/2000

15105 I

II

10/13/2000

15106 A

II

10/18/2000

7746272 (RM46272) GREEN POLYPROPYLENE MASTERBATCH AS MFG IN TERRE HAUTE, IN;


DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH; LATEXO, TX; AND MESSANCY, BELGIUM
AMPACET CORP
816030 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN KITCHENER ONTARIO,
CANADA
PROCOS SPA PRODOTTI CHIMICI
1-(4- FLUOROBENZYL)-2-CHLOROBENZIMIDAZOLE HYDROCHLORIDE MONOHYDRATE AS
MANUFACTURED IN CAMERI (NOVARA), ITALY
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEPHALEXIN, USP, AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA

15107 I

III

10/17/2000

FLINT HILLS RESOURCES LP

15108 I

II

10/24/2000

WENZHOU NO.3 PHARMACEUTICAL FACTORY

HUNTSMAN POLYETHYLENES (LLDPE) L2101, L2102 AND H2110 AS MANUFACTURED IN


ODESSA, TEXAS
RIBAVARIN, USP, AS MANUFACTURED IN ZHEJIANG, CHINA

15109 I

II

10/23/2000

SANDOZ GMBH

CYCLOSPORIN D AS MANUFACTUERD IN KUNDL TYROL, AUSTRIA

15110 I

II

10/25/2000

YUNG ZIP CHEMICAL INDUSTRY CO LTD AIC

MICONAZOLE AS MANUFACTURED IN TACHIA, TAIWAN

15111 I

III

10/24/2000

AMPACET CORP

15112 I

II

10/23/2000

WOCKHARDT AMERICAS INC

11070-DR WHITE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN; DERIDDER,LA;


CARTERSVILLE,GA; HEATH,OH; OR LATEXO,TX
LORAIDINE AS MANUFACTURED IN DIST.BHARUCH GUJARAT STATE, INDIA

15113 A

II

10/30/2000

SANDOZ GMBH

ASCOMYCIN AS MANUFACTURED IN KUNDL TYROL, AUSTRIA

15114 A

IV

10/6/2000

COLORCON INC

SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCTS AS MANUFACTURED IN WEST


POINT, PA, ENGLAND, INDIA, PUERTO RICO, PEOPLES REPUBLIC OF CHINA AND JAPAN

15115 I

II

2/5/2001

MEDIS

15116 I

II

12/11/2000

MEDIS

15117 I

II

10/31/2000

CATALENT PHARMA SOLUTIONS LLC

15118 I

II

10/30/2000

NEOMPS INC

MEDICAINE 2%-MEPIVICAINE 2%, EPINEPHIDRINE 1/100000, 1.8 AMPOULES AS MFG IN


NABEUL, ITALY
MEDICAINE 3%- MEPIVICAINE 3%, WITHOUT A VASOCONSTRICTOR, 1.8 AMPOULES AS MFG IN
NABEUL, ITALY
YXSORALEN-ULTRA SOFT GELATIN CAPSULES MANUFACTURE AS MANUFACTURED IN ST.
PETERSBURG, FLORIDA
SYNTHETIC PEPTIDE SYSTEMS MPS-116 AS MANUFACTURED IN SAN DIEGO, CA

15119 I

II

11/1/2000

PHARMACIA AND UPJOHN CORK LTD

CYKLOKAPRON TABLETS AS MANUFACTURED IN MARINO DEL TORONTO, ITALY

SPIROMETHYL-BIPHENYL-NITRILE (SR47563) AS MFG IN BUDAPEST, HUNGARY


PACLITAXEL DRUG SUBSTANCE AS MFG IN BOULDER, COLORADO

Page 434

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15120 A
II
11/1/2000
SAFC BIOSCIENCES INC

SUBJECT
EX-CELL (R) 420 W/L-GLUTAMINE, CATALOG NO. 14420 AS MANUFACTURED IN DENVER,
PENNSYLVANIA
TAMOXIFEN CITRATE BULK AS MANUFACTURED IN BUDAPEST, KORMEND, HUNGARY

15121 I

II

10/31/2000

EGIS PHARMACEUTICALS PUBLIC LTD CO

15122 I

II

10/30/2000

RHODES TECHNOLOGIES

15123 I

III

10/31/2000

COGNIS GMBH

MILLING OF ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS & FINE CHEMICALS


MANUFACTURED IN COVENTRY, RI
MYRITOL 318 AS MFG IN DUSSELDORF, GERMANY

15124 A

10/24/2000

ACTAVIS ITALY SPA

STERILE PRODUCTS MANUFACTURING FACILITIES IN NERVIANO, ITALY

15125 I

II

10/31/2000

FAKO ILACLARI A S BUYUKDERE

RANITIDINE HYDROCHLORIDE FORM I BULK AS MFG IN ISTANBUL, TURKEY

15126 A

II

11/2/2000

TASMANIAN ALKALOIDS PROPRIETARY LTD

BUPRENORPHINE BASE AS MANUFACTURED IN WESTBURY, TASMANIA, AUSTRALIA

15127 I

II

11/2/2000

ESTEVE QUIMICA SA

AMLODIPINE BESILATE AS MANUFACTURED IN BARCELONA, SPAIN

15128 A

II

10/31/2000

MICROBIOPHARM JAPAN CO LTD

CALCITRIOL AS MANUFACTURED IN SHIZUOKA, JAPAN

15129 I

III

11/1/2000

CIBA SPECIALTY CHEMICALS CORPORATION

CROMOPHTAL YELLOW GT-AD AS MFG IN MONTHEY, SWITZERLAND

15130 A

II

11/6/2000

NEULAND LABORATORIES LTD

IPRATROPIUM BROMIDE AS MANUFACTURED IN TELANGANA, INDIA

15131 A

II

11/8/2000

UQUIFA MEXICO SA DE CV

ZOLPIDEM TARTRATE AS MFG IN MORELOS, MEXICO

15132 I

III

10/30/2000

ENICHEM SPA

SINKRAL L 320 WHITE 17664 AS MFG IN RAVENNA, ITALY.

15133 I

III

12/11/2000

ENICHEM AMERICA INC

SINKRAL L 320 NA 18001 AS MFG IN RAVENNA, ITALY

15134 A

II

10/18/2000

PENTAGON FINE CHEMICAL LTD

15135 I

III

11/7/2000

CATALENT PHARMA SOLUTIONS LLC

3-OXAZOLIDINEATIC ACID,4-METHYL-2,5-DIOXO-A-(2-PHENYLETHYL) ETHYL ESTER AS MFG IN


CHESHIRE, UNITED KINGDOM
PACKAGING MATERIAL AS MFG IN WOODSTOCK, ILLINOIS

15136 A

III

11/6/2000

POLYONE CORP

CC0001269D4 AS MANUFACTURED IN VONORE, TN.

15137 I

III

11/2/2000

CHROMA CORPORATION

LC22710 25/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS

15138 I

III

11/2/2000

CHROMA CORPORATION

LC22711 25/1 WHITE COLOR CONCENTRATE MANUFACTURED AT MCHENRY, ILLINOIS

15139 I

II

11/7/2000

CUNO EUROPE SA

ZETA PLUS CA,LA,SA,ZA, SERIES AS MFG IN FRANCE

15140 I

II

11/10/2000

15141 A

II

11/13/2000

ELAN PHARMACEUTICAL RESEARCH


CORPORATION
NEULAND LABORATORIES LTD

N1179(BMS-347070-01)NANO CRYSTAL SPRAY GRANULATED INTERMEDIATE AS MFG IN


HORSHAM, PA
RANITIDINE HYDROCHLORIDE USP AS MFG IN TELANGANA, INDIA

15142 A

III

11/15/2000

BERRY PLASTICS

SVP PLASTIC BOTTLES AS MFG IN BATTLEBORO, NORTH CAROLINA

15143 I

II

11/20/2000

VIBRANTIS SA DE CV

METFORMIN HYDROCHLORIDE AS MFG IN EL SALTO, JALISCO, C.P., MEXICO

15144 A

II

11/20/2000

ACS DOBFAR SPA

CEFAZOLIN FOR INJECTION 100G & 300G PHARMACY BULK PACKS AS MFG IN MILANO, ITALY

15145 A

II

11/17/2000

CIPLA LTD

CETIRIZINE DIHYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD(MAHARASHTRA) INDIA

15146 I

II

11/22/2000

CHR HANSEN INC

15147 A

II

11/17/2000

HERAEUS PRECIOUS METALS GMBH AND CO KG

CAL-CARB 4457 (91:9 CALCIUM CARBONATE/STARCH GRANULATION) AS MFG IN STOUGHTON,


WI
CARBOPLATIN USP AS MFG IN HANAU, GERMANY

15148 A

II

11/16/2000

OLON SPA

METFORMIN HYDROCHLORIDE AS MFG IN MULAZZANO(LO)ITALY

15149 A

II

11/20/2000

BAYER AG

ASPIRIN USP AS MFG IN LA FELGUERA(ASTURIAS)SPAIN

15150 I

II

11/20/2000

DESERET LABORATORIES INC

90:10 CALCIUM CARBONATE/STARCH GRANULATION AS MFG IN ST.GEORGE, UTAH

15151 A

II

11/21/2000

PHILLIPS PLASTICS CORP

5-CNAC DI-SODIUM SALT AS MFG IN MORTON GROVE, IL.

15152 I

III

11/20/2000

MAC CLOSURES INC

CHILD-RESISTANT PUSH & TURN CLOSURES AS MFG IN WATERLOO, QUEBEC, CANADA

15153 I

III

11/20/2000

MAC CLOSURES INC

TAMPER-EVIDENT CLOSURES AS MFG IN WATERLOO, QUEBEC, CANADA

15154 A

II

11/15/2000

MERCK KGAA

EMD 68 843 AS MFG IN DARMSTADT, GERMANY

Page 435

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15155 I
II
11/21/2000
RANKE QUIMICA SL

SUBJECT
LAS 34475 AS MFG IN SANT ANDREU DE LA BARCA, BARCELONA, SPAIN

15156 A

II

11/21/2000

RANBAXY LABORATORIES LTD

LORAZEPAM USP AS MFG IN PUNJAB, INDIA

15157 I

II

11/24/2000

DOTTIKON EXCLUSIVE SYNTHESIS AG

15158 A

II

11/22/2000

ZHEJIANG RUIBANG LABORATORIES INC

15159 A

II

11/27/2000

15160 I

III

1/10/2001

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE DRUG ABUSE
TEK PACKAGING GROUP

2-CHLORO-3-(4 FLUOROBENZYL)-BENZIMIDE HYDROCHLORIDE(FBI HCL) AS MFG IN


SWITZERLAND
THIOSTREPTON USP (NON-STERILE BULK FORM) AS MFG IN ZHEJIANG PROVINCE, PEOPLES
REPUBLIC OF CHINA
(S)-(+)-METHAMPHETAMINE HYDROCHLORIDE AS MFG IN TRIANGLE PARK, NORTH CAROLINA

15161 A

II

11/27/2000

CIPLA LTD

15162 I

II

11/27/2000

THERAPLEX CORPORATION

15163 I

II

11/28/2000

15164 I

II

11/27/2000

SOUTHWEST SYNTHETIC PHARMACEUTICAL


GENERAL FACTORY
LIPOTEC S A

15165 A

II

11/27/2000

BACHEM AG

LEUPROLIDE ACETATE NON-STERILE BULK DRUG SUBSTANCE AS MFG IN HOSPITALET DE


LLOBREGA, SPAIN
SINCALIDE AS MFG IN BUBENDORF, SWITZERLAND

15166 I

II

11/14/2000

F2 CHEMICAL LTD

PERFLUOROBUTANE AS MFG IN PRESTON, LANCASHIRE, ENGLAND

15167 A

II

11/28/2000

DANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MFG IN SHANDONG, CHINA

15168 A

II

11/30/2000

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO


LTD
APOTEX PHARMACHEM INC

15169 A

II

11/29/2000

RANBAXY LABORATORIES LTD

ISOTRETINOIN USP (NON-STERILE BULK) AS MFG IN PUNJAB, INDIA

15170 A

II

11/29/2000

RANBAXY LABORATORIES LTD

MIDAZOLAM (NON-STERILE BULK) AS MFG IN PUNJAB, INDIA.

15171 A

II

12/1/2000

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

MINOCYCLINE HYDROCHLORIDE USP AS MANUFACTURED IN MILAN, ITALY

15172 A

II

12/6/2000

ESTEVE QUIMICA SA

MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, CELRA' (GIRONA), SPAIN

15173 I

II

11/30/2000

JENAHEXAL PHARMA GMBH

0.9% SODIUM CHLORIDE INJECTION,USP-1ML/2ML AMPOULE AS MFG IN GERMANY.

15174 A

II

12/4/2000

FERMION OY

GLIPIZIDE AS MFG IN HANKO,FINLAND.

15175 I

III

1/15/2001

ROHM AND HAAS CO

ADCOTE 15P6M AS MFG IN AMERSFOOT, THE NETHERLANDS.

15176 I

II

11/28/2000

ALDRICH CHEMICAL CO INC

15177 A

III

12/1/2000

REXAM CONSUMER PLASTICS INC

15178 A

II

12/1/2000

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

15179 I

IV

11/14/2000

BHARTI HEALTHCARE LIMITED

ROSE BENGAL, DISODIUM SALT, SIGMA-ALDRICH CHEMICAL CO. PRODUCT NUMBER W184-3
AS MANUFACTURED IN SHEBOYGAN FALLS, WI
QVAR (BERCLOMETHASONE DIPROPIONATE HFA) INHALATION AEROSOL ACTUATORS AND
DUST CAP AS MANUFACTURED IN BUFFALO, IL
CYCLOPHOSPHAMIDE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN HARYANA, INDIA

15180 I

II

12/6/2000

GALENA AS

PERGOLIDE MESYLATE AS MANUFACTURED IN CZECH REPUBLIC

15181 I

II

12/4/2000

EXCELLA GMBH

DICLOFENAC SODIUM AS MFG IN FEUCHT, GERMANY

15182 I

II

12/7/2000

NEOMPS INC

MPS-69 (SYNTHETIC PEPTIDE) AS MFG IN SAN DIEGO, CALIFORNIA

15183 I

III

12/5/2000

LPS INDUSTRIES INC

VF60(METALIZED POLYESTER/LLDPE LAMINATION) AS MFG IN MOONACHIE,NJ.

15184 I

II

12/7/2000

BOEHRINGER INGELHEIM CHEMICALS INC

DEXRAZOXANE AS MFG IN PETERSBURG,VA.

15185 A

III

12/7/2000

CORMACK PACKAGING PTY LTD

15186 I

III

12/5/2000

CORMACK PACKAGING PARTY LTD.

CORMACK/KERR CR-III 2 PIECE CHILD RESISTANT CLOSURE (CRC) AS MFG IN NEW SOUTH
WALES, AUSTRALIA
CORMACK/KERR CR-I 2 PIECE CHILD RESISTANT CLOSURE (CRC) AS MFG IN NEW SOUTH
WALES, AUSTRALIA

PACKAGING MATERIALS AS MFG IN HUNTLEY, IL.


FLUCONAZOLE AS MANUFACTURED IN KURKUMBH VILLAGE TALUKA-DAUND DISTRICTPUNE(MAHARASHTRA), INDIA
PACLITAXEL SUBSTANCE AS MFG IN SHANGHAI, CHINA
BUSPIRONE HYDROCHLORIDE AS MFG IN CHONGQING CITY, PEOPLES REPUBLIC OF CHINA

PIRFENIDONE AS MFG IN TOLUCA, MEXICO

Page 436

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15187 A
II
12/7/2000
PERRIGO API LTD

SUBJECT
MOMETASONE FUROATE AS MFG IN BE'ER SHEVA,ISRAEL

15188 A

III

12/6/2000

QENOS PTY LTD

GF7660 WHITE 22 HDPE AS MFG IN ALTONA,VIC.,AUSTRALIA

15189 I

II

12/11/2000

TEVA PHARMACEUTICAL INDUSTRIES LTD

LEUPROLIDE ACETATE AS MFG IN BE'ER SHEVA AND NETANYA, ISRAEL

15190 I

IV

1/12/2001

PENWEST PHARMACEUTICALS CO

TIMERX-A CONTROLLED RELEASE SYSTEM AS MFG IN DANBURY, CT.

15191 I

II

12/15/2000

ZENTIVA KS

TETRAHYDROZOLINE HYDROCHLORIDE USP,AS MFG IN PRAHA,CZECH REPUBLIC.

15192 A

II

12/18/2000

RANBAXY LABORATORIES LTD

CEFPODOXIME PROXETIL AS MFG IN PUNJAB,INDIA

15193 A

II

12/19/2000

API CORP

15194 A

II

12/18/2000

RANBAXY LABORATORIES LTD

MYCOPHENOLIC ACID, TECHNICAL GRADE (INTERMEDIATE) AS MFG IN SHIZUOKA-PREF.,


JAPAN
CEFPODOXIME ACID AS MFG IN PUNJAB, INDIA

15195 A

II

12/4/2000

BASF PHARMA EVIONNAZ SA

CARBAMAZEPINE (CARBATOL) AS MFG IN ST-VULBAS, EIONNAZ, SWITZERLAND

15196 I

II

12/13/2000

CUNO INC

ZETA PLUS VIRAL REMOVAL MEDIA AS MFG IN STAFFORD SPRINGS, CT.

15197 I

III

12/11/2000

MATRIX PACKAGING INC

PLASTIC CONTAINERS AS MFG IN MISSISSAUGA, ONTARIO, CANADA.

15198 I

III

12/14/2000

PERLOS OYJ CEP PLASTICS KONTIOLAHTI

TURBUHALER M3 AS MFG IN LEHMO, FINLAND.

15199 I

II

12/13/2000

PROLIGO LLC

OLIGONUCLEOTIDE GTI-2501 AS MFG IN BOULDER, COLORADO.

15200 I

II

11/12/2000

SOUTHERN HERBALS LIMITED

PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN ANEKAL TALUK, BANGALORE

15201 A

III

12/18/2000

STERI PLAS PTY LTD

70ML TABLET BOTTLE AS MFG IN MOOREBANK, NEW SOUTH WALES, AUSTRALIA.

15202 I

III

12/20/2000

IWATA GLASS INDUSTRIAL CO.,LTD.

AMPULES AND VIALS AS MFG IN OSAKA, JAPAN.

15203 I

IV

12/18/2000

CERESTAR USA INC

ERYTHRITOL AS MANUFACTURED IN HAMMOND, INDIANA

15204 A

IV

12/19/2000

KEWPIE CORP

PHOSPHATIDYCHOLINE DRUG EXCIPIENT AS MFG IN TOKYO, JAPAN.

15205 A

III

11/30/2000

EASTMAN CHEMICAL CO

15206 A

IV

12/20/2000

INTERNATIONAL SPECIALTY PRODUCTS

EASTAPAK, VORIDIAN, AND EASTAR POLYMER PRODUCTION AT CAROLINA EASTMAN


DIVISION
DIAZOLIDINYL UREA,(GERMALL II) AS MFG IN CHATHAM, NEW JERSEY

15207 A

III

12/18/2000

STERI PLAS PTY LTD

115 ML TABLET BOTTLE AS MFG IN MOOREBANK, NEW SOUTH WALES, AUSTRALIA

15208 A

II

12/19/2000

SANOFI AVENTIS DEUTSCHLAND GMBH

RAMIPRIL AS MFG IN FRANKFURT, GERMANY

15209 A

III

12/21/2000

GERRESHEIMER BUNDE GMBH

15210 A

II

12/21/2000

JSC OLAINFARM

CONTAINERS MADE FROM TUBULAR GLASS AS AMPOULES; CARTRIDGES AND VIALS UP TO


50ML AS MANUFACTURED IN BOLESLAWIEC, POLAND
RIMANTADINE HYDROCHLORIDE AS MFG IN OLAINE, LATVIA

15211 A

II

12/26/2000

LEK PHARMACEUTICALS DD

CLAVULANATE POTASSIUM AS MFG IN TRIMLINI, SLOVENIA

15212 A

IV

12/27/2000

SUHEUNG CAPSULE CO LTD

15213 A

II

12/20/2000

FARCHEMIA SRL

GELATIN AND HYDROXYPROPYL METHYCELLULOSE HARD SHELL CAPSULES AS MFG IN


KYUNGGI-DO, KOREA.
BETHANECHOL CHLORIDE AS MFG IN TREVIGLIO(BERGAMO), ITALY

15214 I

IV

5/8/2000

FONA INTERNATIONAL INC

15215 I

IV

12/22/2000

FONA INTERNATIONAL INC

#884.167 N-C NATURAL ORANGE FLAVOR (WONF) (TG-4NA) AS MFG IN CAROL STREAM,
ILLINOIS
#937.129 BITTERING FLAVOR, NATURAL AS MFG IN CAROL STREAM, ILLINOIS

15216 A

III

12/27/2000

POLYONE CORP

CC00016405DR/WE AS MANUFACTURED IN VONORE, TN.

15217 A

II

1/2/2001

HARMAN FINOCHEM LTD

METFORMIN HYDROCHLORIDE AS MFG IN MAHARASHTRA, INDIA

15218 A

II

12/27/2000

CAMBREX KARLSKOGA AB

HYDROUS BENZOYL PEROXIDE (BPO) USP (BULK) AS MFG INKARLSKOGA,SWEDEN

15219 I

II

12/22/2000

CAMBREX CHARLES CITY INC

CETIRIZINE DIHYDROCHLORIDE AS MFG IN CHARLES CITY, IOWA

15220 I

II

12/30/2000

BACHEM CALIFORNIA

THYMOSIN ALPHAS-1 (BULK) AS MFG IN TORRANCE, CA

15221 I

II

1/3/2001

DIOSYNTH BV

NALTREXONE AS MFG IN APELDOORN, THE NETHERLANDS

15222 I

II

1/3/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

TORSEMIDE AS MFG IN BE'ER SHEVA, ISRAEL

Page 437

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15223 A
II
1/4/2001
STERLING SRL

SUBJECT
MEDROXYPROGESTERONE ACETATE AS MFG IN SOLOMEO DI CORCIANO, PERUGIA

15224 I

III

7/19/2000

PCI SERVICES INC

PACKAGING MATERIAL AS MFG IN WESTHOUGHTON, BOLTON, UNITED KINGDOM

15225 I

III

12/13/2000

COLOR MASTER INC

BL2017E, 638C FDA BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA, IN.

15226 I

II

1/4/2001

ACETAMINOPHEN (PARACETAMOL) AS MFG IN WUXI CITY, JIANGSU PROVINCE, CHINA.

15227 I

II

1/3/2001

WUXI SHANHE GROUP NO.1 PHARMACEUTICAL


CO.LTD.
MEMORIAL SLOAN-KETTERING CANCER CENTER

15228 A

II

1/4/2001

15229 I

II

1/8/2001

ORCHID CHEMICALS AND PHARMACEUTICALS LTD 7-AMINO-DESACETOXY-CEPHALOSPORANIC ACID AS MFG IN KANCHEEPURAN DISTRICT,
INDIA.
DSM DERETIL
D(-)PHENYLGLYCINE AMIDE AS MFG IN GELEEN, THE NETHERLANDS.

15230 I

III

1/2/2001

ALUPAK D.O.O.

15231 N

SODIUM IODIDE-124 AS MFG IN NEW YORK,NY

HEAT-WELDING ALUMINUM FOIL, THICKNESS 0.020MM FOR HEA-SEALING ON PVC AND PVDC
(BLISTERFOIL) AS MFG IN SLOVENIA, EUROPE.

NOT AN ASSIGNED NUMBER

15232 I

II

12/21/2000

PARTICLE DYNAMICS INC

DESTAB CALCIUM SULFATE 90 A/A AS MFG IN ST.LOUIS PARK, MINNESOTA

15233 I

II

10/5/2000

SAN FU CHEMICAL CO LTD

BENZOIC ACID AS MFG IN TAINAN, TAIWAN

15234 A

II

1/4/2001

ACS DOBFAR SPA

CEFUROXIME FOR INJECTION (75G AND 225G BULK PACKS) AS MFG IN TRIBIANO(MI), ITALY

15235 A

II

12/21/2000

LUITPOLD PHARMACEUTICALS INC

STERILE WATER FOR INJECTION,USP,AS MFG IN SHIRLEY,NY

15236 I

II

12/28/2000

LUITPOLD PHARMACEUTICALS INC

NEUTRA-CAINE (SODIUM BICARBONATE INJECTION) USP 7.5%, AS MFG IN SHIRLEY, NY.

15237 A

II

12/28/2000

LUITPOLD PHARMACEUTICALS INC

METHYLENE BLUE INJECTION, USP 1%, AS MFG IN SHIRLEY, NY.

15238 A

II

1/12/2001

KYOWA HAKKO KIRIN CO LTD

KRN7000 AS MFG IN TAKASAKI-SHI GUNMA, JAPAN

15239 A

III

12/19/2000

AMPACET CORP

11989-DI WHITE POLYETHYLENE MASTERBACH AS MFG IN MESSANCY, BELGIUM

15240 I

II

1/16/2001

WOCKHARDT LTD

DOXAZOSIN MESYLATE AS MFG IN ANKLESHWAR, DIST. BHARUCH, GUJARAT STATE, INDIA

15241 I

III

1/15/2001

NEW ENGLAND EXTRUSION INC.

NEX GRADE 4086 SHEETING AS MFG IN TURNERS FALLS, MA AND MILTON, WI

15242 I

III

1/15/2001

NEW ENGLAND EXTRUSION INC.

NEX GRADE C8101 SHEETING AS MFG IN TURNERS FALLS, MA AND MILTON, WI

15243 A

II

6/8/1999

ACS DOBFAR SPA

OXACILLIN SODIUM MONOHYDRATE FOR INJECTION AS MFG IN MILANO, ITALY

15244 A

II

1/15/2001

POLYCARBON INDUSTRIES INC

FLECAINIDE ACETATE USP AS MFG IN LEOMINSTER, MA.

15245 I

II

1/23/2001

APOTHECON INC DIV BRISTOL MYERS SQUIBB

OXACILLIN SODIUM FOR ORAL SOLUTION AS MFG IN PRINCETON, NJ.

15246 I

II

1/17/2001

SREENIVASA PHARMA PRIVATE LIMITED

FAMOTIDINE DRUG SUBSTANCE AS MFG IN ANDHRA PRADESH, INDIA.

15247 A

IV

1/12/2001

HENRY H OTTENS MFG CO INC

15248 I

III

1/17/2001

HUHTAMAKI VAN LEER RONSBERG

15249 A

II

1/15/2001

FERMION OY

SPRAY DRIED NATURAL FLAVOR POTENTIATOR S-100-D AS MANUFACTURED IN


PHILADELPHIA, PA
FLEXIBLE LAMINATE FOR RETORTABLE LID FILM FOR CONTACT LENSES FOR AQUEOUS
SALTY SOLVENT AS MFG IN RONSBERG, GERMANY.
6-MERCAPTOPURINE AS MFG IN ESPOO, FINLAND

15250 I

III

1/18/2001

MO 01716-01 POLYPROPYLENE FILMS AS MFG IN MACEDON, NEW YORK.

15251 A

II

1/17/2001

EXXON MOBIL CHEMICAL COMPANY,FILMS


BUSINESS
RANBAXY LABORATORIES LTD

15252 A

II

1/16/2001

SCINOPHARM TAIWAN LTD

RILUZOLE AS MFG IN SHAN-HUA, TAINAN COUNTY, TAIWAN, R.O.C.

15253 A

II

2/16/2001

FRESENIUS KABI AUSTRIA GMBH

15254 A

II

2/16/2001

FRESENIUS KABI AUSTRIA GMBH

LACTULOSE SOLUTION AS MANUFACTURED IN VICCHIO, ITALY FOR FRESENIUS KABI


AUSTRIA GMBH
LACTULOSE CRYSTALS SCM AS MFG IN VICCHIO, ITALY.

15256 I

II

1/12/2001

INTEROR

ETHYL 4-AMINO-1-PIPERDINE CARBOXYLATE AS MFG IN CLAIS, FRANCE

15257 I

II

1/19/2001

GLAXO GROUP LIMITED D/B/A GLAXOSMITHKLINE

FONDAPARINUX SODIUM AS MFG IN OSS THE NETHERLANDS.

15255 N

LORATADINE (NON-STERILE BULK) AS MFG IN NAWANSHAHAR, PUNJAB, INDIA

NOT AN ASSIGNED NUMBER

Page 438

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15258 A
II
1/23/2001
ISOCHEM SA

SUBJECT
EPAL-NCA AS MFG IN VERT-LE-PETIT, FRANCE

15259 A

II

1/22/2001

SANOFI CHIMIE

15260 I

III

1/22/2001

WL GORE AND ASSOC INC

FONDAPARINUX SODIUM AS MFG IN SISTERON (CEDEX) AND NOTRE DAME DE BONDEVILLE,


FRANCE
LYOGUARD TRAY AS MANUFACTURED IN ELKTON, MD

15261 A

II

1/24/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

AZITHROMYCIN AS MANUFACTURED IN BE'ER SHEVA AND PETACH TIQVA, ISRAEL

15262 A

II

2/5/2001

AMPHASTAR FRANCE PHARMACEUTICALS SAS

RECOMBINANT HUMAN INSULIN AS MFG IN THE NETHERLANDS AND FRANCE

15263 I

III

1/17/2001

RICON COLORS

PACKAGING MATERIAL, WHITE, CPE-W986-1 AS MANUFACTURED IN WEST CHICAGO, IL

15264 I

III

2/22/2001

COLORS FOR PLASTICS

COLORS FOR PLASTICS PRODUCT I.D.:R27624 PEACH AS MFG IN ELK GROVE, IL.

15265 I

III

2/22/2001

COLORS FOR PLASTICS

COLORS FOR PLASTICS PRODUCT ID:B19353 PURPLE AS MFG IN ELK GROVE VILLAGE, IL.

15266 I

III

2/22/2001

COLORS FOR PLASTICS

COLORS FOR PLASTICS PRODUCT ID:R27199 RUST AS MFG IN ELK GROVE VILLAGE, IL.

15267 A

II

1/26/2001

DIVIS LABORATORIES LTD

DILTIAZEM HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15268 I

IV

1/24/2001

TRICON VEREDLUNGS GMBH

15269 I

II

1/25/2001

QINGDAO FTZ UNITED INTERNATIONAL, INC.

PET FILM 15 AND 23 UM, ONE SIDE PRINTED WITH MAT LAQUER TO BE USED IN THE
MANUFACTURE OF TTS SYSTEMS AS MANUFACTURED IN FREIBURG, GERMANY
CAPSAICIN NATURAL AS MANUFACTURED IN SHANGDONG, CHINA

15270 I

II

2/13/2001

ONO PHARMACEUTICAL CO LTD

SIVELESTAT SODIUM HYDRATE AS MFG IN FUKUI, JAPAN.

15271 I

III

1/26/2001

TICONA GMBH

15272 A

II

1/30/2001

ACS DOBFAR SPA

VECTRAN LIQUID CRYSTAL POLYMERS AS MANUFACTURED IN SHELBY, NORTH CAROLINA &


FLORENCE, KENTUCKY
CEFOTAXIME ACID AS MANUFACTURED IN TRIBIANO (MILANO), ITALY

15273 I

III

1/30/2001

ROHM AND HAAS

MORPRIME 10B (51754) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

15274 A

III

1/30/2001

LOPAREX BV

FL2000 19 MICRON PET WITH GRADE CODES 78FX AND 78GJ AS MFG IN THE NETHERLANDS

15275 I

II

2/2/2001

CATALENT PHARMA SOLUTIONS LLC

ACCUTANE (10MG, 40MG) AS MFG IN ST.PETERSBURG, FLORIDA

15276 A

II

2/6/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

CLARITHROMYCIN AS MFG IN EMEK SARA, BE'ER SHEVA, AND PETACH TIQVA, ISRAEL.

15277 I

III

10/4/2000

PLASDENE GLASS-PAK PTY LTD

33MM WHITE WADDED SCT CLOSURE AS MFG IN PRESTON, VICTORIA, AUSTRALIA

15278 I

III

10/4/2000

PLASDENE GLASS-PAK PTY LTD

15279 I

III

10/4/2000

PLASDENE GLASS-PAK PTY LTD

15280 A

III

2/8/2001

ROLLPRINT PACKAGING PRODUCTS INC

200ML AND 500ML HDPE WHITE TABLET CONTAINER AS MFG IN PRESTON AND MORABBIN,
VICTORIA, AUSTRALIA.
38MM WHITE WADDED TAMPER EVIDENT CLOSURE AS MFG IN PRESTON AND MOORABBIN,
VICTORIA, AUSTRALIA.
RPP#26-1117 AS MFG IN ADDISON, ILLINOIS AND BLOOMFIELD, CT.

15281 I

IV

2/8/2001

FONA INTERNATIONAL INC

#825.321 N-C ARTIFICIAL CHERRY FLAVOR AS MFG IN CAROL STREAM, ILLINOIS

15282 I

IV

2/8/2001

FONA INTERNATIONAL INC

825.662 ARTIFICIAL CHERRY FLAVOR AS MFG IN CAROL STREAM, ILLINOIS

15283 I

III

2/9/2001

HARCOSTAR DRUMS LTD

15284 I

II

1/31/2001

SUMITOMO SEIKA CHEMICALS CO LTD

0008E FOR 60L OPEN TOP PLASTIC PACKAGING (60L UNIVERSAL) AS MFG IN THE UNITED
KINGDOM.
KETOSULFONE AS MFG IN HYOGO PREFECTURE, JAPAN.

15285 A

II

2/8/2001

BIDACHEM SPA

CROTAMITON AS MFG IN ITALY

15286 A

III

2/5/2001

HEINKE TECHNOLOGY INC

PREFILLED VAGINAL APPLICATOR AS MFG IN LINCOLN, NEBRASKA

15287 A

II

2/12/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

MUPIROCIN AS MFG IN ZAGREB, CROATIA

15288 A

II

2/27/2001

ELI LILLY AND CO

15289 A

II

2/15/2001

OLON SPA

CAPREOMYCIN SULFATE, STERILE BULK (CAPASAT) AS MANUFACTURED IN LIVERPOOL,


ENGLAND
PHENTERMINE HYDROCHLORIDE AS MFG IN GARBAGNATE MILANESE(MI) ITALY

15290 I

II

2/16/2001

DSM PHARMACEUTICALS INC

CLINDAMYCIN PHOSPHATE AS MFG IN GREENVILLE, NORTH CAROLINA

15291 I

II

2/19/2001

SIFAVITOR SPA

THALIDOMIDE AS MFG IN FRAZIONE MARIANO(LODI), ITALY.

15292 I

II

2/14/2001

ORGAMOL SA

CDT-PHOSPHATE AS MFG IN ST-VULBAS AND EVIONNAZ, SWITZERLAND.

Page 439

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15293 A
II
2/15/2001
CATALENT PHARMA SOLUTIONS LLC

SUBJECT
NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE AS MFG IN ST.PETERSBURG, FLORIDA.

15294 A

IV

1/12/2001

HENRY H OTTENS MANUFACTURING CO INC

FLAVOR POTENTIATOR 2-100 AS MFG IN PHILADELPHIA, PA.

15295 I

III

2/14/2001

AMPACET CORP

15296 A

III

1/31/2001

3M DRUG DELIVERY SYSTEMS

11748 WHITE POLYETHYLENE MASTERBATCH AS MFG IN TERRE


HAUTE,IN;DERIDDER,LA;CARTERSVILLE,GA;HEATH,OH;OR LATEXO,TX.
SCOTCHPAK 9739 (2-MIL POLYESTER LAMINATE) AS MFG IN COTTAGE GROVE, MN.

15297 A

III

1/18/2001

POLIMERI EUROPA FRANCE SA

RIBLENE FC20 AS MFG IN DUNKIRK, FRANCE.

15298 I

II

3/16/2001

FARMABIOS S P A

BUDESONIDE AS MFG IN GROPELLO CAIROLI(PAVIA), ITALY.

15299 A

II

2/23/2001

DR REDDYS LABORATORIES LTD

OLANZAPINE (FORM 1) AS MFG IN ANDHRA PRADESH, INDIA.

15300 A

II

2/22/2001

SUMITOMO CHEMICAL CO LTD

MIRTAZAPINE AS MFG IN GIFU PREFECTURE, JAPAN.

15301 N

NOT AN ASSIGNED NUMBER

15302 A

III

2/8/2001

POLYONE CORP

CC00015957D4/DR AS MANUFACTURED IN VONORE, TN.

15303 I

II

2/16/2001

KOWA CO LTD

NK-104 TABLETS AS MFG IN FUJI SHIZUOKA, JAPAN

15305 A

II

2/26/2001

CAMBREX CHARLES CITY INC

DEXTROAMPHETAMINE SACCHARATE AS MFG IN CHARLES CITY,IA.

15306 A

II

2/26/2001

CAMBREX CHARLES CITY INC

AMPHETAMINE ASPARTATE AS MFG IN CHARLES CITY, IA.

15307 A

II

2/26/2001

CAMBREX CHARLES CITY INC

DEXTROAMPHETAMINE SULFATE AS MFG IN CHARLES CITY, IA.

15308 A

II

2/26/2001

CAMBREX CHARLES CITY INC

AMPHETAMINE SULFATE AS MFG IN CHARLES CITY,IA.

15309 I

IV

2/20/2001

TECHNICAL FLAVORS AND FRAGRANCES INC.

15310 A

II

2/21/2001

INTERNATIONAL SPECIALTY PRODUCTS

NATURAL ANISE EXTRACT(789-647B) AND ARTIFICIAL STRAWBERRY FLAVOR(789-780) AS MFG


IN AMITYVILLE,NY.
ALLANTOIN AS MFG IN CHATHAM, NJ.

15311 A

III

2/22/2001

3M DRUG DELIVERY SYSTEMS

15312 I

III

2/28/2001

PHARM GLASS ASO SDN BHO

COTRAN 9752, NON-WOVEN WHITE RAYON MEDICAL TAPE, WITH ADHESIVE COATING ON
ONE SIDE AS MFG IN BROOKINGS,SD.
GLASS AMPOULES AND VIALS AS MFG IN MALAYSIA.

15313 I

III

2/26/2001

EAGLE COLOR CORPORATION

SHEETFED OFFSET PRINTING INK AS MFG IN PENNSAUKEN, NJ.

15314 A

II

2/28/2001

BIOIBERICA SA

SODIUM HYALURONATE AS MFG IN BARCELONA, SPAIN.

15315 A

IV

2/27/2001

ARAKAWA CHEMICAL INDUSTRIES LTD

ARKON P-100 (EXCIPIENT) AS MFG IN OKAYAMA, JAPAN.

15316 I

III

2/26/2001

MEDISIZE CORPORATION KONTIOLAHTI PLANT

DISPOSABLE SYRINGE FOR JELLY AS MFG IN LEHMO, FINLAND.

15317 I

II

2/28/2001

SAUREFABRIK SCHWEIZERHALL

CDTP (DRUG INTERRMEDIATE) AS MFG IN PRATELN, SWITZERLAND.

15318 A

II

2/28/2001

CATALENT PHARMA SOLUTIONS LLC

ROCALTROL (0.25MCG & 0.5MCG) SOFTGEL CAPSULE AS MFG IN ST. PETERSBURG, FL.

15319 A

II

2/23/2001

PACLITAXEL AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

15320 A

IV

3/2/2001

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO


LTD
KERRY CANADA INC

15321 A

II

2/28/2001

PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE AS MFG IN FRESONARA(AR), ITALY.

15322 I

II

2/28/2001

BIOINDUSTRIA LABORATORIO ITALIANO


MEDICINALI SPA
LONZA LTD

15323 A

II

3/2/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

MIRTAZAPINE AS MFG IN BE'ER SHEVA, ISRAEL.

15324 I

II

2/28/2001

ZACH SYSTEM SPA

KETOSULFONE AS MFG IN LONIGO, ITALY.

15325 A

II

2/28/2001

DELMAR CHEMICALS INC

PYRAZINAMIDE AS MFG IN QUEBEC, CANADA.

15326 A

II

2/28/2001

AMINO CHEMICALS LTD

FOSINOPRIL SODIUM AS MFG IN MARSA, MALTA.

15327 A

II

3/1/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

BETAMETHASONE ACETATE AS MFG IN MILAN, ITALY.

15328 I

II

3/14/2001

WATSON PHARMACEUTICALS INC

CYCLOSPORINE AS MFG IN HANGZHOU, ZHEJIANG, PEOPLES REPUBLIC OF CHINA.

15304 N

NOT AN ASSIGNED NUMBER

BLUE RASPBERRY NA/ARTIFICIAL FLAVOR MC 4778 AS MFG IN GRANBY, CANADA.

KETOSULFONE AS MFG IN VISP, SWITZERLAND

Page 440

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15329 A
III
3/8/2001
3M DRUG DELIVERY SYSTEMS

SUBJECT
COTRAN 9737 POLYOLEFIN FILM AS MFG IN BROOKINGS, SD.

15330 A

III

3/2/2001

NAMICOS CORPORATION

SILICON PROCESS VIALS AND AMPOULES AS MFG IN SHIGA, JAPAN.

15331 I

III

3/12/2001

BUNDER GLAS GMBH

PLASTIC BOTTLES AND DROPPER BOTTLE SYSTEMS FOR OPHTHALMIC PRODUCTS AND
OTHER APPLICATIONS UP TO CONTENTS OF 250ML CAPACITY AS MFG IN BUENDE, FEDERAL
REPUBLIC OF GERMANY AND BOLESLAWIEC, POLAND.

15332 A

II

3/14/2001

XINJIANG HESHOU EPHIDRINE PRODUCTS CO.LTD. PSEUDOEPHEDRINE HYDROCHLORIDE AS MFG IN HESHOU COUNTY, XINJIANG, CHINA.

15333 A

II

3/30/2001

EVONIK DEGUSSA GMBH

15334 I

III

4/4/2001

THE TECH GROUP

N6-TRIFLUORACETYL-L-LYSYL-L-PROLINE MANUFACTURED IN HANAU AND RADEBEUL,


GERMANY.
INHALATION ACTUATORS PACKAGING MATERIALS AS MFG IN SCOTTSDALE, ARIZONA

15335 I

II

3/15/2001

CATALENT PHARMA SOLUTIONS LLC

LANOXICAPS (0.5, 0.10, AND 0.20MG) SOFTGEL CAPSULES AS MFG IN ST.PETERSBURG, FL.

15336 A

III

3/27/2001

DIAMOND POLYMERS INC

POLYMER BLENDS AS MANUFACTURED IN AKRON, OHIO

15337 I

II

3/19/2001

SPI PHARMA INC

MAGNESIUM HYDROXIDE PASTE/POWDER USP AS MFG IN LEWES, DE.

15338 A

II

2/21/2001

CAMBREX CHARLES CITY INC

D-AMPHETAMINE BASE AS MFG IN WARREN, NJ AND CHARLES CITY, IA.

15339 A

II

4/13/2001

TARO PHARMACEUTICAL INDUSTRIES LTD

ETODOLAC USP MICRONIZED AS MFG IN HAIFA BAY, ISRAEL.

15340 A

II

2/21/2001

CAMBREX CHARLES CITY INC

15341 I

IV

2/5/2001

ALPINE AROMATICS INTERNATIONAL INC

DL-AMPHETAMINE BASE ACTIVE PHARMACEUTICAL INGREDIENT AS MFG IN WARREN, NJ AND


CHARLES CITY, IA.
SKIN CARE TYPE FRAGRANCE#223-520 AS MFG IN PISCATAWAY, NJ.

15342 I

III

3/9/2001

BERRY PLASTICS CORP

PRODUCT 24-5-141 AS MANUFACTURED IN HOMER, LA

15343 A

12/14/2000

WEST PHARMACEUTICAL SERVICES INC

15344 I

III

3/27/2001

LUDLOW COATED PRODUCTS

CONTRACT TESTING FOR PACKAGING COMPONENTS FOR THE PHARMACEUTICAL INDUSTRY


IN LIONVILLE, PA.
3 MIL POLYESTER FILM/4W-2 AS MFG IN MERIDIAN, MS.

15345 I

II

3/16/2001

AKZO NOBEL POLYMER CHEMICALS LLC

PERKADOX API (BENZOYL PEROXIDE) AS MFG IN BURT, NY.

15346 I

III

3/21/2001

AMPACET CORP

15347 A

II

3/20/2001

WEX PHARMACEUTICALS INC

15348 A

II

3/23/2001

3M PURIFICATION INC

15349 I

III

3/26/2001

NAMPAK PERSONAL CARE

49974 BLACK SLIP POLYPROPYLENE AS MFG IN TERRE HAUTE, IN; CARTERSVILLE, GA;
DERIDDER, LA; LATEXO, TX; HEATH, OH; AND MESSANCY, BELGIUM.
TETRODOTOXIN DRUG SUBSTANCE AS MFG IN NANNING CITY, GUANGXI, PEOPLES
REPUBLIC OF CHINA
BETAFINE PLEATED POLYPROLYLENE CARTRIDGE PRODUCTS (BETAFINE D SERIES,
BETAFINE XL SERIES, AND BETAFINE PP & PG SERIES)
15ML PHARMAPAC BOTTLE AS MFG IN LEICESTER, UNITED KINGDOM.

15350 A

III

3/26/2001

CONSOLIDATED CONTAINER CO LLC

PACKAGING MATERIAL AS MFG IN HAMPSTEAD, NH.

15351 I

III

3/26/2001

ALUPAK DOO

PRINTED HEAT WELDING ALUMINUM FOIL AS MFG IN SLOVENIA, EUROPE.

15352 A

II

3/28/2001

RELIABLE BIOPHARMACEUTICAL CORP

FLOXURIDINE AS MFG IN ST. LOUIS, MO.

15353 A

II

3/28/2001

SHASUN PHARMACEUTICALS LTD

METHOHEXITAL USP AS MFG IN CUDDALORE, INDIA.

15354 I

IV

3/22/2001

EXXONMOBIL CHEMICAL CO

VISTANEX POLYISOBUTYLENE RUBBER AS MFG IN BAYTOWN, TX.

15355 I

III

3/23/2001

ROHM AND HAAS CO

GREEN BAY ADHESIVE 103 AS MFG IN WEST PHILADELPHIA, PA.

15356 I

III

3/26/2001

BECTON DICKINSON PHARMACEUTICAL SYSTEMS BD MONOVIAL LUER AXS AS MFG IN ENGLAND AND FRANCE.

15357 A

II

4/12/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

DOXERCALCIFEROL AS MFG IN BE'ER SHEVA ISRAEL.

15358 I

III

3/30/2001

WINPAK TECHNOLOGIES INC

PACKAGING MATERIALS AS MFG IN TORONTO, ONTARIO, CANADA

15359 A

II

3/29/2001

PISGAH LABS INC

IMIPRAMINE PAMOATE AS MFG IN PISGAH FORREST, NC.

15360 I

II

3/30/2001

BICIFADINE TABLETS AS MFG IN ATHLONE COUNTY, WESTMEATH, IRELAND.

15361 A

II

3/29/2001

ELAN PHARMACEUTICAL RESEARCH


CORPORATION
GEDEON RICHTER PLC

15362 I

II

4/4/2001

RANBAXY LABORATORIES LTD

FLUOXETINE HYDROCHLORIDE AS MFG IN PUNJAB, INDIA

AZELASTINE HCL AS MANUFACTURED IN BUDAPEST, HUNGARY

Page 441

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15363 A
IV
3/30/2001
ZEON CORP

SUBJECT
QUINTAC 3570C (AN EXCIPIENT) AS MFG IN TOKYO, JAPAN.

15364 A

II

4/2/2001

DIVIS LABORATORIES LTD

NABUMETONE AS MFG IN ANDHRA PRADESH, INDIA.

15365 I

II

4/1/2001

PHARMACEUTICAL FINE CHEMICALS BAHAMAS

METAXALONE AS MFG IN FREEPORT, GRAND BAHAMA ISLAND, BAHAMAS

15366 A

II

4/10/2001

UNIQUE CHEMICALS

DICLOFENAC ACID AS MFG IN GUJARAT, INDIA.

15367 A

II

3/30/2001

WUHAN WUYAO PHARMACEUTICAL CO LTD

NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG AS MFG IN WUHAN, CHINA

15368 I

II

4/10/2001

GENTA INC

DJ-927 DRUG SUBSTANCE AS MFG IN TOKYO, JAPAN.

15369 A

III

4/5/2001

NOLATO JAYCARE LTD

ANTIBIOTIC BOTTLES WITH POURER NECK AS MFG IN NEW CASTLE UPON TYNE, UK.

15370 A

III

4/10/2001

INEOS CHLORVINYLS BELGIUM NV

NORVINYL TM S5902 AS MANUFACTURED IN THE NETHERLANDS.

15371 N

NOT AN ASSIGNED NUMBER

15372 I

III

4/10/2001

CREATIVE FORMING

POLYETHYLENE TEREPHTHALATE SHEET AS MFG IN RIPON, WI

15373 I

III

4/4/2001

CATALENT GERMANY SCHORNDORF GMBH

PACKAGING MATERIALS AS MFG IN SCHORNDORF, GERMANY

15374 I

III

4/5/2001

DUPONT POLYESTER

KALIDAR X70 AS MFG IN FAYETTEVILLE, NC

15375 A

III

4/2/2001

POLYONE CORP

CC00004396WE AS MANUFACTURED IN VONORE, TN.

15376 A

II

4/5/2001

QUIMICA SINTETICA SA

SUMATRIPTAN SUCCINATE AS MFG IN MADRID, SPAIN

15377 I

II

4/6/2001

UNITED LABORATORIES LTD

AMOXICILLIN USP BULK SUBSTANCE AS MFG IN GUANGDONG, PEOPLES REPUBLIC OF CHINA

15378 A

III

4/5/2001

HEINKE TECHNOLOGY INC

PREFILLED VAGINAL APPLICATOR AS MFG IN LINCOLN, NE

15379 I

III

4/9/2001

LIQUITANE ROCHESTER

PACKAGING MATERIAL AS MFG IN ROCHESTER, NY

15380 I

III

4/10/2001

CHROMA CORPORATION

PC2118C 20/1 WHITE COLOR CONCENTRATE AS MFG IN MCHENRY, IL.

15381 I

II

4/11/2001

LONZA INC

CDT PHOSPHATE AS MANUFACTURED IN CONSHOCKEN, PA

15382 I

II

4/16/2001

PACLITAXEL AS MFG IN LUONAN COUNTY SHAANXI PROVINCE, CHINA.

15383 A

IV

5/7/2001

TAIHUA NATURAL PLANT PHARMACEUTICAL


CO.,LTD.
WACKER CHEMIE AG

15384 A

II

5/8/2001

JANSSEN PHARMACEUTICA NV

15385 A

II

4/18/2001

MALLINCKRODT INC

GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC) AS MFG IN BELGIUM AND


AUSTRALIA
DEXTROAMPHETAMINE SULFATE AS MANUFACTURED IN ST.LOUIS, MO.

15386 A

IV

4/18/2001

HEBEI WENDA CHEMICALS CO LTD

EFFERVES (AMINO ACID COMPLEX) AS MFG IN HEBEI PROVINCE, CHINA.

15387 I

III

4/12/2001

SOLUTIA INC

CPFILMS WATER BASED DEEP DYED FILMS AS MFG IN FEILDALE AND MARTINSVILLE, VA.

15388 I

II

4/18/2001

PROLIGO THIOATES LLC

OLIGONUCLEOTIDE INX-3001 AS MFG IN BOULDER, COLORADO

15389 I

III

4/30/2001

CLARIANT(CANADA) INC

01SHI-227, STYRENE WHITE MASTERBATCH AS MFG IN ONTARIO AND QUEBEC, CANADA.

15390 I

III

10/4/2000

PLASDENE GLASS PAK

15391 I

II

4/3/2001

INDUSTRIES MONFEL S.A. DE C.V.

30ML AMBER GLASS TABLET BOTTLE AS MFG IN PRESTON VICTORIA, AUSTRALIA AND
JAKARTA, INDONESIA
ACETYLSALICYLIC ACID AS MFG IN MEXICO

15392 A

III

4/25/2001

WESTLAKE LONGVIEW CORP

EMAC SPECIALTY COPOLYMERS AS MFG IN LONGVIEW, TX.

15393 A

III

4/17/2001

INEOS OLEFINS AND POLYMERS USA

ARCO POLYPROPYLENE HOMOPOLYMERS HM20A1 AS MFG IN LONG BEACH, CALIFORNIA

15394 A

III

4/5/2001

NOLATO JAYCARE LTD

COPHARM BOTTLE AS MFG IN PORTSMOUTH, HAMPSHIRE, UNITED KINGDOM.

15395 I

III

4/5/2001

COPE ALLMAN PLASTIC PACKAGING LIMITED

2 PIECE PUSH-LOK CRC CLOSURE AS MFG IN PORTSMOUTH, HAMPSHIRE, UNITED KINGDOM

15396 I

III

4/17/2001

SOLUTIA INC

CLEARSIL RELEASE FILMS AS MFG IN MARTINSVILLE AND FIELDALE, VA.

15397 I

II

4/19/2001

CEDARBURG PHARMACEUTICALS LLC

DOXERCALCIFEROL AS MFG IN MILWAUKEE, WI.

15398 I

II

4/13/2001

IPCA LABORATORIES LTD

TRICLOSAN AS MFG IN INDIA

AMORPHOUS FUMED SILICON DIOXIDE (HDK N 20) AS MFG IN GERMANY

Page 442

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15399 I
III
4/18/2001
BASELL POLIOLEFINE ITALIA SPA

SUBJECT
LUPOLEN 1810 D AS MFG IN WESSELING, GERMANY

15400 A

III

4/18/2001

WESTLAKE PETROCHEMICALS LP

LINEAR LOW-DENSITY POLYETHYLENE RESINS AS MFG IN SULPHUR, LOUISIANA.

15401 A

IV

4/26/2001

ACG ASSOCIATED CAPSULES PRIVATE LTD

HARD GELATIN CAPSULE SHELLS AS MANUFACTURED IN SATARA, MAHARASHTRA

15402 A

II

4/25/2001

POLYPEPTIDE LABORATORIES INC

HUMAN SECRETIN ACETATE DRUG SUBSTANCE AS MFG IN TORRANCE, CALIFORNIA

15403 I

II

4/26/2001

ERREGIERRE SPA

OXICONAZOLE NITRATE AS MFG IN BERGAMO, ITALY

15404 I

III

3/31/2001

BETTS UK LIMITED

QVAR ACTUATOR AND DUSTCAP AS MFG IN THE UNITED KINGDOM.

15405 I

III

4/23/2001

AKZO NOBEL INKS CORP

PACKAGING MATERIALS INKS AS MFG IN PLYMOUTH, MN

15406 I

II

4/26/2001

BASF ORGAMOL PHARMA SOLUTIONS SA

IRBESARTAN(SR47436) AS MFG IN SWITZERLAND

15407 N

NOT AN ASSIGNED NUMBER

15408 I

II

4/24/2001

BAYER HEALTHCARE LLC ANIMAL HEALTH DIV

HYALURONIC ACID BULK DRUG AS MFG IN SHAWNEE MISSION, KANSAS

15409 A

II

4/30/2001

APOTEX INC

ALENDRONATE SODIUM TRIHYDRATE USP AS MFG IN ONTARIO, CANADA

15410 I

IV

4/30/2001

SEPPIC S.A.

MONTANIDE ISA 703 AS MFG IN CASTRES, FRANCE

15411 I

II

5/1/2001

WOCKHARDT LTD

CEFUROXIME AXETIL(CRYSTALLINE) USP AS MFG IN ANKLESHWAR, INDIA

15412 A

II

5/3/2001

SIGNA SA DE CV

GEMFIBROZIL USP DRUG SUBSTANCE AS MFG IN TOLUCA,MEX.,MEXICO

15413 A

II

5/4/2001

CILAG AG

MEFLOQUINE HYDROCHLORIDE AS MFG IN SCAFFHAUSEN, SWITZERLAND

15414 I

II

5/4/2001

VIBRANTIS SA DE CV

SULFAMETHOXAZOLE AS MFG IN JALISCO, MEXICO

15415 I

II

5/4/2001

R.P. SCHERER NORTH AMERICA

HYDERGINE(ERGOLOID MESYLATES) 1MG SOFTGELS AS MFG IN ST. PETERSBURG, FL

15416 A

III

5/4/2001

MULTISORB TECHNOLOGIES INC

FRESH PAX TYPE A, B, D, AND R OXYGEN ABSORBING PRODUCTS AS MFG IN BUFFALO, NY.

15417 A

II

5/7/2001

JANSSEN PHARMACEUTICA NV

15418 I

II

5/4/2001

FARMAK A S

NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS MANUFACTURED IN GEEL,


BELGIUM
DILTIAZEM HYDROCHLORIDE AS MFG IN CZECH REPUBLIC

15419 A

II

5/3/2001

RANBAXY LABORATORIES LTD

FEXOFENADINE HYDROCHLORIDE AS MFG IN PUNJAB, INDIA

15420 I

III

5/4/2001

SEALED AIR CORPORATION

TRANSDERMAL FILM, TDF SERIES, AS MFG IN NORDERSTEDT, DEUTSCHLAND.

15421 A

II

1/25/2000

YUKI GOSEI KOGYO CO LTD

PROTAMINE SULFATE AS MFG IN IWAKI-CITY, FUKUSHIMA, JAPAN.

15422 A

II

5/11/2001

DSM FINE CHEMICALS NETHERLANDS BV

KETONE BISULFITE ADDUCT (KBA) AS MFG IN THE NETHERLANDS

15423 A

II

4/30/2001

FINETECH PHARMACEUTICAL LTD

CABERGOLINE AS MFG IN NESHER, ISRAEL

15424 A

IV

5/8/2001

ROBERTET FLAVORS INC

SPRAY DRIED ARTIFICIAL CHERRY FLAVOR NV-1489 AS MFG IN PISCATAWAY, NJ.

15425 A

II

5/9/2001

MALLINCKRODT INC

AMPHETAMINE SULFATE AS MANUFACTURED IN ST.LOUIS, MISSOURI

15426 A

IV

5/8/2001

ROBERTET FLAVORS INC

15427 A

II

5/17/2001

GEDEON RICHTER PLC

SPRAY DRIED ARTIFICIAL FLAVOR(CHERRY MIXED FRUIT TYPE) FOR ANTIBIOTIC NV-7757 AS
MFG IN PISCATAWAY, NJ.
OXANDROLONE AS MFG IN BUDAPEST, HUNGARY

15428 A

II

5/15/2001

MALLINCKRODT INC

DEXTROAMPHETAMINE SACCHARATE AS MANUFACTURED IN ST.LOUIS, MISSOURI

15429 I

II

5/15/2001

ROCHE DIAGNOSTICS GMBH

IBANDRONATE, EDITION I, AS MFG IN MANNHEIM, GERMANY

15430 I

III

5/15/2001

AMPACET CORP

15431 I

III

5/14/2001

CLARIANT (CANADA) INC

7011785 RESIN MELT BLEND AS MFG IN TERRE HAUTE,IA; DERIDDER,LA; CARTERSVILLE,GA;


HEATH,OH; OR LATEXO,TX.
REM 104-CAG WHITE POLYETHYLENE MASTERBACH AS MFG IN LAHNSTEIN, GERMANY

15432 I

III

5/14/2001

POLIMERI EUROPA SRL

ERACLENE BB76 AS MFG IN BRINDISI, ITALY

15433 A

II

5/15/2001

NEULAND LABORATORIES LTD

OFLOXACIN AS MFG IN TELANGANA, INDIA

15434 A

II

5/15/2001

NEULAND LABORATORIES LTD

ENALAPRIL MALEATE AS MFG IN TELANGANA, INDIA

Page 443

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15435 A
II
5/15/2001
MALLINCKRODT INC

SUBJECT
AMPHETAMINE ASPARTATE AS MANUFACTURED IN ST. LOUIS, MISSOURI

15436 A

II

5/15/2001

DR REDDYS LABORATORIES LTD

ONDANSETRON HYDROCHLORIDE DIHYDRATE AS MFG IN ANDHRA PRADESH, INDIA

15437 I

III

5/2/2001

TETTAUER GLASHUTTENWERKE AG

GLASS PACKAGING MATERIAL AS MFG IN FRIEDRICHSDORF, GERMANY

15438 A

II

5/8/2001

OLON SPA

FENOFIBRATE AS MFG IN MULAZZANO(LO), ITALY

15439 I

III

5/14/2001

SUNALLOMER LTD

POLYPROPYLENE PACKAGING MATERIALS AS MFG IN OITA PREFECTURE, JAPAN

15440 A

II

5/15/2001

EVONIK TECHNOCHEMIE GMBH

AZELASTINE HYDROCHLORIDE BULK DRUG AS MFG IN RADEBEUL, GERMANY

15441 I

IV

5/18/2001

FONA INTERNATIONAL INC

15442 A

II

5/14/2001

CHEMISCHE FABRIK BERG GMBH

#884.56 N-C ORANGE CREAM FLAVOR NATURAL AND ARTIFICIAL AS MFG IN CAROL STREAM,
IL.
PHENTERMINE HYDROCHLORIDE USP AS MFG IN BITTERFELD, GERMANY

15443 I

II

5/18/2001

15444 I

II

5/18/2001

TECHNOLOGY COMMERCIALIZATION
INTERNATIONAL INC
AVECIA BIOTECHNOLOGY INC

MOLYBDENUM-99 OF U235 (N,F) PRODUCED BY RUSSIAN ACADEMY OF SCIENCES BRANCH


OF KARPOV INSTITUTE REACTOR, OBNINSK, KALUGA REGION, RUSSIA
ORI-1001 DRUG SUBSTANCE AS MFG IN MILFORD, MA

15445 A

II

5/15/2001

NEULAND LABORATORIES LTD

ITRACONAZOLE USP AS MFG IN ANDHRA PRADESH, INDIA

15446 A

III

5/16/2001

FUJIMORI KOGYO CO LTD

15447 I

II

5/15/2001

15448 I

III

5/24/2001

YUNG SHIN PHARMACEUTICAL INDUSTRIES CO


LTD
SUPREME INDUSTRIES LIMITED

RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES AS MFG IN
OGASA-GUN, SHIZOKA PREFECTURE, JAPAN.
PANCRELIPASE CR PELLETS AS MFG IN TAIWAN, REPUBLIC OF CHINA

15449 A

IV

5/22/2001

KEWPIE CORP

PURIFIED YOLK LECITHIN DRUG EXCIPIENT AS MFG IN TOKYO, JAPAN.

15450 I

II

5/2/2001

BIOSEPRA SA

MEP HYPERCEL AS MANUFACTURED IN ST. PIERRE LES ELBERT, FRANCE.

15451 I

II

5/23/2001

WOCKHARDT LTD

CEFUROXIME AXETIL (AMORPHOUS) AS MANUFACTURED IN GUJARAT STATE, INDIA

15452 A

II

5/11/2001

NAGAOKA AND CO LTD

MENTHOL AS MFG IN HYOGO, JAPAN

15453 A

III

5/24/2001

POLYONE CORP

CC00088583WE AS MANUFACTURED IN VONORE, TN.

15454 I

IV

5/23/2001

EXXONMOBIL CHEMICAL CO

VISTANEX LM POLYISOBUTYLENE PRODUCTS AS MFG IN LINDEN, NJ

15455 I

II

5/17/2001

FINORGA A DIVISION OF SYLACHIM

CRE16336 AS MFG IN CHASSE-SUR-RHONE, FRANCE

15456 A

II

5/24/2001

PERRIGO API LTD

FLUTICASONE PROPIONATE AS MFG IN BE'ER SHEVA, ISRAEL

15457 A

II

5/4/2001

FARMHISPANIA SA

FH-108 AS MFG IN BARCELONA, SPAIN

15458 I

II

5/3/2001

BASF ORGAMOL PHARMA SOLUTIONS SA

CLOPIDOGREL BISULFATE, FORM II, AS MFG IN SWITZERLAND, AND FRANCE.

15459 N

POLYVINYL CHLORIDE FILMS AS MANUFACTURED IN BHIND DISTRICT, INDIA

NOT AN ASSIGNED NUMBER

15460 A

IV

5/31/2001

BASF SE

KOLLIDON SR AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

15461 A

II

5/29/2001

CAMBREX CHARLES CITY INC

PHENTERMINE HYDROCHLORIDE AS MFG IN CHARLES CITY, IA

15462 A

II

5/31/2001

RESOLUTION CHEMICALS LIMITED

LATANOPROST AS MFG IN BERKSHIRE, UK AND ANDHRA PRADESH, INDIA

15463 I

II

5/29/2001

CHEMI SPA

PAROXETINE ACETATE AS MFG IN PATRICIA (FROSINONE), ITALY.

15464 A

II

5/25/2001

SYN TECH CHEM AND PHARM CO LTD

PRAMOXINE HYDROCHLORIDE AS MFG IN TAIWAN, R.O.C.

15465 A

II

5/31/2001

15466 I

II

6/5/2001

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE DRUG ABUSE
ELI LILLY AND COMPANY CLINTON LABORATORIES

METHAMPHETAMINE HYDROCHLORIDE, INJECTABLE 10MG/1ML, 1ML AMPOULES, AS MFG IN


LEXINGTON, KENTUCKY
DIPEPTIDYLAMINOPEPTIDASE (DDAP) AS MANUFACTURED IN FEGERSHEIM, FRANCE.

15467 I

II

5/31/2001

JENAHEXAL PHARMA GMBH

0.9% SODIUM CHLORIDE INJECTION AS MFG IN WEIMAR AND JENA, GERMANY

15468 I

II

5/31/2001

JENAHEXAL PHARMA GMBH

STERILE WATER FOR INJECTION AS MFG IN WEIMAR AND JENA, GERMANY

15469 A

II

6/4/2001

COPRIMA S.A.

FENOFIBRATE AS MFG IN BARCELONA, SPAIN.

Page 444

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15470 I
II
6/1/2001
CHEMICA

SUBJECT
ISOMETHEPTENE MUCATE USP AS MANUFACTURED IN LOS ANGELES, CA

15471 A

IV

6/5/2001

ARAKAWA CHEMICAL INDUSTRIES LTD

EXCIPIENT KE-311 AS MANUFACTURED IN JAPAN

15472

IV

5/17/2001

WILD FLAVORS INC

NATURAL COLA TYPE FLAVOR WITH COLOR #FADS813 AS MANUFACTURED IN ERLANGER, KY

15473 A

III

5/30/2001

POLYONE CORP

PRODUCT NUMBER PK8-0070FG AS MANUFACTURED IN BURLINGTON, NJ

15474 A

IV

5/29/2001

ROBERTET FLAVORS INC

15475 I

II

5/29/2001

LONZA LTD

SPRAY DRIED ARTIFICIAL FLAVOR (CHERRY RASPBERRY TYPE) FOR ANTIBIOTIC NV-7759 AS
MANUFACTURED IN PISCATAWAY, NJ
EPROSARTAN AS MANUFACTURED IN VISP, SWITZERLAND

15476 A

II

6/7/2001

EUTICALS LIMITED

FLUCYTOSINE USP AS MANUFACTURED IN THE UNITED KINGDOM

15477 A

III

6/6/2001

POLYONE CORP

CC00017673WE/DR AS MANUFACTURED IN VONORE, TN.

15478 I

II

5/31/2001

DAICEL CHEMICAL INDUSTRIES LTD

CHIRACEL OF CSP AS MANUFACTURED IN JAPAN

15479 I

III

6/6/2001

AMPACET CORP

15480 A

IV

6/11/2001

PHOSPHOLIPID GMBH

100675 SLIP ANTIBLOCK COP MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH, OR LATEXO, TX
PHOSPHOLIPON 100H GMBH AS MANUFACTURED IN GERMANY

15481 I

IV

6/14/2001

FONA INTERNATIONAL INC

825.382 W.S. ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CAROL STREAM, IL

15482 I

IV

6/14/2001

FONA INTERNATIONAL INC

856.085 ARTIFICIAL GRAPE FLAVOR AS MANUFACTURED IN CAROL STREAM, IL

15483 A

IV

6/12/2001

15484 I

II

6/14/2001

MOLKEREI MEGGLE WASSERBURG GMBH AND CO MEGGLE CELLACTOSE 80 AS MANUFACTURED IN WASSERBURG, GERMANY
KG
SOCIETA ITALIANA MEDICINALI SCANDICCI
OXAPROZIN AS MANUFACTURED IN FIRENZE, ITALY

15485 A

II

6/20/2001

BOEHRINGER INGELHEIM CHEMICALS INC

METHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN PETERSBURG, VA

15486 A

II

6/21/2001

FARMAK AS

ZOLPIDEM TARTRATE AS MANUFACTURED IN CZECH REPUBLIC.

15487 N

NOT AN ASSIGNED NUMBER

15488 I

III

6/12/2001

POLIMERI EUROPA FRANCE SA

ERACLENE MP90 AS MANUFACTURED IN PORTO-TORRES, ITALY

15489 A

IV

6/15/2001

WACKER CHEMIE AG

METHYL BETA-CYCLODEXTRIN AS MANUFACTURED IN EDDYVILLE, IOWA

15490 A

IV

6/18/2001

EASTMAN CHEMICAL CO

15491 I

II

6/15/2001

RECORDATI CORP

CELLULOSE ACETATE BUTYRATE (CAB-171-15) PHARMACEUTICAL GRADE AS


MANUFACTURED IN KINGSPORT, TN
NABUMETONE AS MANUFACTURED IN LATINA, ITALY

15492 A

III

6/18/2001

SOLVIN SA

SOLVIN 260RF AS MANUFACTURED IN BELGIUM, GERMANY, BRAZIL, FRANCE, AND SPAIN

15493 A

II

6/18/2001

INTERQUIM SA

CITICOLINE MONOSODIM SALT AS MANUFACTURED IN BARCELONA, SPAIN.

15494 I

II

6/21/2001

ADVANCED VIRAL RESEARCH

PEPTIDE-NUCLEIC ACID SOLUTION, BULK AS MANUFACTURED IN FREEPORT, BAHAMAS

15495 A

II

6/7/2001

GLAXOSMITHKLINE LLC

TICARCILLIN MONOSODIUM (NON-STERILE) AS MANUFACTURED IN SINGAPORE

15496 N

NOT AN ASSIGNED NUMBER

15497 I

II

6/27/2001

LONZA BIOTEC SRO

THYMIDINE MANUFACTURED BY FERMENTATION AS MANUFACTURED IN CZECH REPUBLIC

15498 I

II

6/22/2001

CHEMI SPA

POPC POSITIONAL PURITY 95% AS MANUFACTURED IN FROSINONE, ITALY.

15499 I

III

4/24/2001

BESPAK PLC

NASAL ACTUATORS AND COVERS AS MANUFACTURED IN APEX, NC

15500 I

III

6/21/2001

SHINKO CHEMICAL CO., LTD

15501 I

IV

6/21/2001

HENRY H OTTENS MFG CO INC

15502 A

IV

6/20/2001

HENRY H OTTENS MANUFACTURING CO INC

15503 A

II

6/21/2001

STAR LAKE BIOSCIENCE CO INC

BOTTLESK-70N AND CAP SK-2OON, AS MANUFACTURED IN FUJIEMINAMI KANAZAWA,


ISHIKAWA, JAPAN
SPRAY DRIED NATURAL/ARTIFICAL COOL PEPPERMINT FLAVOR SD-1651 AS MANUFACTURED
IN PHILADELPHIA, PA.
POWDERED NATURAL ARTIFICIAL COOL PEPPERMINT FLAVOR #9650 AS MANUFACTURED IN
PHILADELPHIA, PA.
RIBAVIRIN, USP, AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA

Page 445

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15504 A
II
7/11/2001
WATSON PHARMA PRIVATE LTD

SUBJECT
NITROFURANTOIN MACROCRYSTAL USP, MANUFACTURED IN MAHARASHTRA, INDIA

15505 A

II

6/26/2001

IRE

SODIUM IODIDE I131 (FISSION) AS MANUFACTURED IN ROMANS CEDEX (FRANCE)

15506 A

II

6/28/2001

INVENTAA CHEMICALS LTD

TRIMETHOPRIM AS MANUFACTURED IN KRISHNA DISTRICT, PIN, INDIA.

15507 I

II

6/28/2001

BOEHRINGER INGELHEIM CHEMICALS INC

GUAIFENESIN USP AS MANUFACTURED IN PETERSBURG, VA

15508 I

III

7/6/2001

TRUDELL MEDICAL INTERNATIONAL

FOREST TOP MOUNTED DOSE INDICATOR AS MANUFACTURED IN ONTARIO, CANADA

15509 N

NOT AN ASSIGNED NUMBER

15510 I

II

6/29/2001

SIFAVITOR SRL

TRIMETHOPRIM AS MANUFACTURED IN FRAZIONE MAIRANO (LODI), ITALY

15511 A

II

7/3/2001

SHANDONG XINHUA PHARMACEUTICAL CO LTD

IBUPROFEN, USP AS MANUFACTURED IN THE PEOPLE'S REPUBLIC OF CHINA

15512 A

III

7/7/2001

METAL COLOR CO LTD

15513 I

II

7/3/2001

ERREGIERRE SPA

BLISTER(PTP) PACKAGE OF PHARMACEUTICAL TABLETS/CAPSULES AS MANUFACTURED IN


OSAKA, JAPAN
GABAPENTIN AS MANUFACTURED IN BERGAMO, ITALY

15514 I

II

7/3/2001

PHARMACIA AND UPJOHN

DOXORUBICIN HCL AS MANUFACTURED IN CO. COCK, IRELAND

15515 A

II

6/28/2001

LONZA LTD

TP4 AS MANUFACTURED IN VISP, SWITZERLAND

15516 A

II

7/4/2001

EXCELLA GMBH

TIMOLOL MALEATE AS MANUFACTURED IN FEUCHT, GERMANY

15517 A

II

6/28/2001

CHIMEX

15518 A

II

6/22/2001

CALYX CHEMICALS AND PHARMACEUTICALS LTD

MEXORYL SV (TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID AS MANUFACTURED IN


MOURENX, FRANCE
ZOPICLONE E.P. AS MANUFACTURED IN MAHARASHTRA, INDIA

15519 I

II

8/31/2001

MALLINCKRODT INC

15520 A

II

6/29/2001

CATALENT PHARMA SOLUTIONS LLC

SODIUM PHOSPHATE MONOBASIC ANHYDRUS CODE 7869 AS MANUFACTURED IN ST. LOUIS,


MO.
ADVIL COLD AND SINUS LIQUID GELS AS MANUFACTURED IN ST. PETERSBURG, FL

15521 A

II

6/22/2001

FARMHISPANIA SA

FH-111 AS MANUFACTURED IN BARCELONA, SPAIN

15522 I

IV

7/12/2001

NIKKEN CHEMICALS CO LTD

ERYTHRITOL, A PHARMACEUTICAL EXCIPIENT AS MANUFACTURED IN CHITA CITY, JAPAN

15523 I

II

7/11/2001

OCEAN NUTRITION CANADA LIMITED

15524 I

II

7/13/2001

AVON ORGANICS LTD

D-GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN MULGRAVE, NOVA SCOTIA,


CANADA
PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

15525 A

II

7/4/2001

FARMAK AS

TIZANIDINE HCL AS MANUFACTURED IN CZECH REPUBLIC

15526 I

II

7/13/2001

ELAN PHARMACEUTICAL TECHNOLOGIES

MIV-150 ORAL NANOCRYSTAL COLLOIDAL DISPERSION AS MANUFACTURED IN HORSHAM, PA

15527 A

III

7/11/2001

DAIKIN INDUSTRIES, LTD

PCTFE MONO FILMS (NEOFLON CTFFE) AS MANUFACTURED IN OSAKA, JAPAN

15528 I

III

6/5/2001

SOLVIN S.A.

DIOFAN DS 2389 AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY

15529 A

II

7/13/2001

SHASUN PHARMACEUTICALS LTD

RANITIDINE HYDROCHLORIDE, USP (FORM II)

15530 I

II

7/17/2001

RP SCHERER NORTH AMERICA

AVC (SULFANILAMIDE) SUPPOSITORIES AS MANUFACTURED IN ST. PETERSBURG, FL

15531 A

III

7/16/2001

HISA KINZOKU KOGYO CO LTD

PLASTIC CAPS AS MANUFACTURED IN OSAKA, JAPAN

15532 I

IV

7/16/2001

THERMAX LTD., CHEMICAL DIVISION

TULSION THERMACOAT L 100 AS MANUFACTURED IN MAHARASHTRA, INDIA

15533 A

II

7/13/2001

CATALENT PHARMA SOLUTIONS LLC

15534 A

II

7/18/2001

FARMABIOS S P A

DRISDOL SOFTGELS (ERGOCALCIFEROL, 50, 000 IU) AS MANUFACTURED IN ST.


PETERSBURG, FL
FLUMETHASONE AS MANUFACTURED IN PAVIA, ITALY

15535 I

III

7/13/2001

BAYER AG

MAKROFOL KG AS MANUFACTURED IN BAYERWERK, GERMANY

15536 I

III

7/17/2001

AMPACET CORP

15537 A

II

6/21/2001

KYONGBO PHARMACEUTICAL CO LTD

11070-T WHITE LLDPE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE,


IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX
CEFUROXIME ACID AS MANUFACTURED IN CHUNGCHEONG NAM-DO, KOREA

Page 446

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15538 I
III
7/6/2001
THE DOW CHEMICAL CO
15539 I

III

7/6/2001

ALVEO AG

SUBJECT
POLYCAPROLACTONE RESINS AND CAPROLACTONE POLYOLS AS MANUFACTURED IN ROCK
HILL, SC
ALVEOLIT TEE POLYMER FOAMS

15540 I

III

6/26/2001

BASF AKTIENGESELLSCHAFT

EPOTAL P 800 AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY

15541 A

III

5/31/2001

FUJIMORI KOGYO CO LTD

15542 I

II

7/25/2001

ASH STEVENS INC

RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES E-0010 NO. 33AS
MANUFACTURED IN SHIZUOKA PREF., JAPAN.
FLUDARABINE PHOSPHATE (ASP) AS MANUFACTURED IN RIVERDALE, MI.

15543 A

II

6/20/2001

WOCKHARDT LTD

D-OXYPHENE BASE AS MANUFACTURED IN GUJARAT STATE, INDIA

15544 A

III

7/20/2001

AR LA VE S SRL

15545 A

II

7/25/2001

DIPHARMA FRANCIS SRL

PACKAGING MATERIALS AMPOULES TYPE I GLASS AS MANUFACTURED IN TREVIGLIO (BG),


ITALY
TRAMADOL HCL AS MANUFACTURED IN MILAN, ITALY

15546 I

II

6/29/2001

MEMORIAL SLOAN-KETTERING

[I124] FIAU AS MANUFACTURED IN NEW YORK, NY

15547 A

IV

7/15/2001

NITTA GELATIN INDIA LTD

GELATIN AS MANUFACTURED IN KERALA, INDIA

15548 I

II

7/26/2001

JOST CHEMICAL CO

MAGNESIUM CITRATE AS MANUFACTURED IN ST. LOUIS, MO

15549 I

III

7/24/2001

AMPACET CORP

110361 WHITE POLYETHYLENE MASTERBATCH

15550 A

II

7/24/2001

FRESENIUS KABI ANTI INFECTIVES SRL

CEFUROXIME SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY

15551 A

II

7/11/2001

CAREFUSION CORPORATION

VIANOX-H (NITRIC OXIDE) AS MANUFACTURED IN CHICAGO, ILLINOIS

15552 A

II

7/27/2001

CATALENT PHARMA SOLUTIONS LLC

ADVIL PM LIQUI-GELS AS MANUFACTURED IN ST. PETERSBURG, FL

15553 A

II

7/31/2001

CALYX CHEMICALS AND PHARMACEUTICALS LTD

PYRAZINAMIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

15554 A

7/26/2001

ADVANCED MICRODEVICES PVT LTD

MEMBRANE DISC AND CARTRIDGE FILTERS USED FOR STERILIZATION OF DRUG PRODUCTS

15555 I

II

7/30/2001

FARCHEMIA SRL

TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY

15556 I

IV

7/31/2001

DUPONT FLUOROPRODUCTS

DYMEL 227 EA/P(HEPTAFLUOROPROPANE) AS MANUFACTURED IN GREGORY, TEXAS

15557 A

II

8/1/2001

USV LIMITED

BLENDED METFORMIN HCL AS MANUFACTURED IN MUMBAI, INDIA

15558 A

III

7/20/2001

DANAPAK FLEXIBLES AS

PHARMACEUTICAL COMPONENT AS MANUFACTURED IN DENMARK

15559 A

II

8/1/2001

PFIZER INC

FLUMETHASONE AS MANUFACTURED IN KALAMAZOO, MI

15560 I

II

7/31/2001

DR REDDYS LABORATORIES LTD

15561 I

II

7/31/2001

DOCTOR REDDYS LABORATORIES LTD

DEXTROMETHORPHAN HYDROBROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
DEXTROMETHORPHAN, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15562 A

II

7/31/2001

COSMA SPA

TORSEMIDE 1016 AS MANUFACTURED IN BERGAMO, ITALY

15563 A

II

7/31/2001

COSMA SPA

TORSEMIDE 1024 AS MANUFACTURED IN BERGAMO, ITALY

15564 I

II

8/2/2001

CATALENT PHARMA SOLUTIONS LLC

CALDEROL SOFTGELS 20MCG AS MANUFACTURED IN ST.PETERSBURG, FL

15565 I

III

7/17/2001

ENICHEM SPA

SINKRAL L 320/S WHITE 17673 AS MANUFACTURED IN RAVENNA, ITALY

15566 I

II

7/24/2001

PROCOS SPA PRODOTTI CHIMICI

NIMESULIDE AS MANUFACTURED IN CAMERI (NOVARA), ITALY

15567 A

II

7/31/2001

EXCELLA GMBH

GANCICLOVIR AS MANUFACTURED IN FEUCHT, GERMANY

15568 I

III

7/31/2001

CLARIANT INC

YELLOW CLARIANT MASTERBATCHES 30PPP-300

15569 I

III

7/31/2001

CLARIANT INC

BLUE CLARIANT MASTERBATCHES 40PPP-656

15570 I

III

7/31/2001

CLARIANT INC

GREEN CLARIANT MASTERBATCHES 50PPP-564

15571 I

III

7/31/2001

CLARIANT INC

PEACH CLARIANT MASTERBATCHES 90PPP-182

15572 I

II

7/30/2001

SICOR SPA

FLUOCINOLONE ACETONIDE 1,2-DIHYDRO AS MANUFACTURED IN MILAN, ITALY

15573 I

II

8/6/2001

GLAXOSMITHKLINE

ASO1B ADJUVANT SYSTEM AS MANUFACTURED IN RIXENSART, BELGIUM

Page 447

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15574 I
II
8/6/2001
ASTELLAS PHARMA INC

SUBJECT
FK778 DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN

15575 I

III

8/7/2001

MITSUBISHI CHEMICAL INDUSTRIES LTD

PHARMAKEEP OXYGEN ABSORBER

15576 I

II

8/6/2001

BASF AKTIENGESELLSCHAFT

RIBOFLAVIN 100 AS MANUFACTURED IN LUGWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

15577 A

II

8/3/2001

ERREDUE SPA INNOVATIVE CHEMICAL & LIFE

TIAMULIN HYDROGEN FUMARATE CLARIANT AS MANUFACTURED IN BERGAMO, ITALY

15578 I

III

7/19/2001

LIQUID CONTAINER/PLAXICON

1-GALLON HDPE CONTAINER AS MANUFACTURED IN WEST CHICAGO, ILLINOIS

15579 A

III

8/7/2001

KB SEIREN LTD

MEDICAL BACKING CLOTH, H20 AS MANUFACTURED IN OSAKA, JAPAN

15580 A

II

8/10/2001

EXCELLA GMBH

TIMOLOL (S) BASE HEMIHYDRATE AS MANUFACTURED IN FEUCHT, GERMANY

15581 A

III

8/13/2001

TOPPAN PRINTING CO LTD

TOPPAN-HP 1

15582 I

III

8/7/2001

LOPAREX BV

FL2000 100UM PET C1S, RT105 AS MANUFACTURED IN AZ APELDOORN, THE NETHERLANDS

15583 I

II

8/10/2001

NATURAL PHARMACEUTICALS INC

15584 I

II

8/15/2001

HOSPIRA INC

SEMI-SYNTHETIC PACLITAXEL ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED


IN RENSSELAER, NY
ATHERO GENICS AGIX-4207 INJECTABLE EMULSION AS MANUFACTURED IN CLAYTON, NC

15585 A

II

8/15/2001

FARMAK AS

BRIMONIDINE TARTRATE AS MANUFACTURED IN CZECH REPUBLIC

15586 A

IV

8/13/2001

WACKER CHEMIE AG

SILFAR S 184 AS MANUFACTURED IN NUNCHRITZ

15587 A

II

8/21/2001

JUBILANT GENERICS LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN KARNATAKA STATE, INDIA.

15588 A

III

8/13/2001

SIGMUND LINDNER GMBH

TECHNICAL GLASS BEADS AS MANUFACTURED IN WARMENSTEINACH, GERMANY

15589 I

III

8/20/2001

15590 I

II

8/10/2001

CCC PLASTIC CANADA COLORS AND CHEMICALS


LTD.
EURAND AMERICA INC

PEPTO PINK MB20-4592 POLYETHYLENE COLOR CONCENTRATE AS MANUFACTURED IN


COLBORNE, ONTARIO
DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS AS MANUFACTURED IN MILAN, ITALY

15591 A

II

7/1/2001

POLYMER LABORATORIES LTD

15592 A

II

8/24/2001

SCINOPHARM TAIWAN LTD

POLY(STYRENE/DIVINYLBENZENE) PARTICLES UNDER THE TRADENAMES PLRP-S AND RPC


POLYBIO AS MANUFACTURED IN SHROPSHIRE, UK
FLUMAZENIL AS MANUFACTURED IN TAINAN COUNTY,TAIWAN,R.O.C.

15593 I

III

8/20/2001

LOPAREX BV

POLY SLIK 111/80 CIS WITH GRADE CODE 76PQ AS MANUFACTURED N THE NETHERLANDS

15594 I

II

8/15/2001

IRVINE SCIENTIFIC SALES CO

IS CHO-V AS MANUFACTURED IN SANTA ANA,CA

15595 I

III

8/22/2001

CODING PRODUCTS

LCF-9 A HOT STAMP INK RIBBON AS MANUFACTURED IN KALKASKA, MI

15596 A

II

8/27/2001

SEVEN STAR PHARMACEUTICAL CO LTD

METHOCARBAMOL AS MANUFACTURED IN TAIPEI HSIENG, TAIWAN, R.O.C.

15597 A

II

8/27/2001

KYORIN PHARMACEUTICAL CO LTD

GATIFLOXACIN DRUG SUBSTANCE AS MANUFACTURED IN TOKYO,JAPAN

15598 I

II

8/27/2001

CATALENT PHARMA SOLUTIONS LLC

NIMODIPINE 30MG SOFTGEL CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL.

15599 I

II

8/27/2001

IHARA CHEMICAL INDUSTRY CO LTD

MKS-1 (AS INTERMEDIATE OF GATIFLOXACIN) AS MANUFACTURED IN SHIZUOKA,JAPAN

15600 I

II

8/27/2001

CELSUS LABORATORIES INC

HEPARIN SODIUM ISOTONIC SOLUTION MANUFACTURED IN CINCINNATI,OH

15601 A

II

8/27/2001

MEDICHEM SA

BRIMONIDINE TARTRATE AS MANUFACTURED IN GIRONA, SPAIN

15602 I

II

8/14/2001

SOFRADIM PRODUCTION

BOVINE ATELOCOLLAGEN CBF AS MANUFACTURED IN SAN DIEGO,CA

15603 I

II

8/28/2001

MALLINCKRODT INC

LEVOAMPHETAMINE SULFATE CODE 8890 AS MANUFACTURED IN ST.LOUIS,MO

15604 A

II

8/29/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

RISPERIDONE AS MANUFACTURED IN BE'ER SHEVA,ISRAEL

15605 A

II

9/1/2001

ISP FREETOWN FINE CHEMICALS INC

AMPHETAMINE ASPARTATE AS MANUFACTURED IN ASSONET,MA

15606 A

II

9/1/2001

ISP FREETOWN FINE CHEMICALS INC

AMPHETAMINE SULFATE AS MANUFACTURED IN ASSONET, MA

15607 A

II

9/1/2001

ISP FREETOWN FINE CHEMICALS INC

DEXTROAMPHETAMINE SULFATE AS MANUFACTURED IN ASSONET, MA

15608 A

II

9/1/2001

ISP FREETOWN FINE CHEMICALS INC

DEXTROAMPHETAMINE SACCHARATE AS MANUFACTURED IN ASSONET, MA

15609 I

II

8/30/2001

JOHNSON MATTHEY INC DBA JOHNSON MATTHEY


PHARMACEUTICAL MATER

METAXALONE AS MANUFACTURED IN WEST DEPTFORD,NJ

Page 448

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15610 A
II
9/4/2001
CADILA HEALTHCARE LTD

SUBJECT
MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

15611 A

II

8/31/2001

YUHAN CHEMICAL INC

15612 A

II

8/25/2001

SUN PHARMACEUTICAL INDUSTRIES LTD

RIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-B-D-RIBOFURANOSYL- AS


MANUFACTURED IN KYUNGGI-DO, KOREA
METFORMIN HYDROCHLORIDE E.P/B.P AS MANUFACTURED IN MAHARASTHRA, INDIA

15613 A

II

9/5/2001

SCINOPHARM TAIWAN LTD

FLAVOXATE HYDROCHLORIDE AS MANUFACTURED IN TAIWAN, R.O.C.

15614 A

II

9/3/2001

API CORP

METHYL SALICYLATE AS MANUFACTURED IN FUKUOKA, JAPAN

15615 I

II

9/6/2001

FERMIC SA DE CV

CLARITHROMYCIN AS MANUFACTURED IN MEXICO CITY, MEXICO

15616 A

III

9/6/2001

WORF GLASKUGELN GMBH

15617 I

III

9/5/2001

LPS INDUSTRIES INC

15618 A

II

9/7/2001

CORDEN PHARMA SWITZERLAND LLC

TECHNICAL 2.5 MM DIAMETER GLASS BEADS AS MANUFACTURED IN MAINZ AND BAISWEIL,


FEDERAL REPUBLIC OF GERMANY
VF42, (POLYESTER/FOIL/LLDPE LAMINATION) AS MANUFACTURED IN MOONACHIE, NEW
JERSEY
SODIUM CHOLESTERYL SULFATE (SCS) AS MANUFACTURED IN LEISTAL, SWITZERLAND

15619 A

II

9/14/2001

APOTEX PHARMACHEM INC

QUINAPRIL HCL AS MANUFACTURED IN BRANTFORD, ONTARIO, CANADA

15620 I

IV

9/11/2001

FONA INTERNATIONAL INC

15621 I

IV

9/11/2001

FONA INTERNATIONAL INC

15622 I

IV

9/11/2001

FONA INTERNATIONAL INC

15623 A

II

9/7/2001

ACS DOBFAR SPA

#921.060 TANGERINE ORANGE FLAVOR, NATURAL (WONF) AS MANUFACTURED IN CAROL


STREAM, ILLINOIS
#936.751 NATURAL AND ARTIFICIAL DEBITTERING FLAVOR AS MANUFACTURED IN CAROL
STREAM, ILLINOIS
#894-088 N-C INTENSE PEPPERMINT FLAVOR, NATURAL (WONF) AS MANUFACTURED IN
CAROL STREAM, ILLINOIS
SODIUM CARBONATE LYOPHILIZED STERILE AS MANUFACTURED IN MILANO, ITALY.

15624 I

III

9/10/2001

COGNIS GMBH

LOXIOL G 70 S AS MANUFACTURED IN DUSSELDORF, GERMANY

15625 I

III

9/11/2001

COGNIS GMBH

LOXIOL G 78 AS MANUFACTURED IN DUSSELDORF, GERMANY

15626 I

III

9/10/2001

COGNIS GMBH

LOXIOL P 1141 AS MANUFACTURED IN DUSSELDORF, GERMANY

15627 I

II

9/18/2001

TEVA GROUP

NAPROXEN AND NAPROXEN SODIUM USP AS MANUFACTURED IN BE'ER SHEVA, ISRAEL

15628 A

IV

9/10/2001

KYOWA CHEMICAL INDUSTRY CO LTD

SYNTHETIC ALUMINUM SILICATE AS MANUFACTURED IN KAGAWA, JAPAN

15629 A

II

9/17/2001

XELLIA PHARMACEUTICALS APS

15630 I

II

9/20/2001

15631 A

III

9/17/2001

TOBRAMYCIN SULPHATE, USP STERILE BULK AS MANUFACTURED IN COPENHAGEN S,


DENMARK
DISHMAN PHARMACEUTICALS AND CHEMICAL PVT TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN AHMEDABAD, INDIA
LTD
POLYONE CORP
CC00012694A2 AS MANUFACTURED IN VONORE, TN.

15632 A

III

9/17/2001

POLYONE CORP

CC00015291D4 AS MANUFACTURED IN VONORE, TN.

15633 I

III

9/21/2001

15634 I

III

9/17/2001

APPLIED TECH PRODUCTS HEALTH AND BEAUTY


CARE DIV
LAJOVIC TUBA EMBALAZA, D.D.

TRIGGER DISPENSER ASSEMBLY, C/R TUBE CLOSURE ASSEMBLY & SLIDE CASE ASSEMBLY
AS MANUFACTURED IN SPARTA, NJ, WEST BERLIN, NJ, AND STRAFORD, CT
INJECTION BLOW MOLDED PLASTIC BOTTLES AS MANUFACTURED IN LJUBJANA, SLOVENIA

15635 A

II

9/20/2001

ZACH SYSTEM SPA

RIFAXIMIN AS MANUFACTURED IN VICENZA, ITALY

15636 A

III

9/14/2001

KOREA ENGINEERING PLASTICS CO LTD

KEPITAL F30-03 NATURAL AS MANUFACTURED IN SEOUL REPUBLIC, KOREA

15637 I

III

9/24/2001

NATIONAL ADHESIVES

15638 A

IV

9/24/2001

INTERNATIONAL SPECIALTY PRODUCTS

UV CURE ADHESIVE AS MANUFACTURED IN BRIDGEWATER, NJ & UNITED KINGDOM,


ENGLAND
GANEX V-220 (VP/EICOSENE COPOLYMER) AS MANUFACTURED IN CALVERT CITY, KY

15639 A

II

9/21/2001

ASAHI KASEI PHARMA CORP

FASUDIL HYDROCHLORIDE HYDRATE AS MANUFACTURED IN MIYAZAKI, JAPAN

15640 I

II

9/25/2001

CLARIANT LSM MISSOURI INC

GAR-936 AS MANUFACTURED IN ORIGGIO (VA), ITALY

15641 I

II

10/1/2001

KOEI CHEMICAL CO LTD

PAA-HC1 [4-PIPERIDYL ACETIC ACID-HCL] AS MANUFACTURED IN OSAKA, JAPAN.

15642 A

II

10/1/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

ONDANSETRON HCL DIHYDRATE AS MANUFACTURED IN HUNGARY

Page 449

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15643 I
II
10/1/2001
CHEMISCHE FABRIK BERG GMBH

SUBJECT
BUTALBITAL USP AS MANUFACTURED IN BITTERFIELD

15644 I

III

2/5/2001

REXAM CONTAINERS LTD

CONTINUOUS SCREW CLOSURES AS MANUFACTURED IN EVANSVILLE, IN

15645 I

II

10/4/2001

GLAXOSMITHKLINE

HIV VACCINE (GPL 120/NEFTA/ASO2A) AS MANUFACTURED IN BELGIUM

15646 A

II

8/13/2001

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

SULFADIMETHOXINE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

15647 I

II

9/28/2001

QUIMICA SINTETICA SA

BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MADRID, SPAIN

15648 A

IV

10/5/2001

HAYASHIBARA CO LTD

15649 A

II

10/4/2001

STERLING SPA

HAYASHIBARA MALTOSE MONOHYDRATE FOR INJECTION AS MANUFACTURED IN OKAYAMA,


JAPAN
NORGESTIMATE AS MANUFACTURED IN PERUGIA, ITALY

15650 I

II

9/25/2001

HYDROGEN PEROXIDE AS MANUFACTURED IN SOUTH CHARLESTON, WV AND PASADENA, TX

15651 I

II

10/5/2001

FMC CORPORATION, HYDROGEN PEROXIDE


DIVISION
BRISTOL MYERS SQIBB COMPANY

15652 A

II

10/8/2001

SANOFI CHIMIE

15653 I

10/5/2001

15654 A

II

10/5/2001

CENTERS FOR DISEASE CONTROL AND


PREVENTION
POLYPEPTIDE LABORATORIES INC

PREDNISOLONE SODIUM METASULFOBENZOATE AS MANUFACTURED IN VERTOLAYE,


FRANCE
PROVISIONAL DATA REPORT ON MALARIA SURVEILLANCE AND USE OF ANTIMALARIAL
CHEMOPROPHYLAXIS AS MANUFACTURED IN ATLANTA, GA
PORCINE SECRETIN, ACETATE AS MANUFACTURED IN TORRANCE, CA

15655 I

II

6/22/2001

XINXIANG PHARMACEUTICAL CO LTD

RIBAVIRIN NON-STERILE BULK FORM AS MANUFACTURED IN HENAN PROVINCE, P.R. CHINA

15656 I

III

9/28/2001

POLIMERI EUROPA FRANCE SA

RIBLENE MP20 AS MANUFACTURED IN DUNKIRK, FRANCE

15657 A

III

9/27/2001

EXXONMOBIL CHEMICAL SAS

POLYPROPYLENE HOMOPOLYMER AS MANUFACTURED IN LILLEBONNE, FRANCE

15658 I

II

10/8/2001

FERRO PFANSTIEHL LABORATORIES

TOPIRAMATE AS MANUFACTURED IN WAUKEGAN, IL

15659 I

II

10/10/2001

LUITPOLD PHARMACEUTICALS INC

15660 A

IV

10/9/2001

CAPSUGEL

15661 I

II

10/12/2001

GILEAD SCIENCES INC

SODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL AS MANUFACTURED IN SHIRLEY,
NY
CAPSULE FOR INHALATION FOR BOEHRINGER INGELHEIM AS MANUFACTURED IN BORNEM,
BELGIUM
FK506LC AND PLACEBO AS MANUFACTURED IN SAN DIMAS, CA

15662 I

II

10/12/2001

ELAN PHARMACEUTICAL TECHNOLOGIES

BUDESONIDE NANOCRISTAL COLLOIDAL DISPERSION AS MANUFACTURED IN HORSHAM, PA

15663 I

II

10/10/2001

MALLINCKRODT INC

NALMEFENE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO

15664 I

II

10/15/2001

RESOLUTION CHEMICALS LTD

AZOTHIAPRINE USP AS MANUFACTURED IN THE UNITED KINGDOM

15665 A

II

10/16/2001

POLYCARBON INDUSTRIES INC

PYRIDOSTIGMINE BROMIDE USP AS MANUFACTURED IN LEOMINSTER, MA

15666 I

II

10/15/2001

SIFA LTD

BMS 20783-01 AS MANUFACTURED IN REPUBLIC OF IRELAND

15667 A

II

10/15/2001

DSM PHARMA CHEMICALS NETHERLANDS BV

FLUMOL 50(35-60% FLUMOL IN ACETONITRIL) AS MANUFACTURED IN NETHERLANDS

15668 I

II

10/13/2001

AVANTI POLAR LIPIDS INC

15669 A

IV

10/10/2001

NIPPON SHINYAKU CO LTD

1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHO-L-SERINE(SODIUM SALT) (DOPS) AS


MANUFACTURED IN ALABASTER, AL
CLZ-42 AS MANUFACTURED IN KYOTO, JAPAN

15670 I

II

10/16/2001

RANBAXY LABORATORIES LTD

CEFUROXIME ACID AS MANUFACTURED IN PUNJAB, INDIA

15671 A

III

10/12/2001

EASTMAN CHEMICAL CO

EASTMAN 168 PLASTICIZER AS MANUFACTURED IN KINGSPORT, TN

15672 A

II

10/15/2001

QUIMICA SINTETICA SA

LEVOFLOXACIN AS MANUFACTURED IN MADRID, SPAIN

15673 A

II

10/22/2001

INDUSTRIA QUIMICA ANDINA Y CIA. S.A.

ACETYLSALICYLIC ACID AS MANUFACTURED IN BOGOTA, COLOMBIA

15674 I

III

10/9/2001

BASELL GMBH

LUPOLEN 5621 DX AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY

15675 I

III

10/9/2001

BASELL POLIOLEFINE ITALIA SPA

LUPOLEN 5021 DX AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY

15676 I

II

10/19/2001

FARCHEMIA SRL

RANITIDINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY

ARIPIPRAZOLE TABLETS AS MANUFACTURED IN MAYAGUEZ, PUERTO RICO

Page 450

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15677 A
II
10/18/2001
LEK PHARMACEUTICALS DD

SUBJECT
LITHIUM CARBONATE ACTIVE SUBSTANCE AS MANUFACTURED IN SLOVENIA

15678 I

III

10/22/2001

PENN COLOR INC

66W42 WHITE AS MANUFACTURED IN HAFIELD, PA

15679 A

II

10/18/2001

LIFE TECHNOLOGIES CORPORATION

POROS CHROMATOGRAPHIC RESINS AS MANUFACTURED IN CAMBRIDGE, MA

15680 A

II

10/22/2001

APOTECNIA SA

TERCONAZOLE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN

15681 A

II

10/15/2001

APTALIS PHARMA SRL

PANCRELIPASE PRODUCTS (EURAND MINITABS) (HP55) AS MANUFACTURED IN MILANO, ITALY

15682 A

II

10/23/2001

INKE SA

RISPERIDONE AS MANUFACTURED IN BARCELONA, SPAIN

15683 I

II

10/24/2001

FINORGA SA

TMC 125 AS MANUFACTURED IN FRANCE

15684 A

II

10/19/2001

POLYPEPTIDE LABORATORIES SWEDEN AB

CALCITONIN (SALMON) USP AS MANUFACTURED IN DENMARK

15685 A

III

10/23/2001

ASO CO LTD

15686 A

II

10/19/2001

SCINOPHARM TAIWAN LTD

15687 A

II

10/29/2001

SIFAVITOR SRL

ASO CLEAN BAG, ASO CLEAN SHEET AND ASO CLEAN TUBE AS MANUFCATURED IN OSAKA,
JAPAN
FLUTICASONE PROPIONATE AS MANUFACTURED IN TAIWAN, EXSTON, PA AND NORTH
CHICAGO, IL
MEFLOQUINE HYDROCHLORIDE AS MANUFACTURED IN (LODI), ITALY

15688 I

III

10/10/2001

BERRY PLASTICS CORP TAPES AND COATINGS DIV IS PAPER/POLYETHYLENE/FOIL/EMAA TERPOLYMER AS MANUFACTURED IN HOMER, LA

15689 A

III

10/19/2001

POLYONE CORP

CC00022659X1 AS MANUFACTURED IN VONORE, TN.

15690 A

II

10/22/2001

E BEGEROW GMBH AND CO

BECODISK LENTICULAR CARTRIDGES AS MANUFACTURED IN GERMANY

15691 A

III

10/25/2001

MWV CALMAR GMBH

ACCUPUMP SPRAY PUMP AS MANUFACTURED IN HEMER, GERMANY

15692 A

II

10/31/2001

PERRIGO API LTD

FLUMAZENIL AS MANUFACTURED IN BE'ER SHEVA, ISREAL

15693 A

II

10/31/2001

CIPLA LTD

TOPIRAMATE AS MANUFACTURED IN BANGALORE, INDIA

15694 A

II

10/29/2001

FINETECH PHARMACEUTICAL LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN NESHER, ISRAEL

15695 I

III

4/24/2001

BESPAK PLC

ORAL ACTUATORS & CAPS AS MANUFACTURED IN APEX, NC

15696 A

III

10/31/2001

RPC FORMATIC GMBH

HANDIHALER DEVICE AS MANUFACTURED IN GERMANY

15697 I

III

10/22/2001

AMPACET CORP

15698 I

II

10/31/2001

RANBAXY LABORATORIES LTD

7182288 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX
LOVASTATION USP AS MANUFACTURED IN PRADESH, INDIA

15699 A

II

11/2/2001

DR REDDYS LABORATORIES LTD

TIZANIDINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15700 A

II

10/30/2001

RIBAVIRIN USP-BP AS MANUFACTURED IN ITALY

15701 A

II

11/2/2001

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
MYLAN LABORATORIES LTD

15702 I

III

10/23/2001

ROLLPRINT PACKAGING PRODUCTS, INC

RPP #33-2021A AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD CT

15703 I

III

10/25/2001

ROLLPRINT PACKAGING PRODUCTS INC

RPP#36-1026A AS MANUFACTURED IN ADDISON, IL & BLOOMFIELD, CT

15704 I

III

10/29/2001

AMPACET CORP

15705 I

III

10/29/2001

AMPACET CORP

15706 I

II

11/8/2001

CIPLA LTD

701709-H FOAM POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA, HEALTH, OH OR LATEXO, TX
7012124 ANTIBLOCK POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE,
IN DERIDDER, LA, CARTERSVILLE, GA, HEALTH, OH OR LATEXO, TX
SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTA, INDIA

15707 A

III

10/25/2001

FUJIMORI KOGYO CO LTD

PLASTIC SHEET AS MANUFACTURED IN JAPAN

15708 I

II

10/31/2001

(-)-HUPERZINE A AS MANUFACTURED IN NINGBO, ZHEJIANG, P.R. CHINA

15709 I

II

11/8/2001

NINGBO TRADITIONAL CHINESE


PHARMACEUTICAL FACTORY
BIOMEDISYN CORPORATION

15710 N

TRAZODONE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH,INDIA

(-)-HUPERZINE A AS IMPORTED BY BIOMEDISYN IN WOODBRIDGE, CT

NOT AN ASSIGNED NUMBER

Page 451

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15711 I
II
11/8/2001
LC UNITED CHEMICAL CORPORATION

SUBJECT
BROMPHENIRAMINE AS MANUFACTURED IN THE REPUBLIC OF CHINA

15712 A

IV

11/12/2001

INGREDION INC

UNIPURE WG-220 AS MANUFACTURED IN INDIANAPOLIS, IN

15713 I

IV

11/12/2001

NATIONAL STARCH CHEMICAL CO

UNIPURE WG-225 AS MANUFACTURED IN INDIANAPOLIS, IN

15714 A

II

11/6/2001

KREBS BIOCHEMICALS AND INDUSTRIES LTD

PSEUDOEPHEDRINE HCL-USP AS MANUFACTURED IN HYDERABAD, INDIA

15715 I

II

11/12/2001

DOCTOR REDDYS LABORATORIES LTD

CLOPIDOGREL BISULFATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15716 A

III

11/5/2001

POLYONE CORP

CC00000987WE AS MANUFACTURED IN VONORE, TN.

15717 A

III

11/5/2001

POLYONE CORP

CC00000985WE AS MANUFACTURED IN VONORE, TN.

15718 A

III

11/5/2001

POLYONE CORP

PRODUCT NUMBER 10016620 AS MANUFACTURED IN GLENDALE, AZ

15719 A

III

11/5/2001

POLYONE CORP

CC00018782WE/60 AS MANUFACTURED IN VONORE, TN.

15720 A

II

11/13/2001

SANDOZ GMBH

RAPAMYCIN AS MANUFACTURED IN AUSTRIA

15721 A

II

11/13/2001

SIGNA SA DE CV

CLOPIDOGREL BISULPHATE AS MANUFACTURED IN TOLUCA, MEXICO

15722 I

II

11/7/2001

RANBAXY LABORATORIES LTD

SIMVASTATION USP AS MANUFACTURED IN PUNJAB, INDIA

15723 I

III

11/15/2001

UCB FILMS, INC.

15724 A

II

11/15/2001

CIPLA LTD

BIAXIALLY ORIENTED POLYPROPYLENE (BOPP) FILMS AS MANUFACTURED IN UNITED


KINGDOM, BELGIUM & AUSTRALIA
ONDANSETRON HCL USP AS MANUFACTURED IN INDIA

15725 A

II

11/14/2001

SAFC BIOSCIENCES INC

EX-CELL 302 MEDIUM (MODIFIED) CAT. #62630 AS MANUFACTURED IN DENVER, PA

15726 I

II

11/16/2001

SUGAI CHEMICAL INDUSTRY CO LTD

SMAP (BROMOSULFONE) AS MANUFACTURED IN FUKUI, JAPAN

15727 A

II

10/31/2001

SUN PHARMACEUTICAL INDUSTRIES LTD

TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

15728 I

II

11/14/2001

HETERO DRUGS LTD

ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15729 A

II

11/15/2001

LONZA LTD

CN25225 (METEXAFIN GADOLINIUM) AS MANUFACTURED IN SWITZERLAND

15730 I

II

11/14/2001

HETERO DRUGS LTD

TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15731 A

II

11/14/2001

HETERO DRUGS LTD

SERTRALINE HCL USP (FORM II PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15732 A

II

11/15/2001

MYLAN LABORATORIES LTD

NAPROXEN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH,INDIA

15733 I

III

11/21/2001

HI TECH RUBBER INC

MEDICAL COMPONENTS AS MANUFACTURED IN ANAHEIM, CA

15734 A

II

11/19/2001

JM HUBER CORP

CALCIUM CARBONATE AS MANUFACTURED IN QUINCY, IL

15735 I

III

11/19/2001

TEKNOR COLOR CO

15736 A

III

11/19/2001

TEKNOR COLOR CO

15737 A

II

11/21/2001

BASF PHARMA EVIONNAZ SA

61,579HCPP MAROON 33:1 AS MANUFACTURED IN HENDERSON, KY, CUMBERLAND, RI,


JACKSONVILLE, TX, LODI, OH, FOOUNTAIN INN, SC & INDUSTRY, CA
90,699 HCC WHITE 1% AS MANUFACTURED IN HENDERSON, KY, CUMBERLAND, RI,
JACKSONVILLE, TX, LODI, OH, FOUNTAIN INN, SC & INDUSTRY, CA
BETHANECHOL CHLORIDE AS MANUFACTURED IN SWITZERLAND

15738 A

II

11/26/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

TORSEMIDE AS MANUFACTURED IN ZAGREB, CROATIA

15739 A

II

11/12/2001

UNICHEM LABORATORIES LTD

TIZANIDINE HCL USP AS MANUFACTURED IN INDIA

15740 A

II

11/15/2001

LONZA AG

CN 28091 LACTOL-LACTAM AS MANUFACTURED IN SWITZERLAND

15741 I

III

10/29/2001

AMPACET CORP

15742 A

II

11/12/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

7010778 AB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX
FLUDARABINE PHOSPHATE AS MANUFACTURED IN MILAN, ITALY

15743 I

II

11/30/2001

BOEHRINGER INGELHEIM LTD

ESMOLOL HCL AS MANUFACTURED IN PETERSBURG, VA

15744 I

II

12/3/2001

ZOPICLONE AS MANUFACTURED IN CEDEX, FRANCE

15745 A

II

11/29/2001

SANOFI CHIMIE (A SUBSIDIARY OF SANOFIAVENTIS)


TEVA PHARMACEUTICAL INDUSTRIES LTD

FLUTICASONE PROPIONATE AS MANUFACTURED IN MEXICO

Page 452

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15746 I
II
12/3/2001
DR REDDY'S LABORATORIES LTD

SUBJECT
AMLODIPINE MALEATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15747 I

III

11/27/2001

AMPACET CORP

15748 A

II

12/3/2001

NORAC CO INC

11078-A WHITE ANTISTAT AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA,


CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX
HYDROUS BENZOYL PEROXIDE, USP AS MANUFACTURED IN AZUSA, CA

15749 A

II

12/5/2001

MEDICHEM SA

MIRTAZAPINE AS MANUFACTURED IN GIRONA, SPAIN

15750 A

II

12/6/2001

TARO PHARMACEUTICAL INDUSTRIES LTD

HYDROCORTISONE 17-BUTYRATE, USP AS MANUFACTURED IN HAIFA BAY, ISRAEL

15751 A

III

12/7/2001

LOPAREX LLC

15752 A

II

12/5/2001

CAMBREX CHARLES CITY INC

GRADE 22421 D 5 MIL WH PET A10/000 AS MANUFACTURED IN IOWA CITY, IA, EDEN, NC,
DIXON, IL & CULLMAN, AL
ONDANSETRON HCL AS MANUFACTURED IN CHARLES CITY, IA

15753 I

II

12/3/2001

KREBS BIOCHEMICALS LTD

L-EPHEDRINE HCL-USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15754 I

II

12/6/2001

DOTTIKON EXCLUSIVE SYNTHESIS AG

DB5, IP-DB5 AS MANUFACTURED IN SWITZERLAND

15755 A

III

11/8/2001

AMCOR FLEXIBLES ITALIA SRL

FLEXIBLE PACKAGING MATERIAL FOR DRUG AS MANUFACTURED IN VICENZA, ITALY

15756 A

II

10/1/2001

BIDACHEM SPA

RIBAVIRIN AS MANUFACTURED IN BERGAMO, ITALY

15757 A

II

12/5/2001

DR REDDYS LABORATORIES LTD

FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15758 A

II

11/27/2001

PIRAMAL HEALTHCARE UK LTD

CLOPROSTENOL SODIUM AS MANUFACTURED IN GRANGEMOUTH, UK

15759 I

II

12/11/2001

DIOSYNTH BV

ESTRADIOL GLUCOSIDE AS MANUFACTURED IN OSS, THE NETHERLANDS

15760 N

NOT AN ASSIGNED NUMBER

15761 I

II

11/30/2001

MDS NORDION S A

THALLOUS (T1-201) CHLORIDE AS MANUFACTURED IN FLEURUS, BELGIUM

15762 I

III

12/12/2001

BASELL USA, INC.

PDC1273, PDC1274, PDC1284, PDC1287, PDC1288, PRO-FAXPH433 AND PRO-FAXPH133

15763 I

III

12/3/2001

CKS PACKAGING, INC.

HIGH DENSITY POLYETHYLENE BOTTLES AS MANUFACTURED IN MOORESVILLE, NC

15764 A

III

12/5/2001

AMPACET CORP

15765 I

II

12/10/2001

DIXIE CHEMICAL CO INC

10090 SLIP POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN,


DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH, OR LATEXO, TX
TP1 AS MANUFACTURED IN PASADENA, TX

15766 A

III

11/23/2001

BPREX HEALTHCARE OFFRANVILLE SAS

EYE-DROPPER SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE

15767 I

II

12/14/2001

SMITHKLINE BEECHAM

L-DM1 AS MANUFACTURED IN LANEXA, KANSAS AND LOWER HUTT, NEW ZEALAND

15768 I

III

12/14/2001

IWATA GLASS INDUSTRIAL CO., LTD.

DRUG AMPULES AND VIALS AS MANUFACTURED IN OSAKA, JAPAN

15769 I

II

12/14/2001

SANDOZ GMBH

CEFUROXIME N-BUTYL AMMONIUM AS MANUFACTURED IN TYROL, AUSTRIA

15770 A

II

12/14/2001

UNION QUIMICO FARMACEUTICA SA

FLUOXETINE HCL AS MANUFACTURED IN BARCELONA, SPAIN

15771 A

II

12/17/2001

INDUSTRIALE CHIMICA SRL

DESOGESTREL AS MANUFACTURED IN VARESE, ITALY

15772 A

II

12/18/2001

WATSON PHARMA PRIVATE LTD

PRILOCAINE BP AS MANUFACTURED IN MAHARASHTRA, INDIA

15773 A

III

12/14/2001

NYPRO INC

METERED DOSE POWDER INHALER AS MANUFACTURED IN ARDEN, NC

15774 A

II

12/19/2001

CIPLA LTD

FLUTICASONE PROPIONATE AS MANUFACTURED IN MAHARASHTRA, INDIA

15775 A

12/17/2001

INTERNATIONAL SPECIALTY PRODUCTS

15776 A

II

12/21/2001

RANBAXY LABORATORIES LTD

TOXICOLOGY STUDIES ON PHARMASOLVE (N-METHYL-2-PYRROLIDONE) AS MANUFACTURED


IN WAYNE, NJ
BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN PUNJAB,INDIA

15777 A

II

12/21/2001

TEVA PHARMACEUTICAL INDUSTRIES LTD

AMLODIPINE BESYLATE AS MANUFACTURED IN GUAYAMA,PUERTO RICO

15778 A

II

12/28/2001

CIPLA LTD

FINASTERIDE USP AS MANUFACTURED IN RAIGAD ,BANGALORE, PUNE, MUMBAI, INDIA

15779 I

IV

12/18/2001

FERRO PFANSTIEHL

SUCROSE ACETATE ISOBUTYRATE AS MANUFACTURED IN WAUKEGAN,IL

15780 I

II

12/20/2001

DAIICHI SANKYO CO LTD

DATICHI PHARMACEUTICAL CO LTD DU-6859A AS MANUFACTURED IN EDOGAWAKU,TOKYO,JAPAN

Page 453

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15781 A
III
12/20/2001
3M DRUG DELIVERY SYSTEMS
15782 A

III

12/20/2001

3M PHARMACEUTICALS DIV

SUBJECT
SCOTCHPAK 9744 RELEASE LINER AS MANUFACTURED IN COTTAGE GROVE, MN, NEVADA,
MO, ST.PAUL, MN, WEST ST.PAUL, MN, DECATUR, AL, GREENVILLE, SC
COTRAN 9701, POLYURETHANE NONWOVEN BACKING AS MANUFACTURED IN BROOKING, SD

15783 I

II

12/18/2001

CHEMSOURCE CORP

ONDANSETRON HCL AS MANUFACTURED IN GUAYAMA,PUERTO RICO

15784 I

III

12/14/2001

POLIMERI EUROPA FRANCE SA

ERACLENE BB82 AS MANUFACTURED IN BRINDISI,ITALY

15785 I

III

12/14/2001

POLIMERI EUROPA FRANCE SA

ERACLENE MP90 AS MANUFACTURED IN PORTO TORRES,ITALY

15786 A

III

12/18/2001

BERRY PLASTICS

15787 A

III

12/20/2001

LAMEPLAST SPA

15788 I

III

12/21/2001

STEDIM SA

INJECTION MOLDED PLASTIC BOTTLES,CLOSURES,AND SPECIALTY ITEMS AS


MANUFACTURED IN FRANKLIN,IN
NON STERILE MONODOSE PRIMARY PLASTIC PACKAGING COMPONENT FOR AN ORAL
VACCINE AS MANUFACTURED IN MODENA, ITALY
STEDIM 100 BAG AS MANUFACTURED IN AUBAGNE CEDEX,FRANCE

15789 I

II

12/13/2001

SANDOZ INDUSTRIAL PRODUCTS SPA

ERYTHROMYCIN ETHYLSUCCINATE AS MANUFACTURED IN TRENTO,ITALY

15790 I

III

12/19/2001

DAR AMI LTD

ALUMINIUM TUBING AND PLASTIC CAPS AS MANUFACTURED IN KONYS, TURKEY

15791 I

II

1/11/2002

BECTON DICKINSON AND CO

15792 I

II

1/11/2002

BECTON DICKINSON AND CO

15793 A

II

1/9/2002

ZACH SYSTEM SPA

BD CELL MAB MEDIUM BASE W/O PHENOL RED AS MANUFACTURED IN SPARKS,


COCKEYSVILLE, MD AND HERNDON, VA
BD CELL MAB MEDIUM, QUANTUM YIELD AS MANUFACTURED IN COCKEYSVILLE, MD AND
HERNDON, VA
PROPOFOL AS MANUFACTURED IN VICENZA, ITALY

15794 A

II

12/27/2001

TARO PHARMACEUTICAL INDUSTRIES LTD

AMIODARONE HCL AS MANUFACTURED IN HAIFA BAY,ISRAEL

15795 A

II

12/28/2001

RANBAXY LABORATORIES LTD

CEFUROXIME AXETIL USP AS MANUFACTURED IN PUNJAB,INDIA

15796 I

III

12/13/2001

COVALENCE COATED PRODUCTS

PRODUCT 24-1-064 AS MANUFACTURED IN HOMER, LA

15797 I

III

12/18/2001

15798 I

III

12/14/2001

BERRY PLASTICS CORP TAPES AND COATINGS DIV 48 GAUGE CHEMICALLY TREATED POLYESTER/0.8#ADHESIVE/0.00032
FOIL/0.8#ADHESIVE/3.25 MIL LLDPE FILM
AMPACET CORP
100388 AB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN,
DERIDDER, LA, TARRYTOWN, NY, CARTERSVILLE, GA, LATEXO, TX, HEATH, OH, MESSANCY,
BELGIUM

15799 I

IV

1/7/2002

FONA INTERNATIONAL INC

#918.011 SWEET-AM (AN ARTIFICIAL FLAVOR) AS MANUFACTURED IN CAROL STREAM, IL

15800 A

IV

1/8/2002

NIPPON SHOKUBAI CO LTD

AQUALIC AS58 AN EXCIPIENT AS MANUFACTURED IN HYOGO PREFECTURE, JAPAN

15801 A

IV

1/11/2002

DUPONT CHEMICALS AND FLUOROPRODUCTS

15802 I

II

1/8/2002

CELSUS LABORATORIES INC

INHALATION GRADE 1,1,1,2,3,3,3 HEPTAFLUOROPROPANE AS MANUFACTURED IN EL


DORADO, AR
HEPARIN CALCIUM AS MANUFACTURED IN CINCINNATI, OH

15803 A

II

1/10/2002

AURANOFIN AS MANUFACTURED IN WEST DEPTFORD, NJ

15804 A

II

1/9/2002

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
UNION QUIMICO FARMACEUTICA SA UQUIFA SA

15805 I

II

1/15/2002

BACHEM INC

15806 A

IV

12/7/2001

HENRY H OTTENS MANUFACTURING CO INC

THROMBIN RECEPTOR ACTIVATED PEPTIDE (TRAP) 508 (BULK) AS MANUFACTURED IN


TORRANCE, CA
ARTIFICIAL BUBBLE GUM FLAVOR #3266-P AS MANUFACTURED IN PHILADELPHIA, PA

15807 A

IV

12/7/2001

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL STRAWBERRY FLAVOR #5532 AS MANUFACTURED IN PHILADELPHIA, PA

15808 A

IV

12/7/2001

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL SWEETNESS ENHANCER #5401-B AS MANUFACTURED IN PHILADELPHIA, PA

15809 I

II

1/10/2002

GRANULES INDIA LTD

COMPRESSO PAP 90CPC AS MANUFACTURED IN HYDERABAD, INDIA

15810 I

II

1/10/2002

GRANULES INDIA LTD

COMPRESSO PAP 90CPF AS MANUFACTURED IN HYDERABAD, INDIA

15811 I

II

1/14/2002

PCAS

CLOMIPRAMINE HCL AS MANUFACTURED IN LIMAY, FRANCE

15812 I

II

1/17/2002

EGIS PHARMACEUTICALS PUBLIC LTD CO

DERAMCICLANE FUMARATE AS MANUFACTURED IN BUDAPEST, HUNGARY

OMEPRAZOLE (SIEVED) AS MANUFACTURED IN BARCELONA, SPAIN

Page 454

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15813 I
II
1/17/2002
CIPLA LTD
15814 I

II

12/3/2001

KREBS BIOCHEMICALS LTD

SUBJECT
CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN PUNE, BANGALORE, RAIGAD, MUMBAI,
INDIA
PSUEDOEPHEDRINE SULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15815 A

II

1/21/2002

SANDOZ PRIVATE LTD

CEFUROXIME AXETIL AS MANUFACTURED IN MAHARASHTRA, INDIA

15816 I

II

1/22/2002

DOTTIKON EXCLUSIVE SYNTHESIS AG

5-METHOXYINDOL-3-ALDEHYDE AS MANUFACTURED IN DOTTIKON, SWITZERLAND

15817 A

II

1/17/2002

PCAS

TRIMEPRAZINE TARTRATE AS MANUFACTURED IN LIMAY, FRANCE

15818 I

IV

1/14/2002

HANGZHOU NANHANG INDUSTRIAL TRADE CO LTD POVIDONE USP AS MANUFACTURED IN NANJING, CHINA

15819 I

II

1/23/2002

LIPHA SAS

15820 A

II

1/22/2002

ACTAVIS GROUP PTC EHF

HOMOTAURINE (CALCIUM ACAMPROSATE INTERMEDIATE) AS MANUFACTURED IN CALAIS,


PITHIVIERS, FRANCE
TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN KANCHIPURAM DISTRICT, INDIA

15821 A

II

1/24/2002

USV LIMITED

GLYBURIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

15822 A

II

1/23/2002

TARO PHARMACEUTICAL INDUSTRIES LTD

FLUCONAZOLE AS MANUFACTURED IN HAIFA BAY, ISRAEL

15823 I

II

1/24/2002

ESTEVE QUIMICA SA

ADATANSERIN HYDROCHLORIDE (CRUDE) AS MANUFACTURED IN BARCELONA, SPAIN

15824 A

II

1/24/2002

SANDOZ GMBH

MYCOPHENOLIC ACID AS MANUFACTURED IN TYROL, AUSTRIA

15825 I

IV

12/3/2001

DERIVADOS MACROQUIMICOS SA DE CV

METHYL CELLULOSE AS MANUFACTURED IN MICHOACAN, MEXICO

15826 A

III

1/21/2002

SEALED AIR CORP

CRYOVAC M916 MEDICAL CONNECTOR TUBING AS MANUFACTURED IN CLAYTON, NC

15827 A

III

1/23/2002

POLYONE CORP

CC00018103WE AS MANUFACTURED IN VONORE, TN.

15828 A

II

1/23/2002

IRVINE SCIENTIFIC SALES CO

IS CHO-V(TM) (P) AS MANUFACTURED IN SANTA ANA, CA

15829 A

II

1/28/2002

ANTIBIOTICOS SA

7-AMINO-DEACETOXY-CEPHALOSPORANIC ACID (7ADCA) AS MANUFACTURED IN LEON, SPAIN

15830 A

III

1/23/2002

CORMACK PACKAGING PTY LTD

15831 I

II

1/30/2002

RHODIA USINE DE MULHOUSE DORNACH

THE CORMACK RING SEAL AND STANDARD CLOSURES PLAIN OR LINED AS MANUFACTURED
IN NEW SOUTH WALES, AUSTRALIA
PARATRIFLUOROMETHOXYANILINE AS MANUFACTURED IN MULHOUSE, FRANCE

15832 A

III

1/29/2002

NEMERA NEUENBURG GMBH

MULTI DOSE POWDER INHALER (MDPI) AS MANUFACTURED IN NEUENBERG, GERMANY

15833 A

III

12/19/2001

LONSTROFF AG

15834 A

IV

1/31/2002

CAPSUGEL

15835 I

IV

1/31/2002

CAPSUGEL

FLUOROELASTOMER RUBBER COMPOUND F5028Q BLACK AS MANUFACTURED IN AARAU,


SWITZERLAND
EMPTY HARD CAPSULES FROM HYDROXYPROPYLMETHYLCELLULOSE (HYPROMELLOSE) AS
MANUFACTURED IN COLMAR, FRANCE
POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN COLMAR, FRANCE

15836 I

II

1/31/2002

SUMITOMO CHEMICAL CO LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN GIFU PREFECTURE, JAPAN

15837 A

II

1/31/2002

MALLINCKRODT INC

NALTREXONE METHOBROMIDE AS MANUFACTURED IN ST.LOUIS, MO

15838 A

II

1/29/2002

BIA SEPARATIONS DOO

15839 A

II

1/25/2002

HUBEI BIOCAUSE PHARMACEUTICAL CO LTD

CIM CONVECTIVE INTERACTION MEDIA(R) DEAE AS MANUFACTURED IN LJUBLJANA,


SLOVENIA
IBUPROFEN USP AS MANUFACTURED IN HUBEI PROVINCE, CHINA

15840 I

II

1/31/2002

QUIMICA SINTETICA SA

ZOLPIDEM TARTRATE AS MANUFACTURED IN MADRID, SPAIN

15841 A

II

2/4/2002

SIGNA SA DE CV

ALLOPURINOL USP AS MANUFACTURED IN TOLUCA, MEXICO

15842 A

II

11/20/2001

SALSBURY CHEMICALS INC

DB5 AS MANUFACTURED IN CHARLES CITY, IOWA

15843 I

III

1/23/2002

BLEN COLOR INC

16-03N AND 06-00 COLOR CONCENTRATES AS MANUFACTURED IN LEOMINSTER, MA

15844 A

III

2/5/2002

TAKETOMO INC

ALUMINIUM FOR PRESS THROUGH PACKAGING AS MANUFACTURED IN TOKYO, JAPAN

15845 I

III

2/5/2002

GRAND POLYMER CO LTD

GRAND POLYPRO J235T AS MANUFACTURED IN YAMAGUICHI, JAPAN

15846 A

II

2/6/2002

SRI KRISHNA PHARMACEUTICALS LTD

ACETAMINOPHEN USP AS MANUFACTURED IN HYDERABAD, INDIA

15847 A

II

2/4/2002

UNICHEM LABORATORIES LTD

BENDROFLUMETHIAZIDE USP AS MANUFACTURED IN RAIGAD, INDIA

Page 455

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15848 I
II
1/31/2002
DIVIS LABORATORIES LTD

SUBJECT
5-PHENYLHYDANTOIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15849 A

II

2/1/2002

IPCA LABORATORIES LTD

PROPRANOLOL HYDROCHLORIDE AS MANUFACTURED IN DIST.RATLAM, INDIA

15850 A

II

2/2/2002

IPCA LABORATORIES LTD

METOPROLOL TARTRATE AS MANUFACTURED IN DIST.RATLAM, INDIA

15851 A

IV

2/6/2002

MANTROSE HAEUSER CO INC

CERTISEAL A-100 AS MANUFACTURED IN ATTLEBORO, MA

15852 A

II

1/31/2002

MEISSNER FILTRATION PRODUCTS INC

STERILUX AND STERIDYNE FILTER ELEMENTS AS MANUFACTURED IN CAMARILLO, CA

15853 I

III

2/5/2002

COLORS FOR PLASTICS

COLORS FOR PLASTICS I.D.: B 18854 AS MANUFACTURED IN ELK GROVE VILLAGE, IL

15854 A

III

2/12/2002

WACKER CHEMICAL CORP

VINNOL(R) H 15/45 M AS MANUFACTURED IN BURGHAUSEN, GERMANY

15855 I

III

12/17/2002

COLORS FOR PLASTICS

B20035 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

15856 A

III

2/5/2002

QENOS PTY LTD

LDJ225 AS MANUFACTURED IN MATRAVILLE, NSW, AUSTRALIA

15857 I

III

5/24/2002

POLYTECH SOUTH INC

MASTER BACHES AS MANUFACTURED IN LAPORTE, TX.

15858 I

II

2/12/2002

CHEMI SPA

SODIUM ALENDRONATE AS MANUFACTURED IN FROSINONE, ITALY

15859 A

II

2/12/2002

JUHUA GROUP CORP PHARMACEUTICAL FACTORY IBUPROFEN AS MANUFACTURED IN ZHEJIANG, CHINA

15860 I

III

2/8/2002

PARYLENE COATING SERVICES INC

PARYLENE COATING AS MANUFACTURED IN KAY, TX

15861 A

IV

2/19/2002

WACKER CHEMIE AG

SILFAR(R) SE 4 AS MANUFACTURED IN NUNCHRITZ, GERMANY

15862 A

II

2/19/2002

TARO PHARMACEUTICAL INDUSTRIES LTD

DIFLORASONE DIACETATE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL

15863 A

II

2/18/2002

SIGMA ALDRICH CO LTD

MEBROFENIN AS MANUFACTURED IN DORSET, UNITED KINGDOM

15864 A

II

2/15/2002

CIPLA LTD

15865 A

II

2/20/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

LEVOFLOXACIN HEMIHYDRATE USP AS MANUFACTURED IN BANGALORE, RAIGAD, POONA,


INDIA
CARVEDILOL AS MANUFACTURED IN BE'ER SHEVA, NETANYA, PETAH TIQVA, ISRAEL

15866 A

II

2/18/2002

SERATEC SARL

BETHANECHOL CHLORIDE USP AS MANUFACTURED IN COURVILLE SUR EURE, FRANCE

15867 I

II

5/20/2002

TCI AMERICA

BMIPP FINAL INTERMEDIATE AS MANUFACTURED IN PORTLAND, OR.

15868 I

III

2/18/2002

ROLLPRINT PACKAGING PRODUCTS INC

RPP#36-1085B AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT

15869 A

IV

2/20/2002

DURECT CORP

15870 I

III

2/5/2002

COLORS FOR PLASTICS

POLYLACTIDE, POLYGLYCOLIDE, AND POLYCAPROLACTONE POLYMERS AND COPOLYMERS


AS MANUFACTURED IN PELHAM, ALABAMA
COLORS FOR PLASTICS I.D.: B18855 AS MANUFACTURED IN ELK GROVE VILLAGE, IL

15871 I

II

2/6/2002

AVI BIOPHARMA INC

AVI 4126 AS MANUFACTRUED IN PORTLAND, OR

15872 I

II

2/19/2002

INDENA SPA

IDN 5109 AS MANUFACTURED IN SETTALA, ITALY

15873 I

II

2/19/2002

API CORP

MCC-555 AS MANUFACTURED IN FUKUROI-CITY, JAPAN

15874 A

II

2/26/2002

SHASUN PHARMA SOLUTIONS LTD

ACRIVASTINE AS MANUFACTURED IN NORTHUMBERLAND, ENGLAND

15875 I

II

2/22/2002

BENTLEY API SL

METHOCARBAMOL AS MANUFACTURED IN PINSEQUE, SPAIN

15876 I

IV

2/25/2002

ROHM AND HAAS CO

SUNSPHERES(TM) LCG AND PGL POLYMER AS MANUFACTURED IN CROYDON, PA

15877 I

II

4/8/2002

INDUSTRIALE CHIMICA SRL

BUDESONIDE AS MANUFACTURED IN SARONNO, ITALY

15878 A

III

2/25/2002

CCL CONTAINER CORP

ALUMINUM AEROSOL CANS, ALUMINUM BOTTLES AND OTHER NON-AEROSOL RIGID


PACKAGING, ALUMINUM PISTON BARRIER PACKAGING AS MANUFACTURED IN HERMITAGE,
PA AND PENETANG, ON

15879 I

II

2/27/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

MITOXANTRONE HYDROCHLORIDE USP AS MANUFACTURED IN LERMA, EDO. MEXICO

15880 I

IV

2/27/2002

MANTROSE HAEUSER CO INC

CERTISEAL FC-300 AS MANUFACTURED IN ATTLEBORO, MA

15881 I

IV

2/27/2002

MANTROSE HAEUSER CO INC

CERTISEAL FC-300 AS MANUFACTURED IN ATTLEBORO, MA

15882 A

II

2/13/2002

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD

GLIMEPIRIDE AS MANUFACTURED IN CHONGQING, CHINA

Page 456

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15883 I
II
3/4/2002
GEDEON RICHTER

SUBJECT
FLUCONAZOLE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY

15884 A

III

2/25/2002

ACG PHARMAPACK PVT LTD

BLISTER FILMS AS MANUFACTURED IN MAHARASHTRA, INDIA

15885 A

III

3/5/2002

STYROLUTION EUROPE GMBH

NOVODUR HD M203FC, VARIOUS COLORS AS MANUFACTURED IN KOLNWORRINGEN,


GERMANY; SCHWARZHEIDE, GERMANY; ALBIS PLASTIC GMBH IN HAMBURG, GERMANY; AND
ALBIS UK LTD IN KNUTSFORD CHESHIRE, UK.

15886 A

II

2/28/2002

ISOCHEM SAS

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GENEVILLIERS, FRANCE

15887 A

II

3/6/2002

DR REDDYS LABORATORIES LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

15888 A

IV

3/4/2002

ROBERTET FLAVORS INC

NATURAL SPRAY DRIED SPEARMINT FLAVOR NV-9466 AS MANUFACTURED IN PISCATAWAY, NJ

15889 I

II

3/5/2002

FARCHEMIA SRL

OXCARBAZEPINE AS MANUFACTURED IN TREVIGLIO, ITALY

15890 A

II

3/8/2002

AVENTIS PHARMA MANUFACTURING PTE LTD

CROMOLYN SODIUM AS MANUFACTURED IN SINGAPORE

15891 I

III

3/5/2002

POLIMERI EUROPA FRANCE SA

SINKRAL L 320 BLUE 14390 AS MANUFACTURED IN RAVENNA, ITALY

15892 I

III

3/11/2002

WINPAK TECHNOLOGIES INC

PACKAGING PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN TORONTO, CANADA

15893 I

III

3/12/2002

SHINKO CHEMICAL CO LTD

SK-MODEL BOTTLE AS MANUFACTURED IN ISHIKAWA, JAPAN

15894 A

IV

3/8/2002

CAPSCANADA CORP

TWO PIECE EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN TECUMSEH, CANADA

15895 A

IV

3/12/2002

SEPPIC SA

MONTANIDE ISA 720 VG AS MANUFACTURED IN CASTRES, FRANCE

15896 I

III

3/4/2002

BASELL AUSTRALIA PTY LTD

MOPLEN HP 400 L AS MANUFACTURED IN ROSEHILL, NSW AND CORIO, VIC, AUSTRALIA

15897 A

II

3/14/2002

SAFC BIOSCIENCES INC

15898 I

IV

3/6/2002

SYMRISE INC

EX-CELL(TM) 325 PF CHO PROTEIN-FREE MEDIUM (MODIFIED) AS MANUFACTURED IN


DENVER, PA
PERFUME DALIN PH 0/214082 AS MANUFACTURED IN HOLZMINDEN, GERMANY

15899 I

II

3/15/2002

GRISEOFULVIN AS MANUFACTURED IN SHANGHAI, CHINA

15900 A

II

3/15/2002

SHANGHAI ZHONGHUA PHARMACEUTICAL


FACTORY
RELIABLE BIOPHARMACEUTICAL CORP

15901 I

II

3/15/2002

BAYER CORP

15902 I

III

3/11/2002

COLOR MASTER INC

15903 I

III

3/11/2002

COLOR MASTER INC

15904 I

III

3/11/2002

COLOR MASTER INC

15905 I

III

3/11/2002

COLOR MASTER INC

15906 I

II

3/19/2002

DAIICHI SANKYO CO LTD

HYALURONIC ACID DRUG SUBSTANCE (EXHALE) (ETX100) AS MANUFACTURED IN SHAWNEE


MISSION, KS
RD1161M,FDA RED TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN
AVILLA, IN
RD1430P, FDA RED TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN
AVILLA, IN
BL1473P, FDA BLUE TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN
AVILLA, IN
BL1175M, FDA BLUE TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN
AVILLA, IN
CS-758 DRUG PRODUCT AS MANUFACTURED IN TOKYO, JAPAN

15907 I

II

3/20/2002

SAFC INC

3-(3-AMINO)-PHTHALAMIDO-GLUTARIMIDE (APG) AS MANUFACTURED IN MADISON, WI

15908 I

II

3/20/2002

DAIICHI SANKYO CO LTD

CS-758 DRUG SUBSTANCE AS MANUFACTURED IN JAPAN

15909 A

IV

12/21/2001

DMV FONTERRA EXCIPIENTS GMBH CO KG

INHALATION LACTOSE AS MANUFACTURED IN THE NETHERLANDS

15910 A

IV

2/28/2002

UNGERER AND CO

ARTIFICIAL STRAWBERRY FLVP FH-6758 AS MANUFACTURED IN LINCOLN PARK, NJ

15911 A

3/22/2002

SANDOZ GMBH

BIOTECH PRODUCTION BUILDING 211 AS MANUFACTURED IN KUNDL, AUSTRIA

15912 A

II

3/25/2002

PHARMACIA AND UPJOHN SUB PFIZER INC

METHYLPREDNISOLONE 100MG TABLETS AS MANUFACTURED IN PUURS, BELGIUM

15913 A

II

3/20/2002

QUIMICA SINTETICA SA

CIPROFLOXACIN AS MANUFACTURED IN MADRID, SPAIN

ADENOSINE AS MANUFACTURED IN ST.LOUIS, MO

Page 457

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15914 A
II
3/27/2002
CATALENT UK SWINDON ZYDIS LTD
15915 A

II

3/28/2002

TEVA PHARMACEUTICALS INDUSTRIES LTD

SUBJECT
SELEGILINE HYDROCHLORIDE ZYDIS TABLET 1.25MG AS MANUFACTURED IN WILTSHIRE,
UNITED KINGDOM
SYNTHETIC CONJUGATED ESTROGENS, A(F00375) AS MANUFACTURED IN CHICAGO, IL

15916 A

IV

3/29/2002

DMV FONTERRA EXCIPIENTS GMBH CO KG

RESPITOSE SV 001 (DPI QUALITY) AS MANUFACTURED IN VEGHEL, THE NETHERLANDS

15917 A

IV

3/29/2002

DMV FONTERRA EXCIPIENTS GMBH CO KG

PHARMATOSE 200 M (DPI QUALITY) AS MANUFACTURED IN VEGHEL, THE NETHERLANDS

15918 A

II

3/29/2002

FLAMMA SPA

MINOXIDIL AS MANUFACTURED IN BERGAMO, ITALY

15919 A

II

3/28/2002

BASF PHARMA EVIONNAZ SA

15920 I

IV

4/2/2002

FMC CORP FMC BIOPOLYMER DIV

15921 A

III

2/22/2002

BORMIOLI ROCCO SPA BU PLASTICS

15922 I

II

4/3/2002

LEK PHARMACEUTICALS DD

ARTICAINE HYDROCHLORIDE AS MANUFACTURED IN ST-VULBAS, FRANCE AND EVIONNAZ,


SWITZERLAND
LUSTRECLEAR(TM) LC 103 MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED
COATING AS MANUFACTURED IN NEWARK, DE
SPOON 2.5-5 ML + CE MARK AS MANUFACTURED IN CASTELGUELFO(PR), RIVANAZZANO(PV),
ITALY AND SAINT SULPICE, FRANCE
PRAVASTATIN SODIUM AS MANUFACTURED IN LJUBLJANA, SLOVENIA

15923 A

II

4/2/2002

SIEGFRIED LTD

15924 A

II

4/4/2002

TEVA GROUP

15925 A

II

4/4/2002

BAXTER PHARMACEUTICALS SOLUTIONS LLC

15926 A

II

4/5/2002

ARCH PHARMALABS LTD

STERILE WATER FOR INJECTION FOR RECONSTITUTION AS MANUFACTURED IN


BLOOMINGTON, IN
MELOXICAM AS MANUFACTURED IN MAHARASHTRA, INDIA

15927 I

III

4/4/2002

DSM RESEARCH

STAMYLAN P PHC 27 AS MANUFACTURED IN AP GELEEN, THE NETHERLANDS

15928 I

IV

4/5/2002

LIPOID GMBH

15929 I

II

4/8/2002

GEDEON RICHTER PLC

LIPOID E PG(EGG PHOSPHATIDYL GLYCEROL) AS MANUFACTURED IN LUDWIGSHAFEN,


FEDERAL REPUBLIC OF GERMANY.
BUTOCONAZOLE NITRATE AS MANUFACTURED IN BUDAPEST, HUNGARY.

15930 I

III

4/3/2002

CLARIANT AUSTRALIA PTY LTD

15931 A

II

3/26/2002

LUPIN LTD

CUSTOM COLOR/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND


PACKAGING IN VICTORIA AND NSW, AUSTRALIA.
CEFTRIAXONE SODIUM USP (STERILE ) AS MANUFACTURED IN MADHYA PRADESH, INDIA

15932 A

II

4/10/2002

ERREGIERRE SPA

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY.

15933 I

II

3/18/2002

IVAX CR

CABERGOLINE AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC

15934 A

II

4/11/2002

QUIMICA SINTETICA SA

FOSINOPRIL SODIUM AS MANUFACTURED IN MADRID, SPAIN.

15935 A

II

4/15/2002

BAXTER PHARMACEUTICALS SOLUTIONS LLC

15936 A

III

4/9/2002

DAK AMERICAS LLC

BACTERIOSTATIC WATER FOR INJECTION, USP AS MANUFACTURED IN BLOOMINGTON,


INDIANA.
B 95 A AS MANUFACTURED IN FAYETTEVILLE, NC.

15937 A

II

4/16/2002

LIPOID GMBH

15938 A

II

4/18/2002

STREM CHEMICALS INC

LIPOID PURIFIED SOYBEAN OIL PH. EUR. AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL


REPUBLIC OF GERMANY.
CARBOPLATIN (USP) AS MANUFACTURED IN NEWBURYPORT, MA.

15939 I

II

4/18/2002

ASUBIO PHARMA CO LTD

SUN N 8075 DRUG SUBSTANCE AS MANUFACTURED IN SAITAMA, JAPAN.

15940 A

II

4/17/2002

CODY LABORATORIES INC

PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT AS MANUFACTURED IN CODY, WY.

15941 I

III

3/11/2002

BASF AKTIENGESELLSCHAFT

15942 A

III

4/5/2002

POLYONE CORP

ULTRAFORM N2320 003 UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL


REPUBLIC OF GERMANY AND THEODORE, AL.
CC00012334DR AS MANUFACTURED IN VONORE, TN.

15943 I

II

4/10/2002

CUNO EUROPE SA

15944 A

II

4/17/2002

LIPOID GMBH

ZETACARBON RX5S, SP AND SLP SERIES AS MANUFACTURED IN MAZERES SUR SALAT,


FRANCE.
LIPOID S VPC-3 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

15945 I

II

4/18/2002

LABORATORIO CHIMICO INTERNAZIONALE SPA

ALLOPURINOL AS MANUFACTURED IN MILAN, ITALY.

O-DESMETHYLVENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN ZOFINGEN,


SWITZERLAND
LAMOTRIGINE AS MANUFACTURED IN BE'ER SHEVA AND PETAH TIQVA, ISRAEL

Page 458

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15946 I
II
4/22/2002
MITSUBISHI TANABE PHARMA CORP

SUBJECT
MCI-196 DRUG SUBSTANCE AS MANUFACTURED IN FUKUOKA-KEN, JAPAN.

15947 A

II

4/22/2002

LEK PHARMACEUTICAL AND CHEMICAL CO DD

OMEPRAZOLE ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN LJUBLJANA, SLOVENIA.

15948 I

II

4/4/2002

BOC MICRO APPLICATIONS CENTRE

15949 A

II

4/8/2002

SCINOPHARM TAIWAN LTD

MICRO-CYLINDER PRESSURISED GAS CAPSULE AS MANUFACTURED IN LONDON, UNITED


KINGDOM.
OMEPRAZOLE AS MANUFACTURED IN TAIWAN, R.O.C.

15950 A

II

4/23/2002

SULFAMETHOXAZOLE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

15951 A

IV

4/26/2002

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO


LTD
SOLVAY FLUOR UND DERIVATE GMBH

15952 I

II

4/26/2002

JOHNSON MATTHEY INC

RAC-AMPHETAMINE ADIPATE AS MANUFACTURED IN WEST DEPTFORD, NJ.

15953 I

II

4/26/2002

JOHNSON MATTHEY INC

D-AMPHETAMINE ADIPATE AS MANUFACTURED IN WEST DEPTFORD, NJ.

15954 I

III

4/3/2002

NYPRO INC

15955 I

III

4/5/2002

SOLVIN SA

METERED DOSE INHALER (MDI) AND SALAMOL EASI-BREATHE (R) CFC FREE AS
MANUFACTURED IN CLINTON, MA AND COUNTY DUBLIN, IRELAND.
DIOFAN A236 AS MANUFACTURED IN TAVAUX CEDEX, FRANCE.

15956 A

II

4/25/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

VINORELBINE TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

15957 I

IV

4/29/2002

BIOCODE INC

PROPRIETARY TRACERS AS MANUFACTURED IN BETHLEHEM, PA.

15958 A

II

4/29/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN DEBRECEN, HUNGARY.

15959 A

II

4/28/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

CYTARABINE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

15960 I

II

4/26/2002

RECORDATI ESPANA SL

KETOCONAZOLE AS MANUFACTURED IN BENIEL, SPAIN.

15961 I

II

4/30/2002

XIAN HIGH TECH INDUSTRIES CO LTD

PACLITAXEL AS MANUFACTURED IN XIAN, CHINA.

15962 A

II

5/1/2002

TEVA PHARMACEUTICALS USA

STERILE WATER FOR INJECTION USP AS MANUFACTURED IN IRVINE, CA.

15963 I

II

4/30/2002

ACE JAPAN CO LTD

PINDOLOL AS MANUFACTURED IN YAMAGATA, JAPAN.

15964 I

II

5/3/2002

EXEKIA THE AMERICAS

15965 A

II

5/7/2002

SAFC BIOSCIENCES INC

CERAMIC ULTRA-FILTRATION AND MICRO-FILTRATION MEMBRANES AS MANUFACTURED IN


BAZET, FRANCE.
EX-CELL (TM) VPRO AS MANUFACTURED IN DENVER, PA.

15966 A

II

4/29/2002

SYN TECH CHEM AND PHARM CO LTD

METOPROLOL SUCCINATE USP AS MANUFACTURED IN HSIN YING, TAIWAN.

15967 A

III

4/16/2002

FPC FLEXIBLE PACKAGING CORP

PAPER/POLYESTER/FOIL/POLYETHYLENE POUCH AS MANUFACTURED IN ONTARIO, CANADA.

15968 I

III

5/2/2002

15969 A

II

5/6/2002

BERRY PLASTICS CORP TAPES AND COATINGS DIV 65 GA PVDC COATED POLYPROPYLENE/1.0# ADHESIVE/1.25 MIL EAA COEX AS
MANUFACTURED IN COLUMBUS, GA.
BORREGAARD AS, BORREGAARD SYNTHESIS
REDUCED ALKYLATED IMIDAZOLE AS MANUFACTURED IN SARPSBORG, NORWAY

15970 I

III

4/26/2002

CLARIANT AUSTRALIA PTY LTD

15971 A

II

5/6/2002

ASH STEVENS INC

CUSTOM COLOR/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND


PACKAGING AS MANUFACTURED IN VICTORIA AND NSW, AUSTRALIA.
ANAGRELIDE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN RIVERVIEW, MI.

15972 A

II

5/2/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

AZITHROMYCIN DIHYDRATE AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA.

15973 I

II

5/10/2002

CHANGZHOU SPL CO

HEPARIN SODIUM USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

15974 A

II

5/10/2002

AVANTOR PERFORMANCE MATERIALS INC

SODIUM PHOSPHATE DIBASIC USP AS MANUFACTURED IN PHILLIPSBURG, NJ.

15975 A

III

5/7/2002

QENOS PTY LTD

GF7660 HDPE AS MANUFACTURED IN VICTORIA, AUSTRALIA.

15976 A

II

5/10/2002

ACS DOBFAR SPA

15977 I

II

5/13/2002

WOCKHARDT LTD

PENICILLIN G POTASSIUM FOR INJECTION, USP (STERILE BULK) AS MANUFACTURED IN


MILANO, ITALY.
FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

15978 I

II

5/13/2002

SKYEPHARMA PRODUCTION SAS

NK-104 TABLETS, 4 AND 8 MG AS MANUFACTURED IN LYON, FRANCE.

15979 I

II

5/10/2002

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

FLUOROSULFONYLETHANONE AS MANUFACTUED IN BARCELONA, SPAIN.

NORFLURANE AS MANUFACTURED IN FRANKFURT, GERMANY.

Page 459

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
15980 I
II
5/13/2002
PHLOX PHARMACEUTICALS LTD

SUBJECT
CEFUROXIME AXETIL, USP (AMORPHOUS) AS MANUFACTURED IN GUJARA, INDIA.

15981 I

II

4/30/2002

SAFC INC

CALCITRIOL, EP AS MANUFACTURED IN MADISON, WI

15982 I

II

5/20/2002

DAIWA CHEMICAL CO LTD

5-ASA CRUDE (5-AMINOSALICYLIC ACID CRUDE) AS MANUFACTURED IN OSAKA, JAPAN.

15983 A

II

5/24/2002

PISGAH LABS INC

ETOMIDATE AS MANUFACTURED IN PISGAH FOREST, NC.

15984 I

II

5/23/2002

15985 A

II

5/28/2002

PUNJAB CHEMICALS AND CROP PROTECTION LTD TRIMETHOPRIM AS MANUFACTURED IN PUNJAB, INDIA.
(PHARMA DIV - ALPHA DRUG)
TEVA PHARMACEUTICAL INDUSTRIES LTD
AZITHROMYCIN N AS MANUFACTURED IN ZAGREB, CROATIA.

15986 A

II

5/24/2002

CHATTEM CHEMICALS INC

BUTALBITAL, USP AS MANUFACTURED IN CHATTANOOGA, TENNESSEE.

15987 I

III

5/22/2002

CCC PLASTICS

15988 A

III

5/28/2002

FORMOSA PLASTICS CORP USA

PURPLE VIOLET MB 50-5021 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED


IN ONTARIO, CANADA.
FORMOLENE POLYPROPYLENE AS MANUFACTURED IN POINT COMFORT, TX.

15990 A

II

5/27/2002

SCINOPHARM TAIWAN LTD

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN.

15991 A

II

5/31/2002

DAIICHI SANKYO EUROPE GMBH

15992 I

IV

6/3/2002

CARDINAL HEALTH CANADA 403 INC

15993 I

III

5/30/2002

3M ENGINEERED ADHESIVES DIV

15994 I

II

6/5/2002

FAKO ILACLARI A S BUYUKDERE

CS-866-HYDROCHLOROTHIAZIDE TABLETS (CS-866HCTZ) AS MANUFACTURED IN


PFAFFENHOFEN, GERMANY.
VEGICAPS TWO PIECE EMPTY HARDSHELL CELLULOSE CAPSULE AS MANUFACTURED IN
SPRINGVILLE, UT.
3M(TM) DOUBLE COATED ADHESIVE TAPE 9596 AS MANUFACTURED IN ABERDEEN, SD AND
NEVADA, MO.
RANITIDINE HYDROCHLORIDE FORM II AS MANUFACTURED IN ISTANBUL, TURKEY.

15995 A

II

5/18/2002

SUN PHARMACEUTICAL INDUSTRIES LTD

METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

15996 A

II

5/20/2002

LUPIN LTD

CEFIXIME USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

15997 A

III

6/3/2002

BISCHOF AND KLEIN GMBH AND CO

15998 A

II

6/3/2002

ASKA PHARMACEUTICAL CO LTD

PACKAGING FOR PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN LENGERICH,


FEDERAL REPUBLIC OF GERMANY.
TZT-1027 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN.

15999 A

III

6/5/2002

3M DRUG DELIVERY SYSTEMS

COATED ALUMINIUM CANISTERS AS MANUFACTURED IN LANCASHIRE, GREAT BRITAIN.

16000 A

II

6/10/2002

HIKMA PHARMACEUTICALS

PREDNISONE ANHYDROUS USP AS MANUFACTURED IN AMMAN, JORDAN.

16001 I

II

6/10/2002

XIAN LIBANG PHARMACEUTICAL CO LTD

METOLAZONE USP AS MANUFACTURED IN SHANXI PROVINCE, CHINA.

16002 A

II

6/6/2002

SUN PHARMACEUTICAL INDUSTRIES LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

16003 I

IV

1/14/2002

GRAIN PROCESSING CORP

POLYALDITOL AS MANUFACTURED IN MUSCATINE, IOWA.

16004 I

2/7/2002

GRAIN PROCESSING CORP

16005 A

II

6/13/2002

16006 A

II

6/13/2002

SMITHKLINE BEECHAM CORP DBA


GLAXOSMITHKLINE
INDUSTRIALE CHIMICA SRL

TOXICOLOGICAL STUDIES ON DRY POLYALDITOL PRODUCTS MANUFACTURED IN


MUSCATINE, IOWA.
CLAVULANATE POTASSIUM STERILE BULK AS MANUFACTURED IN WEST SUSSEX, UNITED
KINGDOM.
MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN SARONNO, ITALY.

16007 A

II

6/11/2002

NEULAND LABORATORIES LTD

MIRTAZAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16008 A

II

6/11/2002

HETERO DRUGS LTD

FOSINOPRIL SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16009 A

II

6/11/2002

DR REDDYS LABORATORIES LTD

SERTRALINE HYDROCHLORIDE (FORM II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16010 A

II

6/11/2002

DR REDDYS LABORATORIES LTD

FINASTERIDE USP (FORM III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16011 A

II

6/14/2002

JIANGSU HANSOH PHARMACEUTICAL CO LTD

VINORELBINE TARTRATE USP AS MANUFACTURED IN JIANG SU, CHINA.

16012 A

II

6/17/2002

DSM FINE CHEMICALS NETHERLANDS BV

CAFOX AS MANUFACTURED IN VENLO, THE NETHERLANDS.

16013 I

II

6/20/2002

MITSUBISHI PHARMA CORP

MKC-231 DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI-KEN, JAPAN.

15989 N

NOT AN ASSIGNED NUMBER

Page 460

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16014 I
II
6/20/2002
ANGELINI ACRAF SPA

SUBJECT
MIRTAZAPINE AS MANUFACTURED IN APRILIA, ITALY.

16015 I

III

6/12/2002

MAC CLOSURES INC

FLIP TOP CHILD RESISTANT COMPACT AS MANUFACUTRED IN QUEBEC, CANADA.

16016 I

III

5/22/2002

CCC PLASTICS

16017 A

II

6/21/2002

EDMOND PHARMA SRL

BLUE AQUA MB 20-6731 POLYETHYLENE COLOUR CONCENTRATE AS MANUFACTURED IN


ONTARIO, CANADA.
MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN PADERNO DUGNANO, ITALY.

16018 I

III

6/14/2002

LITOFAN SA

PACKAGING MATERIAL AS MANUFACTURED IN BARCELONA, SPAIN.

16019 A

II

6/21/2002

AMRI RENSSELAER INC

AMPHETAMINE SULFATE USP AS MANUFACTURED IN RENSSELAER, NY.

16020 A

II

6/21/2002

AMRI RENSSELAER INC

AMPHETAMINE ASPARTATE AS MANUFACTURED IN RENSSELAER, NY.

16021 A

II

6/21/2002

AMRI RENSSELAER INC

DEXTROAMPHETAMINE SULFATE USP AS MANUFACTURED IN RENSSELAER, NY.

16022 A

II

6/21/2002

AMRI RENSSELAER INC

DEXTROAMPHETAMINE SACCHARATE AS MANUFACTURED IN RENSSELAER, NY.

16023 I

II

6/20/2002

DR REDDYS LABORATORIES LTD

RISPERIDONE EP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16024 A

II

6/24/2002

CIPLA LTD

ANAGRELIDE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN BANGALORE, INDIA.

16025 I

II

5/28/2002

CADILA PHARMACEUTICALS

LORATIDINE AS MANUFACTURED IN GUJARAT, INDIA.

16026 A

III

6/21/2002

TEKNOR COLOR CO

16027 I

II

6/21/2002

CADILA PHARMACEUICALS LTD

PACKAGING MATERIAL AS MANUFACTURED IN CUMBERLAND, RI; HENDERSON, KY;


JACKSONVILLE, TX; LODI, OH; FOUNTAIN INN, SC AND INDUSTRY, CA.
LORATIDINE SPECIAL AS MANUFACTURED IN GUJARA, INDIA.

16028 I

III

5/29/2002

DUPONT POLYESTER TECHNOLOGIES

MELINAR(R) LASER+ AS MANUFACTURED IN REDCAR, UNITED KINGDOM.

16029 A

II

6/20/2002

DIPHARMA FRANCIS SRL

FEXOFENADINE HYDROCHLORIDE USP AS MANUFACTURED IN MARSA, MALTA.

16030 I

II

6/24/2002

PHARMACOSMOS A/S

16031 I

II

6/26/2002

RANBAXY LABORATORIES LTD

IRON(III)-HYDROXIDE OLIGOSACCHARIDE COMPLEX AS MANUFACTURED IN VIBY SJ.,


DENMARK.
PRAVASTATIN SODIUM AS MANUFACTURED IN HIMACHAL PRADESH, INDIA.

16032 I

II

6/25/2002

BIOSEPRA SA

DEAE SPHERODEX LS VV AS MANUFACTURED IN CERGY SAINT CHRISTOPHE, FRANCE.

16033 I

II

6/28/2002

GILEAD SCIENCES INC

LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L) AS MANUFACTURED IN SAN DIMAS, CA.

16034 I

II

6/27/2002

ELAN DRUG DELIVERY INC

OCINAPLON TABLETS AS MANUFACTURED IN COUNTY WESTMEAH, IRELAND.

16035 A

II

6/26/2002

PROCOS SPA

PYRIDOSTIGMINE BROMIDE AS MANUFACTURED IN CAMERI, ITALY.

16036 A

II

6/20/2002

ACS DOBFAR SPA

16037 A

IV

7/3/2002

SPI PHARMA INC

7-ADCA (7-AMINO-3-DESACETOXY CEPHALOSPORANIC ACID) AS MANUFACTURED IN MILAN,


ITALY.
PHARMABURST(TM) B SERIES PRODUCTS AS MANUFACTURED IN GRAND HAVEN, MI

16038 A

II

6/27/2002

FORMOSA LABORATORIES INC

LEFLUNOMIDE AS MANUFACTURED IN TAOYUAN, TAIWAN.

16039 I

II

7/3/2002

ALDRICH CHEMICAL CO INC

3-AMINO-1-PROPANESULFONIC ACID AS MANUFACTURED IN SHEBOYGAN FALLS, WI.

16040 A

III

7/1/2002

POLYONE CORP

COLORANTS PRODUCT NO. CC00021366WE AS MANUFACTURED IN FLORENCE, KY.

16041 A

III

7/2/2002

POLYONE CORP

UV ABSORBER PRODUCT NO. CC00012617WE AS MANUFACTURED IN GLENDALE, AZ.

16042 A

III

7/2/2002

POLYONE CORP

UV ABSORBER PRODUCT NO. CC00012601WE AS MANUFACTURED IN GLENDALE, AZ.

16043 I

II

7/8/2002

RANBAXY LABORATORIES LTD

GANCICLOVIR AS MANUFACTURED IN MADHYA PRADESH, INDIA.

16044 A

II

7/8/2002

MOEHS IBERICA SL

CARVEDILOL AS MANUFACTURED IN RUBI, SPAIN.

16045 I

II

7/11/2002

ARCH PHARMALABS LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

16046 A

III

7/10/2002

GERRESHEIMER REGENSBURG GMBH

PULMICORT FLEXHALER AS MANUFACTURED IN PFREIMD, GERMANY.

16047 A

II

7/11/2002

UQUIFA MEXICO SA DE CV

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MORELOS, MEXICO.

16048 A

II

7/12/2002

BIOCON LTD

PRAVASTATIN SODIUM AS MANUFACTURED IN BANGALORE, INDIA.

16049 A

II

7/12/2002

BIOCON LTD

COMPACTIN AS MANUFACTURED IN BANGALORE, INDIA.

Page 461

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16050 I
II
7/9/2002
MALLINCKRODT INC
16051 I

IV

7/8/2002

DAVID MICHAEL AND CO INC

SUBJECT
POTASSIUM IODIDE USP GRANULAR FOOD GRADE, CODE 1112 AND POTASSIUM IODIDE BP
IODURE DE POTASSIUM, CODE 1220 AS MANUFACUTRED IN ST.LOUIS, MO.
ARTIFICIAL GRAPE FLAVOR #21126 AS MANUFACTURED IN PHILADELPHIA, PA.

16052 A

II

7/15/2002

EUTICALS SPA

PANCURONIUM BROMIDE AS MANUFACTURED IN ROZZANO, ITALY.

16053 A

II

6/27/2002

CHEMWERTH INC

ESMOLOL HCL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR CHEMWERTH INC

16054 I

III

7/15/2002

TOKYO KOBUNSHI CO LTD

SILICONE COATING PROCESS AS MANUFACTURED IN SAITAMA PREFECTURE, JAPAN.

16055 A

II

7/19/2002

TRIFARMA SPA

PROCHLORPERAZINE EDISYLATE USP AS MANUFACTURED IN MILANO, ITALY.

16056 A

II

7/22/2002

PANION AND BF BIOTECH INC

FERRIC CITRATE AS MANUFACTURED IN VANCOUVER, CANADA.

16057 I

II

7/18/2002

PHARMACIA AND UPJOHN SUB PFIZER INC

IDARUBICIN HYDROCHLORIDE AS MANUFACTURED IN CORK, IRELAND.

16058 A

II

6/28/2002

KREATIVE ORGANICS P LTD

BISACODYL USP AS MANUFACTURED IN HYDERABAD, INDIA.

16059 A

II

7/15/2002

SUMITOMO DAINIPPON PHARMA CO LTD

SM-13496 AS MANUFACTURED IN TSURUSAKI OITA, JAPAN

16060 A

II

7/24/2002

HIKAL LTD

GABAPENTIN AS MANUFACTURED IN BANGALORE, INDIA.

16061 A

II

7/22/2002

WOCKHARDT LTD

OXYBUTYNIN CHLORIDE USP AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16062 A

III

7/25/2002

PLASTIAPE SPA

MONODOSE INHALER MODEL 5 AS MANUFACTURED IN LECCO, ITALY.

16063 A

II

7/19/2002

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN BIASCA, SWITZERLAND.

16064 I

IV

7/25/2002

HELSINN CHEMICALS SA HELSINN ADVANCED


SYNTHESIS SA
DAVID MICHAEL AND CO INC

16065 I

II

7/25/2002

PCAS

FENOFIBRATE AS MANUFACTURED IN LIMAY, FRANCE.

16066 I

IV

7/10/2002

DMV INTERNATIONAL GMBH

RESPITOSE AN001 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS.

16067 A

IV

7/22/2002

UNGERER AND CO

ARTIFICIAL MASKING AGENT FL FL-5576 AS MANUFACTURED IN BETHLEHEM, PA.

16068 A

IV

7/22/2002

UNGERER AND CO

N/A TROPICAL PUNCH BASE 40709 AS MANUFACTURED IN BETHLEHEM, PA.

16069 A

IV

7/22/2002

UNGERER AND CO

N/A TROPICAL PUNCH FL FL-6182 AS MANUFACTURED IN BETHLEHEM, PA.

16070 A

II

7/24/2002

B-WING AS MANUFACTURED IN ORIGGIO, ITALY.

16071 I

II

7/30/2002

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
MITSUBISHI TANABE PHARMA CORP

16072 A

II

7/22/2002

SCINOPHARM TAIWAN LTD

BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN.

16073 I

II

7/29/2002

AVECIA BIOTECHNOLOGY INC

OLIGONUCLEOTIDE ANV AS MANUFACTURED IN MILFORD, MA.

16074 A

III

7/17/2002

EI DUPONT DENEMOURS AND CO INC

TOPCOAT 3200-100 AS MANUFACTURED IN MECHELEN, BELGIUM.

16075 I

II

7/25/2002

CADILA PHARMACEUTICALS LTD

CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARA, INDIA.

16076 A

II

7/31/2002

GLAXOSMITHKLINE LLC

16077 A

II

7/31/2002

KUREHA CORP

TICARCILLIN DISODIUM BULK (STERILE ) AS MANUFACTURED IN WEST SUSSEX, UNITED


KINGDOM.
KREMEZIN DRUG SUBSTANCE AS MANUFACTURED IN FUKUSHIMA, JAPAN.

16078 I

III

7/18/2002

MAC CLOSURES INC

NASAL PLUG AND SPRAY CAP AS MANUFACTURED IN QUEBEC, CANADA.

16079 A

II

7/30/2002

NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD

HMN-214 AS MANUFACTURED IN KUMAMOTO, JAPAN.

16080 A

II

8/1/2002

AVANTI POLAR LIPIDS INC

16081 I

III

7/29/2002

CONSOLIDATED BOTTLE

1,2-DIPALMITOYL-SN-GLYCERO-3[PHOSPHO-RAC-(1-GLYCEROL)] (SODIUM SALT/EDTA) AS


MANUFACTURED IN ALABASTER, AL.
CAP & PLUG ASSEMBLY AS MANUFACTURED IN STOCKHEIM, GERMANY.

16082 A

II

8/6/2002

SANDOZ GMBH

CEFTAZIDIME FOR INJECTION AS MANUFACTURED IN TYROL, AUSTRIA.

16083 A

II

8/6/2002

SANDOZ INDUSTRIAL PRODUCTS SA

CLARITHROMYCIN (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN.

16084 A

II

8/5/2002

MEDICHEM SA

VENLAFAXINE HCL AS MANUFACTURED IN GIRONA, SPAIN.

NATURAL PEPPERMINT FLAVOR #15318 AS MANUFACTURED IN PHILADELPHIA, PA.

MCC-257 AS MANUFACTURED IN IBARAKI-KEN, JAPAN.

Page 462

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16085 A
II
8/2/2002
SAFC INC
16086 I

II

8/9/2002

PHARMACIA AND UPJOHN

SUBJECT
2-METHYLENE-19-NOR-20-EPI-1 ,25-DIHYDROXYVITAMIN D3 AS MANUFACTURED IN MADISON,
WI.
DIHYDROFLUOCINOLONE ACETONIDE AS MANUFACTURED IN KALAMAZOO, MI.

16087 I

IV

8/6/2002

WILD FLAVORS INC

NATURAL PEPPERMINT FLAVOR WONF #FATEL649 AS MANUFACTURED IN ERLANGER, KY.

16088 I

IV

8/7/2002

FONA INTERNATIONAL INC

16089 A

II

8/6/2002

HIKMA PHARMACEUTICALS

#877.242 N-C MINT ROOTBEER FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN


CAROL STREAM, IL.
HYDROCORTISONE USP AS MANUFACTURED IN AMMAN, JORDAN.

16090 A

II

8/7/2002

DR REDDYS LABORATORIES LTD

CLOPIDOGREL BISULFATE FORM I AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16091 A

IV

8/6/2002

WILD FLAVORS INC

NATURAL ORANGE FLAVOR #FATEB893 AS MANUFACTURED IN ERLANGER, KY.

16092 I

II

8/12/2002

ELAN DRUG DELIVERY INC

N1177 NANOCRYSTAL(R) COLLOIDAL DISPERSION AS MANUFACUTRED IN HORSHAM, PA.

16093 A

II

8/9/2002

LIPOID GMBH

LIPOID FA 16:0 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY.

16094 A

II

8/12/2002

BIOCON LTD

SIMVASTATIN USP AS MANUFACTURED IN BANGALORE, INDIA.

16095 I

II

8/12/2002

BIOCON INDIA LTD

LOVASTATIN TECHNICAL(SFP) AS MANUFACTURED IN BANGALORE, INDIA.

16096 I

8/5/2002

PATHEON UK LTD SWINDON OPERATIONS

STERILE MANUFACTURING AT SWINDON, UNITED KINGDOM.

16097 I

II

8/12/2002

FINE CHEMICALS CORP PTY LTD

FLUPHENAZINE DECANOATE OIL(BMS) AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA.

16098 I

II

8/19/2002

RANBAXY LABORATORIES LTD

ATORVASTATIN CALCIUM(AMORPHOUS) AS MANUFACTURED IN PUNJAB, INDIA.

16099 A

II

8/15/2002

IRIX MANUFACTURING INC

METYROSINE USP AS MANUFACTURED IN GREENVILLE, SC.

16100 I

III

7/10/2002

COLORS FOR PLASTICS

B19558 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16101 A

III

8/20/2002

FORMOSA PLASTICS CORP USA

16102 I

II

8/19/2002

MALLINCKRODT INC

FORMOLON PVC RESINS AS MANUFACTURED IN POINT COMFORT, TX AND BATON ROUGE,


LA.
HYDROCODONE ALKALOID AS MANUFACTURED IN ST.LOUIS, MO.

16103 A

IV

8/21/2002

INGREDION INCORPORATED

UNIPURE(TM) DW AS MANUFACTURED IN INDIANAPOLIS, IN.

16104 A

II

8/16/2002

NEULAND LABORATORIES LTD

ALBUTEROL USP AS MANUFACTURED IN TELANGANA, INDIA.

16105 I

II

8/21/2002

HEBEI ZHONGXING PHARMACEUTICAL CO LTD

7-AMINOCEPHALOSPORANIC ACID AS MANUFACTURED IN HEBEI PROVINCE, CHINA.

16106 I

II

8/21/2002

16107 I

III

8/15/2002

SHIJIAZHUANG PHARM GROUP HEBEI ZHONGRUN PENICILLIN G POTASSIUM AS MANUFACTURED IN HEBEI PROVINCE, CHINA.
PHARMACEUTICAL CO LT
DUPONT PERFORMANCE COATING GMBH & CO KG HERBERTS-1K-LF 190 X3 AS MANUFACTURED IN WUPPERTAL, GERMANY.

16108 A

II

8/21/2002

LUPIN LTD

CEFUROXIME AXETIL (AMORPHOUS) USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

16109 A

II

8/23/2002

CIPLA LTD

LEFLUNOMIDE USP AS MANUFACTURED IN BANGALORE, INDIA.

16110 A

II

8/22/2002

POLYPEPTIDE LABS INC

THYMOSIN-ALPHA 1 DRUG SUBSTANCE AS MANUFACTURED IN TORRENCE, CA.

16111 A

III

8/21/2002

AMPACET CORP

161367 USA INJ.DARK BLUE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN


TARRYTOWN, NY; TERRY HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH,
OH AND MESSANCY, BELGIUM.

16112 A

II

8/29/2002

ALEMBIC PHARMACEUTICALS LTD

LEFLUNOMIDE AS MANUFACTURED IN GUJARAT, INDIA.

16113 A

II

8/22/2002

SUN PHARMACEUTICAL INDUSTRIES LTD

MIRTAZAPINE AS MANUFACTURED IN GUJARAT, INDIA.

16114 I

IV

8/26/2002

HISAMITSU PHARMACEUTICAL CO INC

PIROTIODECANE (HPE-101) AS MANUFACTURED IN TOKYO, JAPAN.

16115 I

II

8/29/2002

CQ INTERNATIONAL

CAMPTOTHECIN AS MANUFACTURED IN HUBEI, CHINA.

16116 A

III

8/20/2002

APTAR FRANCE SAS

APTAR EPDM ELASTOMER AS MANUFACTURED IN VAL-DE REUIL, FRANCE

16117 A

III

8/19/2002

GERRESHEIMER BOLESLAWIEC S A

PLASTIC BOTTLES AND ACCESSORIES, DROPPER BOTTLE SYSTEMS AND CONTAINERS WITH
CLOSURE SYSTEMS AS MANUFACTURED IN BOLESLAWIEC, POLAND.

Page 463

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16118 A
II
8/23/2002
SCINOPHARM TAIWAN LTD

SUBJECT
DANTROLENE SODIUM AS MANUFACTURED IN TAIWAN, R.O.C.

16119 A

II

8/27/2002

WOCKHARDT LTD

BETHANECHOL CHLORIDE USP AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16120 A

II

8/30/2002

PRODUCTOS QUIMICOS NATURALES SA DE CV

16121 I

III

8/23/2002

CLARIANT (CANADA) INC

16122 A

II

9/4/2002

SEVEN STAR PHARMACEUTICAL CO LTD

ESTRADIOL 3 ACETATE AS MANUFACTURED IN IXTACZOQUITLAN, MEXICO AND BERLIN,


GERMANY.
BLUE CLARIANT MASTERBATCHES 04EHD-7206 AS MANUFACTURED IN ONTARIO AND
QUEBEC, CANADA.
GUAIFENESIN USP AS MANUFACTURED IN TAIPEI, R.O.C.

16123 I

II

9/6/2002

REPLIGEN CORP

RG2133(TRIACETYL URIDINE) DRUG SUBSTANCE AS MANUFACTURED IN VARESE, ITALY.

16124 A

II

9/6/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

LEFLUNOMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16125 A

II

9/6/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16126 A

IV

9/6/2002

PETER GREVEN NEDERLAND CV

MAGNESIUM STEARATE AS MANUFACTURED IN PG VENLO, THE NETHERLANDS.

16127 A

II

9/6/2002

BASF PHARMA EVIONNAZ SA

MEFLOQUINE HYDROCHLORIDE AS MANUFACTURED IN EVIONNAZ, SWITZERLAND.

16128 I

III

9/4/2002

AMPACET CORP

100497 SLIP POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE


HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND MESSANCY,
BELGIUM.

16129 A

II

9/10/2002

SIGNA SA DE CV

ALENDRONATE SODIUM TRIHYDRATE AS MANUFACTURED IN TOLUCA, MEXICO.

16130 I

II

9/11/2002

NEULAND LABORATORIES LTD

O-BENZYL ALBUTEROL INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16131 I

III

9/3/2002

AMPACET CORP

11070-K SITE 70 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH; MESSANCY,
BELGIUM AND RAYONG, THAILAND.

16132 I

IV

9/12/2002

FLAVORS AS MANUFACTURED IN OWINGS MILL, MD.

16133 A

III

9/12/2002

QUEST INTERNATIONAL FLAVORS FOOD


INGREDIENTS CO
CCC PLASTICS

16134 A

II

9/13/2002

16135 A

II

9/16/2002

16136 A

II

9/16/2002

16137 I

III

9/13/2002

16138 A

IV

9/23/2002

WHITE MB20-9098 POLYETHYLENE COLOUR CONCENTRATE AS MANUFACTURED IN


ONTARIO, CANADA.
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFAZOLIN SODIUM, USP(STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT,
INDIA.
ACTAVIS GROUP PTC EHF
MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED
IN KANCHIPURAM, INDIA.
3M PHARMACEUTICALS SBC
TESTOSTERONE/ESTRADIOL TRANSDERMAL DELIVERY SYSTEMS CHEMISTRY,
MANUFACTURING, AND CONTROLS (CMC) AND TOXICOLOGY
LORMAC INDUSTRIAL DISTRIBUTORS LTD
LORMAC POLYETHYLENE PRODUCTS AS MANUFACTURED IN CORK, IRELAND AND
BRIGHOUSE, UNITED KINGDOM.
ROBERTET FLAVORS INC
ARTIFICIAL PINEAPPLE FLAVOR NV-13,012 AS MANUFACTURED IN PISCATAWAY, NJ.

16139 I

II

9/17/2002

PROMETIC BIOSCIENCES LTD

P-AMINOBENZAMIDINE AGAROSE 6XL AS MANUFACTURED IN CAMBRIDGE, UNITED KINGDOM.

16140 A

II

9/19/2002

PERRIGO API LTD

MODAFINIL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16141 I

II

9/19/2002

AIR PRODUCTS AND CHEMICALS INC

SURFYNOL(R) SE SURFACTANT AS MANUFACTURED IN CALVERT CITY, KY.

16142 A

II

9/24/2002

JUBILANT GENERICS LTD

LAMOTRIGINE AS MANUFACTURED IN KARNATAKA STATE, INDIA.

16143 A

II

9/23/2002

DR REDDYS LABORATORIES LTD

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16144 A

II

9/24/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

ACYCLOVIR AS MANUFACTURED IN PETAH TIQVA AND BE'ER SHEVA, ISRAEL.

16145 A

II

9/24/2002

CAMBRIDGE MAJOR LABS INC

16146 I

III

9/20/2002

PLASPAK CLOSURES PTY LTD

FENOLDOPAM MESYLATE AS MANUFACTURED IN GERMANTOWN, WI FOR SAGE CHEMICALS,


INC.
28 MM CLOSURE AS MANUFACTURED IN NSW, AUSTRALIA.

16147 A

II

9/5/2002

MALLADI DRUGS AND PHARMACEUTICALS LTD

D-PSEUDOEPHEDRINE SULFATE AS MANUFACTURED IN TAMILNADU, INDIA.

16148 A

II

9/26/2002

AMRI RENSSELAER INC

PHENOBARBITAL SODIUM USP AS MANUFACTURED IN RENSSELAER, NY.

Page 464

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16149 A
IV
9/25/2002
INTERNATIONAL SPECIALTY PRODUCTS
16150 A

II

9/24/2002

LONZA BIOTEC SRO

SUBJECT
GANEX WP-660(VP/1-TRIANCONTENE COPOLYMER) AS MANUFACTURED IN CALVERT CITY,
KY.
L-CARNITINE CRYSTALLINE USP GRADE AS MANUFACTURED IN KOURIM, CZECH REPUBLIC.

16151 A

II

9/25/2002

TARO PHARMACEUTICAL INDUSTRIES LTD

GABAPENTIN AS MANUFACTURED IN HAIFA BAY, ISRAEL.

16152 A

II

9/25/2002

SANOFI CHIMIE

16153 I

III

9/30/2002

WEST PENN PLASTIC INC

16154 A

III

9/24/2002

POLYONE CORP

HYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE AS MANUFACTURED IN


ROMAINVILLE CEDEX, FRANCE.
INJECTION MOLDING USING THERMOPLASTICS, COLORANTS, AND CHEMICAL ADDITIVES AS
MANUFACTURED IN NEW CASTLE, PA.
UV ABSORBER PRODUCT NUMBER CC0003827960 AS MANUFACTURED IN GLENDALE, AZ.

16155 I

IV

9/27/2002

THERMAX LTD.CHEMICAL DIVISION

TULSION(R) 335 AS MANUFACTURED IN MAHARASHTRA, INDIA.

16156 I

III

10/1/2002

BESPAK PLC

ALBUTEROL ACTUATOR-CAP ASSEMBLY AS MANUFACTURED IN APEX, NC.

16157 I

III

9/25/2002

GRAHAM PACKAGING COMPANY L.P.

PLASTIC BOTTLES AS MANUFACTURED CINCINNATI, OH.

16158 I

II

9/30/2002

BECTON DICKINSON AND CO

16159 A

III

9/20/2002

STERI PLAS PTY LTD

BD CELL MAB MEDIUM ANIMAL COMPONENT FREE AS MANUFACTURED IN HERDON, VA AND


COCKEYSVILLE, MD.
35ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA.

16160 A

III

9/23/2002

STERI PLAS PTY LTD

55ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA.

16161 A

III

9/23/2002

STERI PLAS PTY LTD

45ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA.

16162 A

III

9/23/2002

STERI PLAS PTY LTD

20ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA.

16163 A

III

9/24/2002

POLYONE CORP

UV ABSORBER PRODUCT NUMBER CC00003928WE AS MANUFACTURED IN GLENDALE, AZ.

16164 I

II

9/30/2002

BECTON DICKINSON AND CO

16165 I

9/17/2002

STERIS ISOMEDIX SERVICES

BD CELL MAB MEDIUM SERUM-FREE AS MANUFACTURED IN HERDON, VA AND


COCKEYSVILLE, MD.
CONTRACT STERILIZATION FACILITY AS MANUFACTURED IN MINNEAPOLIS, MN.

16166 A

II

10/1/2002

CAMBREX CHARLES CITY INC

NICOTINE POLACRILEX, 15%, USP AS MANUFACTURED IN CHARLES CITY, IOWA.

16167 N

NOT AN ASSIGNED NUMBER

16168 N

NOT AN ASSIGNED NUMBER

16169 N

NOT AN ASSIGNED NUMBER

16170 A

II

10/2/2002

SAFC BIOSCIENCES INC

EX-CELL(TM) 302 SERUM-FREE MEDIUM, W/O L-GLUTAMINE AS MANUFACTURED IN DENVER,


PA.
EX-CELL(TM) 620-HSF, HYBRIDOMA SERUM-FREE MEDIUM, W/O L-GLUTAMINE AS
MANUFACTURED IN DENVER, PA.
ONDANSETRON BASE AS MANUFACTURED IN BARCELONA, SPAIN.

16171 A

II

10/2/2002

SAFC BIOSCIENCES INC

16172 A

II

9/30/2002

INKE SA

16173 A

III

9/30/2002

NIPRO GLASS FRANCE

16174 A

II

9/24/2002

SUN PHARMACEUTICAL INDUSTRIES LTD

16175 A

III

9/27/2002

TOKAI CHEMICAL INDUSTRY CO LTD

16176 A

II

10/4/2002

CHATTEM CHEMICALS INC

16177 A

9/26/2002

134A CONSORTIUM

16178 A

II

10/9/2002

SYNBIAS PHARMA LTD

ACCEPTANCE TESTING OF HFA-134A(1,1,1,2-TETRAFLUOROETHANE) AS MANUFACTURED BY


INEOS FLUOR.
DOXORUBICIN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE.

16179 I

II

9/18/2002

CHEMISCHE FABRIK BUDENHEIM KG

DIBASIC SODIUM PHOSPHATE ANHYDROUS AS MANUFACTURED IN BUDENHEIM, GERMANY.

16180 A

II

10/8/2002

DR REDDYS LABORATORIES LTD

SULINDAC USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16181 I

III

10/8/2002

RIWISA AG

DRY POWDER INHALER AS MANUFACTURED IN HAEGGLINGEN, SWITZERLAND.

PACKAGING MATERIAL AS MANUFACTURED IN AUMALE, AUTHON DU PERCHE AND LUCENAY


LES AIX, FRANCE.
FLUVOXAMINE MALEATE BP AS MANUFACTURED IN MAHARASHTRA, INDIA.
PACKAGING MATERIALS AS MANUFACTURED IN TOYOTA CITY, OBARA VILLAGE AND MOKA
CITY, JAPAN.
METHAMPHETAMINE HYDROCHLORIDE USP AS MANUFACTURED IN CHATTANOOGA, TN.

Page 465

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16182 A
III
10/9/2002
SEALED AIR CORP

SUBJECT
UNIMARK WINGED SPIKE PORT AS MANUFACTURED IN GREER, SC.

16183 I

II

10/14/2002

PEPTISYNTHA SA

ATN 161 BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS, BELGIUM.

16184 I

II

10/11/2002

MERCK SANTE SAS

CRE 15876/A4 INTERMEDIATE AS MANUFACTURED IN CALAIS, FRANCE.

16185 I

II

10/11/2002

MERCK SANTE SAS

CRE 16257 DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS, FRANCE.

16186 A

II

10/8/2002

IRVINE SCIENTIFIC SALES CO

IS CHO-CD(TM) (L) CATALOG #91119 AS MANUFACTURED IN SANTA ANA, CA.

16187 A

II

10/4/2002

UQUIFA MEXICO SA DE CV

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MORELOS, MEXICO.

16188 A

II

10/4/2002

UQUIFA MEXICO SA DE CV

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MORELOS, MEXICO.

16189 A

II

10/4/2002

UNICHEM LABORATORIES LTD

MELOXICAM USP AS MANUFACTURED IN RAIGAD, INDIA.

16190 A

IV

10/15/2002

INGREDION INCORPORATED

16191 I

II

9/24/2002

YANCHENG SUHAI PHARMACEUTICAL CO LTD

UNIPURE(TM) DW-L, PREGELATINIZED CORN STARCH NF, PHEUR AS MANUFACTURED IN


INDIANAPOLIS, IN.
DOXYCYCLINE HYCLATE USP AS MANUFACTURED IN JIANGSU, CHINA.

16192 A

II

9/26/2002

LONZA LTD

SB 200473 AS MANUFACTURED IN VISP, SWITZERLAND.

16193 A

II

10/17/2002

DR REDDYS LABORATORIES INC

RAMIPRIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16194 I

II

10/17/2002

LEK PHARMACEUTICALS DD

DIHYDROERGOTAMINE MESYLATE AS MANUFACTRUED IN KOLODVORSKA, SLOVENIA.

16195 I

III

10/17/2002

WIPF AG

16196 I

III

8/27/2002

BASF SE

POLIALUVEL(R) STERIL OVERWRAP BAG INTENDED FOR DRUG PACKAGING AS


MANUFACTURED IN VOLKETSWIL, SWITZERLAND.
ULTRADUR B 4500 NATURAL AS MANUFACTURED IN SCHWARZHEIDE, GERMANY.

16197 I

III

10/9/2002

COLORS FOR PLASTICS

E13210 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16198 I

III

10/9/2002

COLORS FOR PLASTICS

E13211 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16199 I

III

10/9/2002

COLORS FOR PLASTICS

S34508 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16200 I

II

10/22/2002

VERA LABORATORIES LTD

NAPROXEN SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16201 A

II

10/14/2002

SIFAVITOR SRL

KETOTIFEN FUMARATE AS MANUFACTURED IN LODI, ITALY.

16202 A

III

1/6/2003

JAPAN VILENE CO LTD

MEDICAL BACKING NON-WOVEN FABRIC: EW-4350PE AS MANUFACTURED IN IBARAKI, JAPAN.

16203 I

II

10/18/2002

BANYU PHARMACEUTICAL CO LTD

J-107088 AS MANUFACTURED IN TOKYO, JAPAN.

16204 I

II

10/22/2002

LEK PHARMACEUTICALS DD

PRAVASTATIN SODIUM AS MANUFACTURED IN KOLODVORSKA, SLOVENIA.

16205 A

II

10/22/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16206 I

II

10/15/2002

ROHIT PLASTICS AND CHEMICALS

CLADRIBINE NON-STERILE ACTIVE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA.
CHLORHEXIDINE GLUCONATE 20% AS MANUFACTURED IN MAHARASHTRA, INDIA.

16207 I

II

10/25/2002

VERA LABORATORIES LTD

TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16208 A

II

10/25/2002

ALEMBIC PHARMACEUTICALS LTD

FENOFIBRATE AS MANUFACTURED IN GUJARAT, INDIA.

16209 I

II

10/24/2002

PISGAH LABS INC

BUTALBITAL USP AS MANUFACTURED IN PISGAH FOREST, NC.

16210 A

II

10/23/2002

ZHEJIANG KANGLE PHARMACEUTICAL CO LTD

ACETAMINOPHEN AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16211 I

III

9/27/2002

BASF AKTIENGESELLSCHAFT

RONFALIN SCF 34 WHITE 30265 AS MANUFACTURED IN AP GELEEN, NETHERLANDS.

16212 A

II

10/17/2002

UQUIFA MEXICO SA DE CV

KETOCONAZOLE AS MANUFACTURED IN MORELOS, MEXICO.

16213 A

IV

10/22/2002

FMC CORP FMC BIOPOLYMER DIV

16214 I

III

10/25/2002

BOREALIS AG

PROTANAL(R) SODIUM ALGINATE, NF AS MANUFACTURED IN HAUGESUND, VORMEDAL AND


DRAMMEN, NORWAY.
PACKAGING MATERIAL FB2310 AS MANUFACTURED IN PORVOO, FINLAND.

16215 A

II

10/22/2002

ERREGIERRE SPA

NISOLDIPINE AS MANUFACTURED IN BERGAMO, ITALY.

16216 A

III

10/12/2002

PIRAMAL GLASS LTD

GLASS CONTAINERS AS MANUFACTURED IN GUJARAT, INDIA.

16217 A

II

10/21/2002

OLON SPA

OXANDROLONE AS MANUFACTURED IN MULAZZANO, ITALY.

Page 466

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16218 I
II
10/30/2002
WOCKHARDT LTD

SUBJECT
CLARITHROMYCIN AS MANUFACTURED IN GUJARAT STATE, INDIA.

16219 A

III

10/25/2002

BOREALIS AG

PACKAGING MATERIAL FB2230 AS MANUFACTURED IN PORVOO, FINLAND.

16220 A

III

7/22/2002

ALBIS PLASTIC GMBH

LUPOLEN CONCENTRATE SL 02 EA AS MANUFACTURED IN HAMBURG, GERMANY.

16221 I

III

10/2/2002

AIR PRODUCTS AND CHEMICALS INC

FLEXCRYL(R) AC20 EMULSION AS MANUFACTURED IN PIEDMONT, SC.

16222 I

II

10/24/2002

SANKYO CO LTD

CS-003 DRUG PRODUCT AS MANUFACTURED IN TOKYO AND SHIGA, JAPAN.

16223 I

II

10/24/2002

SANKYO CO LTD

CS-003 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN.

16224 A

II

11/5/2002

CILAG AG

DIVALPROEX SODIUM AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

16225 A

II

11/5/2002

SUZHOU NUMBER 4 PHARMACUTICAL FACTORY

CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

16226 I

II

11/4/2002

TRAGARA PHARMACEUTICALS INC

CS-706 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN.

16227 I

II

10/28/2002

IRVINE SCIENTIFIC SALES CO

IS MAB-V(TM) AS MANUFACTURED IN SANTA ANA, CA.

16228 A

III

10/28/2002

POLYONE CORP

COLORANT PRODUCT NO. CC0003821560 AS MANUFACTURED IN SEABROOK, TX.

16229 I

III

9/25/2002

BANGKOK POLYESTER PUBLIC CO LTD

BANGKOK PET V080P AS MANUFACTURED IN BANGKOK, THAILAND.

16230 I

III

11/11/2002

GRAHAM PACKAGING COMPANY L.P.

PLASTIC BOTTLES AS MANUFACTURED IN FINDLAY, OH.

16231 A

IV

11/4/2002

FERTIN PHARMA AS

16232 A

II

11/8/2002

3M PURIFICATION INC

CHEWING GUM BASE: DAN MED 60 M/BHT (GUMLINK AS ITEM NO.: 25048) AS MANUFACTURED
IN VEJLE, DENMARK.
PTFE MEMBRANCE CARTRIDGE PRODUCTS AS MANUFACTURED IN MERIDEN, CT.

16233 I

III

11/5/2002

ROHM AND HAAS CO

16234 I

II

11/11/2002

NV ORGANON

LAMAL 408-40 AND LAMAL COREACTANT C AS MANUFACTURED IN MEXICO AND ELK GROVE
VILLAGE, IL.
HEPARIN SODIUM III AS MANUFACTURED IN OSS, THE NETHERLANDS.

16235 A

II

11/5/2002

YANGZHOU PHARMACEUTICAL CO LTD

ISONIAZID AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

16236 I

II

11/7/2002

MITSUBISHI PHARMA CORP

MT-210 BULK DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI PREFECTURE, JAPAN.

16237 I

II

11/6/2002

GILEAD SCIENCES INC

LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211) AS MANUFACTURED IN SAN DIMAS, CA.

16238 I

II

11/6/2002

TRAGARA PHARMACEUTICALS INC

CS-706 DRUG PRODUCT AS MANUFACTURED IN TOKYO, JAPAN.

16239 A

III

11/11/2002

RPC FORMATIC GMBH

16240 A

II

11/11/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16241 A

II

11/13/2002

SICOR SWISS BRANCH

M-71 MOUTHPIECE, MATERIAL NO.35155911 AS MANUFACTURED IN MELLRICHSTADT,


GERMANY.
VINBLASTINE SULFATE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA.
FORMOTEROL FUMARATE AS MANUFACTURED IN VACALLO, SWITZERLAND.

16242 A

II

11/13/2002

INDENA SPA

PACLITAXEL P.I. AS MANUFACTURED IN SETTALA, ITALY.

16243 A

II

11/15/2002

DELMAR CHEMICALS INC

MONTELUKAST SODIUM THIOL ACID AS MANUFACTURED IN QUEBEC, CANADA.

16244 A

II

11/14/2002

CHEMAGIS LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16245 A

II

11/15/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

CLONAZEPAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16246 A

II

12/10/2002

MYLAN LABORATORIES LTD

NAPROXEN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16247 I

II

11/19/2002

ITF CHEMICAL LTDA

PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BAHIA, BRAZIL.

16248 I

II

11/18/2002

PROMETIC BIOSCIENCES LTD

MABSORBENT A1P AS MANUFACTURED IN ISLE OF MAN, BRITISH ISLES.

16249 I

II

11/20/2002

SSP CO LTD

SS734 AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN.

16250 A

II

11/19/2002

DIPHARMA FRANCIS SRL

MODAFINIL AS MANUFACTURED IN CARONNO PERTUSELLA, ITALY.

16251 A

II

11/14/2002

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

RANITIDINE BASE AS MANUFACTURED IN BARCELONA, SPAIN.

16252 I

III

11/14/2002

ROHM AND HAAS CO

ROBOND PS-7619 AS MANUFACTURED IN LOUISVILLE, KY.

16253 I

II

11/18/2002

ROHIT PLASTICS AND CHEMICALS

CHLORHEXIDINE ACETATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

Page 467

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16254 A
II
11/19/2002
SIEGFRIED LTD

SUBJECT
AMOROLFINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND.

16255 A

II

11/15/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MESNA AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16256 I

II

1/2/2003

SA AJINOMOTO OMNICHEM NV

BALSALAZIDE DISODIUM AS MANUFACTURED IN BALEN, BELGIUM.

16257 I

IV

11/21/2002

NATIONAL STARCH CHEMICAL CO

DRY-FLOC(R) PC AESTHETIC ENHANCER AS MANUFACTURED IN ISLAND FALS, ME.

16258 A

II

10/31/2002

SYNBIAS PHARMA LTD

EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE.

16259 A

II

11/20/2002

SUVEN LIFE SCIENCES LTD

LAMOTRIGINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16260 A

IV

1/14/2003

NATUREX LTD

TALIN ( THAUMATIN ) AS MANUFACTURED IN OVERSEAL, UNITED KINGDOM

16261 A

II

11/27/2002

RANBAXY LABORATORIES LTD

QUINAPRIL HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA.

16262 A

II

11/27/2002

TARO PHARMACEUTICAL INDUSTRIES LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

16263 A

II

11/18/2002

UNICHEM LABORATORIES LTD

METRONIDAZOLE USP AS MANUFACTURED IN RAIGAD, INDIA.

16264 A

II

11/25/2002

FERMIC SA DE CV

CLAVULANATE POTASSIUM+SILICON DIOXIDE AS MANUFACTURED IN MEXICO CITY, MEXICO.

16265 A

II

11/25/2002

FERMIC SA DE CV

16266 A

III

11/20/2002

PRESSPART MANUFACTURING LTD

CLAVULANATE POTASSIUM+MICROCRYSTALLINE CELLULOSE AS MANUFACTURED IN MEXICO


CITY, MEXICO.
STAINLESS STEEL AEROSOL CANISTERS AS MANUFACTURED IN LANCASHIRE, ENGLAND.

16267 A

II

11/25/2002

WOCKHARDT LTD

CEFUROXIME AXETIL(AMORPHOUS) AS MANUFACTURED IN GUJARAT STATE, INDIA.

16268 A

II

11/25/2002

WOCKHARDT LTD

AZITHROMYCIN-FORM I AS MANUFACTURED IN GUJARAT STATE, INDIA.

16269 A

11/26/2002

CURRICULA VITAE (CV) FOR HIV PREVENTION TRIALS NETWORK (HPTN) INVESTIGATORS.

16270 I

II

11/21/2002

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY INFECTIOUS DISEASES
SICOR SPA

16271 A

II

11/26/2002

GADOR SA

NORGESTIMATE AS MANUFACTURED IN BUENOS AIRES, ARGENTINA.

16272 I

II

11/25/2002

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA.

16273 A

II

11/25/2002

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO


LTD
RELIABLE BIOPHARMACEUTICAL CORP

16274 A

III

11/18/2002

POLYONE CORP

PRODUCT NO. CC00017894DR AS MANUFACTURED IN AVON LAKE, OH.

16275 A

III

11/15/2002

STE PACKAGING DEVELOPMENT SL

16276 I

III

11/19/2002

AMPACET CORP

16277 I

III

11/12/2002

BESPAK DIV CONSORT MEDICAL PLC

16278 A

II

11/26/2002

UNICHEM LABORATORIES LTD

PLASTIC MOLDED COMPONENTS FOR PACKAGING AND DELIVERY OF PHARMACEUTICAL


PRODUCTS AS MANUFACTURED IN TARRAGONA, SPAIN.
12416 PEARL POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;
TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH AND DERIDDER, LA.
BK357951MT PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK,
ENGLAND.
HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN RAIGAD, INDIA.

16279 A

II

12/2/2002

SMS PHARMACEUTICALS LTD

SUMATRIPTAN SUCCINATE AS MANUFACTURED IN ANDHRA PRADES, INDIA.

16280 A

II

12/2/2002

PLIVA LACHEMA AS

CARBOPLATIN AS MANUFACTURED IN BRNO, THE CZEH REPUBLIC.

16281 A

II

12/2/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA AND NETANYA, ISRAEL.

16282 I

III

3/5/2003

WINPAK TECHNOLOGIES INC

16283 A

II

11/28/2002

AMINO CHEMICALS LTD

41.0 GSM PAPER DUNCOTE II HG 605/11.0 GSM PE 5050/24.1 GSM9.0 UM ALUMINIUM FOIL/16.0
GSM EAA TRANCEND EC AS MANUFACTURED IN TORONTO, CANADA.
TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA.

16284 A

IV

12/2/2002

DMV FONTERRA EXCIPIENTS GMBH CO KG

RESPITOSE ML002 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS.

16285 A

IV

12/2/2002

DMV FONTERRA EXCIPIENTS GMBH CO KG

RESPITOSE SV003 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS.

16286 A

II

12/4/2002

AKZO NOBEL CHEMICALS SA DE CV

PERKADOX API (BENZOYL PEROXIDE) AS MANUFACTURED IN LOS REYES, MEXICO.

16287 A

II

12/4/2002

RANBAXY LABORATORIES LTD

GABAPENTIN (NON-STERILE BULK) AS MANUFACTURED IN MADHYA PRADESH, INDIA.

DOXORUBICIN HYDROCHLORIDE, LYOPHILIZED AS MANUFACTURED IN VERCELLI, ITALY.

HYALURONIDASE AS MANUFACTURED IN ST.LOUIS, MO.

Page 468

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16288 I
II
12/6/2002
NV ORGANON

SUBJECT
ESTERIFIED ESTROGENS TYPE BA AS MANUFACTURED IN OSS, THE NETHERLANDS.

16289 I

II

12/5/2002

INTERQUIM SA

ABAPERIDONE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

16290 A

III

12/4/2002

RENOLIT HISPANIA SA

16291 A

III

12/5/2002

STYROLUTION AMERICA LLC

RENOLIT PHARMAFOLIE ART.-GRUPPE 41 AS MANUFACTURED IN WORMS AM RHEIN,


GERMANY.
ZYLAR(R) RESINS AS MANUFACTURED IN CHESAPEAKE, VA.

16292 I

II

12/10/2002

COLLGARD BIOPHARMACEUTICALS LTD

HALOFUGINONE HYDROBROMIDE AS MANUFACTURED IN VERTOLAYE, FRANCE.

16293 I

III

11/27/2002

BASF SE

ULTRAFORM W 2320 003 UNCOLORED Q600 AS MANUFACTURED IN BISHOP, TX.

16294 A

III

12/6/2002

LOPAREX LLC

16295 A

III

12/6/2002

LOPAREX LLC

RELEASE LINERS MADE WITH TIN CURE CHEMISTRY ON POLYESTER FILM SUBSTRATES AS
MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL.
RELEASE LINERS MADE WITH PLATINUM CURE CHEMISTRY ON POLYETHYLENE COATED
KRAFT PAPER AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL.

16296 A

III

12/6/2002

LOPAREX LLC

16297 A

II

12/2/2002

CADILA HEALTHCARE LTD

16298 I

III

12/2/2002

16299 A

II

12/10/2002

16300 A

II

12/11/2002

16301 A

II

12/5/2002

BERRY PLASTICS CORP TAPES AND COATINGS DIV 48 GAUGE CHEMICALLY TREATED POLYESTER/PRIMER/12# WHITE POLYETHYLENE/0.00035
FOIL/1.0# ADHESIVE/2 MIL LDPE FILM AS MANUFACTURED IN COLUMBUS, GA.
CSPC ZHONGNUO PHARMACEUTICAL
7-AMINOCEPHALOSPORANIC ACID 7-ACA AS MANUFACTURED IN HEBEI PROVINCE, CHINA.
SHIJIAZHUANG CO LTD
RANBAXY LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN MADHYA
PRADESH, INDIA.
ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE
PHENYTOIN SODIUM AS MANUFACTURED IN ISSO, ITALY.

16302 I

III

12/10/2002

STELLA KUNSTSTOFFTECHNIK GMBH

16303 I

III

12/2/2002

16304 A

II

11/28/2002

SECRO PP28, CHILD-PROFF CLOSURE, WHITE/YELLOW WITH SEALING DISK AS


MANUFACTURED IN ELTVILLE, FEDERAL REPUBLIC OF GERMANY.
BERRY PLASTICS CORP TAPES AND COATINGS DIV 48 GAUGE CHEMICALLY TREATED POLYESTER/0.8# ADHESIVE/0.00035 FOIL/0.8# ADHESIVE/2
MIL LDPE FILM AS MANUFACTURED IN COLUMBUS, GA.
POLFA TARCHOMIN S A
ERYTHROMYCIN THIOCYANATE AS MANUFACTURED IN WARSAW, POLAND.

16305 A

II

12/11/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16306 A

II

12/12/2002

MYLAN LABORATORIES LTD

SIMVASTATIN USP, NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT AS


MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
MODAFINIL USP AS MANUFACTURED IN TELANGANA, INDIA.

16307 A

12/12/2002

LILLY FRANCE SAS

PROCEDURES FOR STERILE OPERATIONS IN BUILDING 200, FEGERSHEIM, FRANCE.

16308 I

III

11/25/2002

BESPAK EUROPE LTD

16309 A

II

12/13/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16310 A

II

12/13/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

BK 357676MT PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK,


ENGLAND.
PRAVASTATIN SODIUM (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) AS
MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
MODAFINIL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16311 I

II

12/16/2002

MAPRIMED SA

LOSARTAN POTASSIUM AS MANUFACTURED IN BUENOS AIRES, ARGENTINA.

16312 A

II

12/11/2002

KATWIJK CHEMIE BV

DIVALPROEX SODIUM AS MANUFACTURED IN KATWIJK, THE NETHERLANDS.

16313 A

II

12/17/2002

SANDOZ PRIVATE LTD

CEFIXIME AS MANUFACTURED IN MAHARASHTRA, INDIA.

16314 A

II

12/17/2002

TEVA PHARMACEUTICAL INDUSTRIES LTD

LABETALOL HYDROCHLORIDE AS MANUFACTURED IN SETTIMO MILANESE MI, ITALY.

16315 I

II

12/17/2002

RELIABLE BIOPHARMACEUTICAL CORP

APROTININ AS MANUFACTURED IN ST.LOUIS, MO.

16316 A

II

1/27/2003

DR REDDYS LABORATORIES LTD

FLUCONAZOLE (FORM 2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16317 A

II

12/13/2002

INKE SA

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

16318 A

III

12/18/2002

IWATA GLASS INDUSTRIAL CO LTD

DRUG AMPULES AND VIALS AS MANUFACTURED IN OSAKA, JAPAN.

RELEASE LINERS MADE WITH PLATINUM CURE CHEMISTRY ON POLYESTER SUBSTRATES AS


MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL.
FLUCONAZOLE AS MANUFACTURED IN GUJARAT, INDIA.

Page 469

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16319 A
V
12/9/2002
PFIZER PERTH PTY LTD
16320 A

II

1/29/2003

DR REDDYS LABORATORIES LTD

SUBJECT
PERTH ASEPTIC ONCOLOGY MANUFACTURING FACILITY IN WESTERN AUSTRALIA,
AUSTRALIA.
ONDANSETRON AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16321 A

II

12/17/2002

RANBAXY LABORATORIES LTD

FOSINOPRIL SODIUM (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA.

16322 A

III

12/18/2002

LORMAC INDUSTRIAL DISTRIBUTORS LTD

16323 A

II

12/3/2002

SUN CHEMICALS CO LTD

16324 A

II

12/18/2002

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16325 I

II

12/19/2002

FARMABIOS SPA

LORMAC TYPE 30 POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND AND


BRADFORD, ENGLAND.
BENZYL (3S)-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLATE P-TOLUENESULFONIC
ACID SALT AS MANUFACTURED SAITAMA, JAPAN.
EPIRUBICIN HYDROCHLORIDE, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA.
CEFUROXIME SODIUM (INTERMEDIATE) AS MANUFACTURED IN PAVIA, ITALY.

16326 A

II

12/19/2002

PLIVA LACHEMA AS

DACARBAZINE AS MANUFACTURED IN BRNO, THE CZECH REPUBLIC.

16327 A

II

12/23/2002

5N PLUS LUBECK GMBH

BISMUTH SUBSALICYLATE SG AS MANUFACTURED IN LUBECK, GERMANY.

16328 I

III

12/24/2002

PPG INDUSTRIES INC

16329 I

II

12/16/2002

SAFC INC

COVERING PPG2004855 COATING FOR AEROSOL CANS CONTAINING DRUG PRODUCT AS


MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH.
HALOBETASOL PROPIONATE (HBS) AS MANUFACTURED IN MADISON, WI.

16330 A

II

1/29/2003

DR REDDYS LABORATORIES LTD

CARVEDILOL FORM-2 AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16331 A

II

12/20/2002

CHATTEM CHEMICALS INC

16332 I

II

12/19/2002

DOTTIKON EXCLUSIVE SYNTHESIS AG

METHYLPHENIDATE HYDROCHLORIDE, USP AS MANUFACTURED IN CHATTANOOGA,


TENNESSEE.
T-3811A05 AS MANUFACTURED IN DOTTIKON, SWITZERLAND.

16333 I

II

12/20/2002

HEUMANN PHARMA GMBH

CARPROFEN AS MANUFACTURED IN FEUCHT, GERMANY.

16334 A

II

12/20/2002

HOVIONE FARMACIENCIA SA

FLUTICASONE PROPIONATE AS MANUFACTURED IN LOURES, PROTUGAL.

16335 I

II

12/18/2002

OMNICHEM SA

T-3811A15 AS MANUFACTURED IN BALEN, BELGIUM.

16336 I

II

12/17/2002

DAITO CORP

FLAVOXATE HYDROCHLORIDE JP14 AS MANUFACTURED IN TOYAMA CITY, JAPAN.

16337 A

III

12/18/2002

BERRY PLASTICS CORP

PRODUCT 15807-55 AS MANUFACTURED IN COLUMBUS, GA

16338 A

III

12/18/2002

BERRY PLASTICS CORP

PRODUCT 60091-21 MANUFACTURED IN COLUMBUS, GA

16339 A

II

12/26/2002

TARO PHARMACEUTICAL INDUSTRIES LTD

OXCARBAZEPINE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

16340 A

II

12/18/2002

LONZA AG

CN 343 (SAS) AS MANUFACTURED IN VISP, SWITZERLAND.

16341 A

III

12/13/2002

POLYONE CORP

PRODUCT NO. CC00017075WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16342 I

II

12/30/2002

PROCOS SPA

GABAPENTIN AS MANUFACTURED IN NOVARA, ITALY.

16343 A

II

12/24/2002

SANYO FINE CO LTD

HMMP AS MANUFACTURED IN FUKUI PREFECTURE, JAPAN.

16344 A

II

12/20/2002

CHEMPACIFIC CORP

NOREPINEPHRINE BITARTRATE AS MANUFACTURED IN BALTIMORE, MD.

16345 A

II

12/20/2002

ANDHRA SUGARS LTD

ASPIRIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16346 I

II

1/3/2003

DIOSYNTH BV

ALTRENOGEST AS MANUFACTURED IN OSS, THE NETHERLANDS.

16347 I

II

1/3/2003

DIOSYNTH BV

TRENBOLONE ACETATE AS MANUFACTURED IN OSS, THE NETHERLANDS.

16348 I

II

1/2/2003

WENZHOU PHARMACEUTICAL FACTORY

ACETAMINOPHEN DC GRANULAR AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16349 A

II

1/6/2003

SANYO CHEMICAL INDUSTRIES LTD

POLYQUID PA-30 AS MANUFACTURED IN AICHI, JAPAN.

16350 I

II

1/23/2003

OLON SPA

CEFUROXIME AXETIL AS MANUFACTURED IN RODANO, ITALY AND CHENNAI, INDIA.

16351 A

II

12/6/2002

PURDUE PHARMA LP

HYDROMORPHONE HYDROCHLORIDE AS MANUFACTURED IN WHIPPANY, NJ.

16352 A

II

1/2/2003

ERREGIERRE SPA

CICLOPIROX OLAMINE USP-PH.EUR. AS MANUFACTURED IN BERGAMO, ITALY.

16353 A

II

12/30/2002

ERREGIERRE SPA

CICLOPIROX PH.EUR. AS MANUFACTURED IN BERGAMO, ITALY.

Page 470

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16354 A
III
1/6/2003
ADVANEX EUROPE LTD

SUBJECT
GSK MDI COUNTER WIRE FORMS AS MANUFACTURED IN NOTTINGHAMSHIRE, ENGLAND.

16355 A

II

1/14/2003

NITTO DENKO CORP

OLIGONUCLEOTIDE APQ AS MANUFACTURED IN MILFORD, MA.

16356 A

II

1/13/2003

SAFC BIOSCIENCES INC

16357 A

II

1/23/2003

16358 I

II

1/10/2003

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD
AVANTI POLAR LIPIDS INC

16359 I

II

1/10/2003

AVANTI POLAR LIPIDS INC

16360 A

III

1/13/2003

MITSUBISHI GAS CHEMICAL CO INC

16361 A

II

1/15/2003

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS

EX-CELL(TM) 302, SERUM-FREE MEDIUM, W/O L-GLUTAMINE, W/O NAHCO3 AS


MANUFACTURED IN DENVER, PA.
CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN CHONGQING, PEOPLE'S REPUBLIC OF
CHINA.
3-O-[2'-(W-MONOMETHOXYPOLY(ETHYLENE GLYCOL)2000)SUCCINOLY]-1,2-DISTEAROYL-SNGLYCEROL (DSG-PEG 2000) AS MANUFACTURED IN ALABASTER, AL.
1,2-DI-O-OCTADECENYL-3-(N,N-DIEMTHYLAMINOPROPANE) (DODMA) AS MANUFACTURED IN
ALABASTER, AL.
OXYGEN ABSORBERS AGELESS TYPES ZPT, ZP (ZPT-C) AND SS AS MANUFACTURED IN
TOKYO, JAPAN.
2-BUTYL-4-CHLORO-1-[[2'-[2-(TRIPHENYLMETHYL)-2H-TETRAZOL-5-YL]-[1,1'-BIPHENYL]-4YL]METHYL]1-H-IMIDAZOLE-5-METHANOL (TTL) AS MANUFACTURED IN CONSHOHOCKEN, PA.

16362 A

IV

1/16/2003

SPI PHARMA INC

MANNOGEM(TM) EZ SPRAY DRIED MANNITOL USP AS MANUFACTURED IN KENT, ENGLAND.

16363 A

III

1/15/2003

LORMAC INDUSTRIAL DISTRIBUTORS LTD

16364 I

III

1/16/2003

ALKERMES INC

16365 A

III

1/16/2003

FORTEQ NIDAU AG

LORMAC TYPE 7-B POLYETHYLENE AS MANUFACTURED IN CORK, IRELAND AND WEST


YORKSHIRE, UNITED KINGDOM.
C2S DRY POWDER INHALER DRUG DELIVERY SYSTEMS AS MANUFACTURED IN CAMBRIDGE,
MA.
MDI COUNTER PROJECT AS MANUFACTURED IN NIDAU, SWITZERLAND.

16366 A

IV

1/15/2003

KERRY CANADA INC

BUBBLEGUM ARTIFICIAL FLAVOR MC-4938 AS MANUFACTURED IN QUEBEC, CANADA.

16367 A

II

1/17/2003

MEDICHEM SA

ALENDRONATE SODIUM AS MANUFACTURED IN GIRONA, SPAIN.

16368 A

III

1/21/2003

ZEON CORP

CYCLOOLEFIN POLYMER AS MANUFACTURED IN OKAYAMA, JAPAN.

16369 A

II

1/21/2003

SHASUN PHARMACEUTICALS LTD

ISRADIPINE, USP AS MANUFACTURED IN CUDDALORE, INDIA.

16370 I

II

1/16/2003

PHLOX PHARMACEUTICALS LTD

CEFUROXIME ACID AS MANUFACTURED IN GUJARA, INDIA.

16371 A

II

1/20/2003

NEULAND LABORATORIES LTD

ALBUTEROL SULFATE USP AS MANUFACTURED IN TELANGANA, INDIA.

16372 I

II

1/17/2003

SYNTETICA FINE CHEMICALS INC

AMONAFIDE L-MALATE AS MANUFACTURED IN QUEBEC, CANADA.

16373 I

III

11/26/2002

BASF SE

ULTRAFORM N 2320 003 UNCOLORED Q600 AS MANUFACTURED IN BISHOP, TX.

16374 A

II

1/21/2003

PHYTON BIOTECH LLC

SEMI-SYNTHETIC PACLITAXEL API AS MANUFACTURED IN GRAFTON, WI.

16375 I

II

1/21/2003

HOVIONE FARMACIENCIA SA

T-3811A15 (17TY01) AS MANUFACTURED IN LOURES, PORTUGAL.

16376 A

IV

1/2/2003

CAPSCANADA CORP

16377 A

III

1/21/2003

LANXESS CORP

EMPTY HARD VEGETABLE CAPSULE SHELLS AS MANUFACTURED IN BARRANQUILLA,


COLUMBIA.
CHLOROBUTYL 1240 AS MANUFACTURED IN SARINA, CANADA AND ANTWERPEN, BELGIUM.

16378 I

III

1/22/2003

ARGUS-LOC TAMPERTEL CRC CLOSURES AS MANUFACTURED IN VICTORIA, AUSTRALIA.

16379 A

II

1/23/2003

ACI PLASTICS PACKAGING CLOSURE SPECIALTY


PRODUCTS
ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

16380 A

II

1/16/2003

TIANJIN ZHONGAN PHARMACEUTICAL CO LTD

METRONIDAZOLE AS MANUFACTURED IN TIANJIN, P.R.CHINA.

16381 I

II

1/22/2003

RANBAXY LABORATORIES LTD

T-3811A 05 AS MANUFACTURED IN MADHYA PRADESH, INDIA.

16382 I

III

1/20/2003

OWENS ILLINOIS INC

PLASTICS PACKAGING COMPONENTS AS MANUFACTURED IN EL PASO, TX.

16384 A

II

1/22/2003

EXPRESSION SYSTEMS LLC

ESF 921 MEDIUM (A SERUM FREE FORMULATION) AS MANUFACTURED IN WOODLAND, CA.

16385 A

II

1/22/2003

EXPRESSION SYSTEMS LLC

AF 99 MEDIUM (AN ANIMAL FREE FORMULATION) AS MANUFACTURED IN WOODLAND, CA.

16383 N

SULFADIMETHOXINE SODIUM USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

NOT AN ASSIGNED NUMBER

Page 471

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16386 A
III
1/24/2003
ASHLAND INC

SUBJECT
FLEXCRYL(R) SP-38 EMULSION AS MANUFACTURED IN PIEDMONT, SC.

16387 A

II

1/28/2003

SIGNA SA DE CV

16388 A

III

1/24/2003

CURTEC NEDERLAND BV

16389 A

II

1/25/2003

EUTICALS SPA

NEFAZODONE HYDROCHLORIDE AS MANUFACTURED IN TOLUCA, MEXICO AND GUJARAT,


INDIA.
CLICK PACK'S 4500 SERIES AND KEGS 6900 AND 7000 SERIES AS MANUFACTURED IN RIJEN,
NETHERLANDS.
DESOGESTREL BP/PF AS MANUFACTURED IN ROZZANO, ITALY.

16390 A

II

1/30/2003

SANDOZ INDUSTRIAL PRODUCTS SA

16391 I

II

11/26/2002

CADILA PHARMACEUTICALS LTD

AZITHROMYCIN MONOHYDRATE (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA,


SPAIN.
FLUCONAZOLE AS MANUFACTURED IN GUJARAT, INDIA.

16392 I

III

1/27/2003

SOMAR CORP

A MEDICAL BACKING CLOTH: SOMAPET HW-25 AS MANUFACTURED IN SAITAMA, JAPAN.

16393 I

III

1/31/2003

BASF CORP

ACRONAL(R) N-CR 112 AS MANUFACTURED IN MONACA, PA.

16394 A

III

1/15/2003

AMPACET CORP

111203 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND
MESSANCY, BELGIUM.

16395 A

IV

1/23/2003

MANE INC

SPEARMINT FLAVOR S.D. E_9822433 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE.

16396 I

II

2/3/2003

LABORATORI DERIVATI ORGANICI SPA

SODIUM HEPARIN AS MANUFACTURED IN VERCELLI, ITALY.

16397 I

III

1/31/2003

INTERNATIONAL MEDICATION SYSTEMS LTD

16398 A

II

1/29/2003

UNICHEM LABORATORIES LTD

EMPTY PREFILLED DISPOSABLE PIPETTE (PDP), D SERIES TYPES: D1000, D 2500, D5000, AND
D10K AS MANUFACTURED IN SAN FERNANDO, CA.
BISOPROLOL FUMARATE USP AS MANUFACTURED IN RAIGAD, INDIA.

16399 A

II

2/3/2003

RHODES TECHNOLOGIES

OXYCODONE HYDROCHLORIDE AS MANUFACTURED IN COVENTRY, RI.

16400 A

II

1/31/2003

AIR LIQUIDE HEALTHCARE AMERICA CORP

16401 I

II

2/3/2003

RANBAXY LABORATORIES INC

16402 A

II

2/3/2003

CATALENT PHARMA SOLUTIONS LLC

PERFLUOROPROPANE (OCTOFLUROPROPANE) GAS MANUFACTURED IN PLUMSTEADVILLE,


PA.
COMPACTIN DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN HIMACHAL PRADESH,
INDIA.
ZEMPLAR (PARICALCITOL) 2 & 4 MCG CAPSULES AS MANUFACTURED IN ST.PETERSBURG, FL.

16403 A

III

1/31/2003

MITSUBISHI GAS CHEMICAL CO INC

OXYGEN ABSORBERS AGELESS TYPE FX AS MANUFACTURED IN TOKYO, JAPAN.

16404 A

II

2/3/2003

GEDEON RICHTER PLC

NORELGESTROMIN AS MANUFACTURED IN DOROG, HUNGARY.

16405 I

II

1/30/2003

ALKALOIDA CHEMICAL CO ZRT

TOPIRAMATE AS MANUFACTURED IN TISZAVASVARI, HUNGARY.

16406 A

II

1/20/2003

BIOCON LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN BANGALORE, INDIA.

16407 I

II

1/20/2003

BIOCON INDIA LTD

MYCOPHENOLIC ACID AS MANUFACTURED IN BANGALORE, INDIA.

16408 A

III

2/5/2003

WACKER CHEMIE AG

ELASTOSIL(R) R 409/70 MH, AS MANUFACTURED IN NUNCHRITZ,GERMANY

16409 A

II

4/23/2003

MYLAN LABORATORIES LTD

ALLOPURINOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16410 I

II

2/3/2003

ROHIT PLASTICS AND CHEMICALS

CHLORHEXIDINE BASE AS MANUFACTURED IN MAHARASHTRA, INDIA.

16411 I

II

1/31/2003

GMT FINE CHEMCALS SA

DACARBAZINE USP AS MANUFACTURED IN COUVET, SWITZERLAND.

16412 A

III

2/4/2003

BAXTER HEALTHCARE CORP

16413 A

III

2/4/2003

BAXTER HEALTHCARE CORP

PRESS-IN BOTTLE ADAPTERS AND PRESS-IN BOTTLE WELL ASSEMBLIES AS


MANUFACTURED IN ENGLEWOOD, CO; POTTSTOWN, PA AND BLOOMINGTON, IN.
EXACTA-MED(R) ORAL LIQUID DISPENSER AS MANUFACTURED IN RODBY, DENMARK.

16414 A

II

2/7/2003

SENJU PHARMACEUTICAL CO LTD

BROMFENAC SODIUM AS MANUFACTURED IN MORTON GROVE, IL.

16415 A

III

1/29/2003

NOLATO JAYCARE LTD

16416 I

II

2/6/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

16417 I

II

2/6/2003

CHEMAGIS LTD

22OZ AND 30OZ ROUND PACKERS AS MANUFACTURED IN NEW CASTLE UPON TYNE,
ENGLAND.
PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BE'ER SHEVA AND
PETAH TIQVA, ISRAEL.
MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL.

Page 472

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16418 A
II
2/4/2003
FILTROX AG

SUBJECT
DEPTH FILTER SHEETS AS MANUFACTURED IN ST.GALLEN, SWITZERLAND.

16419 A

II

1/29/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

16420 A

II

2/10/2003

SIGNA SA DE CV

BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN OPAVA-KAMAROV, CZECH


REPUBLIC.
FLUCONAZOLE AS MANUFACTURED IN TOLUCA, MEXICO.

16421 I

II

1/10/2003

MDS NORDION

ALTROPANE(R) [123I]-E-IACFT INJECTION AS MANUFACTURED IN VANCOUVER, CANADA.

16422 I

II

2/10/2003

UNIV MISSOURI COLUMBIA

HO-166 CHLORIDE (166 HOCL3) RADIOCHEMICAL AS MANUFACTURED IN COLUMBIA, MO.

16423 A

II

2/12/2003

STERLING SPA

FLUTICASONE PROPIONATE AS MANUFACTURED IN PERUGIA, ITALY.

16424 A

II

2/5/2003

BACHEM SA

RESVERATROL AS MANUFACTURED IN VIONNAZ, SWITZERLAND.

16425 A

II

2/17/2003

PHARMAZELL GMBH

BALSALAZIDE DISODIUM AS MANUFACTURED IN RAUBLING, GERMANY.

16426 I

III

2/14/2003

AMPHASTAR PHARMACEUTICALS INC

16427 A

II

1/21/2003

CKD BIO CORP

PROCESSING FOR WASHING, DEPYROGENAING, SILICONIZING, STERILIZING AND


PACKAGING OF STERILE STOPPERS AS MANUFACTURED IN RANCHO CUCAMONGA, CA.
CLAVULANATE POTASSIUM AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA.

16428 A

II

2/13/2003

INDUSTRIALE CHIMICA SRL

PHENTOLAMINE MESILATE AS MANUFACTURED IN SARONNO, ITALY.

16429 I

IV

2/17/2003

LIPOID GMBH

16430 A

II

3/11/2003

JUBILANT GENERICS LTD

LIPOID TG 8:0/8:0/8:0 (TRICAPRYLIN) AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL


REPUBLIC OF GERMANY.
OXCARBAZEPINE AS MANUFACTURED IN KARNATAKA STREET, INDIA.

16431 I

II

2/17/2003

SUN PHARMACEUTICAL INDUSTRIES LTD

MESALAMINE USP (5-AMINO SALICYLIC ACID) AS MANUFACTURED IN MAHARASHTRA, INDIA.

16432 A

II

2/17/2003

AMSA SPA

TOLMETIN SODIUM AS MANUFACTURED IN COMO, ITALY.

16433 A

II

2/21/2003

ALKERMES GAINESVILLE LLC

16434 A

III

2/19/2003

JOE PIETRYKA INC

AVINZA(TM) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 60MG, 90MG AND


120MG AS MANUFACTURED IN GAINESVILLE, GA.
DOSAGE CUPS AS MANUFACTURED IN PAWLING, NY.

16435 I

III

2/18/2003

ALVEO AG

ALVEOLIT(R) TE POLYMER FOAMS AS MANUFACTURED IN LUCERNE, SWITZERLAND.

16436 I

III

2/11/2003

ROLLPRINT PACKAGING PRODUCTS INC

RPP#33-2023 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT.

16437 A

III

2/11/2003

ROLLPRINT PACKAGING PRODUCTS INC

RPP#31-6151 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT.

16438 I

II

2/10/2003

TAKASAGO INTERNATIONAL CORP

4-AA (NEW CATALYST VERSION) AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN.

16439 A

II

2/19/2003

HOSPIRA BOULDER INC

16440 A

II

2/25/2003

CHEMWERTH INC

16441 I

IV

2/25/2003

HAYASHIBARA CO LTD

PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN MORTON GROVE, IL AND BOULDER,


CO.
ANAGRELIDE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN FREIBURG IM
BREISGAU, GERMANY FOR CHEMWERTH INC.
HAYASHIBARA PULLULAN AS MANUFACTURED IN OKAYAMA, JAPAN.

16442 I

II

2/28/2003

SIGMA ALDRICH CORP

16443 A

III

2/14/2003

FPC FLEXIBLE PACKAGING CORP

16444 A

III

2/3/2003

3M DRUG DELIVERY SYSTEMS

16445 A

III

2/19/2003

ACTION TECHNOLOGY ITALIA SPA

CHO PROTEIN-FREE MEDIUM WITHOUT L-GLUTAMINE AS MANUFACTURED IN ST.LOUIS, MO


AND IRVINE, AYRSHIRE, SCOTLAND, UNITED KINGDOM.
PAPER/POLYESTER/FOIL/POLYETHYLENE POUCH VERSION B AS MANUFACTURED IN
ONTARIO, CANADA.
CICLESONIDE HFA METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN ESSEX,
WORCS. AND MANCHESTER, UNITED KINGDOM.
RUBBER PHARMA COMPOUNDS & GASKETS AS MANUFACTURED IN GAGGIANO, ITALY.

16446 I

III

2/14/2003

INTESYS TECHNOLOGIES INC

ACTUATORS FOR PACKAGING AS MANUFACTURED IN COSTA MESA, CA.

16447 I

II

2/27/2003

PROMETIC BIOSCIENCES LTD

PERFLUOROSORB S AS MANUFACTURED IN ISLE OF MAN, BRITISH ISLES.

16448 I

II

2/28/2003

PRO BIO SINT SPA

TRIACETYLURIDINE AS MANUFACTURED IN VARESE, ITALY.

16449 I

II

3/4/2003

FDC LTD

METAXALONE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16450 A

III

2/27/2003

FORMOSA PLASTICS CORP USA

FORMOLENE POLYETHYLENE RESINS AS MANUFACTURED IN POINT COMFORT, TX.

Page 473

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16451 A
II
3/7/2003
ACS DOBFAR SPA
16452 A

II

3/7/2003

16454 A

III

3/3/2003

FUJIMORI KOGYO CO LTD

FILMBYNA **E-0010 BD AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN.

16455 A

III

3/7/2003

VINS PLASTICS LTD

FLEXIBLE PACKAGING MATERIAL AS MANUFACTURED IN BRADFORD, CANADA.

16456 A

II

2/28/2003

SAFC BIOSCIENCES INC

EX-CELL(TM) 293 MEDIUM W/O L-GLUTAMINE AS MANUFACTURED IN DENVER, PA.

16457 A

II

2/28/2003

SAFC BIOSCIENCES INC

16458 I

II

2/21/2003

CHEMSPEC

EX-CELL(TM) 293 MEDIUM W/L-GLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED


IN DENVER, PA.
HYDROXYUREA AS MANUFACTURED IN KHOPOLI, MS. INDIA.

16459 A

II

3/10/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN NETANIA, ISRAEL.

16460 A

III

3/4/2003

LOG PLASTICON ZRT

PA 45 BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY.

16461 A

III

3/4/2003

LOG PLASTICON ZRT

10 ML DROPPER BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY.

16462 A

III

3/4/2003

LOG PLASTICON ZRT

PA 28 BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY.

16463 A

III

12/20/2002

LOG PLASTICON ZRT

PE BAGS OF DIFFERENT SIZES AS MANUFACTURED IN TOKOL, HUNGARY.

16464 A

III

3/4/2003

LOG PLASTICON ZRT

PA 10 BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY.

16465 A

III

2/28/2003

SCHWABE INCOAT

SILTABS PVDC COATED PVC FILM AS MANUFACTURED IN DADRA, INDIA.

16466 A

II

3/13/2003

CADILA PHARMACEUTICALS LTD

ETHAMBUTOL HYDROCHLORIDE USP SPECIAL AS MANUFACTURED IN GUJARAT, INDIA.

16467 A

II

3/12/2003

SANDOZ GMBH

CEFTRIAXONE SODIUM (STERILE) AS MANUFACTURED IN TYROL, AUSTRIA.

16468 A

II

3/17/2003

BIOFAC AS

CHONDROITIN SULFATE AS MANUFACTURED IN KASTRUP, DENMARK.

16469 A

II

3/18/2003

ORGAPHARM SAS

16470 I

II

3/10/2003

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS,


FRANCE.
GRANISETRON AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16471 I

III

3/19/2003

COLOR MASTER INC

16472 A

II

3/19/2003

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

RD1166M, FDA RED TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN


AVILLA, IN.
ALLOPURINOL AS MANUFACTURED IN MILAN, ITALY.

16473 A

II

3/19/2003

DR REDDYS LABORATORIES LTD

AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16474 I

II

3/18/2003

WOCKHARDT LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16475 I

III

3/19/2003

COLOR MASTER INC

16476 A

II

3/13/2003

HIKAL LTD

BL1189M, FDA BLUE TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN


AVILLA, IN.
BUPROPION HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA.

16477 A

II

3/21/2003

ALEMBIC PHARMACEUTICALS LTD

MODAFINIL AS MANUFACTURED IN GUJARAT, INDIA.

16478 I

II

3/18/2003

HETERO DRUGS LTD

AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16479 I

II

3/19/2003

SIGMA ALDRICH CO LTD

1,4 DIAMINOBUTANE DIHYDROCHLORIDE AS MANUFACTURED IN DORSET, UNITED KINGDOM.

16480 A

II

3/24/2003

DR REDDYS LABORATORIES LTD

LAMOTRIGINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16481 A

II

3/24/2003

CAMBRIDGE MAJOR LABS INC

MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN GERMANTOWN, WI.

16482 A

II

3/26/2003

MANNKIND CORP

16483 A

II

3/25/2003

CHEMWERTH INC

16484 A

III

3/7/2003

BOREALIS AG

INSULIN, HUMAN (RDNA HUMAN INSULIN) HMR 4006 AS MANUFACTURED IN FRANKFURT,


GERMANY.
SODIUM TETRADECYL SULFATE (STDS)(NON-STERILE BULK DRUG SUBSTANCE)AS
MANUFACTURED IN FREIBURG IM BREISGAU, GERMANY FOR CHEMWERTH INC
BORMED RB801CF-01

16453 N

ACS DOBFAR SPA

SUBJECT
AMPICILLIN AND SULBACTAM FOR INJECTION, USP (STERILE BULK) AS MANUFACTURED IN
MILANO, ITALY.
SULBACTAM SODIUM AS MANUFACTURED IN MILANO, ITALY.

NOT AN ASSIGNED NUMBER

Page 474

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16485 I
II
3/25/2003
CHEMAGIS LTD

SUBJECT
PREDNICARBATE AS MANUFACTURED IN BEER SHEVA, ISRAEL.

16486 I

III

3/13/2003

LUMELITE PLASTICS

CLOSURES AS MANUFACTURED IN PAWLING, NY.

16487 I

III

3/13/2003

LUMELITE PLASTICS

APPLICATORS AS MANUFACTURED IN PAWLING, NY.

16488 I

III

3/13/2003

LUMELITE PLASTICS

CONTAINERS AS MANUFACTURED IN PAWLING, NY.

16489 A

IV

3/24/2003

MANE INC

16490 A

II

3/28/2003

AUROBINDO PHARMA LTD

CHERRY BANANA VANILLA FLAVOR S.D. E_0222033 AS MANUFACTURED IN BAR SUR LOUP,
FRANCE.
MIRTAZAPINE AS MANUFACTURED IN A.P., INDIA.

16491 A

II

3/20/2003

WANBURY LTD

MEFENAMIC ACID USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16492 A

II

3/26/2003

FARMABIOS S P A

FLURANDRENOLIDE AS MANUFACTURED IN PAVIA, ITALY.

16493 A

IV

3/25/2003

COGNIS GMBH

EUTANOL(R) G AS MANUFACTURED IN DUESSELDORF, GERMANY.

16494 A

IV

3/25/2003

BASF SE

KOLLICREAM(R) OD AS MANUFACTURED IN DUESSELDORF, GERMANY.

16495 A

IV

3/25/2003

BASF SE

Kollisolv(R) MCT 70 AS MANUFACTURED IN DUESSELDORF, GERMANY.

16496 A

IV

3/25/2003

BASF SE

Kollicream(R) 3C AS MANUFACTURED IN DUESSELDORF, GERMANY.

16497 A

IV

3/25/2003

BASF SE

Kollicream(R) OA AS MANUFACTURED IN DUESSELDORF, GERMANY.

16498 A

IV

3/25/2003

BASF SE

Kollicream(R) IPM AS MANUFACTURED IN DUESSELDORF, GERMANY.

16499 A

IV

3/25/2003

COGNIS GMBH

ISOPROPYLPALMITAT PH AS MANUFACTURED IN DUESSELDORF, GERMANY.

16500 A

IV

3/25/2003

BASF SE

Kollicream(R) DO AS MANUFACTURED IN DUESSELDORF, GERMANY.

16501 A

IV

3/25/2003

BASF SE

Kollicream(R) CP 15 AS MANUFACTURED IN DUESSELDORF, GERMANY.

16502 A

IV

3/25/2003

BASF SE

Kolliwax(R) HCO AS MANUFACTURED IN DUESSELDORF, GERMANY.

16503 A

IV

3/25/2003

BASF SE

Kolliwax(R) GMS II AS MANUFACTURED IN DUESSELDORF, GERMANY.

16504 I

II

3/25/2003

UNICHEM LABORATORIES LTD

LEFLUNOMIDE AS MANUFACTURED IN RAIGAD, INDIA.

16505 A

II

4/22/2003

WATSON PHARMA PRIVATE LTD

NITROFURANTOIN MONOHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

16506 I

IV

12/18/2002

PERLAROM FRANCE SA

STRAWBERRY POWDER SD (PE044587) AS MANUFACTURED IN GRASSE CEDEX, FRANCE.

16507 I

III

3/4/2003

3M DRUG DELIVERY SYSTEMS

3M DOUBLE-COATED MEDICAL TAPE #1522 AS MANUFACTURED IN BROOKINGS, SD.

16508 A

III

3/4/2003

3M DRUG DELIVERY SYSTEMS

3M MEDICAL TAPE #1523 AS MANUFACTURED IN BROOKINGS, SD.

16509 A

II

4/1/2003

UNICHEM LABORATORIES LTD

AMLODIPINE BESYLATE USP AS MANUFACTURED IN RAIGAD, INDIA.

16510 A

II

3/21/2003

HETERO DRUGS LTD

LISINOPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16511 A

II

3/26/2003

GEDEON RICHTER PLC

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN DOROG, HUNGARY.

16512 I

II

3/21/2003

ROCHE DIAGNOSTICS GMBH

SULFADOXINE AS MANUFACTURED IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY.

16513 A

III

3/16/2004

TEKNOR COLOR CO

16514 A

III

3/17/2004

FRANKLIN INTERNATIONAL

90,016HCC WHITE 1% AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC;


JACKSONVILLE, TX AND LODI, OH.
COVINAX 525-08 AS MANUFACTURED IN COLUMBUS, OH.

16515 I

III

3/25/2003

CHROMA CORP

WH08002 WHITE LIQUID COLORANT AS MANUFACTURED IN CHICAGO HEIGHTS, IL.

16516 A

II

4/1/2003

MEDICHEM SA

RISPERIDONE AS MANUFACTURED IN GIRONA, SPAIN.

16517 A

II

4/8/2003

JUBILANT GENERICS LTD

RISPERIDONE AS MANUFACTURED IN KARNATAKA STATE, INDIA.

16518 A

II

4/8/2003

IND SWIFT LABORATORIES LTD

CLARITHROMYCIN AS MANUFACTURED IN PUNJAB, INDIA.

16519 A

IV

4/7/2003

MANE INC

16520 A

IV

4/7/2003

LIPOID GMBH

LEMON ALPINE TOFFEE FLAVOR S.D. E_9947900 AS MANUFACTURED IN BAR-SUR-LOUP,


FRANCE.
LIPOID SODIUM OLEATE AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF
GERMANY.

Page 475

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16521 A
II
4/7/2003
TEVA PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
LEVOFLOXACIN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16522 A

II

2/27/2003

TRIFARMA SPA

TRANYLCYPROMINE SULFATE AS MANUFACTURED IN MILANO, ITALY.

16523 A

IV

3/7/2003

CHP CARBOHYDRATE PIRNA GMBH CO KG

CROSCARMELLOSE USP/NF AS MANUFACTURED IN PIRNA, GERMANY.

16524 I

II

4/7/2003

IFN-OMEGA AS MANUFACTURED IN BIBERACH AN DER RISS, GERMANY.

16525 A

III

4/10/2003

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
SK CHEMICALS CO LTD

16526 I

II

4/5/2003

IPCA LABORATORIES LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA.

16527 A

IV

4/4/2003

MANE INC

ORANGE FLAVOR S.D. E_9816597 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE.

16528 A

IV

4/4/2003

MANE INC

16529 I

III

4/9/2003

BETTS UK LTD

MENTHE ROOTBEER FLAVOR S.D. E_9911748 AS MANUFACTURED IN BAR-SUR-LOUP,


FRANCE.
METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN ESSEX, UNITED KINGDOM.

16530 I

II

4/8/2003

ZENTIVA A S

CARVEDILOL AS MANUFACTURED IN HLOHOVEC, SLOVAKIA.

16531 A

II

3/30/2003

CADILA HEALTHCARE LTD

ANAGRELIDE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

16532 A

II

4/1/2003

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

SULBACTAM SODIUM USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16533 A

II

3/21/2003

DR REDDYS LABORATORIES LTD

TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16534 A

II

3/21/2003

DR REDDYS LABORATORIES LTD

SUMATRIPTAN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16535 A

II

2/6/2003

DEAD SEA WORKS LTD

POTASSIUM CHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16536 I

IV

1/27/2003

DAVID MICHAEL AND CO INC

NATURAL PEPPERMINT FLAVOR #23476 AS MANUFACTURED IN PHILADELPHIA, PA.

16537 I

IV

1/27/2003

DAVID MICHAEL AND CO INC

NATURAL FLAVOR #14499 BUBBLE GUM TYPE AS MANUFACTURED IN PHILADELPHIA, PA.

16538 A

II

4/2/2003

ALZCHEM AG

CREATINE MONOHYDRATE AS MANUFACTURED IN TROSTBERG, GERMANY.

16539 A

III

4/10/2003

POLYONE CORP

PRODUCT NO. CC10019413WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16540 A

III

4/10/2003

POLYONE CORP

PRODUCT NO. CC10002216WE AS MANUFACTURED IN BROADVIEW HEIGHTS, OH.

16541 A

II

4/15/2003

CHEMAGIS LTD

MUPIROCIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16542 A

II

4/15/2003

SANDOZ PRIVATE LTD

CEFPODOXIME PROXETIL AS MANUFACTURED IN MAHARASHTRA, INDIA.

16543 I

II

4/22/2003

DAIICHI SANKYO CO LTD

CS-917 DRUG PRODUCT AS MANUFACTURED IN TOKYO, JAPAN.

16544 A

II

4/23/2003

MYLAN LABORATORIES LTD

CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

16545 I

III

10/1/2003

LAGEEN TUBOBLAST LTD

LAMINATE TUBES AS MANUFACTURED IN KIBUTZ YAGUR, ISRAEL.

16546 I

II

4/22/2003

BRISTOL MYERS SQUIBB COMPANY

16547 I

II

4/24/2003

DAIICHI PHARMACEUTICAL CO LTD

GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCE AS MANUFACTURED IN


LATINA, ITALY.
DK-507K DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

16548 I

IV

4/23/2003

THERMAX LTD CHEMICAL DIV

TULSION(R) 339 AS MANUFACTURED IN MAHARASHTRA, INDIA.

16549 I

IV

4/23/2003

THERMAX LTD CHEMICAL DIV

TULSION(R) 344 AS MANUFACTURED IN MAHARASHTRA, INDIA.

16550 I

II

4/28/2003

DAIICHI SANKYO CO LTD

CS-917 DRUG SUBSTANCE AS MANUFACTURED IN SHIMANE, JAPAN.

16551 A

II

4/29/2003

ALEMBIC PHARMACEUTICALS LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

16552 I

II

4/28/2003

MATRIX LABORATORIES LTD

AMLODIPINE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16553 A

II

4/29/2003

CIPLA LTD

16554 I

III

4/21/2003

AMPACET CORP

16555 A

III

4/10/2003

MICA CORP

CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN MAHARASHTRA, BANGALORE,


MUMBAI AND VERNA SALCETTE GOA, INDIA.
LP-23444 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;
TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH AND DERIDDER, LA.
MICA A-291-C AS MANUFACTURED IN SHELTON, CT.

16556 I

II

4/24/2003

ANTIBIOTICE SA ROMANIA

CYANOCOBALAMIN (VITAMIN B12) AS MANUFACTURED IN IASI, ROMANIA.

SKYGREEN PETG AS MANUFACTURED IN ULSAN, KOREA.

Page 476

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16557 A
V
4/23/2003
CANGENE CORP

SUBJECT
STERILE PROCESSING FACILITY IN WINNIPEG, MANITOBA, CANADA.

16558 A

II

4/28/2003

SCI PHARMTECH INC

VALPROIC ACID AS MANUFACTURED IN TAOYUAN, TAIWAN.

16559 A

III

4/21/2003

PT SCHOTT IGAR GLASS

16560 A

II

4/23/2003

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16561 A

III

4/29/2003

JW CHEMITOWN CORPORATION

PACKAGING AND DEVICES MADE OF TUBULAR GLASS FOR PHARMACEUTICAL AND


COSMETIC APPLICATIONS AS MANUFACTURED IN BEKASI, INDONESIA.
GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S
REPUBLIC OF CHINA.
MEDIROLL CT703 FILM AS MANUFACTURED IN KYEONGGI-DO, KOREA.

16562 A

II

4/23/2003

SUN PHARMACEUTICAL INDUSTRIES LTD

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

16563 A

II

5/2/2003

RANBAXY LABORATORIES LTD

CLARITHROMYCIN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

16564 I

III

4/29/2003

BETTS UK LTD

MDI ACTUATOR AS MANUFACTURED IN ESSEX, UNITED KINGDOM.

16565 I

III

4/25/2003

CLEAR LAM PACKAGING INC

LAMINATED FILMS FOR PACKAGING AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16566 I

III

4/21/2003

AMPACET CORP

16567 A

II

4/29/2003

MALLINCKRODT INC

LP-23443 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH AND DERIDDER, LA.
DEXTROAMPHETAMINE BASE AS MANUFACTURED IN ST.LOUIS, MO.

16568 I

III

5/1/2003

AIR PRODUCTS AND CHEMICALS INC

FLEXCRYL SP65 AS MANUFACTURED IN PIEDMONT, SC.

16569 A

II

6/18/2003

MICRON TECHNOLOGIES LTD

CONTRACT MICRONIZATION FACILITY IN KENT, UNITED KINGDOM.

16570 A

III

4/25/2003

SILGAN PLASTICS CORP

PLASTICS BOTTLES, JARS AND CONTAINERS MANUFACTURED BY THE EXTRUSION BLOWMOLDING PROCESS AS MANUFACTURED IN ANAHEIM AND VALENCIA, CA; OTTAWA AND PORT
CLINTON, OH; QUEBEC AND ONTARIO, CANADA; MONROE, GA; SCOTT CITY, MO; DEEP RIVER,
CT; HOUST

16571 I

III

4/15/2004

ROHM AND HAAS CO

ADCOTE 40-3E AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16572 A

III

5/1/2003

ASHLAND INC

FLEXCRYL(R) AF2066 AS MANUFACTURED IN PIEDMONT, SC.

16573 I

III

5/5/2003

INTELLIGENT DEVICES INC

MED-IC(TM) ECM PACKAGE AS MANUFACTURED IN MULTI-LOCATION.

16574 A

III

4/30/2003

MOLD RITE PLASTICS LLC

PACKAGING MATERIAL AS MANUFACTURED IN PLATTSBURGH, NY

16575 I

II

4/30/2003

CHANGZHOU SIYAO PHARMACEUTICALS CO LTD

MERCAPTOPURINE USP AS MANUFACTURED IN JIANGSU, CHINA.

16576 I

II

5/2/2003

NIH NIAID

16577 A

III

5/9/2003

BD MEDICAL PHARMACEUTICAL SYSTEMS

16578 A

II

5/7/2003

CHEMISCHE FABRIK BERG GMBH

CHARACTERIZATION OF AEDES ALBOPICTUS (C6/36) MOSQUITO CELL LINE AS


MANUFACTURED IN ROCKVILLE, MD.
BD STERIFILL(TM) SCF(TM) PLASTIC PREFILLABLE SYRINGE SYSTEM (CRYSTAL CLEAR
POLYMER) AS MANUFACTURED IN COLUMBUS, BROKEN BOW AND HOLDREGE, NE.
PROPYLTHIOURACIL USP AS MANUFACTURED IN BITTERFELD, GERMANY.

16579 A

II

5/9/2003

16580 A

II

5/12/2003

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE DRUG ABUSE
RANBAXY LABORATORIES LTD

COCAINE HYDROCHLORIDE INJECTION, 2 ML (10 MG/ML AND 20 MG/ML) AS MANUFACTURED


IN LEXINGTON, KY.
ACITRETIN (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA.

16581 I

IV

5/8/2003

BIOFAC A/S

SPLEEN EXTRACT AS MANUFACTURED IN KASTRUP, DENMARK.

16582 A

II

5/12/2003

CHEMWERTH INC

16583 I

II

5/12/2003

GW PHARMA LTD

FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


FREIBURG IM BREISGAU, GERMANY FOR CHEMWERTH INC
CANNABIS BASED MEDICINE AS MANUFACTURED IN WREXHAM, UNITED KINGDOM.

16584 I

III

5/13/2003

LORMAC INDUSTRIAL DISTRIBUTORS LTD

16585 I

III

5/13/2003

LORMAC INDUSTRIAL DISTRIBUTORS LTD

16586 I

II

5/14/2003

ROHIT PLASTICS AND CHEMICALS

LORMAC TYPE 1-E POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND AND


BRIGHOUSE, UNITED KINGDOM.
LORMAC TYPE 1-B ANTI-STATIC POLYETHYLENE BAGS AS MANUFACTURED IN CORK,
IRELAND AND BRIGHOUSE, UNITED KINGDOM.
CHLORHEXIDINE HCL AS MANUFACTURED IN MAHARASHTRA, INDIA.

16587 I

II

5/14/2003

MASTAFA NEVZAT ILAC SANAYII

SULBACTAM SODIUM (NON-STERILE) AS MANUFACTURED IN KOCAELI,TURKEY.

16588 A

II

5/15/2003

EUTICALS SPA

OXCARBAZEPINE AS MANUFACTURED IN LODI, ITALY.

Page 477

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16589 A
II
5/13/2003
EUTICALS SPA

SUBJECT
SUCRALFATE AS MANUFACTURED IN LODI, ITALY.

16590 I

III

5/9/2003

DYNIC USA

HT8 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN.

16591 A

III

5/9/2003

DYNIC USA CORP

HT8 PLUS INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN.

16592 A

III

4/17/2003

DYNIC USA CORP

S245 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

16593 I

II

5/13/2003

ISP CHEMICALS INC

PHENOXYBENZAMINE HYDROCHLORIDE (PBZA) AS MANUFACTURED IN COLUMBUS, OH.

16594 A

II

5/14/2003

DR REDDYS LABORATORIES LTD

ROSIGLITAZONE MALEATE (FORM III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16595 A

IV

5/8/2003

UNGERER AND CO

16596 I

II

5/19/2003

MATRIX LABORATORIES LTD

LEMON SPRAY DRIED FLAVOURING V3938-1N1 AS MANUFACTURED IN CHESTER AND


CEREDIGION, UNITED KINGDOM.
AMLODIPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16597 A

II

5/15/2003

FABBRICA ITALIANA SINTETICI SPA

OXCARBAZEPINE AS MANUFACTURED IN VICENZA, ITALY.

16598 A

II

5/22/2003

CEDARBURG PHARMACEUTICALS LLC

OXANDROLONE USP AS MANUFACTURED IN GRAFTON, WI.

16599 A

IV

5/13/2003

UNGERER AND CO

NATURAL & ARTIFICIAL CHERRY FLVP FL-8568 AS MANUFACTURED IN BETHLEHEM, PA.

16600 I

III

5/16/2003

SPARTECH COLOR

BL22995, BLUE POLYPROPYLENE CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA.

16601 A

II

5/21/2003

PCAS

APRACLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND.

16602 I

II

5/20/2003

AVANTI POLAR LIPIDS INC

16603 I

II

5/15/2003

MEDICARB AB

(+)-N-(2-HYDROXYEHTYL-N,N-DIMETHYL-2,3-BIS(TETRADECYLOXY)-1-PROPANIMINIUM
BROMIDE (DMRIE-BR) AS MANUFACTURED IN ALABASTER, AL.
CHITOSAN AS MANUFACTURED IN BROMMA, SWEDEN.

16604 A

II

5/22/2003

TEVA PHARMACEUTICALS INDUSTRIES LTD

RISEDRONATE SODIUM AS MANUFACTURED IN BE'ER SHEVA AND PETAH TIQVA, ISRAEL.

16605 A

II

5/26/2003

PIRAMAL ENTERPRISES LTD

VERAPAMIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16606 A

II

5/21/2003

DYNAMIT NOBEL GMBH

CICLESONIDE AS MANUFACTURED IN LEVERKUSEN, GERMANY.

16607 I

III

5/28/2003

RICON COLORS

16608 A

II

6/2/2003

AVANTI POLAR LIPIDS INC

BLACK, CPP-BK853-1 RAW MATERIAL FOR PACKAGING (CAPS) AS MANUFACTURED IN WEST


CHICAGO, IL.
L-THREO-DIHYDROSPHINGOSINE (SAFINGOL) AS MANUFACTURED IN ALABASTER, IL.

16609 I

II

6/2/2003

AVANTI POLAR LIPIDS INC

16610 A

II

5/20/2003

CAMBREX CHARLES CITY INC

16611 I

III

5/23/2003

PLASPAK CLOSURES PTY LTD

16612 A

III

5/12/2003

ALBEA TUBES FRANCE SAS

HIGH DENSITY POLYETHYLENE (HDPE)/ETHYLENE-VINLY- ALCOHOL (EVOH)


COPOLYMER/HDPE TUBES WITH POLYPROPYLENE (PP) CAPS AS MANUFACTURED IN VIENNE
LE CHATEAU, VANDIERES, STE MENEHOULD AND ALBERTVILLE, FRANCE.

16613 I

II

5/19/2003

HUAHAI PHARMACEUTICAL GROUP CO LTD

PAROXETINE BASE (BULK) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16614 A

II

5/22/2003

PHOSPHOLIPID GMBH

16615 I

II

5/30/2003

POLYPEPTIDE LABS INC

PHOSPHOLIPON 90 G (1,2-DIACYL-SN-GLYCERO-3-PHOSPHOCHOLINE) AS MANUFACTURED IN


KOLN, GERMANY.
KL4 ACETATE (SINAPULTIDE) AS MANUFACTURED IN TORRANCE, CA.

16616 A

II

5/29/2003

YUHAN CHEMICAL INC

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN KYUNNGI-DO, KOREA.

16617 I

II

5/19/2003

SHASUN CHEMICALS AND DRUGS LTD

ROFECOXIB AS MANUFACTURED IN CUDDALORE, INDIA.

16618 A

III

6/2/2003

AMPACET CORP

111150 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND
MESSANCY, BELGIUM.

16619 I

II

6/5/2003

AVON ORGANICS LTD

EPHEDRINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

16620 A

III

5/28/2003

CLARIANT PRODUCTION FRANCE

DESICCATOR WASHER IN PE AS MANUFACTURED IN ROMORANTIN, FRANCE.

1,2-DIOLEOYL-3-TRIMETHYLAMMONIUM PROPANE (DOTAP) AS MANUFACTURED IN


ALABASTER, AL.
METHYLPHENIDATE HYDROCHLORIDE (RITALIN HCL) AS MANUFACTURED IN CHARLES CITY,
IOWA.
53MM CLOSURE AS MANUFACTURED IN KIRRAWEE, NSW, AUSTRALIA.

Page 478

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16621 A
II
6/19/2003
MOEHS IBERICA SL

SUBJECT
METOPROLOL SUCCINATE AS MANUFACTURED IN BARCELONA, SPAIN.

16622 A

II

5/30/2003

SERAVAC BIOTECH (PTY) LTD

HYALURONIDASE AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA.

16623 A

II

6/3/2003

TATM AS MANUFACTURED IN RADEBERG, GERMANY.

16624 I

II

6/2/2003

ABX ADVANCED BIOCHEMICAL COMPOUNDS


GMBH
ZENTIVA KS

16625 A

II

6/6/2003

GRANULES INDIA LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD, INDIA.

16626 I

III

6/9/2003

TEKNOR COLOR CO

16627 A

III

6/9/2003

TEKNOR COLOR CO

16628 A

II

6/3/2003

INKE SA

18054 SLIP COLOR CONCENTRATE AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN,


SC; JACKSONVILLE, TX AND LODI, OH.
93,947CP WHITE 2% COLOR CONCENTRATE AS MANUFACTURED IN HENDERSON, KY;
FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH.
FORMOTEROL FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN.

16629 I

IV

5/27/2003

MCCORMICK AND CO INC

FLAVOR FORMULAS AS MANUFACTURED IN HUNT VALLEY, MD.

16630 I

IV

6/11/2003

VSP TECHNOLOGIES INC

ZYTREL(TM) AS MANUFACTURED IN OSSINING, NY.

16631 I

II

6/10/2003

AVECIA BIOTECHNOLOGY INC

OLIGONUCLEOTIDE APH AS MANUFACTURED IN MILFORD, MA.

16632 A

II

6/12/2003

FDC LTD

FLUCONAZOLE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16633 A

III

6/12/2003

EMMAUS MEDICAL INC

ORAL GLUTAMINE PACKETS AS MANUFACTURED IN ROCKFORD, IL.

16634 I

II

6/12/2003

ELAN DRUG DELIVERY INC

16635 A

II

6/11/2003

BIOCON LTD

N1406 (AGI-1067) NANOCRYSTAL(R) WHITE TABLETS, 150 MG AS MANUFACTURED IN KING OF


PRUSSIA, PA.
PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BALGALORE, INDIA.

16636 A

II

6/12/2003

CIPLA LTD

16637 I

II

6/12/2003

FH FAULDING AND CO LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND


VERNA SALCETTE GOA, INDIA.
COATED PARACETAMOL POWDER AS MANUFACTURED IN SALISBURY SA, AUSTRALIA.

16638 I

II

6/6/2003

ARCHIMICA SRL

BENZOCAINE USP-EP AS MANUFACTURED IN ORGGIO, ITALY.

16639 A

II

6/12/2003

EMMAUS MEDICAL INC

GLUTAMINE PACKETS (ORAL) AS MANUFACTURED IN ROCKFORD, IL.

16640 I

III

5/23/2003

BASF AKTIENGESELLSCHAFT

ULTRAFORM H4320 UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,

16641 A

II

6/4/2003

ASH STEVENS INC

DIMETHANDROLONE UNDECANOATE (CDB-4521C) AS MANUFACTURED IN SAN ANTONIO, TX.

16642 I

III

6/6/2003

CLARIANT (CANADA) INC

16643 A

6/12/2003

SANTEN OY

16644 A

II

6/11/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

BROWN CLARIANT MASTERBATCH 06MPG-580 AS MANUFACTURED IN ONTARIO AND


QUEBEC, CANADA.
STERILIZATION PROCESS FOR CONTINUOUS MOTION (CM1) COMPOUNDING AND FILLING
LINE AS MANUFACTURED IN TAMPERE, FINLAND.
ONDANSETRON BASE AS MANUFACTURED IN DEBRECEN, HUNGARY.

16645 A

II

6/15/2003

PERRIGO API LTD

CILOSTAZOL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16646 I

IV

6/10/2003

NATIONAL STARCH CHEMICAL CO

UNI-PURE(TM) LQ AS MANUFACTURED IN INDIANAPOLIS, IN AND NORTH KANSAS CITY, MO.

16647 A

II

6/10/2003

NEULAND LABORATORIES LTD

RAMIPRIL USP AS MANUFACTURED IN TELANGANA INDIA.

16648 A

II

6/16/2003

STERLING SPA

MOMETASONE FUROATE AS MANUFACTURED IN PERUGIA, ITALY.

16649 I

II

6/16/2003

WOCKHARDT LTD

CEFUROXIME SODIUM (STERILE) AS MANUFACTURED IN GUJARAT STATE, INDIA.

16650 A

II

6/16/2003

WOCKHARDT LTD

STERILE CEFTRIAXONE SODIUM USP AS MANUFACTURED IN GUJARAT STATE, INDIA.

16651 A

III

6/18/2003

MK SETCAP AS MANUFACTURED IN IBARAKI, JAPAN.

16652 A

III

6/20/2003

MARUTANI CHEMICAL PLANT ENGINEERING CO


LTD
CCC PLASTICS

16653 A

II

6/16/2003

MYTHEN SPA

CALCIUM STE5ARATE MB355-22 POLYETHYLENE ADDITIVE CONCENTRATE AS


MANUFACTURED IN ONTARIO, CANADA.
DEFEROXAMINE MESYLATE AS MANUFACTURED IN CORANA, ITALY.

16654 A

III

6/9/2003

BESPAK DIV CONSORT MEDICAL PLC

BESPAK BK690 DISKUS AS MANUFACTURED IN NORFOLK, ENGLAND.

ZOLPIDEM TARTRATE AS MANUFACTURED IN HLOHOVEC, SLOVAKIA.

Page 479

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16655 A
III
6/23/2003
LANXESS CORP

SUBJECT
BUNA EP T 2450 AS MANUFACTURED IN ORANGE, TX.

16656 I

II

6/18/2003

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFUROXIME ACID AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

16657 I

II

6/19/2003

ESTEVE QUIMICA SA

PANTOPRAZOLE SODIUM AS MANUFACTURED IN CELRA, SPAIN.

16658 A

II

6/24/2003

DR REDDYS LABORATORIES LTD

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16659 A

II

6/19/2003

HIKMA PHARMACEUTICALS

CORTISONE ACETATE AS MANUFACTURED IN AMMAN, JORDAN.

16660 A

III

6/4/2003

COLORTECH INC

11004-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN.

16661 I

III

6/18/2003

TICONA LLC

16662 A

IV

6/25/2003

MANTROSE HAEUSER CO INC

CELCON(R) MT(TM) ACETAL COPOLYMER AS MANUFACTURED IN BISHOP, TX; FLORENCE, KY


AND KELSTERBACH, FEDERAL REPUBLIC OF GERMANY.
MANTROCEL HP55-HPMCP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16663 A

IV

6/25/2003

MANTROSE HAEUSER CO INC

MANTROCEL E5, E6, E15 AND E50 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

16664 A

II

6/20/2003

SUN PHARMACEUTICAL INDUSTRIES LTD

CARBOPLATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

16665 A

II

6/27/2003

CARBOGEN AMCIS AG

ANECORTAVE ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND.

16666 A

III

6/18/2003

POLYONE CORP

PRODUCT NO. CC1003863460 AS MANUFACTURED IN SEABROOK, TX.

16667 I

II

6/27/2003

ASTELLAS PHARMA INC

FK 881 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO AND OSAKA, JAPAN.

16668 A

II

6/26/2003

SANDOZ PRIVATE LTD

CLOFAZIMINE AS MANUFACTURED IN KERALA, INDIA.

16669 A

III

6/6/2003

COMAR LLC

DOSAGE DELIVERY SYSTEMS AS MANUFACTURED IN BUENA, NJ.

16670 I

II

6/25/2003

UCB MANUFACTURING IRELAND LIMITED

MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN CO. CLARE, IRELAND.

16671 A

II

6/30/2003

CIPLA LTD

16672 A

II

6/30/2003

CIPLA LTD

CELECOXIB AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND VERNA


SALCETTE GOA, INDIA.
PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN PUNE, MAHARASHTRA, INDIA

16673 A

III

6/26/2003

BAXTER HEALTHCARE CORP

16674 A

II

6/30/2003

RANBAXY LABORATORIES LTD

EUROPEAN PRESS-IN BOTTLE ADAPTER AS MANUFACTURED IN CO DURHAM, UNITED


KINGDOM.
DONEPEZIL HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA.

16675 A

II

7/2/2003

DR REDDYS LABORATORIES LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16676 A

II

6/30/2003

SCINOPHARM TAIWAN LTD

PACLITAXEL AS MANUFACTURED IN TAINAN COUNTY, TAIWAN.

16677 A

II

6/30/2003

CIPLA LTD

16678 A

II

6/30/2003

CIPLA LTD

ZIDOVUDINEUSP AS MANUFACTURED IN BAGALORE, MAHARASHTRA, MUMBAI AND VERNA


SALCETTE GOA, INDIA.
ALBUTEROL SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

16679 I

III

6/23/2003

CLARIANT (CANADA) INC

16680 A

II

6/27/2003

CADILA HEALTHCARE LTD

16681 I

III

7/4/2003

CCC PLASTICS

16682 A

II

7/3/2003

RANBAXY LABORATORIES LTD

WHITE MB20-9006 POLYETHYLENE COLOR CONCENTRATE AS MANUFACTURED IN ONTARIO,


CANADA.
PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA.

16683 A

II

7/3/2003

SYNKEM SAS

TETRABENAZINE AS MANUFACTURED IN CHENOVE CEDEX, FRANCE.

16684 A

II

7/8/2003

USV LIMITED

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA.

16685 A

III

7/3/2003

ASHLAND INC

FLEXCRYL(R) AF2020 AS MANUFACTURED IN PIEDMONT, SC.

16686 A

II

7/8/2003

ESTEVE QUIMICA SA

MELOXICAM AS MANUFACTURED IN BARCELONA AND GIRONA, SPAIN.

16687 A

II

7/9/2003

CHEMICA INC

BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN LOS ANGELES, CA.

16688 A

II

7/8/2003

TEVA PHARMACEUTICALS INDUSTRIES LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16689 I

II

7/10/2003

SANOFI CHIMIE (A SUBSIDIARY OF SANOFIAVENTIS)

LEVOMEPROMAZINE HYDROCHLORIDE AS MANUFACTURED IN VITRY-SUR-SEINE CEDEX,


FRANCE.

BROWN CLARIANT MASTERBATCH 06MPG-659 AS MANUFACTURED IN ONTARIO AND


QUEBEC, CANADA.
PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA.

Page 480

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16690 I
IV
7/10/2003
FLAVORMATIC INDUSTRIES INC

SUBJECT
N&A BANANA CREAM TYPE FLAVOR #909-489 AS MANUFACTURED IN WAPPINGERS FALLS, NY.

16691 I

IV

7/10/2003

FLAVORMATIC INDUSTRIES INC

N&A CHERRY TYPE FLAVOR #909-504 AS MANUFACTURED IN WAPPINGERS FALLS, NY.

16692 A

III

6/27/2003

AMPACET CORP

16693 I

III

7/1/2003

BERRY PLASTICS CANADA INC

11343 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.
DOUBLE WALLS THREADED CLOSURES AS MANUFACTURED IN QUEBEC, CANADA.

16694 A

IV

6/30/2003

CRODA JAPAN KK

CRODAMOL SE (REFINED DIETHYL SEBACATE) AS MANUFACTURED IN SHIGA, JAPAN.

16695 A

IV

6/30/2003

CRODA JAPAN KK

CRODAMOL DA (DIISOPROPYL ADIPATE) AS MANUFACTURED IN SHIGA, JAPAN.

16696 A

II

7/7/2003

INDUSTRIALE CHIMICA SRL

LEVONORGESTREL USP AS MANUFACTURED IN VARESE, ITALY.

16697 A

IV

7/9/2003

FREUND CORP

NONPAREIL-103 AS MANUFACTURED IN HAMAMATSU CITY, JAPAN.

16698 A

II

7/1/2003

LONZA LTD

16699 A

II

7/11/2003

BASF PHARMA EVIONNAZ SA

D5AA (3-OXO-4-AZA-ANDROSTENE-17 -CARBOXYLIC ACID) AS MANUFACTURED IN VISP,


SWITZERLAND.
LEVONORDEFRIN AS MANUFACTURED IN EVIONNAZ, SWITZERLAND.

16700 A

II

7/11/2003

FERMION OY

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN HANKO, FINLAND.

16701 A

II

7/8/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

PACLITAXEL AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

16702 I

6/26/2003

MERCK RESEARCH LABORATORIES

16703 I

II

7/14/2003

16704 I

IV

7/11/2003

L-829165 POSITRON EMISSION TOMOGRAPHY (PET) TRACER SAFETY AND PHARMACOLOGY


REFERENCE DATA
DISHMAN PHARMACEUTICALS AND CHEMICAL PVT EPROSARTAN MESYLATE AS MANUFACTURED IN AHMEDABAD, INDIA.
LTD
FLAVORMATIC INDUSTRIES INC
N&A GRAPE TYPE FLAVOR #909-510 AS MANUFACTURED IN WAPPINGERS FALLS, NY.

16705 I

IV

7/10/2003

FLAVORMATIC INDUSTRIES INC

N&A BUBBLE GUM TYPE FLAVOR #909-487 AS MANUFACTURED IN WAPPINGERS FALLS, NY.

16706 A

II

7/14/2003

ERIOCHEM SA

VINORELBINE TARTRATE, USP AS MANUFACTURED IN ENTRE RIOS, ARGENTINA

16707 A

II

7/7/2003

IPCA LABORATORIES LTD

HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

16708 A

II

7/16/2003

MYLAN LABORATORIES LTD

CLARITHROMYCIN USP (CXP) AS MANUFACTURED IN TELANGANA, INDIA.

16709 I

II

7/15/2003

CARBOPLATIN AS MANUFACTURED IN VICTORIA, AUSTRALIA.

16710 A

II

7/15/2003

INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA


LTD
HIKAL LTD

16711 I

III

7/10/2003

RICON COLORS

WHITE CPP-W368-8 POLYPROPYLENE AS MANUFACTURED IN WEST CHICAGO, IL.

16712 A

III

7/16/2003

TUBEX TUBENFABRIK WOLFSBERG GMBH

COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN ST. STEFAN, AUSTRIA.

16713 A

II

7/18/2003

USV LIMITED

GLIMEPIRIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

16714 I

IV

7/18/2003

PADDOCK LABORATORIES INC

DERMABASE(TM) CREAM AS MANUFACTURED IN MINNEAPOLIS, MN.

16715 I

II

7/23/2003

DEGUSSA LTD

16716 A

III

7/22/2003

APTAR RADOLFZELLGMBH

16717 I

II

7/21/2003

FABBRICA ITALIANA SINTETICI SPA

INSOLUBLE PRUSSIAN BLUE [IRON (III) HEXACYANOFERRATE (II)] AS MANUFACTURED IN


MANCHESTER, UNITED KINGDOM.
MULTIDOSE DISPENSING SYSTEM FOR UNPRESERVED PRODUCTS AS MANUFACTURED IN
RADOLFZELL AND EIGELTINGEN, GERMANY.
CITALOPRAM AS MANUFACTURED IN VICENZA, ITALY.

16718 I

II

7/18/2003

GMT FINE CHEMCALS SA

LEUCOVORIN CALCIUM, USP AS MANUFACTURED IN COUVET, SWITZERLAND.

16719 I

IV

7/16/2003

FONA INTERNATIONAL INC

#913.006, NAT & ART SPEARMINT FLAVOR AS MANUFACTURED IN CAROL STREAM, IL.

16720 A

IV

7/24/2003

ROBERTET FLAVORS INC

16721 I

IV

7/22/2003

FLAVORMATIC INDUSTRIES INC

ARTIFICIAL SPRAY DRIED SUGAR TASTE FLAVOR NV-24,013 AS MANUFACTURED IN


PISCATAWAY, NJ.
N&A APPLE TYPE FLAVOR #909-359 AS MANUFACTURED IN WAPPINGERS FALLS, NY.

16722 A

II

7/24/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

CILOSTAZOL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA.

Page 481

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16723 I
II
7/28/2003
DAIICHI SANKYO CO LTD

SUBJECT
DX-619 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

16724 I

IV

7/21/2003

SYMRISE INC

16725 I

II

7/29/2003

AVANTI POLAR LIPIDS INC

16726 I

III

7/9/2003

HUHTAMAKI RONSBERG

16727 A

III

7/25/2003

CRESTANI SRL

ARTIFICIAL APPLE FLAVOR 9/70X834 (609041) AND ARTIFICIAL WATERMELON FLAVOR


9/710233 (843657) AS MANUFACTURED IN TETERBORO, TOTOWA, BRANCHBURG, NJ.
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (POPC) AS MANUFACTURED IN
ALABASTER, AL.
TUBE LAMINATES 1327 F, 1337 F, 1338 F AND 2328 F AS MANUFACTURED IN RONSBERG,
FEDERAL REPUBLIC OF GERMANY AND RIO GRANDE DO NORTE, BRAZIL.
GLASS AMPOULES AS MANUFACTURED IN VICENZA, ITALY.

16728 I

II

7/23/2003

SPRING WIND HERBS INC

16729 A

III

7/28/2003

REXAM HEALTHCARE OFFRANVILLE SAS

ARNEBIA INDIGO JADE AND PEARL (AIJP) OINTMENT AS MANUFACTURED IN ALBUQUERQUE,


NM.
PILL JARS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE.

16730 A

II

7/29/2003

UNIQUE CHEMICALS

NIFEDIPINE USP AS MANUFACTURED IN GUJARAT, INDIA.

16731 I

III

7/10/2003

VALOIS SAS

VALOIS BUTYL 540 SERIES ELASTOMER AS MANUFACTURED IN VAL DE REUIL, FRANCE.

16732 A

II

8/1/2003

NORAMCO INC

OXYCODONE BASE DRUG SUBSTANCE AS MANUFACTURED IN ATHENS, GA.

16733 I

II

7/31/2003

L-000825058 AS MANUFACTURED IN RAHWAY, NJ.

16734 A

II

7/31/2003

MERCK SHARP AND DOHME RESEARCH


LABORATORIES DIV MERCK AND CO INC
INTERQUIM SA DE CV

16735 A

II

7/25/2003

FARMHISPANIA SA

QUINAPRIL HYDROCHLORIDE (FH-106) AS MANUFACTURED IN BARCELONA, SPAIN.

16736 A

II

7/28/2003

MEDICHEM SA

GLIMEPIRIDE AS MANUFACTURED IN GIRONA, SPAIN.

16737 A

II

7/31/2003

CU CHEMIE UETIKON GMBH

S-KETAMINE HYDROCHLORIDE AS MANUFACTURED IN LAHR, GERMANY.

16738 I

II

7/22/2003

MICRON TECHNOLOGIES INC

CONTRACT MICRONIZATION FACILITY IN EXTON, PA.

16739 I

6/27/2003

GW PHARMA LTD

CANNABIS BASED MEDICINE AS MANUFACTURED IN WREXHAM, UNITED KINGDOM.

16740 I

III

7/31/2003

TRUDELL MEDICAL INTERNATIONAL

TOP MOUNT DOSE INDICATOR AS MANUFACTURED IN ONTARIO, CANADA.

16741 I

IV

7/31/2003

LAUREATE BIOPHARMACEUTICAL SERVICES INC

ARTIFICIAL GRAPE FLAVOR #1749 AS MANUFACTURED IN KALAMAZOO, MI.

16742 A

II

7/25/2003

PFANSTIEHL, INC

16743 A

III

7/30/2003

SILGAN PLASTICS CORP

ADIPIC ACID BIS (N-HYDROXYSUCCINIMIDE) ESTER (A-163-1) AS MANUFACTURED IN


WAUKEGAN, IL.
PLASTICS BOTTLES, JARS AND CONTAINERS MANUFACTURED BY THE INJECTION BLOWMOLDING PROCESS AS MANUFACTURED IN DEEP RIVER, CT; FLORA, IL; LIGONIER, IN; PENN
YAN, NY; PORT CLINTON, OH; TRIADELPHIA, WV AND, QUEBEC AND ONTARIO, CANADA.

16744 I

II

8/5/2003

LEVOMEPROMAZINE MALEATE AS MANUFACTURED IN VITRY-SUR-SEINE, FRANCE.

16745 A

II

7/31/2003

SANOFI CHIMIE (A SUBSIDIARY OF SANOFIAVENTIS)


PFANSTIEHL, INC

16746 I

II

8/7/2003

ALEMBIC LTD

CLARITHROMYCIN AS MANUFACTURED IN GUJARAT, INDIA.

16747 A

II

8/4/2003

DR REDDYS LABORATORIES LTD

RABEPRAZOLE SODIUM (FORM Y) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16748 I

II

8/8/2003

OPOCRIN SPA

ENOXAPARIN SODIUM AS MANUFACTURED IN CORLO DI FORMIGINE, ITALY.

16749 I

II

8/8/2003

ROCHE DIAGNOSTICS GMBH

BM 17.0744 NA (K-111) AS MANUFACTURED IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY.

16750 A

II

8/8/2003

CHANGZHOU PHARMACEUTICAL FACTORY

HYDROCHLOROTHIAZIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

16751 I

II

8/8/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

AZTREONAM AS MANUFACTURED IN MEXICO, MO AND PETAH TIQVA, ISRAEL.

16752 I

II

8/8/2003

PHF SA

SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN QUEBEC, CANADA.

16753 A

II

8/11/2003

CIPLA LTD

16754 I

II

8/11/2003

KYORIN PHARMACEUTICAL CO LTD

OFLOXACIN USP AS MANUFACTURED IN BANGALORE, MAHARASHTRA, MUMBAI AND GOA,


INDIA.
KRP-297 AS MANUFACTURED IN NAGANO AND AKITA, JAPAN.

TIAMULIN HYDROGEN FUMARATE AS MANUFACTURED IN EDO. DE MEXICO, MEXICO.

2-DEOXY-D-GLUCOSE (D-101-1) AS MANUFACTURED IN WAUKEGAN, IL.

Page 482

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16755 I
II
8/7/2003
NYCOMED AUSTRIA GMBH

SUBJECT
LORNOXICAM AS MANUFACTURED IN LINZ, AUSTRIA.

16756 I

IV

7/31/2003

NATIONAL PRODUCTS CO

APPLE FLAVOR #17178 AS MANUFACTURED IN KALAMAZOO, MI.

16757 I

IV

7/31/2003

NATIONAL PRODUCTS CO

WATERMELON FLAVOR #1709 AS MANUFACTURED IN KALAMAZOO, MI.

16758 I

II

8/11/2003

COGNIS CORP

DERMAZ(TM) 95 AZELAIC ACID AS MANUFACTURED IN CINCINNATI, OH.

16759 A

II

8/13/2003

LANXESS CORP

PREVENTOL SB AS MANUFACTURED IN LEVERKUSEN, GERMAY.

16760 A

II

8/13/2003

BACHEM AMERICAS INC

OCTREOTIDE ACETATE AS MANUFACTURED IN TORRANCE, CA.

16761 A

III

8/13/2003

BALL AEROCAN UK LTD

16762 A

III

8/13/2003

COMAR LLC

ONE PIECE ALUMINIUM AEROSOL CANS AS MANUFACTURED IN WILTSHIRE, UNITED


KINGDOM.
PLASTIC CLOSURES AS MANUFACTURED IN BUENA, NJ.

16763 I

II

8/15/2003

PARTICLE DYNAMICS INC

16764 A

II

8/18/2003

CIPLA LTD

DESTAB(TM) CALCIUM CARBONATE 95 MD ULTRA 250 AS MANUFACTURED IN LITCHFIELD,


MN.
RABEPRAZOLE SODIUM AS MANUFACTURED IN BANGALORE, INDIA.

16765 I

IV

8/13/2003

GUJARAT FLUOROCHEMICALS LTD

PROPELLANT GRADE CFC (S) AS MANUFACTURED IN GUJARAT STATE, INDIA.

16766 I

II

8/15/2003

AVANTI POLAR LIPIDS INC

16767 A

II

8/14/2003

DOTTIKON EXCLUSIVE SYNTHESIS AG

16768 A

II

8/18/2003

FORMOSA LABORATORIES INC

N-HEXANOYL-D-ERYTHRO-SPHINGOSINE (C6 CERAMIDE) AS MANUFACTURED IN ALABASTER,


AL.
PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN DOTTIKON,
SWITZERLAND.
APRACLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN, TAIWAN.

16769 A

II

8/18/2003

FORMOSA LABORATORIES INC

CAPSAICIN AS MANUFACTURED IN TAOYUAN, TAIWAN.

16770 A

12/4/2003

BOEHRINGER INGELHEIM RCV GMBH AND CO KG

CONTRACT MANUFACTURING FACILITY IN VIENNA, AUSTRIA.

16771 A

II

8/15/2003

JOHNSON MATTHEY PHARMA SERVICES

CLEVIDIPINE AS MANUFACTURED IN DEVENS AND NORTH ANDOVER, MA.

16772 A

II

8/19/2003

NOVARTIS PHARMA AG

NAFTIFINE HYDROCHLORIDE AS MANUFACTURED IN BASEL, SWITZERLAND

16773 A

III

8/13/2003

POLYONE CORP

PRODUCT NO. CC00012714WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

16774 A

III

8/14/2003

SILGAN PLASTICS CORP

BOTTLES, JARS AND CONTAINERS BY THE STRETCH-BLOW-MOLDING PROCESS AS


MANUFACTURED IN ANAHEIM, CA; PENN YAN, NY; RICHMOND, VA; LANGHORNE, PA; MONROE,
GA; TRIADELPHIA, WV AND; QUEBEC AND ONTARIO, CANADA.

16775 A

III

8/7/2003

COLORTECH INC

11002-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN.

16776 I

II

8/22/2003

CONTIPRO C A.S.

SODIUM HYALURONATE AS MANUFACTURED IN DOLNI DOBROUC, CZECH REPUBLIC.

16777 I

II

8/18/2003

TAKASAGO INTERNATIONAL CORP

4AA AS MANUFACTURED IN SHIZUOKA AND HYOGO PREFECTURE, JAPAN.

16778 A

III

8/19/2003

POLYONE CORP

PRODUCT NO. CC00017553WE AS MANUFACTURED IN GLENDALE, AZ.

16779 I

III

8/14/2003

CLARIANT (CANADA) INC

BLUE CLARIANT MASTERBATCH 04PPP-7351 AS MANUFACTURED IN ONTARIO AND QUEBEC,


CANADA.

16780 N

NOT AN ASSIGNED NUMBER

16781 N

NOT AN ASSIGNED NUMBER

16782 N

NOT AN ASSIGNED NUMBER

16783 N

NOT AN ASSIGNED NUMBER

16784 A

II

8/20/2003

CHEMAGIS LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16785 I

II

8/20/2003

AMINO CHEMICALS LTD

ZALEPLON AS MANUFACTURED IN MARSA, MALTA.

16786 A

II

9/4/2003

CADILA PHARMACEUTICALS LTD

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

16787 A

II

8/27/2003

GLENMARK GENERICS LTD

AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA.

16788 I

II

8/26/2003

WOCKHARDT LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA STATE INDIA.

16789 A

II

8/25/2003

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD

ETODOLAC AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

Page 483

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16790 I
II
8/22/2003
LONZA LTD

SUBJECT
EPROSARTAN MESYLATE (ROUTE F) AS MANUFACTURED IN VISP, SWITZERLAND.

16791 A

II

8/26/2003

NEULAND LABORATORIES LTD

LEVOFLOXACIN AS MANUFACTURED IN TELANGANA, INDIA.

16792 I

III

8/22/2003

MAC CLOSURES INC

16793 A

II

8/28/2003

WOCKHARDT LTD

RECLOSEABLE CONTINUOUS THREADED JIGGER STYLE CLOSURES AS MANUFACTURED IN


QUEBEC, CANADA.
PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16794 A

II

8/28/2003

WOCKHARDT LTD

CEFTAZIDIME FOR INJECTION AS MANUFACTURED IN GUJARAT STATE, INDIA.

16795 A

II

8/15/2003

BAYER PHARMA AG

TESTOSTERONE UNDECANOATE AS MANUFACTURED IN MEXICO.

16796 A

III

8/19/2003

APTAR FRANCE SAS

APTAR NITRILE ELASTOMERS AS MANUFACTURED IN VAL DE REUIL, FRANCE

16797 I

III

8/13/2003

PLASPAK CLOSURES PTY TD

38MM CLOSURE AS MANUFACTURED IN NSW, AUSTRALIA.

16798 I

II

8/27/2003

ALCHYMARS SPA

ALENDRONIC ACID MONOHYDRATE AS MANUFACTURED IN MILANO, ITALY.

16799 I

II

8/29/2003

GE HEALTHCARE

KVICK(TM) ULTRAFILTRATION CASSETTES AS MANUFACTURED IN WESTBOROUGH, MA.

16800 I

III

8/29/2003

BOREALIS A/S

PACKAGING MATERIAL MA 9230 AS MANUFACTURED IN STATHELLE, NORWAY.

16801 A

II

8/8/2003

CYALUME SPECIALTY PRODUCTS INC

METHENAMINE HIPPURATE, USP AS MANUFACTURED IN BOUND BROOK, NJ.

16802 I

II

8/27/2003

FDC LTD

KETOCONAZOLE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16803 A

II

9/3/2003

PRODOTTI CHIMICI E ALIMENTARI SPA

URSODIOL USP XXVI AS MANUFACTURED IN BASSALUZZO, ITALY.

16804 I

III

9/2/2003

WINPAK TECHNOLOGIES INC

32.1 GSM 23.0UM POLYESTER 10.15.92/ 0.03 GSM PRIMER 10-QQ-1/ 16.0 GSM PE 5050/ 48.6
GSM 18.0 UM ALUMINUM FOIL/ 24.0 GSM PE NUCREL 3990SB AS MANUFACTURED IN
ONTARIO, CANADA.

16805 I

II

9/2/2003

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

MERCAPTOPURINE USP AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

16806 I

II

9/2/2003

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

AZATHIOPRINE USP AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

16807 A

II

8/27/2003

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

16808 A

II

8/29/2003

NOF CORP

FLUDARABINE PHOSPHATE, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG


PROVINCE, P.R. CHINA.
DIOLEOYL PHOSPHATIDYLCHOLINE (DOPC) AS MANUFACTURED IN HYOGO, JAPAN.

16809 A

II

8/15/2003

BAYER PHARMA AG

16810 I

II

8/20/2003

XELLIA PHARMACEUTICALS APS

16811 A

III

8/12/2003

ADVANCED SCIENTIFICS INC

16812 A

II

8/28/2003

CAMBRIDGE MAJOR LABS INC

16813 A

II

9/3/2003

LONZA AG

16814 A

III

9/5/2003

APTAR FRANCE SAS

DESMOPRESSIN (ACETATE) (CODE SF278) AS MANUFACTURED IN BRAINE-L'ALLEUD,


BELGIUM.
APTAR VP7 PUMPS AS MANUFACTURED IN LE VAUDREUIL, FRANCE.

16815 A

II

8/28/2003

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

16816 A

III

9/2/2003

ASHLAND INC

AROSET 3512 AS MANUFACTURED IN DUBLIN, OH.

16817 A

II

9/3/2003

DIVIS LABORATORIES LTD

SULPHAZINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16818 A

II

8/26/2003

KUMAR ORGANIC PRODUCTS LIMITED

TRICLOSAN AS MANUFACTURED IN BANGALORE, INDIA.

16819 A

II

9/2/2003

TRANSO PHARM PRODUKTIONS GMBH

DIAZOXIDE AS MANUFACTURED IN BEXBACH, GERMANY.

16820 I

III

9/9/2003

BOMATIC INC

D-RG 1001 AS MANUFACTURED IN ONTARIO, CANADA.

16821 A

IV

9/2/2003

BASF SE

Kollicream(R) CI AS MANUFACTURED IN DUESSELDORF, GERMANY.

16822 A

IV

9/2/2003

COGNIS GMBH

DEHYMULS HRE 7 AS MANUFACTURED IN DUESSELDORF, GEMANY.

16823 A

IV

9/2/2003

BASF SE

Kolliphor(R) CS A AS MANUFACTURED IN DUESSELDORF, GERMANY.

16824 A

II

9/5/2003

BIOFAC AS

THROMBIN POWDER AS MANUFACTURED IN KASTRUP, DENMARK.

TESTOSTERONE UNDECANOATE 1000 MG I.M. AS MANUFACTURED IN JENA AND WEIMAR,


GERMANY.
TOBRAMYCIN SULFATE, USP STERILE AS MANUFACTUREED IN COPENHAGE, DENMARK
AUTOCLAVABLE POLYPROPYLENE DRUG DELIVERY BAG AS MANUFACTURED IN
MILLERSBURG, PA.
FP-043 AS MANUFACTURED IN GERMANTOWN, WI.

Page 484

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16825 I
II
9/9/2003
AVON ORGANICS LTD

SUBJECT
PSEUDOEPHEDRINE SULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

16826 A

III

9/5/2003

RICHLAND GLASS

GLASS VIALS / AMPOULES AS MANUFACTURED IN VINELAND, NJ.

16827 A

II

9/8/2003

NOVUS FINE CHEMICALS LLC

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN CARLSTADT, NJ.

16828 I

III

9/5/2003

TRESPAPHAN GMBH

TRESPAPHAN NNA AS MANUFACTURED IN NEUNKIRCHEN, GERMANY.

16829 I

II

9/10/2003

MITSUBISHI PHARMA CORP

MCC-977 DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI-KEN, JAPAN.

16830 I

II

9/9/2003

PCAS

CYCLOPIROX OLAMINE AS MANUFACTURED IN LIMAY, FRANCE AND TURKU, FINLAND.

16831 A

III

9/12/2003

BD PHARMACEUTICAL SYSTEMS DIV

BDPS NEEDLE SHIELD AS MANUFACTURED IN BAD RAGAZ, SWITZERLAND.

16832 I

III

9/12/2003

MITSUI CHEMICALS AMERICA INC

16833 A

II

9/12/2003

ASTELLAS PHARMA INC

ADMER(R) QF551E AS MANUFACTURED IN ER KERKRADE, THE NETHERLANDS AND


AHRENSBURG, GERMANY.
TACROLIMUS (FK506) DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN.

16834 I

III

9/10/2003

TECH GROUP EUROPE

INTRANASAL SINGLE LEVER OUTER DEVICE AS MANUFACTURED IN DUBLIN, IRELAND.

16835 I

II

9/11/2003

PCAS

(R)-OXYBUTYNIN BASE AS MANUFACTURED IN LIMAY, FRANCE.

16836 I

II

9/12/2003

AVECIA BIOTECHNOLOGY INC

OLIGONUCLEOTIDE APO AS MANUFACTURED IN MILFORD, MA.

16837 I

II

9/15/2003

BIOTIKA SA

PENICILLIN G POTASSIUM AS MANUFACTURED IN SLOVENSKA L'UPCA, SLOVAKIA.

16838 A

II

9/5/2003

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, CHINA.

16839 A

II

9/9/2003

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD
WOCKHARDT LTD

16840 I

III

9/8/2003

CLARIANT (CANADA) INC

16841 A

II

9/15/2003

YUHAN CHEMICAL INC

ORANGE CLARIANT MASTERBATCH 09PPP-191 AS MANUFACTURED IN ONTARIO AND


QUEBEC, CANADA.
PIPERACILLIN MONOHYDRATE AS MANUFACTURED IN KYUNGGI-DO, KOREA.

16842 I

II

9/15/2003

ALBANY MOLECULAR RESEARCH INC

CITC-DTPA AS MANUFACTURED IN ALBANY, NY.

16843 A

II

9/15/2003

IRVINE SCIENTIFIC SALES CO

IS CHO-CD(TM) (P) CATALOG #94111 AS MANUFACTURED IN SANTA ANA, CA.

16844 A

III

9/16/2003

BAXTER HEALTHCARE CORP

ORAL DISPENSER ACCESSORIES AS MANUFACTURED IN ENGLEWOOD, CO.

16845 A

II

10/10/2003

OLON SPA

TENIPOSIDE AS MANUFACTURED IN RODANO, ITALY.

16846 I

II

9/16/2003

SHANGHAI PHARMACEUTICAL GROUP CO LTD

GRISEOFULVIN USP MICROCRYSTALLINE AS MANUFACTURED IN SHANGHAI, CHINA.

16847 I

II

9/18/2003

SANDOZ INDUSTRIAL PRODUCTS GMBH

16848 I

II

9/17/2003

16849 A

II

9/16/2003

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
EUTICALS SPA

PENICILLIN G POTASSIUM STERILE AND PENICILLIN G POTASSIUM STERILE, BUFFERED AS


MANUFACTURED IN FRANKFURT AM MAIN, GERMANY.
SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA
(LT), ITALY.
OXANDROLONE USP AS MANUFACTURED IN ROZZANO (MI), ITALY.

16850 A

II

9/19/2003

AUROBINDO PHARMA LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MEDAK DIST., A.P., INDIA.

16851 A

II

9/17/2003

ROCHE DIAGNOSTICS GMBH

TORASEMIDE AS MANUFACTURED IN MANNHEIM, GERMANY.

16852 I

IV

9/22/2003

FLAVORS NORTH AMERICA INC

913.004 NOR-CAP NATURAL & ARTIFICIAL SPEARMINT FLAVOR

16853 I

III

9/12/2003

BASELL USA INC

RESIN: PD626 AS MANUFACTURED IN GAHANNA, OH.

16854 A

IV

9/23/2003

ROQUETTE FRERES

SODIUM STARCH GLYCOLATE USP/NF AS MANUFACTURED IN LESTREM CEDEX, FRANCE.

16855 I

II

9/16/2003

GENERAL CHEMICAL CORP

REHYDRAGEL LG AS MANUFACTURED IN BERKELEY HEIGHTS, NJ.

16856 A

II

9/22/2003

PERRIGO API LTD

HALOBETASOL PROPIONATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16857 A

II

9/12/2003

LUPIN LTD

BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

16858 I

II

8/27/2003

GENERAL CHEMICAL CORP

REHYDRAGEL CG AS MANUFACTURED IN BERKELEY HEIGHTS, NJ.

16859 I

II

8/26/2003

GENERAL CHEMICAL CORP

REHYDRAGEL HPA AS MANUFACTURED IN BERKELEY HEIGHTS, NJ.

16860 I

II

8/26/2003

GENERAL CHEMICAL CORP

REHYDRAGEL LV AS MANUFACTURED IN BERKELEY HEIGHTS, NJ.

CEFOTAXIME SODIUM (STERILE) AS MANUFACTURED IN GUJARAT STATE, INDIA

Page 485

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16861 A
II
9/23/2003
STERLING S P A

SUBJECT
HALOBETASOL PROPIONATE AS MANUFACTURED IN PERUGIA, ITALY.

16862 I

III

9/8/2003

CLARIANT (CANADA) INC

16863 A

II

9/24/2003

TARO PHARMACEUTICAL INDUSTRIES LTD

BLUE CLARIANT MASTERBATCH 04EHD-1677 AS MANUFACTURED IN ONTARIO AND QUEBEC,


CANADA
ESMOLOL HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

16864 I

II

9/22/2003

CARDINAL HEALTH

TAZAROTENE 1.5 MG AND 4.5 MG CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL

16865 I

III

9/22/2003

FLEXTRUS AB

TRANSOFOIL EL-OPET/PE LAMINATE AS MANUFACTURED IN LUND, SWEDEN

16866 A

III

7/16/2003

CAPORIZZI AND FRIZZI

16867 I

III

9/25/2003

NATIONAL STARCH CHEMICAL CO

KNACKPACK/0305 GREY AND RED AS MANUFACTURED IN KRANJ, SLOVENIA FOR CAPORIZZI


& FRIZZI
PRODUCER(R) 33-9010 AS MANUFACTURED IN BERKLEY, CA; ENOREE,SC AND HAZELTON, PA

16868 I

II

9/23/2003

EVESTRA INC

CDB-4124 DRUG SUBSTANCE AS MANUFACTURED IN SAN ANTONIO, TX.

16869 I

IV

9/19/2003

KERRY CANADA INC

GRAPE SODA ARTIFICIAL FLAVOR MC006124 AS MANUFACTURED IN GRANBY, CANADA

16870 A

III

9/30/2003

TEKNI PLEX EUROPE NV

ABLEX 501, ABLEX 503, AND ABLEX 701 AS MANUFACTURED IN EREMBODEGEM, BELGIUM.

16871 A

II

9/29/2003

CRYSTAL PHARMA SAU

ALCLOMETASONE DIPROPIONATE AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN.

16872 A

II

9/26/2003

CAMBREX CHARLES CITY INC

FENTANYL AS MANUFACTURED IN NORTH BRUNSWICK, NJ.

16873 A

II

9/25/2003

SOURCETECH QUIMICA LTDA

PILOCARPINE HYDROCHLORIDE AS MANUFACTURED IN PINDAMONHANGABA - SP, BRAZIL.

16874 I

II

9/29/2003

SAFC PHARMA

CHO MEDIUM-ANIMAL COMPONENT-FREE AS MANUFACTURED IN ST. LOUIS, MO.

16875 I

IV

9/30/2003

SYMRISE INC

16876 A

II

10/2/2003

GLENMARK GENERICS LTD

823992 NATURAL & ARTIFICIAL CAPPUCCINO TYPE FLAVOR CONCENTRATE AS


MANUFACTURED IN TETERBORO, TOTOWA AND BRANCHBURG, NJ.
CILOSTAZOL AS MANUFACTURED IN GUJARAT STATE, INDIA.

16877 A

II

9/30/2003

MILLIPORE CORP

16878 I

III

9/19/2003

EASTMAN CHEMICAL CO

16879 I

II

9/23/2003

NEOMPS INC

MILLIPORE CORPORATION EXPRESS(R) MEMBRANE AND FILTERS AS MANUFACTURED IN


BEDFORD, MA AND JEFFREY, NH.
EASTAPAK(R) AND EASTAR(R) POLYMER PRODUCTION AS MANUFACTURED IN KINGSPORT,
TN.
SYNTHETIC PEPTIDE MPS-178 AS MANUFACTURED IN SAN DIEGO, CA.

16880 A

III

9/29/2003

DYNIC USA CORP

HL30 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

16881 A

III

9/29/2003

DYNIC USA CORP

HL32 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

16882 A

III

9/29/2003

DYNIC USA CORP

HL45 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

16883 I

III

9/29/2003

DYNIC USA

L345 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

16884 I

III

9/29/2003

DYNIC USA

S345 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

16885 A

10/6/2003

BASF CORP

KOLLICOAT(R) IR TOXICOLOGY STUDIES IN LUDWIGSHAFEN, GERMANY.

16886 A

IV

9/26/2003

BASF SE

KOLLICOAT(R) IR AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

16887 I

II

10/2/2003

LEK PHARMACEUTICALS DD

AMLODIPINE BESYLATE AS MANUFACTURED IN KOLODVORSKA, SLOVENIA.

16888 I

IV

9/30/2003

PHARMACEUTICAL COATINGS PVT LTD

TABCOAT TC* AS MANUFACTURED IN NAVI MUMBAI, INDIA.

16889 I

III

9/30/2003

POLFA BOLESLAWIEC

16890 A

II

10/1/2003

CHEMWERTH INC

ALUMINIUM TUBES, CANS AND CLOSURE-SYSTEMS AS MANUFACTURED IN BOLESLAWIEC,


POLAND.
SIROLIMUS AS MANUFACTURED IN FUJIAN PROVINCE, CHINA FOR CHEMWERTH INC

16891 I

II

9/30/2003

CHONGQING UNITED PHARMACEUTICAL CO LTD

PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, P.R. CHINA.

16892 A

9/3/2003

AJINOMOTO ALTHEA INC

ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA.

16893 I

III

9/15/2003

ERIE MOLDED PLASTICS INC

LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA.

16894 A

II

10/5/2003

DIVIS LABORATORIES LTD

LEVETIRACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

Page 486

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16895 A
IV
10/6/2003
FIRMENICH INC
16896 A

II

10/6/2003

PFANSTIEHL INC

SUBJECT
NATURAL & ARTIFICIAL ORANGE FLAVOR 501071 AP0551 AS MANUFACTURED IN
PLAINSBORO, NJ.
CYTARABINE USP AS MANUFACTURED IN WAUKEGAN, IL.

16897 I

III

5/22/2003

STE PACKAGIN DEVELOPMENT SL

MRI PACKAGING SYSTEM AS MANUFACTURED IN TARRAGONA, SPAIN.

16898 I

II

10/10/2003

ABBOTT LABORATORIES

FENOFIBRATE SPRAY GRANULATION INTERMEDIATE AS MANUFACTURED IN CORK, IRELAND.

16899 A

II

10/8/2003

16900 I

II

10/13/2003

RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA FOSPHENYTOIN SODIUM API AS MANUFACTURED IN LATINA, ITALY.
SPA
ESTEVE QUIMICA SA
RAMIPRIL AS MANUFACTURED IN BARCELONA AND CELRA, SPAIN.

16901 I

II

10/13/2003

ERCROS INDUSTRIAL SA FYSE

LOVASTATIN (TECHNICAL GRADE) AS MANUFACTURED IN MADRID, SPAIN.

16902 A

II

10/10/2003

DR REDDYS LABORATORIES LTD

RISPERIDONE FORM-1 AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16903 I

II

10/20/2003

QUIMICA SINTETICA SA

SUMATRIPTAN AS MANUFACTURED IN MADRID, SPAIN

16904 A

II

10/16/2003

PIRAMAL ENTERPRISES LTD

LEVOBUNOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

16905 I

II

10/16/2003

PIRAMAL HEALTHCARE LTD

ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16906 A

II

10/15/2003

NORTH CHINA PHARMACEUTICAL VICTOR CO LTD

CYANOCOBALAMIN, USP (VITAMIN B-12) AS MANUFACTURED IN HEBEI, CHINA.

16907 I

II

10/15/2003

NV ORGANON

ANDROSTANOLONE AS MANUFACTURED IN OSS, THE NETHERLANDS.

16908 A

II

10/14/2003

RANBAXY LABORATORIES LTD

LEVOFLOXACIN AS MANUFACTURED IN PUNJAB, INDIA.

16909 A

IV

10/7/2003

DOW CORNING CORP

DOW CORNING(R) EMULSIFIER 10 AS MANUFACTURED IN HEMLOCK, MI.

16910 A

II

10/16/2003

LABORATORIOS HAYMANN SA

NICOTINE POLACRILEX USP , 20% AS MANUFACTURED IN MONTEVIDEO, URUGUAY.

16911 A

II

9/13/2003

CADILA PHARMACEUTICALS LTD

AMLODIPINE BESYLATE ( ESUB) AS MANUFACTURED IN GUJARAT, INDIA.

16912 A

II

10/15/2003

YANTAI DONGCHENG BIOCHEMICALS CO LTD

16913 A

II

10/15/2003

YANTAI DONGCHENG BIOCHEMICALS CO LTD

16914 I

III

10/10/2003

AMPACET CORP

16915 A

II

10/20/2003

GUFIC BIOSCIENCES LTD

CHONDROITIN SULFATE CALCIUM, NON-STERILE BULK DRUG AS MANUFACTURED IN


SHANDONG PROVINCE, CHINA.
CHONDROITIN SULFATE SODIUM, NON-STERILE BULK DRUG AS MANUFACTURED IN
SHANDONG PROVINCE, CHINA.
110021-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;
LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.
KETOCONAZOLE USP AS MANUFACTURED IN GUJARAT STATE, INDIA.

16916 A

II

10/21/2003

CIPLA LTD

CARBOPLATIN AS MANUFACTURED IN BANGALORE, INDIA.

16917 I

II

10/9/2003

REHEIS INTERMEDIATES

REHYDRAPHOS AS MANUFACTURED IN BERKELEY HEIGHTS, NJ

16918 A

II

10/19/2003

DIVIS LABORATORIES LTD

PHENYLEPHRINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16919 A

II

10/21/2003

16920 A

III

10/22/2003

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD
VINS PLASTICS LTD

16921 I

II

10/20/2003

JUZEN CHEMICAL CORP

VENLAFAXINE HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) AS


MANUFACTURED IN CHONGQING, CHINA.
FLEXIBLE PACKAGING MATERIAL IN ROLL FORM FOR PACKAGING OF PHARMACEUTICAL
OINTMENTS AND CREAMS AS MANUFACTURED IN ONTARIO, CANADA.
ECABET SODIUM AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN.

16922 A

II

10/21/2003

CIPLA LTD

LEVOFLOXACIN HEMIHYDRATE USP AS MANUFACTURED IN BANGALORE, INDIA.

16923 A

II

3/11/2005

HOSPIRA BOULDER INC

10-DEACETYL BACCATIN III AS MANUFACTURED IN BOULDER, CO.

16924 A

III

10/3/2003

INVIBIO LTD

16925 I

III

10/15/2003

AMPACET CORP

16926 A

II

10/17/2003

RANKE QUIMICA SL

PEEK-OPTIMA AND PEEK GB GRADES OF POLYETHERETHERKETONE POLYMER AS


MANUFACTURED IN LANCASHIRE, UNITED KINGDOM.
110021-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;
LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.
LAS 34273 AS MANUFACTURED IN SANT ANDREU DE LA BARCA, SPAIN.

16927 I

III

10/24/2003

ACI PLASTICS PACKAGING CLOSURE SPECIALTY


PRODUCTS

CELLOSEAL(TM) WADDING MATERIAL AS MANUFACTURED IN VICTORIA, AUSTRALIA.

Page 487

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16928 A
II
10/20/2003
SAFC INC

SUBJECT
CALCIPOTRIENE AS MANUFACTURED IN MADISON, WI.

16929 A

II

10/6/2003

UNICHEM LABORATORIES LTD

CLONIDINE HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, INDIA.

16930 A

II

10/23/2003

NATCO PHARMA LTD

SUMATRIPTAN SUCCINATE, PH. EUR AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16931 A

III

10/28/2003

BAXTER HEALTHCARE CORP

16932 A

II

10/28/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

BIO-SET(R) LUER 20 (BIO-SET(R) INJECTION) AS MANUFACTURED IN ISSOIRE CEDEX AND


DAGNEUX, FRANCE.
BUDESONIDE AS MANUFACTURED IN EDO. DE MEXICO, MEXICO.

16933 I

III

10/17/2003

CLARIANT (CANADA) INC

16934 I

II

10/20/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

16935 A

II

10/20/2003

DR REDDYS LABORATORIES LTD

RED CLARIANT MASTERBATCH 20PPP-1379 AS MANUFACTURED IN ONTARIO AND QUEBEC,


CANADA.
BECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE AS
MANUFACTURED IN SANTHIA (VERCELLI), ITALY.
FLUNISOLIDE HEMIHYDRATE AS MANUFACTURED IN JIUTEPEC, MORELOS MEXICO

16936 A

II

10/30/2003

CAMBRIDGE MAJOR LABS INC

FP-039 AS MANUFACTURED IN GERMANTOWN, WI.

16937 I

III

10/30/2003

KOHL AND MADDEN

16938 A

II

10/31/2003

SCINOPHARM TAIWAN LTD

2-LF-10554 BACKGROUND BLUE, 3-LF-20488 PMS 206C RED, AND 1-LF-256 DENSE BLACK AS
MANUFACTURED IN TETERBORO, NJ.
OXANDROLONE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN.

16939 I

III

10/24/2003

AMERICHEM INC

46189-CD1 WHITE AS MANUFACTURED IN CUYAHOGA FALLS, OH.

16940 I

II

10/31/2003

ZOLPIDEM TARTRATE AS MANUFACTURED IN INGELHEIM, FEDERAL REPUBLIC OF GERMANY.

16941 A

10/31/2003

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
GALLUS BIOPHARMACEUTICALS NJ LLC

16942 I

III

10/29/2003

TREDEGAR FILM PRODUCTS CORP

LFL-4 POLYETHYLENE FILM AS MANUFACTURED IN MARLIN, PA.

16943 I

II

11/5/2003

BACHEM CALIFORNIA

DESLORELIN AS MANUFACTURED IN TORRENCE, CA.

16944 A

II

11/6/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

HALOBETASOL PROPIONATE AS MANUFACTURED IN MEXICO.

16945 A

III

11/6/2003

SILGAN PLASTICS CORP

16946 A

II

11/7/2003

BASF CORP

INJECTION MOLDED PLASTIC CLOSURE - LINED AND UNLINED / LINERLESS AS


MANUFACTURED IN PENN YAN, NY; PLAINFIELD, IN; QUEBEC AND ONTARIO, CANADA
POLYETHYLENE GLYCOLS AS MANUFACTURED IN WASHINGTON, NJ.

16947 A

II

11/7/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

DESMOPRESSIN AS MANUFACTURED IN BE'ER SHEVA AND NETANYA, ISRAEL.

16948 I

II

11/7/2003

SF-CHEM

16949 A

II

11/10/2003

SIFAVITOR SRL

3-CHLOROMETHYL-1,2,4-TRIAZOLIN-5-ONE (CMT) AS MANUFACTURED IN PRATTELN,


SWITZERLAND.
HALOPERIDOL DECANOATE AS MANUFACTURED IN LODI, ITALY.

16950 A

II

11/14/2003

DSM SINOCHEM PHARMACEUTICALS NL

AMOXICILLIN TRIHYDRATE (PURIMOX(TM)) AS MANUFACTURED IN ALMERIA, SPAIN.

16951 A

II

11/3/2003

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

NIMODIPINE (MICRONIZED) AS MANUFACTURED IN BARCELONA, SPAIN.

16952 A

II

11/11/2003

JOHNSON MATTHEY INC

OXALIPLATIN AS MANUFACTURED IN WEST DEPTFORD, NJ.

16953 A

II

11/13/2003

HOVIONE FARMACIENCIA SA

HALOBETASOL PROPIONATE AS MANUFACTURED LOURES, PORTUGAL.

16954 A

III

10/16/2003

WIPAK OY

INFUKING 200 AS MANUFACTURED IN NASTOLA, FINLAND.

16955 A

III

11/10/2003

LOPAREX LLC

16956 I

III

9/1/2003

PROENFAR SA

GRADE 24950 D 2 CL PET 7300/000 AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL;
CULLMAN, AL AND WILLOWBROOK, IL.
PACKAGING MATERIAL AS MANUFACTURED IN BOGOTA, COLUMBIA.

16957 I

IV

11/3/2003

SYMRISE INC

16958 A

II

11/14/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

16959 A

III

11/14/2003

BD MEDICAL PHARMACEUTICAL SYSTEMS

16960 A

II

11/14/2003

ABBOTT LABORATORIES

CONTRACT MANUFACTURING FACILITY IN PRINCETON, NJ.

815485 NATURAL CHAI SPICE TYPE FLAVOR CONCENTRATE AS MANUFACTURED IN


TETERBORO, TOTOWA AND BRACHBURG, NJ.
CALCIPOTRIENE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.
BD MONOVIAL(TM) SPIKE AS MANUFACTURED IN LE PONT DE CLAIX AND MARSEILLE CEDEX,
FRANCE; AND DANIKEN, SWITZERLAND.
ZOTAROLIMUS AS MANUFACTURED IN NORTH CHICAGO, IL AND TAINAN COUNTY, TAIWAN

Page 488

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16961 A
II
11/18/2003
MYLAN LABORATORIES LTD

SUBJECT
CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

16962 A

II

11/17/2003

PHARMACEUTICAL WORKS POLPHARMA SA

SODIUM ALENDRONATE AS MANUFACTURED IN STROGARD GDANSKI, POLAND.

16963 A

II

11/17/2003

CIPLA LTD

RISPERIDONE USP AS MANUFACTURED IN BANGALORE, INDIA.

16964 A

IV

11/18/2003

CAPSUGEL

16965 I

II

11/17/2003

TEVA GROUP

EMPTY HARD CAPSULES FROM HYDROXYPROPYLMETHYLCELLULOSE (HYPROMELLOSE) AS


MANUFACTURED IN MEXICO.
GATIFLOXACIN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16966 A

II

11/17/2003

DR REDDYS LABORATORIES LTD

LEVETIRACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16967 A

II

11/17/2003

VIFOR INTERNATIONAL INC

VIT-45 POWDER AS MANUFACTURED IN ST. GALLEN, SWITZERLAND

16968 I

II

11/19/2003

RANBAXY LABORATORIES LTD

16969 I

II

11/12/2003

16970 I

II

11/18/2003

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI


SPA
CADILA HEALTHCARE LTD

7-AMINO-3-[(Z)-PROPEN-1-YL]-3-CEPHEM-4-CARBOXYLIC ACID (7-APCA) AS MANUFACTURED


IN PUNJAB, INDIA.
ANAGRELIDE HYDROCHLORIDE AS MANUFACTURED IN COMO, ITALY.

16971 I

II

11/17/2003

ANONIMA MATERIE SINTETICHE AND AFFINI SPA

FENOFIBRATE AS MANUFACTURED IN COMO, ITALY.

16972 A

II

11/13/2003

GLYCOPYRROLATE AS MANUFACTURED IN COMO, ITALY.

16973 A

II

11/21/2003

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI


SPA
RANBAXY LABORATORIES LTD

16974 A

II

11/20/2003

CATALENT PHARMA SOLUTIONS LLC

16975 A

II

11/20/2003

KYOWA HAKKO KOGYO CO LTD

CALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES AS MANUFACTURED IN ST. PETERSBURG,


FL.
PRAVASTATIN SODIUM AS MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN.

16976 A

II

11/25/2003

TARO PHARMACEUTICAL INDUSTRIES LTD

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

16977 A

II

11/21/2003

CHENG FONG CHEMICAL CO LTD

PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN TAO YUAN HSIEN, TAIWAN.

16978 A

II

11/19/2003

CATALENT PHARMA SOLUTIONS LLC

16979 I

II

11/25/2003

WOCKHARDT LTD

RISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN


SOMERSET, NJ.
CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

16980 A

II

11/25/2003

RANBAXY LABORATORIES LTD

CLORAZEPATE USP AS MANUFACTURED IN PUNJAB, INDIA.

16981 I

IV

11/24/2003

SYMRISE INC

346905 EVOGRAN CAPPUCCINO FLAVOR AS MANUFACTURED IN HLOZMINDEN, GERMANY.

16982 I

III

11/17/2003

AMPACET CORP

100991-K PROFLOW 91 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN,


NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA AND
RAYONG, THAILAND.

16983 A

II

11/26/2003

DR REDDYS LABORATORIES LTD

GLIMEPIRIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

16984 A

II

11/25/2003

BIORESPONSE LLC

BIORESPONSE-DIINOLYLMETHANE (PG) (SPRAY DRIED DIINDOLYLMETHANE) AND


BIORESPONSE-DIM (PG) CAPSULES (75 MG DIINDOLYLMETHANE) AS MANUFACTURED IN
EXTON, PA, MIDDLESEX, NJ AND IOWA CITY, IA

16985 I

II

11/26/2003

HAUSER TECHNICAL SERVICES INC

EPIGALLOCATECHIN GALLATE (EGCG) AS MANUFACTURED IN DENVER, CO.

16986 I

III

11/14/2003

ERIE MOLDED PLASTICS INC

16987 A

II

11/14/2003

16988 A

II

11/14/2003

16989 A

III

10/17/2003

16990 I

III

11/20/2003

LORATADINE AS MANUFACTURED IN GUJARAT, INDIA.

CEFPROZIL USP (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA.

DISPENSING PLUG WITH A .178 ORIFICE THAT IS USED ON A BOTTLE FOR DISPENSING LIQUID
MEDICINE AS MANUFACTURED IN ERIE, PA.
NOF CORP
POPC(FN) (1-PALMITOYL-2-OLEOYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO,
JAPAN.
NOF CORP
POPC(ST) (1-PALMITOYL-2-OLEOYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO,
JAPAN.
PLIANT CORP
PLIANT 105.1T POLYETHYLENE SHEETING FILM AS MANUFACTURED IN SOUTH DEERFIELD,
MA
BERRY PLASTICS CORP TAPES AND COATINGS DIV 48 GAUGE CHEMICALLY TREATED POLYESTER/ 0.8# ADHESIVE / 0.0007 FOIL / 0.8# ADHESIVE /
2 MIL LLDPE FILM AS MANUFACTURED IN COLUMBUS, GA

Page 489

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
16991 I
III
11/19/2003
CLARIANT (CANADA) INC
16992 A

II

11/17/2003

EXCELLA GMBH

SUBJECT
WHITE CLARIANT MASTERBATCH 10EHD-196A AS MANUFACTURED IN ONTARIO AND QUEBEC,
CANADA.
GANCICLOVIR SODIUM AS MANUFACTURED IN FEUCHT, GERMANY.

16993 A

II

12/1/2003

AUROBINDO PHARMA LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN A.P., INDIA.

16994 I

III

11/26/2003

LAJOVIC TUBA EMBALAZA D.D.

INJECTION BLOW MOLDED PLASTIC BOTTLES AS MANUFACTURED IN LJUBLJANA, SLOVENIA.

16995 A

II

12/3/2003

TEVA GROUP

TOLTERODINE TARTRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16996 A

II

12/3/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

16997 A

II

10/30/2003

BACHEM AG

HISTRELIN ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND.

16998 A

II

12/1/2003

INTERPHARMA PRAHA A S

DIINDOLYLMETHANE (DIN) AS MANUFACTURED IN MODRANY, CZECH REPUBLIC

16999 A

II

12/2/2003

DR REDDYS LABORATORIES LTD

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17000 A

II

12/3/2003

MYLAN LABORATORIES LTD

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA.

17001 A

II

12/1/2003

OLON SPA

ACITRETIN AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY.

17002 A

II

12/3/2003

CADILA HEALTHCARE LTD

GATIFLOXACIN ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA.

17003 A

II

12/1/2003

ALCHEM INTERNATIONAL LTD

COLCHICINE USP AS MANUFACTURED IN NEW DELHI, INDIA.

17004 A

II

12/8/2003

HENGSHUI JIHENG PHARMACEUTICAL CO LTD

FOLIC ACID AS MANUFACTURED IN HEBEI PROVINCE, CHINA.

17005 I

II

12/8/2003

HENGSHUI JIHENG PHARMACEUTICAL CO LTD

ACETAMINOPHEN AS MANUFACTURED IN HEBEI PROVINCE, CHINA.

17006 I

II

12/8/2003

HENGSHUI JIHENG PHARMACEUTICAL CO LTD

METAMIZOLE SODIUM AS MANUFACTURED IN HEBEI PROVINCE, CHINA.

17007 A

II

12/1/2003

PCAS

CICLOPIROX AS MANUFACTURED IN TURKU, FINALAND.

17008 A

II

12/5/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

BICALUTAMIDE AS MANUFACTURED IN DEBRECEN, HUNGARY.

17009 A

II

12/5/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

17010 I

II

2/28/2005

ITF CHEMICAL LTDA

CLOPIDOGREL BISULFATE AS MANUFACTURED IN CONSHOHOCKEN, PA AND BE'ER SHEVA,


ISRAEL.
AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN BAHIA, BRAZIL.

17011 I

IV

11/24/2003

SYMRISE INC

17012 A

II

12/2/2003

DR REDDYS LABORATORIES LTD

826506 ENTRAPPED NATURAL & ARTIFICIAL CHERRY TYPE FLAVOR AS MANUFACTURED IN


BRANCHBURG, NJ.
GATIFLOXACIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17013 A

II

12/10/2003

MYLAN LABORATORIES LTD

GATIFLOXACIN AS MANUFACTURED IN TELANGANA, INDIA.

17014 I

II

12/9/2003

DR REDDYS LABORATORIES LTD

LANSOPRAZOLE FORM-1 AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17015 A

II

12/1/2003

BASF CORP

GLUCOPONA(R) 600 UP AS MANUFACTURED IN CINCINNATI, OH.

17016 A

II

11/26/2003

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

BETAMETHASONE USP AS MANUFACTURED IN TIANJIN, CHINA.

17017 A

12/11/2003

WEST PHARMACEUTICAL SERVICES INC

WESTAR(R) RS PROCESS AS MANUFACTURED IN LE NOUVION EN THIERACHE, FRANCE.

17018 A

II

12/11/2003

CIPLA LTD

TOLTERODINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

17019 A

II

12/10/2003

MEDICHEM SA

METOPROLOL SUCCINATE AS MANUFACTURED IN CELRA (GIRONA), SPAIN.

17020 A

II

12/11/2003

SIGMA ALDRICH MANUFACTURING LLC

3-5-DIIODOTHYROPROPIONIC ACID (DITPA) AS MANUFACTURED IN ST.LOUIS, MO.

17021 I

III

12/11/2003

RELIANCE INDUSTRIES LTD

POLYPROPYLENE (PP) REPOL H110MA AS MANUFACTURED IN GUJARAT, INDIA.

17022 A

III

12/12/2003

FRANKLIN INTERNATIONAL

COVINAX 379-05 AS MANUFACTURED IN COLUMBUS, OH.

17023 A

II

12/11/2003

APOTEX PHARMACHEM INC

PRAVASTATIN SODIUM AS MANUFACTURED IN MANITOBA, CANADA.

17024 I

II

12/12/2003

API CORP

J-124429 (PED-704) AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN.

17025 I

II

12/15/2003

CIBA SPECIALTY CHEMICALS

TINOSORB(TM) MBBT AS MANUFACTURED IN LAMPERTHEIM, GERMANY.

17026 A

II

12/15/2003

RANBAXY LABORATORIES LTD

TOLTERODINE TARTRATE AS MANUFACTURED IN PUNJAB, INDIA.

Page 490

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17027 A
II
11/30/2003
CHEMAGIS LTD
17028 N

SUBJECT
ZONISAMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

NOT AN ASSIGNED NUMBER

17029 I

II

1/15/2004

BASF ORGAMOL PHARMA SOLUTIONS SA

OXCARBAZEPINE AS MANUFACTURED IN SAINT-VULBAS, FRANCE.

17030 A

II

12/10/2003

EVERLIGHT CHEMICAL INDUSTRIAL CORP

FELODIPINE AS MANUFACTURED IN TAIWAN, R.O.C.

17031 A

II

12/19/2003

TEVA PHARMACEUTICAL INDUSTRIES LTD

PREDNICARBATE AS MANUFACTURED IN LERMA, MEXICO.

17032 A

II

12/17/2003

CIPLA LTD

AMLODIPINE BESYLATE AS MANUFACTURED IN BANGALORE, INDIA.

17033 A

II

12/17/2003

CIPLA LTD

RAMIPRIL AS MANUFACTURED IN PUNE, INDIA.

17034 A

II

12/16/2003

QILU PHARMACEUTICAL CO LTD

ONDANSETRON HCL & BASE AS MANUFACTURED IN JINAN, CHINA.

17035 A

II

12/16/2003

SCINOPHARM TAIWAN LTD

TOPIRAMATE AS MANUFACTURED IN TAIWAN, R.O.C.

17036 A

II

12/17/2003

MALLINCKRODT INC

DCI(R)-63 (IBUPROFEN USP 63%) AS MANUFACTURED IN GREENVILLE, IL.

17037 A

II

2/17/2004

CADILA HEALTHCARE LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

17038 A

III

12/12/2003

PINNACLE POLYMERS CO

POLYPROPYLENE AS MANUFACTURED IN GARYVILLE, LA.

17039 I

II

12/17/2003

PISGAH LABS INC

PHENTERMINE HYDROCHLORIDE, USP AS MANUFACTURED IN PISGAH FOREST, NC.

17040 A

II

12/18/2003

MAC321 DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY.

17041 A

II

12/16/2003

AMRI RENSSELAER INC SUB ALBANY MOLECULAR


RESEARCH INC
OLAINFARM JOINT STOCK CO

17042 A

III

11/28/2003

DANAPAK FLEXIBLES AS

COMPOUND PACKAGING MATERIAL AS MANUFACTURED IN SLAGELSE, DENMARK.

17043 A

II

12/16/2003

ROCHE DIAGNOSTICS GMBH

GUAIACOL-O-ETHYLBENZYLAMINE HCL AS MANUFACTURED IN MANNHEIM, GERMANY.

17044 A

IV

12/22/2003

SPI PHARMA INC

PHARMABURST(TM) C1 AS MANUFACTURED IN GRAND HAVEN, MI.

17045 A

II

12/1/2003

17046 A

II

12/23/2003

GUILIN HUIANG BIOCHEMISTRY PHARMACEUTICAL PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN GUANGXI, P.R.CHINA.
CO LTD
CRYSTAL PHARMA SAU
BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN BOECILLO, SPAIN.

17047 A

II

12/23/2003

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFUROXIME ACID AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

17048 I

II

12/15/2003

ZACH SYSTEM S P A

GLIMEPIRIDE AS MANUFACTURED IN BARCELONA, SPAIN.

17049 A

II

12/22/2003

DSM FINE CHEMICALS AUSTRIA

SECONDARY AMINE HCL AS MANUFACTURED IN LINZ, AUSTRIA.

17050 A

II

12/22/2003

DIPHARMA FRANCIS SRL

CILOSTAZOL AS MANUFACTURED IN MERETO DI TOMBA, ITALY.

17051 A

II

12/17/2003

TOMITA PHARMACEUTICAL CO LTD

MAGNESIUM HYDROXIDE GRANULAR AS MANUFACTURED IN TOKUSHIMA, JAPAN.

17052 I

II

12/23/2003

CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

17053 I

II

12/22/2003

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
TEVA PHARMACEUTICAL INDUSTRIES LTD

17054 I

II

12/12/2003

CAMBREX CHARLES CITY INC

BUTALBITAL AS MANUFACTURED IN CHARLES CITY, IA.

17055 A

II

12/19/2003

CAMBREX CHARLES CITY INC

FENTANYL CITRATE USP AS MANUFACTURED IN NORTH BRUNSWICK, NJ.

17056 I

II

12/22/2003

IPCA LABORATORIES LTD

METOPROLOL SUCCINATE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17057 A

III

12/15/2003

CLARIANT PRODUCTION FRANCE

DESICCANT SACHET AS MANUFACTURED IN ST. MAMMES, FRANCE.

17058 I

III

12/15/2003

BESPAK INC

SPACER INHALER AS MANUFACTURED IN APEX, NC.

17059 A

II

12/19/2003

FIS FABBRICA ITALIANA SINTETICI SPA

CMT AS MANUFACTURED IN VICENZA, ITALY.

17060 A

II

12/18/2003

PHARMACEUTICAL WORKS POLPHARMA SA

CARVEDILOL AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

17061 A

II

12/8/2003

UQUIFA MEXICO SA DE CV

CIPROFLOXACIN HYDROCHLORIDE, USP AS MANUFACTURED IN MORELOS, MEXICO.

17062 I

IV

12/26/2003

DAICEL CHEMICAL INDUSTRIES LTD

1, 3-BUTYLENE GLYCOL DRUG EXCIPIENT AS MANUFACTURED IN NIIGATA, JAPAN.

17063 A

II

12/29/2003

SUVEN LIFE SCIENCES LTD

GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ANAGRELIDE HYDROCHLORIDE AS MANUFACTURED IN OLAINE, LATVIA.

ONDANSETRON HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN ZAGREB, CROATIA.

Page 491

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17064 A
II
12/29/2003
CIPLA LTD

SUBJECT
RIVASTIGMINE HYDROGEN TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17065 I

II

12/23/2003

OLAINFARM

CYCLOPHOSPHAMIDE AS MANUFACTURED IN OLAINE, LATVIA.

17066 A

II

12/31/2003

SCINOPHARM TAIWAN LTD

MESTRANOL AS MANUFACTURED IN TAIWAN, R.O.C.

17067 A

II

12/31/2003

SCINOPHARM TAIWAN LTD

LEVONORGESTREL AS MANUFACTURED IN TAIWAN, R.O.C.

17068 A

II

12/31/2003

SCINOPHARM TAIWAN LTD

NORGESTREL AS MANUFACTURED IN TAIWAN, R.O.C.

17069 A

II

1/5/2004

ERCROS SA

LOVASTATIN AS MANUFACTURED IN MADRID, SPAIN.

17070 A

II

12/29/2003

MOEHS IBERICA SL

AMLODIPINE BESILATE AS MANUFACTURED IN BARCELONA, SPAIN.

17071 A

IV

12/2/2003

CRODA INC

TWEEN 80 HP-LQ-(MH) AS MANUFACTURED IN MILL HALL PA

17072 A

III

11/14/2003

3M PHARMACEUTICALS

COTRAN(R) 9707 AS MANUFACTURED IN BROOKINGS, SD.

17073 I

III

12/22/2003

ERIE MOLDED PLASTICS INC

DOSAGE SPOON AS MANUFACTURED IN ERIE, PA.

17074 A

II

1/6/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN GUJARAT, INDIA.

17075 I

II

1/7/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

RASAGILINE MESYLATE AS MANUFACTURED IN BEER SHEVA AND KFARSABA, ISRAEL.

17076 A

II

11/25/2003

EVERLIGHT CHEMICAL INDUSTRIAL CORP

MISOPROSTOL - HPMC 1% DISPERSION AS MANUFACTURED IN TAIWAN, R.O.C.

17077 A

IV

1/5/2004

TAKASAGO INTERNATIONAL CORP

17078 I

IV

1/5/2004

TAKASAGO INTERNATIONAL CORP

17079 A

IV

12/17/2003

BASF SE

TAK-031431 MICRON(R) INTENSATES(R) NATURAL & ARTIFICIAL BLEND MASKING TYPE AS


MANUFACTURED IN TETERBORO, NJ.
TAK-032230 NATURAL & ARTIFICIAL COOL PEPPERMINT FLAVOR OS AS MANUFACTURED IN
TETERBORO, NJ.
Kolliphor(R) CS 12 AS MANUFACTURED IN DUESSELDORF, GERMANY.

17080 A

IV

12/17/2003

BASF SE

KOLLIWAX(R) CSA 50 AS MANUFACTURED IN DUESSELDORF, GERMANY.

17081 A

IV

12/17/2003

BASF SE

KOLLIWAX(R) SA AS MANUFACTURED IN DUESSELDORF, GERMANY.

17082 A

IV

12/17/2003

BASF SE

KOLLIWAX(R) CA AS MANUFACTURED IN DUESSELDORF, GERMANY.

17083 I

12/30/2003

CANGENE CORP

17084 A

II

12/12/2003

ISOCHEM SAS

NP-015-ANTHRAX IMMUNE GLOBULIN (HUMAN) INTRAVENOUS AS MANUFACTURED IN


MANITOBA, CANADA.
DIOSMINE AS MANUFACTURED IN PITHIVIERS, FRANCE.

17085 I

II

12/29/2003

YONEZAWA HAMARI CHEMICALS LTD

FARGA-3 AS MANUFACTURED IN YAMAGATA, JAPAN.

17086 A

II

1/5/2004

BUCHLER GMBH

QUININE SULFATE, USP AS MANUFACTURED IN BRAUNSCHWEIG, GERMANY.

17087 A

IV

12/3/2003

EMERSON RESOURCES INC

PLAS II AS MANUFACTURED IN NORRISTOWN, PA.

17088 A

IV

3/30/2004

MANE INC

BANANA FLAVOR E_9930469 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE.

17089 N

NOT AN ASSIGNED NUMBER

17090 A

II

1/8/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA.

17091 I

II

12/31/2003

ALEMBIC LTD API DIV

AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA.

17092 A

II

1/12/2004

CADILA HEALTHCARE LTD

GATIFLOXACIN SESQUIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA.

17093 A

II

1/14/2004

CADILA PHARMACEUTICALS LTD

GLYBURIDE AS MANUFACTURED IN GUJARAT, INDIA.

17094 I

II

1/14/2004

HENAN KAIFENG PHARMACEUTICAL FACTORY

DOXYCYCLINE HYDROCHLORIDE AS MANUFACTURED IN KAIFENG, CHINA

17095 A

IV

1/12/2004

LUBRIZOL ADVANCED MATERIALS INC

CARBOPOL(R) 71G NF AS MANUFACTURED IN CALVERT CITY, KY.

17096 I

II

12/16/2003

GE HEALTHCARE

17097 I

II

1/14/2004

GLENMARK GENERICS LTD

123I-META-IODOBENZYLGUANIDINE (MIBG) AS MANUFACTURED IN EINDHOVEN,


NETHERLANDS
FLUCONAZOLE AS MANUFACTURED IN GUJARAT STATE, INDIA.

17098 A

II

12/12/2003

CAMBREX PROFARMACO MILANO SRL

ZOLPIDEM TARTRATE AS MANUFACTURED IN CHARLES CITY, IOWA.

17099 I

III

1/7/2004

BETTS UK LTD

METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN ESSEX, UNITED KINGDOM.

Page 492

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17100 I
III
1/14/2004
SOLVIN SA

SUBJECT
SOLVIN(R) 260RC AS MANUFACTURED IN BELGIUM, FRANCE, GERMANY, SPAIN AND BRAZIL.

17101 I

III

1/9/2004

ALBIS PLASTIC GMBH

ALTECH SAN B 1000/01 BK1092-03 AS MANUFACTURED IN HAMBURG, GERMANY.

17102 I

III

1/9/2004

ALBIS PLASTIC GMBH

ALTECH SAN B 1000/01 VT1093-03 AS MANUFACTURED IN HAMBURG, GERMANY.

17103 A

II

1/20/2004

DR REDDYS LABORATORIES LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17104 I

II

1/13/2004

HEUMANN PHARMA GMBH

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN FEUCHT, GERMANY.

17105 I

II

1/14/2004

MOEHS IBERICA SL

AMLODIPINE BASE AS MANUFACTURED IN BARCELONA, SPAIN.

17106 A

II

1/14/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFADROXIL AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

17107 I

II

1/21/2004

CIPLA LTD

AMLODIPINE MESYLATE MONOHYDRATE AS MANUFACTURED IN BANGALORE, INDIA.

17108 I

II

1/20/2004

FUJIAN FUKANG PHARMACEUTICAL CO LTD

7-AMINO CEPHALOSPORANIC ACID (7-ACA) AS MANUFACTURED IN FUZHOU, CHINA.

17109 I

II

1/20/2004

FUJIAN FUKANG PHARMACEUTICAL CO LTD

TOBRAMYCIN SULFATE AS MANUFACTURED IN FUZHOU, THE PEOPLE'S REPUBLIC OF CHINA.

17110 A

II

1/21/2004

HETERO DRUGS LTD

GATIFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17111 I

IV

1/19/2004

SYMRISE INC

17112 I

IV

1/19/2004

SYMRISE INC

17113 A

II

1/21/2004

ASPEN OSS BV

204798 OPTAMINT ROSE FLAVOR AS MANUFACTURED IN HOLZMINDEN, FEDERAL REPUBLIC


OF GERMANY.
205622 OPTACOOL(R) C SPECIAL FLAVORING AS MANUFACTURED IN HOLZMINDEN,
GERMANY.
HYDROXYPROGESTERONE CAPROATE AS MANUFACTURED IN OSS, THE NETHERLANDS.

17114 A

II

1/19/2004

MALLINCKRODT INC

EXENATIDE AS MANUFACTURED IN ST. LOUIS, MO.

17115 A

II

1/23/2004

SANOFI CHIMIE

17116 I

III

12/15/2003

BASF SE

17-DEACETYLNORGESTIMATE (NORELGESTROMIN) AS MANUFACTURED IN VERTOLAYE,


FRANCE.
LUWAX AF 31 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

17117 A

II

1/23/2004

LONZA INC

17118 A

II

1/26/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL) AS MANUFACTURED IN


CONSHOHOCKEN, PA.
PANTOPRAZOLE SODIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17119 I

III

1/14/2004

HINDALCO INDUSTRIES LTD

ALUMINIUM STRIP PACKAGING FOIL AS MANUFACTURED IN THANE, INDIA.

17120 I

III

1/14/2004

HINDALCO INDUSTRIES LTD

ALUMINIUM BLISTER PACKAGING FOIL AS MANUFACTURED IN THANE, INDIA.

17121 I

III

1/14/2004

HINDALCO INDUSTRIES LTD

ALU-ALU BLISTER FOIL AS MANUFACTURED IN THANE, INDIA.

17122 A

II

1/29/2004

DR REDDYS LABORATORIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17123 A

II

1/27/2004

BIOCON LTD

HUMAN INSULIN-BULK (RDNA ORIGIN) AS MANUFACTURED IN BANGALORE, INDIA.

17124 I

III

1/22/2004

INOAC PACKAGING GROUP INC

50ML POLYETHYLENE TEREPHTHALATE BOTTLE PACKAGING COMPONENT AS


MANUFACTURED IN BARDSTOWN, KY AND MEXICO.

17126 I

II

1/12/2004

17127 A

IV

1/28/2004

SANDOZ SYNTEK ILAC HAMMADDELERI SANAYI VE OMEPRAZOLE AS MANUFACTURED IN ISTANBUL, TURKEY.


TICARET AS
HENKEL CORP
DURO-TAK(R) 87-6173 AS MANUFACTURED IN SALISBURY, NC.

17128 A

II

1/28/2004

HARMAN FINOCHEM LTD

ALLOPURINOL AS MANUFACTURED IN MAHARASHTRA, INDIA.

17129 I

III

1/23/2004

SUMMIT PACKAGING SYSTEMS INC

AEROSOL VALVE AS MANUFACTURED IN MANCHESTER, NH AND RACINE, WI.

17130 I

II

1/23/2004

XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD

17131 I

II

1/19/2004

DOTTIKON EXCLUSIVE SYNTHESIS AG

17132 A

IV

1/29/2004

ESSENTRA POROUS TECHNOLOGIES

AMLODIPINE MALEATE AND BESYLATE (NON-STERILE BULK DRUG SUBSTANCE) AS


MANUFACTURED IN SHANXI, CHINA.
PENTAERYTHRITOL TETRANITRATE (DILUTED) AS MANUFACTURED IN DOTTIKON,
SWITZERLAND.
HDW-2002 PREPOLYMER AS MANUFACTURED IN ST. CHARLES, MI.

17125 N

NOT AN ASSIGNED NUMBER

Page 493

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17133 I
II
1/26/2004
CORDEN PHARMA SWITZERLAND LLC

SUBJECT
VAPREOTIDE ACETATE AS MANUFACTURED IN LIESTAL, SWITZERLAND.

17134 A

II

1/30/2004

17135 A

II

1/30/2004

17136 A

II

1/30/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFUROXIME AXETIL, AMORPHOUS AS MANUFACTURED IN KANCHEEPURAM DISTRICT,
INDIA.
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFUROXIME AXETIL, CRYSTALLINE AS MANUFACTURED IN KANCHEEPURAM DISTRICT,
INDIA.
RELIABLE BIOPHARMACEUTICAL CORP
FLUDARABINE PHOSPHATE AS MANUFACTURED IN ST. LOUIS, MO.

17137 A

III

1/30/2004

DEWAL INDUSTRIES INC

17138 I

III

1/12/2004

SPARTECH COLOR

17139 A

III

2/2/2004

MITSUBISHI GAS CHEMICAL CO INC

17140 A

II

2/6/2004

TOKUYAMA CORP

950-56 (LAMINATE OF PTFE FILM AND POLYETHYLENE FOAM) AS MANUFACTURED IN


NARRAGANSETT, RI.
WH 18485, WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN ONTARIO,
CANADA.
OXYGEN ABSORBERS PHARMAKEEP TYPES KD AND KH AS MANUFACTURED IN TOKYO,
JAPAN.
PROPANTHELINE BROMIDE AS MANUFACTURED IN IBARAKI, JAPAN.

17141 A

II

2/4/2004

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

DEXAMETHASONE, USP AS MANUFACTURED IN TIANJIN, CHINA.

17142 A

II

1/30/2004

NCPC HUALUAN PHARMACEUTICAL CO LTD

LINCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN SHIJIAZHUANG, CHINA.

17143 A

II

2/4/2004

MEDICHEM SA

CHLORHEXIDINE DIHYDROCHLORIDE AS MANUFACTURED IN CELRA (GIRONA), SPAIN.

17144 I

II

2/4/2004

ACS DOBFAR UK LTD

17145 I

II

2/4/2004

ASAHI GLASS CO LTD

6-AMINOPENICILLANIC ACID (6-APA) AS MANUFACTURED IN NORTHUMBERLAND, UNITED


KINGDOM.
HYDRAZINE-DIOL AS MANUFACTURED IN KANAGAWA, JAPAN.

17146 I

II

2/10/2004

UBE INDUSTRIES LTD

CS-526 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

17147 I

III

9/15/2004

ATOFINA RESEARCH SA

17148 A

II

2/6/2004

CIPLA LTD

17149 A

III

2/10/2004

CONSTANTIA TOBEPAL SLU

17150 A

II

2/10/2004

SANOFI AVENTIS SPA

POLYPROPYLENE RESIN PELLETS PPH 7060, PPC 5660, PPR 7220, PPR 3261 AS
MANUFACTURED IN FRANCE AND BELGIUM.
MELOXICAM USP AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND VERNA
SALCETTE GOA, INDIA.
FLEXIBLE PACKAGING MATERIAL FOR HEALTHCARE AND FOOD PRODUCTS AS
MANUFACTURED IN LOGRONO AND BURGOS, SPAIN.
RIFAXIMIN AS MANUFACTURED IN BRINDISI, ITALY.

17151 A

II

2/10/2004

KREBS BIOCHEMICALS INDUSTRIES LTD

SIMVASTATIN USP AS MANUFACTURED IN HYDERABAD, INDIA.

17152 A

II

1/20/2004

AUROBINDO PHARMA LTD

GLYBURIDE AS MANUFACTURED IN A.P., INDIA.

17153 I

III

2/5/2004

BERRY PLASTICS CORP TAPES AND COATINGS DIV 25# OR 26# BLEACHED C1S KRAFT PAPER/ 9# LDPE/ .000332 FOIL/ 21# SURLYN AS
MANUFACTURED IN HOMER, LA.
NOT AN ASSIGNED NUMBER

17155 A

IV

2/16/2004

COLORCON

COLORCON NO-TOX(R) PRODUCTS AS MANUFACTURED IN CHALFONT, PA.

17156 A

II

2/16/2004

SIFAVITOR SRL

CICLOPIROX AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY.

17157 A

II

2/13/2004

ASPEN OSS BV

17158 A

III

2/13/2004

ILC DOVER

TETRACOSACTIDE AS MANUFACTURED IN OSS, THE NETHERLANDS AND SERIFONTAINE,


FRANCE.
MASTERBATCHES AND FILMS FOR THE PHARMACEUTICAL INDUSTRY AS MANUFACTURED IN
FREDERICA, DE; CARBONDALE, PA; MARTIN, MI; CINCINNATI, OH; AND HAMMONTON AND
HAWTHORNE, NJ.

17159 I

2/4/2004

DISCOVERY LABORATORIES INC

STERILE MANUFACTURING FACILITY IN TOTOWA, NJ.

17160 I

1/20/2004

17161 A

III

2/6/2004

CINCINNATI CHILDREN'S HOSPITAL MEDICAL


CENTER
BHARAT RUBBER WORKS PVT LTD

TRANSLATIONAL TRIALS DEVELOPMENT AND SUPPORT LABORATORY (TTDSL) AND


CINCINNATI CHILDREN'S RESEARCH FOUNDATION (CCRF) IN CINCINNATIO, OH.
MANUFACTURE OF RUBBER AND PLASTIC PACKAGING COMPONENTS FOR
PHARMACEUTICAL AND HEALTH CARE INDUSTRIES

17162 I

II

2/13/2004

DAIICHI SANKYO CO LTD

DU-176B DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

17154 N

Page 494

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17163 I
III
2/16/2004
BESPAK DIV CONSORT MEDICAL PLC

SUBJECT
BK 357916MT PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK,
ENGLAND.
SECAMINE HYDROCHLORIDE AS MANUFACTURED IN VISP, SWITZERLAND.

17164 A

II

12/10/2003

LONZA LTD

17165 I

III

2/19/2004

COLORTECH INC

17166 A

II

2/18/2004

PROTO CHEMICALS AG

17167 I

III

1/30/2004

TOTAL PETROCHEMICALS RESEARCH FELUY SA

17168 I

II

2/19/2004

ASTELLAS PHARMA INC

HIGH DENSITY POLYETHYLENE RESINS LACQTENE 2003SN53 AND LACQTENE 2020SB5 AS


MANUFACTURED IN HARFLEUR, FRANCE.
FK962 AS MANUFACTURED IN OSAKA, JAPAN.

17169 I

III

11/25/2003

REXPLAS

PACKAGING MATERIAL AS MANUFACTURED IN ONTARIO, CANADA.

17170 A

II

2/18/2004

BAYER SCHERING PHARMA AG

ILOPROST AS MANUFACTURED IN BERLIN, GERMANY.

17171 I

II

2/11/2004

OLON SPA

17172 A

III

2/18/2004

POLYONE CORP

SIBUTRAMINE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN GARBANGNATE


MILANESE (MI), ITALY.
CC00018098WE AS MANUFACTURED IN GLENDALE, AZ.

17173 A

III

1/21/2004

ASTRA PLASTIQUE

CLOSURE VISTOP 36 AS MANUFACTURED IN SAINT-GEORGE DE RENEINS, FRANCE.

17174 A

II

2/13/2004

KREBS BIOCHEMICALS INDUSTRIES LTD

LOVASTATIN USP AS MANUFACTURED IN A.P., INDIA.

17175 A

II

1/23/2004

NATCO PHARMA LTD

ECT-12003 (S-CITALOPRAM OXALATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17176 A

III

2/13/2004

POLYONE CORP

CC10009664BG AS MANUFACTURED IN BENDORF, GERMANY.

17177 A

III

2/13/2004

POLYONE CORP

CC10009679BG AS MANUFACTURED IN BENDORF, GERMANY.

17178 A

III

2/13/2004

POLYONE CORP

CC10009685BG AS MANUFACTURED IN BENDORF, GERMANY.

17179 A

III

2/13/2004

POLYONE CORP

CC10009868BG AS MANUFACTURED IN BENDORF, GERMANY.

17180 A

III

2/13/2004

POLYONE CORP

CC10009872BG AS MANUFACTURED IN BENDORF, GERMANY.

17181 A

III

2/13/2004

POLYONE CORP

CC10009662BG AS MANUFACTURED IN BENDORF, GERMANY.

17182 I

III

2/19/2004

AMPACET CORP

LR-124510 BLUE MLLD POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN,


NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.

17183 A

II

2/20/2004

SANDOZ GMBH

VICA CRUDE AS MANUFACTURED IN TYROL, AUSTRIA.

17184 A

II

2/23/2004

EUTICALS SPA

17185 A

II

2/4/2004

NATCO PHARMA LTD

AZTREONAM INTERMEDIATE NON-STERILE ALPHA-FORM AS MANUFACTURED IN ROZZANO,


ITALY.
CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17186 A

II

2/26/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

AMIFOSTINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17187 A

II

2/25/2004

CIPLA LTD

CARVEDILOL AS MANUFACTURED IN PUNE, INDIA.

17188 A

III

2/19/2004

FUJIMORI KOGYO CO LTD

17189 A

II

3/9/2004

17190 I

III

2/9/2004

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI


LORENZINI
INEOS USA LLC

PLASTIC FILM AND BAG FOR USE IN DRUG SUBSTANCE AND PRODUCT CONTAINERS AS
MANUFACTURED IN MIE AND SHIZUOKA PREFECTURE, JAPAN.
SULBACTAM SODIUM STERILE, USP (BULK) AS MANUFACTURED IN LATINA, ITALY.

17191 I

III

2/9/2004

RELIANCE INDUSTRIES LTD

POLYPROPYLENE RAW MATERIAL REPOL R019MZ AS MANUFACTURED IN GUJARAT, INDIA.

17192 I

III

2/9/2004

RELIANCE INDUSTRIES LTD

POLYPROPYLENE RAW MATERIAL REPOL H200MK AS MANUFACTURED IN GUJARAT, INDIA.

17193 A

II

2/26/2004

EGIS PHARMACEUTICALS PLC

ETHACRYNIC ACID AS MANUFACTURED IN BUDAPEST, HUNGARY.

17194 I

IV

3/1/2004

COLORCON

CHR. HANSEN(TM) SUGAR SPHERE AS MANUFACTURED IN STOUGHTON, WI.

17195 A

III

2/18/2004

POLYONE CORP

CC00015878WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17196 A

III

2/18/2004

POLYONE CORP

CC00015846WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

11002-19 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN


AND ONTARIO, CANADA.
TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN MITLODI, SWITZERLAND.

POLYPROPYLENE RAW MATERIAL REPOL R120MK AS MANUFACTURED IN GUJARAT, INDIA.

Page 495

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17197 I
II
2/22/2004
HEBEI ZHONGRUN PHARMACEUTICAL CO LTD

SUBJECT
6 APA (6-AMINO-PENICILLIC ACID) AS MANUFACTURED IN HEBEI, CHINA.

17198 A

IV

2/27/2004

BASF SE

KOLLIPHOR(R) CS 20 AS MANUFACTURED IN DUESSELDORF, GERMANY.

17199 I

II

2/26/2004

PIERRE FABRE MEDICAMENT

CICLOPIROX AS MANUFACTURED IN GAILLAC CEDEX, FRANCE.

17200 A

2/18/2004

WAISMAN CENTER

WAISMAN CLINICAL BIOMANUFACTURING FACILITY IN MADISON, WI.

17201 I

III

2/27/2004

TEKNOR COLOR CO

17202 I

III

2/27/2004

TEKNOR COLOR CO

17203 I

III

2/27/2004

TEKNOR COLOR CO

17204 I

III

2/27/2004

TEKNOR COLOR CO

COLOR CONCENTRATE 84,060CP YELLOW 2% AND ITS COMPOSITION AS MANUFACTURED IN


HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH.
COLOR CONCENTRATE 55,275CP GREEN 2% AND ITS COMPOSITION AS MANUFACTURED IN
HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH.
COLOR CONCENTRATE 45,703CP BLUE 2% AND ITS COMPOSITION AS MANUFACTURED IN
HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH.
COLOR CONCENTRATE 65,843CP RED 2% AND ITS COMPOSITION AS MANUFACTURED IN
HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH.

17205 N

NOT AN ASSIGNED NUMBER

17206 I

III

2/19/2004

AMPACET CORP

171083 TRANS MINT GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN


TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND
DERIDDER, LA.

17207 A

IV

2/18/2004

EMERSON RESOURCES INC

MARCOAT 125 AS MANUFACTURED IN NORRISTOWN, PA.

17208 A

IV

2/18/2004

EMERSON RESOURCES INC

MARCOAT 125N AS MANUFACTURED IN NORRISTOWN, PA.

17209 A

III

12/23/2003

BORMIOLI ROCCO SPA BU PLASTICS

17210 A

IV

3/5/2004

CAPSUGEL

CHILD-PROOF CAP 18 MM AS MANUFACTURED IN SAINT SULPICE, FRANCE, CASTELGUELFO


(PR) AND RIVANAZZANO (PV), ITALY.
POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN PUEBLA, MEXICO.

17211 A

II

3/4/2004

MYLAN LABORATORIES LTD

AMLODIPINE BESYLATE USP (ADP) AS MANUFACTURED IN TELANGANA, INDIA.

17212 I

III

2/24/2004

HB FULLER CO

HL0916SUV AS MANUFACTURED IN QUEBEC, CANADA.

17213 A

IV

3/1/2004

DOW CORNING CORP

DOW CORNING(R) ST ELASTOMER 10 AS MANUFACTURED IN HEMLOCK, MI.

17214 I

II

3/30/2004

SIGMA ALDRICH CO

CHO ANIMAL-FREE MEDIUM MODIFICATION 21 AS MANUFACTURED IN ST. LOUIS, MO.

17215 A

II

3/4/2004

IRVINE SCIENTIFIC SALES CO

IS CHO-CD4(TM) A CELL CULTURE MEDIUM AS MANUFACTURED IN SANTA ANA, CA.

17216 A

II

3/4/2004

IRVINE SCIENTIFIC SALES CO

IS CHO-CD4(TM) POWDER A CELL CULTURE MEDIUM AS MANUFACTURED IN SANTA ANA, CA.

17217 I

II

3/5/2004

AUROBINDO PHARMA LTD

AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN A.P., INDIA.

17218 I

II

3/4/2004

CHEMWERTH INC

17219 A

III

3/8/2004

3M DRUG DELIVERY SYSTEMS

DAUNORUBICIN HYDROCHLORIDE (TECHNICAL GRADE) AS MANUFACTURED IN DISTRICT


BHARUCH, INDIA FOR CHEMWERTH INC
SCOTCHPAK(TM) 9730 AS MANUFACTURED IN COTTAGE GROVE, MN.

17220 I

III

3/4/2004

HUMPHREY COSBURN PLASTICS

FLIP-TOP DISPENSING CAP AS MANUFACTURED IN ONTARIO, CANADA.

17221 A

II

3/9/2004

SIEGFRIED LTD

NICOTINE BITARTRATE DIHYDRATE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND.

17222 I

III

3/10/2004

SOVEREIGN SPECIALTY CHEMICALS INC

PROXSEAL 8480-107 AS MANUFACTURED IN BUFFALO, NY.

17223 A

II

3/10/2003

CIPLA LTD

17224 A

II

3/5/2004

SIGNA SA DE CV

VALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA,


INDIA.
VALPROIC ACID AS MANUFACTURED IN TOLUCA, MEXICO.

17225 A

II

3/5/2004

SIGNA SA DE CV

SODIUM VALPROATE ACID AS MANUFACTURED IN TOLUCA, MEXICO.

17226 A

II

3/9/2004

ECKERT AND ZIEGLER RADIOPHARMA INC

17227 A

II

3/5/2004

BACHEM AMERICAS INC

YTTRIUM-90 CHLORIDE STERILE SOLUTION AS MANUFACTURED IN BRAUNSCHWEIG,


GERMANY.
EXENATIDE (BULK) AS MANUFACTURED IN TORRANCE, CA.

17228 I

III

3/12/2004

CYTEC SSURFACE SPECIALITIES

PHENODUR(R) PR 612/80B AS MANUFACTURED IN WEISBADEN, GERMANY.

Page 496

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17229 I
II
3/12/2004
DAIICHI SANKYO CO LTD

SUBJECT
CS-023 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN.

17230 I

II

3/12/2004

MEDICHEM SA

ZALEPLON AS MANUFACTURED IN CELRA (GIRONA), SPAIN.

17231 A

II

3/12/2004

MEDICHEM SA

LAMOTRIGINE AS MANUFACTURED IN CELRA (GIRONA), SPAIN.

17232 I

III

3/3/2004

CLARIANT AUSTRALIA PTY LTD

17233 A

II

3/12/2004

SIGMA ALDRICH MANUFACTURING LLC

CUSTOM COLOUR/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND


PACKAGING
POLY-L-LYSINE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO.

17234 A

II

3/8/2004

NOF CORP

17235 A

II

2/16/2004

SIFAVITOR SRL

PURIFIED EGG YOLK SPHINGOMYELIN (PURIFIED EY-SPM) AS MANUFACTURED IN HYOGO,


JAPAN.
BETAXOLOL HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN.

17236 A

III

3/9/2004

ZEON CORP

CYCLO OLEFIN POLYMER 2 AS MANUFACTURED IN OKAYAMA, JAPAN.

17237 A

III

2/6/2004

NIPRO TUBE GLASS LIMITED

GLASS CONTAINERS AS MANUFACTURED IN MAHARASHTRA, INDIA.

17238 A

II

3/16/2004

ANONIMA MATERIE SINTETICHE AND AFFINI SPA

MELOXICAM AS MANUFACTURED IN COMO, ITALY

17239 I

IV

3/18/2004

COLORCON

CHR. HANSEN(TM) CAL-CARB AS MANUFACTURED IN STOUGHTON, WI.

17240 A

II

3/18/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

GABAPENTIN AS MANUFACTURED IN MAHARASHTRA, INDIA.

17241 A

3/12/2004

PRECLINICAL STUDIES ON IBOGAINE

17242 A

IV

3/5/2004

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE DRUG ABUSE
CAPSUGEL

17243 A

II

3/19/2004

ASPEN OSS BV

17244 A

III

3/18/2004

FLEXTRUS AB

17245 A

II

3/19/2004

DR REDDYS LABORATORIES LTD

17246 A

III

3/8/2004

COLORTECH INC

17247 A

II

3/19/2004

DR REDDYS LABORATORIES LTD

11002-19 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN


AND ONTARIO, CANADA.
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17248 A

II

3/22/2004

RELIABLE BIOPHARMACEUTICAL CORP

FENOLDOPAM MESYLATE, USP AS MANUFACTURED IN ST. LOUIS, MO.

17249 A

II

3/19/2004

DR REDDYS LABORATORIES LTD

RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17250 I

III

3/10/2004

AMPACET CORP

17251 A

III

3/18/2004

POLYONE CORP

191121 GREY POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.
CC00014449WE AS MANUFACTURED IN GLENDALE, AZ.

17252 I

II

3/18/2004

LONZA LTD

KW-2401 AS MANUFACTURED IN VISP, SWITZERLAND.

17253 A

III

2/25/2004

BLISTER FILMS AS MANUFACTURED IN SAO PAULO, BRAZIL.

17254 I

II

3/26/2004

PLASTWAL LATINO AMERICANA INDUSTRIA E


COMERCIO LTDA
PROCOS SPA

17255 A

II

3/23/2004

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

OMEPRAZOLE AS MANUFACTURED IN BARCELONA, SPAIN.

17256 I

III

2/27/2004

MATRIX PACKAGING INC

PLASTICS CONTAINERS AS MANUFACTURED IN BRAMPTON, ON, CANADA.

17257 A

II

3/30/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFTRIAXONE SODIUM AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

17258 A

II

3/1/2004

MOEHS IBERICA SL

17259 A

II

3/25/2004

ACS DOBFAR SPA

17260 I

II

3/24/2004

CATALENT PHARMA SOLUTIONS LLC

17261 I

IV

3/25/2004

WILD FLAVORS INC

POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN KANAGAWA


PREFECTURE, JAPAN.
LEUPRORELIN AS MANUFACTURED IN OSS, THE NETHERLANDS
TRANSOFOIL EL-OPET/PE LAMINATE, MATERIAL SPECIFICATION: M80109 AS MANUFACTURED
IN LUND, SWEDEN.
REPAGLINIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ZONISAMIDE AS MANUFACTURED IN NOVARA, ITALY.

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN SANTANDER AND BARCELONA,


SPAIN.
CEFTRIAXONE SODIUM, USP (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY.
RISPERIDONE 2.0 MG ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN SOMERSET,
NJ.
NATURAL AND ARTIFICIAL GRAPE FLAVOR WITH COLOR #FAFH081 (ALSO REFERRED TO AS
#450679) AS MANUFACTURED IN ERLANGER, KY.

Page 497

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17262 I
II
3/26/2004
SIGMA ALDRICH CO

SUBJECT
3-AMINO-1-PROPANESULFONIC ACID AS MANUFACTURED IN ST. LOUIS, MO.

17263 A

II

3/15/2004

SHANDONG XINHUA PHARMACEUTICAL CO LTD

17264 A

II

3/26/2004

SANOFI CHIMIE

17265 A

III

3/26/2004

MULTISORB TECHNOLOGIES INC

HYDROCORTISONE ACETATE, USP (BULK) AS MANUFACTURED IN SHANDONG PROVINCE, P.R.


CHINA.
SPIRONOLACTONE MICRONIZED, PH. EUR, USP, JP AS MANUFACTURED IN VERTOLAYE,
FRANCE.
STABILOX(TM) OXYGEN ABSORBING PRODUCTS AS MANUFACTURED IN BUFFALO, NY.

17266 N

NOT AN ASSIGNED NUMBER

17267 I

III

3/17/2004

DYNA-TECH ADHESIVES

DYNA-TECH ADHESIVES - TECHCRYL 2233 AS MANUFACTURED IN GRAFTON, WV.

17268 I

III

3/17/2004

DYNA-TECH ADHESIVES

DYNA-TECH ADHESIVES - TECHCRYL 6136 AS MANUFACTURED IN GRAFTON, WV.

17269 I

III

3/17/2004

DYNA-TECH ADHESIVES

DYNA-TECH ADHESIVES - DYTAC 2105 AS MANUFACTURED IN GRAFTON, WV.

17270 A

II

3/23/2004

ICROM SPA

MINOXIDIL AS MANUFACTURED IN MILAN, ITALY.

17271 A

IV

3/25/2004

WILD FLAVORS INC

17272 A

IV

3/25/2004

WILD FLAVORS INC

17273 I

IV

3/25/2004

WILD FLAVORS INC

17274 A

IV

3/25/2004

WILD FLAVORS INC

17275 A

IV

3/25/2004

WILD FLAVORS INC

17276 A

IV

4/5/2004

MANE INC

NATURAL BANANA FLAVOR WONF #FAFH080 (ALSO REFERRED TO AS #471608) AS


MANUFACTURED IN ERLANGER, KY.
NATURAL GRAPE FLAVOR WONF #FAFH082 (ALSO REFERRED TO AS #471477) AS
MANUFACTURED IN ERLANGER, KY.
NATURAL GRAPE TYPE FLAVOR #FAFH083 (ALSO REFERRED TO AS #800715) AS
MANUFACTURED IN ERLANGER, KY.
NATURAL BANANA FLAVOR WONF #FAFH079 (ALSO REFERRED TO AS #208830) AS
MANUFACTURED IN ERLANGER, KY.
NATURAL BANANA TYPE FLAVOR #FAFH078 (ALSO REFERRED TO AS #203410) AS
MANUFACTURED IN ERLANGER, KY.
MINT FLAVOR E_0325609 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE.

17277 A

II

3/24/2004

LUPIN LTD

CEPHALEXIN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17278 I

II

3/31/2004

DOCTOR REDDYS LABORATORIES LTD

ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17279 A

II

3/31/2004

UQUIFA MEXICO SA DE CV

CIPROFLOXACIN AS MANUFACTURED IN MORELOS, MEXICO.

17280 A

II

4/2/2004

POLYCARBON INDUSTRIES INC

17281 A

III

3/29/2004

POLYONE CORP

PCI-8001 (1,2-BENZISOXAZOLE-3-METHANESULFONAMIDE) AS MANUFACTURED IN


LEOMINSTER, MA.
CC10022488WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17282 A

III

3/29/2004

POLYONE CORP

CC00014040WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17283 A

III

3/29/2004

POLYONE CORP

CC00007232WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17284 A

III

3/29/2004

POLYONE CORP

CC00007234WE AS MANUFACTURED IN ST. PETERS, MO.

17285 A

II

3/25/2004

MALLINCKRODT INC

HYDROCODONE POLISTIREX AS MANUFACTURED IN ST. LOUIS, MO.

17286 A

II

4/2/2004

CADILA HEALTHCARE LTD

PAROXETINE HYDROCHLORIDE, ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA.

17287 A

II

4/6/2004

MYLAN LABORATORIES LTD

LORATADINE USP (LDP) AS MANUFACTURED IN TELANGANA, INDIA.

17288 I

II

4/6/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

GLIMEPIRIDE AS MANUFACTURED IN GUJARAT, INDIA.

17289 A

II

4/6/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

RIVASTIGMINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

17290 A

II

4/2/2004

PIRAMAL ENTERPRISES LTD

KETOCONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17291 I

II

3/19/2004

RECORDATI ESPANA SL

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN.

17292 I

II

3/16/2004

APOTECNIA SA

ITRACONAZOLE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN.

17293 I

II

3/12/2004

RECORDATI ESPANA SL

17294 I

II

3/15/2004

APOTECNIA SA

PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BENIEL (MURCIA),


SPAIN.
FLUCONAZOLE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN.

17295 A

III

3/29/2004

POLYONE CORP

CC10007232WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

Page 498

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17296 A
III
3/29/2004
POLYONE CORP

SUBJECT
CC10007234WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17297 A

III

3/30/2004

AMPACET CORP

16869-A BLUE (ALCAN CODE WF2804) POLYETHYLENE MASTERBATCH AS MANUFACTURED IN


TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND
DERIDDER, LA.

17298 A

III

3/30/2004

AMPACET CORP

11078-K LAMINATE 78 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN,


NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.

17299 A

III

3/31/2004

PRESSPART GMBH CO KG

17300 A

II

4/3/2004

SHISEIDO CO LTD

RESPIMAT(R) ALUMINUM CYLINDER AS MANUFACTURED IN MARSBERG (BREDELAR),


GERMANY.
CAPCELL C18 AS MANUFACTURED IN SHIZUOKA, JAPAN.

17301 I

II

4/5/2004

BASIC PHARMA CHEM

CHLORHEXIDINE GLUCONATE (BP) AS MANUFACTURED IN GUJARAT, INDIA.

17302 I

II

3/18/2004

SHANDONG XINHUA PHARMACEUTICAL CO LTD

IRISQUINONE AS MANUFACTURED IN SHANDONG, CHINA.

17303 A

II

4/2/2004

DIPHARMA FRANCIS SRL

ZONISAMIDE AS MANUFACTURED IN MERETO DI TOMBA (UD), ITALY.

17304 I

II

4/8/2004

SANOFI CHIMIE

17305 A

II

4/9/2004

MYLAN LABORATORIES LTD

HYDROXY ACID AS MANUFACTURED IN VERTOLAYE AND NEUVILLE-SUR-SAONE CEDEX,


FRANCE.
CIPROFLOXACIN USP AS MANUFACTURED IN TELANGANA, INDIA.

17306 A

II

4/12/2004

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

ADENOSINE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

17307 A

II

4/16/2004

BAYER SCHERING PHARMA AG

NORGESTREL AS MANUFACTURED IN BERLIN AND BERGKAMEN, GERMANY.

17308 I

II

4/6/2004

OFLOXACIN AS MANUFACTURED IN JIANGSU, CHINA.

17309 I

II

4/7/2004

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO


LTD
ARCHER DANIELS MIDLAND COMPANY

17310 A

II

3/31/2004

LUPIN LTD

SIO/BXR REFINED SOYBEAN OIL AS MANUFACTURED IN SAINT LAURENT-BLANGY CEDEX,


FRANCE.
LOVASTATIN AS MANUFACTURED IN MAHARASHTRA, INDIA.

17311 A

II

4/1/2004

MALLINCKRODT INC

CHLORPHENIRAMINE AS MANUFACTURED IN ST. LOUIS, MO.

17312 A

II

4/20/2004

SCINOPHARM TAIWAN LTD

IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN TAIWAN, R.O.C.

17313 I

III

3/15/2004

CONTINENTALAFA DISPENSING CO

DISPENSING PUMPS AS MANUFACTURED IN FOREST CITY, NC.

17314 A

III

4/15/2004

BRASKEM AMERICA INC

POLYPROPYLENE PRODUCTS AS MANUFACTURED IN FREEPORT, TX.

17315 A

III

4/15/2004

DOW CHEMICAL CO

SARAN* PRODUCTS AS MANUFACTURED IN FREEPORT, TX.

17316 I

II

4/12/2004

ZINCOLLIED (INDIA)

ZINC OXIDE AS MANUFACTURED IN DAMAN, INDIA.

17317 A

II

4/15/2004

CIPLA LTD

SERTRALINE HYDROCHLORIDE (FORM II) AS MANUFACTURED IN PUNE, INDIA.

17318 A

II

4/9/2004

LEK PHARMACEUTICALS DD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN MENGES, SLOVENIA.

17319 I

II

4/13/2004

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

LABETALOL HYDROCHLORIDE AS MANUFACTURED IN BARCELONA SPAIN

17320 A

II

5/7/2004

NOF CORP

17321 I

II

4/16/2004

KV PHARMACEUTICAL CO

DOPS-NA (DIOLEOYL PHOSPHATIDYLSERINE, SODIUM SALT) AS MANUFACTURED IN HYOGO,


JAPAN.
DESTAB(TM) FERROUS FUMARATE 90 S ULTRA AS MANUFACTURED IN ST. LOUIS, MO.

17322 I

III

3/25/2004

BOEHRINGER INGELHEIM MICROPARTS GMBH

RESPIMAT(R) INHALER AS MANUFACTURED IN DORTMUND, GERMANY.

17323 A

8/6/2004

BOEHRINGER INGELHEIM FREMONT INC

ABGENIX PRODUCTION FACILITIES IN FREMONT, CA.

17324 A

II

4/19/2004

AMOXICILLIN AS MANUFACTURED IN HEBEI, P.R. CHINA.

17325 A

II

4/20/2004

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
MYLAN LABORATORIES LTD

17326 A

II

4/19/2004

FORMOSA LABORATORIES INC

SERTRALINE HYDROCHLORIDE USP (FORM II) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
BALSALAZIDE DISODIUM DIHYDRATE USP AS MANUFACTURED IN TAOYUAN, TAIWAN.

17327 A

II

4/26/2004

ESTEVE QUIMICA SA

LEVETIRACETAM AS MANUFACTURED IN TARRAGONA, SPAIN.

Page 499

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17328 I
II
4/23/2004
HOVIONE FARMACIENCIA SA

SUBJECT
17ST75030 AS MANUFACTURED IN LOURES, PORTUGAL.

17329 I

II

4/27/2004

QUIMICA SINTETICA SA

LANZOPRAZOLE AS MANUFACTURED IN MADRID, SPAIN.

17330 A

II

4/22/2004

CIPLA LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN PUNE, INDIA.

17331 A

IV

4/21/2004

TAKASAGO INTERNATIONAL CORP

17332 A

IV

4/21/2004

TAKASAGO INTERNATIONAL CORP

17333 A

II

4/26/2004

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD

17334 I

II

4/28/2004

RANBAXY LABORATORIES LTD

TAK-020184 MICRON(R) ARTIFICIAL MENTHOL FLAVOR AS MANUFACTURED IN TETERBORO,


NJ.
TAK-022173 MICRON(R) NATURAL & ARTIFICIAL MENTHOL FLAVOR AS MANUFACTURED IN
TETERBORO, NJ.
FOSPHENYTOIN SODIUM USP AS MANUFACTURED IN SHANGHAI, CHINA FOR CHEMWERTH
INC
CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17335 A

II

4/15/2004

SAFC BIOSCIENCES INC

EX-CELL(TM) 302, CHO, SERUM-FREE MEDIUM AS MANUFACTURED IN DENVER, PA.

17336 I

II

4/12/2004

TAIHO PHARMACEUTICAL CO LTD

IPD-1151T DRUG SUBSTANCE AS MANUFACTURED IN SAITAMA, JAPAN.

17337 I

II

4/22/2004

ASTELLAS PHARMA INC

FK330 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO AND OSAKA, JAPAN.

17338 I

III

4/28/2004

ROHM AND HAAS CO

ADHESIVE E-2723LV AS MANUFACTURED IN CROYDON, PA.

17339 I

III

5/3/2004

ROHM AND HAAS CO

ROSBOND PS-67LV AS MANUFACTURED IN CROYDON, PA.

17340 I

III

4/28/2004

ROHM AND HAAS CO

ADHESIVE E-2723RG AS MANUFACTURED IN CROYDON, PA.

17341 I

III

4/21/2004

CLARIANT (CANADA) INC

17342 I

III

4/21/2004

CLARIANT (CANADA) INC

17343 A

II

3/6/2004

ANQIU LUAN PHARMACEUTICAL CO LTD

WHITE CLARIANT MASTERBATCH 01MPG-090 AS MANUFACTURED IN TORONTO AND


QUEBEC, CANADA.
WHITE CLARIANT MASTERBATCH 01VFV-110 AS MANUFACTURED IN TORONTO AND QUEBEC,
CANADA.
ACETAMINOPHEN AS MANUFACTURED IN SHANDONG PROVINCE, CHINA.

17344 I

IV

4/23/2004

BIO INVIGOR CORP

BIODEGRADABLE POLYMERS AS MANUFACTURED IN TAIPEI, TAIWAN.

17345 I

II

4/22/2004

IPCA LABORATORIES LTD

PENTOXIFYLLINE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17346 A

II

4/5/2004

INKE SA

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

17347 A

II

4/29/2004

SYNKEM SAS

CICLOPIROX AS MANUFACTURED IN CHENOVE, FRANCE.

17348 I

II

5/13/2004

CHEMWERTH INC

17349 I

II

5/3/2004

PROCOS SPA

IRINOTECAN HCL (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN JIANGSU,


CHINABY JIANHSU HENGRUI MEDICINE CO. LTD FOR CHEMWERTH.
DIVALPROEX SODIUM AS MANUFACTURED IN NOVARA, ITALY.

17350 A

II

5/6/2004

MYLAN LABORATORIES LTD

CLARITHROMYCIN USP(COP) AS MANUFACTURED IN TELANGANA, INDIA.

17351 I

II

4/29/2004

ERREGIERRE SPA

GABAPENTIN AS MANUFACTURED IN BERGAMO, ITALY.

17352 A

II

4/29/2004

MOEHS IBERICA SL

SUMATRIPTANE SUCCINATE AS MANUFACTURED IN BARCELONA, SPAIN.

17353 A

II

4/27/2004

LUPIN LTD

LOVASTATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17354 A

III

4/22/2004

FENOPLAST LTD

17355 A

II

4/26/2004

SCI PHARMTECH INC

RIGID PVC FILM & PVC/PVDC COMPOSITE FILM AS MANUFACTURED IN ANDHRA PRADESH,
INDIA.
PROBUCOL AS MANUFACTURED IN TAOYUAN, TAIWAN.

17356 I

II

4/29/2004

SIGMA ALDRICH CO

17357 A

II

4/22/2004

PIERRE FABRE MEDICAMENT

STEMLINE(TM) II HEMATOPOIETIC STEM CELL EXPANSION MEDIUM AS MANUFACTURED IN


ST. LOUIS, MO.
VINFLUNINE DITARTRATE AS MANUFACTURED IN GAILLAC CEDEX, FRANCE.

17358 A

II

5/5/2004

CADILA HEALTHCARE LTD

MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA.

17359 A

III

5/3/2004

AICELLO CORP

CLEAN BAG (FB01, KB02, KC04 AND FA12) AS MANUFACTURED IN AICHI, JAPAN.

17360 I

II

6/23/2004

MALLINCKRODT INC

OPTIMARK(R) (GADOVERSETAMIDE INJECTION) PARAMETRIC RELEASE AS MANUFACTURED


IN RALEIGH, NC.

17361 N

NOT AN ASSIGNED NUMBER

Page 500

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17362 I
IV
5/3/2004
FONA INTERNATIONAL INC
17363 I

IV

5/3/2004

FONA INTERNATIONAL INC

17364 A

II

2/20/2004

CHANGZHOU SIYAO PHARMACEUTICALS CO LTD

SUBJECT
926.029 NOR-VAN POWDER (A NATURAL & ARTIFICIAL FLAVOR) AS MANUFACTURED IN CAROL
STREAM, IL.
863.002 N-C NATURAL LEMON-LIME FLAVOR (WONF) AS MANUFACTURED IN CAROL STREAM,
IL.
CYPROHEPTADINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA.

17365 I

II

5/7/2004

ELAN DRUG DELIVERY INC

N1486 NANOCRYSTAL(R) TABLET CORES AS MANUFACTURED IN KING OF PRUSSIA, PA.

17366 I

II

5/10/2004

DR REDDYS LABORATORIES LTD

MELOXICAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17367 A

II

5/5/2004

CHEMO IBERICA SA MADRID

ISRADIPINE AS MANUFACTURED IN MADRID, SPAIN.

17368 I

IV

4/22/2004

DAH FENG CAPSULE INDUSTRY CO LTD

EMPTY GELATIN CAPSULE (HARD SHELL) AS MANUFACTURED IN TAICHUNG, TAIWAN.

17369 A

II

5/6/2004

SANDOZ INDUSTRIAL PRODUCTS GMBH

VICA, PURE (3-VINYL-ACA) AS MANUFACTURED IN FRANKFURT, GERMANY.

17370 I

III

5/5/2004

CCC PLASTICS

17371 I

II

4/16/2004

THERAGENICS CORP

WHITE MB50-926 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN


ONTARIO, CANADA.
GALLIUM CHLORIDE GA-67 (BULK) RADIOCHEMICAL AS MANUFACTURED IN BUFORD, GA.

17372 I

II

5/12/2004

S.A. AJINOMOTO OMNICHEM N.V.

CILOSTAZOL AS MANUFACTURED IN WETTEREN, BELGIUM.

17373 I

II

5/10/2004

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

CHLORAMPHENICOL HEMISUCCINATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

17374 A

II

5/13/2004

EUTICALS SPA

FLUDARABINE PHOSPHATE AS MANUFACTURED IN VARESE, ITALY.

17375 A

II

5/13/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFPROZIL AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

17376 I

III

5/13/2004

LORMAC INDUSTRIAL DISTRIBUTORS LTD

LORMAC TYPE 20 POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND.

17377 I

III

5/11/2004

CLARIANT (CANADA) INC

17378 I

III

5/11/2004

CLARIANT (CANADA) INC

17379 A

III

5/14/2004

DYNIC USA CORP

RED CLARIANT MASTERBATCH 20PP-1396 AS MANUFACTURED IN ONTARIO AND QUEBEC,


CANADA.
RED CLARIANT MASTERBATCH 02EHD-1870 AS MANUFACTURED IN ONTARIO AND QUEBEC,
CANADA.
HL21 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

17380 A

III

5/14/2004

DYNIC USA CORP

NK21 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

17381 I

III

5/11/2004

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 17-1006 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT.

17382 A

II

5/17/2004

HUASHU PHARMACEUTICAL CORP

NEOMYCIN SULFATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA.

17383 A

III

5/11/2004

ALUBERG SPA

17384 A

II

5/17/2004

YANGZHOU PHARMACEUTICAL CO LTD

COLD FORMABLE-LAMINATED ALUMINIUM FOIL DRUG PACKAGING MATERIALS AS


MANUFACTURED IN BERGAMO, ITALY.
ISRADIPINE (USP26) AS MANUFACTURED IN JIANGSU, CHINA.

17385 N

NOT AN ASSIGNED NUMBER

17386 A

II

5/20/2004

CATALENT PHARMA SOLUTIONS LLC

ZEMPLAR (PARACALCITOL) CAPSULES, 1 MCG AS MANUFACTURED IN SOMERSET, NJ.

17387 I

III

5/10/2004

STELLA KUNSTSTOFFTECHNIK GMBH

REDIPAC/MO-DO-CO, 1 ML, WHITE/WHITE AS MANUFACTURED IN ELTVILLE, GERMANY.

17388 A

II

5/17/2004

NITROFURAZONE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

17389 A

III

5/11/2004

MINSHENG GROUP SHAOXING PHARMACEUTICAL


CO LTD
3M DRUG DELIVERY SYSTEMS

17390 I

IV

5/18/2004

BP AMOCO CHEMICALS

17391 I

IV

5/18/2004

INEOS USA LLC

17392 A

II

5/18/2004

SCINOPHARM TAIWAN LTD

INDOPOL(R) POLYBUTENE PRODUCTS AS MANUFACTURED IN LAVERA, FRANCE AND


WHITING, IN.
PANALANE(R) POLYBUTENE PRODUCTS AS MANUFACTURED IN LAVERA, FRANCE AND
WHITING, IN.
OMEPRAZOLE AS MANUFACTURED IN TAIWAN, R.O.C.

17393 A

II

5/17/2004

CONCORD BIOTECH LTD

LOVASTATIN USP AS MANUFACTURED IN AHMEDABAD, INDIA.

17394 A

II

5/18/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

IRBESARTAN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17395 A

II

5/19/2004

FARMABIOS S P A

FLUOCINOLONE ACETONIDE AS MANUFACTURED IN GROPELLO CAIROLI, ITALY.

COTRAN(TM) 9715 AS MANUFACTURED IN BROOKINGS, SD.

Page 501

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17396 A
II
5/25/2004
CIPLA LTD

SUBJECT
CLOPIDOGREL BISULPHATE AS MANUFACTURED IN PUNE, INDIA.

17397 A

II

5/25/2004

CIPLA LTD

SUMATRIPTAN SUCCINATE AS MANUFACTURED IN RAIGAD, INDIA.

17398 A

II

5/24/2004

INCELL CORP LLC

M3(TM) CELL CULTURE MEDIA AS MANUFACTURED IN SAN ANTONIO, TX.

17399 A

II

5/20/2004

RAPAMYCIN AS MANUFACTURED IN TAIWAN, R.O.C.

17400 A

II

5/19/2004

17401 A

II

5/20/2004

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH
CO LTD
SMS PHARMACEUTICALS LTD

17402 A

III

5/11/2004

3M DRUG DELIVERY SYSTEMS

COTRAN(TM) 9712 AS MANUFACTURED IN BROOKINGS, SD.

17403 I

III

5/10/2004

BOEHRINGER INGELHEIM MICROPARTS GMBH

17404 A

IV

5/17/2004

NOF CORP

17405 I

II

5/17/2004

ZACH SYSTEM SPA

PLASTIC CAP WITH INTEGRATED SEALING RING FOR THE USE WITH RESPIMAT(R) INHALER
CARTRIDGE AS MANUFACTURED IN DORTMUND, GERMANY.
REFINED EGG YOLK PHOSPHATIDYLCHOLINE; COATSOME NC-50 AS MANUFACTURED IN
HYOGO, JAPAN.
CARVEDILOL AS MANUFACTURED IN BARCELONA, SPAIN.

17406 I

II

5/28/2004

POLYCARBON INDUSTRIES INC

DISULFIRAM USP AS MANUFACTURED IN LEOMINSTER, MA.

17407 A

II

5/27/2004

ERIOCHEM SA

17408 I

II

5/31/2004

DAI ICHI KARKARIA LTD

VINDOLINE AND CATHARANTHINE MIXTURE (VYC) AS MANUFACTURED IN ENTRE RIOS,


ARGENTINA.
TRAMADOL HYDROCHLORIDE EP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17409 I

IV

5/28/2004

AUTHENTIX INC

PROPRIETARY MARKERS AS MANUFACTURED IN ADDISON, TX.

17410 I

III

5/14/2004

CLARIANT AUSTRALIA PTY LTD

REMAFIN WHITE L1071 AS MANUFACTURED IN AUSTRALIA.

17411 I

II

5/24/2004

SUMITOMO CHEMICAL CO LTD

SNK-860 AS MANUFACTURED IN JAPAN.

17412 I

III

5/24/2004

RITE SYSTEMS

17413 A

II

5/26/2004

SIGNA SA DE CV

LIQUID COLOR-NQT-BR1230-1 AS MANUFACTURED IN WEST CHICAGO, IL; STATESVILLE, NC


AND CITY OF INDUSTRY, CA.
DIDEOXYINOSINE AS MANUFACTURED IN TOLUCA, MEXICO.

17414 I

IV

5/27/2004

HAYASHIBARA CO LTD

TREHALOSE AS MANUFACTURED IN OKAYAMA, JAPAN.

17415 I

II

5/24/2004

EXCELLA GMBH

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY.

17416 A

II

5/25/2004

LG LIFE SCIENCES

SODIUM HYALURONATE AS MANUFACTURED IN JEONBUK-DO, KOREA.

17417 I

II

5/21/2004

UQUIFA ITALIA SPA

DOXYLAMINE SUCCINATE USP AS MANUFACTURED IN MILAN, ITALY.

17418 A

II

5/26/2004

CAMBRIDGE ISOTOPE LABORATORIES INC

OXYGEN-18 ENRICHED WATER, CIL PART NUMBER OLM-240 AS MANUFACTURED IN


ANDOVER, MA.

17420 A

III

5/21/2004

BORMIOLI ROCCO AND FIGLIO SPA

17421 A

II

4/22/2004

BASF SE

HDPE BOTTLE 240 ML AS MANUFACTURED IN CASTELGUELFO AND RIVANAZZANO, ITALY; AND


SAINT SULPICE, FRANCE.
DRY VITAMIN D3 100 AS MANUFACTURED IN BALLERUP, DENMARK.

17422 A

II

5/9/2004

ZHEJIANG TIANTAI PHARMACEUTICAL CO LTD

CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

17419 N

CARISOPRODOL AS MANUFACTURED IN TAIWAN, R.O.C.


RAMIPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

NOT AN ASSIGNED NUMBER

17423 N

NOT AN ASSIGNED NUMBER

17424 I

II

6/10/2004

UOP LLC

UOP MOLSIV TYPE GMP-3A AS MANUFACTURED IN CHICKASAW, AL.

17425 A

III

5/11/2004

3M DRUG DELIVERY SYSTEMS

COTRAN(TM) 9716 AS MANUFACTURED IN BROOKINGS, SD.

17426 I

III

5/24/2004

ROHM AND HAAS CO

ADCOTE 518 ADHESIVE AS MANUFACTURED IN RINGWOOD, IL.

17427 I

III

5/18/2004

HUMPHREY COSBURN PLASTICS

17428 I

III

5/17/2004

HUMPHREY COSBURN PLASTICS

LOPROX TOTTLE 40ML-SNAP ON WITH NEW RESIN AS MANUFACTURED IN ONTARIO,


CANADA.
22MM SPECIAL H FLIP TOP LOPROX CAP AS MANUFACTURED IN ONTARIO, CANADA.

Page 502

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17429 I
III
5/18/2004
HUMPHREY COSBURN PLASTICS

SUBJECT
LOPROX TOTTLE 75ML-SNAP ON WITH OLD RESIN AS MANUFACTURED IN ONTARIO, CANADA.

17430 I

III

5/18/2004

HUMPHREY COSBURN PLASTICS

LOPROX TOTTLE 40ML-SNAP ON WITH OLD RESIN AS MANUFACTURED IN ONTARIO, CANADA.

17431 I

III

5/18/2004

HUMPHREY COSBURN PLASTICS

17432 I

III

5/18/2004

17433 I

III

5/18/2004

17434 I

II

5/25/2004

17435 A

II

5/31/2004

17436 A

IV

6/1/2004

17437 I

III

6/1/2004

17438 I

III

5/24/2004

17441 A

II

5/27/2004

SRI KRISHNA PHARMACEUTICALS LTD

ACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F) AS MANUFACTURED IN A.P., INDIA.

17442 A

III

5/27/2004

CFC INTERNATIONAL

PIGMENTED FOILS AS MANUFACTURED IN CHICAGO HEIGHTS, IL.

17443 A

III

4/16/2004

ST GOBAIN PERFORMANCE PLASTICS

17444 A

II

6/3/2004

UQUIFA ITALIA SPA

POLYESTER C1S 8310 UV CURABLE SILICONE RELEASE COATING AS MANUFACTURED IN


WORCESTER, MA.
CARISOPRODOL USP AS MANUFACTURED IN MILAN, ITALY.

17445 A

II

6/1/2004

CAYMAN CHEMICAL CO

LATANOPROST DRUG SUBSTANCE AS MANUFACTURED IN ANN ARBOR, MI.

17446 I

II

5/27/2004

FDC LTD

DANTROLENE SODIUM AS MANUFACTURED IN MAHARASHTRA STATE, INDIA.

17447 A

II

6/3/2004

BIOCON LTD

PRAVASTATIN SODIUM AS MANUFACTURED IN BANGALORE, INDIA.

17448 A

III

6/1/2004

COLORTECH INC

17449 I

III

5/27/2004

ROLLPRINT PACKAGING PRODUCTS INC

11002-13 WHITE POLYETHYLENE CONCENTRATION AS MANUFACTURED IN MORRISTOWN, TN


AND ONTARIO, CANADA.
RPP# 37-1045 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT.

17450 I

III

5/27/2004

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 37-1023 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT.

17451 A

IV

5/27/2004

PCAS

LACTIDE: GLYCOLIDE COPOLYMER (PLGA 50:50) AS MANUFACTURED IN ARAMON, FRANCE.

17452 A

IV

5/27/2004

PCAS

LACTIDE: GLYCOLIDE COPOLYMER (PLGA 75:25) AS MANUFACTURED IN ARAMON, FRANCE.

17453 A

II

6/7/2004

SANDOZ PRIVATE LTD

CEFPROZIL AS MANUFACTURED IN MAHARASHTRA, INDIA.

17454 A

III

5/1/2004

NAN YA PLASTICS CORP USA

RIGID PVC SHEET AS MANUFACTURED IN WHARTON, TX.

17455 I

III

5/19/2004

AMPACET CORP

190895 BLACK AO POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA; AND
MESSANCY, BELGIUM.

17456 A

II

6/8/2004

CIPLA LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

17457 I

II

6/7/2004

PAXIS PHARMACEUTICALS

PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN BOULDER, CO.

17458 I

II

6/10/2004

ORGANICS LLC

17B-ESTRADIOL-3-PHOSPHATE, ACID FORM (F00152) AS MANUFACTURED IN CHICAGO, IL.

17459 I

II

6/9/2004

NV ORGANON

OXANDROLONE AS MANUFACTURED IN OSS, THE NETHERLANDS.

17439 N
17440 N

LOPROX TOTTLE 100ML - SNAP ON WITH OLD RESIN AS MANUFACTURED IN ONTARIO,


CANADA.
HUMPHREY COSBURN PLASTICS
LOPROX TOTTLE 100ML - SNAP ON WITH NEW RESIN AS MANUFACTURED IN ONTARIO,
CANADA.
HUMPHREY COSBURN PLASTICS
LOPROX TOTTLE 75ML - SNAP ON WITH NEW RESIN AS MANUFACTURED IN ONTARIO,
CANADA.
ZHEJIANG HISUN PHARMACEUTICAL CO LTD
COMPACTIN (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN
ZHEJIANG PROVINCE, CHINA.
AUROBINDO PHARMA LTD
SERTRALINE HYDROCHLORIDE CRYSTALLINE POLYMORPH FORM II AS MANUFACTURED IN
ANDHRA PRADESH, INDIA.
ABITEC CORP
CAPMUL(R) PG-8 (PROPYLENE GLYCOL MONOCAPRYLATE) AS MANUFACTURED IN
COLUMBUS, OH.
TEKNOR COLOR CO
COLOR CONCENTRATE 26,880CP BLACK 50/1 AND ITS COMPOSITION AS MANUFACTURED IN
HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, FL; AND LODI, OH.
BERRY PLASTICS CORP TAPES AND COATINGS DIV 1058D TYVEK/10.8# POLYETHYLENE/.0003 ALUMINUM FOIL/PRIMER/10.0# POLYETHYLEN/1.5
MIL EVA FILM AS MANUFACTURED IN HOMER, LA.
NOT AN ASSIGNED NUMBER
NOT AN ASSIGNED NUMBER

Page 503

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17460 A
II
6/10/2004
IPCA LABORATORIES LTD

SUBJECT
LOSARTAN POTASSIUM PROCESS II AS MANUFACTURED IN RATLAM, INDIA.

17461 I

II

6/14/2004

DAIICHI SANKYO CO LTD

CS-088 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN.

17462 I

II

6/14/2004

IHARA CHEMICAL INDUSTRY CO LTD

MKS-1 (AN INTERMEDIATE OF GATIFLOXACIN) AS MANUFACTURED IN SHIZUOKA, JAPAN.

17463 A

II

5/24/2004

TAKASAGO INTERNATIONAL CORP

RUTHENIUM COMPLEX AS MFG IN SHIQUOKA PREFECTURE, JAPAN

17464 I

III

6/11/2004

EASTMAN CHEMICAL CO

ELEGANTE(R) POLYMER AS MANUFACTURED IN KINGSPORT, TN.

17465 N

NOT AN ASSIGNED NUMBER

17466 N

NOT AN ASSIGNED NUMBER

17467 I

II

5/24/2004

17468 N

S.A. AJINOMOTO OMNICHEM NV

AMINO ACID MIXTURE BAX-D AS MANUFACTURED IN LOUVAIN-LA-NEUVE BELGIUM

NOT AN ASSIGNED NUMBER

17469 A

II

6/21/2004

WOCKHARDT LTD

DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA.

17470 I

III

6/16/2004

AMPACET CORP

17471 I

II

6/17/2004

PEPTISYNTHA SA

181198 AMBER POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA.
AFAMELANOTIDE BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS, BELGIUM.

17472 A

II

6/16/2004

INO THERAPEUTICS INC

NITRIC OXIDE FOR INHALATION, 800PPM AS MANUFACTURED IN PORT ALLEN, LA.

17473 A

IV

6/7/2004

DAI ICHI KOGYO SEIYAKU CO LTD

DK ESTERS (SUCROSE FATTY ACID ESTERS) AS MANUFACTURED IN SHIGA, JAPAN.

17474 I

III

6/17/2004

CIBA SPECIALTY CHEMICALS

IRGAGUARD B5000 AS MANUFACTURED IN OSAKA, JAPAN.

17475 I

II

6/22/2004

ALEMBIC PHARMACEUTICALS LTD

CILOSTAZOL AS MANUFACTURED IN GUJARAT, INDIA.

17476 A

II

6/18/2004

AMINO CHEMICALS LTD

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA.

17477 A

III

6/18/2004

PARAMAK CORP

DROPPER ASSEMBLY AS MANUFACTURED IN BALTIMORE, MD.

17478 A

II

6/22/2004

LEK PHARMACEUTICAL AND CHEMICAL CO DD

17479 I

II

2/7/2004

DINESH PHARMACEUTICALS PRIVATE LTD

VANCOMYCIN HYDROCHLORIDE ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN MENGES,


SLOVENIA.
ACETAMINOPHEN USP AS MANUFACTURED IN GUJARAT, INDIA.

17480 I

II

6/22/2004

ARCHER DANIELS MIDLAND CO

17481 I

III

6/2/2004

STEAG MICROPARTS GMBH

17482 A

II

6/22/2004

MEIJI SEIKA PHARMA CO LTD

SIO/BXR REFINED OLIVE OIL AS MANUFACTURED IN SAINT LAURENT-BLANGY CEDEX,


FRANCE.
ALUMINUM CYLINDER FOR THE USE WITH RESPIMAT(R) INHALER CARTRIDGE AS
MANUFACTURED IN DORTMUND, GERMANY.
CEFDITOREN PIVOXIL DRUG SUBSTANCE AS MANUFACTURED IN JAPAN.

17483 A

II

6/21/2004

GUFIC BIOSCIENCES LTD

LIDOCAINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA.

17484 I

II

6/21/2004

RANBAXY LABORATORIES LTD

ATORVASTATIN MAGNESIUM AS MANUFACTURED IN PUNJAB, INDIA.

17485 I

III

6/16/2004

AMCOR FLEXIBLES RAACKMANN

PETP 12/ALU 7/LLDPE 60 AS MANUFACTURED IN HORSENS, DENMARK.

17486 A

II

6/22/2004

TIANJIN ZHONGAN PHARMACEUTICAL CO LTD

CAFFEINE (ANHYDROUS) AS MANUFACTURED IN TIANJIN, P.R. CHINA.

17487 I

II

6/24/2004

USV LTD

CARVEDILOL PH. EUR. AS MANUFACTURED IN MAHARASHTRA, INDIA.

17488 A

II

6/25/2004

TRIFARMA SPA

OXCARBAZEPINE AS MANUFACTURED IN MILANO, ITALY.

17489 A

II

6/21/2004

CAMBREX CHARLES CITY INC

TORSEMIDE AS MANUFACTURED IN CHARLES CITY, IA.

17490 A

III

6/16/2004

BERRY PLASTICS CORP

PRODUCT 60110-18

17491 A

III

6/23/2004

ALTIRA INC

PLASTIC BOTTLES AS MANUFACTURED IN MIAMI, FL.

17492 A

IV

6/28/2004

AUXILIUM PHARMACEUTICALS INC

OXACYCLOHEXADECAN-2-ONE AS MANUFACTURED IN NORRISTOWN, PA.

17493 I

III

6/14/2004

POLIMERI EUROPA FRANCE SNC

ERACLENE ML70 AS MANUFACTURED IN PORTO-TORRES, ITALY.

17494 I

III

6/14/2004

POLIMERI EUROPA FRANCE SNC

ERACLENE MR80 AS MANUFACTURED IN PORTO-TORRES, ITALY.

17495 I

III

6/14/2004

POLIMERI EUROPA FRANCE SNC

ERACLENE MQ70 AS MANUFACTURED IN PORTO-TORRES, ITALY.

Page 504

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17496 A
III
6/22/2004
FARMASERVICE SRL

SUBJECT
ROUND HDPE BOTTLE 200 ML AS MANUFACTURED IN SERMONETA (LT), ITALY.

17497 A

III

6/22/2004

FARMASERVICE SRL

ROUND HDPE BOTTLE 150 ML AS MANUFACTURED IN SERMONETA (LT), ITALY.

17498 I

II

6/23/2004

LOVASTATIN AS MANUFACTURED IN TAIWAN, THE REPUBLIC OF CHINA.

17499 A

III

6/21/2004

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
POLIMERI EUROPA FRANCE SNC

17500 I

II

6/25/2004

FARCHEMIA SRL

BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN BERGAMO, ITALY.

17501 A

II

6/14/2004

CODY LABORATORIES INC

HYDROMORPHONE HYDROCHOLORIDE AS MANUFACTURED IN CODY, WY.

17502 I

II

6/29/2004

CAMBREX CHARLES CITY INC

PROPOXYPHENE HYDROCHLORIDE AS MANUFACTURED IN CHARLES CITY, IA.

17503 I

II

6/28/2004

CAMBREX CHARLES CITY INC

PROPOXYPHENE NAPSYLATE AS MANUFACTURED IN CHARLES CITY, IA.

17504 A

II

6/26/2004

SYNBIAS PHARMA LTD

IDARUBICIN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE.

17505 N

GREENFLEX FF55 AS MANUFACTURED IN OBERHAUSEN, GERMANY.

NOT AN ASSIGNED NUMBER

17506 A

III

6/30/2004

ACS DOBFAR SPA

STERBAG(R) PACKAGING SYSTEM AS MANUFACTURED IN TRIBIANO, ITALY.

17507 A

II

7/2/2004

HETERO LABS LTD

IRBESARTAN (FORM A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17508 A

III

4/23/2004

PLAMI SA DE CV

BLISTER FILMS AS MANUFACTURED IN NAUCALPAN, MEXICO.

17509 A

II

7/1/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

CEFADROXIL AS MANUFACTURED IN MEXICO, MO.

17510 I

II

7/6/2004

DAIICHI SANKYO CO. LTD

DW-908E DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

17511 I

II

7/1/2004

ESTEVE QUIMICA SA

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN BARCELONA AND CELRA, SPAIN.

17512 I

II

7/6/2004

SANDOZ GMBH

SULBACTAM SODIUM (STERILE) AS MANUFACTURED IN TYROL, AUSTRIA.

17513 A

II

6/18/2004

UCB FARCHIM SA

CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN SWITZERLAND.

17515 A

IV

6/28/2004

MS ERAWAT PHARMA LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN PITHAMPUR, INDIA.

17516 I

III

6/17/2004

RIBEYRON FRANCE

TECHNICAL FILM AS MANUFACTURED IN SAINTE SIGOLENE, FRANCE.

17517 A

II

7/14/2004

JANSSEN PHARMACEUTICA NV

TIPIFARNIB (R115777) DRUG SUBSTANCE AS MANUFACTURED IN BELGIUM AND IRELAND.

17518 A

II

7/12/2004

17519 I

III

7/9/2004

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA.
CO LTD
ROHM AND HAAS CO
ADCOTE 37P295HV AS MANUFACTURED IN RINGWOOD, IL.

17520 A

II

7/13/2004

MYLAN LABORATORIES LTD

RISPERIDONE USP AS MANUFACTURED IN TELANGANA, INDIA

17521 A

II

7/13/2004

MYLAN LABORATORIES LTD

MIRTAZAPINE USP (HEMIHYDRATE) AS MANUFACTURED IN TELANGANA, INDIA.

17522 I

III

7/9/2004

ROHM AND HAAS CO

ADCOTE 2730-2B AS MANUFACTURED IN RINGWOOD, IL.

17523 A

II

7/8/2004

CHEMAGIS LTD

17524 A

II

7/14/2004

WOCKHARDT LTD

DONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS AS MANUFACTURED IN BE'ER


SHEVA, ISRAEL
CLARITHROMYCIN USP AS MANUFACTURED IN GUJARAT, INDIA.

17525 A

II

7/13/2004

MYLAN LABORATORIES LTD

VENLAFAXINE HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

17514 N

NOT AN ASSIGNED NUMBER

17526 N

NOT AN ASSIGNED NUMBER

17527 I

III

7/8/2004

CHROMA CORP

PC56252B 33/1 BLUE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL.

17528 I

III

7/9/2004

GLOBAL ADVANTAGE LLC

PVC PACKAGING MATERIAL AS MANUFACTURED IN ELKTON, MD.

17529 A

II

7/14/2004

TARO PHARMACEUTICAL INDUSTRIES LTD

HALOBETASOL PROPIONATE, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL.

17530 A

II

7/3/2004

17531 I

II

7/15/2004

ZHEJIANG YONGNING PHARMACEUTICAL


FACTORY.
BAYER SCHERING PHARMA AG

3990 ACID, PHARMACEUTICAL INTERMEDIATE AS MANUFACTURED IN ZHEJIANG PROVINE,


CHINA.
ASOPRISNIL AS MANUFACTURED IN BERLIN, GERMAY.

Page 505

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17532 A
II
7/13/2004
MYLAN LABORATORIES LTD

SUBJECT
LEVOFLOXACIN USP (HEMIHYDRATE) AS MANUFACTURED IN TELANGANA, INDIA.

17533 A

IV

7/9/2004

UNGERER AND CO

ARTIFICIAL GRAPE FLAVOR FI-7723 AS MANUFACTURED IN BETHLEHEM, PA.

17534 A

II

7/27/2004

MONACHEM

GRADE B NOMAC AS MANUFACTURED IN RUE DU GABIAN, MONACO.

17535 A

II

7/19/2004

CIPLA LTD

LAMIVUDINE USP AS MANUFACTURED IN PUNE, INDIA.

17536 A

II

6/30/2004

SCANDINAVIAN FORMULAS INC

17537 A

III

6/30/2004

SCANDINAVIAN FORMULAS INC

17538 A

II

7/12/2004

XELLIA PHARMACEUTICALS APS

SPB11(TM) (SODIUM PHENYLBUTYRATE) 1-GRAM TABLETS AS MANUFACTURED IN SOUTH


PLAINFIELD, NJ.
PACKAGING MATERIAL FOR SPB11(TM) (SODIUM PHENYLBUTYRATE) 1-GRAM TABLETS AS
MANUFACTURED IN SOUTH PLAINFIELD, NJ.
GRAMICIDIN, USP AS MANUFACTURED IN BUDAPEST, HUNGARY.

17539 I

III

5/24/2004

ROHM AND HAAS CO

COREACTANT T-8384 AS MANUFACTURED IN RINGWOOD, IL.

17540 A

III

7/16/2004

CAPRIHANS INDIA LTD

17541 A

II

7/1/2004

ACS DOBFAR SPA

COVER PVC AND PVDC-COATED PVC FILM PRODUCTS PACKAGING MATERIAL AS


MANUFACTURED IN NASIK, INDIA.
CEFTRIAXONE SODIUM, ORAL GRADE AS MANUFACTURED IN MILANO, ITALY.

17542 A

II

7/13/2004

SMS PHARMACEUTICALS LTD

RANITIDINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17543 A

II

7/19/2004

SHASUN PHARMACEUTICALS LTD

GABAPENTIN USP AS MANUFACTURED IN CUDDALORE, INDIA.

17544 A

II

7/20/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

FLUTICASONE PROPIONATE E//BP AS MANUFACTURED IN GUJARAT, INDIA.

17545 I

II

7/19/2004

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

MODAFINIL AS MANUFACTURED IN BARCELONA SPAIN

17546 I

II

7/19/2004

SANDOZ INDUSTRIAL PRODUCTS GMBH

17547 A

II

7/19/2004

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

STERILE BULK MIXTURE AMPICILLIN/SULBACTAM FOR INJECTION AS MANUFACTURED IN


FRANKFURT, GERMANY.
METHYLPREDNISOLONE USP AS MANUFACTURED IN TIANJIN, CHINA.

17548 A

III

6/16/2004

BERRY PLASTICS CORP

PRODUCT 41763-43 AS MANUFACTURED IN COLUMBUS, GA

17549 I

III

7/1/2004

VALOIS SAS

17550 I

III

7/15/2004

17551 A

II

7/20/2004

METHODS FOR CONTROLLING VALOIS PACKAGING COMPONENTS AS MANUFACTURED IN


VAL DE REUIL, FRANCE
PDC PHARMACEUTICAL DEVELOPMENT CHINA CO PACKAGING MATERIALS AND COMPONENTS FOR LARGE VOLUME PARENTERAL DRUG AND
LTD
BIOLOGICAL PRODUCTS AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA.
TEVA PHARMACEUTICAL INDUSTRIES LTD
LANSOPRAZOLE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17552 I

III

7/22/2004

UNIVERSAL MEDICAP LTD

17553 I

III

7/22/2004

UNIVERSAL MEDICAP LTD

17554 I

III

7/22/2004

UNIVERSAL MEDICAP LTD

17555 I

III

7/22/2004

UNIVERSAL MEDICAP LTD

17556 I

III

7/22/2004

UNIVERSAL MEDICAP LTD

17557 I

III

7/22/2004

UNIVERSAL MEDICAP LTD

17558 A

II

4/26/2004

GLIDE CHEM PVT LTD

17559 A

II

4/26/2004

GLIDE CHEM PVT LTD

17560 I

II

5/26/2004

MUSTAFA NEVZAT ILAC SANAYI AS

CHLORHEXIDINE GLUCONATE SOLUTION 20% AS MANUFACTURED IN HIMACHAL PRADESH,


INDIA.
SULBACTAM SODIUM (NON-STERILE) AS MANUFACTURED IN KOCAELI,TURKEY.

17561 A

II

7/23/2004

FARMABIOS S P A

TRIAMCINOLONE DIACETATE AS MANUFACTURED IN PAVIA, ITALY.

17562 I

II

7/5/2004

AUROBINDO PHARMA LTD

7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.

BIOCLEAN BUTYL PHARMA RUBBER CLOSURES (NON-RFS) AS MANUFACTURED IN GUJARAT,


INDIA.
BIOCLEAN BUTYL PHARMA RUBBER CLOSURES (RFS) AS MANUFACTURED IN GUJARAT,
INDIA.
BIOCLEAN CHLOROBUTYL PHARMA RUBBER CLOSURES (NON-RFS) AS MANUFACTURED IN
GUJARAT, INDIA.
BIOCLEAN CHLOROBUTYL PHARMA RUBBER CLOSURES (RFS) AS MANUFACTURED IN
GUJARAT, INDIA.
BIOCLEAN BROMOBUTYL PHARMA RUBBER CLOSURES (NON-RFS) AS MANUFACTURED IN
GUJARAT, INDIA.
BIOCLEAN BROMOBUTYL PHARMA RUBBER CLOSURES (RFS) AS MANUFACTURED IN
GUJARAT, INDIA.
POVIDONE IODINE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA.

Page 506

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17563 A
II
7/20/2004
NV ORGANON

SUBJECT
NALTREXONE AS MANUFACTURED IN AK APELDOORN, THE NETHERLANDS.

17564 A

III

7/20/2004

COLORTECH INC

17565 A

II

7/22/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

11030-13 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN


AND ONTARIO, CANADA.
ZALEPLON AS MANUFACTURED IN DEBRECEN, HUNGARY.

17566 I

II

7/19/2004

IPCA LABORATORIES LTD

NABUMETONE AS MANUFACTURED IN DIST. RATLAM (MP), INDIA.

17567 A

II

7/22/2004

APOTEX PHARMACHEM INC

17568 I

II

7/27/2004

LEK PHARMACEUTICALS DD

MISOPROSTOL 4% DISPERSION ON HYDROXYPROPYL METHYLCELLULOSE (HPMC) AS


MANUFACTURED IN ONTARIO, CANADA.
SIMVASTATIN AS MANUFACTURED IN MENGES, SLOVENIA.

17569 I

II

7/20/2004

SHIRATORI PHARMACEUTICAL CO LTD

17570 A

II

7/16/2004

AUROBINDO PHARMA LTD

17571 A

II

7/20/2004

(-)-HUPERZINE A AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

17572 A

III

7/15/2004

NINGBO GREEN-HEALTH PHARMACEUTICAL CO


LTD
RN FINK MANUFACTURING CO INC

17573 A

II

7/27/2004

TRANDOLAPRIL AS MANUFACTURED IN TAIWAN, R.O.C.

17574 A

III

7/23/2004

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
COLORTECH INC

17575 A

II

7/26/2004

GEDEON RICHTER PLC

17576 A

IV

7/30/2004

DMV FONTERRA EXCIPIENTS GMBH CO KG

17577 A

IV

7/30/2004

DMV FONTERRA EXCIPIENTS GMBH CO KG

17578 A

IV

7/30/2004

SEPPIC SA

PHARMATOSE(R) DCL 11 AS MANUFACTURED IN GE VEGHEL, THE NETHERLANDS AND


NORTEN-HARDENBERG, GERMANY.
PHARMATOSE(R) DCL 21 AS MANUFACTURED IN GE VEGHEL, THE NETHERLANDS AND
NORTEN-HARDENBURG, GERMANY.
SEPISPERSE DRY AS MANUFACTURED IN CASTRES CEDEX, FRANCE.

17579 A

II

7/29/2004

CODY LABORATORIES INC

FENTANYL CITRATE ACTIVE INGREDIENT AS MANUFACTURED IN CODY, WY.

17580 A

II

7/30/2004

ITF CHEMICAL LTDA

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN BAHIA, BRAZIL.

17581 I

II

8/2/2004

ACYCLOVIR AS MANUFACTURED IN JIANGSU, P.R. CHINA.

17582 A

II

7/10/2004

LIVZON GROUP CHANGZHOU KONY


PHARMACEUTICAL CO LTD
CADILA PHARMACEUTICALS LTD

17583 I

II

8/3/2004

BIOCRYST PHARMACEUTICALS INC

BCX-4208 DRUG SUBSTANCE AS MANUFACTURED IN BIRMINGHAM, AL.

17584 I

II

8/2/2004

GEDEON RICHTER LTD

AMLODIPINE BESYLATE AS MANUFACTURED IN BUDAPEST, HUNGARY.

17585 A

III

8/3/2004

EXXONMOBIL CHEMICAL CO

17586 I

III

7/30/2004

AMPACET CORP

17587 I

III

7/23/2004

COLORTECH INC

17588 A

II

8/5/2004

PIRAMAL ENTERPRISES LTD

SANTOPRENE(TM) THERMOPLASTIC RUBBER GRADE 181-57W180 AS MANUFACTURED IN


AKRON, OH.
101499 DESSICANT POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;
LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA.
10002-12 SLIP POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND
ONTARIO, CANADA.
BRIMONIDINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17589 I

IV

8/6/2004

SHASUN PHARMACEUTICALS LTD

HYPROMELLOSE PHTHALATE AS MANUFACTURED IN CUDDLORE, INDIA.

17590 A

II

8/10/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

CARVEDILOL EP/BP AS MANUFACTURED IN GUJARAT, INDIA.

17591 A

III

8/9/2004

APTAR RADOLFZELL GMBH

17592 A

III

8/2/2004

POLYONE CORP

UNIT DOSE / BIDOSE DISPENSING SYSTEMS, MANUFACTURED IN EIGELTINGEN, GERMANY


AND LE VAUDREUIL, FRANCE.
CC10056380WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17593 A

III

7/30/2004

NOLATO JAYCARE LTD

300ML ROUND PACKER AS MANUFACTURED IN UNITED KINGDOM.

17594 A

II

8/12/2004

GLENMARK GENERICS LTD

GLIMEPIRIDE AS MANUFACTURED IN GUJARAT, INDIA.

SAPROPTERIN HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN CHIBA-KEN,


JAPAN.
RAMIPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

PLASTICS CONTAINERS AS MANUFACTURED IN WILLIAMSTON, MI.

10001-12 ANTIBLOCK POLYETHYLENE CONCENTRATION AS MANUFACTURED IN


MORRISTOWN, TN AND ONTARIO, CANADA.
FINASTERIDE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY.

LORATADINE USP POWDER AS MANUFACTURED IN GUJARAT, INDIA.

Page 507

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17595 A
II
8/10/2004
CHATTEM CHEMICALS INC

SUBJECT
FENTANYL BASE AS MANUFACTURED IN CHATTANOOGA, TN.

17596 A

III

8/10/2004

MEDIPHARMAPLAN CO LTD

17597 I

III

5/27/2004

CHROMA CORP

PACKAGING MATERIALS FOR I.V. SOLUTIONS AND BLOOD BAGS WITH NON PVC TUBING AND
FILM AND RUBBER STOPPERS FOR INJECTION AND INFUSION
PC23335 AS REQUIRED WHITE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL.

17598 A

II

8/12/2004

RESOLUTION CHEMICALS LIMITED

AZATHIOPRINE USP AS MANUFACTURED IN ZHEJIANG, CHINA.

17599 A

II

8/12/2004

PHARMACEUTICAL WORKS POLPHARMA SA

HYDROCHLOROTHIAZIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

17600 A

II

8/16/2004

SRI KRISHNA PHARMACEUTICALS LTD

FOLIC ACID USP AS MANUFACTURED IN A.P., INDIA.

17601 A

III

8/11/2004

ASTRA PLASTIQUE

CLOSURE VISTOP 28 CRC AS MANUFACTURED IN SAINT-GEORGES DE RENEINS, FRANCE.

17602 A

II

8/13/2004

CILAG AG

SODIUM FERRIC GLUCONATE AS MANUFACTURED IN SCHAUFFHAUSEN, SWITZERLAND.

17603 A

II

8/16/2004

CILAG AG

CLADRIBINE DRUG SUBSTANCE AS MANUFACTURED IN SCHAUFFHAUSEN, SWITZERLAND.

17604 A

II

7/31/2004

AUROBINDO PHARMA LTD

CEPHALEXIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17605 A

II

8/16/2004

CADILA HEALTHCARE LTD

TERAZOSIN HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA.

17606 A

II

8/16/2004

SRI KRISHNA PHARMACEUTICALS LTD

ACETAMINOPHEN GRANULES DC 90% AS MANUFACTURED IN HYDERABAD, INDIA.

17607 A

IV

8/9/2004

FMC BIOPOLYMER AS

CHITOSAN (TRADE NAME PROTASAN(TM)) AS MANUFACTURED IN OSLO, NORWAY.

17608 A

III

8/13/2004

MULTISORB TECHNOLOGIES INC

MULTIFORM(TM) CSF AS MANUFACTURED IN BUFFALO, NY.

17609 A

II

8/17/2004

SAFC BIOSCIENCES INC

17610 A

II

8/17/2004

SAFC BIOSCIENCES INC

EX-CELL(TM) 302, CHO, SERUM-FREE MEDIUM(MODIFIED) AS MANUFACTURED IN DENVER,


PA.
EX-CELL(TM) 302, MEDIUM, SERUM-FREE MEDIUM AS MANUFACTURED IN DENVER, PA.

17611 A

II

8/17/2004

SAFC BIOSCIENCES INC

ISCOVE'S MODIFIED DULBECCO'S MEDIUM (IMDM) AS MANUFACTURED IN DENVER, PA.

17612 A

IV

8/13/2004

UNGERER AND CO

17613 A

III

8/2/2004

KIRCHNER SIMON AND CO GMBH

17614 A

II

8/18/2004

PARTICLE DYNAMICS INC

NATURAL & ARTIFICIAL PEPPERMINT FLAVOR FM-4134 AS MANUFACTURED IN BETHLEHEM,


PA.
D55-31011, CAP MADE OF PHENOLIC RESIN WITH PE CONE LINER AS MANUFACTURED IN
OESTRICH-WINKEL, GERMANY.
DESTAB(TM) CALCIUM CARBONATE 95S ULTRA 250 AS MANUFACTURED IN LITCHFIELD, MN.

17615 I

II

4/8/2004

NORTH CHINA PHARMACEUTICAL GROUP CORP

DEMECLOCYCLINE HYDROCHLORIDE AS MANUFACTURED IN SHIJIAZHUANG, CHINA.

17616 I

IV

8/19/2004

DEGUSSA FLAVORS & FRUIT SYSTEMS US LLC

17617 I

III

8/19/2004

MULTISORB TECHNOLOGIES LTD

ARTIFICIAL FRUIT PUNCH FLAVOR (120-00219) AS MANUFACTURED IN CINCINNATI, OH AND


BRIDGEPORT, NJ.
DRI-MAC(TM) DESICCANT CANISTER AS MANUFACTURED IN SHROPSHIRE, ENGLAND.

17618 A

II

8/20/2004

TARO PHARMACEUTICAL INDUSTRIES LTD

FLUTICASONE PROPIONATE, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL.

17619 A

III

8/20/2004

MITSUBISHI GAS CHEMICAL CO INC

OXYGEN ABSORBER PHARMAKEEP(R) INGREDIENT TYPE GKH AS MANUFACTURED IN


SAITAMA PREF., JAPAN.

17621 I

II

8/16/2004

AJINOMOTO CO INC

ADENOSINE AS MANUFACTURED IN YOKKAICHI, JAPAN.

17622 I

II

8/24/2004

HETERO DRUGS LTD

TRANDOLAPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17623 A

III

8/23/2004

APTAR FRANCE SAS

17624 A

II

8/24/2004

EXCELLA GMBH

APTAR METHODS FOR CONTROLLING PACKAGING COMPONENTS AS MANUFACTURED IN LE


VAUDREUIL, FRANCE AND CONGERS, NEW YORK
ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY.

17625 I

II

8/16/2004

KYONGBO PHARMACEUTICAL CO LTD

17626 A

II

8/26/2004

UNIMARK REMEDIES LTD

BACAMPICILLIN HYDROCHLORIDE NON-STERILE, BULK AS MANUFACTURED IN


CHUNGCHEONG NAM-DO, KOREA.
LISINOPRIL USP AS MANUFACTURED IN MUMBAI, INDIA.

17627 A

II

9/29/2004

ACS DOBFAR SPA

STERILE SODIUM CARBONATE AS MANUFACTURED IN BRAZIL FOR ACS DOBFAR SPA.

17628 A

II

8/17/2004

ACS DOBFAR SPA

CEFTAZIDIME DIHYDROCHLORIDE AS MANUFACTURED IN MILANO, ITALY.

17620 N

NOT AN ASSIGNED NUMBER

Page 508

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17629 I
II
8/27/2004
MALLINCKRODT INC

SUBJECT
DRONABINOL IN SESAME OIL AS MANUFACTURED IN ST. LOUIS, MO.

17630 I

III

8/16/2004

SUMMIT PACKAGING SYSTEMS INC

17631 A

II

8/26/2004

LABORATORIOS MIRET SA

17632 I

III

8/23/2004

RITE SYSTEMS

17633 A

II

8/30/2004

CIPLA LTD

AEROSOL VALVE FOR USE WITH: TBC-V (PHARMACEUTICAL OIL) AS MANUFACTURED IN


MANCHESTER, NH AND RACINE, WI.
ETHYL-N -DODECANOYL-L-ARGINATE HYDROCHLORIDE (LAE) AS MANUFACTURED IN
BARCELONA, SPAIN.
LIQUID COLOR-WHITE LQC-W1454-1 AS MANUFACTURED IN WEST CHICAGO, IL;
STATESVILLE, NC; AND CITY OF INDUSTRY, CA.
RIZATRIPTAN BENZOATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

17634 A

III

8/12/2004

WIPAK OY

PPP 200 INFU 13 PEEL 2 AS MANUFACTURED IN NOSTOLA, FINLAND.

17635 N

NOT AN ASSIGNED NUMBER

17636 N

NOT AN ASSIGNED NUMBER

17637 N

NOT AN ASSIGNED NUMBER

17638 A

II

8/18/2004

AUROBINDO PHARMA LTD

ZIDOVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17639 A

II

10/6/2004

NANOTHERAPEUTICS INC

17640 A

IV

8/20/2004

CAPSUGEL DIV PFIZER INC

TRIAPINE(R) CAPSULES AS MANUFACTURED IN GREENVILLE, NC FOR NANOTHERAPEUTICS


INC
POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN BANGKOK, THAILAND.

17641 I

IV

8/20/2004

CAPSUGEL

POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN BORNEM, BELGIUM.

17642 A

IV

8/20/2004

PFIZER INC

POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN WEST JAVA, INDONESIA.

17643 I

IV

8/20/2004

CAPSUGEL

POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN SUZHOU, CHINA.

17644 I

IV

8/20/2004

CAPSUGEL

POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN GREENWOOD, SC.

17645 A

II

8/30/2004

OPOCRIN SPA

SODIUM FERRIC GLUCONATE AS MANUFACTURED IN MODENA, ITALY.

17646 A

II

8/31/2004

CIPLA LTD

STAVUDINE USP AS MANUFACTURED IN BANGALORE, INDIA.

17647 I

II

8/30/2004

YONEZAWA HAMARI CHEMICALS LTD

L-CARNITINE AS MANUFACTURED IN YAMAGATA, JAPAN.

17648 A

II

8/30/2004

DR REDDYS LABORATORIES LTD

NARATRIPTAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17649 A

II

8/31/2004

SHASUN PHARMACEUTICALS LTD

SULPHAZINE AS MANUFACTURED IN CUDDALORE, INDIA.

17650 I

II

9/2/2004

ACCORD HEALTHCARE INC

PACLITAXEL API AS MANUFACTURED IN RANCHO CORDOVA, CA FOR BIOXEL PHARMA INC

17651 A

II

9/2/2004

FORMOSA LABORATORIES INC

COLESTIPOL HYDROCHLORIDE AS MANUFACTURED IN TAOYAUN, TAIWAN.

17652 A

II

9/7/2004

MOREPEN LABORATORIES LTD

DESLORATADINE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA.

17653 A

III

9/1/2004

SCHOTT KAISHA PVT LTD

AMPOULES AND VIALS AS MANUFACTURED IN NANI DAMAN, INDIA.

17654 I

III

8/30/2004

BASF AKTIENGESELLSCHAFT

ACRONAL(R) 3570 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

17655 I

II

9/7/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFIXIME, USP AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

17656 A

II

9/9/2004

HETERO DRUGS LTD

GLIMEPIRIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17657 A

II

8/30/2004

AUROBINDO PHARMA LTD

DIDANOSINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17658 A

II

8/31/2004

LUPIN LTD

TRANDOLAPRIL AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17659 A

II

9/8/2004

TEVA PHARMACEUTICALS INDUSTRIES LTD

CARBOPLATIN AS MANUFACTURED IN EDO DE MEXICO, MEXICO.

17660 A

III

9/7/2004

3M DRUG DELIVERY SYSTEMS

3M RELEASE LINER SCOTHPAK(TM) 9741 AS MANUFACTURED IN NEVADA, MO; COTTAGE


GROVE AND WEST ST. PAUL, MN; DECATUR, AL; GREENVILLE, SC; AND ZWIJNDRECHT,
BELGIUM.

17661 A

II

9/2/2004

JUZEN CHEMICAL CORP

ZONISAMIDE AS MANUFACTURED IN MIE PREFECTURD, JAPAN.

17662 I

II

9/8/2004

LEK PHARMACEUTICALS DD

LOVASTATIN AS MANUFACTURED IN LJUBLJANA, SLOVENIA.

Page 509

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17663 I
III
8/27/2004
AMARTARA PRIVATE LTD

SUBJECT
NON-TOXIC PVDC COATED PVC FILM FOR PHARMACEUTICAL PACKAGING SUITABLE FOR
BLISTER PACKAGING OF ORAL TABLETS AND CAPSULES AS MANUFACTURED IN
MAHARASHTRA STATE, INDIA.

17664 I

III

9/6/2004

REXAM PHARMA SAS

17665 I

II

9/10/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

TABLET JARS IN 60 ML AND 100 ML (WHITE COLOR) AS MANUFACTURED IN OFFRANVILLE,


FRANCE.
TRIMIPRAMINE MALEATE AS MANUFACTURED IN NETANYA, ISRAEL.

17667 A

II

9/3/2004

JUZEN CHEMICAL CORP

PRULIFLOXACIN AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN.

17668 A

II

9/14/2004

CHATTEM CHEMICALS INC

METHYLPHENIDATE BASE AS MANUFACTURED IN CHATTANOOGA, TN.

17669 A

II

9/8/2004

AMERICAN PEPTIDE CO

PEPTIDE 312868 (TP508) AS MANUFACTURED IN VISTA, CA.

17670 I

III

9/8/2004

WINPAK TECHNOLOGIES INC

41.0 GSM BLEACHED PAPER MG 912/250/ 11.0 GSM PE 5050/ 24.1 GSM 9.0 UM ALUMINUM FOIL/
0.2 GSM PRIMER 10-ZZ-2/ 12.0 GSM PE 5050 AS MANUFACTURED IN ONTARIO, CANADA.

17671 I

III

9/9/2004

WINPAK TECHNOLOGIES INC

17672 I

II

8/3/2004

PCAS

INK/ 41.0 GSM BLEACHED PAPER MG 912/250/ 11.0 GSM PE 5050/ 24.1 GSM 9.0 UM ALUMINUM
FOIL/ 12 GSM PE SURLYN 1652-SR AS MANUFACTURED IN ONTARIO, CANADA.
SODIUM VALPROATE SOLUTION AS MANUFACTURED IN LIMAY, FRANCE.

17673 I

II

7/18/2004

DELTA TECH LTD

17674 I

II

9/27/2004

STRAINRITE

17675 A

III

9/9/2004

DINSHI AMPOULE MAKERS PRIVATE LTD

17676 A

IV

9/10/2004

DAVID MICHAEL AND CO INC

17677 A

II

9/13/2004

DOTTIKON EXCLUSIVE SYNTHESIS AG

MICHAELOK ARTIFICIAL STRAWBERRY FLAVOR #3220 AS MANUFACTURED IN PHILADELPHIA,


PA.
OLSALAZINE SODIUM AS MANUFACTURED IN DOTTIKON, SWITZERLAND.

17678 A

II

9/15/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

OCTREOTIDE ACETATE (PROCESS I) AS MANUFACTURED IN MAHARASHTRA, INDIA.

17679 I

II

9/10/2004

SMOPTECH LTD

SMOPEX-111 AS MANUFACTURED IN TURKU, FINLAND.

17680 A

II

9/9/2004

CIPLA LTD

FINASTERIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17681 I

II

9/15/2004

ASTELLAS PHARMA INC

FK555 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO AND OSAKA, JAPAN.

17682 A

III

9/13/2004

BPREX HEALTHCARE OFFRANVILLE SAS

HDPE BOTTLES

17683 A

II

9/10/2004

SANDOZ GMBH

7-AMCA AS MANUFACTURED IN TYROL, AUSTRIA.

17684 I

II

9/9/2004

ISO TEX DIAGNOSTICS INC

METHYLENE BLUE I-125 AS MANUFACTURED IN FRIENDSWOOD, TX.

17685 A

II

9/14/2004

DAIICHI SANKYO CO LTD

BENICAR(TM) TABLETS 5 MG, 20 MG AND 40 MG AS MANUFACTURED IN KANAGAWA, JAPAN.

17686 A

II

9/5/2004

CATALENT PHARMA SOLUTIONS LLC

17687 I

III

9/2/2004

BASF AKTIENGESELLSCHAFT

ATRASENTAN HYDROCHLORIDE, SOFT GELATIN CAPSULES, 10 MG (BASE EQUIVALENT) AS


MANUFACTURED IN ST. PETERSBURG, FL.
ACRONAL(R) N-CR 162 AS MANUFACTURED IN MONACA, PA.

17688 A

II

9/17/2004

CADILA HEALTHCARE LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

17689 A

III

9/16/2004

POLYONE CORP

CC00017762WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17690 A

III

9/20/2004

EXXONMOBIL CHEMICAL CO

17691 A

III

9/20/2004

PHILLIPS PLASTICS CORP

17692 A

II

9/22/2004

AMRI RENSSELAER INC

SANTOPRENE(TM) THERMOPLASTIC RUBBER 181-XXMED AND 281-XXMED GRADE SERIES AS


MANUFACTURED IN CANTONMENT, FL AND SOUTH WALES, UNITED KINGDOM.
DIASTAT(R) (DIAZEPAM RECTAL GEL) RECTAL DELIVERY SYSTEM AS MANUFACTURED IN
MENOMONIE, WI.
AMPHETAMINE ASPARTATE, MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN
RENSSELAER, NY.

17666 N

NOT AN ASSIGNED NUMBER

IVERMECTIN AS MANUFACTURED IN SHANGHAI VETERINARY PHARMACEUTICAL WORKS IN


SHANGHAI, CHINA FOR DELTA TECH LTD.
DCM-MD-XX-630, 352000: CLARIFICATION VESSEL FOR ONE-TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
GLASS AMPOULES AS MANUFACTURED IN MAHARASHTRA, INDIA.

Page 510

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17693 A
II
9/15/2004
ARCH PHARMALABS LTD
17694 A

II

9/9/2004

NCPC HUALUAN PHARMACEUTICAL CO LTD

SUBJECT
3-(2-CHLOROPHENYL)-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE (CMIC CHLORIDE) AS
MANUFACTURED IN HYDERABAD, INDIA.
6-AMINOPENICILLANIC ACID (6-APA) AS MANUFACTURED IN HEBEI, CHINA.

17695 A

II

3/11/2004

EVONIK TECHNOCHEMIE GMBH

CHLOROHEXIDINE BASE AS MANUFACTURED IN MIDDLESBOROUGH, ENGLAND.

17696 A

II

9/17/2004

PROMETIC BIOSCIENCES LTD

MABSORBENT A2P AS MANUFACTURED IN ISLE OF MAN, BRITISH ISLES.

17697 A

II

9/22/2004

MYLAN LABORATORIES LTD

CELECOXIB AS MANUFACTURED IN TELANGANA, INDIA.

17698 A

II

9/22/2004

SARACA LABORATORIES LTD

RANITIDINE HYDROCHLORIDE (FORM-II) AS MANUFACTURED IN MEDAK, INDIA.

17699 I

II

9/19/2004

DIVIS LABORATORIES LTD

METHYLDOPA USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17700 I

II

9/23/2004

17701 I

II

9/23/2004

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
MOREPEN LABORATORIES LTD

METHOHEXITAL, NON-STERILE, BULK DRUG AS MANUFACTURED IN ZHEJIANG, CHINA FOR


CHEMWERTH INC
PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN HIMALCHAL PRADESH, INDIA.

17702 A

II

9/8/2004

JOST CHEMICAL CO

SODIUM SULFATE AS MANUFACTURED IN ST. LOUIS, MO.

17703 A

II

9/13/2004

ACIDCHEM INTERNATIONAL SDN BHD

ISOPROPYL MYRISTATE AS MANUFACTURED IN PENANG, MALAYSIA.

17704 A

III

9/20/2004

POLYONE CORP

CC00017105DR AS MANUFACTURED IN GLENDALE, AZ.

17705 A

II

9/24/2004

LUPIN LTD

CEFDINIR AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17706 A

II

9/24/2004

DR REDDYS LABORATORIES LTD

OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17707 A

II

9/20/2004

AUROBINDO PHARMA LTD

CEFUROXIME AXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17708 A

II

9/14/2004

ZHEJIANG NHU CO LTD

17709 A

III

9/9/2004

SOLVIN SA

VITAMIN A PALMITATE/VITAMIN E OIL/SOYBEAN SALAD OIL BLEND AS MANUFACTURED IN


ZHEJIANG, CHINA.
DIOFAN SUPER B AS MANUFACTURED IN TAVAUX, FRANCE.

17710 A

III

9/23/2004

POLYONE CORP

CC10009918WE 19362WC AQUA AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17711 I

II

9/29/2004

HELICON THERAPEUTICS INC

17712 A

II

9/30/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

IPL-455,903 (HT-0712) ACTIVE PHARMACEUTICAL INGREDIENT (API) AS MANUFACTURED IN


CINCINNATI, OH.
ZOLPIDEM TARTRATE USP AS MANUFACTURED IN GUJARAT, INDIA.

17713 A

II

9/30/2004

GLENMARK GENERICS LTD

PERINDOPRIL ERBUMINE AS MANUFACTURED IN GUJARAT, INDIA.

17714 I

II

9/29/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFTRIAXONE SODIUM AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

17715 I

II

9/27/2004

STRAINRITE

17716 I

IV

9/29/2004

FONA INTERNATIONAL INC

17717 I

II

10/19/2004

AXCAN PHARMA INC

DCM-MD-XX-420, 352002: CLARIFICATION VESSEL FOR ONE-TIME USE AS MANUFACTURED IN


AUBURN, MAINE.
857.008. N-C NATURAL GRAPEFRUIT FLAVOR (WONF) AS MANUFACTURED IN CAROL STREAM,
IL.
URSODIOL SUSPENSION, 250 MG/ML AS MANUFACTURED IN QUEBEC, CANADA.

17718 A

IV

9/30/2004

DOW CORNING CORP

DOW CORNING(R) ST-CYCLOMETHICONE5-NF AS MANUFACTURED IN HEMLOCK, MI.

17719 I

II

10/5/2004

SANDOZ GMBH

17720 A

II

9/30/2004

CIPLA LTD

SOMATROPIN (HUMAN GROWTH HORMONE) SANDOZ AS MANUFACTURED IN KUNDL,


AUSTRIA.
PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN BANGALORE, INDIA.

17721 I

II

9/22/2004

GRANULES INDIA LTD

ACETAMINOPHEN AS MANUFACTURED IN HYDERABAD, INDIA.

17722 A

II

9/22/2004

GRANULES INDIA LTD

COMPRESSO PAP 90 CPF (ACETAMINOPHEN DC 90) AS MANUFACTURED IN A.P., INDIA.

17723 A

II

9/22/2004

GRANULES INDIA LTD

17724 I

II

9/30/2004

JENAHEXAL PHARMA GMBH

17725 A

IV

10/4/2004

IDEAL CURES PVT LTD

COMPRESSO 95 P (DIRECT COMPRESSION 95% METFORMIN HCL) AS MANUFACTURED IN


A.P., INDIA.
0.9% SODIUM CHLORIDE INJECTION, USP - 1 ML/2 ML AMPOULE AS MANUFACTURED IN JENA,
GERMANY.
INSTAGLOW POLISHING SYSTEM FOR COATED & UNCOATED TABLETS AS MANUFACTURED IN
MAHARASHTRA, INDIA.

Page 511

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17726 A
IV
10/4/2004
IDEAL CURES PVT LTD
17727 A

II

10/6/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
INSTACOAT COATING SYSTEMS USING COLOR DISPERSION AS MANUFACTURED IN
MAHARASHTRA, INDIA.
CLONAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17728 A

II

9/24/2004

AUROBINDO PHARMA LTD

HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17729 A

II

10/6/2004

GLENMARK GENERICS LTD

TOPIRAMATE AS MANUFACTURED IN GUJARAT STATE, INDIA.

17730 A

II

9/30/2004

LUPIN LTD

7-APCA INTERMEDIATE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17731 A

II

9/29/2004

LUPIN LTD

CEFPROZIL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17732 A

II

7/24/2004

CAFFEINE ANHYDROUS, USP AS MANUFACTURED IN JILIN PROVINCE, P.R. CHINA.

17733 A

III

9/30/2004

JILIN SHULAN SYNTHETIC PHARMACEUTICAL CO


LTD
POLYONE CORP

17734 A

II

10/7/2004

KISSEI PHARMACEUTICAL CO LTD

KUR-1246 DRUG SUBSTANCE AS MANUFACTURED IN FUKUI PREFECTURE, JAPAN.

17735 I

IV

10/5/2004

TOLMAR THERAPEUTICS INC

17736 A

II

10/6/2004

DR REDDYS LABORATORIES LTD

POLY(DL-LACTIDE-CO-GLYCOLIDE) BIODEGRADABLE POLYMER EXCIPIENTS AS


MANUFACTURED IN FORT COLLINS, CO.
TOLTERODINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17737 A

II

9/30/2004

LUPIN LTD

LOVASTATIN TECHNICAL AS MANUFACTURED IN MAHARASHTRA, INDIA.

17738 A

II

10/7/2004

HETERO LABS LTD

LEVETIRACETAM (FORM 1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17739 A

II

10/8/2004

MYLAN LABORATORIES LTD

ITRACONAZOLE USP AS MANUFACTURED IN TELANGANA, INDIA.

17740 A

II

10/8/2004

MYLAN LABORATORIES LTD

LAMOTRIGINE USP AS MANUFACTURED IN TELANGANA, INDIA.

17741 A

II

10/8/2004

MYLAN LABORATORIES LTD

CETIRIZINE HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

17742 A

III

10/8/2004

PACKAGING CONCEPTS ASSOC LLC

17743 A

II

10/14/2004

USV LIMITED

CHILD RESISTANCE (CR) SPRAY DISPENSING SYSTEM AS MANUFACTURED IN BOYNTON


BEACH, FL.
METFORMIN HYDROCHLORIDE DC GRANULES AS MANUFACTURED IN DAMAN, INDIA.

17744 A

II

10/14/2004

USV LIMITED

METFORMIN HYDROCHLORIDE BP (COARSE) AS MANUFACTURED IN MAHARASHTRA, INDIA.

17745 A

II

10/5/2004

NOVACYL SAS

17746 A

II

10/7/2004

BIOFER SPA

17747 A

III

9/29/2004

POLYONE CORP

RHODAPAP AND RHODAPAP DC PRODUCTS (ACETAMINOPHEN) AS MANUFACTURED IN WUXI,


CHINA.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION AS MANUFACTURED IN
MEDOLLA, ITALY.
CC10048656WE WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

17748 A

III

10/17/2004

ETIMEX PRIMARY PACKAGING GMBH

17749 A

III

10/18/2004

TORAY PLASTICS AMERICA INC

17750 A

II

10/8/2004

MYLAN LABORATORIES LTD

PURELAY PHARM FG 100/E TRANSPARENT (300UM) AND PURELAY PHARM FG 100/E WHITE
(300 UM) DRUG PACKAGING PACKAGE AS MANUFACTURED IN DIETENHEIM, GERMANY.
TORAY'S PA10 AND PA20 MULTILAYER PET FILM PRODUCTS INTENDED FOR USE IN DRUG
PACKAGING AS MANUFACTURED IN NORTH KINGSTOWN, RI.
LAMIVUDINE USP AS MANUFACTURED IN TELANGANA AND ANDHRA PRADESH, INDIA

17751 A

II

10/8/2004

MYLAN LABORATORIES LTD

ZIDOVUDINE USP ( PROCESS-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17752 I

II

9/30/2004

MALLINCKRODT INC

MORPHINE ALKALOID, CODE 1547 AS MANUFACTURED IN ST. LOUIS, MO.

17753 I

II

10/14/2004

DIPHARMA SPA

MANDELATE SALT, INTERMEDIATE AS MANUFACTURED IN UD, ITALY.

17754 A

II

11/8/2004

UNIMARK REMEDIES LTD

ALBENDAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA.

17755 A

II

10/12/2004

FORMOSA LABORATORIES INC

PARSOL 1789 (AVOBENZONE) AS MANUFACTURED IN TAIWAN, R.O.C.

17756 A

III

8/16/2004

ALLTUB CENTRAL EUROPE SRO

ALUMINIUM TUBES AS MANUFACTURED IN KOLIN, CZECH REPUBLIC.

17757 I

III

10/11/2004

DUPONT ENGINEERING POLYMERS

CRESTIN(R) 6131C NC010 AS MANUFACTURED IN MONCK'S CORNER, SC.

17758 A

II

10/15/2004

FARMABIOS S P A

TRIAMCINOLONE HEXACETONIDE AS MANUFACTURED IN PAVIA, ITALY.

17759 A

II

10/18/2004

FARMABIOS S P A

DESOXIMETASONE AS MANUFACTURED IN PAVIA, ITALY.

CC00002829WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

Page 512

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17760 A
IV
9/28/2004
BASF SE

SUBJECT
Kolliwax(R) S Fine AS MANUFACTURED IN DUESSELDORF, GERMANY.

17761 A

IV

9/28/2004

BASF SE

Kolliphor(R) SLS Fine AS MANUFACTURED IN DUESSELDORF, GERMANY.

17762 A

IV

9/28/2004

BASF SE

Kolliphor(R) SLS AS MANUFACTURED IN DUESSELDORF, GERMANY.

17763 A

IV

9/28/2004

BASF SE

Kolliwax(R) S AS MANUFACTURED IN DUESSELDORF, GERMANY.

17764 A

II

10/15/2004

SAFC PHARMA

TRYPAN BLUE PURIFIED MANUFACTURING IN NEW ROAD GILLINGHAM DORSET SP8 4XT U.K.

17765 A

II

10/20/2004

CIPLA LTD

LORAZEPAM AS MANUFACTURED IN MAHARASHTRA, INDIA.

17766 A

III

10/20/2004

BILCARE LTD

17767 I

II

10/13/2004

MALLINCKRODT INC

BILCARE SPECIALITY METALIZED, NON-METALIZED ECOFRIENDLY, MONO AND


MULTILAYERED FILMS AND SUBSTRATES AS MFG IN MAHARASHTRA, INDIA
PROSAPTIDE AS MANUFACTURED IN ST. LOUIS, MO.

17768 A

II

10/18/2004

CHEMI SPA

GOSERELIN ACETATE AS MANUFACTURED IN MILANO, ITALY.

17769 I

III

10/18/2004

BASF AKTIENGESELLSCHAFT

STYROLUX(R) 3G33 AS MANUFACTURED IN MEXICO AND BELGIUM.

17770 I

III

10/18/2004

BASF AKTIENGESELLSCHAFT

STYROLUX(R) 3G55 Q420 AS MANUFACTURED IN MEXICO AND BELGIUM.

17771 A

III

10/18/2004

STYROLUTION GMBH

STYROLUX(R) 684 D AS MANUFACTURED IN MEXICO AND BELGIUM.

17772 A

III

10/18/2004

STYROLUTION GMBH

STYROLUX(R) 656 C AS MANUFACTURED IN MEXICO AND BELGIUM.

17773 I

III

10/20/2004

ROHM AND HAAS CO

ADCOTE HS 35X120 AS MANUFACTURED IN RINGWOOD, IL.

17774 A

IV

9/15/2004

CRODA INC

SUPER REFINED OLEIC ACID NF AS MANUFACTURED IN MILL HALL, PA.

17775 I

II

10/21/2004

THERAGENICS CORP

BULK INDIUM CHLORIDE IN-111 RADIOCHEMICAL AS MANUFACTURED IN BUFORD, GA.

17776 I

II

10/22/2004

ELAN DRUG DELIVERY INC

17777 A

II

10/21/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

N1296 ORAL NANOCRYSTAL(R) COLLOIDAL DISPERSION AS MANUFACTURED IN KING OF


PRUSSIA, PA.
OCTREOTIDE ACETATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17778 A

II

10/25/2004

TEVA PHARMACEUTICALS INDUSTRIES LTD

SILDENAFIL CITRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17779 A

II

10/26/2004

DR REDDYS LABORATORIES LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17780 I

II

10/20/2004

IPCA LABORATORIES LTD

BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN MUMBAI, INDIA.

17781 A

II

10/28/2004

ATUL LTD

DAPSONE USP AS MANUFACTURED IN GUJARAT, INDIA.

17782 A

II

10/26/2004

HETERO LABS LTD

NEVIRAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17783 A

II

10/26/2004

CATALENT PHARMA SOLUTIONS LLC

TIPRANAVIR CAPSULES 250 MG (IMPRINTED) AS MANUFACTURED IN ST. PETERSBURG, FL.

17784 A

II

10/8/2004

OLON SPA

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY.

17785 A

III

10/21/2004

BPREX HEALTHCARE OFFRANVILLE SAS

RISPHARM EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE.

17786 A

II

10/22/2004

UNIQUE CHEMICALS

CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

17787 A

II

10/28/2004

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

LANSOPRAZOLE AS MANUFACTURED IN BARCELONA, SPAIN.

17788 I

II

10/29/2004

NUVELO INC

ALFIMEPRASE AS MANUFACTURED IN THOUSAND OAKS, CA.

17789 A

II

10/29/2004

SEVEN STAR PHARMACEUTICAL CO LTD

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN TAIWAN, R.O.C.

17790 A

II

10/29/2004

TARO PHARMACEUTICAL INDUSTRIES LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

17791 A

III

9/27/2004

LEPTON DOO

17792 A

II

10/27/2004

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

B 250 204 GREY AND RED ELASTOMERIC INJECTION CLOSURES FOR PHARMACEUTICALS AS
MANUFACTURED IN KRANJ, SLOVENIA FOR LEPTON D.O.O.
BENAZEPRIL HYDROCHLORIDE (BULK) AS MANUFACTURED IN ZHEJIANG, CHINA.

17793 A

II

10/25/2004

CIPLA LTD

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA.

17794 A

II

10/25/2004

TEVA PHARMACEUTICALS INDUSTRIES LTD

VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17795 A

II

9/29/2004

DOW AGROSCIENCES LLC

SPINOSAD PHARMACEUTICAL GRADE AS MANUFACTURED IN HARBOR BEACH, MI.

Page 513

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17796 I
II
10/29/2004
RANBAXY LABORATORIES LTD

SUBJECT
IRBESARTAN USP AS MANUFACTURED IN PUNJAB, INDIA.

17797 I

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN PILAR, ARGENTINA.

II

10/12/2004

17798 N

GADOR SA
NOT AN ASSIGNED NUMBER

17799 A

II

11/2/2004

NEULAND LABORATORIES LTD

LEVETIRACETAM AS MANUFACTURED IN TELANGANA, INDIA.

17800 A

II

10/15/2004

UQUIFA MEXICO SA DE CV

TROPICAMIDE AS MANUFACTURED IN MORELOS, MEXICO.

17801 A

II

10/29/2004

DMSAM AS MANUFACTURED IN BLASCA, SWITZERLAND.

17802 A

II

10/23/2004

HELSINN CHEMICALS SA HELSINN ADVANCED


SYNTHESIS SA
AUROBINDO PHARMA LTD

17803 I

II

11/1/2004

CRYSTAL PHARMA SAU

BETAMETHASONE SODIUM PHOSPHATE AS MANUFACTURED IN VALLADOLID, SPAIN.

17804 A

III

11/2/2004

BPREX HEALTHCARE OFFRANVILLE SAS

PILL JARS SETS - CRC RANGE AS MANUFACTURED IN OFFRANVILLE, FRANCE.

17805 A

II

10/27/2004

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

FOSINOPRIL SODIUM (BULK) AS MANUFACTURED IN ZHEJIANG, CHINA.

17806 I

II

11/1/2004

RHODIA ORGANIQUE SAS

17807 A

II

11/2/2004

NOF CORP

17808 A

II

11/3/2004

IPCA LABORATORIES LTD

4-NITRO-3-TRIFLUOROMETHYLANILINE (NTFMA) AS MANUFACTURED IN MULHOUSE,


FRANCE.
DIMYRISTOYL PHOSPHATIDYL GLYCEROL SODIUM SALT (DMPG-NA) AS MANUFACTURED IN
HYOGO, JAPAN.
CHLORTHALIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA.

17809 A

II

11/3/2004

SULFADOXINE AS MANUFACTURED IN SHANGHAI, CHINA.

17810 A

II

11/7/2004

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
DIVIS LABORATORIES LTD

17811 A

II

11/8/2004

CIPLA LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN PUNE, INDIA.

17812 A

II

11/3/2004

CARBOGEN AMCIS AG

NEPAFENAC AS MANUFACTURED IN BUBENDORF, SWITZERLAND.

17813 A

II

11/4/2004

CEDARBURG PHARMACEUTICALS INC

EXEMESTANE AS MANUFACTURED IN GRAFTON, WI.

17814 A

II

10/25/2004

17815 A

II

11/10/2004

NATIONAL INSTITUTES HEALTH NATIONAL CANCER HUMANIZED MIK-BETA-1 MONOCLONAL ANTIBODY AS MANUFACTURED IN FREDERICK, MD.
INSTITUTE
HELSINN ADVANCED SYNTHESIS SA
MODAFINIL AS MANUFACTURED IN BIASCA, SWITZERLAND.

17816 A

II

11/8/2004

ANDHRA SUGARS LTD

17817 A

II

11/9/2004

17818 A

III

11/1/2004

17819 A

II

11/2/2004

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY EPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA.
CO LTD
COLORTECH INC
10002-12 SLIP POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND
ONTARIO, CANADA.
MOEHS IBERICA SL
LANSOPRAZOLE AS MANUFACTURED IN BARCELONA, SPAIN.

17820 I

IV

11/8/2004

SHOWA DENKO KK

17821 A

II

11/1/2004

CHEMWERTH INC

17822 I

II

11/11/2004

UQUIFA MEXICO S.A. DE C.V.

VISCOMATE NP-700 (PARTIALLY NEUTRALIZED POLYACRYLATE) AS MANUFACTURED IN


KANAGAWA, JAPAN.
LOVASTAIN (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN CHONQING,
CHINA FOR CHEMWERTH INC
GATIFLOXACIN HEMIHYDRATE AS MANUFACTURED IN MORELOS, MEXICO.

17823 A

II

11/10/2004

HARMAN FINOCHEM LTD

PHENOBARBITAL USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17824 A

II

10/30/2004

AUROBINDO PHARMA LTD

CEFTRIAXONE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17825 A

II

11/10/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

REPAGLINIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

17826 I

II

11/12/2004

BOEHRINGER INGELHEIM CHEMICALS INC

FENTANYL CITRATE AS MANUFACTURED IN PETERSBURG, VA.

17827 A

II

11/16/2004

TEVA PHARMACEUTICALS USA INC

CEFPROZIL AS MANUFACTURED IN MEXICO, MO.

17828 A

II

12/15/2004

JANSSEN PHARMACEUTICA NV

DAPOXETINE HYDROCHLORIDE AS MANUFACTURED IN GEEL, BELGIUM.

17829 A

II

11/8/2004

AUROBINDO PHARMA LTD

SIMVASTATIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

LORATADINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ASPIRIN STARCH GRANULES AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

Page 514

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17830 I
IV
11/10/2004
FONA INTERNATIONAL INC
17831 I

IV

11/10/2004

FONA INTERNATIONAL INC

17832 I

II

9/8/2004

NANTONG GENERAL PHARMACEUTICAL FACTORY

SUBJECT
894.143 PEPPERMINT FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL
STREAM, IL.
862.547 LEMON MINT FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL
STREAM, IL.
FLUOROURACIL AS MANUFACTURED IN JIANGSU, P.R. CHINA.

17833 I

II

11/8/2004

MEDICHEM SA

LOSARTAN POTASSIUM AS MANUFACTURED IN GIRONA, SPAIN.

17834 A

II

11/16/2004

MERCK KGAA

17835 A

IV

11/17/2004

GUJARAT MICROWAX PRIVATE LTD

MAGNESIUM CHLORIDE HEXAHYDRATE AS MANUFACTURED IN FRANKFURTER STRABE,


GERMANY.
MICROCRYSTALLINE CELLULOSE AS MANUFACTURED IN NORTH GUJARAT, INDIA.

17836 A

II

11/15/2004

USV LIMITED

ROSIGLITAZONE MALEATE AS MANUFACTURED IN MUMBAI, INDIA.

17837 A

II

11/18/2004

CAMBRIDGE ISOTOPE LABORATORIES INC

2-13C URACIL AS MANUFACTURED IN ANDOVER, MA.

17838 A

II

11/3/2004

BIOIBERICA SA

HEPARIN SODIUM AS MANUFACTURED IN BARCELONA, SPAIN.

17839 I

III

11/15/2004

BORMIOLI ROCCO E FIGLIO SPA PLASTIC DIV

PET BOTTLE 300 ML AS MANUFACTURED IN ITALY AND FRANCE.

17840 A

II

11/19/2004

FARMHISPANIA SA

FH-109 (MOEXIPRIL HYDROCHLORIDE) AS MANUFACTURED IN BARCELONA, SPAIN.

17841 N

NOT AN ASSIGNED NUMBER

17842 A

II

11/22/2004

CIPLA LTD

DISODIUM PAMIDRONATE AS MANUFACTURED IN PUNE, INDIA.

17843 A

III

11/8/2004

RAUMEDIC AG

17844 I

II

11/15/2004

JUZEN CHEMICAL CORP

17845 A

II

11/17/2004

SHENZHEN HEPALINK PHARMACEUTICAL CO LTD

RAUMEDIC PVC-FREE COEXTRUDED FILLING TUBES AS MANUFACTURED IN HELBRECHTS


AND REHAU, GERMANY.
5-AMINOLEVULINIC ACID HYDROCHLORIDE (JALA) AS MANUFACTURED IN TOYAMA
PREFECTURE, JAPAN.
HEPARIN SODIUM USP AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA.

17846 A

II

11/20/2004

DIVIS LABORATORIES LTD

CARBIDOPA USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17847 A

II

11/22/2004

DR REDDYS LABORATORIES LTD

NATEGLINIDE (PREMIX) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17848 A

II

11/17/2004

QUIMICA SINTETICA SA

PANTOPRAZOLE SODIUM AS MANUFACTURED IN MADRID, SPAIN.

17849 I

II

11/22/2004

USV LIMITED

NIMODIPINE USP AS MANUFACTURED IN MUMBAI, INDIA.

17850 I

II

11/22/2004

NOVADEL PHARMA INC

PROPOFOL LINGUAL SPRAY AS MANUFACTURED IN FLEMINGTON, NJ.

17851 A

II

11/16/2004

AUROBINDO DATONG BIO PHARMA CO LTD

NEVIRAPINE AS MANUFACTURED IN ANHRA PRADESH, INDIA.

17852 A

II

12/1/2004

OCEAN SPRAY CRANBERRIES INC

17853 I

II

11/15/2004

BOC MICRO APPLICATIONS CENTRE

17854 A

III

11/24/2004

WACKER CHEMICAL CORP

17855 I

II

10/28/2004

AXITEC CO LTD

LOW CALORIE CRANBERRY JUICE COCKTAIL AND PLACEBO AS MANUFACTURED IN


MIDDELBORO, MA.
MICRO-CYLINDER PRESSURIZED GAS CAPSULES (LINE 1) AS MANUFACTURED IN SURREY,
UNITED KINGDOM.
VINNOL(R) LL 4320 AS MANUFACTURED IN VINNOLIT GMBH & CO KG IN BURGHAUSEN,
GERMANY FOR WACKER POLYMER SYSTEMS LP.
ALLOPURINOL USP AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA.

17856 A

II

10/26/2004

ASIAN HERBEX LTD

CAPSAICIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17857 A

III

11/18/2004

HENKEL CORP

MACROMELT(R) 6900B AS MANUFACTURED IN KANKAKEE, IL.

17858 I

II

11/29/2004

DAICEL CHEMICAL INDUSTRIES LTD

FK 307 DRUG SUBSTANCE AS MANUFACTURED IN NIIGATA, JAPAN.

17860 A

II

11/29/2004

CU CHEMIE UETIKON GMBH

4-AMINOPYRIDINE AS MANUFACTURED IN LAHR, GERMANY.

17861 I

III

3/10/2004

BASF CORP

EPOTAL(R) P 350 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

17862 A

II

12/2/2004

HARMAN FINOCHEM PVT LTD

PHENYTOIN SODIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17863 A

II

12/1/2004

SCINOPHARM TAIWAN LTD

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN TAIWAN, R.O.C.

17859 N

NOT AN ASSIGNED NUMBER

Page 515

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17864 A
III
12/2/2004
PLASTIAPE SPA

SUBJECT
RS01 DRY POWDER INHALER - MODEL 7 AS MANUFACTURED IN LECCO, ITALY.

17865 A

II

12/6/2004

RANBAXY LABORATORIES LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACUTERED IN PUNJAB, INDIA

17866 A

II

12/3/2004

GEDEON RICHTER PLC

DROSPIRENONE AS MANUFACTURED IN BUDAPEST, HUNGARY.

17867 I

II

12/1/2004

LEK PHARMACEUTICALS DD

LOSARTAN POTASSIUM AS MANUFACTURED IN MENGES, SLOVENIA.

17868 I

II

12/21/2004

TIANJIN CENTRAL PHARMACEUTICAL CO LTD

ATENOLOL USP AS MANUFACTURED IN TIANJIN, CHINA.

17869 A

II

12/1/2004

SEKISUI MEDICAL CO LTD

TAURINE AS MANUFACTURED IN IWATE PREFECTURE, JAPAN.

17870 A

III

11/30/2004

LOPAREX LLC

17871 A

II

12/6/2004

SIFAVITOR SRL

GRADE 30158 S 2.5 BL SCK 6000/000 AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON,
IL; AND CULLMAN, AL.
MICONAZOLE AS MANUFACTURED IN LODIGIANO, ITALY.

17872 A

II

12/3/2004

GRANULES INDIA LTD

METHOCARBAMOL AS MANUFACTURED IN HYDERABAD, INDIA.

17873 A

II

12/7/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

ISRADIPINE UPS AS MANUFACTURED IN MAHARASHTRA, INDIA.

17874 A

II

12/3/2004

DIVIS LABORATORIES LTD

LEVODOPA USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17875 A

III

9/27/2004

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 50 ML AS MANUFACTURED IN ITALY AND FRANCE.

17876 A

III

12/2/2004

APTAR FRANCE SAS

17877 A

III

12/6/2004

EI DUPONT DE NEMOURS AND CO INC

17878 A

II

12/3/2004

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

METHODS FOR CONTROLLING APTAR NITRILE ELASTOMERS AS MANUFACTURED IN VAL DE


REUIL, FRANCE.
TYVEK(R) NONWOVEN SHEET AS MANUFACTURED IN RICHMOND, VA AND CONTERN,
LUXEMBOURG.
BICALUTAMIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA.

17879 I

II

12/7/2004

CADILA HEALTHCARE LTD

FLUVASTATIN SODIUM AS MANUFACTURED IN GUJARAT, INDIA.

17880 A

II

12/8/2004

URQUIMA SA

ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

17881 I

IV

12/2/2004

FONA INTERNATIONAL INC

926.418 N-C ARTIFICIAL VANILLA FLAVOR AS MANUFACTURED IN CAROL STREAM, IL.

17882 I

IV

12/2/2004

FONA INTERNATIONAL INC

856.435 GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL.

17883 A

II

12/7/2004

BIOVECTRA INC

H.P. ACTHAR BULK AS MANUFACTURED IN CHARLOTTETOWN, CANADA.

17884 I

II

12/4/2004

HAMNMI FINE CHEMICAL CO LTD

CEFTRIAXONE SODIUM, USP AS MANUFACTURED IN KYONGGI-DO, KOREA.

17885 I

II

10/5/2004

CIBA SPECIALTY CHEMICALS

TINUVIN 326 AS MANUFACTURED IN TARRYTOWN, NY.

17886 A

III

12/2/2004

LAJOVIC TUBA EMBALAZA DD

PLASTIC BLOW MOLDED CONTAINERS AS MANUFACTURED IN LJUBLJANA, SLOVENIA.

17887 I

II

12/21/2004

LONZA INC

TRIPROLIDINE HYDROCHLORIDE AS MANUFACTURED IN CONSHOHOCKEN, PA.

17888 A

II

12/9/2004

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFOTAXIME SODIUM, USP (STERILE BULK) AS MANUFACTURED IN NUNGAMBAKKAM, INDIA.

17889 A

II

12/14/2004

SUN PHARMACEUTICAL INDUSTRIES LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

17890 I

IV

5/12/2005

RIBA FAIRFIELD INC

ETHYL LACTATE, PHARMACEUTICAL GRADE AS MANUFACTURED IN DECATUR, IL.

17891 I

II

12/13/2004

ALBANY MOLECULAR RESEARCH INC

SPI-860-1 DRUG SUBSTANCE AS MANUFACTURED IN ALBANY, NY.

17892 I

IV

11/22/2004

ROHM AND HAAS CO

17893 A

III

12/3/2004

FPC FLEXIBLE PACKAGING CORP

DOW CORNING(R) ACRYLIC ADHESIVE EMULSIONS AS MANUFACTURED IN PIEDMONT, SC


FOR ROHM AND HAAS CO
POLYESTER/FOIL/POLYETHYLENE POUCH AS MANUFACTURED IN ONTARIO, CANADA.

17894 A

III

12/13/2004

SPL DESSECANTES LTDA

DESSECAP CAP - PLASTIC TOP CANISTER AS MANUFACTURED IN SAO PAULO, BRAZIL.

17895 A

III

12/13/2004

SPL DESSECANTES LTDA

DESSECAP CAC - PAPER TOP CANISTER AS MANUFACTURED IN SAO PAULO, BRAZIL.

17896 A

III

12/13/2004

SPL DESSECANTES LTDA

DESSECAP CPE - SIEVE EDGE CANISTER AS MANUFACTURED IN SAO PAULO, BRAZIL.

17897 A

II

12/15/2004

RANBAXY LABORATORIES LTD

VALSARTAN AS MANUFACTURED IN PUNJAB, INDIA.

17898 A

III

12/10/2004

NYPRO INC

METERED-DOSE INHALER COUNTER ACTUATOR/STRAPCAP AS MANUFACTURED IN ARDEN,


NC.

Page 516

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17899 I
II
12/10/2004
FUJIMOTO PHARMACEUTICAL CORP
17900 A

II

12/3/2004

AUROBINDO PHARMA LTD

SUBJECT
(2Z)-[(ACETYLOXY)IMINO](2-AMINO-1,3-THIAZOL-4-YL)ACETIC ACID OR 3990 ACID AS
MANUFACTURED IN OSAKA, JAPAN.
LAMIVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17901 I

III

2/16/2005

REXAM PHARMA SAS

DAIVOBET RANGE AS MANUFACTURED IN OFFRANSVILLE, FRANCE.

17902 A

II

10/14/2004

MALLADI DRUGS AND PHARMACEUTICALS LTD

TRIPROLIDINE HYDROCHLORIDE AS MANUFACTURED IN TAMIL NADU, INDIA.

17903 A

III

12/13/2004

SCANDOLARA SPA

17904 A

III

12/17/2004

REXAM HEALTHCARE PACKAGING INC

COLLAPSIBLE ALUMINUM TUBES FOR PHARMACEUTICAL USE AS MANUFACTURED IN ASCOLI


PICENO, ITALY.
MULTILAYER MLX PLASTIC COMPONENTS AS MANUFACTURED IN TOLEDO, OH.

17905 A

II

12/17/2004

CIPLA LTD

NEVIRAPINE AS MANUFACTURED IN PUNE, INDIA.

17906 A

II

12/13/2004

CIPLA LTD

NATEGLINIDE USP AS MANUFACTURED IN PUNE, INDIA.

17907 I

IV

12/9/2004

FREUND CORP

NONPAREIL-108 AS MANUFACTURED IN HAMAMATSU CITY, JAPAN.

17908 A

II

12/16/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

FAMCICLOVIR AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17909 A

II

12/16/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

VALSARTAN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17910 A

II

12/16/2004

TEVA PHARMACEUTICAL INDUSTRIES LTD

NATEGLINIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

17911 I

II

12/8/2004

AUROBINDO PHARMA LTD

CEFTRIAXONE SODIUM (STERILE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17912 A

II

12/20/2004

MYLAN LABORATORIES LTD

IRBESARTAN USP AS MANUFACTURED IN TELANGANA, INDIA

17913 A

II

12/15/2004

RHODIA ORGANIQUE

ACETAMINOPHEN USP AS MANUFACTURED IN ROUSSILLON, FRANCE.

17914 A

II

12/14/2004

QUIMICA SINTETICA SA

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MADRID, SPAIN.

17915 A

II

12/16/2004

MYLAN LABORATORIES LTD

NEVIRAPINE USP (ANHYDROUS) AS MANUFACTURED IN TELANGANA, INDIA

17916 A

II

12/22/2004

CODY LABORATORIES INC

FENTANYL BASE USP AS MANUFACTURED IN CODY, WY.

17917 I

II

12/6/2004

STRAINRITE

17918 I

II

12/6/2004

STRAINRITE

17919 I

II

12/6/2004

STRAINRITE

17920 I

II

9/27/2004

STRAINRITE

17921 I

II

12/20/2004

SOCIETA ITALIANA MEDICINALI SCANDICCI

MD-3M-420, 282556: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN


AUBURN, MAINE.
MD-3M-45, 282513: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
MD-3M-630, 282559: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
DCC-MD-XX-45, 352001: CLARIFICATION CAPSULE FOR ONE TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
ITRACONAZOLE AS MANUFACTURED IN FIRENZE, ITALY.

17922 A

II

12/23/2004

DR REDDYS LABORATORIES LTD

ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17923 A

II

12/15/2004

LIFE TECHNOLOGIES CORP

CELL CULTURE MEDIA AS MANUFACTURED IN GRAND ISLAND, NY.

17924 A

III

12/22/2004

AIRSEC SA

DESICCANT JOINT AS MANUFACTURED IN ROMORANTIN, FRANCE.

17925 I

II

12/23/2004

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN BARCELONA SPAIN

17926 I

III

12/21/2004

BOREALIS AS

BORMED(TM) LE6603-PH AS MANUFACTURED IN STATHELLE, NORWAY.

17927 A

III

12/21/2004

BOREALIS AG

BORMED TM LE6609-PH AS MANUFACTURED IN PORVOO, FINLAND

17928 I

III

12/2/2004

BOREALIS AG

BORMED(TM) HF855MO AS MANUFACTURED IN AUSTRIA FOR BOREALIS AG

17929 A

III

12/21/2004

BOREALIS AG

BORMED(TM) HD850MO AS MANUFACTURED IN SCHWECHAT, AUSTRIA

17930 A

III

12/21/2004

BOREALIS AG

BORMED TM BE860MO AS MANUFACTURED IN BERINGEN, BELGIUM

17931 A

III

12/21/2004

BOREALIS AG

BORMED(TM) RB845MO AS MANUFACTURED IN BURGHAUSEN, GERMANY

17932 A

II

12/17/2004

ZHEJIANG HUAKANG PHARMACEUTICAL CO LTD

XYLITOL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

17933 A

II

12/27/2004

TARO PHARMACEUTICAL INDUSTRIES LTD

CIPROFLOXACIN HYDROCHLORIDE, USP AS MANUFACTURED IN HAIFA BAY, ISRAEL.

Page 517

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17934 A
II
12/27/2004
LUPIN LTD

SUBJECT
SIMVASTATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

17935 A

II

12/20/2004

PCAS

ARTICAINE HCL AS MANUFACTURED IN TURKU, FINLAND FOR PCAS

17936 I

II

12/10/2004

STRAINRITE

17937 I

II

12/10/2004

STRAINRITE

17938 I

II

12/10/2004

STRAINRITE

17939 I

II

12/10/2004

STRAINRITE

17940 I

II

12/10/2004

STRAINRITE

17941 I

II

12/10/2004

STRAINRITE

17942 A

III

11/30/2004

NOLATO JAYCARE LTD

17943 A

II

12/29/2004

MYLAN LABORATORIES LTD

MD-3F-420, 282557: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN


AUBURN, MAINE.
MD-3F-630, 282560: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
MD-3C-420, 282555: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
MD-3C-45, 282553: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN,
MAINE.
MD-3F-45, 282554: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN,
MAINE.
MD-3C-630, 282558: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN
AUBURN, MAINE.
JAYCAP CLOSURE RANGE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED
KINGDOM.
VALACYCLOVIR HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

17944 I

II

12/3/2004

HONEYWELL IROPHARM PLC

BUTOCONAZOLE AS MANUFACTURED IN CO. WICKLOW, IRELAND.

17945 A

II

12/29/2004

GLENMARK GENERICS LTD

ZONISAMIDE AS MANUFACTURED IN GUJARAT STATE, INDIA.

17946 A

II

12/29/2004

GLENMARK GENERICS LTD

ITRACONAZOLE AS MANUFACTURED IN GUJARAT STATE, INDIA.

17947 A

II

12/29/2004

CADILA HEALTHCARE LTD

CARVEDILOL USP AS MANUFACTURED IN GUJARAT, INDIA.

17948 A

III

1/17/2005

POLYTAINERS INC

PLASTIC BLOW MOLDED BOTTLES AS MANUFACTURED IN SIMI VALLEY, CA.

17949 A

III

12/16/2004

CL SMITH CO

17950 I

IV

12/28/2004

FONA INTERNATIONAL INC

ROUND, WHITE HIGH-DENSITY POLYETHYLENE (HDPE) BOTTLE WITH GRADUATIONS AND


VIEW STRIPE AS MANUFACTURED IN ST. LOUIS, MO.
825.0029U CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL.

17951 I

II

12/29/2004

QUIMICA SINTETICA SA

AZITHROMYCIN HYDROGENCITRATE AS MANUFACTURED IN MADRID, SPAIN.

17952 I

II

12/20/2004

MATRIX LABORATORIES (XIAMEN) LIMITED

ZIDOVUDINE, USP AS MANUFACTURED IN FUJIAN, PEOPLE'S REPUBLIC OF CHINA.

17953 A

II

12/27/2004

ARCH PHARMALABS LTD

FCMIC CHLORIDE AS MANUFACTURED IN HYDERABAD, INDIA.

17954 A

II

12/12/2004

ARCH PHARMALABS LTD

DICMIC CHLORIDE AS MANUFACTURED IN HYDERABAD, INDIA.

17955 A

III

12/30/2004

TEIJIN LIMITED

POLYETHYLENENAPHTHALATE RESIN AS MANUFACTURED IN EHIME-PREF., JAPAN.

17956 A

II

12/31/2004

LUPIN LTD

RAMIPRIL USP (PROCESS B) AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17957 A

II

12/31/2004

LUPIN LTD

QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17958 A

II

12/29/2004

LUPIN LTD

PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

17959 I

II

12/30/2004

GLENMARK PHARMACEUTICALS LTD

SIMVASTATIN AS MANUFACTURED IN GUJARAT STATE, INDIA.

17960 A

II

12/29/2004

HETERO LABS LTD

ESCITALOPRAM OXALATE (PROCESS-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17961 A

III

12/30/2004

LOPAREX BV

17962 A

II

1/5/2005

TRIFARMA SPA

FL2000(TM) 75 UM PET C1S WITH GRADE CODE RT149 AS MANUFACTURED IN AZ


APELDOORN, THE NETHERLANDS.
OXANDROLONE USP AS MANUFACTURED IN MILANO, ITALY.

17963 A

III

1/5/2005

BILCARE LTD

17964 A

II

12/23/2004

MITSUI NORIN CO LTD

BILCARE SPECIALTY ALUMINUM LID, STRIP AND COLD FORMING FOILS AS MANUFACTURED
IN MAHARASHTRA, INDIA.
POLYPHENON(R) E AS MANUFACTURED IN SHIZUOKA, JAPAN.

17965 I

II

1/3/2005

YUNNAN ZIYUN BIO TECH CO LTD

PACLITAXEL, USP (BULK) AS MANUFACTURED IN YUNNAN, P.R. CHINA.

17966 A

II

12/30/2004

FRESENIUS KABI ONCOLOGY LTD

PACLITAXEL SEMISYNTHETIC AS MANUFACTURED IN WEST BENGAL, INDIA.

Page 518

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17967 A
II
1/3/2005
WUHAN SHIJI PHARMACEUTICAL CO LTD

SUBJECT
GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN HUBEI, CHINA.

17968 A

II

12/30/2004

AUROBINDO PHARMA LTD

STAVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17969 I

IV

1/5/2005

NOVA NUTRACEUTICAL TECHNOLOGY LTD

17970 A

II

1/5/2005

WANBURY LTD

MICROCRYSTALLINE CELLULOSE/CARBOXY METHYL CELLULOSE AS MANUFACTURED IN


ZHEJIANG PROVINCE, CHINA.
TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, STATE, INDIA.

17971 A

II

12/12/2004

HUBEI HAOSUN PHARMACEUTICAL CO LTD

FLUMAZENIL AS MANUFACTURED IN HUBEI, P.R. CHINA.

17972 A

II

1/5/2005

ZHEJIANG YIXIN PHARMACEUTICAL CO LTD

GALANTAMINE HBR. AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

17973 I

II

1/6/2004

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

CILOSTAZOL AS MANUFACTURED IN BARCELONA SPAIN

17974 A

II

12/14/2004

OLON SPA

RIFAXIMIN AS MANUFACTURED IN MULAZZANO (LO), ITALY.

17975 A

II

1/6/2005

MYLAN LABORATORIES LTD

ZONISAMIDE AS MANUFACTURED IN TELANGANA, INDIA.

17976 A

II

1/6/2004

MYLAN LABORATORIES LTD

STAVUDINE USP AS MANUFACTURED IN TELANGANA, INDIA.

17977 A

II

1/6/2005

MYLAN LABORATORIES LTD

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN TELANGANA, INDIA

17978 A

II

1/6/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

17979 A

II

1/12/2005

HETERO DRUGS LTD

17980 A

II

1/11/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

CITALOPRAM HYDROBROMIDE (PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
ONDANSETRON AS MANUFACTURED IN GUJARAT, INDIA.

17981 A

12/21/2004

MYCENAX BIOTECH INC

17982 A

II

1/12/2005

OLON SPA

17983 I

III

1/3/2005

HUMPHREY COSBURN PLASTICS

17984 A

III

1/3/2005

HUMPHREY COSBURN PLASTICS

17985 I

III

1/3/2005

HUMPHREY COSBURN PLASTICS

17986 A

II

12/1/2004

OLON SPA

48/400 BLACK ROUND STACKING TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO,


CANADA.
53/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO,
CANADA.
43/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO,
CANADA.
CEFDINIR HYDRATE AS MANUFACTURED IN RODANO (MI), ITALY AND LEON, SPAIN.

17987 A

II

1/12/2005

HETERO LABS LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17988 A

II

1/12/2005

SIGNA SA DE CV

OXCARBAZEPINE AS MANUFACTURED IN TOLUCA, MEXICO.

17989 N

NOT AN ASSIGNED NUMBER

17990 N

NOT AN ASSIGNED NUMBER

17991 N

NOT AN ASSIGNED NUMBER

17992 N

NOT AN ASSIGNED NUMBER

17993 N

PROCESS DEVELOPMENT AND PRODUCTION FOR BIOLOGICAL THERAPEUTICS IN MIAOLI,


TAIWAN.
PERGOLIDE MESYLATE AS MANUFACTURED IN RODANO (MI), ITALY.

NOT AN ASSIGNED NUMBER

17994 A

IV

1/3/2005

HANNS G WERNER GMBH CO KG

PHARM-A-SPHERES(TM) SUGAR SPHERES NF AS MANUFACTURED IN TORNESCH, GERMANY.

17995 A

IV

12/30/2004

HESEGO INDUSTRY

17996 A

III

1/20/2005

AMARTARA PRIVATE LTD

TRISTAR NF AND TRISTAR 149 AS MANUFACTURED IN SELANGOR, MALAYSIA FOR HESEGO


INDUSTRY
PVC/PVDC PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA, INDIA.

17997 A

II

1/17/2005

HETERO LABS LTD

STAVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

17998 I

III

1/10/2005

CODING PRODUCTS

CDF-4, A HOT STAMP INK RIBBON USED IN THE LABELING OF A VARIETY OF DRUG PRODUCTS
SUCH AS IV BAGS AND SINGLE DOSE VIALS AS MANUFACTURED IN KALKASKA, MI.

Page 519

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
17999 I
III
1/10/2005
CODING PRODUCTS

SUBJECT
DOI-4, A HOT STAMP INK RIBBON USED IN THE LABELING OF A VARIETY OF DRUG PRODUCTS
SUCH AS IV BAGS AND SINGLE DOSE VIALS AS MANUFACTURED IN KALKASKA, MI.

18000 A

II

1/18/2005

AVANTI POLAR LIPIDS INC

FENRETINIDE LYM-X-SORB(TM) POWDER AS MANUFACTURED IN ALABASTER, AL.

18001 A

II

1/18/2005

AVANTI POLAR LIPIDS INC

FENRETINIDE LYM-X-SORB(TM) OIL AS MANUFACTURED IN ALABASTER, AL.

18002 A

II

1/18/2005

AVANTI POLAR LIPIDS INC

LYM-X-SORB(TM) LIPID MATRIX FOR DRUG DELIVERY AS MANUFACTURED IN ALABASTER, AL.

18003 I

II

1/12/2005

CHEMWERTH INC

18004 I

II

1/13/2005

18005 A

II

1/10/2005

KUNSHAN CHEMICAL AND PHARMACEUTICAL CO


LTD
SYN TECH CHEM AND PHARM CO LTD

REPAGLINIDE USP AS MANUFACTURED BY LIANYUNGANG HANSEN PHARMACEUTICAL CO


LTD IN LIANYUNGANG, CHINA FOR CHEMWERTH INC.
DOXYCYCLINE HYCLATE USP AS MANUFACTURED IN IN KUNSHAN CITY, JIANGSU, CHINA

18006 A

III

1/14/2005

WEST PHARMACEUTICAL SERVICES INC

CLIP 'N' JECT(TM) RECONSTITUTION SYSTEM AS MANUFACTURED IN MONTGOMERY, PA.

18007 A

II

1/12/2005

KATWIJK CHEMIE BV

SODIUM VALPROATE POWDER AS MANUFACTURED IN KATWIJK, THE NETHERLANDS.

18008 I

III

8/30/2004

INDUSTRIAL GOMERA SA DE CV

RIB-TIP-CAP CHLOROBUTYL RUBBER AS MANUFACTURED IN EDO. DE MEXICO, MEXICO.

18009 A

III

1/3/2005

HUMPHREY COSBURN PLASTICS

18010 I

III

1/3/2005

HUMPHREY COSBURN PLASTICS

18011 A

IV

1/14/2005

FONA INTERNATIONAL INC

18012 I

III

1/3/2005

US INGREDIENTS INC DBA ABELEI

38/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO,


CANADA.
70/400 WHITE ROUND STACKING TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO,
CANADA.
831.028 PINA COLADA FLAVOR (A NATURAL AND ARTIFICIAL FLAVOR) AS MANUFACTURED IN
ONTARIO, CANADA.
CHERRY FLAVOR FORMULATIONS

18013 A

II

1/20/2005

DR REDDYS LABORATORIES LTD

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18014 A

II

1/20/2005

PHARMACEUTICAL WORKS POLPHARMA SA

BACLOFEN AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

18015 I

II

1/12/2005

BIOFER SPA

IRON SUCROSE INJECTION AS MANUFACTURED IN MEDOLLA (MO), ITALY.

18016 A

II

1/19/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

SODIUM VALPORATE EP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18017 A

II

1/17/2005

SAFC BIOSCIENCES INC

18018 A

II

1/21/2005

SANOFI INDIA LTD

18019 A

II

1/18/2005

JOHNSON MATTHEY PHARMA SERVICES

EX-CELL(TM) 325 PF CHO, SERUM-FREE MEDIUM, PROTEIN FREE AS MANUFACTURED IN


DENVER, PA.
GLYBURIDE USP (GLIBENCLAMIDE), MILLED AS MANUFACTURED IN GUJARAT, INDIA FOR
AVENTIS PHARMA DEUTSCHLAND GMBH
EPOPROSTENOL SODIUM AS MANUFACTURED IN CORK, IRELAND.

18020 A

III

1/13/2005

RENOLIT NEDERLAND BV

18021 A

II

1/26/2005

CIPLA LTD

SOLMED(R) ALKA FORMULATIONS AS MANUFACTURED IN AA ENKHUIZEN, THE


NETHERLANDS.
RIZATRIPTAN BENZOATE AS MANUFACTURED IN PUNE, INDIA.

18022 A

II

1/26/2005

CIPLA LTD

ZALEPLON AS MANUFACTURED IN PUNE, INDIA.

18023 N

LIDOCAINE AS MANUFACTURED IN HSING-YING, TAIWAN, R.O.C.

NOT AN ASSIGNED NUMBER

18024 A

II

3/22/2005

LUPIN LTD

RAMIPRIL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

18025 A

IV

1/27/2005

BASF CORP

POLOXAMERS AS MANUFACTURED IN WASHINGTON, NJ.

18026 A

III

1/25/2005

BOREALIS AG

18027 A

III

1/25/2005

BOREALIS AG

18028 A

III

1/3/2005

HUMPHREY COSBURN PLASTICS

18029 I

II

1/24/2005

NINGBO SMART PHARMACEUTICAL CO LTD

BOREALIS POLYETHYLENE FG5224 AS MANUFACTURED BY BOREALIS AB IN STENUNGSUND,


SWEDEN FOR BOREALIS AS.
BOREALIS POLYETHYLENE FG5223 AS MANUFACTURED BY BOREALIS AB IN STENUNGSUND,
SWEDEN FOR BOREALIS AS.
33/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO,
CANADA.
GUAIFENESIN USP AS MANUFACTURED IN NINGBO, CHINA.

Page 520

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18030 A
II
1/24/2005
ZHEJIANG HISUN PHARMACEUTICAL CO LTD
18031 A

II

1/26/2005

TARO PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
TOLTERODINE TARTRATE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS
MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA.
IMIQUIMOD AS MANUFACTURED IN HAIFA BAY, ISRAEL.

18032 I

II

1/25/2005

ALKALOIDS CORP

COLCHICINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18033 A

IV

1/29/2005

DAIDO CHEMICAL CORP

18034 A

III

1/17/2005

3M DRUG DELIVERY SYSTEMS

POVACOAT(TM) (POLYVINYLALCOHOL-ACRYLIC ACID-METHYL METHACRYLATE COPOLYMER)


AS MANUFACTURED IN OSAKA, JAPAN.
SCOTCHPAK (TM) 1109 AS MANUFACTURED IN COTTAGE GROVE, MN

18035 A

III

1/17/2005

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK (TM) 1006 AS MANUFACTURED IN COTTAGE GROVE, MN

18036 A

III

1/17/2005

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK (TM) 1020 AS MANUFACTURED IN COTTAGE GROVE, MN

18037 A

III

1/17/2005

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK (TM) 1220 AS MANUFACTURED IN COTTAGE GROVE, MN

18038 A

III

1/17/2005

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK (TM) 1012 AS MANUFACTURED IN COTTAGE GROVE, MN

18039 A

III

1/17/2005

3M DRUG DELIVERY SYSTEMS

SCOTCHPAK (TM) 1022 AS MANUFACTURED IN COTTAGE GROVE, MN

18040 A

III

2/1/2005

BOREALIS AG

BOREALIS HE9621-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY

18041 A

III

2/1/2005

BOREALIS AG

18042 I

II

1/31/2005

RANBAXY LABORATORIES LTD

BOREALIS BORMED(TM) HE2581-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR


BOREALIS AG
ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA.

18043 A

II

2/1/2005

FARMABIOS S P A

CYPROTERONE ACETATE AS MANUFACTURED IN PAVIA, ITALY.

18044 A

II

2/1/2005

SANDOZ INDUSTRIAL PRODUCTS SA

AMOXICILLIN SODIUM (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN.

18045 I

II

1/28/2005

SA AJINOMOTO OMNICHEM NV

GALANTAMINE HBR AS MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM

18046 I

III

2/1/2005

AVERY DENNISON

ACCU-PLACE-IN-MOLD LABEL (APIML) PRODUCT AS MANUFACTURED IN STRONGSVILLE, OH.

18047 A

1/18/2005

MONOGRAM BIOSCIENCES A LABCORP SUB

PHENOSENSE(TM) HIV ENTRY TROPISM ASSAY VALIDATION PACKET AS MANUFACTURED IN


SOUTH SAN FRANCISCO, CA.

18049 A

II

2/3/2005

CADILA HEALTHCARE LTD

SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

18050 A

II

2/3/2005

APOTEX PHARMACHEM INC

ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN ONTARIO, CANADA.

18051 A

II

2/2/2005

CHIFENG PHARMACEUTICAL GROUP CO LTD

GRISEOFULVIN, USP AS MANUFACTURED IN INNER MONGOLIA, CHINA.

18052 A

II

2/1/2005

MEDICHEM SA

PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN GIRONA, SPAIN.

18053 A

II

2/2/2005

POLYCARBON INDUSTRIES INC

PCI-8024 (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN LEOMINSTER, MA.

18054 I

II

2/2/2005

SOCIETA ITALIANA MEDICINALI SCANDICCI

MESALAMINE AS MANUFACTURED IN FIRENZE, ITALY.

18055 A

II

2/4/2005

LUPIN LTD

ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18056 A

II

2/3/2005

ISOCHEM SAS

GEMFIBROZIL AS MANUFACTURED IN PITHIVIERS, FRANCE.

18057 A

II

1/24/2005

CHENG FONG CHEMICAL CO LTD

PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN TAIWAN, R.O.C.

18058 I

II

2/1/2005

SUZHOU WANQING PHARMACEUTICALS CO LTD

LORATADINE AS MANUFACTURED IN JIANGSU, CHINA.

18059 A

II

2/7/2005

WOCKHARDT LTD

ZONISAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18060 A

II

2/7/2005

WOCKHARDT LTD

STERILE SODIUM CARBONATE AS MANUFACTURED IN GUJARAT, INDIA.

18061 A

III

1/26/2005

AMPACET CORP

18062 A

II

2/3/2005

FLAMMA SPA

111680 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;


DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH; AND LATEXO, TX.
MODAFINIL AS MANUFACTURED IN BERGAMO, ITALY.

18063 A

II

2/8/2005

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

PREDNISOLONE ANHYDROUS, USP AS MANUFACTURED IN ZHEJIANG, CHINA.

18064 I

II

2/4/2005

CHENG FONG CHEMICAL CO LTD

DIVALPROEX SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN.

18048 N

NOT AN ASSIGNED NUMBER

Page 521

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18065 A
II
2/6/2005
DIVIS LABORATORIES LTD

SUBJECT
PROGUANIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18066 A

II

2/6/2005

DIVIS LABORATORIES LTD

IOPAMIDOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18067 I

II

1/22/2005

TAI HENG INDUSTRY CO LTD

18068 A

II

2/9/2005

CADILA HEALTHCARE LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN CHANZHOU SIYAO PHARMACEUTICAL


CO LTD IN JIANGSU, CHINA FOR TAI HENG INDUSTRY TRADE & CO LTD.
RISPERIDONE AS MANUFACTURED IN GUJARAT, INDIA.

18069 A

II

2/8/2005

18070 A

III

2/9/2005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
CEODEUX SA

18071 I

II

1/21/2005

AXITEC CO LTD

HIGH PRESSURE VALVE SERIE D 413 FOR CYLINDERS CONTAINING GASEOUS MIXTURE
DRUGS UNDER PRESSURE AS MANUFACTURED IN LINTGEN, LUXEMBORG.
CYTARABINE, USP AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA.

18072 I

II

1/31/2005

AXITEC CO LTD

CLADRIBINE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA.

18073 A

II

2/11/2005

WOCKHARDT LTD

ANHYDROUS AZITHROMYCIN AS MANUFACTURED IN GUJARAT, INDIA.

18074 A

III

1/4/2005

STYROLUTION EUROPE GMBH

18075 A

II

2/6/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

TERLUX(R) HD 2802 AS MANUFACTURED IN LUDWIGSHAFEN AND SCHWARZHEIDE,


GERMANY.
ALPRAZOLAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

18076 A

II

2/11/2005

CATALENT PHARMA SOLUTIONS LLC

LUBIPROSTONE, 24 MCG CAPSULES AS MANUFACTURED IN ST. PERTERSBURG, FL.

18077 A

II

2/11/2005

PEPTISYNTHA SA

18078 A

II

2/9/2005

MACFARLAN SMITH LTD

CETRORELIX ACETATE BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS,


BELGIUM.
GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN SCOTLAND, ENGLAND.

18079 A

II

2/9/2005

LONZA AG

EPROSARTAN MESYLATE (ROUTE F1) AS MANUFACTURED IN VISP, SWITZERLAND.

18080 I

II

2/10/2005

FIS FABBRICA ITALIANA SINTETICI SPA

CLOBAZAM AS MANUFACTURED IN VICENZA, ITALY.

18081 A

II

2/3/2005

CORDEN PHARMA LATINA SPA

CEPHAPIRIN BENZATHINE AS MANUFACTURED IN LATINA, ITALY.

18082 A

II

2/1/2005

LEK PHARMACEUTICALS DD

ATORVASTATIN CALCIUM, ACTIVE SUBSTANCE AS MANUFACTURED IN MENGES, SLOVENIA.

18083 A

II

12/12/2004

ZHEJIANG HUAYI PHARMACEUTICAL CO LTD

CIPROFLOXACIN AS MANUFACTURED IN ZHEJIANG, CHINA.

18084 A

II

2/15/2005

PERRIGO API LTD

PENTOXYFYLLINE AS MANUFACTURED IN WIESBADEN, GERMANY.

18085 I

III

11/23/2004

JAYCARE LTD

18086 I

II

2/4/2005

MALLINCKRODT INC

1LITRE PHARMA BOTTLE AS MANUFACTURED IN NEW CASTLE UPON TYNE, UNITED


KINGDOM.
BUTALBITAL USP, CODE 5678 AS MANUFACTURED IN ST. LOUIS, MO.

18087 N

METHSCOPOLAMINE BROMIDE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY.

NOT AN ASSIGNED NUMBER

18088 N

NOT AN ASSIGNED NUMBER

18089 I

III

2/3/2005

AMPACET CORP

18090 A

II

2/17/2005

CADILA HEALTHCARE LTD

111155 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY;


TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH; AND DERIDDER, LA.
LAMOTRIGINE AS MANUFACTURED IN GUJARAT, INDIA.

18091 A

II

2/18/2005

R TECH UENO LTD

LUBIPROSTONE (RU-0211) AS MANUFACTURED IN HYOGO, JAPAN.

18092 A

III

2/8/2005

DUPONT PERFORMANCE POLYMERS

CRASTIN(R) 6131C NC010 AS MANUFACTURED IN MONCK'S CORNER, SC.

18093 A

III

2/10/2005

POLYONE CORP

CC10004832WE ACC05612P ORANGE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

18094 A

III

2/10/2005

POLYONE CORP

CC00022000WE TVC01545P WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

18095 A

III

2/10/2005

POLYONE CORP

CC10004654WE ACC40487P YELLOW AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

18096 A

IV

2/8/2005

AUTHENTIX INC

18097 I

III

2/4/2005

AUTHENTIX SECURITY INK FORMULATION FOR PACKAGING AS MANUFACTURED IN


DOUGLASSVILLE, PA.
BERRY PLASTICS CORP TAPES AND COATINGS DIV 72 GA PVDC COATED NYLON/10# LDPE/.00285 FOIL/10# LDPE/1.75 MIL LLDPE WITH EVA FILM
AS MANUFACTURED IN COLUMBUS, GA.

Page 522

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18098 I
III
11/18/2004
JAYCARE LTD

SUBJECT
150ML ANTIBIOTIC BOTTLE WITH 28MM CLIC-LOC NECK FINISH AS MANUFACTURED IN
NEWCASTLE UPON TYNE, UNITED KINGDOM.
SMOPEX-111 AS MANUFACTURED IN TURKU, FINLAND.

18099 A

II

9/10/2004

JOHNSON MATTHEY FINLAND LTD

18100 A

III

2/12/2005

AUTOFITS PACKAGING PVT LTD UNIT II

18101 I

II

1/25/2005

ZHEJIANG RUIBANG LABORATORIES

CLOSURES CAPS FOR BOTTLES AND SEALS FOR INJECTION VIALS AS MANUFACTURED IN
NASHIK, INDIA.
SIMVASTATIN USP AS MANUFACTURED IN ZHEJIANG, CHINA.

18102 A

II

2/16/2005

DAINIPPON SUMITOMO PHARMA CO LTD

MEROPENEM BULK BLEND AS MANUFACTURED IN OITA, JAPAN.

18103 I

II

2/18/2005

DR REDDYS LABORATORIES LTD

ZONISAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18104 I

II

2/16/2005

IPCA LABORATORIES LTD

LISINOPRIL AS MANUFACTURED IN RATLAM, INDIA.

18105 I

II

2/16/2005

BENZOCAINE AS MANUFACTURED IN JIANGSUPROS, CHINA.

18106 A

II

2/22/2005

CHANGZHOU JIAREKE PHARMACEUTICAL GROUP


CORP LTD
PCAS

18107 A

II

2/21/2005

SIGMA ALDRICH IRELAND LTD

ARMODAFINIL DRUG SUBSTANCE AS MANUFACTURED IN CO. WICKLOW, IRELAND.

18108 I

II

2/7/2005

VENKAT PHARMA LTD

OLANZAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18109 A

II

2/18/2005

NOVASEP PROCESS SAS

ARMODAFINIL AS MANUFACTURED IN POMPEY, FRANCE.

18110 A

IV

2/16/2005

MEDI CAPS LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN M.P., INDIA.

18111 A

II

2/10/2005

R L FINE CHEM

AMITRIPTYLINE HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA.

18112 A

II

2/23/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

GALANTHAMINE HYDROBROMIDE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

18113 A

II

2/21/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

CABERGOLINE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

18114 A

II

2/22/2005

RANBAXY LABORATORIES LTD

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN PUNJAB, INDIA.

18115 I

II

2/25/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

OXAZEPAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

18116 I

II

2/25/2005

JM HUBER CORP

18117 A

II

2/17/2005

AUROBINDO PHARMA LTD

CALCIUM CARBONATE AS MANUFACTURED BY J.M. HUBER MICROPOWDERS INC IN BENICIA,


CA FOR JM HUBER CORP.
LISINOPRIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18118 A

II

2/23/2005

CADILA HEALTHCARE LTD

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA.

18119 A

II

2/25/2005

CADILA HEALTHCARE LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA.

18120 A

II

2/18/2005

AUROBINDO PHARMA LTD

RISPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18121 I

III

2/25/2005

PORVAIR FILTRATION GROUP

PLASTIC FILTERS AS MANUFACTURED IN WREXHAM, UNITED KINGDOM.

18122 A

II

2/23/2005

MOREPEN LABORATORIES LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN HIMACHAL PRADESH, INDIA.

18123 I

II

2/17/2005

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, R.P. CHINA.

18124 A

II

2/24/2005

GEMFIBROZIL AS MANUFACTURED IN SHANGHAI, CHINA

18125 A

II

2/28/2005

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
STERLING SPA

18126 A

II

2/28/2005

HIKMA PHARMACEUTICALS

BETAMETHASONE ACETATE (STERILE) USP AS MANUFACTURED IN AMMAN, JORDAN.

18127 I

II

3/3/2005

PHARMACEUTICAL WORKS POLPHARMA SA

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

18128 A

II

2/21/2005

HEPARIN SODIUM USP AS MANUFACTURED IN JIANGSU, CHINA.

18129 A

II

3/3/2005

NANJING KING FRIEND BIOCHEMICAL


PHARMACEUTICAL CO LTD
SMS PHARMACEUTICALS LTD

18130 A

IV

2/25/2005

UNGERER AND CO

NATURAL & ARTIFICIAL ORANGE FLAVOR FN-924 AS MANUFACTURED IN BETHLEHEM, PA.

18131 A

IV

2/25/2005

UNGERER AND CO

NATURAL & ARTIFICIAL GRAPE FLAVOR FM-4962 AS MANUFACTURED IN BETHLEHEM, PA.

18132 I

II

3/2/2005

SHANGHAI SUNVE PHARMACEUTICAL CO. LTD.

GEMFIBROZIL AS MANUFACTURED IN SHANGHAI, CHINA.

GLYCOPYRROLATE AS MANUFACTURED IN TURKU, FINLAND FOR PCAS

NORELGESTROMIN AS MANUFACTURED IN PERUGIA, ITALY.

RANITIDINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

Page 523

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18133 A
II
3/1/2005
SEKISUI MEDICAL CO LTD

SUBJECT
N-ACETYL-L-TYROSINE AS MANUFACTURED IN IWATE PREFECTURE, JAPAN.

18134 A

III

3/1/2005

MGJ

CORELEN/AI/PTFE LINER AS MANUFACTURED IN CHAZAY D'AZERGUES, FRANCE.

18135 A

II

3/3/2005

18136 A

III

1/14/2005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
SCHOTT KAISHA PVT LTD

TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGELHEIM AM RHEIN,


GERMANY.
GLASS CYLINDERS FOR CARTRIDGES AS MANUFACTURED IN DAMAN, INDIA.

18137 I

II

3/3/2005

CF PHARMA LTD

LAMOTRIGINE AS MANUFACTURED IN BUDAPEST, HUNGARY.

18138 A

II

2/24/2005

HAUDONG MEDICINE CO LTD

ACARBOSE AS MANUFACTURED IN ZHEJIANG, CHINA.

18139 I

II

3/7/2005

BOEHRINGER INGELHEIM CHEMICALS INC

FENTANYL BASE AS MANUFACTURED IN PETERSBURG, VA.

18140 A

IV

3/1/2005

CRODA INC

SUPER REFINED NOVOL NF (OLEYL ALCOHOL) AS MANUFACTURED IN MILL HALL, PA.

18141 I

II

3/3/2005

CF PHARMA LTD

BICALUTAMIDE AS MANUFACTURED IN BUDAPEST, HUNGARY.

18142 A

II

3/4/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

HYDROCORTISONE BUTYRATE AS MANUFACTURED IN LERMA, MEXICO.

18143 A

IV

3/8/2005

ROQUETTE FRERES

MANNITOL USP POWDER PEARLITOL (R) AS MANUFACTURED IN LESTREM CEDEX, FRANCE.

18144 A

III

2/28/2005

SHREE RUBBERPLAST CO. PVT. LTD.

DROPPER BOTTLES, NOZZLES AND CAPS AS MANUFACTURED IN GOKHIWARE, INDIA.

18145 A

II

3/7/2005

TARO PHARMACEUTICAL INDUSTRIES LTD

CARVEDILOL AS MANUFACTURED IN HAIFA BAY, ISRAEL.

18146 I

II

3/2/2005

DAINIPPON SUMITOMO PHARMA CO LTD

SMP-797 DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN.

18147 A

II

3/4/2005

SIFAVITOR SRL

NAFTIFINE HYDROCHLORIDE AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY.

18148 I

II

2/21/2005

BIDACHEM SPA

KETOPROFEN AS MANUFACTURED IN FORNOVO S. GIOVANNI, ITALY.

18149 A

II

3/8/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFOXITIN SODIUM USP (STERILE) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA

18150 A

II

3/2/2005

WANBURY LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18151 I

II

2/24/2005

COATING PLACE INC

COATED DEXTROMETHORPHAN POLISTIREX AS MANUFACTURED IN VERONA, WI.

18152 A

II

3/3/2005

SA AJINOMOTO OMNICHEM NV

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN WETTEREN, BELGIUM.

18153 A

II

3/4/2005

CADILA HEALTHCARE LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN GUJARAT, INDIA.

18154 I

II

2/28/2005

AUROBINDO PHARMA LTD

CEFOTAXIME SODIUM (STERILE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18155 A

II

3/7/2005

EPROSARTAN MESYLATE AS MANUFACTURED IN AHMEDABAD, INDIA.

18156 A

III

3/7/2005

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
APTAR FRANCE SAS

18157 A

II

3/10/2005

18158 I

II

3/11/2005

NORTH CHINA PHARMACEUTICAL HUASHENG CO


LTD
URQUIMA SA

18159 A

II

3/8/2005

UQUIFA MEXICO SA DE CV

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN MORELOS, MEXICO.

18160 A

II

3/10/2005

DERMAL RESEARCH LABORATORIES, INC.

GEN443 (TM) SODIUM HYALURONATE AS MANUFACTURED IN SHAWNEE, KS.

18161 A

II

3/11/2005

SANDOZ INDUSTRIAL PRODUCTS SA

PIPERACILLIN AS MANUFACTURED IN BARCELONA, SPAIN.

18162 I

IV

3/11/2005

BORREGAARD INDUSTRIES LTD

CELLOBIOSE OCTAACETATE XP AS MANUFACTURED IN SARPSBORG, NORWAY.

18163 A

II

3/14/2005

GLENMARK GENERICS LTD

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

18164 A

II

3/14/2005

GLENMARK GENERICS LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT, INDIA.

18165 A

II

3/14/2005

GLENMARK GENERICS LTD

TRANDOLAPRIL AS MANUFACTURED IN GUJARAT, INDIA.

18166 A

II

3/8/2005

SAFC BIOSCIENCES INC

EX-CELL (TM) 293 MEDIUM AS MANUFACTURED IN DENVER, PA

18167 I

II

11/19/2004

SANDOZ INDUSTRIAL PRODUCTS GMBH

PACA, PURE AS MANUFACTURED IN FRANKFURT, GERMANY.

APTAR PACKAGING COMPONENTS FOR TOPICAL OR TRANSDERMAL APPLICATIONS AS


MANUFACTURED IN FRANCE, SWITZERLAND, US AND IRELAND
AMPHOTERICIN B USP NON-STERILE BULK DRUG AS MANUFACTURED IN HEBEI, CHINA.
CARVEDILOL, MICRONIZED AS MANUFACTURED IN BARCELONA, SPAIN.

Page 524

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18168 A
III
3/16/2005
JAMES ALEXANDER CORP

SUBJECT
PLASTIC AMPOULE AS MANUFACTURED IN BLAIRSTOWN, NJ

18169 I

II

3/15/2005

LR-103 AS MANUFACTURED IN BE'ER SHEVA, ISRAEL

18170 I

III

3/7/2005

18171 A

II

3/3/2005

TEVA GROUP ACTIVE PHARMACEUTICAL


INGREDIENTS DIV
CARCLO TECHNICAL PLASTICS (MITCHAM)
LIMITED
LABORATORIO CHIMICO INTERNAZIONALE SPA

18172 A

II

3/4/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

TOPIRAMATE AS MANUFACTURED IN GUJARAT, INDIA.

18173 I

II

3/2/2005

WANBURY LTD

PROMETHAZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18174 I

II

3/2/2005

WANBURY LTD

AMITRIPTYLINE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18175 A

II

3/14/2005

GLENMARK GENERICS LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

18176 A

II

2/28/2005

AUROBINDO PHARMA LTD

FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18177 A

II

3/15/2005

WOCKHARDT LTD

FLUOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

18178 A

II

3/14/2005

CEDARBURG PHARMACEUTICALS LLC

FENTANYL CITRATE AS MANUFACTURED IN GRAFTON, WI.

18179 I

II

3/11/2005

CIPLA LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18180 A

II

2/25/2005

NATCO PHARMA LTD

ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18181 I

III

3/7/2005

AMPACET CORP

18182 I

III

3/7/2005

AMPACET CORP

18183 I

III

3/7/2005

AMPACET CORP

18184 I

III

3/7/2005

AMPACET CORP

18185 I

III

3/7/2005

AMPACET CORP

18186 I

II

3/14/2005

ZENTIVA KS

18187 A

II

3/17/2005

CATALENT PHARMA SOLUTIONS LLC

18188 I

II

3/15/2005

ZHEJIANG RUIBANG LABORATORIES

180660 BEIGE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;


LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA.
19270 BLACK POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;
LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA.
18109 BROWN POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;
LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA.
12083 SILVER POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;
LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA.
13599 YELLOW POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;
LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA.
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN DOLNI MECHOLUPY, CZECH
REPUBLIC.
PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS AS MANUFACTURED IN SOMERSET,
NJ.
LOVASTATIN USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

18189 A

IV

3/14/2005

18190 I

II

3/9/2005

STANDARD CHEMICAL AND PHARMACEUTICAL CO


LTD
PARTICLE DYNAMICS INC

18191 A

II

3/22/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

DESTAB (TM) MAGNESIUM HYDROXIDE 95% AS MANUFACTURED BY NORTH STAR


PROCESSING IN LITCHFIELD, MN FOR PARTICLE DYNAMICS, INC.
ZONISAMIDE AUSP S MANUFACTURED IN GUJARAT, INDIA.

18192 A

II

3/11/2005

AUROBINDO PHARMA LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18193 A

II

3/22/2005

CYALUME SPECIALTY PRODUCTS INC

MEPROBAMATE AS MANUFACTURED IN BOUND BROOK, NJ.

18194 A

II

3/23/2005

CEDARBURG PHARMACEUTICALS LLC

FENTANYL AS MANUFACTURED IN GRAFTON, WI.

18195 I

II

3/18/2005

WOCKHARDT LTD

18196 A

II

3/21/2005

GE HEALTHCARE BIO SCIENCES CORP

DEXTROPROPOXYPHENE NAPSYLATE (PROPOXYPHENE NAPSYLATE USP) AS


MANUFACTURED IN GUJARAT, INDIA.
HOLLOW FIBER TANGENTIAL CARTRIDGE AS MANUFACTURED IN WESTBOROUGH, MA.

18197 A

II

3/23/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

ZONISAMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

18198 I

IV

3/22/2005

UNICHEMA CHEMIE BV

18199 I

II

3/21/2005

GEDEON RICHTER PLC

ARLAMOL (R) E (PPG 15-STEARYL ETHER) AS MANUFACTURED IN REDCAR, U.K. FOR


UNICHEMA CHEMIE BV
CABERGOLINE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY.

MDI ACTUATOR AND CAP AS MANUFACTURED IN SURRAY, U.K.


GABAPENTIN AS MANUFACTURED IN MILAN, ITALY.

SODIUM STEARYL FUMARATE AS MANUFACTURED IN TAIWAN, R.O.C.

Page 525

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
18200 A
II
3/22/2005
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
LTD
18201 I
II
3/1/2005
IND SWIFT LABORATORIES LTD
VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA.
18202 I

II

3/28/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

CLOBETASOL PROPIONATE AS MANUFACTURED IN SANTHIA, ITALY.

18203 A

II

3/24/2005

APOTEX PHARMACHEM INC

ZONISAMIDE AS MANUFACTURED IN BRANTFORD, CANADA.

18204 A

III

3/21/2005

DYNIC USA CORP

HT 8 PLUS WHITE-INK-THERMAL TRANSFER RIBBON, MANUFACTURED IN TOKOYO, JAPAN

18205 I

II

3/22/2005

ITF CHEMICAL LTDA

LANSOPRAZOLE AS MANUFACTURED IN BAHIA, BRAZIL.

18206 I

IV

12/28/2004

FLAVORS NORTH AMERICA INC

825.0033U CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL.

18207 A

II

3/25/2005

CADILA HEALTHCARE LTD

ZONISAMIDE AS MANUFACTURED IN GUJARAT, INDIA.

18208 A

III

3/21/2005

REXAM PHARMA PACKAGING INDIA P LTD

18209 A

III

3/21/2005

REXAM PHARMA PACKAGING INDIA P LTD

18210 A

III

3/21/2005

REXAM PHARMA PACKAGING INDIA P LTD

18211 A

II

3/28/2005

CADILA HEALTHCARE LTD

TAMP SAFE (O) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE,


INDIA.
TAMP SAFE (I) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE,
INDIA.
TAMP SAFE (R) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE,
INDIA.
VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

18212 A

II

3/28/2005

MYLAN LABORATORIES LTD

NABUMETONE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18213 A

II

3/30/2005

MYLAN LABORATORIES LTD

ESCITALOPRAM OXALATE USP AS MANUFACTURED IN TELANGANA, INDIA.

18214 A

II

3/30/2005

MYLAN LABORATORIES LTD

ALPRAZOLAM USP AS MANUFACTURED IN TELANGANA, INDIA.

18215 A

II

3/28/2005

ARCH PHARMALABS LTD

18216 A

II

3/30/2005

SANOFI CHIMIE

3-PHENYL-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE (PMIC CHLORIDE) AS


MANUFACTURED IN ANDHRA PRADESH, INDIA.
HYDROXOCOBALAMIN AS MANUFACTURED IN ROMAINVILLE CEDEX, FRANCE.

18217 A

III

3/23/2005

AMPACET CORP

18218 A

III

3/18/2005

REXAM HEALTHCARE OFFRANVILLE SAS

11748-K LAMITE 48 AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE,


GA; HEATH, OH; DERIDDER, LA; RAYONG, THAILAND.
OCUMETER PLUS ASSEMBLED BOTTLE AS MANUFACTURED IN OFFRANVILLE, FRANCE.

18219 I

II

3/31/2005

ASTELLAS PHARMA INC

FK1706 AS MANUFACTURED IN OSAKA, JAPAN.

18220 A

II

3/30/2005

MYLAN LABORATORIES LTD

BACLOFEN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18221 A

II

3/30/2005

MYLAN LABORATORIES LTD

ZOLPIDEM TARTRATE USP AS MANUFACTURED IN TELANGANA, INDIA.

18222 I

IV

2/17/2005

FONA INTERNATIONAL INC

18223 A

II

3/31/2005

CADILA HEALTHCARE LTD

884.458 N-C ORANGE FLAVOR, NATURAL AND ARTIFICIAL MANUFACTURED IN CAROL


STREAM, IL.
SIMVASTATIN AS MANUFACTURED IN GUJARAT, INDIA.

18224 A

II

3/30/2005

MYLAN LABORATORIES LTD

TERBINAFINE HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

18225 A

II

3/30/2005

MYLAN LABORATORIES LTD

GABAPENTIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18226 A

II

3/31/2005

CADILA HEALTHCARE LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA.

18227 A

II

3/21/2005

FORMOSA LABORATORIES INC

CALCITRIOL AS MANUFACTURED IN TAOYUAN, TAIWAN.

18228 A

II

3/30/2005

MYLAN LABORATORIES LTD

PANTOPRAZOLE SODIUM USP (SESQUIHYDRATE) AS MANUFACTURED IN TELANGANA, INDIA.

18229 A

II

3/30/2005

MYLAN LABORATORIES LTD

ABACAVIR SULFATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18230 A

II

3/30/2005

MYLAN LABORATORIES LTD

EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18231 A

II

4/1/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

LISURIDE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

18232 A

II

4/1/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

LISURIDE HYDROGENMALEATE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

18233 I

III

4/1/2005

NAKAMURA PRINT CO. LTD.

POLYETHYLENE BAG OF TYPE E AS MANUFACTURED IN YAMAGUCHI, JAPAN.

Page 526

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18234 I
II
3/28/2005
STANDARD CHEM AND PHARM CO LTD

SUBJECT
PRAZOSIN HYDROCHLORIDE AS MANUFACTURED IN HSIN-YING, TAIWAN.

18235 A

II

3/30/2005

CHEMPACIFIC CORP

PENTOSTATIN AS MANUFACTURED IN BALTIMORE, MD.

18236 A

II

4/1/2005

FINE CHEMICALS CORP PTY LTD

LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA.

18237 A

III

3/14/2005

KIRCHNER SIMON AND CO GMBH

18238 A

II

3/31/2005

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

GL45Y0060 CAP GL45 MADE OF PFA NATURE, WITH LINER MADE OF SILICONE ONE-SIDED
PTFE AS MANUFACTURED IN OESTRICH-WINKEL, GERMANY.
SPIRONOLACTONE USP AS MANUFACTURED IN TIANJIN, CHINA.

18239 A

II

3/29/2005

LUPIN LTD

SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18240 I

II

2/25/2005

18241 A

II

3/31/2005

CHEMISCH-PHARMAZEUTISCHES LABOR, ROLF


SACHSE GMBH
CHENG FONG CHEMICAL CO LTD

ANAGRELIDE HYDROCHLORIDE AS MANUFACTURED IN BERLIN, FEDERAL REPUBLIC OF


GERMANY.
PSEUDOEPHEDRINE SULFATE AS MANUFACTURED IN TAIWAN, R.O.C.

18242 A

IV

3/29/2005

NICHIRIN CHEMICAL INDUSTRIES LTD

CROSCARMELLOSE SODIUM, NF AS MANUFACTURED IN HYOGO PREFECTURE, JAPAN.

18243 I

III

4/1/2005

SHINKO CHEMICAL CO LTD

FK506 PLASTIC CONTAINER AS MANUFACTURED IN ISHIKAWA, JAPAN.

18244 I

II

4/4/2005

BRISTOL MYERS SQUIBB

18245 A

II

4/5/2005

SMRUTHI ORGANICS LTD

MDX-1100 (ANTI-CXCL 10/ANTI-IP-10 HUMAN MONOCLONAL ANTIBODY) AS MANUFACTURED


IN ANNANDALE, NJ.
CARBIDOPA USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18246 I

II

3/29/2005

PCAS

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ARAMON & LIMAY, FRANCE.

18247 I

II

4/5/2005

MAPRIMED SA

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN BUENOS AIRES, ARGENTINA.

18248 I

II

4/1/2005

FARCHEMIA SRL

MICONAZOLE BASE AS MANUFACTURED IN BERGAMO, ITALY.

18249 A

II

3/29/2005

AUROBINDO PHARMA LTD

PENTOXIFYLLINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18250 I

II

4/4/2005

DAICEL CHEMICAL INDUSTRIES LTD

AAIA AS MANUFACTURED IN NIIGATA, JAPAN.

18251 A

II

3/29/2005

LUPIN LTD

LANSOPRAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18252 A

II

4/7/2005

HETERO LABS LTD

LAMIVUDIN, USP (PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18253 A

II

4/7/2005

MYLAN LABORATORIES LTD

VALSARTAN USP AS MANUFACTURED IN TELANGANA AND ANDHRA PRADESH, INDIA

18254 A

II

4/6/2005

APOTEX PHARMACHEM INC

FAMOTIDINE USP AS MANUFACTURED IN ONTARIO, CANADA.

18255 A

II

4/7/2005

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

MELOXICAM AS MANUFACTURED IN BARCELONA SPAIN

18256 A

II

3/24/2005

AUROBINDO PHARMA LTD

ABACAVIR SULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18257 A

II

4/11/2005

INTERQUIM SA

RISPERIDONE AS MANUFACTURED IN BARCELONA, SPAIN.

18258 I

II

4/8/2005

SANOFI AVENTIS CHIMIE

RIMONABANT AS MANUFACTURED IN SISTERON, FRANCE AND DARTFORD, ENGLAND.

18259 A

II

4/8/2005

TEVA PHARMACEUTICALS USA INC

AMOXICILLIN SODIUM AS MANUFACTURED IN MEXICO, MO.

18260 A

II

4/8/2005

SHASUN PHARMACEUTICALS LTD

OLANZAPINE AS MANUFACTURED IN CUDDALORE, INDIA.

18261 A

II

4/11/2005

NAVINTA LLC

IRON SUCROSE COMPLEX AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18262 I

1/30/2004

BIOGEN IDEC INC

RITUXAN (RITUXIMAB) MANUFATURED IN SAN DIEGO, CA

18263 I

IV

4/4/2005

FONA INTERNATIONAL INC

18264 I

II

4/11/2005

ELAN DRUG DELIVERY INC

18265 A

III

4/8/2005

BEACON CONVERTERS INC

884.0028U FONATECH (TM) JUICY ORANGE FLAVOR, NATURAL AND ARTIFICIAL AS


MANUFACTURED IN CAROL STREAM, IL.
N1506 NANOCRYSTAL (R) COLLOIDAL DISPERSION AS MANUFACTURED IN KING OF PRUSSIA,
PA.
PHARMACEUTICAL PACKAGING MATERIAL AS MANUFACTURED IN SADDLE BROOK, NJ.

18266 I

II

4/11/2005

18267 A

III

2/11/2005

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
NOLATO JAYCARE LTD

18268 A

II

4/11/2005

SIGNA SA DE CV

GLYBURIDE USP AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN R.O.C.


360ML OPTHALMIC CYLINDRICAL BOTTLE WITH 18MM NOZZLE & 18MM OPTHALMIC CLOSURE
AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM.
TERAZOSIN HYDROCHLORIDE DIHYDRATE USP AS MANUFACTURED IN TOLUCA, MEXICO.

Page 527

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18269 I
II
4/10/2005
CF PHARMA LTD

SUBJECT
TOPIRAMATE AS MANUFACTURED IN BUDAPEST, HUNGARY.

18270 A

II

3/31/2005

LUPIN LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18271 A

II

3/31/2005

18272 A

III

2/11/2005

18273 A

II

4/13/2005

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO PSEUDOEPHEDRINE HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG, CHINA.
LTD
NOLATO JAYCARE LTD
110ML OPTHALMIC CYLINDRICAL BOTTLE WITH 18MM NOZZLE & 18MM OPTHALMIC CLOSURE
AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM.
DAINIPPON SUMITOMO PHARMA AMERICA INC
SMP-986 AS MANUFACTURED IN OSAKA, JAPAN.

18274 I

III

3/23/2005

JAYCARE LTD

300ML SYRUP BOTTLE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM.

18275 A

III

2/11/2005

NOLATO JAYCARE LTD

18276 A

III

4/4/2005

SHANGHAI HAICHANG MEDICAL PLASTIC PLANT

18277 A

II

4/12/2005

BACHEM AG

250ML OPHTHALMIC FLAT BOTTLE WITH 18MM NOZZLE & 18MM OPHTHALMIC CLOSURE AS
MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM.
PACKAGING COMPONENTS (BOTTLES, CAPS AND LINERS) AS MANUFACTURED IN SHANGHAI,
CHINA.
GLUCAGON AS MANUFACTURED IN BUBENDORF, SWITZERLAND.

18278 A

II

4/11/2005

SAFC BIOSCIENCES

SERUM-FREE MEDIA SUPPLEMENT PART A (100 X) AS MANUFACTURED IN DENVER, PA.

18279 A

II

4/13/2005

CATALENT PHARMA SOLUTIONS LLC

NEORAL 25 MG AND 100 MG SOFTGELS AS MANUFACTURED IN ST. PETERSBURG, FL.

18280 A

II

4/18/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

DISODIUM PAMIDRONATE BP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18281 I

III

4/15/2005

18282 I

II

3/31/2005

18283 I

II

4/14/2005

DUPONT PACKAGING AND INDUSTRIAL POLYMERS DUPONT SECURITY FILMS AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY AND
AUSTRIA.
TORONTO RESEARCH CHEMICALS INC
2-CHLORO-2',3'-O-ISOPROPYLIDENEADENOSINE-5'-N-ETHYLCARBOXAMIDE AS
MANUFACTURED IN ONTARIO, CANADA.
MEDICHEM SA
PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GIRONA, SPAIN.

18284 A

II

4/12/2005

DIXIE CHEMICAL CO INC

TP1 AS MANUFACTURED IN PASADENA, TX.

18285 A

II

4/8/2005

SCI PHARMTECH INC

DIVALPROEX SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN R.O.C.

18286 A

II

4/19/2005

UNIMARK REMEDIES LTD

MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA.

18287 I

II

4/19/2005

SMS PHARMACEUTICALS LTD

SUMATRIPTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18288 A

II

4/15/2005

EXCELLA GMBH

ROPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY.

18289 A

12/23/2004

DANIPHARM APS

AVECIA BILLINGHAM SITE IN BILLINGHAM, U.K.

18290 I

III

4/21/2005

INTERNATIONAL CONVERTER LLC

18291 A

II

4/20/2005

HETERO LABS LTD

LAMINATED PRODUCTS FOR PACKAGING MATERIAL AS MANUFACTURED IN CALDWELL AND


BELPRE, OH; AND LUKA, MS.
ZIDOVUDINE (PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

18292 A

III

4/18/2005

REXAM HEALTHCARE OFFRANVILLE SAS

KERPHARM EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE.

18293 A

II

4/11/2005

LONZA LTD

NIACIN USP GRANULAR SPECIAL AS MANUFACTURED IN VISP, SWITZERLAND.

18294 I

II

4/20/2005

18295 I

II

4/21/2005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
STRYKER BIOTECH INC

METHSCOPOLAMINE NITRATE AS MANUFACTURED IN INGELHEIM AM RHEIN, FEDERAL


REPUBLIC OF GERMANY.
OP-1 AS MANUFACTURED IN WEST LEBANON, NH.

18296 I

III

4/13/2005

TRUDELL MEDICAL INTERNATIONAL

TOP MOUNT DOSE INDICATOR AS MANUFACTURED IN ONTARIO, CANADA.

18297 A

II

4/21/2005

AMINO CHEMICALS LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN MARSA, MALTA.

18298 A

III

4/22/2005

SIEGWERK USA CO

PRINTING INK AS MANUFACTURED IN DES MOINES, IA AND BOILING SPRINGS, SC.

18299 I

II

4/18/2005

POLYCARBON INDUSTRIES INC

PCI-8014 NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN LEOMINSTER, MA.

18300 I

II

10/29/2004

GITANJALI CHEMICALS PVT LTD

1-(2,6-DICHLOROPHENYL)-2-INDOLINONE

III

4/20/2005

18301 N
18302 A

NOT AN ASSIGNED NUMBER


CENTURY PLASTICS INC

CONTINUOUS THREAD CLOSURES (CAPS) FOR PHARMACEUTICAL & FOOD CONTAINERS AS


MANUFACTURED IN SIMPSONVILLE, SC.

Page 528

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18303 I
II
4/14/2005
STRAINRITE
18304 I

II

4/14/2005

STRAINRITE

18305 A

III

3/29/2005

INEOS ABS USA CORP

18306 A

II

4/24/2005

DIVIS LABORATORIES LTD

SUBJECT
MD-2X-6XX: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN,
MAINE.
MD-1X-6XX: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN,
MAINE.
LUSTRAN ABS M301 FC 000000 AND LUSTRAN ABS M301 FC 018646 AS MANUFACTURED IN
GERMANY, ITALY, SPAIN AND U.K.
BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18307 A

II

4/26/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

EPIRUBICIN HYDROCHLORIDE LYOPHILIZED AS MANUFACTURED IN VERCELLI, ITALY.

18308 A

III

4/25/2005

BAXTER HEALTHCARE CORP

AVIVA CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN MARION, NC.

18309 I

II

4/20/2005

ZHEJIANG APELOA PHARMACEUTICAL CO LTD

SIMVASTATIN USP BULK AS MANUFACTURED IN ZHEJIANG, CHINA.

18310 I

III

4/27/2005

KUNSTSTOFFWERK KREMSMUNSTER GMBH

PP 28 CAPS T/E CRC AS MANUFACTURED IN KREMSMUNSTER, AUSTRIA.

18311 A

II

4/29/2005

TORRENT PHARMACEUTICALS LTD

SERTRALINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA.

18312 A

II

4/27/2005

SHASUN PHARMACEUTICALS LTD

IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN PONDICHERRY, INDIA.

18313 I

II

4/26/2005

HUASHU PHARMACEUTICAL CORP

DOXYCYCLINE MONOHYDRATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA.

18314 I

II

4/26/2005

HUASHU PHARMACEUTICAL CORP

DOXYCYCLINE HYCLATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA.

18315 A

III

4/28/2005

NYPRO INC

ORLISTAT 60 MG PORTABLE PACKAGE (R) AS MANUFACTURED IN CLINTON, MA.

18316 A

III

4/13/2005

POLYONE CORP

CC00039994BG 310NV33236NOENXIPPMB AS MANUFACTURED IN MANCHESTER, U.K.

18317 A

II

4/27/2005

PHARMACEUTICAL WORKS POLPHARMA SA

18318 A

II

4/29/2005

SIMS SRL

CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI,


POLAND.
LIDOCAINE BASE AS MANUFACTURED IN FLORENCE, ITALY.

18319 A

II

5/6/2005

SYN TECH CHEM AND PHARM CO LTD

PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

18320 N

NOT AN ASSIGNED NUMBER

18321 N

NOT AN ASSIGNED NUMBER

18322 A

III

4/20/2005

ADVANCED SCIENTIFICS INC

18323 A

II

5/26/2005

IPCA LABORATORIES LTD

INJECTION MOLDED AUTOCLAVABLE WINGED SPIKE PORT AS MANUFACTURED IN


MILLERSBURG, PA.
METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH (MP), INDIA.

18324 A

III

4/28/2005

RELIANCE INDUSTRIES LTD

POLYETHYLENE (PE) RELENE B56003 RAW MATERIAL AS MANUFACTURED IN GUJARAT, INDIA.

18325 I

II

4/15/2005

XIAN LIBANG PHARMACEUTICAL CO LTD

DIATRIZOIC ACID BULK AS MANUFACTURED IN SHAANXI, CHINA.

18326 A

III

3/7/2005

PLASPAK QP PTY LIMITED

PLASTIC TABLET BOTTLES AS MANUFACTURED IN VIRGINIA QLD, AUSTRALIA.

18327 A

II

5/3/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

18328 A

1/31/2005

DSM BIOLOGICS CO BV

ALENDRONATE MONOSODIUM TRIHYDRATE AS MANUFACTURED BY ASSIA CHEMICAL


INDUSTRIES LTD IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
MAMMALIAN MANUFACTURING AREAS IN AP GRONINGEN, THE NETHERLANDS.

18329 A

II

5/9/2005

USV LIMITED

REPAGLINIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18330 A

II

5/5/2005

SMRUTHI ORGANICS LTD

METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18331 A

II

4/30/2005

AUROBINDO PHARMA LTD

CEFADROXIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18332 A

III

4/29/2005

BAXTER HEALTHCARE CORP

ORAL DISPENSER ACCESSORIES AS MANUFACTURED IN ENGLEWOOD, CO FOR BAXA CORP

18333 I

III

4/28/2005

TECH GROUP EUROPE

NOVEL DUAL STRIP DPI AS MANUFACTURED IN DUBLIN, IRELAND.

18334 I

II

4/27/2005

VENKAT PHARMA LTD

OMEPRAZOLE PELLETS 8.5% W/W AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18335 A

II

5/6/2005

SCINOPHARM TAIWAN LTD

ANASTROZOLE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

18336 A

II

5/9/2005

CAMBRIDGE MAJOR LABS INC

DEXRAZOXANE AS MANUFACTURED IN GERMANTOWN, WI.

Page 529

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18337 A
III
4/15/2005
HUMPHREY COSBURN PLASTICS

SUBJECT
250ML WHITE LDPE FLAT OVAL BOTTLE 24/410 AS MANUFACTURED IN ONTARIO, CANADA.

18338 A

II

5/9/2004

HETERO LABS LTD

RAMIPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18339 A

III

5/10/2005

GRAHAM PACKAGING CO LP

PLASTIC BOTTLES AS MANUFACTURED IN BELVIDERE, NJ.

18340 A

II

5/9/2005

SANOFI AVENTIS DEUTSCHLAND GMBH

CLOBAZAM AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY.

18341 A

II

5/9/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

18342 A

II

5/9/2005

DR REDDYS LABORATORIES LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN TELANGANA, INDIA.

18343 A

II

5/24/2005

CHIROGATE INTERNATIONAL INC

LATANOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN R.O.C.

18344 A

IV

5/5/2005

RANQ REMEDIES PVT LTDY

MICROCRYSTALLINE CELLULOSE USP AS MANUFACTURED IN SINNAR, INDIA.

18345 A

II

2/11/2005

OLON SPA

PENTAZOCINE HYDROCHLORIDE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY.

18346 A

II

5/12/2005

HETERO DRUGS LTD

TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18347 A

II

5/11/2005

DR REDDYS LABORATORIES LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18348 A

II

5/13/2005

DR REDDYS LABORATORIES LTD

METOPROLOL SUCCINATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18349 A

III

5/12/2005

DYNIC USA CORP

HL35 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN.

18350 A

III

5/12/2005

EXXONMOBIL CHEMICAL CO

18351 A

III

5/13/2005

BOREALIS AG

CHLORINATED ISOBUTYLENE-ISOPRENE RUBBER AS MANUFACTURED IN BATON ROUGE


LOUISIANA , JAPAN AND ENGLAND.
BORMED HE7541-PH AS MANUFACTURED IN BURGHAYSEN, GERMANY

18352 A

II

5/13/2005

FARMABIOS S P A

HALCINONIDE MICRONIZED USP AS MANUFACTURED IN PAVIA, ITALY.

18353 I

II

5/17/2005

GEDEON RICHTER LTD

LAMOTRIGINE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY.

18354 N

NOT AN ASSIGNED NUMBER

18355 A

II

4/28/2005

YANTAI DONGCHENG BIOCHEMICALS CO LTD

HEPARIN SODIUM, INJECTABLE GRADE NON-STERILE BULK DRUG AS MANUFACTURED IN


SHANDONG PROVINCE, CHINA.
LAMOTRIGINE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18356 A

II

5/18/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

18357 A

IV

5/16/2005

NATURAL CAPSULES LTD

18358 A

IV

5/16/2005

NATURAL CAPSULES LTD

EMPTY HARD CELLULOSE CAPSULES (VEGE CAPSULES) AS MANUFACTURED IN


BANGALORE, INDIA.
EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN BANGALORE, INDIA.

18359 A

IV

5/16/2005

NATURAL CAPSULES LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN PONDICHERRY, INDIA.

18360 A

II

6/26/2007

HETERO LABS LTD

TORSEMIDE AS MANUFACTURED ANDHRA PRADESH INDIA

18361 A

II

5/20/2005

UNIMARK REMEDIES LTD

CEPHALEXIN USP AS MANUFACTURED IN GUJARAT, INDIA.

18362 A

II

4/14/2005

CKD BIO CORP

18363 A

II

4/14/2005

CKD BIO CORP

18364 A

II

5/16/2005

ION EXCHANGE INDIA LTD

CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK
DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA.
CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1, NONSTERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA.
SODIUM POLYSTYRENE SULFONATE (INDION 254) AS MANUFACTURED IN GUJARAT, INDIA.

18365 A

IV

5/16/2005

ION EXCHANGE (INDIA) LTD

INDION 204 AS MANUFACTURED IN GUJARAT, INDIA.

18366 A

IV

5/16/2005

ION EXCHANGE (INDIA) LTD

INDION 234 AS MANUFACTURED IN GUJARAT, INDIA.

18367 A

IV

5/19/2005

WILD FLAVORS INC

NATURAL BANANA FLAVOR WONF #FAFH079 AS MANUFACTURED IN ERLANGER, KY.

18368 A

II

5/18/2005

NUVIEW LIFE SCIENCES

SODIUM IODIDE (I-123) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TX.

18369 A

4/4/2005

A BIO PHARMA PTE LTD

18370 A

5/11/2005

WEST PHARMACEUTICAL SERVICES INC

CGMP MANUFACTURING FACILITY FOR PRODUCTION OF BIOLOGICS FOR CLINICAL TRIALS IN


SINGAPORE.
WESTAR(R) RS PROCESS IN ESCHWEILER, GERMANY.

18371 A

III

11/16/2004

UNITED CLOSURES AND PLASTICS PLC

PP28 MEDI-LOC TAMPER-EVIDENT CLIC-LOC CLOSURES AS MANUFACTURED IN NORWICH,


ENGLAND.

Page 530

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18372 I
III
5/25/2005
MEYERS COLOUR COMPOUNDS LTD

SUBJECT
MEYERS COLOUR COMPOUNDS WHITE MMB9524 AS MANUFACTURED IN ONTARIO, CANADA.

18373 A

II

5/24/2005

CATALENT PHARMA SOLUTIONS LLC

NIMODIPINE 30MG SOFTGELS AS MANUFACTURED IN SOMERSET, NJ.

18374 A

II

5/26/2005

USV LIMITED

BICALUTAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

18375 A

II

5/26/2005

EBAB AS MANUFACTURED IN ORIGGIO, ITALY.

18376 A

III

5/21/2005

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
COPE ALLMAN JAYCARE LTD

18377 A

III

5/21/2005

COPE ALLMAN JAYCARE LTD

500ML PET ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, U.K.

18378 A

II

5/26/2005

CIPLA LTD

SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18379 A

II

5/21/2005

IND SWIFT LABORATORIES LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA.

18380 I

II

5/25/2005

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

DELTA CORTISONE ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA.

18381 A

II

5/27/2005

DR REDDYS LABORATORIES LTD

OXCARBAZEPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18382 A

II

5/27/2005

BASF CORP

POLOXALENE USP AS MANUFACTURED IN WASHINGTON, NJ.

18383 A

II

6/1/2005

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE

OXCARBAZEPINE AS MANUFACTURED IN ISSO, ITALY.

18384 I

II

5/27/2005

SYNTHON BV

SIMVASTATIN AS MANUFACTURED IN ZHEJIANG, CHINA FOR SYNTHON BV.

18385 A

II

5/31/2005

CRYSTAL PHARMA SAU

DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN VALLADOLID, SPAIN.

18386 I

II

5/21/2005

AUROBINDO PHARMA LTD

CEFAZOLIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18387 A

II

5/27/2005

DOCTOR REDDYS LABORATORIES LTD

MESALAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18388 A

II

6/3/2005

NATCO PHARMA LTD

LETROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18389 I

II

6/1/2005

DANIPHARM A S

LACTULOSE PURUM LIQUIDUM AS MANUFACTURED IN NIBE, DENMARK.

18390 A

II

5/31/2005

18391 A

II

5/31/2005

CHONGQING PHARMACEUTICAL RESEARCH


INSTITUTE CO LTD
JOHNSON MATTHEY PHARMA SERVICES

IRON SUCROSE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


CHONGQING, CHINA FOR CHEMWERTH INC
TALAPORFIN SODIUM AS MANUFACTURED IN DEVENS AND NORTH ANDOVER, MA.

18392 A

II

6/3/2005

NATCO PHARMA LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18393 I

II

5/11/2005

18394 A

II

6/3/2005

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY DIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN INNER
CO LTD
MONGOLIA, CHINA.
NATCO PHARMA LTD
SALMETEROL XINAFOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18395 A

II

5/27/2005

DR REDDYS LABORATORIES LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18396 A

II

6/3/2005

URQUIMA SA

GLIMEPIRIDE, MICRONISED AS MANUFACTURED IN BARCELONA, SPAIN.

18397 A

II

5/23/2005

POLYMED THERAPEUTICS INC

PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA.

18398 A

II

6/1/2005

DAITO CORP

AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN TOYAMA, JAPAN.

18399 A

III

6/1/2005

ADVANEX EUROPE LTD

GSK TORSION HUB SPRINGS AS MANUFACTURED IN NOTTINGHAMSHIRE, U.K.

18400 A

II

6/10/2005

CML EUROPE BV

PHENELZINE SULFATE AS MANUFACTURED IN AA WEERT, THE NETHERLANDS.

18401 A

II

5/22/2005

AUROBINDO PHARMA LTD

NEVIRAPINE HEMIHYDRATE UPS AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18402 I

II

6/6/2005

MOREPEN LABORATORIES LTD

18403 A

II

6/2/2005

BAYER PHARMA AG

ATORVASTATIN CALCIUM AMORPHOUS, BULK SUBSTANCE AS MANUFACTURED IN HIMACHAL


PRADESH, INDIA.
LEVONORGESTREL (DCM) AS MANUFACTURED IN BERLIN AND BERGKAMEN, GERMANY.

18404 I

II

6/7/2005

SANDOZ GMBH

MYCOPHENOLIC ACID PURE AS MANUFACTURED IN TYROL, AUSTRIA.

18405 I

II

6/2/2005

CIPLA LTD

SERTRALINE HYDROCHLORIDE (FORM-I) AS MANUFACTURED IN MAHARASHTRA, INDIA.

18406 A

IV

3/23/2005

MANE INC

BANANA FLAVOR E_0501695 AS MANUFACTURED IN BAR SUR LOUP, FRANCE FOR MANE INC

250ML PET ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, U.K.

Page 531

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18407 A
IV
3/15/2005
MANE INC

SUBJECT
ARANCIA FLAVOR E_9940619/01 AS MANUFACTURED IN BAR SUR LOUP, FRANCE FOR MANE
INC
DUTASTERIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18408 A

II

6/7/2005

DR REDDYS LABORATORIES LTD

18409 A

II

6/8/2005

SANOFI CHIMIE

18410 A

III

6/3/2005

3M DRUG DELIVERY SYSTEMS

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN SISTERON CEDEX AND ARAMON,


FRANCE.
3M COTRAN 9773 POLYOLEFIN FOAM TAPE

18411 A

II

6/9/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

MODAFINIL AS MANUFACTURED IN GUJARAT, INDIA.

18412 A

II

6/9/2005

DR REDDYS LABORATORIES LTD

ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18413 A

II

6/9/2005

ZIBO XINHUA PERRIGO PHARMACEUTICAL CO LTD IBUPROFEN USP DRUG SUBSTANCE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA.

18414 A

III

6/10/2005

SHRIJI POLYMERS INDIA LTD

HIGH DENSITY POLYETHYLENE BOTTLES AS MANUFACTURED IN M.P., INDIA.

18415 A

III

5/24/2005

BERRY PLASTICS CORP

PRODUCT 41809-26 AS MANUFACTURED IN COLUMBUS, GA.

18416 A

III

5/26/2005

SCHWEIZ SCHOTT AG

TOPPAC (TM) SYRINGE AS MANUFACTURED IN ST. GALLEN, SWITZERLAND.

18417 A

II

6/9/2005

H LUNDBECK AS

18418 A

III

6/10/2005

PLASTIAPE SPA

GABOXADOL MONOHYDRATE AS MANUFACTURED IN NYKOEBING SJ. AND COPENHAGEN,


DENMARK.
DRY POWDER INHALER (CYCLOHALER) MODEL 8 AS MANUFACTURED IN LECCO, ITALY.

18419 A

II

6/7/2005

WACKER CHEMIE AG

ELASTOSIL(R) LR 3003/20 A/B - RAL 6010 AS MANUFACTURED IN BURGHAUSEN, GERMANY.

18420 A

II

6/9/2005

SUFENTANIL BASE AS MANUFACTURED IN WEST DEPTFORD, NJ.

18421 A

II

6/9/2005

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
CIPLA LTD

18422 A

II

6/9/2005

CIPLA LTD

DONEPEZIL HYDROCHLORIDE (FORM-I) AS MANUFACTURED IN BANGALORE, INDIA

18423 A

III

6/6/2005

HUMPHREY COSBURN PLASTICS

20MM GREEN M14102 PP OVERCAP AS MANUFACTURED IN ONTARIO, CANADA.

18424 I

II

5/19/2005

WELDING GMBH & CO KG

18425 I

III

1/14/2005

KLOCKE VERPACKUNGS-SERVICE GMBH

18426 A

II

6/15/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

CRUDE HEPARIN SODIUM AS MANUFACTURED BY HUAIAN WELLKONG BIOCHEMISTRY CO.


LTD. IN JIANGSU, CHINA FOR WELDING GMBH & CO KG.
NOA44X NOVEL PACKAGING SYSTEM AS MANUFACTURED IN WEINGARTEN, FEDERAL
REPUBLIC OF GERMANY.
GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

18427 A

III

5/24/2005

SONOLITE PLASTICS CORP

ENEMA APPLICATOR ASSEMBLY AS MANUFACTURED IN GLOUCESTER, MA.

18428 A

II

6/8/2005

INDUSTRIALE CHIMICA SRL

IDEBENONE AS MANUFACTURED IN VARESE, ITALY.

18429 A

II

6/13/2005

WACKER CHEMIE AG

ELASTOSIL(R) LR 3003/30 A/B - RAL 6010 AS MANUFACTURED IN BURGHOUSEN, GERMANY.

18430 A

II

6/10/2005

LUPIN LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18431 A

II

6/15/2005

WACKER CHEMIE AG

ELASTOSIL(R) LR 3003/70 A/B - RAL 6010 AS MANUFACTURED IN BURGHAUSEN, GERMANY.

18432 I

III

6/6/2005

MAC CLOSURES INC

FLIP TOP CHILD RESISTANT CONTAINER AS MANUFACTURED IN QUEBEC, CANADA.

18433 A

II

6/16/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

18434 I

II

6/16/2005

HETERO DRUGS LTD

LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN CARONNO PERTUSELLA (VA), ITALY


FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
CEFPROZIL MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18435 A

II

6/17/2005

JOHNSON MATTHEY PHARMA SERVICES

CANGRELOR AS MANUFACTURED IN DEVENS AND NORTH ANDOVER, MA.

18436 A

II

6/17/2005

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA SPAIN

18437 A

II

6/17/2005

SAFC BIOSCIENCES INC

18438 A

5/18/2005

PFIZER INC

18439 A

II

6/20/2005

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

EX-CELL(TM) 302 CHO, SERUM-FREE MEDIUM, W/O L-GLUTAMINE, W/O PHENOL RED, W/O
NAHC03 AS MANUFACTURED IN DENVER, PA.
HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE (HPMCAS) AS MANUFACTURED
IN NEW LONDON, CT.
LAMOTRIGINE AS MANUFACTURED IN BARCELONA, SPAIN.

18440 A

II

6/22/2005

DR REDDYS LABORATORIES LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA.

LAMOTRIGINE AS MANUFACTURED IN BANGALORE, INDIA.

Page 532

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18441 A
II
6/10/2005
JOHNSON MATTHEY FINLAND LTD

SUBJECT
SMOPEX-102 AS MANUFACTURED IN TURKU, FINLAND.

18442 A

II

6/21/2005

BIOCON LTD

TACROLIMUS AS MANUFACTURED IN BANGALORE, INDIA.

18443 A

IV

6/21/2005

DOW CORNING CORP

18444 I

II

6/21/2005

CF PHARMA LTD

DOW CORNING(R) UNFILLED SILICONE ELASTOMER GELS AS MANUFACTURED IN HEMLOCK,


MI.
ATRACURIUM BESYLATE AS MANUFACTURED IN BUDAPEST, HUNGARY.

18445 A

II

5/30/2005

IRVINE SCIENTIFIC SALES CO

KI NSM-3 (KIRIN) POWDER, A CELL CULTURE MEDIUM AS MANUFACTURED IN SANTA, CA.

18446 I

II

6/23/2005

GEDEON RICHTER LTD

RISPERIDONE AS MANUFACTURED IN BUDAPEST, HUNGARY.

18447 A

II

6/15/2005

JOHNSON MATTHEY FINLAND LTD

SMOPEX-105 AS MANUFACTURED IN TURKU, FINLAND.

18448 A

II

6/23/2005

OLON SPA

THALIDOMIDE AS MANUFACTURED IN MILAN, ITALY.

18449 A

II

6/23/2005

BIOCON LTD

SIMVASTATIN AS MANUFACTURED IN BANGALORE, INDIA.

18450 A

IV

6/22/2005

TAKASAGO INTERNATIONAL CORP

18451 A

III

6/10/2005

18452 A

II

5/28/2005

BASELL POLYOLEFINE ITALIA SRL


LYONDELLBASELL INDUSTRIES CO
DONGYING TIANDONG PHARMACEUTICAL CO LTD

18453 A

II

6/16/2005

AUROBINDO PHARMA LTD

TAK-051366 INTENSATES(R) NATURAL & ARTIFICIAL PEPPERMINT MASK (686) AS


MANUFACTURED IN TETERBORO, NJ.
PURELL 2410 T AS MANUFACTURED IN WESSELING, GERMANY FOR BASELL POLYOLEFINE
ITALIA SPA
ENOXAPARIN SODIUM (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG,
CHINA.
CEFUROXIME ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18454 A

II

6/18/2005

AUROBINDO PHARMA LTD

NELFINAVIR MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18455 A

6/16/2005

WEST PHARMACEUTICAL SERVICES INC

WESTAR(R) RS PROCESS IN JURONG, SINGAPORE.

18456 I

4/15/2005

DIVISION OF AIDS NIAID

18457 A

II

6/27/2005

SANDOZ GMBH

CURRICULA VITAE (CV) FOR ACUTE INFECTION AND EARLY DISEASE RESEARCH PROGRAM
(AIEDRP) INVESTIGATORS.
CEFDINIR AS MANUFACTURED IN TYROL, AUSTRIA.

18458 I

II

6/24/2005

MEDAREX INC

18459 A

II

6/27/2005

EXCELLA GMBH

18461 A

II

6/30/2005

DAIICHI SANKYO CO LTD

18462 I

II

6/29/2005

CHEMWERTH INC

18463 I

IV

6/4/2005

DOW CHEMICAL CO

SUN11031 (HUMAN GHRELIN) DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA AND


GUNMA, JAPAN FOR ASUBIO PHARMA CO LTD
DOXORUBICIN HYDROCHLORIDE USP (NON-STERILE, BULK DRUG SUBSTANCE) AS
MANUFACTURED IN DISTRICT BHARUCH, INDIA FOR CHEMWERTH INC
WALOCEL(R) HM HYPROMELLOSE USP AS MANUFACTURED IN BOMLITZ, GERMANY.

18464 I

II

6/29/2005

SYMED LABS LTD

GEMFIBROZIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18465 A

II

6/24/2005

NEULAND LABORATORIES LTD

CIPROFLOXACIN USP AS MANUFACTURED IN TELANGANA, INDIA.

18466 A

II

6/29/2005

APOTEX PHARMACHEM INC

TORSEMIDE USP AS MANUFACTURED IN ONTARIO, CANADA.

18467 I

II

6/29/2005

DR REDDYS LABORATORIES LTD

TRANDOLAPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18468 A

II

6/29/2005

DR REDDYS LABORATORIES LTD

ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18469 A

II

6/28/2005

AUROBINDO PHARMA LTD

CEFPROZIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18470 A

II

6/30/2005

APOTEX PHARMACHEM INC

18471 A

II

6/30/2005

DR REDDYS LABORATORIES LTD

MIDODRINE HYDROCHLORIDE AS MANUFACTURED BY SIGNA S.A. DE C.V. AND APOTEX


PHARMACHEM INC IN TOLUCA, MEXICO AND ONTARIO, CANADA.
ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18472 A

II

6/30/2005

18473 A

III

6/25/2005

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
POLYONE CORP

18460 N

MDX-1303 VALORTIM (TM), ANTI-BACILLUS ANTHRACIS PROTECTIVE ANTIGEN HUMAN


MONOCLONAL ANTIBODY AS MANUFACTURED IN ANNANDALE, NJ.
DEFEROXAMINE MESYLATE AS MANUFACTURED IN FEUCHT, GERMANY.

NOT AN ASSIGNED NUMBER

OXYCODONE HYDROCHLORIDE AS MANUFACTURED IN WEST DEPTFORD, NJ.


CC00015929WE/DR AS MANUFACTURED IN ST. PETERS, MO.

Page 533

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18474 N
NOT AN ASSIGNED NUMBER

SUBJECT

18475 A

III

7/1/2005

MGJ

CORELEN/TRESYLENE LINERS AS MANUFACTURED IN CHAZAY D'AZERGUES, FRANCE.

18476 I

III

6/28/2005

POLIMERI EUROPA FRANCE

RIBLENE MP31 AS MANUFACTURED IN MARDYCK, FRANCE.

18477 I

III

6/28/2005

POLIMERI EUROPA FRANCE

FLEXIRENE MS26 AS MANUFACTURED IN MARDYCK, FRANCE.

18478 A

II

6/28/2005

NANTONG JINGHUA PHARMACEUTICAL CO LTD

FLUOROURACIL USP AS MANUFACTURED IN JIANGSU, CHINA.

18479 A

II

6/28/2005

SAFC BIOSCIENCES INC

18480 A

II

7/6/2005

UQUIFA MEXICO SA DE CV

EX-CELL(TM) 325 PF CHO, SERUM-FREE MEDIUM, PROTEIN-FREE (MODIFIED), W/O LGLUTAMINE, W/O PHENOL RED, W/O NAHC03 AS MANUFACTURED IN DENVER, PA.
PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN MORELOS, MEXICO.

18481 A

II

7/5/2005

DIVIS LABORATORIES LTD

NIACIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18482 A

II

7/6/2005

BIOCON LTD

REPAGLINIDE AS MANUFACTURED IN BANGALORE, INDIA.

18483 A

II

7/6/2005

STERLING SPA

FINASTERIDE AS MANUFACTURED IN PERUGIA, ITALY.

18484 A

III

7/5/2005

INDIAN SCIENTIFIC GLASS INDUSTRIES

NEUTRAL GLASS AMPOULES AS MANUFACTURED IN GUJARAT, INDIA.

18485 A

III

7/5/2005

KHEMKA GLASS PRODUCTS PVT LTD

18486 A

IV

6/22/2005

TAKASAGO INTERNATIONAL CORP

18487 A

III

7/5/2005

KHEMKA GLASS PRODUCTS PVT LTD

GLASS CYLINDERS, DENTAL LOCAL ANESTHETICS CARTRIDGES AND PEN INJECTOR


CARTRIDGES AS MANUFACTURED IN GUJARAT, INDIA.
TAK-051367 INTENSATES(R) NATURAL & ARTIFICIAL PEPPERMINT MASK (859) AS
MANUFACTURED IN TETERBORO, NJ.
NEUTRAL GLASS VIALS AS MANUFACTURED IN GUJARAT, INDIA.

18488 A

II

7/7/2005

HETERO LABS LTD

ZONISAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18489 I

II

7/8/2005

SANDOZ INDUSTRIAL PRODUCTS SA

GABAPENTIN (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN.

18490 A

III

7/7/2005

PACIFIC VIAL MANUFACTURING INC

GLASS VIALS AS MANUFACTURED IN COMMERCE, CA.

18491 I

III

7/5/2005

RICON COLORS

WHITE, CPP-W1528-1 AS MANUFACTURED IN WEST CHICAGO, IL.

18492 A

III

7/8/2005

STYROLUTION AMERICA LLC

18493 A

II

7/7/2005

BIOCON LTD

GENERAL PURPOSE POLYSTYRENE (GPPS) AND HIGH IMPACT POLYSTYRENE (HIPS) AS


MANUFACTURED IN CHANNAHON, IL.
FLUVASTATIN SODIUM AMORPHOUS AS MANUFACTURED IN BANGALORE, INDIA.

18494 A

II

7/11/2005

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN R.O.C.

18495 A

II

7/12/2005

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
MYLAN LABORATORIES LTD

18496 A

II

7/7/2005

HETERO LABS LTD

BICALUTAMIDE (FORM-H1), AS MANUFACTURED IN ANDHRA PRADESH, INDIA

18497 I

II

7/5/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

18498 A

II

7/6/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

18499 A

II

7/12/2005

MYLAN LABORATORIES LTD

VANCOMYCIN HYDROCHLORIDE USP (NON-STERILE, ACTIVE PHARMACEUTICAL


INGREDIENT) AS MANUFACTURED IN ZHEJIANG, CHINA.
EPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE ACTIVE PHARMACEUTICAL
INGREDIENT AS MANUFACTURED IN ZHEJIANG, CHINA.
CARVEDILOL USP AS MANUFACTURED IN TELANGANA, INDIA

18500 A

II

7/12/2005

MYLAN LABORATORIES LTD

NELFINAVIR MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

18501 I

II

7/11/2005

CADILA HEALTHCARE LTD

OMEPRAZOLE AS MANUFACTURED IN GUJARAT, INDIA.

18502 A

II

7/1/2005

MERCK KGAA

CALCIUM CHLORIDE DIHYDRATE AS MANUFACTURED IN DARMSTADT, GERMANY.

18503 A

II

7/12/2005

MYLAN LABORATORIES LTD

AMLODIPINE BESILATE USP (AYP) AS MANUFACTURED IN TELANGANA, INDIA

18504 A

II

7/12/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

OXCARBAZEPINE AS MANUFACTURED IN GUJARAT, INDIA

18505 A

II

7/11/2005

18506 A

II

7/11/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFPODOXIME PROXETIL USP (NON-STERILE BULK) AS MANUFACTURED IN
KANCHEEPURAM, INDIA.
HOSPIRA HEALTHCARE INDIA PVT LTD
TAZOBACTAM ACID USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18507 A

III

7/11/2005

NEMERA LA VERPILLIERE

INDINAVIR SULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN LA VERPILLIERE, FRANCE.

Page 534

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18508 A
II
7/6/2005
MALLINCKRODT INC

SUBJECT
COMPAP(R) COURSE L AS MANUFACTURED IN GREENVILLE, IL.

18509 A

II

7/12/2005

SCINOPHARM TAIWAN LTD

EFLORNITHINE HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

18510 I

II

7/5/2005

PCAS

FELODIPINE AS MANUFACTURED IN TURKU, FINLAND.

18511 A

III

7/14/2005

FARMACAP INDUSTRIA E COMERCIO LTDA

RUBBER STOPPERS AS MANUFACTURED IN ITAPECERICA DA SERRA, BRAZIL.

18512 I

III

7/14/2005

COMPANHIA INDUSTRIAL DE VIDROS - CIV

GLASS VIALS AS MANUFACTURED IN VARZEA, BRAZIL.

18513 A

III

7/14/2005

WHEATON BRASIL VIDROS SA

GLASS VIALS AS MANUFACTURED IN SAO PAULO, BRAZIL.

18514 N

NOT AN ASSIGNED NUMBER

18515 I

II

7/3/2005

CADILA PHARMACEUTICALS LTD

CARVEDILOL AS MANUFACTURED IN GUJARAT, INDIA.

18516 A

III

4/4/2005

BOREALIS AG

STAMYLEX 5119S AS MANUFACTURED IN AP GELEEN, THE NETHERLANDS.

18517 A

III

4/4/2005

BOREALIS AG

STAMYLEX 2258 AS MANUFACTURED IN AP GELEEN, THE NETHERLANDS.

18518 A

II

6/30/2005

JOHNSON MATTHEY FINLAND LTD

SMOPEX-234 AS MANUFACTURED IN TURKU, FINLAND.

18519 A

IV

7/15/2005

IPC PROCESS CENTER GMBH AND CO KG

18520 A

II

7/15/2005

FARMHISPANIA SA

CELLETS(R) (CELLULOSE MICROCRYSTALLINE, PELLETIZED) AS MANUFACTURED IN


DRESDEN, GERMANY.
FH-113 (RAMIPRIL) AS MANUFACTURED IN BARCELONA, SPAIN.

18521 A

II

6/30/2005

FABBRICA ITALIANA SINTETICI SPA

OXCARBAZEPINE AS MANUFACTURED IN VICENZA, ITALY.

18522 I

II

7/18/2005

ARTEMIS BIOTECH

SIMVASTATIN USP AS MANUFACTURED IN HYDERABAD, INDIA.

18523 I

II

7/17/2005

DIVIS LABORATORIES LTD

VERAPAMIL HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18524 A

II

7/19/2005

CADILA HEALTHCARE LTD

FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA.

18525 A

II

11/8/2005

PARABOLIC DRUGS LTD

6-AMINOPENICILLANIC ACID (6-APA) AS MANUFACTURED IN HARYANA, INDIA.

18526 A

IV

7/20/2005

SYMRISE INC

18527 A

II

7/18/2005

TAKASAGO INTERNATIONAL CORP

826130 ENTRAPPED NATURAL & ARTIFICIAL CHERRY TYPE FLAVOR AS MANUFACTURED IN


BRANCHBURG, NJ.
D-THREO-RITALINIC ACID AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN.

18528 A

III

7/19/2005

REXAM HEALTHCARE OFFRANVILLE SAS

18529 A

II

7/14/2005

ACIDCHEM INTERNATIONAL SDN BHD

BOTTLE AND PISTON FOR DERMATOLOGICAL DISPENSER AS MANUFACTURED IN


OFFRANVILLE, FRANCE.
ISOPROPYL PALMITATE AS MANUFACTURED IN PENAN, MALAYSIA.

18530 A

II

7/15/2005

AUROBINDO PHARMA LTD

CEFUROXIME SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18531 I

III

7/22/2005

INTRAPAC GROUP

INJECTION MOLDED PLASTIC PRODUCTS AS MANUFACTURED IN SAN JOSE, COSTA RICA.

18532 I

II

7/20/2005

FRESENIUS KABI ONCOLOGY LTD

DISODIUM PAMIDRONATE AS MANUFACTURED IN WEST BENGAL, INDIA.

18533 I

II

7/22/2005

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

CLINDAMYCIN PHOSPHATE USP (AR) AS MANUFACTURED IN BARCELONA SPAIN

18534 I

IV

7/19/2005

FONA INTERNATIONAL INC

18535 I

IV

7/19/2005

FONA INTERNATIONAL INC

18536 A

III

5/13/2005

ESS DEE ALUMINIUM LTD

929.042 N-C NATURAL & ARTIFICIAL WATERMELON FLAVOR AS MANUFACTURED IN CAROL


STREAM, IL.
852.154 N-C NATURAL & ARTIFICIAL FRUIT PUNCH FLAVOR AS MANUFACTURED IN CAROL
STREAM, IL.
ALUMINUM FOIL (BLISTER PACK) AS MANUFACTURED IN WEST BENGAL, INDIA.

18537 A

III

5/13/2005

ESS DEE ALUMINIUM LTD

ALUMINUM FOIL (STRIP PACK) AS MANUFACTURED IN WEST BENGAL, INDIA.

18538 I

III

7/26/2005

DYNEON GMBH & CO KG

18539 A

II

7/20/2005

18540 I

II

7/20/2005

18541 A

II

7/29/2005

PFA POLYMER DISPERSIONS AS MANUFACTURED IN BURGKIRCHEN, FEDERAL REPUBLIC OF


GERMANY.
LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LOVASTATIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDONG PROVINCE,
LTD
CHINA.
GUANGDONG NEW NORTH RIVER
MEVASTATIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDON PROVINCE,
PHARMACEUTICAL CO LTD
CHINA.
NAVINTA LLC
SODIUM FERRIC GLUCONATE COMPLEX AS MANUFACTURED IN ANDHRA PRADESH, INDIA
FOR NAVINTA LLC

Page 535

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18542 A
IV
7/12/2005
WINCOAT COLOURS COATINGS PVT LTD

SUBJECT
WINCOAT/SELECOAT (COATING MATERIAL) AS MANUFACTURED IN MAHARASHTRA, INDIA.

18543 A

III

8/1/2005

ANADOLU CAM ESKISEHIR SANAYI AS

PHARMACEUTICAL GLASS CONTAINERS AS MANUFACTURED IN ESKISEHIR, TURKEY.

18544 A

II

7/29/2005

TROSPIUM CHLORIDE AS MANUFACTURED IN BIASCA, SWITZERLAND.

18545 A

II

7/20/2005

HELSINN CHEMICALS SA HELSINN ADVANCED


SYNTHESIS SA
OLON SPA

18546 I

II

7/20/2005

OLON SPA

SPIRONOLACTONE AS MANUFACTURED IN MULAZZANO (LO) ITALY

18547 A

III

7/26/2005

REXAM PHARMA PACKAGING INDIA P LTD

18548 A

III

7/26/2005

REXAM PHARMA PACKAGING INDIA P LTD

18549 A

IV

7/25/2005

KERRY CANADA INC

TAMP LOCK / DOUBLE SAFE (R) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED
IN KARNATAKA, INDIA
PLASTIC CONTAINER & CLOSURES FOR ORAL PREPARATION AS MANUFACTURED IN
BANGALORE, INDIA
GRAPE NAT/ART FLAVOR MC006357 AS MANUFACTURED IN GRANBY, CANADA

18550 I

III

8/1/2005

COLORS FOR PLASTICS INC

W07071-XRF AS MANUFACTURED IN ELK GROVE VILLAGE, IL

18551 I

II

7/28/2005

CRYSTAL PHARMA SA

FINASTERIDE AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN

18552 I

III

7/26/2005

AMCOR FLEXIBLES BURGDORF GMBH

18553 A

III

7/26/2005

AMCOR FLEXIBLES BURGDORF GMBH

18554 A

II

7/25/2005

18555 I

III

7/19/2005

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
COPE ALLMAN JAYCARE LTD

COMPOUND PACKAGING MATERIAL (LAMINATE) PETP 12/ALU 12/LDPE 40 (SOP 51810) AS


MANUFACTURED IN BURGDORF, SWITZERLAND.
COMPOUND PACKAGING MATERIAL (LAMINATE) PETP 12/ALU 12/LDPE50 (SOP 51811) AS
MANUFACTURED IN BURGDORF, SWITZERLAND.
NAPROXEN USP (BULK) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

18556 A

II

8/1/2005

ASPEN OSS BV

150ML PET ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED


KINGDOM.
ESTERIFIED ESTROGENS TYPE AC AS MANUFACTURED IN OSS, THE NETHERLANDS.

18557 A

II

8/2/2005

SANDOZ GMBH

HEPARIN SODIUM AS MANUFACTURED IN TYROL, AUSTRIA.

18558 A

II

7/25/2005

AUROBINDO PHARMA LTD

CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18559 A

II

8/3/2005

RANBAXY LABORATORIES LTD

18560 A

III

8/3/2005

POLYONE CORP

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE) AS


MANUFACTURED IN PUNJAB, INDIA.
CC10042164WE AS MANUFACTURED IN GLENDALE, AZ.

18561 A

II

8/5/2005

PEPTISYNTHA SA

LARAZOTIDE AS MANUFACTURED IN BRUSSELS, BELGIUM.

18562 A

II

7/29/2005

OLON SPA

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY.

18563 A

II

11/11/2005

IPCA LABORATORIES LTD

18564 A

II

7/30/2005

IND SWIFT LABORATORIES LTD

HYDROCHLOROTHIAZIDE USP, API PROCESS II AS MANUFACTURED IN MADHYA PRADESH,


INDIA.
ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA

18565 A

II

8/1/2005

LONZA AG

EPTIFIBATIDE AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM

18566 A

II

8/4/2005

TRIFARMA SPA

HALOBETASOL PROPIONATE AS MANUFACTURED IN CERIANO LAGHETTO (MI) ITALY

18567 A

III

8/3/2005

EMS CHEMIE NORTH AMERICA INC

GRILAMID TR 55 NATURAL AS MANUFACTURED IN DOMAT/EMS, SWITZERLAND

18568 I

III

7/27/2005

LONSTROFF AG

E5218C GREY AS MANUFACTURED IN AARAU, SWITZERLAND

18569 A

III

8/3/2005

PRESSPART GMBH CO KG

18570 I

III

7/29/2005

AMPACET CORP

18571 I

II

8/8/2005

DAINIPPON SUMITOMO PHARMA CO LTD

ALUMINUM ALLOY METERED DOSE INHALER CONTAINERS (ANODIZED AND INTERNALLY


COATED) AS MANUFACTURED IN MARSBERG, GERMANY
102286 CLARITY SLIP AB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN
SMP-114 AS MANUFACTURED IN FUKUI, JAPAN

18572 I

II

5/7/2005

18573 I

II

5/7/2005

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY PSEUDOEPHEDRINE SULFATE USP AS MANUFACTURED IN INNNER MONGOLIA, CHINA
CO LTD
CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN MONGOLIA, CHINA
CO LTD

NIZATIDINE AS MANUFACTURED IN MULAZZANO (LO) ITALY

Page 536

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18574 A
IV
8/5/2005
AEGIS THERAPEUTICS LLC

SUBJECT
INTRAVAIL(TM) A-5 (TETRADECYLMALTOSIDE) AS MANUFACTURED IN SAN LUIS OBISPO, CA &
PISTOIA, ITALY.
PLEXIGLAS(R) HF110-101, PLEXIGLAS(R) HF110G-101 AND PLEXIGLAS(R) VS-100 AS
MANUFACTURED IN BRISTOL, PA AND LOUISVILLE, KY.
NEVIRAPINE ANHYDROUS USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18575 I

III

8/10/2005

ARKEMA INC

18576 A

II

7/30/2005

AUROBINDO PHARMA LTD

18577 I

II

6/6/2005

18578 I

II

4/29/2005

18579 I

II

8/8/2005

SHIJIAZHUANG PHARMACEUTICAL GROUP OUYI


PHARMA CO LTD
SHIJIAZHUANG PHARMACEUTICAL GROUP
HUASHENG PHARMA CO LTD
GUANGZHOU HUANYE PHARMACEUTICAL CO LTD

18580 I

II

8/11/2005

18581 A

II

6/24/2005

18582 I

III

8/11/2005

GUANGDONG NEW NORTH RIVER


PHARMACEUTICAL CO LTD
SOUTHWEST SYNTHETIC PHARMACEUTICAL CO
LTD
AMERICHEM INC

18583 A

III

8/11/2005

AMERICHEM INC

46603-CD2 RED AS MANUFACTURED IN CUYAHOGA FALLS, OH

18584 I

II

8/15/2005

INCELL CORP LLC

ACE(TM) CELL CULTURE MEDIUM AS MANUFACTURED IN SAN ANTONIO, TX.

18585 A

II

8/15/2005

INCELL CORP LLC

18586 I

II

5/24/1991

CENTOCOR INC

18587 I

II

5/28/1991

BERKELEY ANTIBODY CO

EZ-CPZ(TM) AND EZ-CPZ-H(TM) CELL CRYOPRESERVATION MEDIA AS MANUFACTURED IN


SAN ANTONIO, TX.
HUMAN-MURINE CHIMERIC MONOCLONAL ANTIBODY TO TUMOR NECROSIS FACTOR FOR
SEPSIS (CENTOCOR)
MURINE MONOCLONAL ANTIBODY PRODUCTION (ASCITES)

18589 I

II

9/14/1990

IMMUNOMEDICS INC

18590 I

II

5/8/1987

NEORX CORPORATION

18591 I

II

3/16/1989

YU ALICE L MD PHD

18592 I

II

4/15/1988

YU ALICE L MD PHD

MURINE MONOCLONAL ANTIBODY AND F(AB)2 FRAGMENT (IMMU-14) TO


CARCINOEMBRYONIC ANTIGEN (CEA)
99M TC MURINE MONOCLONAL ANTIBODIES TO HUMAN CARCINOMA SURFACE ANTIGEN
(P39)
CHIMERIC (HUMAN/MURINE) MONOCLONAL ANTIBODY (14.18) TO GD2 ANTIGEN
(NEUROBLASTOMA)
MURINE MONOCLONAL ANTIBODY (14G2A) TO GD2

18593 I

II

9/22/1987

CENTOCOR INC

99M-TC-MURINE MONOCLONAL ANTIBODY (FAB') (T2G1S) TO HUMAN FIBRIN II (B-CHAIN)

18594 A

II

3/19/1985

CENTOCOR INC

EDRECOLOMAB [MURINE MONOCLONAL ANTIBODY (17-1A) TO COLORECTAL CARCINOMA]

18595 I

II

8/22/1988

PROGEN INDUSTRIES LTD

MONOCLONAL ANTIBODIES

18596 A

II

2/13/1985

LONZA BIOLOGICS PLC

IMMOBILIZED MONOCLONAL ANTIBODY (NK2) TO INTERFERON

18597 I

4/25/1986

SANOFI WINTHROP INC

MANUFACTURING FACILITY - INTERFERON

18598 I

II

3/21/1988

BIOLOGICAL THERAPY INSTITUTE

MURINE MONOCLONAL ANTIBODIES

18599 I

II

7/14/1988

BIOLOGICAL THERAPY INSTITUTE

MITOMYCIN-C CONJUGATED MURINE MONOCLONAL ANTIBODIES

18600 I

II

4/28/1989

IMMUNOMEDICS INC

MURINE MONOCLONAL ANTIBODY (IMMU-31) TO ALPHA-FETOPROTEIN

18601 I

II

5/5/1989

NEORX CORP

18602 I

II

9/28/1989

BIOINVENT PRODUCTION AB

RHENIUM RE 186 CONJUGATED (MAGG) MURINE MONOCLONAL ANTIBODY (NR-LU-10) TO


HUMAN CARCINOMA SURFACE ANTIGEN (P39)
MONOCLONAL ANTIBODY PRODUCTION

18603 I

II

11/2/1989

IMMUNOMEDICS INC

MURINE MONOCLONAL ANTIBODY (IMM-LL-2) TO B-CELL LYMPHOMA AND LEUKEMIA CELLS

18604 I

II

12/12/1989

BEN VENUE LABORATORIES INC

MF PEG-L-ASPARAGINASE

18605 I

II

7/3/1991

MILLIPORE CORP

DURAPORE FILTER MEMBRANE

18588 N

ALENDRONATE SODIUM USP 28 AS MANUFACTURED IN HEBEI, CHINA.


TRAMADOL HYDROCHLORIDE EP AS MANUFACTURED IN HEBEI, CHINA.
VINCRISTINE SULFATE USP (NON-STERILE BULK DRUG) AS MANUFACTURED IN GUANGDONG
PROVINCE, CHINA.
PRAVASTATIN SODIUM AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA.
NABUMETONE USP AS MANUFACTURED IN CHONGQING, CHINA.
46603-CD1 RED AS MANUFACTURED IN CUYAHOGA FALLS, OH.

NOT AN ASSIGNED NUMBER

Page 537

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18606 I
II
8/1/1991
MEDAREX INC

SUBJECT
MURINE MONOCLONAL ANTIBODY (PM-81) TO HUMAN MYELOID DIFFERENTIATION ANTIGEN

18607 I

II

12/13/1991

GOODWIN BIOTECHNOLOGY INC

PRODUCTION OF MONOCLONAL ANTIBODIES

18608 I

II

6/30/1992

INSTITUTE MOLECULAR BIOLOGY INC

18609 I

II

6/30/1992

INSTITUTE MOLECULAR BIOLOGY INC

18610 I

II

8/14/1992

EISAI INC

INSULIN-LIKE GROWTH FACTOR-I (HUMAN, RECOMBINANT, YEAST, INSTITUTE OF


MOLECULAR BIOLOGY)
PLATELET DERIVED GROWTH FACTOR-BB (HUMAN, RECOMBINANT, C-127 MOUSE MAMMARY
CELLS, INSTITUTE OF MOLECULAR BIOLOGY)
INTERLEUKIN-2 DIPHTHERIA TOXIN FUSION PROTEIN (DAB 389 IL-2)

18611 I

II

8/13/1992

MILLIPORE CORP

VIRAL FILTER MEMBRANES (MILLIPORE)

18612 I

II

6/25/1990

DOW CHEMICAL CO

MURINE MONOCLONAL ANTIBODY (COL-1) TO CEA

18613 I

II

7/13/1990

GENETICS AND IVF INSTITUTE

18614 A

II

10/22/1992

HEMISPHERX BIOPHARMA INC

MF-MODIFIED TISSUE PLASMINOGEN ACTIVATOR, FEIX, (DEL 6-86, ASP-GLU117)


(RECOMBINANT, HUMAN, CHO CELLS)
INTERFERON ALFA-N3 GEL (HUMAN LEUKOCYTE, INTERFERON SCIENCES)

18615 I

II

3/22/1993

18616 I

II

1/17/1989

NATIONAL INSTITUTES HEALTH NATIONAL CANCER PSEUDOMONAS EXOTOXIN (RECOMBINANT, NLYSPE38) CONJUGATED MURINE MAB (B3) TO
INSTITUTE
B3 ANTIGEN AND RITUXIMAB [CHIMERIC MOAB (C2B8) (IDEC) TO CD20]
HOECHST MARION ROUSSEL
MURINE MONOCLONAL ANTIBODY BMA-031 TO T CELL RECEPTOR

18617 A

II

4/1/1993

18618 I

II

6/29/1993

18619 I

II

10/8/1993

18620 I

II

18621 I

II

18622 I
18623 I

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
PIERCE CHEMICAL CO

NR-LU-10 MURINE MONOCLONAL ANTIBODY FAB FRAGMENT (NOFETUMOMAB) AND


PHENTHIOATE LIGAND BULK MATERIAL FOR ONCOTRAC KIT (NEORX)
HYDRATED AZLACTONE FUNCTIONAL BEADS AS BIOSUPPORT MEDIUM
EPIDERMAL GROWTH FACTOR DIPHTHERIA TOXIN FUSION PROTEIN (DAB389EGF)

5/23/1988

SERAGEN INC SUB LIGAND PHARMACEUTICALS


INC
SYNTEX (USA) INC

11/12/1993

ENZON INC

II

11/11/1993

GENENTECH INC

BULK SINGLE CHAIN FV MONOCLONAL ANTIBODY (CC49) (MURINE, RECOMBINANT, E.COLI)


TO TAG-72
TUMOR NECROSIS FACTOR RECEPTOR IMMUNOGLOBULIN G

II

12/14/1993

NEORX CORP

18624 I

II

12/31/1991

SEPRACOR INC

18625 I

II

9/3/1993

NEORX CORP

MURINE MONOCLONAL ANTIBODY (NR-LU-10)/STREPTAVADIN CONJUGATE LABELED


W/RHENIUM-186 CONJUGATE (MAG2GABA), BIOTIN-GALACTOSE-HSA, INDIUM-111/YTTRIUM90-DOTA-BIOTIN

18626 A

II

2/1/1994

HYCLONE LABS INC

HYQ-CCM1 WITH AND WITHOUT PHENOL RED

18627 I

II

3/16/1994

DOW CHEMICAL CO

18628 I

4/5/1994

ELAN DRUG DELIVERY INC

CHIMERIC (MURINE VARIABLE, HUMAN CONSTANT) MONOCLONAL ANTIBODY (CC49) TO


TUMOR ASSOCIATED GLYCOPROTEIN (TAG)-72
TREHALOSE

18629 I

II

5/1/1990

DRAXIMAGE INC

STANNOUS GLUCONATE COMPLEX

18630 A

II

4/6/1994

KREITMAN ROBERT J MD

18631 I

II

10/9/1978

ADVANCE BIOFACTURES CORP

INTERLEUKIN-6 PSEUDOMONAS EXOTOXIN FUSION PROTEIN (HUMAN, RECOMBINANT, E.


COLI)
COLLAGENASE (C. HISTOLYTICUM, ADVANCE BIOFACTURES)

18632 I

II

8/9/1994

SCANTIBODIES LABS INC

REAGENTS FOR HUMAN ANTI-MOUSE ANTIBODY (HAMA) TESTING

18633 I

II

9/16/1994

GLAXOSMITHKLINE

18634 I

II

11/4/1994

NEORX CORP

CHIMERIC (MACAQUE VARIABLE/HUMAN CONSTANT) (RECOMBINANT, CHO CELLS)


MONOCLONAL ANTIBODY (SB 210396; CE9.1) TO HUMAN CD4 ANTIGEN
TECHNETIUM-TC-99M LABELED R-ANNEXIN V (NEORX)

18635 I

II

2/21/1995

CEL SCI CORP

LEUKOCYTE INTERLEUKIN, INJECTION

18636 I

2/24/1995

CHIRON BETA CORP

CHIRON BETA CORPORATION, CANOVANAS PUERTO RICO

INTERLEUKIN-1 BETA (RECOMBINANT, E. COLI) (IMMUNEX)

MURINE MONOCLONAL ANTIBODY (NR-LU-10) FAB FRAGMENT AND PHENTHIOATE LIGAND


BULK MATERIAL FOR ONCOTRAC KIT (MANUFACTURING HISTORY)
MEMBRANE AFFINITY PURIFIER FOR ANTIBODIES AND OTHER BIOLOGICALS

Page 538

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18637 I
II
2/23/1995
BOEHRINGER INGELHEIM PHARMA GMBH AND CO
KG
18638 I
II
4/4/1995
BIOTRANSPLANT INC

SUBJECT
INTERLEUKIN-12 BULK SUBSTANCE

18639 I

II

4/11/1995

ADVANCE BIOFACTURES CORP

RAT MONOCLONAL ANTIBODY (BTI-322) TO CD2+ T CELLS AND NK CELLS (BIOTRANSPLANT)


OR MUROMONAB-CD3 (OKT3, ORTHO) EACH WITH IMMUNOSUPPRESSIVE AGENTS
COLLAGENASE INJECTABLE

18640 I

II

8/21/1995

GENENTECH INC

THROMBOPOIETIN (HUMAN, RECOMBINANT, CHO CELLS, GENENTECH)

18641 A

II

8/31/1996

LONZA BIOLOGICS PLC

18642 I

II

9/19/1996

VISTA BIOLOGICALS CORP

BULK PURIFIED HUMANIZED MONOCLONAL ANTIBODY (AN100226)(NSO CELLS, LONZA) TO


ALPHA 4 INTEGRIN
MURINE MONOCLONAL ANTIBODIES TO HUMAN LEUCOCYTE FUNCTION ANTIGEN-1 (LFA-1)

18643 I

II

10/11/1996

NEKTAR AL

PEG-2 REAGENT AND MSPA20K

18644 I

II

11/26/1996

KYOWA HAKKO KOGYO CO LTD

PEGYLATED GRANULOCYTE COLONY-STIMULATING FACTOR MUTEIN BULK SUBSTANCE

18645 I

II

12/23/1996

MEDIMMUNE INC

HUMANIZED MONOCLONAL ANTIBODY (HULM609) TO HUMAN VITRONECTIN RECEPTOR

18646 I

II

2/26/1997

BIOGEN IDEC INC

MURINE MONOCLONAL ANTIBODY (2B8) TO CD20

18647 A

II

3/27/1997

MEDIMMUNE INC

18648 I

II

11/12/1997

MEDAREX INC

18649 I

II

12/30/1997

ABGENIX INC

SIPLIZUMAB [HUMANIZED MONOCLONAL ANTIBODY (MEDI-507) (NSO CELLS, MEDIMMUNE) TO


CD2]
RICIN CONJUGATED MURINE MONOCLONAL ANTIBODY (MDX-RA) TO HUMAN LENS
EPITHELIAL CELLS
BULK PURIFIED HUMAN MONOCLONAL ANTIBODY (ANTI-IL8) (NSO CELLS, LONZA) TO IL-8

18650 I

II

1/12/1998

NEORX CORP

18651 I

II

3/24/1998

SMITHKLINE BEECHAM PHARMACEUTICALS

18652 A

II

4/15/1998

GENMAB AS

MURINE MONOCLONAL ANTIBODY (NR-LU-10)/STREPTAVIDIN CONJUGATE, BIOTINGALACTOSE-HUMAN SERUM ALBUMIN, YTTRIUM-Y-90-DOTA-BIOTIN


CLENOLIXIMAB [CHIMERIC (MACAQUE/HUMAN) MONOCLONAL ANTIBODY (SB-217969) (CHO
CELLS, SMITHKLINE BEECHAM) TO CD4]
HUMAN MONOCLONAL ANTIBODY TO CD4 (ZANOLIMUNAB)

18653 I

12/2/1997

UNIV BRITISH COLUMBIA

MS/MRI RESEARCH GROUP AT THE UNIVERSITY OF BRITISH COLUMBIA

18654 I

II

5/7/1998

DIAMYD THERAPEUTICS AB

RECOMBINANT HUMAN GLUTAMIC ACID DECARBOXYLASE (RHGAD65)

18655 I

II

8/20/1998

BIOGEN IDEC INC

18656 I

II

11/4/1998

NEORX CORP

18657 I

II

1/8/1999

PROTEIN DESIGN LABS INC

IDEC-114 (GALIXIMAB);CHEMERIC (MACAQUE/HUMAN) MONOCLONAL ANTIBODY TO CD80


(B7.1)
INDIUM-IN-111 RADIOLABELED HUMANIZED MAB SINGLE CHAIN FV/STREPTAVIDIN FUSION
PROTEIN (HUNRLU10 SCFV/SA), BIOTIN-GALACTOSE (SYNTHETIC), IN-111/Y-90-DOTA-BIOTIN
HUMANIZED MONOCLONAL ANTIBODY (HU1D10) TO HLA-DR.

18658 A

II

4/9/1999

HYCLONE LABS INC

HYQ-PF CHO SERUM-FREE MEDIUM

18659 I

II

5/15/1999

ABGENIX INC

HUMAN MONOCLONAL ANTIBODY (ABX-EGF) TO EPIDERMAL GROWTH FACTOR RECEPTOR

18660 I

II

6/4/1999

ABGENIX INC

BULK PURIFIED MURINE MONOCLONAL ANTIBODY (ABX-CBL) TO BLAST CELLS

18661 I

II

6/30/1999

LONZA BIOLOGICS PLC

TOSITUMOMAB [MURINE MONOCLONAL ANTIBODY (B1) AGAINST B LYMPHOCYTES (CD20)]

18662 I

II

10/6/1999

MEDAREX INC

MURINE MONOCLONAL ANTIBODY (ALPHA CTLA4) TOCTLA4

18663 I

II

11/9/1999

GENENTECH INC

DORNASE ALFA INHALATION SOLUTION (GENENTECH)

18664 I

1/13/2000

GENETICS INSTITUTE INC

18665 I

12/28/1999

CANCER AND LEUKEMIA GROUP B

GENETICS INSTITUTE, INCORPORATED, ANDOVER, MASSACHUSETTS CLINICAL FILL/FINISH


FACILITY
CANCER AND LEUKEMIA GROUP B (CALGB)

18666 I

II

6/29/2000

MDS NORDION

YTTRIUM - Y - 90 CHLORIDE STERILE SOLUTION

18667 I

II

9/20/2000

BIOGEN IDEC INC

HUMANIZED MONOCLONAL ANTIBODY (IDEC-131) (CHO CELLS, IDEC) TO CD40L (CD 154)

18668 A

II

9/18/2000

FRED HUTCHINSON CANCER RESCTR

MURINE MONOCLONAL ANTIBODY (BC8) TO CD45

18669 I

II

10/18/2000

MDS NORDION

YTTRIUM-Y-90 CHLORIDE (FISSION)

Page 539

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18670
II
1/31/2001
MILLIPORE CORP
A
18671 A

II

3/13/2001

MEDIMMUNE LLC

18672 I

II

4/2/2001

AMGEN INC

SUBJECT
RETROPORE MEMBRANE AND VIRESOLVE NORMAL FLOW RETROVIRUS FILTER DEVICE
(MILLIPORE)
HUMANIZED MONOCLONAL ANTIBODY (MEDI-522) TO THE VITRONECTIN (ALPHA-5 BETA-3)
RECEPTOR
HUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15

18673 I

II

4/30/2001

LONZA BIOLOGICS PLC

BULK PURIFIED HUMANIZED MONOCLONAL ANTIBODY (H5G1-1)(NSO CELLS. LONZA) TO C5

18674 A

II

8/6/2001

NEKTAR AL

METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL BUTANOATE, MW 30,000 (MSBA30K)

18675 I

II

12/20/2001

FRED HUTCHINSON CANCER RESCTR

HUMAN MONOCLONAL ANTIBODY (ABX-MA1) TO MUC-18

18676 I

II

2/25/2002

CHEMICON INTERNATIONAL

MURINE MONOCLONAL ANTIBODY (T10B9-1A31) TO T CELLS

18677 I

II

2/28/2002

VIRON THERAPEUTICS

SERINE PROTEINASE INHIBITOR-1 (CHO CELLS, BIOVEST INTERNATIONAL)

18678 I

II

10/4/2000

VIVENTIA BIOTECH INC

GELONIN, RECOMBINANT (E. COLI)

18679 I

II

4/17/2002

BRISTOL MYERS SQUIBB CO

HUMAN MONOCLONAL ANTIBODY (MDX-060) TO CD30

18680 A

II

9/6/2002

WYETH PHARMACEUTICALS INC

BONE MORPHOGENETIC PROTEIN-2 (HUMAN, RECOMBINANT, CHO CELLS, WYETH) AS

18681 I

II

12/9/2002

MEDAREX INC

HUMAN MONOCLONAL ANTIBODY (MDX-070) TO PROSTATE SPECIFIC MEMBRANE ANTIGEN

18682 I

II

6/24/2003

MEDAREX INC

18683 I

II

9/15/2003

FRED HUTCHINSON CANCER RESCTR

HUMAN MONOCLONAL ANTIBODY (MDX-214) TO THE EPIDERMAL GROWTH FACTOR


RECEPTOR (EGFR)
MURINE MONOCLONAL ANTIBODY (9.3) TO CD-28

18684 I

II

9/22/2003

MEDAREX INC

HUMAN MONOCLONAL ANTIBODY (MDX-067) TO HEPARANASE

18685 I

II

10/15/2003

MDS NORDION

YTTRIUM (Y-90) CHLORIDE (FISSION)

18686 I

II

3/15/2004

ELI LILLY AND CO

MDX-068 (HUMANIZED ANTI-B-AMYLOID MONOCLONAL ANTIBODY)

18687 A

II

8/5/2005

RIOCARE INDIA PVT LTD

SIMETHICONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18688 A

II

8/5/2005

RIOCARE INDIA PVT LTD

DIMETHICONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18689 A

II

8/5/2005

RIOCARE INDIA PVT LTD

SIMETHICONE EMULSION USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18690 A

II

8/18/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

18691 A

II

8/18/2005

DELMAR CHEMICALS LTD

FAMCICLOVIR (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN


ZHEJIANG PROVINCE, CHINA.
(R)-BAP L-MA AS MANUFACTURED IN QUEBEC, CANADA.

18692 A

II

8/19/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

18693 I

III

8/15/2005

ADHESIVES RESEARCH INC

18694 I

III

8/15/2005

ADHESIVES RESEARCH INC

18695 I

III

8/15/2005

ADHESIVES RESEARCH INC

18696 A

II

8/23/2005

CATALENT PHARMA SOLUTIONS LLC

18697 A

II

8/24/2005

18698 A

IV

8/24/2005

SHANDONG LUNAN BETTER PHARMACEUTICAL CO ZOLPIDEM TARTRATE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG
LTD
PROVINCE, CHINA.
GATTEFOSSE SA
PANCOGENE(R) MARIN AS MANUFACTURED IN PERSAN, FRANCE.

18699 I

II

8/24/2005

DOCTOR REDDYS LABORATORIES LTD

DISODIUM PAMIDRONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18700 A

II

8/25/2005

CADILA HEALTHCARE LTD

TOPIRAMATE AS MANUFACTURED IN GUJARAT, INDIA.

18701 A

II

8/25/2005

CIPLA LTD

18702 A

II

8/25/2005

CADILA HEALTHCARE LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN


MAHARASHTRA, INDIA.
LORATADINE AS MANUFACTURED IN GUJARAT, INDIA.

LOSARTAN POTASSIUM (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS


MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
MA-24B ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC AND ADHESIVES
RESEARCH IRELAND LTD IN GLEN ROCK, PA AND LIMERICK, IRELAND.
HY-9 ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND
ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND.
HY-10 ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND
ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND.
LORATADINE SOFTGELS (10 MG) AS MANUFACTURED IN ST. PETERSBURG, FL.

Page 540

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18703 A
II
9/29/2005
BITOLEA SPA CHIMICA ECOLOGICA

SUBJECT
KETOENAMINE AS MANUFACTURED IN LANDRIANO, ITALY.

18704 I

II

8/8/2005

ACS DOBFAR SPA

CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY.

18705 A

II

8/8/2005

ACS DOBFAR SPA

CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN BERGAMO, ITALY.

18706 A

II

8/15/2005

ERREGIERRE SPA

ARIPIPRAZOLE AS MANUFACTURED IN BERGAMO, ITALY.

18707 A

II

8/16/2005

ERREGIERRE SPA

BUTENAFINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY.

18708 I

II

8/26/2005

CATALENT PHARMA SOLUTIONS LLC

R115866 SOFTGELS AS MANUFACTURED IN SOMERSET, NJ.

18709 I

II

8/24/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

18710

II

8/25/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

18711 A

III

8/29/2005

WACKER CHEMIE AG

18712 I

III

8/25/2005

CODING PRODUCTS

PRAVASTATIN SODIUM (AMORPHOUS, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)


AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
TAZOBACTAM SODIUM (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS
MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
VINNAPAS(R) B 100 AS MANUFACTURED BY WACKER POLYMERS GMBH & CO KG IN
BURGHAUSEN, GERMANY FOR WACKER POLYMER SYSTEMS LP.
TTR-51524 THERMAL TRANSFER INK RIBBON AS MANUFACTURED IN KALKASKA, MI.

18713 A

II

8/18/2005

AUROBINDO PHARMA LTD

LAMIVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18714 A

II

8/18/2005

AUROBINDO PHARMA LTD

ZIDOVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18715 A

II

8/30/2005

TORRENT PHARMACEUTICALS LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

18716 A

II

8/29/2005

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

PREDNISOLONE USP BULK AS MANUFACTURED IN TIANJIN, CHINA.

18717 A

II

8/29/2005

SCINOPHARM TAIWAN LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN TAINAN, TAIWAN R.O.C.

18718 I

IV

8/31/2005

CARGILL POLYOLS LLC

ERYTHRITOL 16956 (PHARMA EXCIPIENT GRADE) AS MANUFACTURED IN BLAIR, NE.

18719 A

II

8/31/2005

ALEMBIC PHARMACEUTICALS LTD

AZITHROMYCIN MONOHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA.

18720 A

III

8/31/2005

NOVARTIS PHARMACEUTICALS CORP

T-326 DRY POWDER INHALER DEVICE AS MANUFACTURED IN SAN CARLOS, CA.

18721 I

II

8/23/2005

STRAINRITE

18722 A

II

9/1/2005

FARMABIOS S P A

DCX-8XX-MD-XX-XXX-XXX: 8-INCH NOMINAL DIAMETER CLARIFICATION VESSEL FOR ONETIME USE.


CEFUROXIME SODIUM STERILE USP AS MANUFACTURED IN PAVIA, ITALY.

18723 A

II

8/31/2005

CIPLA LTD

BICALUTAMIDE AS MANUFACTURED IN BANGALORE, INDIA.

18724 A

III

9/1/2005

APTAR FRANCE SAS

18725 A

II

9/2/2005

NOVARTIS PHARMACEUTICALS CORP

QUALITY CONTROL METHODS FOR APTAR PACKAGING COMPONENTS AS MANUFACTURED IN


LE VAUDREUIL, FRANCE AND CONGERS, NEW YORK
PULMOSPHERE(R) PLACEBO INHALATION POWDER AS MANUFACTURED IN SAN CARLOS, CA.

18726 A

II

8/31/2005

18727 A

II

8/31/2005

EVONIK REXIM NANNING PHARMACEUTICAL CO


LTD
HIKMA PHARMACEUTICALS

L-METHIONINE (PHARMACEUTICAL INFUSION GRADE) AS MANUFACTURED IN GUANGXI,


CHINA.
GLYCOPYRROLATE USP AS MANUFACTURED IN AMMAN, JORDAN.

18728 I

II

9/2/2005

18729 I

III

9/7/2005

18730 A

IV

9/6/2005

NATIONAL INSTITUTES HEALTH NATIONAL CANCER 2-CYANO-3, 12-DIOXOOLEANA-1, 9(11)-DIEN-28-OIC ACID (CDDO) AS MANUFACTURED BY
INSTITUTE
STARKS ASSOCIATES, INC IN BUFFALO, NY.
KUNSTSTOFFWERK KREMSMUNSTER GMBH
71.216.32 DP1S1 PP 28 CAPS T/E CRC WITH SILICAGEL AS MANUFACTURED IN
KREMSMUNSTER, AUSTRIA.
DMV FONTERRA EXCIPIENTS GMBH CO KG
RESPITOSE(R) ML003 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS.

18731 A

II

9/7/2005

RESOLUTION CHEMICALS LIMITED

18732 A

II

9/9/2005

ALEMBIC PHARMACEUTICALS LTD

DRONABINOL USP AS MANUFACTURED IN SCOTLAND AND HERTFORDSHIRE, U.K. FOR


RESOLUTION CHEMICALS LTD.
LAMOTRIGINE AS MANUFACTURED IN GUJARAT, INDIA.

18733 A

II

9/7/2005

HETERO LABS LTD

DIDANOSINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18734 A

II

9/9/2005

ALEMBIC PHARMACEUTICALS LTD

VENLAFAXINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

18735 I

IV

8/12/2005

SUNIL HEALTHCARE LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTHAN, INDIA.

Page 541

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18736 A
III
9/1/2005
POLYONE CORP

SUBJECT
CC10037686BG AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM.

18737 A

III

9/1/2005

POLYONE CORP

CC10037779BG AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM.

18738 A

III

9/8/2005

SABIC INNOVATIVE PLASTICS

18739 I

II

9/9/2005

PROMETHEUS LABORATORIES INC

18740 A

II

9/8/2005

BCN PEPTIDES

18741 A

IV

9/9/2005

NANOTHERAPEUTICS INC

18742 A

II

9/9/2005

INFAR SA

CYCOLOY * RESINS AS MANUFACTURED BY IN CARTAGENA, SPAIN , MT VERNON, INDIANA


(USA), AND SELKIRK, NEW YORK (USA)
AZATHIOPRINE 50 MG TABLETS AND PLACEBO TABLETS AS MANUFACTURED IN DARTFORD,
U.K. FOR PROMETHEUS LABORATORIES, INC.
OCTREOTIDE ACETATE BULK ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN
BARCELONA, SPAIN.
GELSITE(R) POLYMER, A PHARMACEUTICAL EXCIPIENT FOR MUCOSAL DELIVERY
APPLICATIONS.
5-AMINOSALICYLIC ACID I (MESALAMINE) AS MANUFACTURED IN BARCELONA, SPAIN.

18743 I

II

9/9/2005

MITSUBISHI TANABE PHARMA CORP

MP-513 DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI, JAPAN.

18744 A

III

9/2/2005

ELM PLASTIC GMBH

18745 A

IV

8/10/2005

UNGERER AND CO

PLASTIC DOSING PIPETTES AND ACCESSORY AS MANUFACTURED IN DUDELDORF,


GERMANY.
NATURAL PEPPERMINT EXT. FN-2356 AS MANUFACTURED IN BETHLEHEM, PA.

18746 I

II

9/8/2005

QUIMICA SINTETICA SA

IRBESARTAN AS MANUFACTURED IN MADRID, SPAIN.

18747 I

IV

9/2/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL CREAM FLAVOR #20761 AS MANUFACTURED IN PHILADELPHIA, PA.

18748 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL CREAM FLAVOR #12034 AS MANUFACTURED IN PHILADELPHIA, PA.

18749 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL CREAM FLAVOR #20844 AS MANUFACTURED IN PHILADELPHIA, PA.

18750 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL VANILLA FLAVOR #15448 AS MANUFACTURED IN PHILADELPHIA, PA.

18751 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL VANILLA FLAVOR #1119 AS MANUFACTURED IN PHILADELPHIA, PA.

18752 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL VANILLA CREAM FLAVOR #24549 AS MANUFACTURED IN PHILADELPHIA, PA.

18753 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

18754 A

IV

9/2/2005

DAVID MICHAEL AND CO INC

MICHAEL-THERMICS(R) ARTIFICIAL VANILLA FLAVOR #16618 AS MANUFACTURED IN


PHILADELPHIA, PA.
ARTIFICIAL VANILLA CREAM FLAVOR #20397 AS MANUFACTURED IN PHILADELPHIA, PA.

18755 A

II

9/13/2005

JUBILANT GENERICS LTD

SIMVASTATIN USP AS MANUFACTURED IN KARNATAKA, INDIA.

18756 A

II

9/12/2005

GLENMARK GENERICS LTD

ADAPALENE AS MANUFACTURED IN GUJARAT, INDIA.

18757 I

II

8/26/2005

MOEHS IBERICA SL

TRIAMTERENE AS MANUFACTURED IN BARCELONA, SPAIN.

18758 I

II

9/12/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ZAGREB, CROATIA.

18759 I

II

9/12/2005

GLENMARK PHARMACEUTICALS LTD

TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA.

18760 N

NOT AN ASSIGNED NUMBER

18761 N

NOT AN ASSIGNED NUMBER

18762 A

II

9/13/2005

BIOCON LTD

FLUVASTATIN SODIUM AS MANUFACTURED IN BANGALORE, INDIA.

18763 A

III

9/1/2005

POLYONE CORP

CC10064753BG AS MANUFACTURED IN MANCHESTER, U.K.

18764 A

III

9/1/2005

POLYONE CORP

CC10069184BG AS MANUFACTURED IN MANCHESTER, U.K.

18765 I

III

9/8/2005

AMPACET CORP

AMPACET 191423-K GREY 423 AS MANUFACTURED IN RAYONG, THAILAND.

18766 I

III

9/8/2005

AMPACET CORP

AMPACET 140456-K ORANGE 456 AS MANUFACTURED IN RAYONG,THAILAND.

18767 I

III

9/8/2005

AMPACET CORP

AMPACET 181060-K BROWN 060 AS MANUFACTURED IN RAYONG, THAILAND.

18768 I

III

9/8/2005

AMPACET CORP

AMPACET 162057-K BLUE 057 AS MANUFACTURED IN RAYONG, THAILAND.

18769 I

III

9/8/2005

AMPACET CORP

AMPACET 191422-K BLACK 422 AS MANUFACTURED IN RAYONG, THAILAND.

18770 A

III

9/8/2005

AMPACET CORP

AMPACET PRODUCT 7188175 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN


TERRE HAUTE, IN AND CARTERSVILLE, GA.

Page 542

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18771 I
III
9/8/2005
AMPACET CORP

SUBJECT
AMPACET 162058-K VIOLET 058 AS MANUFACTURED IN RAYONG, THAILAND.

18772 I

III

9/8/2005

AMPACET CORP

AMPACET 171463-K GREEN 463 AS MANUFACTURED IN RAYONG, THAILAND.

18773 A

IV

9/12/2005

DAVID MICHAEL AND CO INC

ARTIFICIAL VANILLA CREAM FLAVOR #27699 AS MANUFACTURED IN PHILADELPHIA, PA.

18774 A

II

9/13/2005

CAMBREX CHARLES CITY INC

ARIPIPRAZOLE AS MANUFACTURED IN CHARLES CITY, IA.

18775 I

II

9/15/2005

LIGHT SCIENCES ONCOLOGY INC

18776 I

II

9/15/2005

GEDEON RICHTER LTD

TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG PRODUCT AS MANUFACTURED IN


BLOOMINGTON, IN FOR LIGHT SCIENCES CORP
BICALUTAMIDE (MICRONIZED) AS MANUFACTURED IN DOROG AND BUDAPEST, HUNGARY.

18777 A

II

9/14/2005

TORRENT PHARMACEUTICALS LTD

ROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA.

18778 I

II

9/8/2005

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORY

CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

18779 A

II

9/15/2005

MOEHS IBERICA SL

PANTOPRAZOLE SODIUM AS MANUFACTURED IN CANTABRIA, SPAIN.

18780 I

II

8/22/2005

ZHEJIANG TIANYU PHARMACEUTICAL CO LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

18781 A

II

9/12/2005

AUROBINDO PHARMA LTD

BISOPROLOL FUMARATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18782 A

II

9/19/2005

WATSON PHARMA PRIVATE LTD

IMIQUIMOD AS MANUFACTURED IN MAHARASHTRA, INDIA.

18783 N

NOT AN ASSIGNED NUMBER

18784 A

IV

9/19/2005

MANE INC

18785 I

III

9/12/2005

AMERICAN RENOLIT CORP

E_0405329 STRAWBERRY FLAVOR AS MANUFACTURED IN BAR SUR LOUP, FRANCE FOR


MANE INC
PVC FILMS AS MANUFACTURED IN LAPORTE, IN.

18786 I

II

9/19/2005

BOEHRINGER INGELHEIM CHEMICALS INC

LANTHANUM CARBONATE HYDRATE AS MANUFACTURED IN PETERSBURG, VA.

18787 A

II

9/19/2005

HETERO DRUGS LTD

AMLODIPINE BESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18788 A

II

9/20/2005

MALLADI DRUGS AND PHARMACEUTICALS LTD

PHENYLEPHRINE AND SALT AS MANUFACTURED IN TAMIL NADU, INDIA.

18789 A

II

9/19/2005

NEULAND LABORATORIES LTD

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA.

18790 A

III

9/19/2005

NOLATO CERBO AB

18791 A

II

9/16/2005

DELMAR CHEMICALS INC

AB CERBO PHARMACEUTICAL CONTAINERS AND CLOSURES AS MANUFACTURED IN


TROLLHATTAN, SWEDEN.
FLUORESCEIN AS MANUFACTURED IN QUEBEC, CANADA.

18792 I

II

9/19/2005

EXCELLA GMBH

BICALUTAMIDE AS MANUFACTURED IN FEUCHT, GERMANY.

18793 A

II

9/17/2005

IND SWIFT LABORATORIES LTD

AT1 DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN PUNJAB, INDIA.

18794 A

III

8/30/2005

ARIDIEN INC

DESICCANT PACKAGING AS MANUFACTURED IN BELEN, NM.

18795 A

IV

9/19/2005

UNGERER AND CO

N&A MENTHOL FLVP FN-6067 AS MANUFACTURED IN BETHLEHEM, PA.

18796 A

IV

9/19/2005

UNGERER AND CO

N&A PEPPERMINT FLVP FN-6243 AS MANUFACTURED IN BETHLEHEM, PA.

18797 A

II

9/12/2005

IND SWIFT LABORATORIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN PUNJAB, INDIA.

18798 I

III

9/21/2005

FPC FLEXIBLE PACKAGING CORP

18799 I

II

9/20/2005

SHENZHEN ORIENTAL PHARMACEUTICAL CO LTD

PHARMACEUTICAL POUCH - FPC SPECIFICATION 47100E AS MANUFACTURED IN ONTARIO,


CANADA.
PHENYLEPHRINE HYDROCHLORIDE (API) AS MANUFACTURED IN SHENZHEN, CHINA.

18800 A

II

9/21/2005

CIPLA LTD

FEXOFENADINE HYDROCHLORIDE (FORM C) AS MANUFACTURED IN MAHARASHTRA, INDIA.

18801 I

II

9/2/2005

R L FINE CHEM

IMIPRAMINE PAMOATE AS MANUFACTURED IN BANGALORE, INDIA.

18802 N

NOT AN ASSIGNED NUMBER

18803 A

II

9/27/2005

JUBILANT GENERICS LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA.

18804 I

II

9/19/2005

METHYLTESTOSTERONE USP AS MANUFACTURED IN HENAN PROVINCE, CHINA.

18805 A

II

9/26/2005

HENAN QUANXIN MEDICAL & CHEMICAL


TECHNOLOGY CO LTD
ALKERMES GAINESVILLE LLC

18806 A

II

9/25/2005

DIVIS LABORATORIES LTD

FOSPHENYTOIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

MELOXICAM NANOCRYSTAL(R) TABLETS AS MANUFACTURED IN KING OF PRUSSIA, PA.

Page 543

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18807 A
II
9/25/2005
DIVIS LABORATORIES LTD

SUBJECT
RISEDRONATE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18808 A

II

9/25/2005

DIVIS LABORATORIES LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18809 A

II

9/26/2005

LIPOID GMBH

LIPOID DPPC/PG 7:3 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

18810 A

II

9/24/2005

JIANGSU HANSOH PHARMACEUTICAL CO LTD

GEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) AS


MANUFACTURED BY JIANGSU HANSEN PHARMACEUTICAL CO LTD IN JIANGSU, CHINA.

18811 N

NOT AN ASSIGNED NUMBER

18812 N

NOT AN ASSIGNED NUMBER

18813 N

NOT AN ASSIGNED NUMBER

18814 N

NOT AN ASSIGNED NUMBER

18815 A

II

9/15/2005

HIKAL LTD

GEMFIBROZIL API AS MANUFACTURED IN BANGALORE, INDIA.

18816 A

II

8/31/2005

AUROBINDO PHARMA LTD

AMOXICILLIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18817 A

II

9/20/2005

18818 A

II

9/23/2005

NATIONAL CENTER FOR NATURAL PRODUCTS


RESEARCH
FRESENIUS KABI ONCOLOGY LTD

CANNABIS EXTRACT (PRODUCT CODE 1101), A DRUG SUBSTANCE INTERMEDIATE AS


MANUFACTURED IN UNIVERSITY, MS.
IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN WEST BENGAL, INDIA.

18819 A

III

9/27/2005

BAYER MATERIALSCIENCE LLC

MAKROBLEND UT 408 RESINS AS MANUFACTURED IN HEBRON, OH.

18820 A

II

9/28/2005

CIPLA LTD

GRANISETRON BASE AS MANUFACTURED IN BANGALORE, INDIA.

18821 A

II

9/28/2005

CIPLA LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN BANGALORE, INDIA.

18822 A

II

9/30/2005

CADILA HEALTHCARE LTD

ATORVASTATIN PROTECTED DIOL AS MANUFACTURED IN GUJARAT, INDIA.

18823 A

II

9/29/2005

MALLINCKRODT INC

LEVORPHANOL TARTRATE USP SPECIAL AS MANUFACTURED IN ST. LOUIS, MO.

18824 A

II

9/26/2005

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

18825 A

II

11/2/2005

JANSSEN PHARMACEUTICA NV

TINIDAZOLE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA.
DARUNAVIR (R319064) DRUG SUBSTANCE AS MANUFACTURED BY CILAG AG IN
SCHAFFHAUSEN, SWITZERLAND, JANSSEN PHARMACEUTICA, NV IN GEEL, BELGIUM AND
JANSSEN PHARMACEUTICA LTD IN CORK, IRELAND.

18826 A

II

9/30/2005

HELSINN ADVANCED SYNTHESIS SA

ADAPALENE AS MANUFACTURED IN BIASCA, SWITZERLAND.

18827 A

II

9/30/2005

CADILA HEALTHCARE LTD

AMLODIPINE BESILATE AS MANUFACTURED IN GUJARAT, INDIA.

18828 A

II

10/3/2005

CADILA HEALTHCARE LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA.

18829 A

II

9/3/2005

HIKAL LTD

ONDANSETRON API AS MANUFACTURED IN BANGALORE, INDIA.

18830 A

IV

10/4/2005

BASF SE

18831 A

II

9/22/2005

18832 I

II

9/26/2005

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
TAI HENG INDUSTRY CO LTD

KOLLICOAT(R) IR WHITE AS MANUFACTURED BY AKTIENGESELLSCHAFT IN LUDWIGSHAFEN,


GERMANY AND SHWARZWALDMILCH GMBH IN OFFENBERG, GERMANY.
ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA FOR CHEMWERTH INC
URACIL AS MANUFACTURED IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD

18833 A

II

1/22/2005

18834 I

II

9/30/2005

18835 A

II

10/4/2005

18836 A

II

18837 A
18838 A

ZHEJIANG MEDICAL CO LTD XINCHANG


PHARMACEUTICAL FACTORY
MALLINCKRODT INC

MIGLITOL USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

ATORVASTATIN ATV (L1) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

10/6/2005

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
ALEMBIC PHARMACEUTICALS LTD

II

9/30/2005

SWATI SPENTOSE PRIVATE LTD

MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA.

III

11/28/2005

3M DRUG DELIVERY SYSTEMS

BECLOMETHASONE DIPROPIONATE HFA METERED DOSE INHALER VALVE AS


MANUFACTURED IN SCHAUMBURG, IL;COLUMBUS, NE;BOUND BROOK,NJ;
BUCKINGHAMSHIRE,LANCASHIRE,STAFFORDSHIRE AND DURHAM, U.K.

HYDROMORPHONE BASE AS MANUFACTURED IN ST. LOUIS, MO.

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA.

Page 544

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18839 A
II
10/5/2005
LUPIN LTD

SUBJECT
AMLODIPINE BESILATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

18840 I

II

10/3/2005

BASIC PHARMA LIFE SCIENCE PVT LTD

CHLORHEXIDINE ACETATE AS MANUFACTURED IN GUJARAT, INDIA.

18841 I

II

10/3/2005

BASIC PHARMA LIFE SCIENCE PVT LTD

CHLORHEXIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

18842 I

II

10/3/2005

BASIC PHARMA LIFE SCIENCE PVT LTD

CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT, INDIA.

18843 A

II

10/7/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ARGININE (STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

18844 A

II

10/7/2005

18845 A

II

10/7/2005

18846 I

II

10/10/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD TERBINAFINE HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN
MAHARASHTRA, INDIA.
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEPHALOSPORIN INTERMEDIATE (CAVA) AS MANUFACTURED IN KANCHEEPURAM DISTRICT,
INDIA.
BASF CO LTD
RIBOFLAVIN (BULK DRUG SUBSTANCE) AS MANUFACTURED IN JEONBUK, KOREA.

18847 I

III

9/30/2005

ADHESIVES RESEARCH INC

18848 A

II

10/7/2005

ORGAPHARM SAS

18849 I

IV

10/3/2005

LUBRIZOL ADVANCED MATERIALS INC

18850 I

IV

10/7/2005

FONA INTERNATIONAL INC

ESTANE PRODUCTS 5714, 58239, 58311, 58630 AS MANUFACTURED IN AVON LAKE, OH AND
WESTERLO-OEVEL, BELGIUM.
894.115 N-C PEPPERMINT FLAVOR, NATURAL AS MANUFACTURED IN CAROL STREAM, IL.

18851 A

IV

10/7/2005

FONA INTERNATIONAL INC

915.843 STRAWBERRY FLAVOR, NATURAL WONF AS MANUFACTURED IN CAROL STREAM, IL.

18852 I

IV

10/7/2005

FONA INTERNATIONAL INC

825.746 CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL.

18853 I

IV

10/7/2005

FONA INTERNATIONAL INC

950.020 VANILLIN, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL.

18854 I

IV

10/7/2005

FONA INTERNATIONAL INC

18855 I

IV

10/7/2005

FONA INTERNATIONAL INC

18856 I

IV

10/7/2005

FONA INTERNATIONAL INC

884.616 N-C ORANGE FLAVOR, NATURAL & ARTIFICIAL AS MANUFACTURED IN CAROL


STREAM, IL.
827.158 W.S. NATURAL & ARTIFICIAL HOT CINNAMON FLAVOR AS MANUFACTURED IN CAROL
STREAM, IL.
857.078 GRAPEFRUIT FLAVOR, NATURAL WONF AS MANUFACTURED IN CAROL STREAM, IL.

18857 A

II

10/11/2005

DR REDDYS LABORATORIES LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18858 A

III

9/15/2005

STYROLUTION EUROPE GMBH

NOVODUR R HD-15, VARIOUS COLORS AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

18859 A

III

10/4/2005

POLYONE CORP

CC0003828160 15060 WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

18860 A

III

10/4/2005

POLYONE CORP

CC10075392WE WHITE #05-089 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

18861 I

III

10/4/2005

MEDRAD INC

18862 A

II

10/5/2005

POLYCARBON INDUSTRIES INC

18863 A

IV

10/11/2005

AEGIS THERAPEUTICS LLC

READY TO FILL SYRINGE FLS-I AS MANUFACTURED IN NEUMUNSTER, FEDERAL REPUBLIC OF


GERMANY FOR MEDRAD INC
PCI-PT6033 PODOPHYLLOTOXIN (NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN DEVENS, MA.
INTRAVAIL (R) FUNCTIONAL EXCIPIENT

18864 A

II

10/12/2005

DR REDDYS LABORATORIES LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18865 A

II

10/14/2005

MYLAN LABORATORIES LTD

PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN TELANGANA, INDIA.

18866 A

II

10/14/2005

MYLAN LABORATORIES LTD

CLARITHROMYCIN USP (CLP) AS MANUFACTURED IN TELANGANA, INDIA.

18867 A

II

10/14/2005

MYLAN LABORATORIES LTD

OLANZAPINE AS MANUFACTURED IN TELANGANA, INDIA.

18868 A

II

10/14/2005

JUBILANT GENERICS LTD

AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN KARNATAKA, INDIA.

18869 A

II

10/14/2005

MYLAN LABORATORIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN TELANGANA, INDIA.

18870 A

III

10/5/2005

KLASSPACK PVT LTD

NEUTRAL GLASS AMPOULES AS MANUFACTURED IN MAHARASHTRA, INDIA.

18871 A

III

10/5/2005

KLASSPACK PVT LTD

NEUTRAL GLASS TUBULAR VIALS AS MANUFACTURED IN MAHARASHTRA, INDIA.

A-4389-99 ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA


AND ADHESIVES RESEARCH IRELAND LIMITED IN LIMERICK, IRELAND.
3-FORMYL-5-METHOXYINDOLE INTERMEDIATE AS MANUFACTURED IN PITHIVIERS, FRANCE.

Page 545

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18872 I
II
10/11/2005
SYNTHON BV
18873 A

III

10/11/2005

CLARIANT MASTERBATCHES NORDEN AB

SUBJECT
AMLODIPINE BESYLATE MONOHYDRATE AS MANUFACTURED BY SYNTHON ARGENTINA SA IN
PROVINCIA DE SANTA FE, ARGENTINA FOR SYNTHON BV.
PEZ340155X REMAFIN(R) - RED AS MANUFACTURED IN MALMO,SWEDEN.

18874 A

III

10/4/2005

POLIMERI EUROPA FRANCE SNC

FLEXIRENE MS20 AS MANUFACTURED IN MARDYCK, FRANCE.

18875 A

IV

9/22/2005

RELIANCE CELLULOSE PRODUCTS LTD

CROSCARMELLOSE SODIUM USP AS MFG IN A.P. INDIA

18876 I

II

10/14/2005

ELAN DRUG DELIVERY INC

18877 A

II

10/14/2005

NINGBO SMART PHARMACEUTICAL CO LTD

N1515 NANOCRYSTAL(R) COLLOIDAL DISPERSION AS MANUFACTURED IN KING OF PRUSSIA,


PA.
DICLOFENAC SODIUM AS MANUFACTURED IN NINGBO, CHINA.

18878 A

II

10/14/2005

AMINO CHEMICALS LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA.

18879 I

III

10/16/2006

RKW AG RHEINISCHE KUNSTSTOFFWERKE

POLYETHYLENE-FILM K460/50 AS MANUFACTURED IN PETERSAURACH, GERMANY

18880 I

IV

10/15/2005

DURECT CORP

18881 A

IV

10/15/2005

DURECT CORP

18882 A

10/3/2005

ABBOTT VASCULAR INC

CELLULOSE ACETATE BUTYRATE (CAB)-381-20BP, ETHANOL WASHED AS MANUFACTURED IN


PELHAM, AL.
PHARMACEUTICAL GRADE SAIB (SUCROSE ACETATE ISOBUTYRATE) AS MANUFACTURED IN
VACAVILLE, CA.
CLINICAL AND NON-CLINICAL STUDIESFOR ABT-578 (ZOTAROLIMUS)

18883 A

II

10/18/2005

QILU TIANHE PHARMACEUTICAL CO LTD

18884 I

III

10/14/2005

GERRESHEIMER REGENSBURG GMBH

TAZOBACTAM ACID (INTERMEDIATE, NON-STERILE BULK) AS MANUFACTURED IN SHANDONG


PROVINCE, CHINA.
HANDIHALER(R) DEVICE AS MANUFACTURED BY WILDEN PLASTICS (USA) LP IN PEACHTREE
CITY, GA AND WILDEN AG MEDICAL PLASTIC SYSTEMS IN PFREIMD, FEDERAL REPUBLIC OF
GERMANY.

18885 I

II

10/1/2005

AUROBINDO PHARMA LTD

CEFUROXIME SODIUM (STERILE) USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18886 A

II

10/18/2005

TETRAHYDROCANNABINOL (THC) IN ETHANOL AS MANUFACTURED IN WEST DEPTFORD, NJ.

18887 A

II

10/14/2005

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
WANBURY LTD

18888 A

II

10/14/2005

WANBURY LTD

18889 I

II

10/17/2005

ZAMBON S A

18890 A

II

10/19/2005

18891 A

II

10/20/2005

ZHEJIANG MEDICINE CO LTD XINCHANG


PHARMACEUTICAL FACTORY
YAKULT HONSHA CO LTD

VANCOMYCIN HYDROCHLORIDE USP (NON-STERILE API) AS MANUFACTURED IN ZHEJIANG


PROVINCE, CHINA.
TOTAL SYNTHESIS OF TSN-38B-11 INTERMEDIATE COMPOUND USED IN THE MANUFACTURE
OF IRINOTECAN HYDROCHLORIDE TRIHYRATE (CPT-11) DRUG SUBSTANCE AS
MANUFACTURED IN GIFU, JAPAN FOR YAKULT HONSHA CO LTD

18892 A

II

10/21/2005

NEULAND LABORATORIES LTD

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN TELANGANA, INDIA.

18893 A

II

10/21/2005

CHATTEM CHEMICALS INC

BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN CHATTANOOGA, TN.

18894 A

II

10/21/2005

SIGNA SA DE CV

BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN TOLUCA, MEXICO.

18895 A

IV

10/21/2005

GATTEFOSSE SAS

CAPRYOL(R) 90 AND CAPRYOL(R) PGMC AS MANUFACTURED IN SAINT PRIEST, FRANCE.

18896 I

II

10/17/2005

THEOPHYLLINE SODIUM GLYCINATE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

18897 I

II

10/24/2005

STANDARD CHEMICAL AND PHARMACEUTICAL CO


LTD
DAIICHI SANKYO CO.LTD

18898 I

II

10/8/2005

AXITEC CO LTD

18899 A

II

10/21/2005

NOVUS FINE CHEMICALS LLC

18900 I

IV

10/21/2005

FERRO PFANSTIEHL INC

AMIFOSTINE USP (NON-STERILE BULK DRUG) AS MANUFACTURED IN GUANGDONG


PROVINCE, CHINA.
PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED BY NOVUS FINE CHEMICALS LLC IN
CARLSTADT, NJ AND MALLADI DRUGS & PHARMACEUTICALS LTD IN TAMIL NADU, INDIA.
A,A-TREHALOSE DIHYDRATE, HIGH PURITY(LOW ENDOTOXIN) MULTIPLE COMPENDIAL (T-1041-MC) AS MANUFACTURED IN WAUKEGAN, IL.

METFORMIN HYDROCHLORIDE DC GRADE - 90% AS MANUFACTURED IN MAHARASHTRA,


INDIA.
METFORMIN HYDROCHLORIDE DC GRADE - 95% AS MANUFACTURED IN MAHARASHTRA,
INDIA.
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

DZ-697B DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

Page 546

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
18901 I
II
10/24/2005
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFPROZIL (PROCESS-2) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.
18902 A

II

10/24/2005

18903 A

II

10/25/2005

18904 A

II

9/21/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFEPIME HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM
DISTRICT, INDIA.
SANDOZ INDUSTRIAL PRODUCTS SA
PIPERACILLIN SODIUM & TAZOBACTAM SODIUM (8:1), STERILE AS MANUFACTURED IN
BARCELONA, SPAIN.
CHENG FONG CHEMICAL CO LTD
MEFENAMIC ACID AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN R.O.C.

18905 I

III

10/24/2005

PET POWER BV

18906 I

II

10/24/2005

RANBAXY LABORATORIES LTD

18907 A

III

10/14/2005

MEDRAD INC

18908 A

II

10/24/2005

CONCORD BIOTECH LTD

READY TO FILL SYRINGE FLS-2 AS MANUFACTURED IN NEUMUNSTER, GERMANY FOR


MEDRAD INC
TACROLIMUS MONOHYDRATE AS MANUFACTURED IN AHMEDABAD, INDIA.

18909 I

II

10/27/2005

SANDOZ INDUSTRIAL PRODUCTS SA

ERYTHROMYCIN A (E)-9-OXIME AS MANUFACTURED IN BARCELONA, SPAIN.

18910 A

II

10/26/2005

FARMABIOS S P A

BUDESONIDE PH. EUR. (MICRONIZED) AS MANUFACTURED IN PAVIA, ITALY.

18911 A

II

10/11/2005

PHF SA

FLUVASTATIN SODIUM HYDRATE AS MANUFACTURED IN QUEBEC, CANADA FOR PHF SA.

18912 A

IV

10/24/2005

NITIKA PHARMACEUTICAL SPECIALITIES

MAGNESIUM STEARATE USP AS MANUFACTURED IN NAGPUR, INDIA.

18913 I

III

10/26/2005

FEDERAL PACKAGE NETWORK INC

18914 I

III

10/28/2005

AIRSEC SA

NO.750 LIGHTWEIGHT PROPEL/REPEL STICK AS MANUFACTURED IN ROGERS AND CHASKA,


MN.
DESICCANT POLYMER PLATE AS MANUFACTURED IN ROMORANTIN, FRANCE.

18915 A

II

11/29/2005

JANSSEN PHARMACEUTICA NV

18916 A

III

10/25/2005

BORMIOLI ROCCO SPA BU PLASTICS

18917 A

III

10/5/2005

BHAVIN CONTAINERS PRIVATE LTD

18918 A

III

10/26/2005

LOPAREX LLC

18919 A

III

10/14/2005

RELIANCE INDUSTRIES LTD

18920 A

III

12/9/2005

RELIANCE INDUSTRIES LTD

18921 A

II

10/24/2005

AUROBINDO PHARMA LTD

ALUMINIUM COLLAPSIBLE TUBES SUITABLE FOR PACKAGING PHARMACEUTICAL DASAGES


AS MANUFACTURED IN DADRA & NAGAR HAVELI, INDIA.
GRADE 27455 D 67# WH PET 2300A/000 C AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC;
DIXON, IL AND CULLMAN, AL.
POLYVINYL CHLORIDE (PVC) RAW MATERIAL GRADE REON 60-11 AS MANUFACTURED IN
GUJARAT, INDIA.
POLYVINYLCHLORIDE (PVC) RAW MATERIAL GRADE REON 57-11 RAW MATERIAL AS
MANUFACTURED IN GUJARAT, INDIA.
MELOXICAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18922 A

II

10/27/2005

CHEMI SPA

CHE001-05 AS MANUFACTURED IN FROSINONE AND MILAN, ITALY.

18923 A

II

10/31/2005

18924 A

III

10/31/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFEPIME & ARGININE (STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT,
INDIA.
NOVA CHEMICALS CORP
SCLAIR(R) FP120-DD AS MANUFACTURED IN ALBERTA, CANADA.

18925 A

IV

11/1/2005

SEPPIC SA

18926 N

PET BOTTLES & CONTAINERS FOR PHARMA AND FOOD APPLICATIONS AS MANUFACTURED
IN ETTEN-LEUR, THE NETHERLANDS.
SERTRALINE HYDROCHLORIDE DRUG SUBTANCE AS MANUFACTURED IN PUNJAB, INDIA.

PALIPERIDONE (R076477) DRUG SUBSTANCE MANUFACTURED IN B-2400 GEEL, BELGIUM AND


CO.CORK, IRELAND
HDPE BOTTLE 60 ML AS MANUFACTURED IN SAINT SULPICE, FRANCE.

SEPINEO SE 68

NOT AN ASSIGNED NUMBER

18927 A

II

10/31/2005

TORAY INDUSTRIES INC

NALFURAFINE (TRK-820) DRUG SUBSTANCE AS MANUFACTURED IN SHIZUOKA, JAPAN.

18928 I

II

11/1/2005

REGENT BIO SCIENCE AND TECHNOLOGY CO LTD

SODIUM CHONDROITIN SULFATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

18929 A

II

11/2/2005

INTERQUIM SA

CICLOPIROX USP AS MANUFACTURED IN BARCELONA, SPAIN.

18930 I

II

10/27/2005

ARCH PHARMALABS LTD

CLOPIDOGREL BISULFATE (USP - XXVIII) AS MANUFACTURED IN MAHARASHTRA, INDIA.

18931 I

II

11/4/2005

CIPLA LTD

ROSIGLITAZONE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

18932 A

II

9/6/2005

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD

CYCLOSPORINE (NON-STERILE BULK FORM) AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA.

Page 547

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18933 A
III
11/3/2005
VETTER PHARMA FERTIGUNG GMBH AND CO KG

SUBJECT
V-LK(R) S-CARTRIDGE SYSTEM AS MANUFACTURED IN LANGENARGEN, GERMANY.

18934 I

II

11/4/2005

RANBAXY LABORATORIES LTD

TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN PUNJAB, INDIA.

18935 I

II

11/2/2005

MALLINCKRODT INC

18936 A

II

11/7/2005

LEK PHARMACEUTICALS DD

SODIUM PHOSPHATE, MONOBASIC MONOHYDRATE USP AS MANUFACTURED IN


PHILLIPSBURG, NJ.
MYCOPHENOLATE MOFETIL (ACTIVE SUBSTANCE) AS MANUFACTURED IN MENGES,
SLOVENIA.

18937 N

NOT AN ASSIGNED NUMBER

18938 I

III

11/7/2005

KJ SPECIALTY PAPER CO LTD

18939 A

III

11/7/2005

KJ SPECIALTY PAPER CO LTD

18940 I

II

10/25/2005

OLON SPA

18941 A

II

10/31/2005

AUROBINDO PHARMA LTD

MEDICAL BACKING MATERIALS (2 TYPES) OF PET FILM AND UNWOVEN CLOTH LAMINATED
WITH A VINYL ACETATE-SERIES ADHESIVE AS MANUFACTURED IN SHIZUOKA, JAPAN
MEDICAL BACKING MATERIALS (5 TYPES) OF PET FILM AND UNWOVEN CLOTH LAMINATED
WITH A POLYESTER ADHESIVE AS MANUFACTURED IN SHIZUOKA, JAPAN.
VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GARBAGNATE
MILANESE, ITALY.
CEFPODOXIME PROXETIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18942 A

II

11/8/2005

HALYARD HEALTH

[14C]-UREA, USP (PYTEST DRUG SUBSTANCE) AS MANUFACTURED IN LENEXA, KS.

18943 A

II

11/8/2005

ORCHID CHEMICALS AND PHARMACEUTICALS LTD TRANS RESVERATROL AS MANUFACTURED IN MAHARASHTRA, INDIA.

18944 I

II

11/9/2005

HENAN LIHUA PHARMACEUTICAL CO LTD

HYDROCORTISONE AS MANUFACTURED IN HENAN, CHINA.

18945 A

III

11/4/2005

POLYONE CORP

CC00002580WE 10037533 BURGUNDY AS MANUFACTURED IN ELK GROVE, IL.

18946 I

III

11/8/2005

POLIMOON MEDICAL PACKAGING AS

30 ML CONTAINER AS MANUFACTURED IN LANGESKOV, DENMARK.

18947 A

II

11/8/2005

ROLABO OUTSOURCING SL

TRANDOLAPRIL AS MANUFACTURED IN ZARAGOZA, SPAIN.

18948 A

II

11/9/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

18949 A

II

11/9/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

FEXOFENADINE BASE AS MANUFACTURED IN NETANYA, ISRAEL AND SETTIMO MILANESE MI


AND VILLANTERIO PV, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED BY PLANTEX LTD. CHEMICAL
INDUSTRIES AND ABIC LTD IN NETANYA, ISRAEL AND ASSIA CHEMICAL INDUSTRIES LTD IN
BE'ER SHEVA, ISRAEL.

18950 I

II

11/10/2005

PHARMACEUTICAL WORKS POLPHARMA SA

ENALAPRIL MALEATE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

18951 I

II

11/11/2005

SUMITOMO CHEMICAL CO LTD

18952 A

II

11/11/2005

CADILA HEALTHCARE LTD

PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES) AS MANUFACTURED


IN GIFU PREFECTURE, JAPAN.
ZIPRASIDONE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA.

18953 I

III

11/15/2005

MITSUI CHEMICALS AMERICA INC

ADMER(R) SF731 AS MANUFACTURED IN CHIBA, JAPAN FOR MITSUI CHEMICALS AMERICA INC

18954 I

II

11/14/2005

CILAG AG

18955 A

II

11/8/2005

SYN TECH CHEM AND PHARM CO LTD

FOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT) AS


MANUFACTURED IN SCHAUFFHAUSEN, SWITZERLAND.
PHENYLTOLOXAMINE CITRATE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

18956 A

II

1/5/2006

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

METHYLPREDNISOLONE ACETATE (BULK) USP AS MANUFACTURED IN TIANJIN, CHINA.

18957 A

II

11/9/2005

FIS FABBRICA ITALIANA SINTETICI SPA

ENAMINE AMIDE (FIS0448) AS MANUFACTURED IN VICENZA, ITALY.

18958 A

II

11/2/2005

LONZA AG

EC-037 AS MANUFACTURED IN VISP, SWITZERLAND.

18959 A

II

11/9/2005

CHANGZHOU PHARMACEUTICAL FACTORY

DOXYCYCLINE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

18960 A

II

11/17/2005

TARO PHARMACEUTICAL INDUSTRIES LTD

LAMOTRIGINE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

18961 I

II

11/17/2005

BIOCRYST PHARMACEUTICALS INC

18962 A

II

11/18/2005

SMS PHARMACEUTICALS LTD

PERAMIVIR DRUG SUBSTANCE AS MANUFACTURED BY CILAG AG IN SCHAFFHAUSEN,


SWITZERLAND.
ALMOTRIPTAN MALATE AS MANUFACTURED IN TELANGANA, INDIA.

18963 A

II

11/18/2005

BCN PEPTIDES SA

TETRACOSACTIDE AS MANUFACTURED IN BARCELONA, SPAIN.

Page 548

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18964 A
II
11/18/2005
PISGAH LABS INC
18965 A

II

11/9/2005

AUROBINDO PHARMA LTD

SUBJECT
ZOLEDRONIC ACID MONOHYDRATE (ACTIVE PHARMACEUTICAL INGREDIENT) AS
MANUFACTURED IN PISGAH FOREST, NC.
AMLODIPINE BESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18966 A

III

11/21/2005

IWATA LABEL CO LTD

SHRINKTACK LABEL AS MANUFACTURED IN AICHI AND TOCHIGI PREFECTURES, JAPAN.

18967 A

II

11/22/2005

JUBILANT GENERICS LTD

VALSARTAN AS MANUFACTURED IN KARNATAKA, INDIA.

18968 A

III

11/16/2005

LPS INDUSTRIES INC

18969 I

II

10/30/2005

POLYMED THERAPEUTICS INC

18970 I

III

11/7/2005

NYPRO INC

18971 A

II

11/25/2005

DIVIS LABORATORIES LTD

LAMINATIONS VF42, VF43, VF45, VF48, VF49, VF15, VF16, VF54 AND VF60 AS MANUFACTURED
IN MOONACHIE, NJ.
IRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE AS
MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR POLYMED THERAPEUTICS INC
OCUMETER(R) PLUS VIAL AS MANUFACTURED BY NYPRO FRANCE IN FONTENAY SUR EURE,
FRANCE FOR NYPRO INC.
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18972 A

II

11/25/2005

RESOLUTION CHEMICALS LIMITED

18973 A

II

11/23/2005

AUROBINDO PHARMA LTD

CABERGOLINE DRUG SUBSTANCE AS MANUFACTURED IN HERTFORDSHIRE, UNITED


KINGDOM.
RIBAVIRIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18974 A

II

11/16/2005

AUROBINDO PHARMA LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

18975 I

II

11/28/2005

DSM NUTRITIONAL PRODUCTS LTD

5-FLUOROURACIL AS MANUFACTURED IN SISSELN, SWITZERLAND.

18976 I

II

4/8/2007

JIANGSU ZHONGDAN PHARMACEUTICAL CO LTD

NABUMETONE AS MANUFACTURED IN JIANGSU CHINA

18977 A

II

11/28/2005

ACS DOBFAR SPA

CEFOTETAN DISODIUM (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY.

18978 A

II

11/28/2005

GRANULES INDIA LTD

18979 A

II

11/18/2005

18980 A

II

11/23/2005

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
AUROBINDO PHARMA LTD

COMPRESSO PAP 90 CPL, ORAL (DIRECTLY COMPRESSIBLE GRANULES OF ACETAMINOPHEN


90%) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.
RITALINIC ACID AS MANUFACTURED IN ORIGGIO, ITALY.

18981 A

II

11/29/2005

DERIVADOS QUIMICOS SAU

BUTOCONAZOLE NITRATE AS MANUFACTURED IN MURCIA, SPAIN FOR MEDIOLAST SPA

18982 I

II

11/28/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN ZAGREB, CROATIA.

18983 I

II

11/28/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ZAGREB, CROATIA.

18984 A

II

11/24/2005

QUIMICA SINTETICA SA

MELOXICAM AS MANUFACTURED IN MADRID, SPAIN.

18985 A

II

11/28/2005

TACROLIMUS AS MANUFACTURED IN TAIPEI, TAIWAN R.O.C.

18986 A

II

8/4/2005

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
CADILA PHARMACEUTICALS LTD

18987 A

II

11/30/2005

CATALENT PHARMA SOLUTIONS LLC

SANDIMMUNE 25 MG AND 100 MG SOFTGELS AS MANUFACTURED IN ST. PETERSBURG, FL.

18988 A

II

11/28/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

METHYLERGONOVINE MALEATE USP AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

18989 I

II

11/28/2005

IVAX PHARMACEUTICALS SRO

MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

18990 A

II

11/30/2005

DAINIPPON SUMITOMO PHARMA CO LTD

SM-5887 (AMRUBICIN HYDROCHLORIDE) AS MANUFACTURED IN TSURUSAKI, JAPAN.

18991 I

II

11/30/2005

SUMITOMO CHEMICAL CO LTD

18992 I

II

12/2/2005

BELCHER PHARMACEUTICALS INC

18993 A

III

12/2/2005

JSR LIFE SCIENCES CORP.

18994 A

II

12/2/2005

VALEANT INTERNATIONAL BERMUDA

18995 A

II

11/28/2005

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES) AS MANUFACTURED


IN OKAYAMA PREFECTURE, JAPAN.
OMEPRAZOLE PELLETS (8.5% W/W) AS MANUFACTURED BY MURLI KRISHNA PHARMA PVT
LTD IN MAHARASHTRA, INDIA.
STYRENE ISOPRENE BLOCK COPOLYMER (JSR SIS5002), STYRENIC THERMOPLASTIC
ELASTOMERS AS MANUFACTURED IN IBARAKI, JAPAN, FOR JSR CORP
METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETS AS MANUFACTURED IN STEINBACH,
MANITOBA, CANADA FOR VALEANT INTERNATIONAL BERMUDA
ISOFLURANE (NON-STERILE BULK) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA.

FLUOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT, INDIA.

Page 549

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
18996 I
II
12/1/2005
EURAND INC

SUBJECT
EUR-1038 MODIFIED RELEASE CAPSULES AS MANUFACTURED IN VANDALIA, OH.

18997 A

II

11/25/2005

NIACET BV

CALCIUM ACETATE AS MANUFACTURED IN PAPESTEEG, THE NETHERLANDS.

18998 A

II

11/30/2005

LABORATORIO CHIMICO INTERNAZIONALE SPA

ALPHA LIPOIC ACID AS MANUFACTURED IN MILANO, ITALY.

18999 A

IV

11/28/2005

COGNIS GMBH

PLANTACARE 2000 UP AS MANUFACTURED IN DUSSELDORF, GERMANY.

19000 A

II

12/4/2005

DIVIS LABORATORIES LTD

GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19001 A

II

12/5/2005

KYOWA HAKKO BIO CO LTD

D-SERINE (BULK SUBSTANCE) AS MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN.

19002 A

II

12/5/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

DEXRAZOXANE (ICRF-187) AS MANUFACTURED IN MILANO, ITALY.

19003 I

II

11/11/2005

GE HEALTHCARE BIO SCIENCES CORP

BF-1400 FILM CELLBAG(R) AS MANUFACTURED IN SOMERSET, NJ.

19004 A

III

12/6/2005

EMS CHEMIE NORTH AMERICA INC

19005 I

II

12/7/2005

TEVA PHARMACEUTICALS INDUSTRIES LTD

19006 A

II

11/28/2005

R L FINE CHEM

GRIVORY G21 NATURAL AS MANUFACTURED BY EMS-CHEMIE AG IN DOMAT/EMS,


SWITZERLAND IN EMS-CHEMIE (NORTH AMERICA) INC.
ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD
IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
LORAZEPAM AS MANUFACTURED IN KARNATAKA, INDIA.

19007 I

II

12/5/2005

CHANGZHOU QIANHONG BIO PHARMA CO LTD

HEPARIN SODIUM USP AS MANUFACTURED IN JIANGSU, CHINA.

19008 A

II

12/2/2005

RELIABLE BIOPHARMACEUTICAL CORP

PROTAMINE SULFATE USP AS MANUFACTURED IN ST. LOUIS, MO.

19009 A

II

12/5/2005

PERRIGO API LTD

IMIQUIMOD AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

19010 I

II

12/7/2005

RANBAXY LABORATORIES LTD

REPAGLINIDE USP AS MANUFACTURED IN PUNJAB, INDIA.

19011 I

II

12/7/2005

RANBAXY LABORATORIES LTD

CEFDITOREN PIVOXIL DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA.

19012 I

II

12/7/2005

RANBAXY LABORATORIES LTD

19013 A

II

11/28/2005

AUROBINDO PHARMA LTD

CEFDITOREN SODIUM INTERMEDIATE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB,


INDIA.
BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19014 A

II

12/8/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19015 A

II

12/13/2005

GADOR SA

ZALEPLON AS MANUFACTURED IN PROVINCIA DE BUENOS AIRES, ARGENTINA.

19016 I

II

12/6/2005

INTERNATIONAL MEDICATION SYSTEMS LTD

SODIUM NITRITE INJECTION USP, 30 MG / ML, 10 ML AS MANUFACTURED IN S. EL MONTE, CA.

19017 A

II

11/21/2005

SI GROUP

ALBE-TAB(TM) IBUPROFEN 90 (IBUPROFEN 90) AS MANUFACTURED IN ORANGEBURG, SC.

19018 I

II

12/6/2005

LABORATOIRES FOURNIER SA

19019 A

II

12/8/2005

HIKAL LTD

FENOFIBRATE SPRAY GRANULATION INTERMEDIATE AS MANUFACTURED IN FONTAINE-LESDIJON, FRANCE.


TRIPROLIDINE HYDROCHLORIDE API AS MANUFACTURED IN BANGALORE, INDIA.

19020 A

II

1/4/2006

UNIQUE CHEMICALS

DICLOFENAC DIETHYAMINE AS MANUFACTURED IN GUJARAT, INDIA.

19021 A

II

12/5/2005

SMRUTHI ORGANICS LTD

NORFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19022 A

II

12/9/2005

NOF CORP

DIERUCOYL PHOSPHATIDYLCHOLINE (DEPC) AS MANUFACTURED IN HYOGO, JAPAN.

19023 A

III

12/9/2005

3M DRUG DELIVERY SYSTEMS

MOMETASONE & FORMOTEROL COMBINATION PRODUCT PMDI ACTUATOR

19024 I

II

12/14/2005

ESTEVE QUIMICA SA

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN TARROGONA, SPAIN.

19025 A

II

12/13/2005

CAMBRIDGE MAJOR LABS INC

ANASTROZOLE FP-046 AS MANUFACTURED IN GERMANTOWN, WI.

19026 A

II

12/10/2005

AKSHAT PHARMA PRIVATE LTD

19027 I

III

12/5/2005

ROLLPRINT PACKAGING PRODUCTS INC

GLYCOPYRROLATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR AKSHAT


PHARMA PRIVATE LIMITED
RPP #36-1210 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT.

19028 A

II

12/13/2005

MICRONISIERUNGS KONTOR OBERROT GMBH

CICLESONIDE, MICRONIZED (ITEM NO. 37) AS MANUFACTURED IN OBERROT, GERMANY.

19029 I

II

12/9/2005

ALPHARMA APS

TOBRAMYCIN BASE USP (NON-STERILE BULK) AS MANUFACTURED

19030 I

II

12/9/2005

ALPHARMA APS

TOBRAMYCIN SULPHATE USP (NON-STERILE BULK) AS MANUFACTURED BY FUJIAN FUKANG


PHARMACEUTICALS CO LTD IN FUZHOU, CHINA.

Page 550

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19031 A
II
12/14/2005
HOSPIRA HEALTHCARE INDIA PVT LTD

SUBJECT
PIPERACILLIN AS MANUFACTURED IN MAHARASHTRA, INDIA.

19032 A

II

12/15/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

19033 A

II

12/15/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

19034 A

II

12/16/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

19035 A

II

12/13/2005

WANBURY LTD

LINEZOLID AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
LEVETIRACETAM AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD. IN BE'ER SHEVA,
ISRAEL.
ANASTROZOLE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO AND RHO, ITALY FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19036 A

II

12/17/2005

RANBAXY LABORATORIES LTD

ZOLPIDEM TARTRATE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA.

19037 A

II

12/9/2005

AUROBINDO PHARMA LTD

RITONAVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

19038 A

II

12/15/2005

RELIABLE BIOPHARMACEUTICAL CORP

DALTEPARIN SODIUM AS MANUFACTURED IN ST. LOUIS, MO.

19039 A

III

12/16/2005

NYPRO INC

19040 I

II

12/15/2005

DAINIPPON SUMITOMO PHARMA CO LTD

PROVENTIL(R) HFA (ALBUTEROL SULFATE) INHALATION AEROSOL ACTUATOR & DUST CAP AS
MANUFACTURED BY NYPRO IRELAND IN COUNTY DUBLIN, IRELAND.
SMP-028 AS MANUFACTURED IN OSAKA, JAPAN.

19041 I

II

12/16/2005

AVANTI POLAR LIPIDS INC

DSPE-PEG2000 MALEIMIDE AS MANUFACTURED IN ALABASTER, AL.

19042 A

IV

12/19/2005

NOF CORP

DSPE-PEG5000 AS MANUFACTURED IN KANAGAWA, JAPAN.

19043 A

II

12/1/2005

SECOND PHARMA CO LTD

AMLODIPINE BESILATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

19044 A

II

12/13/2005

CONCORD BIOTECH LTD

SIMVASTATIN USP AS MANUFACTURED IN AHMEDABAD, INDIA.

19045 A

II

12/19/2005

USV LIMITED

ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19046 A

II

11/30/2005

AUROBINDO PHARMA LTD

QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19047 A

II

12/22/2005

SUN PHARMACEUTICAL INDUSTRIES LTD

SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19048 A

II

12/16/2005

JUBILANT GENERICS LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA.

19049 A

II

12/21/2005

RANBAXY LABORATORIES LTD

GANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE) AS MANUFACTURED IN GUJARAT, INDIA.

19050 A

II

12/20/2005

PLIVA LACHEMA AS

19051 I

II

12/19/2005

RANBAXY LABORATORIES LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN BRNO, CZECH


REPUBLIC.
LEVETIRACETAM AS MANUFACTURED IN PUNJAB, INDIA.

19052 A

II

12/17/2005

MYTHEN SPA

DEFEROXAMINE MESYLATE NT AS MANUFACTURED IN CORANA, ITALY.

19053 A

II

12/19/2005

SCINOPHARM TAIWAN LTD

GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

19054 I

II

12/19/2005

BRIDGE ORGANICS CO

Z4124 FINAL INTERMEDIATE AS MANUFACTURED IN VICKSBURG, MI.

19055 I

III

12/6/2005

INDIAN PETROCHEMICAL CORP LTD

POLYETHYLENE (PE) INDOTHENE 22FA002 AS MANUFACTURED IN GUJARAT, INDIA.

19056 A

II

12/8/2005

ANHUI WANBEI PHARMACEUTICAL CO LTD

LINCOMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN ANHUI, CHINA.

19057 A

III

12/6/2005

TECHNOFLEX

19058 A

II

12/21/2005

APOTEX PHARMACHEM INDIA PVT LTD

CONTAINERS AND CLOSURE SYSTEM FOR INJECTABLE SOLUTION AND DRUGS AS


MANUFACTURED IN BIDART, FRANCE.
ENALAPRIL MALEATE USP AS MANUFACTURED IN BANGALORE, INDIA

19059 I

III

12/22/2005

SYNTHETIC RUBBER TECHNOLOGIES INC

RUBBER AND POLYMERIC COMPOUNDS

19060 A

II

12/21/2005

RANBAXY LABORATORIES LTD

19061 I

II

12/22/2005

INTRALYTIX INC

19062 A

II

12/19/2005

SOFRADIM PRODUCTION

VALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN MADHYA


PRADESH, INDIA.
WPP-201, A BACTERIOPHAGE COCKTAIL FOR P. AERUGINOSA, S. AUREUS, AND E. COLI AS
MANUFACTURED IN BALTIMORE, MD.
PORCINE ATELOCOLLAGEN CPP AS MANUFACTURED IN TREVOUX, FRANCE.

19063 A

II

12/23/2005

EUTICALS INC

METHYLPHENIDATE HYDROCHLORIDE USP AS MANUFACTURED IN SPRINGFIELD, MO.

19064 I

II

12/20/2005

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

CALCIUM POLYCARBOPHIL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

Page 551

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19065 A
III
12/22/2005
BIRGI SANAYI AS
19066 A

III

12/22/2005

BIRGI SANAYI AS

19067 A

III

12/22/2005

BIRGI SANAYI AS

19068 A

III

12/22/2005

BIRGI SANAYI AS

19069 A

II

12/14/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

19070 A

II

12/24/2005

APICORE US LLC

SUBJECT
1-30 ML COLOURLESS AMPOULES FOR INJECTABLES MADE OF TUBULAR GLASS AS
MANUFACTURED IN ISTANBUL, TURKEY.
1-30 ML AMBER AMPOULES FOR INJECTABLES MADE OF TUBULAR GLASS AS
MANUFACTURED IN ISTANBUL, TURKEY.
2-30 ML COLOURLESS INJECTION VIALS MADE OF TUBULAR GLASS AS MANUFACTURED IN
ISTANBUL, TURKEY.
2-30 ML AMBER INJECTION VIALS MADE OF TUBULAR GLASS AS MANUFACTURED IN
ISTANBUL, TURKEY.
ACARBOSE (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN
ZHEJIANG PROVINCE, CHINA.
GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN SOMERSET, NJ.

19071 A

II

12/19/2005

AUROBINDO PHARMA LTD

ONDANSETRON HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19072

II

12/22/2005

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

19073 A

II

12/21/2005

3M PURIFICATION INC

TACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN


ZHEJIANG PROVINCE, CHINA.
BIOASSURE(TM) FILTER PRODUCTS AS MANUFACTURED IN MERIDEN, CT.

19074 I

II

12/21/2005

CUNO INC

BIOLIFE(TM) FILTER PRODUCTS AS MANUFACTURED IN MERIDEN, CT.

19075 A

II

12/27/2005

VIVIMED LABS LTD

TRICLOSAN USP AS MANUFACTURED IN KARNATAKA, INDIA.

19076 I

II

12/28/2005

RANBAXY LABORATORIES LTD

CILOSTAZOL DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA.

19077 A

III

12/22/2005

POLYONE CORP

CC00018519DR COLORANT PRODUCT AS MANUFACTURED IN GLENDALE, AZ.

19078 A

II

12/15/2005

19079 A

II

12/30/2005

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
SIGMA ALDRICH MANUFACTURING LLC

GRANISETRON HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE AS


MANUFACTURED IN WUHAN, CHINA.
N-DODECYL B-D-MALTOSIDE AS MANUFACTURED IN ST. LOUIS, MO.

19080 A

II

12/30/2005

LUPIN LTD

LEVETIRACETAM AS MANUFACTURED IN MAHARASHTRA, INDIA.

19081 I

II

1/3/2006

NV ORGANON

FENTANYL CITRATE AS MANUFACTURED IN APELDOORN, THE NETHERLANDS.

19082 A

II

12/16/2005

FINE ORGANICS LTD

KETAMINE HYDROCHLORIDE AS MANUFACTURED IN MIDDLESBROUGH, UNITED KINGDOM.

19083 A

II

12/27/2005

LUPIN LTD

DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19084 A

II

12/30/2005

NAVINTA LLC

19085 A

II

1/4/2006

TRIFARMA SPA

ROPIVACAINE HYDROCHLORIDE FOR INJECTION AS MANUFACTURED IN ANDHRA PRADESH,


INDIA FOR NAVINTA LLC
FOSCARNET SODIUM HEXAHYDRATE AS MANUFACTURED IN MILANO, ITALY.

19086 A

III

1/2/2006

HINDALCO INDUSTRIES LTD KOLLUR WORKS

STRIP PACKAGING ALUMINIUM FOIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19087 A

III

1/2/2006

HINDALCO INDUSTRIES LTD KOLLUR WORKS

BLISTER PACKAGING ALUMINIUM FOIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19088 A

II

12/24/2005

AUROBINDO PHARMA LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19089 I

II

1/3/2006

BASF SE

TAZAROTENE AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

19090 A

II

12/20/2005

TEVA PHARMACEUTICAL INDUSTRIES LTD

ERGONOVINE MALEATE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC.

19091 I

II

12/20/2005

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

19092 A

II

1/6/2006

SUVEN LIFE SCIENCES LTD

SEVOFLURANE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE,


CHINA.
ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19093 A

II

1/6/2006

19094 I

II

1/3/2006

AMRI RENSSELAER INC SUB ALBANY MOLECULAR


RESEARCH INC
EXOPHARM COMPANY LTD

19095 A

II

1/6/2006

HETERO DRUGS LTD

VINORELBINE TARTRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


SHANGHAI PROVINCE, CHINA FOR EXOPHARM COMPANY LTD
PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19096 A

II

1/5/2006

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

TRIAMCINOLONE ACETONIDE (BULK) USP AS MANUFACTURED IN TIANJIN, CHINA.

19097 A

II

1/10/2006

MYLAN LABORATORIES LTD

SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

VORINOSTAT DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY.

Page 552

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19098 A
II
1/10/2006
MYLAN LABORATORIES LTD

SUBJECT
RIZATRIPTAN BENZOATE AS MANUFACTURED IN TELANGANA, INDIA.

19099 A

II

1/10/2006

EVONIK TECHNOCHEMIE GMBH

D-PENICILLAMINE AS MANUFACTURED IN HANAU, GERMANY.

19100 A

III

1/10/2006

3M DRUG DELIVERY SYSTEMS

COTRAN(TM) 9719 POLYETHYLENE FILM AS MANUFACTURED IN BROOKINGS, SD.

19101 A

III

1/10/2006

3M DRUG DELIVERY SYSTEMS

19102 A

IV

10/28/2005

EVONIK INDUSTRIES AG

19103 A

IV

10/28/2005

EVONIK INDUSTRIES AG

19104 I

II

1/10/2006

HIKAL LTD

SCOTCHPAK(TM) 9680, 2-MIL POLYESTER FILM LAMINATE AS MANUFACTURED IN COTTAGE


GROVE, MN AND DECATUR, AL FOR 3M DRUG DELIVERY SYSTEMS
RESOMER(R) R FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM,
GERMANY AND BLANQUEFORT, FRANCE.
RESOMER(R) RG FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM,
GERMANY AND BLANQUEFORT, FRANCE.
LEVETIRACETAM API AS MANUFACTURED IN BANGALORE, INDIA.

19105 A

II

12/31/2005

LUPIN LTD

ESCITALOPRAM OXALATE

19106 A

II

1/6/2006

AUROBINDO PHARMA LTD

CARVEDILOL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19107 I

II

1/16/2006

ELAN DRUG DELIVERY INC

19108 A

III

1/13/2006

19109 A

II

1/12/2006

SENAWANG LAMINATING TECHNOLOGIES SDN


BHD
MACFARLAN SMITH LTD

N1504 NANOCRYSTAL(R) COLLOIDAL DISPERSION - STERILE INTERMEDIATE AS


MANUFACTURED IN ATHLONE, IRELAND
SL5825A, CLEAR LAMINATE FOR MEDICAL PACKAGING AS MANUFACTURED IN NEGERI
SEMBILAN, MALAYSIA.
BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM.

19110 A

III

1/13/2006

NAIGAI GLASS INDUSTRY CO LTD

AMPOULE AND VIAL AS MANUFACTURED IN OSAKA, JAPAN.

19111 A

II

1/12/2006

YUNNAN HANDE BIO TECH CO LTD

19112 I

II

1/18/2006

N S CHEMICALS

PACLITAXEL DRUG SUBSTANCE ISOLATED FROM TAXUS CANADENSIS AS MANUFACTURED IN


KUNMING, CHINA.
PARA CHLORO META XYLENOL (PCMX), USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19113 A

II

1/18/2006

APOTEX PHARMACHEM INC

MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN ONTARIO, CANADA.

19114 A

II

12/23/2005

BIOIBERICA SA

19115 I

II

1/19/2006

NEULAND LABORATORIES LTD

CHONDROITIN SULFATE SODIUM SHARK INJECTABLE GRADE AS MANUFACTURED IN


BARCELONA, SPAIN.
FLUTICASONE PROPIONATE PH.EUR AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19116 A

III

12/15/2005

BASELL POLYOLEFINE ITALIA SRL

PURELL ACP 6541 A (POLYETHYLENE HIGH DENSITY) AS MANUFACTURED BY BISELL


POLYOLEFINE GMBH IN FRANKFURT AM MAIN AND MUENCHSMUENSTER, GERMANY FOR
BISELL POLYOLEFINE ITALIA SRL.

19117 I

II

1/19/2006

AREVIPHARMA GMBH

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY.

19118 A

III

1/20/2006

SHINKO CHEMICAL CO LTD

EYEDROP CONTAINER TYPE 6 AS MANUFACTURED IN ISHIKAWA, JAPAN.

19119 A

II

1/16/2006

MOEHS IBERICA SL

MICRONISED FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN.

19120 A

III

1/6/2006

AMPACET CORP

19121 A

III

1/6/2006

AMPACET CORP

19122 A

III

1/6/2006

AMPACET CORP

19123 A

III

1/6/2006

AMPACET CORP

19124 A

III

1/13/2006

KIRCHNER SIMON AND CO GMBH

100664-K RELEASY 64 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN RAYONG,


THAILAND.
100665-K RELEASY 65 POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN RAYONG,
THAILAND.
11447-K BLOMITE 47 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN RAYONG,
THAILAND.
11343-K PROMITE 43 POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN RAYONG,
THAILAND.
O28L89070 TAMPER EVIDENT CAP PP 28 WITH HOLE 5 MM MADE OF PP WHITE WITH TAMPER
EVIDENT RING MADE OF PP BLUE AND INJECTED JOINT MADE OF TPE AS MANUFACTURED IN
OESTRICH-WINKEL, GERMANY.

19125 A

III

1/13/2006

KIRCHNER SIMON AND CO GMBH

OV2889070 TAMPER EVIDENT CAP PP 28 MADE OF PP WHITE WITH TAMPER EVIDENT RING
MADE OF PP BLUE AND INJECTED JOINT MADE OF TPE AS MANUFACTURED IN OESTRICHWINKEL, GERMANY.

19126 A

II

1/23/2006

XIAN LIJUN PHARMACEUTICAL CO LTD

ERYTHROMYCIN THIOCYANATE AS MANUFACTURED IN SHAANXI, CHINA.

Page 553

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19127 I
IV
1/19/2006
ALBEMARLE CORP

SUBJECT
AZONE(R), AN INACTIVE INGREDIENT AS MANUFACTURED IN DAYTON, OH.

19128 A

II

1/24/2006

CYALUME SPECIALTY PRODUCTS INC

19129 A

II

1/25/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

CHLORHEXIDINE GLUCONATE 20% SOLUTION, USP AS MANUFACTURED IN BOUND BROOK,


NJ.
DONEPEZIL HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19130 I

III

1/13/2006

EXEMPLAR PHARMACEUTICALS LLC

HFA 134A PLACEBO AS MANUFACTURED IN FALL RIVER, MA.

19131 A

II

1/25/2006

CIPLA LTD

19132 I

II

1/26/2006

KATAYAMA SEIYAKUSYO CO LTD

LEVO SALBUTAMOL HYDROCHLORIDE/LEVALBUTEROL HYDROCHLORIDE, ACTIVE


PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN MAHARASHTRA, INDIA.
LOMEFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN TOYAMA, JAPAN.

19133 I

II

1/22/2006

WORLD JIANGSU INDUSTRY CO LTD

19134 I

II

1/22/2006

JIANGSU SUNNY HEALTH INDUSTRY CO LTD

19135 I

IV

1/26/2006

FONA INTERNATIONAL INC

BACITRACIN ZINC USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN FUJIANG,


CHINA.
GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
JIANGSU, CHINA.
833.051 N-C NATURAL & ARTIFICIAL COFFEE FLAVOR AS MANUFACTURED IN GENEVA, IL.

19136 I

IV

1/26/2006

FONA INTERNATIONAL INC

861.094 HONEY FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL.

19137 I

IV

1/26/2006

FONA INTERNATIONAL INC

857.080 NATURAL GRAPEFRUIT EXTRACT (WONF) AS MANUFACTURED IN GENEVA, IL.

19138 A

II

1/26/2006

EVONIK TECHNOCHEMIE GMBH

19139 A

II

1/25/2006

SCINOPHARM TAIWAN LTD

LISINOPRIL DIHYDRATE AS MANUFACTURED IN HANAU, GERMANY AND HAM, FRANCE FOR


DEGUSSA AG.
LETROZOLE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

19140 A

II

1/27/2006

NEKTAR THERAPEUTICS

PEG2MAL40K/B AS MANUFACTURED IN HUNTSVILLE, AL.

19141 A

II

1/31/2006

GLENMARK GENERICS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA.

19142 A

II

1/26/2006

CHENGDA PHARMACEUTICALS CO LTD

LEVOCARNITINE USP AS MANUFACTURED IN ZHEJIANG, CHINA.

19143 A

II

1/20/2006

WANBURY LTD

19144 A

IV

1/30/2006

NITTO DENKO CORP

19145 A

III

2/1/2006

BORMIOLI ROCCO AND FIGLIO SPA

GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR


WANBURY LTD
PHARMACEUTICAL ADHESIVE FOR TRANSDERMAL SYSTEM: AV-V SOLUTION AS
MANUFACTURED IN MIYAGI, JAPAN.
PET BOTTLE 100 ML-FI8095 AS MANUFACTURED IN SAINT SULPICE, FRANCE.

19146 A

III

2/1/2006

BORMIOLI ROCCO SPA BU PLASTICS

TAMPER EVIDENT CLOSURE 28 MM AS MANUFACTURED IN SAINT SULPICE, FRANCE.

19147 A

III

2/1/2006

BORMIOLI ROCCO SPA BU PLASTICA

19148 A

II

2/2/2006

AMINO CHEMICALS LTD

CHILD RESISTANT CLOSURE 28 MM: CHILD RESISTANT PLUS AS MANUFACTURED IN SAINT


SULPICE, FRANCE.
BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA.

19149 A

II

1/31/2006

ANQIU LUAN PHARMACEUTICAL CO LTD

ACETAMINOPHEN, DC 90% AS MANUFACTURED IN SHANDONG PROVINCE, CHINA.

19150 A

IV

2/3/2006

EVONIK DEGUSSA CORP

BIODEGRADABLE POLYMER EXCIPIENTS AS MANUFACTURED IN BIRMINGHAM, AL.

19151 A

II

2/3/2006

CAMBRIDGE MAJOR LABS INC

FP-059 (FOMEPIZOLE) DRUG SUBSTANCE AS MANUFACTURED IN GERMANTOWN, WI.

19152 A

II

1/30/2006

AUROBINDO PHARMA LTD

19153 A

II

1/30/2006

AUROBINDO PHARMA LTD

PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.
BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19154 I

III

1/31/2006

NYPRO INC

19155 A

II

1/19/2006

CADILA PHARMACEUTICALS LTD

19156 A

III

2/4/2006

P CHHOTALAL MANUFACTURERS EXPORTERS

PLASTIC BOTTLES (MADE OF HDPE, LDPE, MDPE & PP) ALUMINUM COLLAPSIBLE TUBES,
ALUMINUM AEROSOL CANS, ALUMINUM PHARMACEUTICAL FOIL AND POLYAL TAPE AS
MANUFACTURED IN DAMAN, INDIA.

19157 A

II

2/6/2006

NEKTAR THERAPEUTICS

PEG2NHS40KP/B (MODIFIED LYSINE) AS MANUFACTURED IN HUNTSVILLE, AL.

19158 I

II

2/3/2006

LIMTECH CARBONATE INC

LITHIUM CARBONATE, USP GRADE AS MANUFACTURED IN QUEBEC, CANADA.

CONTAINER CLOSURE SYSTEM OF THE DRY POWDER INHALER (DPI) AS MANUFACTURED IN


CLINTON, MA FOR NYPRO INC
CELECOXIB AS MANUFACTURED IN GUJARAT, INDIA.

Page 554

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19159 I
II
1/30/2006
CHONGQING UNITED PHARMACEUTICAL CO LTD

SUBJECT
PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA.

19160 A

II

2/2/2006

FERMION OY

19161 A

II

2/8/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

QUETIAPINE FUMARATE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN


ESPOO, FINLAND.
CARISOPRODOL USP (ACTIVE SUBSTANCE) AS MANUFACTURED IN GUJARAT, INDIA.

19162 A

II

2/8/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

CEPHALEXIN USP (ACTIVE SUBSTANCE) AS MANUFACTURED IN GUJARAT, INDIA.

19163 I

II

2/8/2006

NIPPON CHEMIPHAR CO LTD

19164 A

12/23/2005

EIRGENIX INC

19165 A

IV

10/20/2005

SASOL GERMANY GMBH

NC-2300 DRUG SUBSTANCE AS MANUFACTURED IN IWATE, JAPAN FOR NIPPON CHEMIPHAR


CO LTD
CGMP MANUFACTURING FACILITY FOR PRODUCTION OF BIOPHARMACEUTICALS FOR
CLINICAL TRIALS, TAIWAN R.O.C.
LIPOXOL(R) MED AS MANUFACTURED IN MARL, GERMANY.

19166 I

III

2/10/2006

GRAHAM PACKAGING CO LP

PLASTIC CONTAINERS AS MANUFACTURED IN HARRISONBURG, VA.

19167 A

II

2/8/2006

ACS DOBFAR SPA

ACID CEFOTETAN AS MANUFACTURED IN MILANO, ITALY.

19168 A

II

2/10/2006

CADILA HEALTHCARE LTD

OLANZAPINE AS MANUFACTURED IN GUJARAT, INDIA.

19169 A

II

2/9/2006

EXCELLA GMBH

ADAPALENE AS MANUFACTURED IN FEUCHT, GERMANY

19170 A

II

2/13/2006

CAMBRIDGE MAJOR LABS INC

LETROZOLE, USP AS MANUFACTURED IN GERMANTOWN, WI.

19171 A

II

3/15/2006

CARDIOME DEVELOPMENT AG

19172 I

IV

2/14/2006

FONA INTERNATIONAL INC

RSD1235 DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND FOR


CARDIOME PHARMA CORP.
805.124 N-C ARTIFICIAL BANANA FLAVOR AS MANUFACTURED IN GENEVA, IL.

19173 I

IV

2/14/2006

FONA INTERNATIONAL INC

936.420 MASKING AGENT FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL.

19174 I

IV

2/14/2006

FONA INTERNATIONAL INC

875.017 MENTHOL FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL.

19175 I

IV

2/14/2006

FONA INTERNATIONAL INC

915.010 N-C ARTIFICIAL FRESH STRAWBERRY FLAVOR AS MANUFACTURED IN GENEVA, IL.

19176 A

II

2/14/2006

ALCHYMARS ICM SM PRIVATE LTD

CLINDAMYCIN HYDROCHLORIDE, USP AS MANUFACTURED IN TAMIL NADU, INDIA.

19177 A

II

2/10/2006

CAMBREX KARLSKOGA AB

BUPIVACAINE BASE AS MANUFACTURED IN KARLSKOGA, SWEDEN.

19178 A

II

2/14/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA.

19179 A

II

2/14/2006

DR REDDYS LABORATORIES LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19180 I

II

8/7/2006

CIPLA LTD

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19181 A

II

3/9/2006

CIPLA LTD

FAMCICLOVIR AS MANUFACTURED IN MAHARASHTRA, INDIA.

19182 A

II

5/18/2006

CIPLA LTD

DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19183 A

II

2/17/2006

CIPLA LTD

LEVO SALBUTAMOL SULPHATE AS MANUFACTURED IN MAHARASHTRA INDIA

19184 A

IV

2/10/2006

BASF SE

19185 I

II

2/8/2006

EXOPHARM CO LTD

19186 A

II

1/31/2006

AUROBINDO PHARMA LTD

KOLLICOAT(R) PROTECT AS MANUFACTURED IN LUDWIGSHAFEN AND OFFENBURG,


GERMANY FOR BASF AKTIENGESELLSCHAFT.
IDARUBICIN HYDROCHLORIDE, USP NON-STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN SHANGHAI, CHINA FOR EXOPHARM CO LTD
RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19187 I

III

2/10/2006

FARMASERVICE SRL

SQUARE HDPE BOTTLE, 95 ML AS MANUFACTURED IN SERMONETA, ITALY.

19188 I

III

2/10/2006

FARMASERVICE SRL

SQUARE HDPE BOTTLE, 25 ML AS MANUFACTURED IN SERMONETA, ITALY.

19189 I

III

2/10/2006

FARMASERVICE SRL

SQUARE HDPE BOTTLE, 165 ML AS MANUFACTURED IN SERMONETA, ITALY.

19190 A

II

2/17/2006

WEIFA AS

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SANNIDAL, NORWAY.

19191 A

II

10/25/2005

19192 A

II

2/21/2006

JIANGXI HENGXIANG PHARMACEUTICAL


TECHNOLOGY CO LTD
DR REDDYS LABORATORIES LTD

ISOTRETINOIN (NON-STERILE BULK FORM) AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA.
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS FORM) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA.

Page 555

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19193 A
IV
2/15/2006
KERRY INGREDIENTS AND FLAVOURS

SUBJECT
NATURAL SPEARMINT FLAVOR WONF (080-00707) POWDER AS MANUFACTURED IN
CINCINNATI, OH.
HEPARIN SODIUM USP AS MANUFACTURED IN HEBEI, CHINA.

19194 I

II

2/21/2006

19195 A

II

2/23/2006

HEBEI CHANGSHAN BIOCHEMICAL &


PHARMACEUTICAL CO LTD
ARCH PHARMALABS LTD

19196 I

III

2/20/2006

BESPAK DIV CONSORT MEDICAL PLC

BK357933MTA PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK, U.K.

19197 I

II

2/21/2006

EXCELLA GMBH

19198 I

II

2/22/2006

PCAS

HALOPERIDOL DECANOATE AS MANUFACTURED IN FEUCHT, FEDERAL REPUBLIC OF


GERMANY.
ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND.

19199 A

III

2/23/2006

FPC FLEXIBLE PACKAGING CORP

19200 N

NOT AN ASSIGNED NUMBER

19201 N

NOT AN ASSIGNED NUMBER

MEFENAMIC ACID, USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

PHARMACEUTICAL POUCH - FPC SPECIFICATION 47515X AS MANUFACTURED IN ONTARIO,


CANADA.

19202 A

II

2/21/2006

MYLAN LABORATORIES LTD

FORMOTEROL FUMARATE DIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19203 A

II

2/14/2006

IND SWIFT LABORATORIES LTD

ARIPIPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA.

19204 A

III

2/6/2006

ANSA PRINTPACK PVT LTD

ALUMINIUM FOIL & PAPER LAMINATES -POLYLAMINATED & HEAT SEAL LACQUER (HSL)
COATED FOR PACKING TABLETS, CAPSULES AND OTHER SOLID DOSAGE FORMS AS
MANUFACTURED IN MAHARASHTRA, INDIA.

19205 I

II

2/24/2006

MDS NORDION

IODOFILTIC ACID I-123 STERILE INJECTION AS MANUFACTURED IN VANCOUVER, CANADA.

19206 I

2/16/2006

CATALENT PHARMA SOLUTIONS LLC

CARDINAL HEALTH'S STERILE MANUFACTURING FACILITIES IN SAN DIEGO, CA.

19207 A

II

2/28/2006

AUSTIN PHARMA LLC

DRONABINOL USP AS MANUFACTURED IN ROUND ROCK, TX.

19208 I

III

11/7/2005

HEINKE TECHNOLOGY INC

A MEASURING SPOON AS MANUFACTURED IN LINCOLN, NE.

19209 A

II

2/10/2006

19210 I

III

3/2/2006

SHANDONG WEIFANG PHARMACEUTICAL


FACTORY CO LTD
LG CHEM LTD

19211 I

II

2/27/2006

SYNTHON BV

HYDRALAZINE HYDROCHLORIDE (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS


MANUFACTURED IN SHANDONG PROVINCE, CHINA.
ABS PRODUCTS INTENDED FOR USE IN DRUG PACKAGING APPLICATIONS AS
MANUFACTURED IN SEOUL, KOREA.
ANASTROLZOLE AS MANUFACTURED IN PRAGUE, CZECH REPUBLIC FOR SYNTHON BV

19212 A

II

3/3/2006

NATCO PHARMA LTD

SUMATRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19213 I

II

2/23/2006

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

19214 I

II

3/2/2006

NARD CHEMICALS LTD

RIBAVIRIN (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN


ZHEJIANG, CHINA.
SON-216 API AS MANUFACTURED IN OSAKA, JAPAN.

19215 A

II

3/3/2006

NATCO PHARMA LTD

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19216 I

II

1/19/2006

CADILA PHARMACEUTICALS LTD

MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA.

19217 A

II

3/1/2006

19218 A

II

2/28/2006

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LOVASTATIN USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED
LTD
IN ZHEJIANG PROVINCE, CHINA.
LUPIN LTD
CARVEDILOL AS MANUFACTURED IN MAHARASHTRA, INDIA.

19219 N

NOT AN ASSIGNED NUMBER

19220 N

NOT AN ASSIGNED NUMBER

19221 A

IV

3/3/2006

YKF INC

19222 I

II

3/6/2006

TERUMO CORP

19223 A

II

2/18/2006

IND SWIFT LABORATORIES LTD

SYNTHETIC AMORPHOUS SILICA PRODUCTS - SYLYSIA / ADSOLIDER AS MANUFACTURED IN


AICHI, JAPAN.
IHL- 305 IRINOTECAN LIPOSOME INJECTION AS MANUFACTURED IN HYOGO, JAPAN FOR
TERUMO CORP
CLARITHROMYCIN SPECIAL AS MANUFACTURED IN PUNJAB, INDIA.

19224 A

II

3/3/2006

CADILA HEALTHCARE LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT, INDIA.

Page 556

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19225 A
II
3/4/2006
CADILA HEALTHCARE LTD
19226 A

II

2/28/2006

AUROBINDO PHARMA LTD

SUBJECT
CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA FOR PHARMADEV
LLC
AMPICILLIN TRIHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19227 A

II

2/28/2006

LUPIN LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE

19228 I

II

2/25/2006

IONS PHARMA

METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19229 I

II

3/3/2006

FLAMMA SPA

LANSOPRAZOLE AS MANUFACTURED IN BERGAMO, ITALY.

19230 I

3/13/2005

STERIS ISOMEDIX SERVICES

STERIS INC ISOMEDIX SERVICES FACILITY IN NOGALES, AZ.

19231 A

II

3/7/2006

CONCORD BIOTECH LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN AHMEDABAD, INDIA.

19232 I

III

2/24/2006

COGNIS DEUTSCHLAND GMBH CO KG

19233 I

III

2/24/2006

CHITINOR AS

19234 A

III

3/1/2006

POLYONE CORP

19235 A

9/23/2005

TERUMO BCT LTD

SPEZIOL G 86% PF AS MANUFACTURED BY COGNIS OLEOCHEMICALS IN DUSSELDOLF,


FEDERAL REPUBLIC OF GERMANY FOR COGNIS DEUTSCHLAND GMBH CO KG.
SPEZIOL G 99,8% PF AS MANUFACTURED IN DUSSELDOLF, FEDERAL REPUBLIC OF GERMANY
FOR COGNIS DEUTSCHLAND GMBH CO KG
CC10047660BG COLORANT PRODUCT AS MANUFACTURED IN NAVARRA, SPAIN FOR POLYONE
CORP
GAMBRO MANUFACTURING FACILITY IN ANTRIM, NORTHERN IRELAND.

19236 I

II

3/10/2006

CADILA HEALTHCARE LTD

GLYBURIDE AS MANUFACTURED IN GUJARAT, INDIA.

19237 A

II

3/8/2006

TORSEMIDE (MOD 1) BULK SUBSTANCE AS MANUFACTURED IN FRESONARA, ITALY.

19238 A

II

2/28/2006

BIOINDUSTRIA LABORATORIO ITALIANO


MEDICINALI SPA
AUROBINDO PHARMA LTD

19239 A

III

3/9/2006

COLORS FOR PLASTICS

19240 A

III

3/10/2006

TOYO INK MFG CO LTD

19241 I

III

12/19/2005

HEINKE TECHNOLOGY INC

THERMOPLASTIC RESIN COLORANT MASTERBATCHES E14070, E14071, AND W07769 AS


MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC.
MF357PTPHS VARNISH AND 790PTPOP VARNISH AS MANUFCATURED IN KAWAGOE-SHI
SAITAMA, JAPAN.
SKIN TAG (ACROCHORDON) REMOVAL DEVICE TAGNER AS MANUFACTURED IN LINCOLN, NE.

19242 A

II

3/8/2006

ALENDRONIC ACID MONOHYDRATE (ALC) AS MANUFACTURED IN CONSHOHOCKEN, PAN.

19243 A

II

3/7/2006

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
ERREGIERRE SPA

19244 A

IV

1/20/2006

CHITINOR AS

19245 A

IV

1/20/2006

CHITINOR AS

19246 A

IV

1/20/2006

CHITINOR AS

19247 A

II

3/4/2006

AUROBINDO PHARMA LTD

CHITOPHARM L AS MANUFACTURED IN TROMSOE, NORWAY FOR COGNIS DEUTSCHLAND


GMBH CO KG
CHITOPHARM M AS MANUFACTURED IN TROMSOE, NORWAY FOR COGNIS DEUTSCHLAND
GMBH CO KG
CHITOPHARM S AS MANUFACTURED IN TROMSOE, NORWAY FOR COGNIS DEUTSCHLAND
GMBH CO KG
TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19248 I

III

3/7/2006

MATRIX TOOL INC

19249 I

II

3/8/2006

OCEAN NUTRITION CANADA LTD

19250 A

II

3/10/2006

USV LIMITED

19251 A

II

3/16/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

PIOGLITAZONE HYDROCHLORIDE (EXTRA PURE) AS MANUFACTURED IN MAHARASHTRA,


INDIA
ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA.

19252 A

III

3/1/2006

KEY INTERNATIONAL INC

PVC/PVDC/PE LAMINATED FILM AS MANUFACTURED IN ENGLISHTOWN, NJ.

19253 A

II

1/3/2006

CADILA PHARMACEUTICALS LTD

CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT, INDIA.

19254 I

II

3/8/2006

YANGTZE RIVER PHARMACY GROUP JIANGSU HAI


CI BIOLOGICAL PHARMACY CO LTD

LANSOPRAZOLE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU


PROVINCE, CHINA.

OXACILLIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

NABUMETONE PH. EUR. AS MANUFACTURED IN BERGAMO, ITALY.

APPLICATOR STICK (PLASTIC INJECTION MOLDED COMPONENT) AS MANUFACTURED IN


FAIRVIEW, PA.
18/12 TG COMPLEX CAPSULES AS MANUFACTURED IN NOVA SCOTIA, CANADA.

Page 557

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19255 A
III
3/15/2006
CORMACK PACKAGING PTY LTD
19256 A

III

3/14/2006

OKADA SHIGYO CO LTD

SUBJECT
CORMACK TECR-PP (3 PIECE TAMPER EVIDENT CHILD RESISTANT CLOSURE FOR PILFER
PROOF NECK FINISH, 28 MM) AS MANUFACTURED IN NEW SOUTH WALES, AUSTRALIA.
HI-GALFILM, HI-COAT K TYPE AS MANUFACTURED IN OSAKA, JAPAN.

19257 A

II

3/17/2006

CSL BEHRING GMBH

STERILE WATER FOR INJECTION (DILUENT) AS MANUFACTURED IN MARBURG, GERMANY.

19258 I

II

2/6/2006

XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD

19259 I

II

2/6/2006

XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD

19260 A

II

3/14/2006

ALCHEM INTERNATIONAL LTD

TROXERUTIN, NON-STERILE BULK FORM AS MANUFACTURED IN SHAANXI PROVINCE, CHINA


FOR XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD
DIOSMIN, NON-STERILE BULK FORM AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR
XI'AN HUIFENG BIOCHEMISTRY GROUP CO. LTD.
10 DEACETYL BACCATIN III (10 DAB III) AS MANUFACTURED IN HARYANA, INDIA.

19261 A

II

4/18/2006

IPCA LABORATORIES LTD

MESALAMINE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

19262 I

II

3/14/2006

CHEMISCHE FABRIK BERG GMBH

19263 I

III

3/13/2006

COPE ALLMAN JAYCARE LTD

19264 I

IV

3/14/2006

DAH FENG CAPSULE INDUSTRY CO LTD

19265 A

II

3/15/2006

AUROBINDO PHARMA LTD

PENTOBARBITAL SODIUM USP AS MANUFACTURED IN BITTERFELD, FEDERAL REPUBLIC OF


GERMANY.
60ML HDPE ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED
KINGDOM.
EMPTY HARD SHELL VEGETABLE CAPSULES (HYDROXYPROPYL METHYL CELLULOSE) AS
MANUFACTURED IN TAICHUNG, TAIWAN R.O.C.
PIPERACILLIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19266 A

II

3/18/2006

SUVEN LIFE SCIENCES LTD

DIVALPROEX SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19267 A

II

3/16/2006

LUPIN LTD

RISPERIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19268 A

II

3/21/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

19269 A

II

3/20/2006

ENDORECHERCHE INC

19270 A

II

3/22/2006

AMRI RENSSELAER INC

LORAZEPAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD.
ACOLBIFENE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN
ONTARIO, CANADA.
SGD-1006 (VC-MMAE) INTERMEDIATE AS MANUFACTURED IN RENSSELAER, NY.

19271 A

III

3/20/2006

CREATIVE TECHNOPLAST

19272 A

II

3/23/2006

UNIMARK REMEDIES LTD

HDPE BOTTLE FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN DAMAN UNION


TERRITORY, INDIA.
FLECAINIDE ACETATE USP AS MANUFACTURED IN GUJARAT, INDIA.

19273 A

II

1/23/2006

GLOCHEM INDUSTRIES LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN TELANGANA STATE, INDIA.

19274 N

NOT AN ASSIGNED NUMBER

19275 A

IV

3/20/2006

UNGERER AND CO

ARTIFICIAL BITTER MASKING FLAVOR FM-4730 AS MANUFACTURED IN BETHLEHEM, PA.

19276 A

IV

3/20/2006

UNGERER AND CO

N/A BLUEBERRY FLAVOR FM-4726 AS MANUFACTURED IN BETHLEHEM, PA.

19277 A

IV

3/20/2006

UNGERER AND CO

N/A STRAWBERRY FLAVOR FN-2356 AS MANUFACTURED IN BETHLEHEM, PA.

19278 A

IV

3/20/2006

UNGERER AND CO

N/A GRAPE FLAVOR FM-2727 AS MANUFACTURED IN BETHLEHEM, PA.

19279 I

II

3/16/2006

SHANDONG FREDA BIOCHEM CO LTD

19280 A

III

3/21/2006

ADIT INDUSTRIES

19281 A

II

3/17/2006

AUROBINDO PHARMA LTD

SODIUM HYALURONATE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG


PROVINCE, CHINA.
NEUTRAL GLASS AMPOULES AND VIALS USP (TYPE 1) AS MANUFACTURED IN SARIGAM,
INDIA.
METOPROLOL SUCCINATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19282 A

II

3/24/2006

NEULAND LABORATORIES LTD

OLANZAPINE FORM-1 AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19283 A

II

3/21/2006

AUROBINDO PHARMA LTD

METOPROLOL TARTRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19284 I

II

3/8/2006

TAMOXIFEN CITRATE USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

19285 A

III

3/15/2006

YANGTZE RIVER PHARMACY GROUP JIANGSU HAI


CI BIOLOGICAL PHARMACY CO LTD
GENESIS INDUSTRIES INC

19286 A

II

3/24/2006

USV LIMITED

DONEPEZIL HYDROCHLORIDE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED


IN MAHARASHTRA, INDIA.

PACKAGING MATERIAL AS MANUFACTURED IN ELMWOOD, WI.

Page 558

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19287 N
NOT AN ASSIGNED NUMBER

SUBJECT

19288 A

II

2/27/2006

WOCKHARDT LTD

CLOPIDOGREL BISULFATE USP (FORM-1) AS MANUFACTURED IN GUJARAT, INDIA.

19289 A

II

2/27/2006

WOCKHARDT LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT AND MAHARASHTRA, INDIA.

19290 A

II

3/21/2006

LUPIN LTD

CEFADROXIL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

19291 I

II

3/24/2006

PHARMACIA AND UPJOHN SUB PFIZER INC

TRIAMCINOLONE 5 DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN KALAMAZOO,


MI.

II

3/24/2006

19295 A

II

3/20/2006

LUPIN LTD

LOSARTAN POTASSIUM (AMORPHOUS)

19296 A

II

3/24/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

19297 A

II

3/28/2006

CADILA HEALTHCARE LTD

FLUVASTATIN SODIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL AND REGENT DRUGS


LTD (RDL) IN U.P., INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
BUPROPION HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

19298 A

IV

3/28/2006

GATTEFOSSE SAS

EMULFREE(R) P PHARMA AS MANUFACTURED IN SAINT PRIEST, FRANCE.

19299 A

II

3/27/2006

LUPIN LTD

ALENDRONATE SODIUM USP

19300 I

III

3/6/2006

ADHESIVES RESEARCH INC

19301 A

II

3/27/2006

LUPIN LTD

AS-131 ADHESIVE AS MANUFACTURED IN LIMERICK, IRELAND AND GLEN ROCK, PA FOR


ADHESIVES RESEARCH, INC.
VALSARTAN

19302 A

III

3/28/2006

BPREX HEALTHCARE OFFRANVILLE SAS

PILLJARS BI (80 ML & 120 ML) AS MANUFACTURED IN OFFRANVILLE, FRANCE.

19303 A

III

11/17/2004

SFB PLASTICS INC

CONTAINERS FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN WICHITA, KS.

19304 A

IV

4/4/2006

LYNE LABORATORIES INC

PLASTIGEL 5 (PLASTICIZED HYDROCARBON GEL) AS MANUFACTURED IN BROCKTON, MA.

19305 I

III

3/20/2006

POLIMERI EUROPA FRANCE

FLEXIRENE MT40 AS MANUFACTURED IN MARDYCK, FRANCE.

19306 A

III

3/29/2006

POLYONE CORP

CC10075538WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

19307 A

II

3/28/2006

NECTAR LIFESCIENCES LTD

CEFIXIME USP AS MANUFACTURED IN PUNJAB, INDIA.

19308 A

II

3/27/2006

AUROBINDO PHARMA LTD

FINASTERIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19309 A

II

3/2/2007

CIPLA LTD

MITOXANTRONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE INDIA

19310 A

II

3/9/2006

ESTEVE QUIMICA SA

LANSOPRAZOLE AS MANUFACTURED IN GIRONA, SPAIN.

19311 I

II

3/31/2006

SUMITOMO CHEMICAL CO LTD

19312 A

II

3/30/2006

SHISEIDO CO LTD

BICALUTAMIDE DRUG SUBSTANCE AS MANUFACTURED IN OSAKA CITY AND GIFU


PREFECTURE, JAPAN.
SALAMANDER 300 AS MANUFACTURED IN SHIZUOKA, JAPAN.

19292 N
19293 A

NOT AN ASSIGNED NUMBER

19294 N

SHANGHAI JINSHAN BIOTECH CO LTD

PACLITAXEL AS MANUFACTURED IN SHANGHAI, CHINA.

NOT AN ASSIGNED NUMBER

19313 N

NOT AN ASSIGNED NUMBER

19314 N

NOT AN ASSIGNED NUMBER

19315 N

NOT AN ASSIGNED NUMBER

19316 N

NOT AN ASSIGNED NUMBER

19317 N

NOT AN ASSIGNED NUMBER

19318 N

NOT AN ASSIGNED NUMBER

19319 N

NOT AN ASSIGNED NUMBER

19320 N

NOT AN ASSIGNED NUMBER

19321 N

NOT AN ASSIGNED NUMBER

19322 N

NOT AN ASSIGNED NUMBER

Page 559

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19323 I
IV
3/28/2006
SAFC PHARMA

SUBJECT
OLEYLAMINE, PURIFIED (AN EXCIPIENT) AS MANUFACTURED IN DORSET, UNITED KINGDOM.

19324 A

II

3/31/2006

LUPIN LTD

TOLTERODINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19325 A

II

3/30/2006

LUPIN LTD

TOPIRAMATE

19326 I

II

3/31/2006

LUPIN LTD

AZITHROMYCIN MONOHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19327 I

II

4/6/2006

NV ORGANON

NORGESTIMATE AS MANUFACTURED IN OSS, THE NETHERLANDS.

19328 N

NOT AN ASSIGNED NUMBER

19329 I

II

4/4/2006

SANMAR SPECIALTY CHEMICALS LTD

19330 A

II

3/31/2006

AUROBINDO PHARMA LTD

NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU,


INDIA.
SUMATRIPTAN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19331 I

II

4/7/2006

SPI PHARMA INC

BARCROFT(TM) 5300D MAGNESIUM HYDROXIDE USP AS MANUFACTURED IN LEWES, DE.

19332 I

III

4/7/2006

BESPAK DIV CONSORT MEDICAL PLC

19333 I

II

4/5/2006

LIPOID GMBH

BK357978MTA PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK,


UNITED KINGDOM.
LIPOID S 100 E AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY.

19334 A

II

4/6/2006

BCN PEPTIDES

DESMOPRESSIN ACETATE AS MANUFACTURED IN BARCELONA, SPAIN.

19335 A

II

4/7/2006

RHODES TECHNOLOGIES

DRONABINOL, 10% IN SESAME OIL AS MANUFACTURED IN COVENTRY, RI.

19336 A

II

4/7/2006

SUVEN LIFE SCIENCES LTD

19337 A

II

4/4/2006

ANTIBIOTICOS DO BRASIL LTDA

2-(2-ETHOXY PHENOXY) ETHYL BROMIDE - DRUG INTERMEDIATE AS MANUFACTURED IN


ANDHRA PRADESH, INDIA.
CEFTRIAXONE SODIUM USP (STERILE BULK) AS MANUFACTURED IN COSMOPOLIS, BRASIL.

19338 A

II

3/31/2006

AUROBINDO PHARMA LTD

19339 A

II

4/11/2006

6-AMINO PENICILLANIC ACID DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN


ANDHRA PRADESH, INDIA.
ORCHID CHEMICALS AND PHARMACEUTICALS LTD DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19340 A

II

4/11/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD SUMATRIPTAN SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19341 A

III

4/3/2006

PRAVESHA INDUSTRIES PRIVATE LTD

19342 A

II

4/11/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

HIGH DENSITY POLYETHYLENE CONTAINERS (40CC, 60CC, 75CC, 100CC, 120CC, 200CC,
250CC, 500CC, 850CC & 75CCHW) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.
AZTREONAM USP AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO.

19343 A

II

4/4/2006

ERREGIERRE SPA

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY.

19344 A

III

4/11/2006

BARALAN INTERNATIONAL SPA

PLASTIC CAPS, PLASTIC RODS AND NYLON BRUSHES AS MANUFACTURED BY LABOR PLAST
S.R.L. AND SORINI & MIGLIAVACCA S.P.A. IN MILAN, ITALY; DUPONT FILAMENTS IN
LANDGRAAF, THE NETHERLANDS.

19345 A

III

4/11/2006

BARALAN INTERNATIONAL SPA

GLASS BOTTLES AS MANUFACTURED IN PARMA, ITALY.

19346 A

IV

4/7/2006

STEPAN SPECIALTY PRODUCTS LLC

ONAMER(R) M, POLYQUATERNIUM-1 AS MANUFACTURED IN MAYWOOD, NJ.

19347 A

II

4/10/2006

PERRIGO API LTD

TEMOZOLOMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

19348 A

IV

4/3/2006

CRODA INC

SUPER REFINED POLYETHYLENE GLYCOL 400 NF AS MANUFACTURED IN MILL HALL, PA.

19349 I

II

4/12/2006

ARDANA BIOSCIENCE LTD

19350 A

II

4/12/2006

CHEMPACIFIC CORP

TESTOSTERONE CREAM 1% (ARD-0403) AS MANUFACTURED BY INSTITUTE DE


DEVELOPPEMENT DE PRODUITS DE SANTE) IN ARTIGUES PRES BORDEAUX, FRANCE.
METHOXSALEN DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD.

19351 A

III

4/6/2006

SCHOTT KAISHA PVT LTD

NON-STERILE GLASS BARRELS (SYRINGES) AS MANUFACTURED IN NANI DAMAN, INDIA.

19352 A

III

4/6/2006

SCHOTT KAISHA PVT LTD

19353 A

IV

4/14/2006

CAFOSA GUM SA

SAFEPAC STERILE PRE-FILLABLE GLASS SYRINGE COMPONENTS AS MANUFACTURED IN


NANI DAMAN, INDIA.
DREYCO(R) CHEWING GUM BASE AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN.

19354 A

IV

4/14/2006

CAFOSA GUM SA

CAFOSA 257 CLASSIC AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN.

19355 A

IV

4/14/2006

CAFOSA GUM SA

CAFOSA 258 SOFT AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN.

Page 560

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19356 I
II
4/3/2006
PCAS

SUBJECT
BISMUTH SUBSALICYLATE AS MANUFACTURED IN LA VOULTE SUR RHONE, FRANCE.

19357 A

III

4/12/2006

HEINKE TECHNOLOGY INC

COMFORT TIP VAGINAL CREAM APPLICATOR AS MANUFACTURED IN LINCOLN, NE.

19358 A

IV

4/12/2006

UNGERER AND CO

N/A BANANA FLAVOR WS FN-6713 AS MANUFACTURED IN BETHLEHEM, PA.

19359 A

IV

4/12/2006

UNGERER AND CO

N/ACITRUS FLAVOR FN-7176 AS MANUFACTURED IN BETHLEHEM, PA.

19360 A

IV

4/12/2006

UNGERER AND CO

N/A FRUIT FLAVOR FN-6714 AS MANUFACTURED IN BETHLEHEM, PA.

19361 A

IV

4/12/2006

UNGERER AND CO

N/A MASKER FLAVOR FN-6820 AS MANUFACTURED IN BETHLEHEM, PA.

19362 I

II

4/8/2006

SECOND PHARMA CO LTD

TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

19363 A

IV

4/14/2006

EVONIK CORP

19364 A

III

4/7/2006

FUJIMORI KOGYO CO LTD

19365 A

II

4/10/2006

HUBEI HAOSUN PHARMACEUTICAL CO LTD

PRECIPITATED SILICA AS MANUFACTURED IN CHESTER, PA, GERMANY,INDIA),SPAIN, TAIWAN,


THAILAND, TURKEY, AND JAPAN.
RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES - FIM IN
SHIZUOKA PREF., JAPAN. FOR FUJIMORI KOGYO CO LTD
GRANISETRON HYDROCHLORIDE (NON-STERILE) AS MANUFACTURED IN HUBEI, CHINA.

19366 A

II

4/14/2006

MYLAN LABORATORIES LTD

LABETALOL HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA.

19367 A

II

4/14/2006

MYLAN LABORATORIES LTD

OMEPRAZOLE MAGNESIUM USP AS MANUFACTURED IN TELANGANA, INDIA.

19368 A

II

4/14/2006

MYLAN LABORATORIES LTD

NEVIRAPINE HEMIHYDRATE USP AS MANUFACTURED IN TELANGANA, INDIA.

19369 A

II

4/14/2006

MYLAN LABORATORIES LTD

MIRTAZAPINE ANHYDROUS USP AS MANUFACTURED IN TELANGANA, INDIA.

19370 I

II

4/7/2006

ERREGIERRE SPA

RISPERIDONE PH. EUR. AS MANUFACTURED IN BERGAMO, ITALY.

19371 A

4/17/2006

PAIN THERAPEUTICS INC

19372 A

II

4/19/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

REFERENCE INFORMATION TO SUPPORT THE SAFETY OF TRIACETIN (GLYCEROL


TRIACETATE) USP, AS A PHARMACEUTICAL EXCIPIENT.
SUMATRIPTAN SUCCINATE EP/BP AS MANUFACTURED IN GUJARAT, INDIA.

19373 I

II

4/18/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CARVEDILOL AS MANUFACTURED IN MAHARASHTRA, INDIA.

19374 A

III

4/15/2006

JEEVANLAKSHMI PACKAGING SOLUTIONS PVT LTD ROLL ON PILFER PROOF (ROPP) CAPS AS MANUFACTURED IN GOA, INDIA.

19375 A

III

4/15/2006

JEEVANLAKSHMI PACKAGING SOLUTIONS PVT LTD COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN GOA, INDIA.

19376 A

II

4/19/2006

DUPONT CHEMOSWED

ISRADIPINE AS MANUFACTURED IN MALMO, SWEDEN.

19377 A

III

4/20/2006

STREAM PEAK INTERNATIONAL PTE LTD

19378 A

III

4/20/2006

STREAM PEAK INTERNATIONAL PTE LTD

19379 I

II

10/10/2005

MATRIX LABORATORIES (XIAMEN) LIMITED

PERFORMANCE DRY DESICCANT PACKETS AS MANUFACTURED IN SINGAPORE AND


SHANGHAI, CHINA FOR STREAM PEAK INTERNATIONAL PTE LTD.
HUMI DRI DESICCANT PACKETS AS MANUFACTURED IN SINGAPORE AND SHANGHAI, CHINA
FOR STREAM PEAK INTERNATIONAL PTE LTD.
NEVIRAPINE USP, NON-STERILE BULK FORM AS MANUFACTURED IN FUJIAN, CHINA.

19380 A

4/18/2006

PAIN THERAPEUTICS INC

19381 A

4/19/2006

PAIN THERAPEUTICS INC

19382 A

4/20/2006

PAIN THERAPEUTICS INC

19383 I

II

4/20/2006

TONIRA PHARMA LTD

REFERENCE INFORMATION TO SUPPORT THE SAFETY OF CELLULOSE ACETATE BUTYRATE


381-20BP AS A PHARMACEUTICAL EXCIPIENT.
REFERENCE INFORMATION TO SUPPORT THE SAFETY OF ISOPROPYL MYRISTATE AS A
PHARMACEUTICAL EXCIPIENT.
REFERENCE INFORMATION TO SUPPORT THE SAFETY OF ETHYL LACTATE AS A
PHARMACEUTICAL EXCIPIENT.
FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA.

19384 A

II

4/20/2006

DR REDDYS LABORATORIES LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19385 A

II

3/1/2006

WOCKHARDT LTD

ENTACAPONE AS MANUFACTURED IN GUJARAT, INDIA.

19386 A

II

9/16/2005

CADILA PHARMACEUTICALS LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

19387 A

II

4/18/2006

AUROBINDO PHARMA LTD

LEVETIRACETAM DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19388 A

II

4/18/2006

AUROBINDO PHARMA LTD

CARISOPRODOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

Page 561

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19389 I
IV
4/10/2006
SPI PHARMA

SUBJECT
PHARMAGUM(TM) C AS MANUFACTURED IN GRAND HAVEN, MI.

19390 A

II

4/18/2006

ZHEJIANG HUAYI PHARMACEUTICAL CO LTD

CLARITHROMYCIN AS MANUFACTURED IN ZHEJIANG, CHINA.

19391 I

III

4/24/2006

PETROMONT INC

19392 I

III

4/20/2006

TEKNOR COLOR CO

HIGH DENSITY POLYETHYLENE RESINS HDPE 1000 AND HDPE 1002 AS MANUFACTURED IN
QUEBEC, CANADA.
COLOR CONCENTRATE 91,355HCTPE WHITE 50:1 AS MANUFACTURED IN HENDERSON, KY.

19393 A

III

4/25/2006

EMS CHEMIE NORTH AMERICA INC

19394 I

III

4/7/2006

RESPONSIVE POLYMERS LTD

19395 A

III

5/1/2006

INEOS CHLORVINYLS BELGIUM NV

19396 I

II

5/1/2006

SIEGFRIED LTD

19397 A

II

4/29/2006

SUVEN LIFE SCIENCES LTD

19398 A

II

4/26/2006

AUROBINDO PHARMA LTD

(R)-(-)-5-(2-AMINOPROPYL)-2-METHOXYBENZENE SULPHONAMIDE HYDROCHLORIDE DRUG


INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.
ZALEPLON DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19399 I

II

5/1/2006

SANDOZ INDUSTRIAL PRODUCTS SPA

LOVASTATIN DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN TRENTO, ITALY.

19400 A

II

5/2/2006

GLENMARK GENERICS LTD

LORATADINE AS MANUFACTURED IN GUJARAT, INDIA.

19401 A

II

5/2/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFDINIR FORM-B AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA.

19402 A

II

4/20/2006

SYMBIOTEC PHARMALAB LTD

HALOBETASOL PROPIONATE AS MANUFACTURED IN INDORE, INDIA.

19403 A

II

5/2/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

19404 A

II

5/1/2006

BIOCON LTD

DESLORATADINE AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD.
ROSIGLITAZONE MALEATE DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA.

19405 I

IV

4/25/2006

HENRY H OTTENS MANUFACTURING CO INC

NATURAL MINT FLAVOR #9295 AS MANUFACTURED IN PHILADELPHIA, PA.

19406 I

IV

4/25/2006

HENRY H OTTENS MANUFACTURING CO INC

NATURAL PEPPERMINT FLAVOR EXTRACT #7801 AS MANUFACTURED IN PHILADELPHIA, PA.

19407 A

II

6/13/2006

ZHEJIANG EXCEL PHARMACEUTICAL CO LTD

GEMFIBROZIL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

19408 A

II

5/5/2006

ISOCHEM SAS

CARISOPRODOL AS MANUFACTURED IN VERT-LE-PETIT, FRANCE FOR ISOCHEM S.A.

19409 A

II

4/29/2006

AUROBINDO PHARMA LTD

CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19410 A

II

4/21/2006

COSMA SPA

BICALUTAMIDE AS MANUFACTURED IN BERGAMO, ITALY.

19411 I

II

4/26/2006

ERCROS INDUSTRIAL SA FYSE

COMPACTIN AS MANUFACTURED IN MADRID, SPAIN.

19412 I

III

5/3/2006

M AND H PLASTICS

PACKAGING MATERIAL AS MANUFACTURED IN WINCHESTER, VA AND SUFFOLK, U.K.

19413 A

II

5/8/2006

AARTI INDUSTRIES LTD

QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

19414 A

III

5/5/2006

3M DRUG DELIVERY SYSTEMS

19415 A

II

5/9/2006

FORMOSA LABORATORIES INC

SCOTCHPAK 9734, 2-MIL POLYESTER FILM LAMINATE AS MANUFACTURED IN COTTAGE


GROVE, MN FOR 3M DRUG DELIVERY SYSTEMS
CALCIPOTRIOL AS MANUFACTURED IN TAOYUAN, TAIWAN R.O.C.

19416 A

II

5/9/2006

MALLADI DRUGS AND PHARMACEUTICALS LTD

THREO-RITALINIC ACID AND SALT AS MANUFACTURED IN TAMIL NADU, INDIA.

19417 A

II

5/9/2006

URQUIMA SA

OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

19418 A

5/5/2006

DAIKYO SEIKO LTD

RSV COMPONENT WASHING PROCESS AT TOCHIGI, JAPAN.

19419 A

II

4/28/2006

MECLIZINE HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, CHINA.

19420 A

II

5/8/2006

19421 I

II

5/8/2006

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD
HANZHONG HANJIANG VENTUREPHARM
PHARMACEUTICAL LTD
BEIJING YI HE BIOTECH CO LTD

19422 A

II

5/5/2006

EUTICALS SPA

AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN MILAN, ITALY.

GRIVORY HB 7103 NATURAL AS MANUFACTURED IN DOMAT/EMS, SWITZERLAND FOR EMS


CHEMIE (NORTH AMERICA) INC
PVC FILMS AS MANUFACTURED IN BOISAR, INDIA.
NORVINYL TM S7102 AS MANUFACTURED BY DSM POLYMERS IN BEEK, THE NETHERLANDS
FOR LIMBURGSE VINYL MAATSCHAPPIJ NV.
OXYCODONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE, NJ.

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR


HANZHONG HANJIANG - VENTUREPHARM PHARMACEUTICAL LTD.
PACLITAXEL USP, NON-STERILE BULK AS MANUFACTURED IN BEJING, CHINA.

Page 562

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19423 I
II
5/8/2006
PCAS

SUBJECT
INDOCYANINE GREEN AS MANUFACTURED IN ARAMON, FRANCE FOR PCAS

19424 I

IV

4/27/2006

EVONIK DEGUSSA CORP

CALCIUM SILICATE AS MFG BY DEGUSSA CORP(CHESTER,PA);DEGUSSA AG(FEDERAL


REPUBLIC OF GERMANY);INSILCO LTD (INDIA);SILQUIMICA SA(SPAIN);UNITED SILICA
INDUSTRIAL LTD(TAIWAN);UNITED SILICA(THAILAND); EGESIL KIMYA SANAYI (TURKEY) &
DEGUSSA SHIONOGI JAPAN CO (JAPAN).

19425 A

II

4/20/2006

19426 A

II

5/12/2006

MOSAPRIDE CITRATE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG


PROVINCE, CHINA.
SODIUM BENZOATE AS MANUFACTURED IN BIASCA, SWITZERLAND.

19427 A

II

5/16/2006

SHANDONG LUNAN BETTER PHARMACEUTICAL CO


LTD
HELSINN CHEMICALS SA HELSINN ADVANCED
SYNTHESIS SA
SUN PHARMACEUTICAL INDUSTRIES LTD

19428 A

II

5/12/2006

GLENMARK GENERICS LTD

DESLORATADINE AS MANUFACTURED IN GUJARAT, INDIA.

19429 A

II

5/15/2006

GEDEON RICHTER PLC

NORGESTIMATE AS MANUFACTURED IN DOROG, HUNGARY.

19430 A

IV

5/5/2006

RELIANCE CELLULOSE PRODUCTS LTD

19431 A

III

5/15/2006

WACKER CHEMICAL CORP

19432 I

II

5/15/2006

SINTENOVO SA DE CV

CARBOXYMETHYLCELLULOSE SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
VINNOL(R) E 22/48 A AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR WACKER
POLYMER SYSTEMS LP
CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO.

19433 A

II

5/10/2006

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

19434 A

II

5/16/2006

IBA MOLECULAR EASTERN ISOTOPES INC

19435 I

III

5/4/2006

FLEXTRUS AB

19436 I

III

5/4/2006

FLEXTRUS AB

19437 I

III

5/4/2006

FLEXTRUS AB

19438 A

II

5/12/2006

ISOTEC

19439 A

IV

5/16/2006

ACCUCAPS INDUSTRIES LTD

TRANSOFOIL EL-OPET/PELD LAMINATE, SPECIFICATION 2383150-0008 AS MANUFACTURED IN


LUND, SWEDEN.
TRANSOFOIL EL-OPET/PELD, SPECIFICATION 2383150-0008 AS MANUFACTURED IN LUND,
SWEDEN.
TRANSOFOIL EL-OPET/PE LAMINATE, MATERIAL SPECIFICATION M80142 AS MANUFACTURED
IN LUND, SWEDEN.
POTASSIUM PALMITATE-1,2,3,4-(13)C(4) FOR CLINICAL RESEARCH AS MANUFACTURED IN
MIAMISBURG, OH.
GELATIN MASS FOR SOFT GEL CAPSULES AS MANUFACTURED IN ONTARIO, CANADA.

19440 A

II

5/16/2006

AARTI DRUGS LTD

ZOLPIDEM TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19441 A

II

5/17/2006

DIVIS LABORATORIES LTD

DESLORATADINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19442 I

II

3/10/2006

HEC PHARM CO

19443 A

II

3/20/2006

HEC PHARM CO LTD

19444 A

II

3/20/2006

HEC PHARM CO LTD

19445 A

III

5/9/2006

ROY AND LECLAIR EMBALLAGE INC

METRONIDAZOLE USP, NON-STERILE BULK FORM AS MANUFACTURED IN HUBEI PROVINCE,


CHINA.
ERYTHROMYCIN THIOCYANATE, PHARMACEUTICAL INTERMEDIATE BULK FORM AS
MANUFACTURED IN HUBEI PROVINCE, CHINA.
ERYTHROMYCIN USP, NON-STERILE BULK FORM AS MANUFACTURED IN HUBEI PROVINCE,
CHINA.
ROPACKS (ROUND PACKER BOTTLES) AS MANUFACTURED IN QUEBEC, CANADA.

19446 A

II

5/12/2006

JUBILANT GENERICS LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN KARNATAKA, INDIA.

19447 A

II

5/1/2006

PIRAMAL ENTERPRISES LTD

19448 A

II

5/18/2006

NURAY CHEMICALS PVT LTD

OXYBUTYNIN CHLORIDE, BULK ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED


IN ANDHRA PRADESH, INDIA.
MOLINDONE HYDROCHLORIDE AS MANUFACTURED IN TAMILNADU, INDIA.

19449 A

II

5/16/2006

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

19450 A

II

5/16/2006

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

MEDROXYPROGESTERONE ACETATE USP, NON-STERILE BULK DRUG SUBSTANCE AS


MANUFACTURED IN ZHEJIANG, CHINA
IODINE-124 AS MANUFACTURED IN RICHMOND, VA.

FELODIPINE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA.
SECNIDAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

Page 563

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19451 I
II
5/22/2006
MITSUBISHI TANABE PHARMA CORP
19452 A

II

5/17/2006

CHEMCO PLUS SCIENTIFIC CO LTD

19453 A

IV

5/22/2006

COREL PHARMACHEM

SUBJECT
Y-39983 DRUG SUBSTANCE AS MANUFACTURED IN FUKUI, JAPAN FOR MITSUBISHI TANABE
PHARMA CORP
LC-SORB SPW-C-ODS(S) - CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN OSAKA,
JAPAN FOR CHEMCO SCIENTIFIC CO LTD
ACRYCOAT, METHACRYLIC ACID COPOLYMER AS MANUFACTURED IN KADI, INDIA.

19454 A

II

5/22/2006

AUROBINDO PHARMA LTD

GEMFIBROZIL USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19455 A

II

5/25/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

FOSPHENYTOIN SODIUM USP AS MANUFACTURED IN GUJARAT, INDIA.

19456 A

II

5/24/2006

DR REDDYS LABORATORIES LTD

DESLORATADINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19457 A

II

5/23/2006

KETOPROFEN AS MANUFACTURED IN FLORENCE, ITALY.

19458 A

II

5/19/2006

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
APOTEX PHARMACHEM INDIA PVT LTD

19459 A

III

5/19/2006

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9691 POLYESTER TAPE AS MANUFACTURED IN BROOKINGS, SD

19460 A

II

5/26/2006

SIEGFRIED USA LLC

HYDROCODONE BITARTRATE USP AS MANUFACTURED IN PENNSVILLE, NJ.

19461 A

II

5/23/2006

3M DRUG DELIVERY SYSTEMS

19462 A

III

5/23/2006

BESPAK DIV CONSORT MEDICAL PLC

19463 A

II

5/24/2006

MEDICHEM MANUFACTURING MALTA LTD

DROSPIRENONE/ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM AS


MANUFACTURED IN ST. PAUL, MN.
BK920 SERIES PHARMACEUTICAL ORAL ACTUATORS AND DUST CAPS AS MANUFACTURED IN
NORFOLK, U.K.
ZALEPLON (MED - 201970) AS MANUFACTURED IN HAL FAR, MALTA.

19464 A

II

5/22/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

SANIPURE(TM) 60 BIOPHARMACEUTICAL TUBING AS MANUFACTURED IN AKRON, OH.

19465 A

II

5/22/2006

INDUSTRIALE CHIMICA SRL

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN VARESE, ITALY.

19466 A

II

5/26/2006

JOHNSON MATTHEY INC

19467 A

II

5/19/2006

PEPTIDO GMBH

OXANDROLONE AS MANUFACTURED IN WEST DEPTFORD, NJ; DEVENS, MA AND NORTH


ANDOVER, MA.
LIOTHYRONINE SODIUM AS MANUFACTURED IN BEXBACH, GERMANY.

19468 A

II

5/24/2006

RHODIA OPERATIONS

GADOLINIUM OXIDE AS MANUFACTURED IN LA ROCHELLE, FRANCE.

19469 I

II

4/15/2006

DOSHION LIMITED

19470 I

II

4/15/2006

DOSHION LIMITED

19471 I

II

4/15/2006

DOSHION LIMITED

P-544S - POTASSIUM SALT OF POLACRYLIC ACID WITH PERCENTAGE OF POTASSIUM TO


EXTENT OF 17-20% AS MANUFACTURED IN GUJARAT, INDIA.
P-544D - POTASSIUM SALT OF POLACRYLIC ACID WITH PERCENTAGE OF POTASSIUM TO
EXTENT OF 24.5-25.5% AS MANUFACTURED IN GUJARAT, INDIA.
P-542, SODIUM SALT OF POLACRYLIC ACID AS MANUFACTURED IN GUJARAT, INDIA.

19472 A

II

5/24/2006

APICORE US LLC

FOMEPIZOLE AS MANUFACTURED IN SOMERSET, NJ.

19473 A

II

5/26/2006

NOF CORP

PL-2000CS PHOSPHOLIPID COMPOUND AS MANUFACTURED IN HYOGO, JAPAN.

19474 A

II

5/26/2006

DSM NUTRITIONAL PRODUCTS LTD

BONISTEIN(TM) - GENISTEIN CRYSTALLINE AS MANUFACTURED IN SISSEIN, SWITZERLAND.

19475 A

II

5/17/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

TYGON (R)R 3350 - SANITARY SILICONE TUBING AS MANUFACTURED IN BEAVERTON, MI

19476 A

II

5/26/2006

FARMAK AS

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC.

19477 A

II

5/31/2006

FARMABIOS S P A

FLUNISOLIDE ANHYDROUS USP AS MANUFACTURED IN GROPELLO CAIROLI, ITALY.

19478 A

II

5/26/2006

AUROBINDO PHARMA LTD

19479 A

II

5/31/2006

UNIMARK REMEDIES LTD

CEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCE AS


MANUFACTURED IN ANDHRA PRADESH, INDIA.
BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

19480 I

II

5/25/2006

ARCHIMICA SRL

TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN ORIGGIO, ITALY.

19481 A

II

5/31/2006

BASF SE

DERMAZ 99 (AZELAIC ACID) AS MANUFACTURED IN QUEBEC, CANADA. FOR COGNIS CORP

19482 A

II

5/30/2006

PCAS

CICLETANINE AS MANUFACTURED IN ARAMON, FRANCE FOR PCAS

19483 I

III

5/30/2006

3M DRUG DELIVERY SYSTEMS

3M COTRAN(TM) 9768 DOUBLE-COATED POLYESTER TAPE AS MANUFACTURED BY 3M


BROOKINGS IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS DIVISION.

LEVOFLOXACIN USP AS MANUFACTURED IN BRANTFORD, CANADA.

Page 564

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19484 A
II
5/31/2006
AUROBINDO PHARMA LTD
19485 A

II

5/31/2006

NUVIEW LIFE SCIENCES

SUBJECT
PERINDOPRIL TERT-BUTYLAMINE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA
PRADESH, INDIA.
COPPER CHLORIDE (CU-64) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TEXAS.

19486 A

III

6/2/2006

BPREX HEALTHCARE OFFRANVILLE SAS

SOF' BAG SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE.

19487 I

II

5/30/2006

QUIMICA SINTETICA SA

LEVOFLOXACIN AS MANUFACTURED IN MADRID, SPAIN.

19488 I

III

6/1/2006

APPLE CONVERTING INC

PACKAGING FILMS AND PAPERS AS MANUFACTURED IN NORWICH, NY.

19489 A

II

5/30/2006

POLYMED THERAPEUTICS INC

19490 A

II

6/1/2006

AARTI DRUGS LTD

CHOLECALCIFEROL CRYSTAL (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED


IN ZHEJIANG PROVINCE, CHINA FOR POLYMED THERAPEUTICS INC
METOPROLOL SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19491 I

III

5/2/2006

AEGIS AMPOULES AND VIALS LTD

NEUTRAL GLASS AMPOULES AS MANUFACTURED IN MAHARASHTRA, INDIA.

19492 I

III

5/2/2006

AEGIS AMPOULES AND VIALS LTD

19493 I

III

5/2/2006

AEGIS AMPOULES AND VIALS LTD

GLASS CYLINDERS FOR DENTAL LOCAL ANESTHETIC CARTRIDGES AND PEN INJECTOR
CARTRIDGES AS MANUFACTURED IN MAHARASHTRA, INDIA.
NEUTRAL GASS TUBULAR VIALS AS MANUFACTURED IN MAHARASHTRA, INDIA.

19494 I

5/4/2006

ISOTRON NEDERLAND BV

ISOTRON NEDERLAND FACILITY IN EDE, THE NETHERLANDS.

19495 A

II

6/5/2006

SIFAVITOR SRL

BETAHISTINE DIHYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY.

19496 I

II

4/30/2006

TAI HENG INDUSTRY CO LTD

ANASTROZOLE AS MANUFACTURED IN SHANGHAI, CHINA.

19497 A

II

3/31/2006

CHEMPACIFIC CORP

DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD.

19498 A

II

6/1/2006

DANTROLENE SODIUM DRUG SUBSTANCE AS MANUFACTURED IN BIASCA, SWITZERLAND.

19499 A

II

6/6/2006

HELSINN CHEMICALS SA HELSINN ADVANCED


SYNTHESIS SA
SUN PHARMACEUTICAL INDUSTRIES LTD

19500 A

II

5/27/2006

WOCKHARDT LTD

RANITIDINE HYDROCHLORIDE USP (FORM II) AS MANUFACTURED IN GUJARAT, INDIA.

19501 I

III

3/26/2006

LUXFER GAS CYLINDERS

COMPRESSED GAS CYLINDER PACKAGE AS MANUFACTURED IN RIVERSIDE, CA.

19502 A

III

6/7/2006

DYNIC USA CORP

19503 A

II

5/30/2006

WOCKHARDT LTD

NK45 BLACK THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN FOR DYNIC
USA CORP
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA.

19504 A

III

6/7/2006

DYNIC USA CORP

19505 I

III

5/10/2006

ONAWAY INDUSTRIES LTD (GLASS DIV)

19506 A

II

6/7/2006

CHONGQING DAXIN PHARMACEUTICAL CO LTD

19507 A

II

6/6/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

19508 A

II

6/7/2006

RANBAXY LABORATORIES LTD

19509 I

II

6/7/2006

NV ORGANON

19510 I

II

6/7/2006

ITF CHEMICAL LTDA

19511 A

II

6/6/2006

19512 A

II

8/23/2005

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LEVOFLOXACIN HEMIHYDRATE, USP AS MANUFACTURED IN ZHEJIANG, CHINA.
LTD
BRISTOL MYERS SQUIBB CO
MDX-010 (ANTI-CTLA4 HUMAN MONOCLONAL ANTIBODY)

19513 N

IMATINIB MESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

NK45 WHITE INK THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN FOR
DYNIC USA CORP
TUBULAR GLASS VIALS CONTAINER AS MANUFACTURED IN MAHARASHTRA, INDIA.
TOBRAMYCIN (FORM-1) USP, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, CHINA.
IMIQUIMOD AS MANUFACTURED IN DEBRECEN, HUNGARY FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
DESLORATADINE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA.
16-ALPHA-HYDROXYPREDNISOLONE (INTERMEDIATE) AS MANUFACTURED IN OSS, THE
NETHERLANDS.
TOLTERODINE L-TARTRATE AS MANUFACTURED IN BAHIA, BRAZIL.

NOT AN ASSIGNED NUMBER

19514 A

II

6/12/2006

FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG

19515 I

II

6/9/2006

ENDORECHERCHE INC

SODIUM HYALURONATE OPHTHALMIC - FERMENTATIVE ORIGIN (TOPICAL GRADE) AS


MANUFACTURED IN PADOVA, ITALY.
ACOLBIFENE CAPSULES, 20 MG AS MANUFACTURED IN WILMINGTON, NC FOR
ENDORECHERCHE INC

Page 565

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19516 A
II
6/5/2006
AUROBINDO PHARMA LTD

6/6/2006

AMRI RENSSELAER INC SUB ALBANY MOLECULAR


RESEARCH INC
POLIMERI EUROPA FRANCE

SUBJECT
QUETIAPINE FUMARATE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH,
INDIA.
DEXTROAMPHETAMINE DRUG INTERMEDIATE AS MANUFACTURED IN RENSSELAER, NEW
YORK.
RIBLENE FC30 AS MANUFACTURED IN RAGUSA AND GELA, ITALY.

6/6/2006

POLIMERI EUROPA FRANCE

RIBLENE BD20 AS MANUFACTURED IN RAGUSA AND GELA, ITALY.

5/24/2006

NIACET CORP

CALCIUM ACETATE USP GRADE - EXCIPIENT AS MANUFACTURED IN NIAGARA FALLS, NY.

II

6/1/2006

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

19522 A

II

6/15/2006

UNIMARK REMEDIES LTD

CEFUROXIME SODIUM, STERILE BULK ANTIBIOTIC DRUG SUBSTANCE AS MANUFACTURED IN


SHANDONG PROVINCE, CHINA.
RAMIPRIL USP AS MANUFACTURED IN GUJARAT, INDIA.

19523 A

II

6/15/2006

NATCO PHARMA LTD

ZOLEDRONIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19524 I

III

6/15/2006

BAXTER HEALTHCARE CORP

CLEARSHOT PLASTIC PREFILLED SYRINGES AS MANUFACTURED IN CLEVELAND, MS.

19525 A

II

6/19/2006

6-AMINOPENICILLANIC ACID AS MANUFACTURED IN INNER MONGOLIA, CHINA

19526 A

II

6/14/2006

INNER MONGOLIA CHANGSHENG


PHARMACEUTICAL CO LTD
CRYSTAL PHARMA SAU

19527 A

II

5/29/2006

CENWAY PHARMACEUTICALS LTD

PACLITAXEL, NON-STERILE BULK FORM AS MANUFACTURED IN TIANJIN, CHINA.

19528 A

II

6/14/2006

CRYSTAL PHARMA SAU

BUDESONIDE STERILE MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN.

19529 A

II

6/19/2006

HOFFMANN LA ROCHE INC

INTERLEUKIN-2 (HUMAN, RECOMBINANT, E. COLI, HOFFMAN-LA ROCHE)

19530 A

IV

6/13/2006

UNGERER AND CO

N/A CHERRY FLVP FLAVOR WS FO-1979 AS MANUFACTURED IN BETHLEHEM, PA.

19531 A

II

4/30/2006

CAMBREX KARLSKOGA AB

LIDOCAINE HYDROCHLORIDE AS MANUFACTURED IN KARLSKOGA SWEDEN

19532 A

II

4/30/2006

CAMBREX KARLSKOGA AB

LIDOCAINE AS MANUFACTURED IN KARLSKOGA SWEDEN

19533 A

II

6/15/2006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

CARVEDILOL AS MANUFACTURED IN ZHEJIANG, CHINA.

19534 A

II

6/19/2006

ISOCHEM SAS

AMBOX AS MANUFACTURED IN PITHIVIERS, FRANCE FOR ISOCHEM SA

19535 A

II

6/20/2006

FINETECH PHARMACEUTICAL LTD

LATANOPROST (LAT-00) DRUG SUBSTANCE AS MANUFACTURED IN NESHER, ISRAEL.

19536 A

II

6/19/2006

KREBS BIOCHEMICALS INDUSTRIES LTD

19537 A

II

6/14/2006

SYN TECH CHEM AND PHARM CO LTD

SIMVASTATIN AMMONIUM SALT (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
LANSOPRAZOLE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

19538 A

IV

6/20/2006

PFANSTIEHL INC

19539 A

II

6/22/2006

19540 A

III

6/21/2006

CHINOIN PHARMACEUTCIAL AND CHEMICAL


WORKS CO LTD
NYPRO INC

19541 A

II

6/20/2006

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

19542 A

II

6/20/2006

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

19543 I

IV

6/23/2006

ASSOCIATED CAPSULES PVT LTD

FLOVENTR 120 DOSE 8ML METERED-DOSE INHALER COUNTER ACTUATOR/STRAPCAP AS


MANUFACTURED IN ARDEN, NC FOR NYPRO INC
LAMOTRIGINE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA.
QUETIAPINE FUMARATE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA.
CELLULOSE CAPSULE SHELLS (EXCIPIENT) AS MANUFACTURED IN MUMBAI, INDIA.

19544 A

II

6/26/2006

CILAG AG

IRON SUCROSE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

19545 A

II

4/20/2006

TOPFOND PHARMACEUTICAL CO LTD

19546 A

II

4/30/2006

TAI HENG INDUSTRY CO LTD

SIMVASTATIN, NON-STERILE BULK FORM AS MANUFACTURED IN HENAN PROVINCE, CHINA


FOR HENAN TOPFOND PHARMACEUTICAL CO. LTD.
BICALUTAMIDE AS MANUFACTURED IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD

19547 A

II

6/26/2006

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP

19517 A

II

6/12/2006

19518 I

III

19519 I

III

19520 A

IV

19521 A

OLOPATADINE HYDROCHLORIDE (PROCESS I) AS MANUFACTURED IN VALLADOLID, SPAIN.

SUCROSE USP - NF, EP, JP, HIGH PURITY, LOW ENDOTOXIN, BEET DERIVED (S-124-2-MC) AS
MANUFACTURED IN WAUKEGAN, IL.
EPOPROSTENAL SODIUM DRUG SUBSTANCE AS MANUFACTURED IN BUDAPEST, HUNGARY.

METHYLPHENIDATE HYDROCHLORIDE, USP AS MANUFACTURED IN WEST DEPTFORD, NJ.

Page 566

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19548 A
II
6/21/2006
AUROBINDO PHARMA LTD

SUBJECT
TRANDOLAPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19549 A

II

6/20/2006

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MILANO, ITALY.

19550 A

II

6/27/2006

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI


SPA
CAMBREX CHARLES CITY INC

19551 A

II

6/27/2006

TARO PHARMACEUTICAL INDUSTRIES LTD

BUTENAFINE HYDROCHLORIDE AS MANUFACTURED IN HAIFA, ISRAEL.

19552 A

II

6/26/2006

CHEMWERTH INC

19553 A

II

6/20/2006

AUROBINDO PHARMA LTD

NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED


IN FREIBURG, GERMANY FOR CHEMWERTH INC
DICLOXACILLIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19554 A

II

6/28/2006

MYLAN LABORATORIES LTD

ARIPIPRAZOLE USP AS MANUFACTURED IN TELANGANA, INDIA

19555 A

II

6/27/2006

MYLAN LABORATORIES LTD

LANSOPRAZOLE USP AS MANUFACTURED IN TELANGANA, INDIA

19556 A

II

6/28/2006

MITSUBISHI TANABE PHARMA CORP

MP-124 DRUG SUBSTANCE AS MANUFACTURED IN CHIBA, JAPAN.

19557 A

II

5/29/2006

SAFC BIOSCIENCES INC

19558 A

II

6/28/2006

ZHEJIANG HUAYI PHARMACEUTICAL CO LTD

EX-CELL XJEM WITHOUT L-GLUTAMINE, WITHOUT SODIUM BICARBONATE AS


MANUFACTURED IN DENVER, PA
PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA.

19559 A

II

6/28/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

OXALIPLATIN AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO.

19560 I

II

6/29/2006

ABBOTT HEALTHCARE PRODUCTS BV

19561 A

II

6/29/2006

NORAMCO INC

19562 A

III

6/29/2006

MULTISORB TECHNOLOGIES INTERNATIONAL

19563 A

II

6/16/2006

INKE SA

BIFEPRUNOX MESYLATE BULK DRUG SUBSTANCE AS MANUFACTURED IN WEESP, THE


NETHERLANDS.
HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN ATHENS,
GA.
NATRASORBR DESICCANT PRODUCTS AS MANUFACTURED IN CHESHIRE, UNITED KINGDOM
FOR MULTISORB TECHNOLOGIES INTERNATIONAL
QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN BARCELONA, SPAIN.

19564 I

II

6/23/2006

19565 I

III

6/28/2006

CHINA NATIONAL PHARMACEUTICAL FOREIGN


TRADE CORP
RICON COLORS INC

RITALINIC ACID AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR CHINA NATIONAL


PHARMACEUTICAL FOREIGN TRADE CORP.
FDA BLACK, CPP-BK1296-1 AS MANUFACTURED IN WEST CHICAGO, IL.

19566 A

II

6/30/2006

MYLAN LABORATORIES LTD

EMTRICITABINE AS MANUFACTURED IN TELANGANA, INDIA

19567 A

II

6/28/2006

CHEMI SPA

OCTREOTIDE ACETATE AS MANUFACTURED IN MILANO, ITALY.

19568 A

II

6/20/2006

19569 A

II

6/30/2006

19570 I

II

6/29/2006

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO METOPROLOL SUCCINATE USP ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED
LTD
IN ZHEJIANG PROVINCE, CHINA.
SRI KRISHNA PHARMACEUTICALS LTD
SODIUM-4-PHENYL BUTYRIC (4-PHENYL BUTYRIC ACID SODIUM SALT) DRUG SUBSTANCE/API
AS MANUFACTURED IN ANDHRA PRADESH, INDIA.
NECTAR LIFESCIENCES LTD
CEFUROXIME AXETIL AMORPHOUS USP AS MANUFACTURED IN PUNJAB, INDIA.

19571 I

II

6/4/2006

WORLD JIANGSU INDUSTRY CO LTD

TEICOPLANIN, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN FUJIANG, CHINA.

19572 A

II

6/29/2006

PERRIGO API LTD

ROCURONIUM BROMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

19573 A

II

7/3/2006

HOSPIRA BOULDER INC

PAMIDRONIC ACID DRUG SUBSTANCE AS MANUFACTURED IN BOULDER, CO.

19574 A

II

7/6/2006

FARMABIOS S P A

DESONIDE DRUG SUBSTANCE AS MANUFACTURED IN PAVIA, ITALY.

19575 A

II

6/29/2006

CONTIPRO PHARMA AS

19576 A

III

6/30/2006

CLARIANT MASTERBATCHES NORDEN AB

SODIUM HYALURONATE DRUG SUBSTANCE AS MANUFACTURED IN DOLNI DOBROUC, CZECH


REPUBLIC.
PPZ1944910 REMAFIN(R) BLUE AS MANUFACTURED IN MALMO, SWEDEN.

19577 A

IV

7/3/2006

NIPPON FINE CHEMICAL CO LTD

19578 A

II

6/28/2006

AUROBINDO PHARMA LTD

19579 A

II

7/5/2006

BCN PEPTIDES

PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN CHARLES CITY, IA.

DIERUCOYLPHOSPHATIDYLCHOLINE (DEPC), A LIPOSOMAL EXCIPIENT, AS MANUFACTURED


IN HYOGO, JAPAN .
PANTOPRAZOLE SODIUM SESQUIHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN
ANDHRA PRADESH, INDIA.
SALMON CALCITONIN AS MANUFACTURED IN BARCELONA, SPAIN.

Page 567

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19580 A
II
7/2/2006
TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD

SUBJECT
GLIPIZIDE USP, NON-STERILE DRUG SUBSTANCE, AS MANUFACTURED IN ZHEJIANG, CHINA.

19581 I

III

7/7/2006

BRENNTAG CANADA INC

COLOR CONCENTRATE WHITE 33692DF AS MANUFACTURED IN ONTARIO, CANADA.

19582 A

II

7/7/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD AMLODIPINE BESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19583 A

II

6/26/2006

CADILA PHARMACEUTICALS LTD

CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN GUJARAT, INDIA.

19584 A

II

6/30/2006

PHARMACOSMOS AS

DEXTRAN POWDER ACTIVE INGREDIENT AS MANUFACTURED IN HOLBAEK, DENMARK.

19585 A

III

6/23/2006

THERMODORS PVT LTD

19586 A

II

7/11/2006

FORMOSA LABORATORIES INC

PLASTIC BOTTLE, NOZZLE AND PILFER PROOF CAP - READY TO USE STERILE DROPPER
ASSEMBLY AS MANUFACTURED IN PUNE, INDIA.
DDAIP.HCI AS MANUFACTURED IN TAOYUAN, TAIWAN R.O.C.

19587 A

II

6/30/2006

LUPIN LTD

BICALUTAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19588 A

II

6/30/2006

AUROBINDO PHARMA LTD

19589 A

II

7/12/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

CITALOPRAM HYDROBROMIDE USP (ROUTE-1) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
AMITRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

19590 A

II

7/10/2006

NEULAND LABORATORIES LTD

ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19591 A

II

7/11/2006

GLOCHEM INDUSTRIES LTD

AMLODIPINE BESILATE P-III EP AS MANUFACTURED IN TELANGANA, INDIA.

19592 I

III

7/5/2006

ROHM AND HAAS CO

19593 I

II

6/23/2006

DISPHAR INTERNATIONAL B.V.

AQUA-LAM 444A AND CR 7-103 AS MANUFACTURED IN TOLUCA EDO, MEXICO FOR ROHM AND
HAAS CO
BETAHISTINE.2HCL, 8MG AND 16MG TABLETS AS MANUFACTURED BY LOSAN PHARMA GMBH
IN NEUENBERG, FEDERAL REPUBLIC OF GERMANY; CARDINAL HEALTH FEDERAL REPUBLIC
OF GERMANY 405 GMBH IN SCHORNDORF, FEDERAL REPUBLIC OF GERMANY; SIFAVITOR
S.P.A. IN CASALETTO LODIGIANO, ITALY FOR DISPHAR INTERNATIONAL B.V.

19594 A

II

7/11/2006

PLIVA LACHEMA AS

OXALIPLATIN AS MANUFACTURED IN BRNO, CZECH REPUBLIC.

19595 I

II

6/20/2006

ALKALI METALS LTD

SODIUM AZIDE AS MANUFACTURED IN HYDERABAD, INDIA.

19596 A

II

7/12/2006

SYMED LABS LTD

HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19597 I

III

6/22/2006

AMPACET CORP

19598 A

II

7/14/2006

ALKERMES GAINESVILLE LLC

181691 DARK BROWN POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE,


IN; LATEXO, TX: CARTERSVILLE, GA; HEATH, OH AND DERIDDER, LA.
ELN-NM-101-G AS MANUFACTURED IN GAINESVILLE, GA.

19599 A

II

7/14/2006

INTERQUIM SA

TOLTERODINE TARTRATE AS MANUFACTURED IN BARCELONA, SPAIN.

19600 A

II

7/17/2006

MYLAN LABORATORIES LTD

LOPINAVIR (LVR) AS MANUFACTURED IN TELANGANA, INDIA

19601 A

II

7/13/2006

ORGANICA FEINCHEMIE GMBH WOLFEN

INDOCYANINE GREEN DRUG SUBSTANCE AS MANUFACTURED IN WOLFEN, GERMANY.

19602 A

III

7/14/2006

ESS DEE ALUMINIUM LTD

PVC FILM AND ALUMINIUM FOIL AS MANUFACTURED IN GOA AND DAMAN, INDIA.

19603 I

III

7/17/2006

DYNA TECH ADHESIVES

TECHCRYL 2201 WATER BASED ADHESIVES AS MANUFACTURED IN GRAFTON, WV.

19604 A

III

2/15/2007

AMERICHEM INC

46344-CD1 AS MANUFACTURED IN CUYAHOGA FALLS OH

19605 A

II

3/16/2007

AUROBINDO PHARMA LTD

19606 A

III

7/14/2006

FLEX ART FOIL LTD

ATOMOXETINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
PLAIN ALUMINIUM FOIL/GLASSINE/LAMINATES AND PRINTED ALUMINIUM
FOIL/GLASSINE/LAMINATES/CR FOIL AS MANUFACTURED IN VASAI, DAMAN AND GOA, INDIA.

19607 A

II

7/11/2006

AUROBINDO PHARMA LTD

CEFDINIR CRYSTAL B DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19608 A

II

7/10/2006

AUROBINDO PHARMA LTD

19609 A

III

7/18/2006

ASHLAND INC

SULBACTAM SODIUM USP (NON-STERILE BULK)AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
FLEXCRYL GP6W EMULSION AS MANUFACTURED IN PIEDMONT, SC.

19610 A

II

7/17/2006

FRESENIUS KABI ONCOLOGY LTD

OXALIPLATIN AS MANUFACTURED IN WEST BENGAL, INDIA.

19611 A

II

7/17/2006

AARTI DRUGS LTD

CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

Page 568

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19612 A
II
7/4/2006
R L FINE CHEM

SUBJECT
IMIPRAMINE PAMOATE DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA.

19613 A

II

7/17/2006

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

19614 I

II

7/10/2006

AXITEC CO LTD

19615 I

III

7/18/2006

POLIMERI EUROPA FRANCE

IDARUBICIN HYDROCHLORIDE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS


MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
FLUDARABINE PHOSPHATE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU
PROVINCE, CHINA.
RIBLENE FL24 AS MANUFACTURED IN MARDYCK, FRANCE.

19616 I

IV

7/21/2006

CAFOSA GUM SA

ALL IN GUM SF ART AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN.

19617 I

IV

7/20/2006

QUALICAPS CO LTD

EMPTY PONDAC CAPSULES AS MANUFACTURED IN NARA, JAPAN.

19618 A

II

7/21/2006

SYNTESE AS

19619 I

II

6/15/2006

DELAVAU LLC

19620 A

II

7/24/2006

19621 A

II

7/10/2006

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
OLON SPA

MESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE AS MANUFACTURED IN


HVIDOVRE, DENMARK.
CALCIUM CARBONATE GRANULATION ACTIVE PHARMACEUTICAL INGREDIENT AS
MANUFACTURED IN PHILADELPHIA, PA.
REPAGLINIDE DRUG SUBSTANCE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY.

19622 A

II

7/10/2006

OLON SPA

LETROZOLE DRUG SUBSTANCE AS MANUFACTURED IN MULAZZANO, ITALY.

19623 I

II

7/10/2006

OLON SPA

19624 A

II

7/10/2006

OLON SPA

ATOMOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GARBAGNATE


MILANESE, ITALY.
BICALUTAMIDE DRUG SUBSTANCE AS MANUFACTURED IN MULAZZANO, ITALY.

19625 I

II

7/21/2006

INTERQUIM SA

TOLTERODINE TARTRATE MICRONIZED AS MANUFACTURED IN BARCELONA, SPAIN.

19626 A

II

6/30/2006

LUPIN LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19627 A

II

7/21/2006

FRESENIUS KABI ANTI INFECTIVES SRL

CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN ROVIGO, ITALY.

19628 I

II

7/20/2006

HERCULES INC., AQUALON DIV

19629 A

II

7/25/2006

DAIICHI SANKYO CO LTD

19630 A

II

6/29/2006

ROCHE CAROLINA INC

BENECEL(R) HYDROXYPROPYLMETHYLCELLULOSE (HPMC) AS MANUFACTURED IN


BEVEREN, BELGIUM.
BENICAR HCTR (OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE) TABLETS, 20/12.5 MG,
40/12.5 MG AND 40/25 MG AS MANUFACTURED IN KANAGAWA, JAPAN.
MSBA30K PEG REAGENT FOR MIRCERA (RO0503819) AS MANUFACTURED IN FLORENCE, SC.

19631 A

II

7/25/2006

CADILA HEALTHCARE LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

19632 I

II

7/27/2006

JAGSONPAL PHARMACEUTICALS LTD

D-OXYPHENE AS MANUFACTURED IN FARIDABAD, INDIA.

19633 A

II

7/28/2006

HERAEUS PRECIOUS METALS GMBH AND CO KG

OXALIPLATIN AS MANUFACTURED IN HANAU, GERMANY.

19634 A

III

7/28/2006

POLYONE CORP

CC00011090WE 10098632 TAN 467C AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

19635 A

II

7/28/2006

VASUDHA PHARMA CHEM LTD

AMITRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN HYDERABAD, INDIA.

19636 I

II

6/14/2006

EPOCH BIOSCIENCES SHENZHEN CO LTD

19637 A

III

7/31/2006

HEINLEIN PLASTIK TECHNIK GMBH

FENOLDOPAM MESYLATE BULK ACTIVE API AS MANUFACTURED IN GUANGDONG PROVINCE,


CHINA
CLOSURES FOR BOTTLES AS MANUFACTURED IN ANSBACH, GERMANY.

19638 A

II

8/24/2006

IPCA LABORATORIES LTD

METOPROLOL SUCCINATE PROCESS-II AS MANUFACTURED IN RATLAM, INDIA.

19639 A

II

7/22/2006

WANBURY LTD

19640 A

IV

7/20/2006

ACG ASSOCIATED CAPSULES PRIVATE LTD

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA FOR WANBURY LTD.
EXCIPIENT CELLULOSE CAPSULE SHELLS AS MANUFACTURED IN THANE, INDIA.

19641 A

II

7/22/2006

WANBURY LTD

19642 A

II

7/31/2006

NOF CORP

GLUCOSAMINE SULFATE SODIUM CHLORIDE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA FOR WANBURY LTD.
DSPC (DISTEAROYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO, JAPAN.

19643 A

II

7/26/2006

AUROBINDO PHARMA LTD

CEFACLOR USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ADAPALENE DRUG SUBSTANCE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY.

Page 569

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19644 A
II
7/28/2006
AUROBINDO PHARMA LTD
19645 A

II

8/3/2006

SUBJECT
CEFTAZIDIME DIHYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE INTERMEDIATE AS
MANUFACTURED IN ANDHRA PRADESH, INDIA.
ORCHID CHEMICALS AND PHARMACEUTICALS LTD MODAFINIL AS MANUFACTURED IN MAHARASHTRA, INDIA.

19646 A

II

7/31/2006

LONZA AG

EXENATIDE DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM.

19647 A

II

8/2/2006

SUVEN LIFE SCIENCES LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA.

19648 A

II

8/4/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

OXALIPLATIN EP/BP ACTIVE SUBSTANCE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19649 A

II

7/31/2006

AUROBINDO PHARMA LTD

19650 A

III

8/2/2006

LABLABO

TOLTERODINE TARTRATE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.
SELECT AIRLESS PUMP AND BOTTLE AS MANUFACTURED IN ANNEMASSE CEDEX, FRANCE.

19651 I

III

6/15/2006

RITE SYSTEMS INC

19652 A

II

8/3/2006

ERREGIERRE SPA

19653 A

IV

7/4/2006

19654 A

7/28/2006

DOOSAN RESEARCH AND DEVELOPMENT CENTER DS-PL95E PURIFIED EGG YOLK LECITHIN FOR UTILIZATION IN FAT EMULSION PRODUCTION
AS MANUFACTURED IN IKSAN CITY, REPUBLIC OF KOREA.
CELSIS INC
CELSIS RAPISCREEN HEALTH AS MANUFACTURED IN LANDGRAAF, THE NETHERLANDS.

19655 A

II

8/3/2006

ANTIBIOTICOS DO BRASIL LTDA

19656 I

II

8/4/2006

ABBOTT LABORATORIES

19657 A

II

7/5/2006

19658 A

II

8/4/2006

HYDROCODONE/ACETAMINOPHEN EXTENDED RELEASE TABLETS AS MANUFACTURED IN


LUDWIGSHAFEN GERMANY FOR ABBOTT LABORATORIES
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO METHOCARBAMOL ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG
LTD
PROVINCE, CHINA.
OPOCRIN SPA
DALTEPARIN SODIUM BULK AS MANUFACTURED IN MODENA, ITALY.

19659 A

III

8/1/2006

BASELL POLIOLEFINE ITALIA SRL

19660 I

II

7/27/2006

SAI PHYTOCEUTICALS PVT LTD

19661 I

II

7/27/2006

SAI PHYTOCEUTICALS PVT. LTD.

19662 A

II

8/7/2006

NEULAND LABORATORIES LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MADHYA PRADESH,


INDIA.
ESCITALOPRAM OXALATE AS MANUFACTURED IN TELANGANA, INDIA.

19663 A

II

6/20/2006

ARCH PHARMALABS LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

19664 A

IV

7/31/2006

UNGERER AND CO

N/A COUGH SYRUP MASKER FLAVOR FN-6819 AS MANUFACTURED BETHLEHEM, PA.

19665 A

IV

7/31/2006

UNGERER AND CO

N/A CHERRY BERRY FL FM-4725 AS MANUFACTURED BETHLEHEM, PA.

19666 A

IV

7/31/2006

UNGERER AND CO

ART. STRAWBERRY FLAVOR FO-1022 AS MANUFACTURED BETHLEHEM, PA.

19667 A

IV

7/31/2006

UNGERER AND CO

N/A STRAWBERRY FL WS FN-8378 AS MANUFACTURED BETHLEHEM, PA.

19668 I

II

8/6/2006

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

19669 I

II

8/6/2006

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

19670 I

II

8/9/2006

DAIICHI SANKYO CO LTD

MERCAPTOPURINE, USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS


MANUFACTURED IN ZHEJIANG, CHINA.
AZATHIOPRINE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS
MANUFACTURED IN ZHEJIANG, CHINA.
SUN13834 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN.

19671 A

II

8/5/2006

AUROBINDO PHARMA LTD

19672 A

II

7/10/2006

PHARMAZELL GMBH CO KG

19673 A

II

8/7/2006

19674 A

III

8/7/2006

AJINOMOTO DO BRASIL IND E COM DE ALIMENTOS L-GLUTAMINE AS MANUFACTURED INLIMEIRA, BRAZIL.


LTDA
ADVANCED FILMS LLC
MEDICAL POUCH FILM AS MANUFACTURED IN LAKEVILLE,MN AND VANCOUVER, WA FOR
ADVANCED FILMS LLC

WHITE, NQC-W1317-7, LIQUID COLOR CONCENTRATE AS MANUFACTURED IN MOORESVILLE,


NC.
CELECOXIB AS MANUFACTURED IN BERGAMO, ITALY.

ARGININE USP, STERILE BULK AS MANUFACTURED IN COSMOPOLIS, BRAZIL.

PURELL PE 3220 D AS MANUFACTURED IN WESSELING, GERMANY FOR BASELL


POLYOLEFINE ITALIA S.R.L.
PACLITAXEL AS MANUFACTURED IN MADHYA PRADESH, INDIA.

LOSARTAN POTASSIUM USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
ATENOLOL USP AS MANUFACTURED IN CHENNAI, INDIA FOR PHARMAZELL GMBH & CO KG

Page 570

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19675 A
II
8/10/2006
GLENMARK GENERICS LTD

SUBJECT
ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

19676 A

II

7/10/2006

ANUH PHARMA LTD

ERYTHROMYCIN USP AS MANUFACTURED IN MAHRASHTRA, INDIA.

19677 I

II

6/16/2006

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

19678 A

II

8/14/2006

SYMED LABS LTD

POTASSIUM CLAVULANATE, DILUTED, NON-STERILE BULK FORM AS MANUFACTURED IN


SHANDONG PROVINCE, CHINA.
MEPROBAMATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19679 A

II

8/10/2006

SANDOZ INDUSTRIAL PRODUCTS SA

NAFCILLIN ACID AS MANUFACTURED IN BARCELONA, SPAIN.

19680 A

II

8/7/2006

SHASUN PHARMACEUTICALS LTD

MEPROBAMATE AS MANUFACTURED IN CUDDALORE, INDIA.

19681 A

III

8/4/2006

E I DUPONT DE NEMOURS & CO INC

19682 A

II

8/11/2006

SYNTHON BV

TOPCOAT 3200-200 AS MANUFACTURED IN MECHELEN, BELGIUM FOR E I DUPONT DE


NEMOURS & CO INC
ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA FOR SYNTHON BV

19683 A

II

8/10/2006

NAVINTA LLC

FOMEPIZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR NAVINTA LLC

19684 A

II

8/3/2006

OLON SPA

BALSALAZIDE DISODIUM SALT AS MANUFACTURED IN MULAZZANO, ITALY.

19685 A

II

8/15/2006

CEPHALON INC

ARMODAFINIL DRUG SUBSTANCE AS MANUFACTURED IN NYKOEBING S, DENMARK.

19686 A

II

8/14/2006

STERLING SPA

TRILOSTANE AS MANUFACTURED IN PERUGIA, ITALY.

19687 A

II

8/11/2006

NATCO PHARMA LTD

ANASTROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19688 N

NOT AN ASSIGNED NUMBER

19689 A

III

8/14/2006

APTAR FRANCE SAS

POLYCHLOROPRENE ELASTOMERS AS MANUFACTURED IN VAL DE REUIL, FRANCE.

19690 A

II

8/15/2006

IRBESARTAN AS MANUFACTURED IN BUDAPEST, HUNGARY.

19691 A

III

8/10/2006

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS PRIVATE CO LTD
LUTZ GMBH AND CO KG

19692 A

II

8/17/2006

FAMCICLOVIR AS MANUFACTURED IN CHONGQING, CHINA.

19693 A

II

8/16/2006

CHONGQING SHENGHUAXI PHARMACEUTICAL CO


LTD
SIEGFRIED USA LLC

19694 A

IV

8/31/2007

EASTMAN CHEMICAL CO

19695 A

II

7/26/2006

BIA SEPARATIONS DOO

BIOSUSTANE(R) SAIB (SUCROSE ACETATE ISOBUTYRATE) AS MANUFACTURED IN


KINGSPORT, TN
CIM CONVECTIVE INTERACTION MEDIA(R) QA AS MANUFACTURED IN LJUBLJANA, SLOVENIA.

19696 I

II

8/18/2006

SANDOZ GMBH

STERILE NAFCILLIN SODIUM, BUFFERED AS MANUFACTURED IN KUNDL, AUSTRIA.

19697 A

II

8/18/2006

LUPIN LTD

19698 I

II

8/21/2006

3M DRUG DELIVERY SYSTEMS DIV

BENAZEPRIL HYDROCHLORIDE PROCESS B AS MANUFACTURED IN MADHYA PRADESH,


INDIA.
MINITRAN (NITROGLYCERIN) TRANSDERMAL DELIVERY SYSTEM - CHEMISTRY, MFG &
CONTROLS (CMC) FOR DOSAGES: 0.1 MG/HR (2.5 MG/24 HRS), 0.2 MG/HR (5 MG/24 HRS), 0.4
MG/HR (10 MG/24 HRS), 0.6 MG/HR (15 MG/24 HRS) AS MANUFACTURED IN NORTHRIDGE, CA.

19699 A

IV

8/16/2006

UNGERER AND CO

N/A PINEAPPLE FLAVOR FM-4130 AS MANUFACTURED IN BETHLEHEM, PA.

19700 A

III

8/22/2006

ACTEGA RHENANIA GMBH

19701 A

II

8/22/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

19702 I

II

8/14/2006

WOCKHARDT LTD

28505-18014 (LOR 30) COATING LACQUER AS MANUFACTURED IN GREVENBROICH,


GERMANY.
ZOLEDRONIC ACID AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD.
CYANOCOBALAMIN USP AS MANUFACTURED IN MUMBAI, INDIA FOR WOCKHARDT LTD

19703 I

II

4/2/2007

MERRION PHARMACEUTICALS

MER-104A GIPET 10MG ENTERIC TABLETS AS MANUFACTURED IN DUBLIN IRELAND

19704 A

IV

8/18/2006

HONEYWELL INTERNATIONAL INC

HONEYWELL PHARMACEUTICAL HFA-134A AS MANUFACTURED IN GEISMAR, LA FOR


HONEYWELL INTERNATIONAL INC

AMPOULES AND BOTTLES AS MANUFACTURED IN WERTHEIM, GERMANY.

MORPHINE SULFATE USP AS MANUFACTURED IN PENNSVILLE, NJ.

Page 571

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19705
II
8/25/2006
MARTEK BIOSCIENCES CORP
A

SUBJECT
DOCOSAHEXAENOIC ACID ACTIVE SINGLE CELL OIL (DHASCO) 55%, DHASCO CAPSULES, 510
MG DHA, AND PLACEBO TO MATCH DHASCO CAPSULES AS MANUFACTURED BY MARTEK
BIOSCIENCES WINCHESTER FACILITY IN WINCHESTER, KY AND SWISS CAPS USA INC IN
MIAMI, FL.

19706 A

IV

8/18/2006

STERLING BIOTECH LTD

GELATIN TYPE B AS MANUFACTURED IN GUJARAT, INDIA.

19707 I

III

8/22/2006

PRETIUM PACKAGING LLC

19708 A

II

8/21/2006

WOCKHARDT LTD

PLASTIC RESINS, PLASTIC COLORANTS AND PLASTIC ADDITIVES AS MANUFACTURED IN ST.


CHARLES, MO.
GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

19709 I

II

8/28/2006

SAI LIFE SCIENCES LIMITED

MILRINONE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19710 A

II

8/28/2006

HARMAN FINOCHEM LTD

GLYCOPYRROLATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

19711 A

II

8/17/2006

AUROBINDO PHARMA LTD

FOSINOPRIL SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

19712 A

II

8/11/2006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

19713 A

II

8/28/2006

DR REDDYS LABORATORIES LTD

NEVIRAPINE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG,


CHINA.
OMEPRAZOLE (FORM B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

19714 A

II

8/28/2006

AARTI INDUSTRIES LTD

RAMIPRIL USP (GRADE 1) AS MANUFACTURED IN MAHARASHTRA INDIA

19715 A

II

9/8/2006

INDUSTRIALE CHIMICA SRL

EPLERENONE AS MANUFACTURED IN SARONNO ITALY

19716 A

II

8/29/2006

CLOTRIMAZOLE AS MANUFACTURED IN SHANGHAI PR CHINA

19717 A

II

8/30/2006

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
GLENMARK GENERICS LTD

19718 A

III

8/28/2006

APTAR FRANCE SAS

EQUADEL METERED DOSE PUMPS AS MANUFACTURED AT LE VAUDREUIL, FRANCE.

19719 I

II

8/30/2006

AARTI INDUSTRIES LTD

RAMIPRIL USP, GRADE II AS MANUFACTURED IN MAHARASHTRA, INDIA.

19720 A

II

8/26/2006

WOCKHARDT LTD

TRANDOLAPRIL AS MANUFACTURED IN GUJARAT, INDIA.

19721 A

II

8/31/2006

POSH CHEMICALS PRIVATE LTD

HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN HYDERABAD INDIA

19722 A

II

8/31/2006

MALLADI DRUGS AND PHARMACEUTICALS LTD

19723 A

II

8/31/2006

19724 A

II

7/28/2006

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
CAMBREX CHARLES CITY INC

2-(4' METHOXYPHENYL) -2-(1-HYDROXYCYCLOHEXYL) ETHYLAMINE ACETATE (MHE ACETATE)


AS MANUFACTURED IN TAMIL NADU INDIA
FLUMAZENIL AS MANUFACTURED IN WUHAN PEOPLES REPUBLIC OF CHINA

19725 A

II

9/1/2006

CIPLA LTD

LANSOPRAZOLE USP AS MANUFACTURED IN BANGALORE INDIA

19726 A

II

8/31/2006

MILRINONE AS MANUFACTURED IN WUHAN PEOPLES REPUBLIC OF CHINA

19727 I

III

8/25/2006

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
CEODEUX MEDITEC SA

19728 I

II

7/27/2006

BENGBU BAYI PHARMACEUTICAL CO LTD

19729 I

II

9/4/2006

DIVIS LABORATORIES LTD

19730 A

II

8/31/2006

AUROBINDO PHARMA LTD

19731 A

IV

8/31/2006

NOF CORP

19732 A

II

8/31/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

N-[METHOXYPOLYETHYLENE GLYCOL(2000)-CARBAMYL] DISTEAROYLPHOSPHATIDYLETHANOLAMINE (DSPE-PEG2000) AS MANUFACTURED IN KANAGAWA JAPAN


SANIPURE(TM) BDF(TM) BIOPHARMACEUTICAL TUBING AS MANUFACTURED IN AKRON OHIO

19733 I

II

8/31/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

TYGON(R) LFL BIOPHARMACEUTICAL TUBING AS MANUFACTURED IN AKRON OHIO

19734 A

II

9/6/2006

TIANJIN JINJIN PHARMACEUTICAL CO LTD

HYDROCORTISONE BASE AS MANUFACTURED IN TIANJIN CHINA

19735 A

II

9/6/2006

GLENMARK GENERICS LTD

IMIQUIMOD AS MANUFACTURED IN GUJARAT INDIA

EZETIMIBE AS MANUFACTURED IN GUJARAT, INDIA.

FENTANYL CITRATE USP MICRONIZED AS MANUFACTURED IN CHARLES CITY IA

HIGH PRESSURE VALVE RANGE D 335 FOR CYLINDERS CONTAINING GASEOUS MIXTURE
DRUGS UNDER PRESSURE AS MANUFACTURED IN LUXEMBOURG
PARACETAMOL (OR ALTERNATIVELY KNOWN AS ACETAMINOPHEN) AS MANUFACTURED IN
BENGBU CHINA
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH
INDIA
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

Page 572

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19736 A
II
11/7/2006
CAMBRIDGE MAJOR LABS INC

SUBJECT
FP-062 AS MANUFACTURED IN GERMANTOWN, WI

19737 A

II

9/6/2006

DIPHENHYDRAMINE HYDROCHLORIDE AS MANUFACTURED IN BEIJING CHINA

19738 A

II

8/31/2006

BEIJING TAIYANG PHARMACEUTICAL INDUSTRY


CO LTD
CAMBREX CHARLES CITY INC

19739 A

II

8/31/2006

JUBILANT GENERICS LTD

ARIPIPRAZOLE AS MANUFACTURED IN KARNATAKA INDIA

19740 I

II

5/15/2006

ZHEJIANG WEPON PHARMACEUTICAL CO LTD

LORATADINE AS MANUFACTURED IN ZHEJIANG CHINA

19741 I

II

5/15/2006

ZHEJIANG WEPON PHARMACEUTICAL CO LTD

CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ZHEJIANG CHINA

19742 A

III

9/1/2006

KUNSTSTOFFWERK KREMSMUNSTER GMBH

PP 28 CAPS T/E AS MANUFACTURED IN KREMSMUNSTER AUSTRIA

19743 A

II

9/8/2006

PHARMACEUTICAL WORKS POLPHARMA SA

METOPROLOL SUCCINATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

19744 A

II

9/5/2006

CLOPIDOGREL BISULFATE AS MANUFACTURED IN HARYANA INDIA

19745 A

II

9/11/2006

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
HETERO LABS LTD

19746 A

II

9/11/2006

GLENMARK GENERICS LTD

LINEZOLID AS MANUFACTURED IN GUJARAT INDIA

19747 A

II

9/11/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD LEVETIRACETAM AS MANUFACTURED IN AURANGABAD MAHARASHTRA INDIA

19748 A

II

2/7/2008

CIPLA LTD

ANASTROZOLE AS MANUFACTURED IN BANGALORE, INDIA

19749 A

II

8/24/2006

CIPLA LTD

ZOLEDRONIC ACID AS MANUFACTURED IN PUNE INDIA

19750 A

II

8/24/2006

CIPLA LTD

BECLOMETHASONE DIPROPIONATE AS MANUFACTURED IN MAHARASHTRA INDIA

19751 A

II

9/11/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD PAROXETINE HYDROCHLORIDE AS MANUFACTURED IN AURANGABAD MAHARASHTRA INDIA

19752 A

II

9/8/2006

SUVEN LIFE SCIENCES LTD

NITAZOXANIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19753 A

II

4/3/2008

CIPLA LTD

NEVIRAPINE HEMIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

19754 A

8/15/2006

SANDOZ GMBH

19755 I

II

9/7/2006

AUROBINDO PHARMA LTD

19756 A

III

9/11/2006

SHIN ETSU KASEI KOGYO CO LTD

STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE PENICILLIN PLANT AS


MANUFACTURED IN KUNDL TYROL AUSTRIA
CEFEPIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN AND ANDHRA
PRADESH INDIA
ADSORBENT SE-PACK AS MANUFACTURED IN IBARAKI PREFECTURE JAPAN

19757 A

III

8/30/2006

DURAN PRODUKTIONS GMBH AND CO KG

19758 A

II

9/6/2006

ROTEM INDUSTRIES LTD

DURAN PREMIUM LABORATORY BOTTLE WITH SCREW CAP AS MANUFACTURED IN MAINZ,


GERMANY
OXYGEN 18 ENRICHED WATER AS MANUFACTURED IN BE'ER SHEVA ISRAEL

19759 A

II

9/11/2006

DR REDDYS LABORATORIES LTD

TELMISARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

19760 A

II

9/13/2006

CADILA HEALTHCARE LTD

METOPROLOL SUCCINATE AS MANUFACTURED IN GUJARAT INDIA

19761 A

III

9/11/2006

ARCH PLASTICS PACKAGING

PACKAGING MATERIALS AS MANUFACTURED IN CHATTANOOGA, TN

19762 I

II

9/13/2006

QILU PHARMACEUTICAL CO LTD

ONDANSETRON AS MANUFACTURED IN JINAN CHINA

19763 A

II

8/24/2006

NAKODA CHEMICALS LTD

ACETAZOLAMIDE AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH INDIA

19764 I

II

9/14/2006

EURAND INC

EUR-1042 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA OH

19765 A

II

9/12/2006

ISOCHEM SAS

TRIMEBUTINE MALEATE AS MANUFACTURED IN PARIS FRANCE

19766 A

II

8/28/2006

L-ASPARTIC ACID PHIG AS MANUFACTURED IN NANNING CHINA

19767 A

IV

9/11/2006

EVONIK REXIM NANNING PHARMACEUTICAL CO


LTD
NICHIRIN CHEMICAL INDUSTRIES LTD

19768 A

II

9/2/2006

ISOCHEM

FENOLDOPAM MESYLATE USP AS MANUFACTURED IN GUANGDONG CHINA

19769 A

II

8/28/2006

EVONIK REXIM NANNING PHARMACEUTICAL CO


LTD

L-ALANINE PHIG AS MANUFACTURED IN NANNING CHINA

LEVETIRACETAM AS MANUFACTURED IN CHARLES CITY IA

THALIDOMIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

CARMELLOSE JP AS MANUFACTURED IN HYOGO PREFECTURE JAPAN

Page 573

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19770 A
II
9/1/2006
SAFC BIOSCIENCES INC

SUBJECT
EX-CELL 302 CHO SERUM-FREE MEDIUM W/O L-GLUTAMINE AS MANUFACTURED IN DENVER,
PA
EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE PROTEIN-FREE W/L-GLUTAMINE AS
MANUFACTURED IN DENVER PA
EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE PROTEIN-FREE W/L-GLUTAMINE W/O SODIUM
BICARBONATE
NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN EWING NJ

19771 A

II

9/1/2006

SAFC BIOSCIENCES INC

19772 A

II

9/1/2006

SAFC BIOSCIENCES INC

19773 A

II

9/15/2006

NAVINTA LLC

19774 A

II

9/14/2006

SCOPOLAMINE (HYOSCINE) AS MANUFACTURED IN INGELHEIM, GERMANY

19775 A

II

9/13/2006

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
AARTI DRUGS LTD

19776 I

II

9/18/2006

PHOSPHAGENICS LTD

TOCOPHERYL PHOSPHATE MIX (TPM) AS MANUFACTURED IN MELBOURNE AUSTRALIA

19777 A

II

9/18/2006

ABBEY COLOR INC

FLUORESCEIN USP AS MANUFACTURED IN PHILADELPHIA PA

19778 A

III

9/19/2006

KYORAKU CO LTD

19779 I

II

4/3/2007

SHISEIDO CO LTD

19780 A

II

9/11/2006

ALEMBIC PHARMACEUTICALS LTD

POLYETHYLENE BAG FOR MEDICAL SUPPLIES (MIRASON 53) AS MANUFACTURED IN


HIROSHIMA JAPAN
SODIUM HYALURONATE OF PHARMACEUTICAL GRADE CONSISTING OF INTERMEDIATE (SZE
AND API (LM) AS MANUFACTURED IN KAKEGAWA, JAPAN
ROPINIROLE HYDROCHLORIDE, USP AS MANUFACTURED IN GUJARAT INDIA

19781 I

II

9/20/2006

SYMBIOTEC PHARMALAB LIMITED

MOMETASONE FUROATE AS MANUFACTURED IN INDORE INDIA

19782 A

II

9/19/2006

DR REDDYS LABORATORIES LTD

BICALUTAMIDE AS MANUFACTURED IN SRIKAKULAM INDIA

19783 A

II

9/20/2006

19784 I

II

11/13/2008

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
CIPLA LTD

TETRAHYDROCANNABINOL (THC) IN SESAME OIL AS MANUFACTURED IN WEST DEPTFORD


NJ
DIDANOSINE USP AS MANUFACTURED IN BANGALORE, INDIA

19785 A

II

9/22/2006

CIPLA LTD

EMTRICITABINE AS MANUFACTURED IN MAHARASHTRA INDIA

19786 I

II

12/1/2006

STANDARD CHEM AND PHARM CO LTD

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN TAINAN TAIWAN

19787 I

II

9/19/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

19788 A

II

9/19/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

TYGON 2775 HIGH PURITY TUBING AND TYGON 2275 IB HIGH PURITY PRESSURE TUBING AS
MANUFACTURED IN AKRON, OH
PHARMAPURE LOW SPALLATION PUMP TUBING AS MANUFACTURED IN AKRON OH

19789 A

II

9/19/2006

ANTIBIOTICOS DO BRASIL LTDA

CEFOXITIN SODIUM STERILE BULK AS MANUFACTURED IN BRASIL

19790 A

II

9/14/2006

JUBILANT GENERICS LTD

IRBESARTAN AS MANUFACTURED IN KARNATAKA INDIA

19791 I

II

9/21/2006

NUVIEW LIFE SCIENCES

COPPER CHLORIDE CU-67 RADIOCHEMICAL AS MANUFACTURED IN DENTON TX

19792 A

II

9/18/2006

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD

PROGESTERONE USP (BULK) AS MANUFACTURED IN ZHEJIANG CHINA

19793 A

III

9/21/2006

BORMIOLI ROCCO SPA BU PLASTICS

HDPE BOTTLE 60 ML FI9190 AS MANUFACTURED IN CASTELGUELFO ITALY

19794 A

II

10/3/2006

CADILA HEALTHCARE LTD

LANSOPRAZOLE AS MANUFACTURED IN GUJARAT INDIA

19795 A

III

9/25/2006

PPC INDUSTRIES INC

FORM-FILL-SEAL WEB MATERIAL AS MANUFACTURED IN PLEASANT PRAIRIE WI

19796 A

II

9/25/2006

APOTEX PHARMACHEM INC

EPLERENONE AS MANUFACTURED IN ONTARIO CANADA

19797 N

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

NOT AN ASSIGNED NUMBER

19798 A

II

9/26/2006

ACS DOBFAR SPA

CRUDE CEFEPIME HYDROCHLORIDE AS MANUFACTURED IN MILANO ITALY

19799 A

II

9/22/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

19800 A

II

9/26/2006

MYLAN LABORATORIES LTD

RITONAVIR USP (FORM-II) ( ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA

19801 I

II

9/26/2006

FLEMING LABORATORIES (INDIA)

CARISOPRODOL USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

19802 I

IV

9/27/2006

EVONIK DEGUSSA CORP

SODIUM ALUMINUM SILICATE AS MANUFACTURED IN WESSELING FEDERAL REPUBLIC OF


GERMANY

Page 574

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19803 I
II
9/22/2006
TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD

SUBJECT
PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP AS MANUFACTURED IN ZHEJIANG CHINA

19804 A

II

9/28/2006

GRANULES INDIA LTD

ACETAMINOPHEN USP AS MANUFACTURED IN MEDAK INDIA

19805 A

II

9/25/2006

AUROBINDO PHARMA LTD

SULBACTAM SODIUM USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA

19806 A

II

9/26/2006

ANTIBIOTICOS DO BRASIL LTDA

CEFEPIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN COSMOPOLIS BRASIL

19807 I

II

9/4/2006

CHONGQING LUMMY PHARMACEUTICAL CO LTD

BISOPROLOL FUMARATE USP AS MANUFACTURED IN CHONGQING CITY CHINA

19808 A

II

9/27/2006

PERRIGO API LTD

ANASTROZOLE AS MANUFACTURED IN BE'ER SHEVA ISRAEL

19809 A

II

9/28/2006

HIKMA PHARMACEUTICALS PLC

ENALAPRILAT USP AS MANUFACTURED IN AMMAN JORDAN

19810 A

II

8/31/2006

SANDOZ GMBH

MPI-ACA AS MANUFACTURED IN KUNDL AUSTRIA

19811 A

IV

9/28/2006

LIPOID GMBH

LIPOID PC 18:1/18:1 (DOPC) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

19812 A

II

9/29/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZOLPIDEM TARTRATE AS MANUFACTURED IN CHENNAI INDIA

19813 A

II

9/28/2006

LONZA AG

SIROLIMUS AS MANUFACTURED IN VISP SWITZERLAND

19814 A

III

6/9/2006

ROY AND LECLAIR EMBALLAGE INC

BOSTON ROUND FAMILY OF BOTTLES AS MANUFACTURED IN QUEBEC CANADA

19815 A

II

9/29/2006

UQUIFA ITALIA SPA

PYRANTEL PAMOATE USP AS MANUFACTURED IN MILAN ITALY

19816 A

II

9/29/2006

WOCKHARDT LTD

FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

19817 I

II

9/28/2006

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

CLORSULON USP AS MANUFACTURED IN ZHEJIANG CHINA

19818 A

II

8/18/2006

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG CHINA

19819 A

II

9/15/2006

FARMHISPANIA SA

ML-212 (ROCURONIUM BROMIDE) AS MANUFACTURED IN MONTMELO SPAIN

19820 A

IV

10/2/2006

NIPPON FINE CHEMICAL CO LTD

19821 A

IV

10/2/2006

NIPPON FINE CHEMICAL CO LTD

19822 A

II

10/2/2006

WUHAN SHIJI PHARMACEUTICAL CO LTD

A LIPOSOMAL EXCIPIENTDIPALMITOYLPHOSPHATIDYLCHOLINE (DPPC) AS MANUFACTURED


IN HYOGO JAPAN
A LIPOSOMAL EXCIPIENT 1-PALMITOYL-2-OLEOYL-PHOSPHATIDYLGLYCEROL (POPG) AS
MANUFACTURED IN HYOGO JAPAN
CLOZAPINE AS MANUFACTURED IN WUHAN CHINA

19823 A

II

9/27/2006

AUROBINDO PHARMA LTD

19824 I

III

9/25/2006

ROLLPRINT PACKAGING PRODUCTS INC

TAZOBACTAM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
RPP# 36-1216 AS MANUFACTURED IN ADDISON IL

19825 A

III

9/21/2006

CONSOLIDATED BOTTLE CORP

4 LITRE WIDEMOUTH ROUND JAR 110MM AS MANUFACTURED IN ONTARIO CANADA

19826 I

III

6/6/2006

T AND S BLOWMOULDING INC

30ML NATURAL HDPE CYLINDER (RESIN SCLAIR 58A)

19827 I

III

6/6/2006

T AND S BLOWMOULDING INC

19828 A

III

9/28/2006

APTAR FRANCE SAS

30ML NATURAL HDPE CYLINDER (RESIN INEOS B53-35H-011) AS MANUFACTURED IN ONTARIO


CANADA
LANDMARK DOSE INDICATING ACTUATOR AS MANUFACTURED IN LE VAUDREUIL FRANCE

19829 A

II

10/4/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

MONTELUKAST SODIUM AS MANUFACTURED IN NETANYA ISRAEL

19830 I

III

9/27/2006

AMPACET CORP

AMPACET 162805-MX MB AZUL AS MANUFACTURED IN QUERETARO MEXICO

19831 I

III

9/27/2006

AMPACET CORP

AMPACET 169181-MX MB AZUL AS MANUFACTURED IN QUERETARO MEXICO

19832 I

III

9/27/2006

AMPACET CORP

AMPACET 171921-MX MB VERDE AS MANUFACTURED IN QUERETARO MEXICO

19833 I

III

9/27/2006

AMPACET CORP

AMPACET 171920-MX MB AZUL AS MANUFACTURED IN QUERETARO MEXICO

19834 A

II

10/4/2006

DR REDDYS LABORATORIES LTD

TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19835 A

II

9/27/2006

JUBILANT GENERICS LTD

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA INDIA

19836 I

II

9/26/2006

JUBILANT ORGANOSYS LIMITED

QUETIAPINE FUMARATE AS MANUFACTURED IN KARNATAKA INDIA

19837 A

II

9/29/2006

AUROBINDO PHARMA LTD

STAVUDINE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA

Page 575

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19838 I
III
9/27/2006
ROHM AND HAAS CO
19839 A

II

10/5/2006

MYLAN LABORATORIES LTD

SUBJECT
AQUABOND 444A AND AQUABOND 444D AS MANUFACTURED IN BREMEN FEDERAL REPUBLIC
OF GERMANY
RITONAVIR USP (FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA

19840 A

II

10/9/2006

CADILA HEALTHCARE LTD

PROMETHAZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

19841 A

II

10/9/2006

CADILA HEALTHCARE LTD

ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA

19842 I

II

10/5/2006

BASF SE

DRY VITAMIN D3 50 AS MANUFACTURED IN BALLERUP DENMARK

19843 A

II

10/5/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

PHARMED BPT BIOCOMPATIBLE TUBING AS MANUFACTURED IN AKRON OHIO

19844 A

II

10/5/2006

ST GOBAIN PERFORMANCE PLASTICS CORP

TYGON S-50-HL MEDICAL/SURGICAL TUBING AS MANUFACTURED IN AKRON OHIO

19845 A

III

10/6/2006

WEATHERCHEM CORPORATION

DISPENSING CLOSURE AS MANUFACTURED IN TWINSBURG OH

19846 A

II

10/6/2006

HYDROMORPHONE HCI, USP AS MANUFACTURED IN WEST DEPTFORD, NJ

19847 I

II

10/6/2006

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
3M DRUG DELIVERY SYSTEMS DIV

19848 A

II

10/3/2006

19849 I

III

10/6/2006

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
ROLLPRINT PACKAGING PRODUCTS INC

19850 I

III

10/6/2006

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 20-0204 AS MANUFACTURED IN ADDISON IL

19851 I

II

10/6/2006

AUROBINDO PHARMA LTD

19852 A

II

10/10/2006

HETERO LABS LTD

INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTERED IN ANDHRA


PRADESH INDIA
LOPINAVIR USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

19853 A

II

10/10/2006

HETERO DRUGS LTD

PRAMIPEXOLE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19854 A

III

6/9/2006

ROY AND LECLAIR EMBALLAGE INC

FLAT OVAL FAMILY OF BOTTLES AS MANUFACTURED IN QUEBEC CANADA

19855 A

III

6/9/2006

ROY AND LECLAIR EMBALLAGE INC

CYLINDER FAMILY OF BOTTLES AS MANUFACTURED IN QUEBEC CANADA

19856 A

II

12/6/2006

EMCURE PHARMACEUTICALS LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA INDIA

19857 I

II

11/7/2006

IPCA LABORATORIES LTD

BENDROFLUMETHIAZIDE USP AS MANUFACTURED IN RATLAM (MP) INDIA

19858 A

II

11/1/2006

AURISCO PHARMACEUTICAL LTD

FLUMETHASONE AS MANUFACTURED IN ZHEJIANG CHINA

19859 I

II

10/12/2006

ZHEJIANG XINHUA PHARMACEUTICAL CO LTD

SPIRONOLACTONE AS MANUFACTURED IN ZHEJIANG CHINA

19860 I

II

10/12/2006

MATRIX LABORATORIES LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19861 A

II

10/12/2006

MYLAN LABORATORIES LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

19862 A

II

10/9/2006

AUROBINDO PHARMA LTD

19863 A

II

10/3/2006

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE

LOPINAVIR (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH


INDIA
STAVUDINE AS MANUFACTURED IN ISSO ITALY

19864 A

IV

10/13/2006

SIEGFRIED USA LLC

CELLULOSE ACETATE BUTYRATE NF AS MANUFACTURED IN PENNSVILLE NJ

19865 I

II

10/13/2006

RANBAXY LABORATORIES LTD

19866 I

II

10/13/2006

RANBAXY LABORATORIES LTD

7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID [7-AVCA] DRUG SUBSTANCE INTERMEDIATE


AS MANUFACTURED IN PUNJAB INDIA
CEFDINIR AS MANUFACTURED IN PUNJAB INDIA

19867 I

IV

10/9/2006

CARGILL FLAVOR SYSTEMS US LLC

19868 A

III

10/18/2006

ALUFLEXPACK NOVI D.O.O

NATURAL MIXED BERRY FLAVOR WONF (125-01054) - LIQUID AS MANUFACTURED IN


CINCINNATI OH
BLISTER FOIL AS MANUFACTURED IN ZADAR CROATIA

19869 I

IV

10/17/2006

PREMIUM INGREDIENTS GROUP

ARTIFICIAL MIXED BERRY FLAVOR (118A09F) AS MANUFACTURED IN WEST CHICAGO IL

19870 A

II

10/16/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

DIFLUPREDNATE AS MANUFACTURED IN MILANO ITALY

19871 A

II

10/16/2006

DR REDDYS LABORATORIES LTD

DIVALPROEX SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

MAXAIR AUTOHALER (PIRBUTEROL ACETATE INHALATION AEROSOL) AS MANUFACTURED IN


NORTHRIDGE CA
HYDROCODONE BITARTRATE USP AS MANUFACTURED IN WEST DEPTFORD NJ
RPP# 36-1223 AS MANUFACTURED IN ADDISON IL

Page 576

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19872 A
III
10/9/2006
WACKER CHEMIE AG

SUBJECT
ELASTOSIL R PLUS 400/40 AS MANUFACTURED IN BURGHAUSEN, GERMANY

19873 A

III

10/13/2006

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9699 POLYURETHANE-POLYOLEFIN TAPE AS MANUFACTURED IN VALLEY NE

19874 A

III

10/16/2006

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9700 AS MANUFACTURED IN VALLEY NE

19875 A

III

10/16/2006

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9767 EVA-BLEND TAPE AS MANUFACTURED IN VALLEY NE

19876 I

II

10/16/2006

ZHEJIANG XINHUA PHARMACEUTICAL CO LTD

CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

19877 I

II

10/17/2006

RAGACTIVES S L

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN VALLADOLID SPAIN

19878 A

III

10/18/2006

ALPLA MEXICO SA DE CV

TOOTHPASTE BOTTLE AND CAP AS MANUFACTURED IN TOLUCA MEXICO

19879 A

II

10/11/2006

AARTI INDUSTRIES LTD

VENLAFAXINE HYDROCLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

19880 A

II

10/17/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN BE'ER SHEVA ISRAEL

19881 I

III

10/12/2006

AMPACET CORP

AMPACET 151334-K RED 334 AS MANUFACTURED IN RAYONG THAILAND

19882 I

II

10/17/2006

MALLINCKRODT LLC

AMPHETAMINE BASE CODE 6507 AS MANUFACTURED IN ST LOUIS MO

19883 A

III

10/10/2006

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9761 POLYETHYLENE TAPE AS MANUFACTURED IN BROOKINGS SD

19884 A

II

10/14/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA

19885 I

II

10/20/2006

NUVIEW LIFE SCIENCES

SODIUM IODIDE-123-02 DRY IODINE AS MANUFACTURED IN DENTON TX

19886 I

III

10/18/2006

DYNIC USA

SPEED WAX THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO OR

19887 A

II

10/19/2006

APTALIST PHARMATECH INC

EUR-1046 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA OH

19888 A

III

10/4/2006

BASF SE

19889 A

III

10/4/2006

BASF SE

19890 A

II

6/2/2006

TRIFARMA SPA

ULTRAFORM S2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,


GERMANY
ULTRAFORM W2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
PROCHLORPERAZINE BASE

19891 A

III

6/13/2006

CLARIANT PRODUCTION FRANCE

CHILD RESISTANT CLOSURE AS MANUFACTURED IN ROMORANTIN FRANCE

19892 A

II

10/5/2006

LUPIN LTD

LAMOTRIGINE (MICRONISED) AS MANUFACTURED IN MAHARASHTRA INDIA

19893 A

II

10/23/2006

MERCK KGAA

19894 I

II

10/23/2006

SANDOZ PRIVATE LTD

DI-POTASSIUM HYDROGEN PHOSPHATE AS MANUFACTURED IN FRANKFURTER STRASSE,


GERMANY
ROSIGLITAZONE MALEATE AS MANUFACTURED IN MAHARASHTRA INDIA

19895 A

III

10/24/2006

MURASE GLASS CO LTD

AMPOULE VIAL AND SCREW VIAL AS MANUFACTURED IN CHIBA JAPAN

19896 I

5/25/2005

DIOSYNTH BV

DOWN STREAM PROCESSING FACILITY LOCATED IN OSS THE NETHERLANDS

19897 A

III

10/23/2006

STELLA KUNSTSTOFFTECHNIK GMBH

MEASURING CUP AS MANUFACTURED IN KASTELLAUN, GERMANY

19898 A

II

10/17/2006

MALLINCKRODT INC

OXYCODONE BASE - CODE 8180 AS MANUFACTURED IN ST LOUIS MO

19899 A

II

10/16/2006

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD

CARBIDOPA AS MANUFACTURED IN ZHEJIANG CHINA

19900 A

III

10/16/2006

FARMACAP INDUSTRIA E COMERCIO LTDA

RUBBER STOPPERS AS MANUFACTURED IN POTUVERA BRAZIL

19901 A

II

10/17/2006

APOTEX PHARMACHEM INC

PAMIDRONIC ACID AS MANUFACTURED IN ONTARIO CANADA

19902 A

II

10/20/2006

LUPIN LTD

RIFABUTIN USP AS MANUFACTURED IN MAHARASHTRA INDIA

19903 A

II

10/25/2006

LUPIN LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA

19904 A

II

10/26/2006

NAVINTA LLC

HYDRALAZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

19905 I

II

10/24/2006

PT SINKONA INDONESIA LESTARI

QUININE SULFATE USP AS MANUFACTURED IN WEST JAVA INDONESIA

19906 A

III

10/24/2006

NOLATO JAYCARE LTD

150ML BOTTLE AS MANUFACTURED IN PORTSMOUTH HAMPSHIRE UK

19907 A

III

10/24/2006

NOLATO JAYCARE LTD

SAF PAK RANGE OF BOTTLES AS MANUFACTURED IN PORTSMOUTH HAMPSHIRE UK

Page 577

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19908 A
II
10/26/2006
AUROBINDO PHARMA LTD
19909 A

II

10/28/2006

APTALIS PHARMATECH INC

SUBJECT
LAMOTRIGINE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH
INDIA
EUR-1048 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA OH

19910 I

II

10/28/2006

AURO LABORATORIES LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

19911 A

II

10/30/2006

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

FAMOTIDINE USP AS MANUFACTURED IN BARCELONA SPAIN

19912 A

II

10/26/2006

IRVINE SCIENTIFIC SALES CO

FMDF-6 (KIRIN) AS MANUFACTURED IN SANTA ANA CALIFORNIA

19913 A

II

10/26/2006

IRVINE SCIENTIFIC SALES CO

KI NSM-12 (KIRIN) AS MANUFACTURED IN SANTA ANA CALIFORNIA

19914 A

II

10/25/2006

ALDRICH CHEMICAL CO ISOTEC FACILITY

19915 A

II

11/1/2006

CYALUME SPECIALTY PRODUCTS INC

CARBAMAZEPINE-13C1, 15N1 FOR CLINICAL RESEARCH AS MANUFACTURED IN MIAMISBURG,


OH
PRAMOXINE HYDROCHLORIDE USP AS MANUFACTURED IN BOUND BROOK, NJ

19916 I

II

8/31/2006

KAIFENG PHARMACEUTICAL (GROUP) CO LTD

GENTAMICIN SULFATE AS MANUFACTURED IN KAIFENG CHINA

19917 I

II

10/30/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN ZAGREB CROATIA

19918 A

II

10/30/2006

HELSINN ADVANCED SYNTHESIS SA

ISOTRETINOIN AS MANUFACTURED IN BIASCA SWITZERLAND

19919 I

II

11/1/2006

CARISOPRODOL USP AS MANUFACTURED IN ZHEJIANG CHINA

19920 A

II

11/2/2006

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
SANDOZ PRIVATE LTD

19921 A

II

8/15/2006

NINGBO DOUBLE SUN PHARMACEUTICAL CO LTD

GLICLAZIDE AS MANUFACTURED IN ZHEJIANG CHINA

19922 A

II

10/17/2006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) AS MANUFACTURED IN ZHEJIANG CHINA

19924 I

IV

10/28/2006

CHEMCAPS LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTAN INDIA

19925 A

II

11/20/2006

IPCA LABORATORIES LTD

19926 A

II

11/2/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

METFORMIN HYDROCHLORIDE USP (PROCESS-II) AS MANUFACTURED IN MADHYA PRADESH


INDIA
ARIPIPRAZOLE AS MANUFACTURED IN BE'ER SHEVA ISRAEL

19927 A

II

11/1/2006

ACS DOBFAR SPA

CEFEPIME HYDROCHLORIDE ORAL GRADE AS MANUFACTURED IN MILANO ITALY

19928 A

III

9/20/2006

SHANDONG PHARMACEUTICAL GLASS CO LTD

19929 A

III

10/28/2006

SHANDONG PHARMACEUTICAL GLASS CO LTD

19930 I

III

9/20/2006

SHANDONG PHARMACEUTICAL GLASS CO LTD

19931 A

II

10/10/2006

WANBURY LTD

GLASS (TYPE III) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN


SHANDONG CHINA
GLASS (TYPE I) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN
SHANDONG CHINA
ELASTOMERIC CLOSURES FOR PHARMA PACKAGING AS MANUFACTURING IN SHANDONG
CHINA
SERTRALINE HYDROCHLORIDE FORM I AS MANUFACTURED IN ANDHRA PRADESH INDIA

19932 A

II

10/30/2006

AUROBINDO PHARMA LTD

19933 I

II

8/18/2006

CADILA PHARMACEUTICALS LTD

EFAVIRENZ (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH


INDIA
ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

19934 A

II

11/3/2006

CHEMI SPA

SODIUM ALENDRONATE TRIHYDRATE AS MANUFACTURED IN PATRICA ITALY

19935 A

III

10/30/2006

AMCOR FLEXIBLES BURGDORF GMBH

19936 A

II

11/6/2006

CAMBREX CHARLES CITY INC

COATED PAPER 60/ALUMINIUM 8/LLDPE 50 (SOP 50158) AS MANUFACTURED IN BURGDORF


SWITZERLAND
CARVEDILOL AS MANUFACTURED IN CHARLES CITY IA

19937 A

II

11/2/2006

SAVIOR LIFETEC CORP TAINAN BRANCH

IMIPENEM AS MANUFACTURED IN TAINAN TAIWAN

19938 A

II

10/30/2006

SAVIOR LIFETEC CORP TAINAN BRANCH

CILASTATIN AS MANUFACTURED IN TAINAN TAIWAN

19939 I

III

11/1/2006

LORMAC INDUSTRIAL DISTRIBUTORS LTD

19940 I

III

11/1/2006

LORMAC INDUSTRIAL DISTRIBUTORS LTD

LORMAC TYPE 1P ANTI-STATIC POLYETHYLENE PRODUCTS AS MANUFACTURED IN CO CORK


IRELAND
LORMAC TYPE 1X ANTI-STATIC POLYETHYLENE PRODUCTS AS MANUFACTURED IN CO CORK
IRELAND

19923 N

ARIPIPRAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA

NOT AN ASSIGNED NUMBER

Page 578

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19941 A
III
11/1/2006
ULTRAAFLEX INDIA

SUBJECT
PLAIN/PRINTED ALUMINIUM FOILS AS MANUFACTURED GOA INDIA

19942 A

II

11/1/2006

IMMUTEP SA

IMP321 AS MANUFACTURED IN GOSSELIES BELGIUM

19943 A

II

11/8/2006

CATALENT PHARMA SOLUTIONS

19944 A

11/7/2006

CELSIS INC

MICONAZOLE GELATIN ENCAPSULATED VAGINAL SUPPOSITORY 200 MG AS MANUFACTURED


IN SOMERSET NJ
CELSIS AKUSCREEN AS MANUFACTURED IN LANDGRAAF THE NETHERLANDS

19945 A

III

11/2/2006

AMPACET CORP

AMPACET PRODUCT 112147 WHITE POLYETHYLENE AS MANUFACTURED IN TERRE HAUTE IN

19946 A

IV

7/26/2006

NATURAL BANANA FLAVOR WONF #8763 AS MANUFACTURED IN PHILADELPHIA PA

19947 A

II

11/8/2006

HENRY H OTTENS MANUFACTURING COMPANY


INC
TARO PHARMACEUTICAL INDUSTRIES LTD

19948 A

II

11/1/2006

YUNG ZIP CHEMICAL IND CO LTD

ACYCLOVIR (PROCESS II) AS MANUFACTURED IN TACHIA TAIWAN

19949 A

II

11/6/2006

SUN PHARMACEUTICAL INDUSTRIES LTD

ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA

19950 A

III

11/9/2006

SCHOTT BRASIL LTDA

GLASS PRODUCTS AS MANUFACTURED IN ITUPEVA SP BRAZIL

19951 I

II

11/2/2006

JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD

FLUTAMIDE AS MANUFACTURED IN JIANGSU CHINA

19952 I

IV

11/7/2006

BIO CIDE INTERNATIONAL INC

SODIUM CHLORITE EXCIPIENT INGREDIENT AS MANUFACTURED IN NORMAN OK

19953 A

III

11/13/2006

19954 A

IV

10/30/2006

INYECCIONES PLASTICAS DE QUERETARO SA DE


CV
FREUND CORP

PET INJECTED FLAVOR BARRIER INSERT AND HDPE INJECTED SHOULDER FOR TOOTHPASTE
BOTTLE AS MANUFACTURED IN MEXICO CITY MEXICO
NONPAREIL-108 AS MANUFACTURED IN HAMAMATSU CITY JAPAN

19955 I

III

10/30/2006

REXAM PHARMA SAS

SEABISCUIT RANGE AS MANUFACTURED IN OFFRANVILLE FRANCE

19956 A

II

11/4/2006

IND SWIFT LABORATORIES LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA

19957 A

II

11/13/2006

APOTEX PHARMACHEM INC

ARIPIPRAZOLE AS MANUFACTURED IN ONTARIO CANADA

19958 I

III

11/14/2006

ARTE CORP

SINGLE CHAMBER PREFILLABLE SYRINGE AS MANUFACTURED IN TAKAHAGI CITY JAPAN

19959 A

II

11/7/2006

AUROBINDO PHARMA LTD

19960 A

II

11/14/2006

DOXAZOSIN MESYLATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFIXIME AS MANUFACTURED IN KANCHEEPURAM INDIA

19961 A

II

11/14/2006

DR REDDYS LABORATORIES LTD

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19962 I

IV

11/13/2006

FONA INTERNATIONAL INC

825.609 N-C CHERRY BERRY FLAVOR ARTIFICIAL AS MANUFACTURED IN GENEVA IL

19963 I

IV

11/13/2006

FONA INTERNATIONAL INC

935.195 N-C COOLING FLAVOR, NATURAL AS MANUFACTURED IN GENEVA IL

19964 I

IV

11/13/2006

FONA INTERNATIONAL INC

848.0001U N-C EUCALYPTUS FLAVOR NATURAL AS MANUFACTURED IN GENEVA IL

19965 I

II

11/10/2006

FARCHEMIA SRL

TRIMETHOBENZAMIDE HCI AS MANUFACTURED IN BERGAMO ITALY

19966 A

II

11/15/2006

UBE INDUSTRIES LTD

BEPOTASTINE BESILATE AS MANUFACTURED IN UBE YAMAGUCHI JAPAN

19967 A

II

11/15/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

19968 A

II

11/3/2006

JUBILANT GENERICS LTD

RISEDRONATE SODIUM AS MANUFACTURED IN KARNATAKA INDIA

19969 A

III

11/14/2006

PHILLIPS 66

POLYPROPYLENE HOMOPOLYMER CH200LN-02 AS MANUFACTURED IN LINDEN NJ

19970 I

II

11/16/2006

DR REDDYS LABORATORIES LTD

19971 A

II

11/15/2006

SAI ADVANTIUM PHARMA LTD

PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH


INDIA
EPOPROSTENOL SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

19972 A

II

11/16/2006

GRANULES INDIA LTD

COMPRESSO PAP 90 CPC AS MANUFACTURED IN AP INDIA

19973 A

II

11/8/2006

SARACA LABORATORIES LIMITED

RANITIDINE HCI (FORM-I) AS MANUFACTURED IN HYDERABAD INDIA

19974 I

II

11/3/2006

OLON SPA

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN MILANO ITALY

19975 A

II

11/3/2006

OLON SPA

FUROSEMIDE AS MANUFACTURED IN MULAZZANO (LO) ITALY

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY ISRAEL

Page 579

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
19976 A
III
11/15/2006
PPG INDUSTRIES INC

SUBJECT
PPG2004877 AS MANUFACTURED IN OAK CREEK WI

19977 I

III

11/13/2006

ASHLAND INC

FLEXCRYL AF2027 AS MANUFACTURED IN PIEDMONT SC

19978 A

II

12/13/2006

STREM CHEMICALS INC

FOMEPIZOLE AS MANUFACTURED IN NEWBURYPORT MA FOR CHEMWERTH

19979 A

II

11/20/2006

LEK PHARMACEUTICALS DD

TACROLIMUS AS MANUFACTURED IN MENGES SLOVENIA

19980 A

II

10/10/2006

CHANGZHOU SIYAO PHARMACEUTICALS CO LTD

FLUOXETINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU CHINA

19981 I

II

11/17/2006

HOVIONE FARMACIENCIA SA

FLUMETHASONE AS MANUFACTURED IN LOURES PORTUGAL

19982 A

II

10/10/2006

TAI HENG INDUSTRY CO LTD

ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG CHINA

19983 A

II

11/16/2006

AUROBINDO PHARMA LTD

19984 A

II

11/17/2006

NEULAND LABORATORIES LTD

CEPHALOTHIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED


IN ANDHRA PRADESH INDIA
ENALAPRIL MALEATE USP AS MANUFACTURED IN TELANGANA, INDIA

19985 I

II

10/19/2006

M/S MARKSANS PHARMA LIMITED

METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN PUNE INDIA

19986 A

II

11/15/2006

WANBURY LTD

DIPHENHYDRAMINE CITRATE AS MANUFACTURED IN MAHARASHTRA INDIA

19987 A

II

11/22/2006

CIPLA LTD

TELMISARTAN AS MANUFACTURED IN MAHARASHTRA INDIA

19988 A

II

11/22/2006

HETERO LABS LTD

LOSARTAN POTASSIUM (FORM 1) AS MANUFACTURED IN ANDHRA PRADESH INDIA

19989 A

II

11/23/2006

ITF CHEMICAL LTDA

ROSIGLITAZONE MALEATE AS MANUFACTURED IN BAHI BRAZIL

19990 A

II

11/22/2006

DR REDDYS LABORATORIES LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH INDIA

19991 A

II

11/22/2006

MOEHS IBERICA SL

MEPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA SPAIN

19992 A

III

11/13/2006

AMPACET CORP

19993 A

II

11/20/2006

FARCHEMIA SRL

AMPACET 163058 DARK BLUE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN


TERRE HAUTE IN
MESALAZINE HIGH DENSITY AS MANUFACTURED IN BERGAMO ITALY

19994 I

III

11/17/2006

RICON COLORS INC

BLUE REFLEX FDA CPP-BL-3578-1 AS MANUFACTURED IN WEST CHICAGO IL

19995 A

II

11/24/2006

LABORATORIO CHIMICO INTERNAZIONALE SPA

FENOFIBRIC ACID AS MANUFACTURED IN MILAN ITALY

19996 A

II

11/27/2006

DR REDDYS LABORATORIES LTD

VORICONAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA

19997 A

II

11/27/2006

DR REDDYS LABORATORIES LTD

ATORVASTATIN CALCIUM (FORM P) AS MANUFACTURED IN ANDHRA PRADESH INDIA

19998 I

II

11/17/2006

AUROBINDO PHARMA LTD

19999 I

II

11/21/2006

WANBURY LTD

CEFTAZIDIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
IBUPROFEN DC GRADE-65% AS MANUFACTURED IN MAHARASHTRA INDIA

20000 A

III

9/21/2006

THE CONTROL GROUP

LAMINATED AND PRINTED PACKAGING FILMS AS MANUFACTURED IN NORWOOD NJ

20001 I

II

11/23/2006

PALL BIOSEPRA DIVISION OF PALL FRANCE SA

BIOSEPRA PPAHYPERCEL SORBENT AS MANUFACTURED IN ST PIERRE LES ELBEUF FRANCE

20002 I

II

11/23/2006

PALL BIOSEPRA DIVISION OF PALL FRANCE SA

BIOSEPRA HEA HYPERCEL AS MANUFACTURED IN ST PIERRE LES ELBEUF FRANCE

20003 A

II

11/29/2006

CIPLA LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN MAHARASHTRA INDIA

20004 A

II

11/30/2006

GADOR SA

20005 A

III

11/22/2006

COLORS FOR PLASTICS INC

20006 I

II

11/30/2006

SCORA

20007 A

II

11/30/2006

DR REDDYS LABORATORIES LTD

18-METHYLNORETHINDRONE OXIME (NORELGESTROMIN) AS MANUFACTURED IN BUENOS


AIRES ARGENTINA
THERMOPLASTIC RESIN COLORANT MASTERBATCH W04200 AS MANUFACTURED IN ELK
GROVE VILLAGE IL
SCORALITE AND SCORALITE LOW LEAD CALCIUM CARBONATE AS MANUFACTURED IN
CAFFIERS FRANCE
PRIMIDONE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20008 A

II

12/1/2006

DR REDDYS LABORATORIES LTD

IRBESARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

20009 I

II

11/30/2006

PHARMACEUTICAL WORKS POLPHARMA SA

SULFADIMETHOXINE SODIUM AS MANUFACTURED IN STAROGARD GDANSKI POLAND

20010 A

II

11/30/2006

INDUSTRIALE CHIMICA SRL

BUDESONIDE USP AS MANUFACTURED IN SARONNO ITALY

Page 580

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20011 A
II
11/29/2006
APICORE US LLC
20012 N

SUBJECT
PHENOXYBENZAMINE HYDROCHLORIDE AS MANUFACTURED IN SOMERSET, NJ

NOT AN ASSIGNED NUMBER

20013 A

II

11/24/2006

JUBILANT GENERICS LTD

20014 I

II

12/5/2006

ORCHID CHEMICALS AND PHARMACEUTICALS LTD AZTREONAM AS MANUFACTURED IN MAHARASHTRA INDIA

20015 A

II

12/5/2006

HETERO LABS LTD

EFAVIRENZ(PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH INDIA

20016 A

III

11/28/2006

POLYONE CORP

CC00001986DR 10031450 ALCOA WHITE AS MANUFACTURED IN VONORE TN

20017 A

III

11/26/2006

STYROLUTION EUROPE GMBH

TERLUX HD 2812 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

20018 A

III

11/25/2006

ISHAN INDUSTRIES

PET BOTTLES AS MANUFACTURED IN SILVASSA INDIA

20019 A

III

11/25/2006

ISHAN INDUSTRIES

COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN SILVASSA INDIA

20020 I

II

12/9/2006

SANMAR SPECIALITY CHEMICALS LTD

LETROZOLE USP AS MANUFACTURED IN TAMIL NADU INDIA

20021 A

II

12/8/2006

SCINOPHARM TAIWAN LTD

DOCETAXEL AS MANUFACTURED IN TAINAN TAIWAN

20022 A

II

12/8/2006

SIEMENS MOLECULAR IMAGING

20023 A

II

11/21/2006

ALEMBIC PHARMACEUTICALS LTD

STERILE NON-PYROGENIC 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT) AS


MANUFACTURED IN CULVER CITY CA
CLARITHROMYCIN USP AS MANUFACTURED IN GUJARAT INDIA

20024 A

III

11/21/2006

APEX PLASTICS INC

PACKAGING BLOW MOLDED BOTTLE AS MANUFACTURED IN BROOKFIELD MO

20025 I

II

10/31/2006

STANDARD CHEM AND PHARM CO LTD

TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN TAINAN TAIWAN

20026 N

CITALOPRAM HYDROBROMIDE (DGR) AS MANUFACTURED IN KARNATAKA INDIA

NOT AN ASSIGNED NUMBER

20027 A

III

12/4/2006

NATIONAL PLASTICS COLOR INC

20028 I

III

11/27/2006

BERRY PLASTICS CORP TAPES AND COATINGS DIV MS-H-2530SR AS MANUFACTURED IN HOMER LA

COLORANT AS MANUFACTURED IN VALLEY CENTER KS

20029 A

II

12/10/2006

NOF CORP

20030 I

III

12/6/2006

ROHM AND HAAS CO

20031 A

II

12/4/2006

AUROBINDO PHARMA LTD

20032 A

II

12/7/2006

FIS FABBRICA ITALIANA SINTETICI SPA

ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
FIS0127 AS MANUFACTURED IN VICENZA ITALY

20033 A

II

12/13/2006

HERAEUS PRECIOUS METALS GMBH AND CO KG

ARSENIC TRIOXIDE USP AS MANUFACTURED IN HANAU, GERMANY

20034 A

II

12/14/2006

ANJAN DRUG PRIVATE LTD

VALPROIC ACID USP AS MANUFACTURED IN TAMIL NADU INDIA

20035 A

II

12/14/2006

DR REDDYS LABORATORIES LTD

MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

20036 A

II

12/14/2006

ANJAN DRUG PRIVATE LTD

DIVALPROEX SODIUM USP AS MANUFACTURED IN TAMIL NADU INDIA

20037 A

II

12/19/2006

IPCA LABORATORIES LTD

GLIMEPIRIDE USP AS MANUFACTURED IN RATLAM (MP) INDIA

20038 A

II

12/11/2006

WANBURY LTD

METHOXSALEN AS MANUFACTURED IN ANDHRA PRADESH INDIA

20039 A

II

12/13/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

EZETIMIBE AS MANUFACTURED IN BE'ER SHEVA ISRAEL

20040 A

II

12/12/2006

MERCK AND CIE

L-METHYLFOLATE CALCIUM AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

20041 A

II

12/14/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

MUPIROCIN CALCIUM AS MANUFACTURED IN HUNGARY

20042 A

III

11/24/2006

AMCOR FLEXIBLES HORSENS

PETP12/ALU7/PETP12/LLDPE60 AS MANUFACTURED IN HORSENS DENMARK

20043 I

II

12/11/2006

WANBURY LTD

IBUPROFEN DC GRADE-90% AS MANUFACTURED IN MAHARASHTRA INDIA

20044 A

III

12/14/2006

NOLATO JAYCARE LTD

PUSH-LOK RANGE OF CLOSURES AS MANUFACTURED IN HAMPSHIRE UK

20045 A

II

12/15/2006

SANDOZ PRIVATE LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA INDIA

20046 A

II

12/16/2006

RANBAXY LABORATORIES LTD

CILASTATIN ACID AS MANUFACTURED IN MADHYA PRADESH INDIA

METHOXYPOLY(ETHYLENE GLYCOL)-PROPYLALDEHYDE MW20000 AS MANUFACTURED IN


KANAGAWA JAPAN
ROBOND PS-8136 AS MANUFACTURED IN CROYDON PA

Page 581

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20047 A
II
12/16/2006
RANBAXY LABORATORIES LTD

SUBJECT
BICYCLOKETONE DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN PUNJAB INDIA

20048 A

II

12/16/2006

RANBAXY LABORATORIES LTD

20049 A

III

6/26/2006

EMS CHEMIE NORTH AMERICA INC

IMIPENEM TECHNICAL DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN MADHYA


PRADESH INDIA
GRILFLEX ELG 5930 NATURAL AS MANUFACTURED IN DOMAT/EMS SWITZERLAND

20050 I

III

12/15/2006

STELLA KUNSTSTOFFTECHNIK GMBH

20051 A

II

12/14/2006

AARTI DRUGS LTD

PRIMARY PACKAGE CONSISTING OF BOTTLE, PLUG AND BRUSH CLOSURE AS


MANUFACTURED IN
NIACIN AS MANUFACTURED IN MAHARASHTRA INDIA

20052 A

II

12/16/2006

JUBILANT GENERICS LTD

ZOLEDRONIC ACID AS MANUFACTURED IN MYSORE INDIA

20053 A

II

12/18/2006

LEK PHARMACEUTICALS DD

CANDESARTAN CILEXETIL AS MANUFACTURED IN MENGES SLOVENIA

20054 A

II

12/19/2006

HERAEUS PRECIOUS METALS GMBH AND CO KG

OXALIPLATIN PROCESS HER-2 USP AS MANUFACTURED IN HANAU, GERMANY

20055 I

II

12/8/2006

SAI PHYTOCEUTICALS PVT LTD

CAMPTOTHECIN AS MANUFACTURED IN MADHYA PRADESH INDIA

20056 I

IV

12/19/2006

FONA INTERNATIONAL INC

833.046 NATURAL COFFEE CONCENTRATE AS MANUFACTURED IN GENEVA IL

20057 I

IV

12/19/2006

FONA INTERNATIONAL INC

807.002 NAT. MIXED BERRY FLAVOR WONF AS MANUFACTURED IN GENEVA IL

20058 I

II

5/31/2006

NUVIEW LIFE SCIENCES

INDIUM CHLORIDE (111-IN) RADIOCHEMICAL AS MANUFACTURED DENTON TX

20059 A

II

12/19/2006

ASPEN OSS BV

VECURONIUM BROMIDE AS MANUFACTURED IN AB OSS THE NETHERLANDS

20060 A

II

11/23/2006

S M HERBALS PVT LTD

CAMPTOTHECIN [CAS NO. 7689-03-4] AS MANUFACTURED IN RAJASTHAN INDIA

20061 A

II

12/19/2006

CHONGQING DAXIN PHARMACEUTICAL CO LTD

LOVASTATIN AS MANUFACTURED IN CHONGQING CHINA

20062 I

II

12/8/2006

SAI PHYTOCEUTICALS PVT LTD

10-DEACETYL BACCATIN-III AS MANUFACTURED IN MADHYA PRADESH INDIA

20063 I

II

12/13/2006

WATSON PHARMA PRIVATE LTD

TAZAROTENE AS MANUFACTURED IN MAHARASHTRA INDIA

20064 A

II

12/13/2006

WATSON PHARMA PRIVATE LTD

ADAPALENE AS MANUFACTURED IN MAHARASHTRA INDIA

20065 A

III

12/14/2006

POLYONE CORP

VC1000388260 GEON XV3432 TRANS 9000 AS MANUFACTURED IN AVON LAKE OH

20066 A

II

12/21/2006

CILAG AG

ALCAFTADINE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

20067 A

II

12/14/2006

RANBAXY LABORATORIES LTD

LAMIVUDINE USP AS MANUFACTURED IN PUNJAB INDIA

20068 A

II

12/20/2006

TEVA PHARMACEUTICALS INDUSTRIES LTD

ROCURONIUM BROMIDE AS MANUFACTURED IN LERMA MEXICO

20069 A

II

12/20/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN BE'ER SHEVA ISRAEL

20070 A

II

5/18/2007

APOTEX PHARMACHEM INC

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN BRANTFORD ON CANADA

20071 A

II

5/15/2007

WOCKHARDT LTD

ADENOSINE USP AS MANUFACTURED IN GUJARAT INDIA

20072 A

II

12/20/2006

TEVA PHARMACEUTICAL INDUSTRIES LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN DEBRECEN HUNGARY

20073 A

II

12/20/2006

CHEMPACIFIC CORP

MELPHALAN DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD

20074 I

II

12/18/2006

AZITHROMYCIN USP (API) AS MANUFACTURED IN SHIJIAZHUANG CHINA

20075 I

II

12/22/2006

SHIJIAZHUANG PHARMACEUTICAL GROUP


HUASHENG PHARMA CO LTD
RANBAXY LABORATORIES LTD

20076 A

II

12/26/2006

SANDOZ GMBH

CEFPODOXIME PROXETIL AS MANUFACTURED IN KUNDL AUSTRIA

20077 A

II

11/9/2006

KYONGBO PHARMACEUTICAL CO LTD

20078 A

12/20/2006

BIOPHARMA SRL

CEFTRIAXONE SODIUM STERILE BULK AS MANUFACTURED IN CHUNGCHEONG NAM DO


KOREA
BIOPHARMA SRL MANUFACTURING IN ROMA ITALY

20079 A

II

12/22/2006

20080 A

III

12/20/2006

CARDINAL HEALTH 414 LLC CARDINAL HEALTH


NUCLEAR PHARMACY SERVICES
3M DRUG DELIVERY SYSTEMS

TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER (I) TETRAFLUOROBORATE DRUG


SUBSTANCE AS MANUFACTURED IN DUDLEY CRAMLINGTON UK
SCOTHCHPAK 9748 RELEASE LINER AS MANUFACTURED IN ZWIJNDRECHT BELGIUM

20081 A

II

10/17/2006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN ZHEJIANG CHINA

20082 A

II

12/21/2006

SYNTHON BV

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN PRAGUE CZECH REPUBLIC

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA

Page 582

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20083 A
III
12/22/2006
SRC MEDICAL INC

SUBJECT
DROPPER ASSEMBLIES AS MANUFACTURED IN HANOVER MA

20084 A

IV

12/22/2006

FUJI CHEMICAL INDUSTRY CO LTD

F-MELT TYPE C (EXCIPIENT) AS MANUFACTURED IN TOYAMA JAPAN

20085 I

II

12/21/2006

ZHEJIANG XINHUA PHARMACEUTICAL CO LTD

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

20086 A

II

12/27/2006

RANBAXY LABORATORIES LTD

IMIPENEM USP (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA

20087 I

II

12/27/2006

RANBAXY LABORATORIES LTD

STAVUDINE USP AS MANUFACTURED IN PUNJAB INDIA

20088 I

II

12/27/2006

RANBAXY LABORATORIES LTD

20089 A

II

12/27/2006

RANBAXY LABORATORIES LTD

NEVIRAPINE USP (ANHYDROUS) (NON-STERILE BULK) DRUG SUBSTANCE AS


MANUFACTURED IN PUNJAB INDIA
CILASTATIN SODIUM USP (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA

20090 A

II

12/27/2006

RANBAXY LABORATORIES LTD

SODIUM BICARBONATE USP (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA

20091 I

II

12/27/2006

RANBAXY LABORATORIES LTD

20092 I

III

12/26/2006

KUNSTSTOFFWERK KREMSMUNSTER GMBH

20093 A

II

12/21/2006

AMINO CHEMICALS LTD

CANDESARTAN CILEXETIL (NON STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN


PUNJAB INDIA
PP 28 CHILD RESISTANT TAMPER EVIDENT SCREW CAPS AS MANUFACTURED IN
KREMSMUNSTER AUSTRIA
TOLTERODINE TARTRATE AS MANUFACTURED IN MARSA MALTA

20094 I

II

12/6/2006

CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN JIANGSU CHINA

20095 A

II

12/23/2006

JIANGSU JIWA RINTECH PHARMACEUTICAL CO


LTD
WOCKHARDT LTD

20096 A

II

12/28/2006

UQUIFA MEXICO SA DE CV

TOLTERODINE TARTRATE AS MANUFACTURED IN MORELOS MEXICO

20097 A

II

12/27/2006

AARTI INDUSTRIES LTD

BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

20098 A

II

12/28/2006

EMERALD KALAMA CHEMICAL LLC

BENZYL ALCOHOL NF-API AS MANUFACTURED IN KALAMA WA

20099 A

II

12/28/2006

FRESENIUS KABI ONCOLOGY LTD

BICALUTAMIDE AS MANUFACTURED IN WEST BENGAL INDIA

20100 A

II

12/29/2006

DR REDDYS LABORATORIES LTD

ALENDRONATE SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

20101 A

II

12/29/2006

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS

2-(1-AMINO-1-METHYL-ETHYL)-HYDROXY-1-METHYL-6-OXO-1,6-DIHYDROPYRIMIDINE-4CARBOXYLIC ACID 4-FLUORO-BENZYLAMIDE (ECB) AS MANUFACTURED IN CONSHOHOCKEN


PA

20102 I

II

11/29/2006

LEVOCARNITINE AS MANUFACTURED IN LIAONING CHINA

20103 A

II

12/29/2006

NORTHEAST GENERAL PHARMACEUTICAL


FACTORY
CAMBREX CHARLES CITY INC

20104 I

II

12/28/2006

AGNO PHARMA USA

SULINDAC AS MANUFACTURED IN JIANGSU CHINA

20105 A

II

12/27/2006

AMINO CHEMICALS LTD

ZIPRASIDONE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN MARSA MALTA

20106 I

II

12/27/2006

AMINO CHEMICALS LTD

ADAPALENE AS MANUFACTURED IN MARSA MALTA

20107 A

II

1/2/2007

MYLAN LABORATORIES LTD

STAVUDINE USP (STM) AS MANUFACTURED IN TELANGANA INDIA

20108 A

II

1/3/2007

MYLAN LABORATORIES LTD

20109 A

II

1/3/2007

MYLAN LABORATORIES LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN TELANGANA AND ANDHRA


PRADESH, INDIA
TELMISARTAN USP AS MANUFACTURED IN TELANGANA INDIA

20110 A

II

1/4/2007

SMS PHARMACEUTICALS LTD

ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

20111 A

III

1/2/2007

WACKER CHEMICAL CORP

VINNOL H 40/43 AS MANUFACTURED IN BURGHAUSEN, GERMANY

20112 A

II

1/3/2007

MYLAN LABORATORIES LTD

AMLODIPINE BESYLATE USP AS MANUFACTURED TELANGANA, INDIA

20113 A

II

12/30/2006

AUROBINDO PHARMA LTD

20114 A

II

1/4/2007

UQUIFA ITALIA SPA

TERAZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED


IN ANDHRA PRADESH INDIA
PYRANTEL TARTRATE ZEOLEX AS MANUFACTURED IN MILAN ITALY

20115 A

IV

12/15/2006

CRODA INC

TWEEN 80 HP-LQ-(MH) AS MANUFACTURED IN MILL HALL PA

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

MMB4 DIMESYLATE AS MANUFACTURED IN CHARLES CITY IA

Page 583

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20116 A
II
1/3/2007
PERRIGO API LTD
20117 A

II

12/15/2006

APOTEX PHARMACHEM INC

SUBJECT
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN BE'ER SHEVA
ISRAEL
ATORVASTATIN CALCIUM GRANULATION AS MANUFACTURED IN ONTARIO CANADA

20118 A

II

12/19/2006

SANOFI AVENTIS DEUTSCHLAND GMBH

ARTICAINE HYDROCHLORIDE AS MANUFACTURED IN FRANKFURT, GERMANY

20119 A

II

1/5/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

20120 A

II

12/11/2006

TAIWAN BIOTECH CO LTD

BISOPROLOL FUMARATE AS MANUFACTURED IN TAOYUAN CHINA

20121 A

II

1/9/2007

UNIMARK REMEDIES LTD

20122 A

II

12/27/2006

AUROBINDO PHARMA LTD

20123 A

II

1/8/2007

FERTIN PHARMA AS

7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID (7ACCA) AS MANUFACTURED IN


GUJARAT INDIA
GABAPENTIN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
NICOTINE POLACRILEX USP AS MANUFACTURED IN VEJLE DENMARK

20124 I

II

1/7/2007

DIVIS LABORATORIES LTD

TPE ALCOHOL AS MANUFACTURED IN ANDHRA PRADESH INDIA

20125 A

II

1/8/2007

CADILA HEALTHCARE LIMITED

SIMVASTATIN ( LOVASTATIN ROUTE) AS MANUFACTURED IN VADODARA, GUJARAT, INDIA

20126 A

II

11/16/2006

PCI SYNTHESIS

DISULFIRAM USP AS MANUFACTURED IN NEWBURYPORT MA

20127 A

II

1/9/2007

DR REDDYS LABORATORIES LTD

RANITIDINE HYDROCHLORIDE (FORM-2) AS MANUFACTURED IN ANDHRA PRADESH INDIA

20128 I

II

12/30/2006

AUROBINDO PHARMA LTD

AMOXICILLIN SODIUM (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA

20129 A

II

1/11/2007

APOTEX PHARMACHEM INDIA PVT LTD

LAMOTRIGINE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20130 A

II

1/8/2007

CADILA HEALTHCARE LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT INDIA

20131 A

1/9/2007

COLORCON INC

20132 A

III

12/27/2006

EXECHON

SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCT STARCAP 1500 CO-PROCESSED


STARCH EXCIPIENT AS MANUFACTURED IN GREENVILLE IL
PACKAGING MATERIALS (CONTAINERS & CLOSURES FOR SOLID ORAL DOSAGE FORMS) AS
MANUFACTURED IN GUJARAT INDIA

20134 I

IV

12/4/2006

ROHM AND HAAS CO

RODERM MD-153 RUBBER ADHESIVE AS MANUFACTURED IN PIEDMONT SC

20135 A

II

1/11/2007

CODY LABORATORIES INC

PHENTERMINE RESIN - API AS MANUFACTURED IN CODY WY

20136 I

II

1/2/2007

LOTUS PHARMACEUTICAL CO LTD

20137 A

II

12/14/2006

CALYX CHEMICALS AND PHARMACEUTICALS LTD

TM-1 (N-[2-(2-METHOXYPHENOXY)ETHYL]NORGLAUCINE) AS MANUFACTURED IN TAOYUAN


TAIWAN
ERYTHROMYCIN AS MANUFACTURED IN MAHARASHTRA INDIA

20138 I

III

1/2/2007

SUMMIT PACKAGING SYSTEMS INC

STANDARD TOTTLE CLOSURE AS MANUFACTURED IN MANCHESTER NH

20139 A

IV

1/9/2007

COREL PHARMACHEM

ACRYPOL CARBOMER AS MANUFACTURED IN MEHSANA (NG) INDIA

20140 I

II

1/11/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

ECCPA DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ZHEJIANG CHINA

20141 A

II

1/16/2007

DR REDDYS LABORATORIES LTD

ANASTROZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20142 A

II

1/10/2007

JOHNSON MATTHEY PHARMA SERVICES

LEVALBUTEROL HCI AS MANUFACTURED IN DEVENS MA

20143 A

III

1/12/2007

UACJ FOIL CORP

ALU/ALU LAMINATED FOIL AS MANUFACTURED IN SHIGA JAPAN

20144 A

II

1/12/2007

ZERIA PHARMACEUTICAL CO LTD

ACOTIAMIDE HYDROCHLORIDE AS MANUFACTURED IN TOYAMA JAPAN

20145 A

III

1/9/2007

SCHOTT KAISHA PVT LTD

NEUTRAL GLASS SILICONISED VIALS AS MANUFACTURED IN NANI DAMAN INDIA

20146 A

II

1/4/2007

CENWAY PHARMACEUTICALS LTD

GCLE (NON-STERILE, BULK FORM) AS MANUFACTURED IN TIANJIN CHINA

20147 A

II

12/31/2006

BIO TECHNOLOGY GENERAL (ISRAEL) LTD

20148 A

II

1/12/2007

USV LIMITED

SOMATROPIN (RECOMBINANT HUMAN GROWTH HORMONE) API AS MANUFACTURED IN


BE'ER TUVIA, ISRAEL
IRBESARTAN USP AS MANUFACTURED IN MAHARASHTRA INDIA

20149 A

II

1/12/2007

SANMAR SPECIALITY CHEMICALS LTD

20133 N

NOT AN ASSIGNED NUMBER

COLCHICINE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU


INDIA

Page 584

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20150 I
II
1/9/2007
ZHEJIANG LIAOYUAN PHARMACEUTICALS CO LTD
20151 A

II

4/2/2007

TAI HENG INDUSTRY CO LTD

SUBJECT
1-(3-HYDROXYMETHYLPYRIDYL-2)-2-PHENYL-4-METHYLPIPERAZINE (M3 INTERMEDIATE FOR
MIRTAZAPINE) AS MANUFACTURED IN ZHEJIANG CHINA
MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

20152 A

II

1/5/2007

JUBILANT GENERICS LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN KARNATAKA INDIA

20153 A

III

1/17/2007

MEGA PUMPS LP

STANDARD AND MINI PUMP DISPENSERS AS MANUFACTURED IN EATONTOWN NJ

20154 A

III

1/4/2007

COIM USA INC

PRIMER PR-109 AS MANUFACTURED IN OFFANENGO ITALY

20155 I

III

1/4/2007

BERRY PLASTICS CORP

PRODUCT 60119-21 AS MANUFACTURED IN COLUMBUS GA

20156 A

IV

1/12/2007

HENRY H OTTENS MANUFACTURING CO INC

NATURAL AND ARTIFICIAL MINT FLAVOR #8985-B AS MANUFACTURED IN PHILADELPHIA PA

20157 A

III

1/11/2007

AMCOR FLEXIBLES BURGDORF GMBH

20158 I

II

2/19/2009

CIPLA LTD

COATED PAPER 50/ALUMINIUM 9/PAN-BAREX 28 (SOP 50911) AS MANUFACTURED IN


BURGDORF SWITZERLAND
VINORELBINE TARTRATE USP AS MANUFACTURED IN BANGALORE, INDIA

20159 A

II

6/29/2007

CIPLA LTD

VENLAFAXINE HYDROCHLORIDE FORM B AS MANUFACTURED IN MAHARASHTRA INDIA

20160 P

*** PENDING FILING REVIEW ***

20161 I

II

1/17/2007

CIPLA LTD

SIBUTRAMINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

20162 A

II

3/16/2007

CIPLA LTD

RISEDRONATE SODIUM AS MANUFACTURED IN PUNE INDIA

20163 A

II

1/17/2007

CIPLA LTD

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

20164 A

II

1/17/2007

CIPLA LTD

QUETIAPINE FUMERATE AS MANUFACTURED IN MAHARASHTRA INDIA

20165 A

II

9/6/2007

CIPLA LTD

PERINDOPRIL ERBUMINE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20166 P

*** PENDING FILING REVIEW ***

20167 N

NOT AN ASSIGNED NUMBER

20168 A

II

3/13/2008

CIPLA LTD

OXALIPLATIN PH. EUR. AS MANUFACTURED IN BANGALORE, INDIA

20169 A

II

1/17/2007

CIPLA LTD

OMEPRAZOLE SODIUM AS MANUFACTURED IN BANGALORE, INDIA

20170 A

II

7/31/2008

CIPLA LTD

MOXIFLOXACIN HYDROCHLORIDE PH. EUR. AS MANUFACTURED IN MAHARASHTRA, INDIA

20171 A

II

12/20/2007

CIPLA LTD

MOMETHASONE FUROATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

20172 A

II

4/24/2008

CIPLA LTD

LUMEFANTRINE AS MANUFACTURED IN MAHARASHTRA, INDIA

20173 A

II

1/17/2007

CIPLA LTD

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

20174 P

*** PENDING FILING REVIEW ***

20175 A

II

6/26/2008

CIPLA LTD

LETROZOLE USP AS MANUFACTURED IN BANGALORE, INDIA

20176 I

II

12/3/2008

CIPLA LTD

IRBESARTAN AS MANUFACTURED IN MAHARASHTRA, INDIA

20177 N
20178 A

NOT AN ASSIGNED NUMBER


II

4/24/2007

II

5/6/2009

20179 P
20180 A

FORMOTEROL FUMARATE DIHYDRATE PH. EUR. AS MANUFACTURED IN MAHARASHTRA INDIA

*** PENDING FILING REVIEW ***

20181 N
20182 A

CIPLA LTD

CIPLA LTD

DUTASTERIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER


II

4/24/2007

CIPLA LTD

20183 P

*** PENDING FILING REVIEW ***

20184 N

NOT AN ASSIGNED NUMBER

20185 N

NOT AN ASSIGNED NUMBER

CYPROTERONE ACETATE BP/PH.EUR. AS MANUFACTURED IN MAHARASHTRA INDIA

Page 585

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20186 A
II
6/26/2008
CIPLA LTD
20187 A

II

4/24/2008

CIPLA LTD

SUBJECT
AZELASTINE HYDROCHLORIDE BP/PH.EUR ( ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
ARTEMETHER AS MANUFACTURED IN MAHARASHTRA, INDIA

20188 A

II

4/15/2008

CIPLA LTD

ARTESUNATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20189 A

II

7/16/2007

CIPLA LTD

ARIPIPRAZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA.

20190 N

NOT AN ASSIGNED NUMBER

20191 N

NOT AN ASSIGNED NUMBER

20192 A

II

3/27/2007

CIPLA LTD

ADEFOVIR DIPIVOXIL AS MANUFACTURED IN MAHARASHTRA, INDIA

20193 A

III

2/6/2007

PRIORTY PLASTICS INC

20194 A

II

1/19/2007

DR REDDYS LABORATORIES LTD

MANUFACTURER OF PLASTIC BLOW MOLDED CONTAINERS AND OTHER PRODUCTS AS


MANUFACTURED AT PORTLAND IN
ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

20195 A

II

1/12/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

20196 A

II

1/16/2007

EMCURE PHARMACEUTICALS LTD

EFAVIRENZ USP AS MANUFACTURED IN MAHARASHTRA INDIA

20197 A

1/22/2007

STERILIZATION VALIDATION PACKAGE AS MANUFACTURED IN CLAYTON NC

20198 A

II

1/19/2007

NOVO NORDISK PHARMACEUTICAL INDUSTRIES


INC
LUPIN LTD

20199 A

II

1/18/2007

INDUSTRIALE CHIMICA SRL

FORMOTEROL FUMARATE DIHYDRATE USP AS MANUFACTURED IN VARESE ITALY

20200 A

III

1/18/2007

3M CO

PACKAGING MATERIAL (FPO) AS MANUFACTURED IN MEDINA OH

20201 A

III

1/5/2007

3M CO

PACKAGING MATERIAL (PB009146/147) AS MANUFACTURED IN MEDINA OH

20202 A

III

1/15/2007

IMPRESS CONTAINERS CO

ALUMINIUM COLLAPSIBLE TUBES AS MANUFACTURED IN THANE INDIA

20203 A

II

1/12/2007

ACYCLOVIR USP (API) AS MANUFACTURED IN ZHEJIANG CHINA

20204 I

II

1/23/2007

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
TONIRA PHARMA LTD

20205 A

II

1/24/2007

AMINO CHEMICALS LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN MARSA MALTA

20206 A

II

1/23/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA

20207 A

II

1/16/2007

BIOCON LTD

ATORVASTATIN MAGNESIUM AS MANUFACTURED IN BANGALORE INDIA

20208 A

II

1/18/2007

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

20209 I

II

1/5/2007

CHANGZHOU KANGPU PHARMACEUTICAL CO LTD

SULPIRIDE EP AS MANUFACTURED IN JIANGSU CHINA

20210 A

II

1/23/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN AHMEDNAGAR, INDIA

20211 A

II

1/16/2007

AUROBINDO PHARMA LTD

AMPICILLIN SODIUM USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA

20212 A

II

1/17/2007

XELLIA PHARMACEUTICALS APS

FLUTICASONE PROPIONATE USP AS MANUFACTURED IN ZHEJIANG, CHINA

20213 A

II

1/29/2007

SIEGFRIED USA LLC

CODEINE PHOSPHATE USP AS MANUFACTURED IN PENNSVILLE NJ

20214 I

II

1/24/2007

MEDICHEM SA

MED - 201650/E AS MANUFACTURED IN GIRONA SPAIN

20215 A

III

1/11/2007

AMPACET CORP

11171-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN

20216 A

IV

1/15/2007

HENRY H OTTENS MANUFACTURING CO INC

20217 A

IV

1/23/2007

FONA INTERNATIONAL INC

NATURAL AND ARTIFICIAL MIXED TUTTI FRUTTI FLAVOR #12346-B AS MANUFACTURED IN


PHILADELPHIA PA
913.004 N-C NAT & ART SPEARMENT FLAVOR AS MANUFACTURED IN GENEVA IL

20218 A

II

1/29/2007

TEVA PHARMACEUTICALS INDUSTRIES LTD

OLANZAPINE AS MANUFACTURED IN BEER SHEVA ISRAEL

20219 A

II

1/30/2007

CHEMAGIS LTD

EXEMESTANE AS MANUFACTURED IN BEER SHEVA ISRAEL

20220 A

II

1/31/2007

NUTRITION 21 INC

CHROMAX CHROMIUM PICOLINATE AS MANUFACTURED IN ZEELAND, MI FOR NUTRITION 21


INC

IRBESARTAN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

Page 586

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20221 A
IV
1/31/2007
CORDEN PHARMA SWITZERLAND LLC

SUBJECT
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3PHOSPHOETHANOLAMINE SODIUM SALT (MPEG-2000-DSPE) AS MANUFACTURED IN LIESTAL,
SWITZERLAND

20222 A

II

1/31/2007

GLENMARK GENERICS LTD

ESOMEPRAZOLE AS MANUFACTURED IN GUJARAT INDIA

20223 A

II

1/26/2007

POLYMED THERAPEUTICS INC

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN CHONGQING, P. R CHINA

20224 A

III

1/24/2007

FUJIMORI KOGYO CO LTD

TRF-7 AS MANUFACTURED IN NABARI JAPAN

20225 A

II

1/29/2007

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD

LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ZHEJIANG CHINA

20226 I

II

1/31/2007

RELIABLE BIOPHARMACEUTICAL CORP

DTPA MANNOSYL DEXTRAN (A.K.A. TILMANOCEPT) AS MANUFACTURED IN ST LOUIS MO

20227 A

II

1/29/2007

ERREGIERRE SPA

RIVASTIGMINE TARTRATE AS MANUFACTURED IN BERGAMO ITALY

20228 A

III

1/9/2007

DAIWA SPECIAL GLASS CO LTD

GLASS BOTTLE AS MANUFACTURED IN HYOGO JAPAN

20229 A

III

1/19/2007

AMPACET CORP

20230 I

IV

1/26/2007

20231 A

II

1/27/2007

HENRY H OTTENS MANUFACTURING COMPANY


INC
IND SWIFT LABORATORIES LTD

AMPACET PRODUCT 111818 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN


TERRE HAUTE IN
NATURAL AND ARTIFICIAL CITRUS BERRY FLAVOR #14924 AS MANUFACTURED IN
PHILADELPHIA PA
NATEGLINIDE AS MANUFACTURED IN PUNJAB INDIA

20232 A

II

1/31/2007

FARMABIOS S P A

MIVACURIUM CHLORIDE AS MANUFACTURED IN ST LOUIS MO FOR FARMABIOS S P A.

20233 A

IV

1/31/2007

DOW CORNING CORP

20234 A

II

1/29/2007

BACHEM SA

SILASTIC 7-4870 BIOMEDICAL GRADE LIQUID SILICONE RUBBER AS MANUFACTURED IN


HEMLOCK MI
ETOMIDATE AS MANUFACTURED IN VIONNAZ SWITZERLAND

20235 I

III

1/22/2007

BOREALIS AS

BOREALIS POLYPROPYLENE BORSOFT SC220CF AS MANUFACTURED IN STATHELLE NORWAY

20236 I

III

1/22/2007

BOREALIS AS

20237 A

III

1/22/2007

BOREALIS AG

BOREALIS POLYPROPYLENE STERIPEEL WD170CF AS MANUFACTURED IN STATHELLE


NORWAY
SD233CF AS MANUFACTURED IN BURGHAUSEN BELGIUM

20238 A

III

1/22/2007

BOREALIS AG

SA233CF AND BORMED TM SA833CF AS MANUFACTURED IN BURGHAUSEN GERMANY

20239 I

III

1/22/2007

BOREALIS AG

20240 A

III

1/22/2007

BOREALIS AG

20241 I

III

1/22/2007

BOREALIS AG

20242 A

III

1/22/2007

BOREALIS AG

BOREALIS POLYPROPYLENE BORSEAL TD210BF A TERPOLYMER FOR BOPP FILM


APPLICATIONS AS MANUFACTURED IN BERINGEN BELGIUM
BORMED HD800CF AND BORMED HD800CF-11 AS MANUFACTURED IN BURGHAUSEN FOR
BOREALIS AG
BOREALIS POLYPROPYLENE HC101BF A POLYPROPYLENE HOMOPOLYMER FOR BOPP FILM
APPLICATIONS AS MANUFACTURED IN BERINGEN BELGIUM
WD170CF AS MANUFACTURED IN NORDERSTEDT, GERMANY

20243 A

III

1/22/2007

BOREALIS AG

BORMED SC820CF AND BORMED SC820CF-11

20244 A

III

1/22/2007

BOREALIS AG

BORMED RD808CF AS MANUFACTURED IN BURGHAUSEN GERMANY FOR BOREALIS AG

20245 I

III

1/22/2007

BOREALIS AG

BOREALIS POLYPROPYLENE BD212CF A HIGH IMPACT POLYPROPYLENE RANDOM


HETEROPHASIC COPOLYMER FOR CAST FILM APPLICATIONS AS MANUFACTURED IN
SCHWECHAT-MANNSWORTH AUSTRIA

20246 A

II

2/7/2007

HETERO LABS LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20247 A

II

2/7/2007

INTERQUIM SA

IMIQUIMOD AS MANUFACTURED IN BARCELONA SPAIN

20248 A

II

12/19/2006

WANBURY LTD

PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN NAVI MUMBAI INDIA

20249 A

II

2/2/2007

XIAN LIBANG PHARMACEUTICAL CO LTD

ROPIVACAINE HCI MONOHYDRATE AS MANUFACTURED IN SHANXI CHINA

20250 A

III

2/2/2007

ASTRA PLASTIQUE

CLOSURE CAPE PHARMA AS MANUFACTURED IN SAINT GEORGES DE RENEINS FRANCE

20251 A

II

1/18/2007

ZHEJIANG TOP MEDICINE CO LTD

CALCIUM POLYCARBOPHIL AS MANUFACTURED IN ZHEJIANG CHINA

Page 587

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20252 I
II
2/6/2007
SAI ADVANTIUM PHARMA LTD

SUBJECT
IBUTILIDE FUMARATE AS MANUFACTURED IN HYDERABAD INDIA

20253 A

II

2/9/2007

NAVINTA LLC

DEFEROXAMINE MESYLATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

20254 A

III

2/1/2007

EQUISTAR CHEMICALS LP

20255 A

II

1/8/2007

HUZHOU ZHANWANG PHARMACEUTICAL CO LTD

ADFLEX C202M, Q100F, Q200F, Q401F, Q402, V109F, ADSYL 5C30F AND ADSYL 7372XCP AS
MANUFACTURED IN PASADENA TX
METHOTREXATE AS MANUFACTURED IN ZHEJIANG CHINA

20256 A

II

1/28/2007

TAI HENG INDUSTRY CO LTD

IMIQUIMOD AS MANUFACTURED IN ZHEJIANG CHINA

20257 I

II

1/8/2007

PROGESTERONE AS MANUFACTURED IN JIANGSU CHINA

20258 A

II

1/8/2007

CHANGZHOU JIAERKE PHARMACEUTICALS


GROUP CORP LTD
ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD

20259 A

II

1/8/2007

HEBEI HUARONG PHARMACEUTICAL CO LTD

MECOBALAMIN AS MANUFACTURED IN HEBEI CHINA

20260 I

II

2/12/2007

LUPIN LTD

STERILE CEFEPIME HYDROCHLORIDE USP AS MANUFACTURED IN M P INDIA

20261 I

III

2/9/2007

BASELL USA INC

PRO-FAX HL232R AS MANUFACTURED IN LINDEN NJ

20262 A

II

2/7/2007

ST GOBAIN PERFORMANCE PLASTICS CORP

SANITECH STHT-C HIGH PURITY SILICONE TUBING AS MANUFACTURED IN BEAVERTON MI

20263 A

II

2/10/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

BICALUTAMIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

20264 A

II

2/9/2007

PAION UK LTD

MORPHINE-6-B-D-GLUCURONIDE AS MANUFACTURED IN LINZ AUSTRIA

20265 I

II

2/9/2007

LUPIN LTD

STERILE CEFEPIME HYDROCHLORIDE (BUFFERED) AS MANUFACTURED IN M P INDIA

20266 I

II

1/29/2007

FIS FABBRICA ITALIANA SINTETICI SPA

TERBINAFINE HCL AS MANUFACTURED IN VICENZA ITALY

20267 I

III

1/24/2007

HEINKE TECHNOLOGY INC

PACKAGING PRE-FILED VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN NE

20268 A

II

2/13/2007

WANBURY LTD

ATENOLOL AS MANUFACTURED IN MAHARASHTRA INDIA

20269 A

II

2/15/2007

SYMED LABS LTD

LINEZOLID (FORM III) AS MANUFACTURED IN HYDERABAD INDIA

20270 A

II

2/13/2007

HETERO DRUGS LTD

RITONAVIR, USP (FORM I), PROCESS I AS MANUFACTURED IN ANDHRA PRADESH INDIA

20271 A

II

2/13/2007

HETERO DRUGS LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20272 A

II

2/9/2007

SAFC BIOSCIENCES INC

20273 A

II

1/10/2007

20274 A

II

2/10/2007

LIVZON NINGXIA NEW NORTH RIVER


PHARMACEUTICAL CO LTD
ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

EX CELL VPRO (MODIFIED) SERUM FREE W/O L-GLUTAMINE W/O COD LIVER OIL AS
MANUFACTURED IN ANDOVER HAMPSHIRE UK
MEVASTATIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDONG CHINA

20275 A

II

2/6/2007

SEVEN STAR PHARMACEUTICAL CO LTD

20276 I

II

2/9/2007

20277 I

II

2/9/2007

20278 I

II

2/9/2007

20279 A

IV

2/5/2007

EOS ECZACIBASI OZGUN KIMYASAL URUNLER


SANAYI VE TICARET AS
EOS ECZACIBASI OZGUN KIMYASAL URUNLER
SANAYI VE TICARET A.S.
EOS ECZACIBASI OZGUN KIMYASAL URUNLER
SANAYI VE TICARET A.S.
DAI ICHI KOGYO SEIYAKU CO LTD

20280 I

III

2/14/2007

TEKNOR COLOR CO

20281 A

III

2/5/2007

AMPACET CORP

20282 A

II

2/15/2007

FORMOSA LABORATORIES INC

AMPACET 181907 AMBER POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE


HAUTE IN
ANASTROZOLE AS MANUFACTURED IN TAOYUAN TAIWAN

20283 A

II

2/7/2007

ST GOBAIN PERFORMANCE PLASTICS CORP

SANITECH 65 AS MANUFACTURED IN BEAVERTON MI

20284 I

II

2/15/2007

USV LIMITED

DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN ZHEJIANG CHINA

TRANS-(-)-PAROXOL AS MANUFACTURED IN ZHEJIANG CHINA


METHOCARBAMOL DC 90% AS MANUFACTURED IN TU- CHENG DISTRICT NEW TAIPEI CITY,
TAIWAN, ROC
SODIUM ALENDRONATE TRIHYDRATE AS MANUFACTURED IN TEKIRDAG TURKEY
AMLODIPINE BESYLATE AS MANUFACTURED IN TEKIRDAG TURKEY
VALACYCLOVIR HCI MONOHYDRATE AS MANUFACTURED IN TEKIRDAG TURKEY
CELLOGEN SODIUM CARBOXYMETHYL CELLULOSE (CMC) AS MANUFACTURED IN NIGATA
JAPAN
91,194HCPP WHT"A"100:1 PACKAGING MATERIALS AS MANUFACTURED IN LODI, OH

Page 588

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20285 A
II
2/7/2007
ALEMBIC PHARMACEUTICALS LTD

SUBJECT
TELMISARTAN AS MANUFACTURED IN GUJARAT INDIA

20286 A

II

3/13/2007

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD

SPIRONOLACTONE AS MANUFACTURED IN ZHEJIANG CHINA

20287 A

II

2/20/2007

SANOFI AVENTIS DEUTSCHLAND GMBH

ARTICAINE HYDROCHOLORIDE AS MANUFACTURED IN GUJARAT INDIA

20288 A

II

11/14/2006

KYONGBO PHARMACEUTICAL CO LTD

CEFACLOR NON-STERILE API AS MANUFACTURED IN CHUNGCHEONG NAM-DO KOREA

20289 A

II

2/22/2007

TORRENT PHARMACEUTICALS LTD

LAMOTRIGINE AS MANUFACTURED IN GUJARAT INDIA

20290 I

II

2/20/2007

PCAS

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN LIMAY FRANCE

20291 I

II

2/21/2007

GEDEON RICHTER PLC

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN BUDAPEST HUNGARY

20292 A

II

2/22/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFDITOREN PIVOXIL AS MANUFACTURED IN KANCHEEPURAM INDIA

20293 A

II

2/20/2007

ST GOBAIN PERFORMANCE PLASTICS CORP

SANI-TECH LIM45 AS MANUFACTURED IN BEAVERTON MI

20294 I

IV

2/20/2007

FONA INTERNATIONAL INC

815.124 BUBBLEGUM FLAVOR NATURAL & ARTIFICIAL O.S. AS MANUFACTURED IN GENEVA IL

20295 A

III

2/8/2007

POLYONE CORP

CC00003753WE AS MANUFACTURED IN VONORE TN

20296 A

II

2/26/2007

DR REDDYS LABORATORIES LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN A.P. INDIA

20297 A

II

2/23/2007

INDUSTRIALE CHIMICA SRL

ETHINYLESTRADIOL USP AS MANUFACTURED IN SARONNO ITALY

20298 A

II

2/20/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

IMIPRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

20299 A

II

2/23/2007

EMCURE PHARMACEUTICALS LTD

ACETAZOLAMIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

20300 A

II

2/22/2007

AUROBINDO PHARMA LTD

20301 I

II

2/27/2007

PHARMACEUTICAL WORKS POLPHARMA SA

AMPICILLIN AND SULBACTAM FOR INJECTION USP (STERILE BULK MIXTURE 2:1) AS
MANUFACTURED IN ANDHRA PRADESH INDIA
KETOENAMINE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

20302 A

II

2/23/2007

ALDRICH CHEMICAL CO ISOTEC FACILITY

SODIUM OCTANOATE-1-13C AS MANUFACTURED IN MIAMISBURG OH

20303 A

II

2/23/2007

ALDRICH CHEMICAL CO ISOTEC FACILITY

METHACETIN-METHOXY-13C AS MANUFACTURED IN MIAMISBURG OH

20304 A

III

2/19/2007

JAMESTOWN COATING TECHNOLOGIES

PACKAGING MATERIALS AND COMPONENTS AS MANUFACTURED IN JAMESTOWN PA

20305 A

II

2/26/2007

SERATEC

FOMEPIZOLE (4-METHYLPYRAZOLE) AS MANUFACTURED IN COURVILLE SUR EURE FRANCE

20306 A

II

2/14/2007

ALEMBIC PHARMACEUTICALS LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20307 A

II

2/24/2007

AUROBINDO PHARMA LTD

20308 A

II

2/26/2007

WANBURY LTD

ALFUZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
CARVEDILOL AS MANUFACTURED IN MAHARASHTRA INDIA

20309 A

II

2/21/2007

COSMA SPA

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN CISERANO (BERGAMO), ITALY

20310 A

II

2/27/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

METHYLPREDNISOLONE HEMISUCCINATE AS MANUFACTURED IN SANTHIA (VERCELLI), ITALY

20311 A

II

2/23/2007

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN BARCELONA SPAIN

20312 A

II

2/23/2007

SAFC BIOSCIENCES INC

20313 A

III

2/20/2007

ASTRA PLASTIQUE

EX-CELL CD CHO, SERUM-FREE, CHEMICALLY DEFINED, W/O L-GLUTAMINE, W/O


HYPOXANTHINE, W/O THYMIDINE AS MANUFACTURED IN DENVER PA
CLOSURE: REFERENCE 1944 AS MANUFACTURED IN ST GEORGES DE RENEINS FRANCE

20314 A

II

2/12/2007

URQUIMA SA

AZELASTINE HCI AS MANUFACTURED IN BARCELONA SPAIN

20315 A

II

10/17/2006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

QUINAPRIL HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

20316 A

II

2/19/2007

AUROBINDO PHARMA LTD

20317 I

II

3/2/2007

MAPRIMED SA

CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
ENALAPRIL MALEATE AS MANUFACTURED IN BUENOS AIRES ARGENTINA

20318 I

III

2/20/2007

CONSOLIDATED BOTTLE

500ML AMBER PET METRIC ROUND 28/400 AS MANUFACTURED IN ONTARIO CANADA

20319 A

II

3/2/2007

DR REDDYS LABORATORIES LTD

VALSARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

Page 589

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20320 I
III
2/22/2007
POLIMERI EUROPA FRANCE

SUBJECT
RIBLENE FM34 AS MANUFACTURED IN GELA ITALY

20321 I

III

2/22/2007

POLIMERI EUROPA FRANCE

RIBLENE FH10 AS MANUFACTURED IN OBERHAUSEN GERMANY

20322 A

III

2/22/2007

POLYONE CORP

20323 A

II

3/3/2007

20324 A

2/28/2007

SHANDONG WEIFANG PHARMACEUTICAL


FACTORY CO LTD
NANOINK INC

CC00015845DR/WE 5026002KMBC PEROXIDE BROWN AS MANUFACTURED IN ELG GROVE


VILLAGE IL
GEMFIBROZIL AS MANUFACTURED IN SHANDONG CHINA

20325 A

II

3/6/2007

DR REDDYS LABORATORIES LTD

PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION


AND PROCESS AS MANUFACTURED IN SKOKIE IL
IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20326 A

II

2/28/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

ENTACAPONE AS MANUFACTURED IN GUJARAT INDIA

20327 A

II

2/28/2007

MERCK AND CIE

20328 I

II

2/28/2007

SAFC PHARMA

CALCIUM LEVOFOLINATE PENTAHYDRATE AS MANUFACTURED IN SCHAFFHAUSEN


SWITZERLAND
SODIUM METAARSENITE AS MANUFACTURED IN GILLINGHAM DORSET UK

20329 A

IV

3/6/2007

COLORCON

STARCAP 1500 CO-PROCESSED STARCH EXCIPIENT AS MANUFACTURED IN INDIANAPOLIS IN

20330 I

II

3/7/2007

PERRIGO API LTD

PRAMIPEXOLE BASE AS MANUFACTURED IN BEER SHEVA ISRAEL

20331 I

II

3/8/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFUROXIME SODIUM (STERILE) AS MANUFACTURED IN KANCHEEPURAM INDIA

20332 A

II

3/9/2007

NIPPON ZOKI PHARMACEUTICAL CO LTD

NEUTROTROPIN TABLET AS MANUFACTURED IN HYOGO JAPAN

20333 A

II

3/8/2007

SHASUN PHARMACEUTICALS LTD

QUINAPRIL HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE INDIA

20334 A

II

2/23/2007

DIPHENHYDRAMINE CITRATE AS MANUFACTURED IN LATINA ITALY

20335 A

III

2/23/2007

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
ASTRA PLASTIQUE

20336 I

II

3/2/2007

SEIKAGAKU CORP

20337 A

II

2/28/2007

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD

SODIUM CHONDROITIN SULFATE "SEIKAGAKU" FOR INJECTION AS MANUFACTURED IN


KANAGAWA JAPAN
CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

20338 A

II

3/9/2007

EXCELLA GMBH

ANASTROZOLE AS MANUFACTURED IN FEUCHT GERMANY

20339 A

III

2/28/2007

RELIANCE GROUP OF COMPANIES (IPCL)

POLYPROPYLENE (PP)SR20NC AS MANUFACTURED IN RAIGAD INDIA

20340 A

III

2/28/2007

RELIANCE GROUP OF COMPANIES (IPCL)

POLYPROPYLENE (PP) SRM100NC AS MANUFACTURED IN NAGOTHANE RAIGAD INDIA

20341 A

III

2/28/2007

RELIANCE GROUP OF COMPANIES (IPCL)

POLYPROPYLENE (PP) SR20NS AS MANUFACTURED IN NAGOTHANE RAIGAD INDIA

20342 I

II

3/1/2007

ERREGIERRE SPA

PANTOPRAZOLE SODIUM AS MANUFACTURED IN BERGAMO ITALY

20343 A

III

3/5/2007

BASELL POLYOLEFINE ITALIA SRL

PURELL ACP 6031 D AS MANUFACTURED IN WESSELING GERMANY

20344 A

II

3/6/2007

HIKMA PHARMACEUTICALS

OXANDROLONE USP AS MANUFACTURED IN AMMAN JORDAN

20345 I

II

3/14/2007

ZANDU CHEMICALS LTD

20346 I

III

3/7/2007

RICON COLORS

2-HYDROXYETHYL-N,N,N',N'-TETRAKIS(2-CHLOROETHYL) PHOSPHORODIAMIDATE (TPE


ALCOHOL) AS MANUFACTURED IN GUJARAT INDIA
FDA ORANGE 1505C, CPP-O1261-1 AS MANUFACTURED IN WEST CHICAGO IL

20347 I

III

3/7/2007

RICON COLORS

RED FDA CPP-R2767-2 AS MANUFACTURED IN WEST CHICAGO IL

20348 A

IV

3/8/2007

ABELEI INC

177A32 N&A ORANGE FLAVOR AS MANUFACTURED IN N AURORA IL

20349 A

II

3/16/2007

CETYLPYRIDINIUM CHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20350 I

II

3/13/2007

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
SHANDONG NEW TIME PHARMACEUTICAL CO LTD

20351 A

III

3/16/2007

PROMENS MEDICAL PACKAGING AS

RD BOTTLES AS MANUFACTURED IN LANGESKOV DENMARK

20352 N

CLOSURE: REFERENCE 3845 AS MANUFACTURED IN ST GEORGES DE RENEINS FRANCE

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG CHINA

NOT AN ASSIGNED NUMBER

Page 590

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20353 A
II
4/5/2007
USV LIMITED

SUBJECT
IMIQUIMOD AS MANUFACTURED IN MAHARASHTRA INDIA

20354 I

II

3/16/2007

LEK PHARMACEUTICALS DD

OLANZAPINE AS MANUFACTURED IN MENGES SLOVENIA

20355 A

II

3/1/2007

JOHNSON MATTHEY B1205 AS MANUFACTURED IN WEST DEPTFORD NJ

20356 A

II

3/7/2007

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
ZHEJIANG HISUN PHARMACEUTICAL CO LTD

20357 I

II

3/7/2007

BAYER SCHERING PHARMA AG

FLUDARA FILM-COATED TABLETS AS MANUFACTURED IN BERLIN GERMANY

20358 A

II

3/20/2007

DR REDDYS LABORATORIES LTD

LOSARTAN POTASSIUM FORM-1 AS MANUFACTURED IN ANDHRA PRADESH INDIA

20359 A

III

2/19/2007

ASTRA PLASTIQUE

CLOSURE: VISTOP 28 AS MANUFACTURED IN SAINT-GEORGES DE RENEINS FRANCE

20360 A

III

3/12/2007

FLEXTRUS AB

20361 A

II

3/22/2007

CADILA HEALTHCARE LTD

TRANSOFOIL EL-OPET/PELD LAMINATE, SPECIFICATIONS 2282150-0012 AND 2282150-0020 AS


MANUFACTURED IN LUND SWEDEN
IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA

20362 A

II

3/23/2007

MYLAN LABORATORIES LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20363 A

II

5/30/2007

MYLAN LABORATORIES LTD

LOPINAVIR (LOP) AS MANUFACTURED IN TELANGANA, INDIA

20364 A

II

3/22/2007

CADILA HEALTHCARE LTD

ATOMOXETINE HCL AS MANUFACTURED IN GUJARAT INDIA

20365 A

II

3/22/2007

DIPHARMA FRANCIS SRL

PROTRIPTYLINE HYDROCHLORIDE AS MANUFACTURED IN VARESE ITALY

20366 N

LETROZOLE USP AS MANUFACTURED IN ZHEJIANG CHINA

NOT AN ASSIGNED NUMBER

20367 A

II

3/20/2007

VASUDHA PHARMA CHEM LTD

LORATADINE USP AS MANUFACTURED IN HYDERABAD INDIA

20368 A

II

3/19/2007

OLON SPA

20369 A

III

3/23/2007

MULTISORB TECHNOLOGIES INC

DEACETYL 7 AMINO CEPHALOSPORANIC ACID (HACA) AS MANUFACTURED IN SETTIMO


TORINESE ITALY
MOISTURE REGULATING PRODUCTS AS MANUFACTURED IN BUFFALO NY

20370 I

III

3/22/2007

EP SPRAY SYSTEMS

BAG-ON-VALVE AS MANUFACTURED IN MCHENRY IL

20371 A

III

3/2/2007

DRAGON PLASTICS LTD

CLOSURES AS MANUFACTURED IN PONTYPRIDD, UK

20372 A

II

3/16/2007

ORGAPHARM SAS

20373 A

II

3/26/2007

CADILA HEALTHCARE LTD

PROTOPORPHYRIN IX DIMETHYL ESTER (PPIX-DME) AS MANUFACTURED IN PITHIVIERS


FRANCE
SIMVASTATIN (AMMONIUM SALT ROUTE) AS MANUFACTURED IN GUJARAT INDIA

20374 A

II

3/21/2007

TAI HENG INDUSTRY CO LTD

MEFENAMIC ACID AS MANUFACTURED IN SHANGHAI CHINA

20375 A

II

3/26/2007

STERLING SPA

FLUNISOLIDE ANHYDROUS AS MANUFACTURED IN PERUGIA ITALY

20376 I

II

3/26/2007

PHARMAZELL GMBH

CARBAMAZEPINE AS MANUFACTURED IN RAUBLING GERMANY

20377 I

III

3/26/2007

EI DUPONT DE NEMOURS & CO INC

DUPONT TYVEK RX-CR AS MANUFACTURED IN HAVERHILL MA

20378 A

II

3/19/2007

ALEMBIC PHARMACEUTICALS LTD

IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA

20379 A

II

3/28/2007

CADILA HEALTHCARE LTD

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20380 I

II

3/29/2007

RANBAXY LABORATORIES LTD

RAMIPRIL AS MANUFACTURED IN PUNJAB INDIA

20381 A

II

3/28/2007

GLENMARK GENERICS LTD

APREPITANT AS MANUFACTURED IN GUJARAT INDIA

20382 I

IV

3/13/2007

EEI CAPSULES LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN MADHYA PRADESH INDIA

20383 A

II

3/28/2007

CALYX CHEMICALS AND PHARMACEUTICALS LTD

ERYTHROMYCIN ESTOLATE AS MANUFACTURED IN MAHARASTHTRA INDIA

20384 A

II

3/26/2007

PHARMACEUTICAL WORKS POLPHARMA SA

SODIUM RISEDRONATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

20385 A

II

3/28/2007

EUTICALS INC

DEXMETHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN SPRINGFIELD MO

20386 A

II

3/28/2007

TORRENT PHARMACEUTICALS LTD

TOPIRAMATE AS MANUFACTURED IN GUJARAT INDIA

20387 I

IV

3/8/2007

ACCEL COLOR CORP

1101P3CP1 RED 1608 AS MANUFACTURED IN NAPERVILLE IL

20388 A

II

3/30/2007

CADILA HEALTHCARE LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

Page 591

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20389 A
IV
3/30/2007
SPI PHARMA INC

SUBJECT
SODIUM BICARBONATE PRODUCTS AS MANUFACTURED IN GRAND HAVEN MI

20390 A

II

3/26/2007

TACROLIMUS AS MANUFACTURED IN ZHEJIANG CHINA

20391 A

II

3/31/2007

20392 A

II

4/2/2007

HANGZHOU HUADONG MEDICINE GROUP


BIOTECHNOLOGY INSTITUTE CO LTD
CHONGQING SHENGHUAXI PHARMACEUTICAL CO
LTD
GLENMARK GENERICS LTD

20393 A

II

3/29/2007

AUROBINDO PHARMA LTD

20394 I

IV

3/25/2007

UMANG PHARMATECH PVT LTD

IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
SPRAYSPHERE AS MANUFACTURED IN MAHARASHTRA INDIA

20395 I

IV

3/25/2007

UMANG PHARMATECH PVT LTD

SPRAYMIX AS MANUFACTURED IN MAHARASHTRA INDIA

20396 I

IV

3/25/2007

UMANG PHARMATECH PVT LTD

SPRAYPOL AS MANUFACTURED AT MAHARASHTRA INDIA

20397 I

II

4/3/2007

20398 A

II

4/2/2007

20399 A

II

4/2/2007

JIANGSU YUNYANG GROUP PHARMACEUTICAL CO CLOTRIMAZOLE AS MANUFACTURED IN JIANGSU CHINA


LTD
MYLAN LABORATORIES LTD
RISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
MYLAN LABORATORIES LTD
ATENOLOL USP AS MANUFACTURED IN TELANGANA, INDIA

20400 A

II

4/2/2007

MYLAN LABORATORIES LTD

CANDESARTAN CILEXETIL USP AS MANUFACTURED IN TELANGANA, INDIA

20401 A

II

4/2/2007

MYLAN LABORATORIES LTD

CARVEDILOL PHOSPHATE AS MANUFACTURED IN TELANGANA, INDIA

20402 A

II

4/2/2007

MYLAN LABORATORIES LTD

ALENDRONATE SODIUM USP (TRIHYDRATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA

20403 A

III

4/2/2007

COLORS FOR PLASTICS INC

20404 A

II

3/30/2007

LUPIN LTD

THERMOPLASTIC RESIN COLORANT MASTERBATCH G23379 AS MANUFACTURED IN ELK


GROVE VILLAGE, IL
ETHAMBUTOL HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

20405 A

II

3/29/2007

ERCROS SA

SODIUM FUSIDATE AS MANUFACTURED IN A MADRID SPAIN

20406 A

III

4/4/2007

3M DRUG DELIVERY SYSTEMS

20407 I

II

3/23/2007

TAKASAGO INTERNATIONAL CORP

3M INTEGRATED DOSE-BY-DOSE COUNTER AS MANUFACTURED BY NYPRO LTD IN DUBLIN,


IRELAND FOR 3M DRUG DELIVERY SYSTEMS DIVISION
RU-COMPLEX SOLUTION AS MANUFACTURED IN IWATA JAPAN

20408 I

IV

4/3/2007

SYMRISE INC

VANILLA FL PWD N ET A GIN #605003 AS MANUFACTURED IN MAHWAH NJ

20409 A

II

3/31/2007

WANBURY LTD

RISPERIDONE AS MANUFACTURED IN MAHARASHTRA INDIA

20410 A

II

4/5/2007

NATCO PHARMA LTD

IMATINIB METHANE SULFONATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20411 A

II

4/5/2007

NATCO PHARMA LTD

IBANDRONATE SODIUM MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20412 A

II

4/4/2007

SIGNA SA DE CV

LEVETIRACETAM AS MANUFACTURED IN TOLUCA MEXICO

20413 A

II

4/5/2007

MSN LABORATORIES LTD

20414 A

II

5/14/2007

BAYER PHARMA AG

TERBINAFINE HYDROCHLORIDE USP [ROUTE CODE - "TF"] AS MANUFACTURED IN ANDHRA


PRADESH INDIA
EOB-DTPA AS MANUFACTURED IN BERGKAMEN GERMANY

20415 A

II

4/6/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ALENDRONATE SODIUM TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

20416 A

II

4/6/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD DIPYRIDAMOLE AS MANUFACTURED IN MAHARASHTRA INDIA

20417 A

II

3/23/2007

MYLAN LABORATORIES LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN TELANGANA, INDIA

20418 A

II

3/15/2007

MYLAN LABORATORIES LTD

PROPAFENONE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

20419 A

II

3/27/2007

MYLAN LABORATORIES LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20420 A

II

3/28/2007

ALEMBIC PHARMACEUTICALS LTD

MEPROBAMATE AS MANUFACTURED IN GUJARAT INDIA

20421 A

II

4/9/2007

BASF CORP

IBUPROFEN DC 85 AS MANUFACTURED IN SHREVEPORT LA

20422 A

II

4/9/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD IBANDRONATE SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA

SODIUM IBANDRONATE AS MANUFACTURED IN CHONGQING CHINA


ESOMEPRAZOLE POTASSIUM AS MANUFACTURED IN GUJARAT INDIA

Page 592

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20423 A
II
3/17/2007
MYLAN LABORATORIES LTD

SUBJECT
STAVUDINE USP (STR) AS MANUFACTURED IN TELANGANA INDIA

20424 A

II

3/22/2007

MYLAN LABORATORIES LTD

ALMOTRIPTAN MALATE AS MANUFACTURED IN TELANGANA, INDIA

20425 A

II

3/26/2007

MYLAN LABORATORIES LTD

MONTELUKAST SODIUM USP AS MANUFACTURED IN TELANGANA, INDIA

20426 A

II

4/9/2007

GLENMARK GENERICS LTD

MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20427 A

II

4/5/2007

CHEMI SPA

SODIUM IBANDRONATE MONOHYDRATE AS MANUFACTURED IN PATRICA ITALY

20428 A

II

4/5/2007

QILU TIANHE PHARMACEUTICAL CO LTD

20429 I

IV

4/11/2007

PHARMACEUTICAL COATINGS PVT LTD

TAZOBACTAM ACID (PROCESS I, NON-STERILE BULK) AS MANUFACTURED IN SHANDONG


CHINA
AEROLAC AS MANUFACTURED IN NAVI MUMBAI INDIA

20430 A

III

4/10/2007

HOSPIRA INC

ANSYR SYRINGE DRUG PRODUCT AS MANUFACTURED IN ROCKY MOUNT NC

20431 A

II

4/7/2007

QILU PHARMACEUTICAL CO LTD

PIPERACILLIN (NON STERILE BULK FORM) AS MANUFACTURED IN SHANDONG CHINA

20432 A

II

4/9/2007

QILU PHARMACEUTICAL CO LTD

20433 A

II

3/25/2007

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD

STERILE PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) AS MANUFACTURED IN


SHANDONG CHINA
PHENYTOIN SODIUM AS MANUFACTURED IN JIANGSU CHINA

20434 A

II

3/25/2007

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD

PHENYTOIN AS MANUFACTURED IN JIANGSU CHINA

20435 A

II

4/13/2007

BIO VECTRA INC

20436 A

II

3/31/2007

LUPIN LTD

20 KDA MPEG-O-2-METHYLPROPIONALDEHYDE AS MANUFACTURED IN PRINCE EDWARD


ISLAND CANADA
RIFAXIMIN AS MANUFACTURED IN MAHARASHTRA INDIA

20437 A

II

4/11/2007

PIRAMAL ENTERPRISES LTD

GEMFIBROZIL AS MANUFACTURED IN ANDHRA PRADESH INDIA

20438 I

II

4/12/2007

APICORE US LLC

FELBAMATE AS MANUFACTURED IN SOMERSET NJ

20439 A

II

4/6/2007

WOCKHARDT LTD

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20440 A

II

4/18/2007

JANSSEN PHARMACEUTICA NV

ETRAVIRINE (R165335) DRUG SUBSTANCE AS MANUFACTURED IN BEERSE BELGIUM

20441 A

II

4/19/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

DORZOLAMIDE HCL AS MANUFACTURED IN BE'ER SHEVA ISRAEL

20442 I

II

4/3/2007

BEIJING YI HE BIOTECH CO LTD

10 DEACETYL BACCATIN III AS MANUFACTURED IN BEIJING CHINA

20443 I

II

4/17/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

SODIUM ALENDRONATE AS MANUFACTURED IN ZAGREB CROATIA

20444 A

II

4/14/2007

CLOPIDOGREL BISULFATE USP (FORM-I) AS MANUFACTURED IN HARYANA INDIA

20445 A

II

4/5/2007

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
OLON SPA

20446 A

II

5/3/2007

JANSSEN PHARMACEUTICA NV

CEFTOBIPROLE MEDOCARIL (R473928) DRUG SUBSTANCE AS MANUFACTURED BY


ANTIBIOTICOS SPA IN RODANO, ITALY; PATHEON UK LTD IN U.K.; BUTTERWORTH
LABORATORIES LTD IN U.K. & JANSSEN PHARMACEUTICA N.V. IN BELGIUM FOR JANSSEN
PHARMACEUTICA N.V.

20447 A

II

4/20/2007

MYLAN LABORATORIES LTD

LORATADINE USP (LCP) AS MANUFACTURED IN TELANGANA INDIA

20448 A

II

4/10/2007

MALLADI DRUGS AND PHARMACEUTICALS LTD

ALPRAZOLAM AS MANUFACTURED IN TAMIL NADU INDIA

20449 I

II

4/12/2007

CARPROFEN AS MANUFACTURED IN ZHEJIANG CHINA

20450 A

II

3/28/2007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD


CHUANNAN BRANCH
ZHEJIANG TIANTAI PHARMACEUTICAL CO LTD

20451 A

II

4/10/2007

OTSUKA CHEMICAL CO LTD

P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE AS MANUFACTURED IN TOKUSHIMA


JAPAN

20452 A

II

4/17/2007

CHONGQING DAXIN PHARMACEUTICAL CO LTD

MYCOPHENOLIC ACID AS MANUFACTURED IN CHONGQING CHINA

20453 A

II

4/17/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD PHENYTOIN SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA

20454 A

II

4/16/2007

LUPIN LTD

VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

20455 A

II

4/19/2007

BASF PHARMACHEMIKALIEN GMBH CO KG

THEOPHYLLINE HYDROUS AS MANUFACTURED IN MINDEN GERMANY

ACYCLOVIR AS MANUFACTURED IN MULAZZANO (LO) ITALY

CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

Page 593

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20456 A
II
3/30/2007
LUPIN LTD

SUBJECT
MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

20457 A

II

4/13/2007

LUPIN LTD

20458 A

III

4/13/2007

3M DRUG DELIVERY SYSTEMS

ESOMEPRAZOLE MAGNESIUM DIHYDRATE ( ESUB) AS MANUFACTURED IN MAHARASHTRA


INDIA
3M COTRAN 9718 AS MANUFACTURED IN BROOKINGS SD

20459 A

III

4/13/2007

3M DRUG DELIVERY SYSTEMS

3M SCOTCHPAK 9736 AS MANUFACTURED IN COTTAGE GROVE MN

20460 A

III

4/13/2007

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9750 (TM) WHITE POLYETHYLENE FOAM TAPE

20461 A

III

4/13/2007

3M DRUG DELIVERY SYSTEMS

3M COTRAN(TM) 9762 POLYURETHANE TAPE

20462 A

II

4/18/2007

MEGAFINE PHARMA P LTD

20463 A

II

4/24/2007

FARMABIOS S P A

1-(3-HYDROXY METHYL PYRIDYL-2-)-2-PHENYL-4-METHYL PIPERAZINE (HMPPMP) (NONSTERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN GUJARAT INDIA
FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED) AS MANUFACTURED IN PV ITALY

20464 I

II

4/12/2007

CADILA PHARMACEUTICALS LTD

ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA

20465 A

II

4/23/2007

FORMOSA LABORATORIES INC

MEPROBAMATE AS MANUFACTURED IN TAOYUAN TAIWAN

20466 A

II

4/23/2007

DR REDDYS LABORATORIES LTD

IBANDRONATE SODIUM MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20467 A

III

4/13/2007

POLYONE CORP

CC00022680DR AS MANUFACTURED IN VONORE TN

20468 I

II

3/30/2007

ANHUI BIOCHEM PHARM CO LTD

LAMIVUDINE AS MANUFACTURED IN ANHUI CHINA

20469 I

II

3/14/2007

USV LTD

ANASTROZOLE AS MANUFACTURED IN MAHARASHTRA INDIA

20470 A

II

4/23/2007

FLEMING LABORATORIES LTD

MECLIZINE HCL AS MANUFACTURED IN ANDHRA PRADESH INDIA

20471 A

II

4/23/2007

SEVEN STAR PHARMACEUTICAL CO LTD

CHLORZOXAZONE AS MANUFACTURED IN TAIPEI HSIENG TAIWAN

20472 A

III

4/2/2007

HEINKE TECHNOLOGY INC

SIDE DISPERSION PRE-FILLED VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN NE

20473 I

III

3/8/2007

GERRESHEIMER BOLESLAWIEC S A

GLASS AMPOULES, VIALS, AND SAMPLES MADE FROM GLASS TUBES FOR VARIOUS
PRODUCTS OF HEALTH CARE SECTIONS UP TO CONTENTS OF 30 ML AS MANUFACTURED IN
BOLESLAWIEC POLAND

20474 A

II

4/25/2007

NOF CORP

20475 A

II

4/23/2007

MALLADI DRUGS AND PHARMACEUTICALS LTD

DISTEAROYL PHOSPHATIDYL GLYCEROL SODIUM SALT (DSPG-NA) AS MANUFACTURED IN


HYOGO JAPAN
PHENYLEPHRINE BITARTRATE AS MANUFACTURED IN TAMIL NADU INDIA

20476 A

II

4/24/2007

20477 A

III

4/18/2007

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
ST GOBAIN PERFORMANCE PLASTICS

20478 A

II

4/27/2007

LONZA AG

POLYESTER FILM C/1/S WITH 8005 SILICONE RELEASE COATING AS MANUFACTURED IN


WORCESTER MA
THYMOSIN-A-1, DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-1' ALLEUD BELGIUM

20479 A

II

4/27/2007

ERCROS SA

FUSIDIC ACID AS MANUFACTURED IN ARANJUEZ MADRID SPAIN

20480 I

II

3/19/2007

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

STERILE CEFOTAXIME SODIUM AS MANUFACTURED IN SHANDONG CHINA

20481 A

II

12/28/2006

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

CEFTAZIDIME FOR INJECTION AS MANUFACTURED IN SHANDONG CHINA

20482 A

II

12/30/2006

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

STERILE CEFTRIAXONE SODIUM AS MANUFACTURED IN SHANDONG CHINA

20483 A

II

4/24/2007

ERREGIERRE SPA

TOLTERODINE TARTRATE AS MANUFACTURED IN BERGAMO ITALY

20484 I

III

4/27/2007

BESPAK DIV CONSORT MEDICAL PLC

20485 A

II

12/20/2006

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

BK361003MTA PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK


ENGLAND
STERILE CEFOPERAZONE SODIUM AS MANUFACTURED IN SHANDONG CHINA

20486 I

II

12/28/2006

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

STERILE CEFAZOLIN SODIUM AS MANUFACTURED IN SHANDONG CHINA

20487 I

III

4/17/2007

20488 A

II

4/26/2007

CHESAPEAKE PLASTICS PACKAGING KUNSHAN CO PACKAGING MATERIAL AS MANUFACTURED IN JIANGSU CHINA


LTD
MACCO ORGANIQUES SRO
MAGNESIUM CHLORIDE HEXAHYDRATE AS MANUFACTURED IN BRUNTAL CZECH REPUBLIC

20489 I

IV

4/24/2007

MASTERTASTE SPA

BISACODYL AS MANUFACTURED IN GUJARAT INDIA

06201.1 DRYCELL YOGURT FLAVOUR AS MANUFACTURED IN TORINO ITALY

Page 594

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20490 I
IV
4/24/2007
MASTERTASTE SPA

SUBJECT
06300.1 DRYCELL ORANGE FLAVOUR AS MANUFACTURED IN TORINO ITALY

20491 I

IV

4/24/2007

MASTERTASTE SPA

B03373F.1 ORANGE FLAVOUR AS MANUFACTURED IN TORINO ITALY

20492 A

II

4/27/2007

MITSUI NORIN CO LTD

20493 I

4/30/2007

CATALENT PHARMA SOLUTIONS INC

POLYPHENON E (USAN: SINECATECHINS) AS MANUFACTURED BY ALPS PHARMACEUTICAL


IND CO LTD IN HIDA-SHI GIFU JAPAN
CARDINAL HEALTH NORTH RALEIGH STERILE MANUFACTURING FACILITY

20494 A

II

4/30/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

IBANDRONATE SODIUM AS MANUFACTURED IN GUAYAMA PUERTO RICO

20495 A

II

4/23/2007

WANBURY LTD

CLOPIDOGREL BISULFATE AS MANUFACTURED IN MAHARASHTRA INDIA

20496 A

II

4/30/2007

AARTI DRUGS LTD

LORATADINE AS MANUFACTURED IN MAHARASHTRA INDIA

20497 A

IV

4/24/2007

FMC BIOPOLYMER AS

CALCIUM ALGINATE AS MANUFACTURED IN OSLO NORWAY

20498 A

II

4/26/2007

SUVEN LIFE SCIENCES LTD

FENOPROFEN CALCIUM USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

20499 A

II

4/30/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN MILANO ITALY

20500 A

II

4/30/2007

CHEMWERTH INC

20501 A

II

4/30/2007

ZHEJIANG BETTER PHARMACEUTICALS CO LTD

ETOMIDATE EP NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG


CHINA
CLARITHROMYCIN USP AS MANUFACTURED IN ZHEJIANG CHINA

20502 A

II

5/1/2007

AARTI INDUSTRIES LTD

BICALUTAMIDE AS MANUFACTURED IN MAHARASHTRA INDIA

20503 A

IV

5/3/2007

DO COOP TECHNOLOGIES LTD

NEOWATER AS MANUFACTURED IN OR-YEHUDA ISRAEL

20504 I

II

5/1/2007

PCAS

MIFEPRISTONE AS MANUFACTURED IN ARAMON FRANCE

20505 I

IV

5/3/2007

FONA INTERNATIONAL INC

884.114 N-C NAT & ART ORANGE FLAVOR AS MANUFACTURED IN GENEVA IL

20506 I

IV

5/3/2007

FONA INTERNATIONAL INC

862.378 NATURAL LEMON FLAVOR WONF AS MANUFACTURED IN GENEVA IL

20507 I

IV

5/3/2007

FONA INTERNATIONAL INC

895.032 N-C ART PINEAPPLE FLAVOR AS MANUFACTURED IN GENEVA IL

20508 I

IV

5/3/2007

FONA INTERNATIONAL INC

825.527 N-C CHERRY FLAVOR ARTIFICIAL AS MANUFACTORED IN GENEVA IL

20509 A

II

5/3/2007

CADILA PHARMACEUTICALS LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN GUJARAT INDIA

20510 A

II

5/7/2007

TARO PHARMACEUTICAL INDUSTRIES LTD

PREDNICARBATE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL

20511 A

II

5/7/2007

DR REDDYS LABORATORIES LTD

FOSPHENYTOIN SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

20512 A

II

5/2/2007

BAYER SCHERING PHARMA AG

MS-275 FILM-COATED TABLETS AS MANUFACTURED IN BERLIN GERMANY

20513 A

II

5/2/2007

BAYER PHARMA AKTIENGESELLSCHAFT

MS-275 AS MANUFACTURED IN BERLIN GERMANY

20514 I

II

5/8/2007

OLON SPA

FAMCYCLOVIR AS MANUFACTURED IN GARBAGNATE MILANESE ITALY

20515 A

II

5/8/2007

OLON SPA

ABACAVIR SULFATE AS MANUFACTURED IN MULAZZANO (LO) ITALY

20516 A

II

5/3/2007

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

OXCARBAZEPINE AS MANUFACTURED IN ZHEJIANG CHINA

20517 A

II

5/9/2007

ZHUHAI UNITED LABORATORIES CO LTD

AMOXICILLIN TRIHYDRATE USP AS MANUFACTURED IN ZHUHAI GUANGDONG CHINA

20518 A

II

5/8/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

RISPERIDONE AS MANUFACTURED IN ZHEJIANG CHINA

20519 A

III

4/17/2007

ALUCAN ENTEC SAU

PACKAGING MATERIAL AS MANUFACTURED IN BADALONA SPAIN

20520 A

II

5/9/2007

HETERO LABS LTD

HYDRALAZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20521 A

II

5/10/2007

DR REDDYS LABORATORIES LTD

FINASTERIDE (FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA

20522 I

II

5/8/2007

DELMAR CHEMICALS INC

LEVODOPA METHYL ESTER HYDROCHLORIDE AS MANUFACTURED IN QUEBEC CANADA

20523 I

III

5/8/2007

HEINKE TECHNOLOGY INC

POWDER DISPENSING PRE-FILLED VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN NE

20524 A

II

5/10/2007

POLYMED THERAPEUTICS INC

20525 A

II

5/11/2007

APOTEX PHARMACHEM INC

CHOLECALCIFEROL CONCENTRATE (POWDER FORM) DRUG SUBSTANCE AS


MANUFACTURED IN ZHEJIANG CHINA
IBANDRONATE SODIUM AS MANUFACTURED IN ONTARIO CANADA

Page 595

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20526 A
IV
5/11/2007
COREL PHARMACHEM

SUBJECT
KYRON POLACRILLIN POTASSIUM AS MANUFACTURED IN KADI INDIA

20527 A

IV

5/11/2007

COREL PHARMACHEM

ACRYSOL POLYOXYL 40 HYDROGENATED CASTOR OIL AS MANUFACTURED IN KADI INDIA

20528 I

II

5/11/2007

USV LTD

FLUVASTATIN SODIUM USP AS MANUFACTURED IN MAHARASHTRA INDIA

20529 A

II

5/10/2007

ST GOBAIN PERFORMANCE PLASTICS CORP

PHARMAFLOUR FEP BIOCOMPATIBLE TUBING AS MANUFACTURED IN AKRON OH

20530 A

III

5/9/2007

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9766 AS MANUFACTURED IN ABERDEEN SD

20531 A

III

5/9/2007

3M DRUG DELIVERY SYSTEMS

3M COTRAN 9769 POLYETHYLENE TAPE AS MANUFACTURED IN BROOKINGS SD

20532 I

II

5/10/2007

ASAHI KASEI PHARMA CORP

UBIDECARENONE AS MANUFACTURED IN HOKKAIDO JAPAN

20533 A

II

5/1/2007

KAKEN PHARMACEUTICAL CO LTD

KP-103 AS MANUFACTURED IN TOYAMA JAPAN

20534 A

II

4/18/2007

UNICHEM LABORATORIES LTD

HYDROCHLOROTHIAZIDE USP - PROCESS #2 AS MANUFACTURED IN RAIGAD INDIA

20535 A

II

5/6/2007

20536 A

III

5/4/2007

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
COLORTECH INC

ATORVASTATIN SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


ZHEJIANG CHINA
11030-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN TN

20537 A

IV

5/14/2007

NIPPON FINE CHEMICAL CO LTD

DSPC-K2 (DISTEAROYLPHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO JAPAN

20538 A

II

5/11/2007

ALPS PHARMACEUTICAL IND CO LTD

PROTAMINE SULFATE AS MANUFACTURED IN HIDA GIFU JAPAN

20539 A

II

5/17/2007

ARCH PHARMALABS LTD

20540 I

II

5/15/2007

LUNDBECK PHARMACEUTICALS ITALY SPA

CETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP AS MANUFACTURED IN


MAHARASHTRA INDIA
ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN PODOVA ITALY

20541 A

II

3/27/2007

CHANGZHOU QIANHONG BIO PHARMA CO LTD

DALTEPARIN SODIUM AS MANUFACTURED IN JIANGSU CHINA

20542 A

II

6/26/2007

STRAGEN PHARMA SA

HOMOHARRINGTONINE (HHT) DRUG SUBSTANCE AS MANUFACTURED IN LE MANS, FRANCE.

20543 A

II

5/9/2007

OLAINFARM JOINT STOCK CO

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN OLAINE LATVIA

20544 A

II

5/21/2007

CHEMPACIFIC CORP

CHPO16 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD

20545 A

II

5/23/2007

UNIMARK REMEDIES LTD

CEFUROXIME AXETIL USP AS MANUFACTURED IN GUJARAT INDIA

20546 A

II

5/22/2007

AMRI RENSSELAER INC

ECHOTHIOPHATE IODIDE DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER NY

20547 A

III

5/17/2007

AMCOR FLEXIBLES ITALIA SRL

20548 A

II

5/23/2007

PHARMACEUTICAL WORKS POLPHARMA SA

FLEXIBLE PACKAGING MATERIAL AS PRIMARY PACKAGING COMPONENT FOR DRUG AS


MANUFACTURED IN LUGO DI VICENZA ITALY
LAMOTRIGINE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

20549 A

II

5/18/2007

SIGMA ALDRICH MANUFACTURING LLC

STEMLINE NEURAL STEM CELL EXPANSION MEDIUM AS MANUFACTURED IN ST LOUIS MO

20550 A

II

5/18/2007

SIGMA ALDRICH MANUFACTURING LLC

CHO KIT 2 IRON CHELATOR SOLUTION AS MANUFACTURED IN ST LOUIS MO

20551 A

II

5/18/2007

SIGMA ALDRICH MANUFACTURING LLC

CHO MEDIUM MODIFICATION 21 AS MANUFACTURED IN ST LOUIS MO

20552 A

II

5/21/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20553 A

III

4/18/2007

INEOS SERVICES BELGIUM NV

INEOS POLYPROPYLENE GRADE 101-SA09 AS MANUFACTURED IN BRUSSELS BELGIUM

20554 A

III

4/18/2007

INEOS SERVICES BELGIUM NV

INEOS POLYPROPYLENE GRADE 194-NA25 AS MANUFACTURED IN BRUSSELS BELGIUM

20555 A

5/22/2007

ASEPTIC TECHNOLOGIES SA

20556 A

II

5/23/2007

SUMITOMO DAINIPPON PHARMA CO LTD

PHARMACEUTICAL FILLING FACILITY FOR FILLING STERILE INJECTABLE DEVELOPMENT


SAMPLES AND CLINICAL SUPPLIES AT LES ISNES BELGIUM
DROXIDOPA AS MANUFACTURED IN TSURUSAKI OITA JAPAN

20557 A

II

5/23/2007

AARTI INDUSTRIES LTD

LEVALBUTEROL HCL AS MANUFACTURED IN MAHARASHTRA INDIA

20558 I

III

5/17/2007

SEASONS POLYMERS PVT LTD

PLASTIC BOTTLES/CONTAINERS, NOZZLES, PILFER PROOF/TAMPER EVIDENT CAPS,


MEASURING CUPS, CHILD RESISTANT CAPS, CLOSURES AS MANUFACTURED IN KUNDAIM
INDIA

20559 A

II

5/18/2007

OLON SPA

ATAZANAVIR SULFATE AS MANUFACTURED IN MULAZZANO ITALY

20560 I

II

5/25/2007

RANBAXY LABORATORIES LTD

EFAVIRENZ AS MANUFACTURED IN HARYANA INDIA

Page 596

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20561 I
II
6/25/2007
ALKERMES GAINESVILLE LLC

SUBJECT
ELND-005 AS MANUFACTURED IN ELAN ATHLONE, IRELAND.

20562 A

II

5/29/2007

FRESENIUS KABI AUSTRIA GMBH

LACTULOSE CONCENTRATE USP AS MANUFACTURED IN LINZ AUSTRIA

20563 A

II

5/30/2007

SIEGFRIED LTD

BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN SWITZERLAND

20564 I

II

5/31/2007

UNIMARK REMEDIES LTD

MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT INDIA

20565 A

II

5/15/2007

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD

METHYLDOPA AS MANUFACTURED IN ZHEJIANG CHINA

20566 A

II

5/29/2007

ACTAVIS GROUP PTC EHF

20567 A

II

5/29/2007

ALDRICH CHEMICAL CO ISOTEC FACILITY

LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU


INDIA
POTASSIUM PALMITATE -1,2,3,4-(13)C4 AS MANUFACTURED IN MIAMISBURG OH

20568 A

IV

5/10/2007

20569 A

II

6/1/2007

20570 A

II

5/28/2007

20571 A

II

6/1/2007

MOLKEREI MEGGLE WASSERBURG GMBH AND CO STARLAC AS MANUFACTURED IN WASSERBURG GERMANY


KG
JOHNSON MATTHEY PHARMACEUTICAL
FLUVOXAMINE MALEATE (SVB) AS MANUFACTURED IN CONSHOHOCKEN PA
MATERIALS
MEGAFINE PHARMA P LTD
MIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
NASHIK INDIA
TEVA PHARMACEUTICAL INDUSTRIES LTD
TELMISARTAN AS MANUFACTURED IN BE'ER SHEVA ISRAEL

20572 A

II

4/10/2007

WANBURY LTD

DIPHENHYDRAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20573 A

II

5/29/2007

WANBURY LTD

METFORMIN SR GRADE 70% AS MANUFACTURED IN MAHARASHTRA INDIA

20574 A

II

5/31/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20575 A

II

5/25/2007

GLENMARK GENERICS LTD

TELMISARTAN AS MANUFACTURED IN GUJARAT INDIA

20576 A

II

7/4/2006

RENOLIT NEDERLAND BV

20577 A

II

6/7/2007

HETERO DRUGS LTD

RENOLIT SOLMED SPECIALTY PP/PVC-BASED MULTILAYER TUBING AS MANUFACTURED IN


ENKHUIZEN THE NETHERLANDS
ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

20578 I

II

5/31/2007

BOCA PHARMACAL INC

GLYCOPYRROLATE USP ( ESUB ) AS MANUFACTURED IN MALVERN PA

20579 A

II

6/11/2007

CADILA HEALTHCARE LTD

CSA SALT OF CLOPIDOGREL AS MANUFACTURED IN GUJARAT INDIA

20580 A

II

6/7/2007

MSN PHARMACHEM PVT LTD

MONTELUKAST SODIUM USP [ROUTE CODE - MT"] AS MANUFACTURED IN TELANGANA

20581 A

II

6/6/2007

PHARMACEUTICAL WORKS POLPHARMA SA

TOPIRAMATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

20582 A

II

6/7/2007

HALCYON LABS PRIVATE LTD

BETAMETHASONE DIPROPIONATE USP AS MANUFACTURED IN GUJARAT INDIA

20583 A

II

6/5/2007

WANBURY LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

20584 A

II

4/30/2007

HUNAN JIUDIAN PHARMACEUTICAL CO LTD

DIRITHROMYCIN AS MANUFACTURED IN HUNAN CHINA

20585 A

IV

6/7/2007

MALLINCKRODT INC

MAGNESIUM STEARATE (CODES 2257 & 5712) AS MANUFACTURED IN ST LOUIS MO

20586 A

II

6/4/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN ZHEJIANG CHINA

20587 A

II

6/5/2007

ROCHE DIAGNOSTICS GMBH

CARVEDILOL AS MANUFACTURED IN MANNHEIM GERMANY

20588 A

IV

6/4/2007

SHING LIH FANG ENTERPRISE CO LTD

EMPTY GELATIN CAPSULE AS MANUFACTURED IN TAICHUNG HSIEN TAIWAN

20589 A

III

4/26/2007

PRETIUM PACKAGING

PLASTIC PACKAGING MATERIAL AS MANUFACTURED IN PERU IL

20590 A

II

5/23/2007

SYMRISE INC

NEO HELIOPAN OS AS MANUFACTURED IN GOOSE CREEK, SC

20591 A

II

6/11/2007

HETERO DRUGS LTD

OLANZAPINE (FORM-1) AS MANUFACTURED IN ANDHRA PRADESH INDIA

20592 A

II

6/12/2007

GLENMARK GENERICS LTD

ROSUVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT INDIA

20593 A

II

6/12/2007

GLENMARK GENERICS LTD

ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

20594 A

III

6/6/2007

NEMERA NEUENBURG GMBH

DUAL STRIP DRY POWDER INHALER AS MANUFACTURED IN NEUENBURG, GERMANY

20595 A

II

6/8/2007

APOTEX PHARMACHEM INC

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ONTARIO CANADA

Page 597

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20596 A
II
6/12/2007
AMRI RENSSELAER INC SUB ALBANY MOLECULAR
RESEARCH INC
20597 N
NOT AN ASSIGNED NUMBER

SUBJECT
DRONABINOL IN SESAME OIL DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER NY

20598 A

II

6/11/2007

PURAC BIOMATERIALS BUSINES UNIT OF PURAC

20599 A

IV

5/7/2007

MANTROSE HAEUSER CO INC

PURASAL S/PF 60 (SODIUM (S) LACTATE SOLUTION) AS MANUFACTURED IN BARCELONA AND


THE NETHERLANDS
MANTROCEL E-4000 AS MANUFACTURED IN ZHEJIANG CHINA

20600 I

III

6/7/2007

CCC PLASTICS

20601 A

IV

6/5/2007

ABELEI INC

20602 I

III

6/5/2007

AMPACET CORP

20603 A

III

5/24/2007

HUMPHREY COSBURN PLASTICS

AMPACET 110806-K SITE 06 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN RAYONG


THAILAND
70/400 WHITE ROUND RING TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO CANADA

20604 I

II

6/12/2007

GRANULES INDIA LTD

BROMPHENIRAMINE MALEATE USP AS MANUFACTURED IN HYDERABAD INDIA

20605 A

II

6/6/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

IBANDRONATE MONOSODIUM MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

20606 A

II

6/12/2007

GRANULES INDIA LTD

COMPRESSO IBU 66S AS MANUFACTURED IN RANGA REDDY INDIA

20607 A

III

6/18/2007

PERFEKTUP AS

TUBE PACKAGING FOR DRUG PRODUCTS AS MANUFACTURED IN ISTANBUL TURKEY

20608 I

II

6/11/2007

ACCORD HEALTHCARE INC

20609 A

II

6/13/2007

AARTI INDUSTRIES LTD

ANHYDROUS DOCETAXEL AS MANUFACTURED IN QUEBEC CANADA AND NORTH BRUNSWICK


NJ
BUDESONIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

20610 A

III

6/8/2007

3M DRUG DELIVERY SYSTEMS

COTRAN 9706 9% EVA FILM AS MANUFACTURED IN BROOKINGS SD

20611 A

III

6/8/2007

3M DRUG DELIVERY SYSTEMS

COTRAN 9705 9% EVA FILM AS MANUFACTURED IN BROOKINGS SD

20612 I

III

5/31/2007

AMPACET CORP

20613 A

II

6/15/2007

MEGAFINE PHARMA P LTD

20614 A

II

6/11/2007

XELLIA PHARMACEUTICALS APS

AMPACET 111708 BLUE WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE


HAUTE IN
PYRANTEL PAMOATE USP(NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK
INDIA
VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

20615 A

II

6/15/2007

QILU TIANHE PHARMACEUTICAL CO LTD

HYDROXYUREA USP (NON-STERILE BULK) AS MANUFACTURED IN SHANDONG CHINA

20616 I

II

6/18/2007

WUHAN SHIJI PHARMACEUTICAL CO LTD

POTASSIUM CHLORIDE AS MANUFACTURED IN WUHAN CHINA

20617 I

III

6/6/2007

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 32-2210B AS MANUFACTURED IN ADDISON IL

20618 I

III

6/13/2007

RICON COLORS

FDA AMBER CPT-B2899-3 AS MANUFACTURED IN WEST CHICAGO IL

20619 A

III

6/8/2007

3M DRUG DELIVERY SYSTEMS

M2878 POLYETHYLENE FILM AS MANUFACTURED IN BROOKINGS SD

20620 A

II

7/19/2007

IPCA LABORATORIES LTD

NABUMETONE USP, PROCESS II AS MANUFACTURED IN MADHYA PRADESH, INDIA.

20621 I

II

7/5/2007

IPCA LABORATORIES LTD

METHYLPHENIDATE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH INDIA.

20622 I

IV

6/19/2006

ROHM AND HAAS CO

RODERM SOLVENT ACRYLIC ADHESIVES AS MANUFACTURED IN PIEDMENT SC

20623 A

II

6/20/2007

SANOFI AVENTIS CHIMIE

NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN ARAMON FRANCE

20624 A

III

6/18/2007

LABLABO

SILLAGE AIRLESS PUMP AND BOTTLE AS MANUFACTURED IN ANNEMASSE FRANCE

20625 A

II

6/19/2007

MYLAN LABORATORIES LTD

ENROFLOXACIN USP AS MANUFACTURED IN TELANGANA INDIA

20626 A

II

6/22/2007

EUTICALS SPA

ERGOLOID MESYLATES USP AS MANUFACTURED IN ROZZANO MI ITALY

20627 A

II

6/22/2007

CATALENT PHARMA SOLUTIONS LLC

MICONAZOLE 1200 MG SOFTGELS AS MANUFACTURED IN ST PETERSBURG FL

20628 A

III

6/20/2007

NEUTRAL GLASS AND ALLIED INDUSTRIES


PRIVATE LTD

GLASS VIALS AND BOTTLES AS MANUFACTURED IN GUJARAT INDIA

WHITE MB20-9203 POLYETHYLENE COLUR CONCENTRATE AS MANUFACTURED IN ONTARIO


CANADA
177A44 N&A ORANGE FLAVOR AS MANUFACTURED IN NORTH AURORA IL

Page 598

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20629 A
II
6/22/2007
AUROBINDO PHARMA LTD
20630 I

III

6/25/2007

CIBA SPECIALTY CHEMICALS

SUBJECT
ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
IRGAGUARD B7000 AS MANUFACTURED IN OSAKA JAPAN

20631 I

III

6/18/2007

KUKJE GLASS CO LTD

GLASS VIALS & GLASS AMPOULES AS MANUFACTURED IN CHOONG NAM-DO KOREA

20632 A

II

6/26/2007

INOGENT LABORATORIES PRIVATE LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD INDIA

20633 A

II

6/26/2007

PHARMACEUTICAL WORKS POLPHARMA SA

P-242624 AS MANUFACTURED IN STAROGARD GDANSKI POLAND

20634 I

II

6/27/2007

ZHEJIANG NHU CO LTD

VITAMIN E OIL AS MANUFACTURED IN ZHEJIANG CHINA

20635 I

II

6/20/2007

ACS DOBFAR SPA

CEFOXITIN SODIUM USP STERILE 100 GRAMS AS MANUFACTURED IN MILANO ITALY

20636 A

II

6/20/2007

ACS DOBFAR SPA

CEFTRIAXONE SODIUM USP STERILE 100 GRAMS AS MANUFACTURED IN MILANO, ITALY

20637 A

II

6/27/2007

TAIHO PHARMACEUTICAL CO LTD

20638 I

II

6/27/2007

RANBAXY LABORATORIES LTD

WM-1-DAITO INTERMEDIATE FOR CDHP AS MANUFACTURED BY DAITO PHARMACEUTICAL CO


LTD IN TOYAMA JAPAN FOR TAIHO PHARMACEUTICAL CO LTD
LAMIVUDINE (FORM I) AS MANUFACTURED IN PUNJAB INDIA

20639 A

II

6/23/2007

MYLAN LABORATORIES LTD

ZOLMITRIPTAN AS MANUFACTURED IN TELANGANA INDIA

20640 A

II

6/15/2007

MYLAN LABORATORIES LTD

TADALAFIL USP AS MANUFACTURED IN TELANGANA, INDIA

20641 A

II

6/29/2007

HARTINGTON PHARMACEUTICAL, L.S.

EXTRACT OF CYCLAMEN EUROPAEUM AS MANUFACTURED IN TBILISI GEORGIA

20642 A

III

6/22/2007

BAADE ENDRULAT PAPIERVERARBEITUNG GMBH

CLOSURE LINERS

20643 I

IV

6/15/2007

RANK ORGANICS CHEMICAL PVT LTD

SODIUM STEARYL FUMARATE AS MANUFACTURED IN THANE INDIA

20644 I

II

6/28/2007

NINGXIA QIYUAN PHARMACEUTICAL CO LTD

ERYTHROMYCIN THIOCYANATE AS MANUFACTURED IN NINGXIA CHINA

20645 A

II

5/20/2007

JIANGSU NHWA PHARMACEUTICAL CO LTD

GABAPENTIN AS MANUFACTURED IN JIANGSU CHINA

20646 A

II

6/26/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

METOPROLOL SUCCINATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

20647 A

III

6/28/2007

POLYONE CORP

CC10042428WE TP GREEN AS MANUFACTURED IN ELK GROVE VILLAGE, IL

20648 A

III

6/28/2007

POLYONE CORP

CC00018501WE AS MANUFACTURED IN GLENDALE AZ

20649 A

II

6/29/2007

FERMION OY

IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN OULU, FINDLAND

20650 A

II

7/6/2007

CADILA HEALTHCARE LTD

CLOPIDOGREL BISULFATE USP (FORM-I) AS MANUFACTURED IN GUJARAT INDIA

20651 I

II

6/25/2007

ALEMBIC PHARMACEUTICALS LTD

ALENDRONATE SODIUM USP AS MANUFACTURED IN GUJARAT INDIA

20652 A

III

6/21/2007

3M DRUG DELIVERY SYSTEMS

3M PACKAGING FILM PF200CD AS MANUFACTURED IN DECATUR AL

20653 A

III

6/21/2007

3M DRUG DELIVERY SYSTEMS

3M PACKAGING FILM LF400M AS MANUFACTURED IN COTTAGE GROVE MN

20654 A

II

7/3/2007

FINE CHEMICALS CORP PTY LTD

ROPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN CAPE TOWN SOUTH AFRICA

20655 A

II

7/2/2007

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN SHANDONG CHINA

20656 I

II

7/18/2007

20657 I

III

7/6/2007

JIANGSU JIWA RINTECH PHARMACEUTICAL CO


LTD
DYNEON GMBH & CO KG

RISPERIDONE EP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU


PROVINCE, CHINA.
TFR 1105 PTFE AS MANUFACTURED IN BURGKIRCHEN GERMANY

20658 A

II

6/20/2007

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

DACTINOMYCIN USP AS MANUFACTURED IN ZHEJIANG CHINA

20659 A

II

7/9/2007

HETERO DRUGS LTD

20660 A

II

7/6/2007

FRESENIUS KABI ONCOLOGY LTD

VALACICLOVIR HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH


INDIA
ANASTROZOLE AS MANUFACTURED IN WEST BENGAL INDIA

20661 I

II

8/2/2007

CHEMWERTH INC

20662 A

II

7/9/2007

CHEMPACIFIC CORP

KETOTIFEN HYDROGEN FUMARATE AS MANUFACTURED BY CHEMCON GMBH IN FREIBURG


GERMANY FOR CHEMWERTH INC.
CHP010 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD

20663 I

IV

6/27/2007

CRODA INC

SUPER REFINED POLYETHYLENE GLYCOL 300 NF AS MANUFACTURED IN MILL HALL PA

20664 A

II

6/30/2007

CHONGQING BIOCARE PHARMACEUTICAL CO LTD

DOXAZOSIN MESYLATE USP AS MANUFACTURED IN CHONGQING CHINA

Page 599

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20665 A
II
7/9/2007
JIANGSU HENGRUI MEDICINE CO LTD

SUBJECT
OXALIPLATIN AS MANUFACTURED IN JIANGSU CHINA

20666 A

III

6/18/2007

BERRY PLASTICS CORP

GPWN60 HS AS MANUFACTURED BY BERRY PLASTICS.

20667 A

III

7/2/2007

NAMICOS CORP

20668 A

IV

6/19/2007

ARIES COMPONENTS MANUFACTURING CO

CLEANING OF GLASS VIALS AND OTHER CONTAINER CLOSURE SYSTEMS FOR PACKAGING
DRUG PRODUCTS AS MANUFACTURED IN SHIGA, JAPAN.
EXCIPIENT MARKING SOLUTION AS MANUFACTURED IN MAHARASHTRA, INDIA.

20669 A

II

7/11/2007

MOREPEN LABORATORIES LTD

LORATADINE (PROCESS 2) U.S.P. AS MANUFACTURED IN HIMACHAL PRADESH, INDIA.

20670 A

III

6/18/2007

BERRY PLASTICS CORP

BNF60 AS MANUFACTURED BY BERRY PLASTICS

20671 A

II

7/12/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

20672 I

II

7/6/2007

USV LIMITED

ROSUVASTATIN CALCIUM (BULK) AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD


IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
ATOVAQUONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

20673 A

III

6/13/2007

WIPAK OY

APET 500 AS MANUFACTURED IN NASTOLA, FINLAND.

20674 A

II

7/13/2007

HARMAN FINOCHEM LTD

MEPROBAMATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

20675 A

II

7/12/2007

NATCO PHARMA LTD

20676 A

II

7/11/2007

INDUSTRIALE CHIMICA SRL

ONDANSETRON HYDROCHLORIDE (INJECTABLE GRADE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.
DROSPIRENONE USP AS MANUFACTURED IN SORONNO (VARESE), ITALY.

20677 A

II

7/2/2007

20678 A

II

7/13/2007

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
NATCO PHARMA LTD

20679 I

II

11/7/2007

CIPLA LTD

20680 A

II

8/16/2007

CIPLA LTD

20681 I

II

7/13/2007

20682 A

II

7/16/2007

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
CILAG AG

20683 A

III

5/24/2007

SCANDOLARA SPA

20684 A

II

7/12/2007

SYMBIOTEC PHARMALAB LTD

DRONABINOL DRUG SUBSTANCE IN SESAME OIL AS MANUFACTURED IN SCHAFFHAUSEN,


SWITZERLAND.
COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL USE AS MANUFACTURED IN ASCOLI
PICEBO, ITALY.
MOMETASONE FUROATE USP (MICRONISED) AS MFG. IN MADHYA PRADESH, INDIA.

20685 A

II

7/13/2007

APOTEX PHARMACHEM INDIA PVT LTD

GATIFLOXACIN HEMIHYDRATE AS MANUFACTURED IN BANGALORE, INDIA.

20686 A

II

7/15/2007

DIVIS LABORATORIES LTD

BOC COR SUCCINATE (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

20687 A

II

7/12/2007

DAICEL CORPORATION

BENZINDENE TRIOL AS MANUFACTURED IN NIIGATA, JAPAN.

20688 I

II

7/13/2007

BIOFIRST PHARMACEUTICALS LLC

GLYCOPYRROLATE AS MANUFACTURED IN CORPUS CHRISTI, TX.

20689 A

III

7/12/2007

ROLLS PACK PVT LTD

20690 A

III

7/16/2007

LOPAREX LLC

TAILOR MADE LAMINATED ALUMINIUM BAGS FOR DRUG PACKAGING AS MANUFACTURED IN


MUMBAI, INDIA.
GRADE 27246 D 2.0 CL PET 8400E/000, GRADE 27441 D 3.0 CL PET 8400E/000 AND GRADE
28924 D 3.0 CL BOP 8400E/000 AS MFG. IN WILLOWBROOK, IL; IOWA CITY, IA; EDEN, NC;
CULLMAN, AL; HAMMOND, WI.

20691 A

III

7/10/2007

STYROLUTION EUROPE GMBH

NOVODUR HD M205FC, VARIOUS COLORS AS MFG IN KOLN-WORRINGEN, GERMANY;


SCHWARZHEIDE, GERMANY; ALBIS PLASTIC GMBH IN HAMBURG, GERMANY; AND ALBIS UK
LTD IN KNUTSFORD CHESHIRE, UK

20692 A

II

10/16/2007

HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN BUDAPEST, HUNGARY.

20693 A

IV

9/19/2007

CHINOIN PHARMACEUTCIAL AND CHEMICAL


WORKS CO LTD
IDEAL CURES PVT LTD

ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3) AS MANUFACTURED IN TAIZHOU, CHINA.


GRANISETRON HYDROCHLORIDE (INJECTABLE GRADE) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA.
MYCOPHENOLATE MOFETIL BP/PH. EUR. AS MANUFACTURED IN MAHARASHTRA, INDIA.
TRIMETAZIDINE DIHYDROCHLORIDE BP/PH.EUR. AS MANUFACTURED IN MAHARASHTRA,
INDIA.
TRANDOLAPRIL EP AS MANUFACTURED IN HARYANA, INDIA.

INSTACOAT COLOUR AS MANUFACTURED IN THANE, INDIA

Page 600

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20694 A
III
7/17/2007
BILCARE LTD

SUBJECT
BILCARE SINGAPORE MONO AND MULTILAYERED PHARMACEUTICAL PACKAGING FILMS AS
MANUFACTURED IN SINGAPORE.
SOFT CHEW INNERWRAP FPC SPECIFICATION 32700, 32701X AND SOFT CHEW OUTWRAP
FPC SPECIFICATION 47500X AS MFG. IN ONTARIO, CANADA.
PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MFG. IN GIRONA, SPAIN.

20695 A

III

7/17/2007

FPC FLEXIBLE PACKAGING CORP

20696 I

II

7/9/2007

ESTEVE QUIMICA SA

20698 A

II

7/16/2007

FRESENIUS KABI ANTI INFECTIVES SRL

CEFOXITIN SODIUM (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN ROVIGO, ITALY.

20699 A

II

7/18/2007

NAVINTA LLC

20700 A

III

7/16/2007

AMPACET CORP

20701 A

III

7/31/2007

DYNIC USA CORP

SODIUM 4-PHENYLBUTYRATE AS MANUFACTURED IN MAHARASHTRA, INDIA FOR NAVINTA


LLC
AMPACET 172535 GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.
NK22 THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

20702 I

III

7/3/2007

PENN COLOR INC

COLOR CONCENTRATE 66G1324 ECO GREEN PETG AS MANUFACTURED IN HATFIELD, PA.

20703 I

II

7/19/2007

RANBAXY LABORATORIES LTD

ZIDOVUDINE USP DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA.

20704 A

II

7/11/2007

CADILA PHARMACEUTICALS LTD

ALEDRONATE SODIUM AS MANUFACTURED IN GUJARAT, INDIA.

20705 A

II

7/18/2007

CHANGZHOU PHARMACEUTICAL FACTORY

ROSUVASTATIN CALCIUM AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

20706 A

II

7/20/2007

SUZHOU NUMBER 4 PHARMACUTICAL FACTORY

QUETIAPINE FUMARATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

20707 A

II

7/10/2007

RP SCHERER GMBH & CO. KG

TIPRANAVIR CAPSULES 250 MG (IMPRINT) AS MANUFACTURED IN EBERBACH, GERMANY.

20708 A

II

7/18/2007

AUROBINDO PHARMA LTD

20709 A

II

7/20/2007

CHEMWERTH INC

20710 I

III

7/9/2007

PROMENS SA

EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.
ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED BY
CHEMCON GMBH IN FREIBURG, GERMANY FOR CHEMWERTH INC.
TABLET CONTAINERS AS MANUFACTURED IN OYONNAX, FRANCE

20711 A

II

4/24/2008

CIPLA LTD

EFAVIRENZ AS MANUFACTURED IN MAHARASHTRA, INDIA.

20712 A

II

7/25/2007

MSN LABORATORIES LTD

ROSUVASTATIN CALCIUM [ROUTE CODE - RV"] AS MANUFACTURED IN TELANGANA

20713 A

II

7/24/2007

APOTEX PHARMACHEM INDIA PVT LTD

RAMIPRIL USP AS MANUFACTURED IN BRANTFORD, CANADA.

20714 I

II

7/23/2007

PENICILLIN G POTASSIUM CRUDE AS MANUFACTURED IN INNER MONGOLIA, CHINA.

20715 A

II

7/26/2007

CSPC ZHONGRUN PHARMACEUTICAL INNER


MONGOLIA CO LTD
LUITPOLD PHARMACEUTICALS INC

20716 I

II

4/25/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LOSARTAN POTASSIUM, USP AS MANUFACTURED IN ZHEJIANG, CHINA.

20717 A

II

7/9/2007

SAFC BIOSCIENCES INC

EX-CELL(TM) CD CHO (MODIFIED), SERUM-FREE MEDIUM, CHEMICALLY DEFINED W/O


GLUCOSE, W/O L-GLUTAMINE, W/O HYPOXANTHINE, W/O THYMIDINE AS MFG. IN DENVER, PA

20718 A

III

7/23/2007

BERRY PLASTICS CORP

PRODUCT 15149-28 AS MANUFACTURED IN COLUMBUS, GA

20719 A

III

7/26/2007

PLASTIAPE SPA

CONCEPT1 DRY POWDER INHALATION DEVICE AS MANUFACTURED IN LECCO, ITALY.

20720 A

III

7/20/2007

DALAU LTD

20721 A

III

7/30/2007

LAMINATED TUBES ITALIA SPA

20722 I

II

6/20/2007

SAI PHYTOCEUTICALS PVT LTD

COMPONENTS FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN ESSEX UNITED


KINGDOM
LAMINATED TUBES FOR PHARMACEUTICAL USE AS MANUFACTURED IN CISTERNA DI LATINA,
ITALY.
DOCETAXEL TRIHYDRATE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

20723 I

II

6/20/2007

SAI PHYTOCEUTICALS PVT LTD

TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN MADHYA PRADESH, INDIA.

20724 A

II

7/26/2007

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO TOBRAMYCIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDONG, CHINA.
LTD

20697 N

NOT AN ASSIGNED NUMBER

SODIUM THIOSULFATE INJECTION, USP 25% ML VIAL AS MANUFACTURED IN SHIRLEY, NY.

Page 601

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20725 A
II
7/24/2007
SYNKEM SAS

SUBJECT
FENOFIBRATE INTERMEDIATE DRUG SUBSTANCE AS MANUFACTURED IN CHENOVE, FRANCE.

20726 A

II

7/26/2007

PURAC

20727 A

II

8/16/2007

CONCORD BIOTECH LTD

L(+)LACTIC ACID AS MANUFACTURED BY PURAC BIOQUIMICA IN BARCELONA, SPAIN FOR


PURAC
PRAVASTATIN SODIUM AS MANUFACTURED IN AHMEDABAD, INDIA.

20728 A

II

7/26/2007

20729 A

II

7/16/2007

KETOROLAC TROMETHAMINE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN


CAMPOVERDE DI APRILIA, ITALY.
OXYCODONE HYDROCHLORIDE (MS PROCESS) AS MANUFACTURED IN WEST DEPTFORD,NJ.

20730 A

II

6/28/2007

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
JOHNSON MATTHEY PHARMACEUTICAL
MATERIALS
TEVA PHARMACEUTICAL INDUSTRIES LTD

20731 I

III

7/26/2007

LEVOSIL SPA

20732 A

IV

7/30/2007

CYDEX PHARMACEUTICALS A LIGAND CO

20733 A

II

7/18/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

SILICA GEL DESICCANT BAG WITH TYVEK(R) ENVELOPE AS MANUFACTURED IN CHIUSA SAN
MICHELE (TO), ITALY
CAPTISOL EXCIPIENT AS MANUFACTURED BY HOVIONE FARMACIENCIA S.A. IN LISBON,
PORTUGAL FOR CYDEX INC.
QUETIAPINE HEMIFUMARATE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA.

20734 A

II

7/31/2007

GLENMARK GENERICS LTD

FLUCONAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA.

20735 A

II

7/30/2007

INFA SA

20736 A

II

7/30/2007

AMINO CHEMICALS LTD

TERCONAZOLE AS MANUFACTURED BY DERIVADOS QUIMICOS S.A. FINE CHEMICALS IN


MURCIA, SPAIN FOR NEOLUX LTD.
IMIQUIMOD AS MANUFACTURED IN MARSA, MALTA.

20738 A

II

8/1/2007

ST GOBAIN PERFORMANCE PLASTICS FRANCE

PHARMEDR BPT BIOCOMPATIBLE TUBING MANUFACTURED IN CHARNY, FRANCE

20739 A

II

8/1/2007

JIANGSU HENGRUI MEDICINE CO LTD

20740 A

II

7/27/2007

ZACH SYSTEM SPA

IRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE AS


MANUFACTURED IN JIANGSU PROVINCE, CHINA.
DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN LONIGO, ITALY.

20741 I

III

7/20/2007

ROLLPRINT PACKAGING PRODUCTS INC

RPP #26-1220 - PACKAGING MATERIAL AS MANUFACTURED IN ADDISON, IL.

20742 I

II

7/30/2007

FLAMMA SPA

SULINDAC AS MANUFACTURED IN BERGAMO, ITALY.

20743 A

II

7/25/2007

ST GOBAIN PERFORMANCE PLASTICS FRANCE

TYGON(R) S-50-HL MEDICAL/SURGICAL TUBING MANUFACTURED IN CHARNY, FRANCE.

20744 I

IV

10/19/2007

HERCULES INC

AQUARIUS(TM) COATINGS SYSTEMS AS MANUFACTURED IN WILMINGTON, DE

20745 A

II

7/31/2007

MACFARLAN SMITH LTD

NALOXONE HYDROCHLORIDE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM.

20746 A

II

8/3/2007

SMS PHARMACEUTICALS LTD

20747 I

II

8/2/2007

MALLINCKRODT INC

SUMATRIPTAN SUCCINATE (ALTERNATIVE SYNTHESIS) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.
LEVORPHANOL BASE AS MANUFACTURED IN ST. LOUIS, MO.

20748 A

III

6/29/2007

AMCOR FLEXIBLES INDIA PVT LTD

FLEXIBLE PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA, INDIA.

20749 I

II

8/2/2007

CHEMWERTH INC

ISRADIPINE USP, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY SHANGHAI


ZIYUAN PHARMACEUTICAL CO. LTD. IN SHANGHAI, CHINA FOR CHEMWERTH INC.

20750 I

II

12/7/2007

TITAN PHARMACEUTICAL CO LTD GUANGDONG

20751 A

II

7/27/2007

20752 A

II

7/28/2007

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
SINOPEP PHARMACEUTICALS INC

CEFUROXIME AXETIL DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG PROVINCE,


CHINA.
ROSUVASTATIN CALCIUM INTERMEDIATE (R1.5) AS MANUFACTURED IN TIZHOU, CHINA.

20753 A

II

8/6/2007

DESMOPRESSIN ACETATE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN HAIKOU,


CHINA.
ORCHID CHEMICALS AND PHARMACEUTICALS LTD RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

20754 A

II

7/30/2007

ALEMBIC PHARMACEUTICALS LTD

20737 N

CEFDINIR HYDRATE AS MANUFACTURED IN MEXICO, CO.

NOT AN ASSIGNED NUMBER

AZITHROMYCIN DIHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA

Page 602

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20755 A
II
8/3/2007
MSN PHARMACHEM PVT LTD

SUBJECT
MOXIFLOXACIN HYDROCHLORIDE USP (MONOHYDRATE) [ROUTE CODE - "MM"] AS
MANUFACTURED IN ANDHRA PRADESH, INDIA.
LOPINAVIR (LOR) AS MANUFACTURED BY ASTRIX LABORATORIES LTD IN ANDHRA PRADESH,
INDIA FOR MATRIX LABORATORIES LTD.
STERILE AREA 1 DEPARTMENT AT MONZA FACILITY IN MILAN, ITALY.

20756 I

II

8/7/2007

MATRIX LABORATORIES LTD

20757 A

7/20/2007

PATHEON ITALIA SPA

20758 A

II

8/7/2007

CHONGQING DAXIN PHARMACEUTICAL CO LTD

20759 A

II

7/31/2007

CKD BIO CORP

20760 A

II

8/7/2007

EUTICALS SPA

20761 A

II

7/30/2007

TAI HENG INDUSTRY CO LTD

20762 A

IV

8/6/2007

HINDUSTAN PHOSPHATES PVT LTD

LETROZOLE USP AS MANUFACTURED BY CHANGZHOU SIYAO PHARMACEUTICAL CO LTD IN


JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD.
CALCIUM PHOSPHATES AS MANUFACTURED IN INDORE (M.P.), INDIA.

20763 A

II

7/31/2007

WOCKHARDT LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA.

20764 A

II

8/8/2007

NOF CORP

20765 A

II

8/9/2007

LEK PHARMACEUTICALS DD

HSPC (PURIFIED HYDROGENATED SOY PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN


HYOGO, JAPAN.
ROSUVASTATIN CALCIUM DRUG SUBSTANCE AS MANUFACTURED IN MENGES, SLOVENIA.

20766 A

II

7/31/2007

AUROBINDO PHARMA LTD

20767 A

II

8/10/2007

20768 I

III

8/1/2007

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
PROMENS SA

20769 A

II

8/10/2007

CADILA HEALTHCARE LTD

20770 I

II

8/6/2007

STANDARD CHEM AND PHARM CO LTD

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN GUJARAT,


INDIA.
DOXAZOSIN MESYLATE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN.

20771 A

II

8/20/2007

IPCA LABORATORIES LTD

ONDANSETRON HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

20772 A

IV

8/13/2007

20773 A

III

8/7/2007

20774 A

II

7/18/2007

20775 A

II

8/16/2007

MASTERTASTE INC DBA KERRY INGREDIENTS AND 711497 NATURAL LEMON LIME FLAVOR WONF, EXCIPIENT COLORANT FLAVOR AS
FLAVOURS
MANUFACTURED IN CLARK, NJ.
COLORTECH INC
11430-18 ANTISTAT WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN
MORRISTOWN, TN AND BRAMPTON, CANADA.
YICHANG HUMANWELL PHARMACEUTICAL CO LTD FENTANYL CITRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
YICHANG, CHINA.
APICORE US LLC
MOLINDONE HYDROCHLORIDE USP AS MANUFACTURED IN SOMERSET, NJ.

20776 A

III

8/10/2007

LISA AMPOULES AND VIALS PVT LTD

20777 A

III

8/1/2007

EXCEL PACK LTD

NEUTRAL GLASS AMPOULES & TUBULAR VIALS AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
INDUCTION SEALING WADS AS MANUFACTURED IN NEW DELHI, INDIA.

20778 I

II

8/17/2007

TONIRA PHARMA LTD

MEFENAMIC ACID AS MANUFACTURED IN GUJARAT, INDIA.

20779 A

II

8/16/2007

DANTROLENE SODIUM (DTE) AS MANUFACTURED IN CONSHOHOCKEN, PA.

20780 A

II

8/17/2007

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
DR REDDYS LABORATORIES LTD

20781 A

II

8/21/2007

NATCO PHARMA LTD

20782 A

II

8/17/2007

20783 A

III

8/6/2007

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO OXO-ACID DIPA SALT, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ZHEJIANG
LTD
PROVINCE, CHINA.
PENN COLOR INC
PLASTIC/PASTES COLORANTS AND DISPERSIONS AS MANUFACTURED IN HATFIELD, PA

20784 I

II

8/7/2007

FIS FABBRICA ITALIANA SINTETICI SPA

MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


CHONGQING, CHINA.
ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGI-DO,
SOUTH KOREA.
ARGATROBAN DRUG SUBSTANCE AS MANUFACTURED IN ROZZANO, ITALY.

GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA


PRADESH, INDIA.
MUPIROCIN, NON-STERILE BULK FORM AS MANUFACTURED IN HANGZHOU, CHINA.
EASYLOCK AS MANUFACTURED IN OYONNAX, FRANCE.

VARDENAFIL HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA.
RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

BENZYL HYDRAZINE MSA (FIS0181) AS MANUFACTURED IN VICENZA, ITALY.

Page 603

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20785 I
II
8/1/2007
KEKULE PHARMA LTD

SUBJECT
BICALUTAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

20786 A

II

8/14/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

ALENDRONATE SODIUM USP AS MANUFACTURED IN GUJARAT, INDIA.

20787 A

II

8/23/2007

CODEINE PHOSPHATE USP AS MANUFACTURED IN WEST DEPTFORD, NJ.

20788 A

II

8/21/2007

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
BACHEM SA

20789 A

II

8/22/2007

GUFIC BIOSCIENCES LTD

LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA.

20790 I

IV

8/21/2007

MASTERTASTE SPA

58.3514.2P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20791 I

IV

8/21/2007

MASTERTASTE SPA

58.3520.1P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20792 I

IV

8/21/2007

MASTERTASTE SPA

58.3536.1P PHA LIME FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20793 I

IV

8/21/2007

MASTERTASTE SPA

20.4561.IP PHA BLACKCURRANT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20794 I

IV

8/21/2007

MASTERTASTE SPA

20.4568.1G PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20795 I

IV

8/21/2007

MASTERTASTE SPA

20.4570.3P PHA PASSION FRUIT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20796 I

IV

8/21/2007

MASTERTASTE SPA

58.4262.2L PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20797 I

IV

8/21/2007

MASTERTASTE SPA

20.4564.2P PHA GRAPE FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20798 I

IV

8/21/2007

MASTERTASTE SPA

20.4563.UL PHA CHERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20799 I

IV

8/21/2007

MASTERTASTE SPA

20.4557.1G PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20800 I

IV

8/21/2007

MASTERTASTE SPA

20.4554.CP PHA MILK FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20801 I

IV

8/20/2007

MASTERTASTE SPA

58.3754.1P PHA SPEARMINT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20802 I

IV

8/21/2007

MASTERTASTE SPA

58.3964.2P PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20803 I

IV

8/22/2007

MASTERTASTE SPA

58.3748.UW PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20804 I

IV

8/21/2007

MASTERTASTE SPA

20.4573.5P PHA VANILLA FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20805 I

IV

8/21/2007

MASTERTASTE SPA

20.4571.1V PHA WINTERGREEN FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20806 I

IV

8/21/2007

MASTERTASTE SPA

20.4579.1P PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20807 I

IV

8/21/2007

MASTERTASTE SPA

20.4566.CP PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20808 I

IV

8/21/2007

MASTERTASTE SPA

20.4582.2P PHA SOUR CHERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20809 I

IV

8/21/2007

MASTERTASTE SPA

58.3478.1P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO, ITALY

20810 A

II

8/22/2007

SCINOPHARM TAIWAN LTD

20811 I

II

8/27/2007

ELAN DRUG DELIVERY INC

20812 I

II

8/23/2007

SANOFI CHIMIE

20813 A

II

8/28/2007

AARTI DRUGS LTD

TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN, TAIWAN


R.O.C.
N1296 (PANZEM) NANOCRYSTAL POWDER FOR ORAL SUSPENSION AS MANUFACTURED IN
KING OF PRUSSIA, PA.
SATAVAPTAN PHOSPHATE MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN
SISTERON, FRANCE.
NIMESULIDE AS MANUFACTURED IN MAHARASHTRA, INDIA.

20814 A

II

8/28/2007

SHASUN PHARMA SOLUTIONS LTD

20815 I

III

8/28/2007

ZELLER PLASTIK MEXICO

20816 I

II

8/24/2007

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

20817 I

8/15/2007

QSV BIOLOGICS LTD

ISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN SHANDONG


PROVINCE, CHINA.
EDMONDON FACILITY IN ALBERTA, CANADA

20818 A

II

8/29/2007

AMINO CHEMICALS LTD

RABEPRAZOLE SODIUM MONOHYDRATE AS MANUFACTURED IN MARSA, MALTA.

20819 I

II

8/6/2007

CADILA PHARMACEUTICALS LTD

PSEUDOEPHEDRINE TANNATE AS MANUFACTURED IN GUJARAT, INDIA.

PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN VIONNAZ, SWITZERLAND.

KETONE BISULFITE ADDUCT (KBA) DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN


NORTHUMBERLAND, U.K.
TOOTHPASTE FLIP TOP CAP AS MANUFACTURED IN CUAUTITLAN IZCALLI, MEXICO.

Page 604

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20820 I
II
8/23/2007
CADILA PHARMACEUTICALS LTD

SUBJECT
DIPHENHYDRAMINE TANNATE AS MANUFACTURED IN GUJARAT, INDIA.

20821 A

II

8/29/2007

SYMBIOTEC PHARMALAB LTD

CLOBETASOL PROPIONATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

20822 I

II

8/29/2007

IBA MOLECULAR NA

(F-18)FLT AS MANUFACTURED IN STERLING, VA.

20823 I

II

8/28/2007

BIONORICA AG

DRONABINOL USP AS MANUFACTURED IN NEUMARKT, GERMANY

20824 A

II

8/23/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

LITHIUM CARBONATE USP AS MANUFACTURED IN GUJARAT, INDIA.

20825 I

II

8/29/2007

MEDICHEM SA

RABEPRAZOLE SDOIUM (MED-201580/E) AS MANUFACTURED IN GIRONA, SPAIN

20826 A

II

8/20/2007

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD

GABAPENTIN AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

20827 A

II

8/30/2007

CENTAUR PHARMACEUTICALS PRIVATE LTD

ALPRAZOLAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

20828 I

8/22/2007

DEET JOINT VENTURE DEET TASK FORCE

NON-CLINICAL DATA FOR N,N-DIETHYL-META-TOLUAMIDE AS MFG BY ELGIN FINE CHEMICALS


INC IN ELGIN, SC; MT HOLLY CLARIANT CORP IN MT HOLLY, NC; VERTELLUS PERFORMANCE
MATERIALS INC IN GREENSBORO, NC; QINGDAO SANLI CHEM ENGINEERING TECH CO. LTD

20829 A

II

4/25/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA

20830 I

III

7/20/2007

20831 I

III

7/20/2007

20832 A

II

9/4/2007

NINGBO ZHENGLI PHARMACEUTICAL PACKING CO


LTD
NINGBO ZHENGLI PHARMACEUTICAL PACKING CO
LTD
NIPPON CHEMIPHAR CO LTD

20833 A

II

9/5/2007

GLAND PHARMA LTD

TUBING BOROSILICATE GLASS CONTAINERS FOR PARENTERAL PREPARATIONS AS


MANUFACTURED IN ZHEJIANG, CHINA.
TUBING LOW-BOROSILICATE GLASS CONTAINERS FOR PARENTERAL PREPARATIONS
MANUFACTURED IN ZHEJIANG, CHINA
NP-0730-PP DRUG SUBSTANCE AS MFG. BY DAIICHI PURE IN IWATE, JAPAN FOR NIPPON
CHEMIPHAR CO. LTD.
ROCURONIUM BROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20834 A

IV

12/7/2007

LIPOID GMBH

20835 A

II

9/10/2007

UNICHEM LABORATORIES LTD

LIPOID PC 16:0/18.1 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE) (POPC) AS


MANUFACTURED IN LUDWIGSHAFEN, GERMANY
LAMOTRIGINE USP API AS MANUFACTURED IN MADHYA PRADESH, INDIA

20836 I

II

9/6/2007

NV ORGANON

2-METHOXYESTRADIOL AS MANUFACTURED IN OSS, THE NETHERLANDS

20837 A

II

7/27/2007

LUNDBECK PHARMACEUTICALS ITALY SPA

MELPERONE HYDROCHLORIDE AS MANUFACTURED IN PADOVA, ITALY

20838 A

II

9/3/2007

ST GOBAIN PERFORMANCE PLASTICS FRANCE

TYGON 3350 SANITARY SILICONE TUBING AS MANUFACTURED IN CHARNY, FRANCE

20839 A

II

9/6/2007

IRVINE SCIENTIFIC SALES CO

IS MAB-V(TM) WITH IRON CHELATE AS MANUFACTURED IN SANTA ANA, CA

20840 I

III

9/6/2007

TEKNOR COLOR CO

30,463HCC AMBER 2% AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX

20841 A

II

9/7/2007

DR REDDYS LABORATORIES LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20842 I

II

10/11/2007

7-AMINOCEPHALOSPORANIC ACID AS MANUFACTURED IN SHIJIAZHUANG, CHINA

20843 I

II

9/12/2007

CSPC HEBEI ZHONGRUN PHARMACEUTICAL CO


LTD
HARIKA DRUGS PRIVATE LTD

20844 I

II

9/12/2007

HARIKA DRUGS PRIVATE LTD

PHENYLEPHRINE TANNATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20845 A

II

9/12/2007

HETERO LABS LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20846 I

III

8/28/2007

SHINIL PHARM GLASS CO LTD

VIALS AS MANUFACTURED IN CHUNGNAM, KOREA

20847 I

II

9/10/2007

20848 A

II

9/13/2007

CHINOIN PHARMACEUTCIAL AND CHEMICAL


MISOPROSTOL DISPERSION, HPMC 1% AS MANUFACTURED IN BUDAPEST, HUNGARY
WORKS CO LTD
ORCHID CHEMICALS AND PHARMACEUTICALS LTD MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

20849 A

II

9/13/2007

AMOLI ORGANICS PVT LTD

DICLOFENAC SODIUM AS MANUFACTURED IN GUJARAT, INDIA

20850 A

II

9/10/2007

MSN LABORATORIES LTD

PANTOPRAZOLE SODIUM USP [ROUTE CODE - 'PS'] AS MANUFACTURED IN TELANGANA, INDIA

20851 I

IV

9/14/2007

INTERNATIONAL SPECIALTY PRODUCTS

ADVANTIA(TM) PRIME AS MANUFACTURED BY EMERSON RESOURCES INC IN NORRISTOWN,


PA FOR INTERNATIONAL SPECIALTY PRODUCTS

DEXTROMETHORPHAN TANNATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 605

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20852 I
II
9/10/2007
HEC PHARM CO

SUBJECT
AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED
IN HUBEI PROVINCE, CHINA
BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY AMBIOPHARM
INC IN AUGUSTA, SC AND SHANGHAI AMBIOPHARM INC. IN SHANGHAI, CHINA FOR
AMBIOPHARM INC

20853 A

II

9/14/2007

AMBIOPHARM INC

20854 A

II

9/17/2007

FARMAK AS

QUETIAPINE FUMARATE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

20855 A

II

9/17/2007

FDC LTD

BRIMONIDINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20856 A

II

9/17/2007

FDC LTD

DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

20857 A

III

9/14/2007

POLYONE CORP

CC10097644WE BLUE 286C AS MANUFACTURED IN ELK GROVE VILLAGE, IL

20858 A

III

9/14/2007

POLYONE CORP

CC00016598DR 60558JEMB AMBER AS MANUFACTURED IN ELK GROVE VILLAGE, IL

20859 A

9/10/2007

AAIPHARMA SERVICES CORP

STERILE MANUFACTURING FACILITY IN CHARLESTON, SC

20860 A

III

9/10/2007

ADVANCED FILMS LLC

20861 I

II

9/18/2007

DR REDDYS LABORATORIES LTD

MEDICAL POUCH FILM (NX-779F-6) AS MANUFACTURED BY BERRY/COVALENCE PLASTICS IN


LAKEVILLE, MN AND VANCOUVER, WA FOR ADVANCED FILMS, LLC
ROCURONIUM BROMIDE AS MANUFACATURED IN ANDHRA PRADESH, INDIA

20862 A

II

9/17/2007

BACHEM AG

ICATIBANT ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND

20863 A

II

9/18/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

20864 A

II

9/28/2007

F2 CHEMICALS LTD

BIVALIRUDIN AS MANUFACTURED BY PLANTEX LTD IN NETANYA, ISRAEL FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
PERFLUOROBUTANE AS MANUFACTURED IN LANCASHIRE, UNITED KINGDOM

20865 A

II

9/19/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

20866 A

III

9/7/2007

ARGO SA PLASTIC PACKAGING

20867 A

II

9/17/2007

MSN LABORATORIES LTD

20868 A

II

9/20/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

ALFUZOSIN HYDROCHLORIDE USP [ROUTE CODE-"AE"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
MEMANTINE HYDROCHLORIDE AS MANUFACTURED BY TEVA PHARMACEUTICAL FINE
CHEMICALS SRL IN CARONNO PERTUSELLA AND BULCIAGO, ITALY FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD

20869 A

II

9/21/2007

SCINOPHARM TAIWAN LTD

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

20870 A

II

9/17/2007

AUROBINDO PHARMA LTD

20871 A

II

9/14/2007

JOST CHEMICAL CO

DIDANOSINE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
MAGNESIUM LACTATE DIHYDRATE AS MANUFACTURED IN ST. LOUIS, MO

20872 A

III

9/21/2007

GERRESHEIMER ESSEN GMBH

AMBER AND FLINT GLASS CONTAINERS AS MANUFACTURED IN ESSEN, GERMANY

20873 A

II

9/21/2007

HETERO DRUGS LTD

LANSOPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20874 A

II

9/18/2007

QILU TIANHE PHARMACEUTICAL CO LTD

20875 A

III

9/24/2007

GERRESHEIMER REGENSBURG GMBH

AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMA CEUTICAL INGREDIENT AS


MANUFACTURED IN SHANDONG, CHINA
CAPSULE SLEEVE AS MANUFACTURED IN PFREIMD, GERMANY

20876 A

II

9/24/2007

NOF CORP

DPPC (DIPALMITOYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN AMAGASAKI, JAPAN

20877 A

II

9/24/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZALEPLON AS MANUFACTURED IN MAHARASHTRA, INDIA

20878 A

II

9/24/2007

CHEMPACIFIC CORP

20879 A

II

9/21/2007

S A PHARMACHEM PVT LTD

PROCARBAZINE HYDROCHLORIDE (CHP012) DRUG SUBSTANCE AS MANUFACTURED IN


BALTIMORE, MD
PREGELATINIZED STARCH BP/USP AS MANUFACTURED IN DADRA & NAGAR HAVELI, INDIA

20880 A

9/18/2007

WEST PHARMACEUTICAL SERVICES INC

WESTAR(R) READY-TO-USE (RU) STEAM STERILIZATION PROCESS IN JERSEY SHORE, PA

20881 A

III

9/26/2007

LCY CHEMICAL CORP

POLYPROPLENE POLYMERS: PT231M, ST612, STM866, ST757M, ST868M, PT100 and 8461 AS
MANUFACTURED IN KAOHSIUNG HSIEN, TAIWAN R.O.C.

PARICALCITOL AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD IN BE'ER, SHEVA,


ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
DRUG BOTTLES AND CONTAINERS AS MANUFACTURED BY ARGO SA PLASTIC PACKAGING IN
KAROPI, GREECE AND ARGO ROM PLASTICS IN BUCURESTI, ROMANIA FOR ARGO SA
PLASTIC PACKAGING

Page 606

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20882 A
II
9/26/2007
AMINO CHEMICALS LTD

SUBJECT
TELMISARTAN AS MANUFACTURED IN MARSA, MALTA

20883 A

II

9/24/2007

OLON SPA

MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN RODANO (MI), ITALY

20884 A

II

9/26/2007

TEVA PHARMACEUTICALS INDUSTRIES LTD

20885 A

II

9/25/2007

EXCELLA GMBH

TADALAFIL AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD IN BEER SHEVA,


ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
R-BACLOFEN AS MANUFACTURED IN FEUCHT, GERMANY

20886 I

III

8/31/2007

ROHM AND HAAS CO

20887 A

IV

9/26/2007

APTALIS PHARMATECH INC

ADCOTE 40-51NEF AS MANUFACTURED BY ROHM AND HAAS CHEMICALS LLC IN ELK GROVE
VILLAGE AND RINGWOOD, IL FOR ROHM AND HAAS COMPANY
F001 GRANULATION AS MANUFACTURED IN VANDALIA, OH

20888 A

II

9/27/2007

SANOFI AVENTIS CHIMIE

ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN SISTERON, FRANCE

20889 I

III

9/26/2007

RITE SYSTEMS INC

FDA STANDARD WHITE NQT-W1367-2 AS MANUFACTURED IN MOORESVILLE, NC

20890 A

II

9/24/2007

AUROBINDO PHARMA LTD

20891 I

II

9/27/2007

SAFC PHARMA

FELODIPINE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
ISOSULFAN BLUE AS MANUFACTURED IN DORSET, UNITED KINGDOM

20892 I

III

9/28/2007

ZOTEFOAMS PLC

PLASTAZOTE(R) - CROSSLINKED LOW DENSITY POLYETHYLENE FOAMS AS MANUFACTURED


BY ZOTEFOAMS PLC IN CROYDON, U.K. AND ZOTEFOAMS INC IN WALTON, KY FOR
ZOTEFOAMS PLC

20893 A

II

9/27/2007

HETERO LABS LTD

FINASTERIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20894 A

II

10/1/2007

NATCO PHARMA LTD

20895 A

II

11/13/2007

ABBVIE INC

20896 I

II

11/13/2007

ABBVIE INC

20897 A

II

9/27/2007

POLYMED THERAPEUTICS INC

SUMATRIPTAN SUCCINATE (INJECTABLE GRADE) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
CHOLINE FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN BARCELONETA, PUERTO
RICO
CHOLINE FENOFIBRATE MINI-TABLET INTERMEDIATE AS MANUFACTURED IN BARCELONETA,
PUERTO RICO AND CORK, IRELAND
OXALIPLATIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY CHONGQING
TAIHAO PHARMACEUTICAL CO LTD IN CHONGQING, CHINA FOR POLYMED THERAPEUTICS
INC

20898 A

III

9/20/2007

BERRY PLASTICS CORP

PRODUCT 24-5-215 AS MANUFACTURED IN HOMER, LA

20899 A

III

8/18/2007

HUBEI HUAQIANG HIGH TECH CO LTD

20900 A

III

8/18/2007

HUBEI HUAQIANG HIGH TECH CO LTD

20901 A

III

8/18/2007

HUBEI HUAQIANG HIGH TECH CO LTD

20902 A

II

10/24/2007

JANSSEN PHARMACEUTICA NV

20903 A

II

10/1/2007

MYLAN LABORATORIES LTD

ELASTOMERIC CLOSURES FOR LYOPHILIZED POWDERS FOR INJECTION AS MANUFACTURED


IN HUBEI, CHINA
ELASTOMERIC CLOSURES FOR AQUEOUS PARENTERAL PREPARATIONS AS MANUFACTURED
IN HUBEI PROVINCE, CHINA
ELASTOMERIC CLOSURES FOR STERILE POWDERS FOR INJECTION AS MANUFACTURED IN
HUBEI PROVINCE, CHINA
PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE AS MANUFACTURED IN BEERSE,
BELGIUM
SIMVASTATIN USP AS MANUFACTURED IN TELANGANA, INDIA

20904 I

II

10/2/2007

SANOFI CHIMIE

SAREDUTANT SUCCINATE DRUG SUBSTANCE AS MANUFACTURED IN VERTOLAYE, FRANCE

20905 A

II

9/25/2007

DALTEPARIN SODIUM USP AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

20906 A

II

10/3/2007

DONGYING TIANDONG BIOCHEMICAL INDUSTRY


CO LTD
SMS PHARMACEUTICALS LTD

20907 I

II

9/7/2007

20908 A

II

10/3/2007

CHANGZHOU FANGYUAN PHARMACEUTICAL CO


LTD
CADILA HEALTHCARE LTD

20909 A

II

9/29/2007

AUROBINDO PHARMA LTD

SUMATRIPTAN USP (ALTERNATIVE SYNTHESIS) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
AZTREONAM, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU
PROVINCE, CHINA
ATOVAQUONE USP AS MANUFACTURED IN GUJARAT, INDIA
DONEPEZIL HYDROCHLORIDE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN
ANDHRA PRADESH, INDIA

Page 607

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20910 A
III
9/25/2007
CONSOLIDATED BOTTLE CORP

SUBJECT
4 LITRE WIDEMOUTH JAR WITH HANDLE 110MM AS MANUFACTURED BY EASY PLASTICS
CONTAINERS LTD. IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION
BIMATOPROST (3077.E) AS MANUFACTURED IN DEVENS, MA

20911 A

II

10/4/2007

JOHNSON MATTHEY PHARMA SERVICES

20912 A

III

9/21/2007

ADHESIVES RESEARCH INC

20913 A

III

9/21/2007

ADHESIVES RESEARCH INC

20914 I

IV

9/21/2007

ADHESIVES RESEARCH INC

20915 A

IV

9/25/2007

SIGACHI INDUSTRIES PVT LTD

TD-2B ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND


ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND
EC2-SN2A ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC. IN GLEN ROCK, PA
AND ADHESIVES RESEARCH IRELAND LIMITED IN LIMERICK, IRELAND
TD-1B ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC. IN GLEN ROCK, PA AND
ADHESIVES RESEARCH IRELAND LIMITED IN LIMERICK, IRELAND
MICRO CRYSTALLINE CELLULOSE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20916 A

II

10/1/2007

SMRUTHI ORGANICS LTD

AMLODIPINE BESILATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20917 A

II

9/20/2007

WANBURY LTD

CARVEDILOL PHOSPHATE HEMIHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20918 A

II

10/8/2007

STERLING SPA

DUTASTERIDE AS MANUFACTURED IN PERUGIA, ITALY

20919 I

II

10/5/2007

SYMED LABS LTD

IRON SUCROSE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20920 A

II

10/4/2007

PIRAMAL ENTERPRISES LTD

TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20921 A

II

10/9/2007

POVIDONE IODINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

20922 A

IV

10/10/2007

20923 I

II

12/17/2007

ZHEJIANG MAOYUAN SUNFLOWER


PHARMACEUTICAL CO LTD
ZHEJIANG MAOYUAN SUNFLOWER
PHARMACEUTICAL CO LTD
IPCA LABORATORIES LTD

20924 A

II

10/5/2007

AMRI RENSSELAER INC

DIATRIZOATE SODIUM USP DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY

20925 A

II

10/5/2007

CHEMWERTH INC

20926 A

III

9/19/2007

YEONHAP GLASS CO LTD

LATANOPROST, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY SAI


ADVANTIUM PHARMA LTD IN ANDHRA PRADESH, INDIA FOR CHEMWERTH INC.
CLEAR AMPOULE & VIAL AS MANUFACTURED IN GYEONGGI-DO, SOUTH KOREA

20927 A

II

10/1/2007

BIO 2 INC

BIOCATALYST SUBSTANCE AS MANUFACTURED IN LIVERPOOL, TX

20928 A

II

11/21/2007

SALIENT PHARMACEUTICALS INC

HYDRATED CALCIUM ALUMINOSILICATE UNIFORM PARTICLE SIZE NON-SWELLING (HCAS


UPSN) AS MANUFACTURED BY MID-CONTINENT PACKAGING INC IN ENID, OK FOR SALIENT
PHARMACEUTICALS INC

20929 I

II

10/22/2007

IPCA LABORATORIES LTD

FLUCONAZOLE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

20930 A

II

10/18/2007

IPCA LABORATORIES LTD

CARVEDILOL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

20931 I

II

10/8/2007

CHEMWERTH INC

20932 A

II

10/5/2007

UNIMARK REMEDIES LTD

IMIQUIMOD, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY SAI ADVANTIUM


PHARMA LTD IN ANDHRA PRADESH, INDIA FOR CHEMWERTH INC.
TOPIRAMATE USP AS MANUFACTURED IN GUJARAT, INDIA

20933 I

II

10/11/2007

SALTIGO GMBH

20934 I

III

10/1/2007

T AND S BLOWMOULDING INC

20935 A

IV

10/8/2007

PQ CORP

20936 I

IV

10/9/2007

SILESIA FLAVORS INC

20937 A

II

8/4/2007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ZHEJIANG, CHINA

20938 A

II

10/17/2007

JUBILANT GENERICS LTD

OXCARBAZEPINE CO-PRECIPITATE AS MANUFACTURED IN KARNATAKA, INDIA

20939 A

II

9/24/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

VALSARTAN DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA

PROVIDONE K30 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA


CLOPIDOGREL BISULFATE USP FORM 1 AS MANUFACTURED IN MADHYA PRADESH, INDIA

N-BENZYLHYDRAZINE MSA SALT DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN


LEVERKUSEN, GERMANY
40ML WHITE BELL ROUND HDPE CYLINDER (RESIN SCLAIR 58A) AS MANUFACTURED IN
ONTARIO, CANADA
SORBOSIL(R) AC43, SYNTHETIC AMORPHOUS SILICA PRECIPITATE AS MANUFACTURED IN
WARRINGTON, ENGLAND
N&A CITRUS FRUIT FREEZE-TYPE FLAVOR 1100609500 AS MANUFACTURED BY SILESIA
FLAVORS INC IN HOFFMAN ESTATES, IL AND SILESIA GERHARD HANKE GMBH & CO. KG IN
ALLERHEILLIGEN, GERMANY FOR SILESIA FLAVORS INC.

Page 608

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20940 A
II
10/3/2007
SUN PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

20941 I

II

10/12/2007

RANBAXY LABORATORIES LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA

20942 A

II

10/12/2007

SCINOPHARM TAIWAN LTD

DOCETAXEL TRIHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN, TAIWAN R.O.C.

20943 A

III

9/25/2007

AARDEE EXTRUSIONS INDIA PV LTD

20944 I

II

10/9/2007

WORLD JIANGSU INDUSTRY CO LTD

20945 I

II

10/15/2007

DIVIS LABORATORIES LTD

ALUMINIUM COLLAPSIBLE TUBES FOR FILLING & PACKING OF PHARMACEUTICAL


OINTMENTS, CREAMS AND GELS AS MANUFACTURED IN GUJARAT, INDIA
BACITRACIN USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN FUJIANG
PROVINCE, CHINA
TRIPEPTIDE, DRUG INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20946 A

II

10/15/2007

EURAND INC

EUR-1057 EXTENDED-RELEASE DOSAGE FORMS AS MFG IN VANDALIA, OH

20947 I

II

10/12/2007

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD

20948 A

II

10/15/2007

EXCELLA GMBH

DIDANOSINE EUR.PH NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG


PROVINCE, CHINA
MYCOPHENOLATE MOFETIL AS MANUFACTURED IN FEUCHT, GERMANY

20949 I

II

10/17/2007

CRYSTAL PHARMA SA

MIFEPRISTONE, MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN

20950 A

II

10/15/2007

SYNKEM SAS

CHOLINE FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN CHENOVE, FRANCE

20951 A

II

9/3/2007

PT KIMIA FARMA PERSERO TBK

QUININE SULFATE AS MANUFACTURED IN WEST JAVA, INDONESIA

20952 A

II

9/3/2007

PT KIMIA FARMA PERSERO TBK

QUININE HYDROCHLORIDE AS MANUFACTURED IN WEST JAVA, INDONESIA

20953 I

II

10/18/2007

SANDOZ INDUSTRIAL PRODUCTS SPA

PRAVASTATIN T-BA, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN TRENTO, ITALY

20954 A

IV

10/10/2007

ABELEI INC

127A55 N&A CHERRY TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA, IL

20955 A

IV

10/10/2007

ABELEI INC

134A46 N&A CINNAMON FLAVOR AS MANUFACTURED IN NORTH AURORA, IL

20956 A

IV

10/11/2007

MANE INC

F94249 PEPPERMINT FLAVOR AS MANUFACTURED IN MILFORD, OH

20957 I

II

10/18/2007

SANDOZ GMBH

STERILE OXACILLIN SODIUM, BUFFERED AS MANUFACTURED IN TYROL, AUSTRIA

20958 A

II

10/15/2007

POLYPLUS TRANSFECTION SA

20959 A

II

10/18/2007

20960 A

IV

10/11/2007

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
BASF SE

IN VIVO-JETPEI(TM), NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


FREIBURG IM BREISGAU, GERMANY
BUPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

20961 A

II

10/22/2007

POLYMED THERAPEUTICS INC

20962 A

II

10/22/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD TADALAFIL AS MANUFACTURED IN MAHARASHTRA, INDIA

20963 A

II

10/22/2007

ORCHID CHEMICALS AND PHARMACEUTICALS LTD VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

20965 A

III

10/19/2007

RELIANCE INDUSTRIES LTD

20966 A

III

10/19/2007

RELIANCE INDUSTRIES LTD

20967 I

II

11/7/2007

CIPLA LTD

20969 I

II

12/13/2007

CIPLA LTD

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

20970 A

II

10/24/2007

TRIFARMA SPA

FOSPHENYTOIN SODIUM AS MANUFACTURED IN MILAN, ITALY

20964 I

LUDIFLASH(R) AS MANUFACTURED BY BASF AKTIENGESELLSCHAFT IN LUDWIGSHAFEN,


GERMANY AND IPC PROCESS-CENTER GMBH & CO. KG IN DRESDEN, GERMANY FOR BASF
AKTIENGESELLSCHAFT
DOCETAXEL ANHYDROUS, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY
CHONGQING TAIHAO PHARMACEUTICAL CO. LTD. IN CHONGQING, CHINA FOR POLYMED
THERAPEUTICS, INC.

*** PENDING FILING REVIEW ***

20968 N

POLYVINYL CHLORIDE (PVC) RAW MATERIAL GRADE REON 60GER01 AS MANUFACTURED IN


GUJARAT, INDIA
POLYVINYL CHLORIDE (PVC) RAW MATERIAL GRADE REON 57GER01 AS MANUFACTURED IN
GUJARAT, INDIA
LOSARTAN POTASSIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER

Page 609

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
20971 A
II
10/25/2007
NANYANG PUKANG PHARMACEUTICAL CO LTD

SUBJECT
CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN HENAN, CHINA

20972 A

III

9/25/2007

JITSAN ENTERPRISES

PLASTIC BOTTLE & CONTAINERS, PLUG, NOZZLE & DROPPERS, PILFER PROOF CAP & CHILD
RESISTANCE CAP, MEASURE CUP & SPOONS, APPLICATORS & PESSARI APPLICATORS
MANUFACTURED IN DAMAN, INDIA

20973 I

II

10/25/2007

HEBEI HUARONG PHARMACEUTICAL CO LTD

CYANOCOBALAMIN AS MANUFACTURED IN HEBEI, CHINA

20974 A

III

9/27/2007

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG

ROUND TABLET JAR LINE WITH 2-PART TAMPER-EVIDENT CLOSURE, CHILD-RESISTANT,


SENIOR-FRIENDLY WITH AND WITHOUT DRYING AGENT AS MANUFACTURED IN NEUHAUS A.
RWG, GERMANY

20975 A

II

10/26/2007

NORAMCO INC

OXYCODONE HYDROCHLORIDE AS MANUFACTURED IN ATHENS, GA AND WILMINGTON, DE

20976 A

II

10/26/2007

PHARMACEUTICAL WORKS POLPHARMA SA

PENTOXIFYLLINE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

20977 A

II

10/22/2007

INDENA SPA

PACLITAXELS AS MANUFACTURED IN SETTALA, ITALY

20978 A

III

10/29/2007

SUD CHEMIE PERFORMANCE PACKAGING

MULTI LAYER BOTTLES AS MANUFACTURED IN BELEN, NM

20979 A

II

10/29/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

20980 A

II

10/26/2007

LIFECORE BIOMEDICAL

GEMCITABINE HYDROCHLORIDE AS MANUFACTURED BY PLANTEX LTD CHEMICAL


INDUSTRIES IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
ANIMAL COMPONENT FREE SODIUM HYALURONATE AS MANUFACTURED IN CHASKA, MN

20981 A

II

10/22/2007

CAMBREX PROFARMACO MILANO SRL

QUETIAPINE FUMARATE AS MANUFACTURED IN MILAN, ITALY

20982 A

II

10/29/2007

DR REDDYS LABORATORIES LTD

VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20983 A

II

10/25/2007

DIVIS LABORATORIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

20984 A

II

10/30/2007

SANOFI CHIMIE

ZOLPIDEM TARTRATE AS MANUFACTURED IN SISTERON, FRANCE

20985 A

II

10/31/2007

FRESENIUS KABI ANTI INFECTIVES SRL

BUFFERED CEFTAZIDIME PENTAHYDRATE, STERILE AS MANUFACTURED IN ROVIGO, ITALY

20986 A

IV

10/22/2007

LIPOID GMBH

LIPOID PE 18:0/18.0-PEG 2000 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

20987 A

II

10/31/2007

NEKTAR THERAPEUTICS

AMIKACIN PULMONARY DELIVERY SYSTEM AS MANUFACTURED BY AEROGEN (IRELAND) LTD,


A NEKTAR COMPANY IN GALWAY, IRELAND AND NEKTAR THERAPEUTICS IN CARLOS, CA FOR
NEKTAR THERAPEUTICS

20988 A

II

10/31/2007

NOVARTIS PHARMACEUTICALS CORP

PULMONARY DRUG DELIVERY SYSTEM (PDDS) CLINICAL AS MANUFACTURED BY AEROGEN


(IRELAND) LTD, A NEKTAR COMPANY IN GALWAY, IRELAND AND NEKTAR THERAPEUTICS IN
SAN CARLOS, CA FOR NEKTAR THERAPEUTICS

20989 A

II

10/23/2007

JUBILANT GENERICS LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA

20990 A

II

10/22/2007

JUBILANT GENERICS LTD

OLANZAPINE FORM-I AS MANUFACTURED IN KARNATAKA, INDIA

20991 I

III

10/31/2007

RICON COLORS INC

CPP-R4261-1 FDA RED AS MANUFACTURED IN WEST CHICAGO, IL

20992 A

II

10/31/2007

PCI SYNTHESIS

20993 A

II

11/2/2007

EXCELLA GMBH

PCI-105551, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN NEWBURYPORT,


MASSACHUSETTS
EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY

20994 A

II

10/22/2007

HUAIAN MDC PHARMACEUTICAL CO LTD

HEPARIN SODIUM (CRUDE) AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

20995 A

II

11/2/2007

MALLINCKRODT INC

COCAINE HYDROCHLORIDE USP AS MANUFACTURED IN ST. LOUIS, MISSOURI

20996 A

II

10/30/2007

MSN LABORATORIES LTD

DULOXETINE HYDROCHLORIDE USP [ROUTE CODE - DX"] AS MANUFACTURED IN TELANGANA

20997 A

II

11/30/2007

IPCA LABORATORIES LTD

CETIRIZINE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

20998 A

II

10/31/2007

GRANULES INDIA LTD

20999 A

II

10/1/2007

21000 A

11/12/2007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD


CHUANNAN BRANCH
AMGEN INC

Compresso GGF95SA (Directly Compressible Granules of Guaifenesin 95%) as manufactured in


Andhra Pradesh, India
REPAGLINIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES LOCATED IN JUNCOS,
PUERTO RICO FOR AMGEN INC

Page 610

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21001 I
II
10/1/2007
ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

SUBJECT
Atovaquone as manufactured in Zhejiang Province, China

21002 A

II

11/2/2007

CSPC INNOVATION PHARM CO LTD

Caffeine as manufactured in Hebei, China

21003 I

II

10/31/2007

GRANULES INDIA LTD

Chlorpheniramine Maleate USP as manufactured in Hyderabad, India

21004 A

II

10/26/2007

SAVIOR LIFETEC CORP TAINAN BRANCH

21005 A

II

11/2/2007

DR REDDYS LABORATORIES LTD

Imipenem and Cilastatin Sodium for Injection USP (Sterile Bulk) as manufactured in Tainan County,
Taiwan R.O.C.
Levocetirizine Dihydrochloride as manufactured in Andhra Pradesh, India

21006 A

II

11/2/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

21007 I

II

4/17/2008

IPCA LABORATORIES LTD

Imatinib Mesylate as manufactured by Sicor de Mexico S.A. de C.V. in Estado de Mexico, Mexico and
Sicor S.r.l. in Rho, Italy for Teva Pharmaceutical Industries Ltd.
PAROXETINE HYDROCHLORIDE , AS MANUFACTURED IN MADHYA PRADESH, INDIA

21008 A

II

12/3/2007

IPCA LABORATORIES LTD

ALENDRONATE SODIUM USP MANUFACTURED IN MAHARASHTRA, INDIA

21009 A

II

12/14/2007

IPCA LABORATORIES LTD

QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN MADHYA PRADESH, INDIA

21010 A

II

10/26/2007

WOCKHARDT LTD

Valacyclovir Hydrochloride as manufactured in Gujarat, India

21011 A

II

10/31/2007

WOCKHARDT LTD

Zoledronic Acid Monohydrate as manufactured in Gujarat, India

21012 A

II

10/29/2007

AUROBINDO PHARMA LTD

21013 I

II

10/29/2007

SAI ADVANTIUM PHARMA LTD

Ziprasidone Hydrochloride USP (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh,


India
Isradipine USP as manufactured in Andhra Pradesh, India

21014 A

IV

11/2/2007

DMV FONTERRA EXCIPIENTS GMBH CO KG

21015 I

III

10/30/2007

RICON COLORS INC

Inhalation Grade Lactose (IGL) as manufactured by Fonterra Ltd in Taranaki, New Zealand for DMV
Fonterra Excipients GmbH & Co. KG
FDA Blue CPP-BL5963-1 as manufactured in West Chicago, IL

21016 I

III

10/30/2007

RICON COLORS INC

FDA Dk. Blue CPP-BL5962-1 as manufactured in West Chicago, IL

21017 A

III

10/26/2007

DANAPAK FLEXIBLES AS

Surlyn KISI (Product Code: 04-413-04-0-00035-XX), Composition: Paper 50,0 g/m2/Adhesive 3,0
g/m2/PET 23,0 lm/Polymer 10 g/m2/Al 12.0 lm/Ethylencopolymer 30 g/m2 as manufactured in
Slagelse, Denmark

21018 A

II

11/7/2007

HETERO DRUGS LTD

Donepezil Hydrochloride (Monohydrate) as manufactured in Andhra Pradesh, India

21019 A

II

11/1/2007

TORRENT PHARMACEUTICALS LTD

Donepezil Hydrochloride Drug Substance as manufactured in Gujarat, India

21020 A

11/8/2007

INJECTALIA SRL

Manufacturing Facility in Rome, Italy

21021 A

III

11/6/2007

BORMIOLI ROCCO SPA BU PLASTICS

21022 A

III

11/8/2007

BAYER MATERIALSCIENCE LLC

21023 I

IV

11/7/2007

KERRY BIO SCIENCE

Child Resistant Closure X 24 mm as manufactured in Castelguelfo and Rivanazzano, Italy and Saint
Sulpice, France
Makrolon Resins as manufactured by Bayer Thai Co. Ltd. in Rayong, Thailand for Bayer
MaterialScience LLC
5X00096 Sheffield Tabletting System DTHV as manufactured in Norwich, NY

21024 A

III

10/29/2007

NUPLEX INDUSTRIES AUSTRALIA PTY LTD

Color/Additive Concentrates as manufactured in Victoria and NSW, Australia

21025 I

II

11/7/2007

DAINIPPON SUMITOMO PHARMA CO LTD

SMP-601 DRUG SUBSTANCE AS MANUFACTURED IN OITA, JAPAN

21026 I

IV

11/7/2007

Sheffcoat Clear S2 as manufactured in Norwich, NY

21027 A

II

10/29/2007

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
CADILA PHARMACEUTICALS LTD

21028 I

IV

11/7/2007

Sheffcoat Clear as manufactured in Norwich, NY

21029 A

IV

11/11/2007

21030 I

IV

11/7/2007

21031 I

IV

11/7/2007

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE

Ondansetron as manufactured in Gujarat, India

Sheffield Tabletting System ODT as manufactured in Norwich, NY


Sheffcoat Clear S as manufactured in Norwich, NY
Sheffcoat Clear k as manufactured in Norwich, NY

Page 611

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21032 I
IV
11/7/2007
KERRY BIO SCIENCE

SUBJECT
5X00095 Sheffield Tabletting System DTFD as manufactured in Norwich, NY

21033 A

II

10/24/2007

IND SWIFT LABORATORIES LTD

RISEDRONATE SODIUM AS MANUFACTURED IN PUNJAB, INDIA

21034 A

II

10/30/2007

CADILA PHARMACEUTICALS LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN GUAJARAT, INDIA

21035 I

II

11/9/2007

21036 A

II

11/13/2007

PKUCARE CHONGQING DAXIN PHARMACEUTICAL


CO LTD
DR REDDYS LABORATORIES LTD

Amikacin Sulfate (1:1.8) USP, Non-Sterile Bulk Drug Substance, as manufactured in Chongqing,
CHINA
LETROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21037 A

II

11/13/2007

EUTICALS SPA

Sirolimus as manufactured in Rozzano, Italy

21038 A

II

11/7/2007

ZCL CHEMICALS LTD

RITALINIC ACID (KMN) AS MANUFACTURED IN GUJARAT, INDIA

21039 A

II

11/4/2007

CTX LIFE SCIENCES PVT LTD

Hydrochlorothiazide USP ( ESUB) as manufactured in Gujarat, India

21040 A

II

11/15/2007

POLYMED THERAPEUTICS INC

21041 A

II

11/16/2007

CHEMO IBERICA SA MADRID

21042 A

II

11/12/2007

DR REDDYS LABORATORIES LTD

Docetaxel Trihydrate Drug Substance as manufactured in Chongqing Taihao Pharmaceutical Co. Ltd.
in Chongqing, China for Polymed Therapeutics Inc.
Tamsulosin Hydrochloride as manufactured by Quimica Sintetica S.A. in Madrid, Spain for Chemo
Iberica, S.A.
Famotidine (Form-A) USP as manufactured in Andhra Pradesh, India

21043 A

III

11/7/2007

AMPACET CORP

21044 A

II

11/9/2007

YONSUNG FINE CHEMICALS CO LTD

Ampacet Product 11898-K Lamite 98 as manufactured by Ampacet Thailand Co. Ltd. in Rayong,
Thailand for Ampacet Corporation
Latanoprost as manufactured in Gyeonggi-do, Korea

21045 A

II

3/26/2008

TOPCHEM PHARMACEUTICALS LTD

MALATHION AS MANUFACTURED IN COUNTY SLIGO, IRELAND

21046 A

II

11/15/2007

MYLAN LABORATORIES LTD

LOSARTAN POTASSIUM UPS AS MANUFACTURED IN TELANGANA INDIA

21047 A

II

11/12/2007

Fludarabine Phosphate Drug Substance as manufactured in Hubei Province, CHINA

21048 A

II

11/19/2007

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
DSM NUTRITIONAL PRODUCTS LTD

21049 A

III

11/27/2007

3M DRUG DELIVERY SYSTEMS

Cholecalciferol (Vitamin D3) as manufactured by F. Hoffmann La Roche Ltd in Basel, Switzerland for
DSM Nutritional Products Ltd
EPDM ELASTOMERIC COMPONENTS FOR HFA INHALATION AEROSOL CONTAINER - CLOSURE
SYSTEM AS MANUFACTURED BY PARKER HANNIFIN O-RING DIVISION IN LEBANON, TN;
PARKER TECHSEAL DIVISION IN SPARTANBURG, SC; 3M HEALTH CARE LTD IN LANCASHIRE,
U.K. FOR 3M DRUG

21050 A

II

11/9/2007

SIGMA ALDRICH MANUFACTURING LLC

Stemline(TM) Mesenchymal Stem Cell Expansion Medium as manufactured in St. Louis, MO

21051 I

II

11/6/2007

YANGZHOU PHARMACEUTICAL CO LTD

Felodipine USP as manufactured in Jiangsu Province, China

21052 A

III

11/5/2007

SILGAN WHITE CAP AMERICAS

18PPR Aluminum Pilferproof Roll-On Closure as manufactured in Richmond, IN

21053 A

III

11/5/2007

PACKAGING INDIA PVT LTD

Alu - Alu Cold Foil Laminates as manufactured in Pondicherry, INDIA

21054 A

II

11/20/2007

CRYSTAL PHARMA SA

Fludrocortisone Acetate, USP micronized as manufactured in Valladolid, Spain

21055 A

III

10/25/2007

ESSEL PROPACK LTD

Plastic tubes as manufactured in Maharashtra, INDIA

21056 A

III

10/25/2007

ESSEL PROPACK LTD

Laminated tubes as manufactured in Maharashtra, INDIA

21057 I

II

11/19/2007

BOEHRINGER INGELHEIM AUSTRIA GMBH BIA

rTNF-alpha Drug Substance as manufactured in Vienna, Austria

21058 A

III

11/5/2007

PACKAGING INDIA PVT LTD

Printed Plastic Film/Aluminium Foil Base Laminate & Pouches as manufactured in Pondicherry, INDIA

21059 A

II

11/15/2007

CENTAUR CHEMICALS PRIVATE LTD

Zopiclone as manufactured in Maharashtra, INDIA

21060 A

II

11/12/2007

SIEGFRIED LTD

Buprenorphine Hydrochloride as manufactured in Zofingen, Switzerland

21061 A

II

11/23/2007

SAVIOR LIFETEC CORP

Meropenem USP as manufactured in Miao-Li County, Taiwan R.O.C.

21062 A

II

11/19/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

Clopidogrel Bisulfate USP as manufactured in Maharashtra, India

21063 A

III

11/20/2007

NYPRO INC

ADVAIR(R) METERED-DOSE INHALER COUNTER ACTUATOR/STRAPCAP

21064 A

II

11/27/2007

HARMAN FINOCHEM LTD

Carisoprodol USP as manufactured in Maharashtra, India

Page 612

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21065 A
IV
11/2/2007
CRODA INC

SUBJECT
SUPER REFINED TWEEN 80 LLQ-(MH) AS MANUFACTURED IN MILL HALL PA

21066 A

II

11/13/2007

JUBILANT GENERICS LTD

TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA

21067 A

II

11/9/2007

SIGMA ALDRICH MANUFACTURING LLC

Hemocyanin from Keyhole Limpet as manufactured in St. Louis, MO

21068 A

II

11/25/2007

DIVIS LABORATORIES LTD

Topiramate as manufactured in Andhra Pradesh, INDIA

21069 A

II

11/26/2007

TEVA PHARMACEUTICAL INDUSTRIES LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN BEER SHEVA, ISRAEL

21070 I

III

11/13/2007

AMPACET CORP

21071 A

II

11/22/2007

SIMAFEX SAS

Ampacet 112109 White Polyethylene Masterbatch as manufactured in Terre Haute, IN; Heath, OH;
Cartersville, GA; DeRidder, LA
Cyclam as manufactured in Marans, France

21072 I

II

11/9/2007

SIGMA ALDRICH MANUFACTURING LLC

STEMLINE(TM) DENDRITIC CELL MATURATION MEDIUM AS MANUFACTURED IN ST. LOUIS, MO

21073 N

NOT AN ASSIGNED NUMBER

21074 N

NOT AN ASSIGNED NUMBER

21075 N

NOT AN ASSIGNED NUMBER

21076 N

NOT AN ASSIGNED NUMBER

21077 I

II

11/20/2007

AREVIPHARMA GMBH

Lansoprazole as manufactured in Radebeul, GERMANY

21078 A

II

11/28/2007

3'-deoxy-3'-[18F]Fluorothymidine as manufactured in Oklahoma City, OK

21079 A

II

11/28/2007

MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON


DIV
EXCELLA GMBH

21080 N

MYCOPHENOLATE MOFETIL SIEVED AS MANUFACTURED IN FEUCHT, GERMANY

NOT AN ASSIGNED NUMBER

21081 N

NOT AN ASSIGNED NUMBER

21082 A

II

11/28/2007

SANDOZ PRIVATE LTD

PRAMIPEXOLE DIHYDROCHLORIDE AS MANUFACTURED IN MAHASHTRA, INDIA

21083 A

II

10/18/2007

SUZHOU NUMBER 4 PHARMACUTICAL FACTORY

CLINDAMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN JIANGSU PROVINCE CHINA

21084 A

II

1/23/2008

JANSSEN PHARMACEUTICA NV

TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE AS MANUFACTURED BY


JANSSEN PHARMACEUTICAL N.V. IN GEEL, BELGIUM; NORAMCO INC IN ATHENS, GA FOR
JANSSEN PHARMACEUTICAL N.V.

21085 N
21086 A

NOT AN ASSIGNED NUMBER


III

11/12/2007

21087 N

PARKER HANNIFIN TECHSEAL DIV

EPDM ELASTOMERS AS MANUFACTURED IN SPARTANBURG, SC

NOT AN ASSIGNED NUMBER

21088 I

II

11/15/2007

HANDE PHARMA DEVELOPMENT LTD

21089 A

II

11/16/2007

HUAYI ISOTOPE CO

Galanthamine Hydrobromide (Non-Sterile Bulk Form) as manufactured by Shanghai Shenxing


Pharmaceutical Factory in Shanghai City, China for Hande Pharma Development Limited
Mannose Triflate as manufactured in Jiangsu Province, China

21090 I

II

11/26/2007

CORDEN PHARMACHEM

Benzphetamine Hydrochloride as manufactured in Cork, Ireland

21091 A

II

11/21/2007

TRIFARMA SPA

Testosterone Cypionate USP as manufactured in Milan, Italy

21092 A

II

12/3/2007

TTY BIOPHARM CO LTD

Arsenic Trioxide as manufactured in Taoyuan County, Taiwan R.O.C.

21093 A

II

11/20/2007

NISSAN CHEMICAL INDUSTRIES LTD

Parogrelil (NM-702) as manufactured in Sanyoonoda Yamaguchi, JAPAN

21094 A

III

11/28/2007

BASELL POLIOLEFINE ITALIA SRL

21095 A

II

11/30/2007

APOTEX PHARMACHEM INDIA PVT LTD

21096 A

II

11/23/2007

AUROBINDO PHARMA LTD

21097 I

II

12/5/2007

INDOCO REMEDIES LTD

Purell PE 3020 H as manufactured by Basell Polyolefine GmbH in Wesseling, Germany for Basell
Polyolefine S.r.l.
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED BY APOTEX
PHARMACHEM INDIA PVT LTD IN KARNATAKA, INDIA FOR APOTEX PHARMACHEM INC
Tenofovir Disoproxil Fumarate (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh,
India
Metformin Hydrochloride USP, as maufactured in Raigad District, INDIA

Page 613

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21098 A
II
12/3/2007
RANBAXY LABORATORIES LTD
21099 A

II

12/3/2007

MYLAN LABORATORIES LTD

SUBJECT
TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB,
INDIA
ZOLEDRONIC ACID AS MANUFACTURED IN TELANGANA INDIA

21100 A

II

12/3/2007

RANBAXY LABORATORIES LTD

Omeprazole Magnesium Drug Substance as manufactured in Punjab, INDIA

21101 I

II

12/3/2007

RANBAXY LABORATORIES LTD

Lopinavir Drug Substance as manufactured in Punjab, INDIA

21102 A

II

11/28/2007

JIANGSU ZW PHARMACEUTICALS CO LTD

Sulindac USP BP-EP, Non-Sterile Drug Substance as manufactured in Jiangsu Province, China

21103 A

II

11/30/2007

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

Bicalutamide as manufactured in Barcelona, Spain

21104 A

II

11/29/2007

SHASUN PHARMACEUTICALS LTD

Sevelamer Hydrochloride as manufactured in Cuddalore, INDIA

21105 A

II

11/28/2007

CAMBREX PROFARMACO MILANO SRL

Lamotrigine as manufactured in Milan, ITALY

21106 A

II

11/3/2007

NURAY CHEMICALS PVT LTD

Nisoldipine, Non-Sterile Bulk Drug Substance as manufactured in Tamil Nadu, India

21107 I

IV

12/4/2007

FONA INTERNATIONAL INC

862.536 Lemon Flavor, Nat & Art as manufactured in Geneva, IL

21108 A

III

11/26/2007

AMPACET CORP

21109 I

III

12/4/2007

MEDISIZE CORP

21110 A

II

12/6/2007

GLOCHEM INDUSTRIES LTD

Ampacet Product 40604 Slip BOPP Masterbatch as manufactured in Terre Haute, IN; Heath, OH;
Cartersville, GA; DeRidder, LA
Standard CFC Actuator as manufactured by Medifiq Healthcare, Sunderland Plant in Tyne and Wear,
United Kingdom for Medifiq Healthcare Corporation
Levo Cetirizine Dihydrochloride as manufactured in Andhra Pradesh, India

21111 A

II

12/6/2007

PIRAMAL CRITICAL CARE INC

Desflurane USP Drug Substance as manufactured in Bethlehem, PA

21112 A

III

11/21/2007

POLYONE CORP

21113 A

II

12/3/2007

ZACH SYSTEM SA

CC10066777BG as manufactured by PolyOne France S.A.S. (Cergy Plant) in Saint Quen lAumone,
France for PolyOne Corporation
Methoxy-C15-WITTIG Salt (TGN05), Intermediate for Acitretin API as manufactured in Avrille, France

21114 A

III

1/29/2008

RELIANCE INDUSTRIES LTD

RELENE M60075, POLYETHYLENE (PE) AS MANUFACTURED IN GUJARAT, INDIA

21115 A

II

2/6/2008

WUHAN WUYAO PHARMACEUTICAL CO LTD

21116 I

II

12/4/2007

PALL BIOSEPRA DIV PALL FRANCE SA

HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN


WUHAN, CHINA
BioSepra SP Spherodex M Spec IgGH as manufactured in Cergy Saint Christophe, France

21117 A

II

11/30/2007

MALLINCKRODT INC

Codeine Sulfate USP Powder as manufactured in St. Louis, MO

21118 A

II

11/30/2007

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

21119 A

III

1/29/2008

RELIANCE INDUSTRIES LTD

Methotrexate USP, Non-Sterile Active Pharmaceutical Ingredient as manufactured in Zhejiang


Province, China
RELENE E52009 POLYETHYLENE (PE) AS MANUFACTURED IN GUJARAT, INDIA

21120 A

II

12/11/2007

BIOSYN CORP

21121 A

II

12/6/2007

AUROBINDO PHARMA LTD

21122 I

II

11/26/2007

ALEMBIC PHARMACEUTICALS LTD

SELENASE SOLUTION FOR INJECTION AND SELENASE ORAL SOLUTION DRUG PRODUCTS AS
MANUFACTURED IN WASSERBURG, GERMANY FOR BIOSYN CORP.
Risedronate Sodium Hemipentahydrate USP (Non-Sterile Drug Substance) as manufactured in Andhra
Pradesh, India
Levetiracetam as manufactured in Gujarat, India

21123 A

II

12/11/2007

NEULAND LABORATORIES LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

21124 A

III

12/12/2007

RENOLIT NEDERLAND BV

21125 A

II

12/14/2007

DR REDDYS LABORATORIES LTD

Solmed Materials for Biotechnology and Life Sciences Applications as manufactured in Ma


Enkhuizen, The Netherlands
Atorvastatin Calcium (NO BHA Premix) as manufactured in Andhra Pradesh, INDIA

21126 A

II

12/12/2007

CHEMPACIFIC CORP

BUSULFAN (CHP022) DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD

21127 I

III

10/16/2007

CHROMA CORP

PC501017 33/1 Dark Blue Color Concentrate as manufacured in McHenry, Illinois

21128 I

II

12/10/2007

SAFC INC

Camptothecin-20(s)-O-Propionate Hydrate as manufactured in Madison, WI U.S.A.

21129 A

II

11/18/2007

ANUH PHARMA LTD

Erythromycin Oxime as manufactured in Maharashtra, INDIA

21130 I

II

12/7/2007

ROTEM INDUSTRIES LTD

Mannose Triflate as manufactured in Nes-Ziona, Israel

21131 A

II

12/5/2007

FINE CHEMICALS CORP PTY LTD

FCC - 7250 as manufactured in Cape Town, South Africa

Page 614

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21132 A
II
12/11/2007
NEULAND LABORATORIES LTD

SUBJECT
DONEPEZIL HYDROCHLORIDE ( FORM-I ) MANUFACTURED IN TELANGANA, INDIA

21133 A

II

12/11/2007

CADILA PHARMACEUTICALS LTD

DESLORATADINE AS MANUFACTURED IN GUJARAT, INDIA

21134 A

II

11/15/2007

ALEMBIC PHARMACEUTICALS LTD

Valsartan USP ( PROCESS I) as manufactured in Gujarat, India

21135 A

III

12/14/2007

POLYONE CORP

CC10100935WE 1585c Orange PE as manufactured in Elk Grove, IL

21136 A

III

12/14/2007

POLYONE CORP

CC10100934WE 281c Blue PE as manufactured in Elk Grove Village, IL

21137 I

III

12/12/2007

BASELL USA INC

Softel C102M as manufactured by Basell Europe in Mantova, Italy for Basell USA Inc.

21138 A

II

12/12/2007

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

7-ADCA (Intermediate) as manufactured in Shandong Province, China

21139 I

II

12/14/2007

SANDOZ GMBH

Cefepime, unsterile as manufactured in Kundl, Austria

21140 A

II

12/17/2007

LIST BIOLOGICAL LABORATORIES INC

Botulinum Toxin Type A Pure Neurotoxin as manufactured in Campbell, CA

21141 A

II

12/11/2007

XELLIA PHARMACEUTICALS APS

21142 I

II

11/28/2007

HUAYI ISOTOPE CO

Mometasone Furoate USP, Non-Sterile Bulk as manufactured by Zhejiang Tiantai aurisco


Pharmaceutical Co. Ltd. in Zhejiang Province, China for Alpharma ApS
Cryptand 222 as manufactured in Jiangsu Province, China

21143 I

II

12/26/2007

RANBAXY LABORATORIES LTD

LANSOPRAZOLE USP AS MANUFACTURED IN PUNJAB INDIA

21144 A

II

6/20/2007

SANOFI AVENTIS CHIMIE

NALBUPHINE HYDROCHLORIDE AS MANUFACTURED IN ARAMON, FRANCE

21145 I

II

12/27/2007

RANBAXY LABORATORIES LTD

RITONAVIR AS MANUFACTURED IN HARYANA INDIA

21146 I

II

12/27/2007

RANBAXY LABORATORIES LTD

21147 A

II

12/17/2007

DR REDDYS LABORATORIES LTD

21148 A

II

12/18/2007

GEDEON RICHTER PLC

SODIUM CARBONATE ANHYDROUS USNF (STERILE) AS MANUFACTURED IN MADHYA


PRADESH INDIA
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH
INDIA
CDB-4124 as manufactured in Dorog, Hungary

21149 A

II

12/18/2007

PHARMACEUTICAL WORKS POLPHARMA SA

REPAGLINIDE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

21150 I

II

12/17/2007

SANDOZ INDUSTRIAL PRODUCTS GMBH

CEFEPIME / L-ARGININE STERILE MIXTURE AS MANUFACTURED IN FRANKFURT, GERMANY

21151 I

II

12/12/2007

ORPEGEN PHARMA

TS9708 (GKL02 combinatorial thymus tetrapeptide library) as manufactured in Heidelberg, GERMANY

21152 A

II

12/8/2007

CADILA PHARMACEUTICALS LTD

Nebivolol Hydrochloride as manufactured in Gujarat, INDIA

21153 A

II

12/17/2007

NOF CORP

21154 A

II

12/13/2007

CADILA PHARMACEUTICALS LTD

a- Methoxy-w-(-4-Nitrophenoxy Carbonyl) Polyoxyethylene MW 10000 as manufactured in Kanagawa,


Japan
SILDENAFIL CITRATE AS MANUFACTURED IN GUJARAT, INDIA

21155 I

II

12/6/2007

AREVIPHARMA GMBH

Metoprolol Succinate as manufactured in Radebeul, Germany

21157 A

II

12/17/2007

POLI INDUSTRIA CHIMICA SPA

S(+)Mecamylamine Hydrochloride as manufactured in Milan, Italy

21158 A

II

12/18/2007

NORAMCO INC

21159 A

II

11/26/2007

PROCOS SPA

HYDROCODONE BITARTRATE AS MANUFACTURED IN ATHENS GA 30601-1645 & WILMINGTON


DELAWARE 19801-4417
OXO ACID DIPA SALT AS MANUFACTURED IN CAMERI (NO) ITALY

21160 A

III

12/18/2007

ESS DEE ALUMINIUM LTD

PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN KUNDAIM GOA INDIA

21161 A

III

12/20/2007

MULTISORB TECHNOLOGIES INTERNATIONAL

21162 A

III

11/16/2007

SAGAR RUBBER PRODUCTS PVT LTD

21163 A

II

12/17/2007

GALEN LTD

STABILOX SOLID FORM OXYGEN ABSORBING PRODUCTS AS MANUFACTURED IN BUFFALO


NY
PACKING MATERIAL - ALLIED PRODUCTS FOR HEALTHCARE AS MANUFACTURED IN MEHSANA
INDIA
DaunoXome for Injection (daunorubicin citrate liposome) as manufactured in San Dimas, CA

21164 A

II

12/17/2007

NATCO PHARMA LTD

Tolterodine Tartrate as manufactured in Andhra Pradesh, India

21165 A

II

12/19/2007

MYLAN LABORATORIES LTD

CITALOPRAM HYDROBROMIDE USP (CSP) AS MANUFACTURED IN TELANGANA, INDIA

21156 N

NOT AN ASSIGNED NUMBER

Page 615

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21166 I
II
11/29/2007
CADILA PHARMACEUTICALS LTD

SUBJECT
Carbetapentane Tannate as manufactured in Gujarat, INDIA

21167 A

III

12/21/2007

MITSUI CHEMICALS AMERICA INC

Admer CP-31A as manufactured in LaPorte, Texas

21168 A

II

12/14/2007

TIANJIN GENCOM PHARMACEUTICAL CO LTD

GCLE as manufactured in Tianjin, CHINA

21169 I

II

12/19/2007

CHEMO IBERICA SA MADRID

21170 A

III

11/16/2007

SAGAR RUBBER PRODUCTS PVT LTD

Nedocromil Disodium as manufactured by Quimica Sintetica S.A. in Madrid, Spain for Chemo Iberica
S.A.
Rubber Closures (Rubber Stoppers) for Injectables as manufactured in Mehsana, INDIA

21171 I

II

10/10/2007

INTERPHARMA PRAHA A S

Trospium Chloride as manufactured in Praha, CZECH REPUBLIC

21172 A

II

12/21/2007

ITF CHEMICAL LTDA

21173 A

II

12/20/2007

CRYSTAL PHARMA SAU

SODIUM RISEDRONATE AMORPHOUS AS MANUFACTURED BY ITF CHEMICAL LTDA IN BAHIA,


BRAZIL AND CHEMI SPA IN PATRICA, ITALY FOR ITF CHEMICAL LTDA
Triamcinolone Acetonide Sterile Micronized, USP as manufactured in Boecillo, SPAIN

21174 I

II

12/17/2007

CHATHAM BIOTEC LTD

Semisynthetic Paclitaxel as manufactured in Shanghai, China

21175 A

II

12/21/2007

SCINOPHARM TAIWAN LTD

Exemestane Drug Substance as manufactured in Tainan, Taiwan R.O.C.

21176 I

II

12/21/2007

DR REDDYS LABORATORIES LTD

Pantoprazole Sodium Sesquihydrate as manufactured in Andhra Pradesh, India

21177 A

II

12/10/2007

JUBILANT GENERICS LTD

LOSARTAN POTASSIUM USP AS MANUFACTURED IN KARNATAKA, INDIA

21178 I

II

1/3/2008

CHR HANSEN INC

21179 A

II

12/15/2007

AARTI INDUSTRIES LTD

LACTOBACILLUS GG LGG GRADE PAB GIN #679554 AS MANUFACTURED IN ROSKILDE


DENMARK
IPRATROPIUM BROMIDE AS MANUFACTURED IN MAHARASHTRA INDIA

21180 A

II

1/3/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

PEMETREXED DIACID AS MANUFACTURED IN RHO ITALY

21181 I

II

12/31/2007

SUZHOU LIXIN PHARMACEUTICAL CO LTD

HYDROCHLOROTHIAZIDE AS MANUFACTURED IN JIANGSU CHINA

21182 A

II

12/21/2007

TEVA GROUP

LETROZOLE AS MANUFACTURED IN LERMA MEXICO

21183 A

II

12/25/2007

SCINOPHARM TAIWAN LTD

SN38 AS MANUFACTURED IN TAINAN,TAIWAN

21184 A

II

12/21/2007

LEK PHARMACEUTICALS DD

TOLTERODINE TARTRATE AS MANUFACTURED IN MENGES SLOVENIA

21185 A

III

1/2/2008

MULTISORB TECHNOLOGIES INC

STABILOX CANISTER OXYGEN ABSORGING PRODUCTS AS MANUFACTURED IN BUFFALO NY

21186 I

III

12/26/2007

BAYER PLASTIK TUP AMBALAJ SAN VE TIC AS

PACKAGING (TUBES) AS MANUFACTURED IN ISTANBUL TURKEY

21187 A

II

12/21/2007

MYLAN LABORATORIES LTD

DESLORATADINE AS MANUFACTURED IN TELANGANA INDIA

21188 A

II

12/12/2007

PIRAMAL HEALTHCARE UK LTD

MISOPROSTOL DISPERSION AS MANUFACTURED IN UK

21189 A

II

12/3/2007

GLAND PHARMA LTD

ATRACURIUM BESYLATE USP AS MANUFACTURED IN HYDERABAD INDIA

21190 A

II

11/28/2007

CADILA PHARMACEUTICALS LTD

ITOPRIDE HYDROCHLORIDE AS MANUFACTURED IN GUAJARAT, INDIA

21191 A

II

1/15/2008

FRESENIUS KABI ONCOLOGY LTD

LETROZOLE AS MANUFACTURED IN WEST BENGAL, INDIA

21192 A

II

12/20/2007

CADILA HEALTHCARE LTD

Rabeprazole Sodium (Amorphous) as manufactured in Gujarat, INDIA

21193 A

II

12/28/2007

UNICHEM LABORATORIES LTD

ZOLPIDEM TARTRATE USP AS MANUFACTURED IN DHAR (M.P.), INDIA

21194 I

II

12/24/2007

RANBAXY LABORATORIES LTD

Meropenem Technical as manufactured in Madhya Pradesh, INDIA

21195 A

II

12/28/2007

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

21196 A

II

12/20/2007

EXCELLA GMBH

Bupivacaine Hydrochloride as manufactured in Feucht, GERMANY

21197 A

II

1/4/2008

ZHUHAI UNITED LABORATORIES CO LTD

AMOXICILLIN (COMPACTED) AS MANUFACTURED IN ZHUHAI CHINA

21198 I

IV

12/28/2007

3V INC

SYNTHALEN KP, SYNTHALEN LP, SYNTHALEN MP AS MANUFACTURED IN GEORGETOWN SC

21199 A

II

12/21/2007

APOTEX PHARMACHEM INC

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ONTARIO CANADA

21200 A

II

12/19/2007

MYLAN LABORATORIES LTD

ARMODAFINIL AS MANUFACTURED IN TELANGANA, INDIA

21201 A

II

12/20/2007

MYLAN LABORATORIES LTD

LEVETIRACETAM USP AS MANUFACTURED IN TELANGANA, INDIA

Page 616

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21202 A
II
12/27/2007
SANDOZ INDUSTRIAL PRODUCTS GMBH

SUBJECT
Cefotaxime Sodium, Sterile as manufactured in Frankfurt, Germany

21203 A

II

12/17/2007

MYLAN LABORATORIES LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN TELANGANA INDIA

21204 A

II

12/28/2007

RANBAXY LABORATORIES LTD

PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN PUNJAB INDIA

21205 I

II

12/28/2007

RANBAXY LABORATORIES LTD

Rabeprazole Sodium (Non-Sterile Bulk Drug Substance) as manufactured in Punjab, India

21206 A

II

12/18/2007

MYLAN LABORATORIES LTD

LISINOPRIL USP AS MANUFACTURED IN TELANGANA, INDIA

21207 A

II

1/3/2008

CADILA HEALTHCARE LTD

Quetiapine Fumarate as manufactured in Gujarat, India

21208 A

II

1/2/2008

TARO PHARMACEUTICAL INDUSTRIES LTD

ADAPALENE USP, MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL

21209 A

II

1/7/2008

DR REDDYS LABORATORIES LTD

TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH INDIA

21210 A

II

1/3/2008

LUPIN LTD

GLIPIZIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

21211 A

II

12/31/2007

WOCKHARDT LTD

NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

21212 I

II

12/13/2007

EVESTRA INC

21213 A

II

12/31/2007

WOCKHARDT LTD

ESTRA-1,3,5((10)-TRIENE-3,11B-TRIOL, 3-ACETATE 11,17-DINITRATE (CDB-3701) AS


MANUFACTURED IN SAN ANTONIO TX
Epinephrine USP as manufactured in Gujarat, India

21214 A

II

1/4/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

Levocetirizine Dihydrochloride as manufactured in Gujarat, India

21215 A

II

12/21/2007

MYLAN LABORATORIES LTD

DIDANOSINE USP as manufactured in Telangana, INDIA

21216 A

II

1/2/2008

HALCYON LABS PRIVATE LTD

CLOBETASOL PROPIONATE USP as manufactured in Gujarat, INDIA

21217 A

II

12/28/2007

SUN PHARMACEUTICAL INDUSTRIES LTD

Naltrexone Hydrochloride USP (Dihydrate Form) as manufactured in Gujarat, India

21218 A

12/18/2007

LEK PHARMACEUTICALS DD

Sterile Manufacturing Facility in Ljubljana, Slovenia

21219 A

12/20/2007

ELI LILLY AND CO

PROCEDURES FOR STERILE OPERATIONS IN BUILDING 103, INDIANAPOLIS, INDIANA

21220 I

III

1/3/2008

CONSOLIDATED BOTTLE CORP

21221 A

II

12/7/2007

JIANGSU EQUALCHEM CO LTD

60ml White HDPE Round Bottle 38/400 (010897) as manufactured by Easy Plastics Containers Ltd in
Ontario, Canada for Consolidated Bottle Corporation
Triclosan (Non-Sterile Bulk Form) as manufactured in Jiangsu, China

21222 A

II

12/28/2007

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

21223 A

II

12/31/2007

AUROBINDO PHARMA LTD

Bupropion Hydrochloride USP (Non-Sterile Drug Substance) as manufactured in Zhejiang Province,


China
Omeprazole USP (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh, India

21224 A

II

1/17/2008

H LUNDBECK AS

LU AA21004 HYDROBROMIDE AS MANUFACTURED IN NYKJOEBING SJ AND VALBY, DENMARK

21225 A

IV

1/4/2008

COREL PHARMACHEM

Colorcoat, Ready to Use Coating Material as manufactured in Kadi, India

21226 A

III

1/7/2008

JAPAN VILENE CO LTD

Medical Backing Non-Woven Products as manufactured in Ibaraki, Japan

21227 A

II

1/11/2008

APOTEX PHARMACHEM INDIA PVT LTD

MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN BANGALORE, INDIA

21228 A

II

1/11/2008

SIGMA ALDRICH MANUFACTURING LLC

TrypZean Bovine, Recombinant Expressed in Corn as manufactured in St. Louis, MO

21229 A

II

1/11/2008

GLENMARK GENERICS LTD

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

21230 A

II

1/10/2008

LUPIN LTD

LAMIVUDINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21231 I

II

1/16/2008

DSM ANTI INFECTIVES BV

21232 I

II

1/16/2008

DSM ANTI INFECTIVES BV

21233 A

II

1/15/2008

EVERLIGHT CHEMICAL INDUSTRIAL CORP

Mycophenolic Acid Triethylamine Salt as manufactured by DSM Anti-Infectives Sweden A.B. in


Strangnas, Sweden for DSM Anti-Infectives B.V.
MYCOPHENOLATE MOFETIL AS MANUFACTURED BY VITALIFE LABORATORIES IN HARYANA,
INDIA FOR DSM ANTI-INFECTIVES B.V.
Alprostadil as manufactured in Taoyuan Hsien, Taiwan

21234 I

II

1/15/2008

APICORE LLC

21235 A

II

1/16/2008

GLOCHEM INDUSTRIES LTD

Protriptyline Hydrochloride as manufactured by Tonira Pharma Limited in Gujarat, India for Apicore
LLC
Clopidogrel Bisulphate form II as manufactured in Andhra Pradesh, India

Page 617

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21236 A
III
1/10/2008
AMPACET CORP
21237 A

II

1/11/2008

21238 A

II

1/31/2008

21239 A

II

1/15/2008

SUBJECT
Ampacet 181908 Amber Polyethylene Masterbatch as manufactured in Terre Haute, IN; Heath, OH;
Cartersville, GA; DeRidder, LA
CHEMWERTH INC
MELPHALON USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG,
GERMANY FOR CHEMWERTH INC
ORCHID CHEMICALS AND PHARMACEUTICALS LTD GEMIFLOXACIN MESYLATE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA,
INDIA
INDOCO REMEDIES LTD
Allopurinol USP as manufactured in District Raigas, India

21240 A

III

2/6/2008

TRICORBRAUN

21241 P

MAGNESIUM SULFATE DESICCANT AS MANUFACTURED BY TOMITA PHARMACEUTICAL CO.


LTD. IN TOKUSHIMA PREF, JAPAN FOR TRICORBRAUN

*** PENDING FILING REVIEW ***

21242 I

II

2/18/2008

IPCA LABORATORIES LTD

21243 I

II

1/8/2008

WORLD JIANGSU INDUSTRY CO LTD

21244 I

II

1/9/2008

WORLD JIANGSU INDUSTRY CO LTD

CLOPIDOGREL BISULFATE (FORM 1) USP (PROCESS-II) AS MANUFACTURED IN MADHYA


PRADESH, INDIA
Fusidic Acid & Sodium Fusidate (Non-Sterile Drug Substance) as manufactured in Fujiang Province,
China
Polymyxin B Sulfate USP (Non-Sterile Drug Substance) as manufactured in Fujiang Province, China

21245 A

II

12/19/2007

ASIAN HERBEX LTD

CURCUMIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21246 A

II

1/10/2008

SAI ADVANTIUM PHARMA LTD

Benzindene Triol Intermediate as manufactured in Karnataka, India

21247 A

II

1/14/2008

PROCOS SPA

Felbamate as manufactured in Cameri, Italy

21248 A

II

1/10/2008

BENE PHARMACHEM GMBH AND CO KG

21249 I

II

12/6/2007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

Pentosan Polysulfate Sodium (PPS), Non-Sterile Bulk Drug Substance as manufactured in Geretsried,
Germany
Tramadol Hydrochloride as manufactured in Zhejiang, China

21250 I

II

1/22/2008

SMS PHARMACEUTICALS LTD

Sildenafil Citrate as manufactured in Andhra Pradesh, India

21251 A

II

1/15/2008

RA CHEM PHARMA LTD

METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21252 A

III

1/18/2008

INEOS SERVICES BELGIUM NV

LOW DENSITY POLYETHYLENE GRADES ELTEX MED PH22D630, PH23T630, PH27D630 AND
PH30D630 AS MANUFACTURED BY INEOS BAMBLE IN STATHELLE, NORWAY FOR INEOS
SERVICES BELGIUM NV

21253 A

III

1/22/2008

CODING PRODUCTS

TTR-79160 (THERMAL TRANSFER RIBBON) AS MANUFACTURED IN KALKASKA, MI

21254 A

II

2/7/2008

IPCA LABORATORIES LTD

21255 A

II

1/16/2008

ALP PHARM BEIJING CO LTD

21256 I

II

1/16/2008

CHANGZHOU RUIMING PHARMACEUTICAL CO LTD

21257 A

II

1/20/2006

FINETECH PHARMACEUTICAL LTD

METOPROLOL TARTRATE USP (PROCESS-III) AS MANUFACTURED IN MADHYA PRADESH,


INDIA
PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN BEIJING,
CHINA
AMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED INJIANGSU
PROVINCE, CHINA
TROVOPROST (TOS-00) AS MANUFACTURED IN NESHER, ISRAEL

21259 A

II

1/14/2008

YONEZAWA HAMARI CHEMICALS CO LTD

POLAPREZINC AS MANUFACTURED IN YAMAGATA, JAPAN

21260 I

II

1/11/2008

RIZHAO TOP SCIENCE BIO TECH CO LTD

CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

21261 A

II

1/23/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

FLUOCINONIDE (NEW PROCESS) AS MANUFACTURED IN RHO, ITALY

21262 I

IV

1/22/2008

SYMRISE INC

21263 A

II

1/23/2008

SYMBIOTEC PHARMALAB LTD

387897 NATURAL GRAPE FLAVOR WONF AS MANUFACTURED IN TETERBORO AND


BRANCHBURG, NJ
TRIAMCINOLONE ACETONIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21264 A

II

1/23/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

21265 I

II

1/24/2008

DR REDDYS LABORATORIES LTD

CINACALCET HYDROCHLORIDE AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES IN


BEER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
SIMVASTATIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21266 A

IV

1/18/2008

SEPPIC SA

SEPINEO" P 600 AS MANUFACTURED BY SEPIPROD IN CASTRES, FRANCE FOR SEPPIC S.A

21258 P

*** PENDING FILING REVIEW ***

Page 618

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21267 I
II
1/22/2008
BENZOCHEM LIFESCIENCES PVT LTD

SUBJECT
MERCAPTOPURINE USP AS MANUFACTURED IN BOISAR, INDIA

21268 A

II

12/5/2007

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD

21269 I

III

1/10/2008

FUTURA MEDICAL PRODUCTS P LTD

2,3-DIDEHYDROGEN-2,3-DIDEOXY INOSINE SODIUM FOR DIDANOSINE INTERMEDIATE (D4I


SODIUM) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
CONTAINER FOR PACKAGING HUMAN DRUGS AS MANUFACTURED IN KERALA, INDIA

21270 I

II

1/22/2008

BENZOCHEM LIFESCIENCES PVT LTD

METHOTREXATE USP AS MANUFACTURED IN BOISAR, INDIA

21271 I

II

1/22/2008

BENZOCHEM LIFESCIENCES PVT. LTD.

METOCLOPRAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN BOISAR, INDIA

21272 I

II

1/22/2008

BENZOCHEM LIFESCIENCES PVT LTD

IRINOTICAN HYDROCHLORIDE AS MANUFACTURED IN BOISAR, INDIA

21273 I

IV

1/14/2008

MASTERTASTE INC DBA KERRY INC

709319 NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN CLARK, NJ

21274 I

II

1/22/2008

BENZOCHEM LIFESCIENCES PVT LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN BOISAR, INDIA

21275 I

II

1/22/2008

BENZOCHEM LIFESCIENCES PVT LTD

DOCETAXEL ANHYDROUS AS MANUFACTURED IN BOISAR, INDIA

21276 A

II

1/21/2008

MSN LABORATORIES LTD

FINASTERIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21277 A

II

1/22/2008

ZIDOVUDINE USP AS MANUFACTURED IN SHANGHAI, CHINA

21278 A

II

1/22/2008

21279 A

II

1/22/2008

21280 A

II

1/22/2008

21281 A

III

1/4/2008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL


CO LTD
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL
CO LTD
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL
CO LTD
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL
CO LTD
AUSTAR HANSEN PACKAGE TECHNOLOGY LTD

21282 A

II

1/18/2008

ALDRICH CHEMICAL CO ISOTEC FACILITY

21283 I

II

1/15/2008

TAI HENG INDUSTRY CO LTD

21284 A

II

1/15/2008

TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD

21285 A

II

1/28/2008

POSH CHEMICALS PRIVATE LTD

CHOLESTEROL-3,4-(13)C(2), FOR PHASE I CLINICAL STUDIES AS MANUFACTURED IN


MIAMISBURG, OH
CARBINOXAMINE MALEATE API USP AS MANUFACTURED BY JIANGSU ZW
PHARMACEUTICALS CO. LTD. IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO. LTD.
VALACYCLOVIR HYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN
ZHEJIANG, CHINA
PHENAZOPYRIDINE HYDROCHLORIDE USP AS MANUFACTURED IN HYDERABAD, INDIA

21286 A

II

1/28/2008

POSH CHEMICALS PRIVATE LTD

PHENAZOPYRIDINE DC LACTOSE AS MANUFACTURED IN HYDERABAD, INDIA

21287 A

II

1/28/2008

POSH CHEMICALS PRIVATE LTD

PHENAZOPYRIDINE DC PVP AS MANUFACTURED IN HYDERABAD, INDIA

21288 A

II

1/29/2008

ALKERMES GAINESVILLE LLC

ELN 154088 AS MANUFACTURED IN GAINESVILLE, GA

21289 I

II

1/13/2008

HASKELL PHARMACEUTICALS INC

ISOLATION AND STORAGE OF PECAN SKIN AID AS MANUFACTURED IN BROOKSHIRE, TX

21290 A

III

1/9/2008

AMPACET CORP

21291 I

III

1/25/2008

FEDERAL PACKAGE NETWORK INC

110042 BLUE WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE,


IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA
NO. 500 CLASSIC PROPEL/REPEL STICK AS MANUFACTURED IN CHASKA, MN

21292 I

III

1/23/2008

LG CHEM LTD

21293 A

III

1/15/2008

ROLLPRINT PACKAGING PRODUCTS INC

LDPE PRODUCTS INTENDED FOR USE IN DRUG PACKAGING APPLICATIONS AS


MANUFACTURED IN SEOUL, KOREA
RPP#26-1010 AS MANUFACTURED IN ADDISON, IL

21294 I

II

2/1/2008

AARTI DRUGS LTD

METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21295 A

II

1/31/2008

DR REDDYS LABORATORIES LTD

PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21296 A

III

1/28/2008

TRI STATE DISTRIBUTION

PLASTIC INJECTION BLOW MOLDED BOTTLES AS MANUFACTURED IN SPARTA, TN

21297 A

III

1/28/2008

TRI STATE DISTRIBUTION

PLASTIC INJECTION STRETCH BLOW MOLDED BOTTLES AS MANUFACTURED IN SPARTA, TN

21298 A

III

1/28/2008

TRI STATE DISTRIBUTION

PLASTIC INJECTION MOLDED BOTTLES AS MANUFACTURED IN SPARTA, TN

21299 A

III

1/28/2008

TRI STATE DISTRIBUTION

PLASTIC INJECTION MOLDED CLOSURES AS MANUFACTURED IN SPARTA, TN

LAMIVUDINE AS MANUFACTURED IN SHANGHAI, CHINA


STAVUDINE USP AS MANUFACTURED IN SHANGHAI, CHINA
NEVIRAPINE USP AS MANUFACTURED IN SHANGHAI, CHINA
SPIKE PORT AND INJECTION PORT AS MANUFACTURED IN BEIJING, CHINA

Page 619

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21300 A
II
1/24/2008
SUN PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
FINASTERIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21301 A

II

1/31/2008

MSN PHARMACHEM PVT LTD

21302 A

III

1/15/2008

CAPSEAL

CARBINOXAMINE MALEATE USP [ROUTE CODE - "CX"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
ALUMINIUM SEALS AS MANUFACTURED IN NANI DAMAN, INDIA

21303 A

II

1/1/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

EPIRUBICIN HYDROCHLORIDE PRECIPITATED AS MANUFACTURED IN VERCELLI, ITALY

21304 A

II

1/30/2008

LUNDBECK PHARMACEUTICALS ITALY SPA

ARGATROBAN AS MANUFACTURED IN PADOVA, ITALY

21305 A

III

1/25/2008

BERRY PLASTICS CORP

BPC48-LS AS MNUFACTURED BY BERRY PLASTICS

21306 A

III

1/25/2008

BERRY PLASTICS CORP

BPC48-WLS AS MANUFACTURED BY BERRY PLASTICS

21307 A

II

2/4/2008

PRALIDOXIME CHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

21308 A

II

2/5/2008

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
NATCO PHARMA LTD

21309 A

II

2/4/2008

MSN LABORATORIES LTD

21310 A

II

2/5/2008

NATCO PHARMA LTD

CLOPIDOGREL BISULFATE USP (FORM-1) [ROUTE CODE - "CR1"] AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
OMEPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21311 A

II

2/5/2008

EVERLIGHT CHEMICAL INDUSTRIAL CORP

EPOPROSTENOL SODIUM AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN

21312 I

IV

2/5/2008

FONA INTERNATIONAL INC

906.264 VERY RASPBERRY (AN ARTIFICIAL FLAVOR) AS MANUFACTURED IN GENEVA, IL

21313 A

II

2/6/2008

DR REDDYS LABORATORIES LTD

ZAFIRLUKAST (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21314 I

II

2/6/2008

TAIHO PHARMACEUTICAL CO LTD

21315 A

III

1/30/2008

SCHOTT GLASS TECHNOLOGIES SUZHOU CO LTD

21316 A

III

11/22/2007

REXAM PHARMA PACKAGING INDIA P LTD

TAC-101 DRUG SUBSTANCE AS MANUFACTURED BY UNION QUIMICO FARMACEUTICA S.A.


(UQUIFA) IN SANT CELONI BARCELONA, SPAIN FOR TAIHO PHARMACEUTICAL CO LTD
PRIMARY PACKAGING MATERIAL (VIALS, AMPOULES) AS MANUFACTURED IN JIANGSU
PROVINCE, CHINA
GNEX CONTAINER, CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE, INDIA

21317 I

IV

2/5/2008

21318 I

IV

2/5/2008

21319 A

II

2/5/2008

MASTERTASTE INC DBA KERRY INGREDIENTS AND 700078 ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CLARK, NJ
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND 700512 ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CLARK, NJ
FLAVOURS
OLON SPA
BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY

21320 A

II

2/4/2008

HALCYON LABS PRIVATE LTD

BETAMETHASONE VALERATE USP AS MANUFACTURED IN GUJARAT, INDIA

21321 A

III

1/30/2008

AMPACET CORP

21322 A

II

2/7/2008

CALYX CHEMICALS AND PHARMACEUTICALS LTD

AMPACET 110313-C WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE


HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA
ISONIAZID USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21323 A

II

2/7/2008

PEPTISYNTHA SA

21324 A

II

2/1/2008

CHR HANSEN INC

21325 I

II

2/6/2008

21326 A

II

2/7/2008

SIBRA PHARMACEUTICALS LTD AN ARCH


ENTERPRISE
TAI HENG INDUSTRY CO LTD

21327 I

II

2/11/2008

TEVA PHARMACEUTICALS INDUSTRIES LTD

21328 A

III

2/5/2008

AVON AMPOULES PVT LTD

RALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE AS MANUFACTURED BY SICOR


S.R.L. IN VERCELLI, ITALY FOR TEVA GROUP - ACTIVE PHARMACEUTICAL INGREDIENTS DIV
NEUTRAL GLASS AMPOULES AND TUBULAR VIALS AS MANUFACTURED IN AHMEDABAD, INDIA

21329 I

II

1/31/2008

AUROBINDO PHARMA LTD

CEFOXITIN SODIUM USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21330 A

II

1/31/2008

WATSON PHARMA PRIVATE LTD

NORTRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN AMBERNATH (EAST), INDIA

ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

OMIGANAN PENTAHYDROCHLORIDE BULK DRUG SUBSTANCE AS MANUFACTURED IN


BRUSSELS, BELGIUM
LACTOBACILLUS GG, LGG Grade PAb AS MANUFACTURED BY CHR HANSEN A/S IN ROSKILDE
AND HVIDOVRE, DENMARK FOR CHR HANSEN INC
ZIDOVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
GLYCOPYRROLATE USP AS MANUFACTURED IN SHANGHAI, CHINA

Page 620

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21331 A
II
2/7/2008
WATSON PHARMA PRIVATE LTD

SUBJECT
ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

21332 A

II

2/12/2008

DR REDDYS LABORATORIES LTD

DILUTED TACROLIMUS 20% AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21333 I

II

9/3/2007

GENESEN LABS LTD

BICALUTAMIDE AS MANUFACTURED IN MUMBAI, INDIA

21334 A

II

2/12/2008

AARTI INDUSTRIES LTD

MOMETASONE FUROATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21335 I

II

2/14/2008

SYMED LABS LTD

CARBINOXAMINE MALEATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21336 A

II

2/12/2008

AARTI INDUSTRIES LTD

QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21337 I

IV

2/14/2008

FONA INTERNATIONAL INC

895.096 NAT PINEAPPLE FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL

21338 I

IV

2/14/2008

FONA INTERNATIONAL INC

889. 244 PEACH FLAVOR, NATURAL (WONF) AS MANUFACTURED IN GENEVA, IL

21339 A

III

2/12/2008

CORMACK PACKAGING PTY LTD

CORMACK TECR-TT (3-PIECE TAMPER EVIDENT CHILD RESISTANCE CLOSURE FOR TAMPER
TEL NECK FINISH, SIZE 24 & 28MM) AS MANUFACTURED IN NEW SOUTH WALES, AUSTRALIA

21340 A

III

2/13/2008

BPREX HEALTHCARE OFFRANVILLE SAS

PP EYE-DROPPER RANGE AS MANUFACTURED IN OFFRANVILLE, FRANCE

21341 I

II

9/3/2007

GENESEN LABS LTD

DIVALPROEX SODIUM AS MANUFACTURED IN NAVI MUMBAI, INDIA

21342 A

II

2/15/2008

CHINA NATIONAL PHARMACEUTICAL FOREIGN


TRADE CORP

RITALINIC ACID AS MANUFACTURED BY SUZHOU LIXIN PHARMACEUTICAL CO LTD IN JIANGSU


PROVINCE, CHINA FOR CHINA NATIONAL PHARMACEUTICAL FOREIGN TRADE CORP

21343 A

II

1/31/2008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

21344 A

II

2/18/2008

DR REDDYS LABORATORIES LTD

THIAPROLINE-M-AMINO BENZOIC ACID HYDROCHLORIDE (TPAB HYDROCHLORIDE) DRUG


SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA
ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21345 A

II

2/18/2008

DR REDDYS LABORATORIES LTD

APREPITANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21346 I

III

10/3/2007

SEWA MEDICALS LTD

21347 A

II

2/1/2008

CTX LIFE SCIENCES PVT LTD

TYFILL STERILE & NON-STERILE GLASS PREFILLABLE SYRINGES AS MANUFACTURED IN


PUNE, INDIA
METOPROLOL TARTRATE USP AS MANUFACTURED IN SURAT, INDIA

21348 A

II

2/20/2008

21349 A

II

2/6/2008

AZIENDE CHIMICHE RIUNITE ANGELINI


FRANCESCO SPA
PCAS

21350 A

III

2/20/2008

TAISEI KAKO CO LTD

21351 A

II

2/20/2008

FUJI SILYSIA CHEMICAL LTD

21352 A

IV

2/15/2008

HENRY H OTTENS MANUFACTURING CO INC

SYNTHETIC AMORPHOUS SILICA FOR CHROMATOGRAPHY PRODUCTS AS MANUFACTURED


IN MIYAZAKI-KEN, JAPAN
SPRAY DRIED ARTIFICIAL GRAPE FLAVOR #S-120 AS MANUFACTURED IN PHILADELPHIA, PA

21353 A

II

2/21/2008

NORAMCO INC

PURIFIED OXYCODONE BASE AS MANUFACTURED IN WILMINGTON, DE

21354 A

II

4/2/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD FELODIPINE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA

21355 A

II

2/5/2008

KESHAVA ORGANICS PVT LTD

DEXCHLORPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21356 A

II

2/5/2008

KESHAVA ORGANICS PVT LTD

CHLORPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21357 A

II

2/22/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

21358 A

II

2/21/2008

FIS FABBRICA ITALIANA SINTETICI SPA

FORMOTEROL FUMARATE DIHYDRATE AS MANUFACTURED BY SICOR S.R.L. IN MILAN, ITALY


FOR TEVA GROUP - API DIVISION
QUETIAPINE FUMARATE AS MANUFACTURED IN VICENZA, ITALY

21359 A

4/25/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

STERILE PROCESSING DETAILS OF PLANT - 32 WALUJ, INDIA

21360 A

II

2/15/2008

ROLABO OUTSOURCING SL

ATOVAQUONE AS MANUFACTURED IN ZARAGOZA, SPAIN

21361 A

III

2/21/2008

HYDRO ALUMINIUM ROLLED PRODUCTS GMBH

HARP ALUMINIUM FOIL PACKAGING MATERIALS AS MANUFACTURED IN GREVENBROICH,


GERMANY

ACAMPROSATE CALCIUM AS MANUFACTURED IN APRILIA, ITALY


DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED BY PCAS FINLAND OY IN TURKU,
FINLAND FOR PCAS
PLASTIC SYRINGES AS MANUFACTURED IN KANAGAWA, JAPAN

Page 621

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21362 I
III
2/25/2008
PLASTOP PTY LTD

SUBJECT
PACKAGING MATERIALS FOR DRUG PRODUCTS AS MANUFACTURED IN
BRONKHORSTSPRUIT, SOUTH AFRICA
EX-CELL(TM) 325 PF CHO (MODIFIED) CHO SERUM-FREE MEDIUM, PROTEIN-FREE W/585
MG/L L-GLUTAMINE, W/O SOY HYDROLYSATE, UF W/O SODIUM BICARBONATE AS
MANUFACTURED IN DENVER, PA

21363 A

II

2/1/2008

SAFC BIOSCIENCES INC

21364 A

II

2/26/2008

NIPPON PROTEIN CO LTD

L-CYSTEINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN TOCHIGI, JAPAN

21365 I

IV

2/20/2008

FONA INTERNATIONAL INC

894.132 PEPPERMINT FLAVOR (A NATURAL FLAVOR) AS MANUFACTURED IN GENEVA, IL

21366 A

III

2/22/2008

POLYONE CORP

CC10031855BG, CC00041542BG, CC00039937BG, CC00039936BG AS MANUFACTURED BY


POLYONE FRANCE SAS (CERGY) PLANT IN SAINT QUEN LAUMONE, FRANCE FOR POLYONE
CORPORATION

21367 A

II

2/27/2008

SPI PHARMA INC

21368 A

II

2/1/2008

SAFC BIOSCIENCES INC

21369 A

II

12/31/2007

CADILA PHARMACEUTICALS LTD

BARCROFT(TM) CS 90 DC CALCIUM CARBONATE AS MANUFACTURED IN SEPTEMES-LESVALLONS, FRANCE


EX-CELL(TM) 301 COMPLETE MEDIUM W/ L-GLUTAMINE, W/O SODIUM BICARBONATE AS
MANUFACTURED IN DENVER, PA
IRBESARTAN (POLYMORPHIC FORM-A) AS MANUFACTURED IN GUJARAT, INDIA

21370 I

III

2/16/2008

CMT MATERIALS INC

21371 I

II

2/22/2008

PHARMATHEN INDUSTRIAL SA

21372 A

II

2/18/2008

MALLINCKRODT INC

THERMOFORM PLUG ASSIST MATERIALS FOR BLISTER PACKAGING AS MANUFACTURED IN


ATTLEBORO, MA
VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED BY DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD IN GUJARAT, INDIA FOR OMEGAPHARMA PHARMACEUTICALS LTD
OXYMORPHONE BASE AS MANUFACTURED IN ST. LOUIS, MO

21373 A

II

2/25/2008

CHEMPACIFIC CORP

CH011 (ACITRETIN) DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD

21374 A

II

5/21/2008

JUBILANT GENERICS LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN KARNATAKA, INDIA

21375 I

II

5/23/2008

JUBILANT ORGANOSYS LTD

ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN KARNATAKA, INDIA

21376 A

II

8/1/2008

JUBILANT GENERICS LTD

ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN KARNATAKA, INDIA

21377 A

II

2/26/2008

APOTEX PHARMACHEM INDIA PVT LTD

21378 A

III

2/12/2008

AMPACET CORP

21379 A

III

2/12/2008

AMPACET CORP

21380 A

II

2/25/2008

DISHMAN NETHERLANDS BV

VENLAFAXINE HYDROCHLORIDE USP AS MANUFACTURED BY SRINI PHARMACEUTICALS LTD


IN CHOUTUPPAL AP, INDIA FOR APOTEX PHARMACHEM INDIA PVT LTD
AMPACET PRODUCT 681726-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN; HEATH, OH;DERIDDER, LA; CARTERSVILLE, GA
AMPACET PRODUCT 681725-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN; HEATH, OH;DERIDDER, LA; CARTERSVILLE, GA
CHOLECALCIFEROL AS MANUFACTURED BY SOLVAY PHARMACEUTICALS B.V. IN WEESP, THE
NETHERLANDS; PHARMACEUTICAL WORKS POLPHARMA SA IN STAROGARD GDANSKI,
POLAND FOR DISHMAN NETHERLANDS B.V.

21381 A

II

2/20/2008

CHEMI SPA

21382 A

II

2/26/2008

CHIROGATE INTERNATIONAL INC

DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE) AS MANUFACTURED IN


PATRICA, ITALY
BIMATOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN R.O.C.

21383 A

III

3/3/2008

MITSUI CHEMICALS AMERICA INC

ADMER CP-30A AS MANUFACTURED IN LAPORTE, TX

21384 A

II

2/21/2008

TOMITA PHARMACEUTICAL CO LTD

DRIED ALUMINUM HYDROXIDE GEL AS MANUFACTURED IN TOKUSHIMA, JAPAN

21385 A

II

2/29/2008

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

21386 A

II

2/29/2008

NURAY CHEMICALS PVT LTD

21387 A

III

1/29/2008

REMY AND GEISER GMBH

DULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG


PROVINCE, CHINA
QUETIAPINE HEMIFUMARATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED
IN TAMIL NADU, INDIA
TUBULAR GLASS BOTTLES AS MANUFACTURED IN ALTENFELD, GERMANY

21388 A

III

2/15/2008

HILLSIDE PLASTICS INC

HIGH DENSITY POLYETHYLENE CONTAINERS AS MANUFACTURED IN TURNERS FALLS, MA

21389 A

II

3/3/2008

DR REDDYS LABORATORIES LTD

ZOLEDRONIC ACID TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 622

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21390 I
II
3/20/2008
ALKEM LABORATORIES LTD
21391 A

II

3/3/2008

HEBEI YUXING BIO ENGINEERING CO LTD

SUBJECT
LAMOTRIGINE AS MANUFACTURED IN GUJARAT STATE, INDIA FOR ALKEM LABORATORIES
LTD
CYANOCOBALAMIN AS MANUFACTURED IN HEBEI, CHINA

21392 A

II

3/5/2008

HETERO DRUGS LTD

CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21393 A

II

3/5/2008

APOTEX PHARMACHEM INC

PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED BY APOTEX PHARMACHEM INC IN


ONTARIO, CANADA AND APOTEX PHARMACHEM INDIA PVT LTD IN BANGALORE, INDIA FOR
APOTEX PHARMACHEM INC

21394 I

II

3/5/2008

FDC LTD

LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

21395 A

II

3/5/2008

HOVIONE PHARMASCIENCE LTD

IVERMECTIN USP AS MANUFACTURED IN TAIPA, MACAU S.A.R.

21396 A

II

3/6/2008

CALYX CHEMICALS AND PHARMACEUTICALS LTD

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

21397 A

III

2/12/2008

AMPACET CORP

21398 A

IV

3/3/2008

3M DRUG DELIVERY SYSTEMS

21399 A

II

4/22/2008

FRESENIUS KABI ONCOLOGY LTD

682084 PT AMBER PET AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH;DERIDDER, LA;
CARTERSVILLE, GA
ACETYLOLIGOLACTIC ACID HYDROXYETHYLUREA ESTER [OLA-72] AS MANUFACTURED IN ST.
PAUL, MN
GEMCITABINE AS MANUFACTURED IN WEST BENGAL, INDIA

21400 A

II

3/4/2008

BASF PHARMA EVIONNAZ SA

TROSPIUM CHLORIDE AS MANUFACTURED BY BASF ORGAMOL PHARMA SOLUTIONS SA IN


EVIONNAZ, SWITZERLAND AND BASF ORGAMOL PHARMA SOLUTIONS FRANCE SAS IN SAINTVULBAS, FRANCE FOR BASF ORGAMOL PHARMA SOLUTIONS SA

21401 A

II

2/29/2008

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

GABAPENTIN AS MANUFACTURED IN JIANGXI PROVINCE, CHINA

21402 I

II

2/28/2008

WATSON PHARMA PRIVATE LTD

RAMIPRIL USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21403 A

IV

3/7/2008

ESSENTRA POROUS TECHNOLOGIES

21404 A

II

2/20/2008

21405 A

II

3/6/2008

21406 I

IV

3/5/2008

21407 I

IV

3/5/2008

21408 I

III

21409 I
21410 A

OPTIPOL(TM) PREPOLYMER AND MEDICAL GRADE FLEXIBLE POLYURETHANE FOAM AS


MANUFACTURED IN ST CHARLES, MI
LIVZON NEW NORTH RIVER PHARMACEUTICAL CO MYCOPHENOLIC ACID (NON STERILE BULK FORM) AS MANUFACTURED IN GUANGDONG
LTD
PROVINCE, CHINA
MEDICHEM MANUFACTURING MALTA LTD
CINACALCET HYDROCHLORIDE (MED-200140/M ) AS MANUFACTURED IN HAL FAR, MALTA
Sheffcoat White as manufactured in Norwich, NY

3/7/2008

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
POLIMERI EUROPA SPA

III

3/7/2008

POLIMERI EUROPA SPA

FLEXIRENE MR 50 A AS MANUFACTURED IN DUNKERQUE, FRANCE

II

3/8/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

VALPROIC ACID USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21411 I

III

3/10/2008

STELLA KUNSTSTOFFTECHNIK GMBH

DROP-DISPENSING BOTTLES 3 ML & 6 ML WITH SZ14 NECK FINISH, AMBER AND SCREW CAPS
SZ14 BLUE WITH BRUSH AS MANUFACTURED BY SGD SUCY-EN-BRIE IN SUCY-EN-BRIE,
FRANCE AND STELLA KUNSTSTOFFTECHNIK GMBH IN ELTVILLE, GERMANY FOR STELLA
KUNSTSTOFFTECHNIK GMBH

21412 A

II

3/7/2008

FARMAK AS

ESZOPICLONE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

21413 A

II

3/12/2008

21414 A

II

3/5/2008

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
SUN PHARMACEUTICAL INDUSTRIES LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN INGELHEIM AM


RHEIN, GERMANY
LEVETIRACETAM USP AS MANUFACTURED IN GUJARAT, INDIA

21415 A

III

10/2/2007

CELGARD LLC

CELGARD 2400 SEMI-PERMEABLE MEMBRANE AS MANUFACTURED IN CHARLOTTE, NC

21416 I

IV

3/5/2008

Sheffcoat Clear ENT as manufactured in Norwich, NY

21417 A

II

3/11/2008

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
RA CHEM PHARMA LTD

Sheffcoat White ENT as manufactured in Norwich, NY


FLEXIRENE MS 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 623

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21418 A
III
3/10/2008
SIBO G DOO

SUBJECT
CHILD RESISTANT CLOSURE CRP-045-F AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU

21419 A

III

3/10/2008

SIBO G DOO

CHILD RESISTANT CLOSURE CRP-045-FE AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU

21420 A

III

3/10/2008

SIBO G DOO

CONTAINER 60ML, V-045-060 AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU

21421 A

III

3/10/2008

SIBO G DOO

CONTAINER 120ML, V-055-120 AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU

21422 A

II

3/14/2008

GLENMARK GENERICS LTD

TAZAROTENE AS MANUFACTURED IN GUJARAT STATE, INDIA

21423 I

II

3/7/2008

SHANGHAI YOUNGGREEN BIOTECH CO LTD

MYCOPHENOLATE MOFETIL (NON-STERILE ACTIVE INGREDIENT) AS MANUFACTURED BY


HUADONG MEDICINE CO LTD MANUFACTURING BRANCH IN ZHEJIANG, CHINA FOR SHANGHAI
YOUNGGREEN BIOTECH CO LTD

21424 I

II

3/10/2008

21425 I

II

3/8/2008

SHANDONG FANGXING TECHNOLOGY


DEVELOPMENT CO LTD
WORLD JIANGSU INDUSTRY CO LTD

21426 A

II

3/17/2008

DR REDDYS LABORATORIES LTD

CARPROFEN (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN SHANDONG


PROVINCE, CHINA
RAPAMYCIN/SIROLIMUS (NON-STERILE, ACTIVE INGREDIENT) AS MANUFACTURED IN
FUJIANG PROVINCE, CHINA
LANSOPRAZOLE FORM-1 AS MANUFACTURED IN SRIKAKULAM DISTRICT, INDIA

21427 I

II

3/13/2008

MEDICHEM MANUFACTURING MALTA LTD

MED-201100/M AS MANUFACTURED IN HAL FAR, MALTA

21428 A

III

3/11/2008

MAK AMPOULES PVT LTD

TUBULAR VIALS USP TYPE-1 AS MANUFACTURED IN THANE DISTRICT, INDIA

21429 A

III

3/11/2008

MAK AMPOULES PVT LTD

GLASS AMPOULES USP TYPE-I AS MANUFACTURED IN THANE, INDIA

21430 A

II

3/13/2008

FARMABIOS S P A

FLUOCINONIDE, MICRONIZED BP/USP AS MANUFACTURED IN GROPELLO CAIROLI, ITALY

21431 A

IV

3/10/2008

UNGERER AND CO

ARTIFICIAL BUBBLEGUM FLVP FC-1153 AS MANUFACTURED IN BETHLEHEM, PA

21432 A

III

3/14/2008

NEMERA NEUENBURG GMBH

CLOSED VIAL AS MANUFACTURED IN NEUENBURG, GERMANY

21433 A

III

3/14/2008

NEMERA NEUENBURG GMBH

FLIP AWAY CAP AS MANUFACTURED IN NEUENBURG, GERMANY

21434 A

II

3/17/2008

DAEWOONG BIO INC

URSODIOL USP (URSODEOXYCHOLIC ACID) AS MANUFACTURED IN KYONGGI-DO, KOREA

21435 A

IV

3/5/2008

BIOGRUND GMBH

21436 A

III

4/7/2008

TRICORBRAUN

AQUAPOLISH, PRE-MIXED EXCIPIENTS SYSTEM FOR FILM COATING AS MANUFACTURED IN


HUENSTETTEN, GERMANY
DRY KEEP DESICCANT AS MANUFACTURED BY STANDRIDGE COLOR CORPORATION IN
SOCIAL CIRCLE, GA FOR TRICORBRAUN

21437 N

NOT AN ASSIGNED NUMBER

21438 A

II

3/11/2008

LUPIN LTD

IMIPRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21439 A

II

3/14/2008

AMOLI ORGANICS PVT LTD

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

21440 A

II

3/18/2008

APOTEX PHARMACHEM INC

PAROXETINE HYDROCHLORIDE ANHYDROUS USP (PAX) AS MANUFACTURED BY SIGNA SA DE


CV IN TOLUCA, MEXICO; SRINI PHARMACEUTICALS LTD IN ANDHRA PRADESH, INDIA; APOTEX
PHARMACHEM INC IN BRANTFORD, CANADA FOR APOTEX PHARMACHEM INC

21441 I

II

12/8/2007

YANCHENG XINYI PHARM AND CHEM CO LTD

EXEMESTANE (NON-STERILE, BULK FORM) AS MANUFACTURED IN JIANGSU, CHINA

21442 A

II

3/20/2008

SMS PHARMACEUTICALS LTD

FAMOTIDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21443 A

II

3/18/2008

MEDICHEM MANUFACTURING MALTA LTD

MED-201950/E AS MANUFACTURED IN GIRONA, SPAIN

21444 A

II

3/20/2008

DIPHARMA FRANCIS SRL

IBUPROFEN LYSINE SALT AS MANUFACTURED IN CARONNO PERTUSELLA, ITALY

21445 A

II

3/19/2008

SUMITOMO DAINIPPON PHARMA CO LTD

21446 A

II

3/19/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

RANIRESTAT (AS-3201) AS MANUFACTURED BY YUKI GOSEI KOGYO CO LTD IN FUKUSHIMA,


JAPAN FOR DAINIPPON SUMITOMO PHARMA CO LTD
RISPERIDONE USP AS MANUFACTURED IN GUJARAT, INDIA

21447 A

II

3/21/2008

DR REDDYS LABORATORIES LTD

21448 A

II

5/9/2008

XOMA US LLC

RISEDRONATE SODIUM HEMIPENTAHYDRATE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
CELL LINE (SOURCE, HISTORY AND GENERATION ) FOR SCH 900105 AS MANUFACTURED IN
BERKELEY, CA

Page 624

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21449 I
II
4/16/2008
IPCA LABORATORIES LTD

SUBJECT
ETODOLAC AS MANUFACTURED IN MADHYA PRADESH, INDIA

21450 I

III

3/21/2008

POLIMERI EUROPA SPA

FLEXIRENE MT 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE

21451 I

IV

3/20/2008

21452 A

III

3/3/2008

MASTERTASTE INC DBA KERRY INGREDIENTS AND 709039 ARTIFICIAL BUBBLE GUM FLAVOR AS MANUFACTURED IN CLARK, NJ
FLAVOURS
RAJESH PLASTICS
PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA, INDIA

21453 A

IV

3/6/2008

HEALTHCAPS INDIA LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN PUNJAB, INDIA

21454 A

II

3/1/2008

METOPROLOL SUCCINATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

21455 A

II

3/24/2008

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD


CHUANNAN BRANCH
IRVINE SCIENTIFIC SALES CO

21456 A

II

3/24/2008

IRVINE SCIENTIFIC SALES CO

KI NSM-15 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA

21457 A

II

3/24/2008

IRVINE SCIENTIFIC SALES CO

KI NSM-16 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA

21458 A

II

3/24/2008

IRVINE SCIENTIFIC SALES CO

FMDF-10 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA

21459 A

III

3/18/2008

COLORTECH INC

21460 I

IV

3/26/2008

HALL BIOSCIENCE

11629-09 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN


AND BRAMPTON, CANADA
ZYTAN (GALLOQUINATE) AS MANUFACTURED IN MALLUSK, NORTHERN IRELAND

21461 A

II

3/26/2008

CADILA HEALTHCARE LTD

PROGUANIL HYDROCHLORIDE PH EUR AS MANUFACTURED IN GUJARAT, INDIA

21462 I

II

3/25/2008

CADILA HEALTHCARE LTD

LETROZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

21463 A

II

3/3/2008

SEWON CELLONTECH CO LTD

ATELOCOLLAGEN AS MANUFACTURED IN SEOUL, KOREA

21464 A

III

3/26/2008

CODING PRODUCTS

801 TP (THERMAL TRANSFER RIBBON) AS MANUFACTURED IN KALKASKA, MI

21465 A

II

3/18/2008

ST GOBAIN PERFORMANCE PLASTICS CORP

TYGON 33701B BRAID-REINFORCED SILICONE HOSE AS MANUFACTURED IN BEAVERTON, MI

21466 A

II

7/18/2007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

TELMISARTAN AS MANUFACTURED IN ZHEJIANG, CHINA

21467 A

II

3/24/2008

LUPIN LTD

NABUMETONE (MICRONISED) USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21468 I

II

3/28/2008

EXCELLA GMBH

ATOVAQUONE AS MANUFACTURED IN FEUCHT, GERMANY

21469 I

II

3/27/2008

EXCELLA GMBH

RIVASTIGMINE TARTRATE AS MANUFACTURED IN FEUCHT, GERMANY

21470 A

II

3/8/2008

SAI LIFE SCIENCES LTD

IBUTILIDE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21471 A

II

3/15/2008

UNIMARK REMEDIES LTD

CEFPROZIL USP AS MANUFACTURED IN GUJARAT, INDIA

21472 I

II

4/1/2008

DIXIE CHEMICAL CO INC

NICOTINE USP AND NICOTINE USP-HP AS MANUFACTURED IN PASADENA, TX

21473 A

II

3/28/2008

POLYPEPTIDE LABORATORIES INC

A-CORTICOTROPIN (1-24) ACETATE AS MANUFACTURED IN TORRANCE, CA

21474 A

II

3/22/2008

MYLAN LABORATORIES LTD

PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA

21475 A

II

6/16/2008

IPCA LABORATORIES LTD

PROGUANIL HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21476 A

II

3/22/2008

MYLAN LABORATORIES LTD

QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA

21477 A

II

3/25/2008

MYLAN LABORATORIES LTD

ATORVASTATIN CALCIUM USP AS MANUFACTURED IN TELANGANA, INDIA

21478 A

II

3/29/2008

MYLAN LABORATORIES LTD

DULOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA

21479 A

II

3/25/2008

MYLAN LABORATORIES LTD

ESZOPICLONE AS MANUFACTURED IN TELANGANA, INDIA

21480 A

II

3/26/2008

MEDICHEM SA

MED-200025/E AS MANUFACTURED IN GIRONA, SPAIN

21481 A

II

3/24/2008

IND SWIFT LABORATORIES LTD

ACAMPROSATE CALCIUM AS MANUFACTURED IN PUNJAB, INDIA

21482 A

II

4/1/2008

CADILA HEALTHCARE LTD

ZALEPLON AS MANUFACTURED IN GUJARAT, INDIA

21483 P
21484 A

FMDF-9 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA

*** PENDING FILING REVIEW ***


II

3/25/2008

UNICHEM LABORATORIES LTD

NATEGLINIDE AS MANUFACTURED IN DHAR DISTRICT, INDIA

Page 625

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21485 A
II
3/31/2008
TORRENT PHARMACEUTICALS LTD

SUBJECT
DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA

21486 A

II

3/31/2008

ACS DOBFAR SPA

IMIPENEM AND CILASTATIN (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

21487 A

II

4/1/2008

APOTEX PHARMACHEM INDIA PVT LTD

VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED BY SRINI


PHARMACEUTICALS LTD IN ANDHRA PRADESH, INDIA AND SIGNA SA DE CV IN MEXICO FOR
APOTEX PHARMACHEM INDIA PVT LTD

21488 A

II

3/31/2008

LUPIN LTD

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

21489 A

II

3/28/2008

LUPIN LTD

MESALAMINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21490 I

IV

3/26/2008

VASA PHARMACHEM PVT LTD

MAGNESIUM STEARATE AS MANUFACTURED IN GUJARAT, INDIA

21491 I

IV

3/18/2008

VASA PHARMACHEM PVT LTD

VASAGEL (SODIUM STARCH GLYCOLATE) AS MANUFACTURED IN GUJARAT, INDIA

21492 I

IV

3/18/2008

VASA PHARMACHEM PVT LTD

VASALOSE (CROSCARMELLOSE SODIUM) AS MANUFACTURED IN GUJARAT, INDIA

21493 A

II

3/28/2008

LUPIN LTD

IMIPRAMINE PAMOATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21494 A

5/1/2008

NOVO NORDISK INC

STERILIZATION VALIDATION INFORMATION IN BAGSVAERD, DENMARK

21495 A

II

4/3/2008

UQUIFA MEXICO SA DE CV

RABEPRAZOLE SODIUM AS MANUFACTURED IN MORELOS, MEXICO

21496 I

III

3/31/2008

INGENIA POLYMERS CORP

INGENIA POLYMERS 1026 HIGH PERFORMANCE WHITE FOR USE IN PACKAGING MATERIALS
AS MANUFACTURED BY INGENIA POLYMERS CORP IN ONTARIO AND ALBERTA, CANADA;
INGENIA POLYMERS INC IN HOUSTON, TEXAS FOR INGENIA POLYMERS CORP

21497 I

III

3/31/2008

INGENIA POLYMERS CORP

INGENIA POLYMERS 1027 SUPER WHITE FOR USE IN PACKAGING MATERIALS AS


MANUFACTURED BY INGENIA POLYMERS CORPORATION IN ONTARIO AND ALBERTA, CANADA:
INGENIA POLYMERS INC IN HOUSTON, TEXAS FOR INGENIA POLYMERS CORPORATION

21498 A

II

3/31/2008

LUPIN LTD

OMEPRAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21499 A

III

3/31/2008

HYOSUNG CORP

21500 A

II

3/29/2008

OLON SPA

POLYPROPYLENE (TOPILENE J700-1, J800S, J801, R530, R530A) AS MANUFACTURED IN


ULSAN, KOREA
IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN RODANO, ITALY

21501 A

III

4/4/2008

PLASTUBE NORTH AMERICA

POLYFOIL TUBES AS MANUFACTURED IN QUEBEC, CANADA

21502 A

III

4/4/2008

PLASTUBE NORTH AMERICA

MONOLAYER TUBES AS MANUFACTURED IN QUEBEC, CANADA

21503 A

III

4/4/2008

PLASTUBE NORTH AMERICA

CO-EXTRUSION TUBES AS MANUFACTURED IN QUEBEC, CANADA

21504 A

II

4/4/2008

EVERLIGHT CHEMICAL INDUSTRIAL CORP

LATANOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN

21505 A

III

8/18/2007

THE BOMBAY GLASS BLOWING INDUSTRIES

NEUTRAL GLASS TUBULAR VIALS USP TYPE 1 AS MANUFACTURED IN GUJARAT, INDIA

21506 A

II

3/31/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

OLANZAPINE AS MANUFACTURED IN MAHARASHTRA, INDIA

21507 A

II

3/31/2008

ALEMBIC PHARMACEUTICALS LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA

21508 A

II

3/29/2008

PARABOLIC DRUGS LTD

CEFUROXIME ACID (API STARTING MATERIAL) AS MANUFACTURED IN IN PUNJAB, INDIA

21509 A

II

3/31/2008

LUPIN LTD

FLUVASTATIN SODIUM (MICRONIZED) USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21510 A

II

3/29/2008

ALEMBIC PHARMACEUTICALS LTD

METOPROLOL SUCCINATE USP AS MANUFACTURED IN GUJARAT, INDIA

21511 A

II

4/8/2008

VANGA PRODUCTS PLASTICS INC

21512 A

II

3/31/2008

LUPIN LTD

VANGA PHARMACEUTICAL AND NUTRACEUTICAL (VITAMIN) PLASTIC BOTTLES AS


MANUFACTURED IN BRITISH COLUMBIA, CANADA
CARVEDILOL PHOSPHATE (AMORPHOUS) AS MANUFACTURED IN MAHARASHTRA, INDIA

21513 A

II

3/31/2008

LUPIN LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21514 I

II

3/28/2008

LUPIN LTD

MESALAMINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21515 A

II

4/7/2008

LONZA LTD

EC-125 DRUG SUBSTANCE AS MANUFACTURED IN VISP, SWITZERLAND

21516 A

IV

4/4/2008

UNGERER AND CO

N/A BERRY FLAVOR FO-8432 AS MANUFACTURED IN BETHLEHEM, PA.

21517 A

II

4/9/2008

BIOVECTRA INC

DOCETAXEL AS MANUFACTURED IN CHARLOTTETOWN, CANADA

Page 626

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21518 A
II
4/9/2008
INDUSTRIALE CHIMICA SRL

SUBJECT
NORGESTIMATE USP AS MANUFACTURED IN SARONNO, ITALY

21519 A

II

4/9/2008

NEULAND LABORATORIES LTD

DORZOLAMIDE HYDROCHLORIDE FORM II USP AS MANUFACTURED IN TELANGANA, INDIA

21520 I

II

1/7/2008

UNIV SOUTHERN CALIFORNIA

5-[18F] FLUOROURACIL (5-[18F]FU) AS MANUFACTURED BY UNIV OF SOUTHERN CALIFORNIA


PET ISC RADIOCHEMISTRY LABORATORY IN LOS ANGELES, CA FOR UNIV SOUTHERN
CALIFORNIA DEPT OF RADIOLOGY

21521 A

II

3/31/2008

LUPIN LTD

OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

21522 A

III

3/28/2008

FLEX ART FOIL LTD

21523 A

II

4/8/2008

MSN LABORATORIES LTD

PLAIN AND PRINTED ALUMINIUM FOIL / GLASSINE / LAMINATES / CR FOIL AS MANUFACTURED


IN HIMACHAL PRADESH, INDIA
VORICONAZOLE USP [ROUTE CODE - VZ"] AS MANUFACTURED IN TELANGANA

21524 A

II

4/8/2008

LUPIN LTD

DULOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21525 A

IV

4/7/2008

FONA INTERNATIONAL INC

802.0004U ANISE TYPE FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL

21526 A

II

4/11/2008

NEULAND LABORATORIES LTD

ENTACAPONE (FORM-A) AS MANUFACTURED IN TELANGANA, INDIA

21527 A

II

4/11/2008

CRYSTAL PHARMA SAU

ULIPRISTAL ACETATE MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN

21528 I

II

4/10/2008

SEIKAGAKU CORP

SODIUM CHONDROITIN SULFATE (N) AS MANUFACTURED IN KANAGAWA, JAPAN

21529 A

II

5/24/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

21530 A

4/9/2008

BIOCON LTD

RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP AS MANUFACTURED IN MAHARASHTRA,


INDIA
MANUFACTURING FACILITY OF BIOCON LIMITED AT BANGALORE, INDIA

21531 A

III

3/7/2008

MEDRAD INC

21532 A

II

4/15/2008

HARMAN FINOCHEM LTD

FLS-3 READY-TO-FILL SYRINGE AS MANUFACTURED BY TRANSCOJECT GMBH IN


NEUMUNSTER, GERMANY FOR MEDRAD INC
DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

21533 A

III

4/12/2008

ALUCON PUBLIC CO LTD

COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN SAMUDPRAKARN, THAILAND

21534 A

II

4/15/2008

HETERO LABS LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21535 A

II

4/15/2008

ACS DOBFAR SPA

IMIPENEM (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

21536 A

III

3/24/2008

AMPACET CORP

21537 A

III

4/9/2008

AMPACET CORP

21538 I

IV

4/15/2008

MASTERTASTE INC DBA KERRY INC

AMPACET 172963 LIME GREEN POLYETHYLENE MASTERBATCH AS MANUFACTURED IN


TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA
AMPACET 101797 SLIP POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA
708055 EUCALYPTUS OIL 70/75% AS MANUFACTURED IN CLARK, NJ

21539 A

III

4/7/2008

SAMSUNG MEDICAL RUBBER CO LTD

21540 A

II

4/17/2008

HETERO LABS LTD

RUBBER STOPPER, CONNECTOR AND GASKET AS MANUFACTURED IN GYEONGGI-DO,


KOREA
TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21541 A

IV

3/20/2008

DAVID MICHAEL AND CO INC

ARTIFICIAL STRAWBERRY FLAVOR #12006 AS MANUFACTURED IN PHILADELPHIA, PA

21542 A

II

4/17/2008

PORTON PHARMACEUTICAL LTD

21543 A

II

4/18/2008

21544 A

II

4/17/2008

ABX ADVANCED BIOCHEMICAL COMPOUNDS


GMBH
LUITPOLD PHARMACEUTICALS INC

DEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING,


CHINA
MIBG DRUG SUBSTANCE AS MANUFACTURED BY ABX GMBH IN RADEBERG, GERMANY FOR
ABX ADVANCED BIOCHEMICAL COMPOUNDS GMBH
SODIUM CHLORIDE INJECTION USP 0.9% 10ML VIAL AS MANUFACTURED IN SHIRLEY, NY

21545 A

II

3/31/2008

SAFC BIOSCIENCES INC

21546 A

II

8/19/2008

CIPLA LTD

EX-CELL(TM) NSO SERUM-FREE, CHEMICALLY DEFINED W/O L-GLUTAMINE W/O SODIUM


BICARBONATE AS MANUFACTURED IN LENEXA, KS
TESTOSTERONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21547 A

II

7/3/2008

CIPLA LTD

LEVONORGESTREL USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21548 A

II

4/17/2008

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD

LAMIVUDINE USP AS MANUFACTURED IN HARYANA, INDIA

Page 627

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21549 I
II
4/17/2008
SIBRA PHARMACEUTICALS LTD AN ARCH
ENTERPRISE
21550 A
IV
4/18/2008
SUMITOMO SEIKA CHEMICALS CO LTD

SUBJECT
LAMIVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21551 A

II

4/18/2008

LUPIN LTD

POLYETHYLENE OXIDE (PEO): A NON-IONIC WATER SOLUBLE THERMOPLASTIC RESIN AS


MANUFACTURED IN HYOGO, JAPAN
FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21552 A

II

4/21/2008

SMS PHARMACEUTICALS LTD

LANSOPRAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21553 I

II

4/14/2008

XIAN LIBANG PHARMACEUTICAL CO LTD

21554 A

II

4/17/2008

MSN LABORATORIES LTD

IBUTILIDE FUMARATE, NON-STERILE BULK DRUG AS MANUFACTURED IN SHANXI PROVINCE,


CHINA
EZETIMIBE [ROUTE CODE - EB] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21555 A

III

4/23/2008

VARI SPA

KEMP HFA METERED DOSE AEROSOL VALVES AS MANUFACTURED IN VALMADRERA, ITALY

21556 A

II

6/27/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

THN-CYCLIC (IMIPENEM INTERMEDIATE) AS MANUFACTURED IN MAHARASHTRA, INDIA

21557 A

II

5/29/2008

CIPLA LTD

OSELTAMIVIR PHOSPHATE USP AS MANUFACTURED IN MAHARASHTRA, INDAI

21558 A

III

4/9/2008

VERRETUBEX

AMPOULES, VIALS AND CARTRIDGES MANUFACTURED IN TUBULAR GLASS TO CONTAIN


PHARMACEUTICAL AND MEDICAL PRODUCTS AS MANUFACTURED IN NOGENT LE ROI,
FRANCE

21559 A

II

4/15/2008

DIGOXIN 20 MICROMETER AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY

21560 A

II

4/22/2008

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
MALLINCKRODT INC

21561 A

III

4/21/2008

REXAM HEALTHCARE OFFRANVILLE SAS

60 ML PILLJAR AS MANUFACTURED IN OFFRANVILLE, FRANCE

21562 A

III

4/15/2008

ABSORBENT COTTON/PURIFIED COTTON AS MANUFACTURED IN JALGAON, INDIA

21563 I

II

1/15/2008

RUBY SURGICAL AND ALLIED PRODUCTS PRIVATE


LTD
YANCHENG XINYI PHARM AND CHEM CO LTD

21564 A

III

3/18/2008

CHONGQING ZHENGCHUAN GLASS CO LTD

21565 A

III

3/18/2008

CHONGQING ZHENGCHUAN GLASS CO LTD

21566 A

5/21/2008

21567 A

II

4/25/2008

21568 I

III

4/11/2008

NATIONAL INSTITUTES HEALTH NATIONAL


INSTITUTE ALLERGY INFECTIOUS DISEASES
AMRI RENSSELAER INC SUB ALBANY MOLECULAR
RESEARCH INC
RELIANCE INDUSTRIES LTD

21569 A

III

4/11/2008

RELIANCE INDUSTRIES LTD

POLYPROPYLENE (PP) REPOL H110MA AS MANUFACTURED IN MAHARASHTRA, INDIA

21570 A

II

4/24/2008

ZIDOVUDINE USP AS MANUFACTURED IN HARYANA, INDIA

21571 A

II

4/16/2008

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
BIOCON LTD

21572 A

II

2/13/2008

ANTIBIOTICOS DO BRASIL LTDA

ARGININE USP, STERILE BULK MPM180AF3 AS MANUFACTURED IN COSMOPOLIS, BRAZIL

21573 A

II

5/2/2008

NUVIEW LIFE SCIENCES

INDIUM-111 CHLORIDE SOLUTION AS MANUFACTURED IN DENTON, TEXAS

21574 A

II

4/29/2008

APOTEX PHARMACHEM INC

21575 A

II

4/25/2008

21576 A

II

4/29/2008

21577 A

III

4/18/2008

SODIUM SULFATE USP ANHYDROUS MILLED POWDER AS MANUFACTURED IN ST LOUIS, MO

MEDROXYPROGESTERONE ACETATE (NON-STERILE BULK FORM) AS MANUFACTURED IN


JIANGSU, CHINA
CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF BOROSILICATE GLASS (TYPE I)
TUBING AS MANUFACTURED IN CHONGQING, P.R. CHINA
CONTAINERS FOR PARENTERAL PREPARATIONS OF LOW-BOROSILICATE GLASS (TYPE I)
TUBING AS MANUFACTURED IN CHONGQING, CHINA
ANTHRAX ANIMAL MODEL LOCATED IN BETHESDA, MARYLAND
HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE AS MANUFACTURED IN
RENSSELAER, NY
POLYPROPYLENE (PP) REPOL SRM250NC AS MANUFACTURED IN MAHARASHTRA, INDIA

SIROLIMUS DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE AS MANUFACTURED IN BRANTFORD,


CANADA
SAFC BIOSCIENCES INC
EX-CELL 325 PF CHO (MODIFIED) PRODUCT NO. 63131 AS MANUFACTURED BY SAFC
BIOSCIENCES LTD IN ANDOVER, UNITED KINGDOM FOR SAFC BIOSCIENCES
ZHEJIANG DONGDONG PHARMACEUTICAL CO LTD TORSEMIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
CCC PLASTICS CANADA COLORS AND CHEMICALS WHITE MB20-9576 POLYETHYLENE COLOUR CONCENTRATE AS MANUFACTURED IN
LTD
ONTARIO, CANADA

Page 628

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21578 I
II
4/28/2008
YANGZHOU PHARMACEUTICAL CO LTD

SUBJECT
ETODOLAC USP AS MANUFACTURED IN JIANGSU, CHINA

21579 A

II

4/29/2008

DIVIS LABORATORIES LTD

VIGABATRIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21580 A

II

7/23/2008

BAYER SCHERING PHARMA AG

RIVAROXABAN COATED TABLETS, 10 MG AS MANUFACTURED IN LEVERKUSEN, GERMANY

21581 A

II

7/23/2008

BAYER SCHERING PHARMA AG

21582 I

II

4/29/2008

SIEMENS MOLECULAR IMAGING INC

RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE AS MANUFACTURED IN WUPPERTAL AND


LEVERKUSEN, GERMANY
SODIUM FLUORIDE F18 INJECTION AS MANUFACTURED BY PETNET HOUSTON LLC IN
HOUSTON, TX AND PETNET SOLUTIONS INC IN CULVER CITY & PALO ALTO, CA; PETNET
SOLUTIONS IN CINCINNATI, OH AND DALLAS, TX; DURHAM, NC; ST. LOUIS, MO; WOBURN, MA;
HACKENSACK, NJ FOR SIEME

21583 A

II

4/24/2008

ZACH SYSTEM SPA

CARVEDILOL PHOSPHATE AS MANUFACTURED IN LONIGO, ITALY

21584 A

II

4/28/2008

CAYMAN PHARMA SRO

EPOPROSTENOL SODIUM AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC

21585 A

II

4/30/2008

CHEMO IBERICA SA MADRID

21586 A

4/23/2008

APTAR STELMI SAS

21587 A

II

4/30/2008

BASF CORP

RABEPRAZOLE SODIUM (PROCESS I) AS MANUFACTURED BY QUIMICA SINTETICA S.A. IN


MADRID, SPAIN FOR CHEMO IBERICA S.A. MADRID
STERILE ELASTOMERIC CLOSURE AND ITEMS AS MANUFACTURED IN GRANVILLE CEDEX,
FRANCE
SODIUM IBUPROFEN DIHYDRATE AS MANUFACTURED IN BISHOP, TX

21588 A

II

4/30/2008

21589 A

III

5/1/2008

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
PRESSPART GMBH CO KG

21590 A

II

4/29/2008

MACFARLAN SMITH LTD

21591 A

II

5/1/2008

FARMABIOS S P A

21592 A

II

7/24/2008

JANSSEN ORTHO LLC

TRIAMCINOLONE ACETONIDE MICRONIZED STERILE AS MANUFACTURED IN GROPELLO


CAIROLI, ITALY
RIVAROXABAN 10 MG FILM COATED TABLETS AS MANUFACTURED IN GURABO, PUERTO RICO

21593 I

II

4/29/2008

SHANGHAI AJINOMOTO AMINO ACID CO LTD

L-LEUCINE AS MANUFACTURED IN SHANGHAI, CHINA

21594 A

II

5/5/2008

ACS DOBFAR SPA

CILASTATIN SODIUM (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

21595 A

II

5/7/2008

NATCO PHARMA LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21596 A

IV

5/7/2008

21597 A

IV

5/7/2008

SHEFFIELD BRAND MONOHYDRATE NF INHALATION 120MS AS MANUFACTURED IN NORWICH,


NY
LACTOSE MONOHYDRATE NF INHALATION 120M AS MANUFACTURED IN NORWICH, NY

21598 A

IV

5/7/2008

21599 A

IV

5/6/2008

21600 A

IV

5/7/2008

21601 A

IV

5/6/2008

21602 A

II

5/8/2008

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
NANTONG JINGHUA PHARMACEUTICAL CO LTD

21603 A

II

5/8/2008

SIGNA SA DE CV

21604 A

II

4/29/2008

WOCKHARDT LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED BY SIGNA SA DE CV IN TOLUCA,


MEXICO FOR APOTEX PHARMACHEM INC
DULOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

21605 A

II

4/23/2008

WOCKHARDT LTD

LANSOPRAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

MORPHINE SULFATE USP AS MANUFACTURED IN WEST DEPTFORD, NJ


ALUMINIUM ALLOY METERED DOSE INHALER CONTAINERS (CANS) INTERNALLY COATED
WITH FLUOROPOLYMER AS MANUFACTURED IN MARSBERG, GERMANY
NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM

LACTOSE MONOHYDRATE NF INHALATION 80M AS MANUFACTURED IN NORWICH, NY


LACTOSE ANHYDROUS NF INHALATION 120MS AS MANUFACTURED IN NORWICH, NY
LACTOSE MONOHYDRATE NF INHALATION 40M AS MANUFACTURED IN NORWICH, NY
LACTOSE ANHYDROUS NF INHALATION 40M AS MANUFACTURED IN NORWICH, NY
PRIMIDONE AS MANUFACTURED IN JIANGSU, CHINA

Page 629

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21606 A
II
5/8/2008
KYOWA HAKKO KIRIN CO LTD
21607 A

II

4/25/2008

INTERNATIONAL MEDICAL IMPLANT IMI

SUBJECT
ASKP1240 MONOCLONAL ANTIBODY DRUG SUBSTANCE AND DRUG PRODUCT AS
MANUFACTURED IN GUNMA, JAPAN
BIOPIK AS MANUFACTURED IN PORNICHET, FRANCE

21608 I

III

4/24/2008

PERMIAN PLASTICS INC

DRUG PRODUCT CONTAINER AS MANUFACTURED IN O'FALLON, MO

21609 A

III

4/15/2008

JAMNADAS INDUSTRIES

RUBBER CLOSURES AS MANUFACTURED IN GUJARAT, INDIA

21610 A

II

5/8/2008

ACTAVIS GROUP PTC EHF

IMIQUIMOD, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU, INDIA

21611 A

III

3/27/2008

YONWOO CO LTD

AS30-TC CONTAINER / CLOSURE AS MANUFACTURED IN INCHEON, KOREA

21612 A

II

5/9/2008

HETERO LABS LTD

EMTRICITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21613 I

IV

5/13/2008

INTERNATIONAL SPECIALTY PRODUCTS

21614 I

II

5/9/2008

SHENZHEN HAPPY PHARMACEUTICALS LTD

21615 A

II

5/10/2008

PARABOLIC DRUGS LTD

ADVANTIA PERFORMANCE AS MANUFACTURED BY EMERSON RESOURCES INC IN


NORRISTOWN, PA FOR INTERNATIONAL SPECIALTY PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED BY HAPPY PHARMACEUTICALS LTD
IN SHANDONG PROVINCE, CHINA FOR SHENZHEN HAPPY PHARMACEUTICALS LTD.
CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA

21616 I

II

5/12/2008

STAVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21617 A

II

5/12/2008

SIBRA PHARMACEUTICALS LTD AN ARCH


ENTERPRISE
SYN TECH CHEM AND PHARM CO LTD

21618 A

IV

5/15/2008

CAMBRIDGE ISOTOPE LABORATORIES INC

L-LEUCINE (U-13C6) AS MANUFACTURED IN ANDOVER, MA

21619 A

II

5/15/2008

HETERO DRUGS LTD

SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21620 A

II

8/19/2009

CIPLA LTD

CAPECITABINE USP AS MANUFACTURED IN MUMBAI, INDIA

21621 A

II

7/17/2008

CIPLA LTD

TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA

21622 A

II

4/12/2008

JIANGSU ZW PHARMACEUTICALS CO LTD

21623 A

III

5/15/2008

POLYCINE GMBH

ZOPICLONE API (EP) NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, P.R.


CHINA
INERTA101 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY

21624 A

II

5/8/2008

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

21625 A

II

3/25/2008

LUSOCHIMICA SPA

21626 I

II

5/16/2008

ZACH SYSTEM CORP

IVERMECTIN USP (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) FOR HUMAN USE


AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE) AS MANUFACTURED IN
LOMAGNA, ITALY
DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN LA PORTE, TX

21627 A

III

5/15/2008

NATIONAL LABEL CO

HEAT SEAL ADHESIVE 441BL AS MANUFACTURED IN CONSHOHOCKEN, PA

21628 I

III

5/16/2008

TEKNOR APEX CO

MONPRENE MP-2024A NATURAL AS MANUFACTURED BY QST INC IN SAINT ALBANS, VT AND


TEKNOR PERFORMANCE ELASTOMERS IN HENDERSON, KY FOR TEKNOR APEX COMPANY

21629 A

II

5/16/2008

SIGMA ALDRICH MANUFACTURING LLC

GALACTOMANNAN C (DAVANAT) AS MANUFACTURED IN ST. LOUIS, MO

21630 A

II

5/19/2008

TORRENT PHARMACEUTICALS LTD

RISPERIDONE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA

21631 A

II

5/19/2008

TORRENT PHARMACEUTICALS LTD

21632 A

IV

5/16/2008

QUALICAPS ROMANIA

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED


IN GUJARAT, INDIA
EMPTY GELATIN CAPSULES AS MANUFACTURED IN BUCHAREST, ROMANIA

21633 I

II

5/19/2008

EMCURE PHARMACEUTICALS LTD

OLSALAZINE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

21634 A

II

5/20/2008

FORMOSA LABORATORIES INC

LEVONORGESTREL AS MANUFACTURED IN TAOYUAN, TAIWAN

21635 A

II

6/27/2008

21636 A

II

7/22/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD DULOXETINE HYDROCHLORIDE (NON-STERILE BULK API) AS MANUFACTURED IN
MAHARASHTRA, INDIA
ORCHID CHEMICALS AND PHARMACEUTICALS LTD LANSOPRAZOLE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA

21637 I

II

5/16/2008

LABORATORIO CHIMICO INTERNAZIONALE SPA

ATENOLOL AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

PROPENTOFYLLINE INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER AS MANUFACTURED


IN SEGRATE, ITALY

Page 630

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21638 A
IV
5/19/2008
WACKER CHEMIE AG
21639 A

2/4/2008

IONISOS

SUBJECT
HYDROXYPROPYL BETA CYCLODEXTRIN AS MANUFACTURED BY WACKER CHEMIE AG IN
BURGHAUSEN, GERMANY FOR WACKER FINE CHEMICALS
FACILITY AND PROCEDURES FOR ELECTRON BEAM STERILIZATION IN CHAUMESNIL, FRANCE

21640 A

II

5/19/2008

EMCURE PHARMACEUTICALS LTD

DEFERIPRONE AS MANUFACTURED IN MAHARASHTRA, INDIA

21641 N

NOT AN ASSIGNED NUMBER

21642 I

II

5/16/2008

LONZA AG

21643 I

II

5/14/2008

SANQUIN BLOOD SUPPLY FDN

21644 I

III

5/16/2008

O BERK CO HEALCARE PACKAGING GROUP

2 OZ / 60ML TYPE 3 GLASS OBLONG BOTTLES, ITEM CODE 5403009 AS MANUFACTURED BY


HWA SHIA GLASS COMPANY LTD IN HSINCHU, TAIWAN FOR O. BERK COMPANY, HEALTHCARE
PACKAGING GROUP

21645 I

III

5/21/2008

ROHM AND HAAS CO

21646 A

III

5/20/2008

POREX TECHNOLOGIES GMBH

ADCOTE 35D9 AS MANUFACTURED BY ROHM AND HAAS CHEMICALS LLC IN ELK GROVE
VILLAGE, IL FOR ROHM AND HAAS COMPANY
FILTER DISC PART NS-7363 COMPONENT USED IN A DRUG POWDER INHALER AS
MANUFACTURED BY POREX TECHNOLOGIES GMBH IN AACHEN, GERMANY FOR POREX
CORPORATION

21647 A

III

5/14/2008

UNGERER AND CO

ARTIFICIAL GRAPE FLAVOR FN-5393 AS MANUFACTURED IN BETHLEHEM, PA

21648 A

III

5/14/2008

N E W PLASTICS CORP

21649 A

III

4/18/2008

ADHESIVES RESEARCH INC

HIGH DENSITY POLYETHYLENE PLASTIC CONTAINERS AS MANUFACTURED IN LUXEMBURG,


WI
MA-73B AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND
ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND FOR ADHESIVES RESEARCH INC

21650 A

II

5/22/2008

AARTI DRUGS LTD

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

21651 I

III

5/21/2008

ROHM AND HAAS CO

21652 I

II

5/23/2008

ENALTEC LABS PVT LTD

ADCOTE HS 35X124 AS MANUFACTURED BY ROHM AND HAAS CHEMICALS LLC IN ELK GROVE
VILLAGE AND RINGWOOD, IL FOR ROHM AND HAAS COMPANY
TROSPIUM CHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

21653 A

II

5/23/2008

CHONGQING HUAPONT PHARMACEUTICAL CO LTD ISOTRETINOIN AS MANUFACTURED IN CHONGQING, P.R. CHINA

21654 A

II

5/21/2008

HALCYON LABS PRIVATE LTD

21655 N

ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN VISP,


SWITZERLAND
HOLOTRANSFERRIN AS MANUFACTURED BY SANQUIN PLASMA PRODUCTS IN AMSTERDAM,
THE NETHERLANDS AND CAF-DCF CVBA-SCRL IN BRUSSELS, BELGIUM FOR SANQUIN BLOOD
SUPPLY FOUNDATION

MOMETASONE FUROATE USP AS MANUFACTURED IN GUJARAT, INDIA

NOT AN ASSIGNED NUMBER

21656 A

IV

6/3/2008

UNGERER AND CO

NATURAL PEPPERMINT FLAVOR #2303 AS MANUFACTURED IN BETHLEHEM, PA

21657 A

II

5/26/2008

SIGNA SA DE CV

21658 I

II

5/23/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

TOPIRAMATE USP AS MANUFACTURED BY SIGMA SA DE CV IN TOLUCA, MEXICO FOR APOTEX


PHARMACHEM INC
TRIAMCINOLONE ACETONIDE MICRONIZED STERILE AS MANUFACTURED IN SANTIA, ITALY

21659 I

II

5/30/2008

AMRI INDIA PVT LTD

ATENOLOL, USP DRUG SUBSTANCE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

21660 I

II

5/20/2008

E BEGEROW GMBH AND CO

BECOCAP DEPTH FILTER CAPSULE AS MANUFACTURED IN LANGENLONSHEIM, GERMANY

21661 A

III

5/29/2008

DONGSIN TUBE GLASS IND CO LTD

USP TYPE I BROSILICATE VIALS AND AMPOULES AS MANUFACTURED IN INCHEON, KOREA

21662 A

II

5/21/2008

KESHAVA ORGANICS PVT LTD

BROMPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21663 A

II

5/20/2008

INDUSTRIALE CHIMICA SRL

INDAPAMIDE AS MANUFACTURED IN SARONNO(VARESE), ITALY

21664 I

II

5/20/2008

KOREA UNITED PHARMACEUTICALS INC

FELODIPINE AS MANUFACTURED IN YEONGI-GUN CHUNGNAM, REPUBLIC OF KOREA

21665 A

II

5/28/2008

ALDRICH CHEMICAL CO ISOTEC FACILITY

METHACETIN-METHOXY-13C, MBT GRADE AS MANUFACTURED IN MIAMISBURG, OH

21666 A

II

5/28/2008

MACLEODS PHARMACEUTICALS LTD

EFAVIRENZ AS MANUFACTURED IN GUJARAT, INDIA

21667 I

II

5/20/2008

HTI TECHNOLOGIES

HYDROXYAPATITE COATINGS AS MANUFACTURED IN DECINES, FRANCE

Page 631

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21668 N
NOT AN ASSIGNED NUMBER

SUBJECT

21669 A

II

5/25/2008

JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD

21670 I

II

5/13/2008

AREVIPHARMA GMBH

TEMOZOLOMIDE (BULK, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS


MANUFACTURED IN JIANGSU, CHINA
BICALUTAMIDE AS MANUFACTURED IN RADEBEUL, GERMANY

21671 A

II

5/27/2008

PARABOLIC DRUGS LTD

CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN PUNJAB, INDIA

21672 I

IV

5/29/2008

MASTERTASTE INC DBA KERRY INC

700076 NATURAL & ARTIFICIAL GRAPE FLAVOR AS MANUFACTURED IN CLARK, NJ

21673 A

II

5/26/2008

JENKEM TECHNOLOGY CO LTD

21674 I

II

6/4/2008

RPG LIFE SCIENCES LTD

Y-SHAPE PEG NHS ESTER, MW 40000 (NON-STERILE BULK FORM) AS MANUFACTURED IN


TIANJIN, CHINA
AZATHIOPRINE USP AS MANUFACTURED IN MUMBAI, INDIA

21675 A

II

6/4/2008

OXYMORPHONE HCL, USP AS MANUFACTURED IN WEST DEPTFORD, NJ

21676 A

II

7/25/2008

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
IPCA LABORATORIES LTD

21677 A

II

9/20/2008

IPCA LABORATORIES LTD

FENOFIBRATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21678 A

II

10/20/2008

IPCA LABORATORIES LTD

CILOSTAZOL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21679 A

II

7/1/2008

IPCA LABORATORIES LTD

TRAMADOL HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21680 A

II

8/12/2008

IPCA LABORATORIES LTD

WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21681 A

II

6/10/2008

DAIICHI FINE CHEMICAL CO LTD

BIMATOPROST DRUG SUBSTANCE AS MANUFACTURED IN TAKAOKA, TOYAMA, JAPAN

21682 A

II

6/5/2008

GLOCHEM INDUSTRIES LTD

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21683 I

III

6/5/2008

ROHM AND HAAS CO

ADCOTE 548E AND COREACTANT F AS MANUFACTURED IN RINGWOOD, IL

21684 I

IV

6/6/2008

21685 A

IV

6/6/2008

21686 I

II

5/4/2008

MASTERTASTE INC DBA KERRY INGREDIENTS AND 700355 NATURAL AND ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN COMMERCE, CA
FLAVOURS
CAPSUGEL
EMPTY HARD CAPSULES FROM HYDROXYPROPYLMETHYLCELLULOSE (HYPROMELLOSE) AS
MANUFACTURED IN GREENWOOD, SC
ZHEJIANG SUPOR PHARMACEUTICALS CO LTD
QUETIAPINE FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, R.P. CHINA

21687 I

II

6/11/2008

SIFAVITOR SRL

KETOTIFEN AS MANUFACTURED IN FRAZIONE MAIRANO, ITALY

21688 A

II

6/7/2008

AUROBINDO PHARMA LTD

21689 A

II

7/23/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

VALACYCLOVIR HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
SODIUM BICARBONATE (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA

21690 A

II

6/27/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

MPEP (MEROPENEM INTERMEDIATE) AS MANUFACTURED IN MAHARASHTRA, INDIA

21691 I

II

6/12/2008

CARDINAL HEALTH 414 LLC

FLUOROMISONIDAZOLE F 18 INJECTION AS MANUFACTURED IN DUBLIN, OHIO

21692 A

II

6/7/2008

ERREGIERRE SPA

CHENODEOXYCHOLIC ACID AS MANUFACTURED IN BERGAMO, ITALY

21693 A

II

5/28/2008

MSN LABORATORIES LTD

21694 A

II

6/12/2008

PIRAMAL ENTERPRISES LTD

KETOROLAC TROMETHAMINE USP [ROUTE CODE - 'KM'] AS MANUFACTURED IN TELANGANA,


INDIA
AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21695 A

II

4/9/2008

SOHAN HEALTHCARE PVT LTD

METFORMIN HYDROCHLORIDE EP. PB. IP. USP AS MANUFACTURED IN PUNE, INDIA

21696 A

III

5/16/2008

AMPACET CORP

110017-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN

21697 A

III

6/5/2008

BASELL POLYOLEFINE ITALIA SRL

PURELL PE 2420 F MANUFACTURED IN WESSELING, GERMANY

21698 A

II

7/25/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

CILASTATIN SODIUM (STERILE) AS MANUFACTURED IN MAHARASHATRA, INDIA

21699 A

II

7/31/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

SODIUM CARBONATE (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA

21700 A

II

6/9/2008

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

REBAMIPIDE AS MANUFACTURED IN JIANGXI PROVINCE, CHINA

21701 I

II

6/7/2008

CADILA PHARMACEUTICALS LTD

PHENYLEPHRINE TANNATE AS MANUFACTURED IN GUJARAT, INDIA

21702 A

II

6/16/2008

FORMOSA LABORATORIES INC

MONTELUKAST SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN

ALLOPURINOL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

Page 632

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21703 A
II
6/16/2008
FORMOSA LABORATORIES INC

SUBJECT
BENZONATATE AS MANUFACTURED IN TAOYUAN, TAIWAN

21704 A

II

6/13/2008

POLYPEPTIDE LABORATORIES INC

OCTREOTIDE ACETATE BY GRANULATION AS MANUFACTURED IN TORRANCE, CA

21705 A

II

7/23/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

IMIPENEM (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA

21706 I

II

6/17/2008

RANBAXY LABORATORIES LTD

EMTRICITABINE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21707 A

II

7/25/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

21708 I

II

6/19/2008

21709 A

II

7/31/2008

SIBRA PHARMACEUTICALS LTD AN ARCH


ENTERPRISE
HOSPIRA HEALTHCARE INDIA PVT LTD

IMIPENEM + CILASTATIN SODIUM (STERILE BULK) AS MANUFACTURED IN MAHARASHTRA,


INDIA
EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21710 A

II

7/31/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

MEROPENEM + SODIUM CARBONATE (STERILE BULK) AS MANUFACTURED IN


MAHARASHTRA, INDIA
MEROPENEM (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA

21711 A

II

6/3/2008

MYLAN LABORATORIES LTD

SUMATRIPTAN SUCCINATE USP AS MANUFACTURED IN TELANGANA, INDIA

21712 A

II

5/28/2008

MYLAN LABORATORIES LTD

PRAMIPEXOLE DIHYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA

21713 A

II

6/10/2008

SICHUAN XIELI PHARMACEUTICAL CO LTD

IRINOTECAN HCL AS MANUFACTURED IN SICHUAN, CHINA

21714 A

II

6/13/2008

CHEMSPEC API

BIS (3, 5-DIBROMOSALICYL) FUMARATE (DBSF) AS MANUFACTURED IN FAIRFIELD, NJ

21715 A

II

5/12/2008

TIANJIN TASLY GROUP CO LTD

ESZOPICLONE AS MANUFACTURED IN TIANJIN, CHINA

21716 A

II

6/6/2008

21717 I

II

6/6/2008

AMRI RENSSELAER INC SUB ALBANY MOLECULAR


RESEARCH INC
QILU PHARMACEUTICAL CO LTD

21718 I

III

6/2/2008

RITE SYSTEMS INC

RACEPINEPHRINE HYDROCHLORIDE, USP DRUG SUBSTANCE, AS MANUFACTURED IN


RENSSELAER , NY
TERBINAFINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE, PEOPLE'S REPUBLIC OF CHINA
WHITE, LQC-W2433-1, AS MANUFACTURED IN WEST CHICAGO, IL

21719 I

II

5/19/2008

HARIKA DRUGS PRIVATE LTD

CHLORPHENIRAMINE TANNATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21720 A

II

6/20/2008

SHASUN PHARMACEUTICALS LTD

CYCLOSERINE USP AS MANUFACTURED IN CUDDALORE, INDIA

21721 A

II

6/18/2008

ZHEJIANG SHENGHUA BIOK BIOLOGY CO LTD

PLEUROMUTILIN AS MANUFACTURED IN DEQING, ZHEJIANG, P.R. CHINA

21722 A

II

6/10/2008

DELAVAU LLC

G-0181-API GRAN CC 765/MH 158-MCN-API AS MANUFACTURED IN PHILADELPHIA, PA

21723 A

III

5/26/2008

NUOVA OMPI SRL

E-Z-FILL PRODUCTS AS MANUFACTURED IN PIOMBINO DESE (PD), ITALY

21724 A

III

6/13/2008

EQUISTAR CHEMICALS LP SUB LYONDELLBASELL

PRO-FAX ULTRA SC973 AS MANUFACTURED IN PASADENA, TX AND WEST LAKE, LA

21725 I

II

3/26/2008

THERMAX LTD CHEMICAL DIV

21726 I

II

3/17/2008

THERMAX LTD CHEMICAL DIV

21727 A

III

6/17/2008

RELIANCE INDUSTRIES LTD

TULSION 345 (CALCIUM POLYSTYRENE SULPHONATE BP) AS MANUFACTURED IN


MAHARASHTRA, INDIA
TULSION 412 CHL (CHOLESTYRAMINE RESIN USP) AS MANUFACTURED IN MAHARASHTRA,
INDIA
POLYPROPYLENE (PP), H200MA, AS MANUFACTURED IN JAMNAGAR (GUJRAT), INDIA

21728 A

IV

6/17/2008

KERRY INGREDIENTS AND FLAVOURS

NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR 0011638 AS MANUFACTURED IN CINCINNATI, OH

21729 A

IV

6/17/2008

KERRY INGREDIENTS AND FLAVOURS

ARTIFICIAL COTTON CANDY FLAVOR 0011640 AS MANUFACTURED IN CINCINNATI, OH

21730 A

IV

6/17/2008

KERRY INGREDIENTS AND FLAVOURS

NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR 0011639 AS MANUFACTURED IN CINCINNATI, OH

21731 A

IV

6/17/2008

KERRY INGREDIENTS AND FLAVOURS

21732 A

II

6/14/2008

CTX LIFE SCIENCES PVT LTD

NATURAL/ARTIFICIAL CHERRY BERRY TYPE FLAVOR 0014700 AS MANUFACTURED IN


CINCINNATI, OH
METOPROLOL SUCCINATE USP AS MANUFACTURED IN GUJARAT, INDIA

21733 A

II

6/27/2008

STERLING SPA

DROSPIRENONE AS MANUFACTURED IN PERUGIA, ITALY

21734 I

IV

6/25/2008

CIBA CORP

IRGASURF HL560 AS MANUFACTURED IN OBERNBURG, GERMANY

21735 A

III

7/2/2008

SHRIJI POLYMERS INDIA LTD

POLYPROPYLENE CLOSURES AS MANUFACTURED IN UJJAIN, INDIA

21736 A

II

6/26/2008

TORRENT PHARMACEUTICALS LTD

RABEPRAZOLE SODIUM DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA

Page 633

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21737 A
V
6/26/2008
ACS DOBFAR SPA

SUBJECT
VIALE ADDETTA PLANT - SMART PAK PLANT LOCATED IN MILANO, ITALY

21738 I

II

6/25/2008

AVANTI POLAR LIPIDS INC

21739 I

II

6/25/2008

AVANTI POLAR LIPIDS INC

1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC) AS MANUFACTURED IN


ALABASTER, AL
DICETYL PHOSPHATE AS MANUFACTURED IN ALABASTER, AL

21740 A

II

6/28/2008

MACLEODS PHARMACEUTICALS LTD

INDOMETHACIN DRUG SUBSTANCE AS MANUFACTURED IN IN GUJARAT, INDIA

21741 A

II

6/24/2008

MALLINCKRODT INC

21742 A

6/27/2008

NOVARTIS PHARMACEUTICALS CORP

COMPAP 90 (ACETAMINOPHEN USP 90% ANHYDROUS BASIS) AS MANUFACTURED IN


GREENVILLE, ILLINOIS
DRUG SUBSTANCE MANUFACTURING AT NOVARTIS BPO HUNINGUE

21743 A

II

6/27/2008

WANBURY LTD

LEVETIRACETAM AS MANUFACTURED IN MAHARASHTRA, INDIA

21744 A

III

6/30/2008

BD MEDICAL PHARMACEUTICAL SYSTEMS

21745 A

II

6/30/2008

RELIABLE BIOPHARMACEUTICAL CORP

BD UNIJECT PREFILLABLE INJECTION SYSTEM AS MANUFACTURED BY BD MEDICAL SYSTEM


PTE, LTD IN SINGAPORE
CHLOROTHIAZIDE, USP AS MANUFACTURED IN ST.LOUIS, MO

21746 A

II

6/6/2008

LIANYUNGANG JARI PHARMACEUTICAL CO LTD

21747 A

II

6/27/2008

ZACH SYSTEM SPA

21748 A

6/24/2008

COGNATE BIOSERVICES INC

21749 A

II

7/1/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

21750 A

II

6/27/2008

EDMOND PHARMA

PALONOSETRON HCL AS MANUFACTURED BY IVAX PHARMACEUTICAL S.R.O. IN CZECH


REPUBLIC FOR TECA PHARMACEUTICAL INDUSTRIES, LTD.
TULOBUTEROL BASE AS MANUFACTURED IN PADERMO DUGNANO (MI), ITALY

21751 A

II

7/18/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

21752 A

II

7/21/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

DULOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

21753 A

II

7/19/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

ROSIGLITAZONE MALEATE ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA

21754 I

II

6/27/2008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

IRBESARTAN AS MANUFACTURED IN ZHEJIANG, CHINA

21755 A

II

6/23/2008

PHARMA MAR SA

TRABECTEDIN AS MANUFACTURED IN MADRID, SPAIN

21756 A

II

7/1/2008

CAMBREX CHARLES CITY INC

NICOTINE RESINATE, 20% AS MANUFACTURED IN CAMBREX CITY, IA

21757 I

II

6/5/2008

OLON SPA

TAMOXIFEN CITRATE AS MANUFACTURED IN MULAZZANO (LO), ITALY

21758 A

II

7/1/2008

RPG LIFE SCIENCES LTD

MERCAPTOPURINE USP AS MANUFACTURED IN MUMBAI, INDIA

21759 A

II

6/30/2008

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

21760 A

IV

6/30/2008

SYMRISE INC

CAPREOMYCIN SULFATE CONCENTRATE AS MANUFACTURED IN TAIZHOU CITY, ZHEJIANG


PROVINCE, PEOPLE'S REPUBLIC OF CHINA
992890 ARTIFICIAL GRAPE FLAVOR 605935 AS MANUFACTURED IN TETERBORO, NJ

21761 A

II

7/3/2008

SHANGHAI AJINOMOTO AMINO ACID CO LTD

L-LEUCINE AS MANUFACTURED IN SHANGHAI, CHINA

21762 A

II

7/3/2008

ASPEN OSS BV

NANDROLONE DECANOATE AS MANUFACTURED IN OSS, THE NETHERLANDS

21763 A

II

9/30/2008

CIPLA LTD

LAMIVUDINE (PROCESS 3) AS MANUFACTURED IN MAHARASHTRA, INDIA

21764 A

II

9/30/2008

CIPLA LTD

LAMIVUDINE (PROCESS 2) AS MANUFACTURED IN MAHARASHTRA, INDIA

21765 A

II

6/26/2008

21766 A

III

6/1/2008

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO AMIFOSTINE AS MANUFACTURED IN JIANGSU, CHINA


LTD
JAMNADAS INDUSTRIES
ALUMINUM FLIP OFF SEALS AS MANUFACTURED IN GUJARAT, INDIA

21767 A

II

6/27/2008

AUROBINDO PHARMA LTD

21768 A

II

7/2/2008

SIEGFRIED LTD

DULOXETINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
FLUOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND

21769 I

II

6/18/2008

FIS FABBRICA ITALIANA SINTETICI SPA

FIS1174 AS MANUFACTURED IN VICENZA, ITALY

21770 A

III

7/3/2008

BESPAK DIV CONSORT MEDICAL PLC

BESPAK BK851 GSK DOSE COUNTER AS MANUFACTURED IN NORFOLK, ENGLAND

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN LIANYUNGANG CITY


CHINA
LEVETIRACETAM AS MANUFACTURED BY MALLADI DRUGS & PHARMACEUTICALS LIMITED IN
TAMIL NADU , INDIA FOR ZACH SYSTEM S P A
CONTRACT MANUFACTURING FACILITIES

Page 634

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21771 A
III
7/4/2008
RELIANCE INDUSTRIES LTD

SUBJECT
RELENE F46003 AS MANUFACTURED IN SURAT (GUJARAT), INDIA

21772 A

III

7/4/2008

RELIANCE INDUSTRIES LTD

RELENE F19010 AS MANUFACTURED IN SURAT (GUJARAT), INDIA

21773 A

II

7/3/2008

PKC PHARMACEUTICALS INC

RESINIFERATOXIN AS MANUFACTURED IN WOBURN, MA

21774 A

II

6/30/2008

DOLDER AG

21775 A

II

7/8/2008

HOVIONE FARMACIENCIA SA

FLUOROURACIL AS MANUFACTURED BY CHEMISCHE FABRIK BERG BITTERFIELD GMBH IN


GERMANY FOR DOLDER AG
05ST03P AS MANUFACTURED IN LOURES, PORTUGAL

21776 I

III

6/30/2008

MATRIX PACKAGING INC

PACKAGING MATERIAL AS MANUFACTURED IN CHATSWORTH, CA

21777 A

II

6/27/2008

JOINT STOCK CO GRINDEKS

OXYTOCIN, USP DRUG SUBSTANCE AS MANUFACTURED IN RIGA, LATVIA

21778 A

III

7/1/2008

CHARTER NEX FILMS INC

GRADE NXSLC70E AS MANUFACTURED IN RHINELANDER, WI

21779 A

II

7/8/2008

VASUDHA PHARMA CHEM LTD

CYCLOBENZAPRINE HCL AS MANUFACTURED IN HYDERABAD, INDIA

21780 A

II

5/28/2008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

IRBESARTAN AS MANUFACTURED IN ZHEJIANG, CHINA

21781 A

II

7/8/2008

DR REDDYS LABORATORIES LTD

21782

II

6/26/2008

ZHEJIANG SANHE PHARMACHEM CO LTD

21783 A

IV

6/25/2008

FMC CORP FMC BIOPOLYMER DIV

21784 A

IV

7/11/2008

CAPSUGEL

RIVASTIGMINE HYDROGEN TARTRATE (PROCESS II) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
MONOALDEHYDE (3-[2-(7-CHLORO-QUINOLIN-2-YL)-VINYL]-BENZALDEHYDE) AS
MANUFACTURED IN ZHEJIANG, CHINA
AVICEL HFE MICROCRYSTALLINE CELLULOSE AND MANNITOL AS MANUFACTURED IN
NEWARK, DE
VCAPS/VCAPS PLUS AS MANUFACTURED IN KANAGAWA PREFACTURE, JAPAN

21785 A

III

7/9/2008

TOYO INK MFG CO LTD

GRAVURE INK "LAMISTAR" SERIES AS MANUFACTURED IN TOKYO, JAPAN

21786 A

II

7/11/2008

NATCO PHARMA LTD

ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21787 I

II

6/18/2008

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

21788 A

II

7/10/2008

NIPPON RIKA CO LTD

7-AMINO CEPHALOSPORANIC ACID (7-ACA) AS MANUFACTURED IN SHANDONG PROVINCE,


CHINA
L-TYROSINE DRUG SUBSTANCE AS MANUFACTURED IN TOCHIGI, JAPAN

21789 A

II

7/10/2008

NIPPON RIKA CO LTD

ACETYLCYSTEINE DRUG SUBSTANCE AS MANUFACTURED IN TOCHIGI, JAPAN

21790 A

II

6/24/2008

INKE SA

GRANISETRON BASE AS MANUFACTURED IN CASTELLBISBAL (BARCELONA), SPAIN

21791 A

II

7/11/2008

CRYSTAL PHARMA SAU

21792 A

III

7/4/2008

RELIANCE INDUSTRIES LTD

21793 A

II

7/14/2008

CADILA HEALTHCARE LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN BEOCILLO


(VALLADOLID), SPAIN
POLYPROPYLENE (PP), GRADE: REPOL H200MK AS MANUFACTURED IN HAZIRA (GUJRAT),
INDIA
OMEPRAZOLE USP (FORM-B) AS MANUFACTURED IN GUJARAT, INDIA

21794 I

II

7/14/2008

NIFELINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

21795 A

II

7/9/2008

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD


CHUANNAN BRANCH
COVALENT LABORATORIES PRIVATE LTD

21796 A

II

7/9/2008

PROCOS SPA

PIVAGABINE AS MANUFACTURED IN CAMERI (NO), ITALY

21797 A

III

7/3/2008

MICRODYNE PLASTICS INC

21798 A

II

7/8/2008

CELSUS LABORATORIES INC

ENOXAPARIN SODIUM AS MANUFACTURED IN CINCINNATI, OHIO

21799 A

III

6/25/2008

PROENFAR SA

21800 A

II

6/30/2008

ALEMBIC PHARMACEUTICALS LTD

LDPE CONTAINERS FOR LIQUID OPHTHALMIC PRODUCTS REFERENCES 037E, 040E, CAP
140T, AND DROPTAINER 126S AS MANUFACTURED IN BOGOTA, COLOMBIA
RIVASTIGMINE TARTRATE AS MANUFACTURED IN GUJARAT, INDIA

21801 A

II

7/15/2008

21802 I

II

7/17/2008

CHONGQING SHENGHUAXI PHARMACEUTICAL CO


LTD
AVANTI POLAR LIPIDS INC

CEFUROXIME ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA

BLOW MOLDED POLYETHYLENE OR POLYPROPYLENE PACKAGING MATERIAL OR CONTAINER

DULOXETINE HCL AS MANUFACTURED IN CHONGQING, CHINA


1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-(BIOTINYL) (SODIUM SALT)
(16:0 BIOTINYL PE) AS MANUFACTURED IN ALABASTER, AL

Page 635

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21803 A
II
7/17/2008
HOVIONE FARMACIENCIA SA
21804 N

SUBJECT
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN LOURES, PORTUGAL

NOT AN ASSIGNED NUMBER

21805 A

II

7/15/2008

CSPC OUYI PHARMACEUTICAL CO LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN HEBEI, CHINA

21806 A

II

7/28/2008

PHF SA

THALIDOMIDE AS MANUFACTURED IN OLAINE, LATVIA FOR PHF SA

21807 A

II

7/14/2008

OLON SPA

ACAMPROSATE CALCIUM AS MANUFACTURED IN MULAZZANO (LO), ITALY

21808 A

II

7/16/2008

CHEMWERTH INC

21809 I

II

6/18/2008

SHANDONG KEYUAN PHARMACEUTICAL CO LTD

21810 I

IV

7/11/2008

MASON CHEMICAL CO

TACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED BY FUJIAN KERUI


PHARMACEUTICAL CO., LTD. IN FUJIAN PROVINCE, CHINA FOR CHEMWERTH, INC
DILUTED ISOSORBIDE MONONITRATE (DRUG SUBSTANCE, NON-STERILE) AS
MANUFACTURED IN SHANDONG PROVINCE, CHINA
MACAT LB AS MANUFACTURED IN ARLINGTON HEIGHTS, IL

21811 A

III

7/16/2008

RELIANCE INDUSTRIES LTD

POLYETHYLENE (PE), GRADE: 22FA002 AS MANUFACTURED IN GUJARAT, INDIA

21812 A

III

7/16/2008

RELIANCE INDUSTRIES LTD

POLYETHYLENE (PE), GRADE: 24FS040 AS MANUFACTURED IN GUJARAT, INDIA

21813 A

III

7/16/2008

RELIANCE INDUSTRIES LTD

POLYETHYLENE (PE), GRADE: 1005FY20 AS MANUFACTURED IN GUJARAT, INDIA

21814 A

III

7/16/2008

RELIANCE INDUSTRIES LTD

POLYETHYLENE (PE), GRADE:16MA400 AS MANUFACTURED IN GUJARAT, INDIA

21815 I

II

7/18/2008

SANOFI AVENTIS US LLC

EPLIVANSERIN HEMIFUMARATE AS MANUFACTURED IN ARAMON, FRANCE

21816 I

II

7/18/2008

ORPEGEN PHARMA

TLN-232 DRUG SUBSTANCE AS MANUFACTURED IN HEIDELBERG, GERMANY

21817 A

IV

7/23/2008

PURAC BIOCHEM BV

21818 I

II

7/10/2008

HTI TECHNOLOGIES

21819 A

II

7/18/2008

APOTEX PHARMACHEM INC

PURASORB POLYMERS AS MANUFACTURED BY PURAC BIOMATERIALS IN GORINCHEM, THE


NETHERLANDS FOR PURAC BIOCHEM BV
HYDROXYAPATITE COATINGS WITH PURE TITANIUM BOND COAT AS MANUFACTURED IN
DECINES, FRANCE
RISEDRONATE SODIUM HEMIPENTAHYDRATE AS MANUFACTURED IN ONTARIO, CANADA

21820 I

II

7/17/2008

MALLINCKRODT INC

6-BETA-NALTREXOL HYDROCHLORIDE AS MANUFACTURED IN ST LOUIS, MO

21821 A

II

7/23/2008

CAMBREX CHARLES CITY INC

SUFENTANIL AS MANUFACTURED IN CHARLES CITY, IA

21822 A

II

7/24/2008

NEWCHEM SPA

PREDNISOLONE SODIUM PHOSPHATE AS MANUFACTURED IN VERONA, ITALY

21823 A

III

7/9/2008

RUBBER STOPPER AS MANUFACTURED IN BEIJING, P.R. CHINA

21824 A

II

7/28/2008

SENXING PHARMACEUTICAL CONSUMABLE


BEIJING LTD
SHASUN PHARMACEUTICALS LTD

21825 I

III

7/25/2008

POLIMERI EUROPA SPA

FLEXIRENE MS 20 AS MANUFACTURED IN DUNKERQUE (FRANCE)

21826 I

II

7/28/2008

MENADIONA SL

QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN

21827 A

II

7/28/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

DULOXETINE HCL AS MANUFACTURED IN BEER SHEVA, ISRAEL

21828 A

II

7/10/2008

LAKE CHEMICALS PRIVATE LTD

ALPRAZOLAM AS MANUFACTURED IN BANGALORE, KARNATAKA, INDIA

21829 A

III

7/22/2008

HYDRO ALUMINIUM ROLLED PRODUCTS GMBH

21830 A

II

7/28/2008

ICROM SPA

HARP 506/1 AND 506/2 DRUG PACKAGING MATERIALS AS MANUFACTURED IN


GREVENBROICH, GERMANY
EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN CONCOREZZO (MILAN), ITALY

21831 A

III

7/28/2008

KB SEIREN LTD

H20N AS MANUFACTURED IN SHIGA PREFECTURE, JAPAN

21832 A

III

7/28/2008

KB SEIREN LTD

H20N-TU22 AS MANUFACTURED IN SHIGA PREFECTURE, JAPAN

21833 A

II

7/30/2008

SIGNA SA DE CV

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TOLUCA, MEXICO

21834 A

II

7/29/2008

ISOCHEM SAS

NEFOPAM HYDROCHLORIDE AS MANUFACTURED IN PARIS, FRANCE

21835 A

II

7/24/2008

BAXTER PHARMACEUTICALS SOLUTIONS LLC

0.9% SODIUM CHLORIDE DILUENT, USP AS MANUFACTURED IN BLOOMINGTON, IN

21836 A

II

7/29/2008

MEDICHEM MANUFACTURING MALTA LTD

MED-200448/M AS MANUFACTURED IN HAL FAR, MALTA

21837 A

II

7/28/2008

ESTEVE QUIMICA SA

LEVETIRACETAM INJECTABLE GRADE/NON-STERILE AS MANUFACTURED IN CELRA (GIRONA)


SPAIN

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE, INDIA

Page 636

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21838 I
II
7/30/2008
RANBAXY LABORATORIES LTD

SUBJECT
DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA

21839 I

II

5/30/2008

SYNTHESIA AS

ERGOCALCIFEROL AS MANUFACTURED IN SEMTIN, CZECH REPUBLIC

21840 A

III

6/27/2008

AMPACET CORP

AMPACET 19258-A- BLACK COP MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN

21841 A

II

7/31/2008

CRYSTAL PHARMA SAU

21842 I

II

7/9/2008

ZHEJIANG ANGLIKANG PHARMACEUTICAL CO LTD

21843 A

IV

7/23/2008

COGNIS GMBH

HYDROCORTISONE BUTYRATE, MICRONIZED AS MANUFACTURED IN BOECILLO


(VALLADOLID), SPAIN
CEFALEXIN MONOHYDRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN
SHENGZHOU, ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA
MONOMULS 90-L 12 AS MANUFACTURED IN DUESSELDORF, GERMANY

21844 A

II

9/29/2008

H LUNDBECK AS

21845 A

II

7/30/2008

AUROBINDO PHARMA LTD

21846 A

IV

8/1/2008

SYMRISE AG

LU AA24530 HYDROBROMIDE AS MANUFACTURED IN NYKOEBING SJ., DENMARK; BALERNA,


SWITZERLAND; VALBY, DENMARK
VALSARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
FRUIT PUNCH FLAVOUR SD 204264 AS MANUFACTURED IN HOLZMINDEN, GERMANY

21847 A

IV

8/1/2008

SYMRISE GBMH CO KG

NATURAL PEPPERMINT FLAVOR 290017 AS MANUFACTURED IN HOLZMINDEN, GERMANY

21848 A

II

7/30/2008

TAIYO NIPPON SANSO CORP

WATER-18O AS MANUFACTURED IN CHIBA, JAPAN

21849 A

III

7/31/2008

SABIC PETROCHEMICALS BV

SABIC LDPE PCG80 AS MANUFACTURED IN GELEEN, THE NETHERLANDS

21850 A

II

8/1/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN PETAH TIQVA, ISRAEL

21851 A

II

8/1/2008

TRIFARMA SPA

EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN CERIANO LAGHETTO (MI), ITALY

21852 A

II

7/31/2008

ROLABO OUTSOURCING SL

DOLASETRON MESYLATE AS MANUFACTURED IN ZARAGOZA, SPAIN

21853 A

II

8/4/2008

GLENMARK GENERICS LTD

ESZOPICLONE AS MANUFACTURED IN GUJARAT STATE, INDIA

21854 A

IV

7/30/2008

NECTAR LIFESCIENCES LTD

MENTHOL USP AS MANUFACTURED IN MOHALI (PUNJAB), INDIA

21855 A

III

7/24/2008

SHANDONG PHARMACEUTICAL GLASS CO LTD

21856 A

III

7/24/2008

SHANDONG PHARMACEUTICAL GLASS CO LTD

21857 I

II

8/1/2008

MEDICHEM MANUFACTURING MALTA LTD

BOROSILICATE GLASS (USP TYPE I) BARRELS FOR INJECTABLES FOR PREFILLED SYRINGES
AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA
BOROSILICATE GLASS (USP TYPE I) CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE AS
MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA
MED-201570/M AS MANUFACTURED IN HAL FAR, MALTA

21858 A

II

7/29/2008

BIOCON LTD

ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN BANGALORE, INDIA

21859 A

II

8/5/2008

MYLAN LABORATORIES LTD

SALMETEROL XINAFOATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21860 A

II

7/24/2008

CENTAUR PHARMACEUTICALS PRIVATE LTD

DIAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21861 A

II

7/25/2008

SAVIOR LIFETEC CORP

21862 A

II

8/6/2008

SEQUENT SCIENTIFIC LTD

MEROPENEM AND SODIUM CARBONATE (STERILE BULK) AS MANUFACTURED IN TAIWAN,


R.O.C.
METHOXSALEN USP AS MANUFACTURED IN KARNATAKA, INDIA

21863 A

II

8/4/2008

EXCELLA GMBH

BICALUTAMIDE MILLED Z AS MANUFACTURED IN FEUCHT, GERMANY

21864 A

II

8/5/2008

IWAKI SEIYAKU CO LTD

CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN SHIZUOKA, JAPAN

21865 A

II

9/26/2008

WATSON PHARMA PRIVATE LTD

METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21866 A

II

8/7/2008

AARTI INDUSTRIES LTD

RANOLAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA

21867 A

III

7/23/2008

AMPACET CORP

21868 A

II

7/5/2008

ISOCHEM

AMPACET 172954 LIME GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN


TERRE HAUTE, IN
BUFLOMEDIL HYDROCHLORIDE AS MANUFACTURED IN PARIS, FRANCE

21869 I

II

8/8/2008

NOVARTIS PHARMACEUTICALS CORP

SMT487 ACETATE (EDOTREOTIDE) AS MANUFACTURED IN BASEL, SWITZERLAND

21870 A

II

7/25/2008

KAKEN PHARMACEUTICAL CO LTD

KP-103/B AS MANUFACTURED IN YAMAGATA, JAPAN

21871 A

IV

7/28/2008

DOW CORNING CORP

SILASTIC 7-6840 BIOMEDICAL GRADE LIQUID SILICONE RUBBER AS MANUFACTURED IN


HEMLOCK, MI

Page 637

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21872 A
III
7/30/2008
GERRESHEIMER PLASTICOS SAO PAULO LTDA

SUBJECT
BOTTLES AS MANUFACTURED IN SAO PAULO, BRAZIL

21873 I

IV

8/11/2008

FONA INTERNATIONAL INC

827.014 NAT CINNAMON FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL

21874 I

III

7/21/2008

YONWOO CORP

AS30-J/PP AND AS50-J/PP AS MANUFACTURED IN INCHEON, KOREA

21875 I

III

7/21/2008

YONWOO CORP

AS30/50-J/PP JAR AS MANUFACTURED IN INCHEON, KOREA

21876 A

II

10/31/2008

ABBVIE INC

NIACIN CORE TABLET INTERMEDIATE AS MANUFACTURED IN PUERTO RICO

21877 A

II

8/12/2008

ALMATICA PHARMA INC

21878 I

II

8/14/2008

BASIC PHARMA LIFE SCIENCE PVT LTD

NAPRELAN (NAPROXEN SODIUM) CONTROLLED-RELEASE TABLETS, 375MG, 500MG, 750MG


AS MANUFACTURED IN WESTMEATH, IRELAND
CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA

21879 A

II

8/12/2008

CORAL DRUGS PVT LTD

FLUTICASONE PROPIONATE AS MANUFACTURED IN HARYANA, INDIA

21880 A

II

8/14/2008

FORMOSA LABORATORIES INC

PARICALCITOL AS MANUFACTURED IN TAOYUAN, TAIWAN

21881 A

III

8/1/2008

POLYCINE GMBH

APP107 TUBE AS MANUFACTURED IN SCHIFFWEILER, GERMANY

21882 A

IV

8/15/2008

HENKEL CORP

DURO-TAK 87-613A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

21883 A

II

8/13/2008

APICORE US LLC

ISOSULFAN BLUE AS MANUFACTURED IN SOMERSET, NJ

21884 A

II

7/30/2008

POLYDRUG LABORATORIES PVT LTD

METOPROLOL SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21885 A

III

7/7/2008

STYROLUTION EUROPE GMBH

LURAN R HD 20 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

21886 A

II

8/14/2008

PHARMAZELL INDIA PRIVATE LTD

L-CYSTINE AS MANUFACTURED IN CHENNAI, INDIA

21887 A

II

8/5/2008

FIS FABBRICA ITALIANA SINTETICI SPA

NITROFURANTOIN MONOHYDRATE (CODE 1042) AS MANUFACTURED IN VICENZA (ITALY)

21888 A

III

8/6/2008

3M INDUSTRIAL ADHESIVES TAPE DIV

PB009150 AS MANUFACTURED IN MEDINA, OH

21889 A

III

8/15/2008

3M INDUSTRIAL ADHESIVES TAPE DIV

FP036002 AS MANUFACTURED IN MEDINA, OH

21890 A

III

8/1/2008

SOLVIN SA

DIOFAN A-740 AS MANUFACTURED IN TAVAUX, FRANCE

21891 I

II

8/12/2008

21892 A

II

8/18/2008

TIANJIN PACIFIC CHEMICAL AND


PHARMACEUTICAL CO LTD
MSN PHARMACHEM PVT LTD

21893 I

II

8/14/2008

UNIMARK REMEDIES LTD

METFORMIN HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED


IN TIANJIN, CHINA
ATORVASTATIN CALCIUM USP (FORM-I) [ROUTE CODE - AC1] AS MANUFACTURED IN
TELANGANA, INDIA
MONTELUKAST SODIUM (NI) AS MANUFACTURED IN VALSAD, GUJARAT, INDIA

21894 A

II

8/20/2008

SANDOZ INDUSTRIAL PRODUCTS SPA

21895 A

II

8/8/2008

OLON SPA

MYCOPHENOLIC ACID, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ROVERETO


(TRENTO), ITALY
FLUOXETINE HCL EP/USP AS MANUFACTURED IN GARBAGNATE MILANESE (MI), ITALY

21896 A

II

8/13/2008

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

CLINDAMYCIN PALMITATE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA

21897 I

IV

8/11/2008

MASTERTASTE SPA

58.4108.UL PHA ORANGE FLAVOUR AS MANUFACTURED IN TORINO, ITALY

21898 A

III

8/11/2008

AMPACET CORP

612249-PT WHITE PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN

21899 A

II

10/25/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

21900 A

II

9/27/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN GUJARAT,


INDIA
TAMSULOSIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

21901 A

II

9/28/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

ANASTROZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21902 I

II

8/21/2008

STAVUDINE USP AS MANUFACTURED IN HARYANA, INDIA

21903 I

IV

8/20/2008

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
MASTERTASTE SPA

21904 I

IV

8/20/2008

MASTERTASTE SPA

20.4562.4P PHA ORANGE FLAVOUR AS MANUFACTURED IN TORINO, ITALY

21905 A

III

8/21/2008

NYPRO INC

METERED DOSE INHALER, CONTAINER CLOSURE FOR: PRESS AND BREATH CAPPED
ACTUATOR AS MANUFACTURED IN BRAY, COUNTY DUBLIN, IRELAND

30109.1 DRYCELL CITRON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY

Page 638

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21906 I
II
7/30/2008
ONO PHARMACEUTICAL CO LTD
21907 A

II

8/21/2008

CONCORD BIOTECH LTD

SUBJECT
PROSTAGLANDIN E1 AS MANUFACTURED IN HYOGO, JAPAN BY FUJIMOTO CHEMICALS CO.,
LTD. FOR ONO PHARMACEUTICAL
MYCOPHENOLATE SODIUM AS MANUFACTURED IN AHMEDABAD, INDIA

21908 I

III

8/14/2008

RICON COLORS INC

GREEN TINT, CPT-G4366-1 AS MANUFACTURED IN WEST CHICAGO, IL

21909 I

II

8/11/2008

INDOCO REMEDIES LTD

CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, INDIA

21910 A

II

8/27/2008

HETERO DRUGS LTD

21911 A

II

8/27/2008

CALYX CHEMICALS AND PHARMACEUTICALS LTD

DORZOLAMIDE HYDROCHLORIDE ( PROCESS I ) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
LOSARTAN POTASSIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21912 A

II

8/28/2008

APOTEX PHARMACHEM INC

21913 A

II

8/28/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

21914 A

II

10/18/2008

21915 I

II

8/27/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD LOSARTAN POTASSIUM (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA,
INDIA
KAMUD DRUGS PVT LTD
TRAMADOL HYDROCHLORIDE BP AS MANUFACTURED IN MAHARASHTRA, INDIA

21916 A

III

8/19/2008

AMPACET CORP

682240-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN

21917 A

II

8/29/2008

LAURUS LABS PRIVATE LIMITED

CISPLATIN USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21918 A

II

8/29/2008

LAURUS LABS PRIVATE LTD

CARBOPLATIN USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21919 I

II

8/27/2008

ELDER PHARMACEUTICALS LTD

CLARITHROMYCIN FORM II AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

21920

II

9/2/2008

MARTEK BIOSCIENCES CORP

21921 A

II

9/2/2008

DR REDDYS LABORATORIES LTD

DOCOSAHEXAENOIC ACID ACTIVE SINGLE CELL OIL (DHASCO) 55% AS MANUFACTURED IN


KINGSTREE, SC AND WINCHESTER, KY
CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21922 A

IV

8/29/2008

21923 A

II

8/29/2008

CYCLOLAB CYCLODEXTRIN R AND D LABORATORY BETA-CYCLODEXTRIN-SULFOBUTYLETHER DERIVATIVE AS MANUFACTURED IN BUDAPEST,


LTD
HUNGARY
WOCKHARDT LTD
DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

21924 I

II

8/29/2008

NITTO DENKO CORP

DPC 1528 (OLIGONUCLEOTIDE ARM), API, AS MANUFACTURED IN MILFORD, MA

21925 I

II

8/25/2008

NUTRA SPECIALITIES PRIVATE LTD

WARFARIN SODIUM USP (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21926 I

II

8/25/2008

NUTRA SPECIALITIES PRIVATE LTD

WARFARIN SODIUM USP (CLATHRATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21927 I

II

11/19/2008

CIPLA LTD

IMIQUIMOD AS MANUFACTURED IN MAHARASHTRA, INDIA

21928 A

II

8/29/2008

CARDINAL HEALTH 414 LLC

SODIUM FLUORIDE F18 INJECTION AS MANUFACTURED IN DUBLIN, OH

21929 I

II

9/1/2008

SYNBIAS PHARMA LTD

VINORELBINE TARTRATE AS MANUFACTURED IN DONETSK, UKRAINE

21930 I

II

10/23/2008

ACCORD HEALTHCARE INC

21931 A

II

9/4/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

DOCETAXEL TRIHYDRATE API AS MANUFACTURED BY CAMBREX CHARLES CITY, INC IN


CHARLES CITY, IA FOR BIOXEL PHARMA INC
OLMESARTAN MEDOXOMIL AS MANUFACTURED IN MANALPUR, INDIA

21932 I

II

8/25/2008

6 AMINOPENCILLANIC ACID AS MANUFACTURED IN NANGANG, HARBIN

21933 A

III

8/31/2008

HARBIN PHARMACEUTICAL GROUP CO LTD


GENERAL PHARMACEUTICAL FACTORY
FUJIMORI KOGYO CO LTD

21934 A

II

9/2/2008

AUROBINDO PHARMA LTD

21935 A

II

9/5/2008

CADILA HEALTHCARE LTD

GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
CLONIDINE AS MANUFACTURED IN GUJARAT, INDIA

21936 A

II

9/26/2008

RA CHEM PHARMA LTD

VANILLYLAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21937 A

II

9/20/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ARIPIPRAZOLE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA

21938 A

II

10/18/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API) AS MANUFACTURED IN
MAHARASHTRA, INDIA

PANTOPRAZOLE SODIUM SESQUIHYDRATE USP AS MANUFACTURED IN BRANTFORD,


ONTARIO, CANADA
EPTIFIBATIDE AS MANUFACTURED IN NETANYA, ISRAEL

FILMBYNA**E-5511 BD AS MANUFACTURED IN SHIZUOKA PREF., JAPAN

Page 639

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21939 A
II
9/5/2008
BOEHRINGER INGELHEIM PHARMA GMBH AND CO
KG
21940 A
V
9/2/2008
AZBIL NORTH AMERICA BIOVIGILANT DIV

SUBJECT
TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGELHEIM AM RHEIN,
GERMANY
IMD-A 300 AS MANUFACTURED IN TUCSON, AZ

21941 A

II

9/4/2008

POLYDRUG LABORATORIES PVT LTD

METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21942 I

II

9/1/2008

ALP PHARM BEIJING CO LTD

4-AA/AOSA AS MANUFACTURED IN BEIJING, CHINA

21943 A

II

9/1/2008

ALP PHARM BEIJING CO LTD

CALCIPOTRIENE (CALCIPOTRIOL) AS MANUFACTURED IN BEIJING, CHINA

21944 A

II

9/8/2008

MIFEPRISTONE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA

21945 I

III

9/5/2008

21946 A

II

3/10/2008

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO


LTD
BOEHRINGER INGELHEIM PHARMA GMBH AND CO
KG
RN LABORATORIES PVT LTD

21947 I

II

9/8/2008

RANBAXY LABORATORIES LTD

OLANZAPINE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA

21948 I

II

9/1/2008

MELOXICAM USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA

21949 I

II

9/1/2008

SICHUAN SANCHINE SUNNYHOPE


PHARMACEUTICAL CO LTD
ALP PHARM BEIJING CO LTD

21950 I

II

9/1/2008

ALP PHARM BEIJING CO LTD

21951 I

II

9/1/2008

ALP PHARM BEIJING CO LTD

21952 A

II

9/5/2008

FORMOSA LABORATORIES INC

21953 A

II

9/5/2008

DK PHARMA CHEM PVT LTD

ALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING,


CHINA
DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING,
CHINA
AMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING,
CHINA
MYCOPHENOLIC ACID AS MANUFACTURED BY GLORY BIOTECH CO., LTD. IN CHIA-YI HSIEN,
TAIWAN FOR FORMOSA LABORATORIES, INC.
HYDRALAZINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21954 I

II

10/1/2008

CIPLA LTD

TORSEMIDE USP AS MANUFACTUREDIN MAHARASHTRA, INDIA

21955 I

II

9/5/2008

PIERRE FABRE MEDICAMENT PRODUCTION 2

VINFLUNINE INJECTION AS MANUFACTURED BY PLANTES & INDUSTRIE IN GAILLAC CEDEX,


FRANCE FOR PIERRE FABRE MEDICAMENT PRODUCTION - AQUITAINE PHARM
INTERNATIONAL

21956 A

III

9/5/2008

KUNSTSTOFFWERK KREMSMUNSTER GMBH

21957 I

III

8/29/2008

MONDI COATING ZELTWEG GMBH

PP28 CHILD RESISTANT TAMPER-EVIDENT SCREW CAPS WITH FILLED DESICCANT-INSERT AS


MANUFACTURED IN KREMSUMUNSTER, AUSTRIA
FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN ZELTWEG, AUSTRIA

21958 A

II

9/5/2008

MYLAN LABORATORIES LTD

LANTHANUM CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21959 A

II

8/15/2008

AMERICAN PEPTIDE CO

COSYNTROPIN TFA SALT PEPTIDE AS MANUFACTURED IN VISTA, CA

21960 I

II

8/26/2008

CADILA PHARMACEUTICALS LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA

21961 A

II

9/4/2008

ANQIU LUAN PHARMACEUTICAL CO LTD

21962 I

II

9/9/2008

CADILA PHARMACEUTICALS LTD

ACETAMINOPHEN DC 90 6 AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S


REPUBLIC OF CHINA
NATEGLINIDE FORM B AS MANUFACTURED IN GUJARAT, INDIA

21963 A

II

9/5/2008

DISHMAN NETHERLANDS BV

CALCIFEDIOL AS MANUFACTURED IN WEESP, THE NETHERLANDS

21964 A

II

9/10/2008

LAURUS LABS PRIVATE LTD

EFAVIRENZ USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21965 A

III

9/5/2008

FORMOSA PLASTICS CORP USA

21966 A

II

12/3/2008

CIPLA LTD

FORMOLON 690F PVC RESIN AS MANUFACTURED IN POINT COMFORT, TX AND BATON


ROUGE, LA
RANOLAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA

21967 A

II

3/26/2009

CIPLA LTD

ATAZANAVIR SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA

21968 I

II

9/5/2008

NANJING LANYA CHEMICAL CO LTD

21969 A

II

9/11/2008

MYLAN LABORATORIES LTD

MAGNESIUM LACTATE DIHYDRATE AS MANUFACTURED BY GAOYOU SUNSHINE BIOCHEM


CO., LTD. IN GAOYOU, CHINA
EFAVIRENZ USP AS MANUFACTURED IN TELANGANA, INDIA

PLASTIC CONTAINER FOR RESPIMAT(R) AS MANUFACTURED IN INGELHEIM AM RHEIN,


GERMANY
CHLORHEXIDINE GLUCONATE 20% SOLUTION AS MANUFACTURED IN GUJARAT, INDIA

Page 640

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
21970 A
II
9/12/2008
CALYX CHEMICALS AND PHARMACEUTICALS LTD

SUBJECT
VALPROIC ACID AS MANUFACTURED IN THANE, (MAHARASHTRA), INDIA

21971 A

II

9/10/2008

LUPIN LTD

FENOFIBRATE-SLS MIXTURE AS MANUFACTURED IN MAHARASHTRA, INDIA

21972 A

II

9/11/2008

FARMABIOS S P A

21973 A

III

8/12/2008

ESS DEE ALUMINIUM LTD

BECLOMETASONE DIPROPIONATE MONOHYDRATE MICRONIZED AS MANUFACTURED IN


GROPELLO CAIROLI (PV), ITALY
NON TOXIC FOOD/PHARMA GRADE ALU ALU LAMINATE, NON TOXIC FOOD/PHARMA GRADE
CHILD RESISTANT (CR) FOIL, NON TOXIC FOOD/PHARMA GRADE TROPICALISED LAMINATE AS
MANUFACTURED IN NANI DAMAN (U.T.), INDIA

21974 A

II

12/30/2008

CHEMWERTH INC

21975 A

II

10/6/2008

IPCA LABORATORIES LTD

EPINASTINE HCL AS MANUFACTURED BY SICHUAN CREDIT CHEMWERTH PHARMACEUTICAL


CO., LTD. IN SICHUAN PROVINCE, P.R. CHINA FOR CHEMWERTH, INC
INDAPAMIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

21976 A

II

9/13/2008

DR REDDYS LABORATORIES LTD

ESZOPICLONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21977 A

III

9/11/2008

NEMERA NEUENBURG GMBH

MIRENA INSERTER AS MANUFACTURED IN NEUENBURG, GERMANY

21978 A

II

9/16/2008

SMS PHARMACEUTICALS LTD

NICOTINE POLACRILEX USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

21979 A

II

10/13/2008

WATSON PHARMA PRIVATE LTD

METOPROLOL SUCCINATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

21980 A

II

9/17/2008

APOTEX PHARMACHEM INC

OLANZAPINE AS MANUFACTURED IN BRANTFORD ON, CANADA

21981 A

II

9/8/2008

FARCHEMIA SRL

OLSALAZINE SODIUM AS MANUFACTURED IN TREVIGLIO, ITALY

21982 A

II

9/10/2008

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

CEFAZOLIN SODIUM, STERILE BULK AS MANUFACTURED IN JINAN, CHINA

21983 A

II

9/17/2008

EMCURE PHARMACEUTICALS LTD

SODIUM FERRIC GLUCONATE COMPLEX AS MANUFACTURED IN MAHARASHTRA, INDIA

21984 A

II

9/16/2008

CSPC OUYI PHARMACEUTICAL CO LTD

INDOMETHACIN AS MANUFACTURED IN SHIJIAZHUANG, CHINA

21985 I

II

9/15/2008

ATORVASTATIN CALCIUM CRYSTALLINE AS MANUFACTURED IN HARYANA, INDIA

21986 I

II

1/29/2009

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
JUBILANT ORGANOSYS LTD

21987 A

II

12/5/2008

JUBILANT GENERICS LTD

MECLIZINE HYDROCHLORIDE AS MANUFACTURED IN KARNATACA, INDIA

21988 A

II

11/10/2009

JUBILANT GENERICS LTD

LANSOPRAZOLE AS MANUFACTURED IN KARNATAKA, INDIA

21989 A

II

11/26/2008

JUBILANT GENERICS LTD

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN KARNATAKA, INDIA

21990 A

II

9/26/2008

JUBILANT GENERICS LTD

PINAVERIUM BROMIDE AS MANUFACTURED IN KARNATACA, INDIA

21991 A

II

7/17/2008

L-ISOLEUCINE AS MANUFACTURED IN LIMERIA, BRAZIL

21992 A

III

9/1/2008

AJINOMOTO DO BRASIL INDUSTRIA E COMERCIO


DE ALIMENTOS LTDA
ANSA PRINTPACK PVT LTD

21993 A

II

9/15/2008

NEWCHEM SPA

PRINTED CARTONS AND PRINTED LABELS AND LEAFLETS AS MANUFACTURED IN THANE,


MAHARASHTRA, INDIA
MOMETASONE FUROATE MICRONIZED AS MANUFACTURED IN VERONA, ITALY

21994 A

II

9/16/2008

UNITED LABORATORIES CHENGDU CO LTD

6-AMINO-PENICILLANIC ACID (6-APA) AS MANUFACTURED IN SICHUAN, P.R. CHINA

21995 A

9/19/2008

GE HEALTHCARE INC

FASTLAB PET SYNTHESIZER AS MANUFACTURED IN LONCIN, BELGIUM

21996 A

9/2/2008

AZBIL NORTH AMERICA BIOVIGILANT DIV

IMD-A-350 AS MANUFACTURED IN TUCSON, AZ

21997 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-100 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

21998 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-105 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

21999 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-110 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA

Page 641

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22000 I
III
9/16/2008
TEKNOR APEX CO

SUBJECT
MEDALIST MD-115 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22001 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-120 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22002 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-125 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22003 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-130 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22004 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-135 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22005 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-140 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22006 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-145 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22007 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-150 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22008 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-155 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22009 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-160 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22010 I

III

9/16/2008

TEKNOR APEX CO

22011 I

III

9/16/2008

TEKNOR APEX CO

MEDALIST MD-165 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY


FOR TEKNOR APEX CO
MEDALIST MD-170 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22012 I

III

9/17/2008

TEKNOR APEX CO

MEDALIST MD-175 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22013 I

III

9/17/2008

TEKNOR APEX CO

MEDALIST MD-180 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO

22014 I

II

8/28/2008

JIANGSU ZW PHARMACEUTICALS CO LTD

CAPECITABINE AS MANUFACTURED IN JIANGSU, P.R. CHINA

22015 A

II

9/19/2008

JIANGSU HENGRUI MEDICINE CO LTD

22016 A

III

9/19/2008

22017 A

II

9/19/2008

22018 A

II

9/19/2008

GABAPENTIN, USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU,


CHINA
WEST PHARMACEUTICAL SERVICES INC
DAIKYO CRYSTAL ZENITH RU SYRINGE SYSTEM AS MANUFACTURED IN JERSEY SHORE, PA;
MONTGOMERY, PA; AND SAN DIEGO, CA
CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CHLOROTHIAZIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA
CO LTD
MICROBIOPHARM JAPAN CO LTD
EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN KUMAMOTO, JAPAN

Page 642

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22019 A
II
10/22/2008
JANSSEN PHARMACEUTICA NV
22020 A

II

11/12/2008

JANSSEN PHARMACEUTICA, N.V.

SUBJECT
CARISBAMAT (RWJ 333369) AS MANUFACTURED IN GEEL, BELGIUM AND SCHAFFHAUSEN,
SWITZERLAND
TRABECTEDIN (R279741) AS MANUFACTURED IN BEERSE, BELGIUM

22021 A

II

9/23/2008

DR REDDYS LABORATORIES LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22022 A

II

9/19/2008

NOVUS FINE CHEMICALS LLC

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CARLSTADT, NJ

22023 A

II

9/22/2008

22024 A

II

9/24/2008

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
DR REDDYS LABORATORIES LTD

ROPIVACAINE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN AHMEDABAD, GUJARAT,


INDIA
CARVEDILOL PHOSPHATE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22025 I

II

9/22/2008

BD BIOSCIENCES ADVANCED BIOPROCESSING

BD CELL MAB MEDIUM BASE W/O PHENYL RED AS MANUFACTURED BY BD DIAGNOSTICS AND
SAFC BIOSCIENCES IN SPARKS, MD AND DENVER, PA FOR BD BIOSCIENCES-ADVANCED
BIOPROCESSING

22026 A

II

9/26/2008

BIAL PORTELA AND CA SA

22027 A

II

9/24/2008

CADILA HEALTHCARE LTD

ESLICARBAZEPINE ACETATE DRUG SUBSTANCE AS MANUFACTURED BY DOTTIKON


EXCLUSIVE SYNTHESIS AG IN DOTTIKON, SWITZERLAND FOR BIAL PORTELA & CA SA
HYDROCHLOTHIAZIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22028 A

II

9/30/2008

RELIABLE BIOPHARMACEUTICAL CORP

COSYNTROPIN ACETATE AS MANUFACTURED IN ST. LOUIS, MO

22029 I

II

9/24/2008

IBA MOLECULAR

SODIUM [18F] FLUORIDE ([18F]NAF) FOR INJECTION AS MANUFACTURED IN STERLING, VA

22030 A

II

10/1/2008

POLYMYXIN B SULFATE AS MANUFACTURED IN HANGZHOU CHINA

22031 A

II

10/1/2008

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
DR REDDYS LABORATORIES LTD

22032 A

II

9/25/2008

MYLAN LABORATORIES LTD

ZOFENOPRIL CALCIUM AS MANUFACTURED IN RAIGAD, MAHARASHTRA, INDIA

22033 A

II

9/23/2008

CHEMWERTH INC

TIAGABINE HYDROCHLORIDE AS MANUFACTURED IN SICHUAN CHINA

22034 A

II

9/18/2008

SPECIALTY ENZYMES AND BIOCHEMICALS CO

22035 A

IV

9/1/2008

CRODA INC

LACTASE USP AS MANUFACTURED BY ADVANCED ENZYME TECHNOLOGIES LTD IN NASHIK


INDIA FOR SPECIALTY ENZYMES AND BIOCHEMICALS CO
CRODESTA SL 40E (SUCROSE COCOATE) AS MANUFACTURED IN MILL HALL PA

22036 I

II

9/23/2008

QILU TIANHE PHARMACEUTICAL CO LTD

ALPRAZOLAM USP (NON STERILE API) AS MANUFACTURED IN SHANDONG CHINA

22037 A

II

9/25/2008

DR REDDYS LABORATORIES LTD

SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22038 I

III

9/29/2008

CAPS AND CANS

PLASTIC BOTTLES AND CAPS AS MANUFACTURED IN BANGALORE, INDIA

22039 I

II

9/28/2008

QILU TIANHE PHARMACEUTICAL CO LTD

22040 A

II

9/29/2008

MALLINCKRODT INC

BUFLOMEDIL HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN SHANDONG


CHINA
BENZPHETAMINE HYDROCHLORIDE CODE 9223 AS MANUFACTURED IN ST LOUIS, MO

22041 A

II

9/24/2008

CADILA HEALTHCARE LTD

22042 A

II

10/6/2008

AARTI DRUGS LTD

PIOGLITAZONE HYDROCHLORIDE ( ESUB) AS MANUFACTURED IN ANKLESHWAR, GUJARAT,


INDIA
HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

22043 I

II

9/30/2008

CADILA HEALTHCARE LTD

CARVEDILOL (FORM II) AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA

22044 A

II

9/30/2008

DR REDDYS LABORATORIES LTD

NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22045 A

II

9/19/2008

CTX LIFE SCIENCES PVT LTD

XYLOMETAZOLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22046 A

II

10/2/2008

FORMOSA LABORATORIES INC

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN TAOYUAN TAIWAN

22047 A

II

10/1/2008

BACHEM AMERICAS INC

[N-TRANS-3-HEXENOYL] GRF (1-44), ACETATE (BULK) AS MANUFACTURED IN TORRANCE, CA

22048 A

II

10/1/2008

POLYCARBON INDUSTRIES INC

22049 A

III

9/30/2008

3M DRUG DELIVERY SYSTEMS

SODIUM 4-PHENYLBUTYRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED


IN NEWBURYPORT, MA
MOMETASONE & FORMOTEROL COMBINATION PRODUCT HFA SHORTENED BODY ACTUATOR
AS MANUFACTURED BY NYPRO INC. IN DUBLIN, IRELAND FOR 3M DRUG DELIVERY SYSTEMS
DIVISION

22050 A

II

10/2/2008

NATCO PHARMA LTD

LANTHANUM CARBONATE DIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

RABEPRAZOLE SODIUM (FORM-Y) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 643

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22051 A
III
9/26/2008
DYNIC USA

SUBJECT
S2B THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN

22052 A

III

9/26/2008

DYNIC USA

S2C THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN

22053 A

III

9/26/2008

DYNIC USA

S10 THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN

22054 A

II

10/3/2008

AARTI INDUSTRIES LTD

SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA INDIA

22055 A

III

9/30/2008

POLYONE CORP

CC10106574WE AMBER PET AS MANUFACTURED IN ELK GROVE VILLAGE, IL

22056 A

III

9/19/2008

GERRESHEIMER PLASTICOS SAO PAULO LTDA

CLOSURES AS MANUFACTURED IN SAO PAULO, BRAZIL

22057 A

II

10/1/2008

ALCHYMARS ICM SM PRIVATE LTD

ATOVAQUONE USP AS MANUFACTURED IN TAMILNADU, INDIA

22059 A

II

10/6/2008

MYLAN LABORATORIES LTD

PROGUANIL HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, MAHARASHTRA, INDIA

22060 A

II

9/30/2008

CENTAUR PHARMACEUTICALS PRIVATE LTD

OXAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22061 A

II

10/6/2008

CALYX CHEMICALS AND PHARMACEUTICALS LTD

ERYTHROMYCIN STEARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

22062 A

II

10/7/2008

SYMBIOTEC PHARMALAB LTD

BETAMETHASONE VALERATE, USP (MICRONIZED) AS MANUFACTURED IN INDORE, INDIA

22063 A

II

10/7/2008

EURAND INC

EUR 1030 MICROCAPS AS MANUFACTURED IN VANDALIA, OH

22064 A

II

9/26/2008

ALEMBIC PHARMACEUTICALS LTD

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22065 A

II

10/5/2008

DIVIS LABORATORIES LTD

KETOENAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22066 A

III

9/26/2008

COSTER USA INC

BAG-ON-VALVE (BOV) COMPONENTS AND SYSTEMS AS MANUFACTURED BY COSTER USA,


INC. AND COSTER TECHNOLGIE SPECIALI S.P.A. IN SOUTH ELGIN, IL AND CALCERANICA AL
LOGO AND CALDONAZZO, ITALY

22067 A

III

9/24/2008

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 26-2203 AS MANUFACTURED IN ADDISON, IL

22068 I

II

10/8/2008

WOCKHARDT LTD

OCTREOTIDE ACETATE AS MANUFACTURED IN MAHARASHTRA, INDIA

22069 A

II

10/8/2008

EMCURE PHARMACEUTICALS LTD

SEVELAMER HYDROCHLORIDE ( PROCESS I ) AS MANUFACTURED IN MAHARASHTRA, INDIA

22070 A

II

9/30/2008

ELDER PHARMACEUTICALS LTD

TOLFENAMIC ACID AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

22071 A

II

11/27/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ESZOPICLONE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA

22072 A

II

11/12/2008

22073 A

II

8/5/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD PANTOPRAZOLE SODIUM (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA,
INDIA
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
LOSARTAN POTASSIUM (SYNTHESIS II) AS MANUFACTURED IN ZHEJIANG, CHINA

22074 A

III

10/7/2008

AMRAZ LTD

22075 A

IV

10/10/2008

SYMRISE INC

22076 A

III

9/23/2008

AMPACET CORP

22077 A

II

10/9/2008

CHEMPORT INC

22078 A

II

10/9/2008

CHEMPORT INC

22079 A

II

10/8/2008

PROCOS SPA

60 ML PLASTIC BOTTLE FOR CAPSULES/TABLETS PACKAGING AS MANUFACTURED BY AMGAT


PLASTIC IN ASHDOD, ISRAEL FOR AMRAZ LTD.
622065 NATURAL FLAVOR, GRAPE TYPE AS MANUFACTURED IN TETERBORO, NJ AND
BRANCHBURG, NJ
AMPACET 110070 BLUE WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN
TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA
EICOSAPENTAENOIC ACID, 90% ETHYL ESTER AS MANUFACTURED IN NAJU-SI, JEOLLANAMDO, SOUTH KOREA
DOCOSAHEXAENOIC ACID, 80% ETHYL ESTER AS MANUFACTURED IN NAJU-SI, JEOLLANAMDO, SOUTH KOREA
TROSPIUM CHLORIDE AS MANUFACTURED IN CAMERI (NO), ITALY

22080 A

II

10/14/2008

EVERLIGHT CHEMICAL INDUSTRIAL CORP

BIMATOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN

22081 A

II

9/29/2008

ZACH SYSTEM SPA

22082 A

II

10/1/2008

SIEGFRIED USA LLC

CLOPIDOGREL BISULFATE AS MANUFACTURED BY MALLADI DRUGS & PHARMACEUTICALS


LIMITED, UNIT-3 IN TAMIL NADU, INDIA FOR ZACH SYSTEM S.P.A.
HYDROMORPHONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE, NJ

22083 A

II

4/3/2008

AMISHI DRUGS AND CHEMICALS LTD

SILVER SULFADIAZINE USP AS MANUFACTURED IN GUJARAT, INDIA

22058 N

NOT AN ASSIGNED NUMBER

Page 644

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22084 A
III
10/2/2008
AMPACET CORP

SUBJECT
AMPACET 140417 ORANGE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA
AMPACET 181086-K BEIGE 086 AS MANUFACTURED IN RAYONG, THAILAND

22085 A

III

10/3/2008

AMPACET CORP

22086 I

II

9/22/2008

22087 A

II

10/6/2008

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD


CHUANNAN BRANCH
NECTAR LIFESCIENCES LTD

22088 A

II

10/14/2008

JOHNSON MATTHEY PHARMA SERVICES

CEFUROXIME ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN


CHANDIGARH, INDIA
TRAVOPROST (3031.H) AS MANUFACTURED IN DEVENS, MA

22089 A

II

9/29/2008

HUBEI HAOSUN PHARMACEUTICAL CO LTD

GRANISETRON BASE AS MANUFACTURED IN HUBEI, CHINA

22090 A

II

10/9/2008

BASF SE

ACITRETIN AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

22091 A

IV

10/15/2008

SEPPIC SA

22092 A

II

10/16/2008

MYLAN LABORATORIES LTD

MONTANIDE ISA" 720 VG STERILE AS MANUFACTURED BY SEPIPROD IN CASTRES, FRANCE


FOR SEPPIC, S.A.
TOLMETIN SODIUM USP AS MANUFACTURED IN TELANGANA, INDIA

22093 A

II

10/8/2008

IND SWIFT LABORATORIES LTD

LETROZOLE USP AS MANUFACTURED IN PUNJAB, INDIA

22094 A

II

10/17/2008

EXCELLA GMBH

LANTHANUM CARBONATE AS MANUFACTURED IN FEUCHT, GERMANY

22095 P

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

*** PENDING FILING REVIEW ***

22096 A

II

11/20/2008

FIS FABBRICA ITALIANA SINTETICI SPA

PROGESTERONE AS MANUFACTURED IN VICENZA, ITALY

22097 A

III

10/18/2008

SVAM PACKAGING INDUSTRIES PVT LTD

SLITTED ALU-ALU FOIL AS MANUFACTURED IN NEW DELHI, INDIA

22098 A

III

10/10/2008

AMPACET CORP

22099 A

II

11/13/2008

CIPLA LTD

AMPACET PRODUCT 681751-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE


HAUTE, IN; HEATH, OH; DERIDDER, LA; CARTERSVILLE, GA
EXEMESTANE AS MANUFACTURED IN MAHARASHTRE, INDIA

22100 A

II

11/7/2008

KD-PHARMA BEXBACH GMBH

OMEGA-3 ACIDS ETHYL ESTER AS MANUFACTURED IN BEXBACH, GERMANY

22101 A

III

9/25/2008

AMPACET CORP

22102 A

II

10/17/2008

LIPOID GMBH

22103 A

II

10/17/2008

STI PHARMACEUTICALS LTD

22104 A

II

10/15/2008

LUNDBECK PHARMACEUTICALS ITALY SPA

AMPACET PRODUC 682236-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE


HAUTE, IN; HEATH, OH; DERIDDER, LA; CARTERSVILLE, GA
LIPOID PURIFIED SOYBEAN OIL 700 (PH.EUR., USP) AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
SYNTHETIC CANNABIDIOL (CBD) AS MANUFACTURED IN HOLYWELL NORTH WALES, UNITED
KINGDOM
IMIPRAMINE PAMOATE AS MANUFACTURED IN PADOVA, ITALY

22105 A

II

10/22/2008

EMCURE PHARMACEUTICALS LTD

FENOPROFEN CALCIUM (E SUB) AS MANUFACTURED IN MAHARASHTRE, INDIA

22106 A

II

10/17/2008

CRODA EUROPE LTD

OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN STAFFORDSHIRE, UNITED KINGDOM

22107 A

II

10/22/2008

GLENMARK GENERICS LTD

RILUZOLE AS MANUFACTURED IN GUJARAT, INDIA

22108 A

III

10/31/2008

ALMEGA PLASTICS INC

LIQUID MEDICATION DISPENSERS AS MANUFACTURED IN NEW CASTLE, PA

22109 A

II

10/24/2008

USV LIMITED

CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22110 A

II

10/24/2008

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

ORLISTAT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

22111 A

II

10/23/2008

MSN PHARMACHEM PVT LTD

PREGABALIN [ROUTE CODE - PB"] AS MANUFACTURED IN TELANGANA

22112 A

II

10/23/2008

MSN PHARMACHEM PVT LTD

22113 A

II

11/4/2008

USV LIMITED

MEMANTINE HYDROCHLORIDE [ROUTE CODE - MH] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

22114 A

IV

10/17/2008

HENRY H OTTENS MANUFACTURING CO INC

ARTIFICIAL RASPBERRY FLAVOR # 7557-A AS MANUFACTURED IN PHILADELPHIA, PA

22115 A

II

10/29/2008

INDENA SPA

IDN 5404 (THIOCOLCHICINE DERIVATIVE) AS MANUFACTURED IN SETTALA (MI), ITALY

22116 A

II

10/21/2008

ALEMBIC PHARMACEUTICALS LTD

LOSARTAN POTASSIUM USP AS MANUFACTURED IN GUJARAT, INDIA

Page 645

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22117 A
II
10/23/2008
ALP PHARM BEIJING CO LTD

SUBJECT
ATORVASTATION CALCIUM (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN
CHANGPING DISTRICT, BEIJING, P.R. CHINA
CARISOPRODOL (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED BY SHANXI YAOWEI
PHARMACEUTICAL CO., LTD. IN SHANXI PROVINCE, P.R. CHINA FOR ALP PHARM BEIJING CO.
LTD.

22118 I

II

10/23/2008

ALP PHARM BEIJING CO LTD

22119 A

II

11/6/2008

PROPORTIONAL TECHNOLOGIES INC

KIT FOR RAPID PREPARATION OF 64CU-ATSM AS MANUFACTURED IN HOUSTON, TX

22120 A

II

10/27/2008

SAI LIFE SCIENCES LTD

DOXERCALCIFEROL AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA

22121 A

II

10/27/2008

GLENMARK GENERICS LTD

ATOVAQUONE, USP AS MANUFACTURED IN BHARUCH, GUJARAT STATE, INDIA

22122 I

III

10/29/2008

HOSPIRA INC

22123 A

II

11/18/2008

WATSON PHARMA PRIVATE LTD

STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT


PACKAGED IN PVC FLEXIBLE CONTAINER AS MANUFACTURED IN AUSTIN, TX
TELMISARTAN AS MANUFACTURED IN MAHARASHTRA, INDIA

22124 A

II

10/24/2008

MEDICHEM MANUFACTURING MALTA LTD

DARIFENACIN HYDROBROMIDE(MED-200380/M) AS MANUFACTURED IN HAL FAR, MALTA

22125 A

II

8/19/2009

CIPLA LTD

ALOSETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

22126 P

*** PENDING FILING REVIEW ***

22127 P

*** PENDING FILING REVIEW ***

22128 A

II

11/27/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

PREGABALIN AS MANUFACTURED IN MAHARASHTRA, INDIA

22129 A

II

11/29/2008

SUN PHARMACEUTICAL INDUSTRIES LTD

ESZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA

22130 A

II

1/5/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

DESMOPRESIN ACETATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22131 A

II

12/12/2008

22132 A

II

11/11/2008

ORCHID CHEMICALS AND PHARMACEUTICALS LTD NARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API) AS MANUFACTURED IN
MAHARASHTRA, INDIA
FARMAK AS
WARFARIN SODIUM AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

22133 A

II

11/21/2008

USV LIMITED

ENTACAPONE AS MANUFACTURED IN MAHARASHTRA, INDIA

22134 A

II

11/4/2008

MYLAN LABORATORIES LTD

ATOVAQUONE USP AS MANUFACTURED IN TELANGANA, INDIA

22135 A

II

7/6/2010

STELLAR BIOTECHNOLOGIES INC

22136 A

II

10/31/2008

FORMOSA LABORATORIES INC

SUBUNIT KEYHOLE LIMPET HEMOCYANIN FORMULATIONS AS MANUFACTURED IN


LEXINGTON, KY FOR STELLAR BIOTECHNOLOGIES INC
DOXERCALCIFEROL AS MANUFACTURED IN TAOYUAN, TAIWAN

22137 I

III

10/28/2008

MAX WIEGAND GLASWARENFABRIK CRAILSHEIM

GLASS VIALS AS MANUFACTURED IN CRAILSHEIM, GERMANY

22138 I

II

10/23/2008

EMCURE PHARMACEUTICALS LTD

MEFLOQUINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22139 I

III

10/24/2008

REXAM PHARMA SAS

NASLAL SPRAY BOTTLES AS MANUFACTURED IN OFFRANVILLE, FRANCE

22140 A

II

10/27/2008

HETERO LABS LTD

CAPECITABINE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22141 A

II

11/3/2008

22142 A

II

10/31/2008

CHONGQING PHARMACEUTICAL RESEARCH


INSTITUTE CO LTD
TORRENT PHARMACEUTICALS LTD

PEMETREXED DISODIUM, (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


CHONGQING, CHINA
SILDENAFIL CITRATE AS MANUFACTURED IN GUJARAT, INDIA

22143 A

III

10/23/2008

3M DRUG DELIVERY SYSTEMS

22144 A

II

10/27/2008

SAFC INC

3M COTRAN 9770 POLYESTER TAPE AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG


DELIVERY SYSTEMS
SGD-1006 (SG6) AS MANUFACTURED IN MADISON, WI

22145 I

II

10/24/2008

ALP PHARM BEIJING CO LTD

22146 I

III

10/13/2008

SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN


BEIJING, CHINA
BERRY PLASTICS CORP TAPES AND COATINGS DIV MS-H-MEDSHIELD 1108 AS MANUFACTURED IN HOMER, LA

22147 I

III

10/13/2008

BERRY PLASTICS CORP TAPES AND COATINGS DIV MS-H-MEDSHIELD 1008 AS MANUFACTURED IN HOMER, LA

Page 646

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22148 A
III
10/24/2008
SHANDONG PHARMACEUTICAL GLASS CO LTD

SUBJECT
BOROSILICATE GLASS (USP TYPE I) BARRELS (WITH STAINLESS STEEL NEEDLE) FOR
INJECTABLES FOR PREFILLED SYRINGES AS MANUFACTURED BY RUBBER & PLASTICS
PACKAGING MATERIAL DIVISION IN SHANDONG PROVINCE, P.R. CHINA FOR SHANDONG
PHARMACEUTICAL GLASS CO. LTD.

22149 I

II

8/15/2008

HUBEI XUNDA PHARMACEUTICAL CO LTD

KETOPROFEN AS MANUFACTURED IN HUBEI PROVINCE, CHINA

22150 A

II

10/23/2008

WANBURY LTD

22151 I

II

10/23/2008

ALP PHARM BEIJING CO LTD

LOSARTAN POTASSIUM AS MANUFACTURED BY WANBURY LIMITED (R&D CENTRE) IN


MAHARASHTRA, INDIA FOR WANBURY LIMITED
LUTEIN (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA

22152 I

III

11/3/2008

GLENROY INC

GLENROY STRUCTURE NO. EFO 117-001 AS MANUFACTURED IN MENOMONEE FALLS, WI

22153 A

III

11/4/2008

AMPACET CORP

22154 A

II

11/3/2008

SYMRISE INC

112109-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;


LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; AND DERIDDER, LA
MENTHOL, RAC AS MANUFACTURED IN GOOSE CREEK, SC

22155 A

II

11/13/2008

SIEGFRIED LTD

NICOTINE POLACRILEX 20% AS MANUFACTURED IN ZOFINGEN, SWITZERLAND

22156 A

II

10/29/2008

EXCELLA GMBH

MYCOPHENOLATE SODIUM AS MANUFACTURED IN FEUCHT, GERMANY

22157 A

II

10/27/2008

DIVIS LABORATORIES LTD

CAPECITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22158 I

II

11/4/2008

CF PHARMA LTD

BICALUTAMIDE ADSORBATE AS MANUFACTURED IN BUDAPEST, HUNGARY

22159 A

II

11/3/2008

SEQUENT SCIENTIFIC LTD

IMIQUIMOD AS MANUFACTURED IN MANGALORE, INDIA

22160 A

II

10/31/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

BORTEZOMIB AS MANUFACTURED BY IVAX PHARMACEUTICALS S.R.O. IN OPAVA, CZECH


REPUBLIC AND SICOR DE MEXICO S.A. DE C.V IN LERMA, MEXICO FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD.

22161 A

II

11/10/2008

SMS PHARMACEUTICALS LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22162 I

II

11/5/2008

22163 I

II

10/27/2008

VITALIFE LABORATORIES DIV ARCH PHARMALABS


LTD
ALP PHARM BEIJING CO LTD

NEVIRAPINE ANHYDROUS USP AS MANUFACTURED BY ARCH LIFE SCIENCES LIMITED IN


ANDHRA PRADESH, INDIA FOR ARCH PHARMALABS LIMITED
EPO (RECOMBINANT HUMAN ERYTHROPOIETIN) AS MANUFACTURED IN BEIJING, CHINA

22164 A

II

11/3/2008

WOCKHARDT LTD

ESZOPICLONE AS MANUFACTURED IN GUJARAT, INDIA

22165 A

II

11/10/2008

MYLAN LABORATORIES LTD

(S)-PREGABALIN AS MANUFACTURED IN MAHARASHTRA, INDIA

22166 A

II

10/29/2008

INDOCO REMEDIES LTD

BRIMONIDINE TARTRATE AS MANUFACTURED IN RABALE, MNAVI MUMBAI, INDIA

22167 A

II

11/11/2008

APOTEX PHARMACHEM INDIA PVT LTD

22168 I

II

10/27/2008

ALP PHARM BEIJING CO LTD

22169 A

II

10/31/2008

EUTICALS SPA

CLONAZEPAM USP AS MANUFACTURED BY SRINI PHARMACEUTICALS LTD. IN A. P., INDIA FOR


APOTEX PHARMACHEM INDIA PVT LTD
ROSMARINIC ACID (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING,
CHINA
HYDRALAZINE HYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY

22170 I

III

11/5/2008

CHROMA CORP

EC77592 50/1 TRANS AMBER COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL

22171 A

11/11/2008

AMGEN TECHNOLOGY IRELAND

PRODUCTION MODULE 2 (PM2) ASEPTIC FACILITY LOCATED CO. DUBLIN, IRELAND

22172 A

II

11/11/2008

KUREHA CORP

PSK (KRESTIN) DRUG SUBSTANCE AS MANUFACTURED IN FUKUSHIMA, JAPAN

22173 A

II

11/12/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

22174 A

II

11/12/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

22175 I

II

8/22/2008

ZHOUSHAN PUTO XINXING PHARMACHEM CO LTD

22176 A

II

8/22/2008

ZHEJIANG ZHOUHUA ORGANISMS SCIENCE AND


TECHNOLOGY DEVELOPMENT CO LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED BY PLANTEX LTD. IN NETANYA, ISRAEL FOR


TEVA PHARMACEUTICAL INDUSTRIES LTD.
FULVESTRANT AS MANUFACTURED BY SICOR DE MEXICO S.A. DE C.V. IN LERMA, MEXICO
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA

Page 647

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22177 A
II
8/22/2008
ZHEJIANG ZHOUHUA ORGANISMS SCIENCE AND
TECHNOLOGY DEVELOPMENT CO LTD
22178 I
III
11/7/2008
AMPACET CORP

SUBJECT
GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

22179 I

III

11/7/2008

AMPACET CORP

22180 I

II

8/22/2008

ZHOUSHAN PUTO XINXING PHARMACHEM CO LTD

682432-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX;
CARTERSVILLE, GA; HEATH, OH; AND DERIDDER, LA
682433-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX;
CARTERSVILLE, GA; HEATH, OH; AND DERIDDER, LA
GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

22181 A

II

11/13/2008

HIKMA PHARMACEUTICALS

ONDANSETRON HYDROCHLORIDE, USP AS MANUFACTURED IN AMMAN, JORDAN

22182 A

10/24/2008

ONCO THERAPIES LTD

STERILE MANUFACTURING FACILITY FOR ONCOLOGICAL PRODUCTS

22183 I

II

11/14/2008

CADILA PHARMACEUTICALS LTD

VALSARTAN AS MANUFACTURED IN GUJARAT, INDIA

22184 A

II

11/17/2008

GLENMARK GENERICS LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN BHARUCH, GUJARAT STATE, INDIA

22185 A

III

11/7/2008

AMERICHEM INC

46603 RED AS MANUFACTURED IN CUYAHOGA FALLS, OH

22186 A

III

11/3/2008

HINDALCO INDUSTRIES LTD

ALUMINIUM STRIP FOIL (COATED/PRINTED) AS MANUFACTURED IN SILVASSA, INDIA

22187 A

III

11/3/2008

HINDALCO INDUSTRIES LTD

ALUMINIUM BLISTER FOIL (BARE/COATED/PRINTED) AS MANUFACTURED IN SILVASSA, INDIA

22188 I

IV

11/12/2008

FONA INTERNATIONAL INC

805.245 N-C NAT BANANA FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL

22189 A

III

11/14/2008

MINNESOTA RUBBER AND PLASTICS

22190 A

II

11/4/2008

HOSPIRA HEALTHCARE INDIA PVT LTD

RUBBER ELASTOMERS FOR INSULIN APPLICATIONS AS MANUFACTURED IN MASON CITY, IA


AND/OR WATERTOWN, SD
MEROPENEM (NON-STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA

22191 A

II

3/8/2010

AKZONOBEL SALT AS

SODIUM CHLORIDE AS MANUFACTURED IN MARIAGER DENMARK

22192 N

NOT AN ASSIGNED NUMBER

22193 P

*** PENDING FILING REVIEW ***

22194 P

*** PENDING FILING REVIEW ***

22195 A

III

11/14/2008

PARTH FOILS P LTD

22196 A

II

11/17/2008

HETERO LABS LTD

FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED UT OF DADRA NAGAR AND HAVELI,


INDIA AND HIMACHAL PRADESH, INDIA.
ABACAVIR SULFATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22197 A

III

11/3/2008

HINDALCO INDUSTRIES LTD

ALUMINIUM STRIP FOIL (BARE/LAMINATED/PRINTED) AS MANUFACTURED IN SILVASSA, INDIA

22198 A

II

11/14/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

22199 A

II

10/23/2008

OLON SPA

LATANOPROST AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD (TEVA-TECH SITE)


IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES, LTD.
GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TORINO (TO), ITALY

22200 A

II

11/17/2008

EXCELLA GMBH

CEVIMELINE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY

22201 I

II

11/20/2008

HETERO DRUGS LTD

FELBAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22202 I

III

11/7/2008

RICON COLORS INC

AMBER, CPT-B3220-1 AS MANUFACTURED IN WEST CHICAGO, IL

22203 A

II

11/14/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

ESZOPICLONE ( PROCESS I ) AS MANUFACTURED IN GUAYAMA, PUERTO RICO

22204 A

II

11/19/2008

AUROBINDO PHARMA LTD

FAMCICLOVIR USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22205 A

II

11/10/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

ZOLMITRIPTAN AS MANUFACTURED IN ZAGREB, CROATIA

22206 A

II

11/21/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

22207 A

II

11/21/2008

CATALENT ARGENTINA SAIC

DARIFENACIN HBR AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD. IN BE'ER


SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
ADVIL LIQUI-GELS, 200 MG AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

22208 A

II

11/19/2008

NOF CORP

22209 A

II

11/17/2008

NURAY CHEMICALS PVT LTD

HIGH PURITY EGG YOLK PHOSPHATIDYLCHOLINE (HP-EPC) AS MANUFACTURED IN HYOGO,


JAPAN
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)
AS MANUFACTURED IN TAMIL NADU, INDIA

Page 648

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22210 A
II
11/13/2008
SUPRIYA LIFESCIENCE LTD

SUBJECT
CHLORPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA

22211 A

II

11/5/2008

OLON SPA

THIOCTIC ACID AS MANUFACTURED IN RODANO (MI), ITALY

22212 A

IV

10/27/2008

NUSIL TECHNOLOGY LLC

DDU-4630 SILICONE ELASTOMER AS MANUFACTURED IN CARPINTERIA, CA

22213 A

IV

10/27/2008

NUSIL TECHNOLOGY LLC

DDU-4340 SILICONE ELASTOMER AS MANUFACTURED IN CARPINTERIA, CA

22214 A

II

11/21/2008

FRED HUTCHINSON CANCER RESCTR

22215 I

II

1/12/2009

IPCA LABORATORIES LTD

MANUFACTURE AND QUALITY CONTROL OF THE BC8-SA MONOCLONAL ANTIBODY


CONJUGATE (BC8-SA) AS MANUFACTURED IN SEATTLE, WA
WARFARIN SODIUM USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

22216 I

II

2/23/2009

IPCA LABORATORIES LTD

AMODIAQUINE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

22217 I

II

2/23/2009

IPCA LABORATORIES LTD

ARTEMETHER AS MANUFACTURED IN MADHYA PRADESH, INDIA

22218 I

II

1/22/2009

IPCA LABORATORIES LTD

ARTESUNATE AS MANUFACTURED IN MADHYA PRADESH, INDIA

22219 I

II

10/1/2009

IPCA LABORATORIES LTD

Losartan Potassium USP (LB5 Process) AS MANUFACTURED IN MADHYA PRADESH, INDIA

22220 A

III

11/25/2008

POLYONE CORP

22221 I

II

1/13/2009

IPCA LABORATORIES LTD

CC00014033WE 21E14048CMB OCEAN AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND


GLENDALE, AZ
LUMEFANTRINE AS MANUFACTURED IN MADHYA PRADESH, INDIA

22222 A

II

11/24/2008

QINGDAO JIULONG BIOPHARMACEUTICAL CO LTD

HEPARIN SODIUM USP AS MANUFACTURED IN QINGDAO, SHANDONG, P.R. CHINA

22223 A

II

11/24/2008

CHANGZHOU PHARMACEUTICAL FACTORY

PREGABALIN AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

22224 A

III

11/21/2008

BD MEDICAL PHARMACEUTICAL SYSTEMS

BD ACCUSPRAY(TM) NASAL SPRAY SYSTEM AS MANUFACTURED IN COLUMBUS, NE

22225 A

II

11/21/2008

MSN PHARMACHEM PVT LTD

22226 I

II

11/20/2008

NEWCHEM SPA

DARIFENACIN HYDROBROMIDE [ROUTE CODE - "DF" AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
CLOBETASOL 17-PROPIONATE AS MANUFACTURED IN VERONA (VR), ITALY

22227 A

II

11/14/2008

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MEVASTATIN, NON-STERILE, API AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

22228 A

II

11/24/2008

MOEHS IBERICA SL

BUPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN

22229 A

II

11/26/2008

HETERO LABS LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22230 A

II

12/1/2008

SYMED LABS LTD

BRIMONIDINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22231 A

II

12/1/2008

HETERO LABS LTD

ANASTROZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22232 A

II

11/25/2008

ADENOSINE AS MANUFACTURED IN VARESE ITALY

22233 A

II

12/1/2008

PRIME EUROPEAN THERAPEUTICS SPA EUTICALS


SPA
CADILA HEALTHCARE LTD

22234 A

II

11/18/2008

MACLEODS PHARMACEUTICALS LTD

REPAGLINIDE AS MANUFACTURED IN GUJARAT INDIA

22235 A

II

11/21/2008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LEVETIRACETAM API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

22236 A

II

11/21/2008

NEWCHEM SPA

FLUTICASONE PROPIONATE MICRONIZED AS MANUFACTURED IN VERONA ITALY

22237 A

II

12/2/2008

GLENMARK GENERICS LTD

ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT INDIA

22238 A

II

11/24/2008

SULFASALAZINE AS MANUFACTURED IN SHANGHAI PR CHINA

22239 A

II

12/9/2008

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
USV LIMITED

22240 A

III

11/18/2008

AMPACET CORP

AMPACET 181907 K AMBER 907 AS MANUFACTURED IN RAYONG THAILAND

22241 A

11/4/2008

MICROTROL STERILISATION SERVICES PVT LTD

22242 A

II

12/1/2008

TEVA PHARMACEUTICAL INDUSTRIES LTD

GAMMA IRRADIATION STERILISATION TREATMENT FOR MEDICAL DEVICES AS


MANUFACTURED IN BENGALOORU INDIA
PREGABALIN AS MANUFACTURED IN BEER SHEVA ISRAEL

22243 I

III

11/26/2008

AGI GLASPAC

GLASS BOTTLES USP TYPE III AS MANUFACTURED IN HYDERABAD INDIA

22244 A

II

12/19/2008

NORAMCO INC

METHYLPHENIDATE HYDROCHLORIDE (R042928) AS MANUFACTURED IN ATHENS, GA

DONEPEZIL HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

LETROZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 649

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22245 A
II
12/1/2008
JOHNSON MATTHEY PHARMACEUTICAL
MATERIALS
22246 P
*** PENDING FILING REVIEW ***

SUBJECT
JOHNSON MATTHEY B1105 AS MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

22247 A

TIGECYCLINE TECHNICAL AS MANUFACTURED IN GUJARAT, INDIA

II

11/29/2008

22248 N

UNIMARK REMEDIES LTD


NOT AN ASSIGNED NUMBER

22249 I

II

12/3/2008

EMCURE PHARMACEUTICALS LTD

RIVASTIGMINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

22250 A

IV

11/24/2008

NUSIL TECHNOLOGY LLC

DDU-310 SILICONE FLUID AS MANUFACTURED IN CARPINTERIA, CA

22251 I

III

11/18/2008

UPM RAFLATAC INC

RP51 ADHESIVE AS MANUFACTURED IN FLETCHER, NC

22252 A

II

12/4/2008

APOTEX PHARMACHEM INC

RIVASTIGMINE TARTRATE AS MANUFACTURED IN BRANTFORD ON, CANADA

22253 A

II

11/29/2008

ALEMBIC PHARMACEUTICALS LTD

HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22254 I

II

11/20/2008

ANTIBIOTICOS SPA

TACROLIMUS MONOHYDRATE AS MANUFACTURED IN LEON SPAIN

22255 I

II

12/5/2008

KAKEN PHARMACEUTICAL CO LTD

KP-413 DRUG SUBMSTANCE AS MANUFACTURED IN TOYAMA, JAPAN

22256 I

II

11/28/2008

KAMUD DRUGS PVT LTD

KETAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22257 P

*** PENDING FILING REVIEW ***

22258 A

II

12/22/2008

WATSON PHARMA PRIVATE LTD

NABUMETONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22259 A

II

1/8/2009

OLTA PHARMACEUTICALS CORP

LINDANE USP AS MANUFACTURED IN EAST DEKALB, MS

22260 P

*** PENDING FILING REVIEW ***

22261 I

II

12/4/2008

MUSTAFA NEVSAT ILAC SANAYII AS

STERILE SULBACTAM SODIUM AS MANUFACTURED IN KOCAELI, TURKEY

22262 I

II

12/3/2008

CHEMO IBERICA SA MADRID

22263 A

II

12/5/2008

DR REDDYS LABORATORIES LTD

SEVELAMER CARBONATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR CHEMO


IBERICA SA MADRID
SOLIFENACIN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22264 A

II

12/4/2008

MACLEODS PHARMACEUTICALS LTD

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

22265 A

II

12/6/2008

AUROBINDO PHARMA LTD

22266 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

LEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
GRADE XL-TDP PET 12 AS MANUFACTURED IN SILVASSA, INDIA

22267 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 23 AS MANUFACTURED IN SILVASSA, INDIA

22268 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 30 AS MANUFACTURED IN SILVASSA, INDIA

22269 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 36 AS MANUFACTURED IN SILVASSA, INDIA

22270 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 75 AS MANUFACTURED IN SILVASSA, INDIA

22271 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 50 AS MANUFACTURED IN SILVASSA, INDIA

22272 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 100 AS MANUFACTURED IN SILVASSA, INDIA

22273 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 125 AS MANUFACTURED IN SILVASSA, INDIA

22274 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 175 AS MANUFACTURED IN SILVASSA, INDIA

22275 A

III

12/4/2008

KAYGEE LOPAREX INDIA PVT LTD

GRADE XL-TDP PET 250 AS MANUFACTURED IN SILVASSA, INDIA

22276 A

II

12/4/2008

BACHEM SA

ZONISAMIDE AS MANUFACTURED INVIONNAZ, SWITZERLAND

22277 A

II

12/2/2008

ALP PHARM BEIJING CO LTD

TRANEXAMIC ACID AS MANUFACTURED IN BEIJING, CHINA

22278 A

II

12/2/2008

ALP PHARM BEIJING CO LTD

LOTEPREDNOL ETABONATE AS MANUFACTURED IN BEIJING, CHINA

22279 I

II

12/2/2008

ALP PHARM BEIJING CO LTD

ELOCALCITOL AS MANUFACTURED IN BEIJING, CHINA

22280 A

II

11/20/2008

YUNG ZIP CHEMICAL IND CO LTD

CLOPIDOGREL BISULFATE AS MANUFACTURED IN TAI CHUNG, TAIWAN

22281 A

III

12/8/2008

RELIANCE INDUSTRIES LTD

RELENE 54GB012 AS MANUFACTURED IN DAHEJ, INDIA

Page 650

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22282 A
II
12/9/2008
APOTEX PHARMACHEM INDIA PVT LTD

SUBJECT
TIZANIDINE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

22283 I

II

12/9/2008

SANDOZ INDUSTRIAL PRODUCTS SPA

SIMVASTATIN AS MANUFACTURED IN ROVERETO (TRENTO), ITALY

22284 A

II

11/3/2008

OLON SPA

OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN MULAZZANO (LO), ITALY

22285 A

II

10/17/2008

HUATAI BIOPHARM INC

OMEGA-3-ACID ETHYL ESTERS USP AS MANUFACTURED IN SICHUAN, CHINA

22286 A

II

12/15/2008

SYMED LABS LTD

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22287 A

12/10/2008

ACS DOBFAR SPA

VIALE ADDETTA PLANT-CRYSTALLIZATION PLANT 2 LOCATED IN TRIBIANO (MI), ITALY

22288 A

II

12/10/2008

ACS DOBFAR SPA

22289 A

II

12/8/2008

CAYMAN PHARMA SRO

STERILE VANCOMYCIN HYDROCHLORIDE USP, 100G AS MANUFACTURED IN COPENHAGEN S,


DENMARK
TRAVOPROST AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC

22290 A

II

12/8/2008

QIDONG DONGUE PHARMACEUTICAL CO LTD

22291 A

III

12/10/2008

TOWA KAKO CO LTD

DIPHENHYDRAMINE HCL USP AS MANUFACTURED IN QIDONG CITY JIANGSU PROVINCE,


CHINA
TOWA CLEAN FILM SERIES AS MANUFACTURED IN TIYODAKU TOKYO, JAPAN

22292 A

IV

12/10/2008

PREMIER SPECIALTIES INC

FLAVOR AND FRAGRANCE INFORMATION AS MANUFACTURED IN MIDDLESEX, NJ

22293 A

II

12/9/2008

LUPIN LTD

SEVELAMER CARBONATE AS MANUFACTURED IN MAHARASHTRA, INDIA

22294 A

III

12/11/2008

HOSPIRA INC

STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT


PACKAGED IN CR3 FLEXIBLE CONTAINER AS MANUFACTURED IN ROCKY MOUNT, NC AND
AUSTIN, TEXAS

22295 A

II

12/4/2008

INDOCO REMEDIES LTD

22296 A

II

11/21/2008

LAURUS LABS PRIVATE LIMITED

22297 A

II

12/9/2008

LUPIN LTD

DICYCLOMINE HYDROCHLORIDE AS MANUFACTURED IN TALKUKA KHALAPUR, DISTRICT


RAIGAD, INDIA
IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
ESZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA

22298 A

IV

12/12/2008

HENKEL CORPORATION

DURO-TAK 87-617A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC.

22299 A

II

12/10/2008

ALCHYMARS ICM SM PRIVATE LTD

WARFARIN SODIUM USP AS MANUFACTURED IN TAMIL NADU, INDIA

22300 A

II

12/15/2008

DR REDDYS LABORATORIES LTD

IBANDRONATE SODIUM (FORM-BETA) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22301 A

II

12/9/2008

CADILA PHARMACEUTICALS LTD

OLANZAPINE FORM-I AS MANUFACTURED IN GUJARAT, INDIA

22302 I

III

12/15/2008

ALTE REGO CORP

ARC API LINER CLEAR AS MANUFACTURED TORONTO, CANADA

22303 A

II

1/6/2009

FRESENIUS KABI ONCOLOGY LTD

TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN WEST BENGAL, INDIA

22304 I

III

12/15/2008

ALTE REGO CORP

ARC API LINER BLACK AS MANUFACTURED TORONTO, CANADA

22305 I

III

12/15/2008

ALTE REGO CORP

ARC API LINER CLEAR NFPA99 2.0 AS MANUFACTURED IN TORONTO, CANADA

22306 A

III

12/8/2008

RELIANCE INDUSTRIES LTD

RELENE 1020FA20 AS MANUFACTURED IN MAHARASHTRA, INDIA

22307 A

III

12/11/2008

CLARIANT PRODUCTION FRANCE

EQ-PAK SACHET AS MANUFACTURED IN ROMORANTIN, FRANCE

22308 A

II

12/12/2008

CHEMO IBERICA SA MADRID

22309 A

II

12/11/2008

RA CHEM PHARMA LTD

TIANEPTINE SODIUM AS MANUFACTURED BY QUIMICA SINTETICA, S.A. IN MADRID, SPAIN FOR


CHEMO IBERICA, S.A. MADRID
MECLIZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22310 A

II

12/10/2008

IND SWIFT LABORATORIES LTD

ATORVASTATIN CALCIUM USP AS MANUFACTURED IN PUNJAB, INDIA

22311 A

II

12/15/2008

PERRIGO API LTD

GRANISETRON BASE AS MANUFACTURED IN SHEVA, ISRAEL

22312 A

II

5/12/2009

CIPLA LTD

DESLORATADINE FORM I: FORM II (89:11) AS MANUFACTURED IN MAHARASHTRA, INDIA

22313 A

III

12/16/2008

HOSPIRA INC

STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT


PACKAGED IN TYPE I GLASS BOTTLES AS MANUFACTURED IN CLAYTON, NORTH CAROLINA

Page 651

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22314 A
III
12/15/2008
AMPACET CORP

SUBJECT
AMPACET 100977 UV POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRE HAUTE,
INDIANA
994791 ARTIFICIAL BURNT SUGAR FLAVOR 687817 AS MANUFACTURED IN TETERBORO, NJ
AND BRANCHBURG, NEW JERSEY
SOLUTION POLYETHYLENE PRODUCTS AS MANUFACTURED IN FREEPORT, TX; PLAQUEMINE,
LA; ALBERTA, CANADA; TARRAGONA, SPAIN; TERNEUZEN, THE NETHERLANDS; SCHKOPAU,
GERMANY AND MAP TA PHUT, RP THAILAND

22315 A

IV

12/17/2008

SYMRISE INC

22316 A

III

12/16/2008

DOW CHEMICAL CO

22317 A

II

12/15/2008

DAISO CO LTD

22318 A

II

12/17/2008

NOF CORP

22319 A

II

12/18/2008

FARMABIOS S P A

DAISOGEL SP-C8 SERIES CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN HYOGO,


JAPAN
DIPALMITOYL PHOSPHATIDYLGLYCEROL, SODIUM SALT (DPPG-NA) AS MANUFACTURED IN
HYOGO, JAPAN
MOMETASONE FUROATE AS MANUFACTURED IN CAIROLI (PAVIA), ITALY

22320 A

II

12/1/2008

SAFC INC

SGD-1269 (SG9) AS MANUFACTURED IN MADISON, WISCONSIN

22321 A

II

12/17/2008

KRKA DD NOVO MESTO

LANSOPRAZOLE ACTIVE SUBSTANCE AS MANUFACTURED IN NOVO MESTO, SLOVENIACE

22322 A

II

12/16/2008

POLYPEPTIDE LABORATORIES INC

PTH (1-34), HUMAN, ACETATE AS MANUFACTURED IN TORRANCE, CALIFORNIA

22323 I

II

12/17/2008

CADILA HEALTHCARE LTD

ANASTROZOLE AS MANUFACTURED IN GUJARAT, INDIA

22324 A

II

12/19/2008

SCINOPHARM TAIWAN LTD

DESMOPRESSIN ACETATE, AS MANUFACTURED IN SHAN-HUA, TAINAN, TAIWAN

22325 A

II

12/9/2008

LUPIN LTD

RIFAMYCIN O AS MANUFACTURED IN MAHARASHTRA, INDIA

22326 I

III

12/15/2008

COLORMATRIX CORP

LIQUID COLORANT FOR USE IN COLORING PET AS MANUFACTURED IN BEREA, OHIO

22327 A

II

12/17/2008

NECTAR LIFESCIENCES LTD

CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA

22328 A

II

12/20/2008

FRESENIUS KABI AUSTRIA GMBH

LACTULOSE SOLUTION USP AS MANUFACTURED IN GRAZ, AUSTRIA

22329 I

II

12/19/2008

CAMBREX CHARLES CITY INC

DEXTROMETHORPHAN POLISTIREX AS MANUFACTURED IN CHARLES CITY, IA

22330 A

II

12/17/2008

LUPIN LTD

PREGABALIN AS MANUFACTURED IN MAHARASHTRA, INDIA

22331 A

II

12/5/2008

CSPC OUYI PHARMACEUTICAL CO LTD

AZITHROMYCIN AS MANUFACTURED IN SHIJIAZHUANG, HEBEI PROVINCE, CHINA

22332 A

II

12/18/2008

NINGXIA QIYUAN PHARMACEUTICAL CO LTD

ERYTHROMYCIN THIOCYANATE AS MANUFACTURED NINGXIA, CHIANA

22333 A

II

3/31/2009

JUBILANT GENERICS LTD

ALENDRONATE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA

22334 P
22335 A

*** PENDING FILING REVIEW ***


II

12/7/2010

22337 A

II

3/26/2009

JUBILANT GENERICS LTD

PAROXETINE HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA

22338 A

II

3/30/2009

JUBILANT GENERICS LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA

22339 A

II

12/23/2008

SMS PHARMACEUTICALS LTD

ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22340 A

II

12/23/2008

SMS PHARMACEUTICALS LTD

ONDANSETRON HYDROCHLORIDE USP AS MANUFACTURED ANDHRA PRADESH, INDIA

22341 A

III

12/17/2008

RELIANCE INDUSTRIES LTD

RELENE 53EA010 AS MANUFACTURED IN MAHARASHTRA, INDIA

22342 A

II

12/17/2008

ESTEVE QUIMICA SA

AMLODIPINE BESYLATE AS MANUFACTURED IN CELRA (GIRONA), SPAIN

22343 A

III

11/24/2008

SHANDONG PHARMACEUTICAL GLASS CO LTD

ASSEMBLAGES FOR PREFILLED SYRINGES AS MANUFACTURED IN ZIBO CITY, P.R. CHINA

22344 I

IV

11/18/2008

BRAHMAR CELLULOSE PRODUCTS PRIVATE LTD

CARBOXYMETHYLCELLULOSE SODIUM USP-NF AS MANUFACTURED IN TAMILNADU, INDIA

22345 I

IV

11/18/2008

BRAHMAR CELLULOSE PRODUCTS PRIVATE LTD

MICROCRYSTALLINE CELLULOSE USP-NF AS MANUFACTURED IN TAMILNADU, INDIA

22346 I

IV

11/18/2008

BRAHMAR CELLULOSE PRODUCTS PRIVATE LTD

CROSCARMELLOSE SODIUM USP-NF AS MANUFACTURED IN TAMILNADU, INDIA

22347 A

II

12/24/2008

FARMAK AS

ZOPICLONE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

22348 I

II

12/22/2008

BIOFER SPA

HEPARIN SODIUM INJECTION AS MANUFACTURED IN MEDOLLA (MO) ITALY

22336 P

JUBILANT GENERICS LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN KARNATAKA, INDIA

*** PENDING FILING REVIEW ***

Page 652

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22349 I
II
12/23/2008
CHEMO IBERICA SA
22350 A

II

12/22/2008

MSN PHARMACHEM PVT LTD

SUBJECT
SEVELAMER HYDROCHLORIDE MANUFACTURED IN TAIZHOU CITY, ZHEJIANG PROVINCE, P.R.
CHINA FOR CHEMO IBERICA SA
RANOLAZINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22351 A

II

12/22/2008

PIERRE FABRE MEDICAMENT

F2695 AS MANUFACTURED IN GAILLAC, FRANCE

22352 A

II

12/30/2008

RANBAXY LABORATORIES LTD

TELMISARTAN (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA

22353 I

II

12/30/2008

RANBAXY LABORATORIES LTD

MEROPENEM TECHNICAL AS MANUFACTURED IN MADHYA PRADESH, INDIA

22354 A

II

12/17/2008

MYLAN LABORATORIES LTD

TIZANIDINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22355 A

II

12/30/2008

AARTI DRUGS LTD

TICLOPIDINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

22356 A

II

12/19/2008

NINGXIA QIYUAN PHARMACEUTICAL CO LTD

TETRACYCLINE HYDROCHLORIDE AS MANUFACTURED IN NINGXIA CHINA

22357 A

II

12/30/2008

RANBAXY LABORATORIES LTD

ORLISTAT (NON-STERILE BULK) AS MANUFACTURED IN MADHYA PRADESH, INDIA

22358 A

II

12/29/2008

SEQUENT SCIENTIFIC LTD

ACITRETIN BP AS MANUFACTURED IN KARNATAKA, INDIA

22359 I

III

11/21/2008

RITE SYSTEMS INC

AMBER, LQC-BR1966-1 AS MANUFACTURED IN WEST CHICAGO IL

22360 A

II

12/31/2008

SCINOPHARM TAIWAN LTD

AZACITIDINE AS MANUFACTURED IN TAINAN TAIWAN ROC

22361 A

III

12/31/2008

HOSPIRA INC

22362 A

II

12/24/2008

ALEMBIC PHARMACEUTICALS LTD

STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT


PACKAGED IN GLASS VIALS AS MANUFACTURED IN ROCKY MOUNT NC
CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22363 A

II

12/29/2008

CADILA HEALTHCARE LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN GUJARAT , INDIA

22364 A

II

12/30/2008

CADILA HEALTHCARE LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN GUJARAT INDIA

22365 A

II

12/29/2008

TRIFARMA SPA

EXEMESTANE AS MANUFACTURED IN CERIANO LAGHETTO, ITALY

22366 A

II

12/30/2008

MYLAN LABORATORIES LTD

RASAGILINE MESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA

22367 A

II

1/2/2009

KUMAR ORGANIC PRODUCTS LTD

MINOXIDIL USP AS MANUFACTURED IN BANGALORE, INDIA

22368 A

II

12/27/2008

MYLAN LABORATORIES LTD

FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22369 A

II

12/20/2008

MYLAN LABORATORIES LTD

DEFERASIROX AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22370 I

II

12/27/2008

MATRIX LABORATORIES LTD

OXCARBAZEPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22371 A

II

12/27/2008

MYLAN LABORATORIES LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN TELANGANA, INDIA

22372 A

II

12/27/2008

MYLAN LABORATORIES LTD

O-DESMETHYL VENLAFAXINE SUCCINATE AS MANUFACTURED IN TELANGANA, INDIA

22373 I

II

1/2/2009

SREENIVASA PHARMA PRIVATE LTD

22374 A

III

12/16/2008

GRAND PLAST CO LTD

22375 A

II

12/31/2008

MACLEODS PHARMACEUTICALS LTD

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN
BANGKOK, THAILAND
LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

22376 A

II

12/31/2008

DR REDDYS LABORATORIES LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN TELANGANA, INDIA

22377 A

III

12/14/2008

TRIVENI POLYMERS PRIVATE LTD

PLASTIC CAPS/CLOSURES AS MANUFACTURED IN HARYANA, INDIA

22378 A

III

12/23/2008

WINPAK HEAT SEAL PACKAGING INC

FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN QUEBEC, CANADA

22379 A

II

12/25/2008

MEGAFINE PHARMA P LTD

22380 A

II

12/26/2008

MACLEODS PHARMACEUTICALS LTD

DONEPEZIL HYDROCHLORIDE (FORM-1), (NON-STERILE DRUG SUBSTANCE) AS


MANUFACTURED IN NASHIK, INDIA
DONEPEZIL HCL AS MANUFACTURED IN GUJARAT, INDIA

22381 A

II

1/6/2009

HETERO DRUGS LTD

TOLTERODINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22382 A

II

1/4/2009

PERRIGO API LTD

DONEPEZIL BASE AS MANUFACTURED IN BEER SHEVA, ISRAEL

22383 I

III

12/24/2008

SHANDONG PHARMACEUTICAL GLASS CO LTD

MESTRANOL 3-METHOXY-17-ETHINYL-ES POLYISOPRENE RUBBEER CAPS FOR NEEDLES FOR


PREFILLED SYRINGES AS MANUFACTURED IN ZIBO CITY, P.R. CHINA

Page 653

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22384 I
III
12/24/2008
SHANDONG PHARMACEUTICAL GLASS CO LTD
22385 I

III

12/24/2008

SHANDONG PHARMACEUTICAL GLASS CO LTD

22386 A

III

12/24/2008

SHANDONG PHARMACEUTICAL GLASS CO LTD

SUBJECT
HALOGENATED BUTYL RUBBER PLUNGERS FOR PREFILLED AS MANUFACTURED IN ZIBO
CITY, P.R. CHINA
HALOGENATED BUTYL RUBBER PLUNGERS AND DISCS FOR PEN-INJECTORS AS
MANUFACTURED IN ZIBO CITY, P.R. CHINA
ALU-CAPS FOR PEN-INJECTORS AS MANUFACTURED IN ZIBO CITY, P.R. CHINA

22387 A

II

12/22/2008

LAURUS LABS PRIVATE LTD

OXALIPLATIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22388 A

II

1/6/2009

INDAPAMIDE AS MANUFACTURED IN GUJARAT, INDIA

22389 A

II

1/7/2009

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
GENTHON BV

22390 A

II

12/31/2008

NINGXIA QIYUAN PHARMACEUTICAL CO LTD

ERYTHROMYCIN AS MANUFACTURED IN YINCHUAN, NINGXIA, CHINA

22391 A

II

1/9/2009

MACLEODS PHARMACEUTICALS LTD

FAMCICLOVIR AS MANUFACTURED IN GUJARAT, INDIA

22392 A

II

1/9/2009

DAIICHI SANKYO CO LTD

SUN13837 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN

22393 A

II

12/31/2008

22394 A

III

1/6/2009

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
TRASIS SA

22395 I

IV

1/8/2009

SYMRISE INC

22396 I

IV

1/9/2009

SYMRISE INC

22397 I

IV

1/8/2009

SYMRISE INC

22398 A

III

12/22/2008

DANAPAK FLEXIBLES AS

22399 A

II

1/12/2009

PERRIGO API LTD

6-AMINO-PENICILLANIC ACID (BY DIRECT METHOD) AS MANUFACTURED IN SHIJIAZHUANG,


CHINA
PACKAGING MATERIAL AS MANUFACTURED IN ANGLEUR (LIEGE), BELGIUM; VERVIERS,
BELGIUM FOR TRASIS S.A.
688617 EVOGLASS NATURAL FLAVOR PINEAPPLE TYPE AS MANUFACTURED IN TETERBORO,
NJ AND BRANCHBURG, NJ
694942 EVOGLASS NATURAL & ARTIFICIAL FLAVOR GRAPE TYPE AS MANUFACTURED IN
TETERBORO, NJ AND BRANCHBURG, NJ
688620 EVOGLASS NATURAL & ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN
TETERBORO, NJ AND BRANCHBURG, NJ
LAMINATE FILM FOR PACKAGING OF PHARMACEUTICAL PRODUCTS, E.G. TRANSDERMAL
SYSTEMS
TIOCONAZOLE AS MANUFACTURED IN BEER SHEVA, ISRAEL

22400 A

II

1/12/2009

SYMBIOTEC PHARMALAB LTD

DESOXIMETASONE USP, (MICRONIZED) AS MANUFACTURED IN RAU, INDORE (M.P), INDIA

22401 A

II

12/10/2008

CTX LIFE SCIENCES PVT LTD

OXYMETAZOLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22402 A

IV

1/5/2009

CRODA INC

22403 A

III

1/7/2009

CHARTER NEX FILMS INC

22404 I

II

1/16/2009

SMS PHARMACEUTICALS LTD

SUPER REFINED ARLASOLVE DMI (DIMETHYL ISOSORBIDE) AS MANUFACTURED IN MILL HALL,


PA
APPLETON 1019 POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS FALLS,
MA AND MILTON, WI
ROSIGLITAZONE MALEATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22405 A

II

1/15/2009

LIGHT SCIENCES ONCOLOGY INC

TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG PRODUCT FORMULATION AND FILLING AS


MANUFACTURED BY PATHEON ITALIA, S.P.A. IN FERENTINO (FR), ITALY FOR LIGHT SCIENCES
ONCOLOGY, INC.

22406 I

II

1/5/2009

NEWCHEM SPA

BETAMETHASONE 17-VALERATE MICRONIZED AS MANUFACTURED IN VERONA, ITALY

22407 A

II

1/13/2009

EUTICALS SPA

DIHYDROERGOTAMINE MESYLATE USP/EP AS MANUFACTURED IN ROZZANO (MI), ITALY

22408 P

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED BY SYNTHON S.R.O. IN PRAGUE, CZECH


REPUBLIC; SAN LORENZO, ARGENTINA; BLANSKO, CZECH REPUBLIC; FOR GENTHON BV

*** PENDING FILING REVIEW ***

22409 A

III

1/12/2009

3M DRUG DELIVERY SYSTEMS

3M SCOTCHPAK 9755 RELEASE LINER AS MANUFACTURED IN CORDOVA, IL; DECATUR,


ALABAMA; GREENVILLE, SC; ZWIJNDRECHT, BELGIUM; COTTAGE GROVE, MN; SOUTH
NEVADA, MO; ST. PAUL, MN; WEST ST. PAUL, MN; SE HUTCHINSON, MN

22410 A

III

1/16/2009

HUHTAMAKI RONSBERG

22411 A

III

1/15/2009

RELIANCE INDUSTRIES LTD

HUHTAMAKI RONSBERG'S MULTI-LAYER PACKAGING FILM AS MANUFACTURED IN


RONSBERG, GERMANY
REPOL T200MK AS MANUFACTURED IN HAZIRA (GUJARAT), INDIA

Page 654

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22412 A
III
1/15/2009
RELIANCE INDUSTRIES LTD

SUBJECT
REPOL R120MK AS MANUFACTURED IN HAZIRA (GUJARAT), INDIA

22413 A

II

1/16/2009

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

22414 I

IV

1/16/2009

FONA INTERNATIONAL INC

KETOROLAC TROMETHAMINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN


SHANDONG PROVINCE, CHINA
825.0003C CHERRY FLAVOR ARTIFICIAL AS MANUFACTURED IN GENEVA, IL

22415 I

IV

1/16/2009

FONA INTERNATIONAL INC

856.0006C N-C GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL

22416 A

III

1/15/2009

3M DRUG DELIVERY SYSTEMS

22417 A

II

1/29/2009

PFIZER INC

22418 A

II

1/16/2009

GLENMARK GENERICS LTD

3M COTRAN 9698 POLYURETHANE TAPE AS MANUFACTURED IN VALLEY, NE; BROOKINGS, SD;


CORDOVA, IL
LIPITOR (ATORVASTATIN CALCIUM) 10MG, 20MG, 40MG, 80MG ORALTABLETS AS
MANUFACTURED IN CORK, IRELAND
SOLIFENACIN SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA

22419 A

II

1/21/2009

ERREGIERRE SPA

22420 A

II

1/22/2009

REGIS TECHNOLOGIES INC

BUPROPION HYDROBROMIDE AS MANUFACTURED IN SAN PAOLO D' ARGON (BERGAMO),


ITALY
ACETAZOLAMIDE, USP AS MANUFACTURED IN MORTON GROVE, IL

22421 A

II

1/21/2009

FARMABIOS S P A

CLOCORTOLONE PIVALATE (MICRONIZED) AS MANUFACTURED IN CAIROLI (PV), ITALY

22422 A

II

12/26/2008

IND SWIFT LABORATORIES LTD

22423 I

II

12/25/2008

ALP PHARM BEIJING CO LTD

NARATRIPTAN HYDROCHLORIDE USP (VER: 01/NAR/1208/00) AS MANUFACTURED IN NAGAR


(MOHALI) PUNJAB, INDIA
MEPROBAMATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA

22424 A

II

12/10/2008

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD

CARBIDOPA (NON-STERILE, BULK FORM) AS MANUFACTURED IN DONGYANG CITY, CHINA

22425 A

II

12/12/2008

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD

METHYLDOPA (NON-STERILE, BULK FORM) AS MANUFACTURED IN DONGYANG CITY, CHINA

22426 A

II

1/21/2009

NECTAR LIFESCIENCES LTD

CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN PUNJAB, INDIA

22427 A

II

1/20/2009

ESTEVE QUIMICA SA

AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN TARRAGONA, SPAIN

22428 A

IV

1/7/2009

CABOT SANMAR LTD

CAB-O-SIL GRADE M-5 (FUMED SILICA) AS MANUFACTURED IN TAMIL NADU, INDIA

22429 A

II

1/6/2009

LIPOID GMBH

LIPOID MCT (PH.EUR., USP) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

22430 A

II

1/7/2009

OLOPATADINE HCL AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN

22431 A

II

1/15/2009

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
IOL CHEMICALS AND PHARMACEUTICALS LTD

22432 A

II

1/21/2009

RPG LIFE SCIENCES LTD

22433 A

III

1/14/2009

AMPACET CORP

RISPERIDONE USP (ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN MUMBAI,


INDIA
AMPACET PRODUCT 181724 DELSYM AMBER POLYPROPYLENE MASTERBATCH AS
MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH;
DERIDDER, LA

22434 A

II

1/22/2009

BHARAT PHARMA

22435 A

II

1/22/2009

BHARAT PHARMA

22436 A

II

3/23/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

BTD 177: 17.7% NITROGLYCERIN IN SOLVATED ADHESIVE AS MANUFACTURED IN LALITPUR


(UP), INDIA
NITROGLYCERIN AS IN DILUTED NITROGLYCERIN, USP AS MANUFACTURED IN LALITPUR (UP),
INDIA
GLIMEPIRIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22437 A

II

3/16/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

SUN-8016(LIOTHRONINE SODIUM USP) AS MANUFACTURED IN GUJARAT, INDIA

22438 A

II

3/16/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

RILUZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

22439 A

II

1/21/2009

STERLING SPA

EXEMESTANE AS MANUFACTURED IN PERUGIA, ITALY

22440 A

II

1/6/2009

CADILA PHARMACEUTICALS LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA

22441 A

II

1/21/2009

BIO VECTRA INC

ZERANOL AS MANUFACTURED IN CHARLOTTETOWN, PE

22442 A

II

1/27/2009

LISDEXAMFETAMINE DIMESYLATE AS MANUFACTURED IN WEST DEPTFORD, NJ

22443 A

II

1/21/2009

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
CADILA PHARMACEUTICALS LTD

IBUPROFEN USP 31 AS MANUFACTURED IN PUNJAB, INDIA

TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA

Page 655

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22444 I
II
1/20/2009
SHANDONG ZHONGYUAN GREENTECH CO LTD

SUBJECT
CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

22445 I

III

1/14/2009

TEKNOR APEX CO

MEDALIST MD-220 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22446 I

III

1/7/2009

TEKNOR APEX CO

MEDALIST MD-200 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22447 I

III

1/7/2009

TEKNOR APEX CO

MEDALIST MD-205 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22448 I

III

1/7/2009

TEKNOR APEX CO

MEDALIST MD-210 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22449 I

III

1/7/2009

TEKNOR APEX CO

MEDALIST MD-215 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22450 I

III

1/14/2009

TEKNOR APEX CO

MEDALIST MD-225 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22451 A

III

1/14/2009

TEKNOR APEX CO

MEDALIST MD-230 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22452 I

III

1/14/2009

TEKNOR APEX CO

MEDALIST MD-235 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

22453 I

IV

1/27/2009

22454 I

IV

1/27/2009

715770 - NATURAL AND ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CLARK, NEW


JERSEY
715846 - NATURAL LEMON FLAVOR WONF AS MANUFACTURED IN CLARK, NEW JERSEY

22455 I

IV

1/27/2009

22456 I

IV

1/27/2009

22457 I

IV

1/27/2009

22458 I

IV

1/27/2009

22459 I

IV

1/27/2009

22460 A

II

1/23/2009

MASTERTASTE INC DBA KERRY INGREDIENTS AND


FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
CENTAUR PHARMACEUTICALS PRIVATE LTD

22461 I

IV

10/22/2008

FONA INTERNATIONAL INC

862.015 NAT & ART LEMON FLAVOR AS MANUFACTURED IN GENEVA, IL

22462 A

III

11/24/2008

STARPET INC

PERFORMANCE PET 1708CC AS MANUFACTURED IN ASHEBORO, NC

22463 A

II

1/16/2009

CHONGQING KANGLE PHARMACEUTICAL CO LTD

22464 A

II

1/23/2009

AUROBINDO PHARMA LTD

22465 I

III

1/27/2009

FOAMEX INNOVATIONS OPERATING CO

CILOSTAZOL USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN CHEMICAL


INDUSTRIAL PARK, CHINA
OXACILLIN FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
Z110CLMA AS MANUFACTURED IN FORT WAYNE, IN

22466 A

IV

1/21/2009

SYMRISE INC

22467 A

IV

1/22/2009

SYMRISE INC

22469 A

II

1/28/2009

DIVIS LABORATORIES LTD

DEXTROMETHORPHAN BASE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22470 A

II

1/28/2009

DIVIS LABORATORIES LTD

VENLAFAXINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22471 A

II

1/30/2009

SRINI PHARMACEUTICALS LTD

OMEPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22468 N

715870 - NATURAL MINT FLAVOR WONF AS MANUFACTURED IN CLARK, NEW JERSEY


716021 - NATURAL AND ARTIFICIAL MIXED BERRY FLAVOR AS MANUFACTURED IN CLARK,
NEW JERSEY
715990 - NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN CLARK, NEW JERSEY
715787 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CLARK,
NEW JERSEY
715680 - NATURAL AND ARTIFICIAL WINTERGREEN FLAVOR AS MANUFACTURED IN CLARK,
NEW JERSEY
LORAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

623586 ARTIFICIAL VANILLA CREAM FLAVOR POWDER 970W312 AS MANUFACTURED IN


TETEBORO, NJ AND BRANCHBURG, NJ
623590 MICROSEAL ARTIFICIAL STRAWBERRY FLAVOR 979W311 AS MANUFACTURED IN
TETEBORO, NJ AND BRANCHBURG, NJ

NOT AN ASSIGNED NUMBER

Page 656

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22472 A
II
1/22/2009
CADILA PHARMACEUTICALS LTD

SUBJECT
O-DESMETHYL VENLAFAXINE SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA

22473 A

II

1/29/2009

AUROBINDO PHARMA LTD

22474 A

II

1/23/2009

NIPPON SUISAN KAISHA LTD

NAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) MANUFACTURED IN


ANDHRA PRADESH, INDIA
EPA-E NISSUI AS MANUFACTURED IN IBARAKI-PREF., JAPAN

22475 I

II

1/20/2009

VASA PHARMACHEM PVT LTD

MAGNESIUM CARBONATE (HEAVY) AS MANUFACTURED IN GUJARAT, INDIA

22476 I

II

1/20/2009

VASA PHARMACHEM PVT LTD

MANESIUM OXIDE (HEAVY) AS MANUFACTURED IN GUJARAT, INDIA

22477 A

1/22/2009

AUROBINDO PHARMA LTD

22478 A

II

2/3/2009

AVECIA BIOTECHNOLOGY INC

22479 A

II

1/30/2009

DR REDDYS LABORATORIES LTD

STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED, UNIT-V AT


HYDERABAD, INDIA
NFKB (OLIGONUCLEOTIDE ATO) ACTIVE PHARMACEUTICAL INGREDIENT (API) AS
MANUFACTURED IN MILFORD MA
CAPECITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22480 A

II

2/6/2009

SPI PHARMA INC

22481 A

II

2/6/2009

CSPC INNOVATION PHARM CO LTD

22482 A

II

2/5/2009

MSN PHARMACHEM PVT LTD

22483 A

III

1/26/2009

TRASIS SA

SUMATRIPTAN SUCCINATE USP [ROUTE CODE - SU] AS MANUFACTURED IN ANDHRA


PRADESH INDIA
SINGLE USE CARTRIDGE AS MANUFACTURED BY MEDI-LINE S.A. IN LIEGE, BELGIUM

22484 A

II

2/5/2009

MSN PHARMACHEM PVT LTD

MONTELUKAST SODIUM [MB ROUTE] AS MANUFACTURED IN ANDHRA PRADESH INDIA

22485 A

II

2/3/2009

MYLAN LABORATORIES LTD

PREGABALIN AS MANUFACTURED IN TELANGANA, INDIA

22486 A

II

2/6/2009

NEULAND LABORATORIES LTD

TIOTROPIUM BROMIDE AS MANUFACTURED IN TELANGANA, INDIA

22487 A

II

12/31/2008

CHANGZHOU TIANHUA PHARMACEUTICAL CO LTD

TETRACAINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PR CHINA

22488 A

III

2/6/2009

WITTENBURG BV

22489 I

IV

2/2/2009

22490 I

IV

2/2/2009

22491 I

IV

2/2/2009

22492 I

IV

2/2/2009

22493 I

IV

2/2/2009

22494 I

IV

2/2/2009

22495 I

III

2/4/2009

MASTERTASTE INC DBA KERRY INGREDIENTS AND


FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
ALLTUB MEXICO

CAWITON PR6949 AND CAWITON PR8909 AS MANUFACTURED IN NIJKERKERVEEN THE


NETHERLANDS
700511 - NATURAL AND ARTIFICIAL PINEAPPLE FLAVOR AS MANUFACTURED IN CLARK, NJ
AND COMMERCE, CA
700437 - NATURAL AND ARTIFICIAL BANANA FLAVOR AS MANUFACTURED IN CLARK, NJ AND
COMMERCE, CA
700443 - NATURAL AND ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN CLARK, NJ AND
COMMERCE, CA
700439 - NATURAL AND ARTIFICIAL ORANGE PINEAPPLE FLAVOR AS MANUFACTURED IN
CLARK, NJ AND COMMERCE, CA
700059 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CLARK, NJ
AND COMMERCE, CA
707972 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CLARK, NJ
AND COMMERCE, CA
COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN SANTA CLARA MEXICO

22496 A

II

12/31/2008

CHANGZHOU TIANHUA PHARMACEUTICAL CO LTD

TETRACAINE AS MANUFACTURED IN JIANGSU PR CHINA

22497 I

IV

2/2/2009

700661 - NATURAL LEMON FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA

22498 I

IV

2/2/2009

22499 I

IV

2/2/2009

22500 I

IV

2/2/2009

MASTERTASTE INC DBA KERRY INGREDIENTS AND


FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS
MASTERTASTE INC DBA KERRY INGREDIENTS AND
FLAVOURS

MAGNESIUM HYDROXIDE DC MS90 PRODUCTS AS MANUFACTURED IN SEPTEMES LES


VALLONS FRANCE
THEOPHYLLINE AS MANUFACTURED IN HEBEI CHINA

700075 - ARTIFICIAL VANILLA NUT FLAVOR AS MANUFACTURED IN CLARK, NJ AND


COMMERCE, CA
700432 - NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR AS MANUFACTURED IN CLARK, NJ
AND COMMERCE, CA
700464 - NATURAL AND ARTIFICIAL CHOCOLATE FLAVOR AS MANUFACTURED IN CLARK, NJ
AND COMMERCE, CA

Page 657

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
22501 I
III
1/19/2009
BERRY PLASTICS CORP TAPES AND COATINGS DIV MS-C-84EAY AS MANUFACTURED IN COLUMBUS, GA
22502 I

III

1/29/2009

INGENIA POLYMERS CORP

22503 A

II

2/4/2009

ACS DOBFAR SPA

INGENIA POLYMERS 1073 SLIP AND ANTIBLOCK MASTERBATCH IN PACKAGING MATERIALS AS


MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA; AND HOUSTON, TEXAS
MEROPENEM FOR INJECTION, (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

22504 A

II

2/4/2009

ANQIU LUAN PHARMACEUTICAL CO LTD

ACETAMINOPHEN, OTC AS MANUFACTURED IN SHANG SHANDONG PROVINCE, P.R. CHINA

22505 A

II

2/25/2009

LUPIN LTD

NORETHINDRONE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

22506 A

II

3/13/2009

LUPIN LTD

ETHINYL ESTRADIOL USP AS MANUFACTURED IN MADHYA PRADESH INDIA

22507 A

II

3/26/2009

LUPIN LTD

NORETHINDRONE ACETATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

22508 A

II

3/31/2009

LUPIN LTD

LEVONORGESTREL USP AS MANUFACTURED IN MADHYA INDIA

22509 A

II

2/6/2009

APOTEX PHARMACHEM INC

22510 A

II

1/28/2009

LAURUS LABS PRIVATE LIMITED

CEVIMELINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BRANTFORD ON,


CANADA
BRIMONIDINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22511 A

III

2/5/2009

ARTE CORP

22512 I

II

2/2/2009

ALEMBIC LTD API DIV

22513 P

ONE-POINT-CUT AMPOULES FOR INJECTABLES AS MANUFACTURED IN IBARAKI


PREFECTURE, JAPAN
6-AMINOPENICILLANIC ACID AS MANUFACTURED IN GUJARAT, INDIA

*** PENDING FILING REVIEW ***

22514 A

1/30/2009

WEST PHARMACEUTICAL SERVICES INC

WESTAR LINED SEAL RS WASHING PROCESS AS PERFORMED IN ESCHWEILER, GERMANY

22515 I

II

1/16/2009

HUAYI ISOTOPES CORP

22516 A

IV

2/10/2009

GATTEFOSSE SAS

3-N-BOC-5'-0-DIMETHOXYTRITYL-3'-0-NOSYL-THYMIDINE (BOC-FLT-PRECURSOR) AS
MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA
PECEOL AS MANUFACTURED IN SAINT-PRIEST, FRANCE

22517 A

2/6/2009

XELLIA PHARMACEUTICALS APS

STERILE VALIDATION PACKAGE FOR VANCOMYCIN HCL VIALS IN COPENHAGEN, DENMARK

22518 A

IV

1/7/2009

SOLVAY CARBONATE FRANCE

SODIUM CARBONATE, ANHYDROUS AS MANUFACTURED IN MEURTHE, FRANCE

22519 A

IV

1/7/2009

SOLVAY CARBONATE FRANCE

SODIUM BICARBONATE AS MANUFACTURED IN DOMBASLE SUR MEURTHE, FRANCE

22520 I

III

2/11/2009

TEKNOR APEX CO

22521 I

III

2/11/2009

TEKNOR APEX CO

22522 I

III

1/22/2009

TEKNOR APEX CO

22523 I

III

1/22/2009

TEKNOR APEX CO

22524 I

III

2/10/2009

TEKNOR APEX CO

22525 I

III

2/11/2009

TEKNOR APEX CO

22526 I

III

2/10/2009

TEKNOR APEX CO

22527 I

III

2/11/2009

TEKNOR APEX CO

22528 A

II

2/10/2009

CONCORD BIOTECH LTD

MEDALIST MD-240 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE


ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-245 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-300 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-305 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-310 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-315 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-320 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
MEDALIST MD-325 NATURAL AS MANUFACTURED BY QST INC; TEKNOR PERFORMANCE
ELASTOMERS IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX COMPANY
VANCOMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN AHMEDABAD, INDIA

22529 A

II

1/24/2009

SHANDONG PHARMACEUTICAL GLASS CO LTD

22530 A

II

2/16/2009

GLENMARK GENERICS LTD

GLASS (TYPE II) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN


SHANDONG PROVINCE, P.R. CHINA
TADALAFIL AS MANUFACTURED IN GUJARAT, INDIA

Page 658

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22531 I
II
2/11/2009
SEQUEL PHARMACHEM PRIVATE LTD

SUBJECT
TRAMADOL HYDROCHLORID EP AS MANUFACTURED IN MAHARASHTRA, INDIA

22532 A

II

2/12/2009

MEDICHEM SA

MED-201345/E AS MANUFACTURED IN CELRA (GIRONA), SPAIN

22533 A

III

2/10/2009

AMPACET CORP

22534 A

III

10/1/2008

HOSPIRA INC

AMPACET PRODUCT 11070-KT SITE 70 T AS MANUFACTURED IN RAYONG, THAILAND FOR


AMPACET CORPORATION
STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT
PACKED IN ANSYR PLASTIC SYRINGES AS MANUFACTURED IN ROCKY MOUNT, NC

22535 I

II

2/23/2009

ZHEJIANG STARRY PHARMACEUTICAL CO LTD

IOHEXOL AS MANUFACTURED IN ZHEJIANG, CHINA

22536 I

IV

2/17/2009

FONA INTERNATIONAL INC

825.042 N-C NAT CHERRY FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL

22537 I

IV

2/18/2009

FONA INTERNATIONAL INC

877.0088U N-C COOLING MINT FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

22538 A

II

2/17/2009

DIPHARMA FRANCIS SRL

ENTACAPONE AS MANUFACTURED IN BARANZATE (MI) ITALY

22539 A

II

3/26/2009

ORCHID CHEMICALS AND PHARMACEUTICALS LTD NISOLDIPINE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA

22540 A

II

2/19/2009

SIGMA ALDRICH IRELAND LTD

BROMPHENIRAMINE MALEATE AS MANUFACTURED IN CO. WICKLOW, IRELAND

22541 A

II

1/31/2008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN ZHEJIANG, CHINA

22542 A

III

1/19/2009

22543 A

III

1/19/2009

22544 I

III

1/19/2009

22545 A

III

1/19/2009

22546 A

III

1/19/2009

22547 I

II

2/16/2009

GLASS BRANCH NORTH CHINA PHARMACEUTICAL


CO LTD
GLASS BRANCH NORTH CHINA PHARMACEUTICAL
CO LTD
GLASS BRANCH NORTH CHINA PHARMACEUTICAL
CO LTD
GLASS BRANCH NORTH CHINA PHARMACEUTICAL
CO LTD
GLASS BRANCH NORTH CHINA PHARMACEUTICAL
CO LTD
VASA PHARMACHEM PVT LTD

CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF NEUTRAL BOROSILICATE GLASS


(TYPE I) TUBING AS MANUFACTURED IN HEBEI PROVINCE, CHINA
LOW-BOROSILICATE GLASS (TYPE I) CYLINDER FOR PEN-INJECTION FOR MEDICAL USE AS
MANUFACTURED IN HEBEI PROVINCE, CHINA
NEUTRAL BOROSILICATE GLASS (TYPE I) CYLINDER FOR PEN-INJECTION FOR MEDICAL USE
AS MANUFACTURED IN HEBEI PROVINCE, CHINA
CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF LOW-BOROSILICATE GLASS (TYPE
I) TUBING AS MANUFACTURED IN HEBEI PROVINCE, CHINA
CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF SODA-LIME GLASS (TYPE II)
TUBING AS MANUFACTURED IN HEBEI PROVINCE, CHINA
MAGNESIUM OXIDE LIGHT AS MANUFACTURED IN GUJARAT, INDIA

22548 I

II

2/18/2009

VASA PHARMACHEM PVT LTD

MAGNESIUM CARBONATE LIGHT AS MANUFACTURED IN GUJARAT, INDIA

22549 I

II

2/19/2009

VASA PHARMACHEM PVT LTD

MAGNESIUM HYDROXIDE AS MANUFACTURED IN GUJARAT, INDIA

22550 I

II

2/19/2009

VASA PHARMACHEM PVT LTD

CALCIUM ACETATE AS MANUFACTURED IN GUJARAT, INDIA

22551 I

II

2/19/2009

VASA PHARMACHEM PVT LTD

SODIUM CITRATE AS MANUFACTURED IN GUJARAT, INDIA

22552 I

II

2/19/2009

VASA PHARMACHEM PVT LTD

CALCIUM CITRATE AS MANUFACTURED IN GUJARAT, INDIA

22553 A

II

2/16/2009

MALLINCKRODT INC

METHYLNALTREXONE BROMIDE, CODE 1251 AS MANUFACTURED IN ST. LOUIS, MISSOURI

22554 A

2/4/2009

BASF SE

TOXICITY REPORTS FOR KOLLICOATS RS 30 D PROCESSS FACILITY

22555 A

II

2/18/2009

TORRENT PHARMACEUTICALS LTD

OLANZAPINE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA

22556 A

II

3/13/2009

UNICHEM LABORATORIES LTD

LOSARTAN POTASSIUM USP AS MANUFACTURED IN DHAR (M.P.), INDIA

22557 A

III

2/23/2009

SABIC PETROCHEMICALS BV

SABIC LDPE PCG81 AS MANUFACTURED IN GELEEN, THE NETHERLANDS

22558 A

III

2/23/2009

SABIC PETROCHEMICALS BV

SABIC LDPE PCG22 AS MANUFACTURED IN GELEEN, THE NETHERLANDS

22559 A

II

2/20/2009

CHEMPACIFIC CORP

JLP080574 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD

22560 A

III

2/9/2009

HB FULLER CO

HL0916LV AS MANUFACTURED IN QUEBEC, CANADA

22561 A

II

2/26/2009

HUBEI HAOSUN PHARMACEUTICAL CO LTD

GLIMEPIRIDE AS MANUFACTURED IN HUBEI, CHINA

22562 A

II

2/26/2009

HUBEI HAOSUN PHARMACEUTICAL CO LTD

DOCETAXEL ANHYDROUS AS MANUFACTURED IN HUBEI, CHINA

22563 A

II

2/23/2009

HETERO LABS LTD

ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22564 A

II

2/18/2009

ALCHEM INTERNATIONAL LTD

COLCHICINE EXTRA PURE GRADE AS MANUFACTURED IN HARYANA, INDIA

Page 659

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22565 A
II
1/12/2009
INDOCO REMEDIES LTD
22566 N

SUBJECT
GLIMEPIRIDE USP AS MANUFACTURED IN DISTRICT RAIGAD, INDIA

NOT AN ASSIGNED NUMBER

22567 A

IV

2/20/2009

NIPPON FINE CHEMICAL CO LTD

22568 I

II

2/23/2009

DR REDDYS LABORATORIES LTD

A LIPOSOMAL EXCIPIENT, DIPALMITOYL PHOSPHATIDYLGLYCEROL WITH EDTA (DPPG WITH


EDTA) AS MANUFACTURED IN TAKASAGO-CITY HYOGO, JAPAN
CLOPIDOGREL PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22569 A

IV

2/23/2009

MYLAN BERTEK PHARMACEUTICALS INC

POLYOLPREPOLYMER -02 AS MANUFACTURED BY ORTEC INC IN EASLEY SOUTH CAROLINA

22570 A

II

2/23/2009

NOF CORP

22571 A

III

2/19/2009

3M DRUG DELIVERY SYSTEMS

22572 A

II

2/25/2009

APOTEX PHARMACHEM INC

ALPHA -SUCCINIMIDYLOXY CARBONYL- OMEGA -METHOXY, POLYOXYETHYLENE MW5000 AS


MANUFACTURED IN KAWASAKI-SHI KANAGAWA, JAPAN
3M SCOTCHPAK" 9738 POLYESTER FILM LAMINATE AS MANUFACTURED IN COTTAGE GROVE
MN
ZALEPLON AS MANUFACTURED IN BRANTFORD ON CANADA

22573 I

II

2/25/2009

NEULAND LABORATORIES LTD

EZETIMIBE (FORM-X) AS MANUFACTURED IN ANDHRA PRADESH INDIA

22574 I

II

2/21/2009

PHARMAZELL INDIA PRIVATE LTD

N-ACETYL TYROSINE AS MANUFACTURED IN CHENNAI INDIA

22575 A

II

2/26/2009

NEWCHEM SPA

METHYLPREDNISOLONE HEMISUCCINATE AS MANUFACTURED IN VERONA ITALY

22576 A

II

2/26/2009

NATCO PHARMA LTD

TRIHEXYPHENIDYL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22577 A

II

2/5/2009

OAK RIDGE NATIONAL LABORATORY

22578 I

II

2/26/2009

ZYFINE DIV CADILA HEALTHCARE LTD

TUNGSTEN-188/RHENIUM-188 GENERATOR FOR THE ELUTION OF RHENIUM-188 AS SODIUM


PERRHENATE (Na188ReO4) AS MANUFACTURED IN OAK RIDGE TN
EXEMESTANE AS MANUFACTURED IN AHMEDABAD GUJARAT INDIA

22579 A

II

2/26/2009

DR REDDYS LABORATORIES LTD

FONDAPARINUX SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

22580 A

II

2/17/2009

CENTAUR PHARMACEUTICALS PRIVATE LTD

CLONAZEPAM USP AS MANUFACTURED IN MAHARASHTRA INDIA

22581 A

II

2/10/2009

AURISCO PHARMACEUTICAL LTD

22582 A

II

2/20/2009

ALEMBIC PHARMACEUTICALS LTD

9-(2-PHOSPHONYLMETHOXYPROPYL) ADENINE (BULK) AS MANUFACTURED IN ZHEJIANG


PROVINCE CHINA
PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN GUJARAT INDIA

22583 A

II

2/16/2009

LAKE CHEMICALS PRIVATE LTD

CLONAZEPAM AS MANUFACTURED IN KARNATAKA, INDIA

22584 A

II

2/26/2009

SWAN CHEMICAL INC

CHLOROXYLENOL (CAS NO 88-04-0) AS MANUFACTURED IN COUNTY DURHAM, ENGLAND

22585 A

II

2/26/2009

TORRENT PHARMACEUTICALS LTD

ATORVASTATIN CALCIUM DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA

22586 A

II

2/28/2009

DR REDDYS LABORATORIES LTD

SALMETEROL XINAFOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

22587 A

II

2/27/2009

STERLING SPA

CICLESONIDE AS MANUFACTURED IN CORCIANO PERUGIA, ITALY

22588 I

III

3/3/2009

GAYHEART PHARMACEUTICAL INC

PACKING PROCESS AS MANUFACTURED IN CLEARWATER FL

22589 A

II

2/27/2009

AUROBINDO PHARMA LTD

22590 A

II

3/5/2009

POLYMED THERAPEUTICS INC

NAFCILLIN FOR INJECTION USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
DOXERCALCIFEROL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, P.R. CHINA

22591 A

IV

3/4/2009

ESSENTRA POROUS TECHNOLOGIES

22592 A

III

3/4/2009

AMARTARA PRIVATE LTD

22593 A

IV

2/19/2009

NUSIL TECHNOLOGY LLC

HI-LINK PREPOLYMER AND MEDICAL GRADE FEXIBLE POLYURETHANE FOAM MADE USING HILINK PREPOLYMER AS MANUFACTURED IN ST. CHARLES, MI
COLD FORM BLISTER FILM LAMINATE (PVC-ALUMINUM-OPA COMPOSITE) AS MANUFACTURED
IN MAHARASHTRA, INDIA
DDU-4351 SILICONE GEL AS MANUFACTURED IN CARPINTERIA, CA

22594 I

II

12/31/2008

HEBEI JINGYE CHEMICAL CO LTD

ASPIRIN AS MANUFACTURED IN SHIJIAZHUANG CITY, HEBEI, P.R. CHINA

22595 I

II

12/31/2008

HEBEI JINGYE CHEMICAL CO LTD

SALICYLIC ACID AS MANUFACTURED IN SHIJIAZHUANG CITY HEBEI, P.R. CHINA

22596 A

II

3/5/2009

APOTEX PHARMACHEM INDIA PVT LTD

RILUZOLE AS MANUFACTURED IN BANGALORE, INDIA

22597 I

III

3/10/2009

ADHESIVES RESEARCH INC

MA-78 (A4397) ADHESIVE AS MANUFACTURED IN GLEN ROCK, PENNSYLVANIA AND LIMERICK,


IRELAND

Page 660

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22598 A
II
3/5/2009
SHANDONG XINHUA PHARMACEUTICAL CO LTD

SUBJECT
LEVODOPA USP AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA

22599 A

II

3/6/2009

SIGNA SA DE CV

22600 I

II

3/6/2009

EURAND PHARMACEUTICALS INC

SILDENAFIL CITRATE AS MANUFACTURED BY SIGNA S.A. DE C.V. IN TOLUCA, MEXICO FOR


APOTEX PHARMACHEM INC
EUR-1084 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA, OHIO

22601 I

II

3/4/2009

KAMUD DRUGS PVT LTD

22602 A

II

2/27/2009

WOCKHARDT LTD

DIPHENHYDRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN SANGLI MAHARASHTRA,


INDIA; KOLHAPUR, MAHARASHTRA, INIDA
CHLOROTHIAZIDE SODIUM AS MANUFACTURED IN GUJARAT INDIA

22603 A

II

3/5/2009

AJINOMOTO NORTH AMERICA INC

L-ALANYL-L-GLUTAMINE AS MANUFACTURED IN RALEIGH NC

22604 A

IV

1/19/2009

BASF SE

KOLLIDON CL AS MANUFACTURED IN LUDWIGSHAFEN GERMANY

22605 I

II

3/9/2009

AMCOL HEALTH AND BEAUTY SOLUTIONS INC

MICROSPONGE P009A-13 BENZOYL PEROXIDE (BENZOYL PEROXIDE IN METHYL


METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER) AS MANUFACTURED IN
LAFAYETTE LA

22606 A

III

3/3/2009

REXAM HEALTHCARE OFFRANVILLE SAS

PLASTIC CLOSED VIAL AS MANUFACTURED IN OFFRANVILE FRANCE

22607 A

II

3/12/2009

DR REDDYS LABORATORIES LTD

DEXLANSOPRAZOLE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA

22608 I

IV

3/11/2009

FONA INTERNATIONAL INC

22609 I

II

3/12/2009

BEIJING JIKANLITONG PHARM TECH CO LTD

Product 833.0185U FONATECH CAPPUCCINO FLAVOR, NAT & ART (MET) AS MANUFACTURED
IN GENEVA IL
TETRACAINE HYDROCHLORIDE AS MANUFACTURED IN BEIJING CHINA

22610 A

II

3/12/2009

FLAMMA SPA

MELATONIN AS MANUFACTURED IN BERGAMO ITALY

22611 A

II

3/13/2009

SCINOPHARM TAIWAN LTD

FULVESTRANT USP AS MANUFACTURED IN TAIWAN ROC

22612 A

II

3/31/2009

ORCHID CHEMICALS AND PHARMACEUTICALS LTD TRANS-RESVERATROL (SERIES A) AS MANUFACTURED IN MAHARASHTRA, INDIA

22613 I

II

7/22/2009

IPCA LABORATORIES LTD

PERINDOPRIL TERT-BUTYLAMINE PH EUR AS MANUFACTURED IN MADHYA PRADESH INDIA

22614 I

II

4/1/2010

IPCA LABORATORIES LTD

VALSARTAN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

22615 P

*** PENDING FILING REVIEW ***

22616 I

II

6/30/2009

IPCA LABORATORIES LTD

ISOTRETINOIN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

22617 A

II

4/3/2010

IPCA LABORATORIES LTD

MESALAMINE USP (PROCESS II) AS MANUFACTURED IN MADHYA PRADESH, INDIA

22618 A

3/10/2009

LUITPOLD PHARMACEUTICALS INC

22619 A

II

3/5/2009

PHARMAZELL INDIA PRIVATE LTD

SUPPORTING FACILITY, EQUIPMENT & VALIDATION INFORMATION MANUFACTURING FACILITY


IN SHIRLEY, NY
CLOPIDOGREL BISULFATE AS MANUFACTURED IN CHENNAI, INDIA

22620 A

II

3/13/2009

APOTEX PHARMACHEM INDIA PVT LTD

CABERGOLINE USP AS MANUFACTURED IN BANGALORE INDIA

22621 A

II

3/13/2009

APOTEX PHARMACHEM INDIA PVT LTD

NARATRIPTAN HYDROCHLORIDE AS MANUFACTURED IN BANGALORE INDIA

22622 A

II

3/13/2009

SRINI PHARMACEUTICALS LTD

AMLODIPINE BESYLATE AS MANUFACTURED IN CHOUTUPPAL AP INDIA

22623 I

II

3/16/2009

EMCURE PHARMACEUTICALS LTD

TENOFOVIR DISOPROXIL FUMARATE ( ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

22624 A

II

3/13/2009

CRYSTAL PHARMA SAU

PREDNISOLONE SODIUM PHOSPHATE AS MANUFACTURED IN BOECILLO VALLADOLID SPAIN

22625 A

II

3/13/2009

LABORATORIO CHIMICO INTERNAZIONALE SPA

ACAMPROSATE CALCIUM AS MANUFACTURED IN SEGRATE MI ITALY

22626 A

II

3/13/2009

CHEMPACIFIC CORP

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN BALTIMORE MD

22627 A

II

3/12/2009

SCI PHARMTECH INC

22628 A

III

3/9/2009

AMPACET CORP

THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID (RITALINIC ACID) AS MANUFACTURED IN


TAOYUAN TAIWAN
11748-KM BLOMITE 48 AS MANUFACTURED IN RAYONG THAILAND

22629 A

III

3/9/2009

AMPACET CORP

11078-KM BLOMITE 78 AS MANUFACTURED IN RAYONG THAILAND

22630 A

III

3/9/2009

AMPACET CORP

11070-KM BLOMITE 70 AS MANUFACTURED IN RAYONG THAILAND

22631 A

II

3/16/2009

FORMOSA LABORATORIES INC

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN TAIWAN

Page 661

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22632 A
II
3/25/2009
SUN PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
LETROZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

22633 A

II

3/16/2009

SEQUENT SCIENTIFIC LTD

22634 A

II

3/19/2009

DR REDDYS LABORATORIES LTD

22635 A

IV

3/17/2009

CAPSUGEL

HYDRALAZINE HYDROCHLORIDE AS MANUFACTURED IN NEW MANGALORE KARNATAKA


INDIA
O-DESMETHYL VENLAFAXINE SUCCINATE (AMORPHOUS) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
VCAPS PLUS AS MANUFACTURED IN PUEBLA MEXICO

22636 A

II

3/19/2009

CEDARBURG PHARMACEUTICALS LLC

NEPAFENAC ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN GRAFTON WI

22637 A

II

3/20/2009

CHEMPACIFIC CORP

CARMUSTINE DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD

22638 A

II

3/30/2009

UNICHEM LABORATORIES LTD

ALFUZOSIN HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

22639 A

II

5/12/2009

UNICHEM LABORATORIES LTD

22640 I

II

3/16/2009

KAMUD DRUGS PVT LTD

DONEPEZIL HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN MADHYA


PRADESH INDIA
PROBENECID USP AS MANUFACTURED IN MAHARASHTRA INDIA

22641 A

II

3/19/2009

STERLING SPA

BUDESONIDE AS MANUFACTURED IN PERUGIA ITALY

22642 I

IV

3/17/2009

ALFA ADHESIVES INC AKA SIMALFA

SIMALFA 309 AS MANUFACTURED IN HAWTHORNE NJ

22643 I

II

12/25/2008

CHONGQING KANGLE PHARMACEUTICAL CO LTD

22644 A

III

3/17/2009

REXAM HEALTHCARE OFFRANVILLE SAS

22645 A

II

3/23/2009

DR REDDYS LABORATORIES LTD

CILOSTAZOL DRUG SUBSTANCE NON STERILE AS MANUFACTURED IN CHONGQING


CHEMICAL INDUSTRIAL PARK CHINA
INJECTION BLOW MOULDED PLASTIC CONTAINERS AS MANUFACTURED IN OFFRANVILLE
FRANCE
EXEMESTANE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22646 A

II

12/9/2008

MAHIMA LIFE SCIENCES PRIVATE LTD

BETAMETHASONE SODIUM PHOSPHATE USP AS MANUFACTURED IN HARYANA INDIA

22647 A

II

12/9/2008

MAHIMA LIFE SCIENCES PRIVATE LTD

DEXAMETHASONE SODIUM PHOSPHATE USP AS MANUFACTURED IN HARYANA INDIA

22648 A

II

12/9/2008

MAHIMA LIFE SCIENCES PRIVATE LTD

BECLOMETHASONE DIPROPIONATE USP AS MANUFACTURED IN HARYANA INDIA

22649 A

II

12/9/2008

MAHIMA LIFE SCIENCES PRIVATE LTD

BETAMETHASONE DIPROPIONATE USP AS MANUFACTURED IN HARYANA INDIA

22650 A

II

12/9/2008

MAHIMA LIFE SCIENCES PRIVATE LTD

CLOBETASOL PROPIONATE USP AS MANUFACTURED IN HARYANA INDIA

22651 A

II

12/9/2008

MAHIMA LIFE SCIENCES PRIVATE LTD

BETAMETHASONE VALERATE USP AS MANUFACTURED IN HARYANA INDIA

22652 A

II

3/21/2009

AUROBINDO PHARMA LTD

22653 A

III

2/27/2009

MWV CALMAR GMBH

SERTRALINE HYDROCHLORIDE CRYSTALLINE POLYMORPH FORM I AS MANUFACTURED IN


ANDHRA PRADESH INDIA
MK VII SPRAYER MEDICAL DEVICE AS MANUFACTURED IN HEMER GERMANY

22654 A

II

3/9/2009

IND SWIFT LABORATORIES LTD

CLARITHROMYCIN CITRATE AS MANUFACTURED IN PUNJAB INDIA

22655 I

II

3/10/2009

AURISCO PHARMACEUTICAL LTD

22656 A

II

3/14/2009

SEQUEL PHARMACHEM PRIVATE LTD

9-(2-PHOSPHONYIMETHOXYPROPYL) ADENINE AS MANUFACTURED IN ZHEJIANG PROVINCE


CHINA
LAMOTRIGINE EP AS MANUFACTURED IN MAHARASHTRA INDIA

22657 A

IV

3/23/2009

HENKEL CORPORATION

DURO-TAK 87-616A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

22658 A

II

3/24/2009

DR REDDYS LABORATORIES LTD

CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

22659 A

III

3/14/2009

PARIKH PACKAGING PVT LTD

FLEXIBLE PRINTED LAMINATES AND POUCHES AS MANUFACTURED IN GUJARAT INDIA

22660 A

IV

3/18/2009

UNGERER AND CO

22661 A

II

3/25/2009

DR REDDYS LABORATORIES LTD

ORANGE SPRAY DRIED FLAVOURING V7095-1NC1 AS MANUFACTURED IN CHESTER AND


CEREDIGION UNITED KINGDOM
TROSPIUM CHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22662 A

IV

3/25/2009

BASF SE

22663 A

II

4/3/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

KOLLICOATE MAE 100 P AS MANUFACTURED IN LUDWIGSHAFEN FEDERAL REPUBLIC OF


GERMANY
LANSOPRAZOLE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22664 A

II

3/23/2009

AARTI INDUSTRIES LTD

MESNA AS MANUFACTURED IN MAHARASHTRA INDIA

Page 662

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22665 A
III
3/6/2009
NIPRO STERILE GLASS GERMANY AG
22666 A

II

3/26/2009

NISSAN CHEMICAL INDUSTRIES LTD

SUBJECT
STERILE PREFILLABLE DISPOSABLE SYRINGES AS MANUFACTURED IN MUNNERSTADT
GERMANY
NIP-022TM AS MANUFACTURED IN YAMAGUCHI JAPAN

22667 A

II

3/25/2009

AMINO CHEMICALS LTD

RASAGILINE MESYLATE AS MANUFACTURED IN MARSA MALTA

22668 A

II

3/27/2009

SYNTHON BV

ZOLPIDEM TARTRATE AS MANUFACTURED IN PROVINCIA DE SANTA FE ARGENTINA

22669 A

III

3/10/2009

AMPACET CORP

807242 AO POLYETHYLENE MASTERBATCH AS MANUFACTURED IN ONTARIO CANADA

22670 A

II

3/27/2009

HOVIONE PHARMASCIENCE LTD

KB01 AS MANUFACTURED IN TAIPA, MACAU S.A.R

22671 A

II

3/30/2009

TORRENT PHARMACEUTICALS LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT INDIA

22672 A

II

3/30/2009

TORRENT PHARMACEUTICALS LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT INDIA

22673 A

II

3/30/2009

GLENMARK GENERICS LTD

TROSPIUM CHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22674 P

*** PENDING FILING REVIEW ***

22675 I

II

5/14/2009

YUAN XINYAN

FINASTERIDE (API) AS MANUFACTURED IN HUNAN PROVINCE PRC

22676 A

II

3/31/2009

GLENMARK GENERICS LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT INDIA

22677 A

II

3/31/2009

GLENMARK GENERICS LTD

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22678 A

II

3/31/2009

DR REDDYS LABORATORIES LTD

THALIDOMIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22679 A

II

3/25/2009

MEGAFINE PHARMA P LTD

22680 A

II

9/28/2009

CIMA LABORATORIES INC

VENLAFAXINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


NASHIK INDIA
CETIRIZINE HCI COATED GRANULES AS MANUFACTURED IN EDEN PRAIRIE MN

22681 A

II

3/31/2009

CAMBRIDGE MAJOR LABS INC

DEXMEDETOMIDINE HYDROCHLORIDE FP-071 AS MANUFACTURED IN GERMANTOWN WI

22682 A

II

3/20/2009

EUTICALS SPA

HYDRALAZINE HYDROCHLORIDE INJECTABLE GRADE AS MANUFACTURED IN VARESE ITALY

22683 A

II

4/1/2009

AARTI DRUGS LTD

S (-) RIVASTIGMINE BASE AS MANUFACTURED IN MAHARASHTRA INDIA

22684 A

II

3/31/2009

CADILA HEALTHCARE LTD

VALSARTAN USP AS MANUFACTURED IN GUJARAT INDIA

22685 A

II

3/26/2009

ITALFARMACO SPA

STERILE WATER FOR INJECTION USP AS MANUFACTURED IN MILAN

22686 A

II

4/1/2009

MARCUS RESEARCH LABORATORY INC

POVIDONE IODINE (API) AS MANUFACTURED IN ST LOUIS MO

22687 A

II

3/31/2009

CADILA HEALTHCARE LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22688 A

II

3/31/2009

SCINOPHARM TAIWAN LTD

ZOLEDRONIC ACID AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC

22689 A

II

3/31/2009

CADILA HEALTHCARE LTD

TELMISARTAN PH EUR ( E SUB) AS MANUFACTURED IN GUJARAT INDIA

22690 A

II

3/31/2009

CADILA HEALTHCARE LTD

VENLAFAXINE HYDROCHLORIDE PH EUR AS MANUFACTURED IN GUJARAT INDIA

22691 A

II

3/27/2009

ALEMBIC PHARMACEUTICALS LTD

22692 A

II

4/2/2009

22693 A

II

3/31/2009

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD
MITSUI NORIN CO LTD

O-DESMETHYL VENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN GUJARAT


INDIA
SULFADIAZINE AS MANUFACTURED IN CHONGQING PR CHINA

22694 I

II

3/27/2009

ALEMBIC PHARMACEUTICALS LTD

POLYPHENON E (NON TOPICAL USE) AS MANUFACTURED BY ALPS PHARM IND CO LTD IN


HIDA-SHI GIFU JAPAN FOR MITSUI NORIN CO LTD
O-DESMETHYL VENLAFAXINE AS MANUFACTURED IN GUJARAT INDIA

22695 A

II

3/27/2009

ALEMBIC PHARMACEUTICALS LTD

ERYTHROMYCIN USP AS MANUFACTURED IN GUJARAT INDIA

22696 A

II

4/3/2009

GE HEALTHCARE INC

FASTLAB FDG CASSETTE PACK AS MANUFACTURED IN OSLO NORWAY

22697 A

II

3/25/2009

DONGYING TIANDONG PHARMACEUTICAL CO LTD

HEPARIN SODIUM AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA

22698 A

III

4/3/2009

RENOLIT NEDERLAND BV

SOLMED WRAPFLEX AS MANUFACTURED IN ENKHUIZEN THE NETHERLANDS AND THANSAU


GERMANY

Page 663

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22699 A
II
4/3/2009
CARDINAL HEALTH 414 LLC
22700 A

II

4/2/2009

MALLINCKRODT INC

SUBJECT
3-DEOXY-3-[18F]FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN WOBURN MA; SEATTLE
WA; AND BELTSVILLE MD
METHADONE BASE SPECIAL AS MANUFACTURED IN ST LOUIS MO

22701 A

III

3/31/2009

HUDSON COLOR CONCENTRATES

WHITE HC80003LD AS MANUFACTURED IN LEOMINSTER MA

22702 A

III

3/31/2009

HUDSON COLOR CONCENTRATES

WHITE HC81372LD AS MANUFACTURED IN LEOMINSTER MA

22703 A

III

4/6/2009

SABIC INNOVATIVE PLASTICS

22704 I

II

4/7/2009

EMCURE PHARMACEUTICALS LTD

XYLEX * RESINS AS MANUFACTURED IN MT VERNON, INDIANA (USA), AND BERGEN-OP-ZOOM,


THE NETHERLANDS.
EFAVIRENZ (ALTERNATE PROCESS) AS MANUFACTURED IN MAHARASHTRA INDIA

22705 A

II

4/7/2009

SMS PHARMACEUTICALS LTD

IMIDAPRIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22706 A

III

4/7/2009

SHINKO CHEMICAL CO LTD

22707 A

II

3/31/2009

ALEMBIC PHARMACEUTICALS LTD

STANDARD PLASTIC CONTAINER AS MANUFACTURED IN ISHIKAWA JAPAN (KANAZAWA


FACTORY) AND ISHIKAWA JAPAN (MATTO FACTORY)
TADALAFIL AS MANUFACTURED IN GUJARAT INDIA

22708 I

II

4/6/2009

SEQUENT SCIENTIFIC LTD

EFAVIRENZ AS MANUFACTURED IN KARNATAKA INDIA

22709 A

II

4/8/2009

AARTI INDUSTRIES LTD

ADAPALENE AS MANUFACTURED IN MAHARASHTRA INDIA

22710 A

II

3/30/2009

AUCTUS PHARMA LTD

FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

22711 A

II

4/2/2009

AUCTUS PHARMA LTD

LOSARTAN POTASSIUM USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

22712 A

II

4/8/2009

ASAHI KASEI CHEMICALS CORP

ASAHI KASEI PVDC LATEX AS MANUFACTURED IN TOKYO JAPAN

22713 A

II

4/9/2009

SIGNA SA DE CV

22714 A

II

3/25/2009

ARCH PHARMALABS LTD

FAMCICLOVIR AS MANUFACTURED BY SIGNA SA DE DV IN TOLUCA MEXICO FOR APOTEX


PHARMACHEM INC
ENTACAPONE AS MANUFACTURED IN THANE, INDIA

22715 A

II

4/7/2009

INALCO SAS DI GIOVANNI CIPOLLETTI AND C

D-(-)-TAGATOSE AS MANUFACTURED IN PISTOIA ITALY

22716 I

IV

4/8/2009

FONA INTERNATIONAL INC

816.0416U BUTTER FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL

22717 I

IV

4/8/2009

FONA INTERNATIONAL INC

816.0415U BUTTER FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL

22718 A

II

4/7/2009

BEIJING MEDIKING BIOPHARM CO LTD

22719 A

IV

4/14/2009

SYMRISE INC

22720 A

II

4/14/2009

DIPHARMA FRANCIS SRL

TROSPIUM CHLORIDE AS MANUFACTURED BY JINAN JINDA PHARM CHEM CO LTD IN


SHANDONG PROVINCE PR CHINA FOR BEIJING MEDIKING BIOPHARM CO LTD
828936 EVOGLASS NATURAL & ARTIFICIAL MIXED BERRY FLAVOR AS MANUFACTURED IN
TETERBORO NJ AND BRANCHBURG NJ
BUPROPION HYDROBROMIDE AS MANUFACTURED IN VARESE ITALY

22721 A

II

4/14/2009

AMINO CHEMICALS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN MARSA MALTA

22722 A

II

4/13/2009

OTSUKA CHEMICAL INDIA LTD

P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-LAZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE AS MANUFACTURED IN DISTT JAIPUR


(RAJ) INDIA

22723 I

II

4/15/2009

22724 I

III

4/6/2009

SANDOZ SYNTEK ILAC HAMMADDELERI SANAYI VE ATORVASTATIN ATV-44 INTERMEDIATE AS MANUFACTURED IN ISTANBUL TURKEY
TICARET AS
UNIQUE BLOWMOULDING INC
40ML WHITE HDPE BELL ROUND BOTTLE 18-415 AS MANUFACTURED IN ONTARIO CANADA

22725 A

III

4/15/2009

PLIANT CORP

XIO-2.0 SERIES FILM AS MANUFACTURED IN CHIPPEWA FALLS WI

22726 A

II

4/15/2009

LUPIN LTD

NORGESTIMATE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

22727 A

III

9/23/2010

ZOGENIX INC

22728 I

II

4/15/2009

LUPIN LTD

DOSEPRO NEEDLE-FREE DELIVERY SYSTEM AS MANUFACTURED IN SWINDON WILTSHIRE


UK AND DUBLIN IRELAND FOR ZOGENIX INC
ATORVASTATIN AS MANUFACTURED IN MAHARASHTRA INDIA

22729 A

II

5/25/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

NARATRIPTAN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22730 A

II

5/7/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

CHLOROTHIAZIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22731 A

II

4/7/2009

MSN PHARMACHEM PVT LTD

TELMISARTAN USP [ROUTE CODE - TM] AS MANUFACTURED IN ANDHRA PRADESH INDIA

Page 664

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22732 A
II
4/15/2009
ACS DOBFAR SPA

SUBJECT
AMIKACIN 1.8 SULPHATE AS MANUFACTURED IN BERGAMO ITALY

22733 A

II

4/17/2009

GADOR SA

SODIUM ALENDRONATE AS MANUFACTURED IN PROVINCIA DE BUENOS AIRES ARGENTINE

22734 A

IV

4/16/2009

LIPOID GMBH

LIPOID E 80 N AS MANUFACTURED IN LUDWIGSHAFEN GERMANY

22735 A

II

3/31/2009

ZACH SYSTEM SPA

NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN LONIGO ITALY

22736 A

II

4/17/2009

FUJI SILYSIA CHEMICAL LTD

22737 A

III

4/14/2009

FOILS PLUS

22738 A

II

4/20/2009

CHIROGATE INTERNATIONAL INC

SYNTHETIC AMORPHOUS SILICA FOR CHROMATOGRAPHY PRODUCTS - CHROMATOREX AS


MANUFACTURED IN AICHI-KEN JAPAN
PACKAGING MATERIAL FOR PHARMACEUTICAL TABLETS/CAPULES/SOLID DOSAGE FORMS AS
MANUFACTURED IN MAHARASHTRA INDIA
TRAVOPROST AS MANUFACTURED IN TAOYUAN COUNTY TAIWAN

22739 A

II

5/5/2009

ALKERMES INC

22740 A

II

4/20/2009

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

MICROSPHERE DILUENT AS MANUFACTURED BY BAXTER PHARMACEUTICALS SOLUTIONS


INC IN BLOOMINGTON INDIANA FOR ALKERMES INC
SEVOFLURANE AS MANUFACTURED IN SHANDONG PROVINCE CHINA

22741 A

II

4/23/2009

RANBAXY LABORATORIES LTD

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA

22742 A

IV

4/17/2009

INTERNATIONAL SPECIALTY PRODUCTS

22743 A

4/20/2009

22744 A

II

4/20/2009

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
MEGAFINE PHARMA P LTD

ADVANTIA PREFERRED AS MANUFACTURED BY EMERSON RESOURCES INC IN NORRISTOWN


PA FOR INTERNATIONAL SPECIALTY PRODUCTS
BIOPHARMACEUTICAL PRODUCTION FACILITY LOCATED IN BIBERACH GERMANY

22745 A

II

4/20/2009

22746 A

II

4/28/2009

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
SANWA KAGAKU KENKYUSHO CO LTD

22747 A

II

4/23/2009

UNIMARK REMEDIES LTD

PIMOZIDE USP [TYPE-2] AS MANUFACTURED IN GUJARAT INDIA

22748 A

II

4/15/2009

INTAS PHARMACEUTICALS LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

22749 I

II

4/21/2009

NEWCHEM SPA

DESONIDE MICRONIZED AS MANUFACTURED IN VERONA ITALY

22750 A

II

4/18/2009

NEWCHEM SPA

NOMEGESTROL ACETATE AS MANUFACTURED IN VERONA ITALY

22751 A

II

4/29/2009

SEQUENT SCIENTIFIC LTD

INDOMETHACIN SODIUM AS MANUFACTURED IN NEW MANGALORE KARNATAKA INDIA

22752 A

II

4/30/2009

SUVEN LIFE SCIENCES LTD

CALCIUM ACETATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

22753 A

6/25/2009

SANDOZ CANADA INC

STERILE MANUFACTURING FACILITY LOCATED IN BOUCHERVILLE QC CANADA

22754 A

II

4/30/2009

AUROBINDO PHARMA LTD

22755 I

II

5/1/2009

ALKERMES GAINESVILLE LLC

NAPROXEN USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
N1679 NANOCRYSTAL CAPSULE AS MANUFACTURED IN KING OF PRUSSIA PA

22756 I

IV

5/4/2009

LIFEBLOOD MEDICAL INC

22757 I

II

5/5/2009

SANDOZ PRIVATE LTD

LIFOR ACF PERFUSION MEDIA, A NOVEL EXCIPIENT AS MANUFACTURED BY HYCLONE


LABORATORIES INC IN LOGAN UTAH FOR LIFEBLOOD MEDICAL INC
ESCITALOPRAM OXALATE AS MANUFACTURED IN MAHARASHTRA INDIA

22758 A

II

5/1/2009

EUTICALS SPA

DIHYDROLYSERGIC ACID (INTERMEDIATE) AS MANUFACTURED IN ROZZANO MI ITALY

22759 A

4/24/2009

HAUPT PHARMA LATINA SRL

STERILE PEN POWDERS ASEPTIC FACILITY LOCATED IN LATINA ITALY

22760 A

II

5/4/2009

NORDMARK ARZNEIMITTEL GMBH CO KG

NEUTRAL PROTEASE NB GMP GRADE AS MANUFACTURED IN UETERSEN GERMANY

22761 A

II

5/4/2009

NORDMARK ARZNEIMITTEL GMBH CO KG

COLLAGENASE NB 1 GMP GRADE AS MANUFACTURED IN UETERSEN GERMANY

22762 A

III

5/4/2009

AMPACET CORP

22763 A

II

5/8/2009

NATCO PHARMA LTD

22764 I

II

5/8/2009

BOEHRINGER INGELHEIM LABSO CHIMIE FINE

612302-PT WHITE PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,


CATERSVILLE GA, AND HEATH OH
RIZATRIPTAN BENZOATE (ROUTE - 2; PRODUCT CODE: RTB) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
DIPYRIDAMOLE AS MANUFACTURED IN BLANQUEFORT FRANCE

QUETIAPINE HEMIFUMARATE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN DIST


NASHIK INDIA
TOPIRAMATE AS MANUFACTURED IN GUJARAT INDIA
SK 0403 DRUG SUBSTANCE AS MANUFACTURED IN IWATE JAPAN

Page 665

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22765 A
II
5/8/2009
ANJAN DRUG PRIVATE LTD

SUBJECT
GABAPENTIN USP AS MANUFACTURED IN TAMIL NADU INDIA

22766 A

II

5/7/2009

APICORE US LLC

PROCARBAZINE HYDROCHLORIDE USP AS MANUFACTURED IN SOMERSET NJ

22767 A

II

5/11/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

22768 I

II

5/8/2009

SEQUEL PHARMACHEM PRIVATE LTD

TIGECYCLINE AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD IN BEER SHEVA


ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
TELMISARTAN EP AS MANUFACTURED IN MAHARASHTRA INDIA

22769 A

IV

4/7/2009

SANYO CHEMICAL INDUSTRIES LTD

SANWET IM-300MPS AND LS-300 AS MANUFACTURED IN AICHI JAPAN

22770 I

II

5/12/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

22771 A

II

5/13/2009

RANBAXY LABORATORIES LTD

CASPOFUNGIN AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD IN BEER SHEVA


ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB INDIA

22772 A

II

5/13/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

22773 I

II

5/13/2009

INTERQUIM SA

22774 A

III

5/7/2009

EXXONMOBIL CHEMICAL CO

22775 A

II

5/12/2009

RELIANCE LIFE SCIENCES PVT LTD

BROMINATED ISOBUTYLENE - PARAMETHYLSTYRENE RUBBER AS MANUFACTURED IN


BAYTOWN TX
TEMOZOLOMIDE USP AS MANUFACTURED IN NAVI MUMBAI INDIA

22776 A

II

5/14/2009

SIFAVITOR SRL

TROSPIUM CHLORIDE AS MANUFACTURED IN LODI ITALY

22777 A

III

5/8/2009

RELIANCE INDUSTRIES LTD

RELENE B56003 AS MANUFACTURED IN TAL VAGRA DIST BHARUCH INDIA

22778 A

IV

5/14/2009

YASUHARA CHEMICAL CO LTD

YS RESIN PX 1150N AS MANUFACTURED IN EHIME JAPAN

22779 I

5/13/2009

LABORATOIRES THISSEN SA

22780 A

4/30/2009

PHASE V TECHNOLOGIES INC

STERILIZATION PROCESS VALIDATION IN APPLICATIONS FOR HUMAN AND VETERINARY


DRUG PRODUCTS LOCATED IN BRAINE I ALLEUD BELGIUM
PHASE V OUTCOMES INFORMATION SYSTEM LOCATED IN WELLESLEY HILLS MA

22781 I

II

5/15/2009

CF PHARMA LTD

PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN BUDAPEST HUNGARY

22782 A

II

5/15/2009

NURAY CHEMICALS PVT LTD

22783 A

III

5/11/2009

AMPACET CORP

22784 A

II

5/15/2009

APOTEX PHARMACHEM INDIA PVT LTD

22785 A

II

5/18/2009

MSN PHARMACHEM PVT LTD

22786 A

II

5/13/2009

WUXI FORTUNE PHARMACEUTICAL CO LTD

RASAGILINE MESYLATE (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


TAMIL NADU, INDIA
111717 A WHITE PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
BICALUTAMIDE USP AS MANUFACTURED BY SRINI PHARMACEUTICALS LTD IN AP INDIA FOR
APOTEX PHARMACHEM INDIA PVT LTD
ATORVASTATIN CALCIUM (AMORPHOUS) [ROUTE CODE- "ACA"] AS MANUFACTURED IN
ANDHRA PRADESH INDIA
MYCOPHENOLATE MOFETIL AS MANUFACTURED IN WUXI CITY JIANGSU PROVINCE PR CHINA

22787 I

II

5/14/2009

CHONGQING BIOCARE PHARMACEUTICAL CO LTD

RIFABUTIN USP AS MANUFACTURED IN CHONGQING CHINA

22788 A

III

5/13/2009

AMPACET CORP

22789 A

II

5/15/2009

AUROBINDO PHARMA LTD

22790 A

IV

5/20/2009

BASF SE

169625 BLUE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN,


DERIDDER LA, CARTERSVILLE GA, HEATH OH
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA
PRADESH INDIA
KOLLIPHOR(R) TPGS AS MANUFACTURED IN KANKAKEE IL

22791 A

II

5/21/2009

FARMASTUR 2010 SL

AMPICILLIN AND SULBACTAM STERILE MIXTURE AS MANUFACTURED IN ASTURIAS SPAIN

22792 A

III

5/1/2009

JW LIFE SCIENCE

22793 A

III

5/1/2009

JW LIFE SCIENCE

22794 I

II

5/21/2009

EMCURE PHARMACEUTICALS LTD

MEDITUBE (MT-400) AS MANUFACTURED BY CHEMITOWN CO LTD IN KYEONGGI DO KOREA


FOR CHOONGWAE CORPORATION
MEDIROLL (CT-800) AS MANUFACTURED BY CHEMITOWN CO LTD IN KYEONGGI DO KOREA
FOR CHOONGWAE CORPORATION
CYCLOPHOSPHAMIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

FLUNISOLIDE ANHYDROUS (NEW PROCESS) AS MANUFACTURED BY SICOR SRL IN RHO (MI)


ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
RIVASTIGMINE TARTRATE AS MANUFACTURED IN BARCELONA SPAIN

Page 666

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22795 A
II
3/23/2009
YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO
LTD
22796 A
III
10/31/2009
IMARETCIOGLU LTD CO

SUBJECT
MECLOFENAMATE SODIUM "YUNG SHIN" AS MANUFACTURED IN TAIWAN ROC

22797 A

III

10/31/2009

IMARETCIOGLU LTD CO

AMBER ONE POINT CUT (OPC) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY

22798 A

III

5/8/2009

IMARETCIOGLU LTD CO

AMBER COLOUR BREAK (CBR) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY

22799 A

III

5/8/2009

IMARETCIOGLU LTD CO

CLEAR COLOUR BREAK (CBR) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY

22800 A

II

5/16/2009

LAURUS LABS PRIVATE LIMITED

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

22801 A

II

5/26/2009

APICORE US LLC

AZACITIDINE AS MANUFACTURED IN SOMERSET, NJ

22802 A

II

5/15/2009

NEWCHEM SPA

DROSPIRENONE AS MANUFACTURED IN VERONA ITALY

22803 A

IV

5/26/2009

SHOWA DENKO KK

VISCOMATE AS MANUFACTURED IN KANAGAWA JAPAN

22804 A

IV

5/7/2009

DEEPAK CELLULOSE PVT LTD

22805 A

III

5/19/2009

AMPACET CORP

22806 A

III

5/19/2009

AMPACET CORP

HYPROMELLOSE PHTHALATE USP NF (HYDROXYPROPYL METHYLCELLULOSE PHTHALATE


USP NF) AS MANUFACTURED IN GUJARAT INDIA
112213 BLUE WHITE PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA, AND HEATH OH
11134 K SITE 34 AS MANUFACTURED IN RAYONG THAILAND

22807 I

II

5/15/2009

XIAN LIBANG PHARMACEUTICAL CO LTD

SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN SHAANXI PROVINCE CHINA

22808 A

II

5/27/2009

APOTEX PHARMACHEM INDIA PVT LTD

TROSPIUM CHLORIDE USP AS MANUFACTURED IN BANGALORE KARNATAKA INDIA

22809 A

II

5/8/2009

22810 A

II

6/15/2009

22811 A

II

6/15/2009

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO BUPROPION HYDROBROMIDE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
LTD
ARCH PHARMALABS LTD
APIF12B AS MANUFACTURED BY VITALIFE LABORATORIES IN HARYANA INDIA FOR ARCH
PHARMALABS LIMITED
COSMA SPA
RANOLAZINE AS MANUFACTURED IN CISERANO (BERGAMO) ITALY

22812 A

II

5/29/2009

NATCO PHARMA LTD

LETROZOLE (LER) AS MANUFACTURED IN ANDHRA PRADESH INDIA

22813 A

II

5/25/2009

UNIMARK REMEDIES LTD

LAMOTRIGINE USP AS MANUFACTURED IN GUJARAT INDIA

22814 N

CLEAR ONE POINT CUT (OPC) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY

NOT AN ASSIGNED NUMBER

22815 A

IV

5/26/2009

NIPPON FINE CHEMICAL CO LTD

22816 A

II

6/18/2009

NORAMCO INC

22817 A

III

5/15/2009

KOSMA KARE CANADA INC

A LIPOSOMAL EXCIPIENT GLYCERYL TRICAPRYLATE (TRICAPRYLIN) AS MANUFACTURED IN


HYOGO JAPAN
OXYMORPHONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN WILMINGTON,
DE AND ATHENS, GA
COTTON AND RAYON FIBER AS MANUFACTURED IN QUEBEC CANADA

22818 A

III

5/26/2009

KARL OTTO BRAUN GMBH AND CO KG

KOB 051 (ELASTIC POLYESTER FABRIC) AS MANUFACTURED IN WOLFSTEIN GERMANY

22819 A

II

5/28/2009

APOTEX PHARMACHEM INDIA PVT LTD

22820 A

III

5/26/2009

ESSEL PACKAGING GUANGZHOU LTD

MYCOPHENOLATE SODIUM AS MANUFACTURED IN BANGALORE KARNATAKA INDIA AND


WINNIPEG MANITOBA CANADA
LAMINATED TUBES AS MANUFACTURED IN GUANGZHOU PR CHINA

22821 A

IV

5/22/2009

ABELEI INC

127A78 ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN NORTH AURORA IL

22822 A

IV

5/22/2009

ABELEI INC

148A41 ARTIFICIAL GRAPE FLAVOR AS MANUFACTURED IN NORTH AURORA IL

22823 A

II

5/29/2009

ROTEM INDUSTRIES LTD

MANNOSE TRIFLATE AS MANUFACTURED IN BEER SHEVA ISRAEL

22824 A

II

5/29/2009

DAIICHI FINE CHEMICAL CO LTD

GP531T DRUG SUBSTANCE AS MANUFACTURED IN TAKAOKA CITY TOYAMA JAPAN

22825 A

II

6/1/2009

SUVEN LIFE SCIENCES LTD

ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22826 I

IV

6/2/2009

LIFEBLOOD MEDICAL INC

22827 I

IV

5/1/2009

CRODA INC

LIFORCELL ACF PERFUSION MEDIA NOVEL EXCIPIENT AS MANUFACTURED BY HYCLONE


PRODUCTS IN LOGAN UTAH FOR LIFEBLOOD MEDICAL INC
SUPER REFINED PEANUT OIL NF AS MANUFACTURED IN MILL HALL PA

22828 I

III

5/28/2009

DAE HEUNG IBN INC

CONTAINER AND CLOSURE AS MANUFACTURED IN GYEONGGI DO SOUTH KOREA

Page 667

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22829 A
II
6/2/2009
CHEMPACIFIC CORP

SUBJECT
JSP92476 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD

22830 I

II

5/27/2009

AUROBINDO DATONG BIO PHARMA CO LTD

6 AMINO PENICILLANIC ACID AS MANUFACTURED IN SHANXI PROVINCE CHINA

22831 I

5/29/2009

AUROBINDO PHARMA LTD

22832 A

II

5/30/2009

AUROBINDO PHARMA LTD

22833 I

IV

6/2/2009

MASTERTASTE INC DBA KERRY INC

STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED UNIT VI LOCATED IN


HYDERABAD INDIA
NAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA
PRADESH INDIA
716252 NATURAL FLAVOR MODULATOR (SWEET) FMT AS MANUFACTURED IN CLARK NJ

22834 I

IV

6/2/2009

MASTERTASTE INC DBA KERRY INC

716253 NATURAL FLAVOR MODULATOR (SWEET) FMT AS MANUFACTURED IN CLARK NJ

22835 A

II

6/3/2009

CEDARBURG PHARMACEUTICALS INC

TRAVOPROST ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN GRAFTON WI

22836 A

III

6/5/2009

ESSEL PROPACK AMERICAS LLC

LAMINATED TUBES AS MANUFACTURED IN DANVILLE VA

22837 A

III

6/5/2009

ARISTA TUBES INC SUB ESSEL PROPACK

PLASTIC TUBES AS MANUFACTURED IN DANVILLE VA

22838 A

II

6/4/2009

GE HEALTHCARE INC

22839 A

II

6/1/2009

YUNNAN HANDE BIO TECH CO LTD

FASTLAB NAF CASSETTE PACK AS MANUFACTURED BY ABX GMBH IN RADEBERG GERMANY


FOR GE HEALTHCARE INC
SEMI SYNTHETIC PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN KUNMING PR CHINA

22840 I

II

5/29/2009

GUAIFENESIN AS MANUFACTURED IN ZHEJIANG CHINA

22841 A

II

6/9/2009

ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL


CO LTD
SANDOZ GMBH

22842 A

II

6/9/2009

PRAVEEN LABORATORIES PVT LTD

22843 A

II

6/8/2009

CATALENT PHARMA SOLUTIONS LLC

(R)-[1-(4 CHLOROPHENYL) PHENYL METHYL-1-PIPERAZINE] AS MANUFACTURED IN GUJARAT


INDIA
ESTRADIOL VAGINAL SOFT GELATIN CAPSULES AS MANUFACTURED IN ST PETERSBURG FL

22844 A

6/8/2009

WEST PHARMACEUTICAL SERVICES INC

22845 A

II

6/8/2009

MITSUI NORIN CO LTD

22846 A

II

6/9/2009

AARTI INDUSTRIES LTD

WESTAR (R) READY TO USE (RU) GAMMA STERILIZATION PROCESS IN ESCHWEILER


GERMANY
POLYPHENON E CAPSULES AS MANUFACTURED BY APTUIT INC IN KANASAS CITY MO FOR
MITSUI NORIN CO LTD
BENAZEPRIL HYDROCHLORIDE POLYMORPH B AS MANUFACTURED IN MAHARASHTRA INDIA

22847 A

IV

6/5/2009

NUSIL TECHNOLOGY LLC

DDU 4330 SILICONE ELASTOMER AS MANUFACTURED IN CARPINTERIA CA

22848 A

IV

6/10/2009

SYMRISE INC

22849 A

IV

6/3/2009

UNGERER AND CO

993270 NATURAL & ARTIFICIAL FLAVOR CHERRY TYPE 612082 AS MANUFACTURED IN


TETERBORO NJ AND BRANCHBURG NJ
ARTIFICIAL GRAPE CONCENTRATE FLAVOR FP-876 AS MANUFACTURED IN BETHLEHEM PA

22850 A

IV

6/3/2009

UNGERER AND CO

ARTIFICIAL CHERRY CONCENTRATE FLAVOR FS 3931 AS MANUFACTURED IN BETHLEHEM PA

22851 A

II

6/10/2009

VIWIT PHARMACEUTICAL CO LTD

BRINZOLAMIDE USP AS MANUFACTURED IN SHANGHAI CHINA

22852 A

II

6/12/2009

HARMAN FINOCHEM LTD

OXYBUTYNIN CHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

22853 A

II

6/12/2009

APOTEX PHARMACHEM INDIA PVT LTD

22854 A

II

6/22/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

RISPERIDONE AS MANUFACTURED BY APOTEX PHARMACHEM INDIA PVT LTD IN KARNATAKA


INDIA FOR APOTEX PHARMACHEM INC
EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22855 A

II

8/14/2009

CHEMWERTH INC

22856 A

II

8/27/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

INTERMEDIATE 6 OF ARGATROBAN (ARGA 6) AS MANUFACTURED BY TIANJIN WEIJIE


PHARMACEUTICAL CO., LTD. IN TIANJIN, CHINA FOR CHEMWERTH, INC.
BUPRENORPHINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

22857 A

II

6/10/2009

ZHUHAI UNITED LABORATORIES CO LTD

AMPICILLIN TRIHYDRATE AS MANUFACTURED IN ZHUHAI GD CHINA

22858 A

II

6/10/2009

UNITED LABORATORIES CHENGDU CO LTD

7-AMINOCEPHALOSPORANIC ACID (7-ACA) AS MANUFACTURED IN SICHUAN PR CHINA

TIGECYCLINE HYDROCHLORIDE AS MANUFACTURED IN KUNDL TYROL AUSTRIA

Page 668

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22859 A
II
6/30/2010
CHEMWERTH INC
22860 A

II

8/28/2009

SUBJECT
TOPOTECAN HCL AS MANUFACTURED IN SICHUAN PROVINCE PR OF CHINA FOR
CHEMWERTH INC
ORCHID CHEMICALS AND PHARMACEUTICALS LTD PRAMIPEXOLE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

22861 A

II

8/26/2009

CADILA PHARMACEUTICALS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT INDIA

22862 A

II

8/11/2009

CADILA PHARMACEUTICALS LTD

ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22863 A

II

8/31/2009

JUBILANT GENERICS LTD

EPROSARTAN MESYLATE AS MANUFACTURED IN KARNATAKA INDIA

22864 A

II

8/26/2009

JUBILANT GENERICS LTD

ESCITALOPRAM OXALATE (ESP PROCESS) AS MANUFACTURED IN KARNATAKA INDIA

22865 A

II

6/12/2009

AUROBINDO PHARMA LTD

PIOGLITAZONE HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) AS


MANUFACTURED IN ANDHRA PRADESH INDIA

22866 P

*** PENDING FILING REVIEW ***

22867 A

II

6/5/2009

CADILA PHARMACEUTICALS LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22868 I

III

6/15/2009

HEINKE TECHNOLOGY INC

PACKAGING, VAGINAL SUPPOSITORY APPLICATOR AS MANUFACTURED IN LINCOLN NE

22869 A

II

6/12/2009

CHR OLESEN SYNTHESIS AS

22870 A

II

6/16/2009

FORMOSA LABORATORIES INC

PRAMIPEXOLE AS PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED


IN HVIDOVRE DENMARK
COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN TAIWAN

22871 A

II

6/16/2009

HEMMO PHARMACEUTICALS PVT LTD

DESMOPRESSIN ACETATE AS MANUFACTURED IN DIST THANE INDIA

22872 A

II

6/17/2009

ANSTO HEALTH

22873 I

II

5/26/2009

CHANGZHOU AHK TECH INC

SODIUM MOLYBDATE (99MO) FISSION SOLUTION AS MANUFACTURED IN LUCAS HEIGHTS,


AUSTRALIA
AMIFOSTINE AS MANUFACTURED JIANGSU PROVINCE PR CHINA

22874 I

III

6/16/2009

FOAMEX INNOVATIONS OPERATING CO

FLM158 AS MANUFACTURED IN FORT WAYNE IN

22875 I

III

6/16/2009

FXI FOAMEX INNOVATIONS INC

FLM159 AS MANUFACTURED IN FORT WAYNE IN

22876 P

*** PENDING FILING REVIEW ***

22877 A

III

6/10/2009

POLYCINE GMBH

INERTA 103 FILM AS MANUFACTURED IN SCHIFFWEILER GERMANY

22878 A

II

6/18/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

22879 A

III

6/10/2009

INJECTA AMPOULES PVT LTD

22880 A

II

6/26/2009

IPCA LABORATORIES LTD

DROSPIRENONE AS MANUFACTURED BY SICOR SRL IN SANTHIA VC ITALY AND RHO MI ITALY


FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
NEUTRAL GLASS AMPOULES USP TYPE I AS MANUFACTURED IN DAMAN (UNION TERRITORY
OF INDIA) INDIA
PYRIMETHAMINE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

22881 A

II

6/22/2009

SUMITOMO CHEMICAL CO LTD

R BACLOFEN AS MANUFACTURED IN OKAYAMA PREFECTURE JAPAN

22882 A

II

6/22/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

RAMELTEON AS MANUFACTURED IN BEER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD

22883 N

NOT AN ASSIGNED NUMBER

22884 A

II

6/19/2009

VIWIT PHARMACEUTICAL CO LTD

BORTEZOMIB AS MANUFACTURED IN SHANGHAI CHINA

22885 I

II

6/23/2009

EDISON PHARMACEUTICALS INC

22886 A

II

6/30/2009

UNICHEM LABORATORIES LTD

ALPHA TOCOTRIENOL QUINONE (EPI-743) AS MANUFACTURED BY CARBOGEN AMCIS AG IN


HUNZENSCHWIL SWITZERLAND FOR EDISON PHARMACEUTICALS INC
MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN DISTRICT DHAR (MP) INDIA

22887 A

II

7/2/2009

UNICHEM LABORATORIES LTD

22888 A

II

7/1/2009

UNICHEM LABORATORIES LTD

BUPRENORPHINE HYDROCHLORIDE USP AS MANUFACTURED IN DHATA ROHA DIST RAIGAD


INDIA
QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN DISTRICT DHAR (MP) INDIA

22889 A

II

6/24/2009

NEULAND LABORATORIES LTD

ARIPIPRAZOLE (ANHYDROUS FORM - B) AS MANUFACTURED IN TELANGANA INDIA

22890 I

IV

6/24/2009

CARGILL INC

REBIANA AS MANUFACTURED BY PURECIRCLE CORPORATION SDN BHD IN KUALA LUMPUR


MALAYSIA, DR REDDYS IN MORELOS MEXICO AND CAMBREX CHARLES CITY INC IN CHARLES
CITY IOWA FOR CARGILL INC

Page 669

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22891 A
IV
6/18/2009
ROBERTET FLAVORS INC

SUBJECT
SPRAY DRIED CITRUS ICE TYPE NATURAL FLAVOR NV-25829 AS MANUFACTURED IN
PISCATAWAY NJ
SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN KARNATAKA INDIA

22892 A

II

6/24/2009

SEQUENT SCIENTIFIC LTD

22893 A

II

6/25/2009

MYLAN LABORATORIES LTD

22894 A

II

6/16/2009

TIANJIN YAGUANG HIGH TECH DEVELOPMENT CO

VALACYCLOVIR HYDROCHLORIDE USP (VCR) AS MANUFACTURED IN ANDHRA PRADESH


INDIA
SODIUM MONOFLUOROPHOSPHATE AS MANUFACTURED IN TIANJIN PR CHINA

22895 A

III

6/24/2009

KARL OTTO BRAUN GMBH AND CO KG

KOB 053 (BI-ELASTIC POLYESTER FABRIC) AS MANUFACTURED IN WOLFSTEIN GERMANY

22896 I

5/11/2009

INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE

CELL MANUFACTURING FACILITY LOCATED AT CHUTUNG HSINCHU TAIWAN

22897 A

II

6/19/2009

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

OMEPRAZOLE AS MANUFACTURED IN SHOUGUANG CITY PR CHINA

22898 A

II

5/22/2009

AUCTUS PHARMA LTD

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

22899 A

III

6/19/2009

22900 A

II

6/25/2009

SCHOTT XINKANG PHARMACEUTICAL PACKAGING TUBING BOROSILICATE GLASS (TYPE I, USP) CONTAINERS FOR PARENTERAL PREPARATIONS
CO LTD
AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
MACLEODS PHARMACEUTICALS LTD
ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA

22901 A

II

3/31/2009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

22902 A

II

6/25/2009

PROCOS SPA

CHLOPHEDIANOL HYDROCHLORIDE AS MANUFACTURED IN CAMERI (NO) ITALY

22903 A

II

6/23/2009

ALKERMES GAINESVILLE LLC

ELN-CT-105G

22904 A

II

6/29/2009

SYMBIOTEC PHARMALAB LTD

METHYLPREDNISOLONE HEMISUCCINATE AS MANUFACTURED IN INDORE INDIA

22905 A

II

6/22/2009

EMCURE PHARMACEUTICALS LTD

CARMUSTINE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22906 A

II

6/29/2009

TORRENT PHARMACEUTICALS LTD

NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22907 A

II

6/24/2009

FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG

RIFAMYCIN SV SODUM SALT AS MANUFACTURED IN MULAZZANO (LO) ITALY

22908 I

III

6/26/2009

TRUDELL MEDICAL INTERNATIONAL

PACKAGING COMPONENT AS MANUFACTURED IN ONTARIO CANADA

22909 A

II

6/26/2009

ALBEMARLE CORP

AMIFOSTINE AS MANUFACTURED IN SOUTH HAVEN MI

22910 I

II

8/10/2009

IPCA LABORATORIES LTD

SULFADOXINE AS MANUFACTURED IN MADHYA PRADESH INDIA

22911 A

II

7/15/2009

IPCA LABORATORIES LTD

RISPERIDONE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

22912 A

II

6/29/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

22913 I

II

6/29/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

ELETRIPTAN HYDROBROMIDE AS MANUFACTURED BY ASSIA CHEM IND LTD IN BEER SHEVA,


ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
MUPIROCIN CALCIUM DIHYDRATE AS MANUFACTURED IN ZAGREB CROATIA

22914 A

III

6/30/2009

APTAR RADOLFZELL GMBH

22915 A

II

6/30/2009

CAMBRIDGE MAJOR LABS INC

22916 A

III

6/29/2009

AMPACET CORP

22917 A

III

6/23/2009

ROLLS PACK PVT LTD

173409 SMC GREEN PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,


CARTERSVILLE GA AND HEATH OH
TAILOR MADE POLY BAGS AS MANUFACTURED IN MUMBAI INDIA

22918 A

II

6/15/2009

ACS DOBFAR SPA

ARGININE (STERILE BULK) AS MANUFACTURED IN MILANO ITALY

22919 A

II

7/2/2009

CADILA HEALTHCARE LTD

AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

22920 A

III

6/19/2009

LAMINADOS FACARLYTE SA DE CV

22921 I

II

7/1/2009

SYMED LABS LTD

22922 A

II

6/30/2009

APICORE US LLC

GASKET TYPE PACKAGING MATERIALS AS MANUFACTURED IN TLALNEPANTLA ESTADO DE


MEXICO, MEXICO
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH
INDIA
BORTEZOMIB AS MANUFACTURED IN SOMERSET NJ

22923 A

II

6/15/2009

OLON SPA

DAPTOMYCIN AS MANUFACTURED IN TORINO ITALY

22924 A

II

7/6/2009

NURAY CHEMICALS PVT LTD

PIOGLITAZONE HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN


TAMIL NADU INDIA

CARTRIDGE PUMP SYSTEMS (CPS) AS MANUFACTURED IN RADOLFZELL GERMANY AND


EIGELTINGEN GERMANY
FP-098 AS MANUFACTURED IN GERMANTOWN WI

Page 670

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22925 A
II
7/8/2009
CADILA HEALTHCARE LTD

SUBJECT
PREGABALIN AS MANUFACTURED IN GUJARAT INDIA

22926 A

II

7/8/2009

SEQUENT SCIENTIFIC LTD

OSELTAMIVIR PHOSPHATE AS MANUFACTURED IN KARNATAKA INDIA

22927 A

II

7/7/2009

CAMBREX PROFARMACO MILANO SRL

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN MILAN ITALY

22928 A

III

7/1/2009

AMPACET CORP

22929 A

III

7/1/2009

SPL DESSECANTES LTDA

110402 WHITE PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE


GA AND HEATH OH
DESTAMP - DESICCANT TAMPER-EVIDENT CLOSURES AS MANUFACTURED IN ATIBAIA BRAZIL

22930 A

II

7/8/2009

CADILA HEALTHCARE LTD

AMLODIPINE BESYLATE USP AS MANUFACTURED IN GUJARAT INDIA

22931 A

II

7/8/2009

SIGNA SA DE CV

22932 A

II

7/6/2009

EUTICALS SPA

LAMIVUDINE AS MANUFACTURED BY SIGNA SA DE CV IN TOLUCA MEXICO FOR APOTEX


PHARMACHEM INC
ERGOTAMINE TARTRATE USP/EP AS MANUFACTURED IN MILAN ITALY

22933 A

II

7/8/2009

SRIKEM LABORATORIES PVT LTD

MECLIZINE HYDROCHLORIDE USP AS MANUFACTURED IN MUMBAI INDIA

22934 A

III

7/8/2009

AMPACET CORP

22935 A

II

7/10/2009

SCINOPHARM TAIWAN LTD

191029 FDA BLACK PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,


CARTERSVILLE GA AND HEATH OH
ARGATROBAN AS MANUFACTURED IN TAINAN, TAIWAN ROC

22936 A

II

6/25/2009

CTX LIFE SCIENCES PVT LTD

METOPROLOL TARTRATE USP (ROUTE-I) AS MANUFACTURED IN GUJARAT INDIA

22937 A

II

7/13/2009

DR REDDYS LABORATORIES LTD

UDENAFIL AS MANUFACTURED IN ANDHRA PRADESH INDIA

22938 A

III

7/9/2009

AMPACET CORP

181092 K AMBER 092 AS MANUFACTURED IN RAYONG THAILAND

22939 A

II

6/30/2009

JOHNSON MATTHEY INC

METHYLPHENIDATE FREE BASE AS MANUFACTURED IN WEST DEPTFORD NJ

22940 A

II

7/13/2009

SHASUN PHARMACEUTICALS LTD

SEVELAMER CARBONATE AS MANUFACTURED IN CUDDALORE INDIA

22941 A

II

7/10/2009

RA CHEM PHARMA LTD

DOXAZOSIN MESYLATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

22942 I

IV

7/14/2009

FONA INTERNATIONAL INC

852.0093U FRUIT PUNCH FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL

22943 I

II

9/29/2009

LUPIN LTD

22944 A

II

9/18/2009

LUPIN LTD

7-AMINO-3-VINYL 3-CEPHEM-4-CARBOXYLIC ACID(7-AVCA) AS MANUFACTURED IN GUJARAT


INDIA
EMTRICITABINE AS MANUFACTURED IN MAHARASHTRA,INDIA

22945 A

II

7/14/2009

HY GRO CHEMICALS PHARMATEK PRIVATE LTD

22946 A

III

6/29/2009

GERRESHEIMER ZARAGOZA SA

22947 A

II

7/15/2009

SANOFI CHIMIE

D-OXYPHENE BASE (AN INTERMEDIATE FOR DEXTROPROPOXYPHENE HCI USP) AS


MANUFACTURED IN ANDHRA PRADESH INDIA
PLASTIC BOTTLES AND DROPPER BOTTLE SYSTEMS AS MANUFACTURED IN EPILA SPAIN
AND MASALVES (VALENCIA) SPAIN
TRIAMCINOLONE ACETONIDE AS MANUFACTURED IN VERTOLAYE FRANCE

22948 A

IV

7/15/2009

BASF SE

LUDIPRESS AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

22949 A

II

7/16/2009

SIGNA SA DE CV

22950 A

III

7/14/2009

AMPACET CORP

22951 I

III

7/17/2009

SHINKO CHEMICAL CO LTD

ACYCLOVIR AS MANUFACTURED BY SIGNA SA DE CV IN TOLUCA MEXICO FOR APOTEX


PHARMACHEM INC
167378 SMC BLUE PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
EYEDROP CONTAINER UE-5 AS MANUFACTURED IN ISHIKAWA JAPAN

22952 A

II

7/17/2009

GLENMARK GENERICS LTD

FROVATRIPTAN SUCCINATE MONOHYDRATE AS MANUFACTURED IN GUJARAT INDIA

22953 A

II

8/26/2009

USV LIMITED

NARATRIPTAN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22954 A

II

7/17/2009

AARTI INDUSTRIES LTD

CAPECITABINE AS MANUFACTURED IN MAHARASHTRA INDIA

22955 A

II

7/20/2009

CHANGZHOU QIANHONG BIO PHARMA CO LTD

HEPARIN SODIUM USP (NON STERILE BULK) AS MANUFACTURED IN JIANGSU CHINA

22956 A

II

7/18/2009

HIKAL LTD

VENLAFAXINE HYDROCHLORIDE API AS MANUFACTURED IN BANGALORE INDIA

22957 A

II

7/17/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

ARMODAFINIL AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD IN BEER SHEVA


ISRAEL FOR TEVA PHARMACEUTICAL IND LTD

Page 671

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22958 A
II
7/15/2009
APICORE US LLC
22959 A

III

7/21/2009

HUHTAMAKI RONSBERG

22960 A

III

7/16/2009

REXAM PHARMA PACKAGING INDIA P LTD

SUBJECT
FELBAMATE AS MANUFACTURED BY APTUIT LAURUS PRIVATE LIMITED IN ANDHRA PRADESH
INDIA FOR APICORE LLC
TUBE LAMINATES AS MANUFACTURED BY LAMINOR SA IN RIO GRANDE DO NORTE BRAZIL
AND HUHTAMAKI RONSBERG IN RONSBERG GERMANY
RISPHARM CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE INDIA

22961 A

III

7/16/2009

REXAM PHARMA PACKAGING INDIA P LTD

DOUBLE SAFE CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE INDIA

22962 A

II

7/21/2009

GLAND PHARMA LTD

CISATRACURIUM BESYLATE AS MANUFACTURED IN HYDERABAD INDIA

22963 A

II

7/20/2009

AARTI INDUSTRIES LTD

DESONIDE AS MANUFACTURED IN MAHARASHTRA INDIA

22964 A

II

7/21/2009

LEK PHARMACEUTICALS DD

AMLODIPINE BESYLATE (PROCESS 2) AS MANUFACTURED IN MENGES SLOVENIA

22965 A

IV

7/20/2009

AMCOL HEALTH AND BEAUTY SOLUTIONS INC

POLY PORE E100 POLYMER (ALLYL METHACRYLATES CROSSPOLYMER) AS MANUFACTURED


IN LAFAYETTE LA

22966 P

*** PENDING FILING REVIEW ***

22967 P
22968 A

*** PENDING FILING REVIEW ***


II

8/19/2009

22969 P

CIPLA LTD

ARFORMOTEROL TARTRATE AS MANUFACTURED IN MAHARASHTRA INDIA

*** PENDING FILING REVIEW ***

22970 A

II

7/18/2009

AUROBINDO PHARMA LTD

22971 A

II

7/21/2009

AARTI INDUSTRIES LTD

OMEPRAZOLE MAGNESIUM USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
MERCAPTOPURINE AS MANUFACTURED IN MAHARASHTRA INDIA

22972 A

II

7/21/2009

VALDEPHARM

ESTRADIOL HEMIHYDRATE AS MANUFACTURED IN VAL DE REUIL FRANCE

22973 A

II

7/22/2009

NEULAND LABORATORIES LTD

SALMETEROL XINAFOATE USP AS MANUFACTURED IN TELANGANA INDIA

22974 A

II

7/22/2009

INTERQUIM SA

RIVASTIGMINE AS MANUFACTURED IN BARCELONA SPAIN

22975 A

II

7/16/2009

JOINT STOCK CO GRINDEKS

DROPERIDOL USP AS MANUFACTURED IN RIGA LV LATVIA

22976 A

II

4/21/2009

HEBEI HUARONG PHARMACEUTICAL CO LTD

COBAMAMIDE AS MANUFACTURED IN HEBEI CHINA

22977 A

II

7/22/2009

HAUDONG MEDICINE CO LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN ZHEJIANG CHINA

22978 I

IV

7/23/2009

FONA INTERNATIONAL INC

825.0259U CHERRY FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL

22979 A

III

7/22/2009

KRAIBURG TPE GMBH AND CO KG

THERMOLAST R M TM#MED AS MANUFACTURED IN WALDKRAIBURG GERMANY

22980 A

II

7/22/2009

AARTI INDUSTRIES LTD

FLUTICASONE PROPIONATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22981 I

III

7/24/2009

GERRESHEIMER KUESSNACHT AG

SPIROMAX INHALER AS MANUFACTURED IN KUSSNACHT SWITZERLAND

22982 I

II

7/21/2009

LONZEAL PHARMACEUTICALS CO LTD

LAMIVUDINE AS MANUFACTURED IN SHIJIAZHUANG CHINA

22983 A

II

7/24/2009

ACTAVIS GROUP PTC EHF

22984 I

III

7/21/2009

ST GOBAIN PERFORMANCE PLASTICS CORP

ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU


INDIA
F1435 AS MANUFACTURED IN POESTENKILL NY

22986 A

7/24/2009

CATALENT BELGIUM SA

22987 A

II

7/29/2009

R TECH UENO LTD

22988 A

IV

7/27/2009

KAFRIT INDUSTRIES 1993 LTD

PROCEDURES FOR STERILE OPERATIONS IN CATALENT BELGIUM LOCATED IN BRUSSELS


BELGIUM
UNOPROSTONE ISOPROPYL OPHTHALMIC SOLUTION 0.15% AS MANUFACTURED IN SANDA
HYOGO JAPAN
MB CC 12720LD WHITE AS MANUFACTURED IN MP NEGEV ISRAEL

22989 A

IV

7/22/2009

CRODA JAPAN KK

SUPER REFINED CRODAMOL IPM UP LQ (JP) AS MANUFACTURED IN SHIGA JAPAN

22990 A

II

8/3/2009

LUPIN LTD

LEVOFLOXACIN HEMIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

22991 A

III

7/28/2009

PRESSPART GMBH CO KG

ALUMINIUM ALLOY METERED DOSE INHALER CONTAINERS (CANS) INTERNALLY COATED


WITH EPOXY PHENOLIC RESIN AS MANUFACTURED IN MARSBERG (BREDELAR) GERMANY

22985 N

NOT AN ASSIGNED NUMBER

Page 672

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
22992 A
II
7/28/2009
CILAG AG

SUBJECT
NALTREXONE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

22993 A

7/22/2009

MICROTROL STERILISATION SERVICES PVT LTD

MICROTROL STERILISATION SERVICES PVT LTD LOCATED IN GURGAON INDIA

22994 A

II

7/27/2009

APICORE US LLC

FLUDROCORTISONE ACETATE USP AS MANUFACTURED IN SOMERSET, NJ

22995 A

II

7/28/2009

SEQUENT SCIENTIFIC LTD

ARTEMETHER AS MANUFACTURED IN KARNATAKA INDIA

22996 A

II

7/30/2009

APOTEX PHARMACHEM INDIA PVT LTD

TOLTERODINE TARTRATE AS MANUFACTURED IN BANGALORE INDIA

22997 A

II

7/31/2009

AARTI DRUGS LTD

RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN MAHARASHTRA INDIA

22998 A

II

9/23/2009

CHATTEM CHEMICALS INC

D-METHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN CHATTANOOGA, TENNESSEE

22999 A

II

7/31/2009

CADILA HEALTHCARE LTD

MESALAMINE USP AS MANUFACTURED IN GUJARAT INDIA

23000 A

II

6/12/2009

CENWAY PHARMACEUTICALS CO LTD

10 DABIII AS MANUFACTURED IN TIANJIN PR CHINA

23001 A

II

7/31/2009

CADILA HEALTHCARE LTD

ATORVASTATIN CALCIUM (CRYSTALLINE FORM I) AS MANUFACTURED IN GUJARAT INDIA

23002 A

II

6/16/2009

CARDINAL HEALTH 414 LLC

23003 A

II

7/30/2009

MEGAFINE PHARMA P LTD

23004 A

II

8/3/2009

EUTICALS SPA

FLUOROMISONIDAZOLE F18 INJECTION([18F]FMISO) AS MANUFACTURED IN WOBURN MA,


SEATTLE WA, BELTSVILLE MD, VAN NUYS CA AND COLUMBUS OH
MIRTAZAPINE HEMIHYDRATE USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
NASHIK INDIA
RIBAVIRIN AS MANUFACTURED IN CASALETTO LODIGIANO ITALY

23005 A

II

7/27/2009

GLIMEPIRIDE AS MANUFACTURED IN GUJARAT INDIA

23006 A

II

8/3/2009

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
EXPLORA LABORATORIES SA

23007 A

II

8/3/2009

23008 A

II

8/4/2009

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
APOTEX PHARMACHEM INDIA PVT LTD

23009 A

II

7/31/2009

SYN TECH CHEM AND PHARM CO LTD

PHENYLEPHRINE HYDROCHLORIDE 150 MESH AS MANUFACTURED IN INGELHEIM AM RHEIN


GERMANY
DONEPEZIL HYDROCHLORIDE USP AS MANUFACTURED BY APOTEX PHARMACHEM INDIA PVT
LTD IN BANGALORE KARNATAKA INDIA FOR APOTEX PHARMACHEM INC
TIMOLOL MALEATE AS MANUFACTURED IN TAIWAN ROC

23010 A

III

8/4/2009

ST GOBAIN PERFORMANCE PLASTICS

23011 A

III

8/4/2009

NOVEX POLYFILMS PVT LTD

POLYESTER FILM C/1/S WITH 7754 SILICONE RELEASE COATING AS MANUFACTURED


WORCESTER MA
TAILOR MADE POLYTHENE BAGS AS MANUFACTURED IN MAHARASHTRA INDIA

23012 A

II

8/5/2009

HETERO LABS LTD

SIMVASTATIN AS MANUFACTURED IN ANDHRA PRADESH INDIA

23013 A

II

10/26/2009

CHATTEM CHEMICALS INC

FENTANYL CITRATE USP AS MANUFACTURED IN CHATTANOOGA TN

23014 A

II

7/31/2009

CTX LIFE SCIENCES PVT LTD

ACETAZOLAMIDE USP AS MANUFACTURED IN GUJARAT INDIA

23015 A

II

7/23/2009

CTX LIFE SCIENCES PVT LTD

CHLOROTHIAZIDE USP AS MANUFACTURED IN GUJARAT INDIA

23016 A

II

8/7/2009

MALLADI DRUGS AND PHARMACEUTICALS LTD

D THREO RITALINIC ACID HYDROCHLORIDE AS MANUFACTURED IN TAMIL NADU INDIA

23017 A

II

5/20/2009

VIPOR CHEMICALS PRIVATE LTD

CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT INDIA

23018 A

II

5/20/2009

VIPOR CHEMICALS PRIVATE LTD

CHLORHEXIDINE ACETATE BP AS MANUFACTURED IN GUJARAT INDIA

23019 A

II

5/20/2009

VIPOR CHEMICALS PRIVATE LTD

CHLORHEXIDINE GLUCONATE SOLUTION BP AS MANUFACTURED IN GUJARAT INDIA

23020 A

II

5/20/2009

VIPOR CHEMICALS PRIVATE LTD

CHLORHEXIDINE HYDROCHLORIDE BP AS MANUFACTURED IN GUJARAT INDIA

23021 A

II

5/20/2009

VIPOR CHEMICALS PRIVATE LTD

CETRIMIDE BP AS MANUFACTURED IN GUJARAT INDIA

23022 A

II

5/20/2009

VIPOR CHEMICALS PRIVATE LTD

CALAMINE BP AS MANUFACTURED IN GUJARAT INDIA

23023 A

II

8/3/2009

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE

RIBAVIRIN USP EP AS MANUFACTURED IN ISSO (BG) ITALY

23024 A

II

8/3/2009

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE

RITALINIC ACID AS MANUFACTURED IN ISSO (BG) ITALY

23025 A

IV

8/10/2009

CAPSUGEL

EMPTY HARD CAPSULES FROM HYPROMELLOSE (HYDROXYPROPYLMETHYLCELLULOSE)


VCAPS PLUS AS MANUFACTURED BY CAPSUGEL COLMAR FRANCE IN COLMAR FRANCE
FOR CAPSUGEL DIVISION OF PFIZER INC

FLUDARABINE PHOSPHATE AS MANUFACTURED IN MENDRISIO SWITZERLAND

Page 673

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23026 A
IV
7/29/2009
SYMRISE AG
23027 A

IV

7/29/2009

SYMRISE AG

SUBJECT
301877 EVOGRAN NATURAL & ARTIFICIAL GRAPEFRUIT FLAVOR AS MANUFACTURED IN
HOLZMINDEN GERMANY
163592 MENTHOL L SPRAY DRIED AS MANUFACTURED IN HOLZMINDEN GERMANY

23028 A

II

8/12/2009

AMOLI ORGANICS PVT LTD

DICLOFENAC POTASSIUM USP AS MANUFACTURED IN GUJARAT INDIA

23029 I

II

7/30/2009

YUKI GOSEI KOGYO CO LTD

BETA-ALANINE AS MANUFACTURED IN FUKUSHIMA JAPAN

23030 I

II

7/31/2009

ALP PHARM BEIJING CO LTD

BECLOMETHASONE DIPROPIONATE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

23031 A

II

7/31/2009

ALP PHARM BEIJING CO LTD

BROMFENAC SODIUM HYDRATE AS MANUFACTURED BY JINAN JINDA PHARMACEUTICAL


CHEMISTRY CO LTD IN ZHANGQIU MINGSHUI JINAN SHANDONG CHINA FOR ALP PHARM
BEIJING CO LTD

23032 I

II

7/30/2009

ALP PHARM BEIJING CO LTD

23033 I

II

7/31/2009

ALP PHARM BEIJING CO LTD

23034 A

III

8/13/2009

SABIC PETROCHEMICALS BV

23035 A

III

8/13/2009

SABIC PETROCHEMICALS BV

23036 A

II

8/9/2009

HIKMA PHARMACEUTICALS

NEPAFENAC AS MANUFACTURED BY CHANGZHOU RUIMING PHARMACEUTICAL CO LTD IN


JIANGSU PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD
VARENICLINE TARTRATE AS MANUFACTURED BY CHANGZHOU RUIMING PHARMACEUTICAL
CO LTD IN JIANGSU PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD
SABIC HDPE PCG40053 00900 AS MANUFACTURED BY SABIC EUROPE IN AI GELEEN THE
NETHERLANDS FOR SABIC PETROCHEMICALS BV
SABIC HDPE PCG5421 00900 AS MANUFACTURED BY SABIC EUROPE IN AI GELEEN THE
NETHERLANDS FOR SABIC PETROCHEMICALS BV
ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN AMMAN JORDAN

23037 I

III

8/10/2009

COLORMATRIX CORP

PACKAGING MATERIAL AS MANUFACTURED IN BEREA OHIO

23038 A

II

8/11/2009

AARTI INDUSTRIES LTD

AZATHIOPRINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

23039 A

II

8/13/2009

FORMOSA LABORATORIES INC

SEVELAMER CARBONATE AS MANUFACTURED IN TAOYUAN TAIWAN

23040 A

II

8/14/2009

UQUIFA MEXICO SA DE CV

PYRANTEL PAMOATE AS MANUFACTURED IN MORELOS MEXICO

23041 A

II

8/14/2009

YONSUNG FINE CHEMICALS CO LTD

MISOPROSTOL AS MANUFACTURED IN HWASEONG SI GYEONGGI DO KOREA

23042 A

II

8/14/2009

YONSUNG FINE CHEMICALS CO LTD

MISOPROSTOL HPMC 1% DISPERSION AS MANUFACTURED IN HWASEONG SI GYCONGGI DO


KOREA

23044 A

II

8/4/2009

OLON USA INC

23045 A

III

8/13/2009

MWV CALMAR GMBH

23046 I

III

8/13/2009

TEKNOR COLOR CO

VALGANCYCLOVIR HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN MULAZZANO (LO)


ITALY
PRESERVATIVE FREE PUMP PFP SPRAYER MEDICAL DEVICE AS MANUFACTURED IN HEMER
GERMANY
70671LCP ORANGE 716 50:1 AS MANUFACTURED IN HENDERSON KY AND JACKSONVILLE TX

23047 A

II

8/10/2009

ALEMBIC PHARMACEUTICALS LTD

FENOFIBRIC ACID CHOLINE SALT AS MANUFACTURED IN GUJARAT INDIA

23048 A

II

9/30/2009

LUPIN LTD

CHOLINE FENOFIBRATE AS MANUFACTURED IN MAHARASHTRA INDIA

23049 A

II

8/17/2009

INTERQUIM SA

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN BARCELONA SPAIN

23050 I

IV

8/17/2009

FONA INTERNATIONAL INC

889.276 PEACH-MINT FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA IL

23051 A

II

3/5/2009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

23052 A

II

8/19/2009

23053 A

IV

8/13/2009

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
UNGERER AND CO

23054 A

II

8/19/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

ATORVASTATIN CALCIUM CRYSTALLINE AND MICRONIZED AS MANUFACTURED BY VITALIFE


LABORATORIES IN HARYANA INDIA FOR DSM ANTI INFECTIVES BV
NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR FQ-5511 AS MANUFACTURED IN BETHLEHEM
PA
DOCETAXEL AS MANUFACTURED BY SICOR DE MEXICO SA DE CV IN LERMA EDO DE MEXICO
AND SICOR ITALY IN SANTHIA (VC) ITALY FOR TEVA PHARMACUETICAL INDUSTRIES LTD

23055 I

III

8/10/2009

RAVIRAJ FOILS LTD

23043 P

*** PENDING FILING REVIEW ***

ALUMINIUM FOIL CONTAINER AS MANUFACTURED IN GUJARAT INDIA

Page 674

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23056 A
III
8/10/2009
RAVIRAJ FOILS LTD

SUBJECT
ALUMINIUM LIDDING FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA

23057 A

III

8/10/2009

RAVIRAJ FOILS LTD

ALUMINIUM BLISTER FOIL (BARE/COATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA

23058 A

III

8/10/2009

RAVIRAJ FOILS LTD

ALUMINIUM STRIP FOIL (BARE/LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA

23059 A

II

8/20/2009

ALDRICH CHEMICAL CO ISOTEC FACILITY

23060 A

III

8/21/2009

CODING PRODUCTS

CORTISOL-9, 11, 12, 12-D4, FOR EARLY CLINICAL TRIALS AS MANUFACTURED IN MIAMISBURG
OH
TTR-77190 AS MANUFACTURED IN KALKASKA MI

23061 A

II

8/20/2009

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

23062 A

II

8/21/2009

23063 I

II

8/19/2009

AMRI RENSSELAER INC SUB ALBANY MOLECULAR


RESEARCH INC
FLEMING LABORATORIES LTD

23064 I

II

8/20/2009

BIOPHARM GMBH

23065 I

II

8/24/2009

MYCOPHENOLIC ACID AS MANUFACTURED IN HANGZHOU CHINA

23066 A

II

8/26/2009

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
SMS PHARMACEUTICALS LTD

23067 A

II

8/21/2009

NURAY CHEMICALS PVT LTD

23068 A

II

8/24/2009

AUROBINDO PHARMA LTD

23069 I

II

8/19/2009

POLYDRUG LABORATORIES PVT LTD

SILDENAFIL CITRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL


NADU INDIA
REPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
CHLOROBUTANOL (HEMIHYDRATE) AS MANUFACTURED IN MAHARASHTRA INDIA

23070 A

II

8/10/2009

VIRUPAKSHA ORGANICS PVT LTD

FEXOFENADINE HCL AS MANUFACTURED IN ANDHRA PRADESH INDIA

23071 I

IV

8/25/2009

AVANTOR PERFORMANCE MATERIALS INC

23072 A

II

8/17/2009

23073 A

III

8/4/2009

TANGSHAN SANXIN BIOCHEMICAL PRODUCT CO


LTD
SSF PLASTICS INDIA PRIVATE LTD

PANEXCEA TM MHC300G AS MANUFACTURED IN NASIK MAHARASHTRA INDIA FOR AVANTOR


PERFORMANCE MATERIALS INC
CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN HEBEI PROVINCE PR CHINA

23074 A

IV

8/1/2009

CRODA INC

ARLACEL P135 (PEG 30 DIPOLYHYDROXYSTEARATE) AS MANUFACTURED IN NEW CASTLE DE

23075 A

II

8/20/2009

OCTENIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

23076 A

II

8/26/2009

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
FARCHEMIA SRL

23077 A

II

8/28/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED BY PLIVA CROATIA LTD - TAPI CROATIA IN


ZAGREB CROATIA AND PRIGORJE BRDOVECKO CROATIA FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD

23078 A

II

8/28/2009

JUNGBUNZLAUER LADENBURG GMBH

CITRIC ACID AS MANUFACTURED IN LADENBURG GERMANY

23079 A

II

8/28/2009

APOTEX PHARMACHEM INC

SUMATRIPTAN SUCCINATE USP AS MANUFACTURED IN BRANTFORD ONTARIO CANADA

23080 A

II

8/31/2009

UQUIFA MEXICO SA DE CV

PYRANTEL TARTRATE ZEOLEX AS MANUFACTURED IN MORELOS MEXICO

23081 I

IV

9/3/2009

FONA INTERNATIONAL INC

829.0013U FONATECH CLOUDING BLEND AS MANUFACTURED IN GENEVA IL

23082 I

III

8/31/2009

LOPAREX LLC

23083 A

II

9/3/2009

BASF PHARMACHEMIKALIEN GMBH CO KG

GRADE 45821 D 4.0 WH HDP U4195/000 AS MANUFACTURED IN IOWA CITY IA, EDEN NC,
CULLMAN AL AND HAMMOND WI
PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN MINDEN GERMANY

23084 A

II

8/31/2009

AUROBINDO PHARMA LTD

MYCOPHENOLIC ACID NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS


MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA
TARTARIC ACID NF DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER NY
CYCLOBENZAPRINE HYDROCHLORIDE USP BULK AS MANUFACTURED IN ANDHRA PRADESH
INDIA
RHGDF-5 (RECOMBINANT HUMAN GROWTH/DIFFERENTIATION FACTOR 5) AS
MANUFACTURED BY HOECHST MARION ROUSSEL LTD IN KAWAGOE CITY SAITAMA JAPAN
FOR BIOPHARM GMBH

RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

EYE EAR & NASAL DROPPER VIALS AND DRY SYRUP BOTTLE SET AS NANI DAMAN INDIA

IMIPRAMINE PAMOATE AS MANUFACTURED IN TEVIGLIO (BG) ITALY

IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA

Page 675

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23085 I
II
9/4/2009
SEQUENT SCIENTIFIC LTD

SUBJECT
STAVUDINE AS MANUFACTURED IN KARNATAKA INDIA

23086 A

IV

9/2/2009

KOEL COLOURS PVT LTD

LAKE COLOURS AS MANUFACTURED IN GUJARAT INDIA

23087 A

IV

9/2/2009

KOEL COLOURS PVT LTD

IRON OXIDE COLOURS AS MANUFACTURED IN GUJARAT INDIA

23088 A

II

8/28/2009

PARABOLIC DRUGS LTD

CEFUROXIME ACID AS MANUFACTURED IN PUNJAB INDIA

23089 A

II

7/31/2009

SAFC BIOSCIENCES INC

23090 A

II

7/31/2009

SAFC BIOSCIENCES INC

23091 A

II

7/31/2009

SAFC BIOSCIENCES INC

EX-CELL EBX GRO I, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE, W/O PHENOL RED AS MANUFACTURED IN DENVER PA
EX-CELL EBX GRO II, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE AS MANUFACTURED IN DENVER PA
EX-CELL EBX GRO I, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE, W/O PHENOL RED, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER
PA

23092 A

II

7/31/2009

SAFC BIOSCIENCES INC

EX-CELL CD CHO (63206 MODIFIED) CHO SERUM-FREE MEDIUM, CHEMICALLY DEFINED,


W/500 MG/L DEXTRAN SULFATE, W/O L-GLUTAMINE, W/O HYPOXANTINE AS MANUFACTURED
IN DENVER PA

23093 A

II

7/31/2009

SAFC BIOSCIENCES INC

23094 A

II

7/31/2009

SAFC BIOSCIENCES INC

23095 A

II

7/31/2009

SAFC BIOSCIENCES INC

EX-CELL EBX GRO II, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER PA
EX-CELL CD CHO FUSION, ANIMAL-COMPONENT FREE, SERUM-FREE MEDIUM, CHEMICALLY
DEFINED, W/O L-GLUTAMINE AS MANUFACTURED IN DENVER PA
EX-CELL CD CHO FUSION, ANIMAL-COMPONENT FREE, SERUM-FREE MEDIUM, CHEMICALLY
DEFINED, W/O L-GLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER PA

23096 A

II

8/6/2009

SAFC BIOSCIENCES INC

EX-CELL CD HYDROLYSATE FUSION, ANIMAL COMPONENT FREE, CHEMICALLY-DEFINED


LIQUID MEDIA, (PRODUCT NO. 14700C), DRY POWDER MEDIA (PRODUCT NO. 24700C) AS
MANUFACTURED IN DENVER PA

23097 A

II

9/3/2009

ST GOBAIN PERFORMANCE PLASTICS CORP

SANI-TECH ULTRA 50 SILICONE TUBING AS MANUFACTURED IN TAUNTON MA

23098 A

II

9/8/2009

MERCK KGAA

BORIC ACID AS MANUFACTURED IN FRANKFURTER STRAE GERMANY

23099 A

IV

8/31/2009

NECTAR LIFESCIENCES LTD

HARD GELATIN CAPSULE SHELL AS MANUFACTURED IN DISTT SOLAN (HP) INDIA

23100 A

II

9/9/2009

SHASUN PHARMACEUTICALS LTD

23101 I

II

9/10/2009

ZYFINE DIV CADILA HEALTHCARE LTD

CARISOPRODOL USP AS MANUFACTURED BY SHASUN CHEMICALS AND DRUGS LTD IN


CUDDALORE INDIA FOR SHASUN RESEARCH CENTRE
OXALIPLATIN PH EUR AS MANUFACTURED IN GUJARAT INDIA

23102 A

II

9/4/2009

MEGAFINE PHARMA P LTD

23103 A

II

9/9/2009

CERBIOS PHARMA SA

23104 A

IV

9/11/2009

SPI PHARMA INC

23105 A

II

7/8/2009

NANDU CHEMICALS PVT LTD

23106 A

III

9/14/2009

PRO PALS INDUSTRIES LTD

SODIUM CHLORIDE BP (PARENTERAL GRADE) AS MANUFACTURED IN BELUR DHARWAD


INDIA
FOAM LDPE LINER AS MANUFACTURED IN LAVAL QC CANADA

23107 I

II

9/10/2009

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

KETO AS MANUFACTURED IN ZHEJIANG CHINA

23108 A

II

9/11/2009

ALEMBIC PHARMACEUTICALS LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

23109 A

II

9/14/2009

SIROLIMUS AS MANUFACTURED IN HANGZHOU CHINA

23110 A

II

9/14/2009

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
TORRENT PHARMACEUTICALS LTD

23111 A

IV

9/8/2009

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE

LUBRITOSE AN AS MANUFACTURED BY KERRY INGREDIENTS IN BLUE EARTH MN FOR KERRY


BIOFUNCTIONAL INGREDIENTS

VENLAFAXINE HYDROCHLORIDE (AMC ACETATE ROUTE) (NON-STERILE DRUG SUBSTANCE)


AS MANUFACTURED IN NASHIK INDIA
CALCIPOTRIENE ANHYDROUS DRUG SUBSTANCE AS MANUFACTURED IN BARBENGO
SWITZERLAND
ADVANTOL 300 AS MANUFACTURED IN GRAND HAVEN MI

ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN GUJARAT INDIA

Page 676

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23112 A
IV
9/9/2009
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
23113 A
IV
9/9/2009
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
23114 A
III
9/15/2009
ELM PLASTIC GMBH

SUBJECT
DISINTEQUIK AS MANUFACTURED BY FOREMOST FARMS IN ROTHSCHILD WI FOR KERRY
BIOFUNCTIONAL INGREDIENTS
DISINTEQUIK MCC AS MANUFACTURED BY FOREMOST FARMS IN ROTHSCHILD WI FOR
KERRY BIOFUNCTIONAL INGREDIENTS
PLASTIC DOSING PIPETTES (SHORT FORM) AS MANUFACTURED IN DUDELDORF GERMANY

23115 A

II

9/30/2009

LUPIN LTD

23116 A

II

9/10/2009

MEISSNER FILTRATION PRODUCTS INC

CLINDAMYCIN PALMITATE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA


INDIA
TEPOFLEX BIOCONTAINERS AS MANUFACTURED IN CAMARILLO CA

23117 A

II

9/18/2009

CATALENT PHARMA SOLUTIONS LLC

PROCARDIA SOFTGELS 10 MG (NIFEDIPINE) AS MANUFACTURED IN ST PETERSBURG FL

23118 A

II

9/16/2009

FARMABIOS S P A

23119 A

II

9/15/2009

MEISSNER FILTRATION PRODUCTS INC

BETAMETHASONE DIPROPIONATE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI


(PV) ITALY
EVERLUX FILTER CARTRIDGES AS MANUFACTURED IN CAMARILLO CA

23120 A

II

9/16/2009

MYLAN LABORATORIES LTD

23121 A

II

9/21/2009

RAKS PHARMA PVT LTD

23122 A

III

11/25/2008

EMS CHEMIE NORTH AMERICA INC

23123 I

II

9/23/2009

SHILPA MEDICARE LTD

GRILAMID TR 60 NATURAL AS MANUFACTURED BY EMS CHEMIE AGE IN


REICHENAUERSTRASSE DOMAT/EMS FOR EMS CHEMIE (NORTH AMERICA) INC
ANASTROZOLE AS MANUFACTURED IN KARNATAKA INDIA

23124 I

II

9/23/2009

SEQUENT SCIENTIFIC LTD

NEVIRAPINE ANHYDROUS AS MANUFACTURED IN KARNATAKA INDIA

23125 A

II

9/22/2009

ION EXCHANGE INDIA LTD

23126 A

II

10/6/2009

BASF PHARMA CALLANISH LTD

23127 I

III

9/18/2009

AMPACET CORP

23128 A

II

9/25/2009

DR REDDYS LABORATORIES LTD

CALCIUM POLYSTYRENE SULPHONATE BP 2007 (INDION 404) AS MANUFACTURED IN


GUJARAT INDIA
DOCOSAHEXAENOIC ACID ETHYL ESTER (DHA 90 EE) AS MANUFACTURED IN SCOTLAND
UNITED KINGDOM
190826 HP BLACK PE MB AS MANUFACTURED BY AMPACET EUROPE SA IN WINDHOF GRAND
DUCHE DE LUXEMBOURG FOR AMPACET CORPORATION
GRANISETRON AS MANUFACTURED IN ANDHRA PRADESH INDIA

23129 A

II

10/7/2009

JUBILANT GENERICS LTD

PALIPERIDONE AS MANUFACTURED IN KARNATAKA INDIA

23130 A

II

9/28/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

23131 A

III

9/24/2009

AMERICHEM INC

CISATRACURIUM BESYLATE AS MANUFACTURED BY SICOR SRL IN SANTHIA (VC) ITALY AND


RHO (MI) ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
46538 CD4 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS OH

23132 A

II

9/28/2009

RELIABLE BIOPHARMACEUTICAL CORP

DEXMEDETOMIDINE HCI AS MANUFACTURED IN ST LOUIS MO

23133 A

II

9/28/2009

ERREGIERRE SPA

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO ITALY

23134 A

II

10/27/2009

LUPIN LTD

ARMODAFINIL AS MANUFACTURED IN MAHARASHTRA INDIA

23135 I

II

9/28/2009

DERIVADOS QUIMICOS SA FINE CHEMICALS

IPRATROPIUM BROMIDE AS MANUFACTURED MURCIA SPAIN

23136 I

II

7/27/2009

TAI HENG INDUSTRY CO LTD

23137 A

II

9/29/2009

23138 A

II

9/24/2009

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO


LTD
LAURUS LABS PRIVATE LTD

ERLOTINIB HYDROCHLORIDE AS MANUFACTURED BY JIANGSU ZW PHARMACEUTICALS CO


LTD IN JIANGSU PROVINCE PR CHINA FOR TAI HENG INDUSTRY CO LTD
NITROFURAZONE AS MANUFACTURED IN SHANDONG PROVINCE CHINA

23139 A

II

10/1/2009

MYLAN LABORATORIES LIMITED

IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23140 A

II

9/30/2009

JOHNSON MATTHEY PHARMA SERVICES

4116.E AS MANUFACTURED IN DEVENS MA

23141 I

III

9/30/2009

A SUNG PLASTIC IND CO LTD

CONTAINER & CLOSURE AS MANUFACTURED IN KYONGKI DO KOREA

23142 A

II

9/30/2009

SANOFI CHIMIE

NALOXONE HYDROCHLORIDE 350 AS MANUFACTURED IN ARAMON FRANCE

23143 A

II

9/25/2009

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD

(R) -9-[2-(PHOSPHONMETHOXY)PROPYL]ADENINE AN INTERMEDIATE FOR TENOFOVIR


DISOPROXIL FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA

ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II) AS MANUFACTURED IN


TELANGANA, INDIA
TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

DOCETAXEL ANHYDROUS USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

Page 677

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23144 A
II
9/30/2009
MEDICHEM SA

SUBJECT
LOXAPINE BASE AS MANUFACTURED IN GIRONA SPAIN

23145 A

II

9/30/2009

MEDICHEM SA

MED-201750/E AS MANUFACTURED IN GIRONA SPAIN

23146 A

II

10/2/2009

AMINO CHEMICALS LTD

(R)-MODAFINIL AS MANUFACTURED IN MARSA MALTA

23147 A

II

9/29/2009

WUHAN WUYAO PHARMACEUTICAL CO LTD

23148 I

II

10/2/2009

HOVIONE FARMACIENCIA SA

23149 A

IV

10/6/2009

CAFOSA GUM SA

CHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) AS


MANUFACTURED IN WUHAN CHINA
IOHEXOL AS MANUFACTURED BY ZHEJIANG HISYN PHARMACEUTICAL CO LTD IN LINHAI PARK
CHINA FOR HOVIONE FARMACIENCIA SA
HEALTH IN GUM PWD-01

23150 A

II

10/5/2009

SIGNA SA DE CV

23151 A

II

10/6/2009

NISSAN CHEMICAL INDUSTRIES LTD

VALSARTAN USP AS MANUFACTURED BY SIGNA SA DE CV IN ESTADO DE MEXICO, MEXICO


FOR APOTEX PHARMACHEM INC
NTC-801F AS MANUFACTURED IN YAMAGUCHI JAPAN

23152 A

IV

9/29/2009

HENKEL CORP

DURO-TAK 87-611A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

23153 I

II

9/30/2009

NUTRA SPECIALITIES PRIVATE LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ANDHRA PRADESH INDIA

23154 I

II

9/25/2009

DALIAN ZHEN AO BIO TECH CO LTD

ADENOSINE 5' -MONOPHOSPHATE FREE ACID AS MANUFACTURED IN DALIAN CHINA

23155 I

II

9/18/2009

ALP PHARM BEIJING CO LTD

23156 I

II

9/25/2009

ALP PHARM BEIJING CO LTD

23157 A

II

9/30/2009

BIOVET JOINT STOCK CO

ERGOCALCIFEROL USP AS MANUFACTURED BY YUXIN PHARMACEUTICAL CO LTD IN


SICHUAN PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD
D-PENICILLAMINE USP AS MANUFACTURED BY SICHUAN PHARMACRUTICAL CO LTD IN
SICHUAN CHINA FOR ALP PHARM BEIJING CO LTD
TESTOSTERONE AS MANUFACTURED IN PESHTERA BULGARIA

23158 A

II

10/6/2009

FORMOSA LABORATORIES INC

TEMOZOLOMIDE AS MANUFACTURED IN TAOYUAN TAIWAN

23159 I

IV

10/5/2009

SYMRISE INC

23160 A

II

10/5/2009

MYLAN LABORATORIES LTD

695292 EVOGLASS NATURAL & ARTIFICIAL FLAVOR CHERRY TYPE AS MANUFACTURED IN


TETERBORO NJ AND BRANCHBURG NJ
TEMAZEPAM USP AS MANUFACTURED IN TELANGANA INDIA

23161 A

II

10/9/2009

AARTI DRUGS LTD

CELECOXIB AS MANUFACTURED IN MAHARASHTRA INDIA

23162 A

II

10/7/2009

ASCORBIC ACID (VITAMIN C) AS MANUFACTURED IN HEBEI PROVINCE CHINA

23163 A

II

10/7/2009

CSPC WEISHENG PHARMACEUTICAL


SHIJIAZHUANG CO LTD
MACLEODS PHARMACEUTICALS LTD

23164 I

II

10/8/2009

EMCURE PHARMACEUTICALS LTD

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (EUSB) AS MANUFACTURED IN


GUJARAT INDIA
SEVELAMER CARBONATE (E SUB) AS MANUFACTURED IN MAHARASHTRA INDIA

23165 A

II

10/5/2009

JOST CHEMICAL CO

POTASSIUM SULFATE AS MANUFACTURED IN ST LOUIS MO

23166 A

IV

10/8/2009

ARMARK AUTHENTICATION TECHNOLOGIES LLC

EXCIPIENT ON DOSE (EOD) GRADE COVERT MARKERS(CM): A PHYSICAL CHEMICAL


IDENTIFIER (PCID) UTILIZED FOR PHARMACEUTICAL BRAND PROTECTION AS
MANUFACTURED IN GLEN ROCK PA

23167 A

II

10/9/2009

ACS DOBFAR SPA

CEFTAROLINE FOSAMIL STERILE DRUG SUBSTANCE AS MANUFACTURED IN MILANO ITALY

23168 A

II

10/6/2009

ANUS LABORATORIES LTD

23169 A

II

9/30/2009

23170 A

II

10/14/2009

CHONGQING CARE LIFE PHARMACEUTICAL CO


LTD
AMOLI ORGANICS PVT LTD

CIS (+) HYDROXY LACTAM AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR ANUS
LABORATORIES LIMITED
ALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING PR CHINA
CARBAMAZEPINE AS MANUFACTURED IN GUJARAT INDIA

23171 A

II

10/5/2009

ION EXCHANGE INDIA LTD

CHOLESTYRAMINE RESIN USP (INDION 454) AS MANUFACTURED IN GUJARAT INDIA

23172 A

II

9/22/2009

GLAND PHARMA LTD

DEXRAZOXANE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23173 A

II

10/7/2009

GLAND PHARMA LTD

TIROFIBAN HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH, INDIA

Page 678

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23174 A
II
10/9/2009
AUROBINDO PHARMA LTD

SUBJECT
TORSEMIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
LITHIUM CARBONATE PHARMA GRADE AS MANUFACTURED IN LODI ITALY

23175 A

II

10/7/2009

EUTICALS SPA

23176 A

III

11/11/2009

WEENER EMPIRE PLASTICS LTD

23177 A

II

10/15/2009

CRYSTAL PHARMA SAU

HIGH DENSITY POLYETHYLENE BOTTLES AS MANUFACTURED IN SILVASSA (UNION


TERRITORY OF D&NH) INDIA
NESTORONE AS MANUFACTURED IN BOECILLO (VALLADOLID) SPAIN

23178 A

II

10/14/2009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

DONEPEZIL HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN ZHEJIANG CHINA

23179 A

II

10/13/2009

RAKS PHARMA PVT LTD

AZATHIOPRINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23180 A

II

10/13/2009

EUROGENTEC SA

PRODUCTION OF PLASMID DNA AS MANUFACTURED IN SERAING BELGIUM

23181 A

II

10/15/2009

CHOONGWAE PHARMA CORP

CILASTATIN ACID AS MANUFACTURED IN GYEONGGI-DO REPUBLIC OF KOREA

23182 A

III

10/14/2009

BAYER MATERIALSCIENCE LLC

MAKROLON DP1-1869 AND MAKROLON AM2428 RESINS AS MANUFACTURED IN HEBRON OH

23183 A

II

10/16/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

23184 I

II

10/16/2009

EMCURE PHARMACEUTICALS LTD

ERLOTINIB HCL AS MANUFACTURED IN LERMA ESTADO DE MEXICO, MEXICO FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
EMTRICITABINE AS MANUFACTURED IN MAHARASHTRA INDIA

23185 A

II

7/31/2009

SAFC BIOSCIENCES INC

EX-CELL EBX PRO-I SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS W/O LGLUTAMINE W/O PHENOL RED W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER
PA

23186 A

II

10/15/2009

AMCOL HEALTH AND BEAUTY SOLUTIONS INC

23187 A

IV

10/16/2009

BASF SE

23188 A

II

9/30/2009

LABORATORIO OPOTERAPICO ARGENTINO SA

23189 A

II

7/31/2009

SAFC BIOSCIENCES INC

23190 A

II

9/30/2009

LABORATORIO OPOTERAPICO ARGENTINO SA

23191 A

II

10/20/2009

AMOLI ORGANICS PVT LTD

TRETINOIN 4% IN POLY-PORE POLYMER (TRETINOIN IN ALLYL METHACRYLATES


CROSSPOLYMER) AS MANUFACTURED IN LAFAYETTE LA
KOLLICOAT IR COATING SYSTEMS AS MANUFACTURED IN LUDWIGHAFEN FEDERAL
REPUBLIC OF GERMANY
THYROID USP POWDER F.S./THYROID 3 X USP POWDER AS MANUFACTURED IN BUENOS
ARIES ARGENTINA
EX-CELL EBX PRO I SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS W/O LGLUTAMINE W/O PHENOL RED AS MANUFACTURED IN DENVER PA
PANCREATIN 4 X USP POWDER/PANCREALIPASE USP POWDER AS MANUFACTURED IN
BUENOS AIRES ARGENTINA
OXCARBAZEPINE AS MANUFACTURED IN GUJARAT INDIA

23192 A

II

10/14/2009

UNIMARK REMEDIES LTD

FLECAINIDE ACETATE USP (PROCESS B) AS MANUFACTURED IN GUJARAT INDIA

23193 A

II

10/16/2009

NOVUS FINE CHEMICALS LLC

ALPRAZOLAM (CIV) AS MANUFACTURED IN CARLSTADT NJ

23194 A

II

10/19/2009

CHOONGWAE PHARMA CORP

PNB-THIENAMYCIN IMINE AS MANUFACTURED IN GYEONGGI-DO REPUBLIC OF KOREA

23195 A

III

10/20/2009

TUBETTIFICIO M FAVIA SRL

23196 A

II

10/18/2009

YONEZAWA HAMARI CHEMICALS LTD

ALUMINIUM COLLAPSIBLE TUBES FOR DRUG PRODUCTS AS MANUFACTURED IN MILANO


ITALY
LULICONAZOLE AS MANUFACTURED IN YAMAGATA JAPAN

23197 I

IV

10/14/2009

SURETY LABORATORIES INC

SURFASIL 1520 AS MANUFACTURED IN CASSOPOLIS MI FOR SURETY LABORATORIES INC

23198 I

IV

10/14/2009

SURETY LABORATORIES INC

SURFASIL 1511 AS MANUFACTURED IN CASSOPOLIS MI FOR SURETY LABORATORIES INC

23199 A

II

11/16/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT INDIA

23200 A

II

10/21/2009

ESTEVE QUIMICA SA

23201 I

II

9/18/2009

23202 I

IV

10/6/2009

23203 I

IV

10/6/2009

HUBEI HUANGSHI SHIXING PHARMACEUTICAL CO


LTD
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE

DICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE AS MANUFACTURED IN CELRA


(GIRONA) SPAIN
DEXKETOPROFEN TROMETAMOL AS MANUFACTURED IN HUBEI PROVINCE PR CHINA
5X00138 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY
5X00139 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY

Page 679

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23204 I
IV
10/6/2009
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
23205 A
II
10/20/2009
TOMITA PHARMACEUTICAL CO LTD

SUBJECT
5X00140 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY

23206 A

II

10/20/2009

INALCO SAS DI GIOVANNI CIPOLLETTI AND C

GOS 95 AS MANUFACTURED IN PISTOIA ITALY

23207 A

II

10/20/2009

SUVEN LIFE SCIENCES LTD

ZOLMITRIPTAN AS MANUFACTURED IN TELANGANA INDIA

23208 A

II

10/19/2009

CHEMI SPA

BUPROPION HCL FV3307 AS MANUFACTURED IN PATRICA (FR) ITALY

23209 A

II

10/12/2009

ALP PHARM BEIJING CO LTD

23210 A

III

10/5/2009

STOLZE UNION SRO

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR


ALP PHARM BEIJING CO LTD
GLASS PRIMARY PACKAGING AS MANUFACTURED IN HERMANOVA HUT CZECH REPUBLIC

23211 I

II

10/10/2009

DALIAN ZHEN AO BIO TECH CO LTD

URIDINE 5' -MONOPHOSPHATE DISODIUM SALT AS MANUFACTURED IN DALIAN CHINA PC

23212 I

II

10/29/2009

CSL BEHRING LLC

ISCOMATRIX ADJUVANT AS MANUFACTURED IN BRADLEY IL

23213 A

II

10/26/2009

TACROLIMUS SD20 AS MANUFACTURED IN SHU-LIN TAIPEI HSIEN TAIWAN

23214 A

II

10/21/2009

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
SIEGFRIED LTD

23215 A

II

10/26/2009

HETERO DRUGS LTD

RILUZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23216 A

II

10/21/2009

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

23217 A

II

10/21/2009

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

23218 A

IV

10/23/2009

HENKEL CORP

DILUTED ISOSORBIDE MONONITRATE (60%) AS MANUFACTURED IN SHANDONG PROVINCE


CHINA
DILUTED ISOSORBIDE MONONITRATE (70%) AS MANUFACTURED IN SHANDONG PROVINCE
PR CHINA
DURO-TAK 87-612A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

23219 A

II

10/20/2009

OMEPRAZOLE AS MANUFACTURED IN GAJARAT INDIA

23220 A

II

10/27/2009

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
EMCURE PHARMACEUTICALS LTD

23221 A

IV

10/29/2009

FONA INTERNATIONAL INC

815.0033U BUBBLEGUM FLAVOR, ART AS MANUFACTURED IN GENEVA IL

23222 A

II

10/28/2009

LEK PHARMACEUTICALS DD

CASPOFUNGIN ACETATE AS MANUFACTURED IN MENGES SLOVENIA

23223 A

II

10/29/2009

CHANGZHOU PHARMACEUTICAL FACTORY

23224 A

II

10/29/2009

DELMAR CHEMICALS INC

RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE) AS


MANUFACTURED IN JIANGSU PROVINCE CHINA
SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN QUEBEC CANADA

23225 A

III

10/23/2009

FOUR M PROPACK PVT LTD

BOTTLES AND CLOSURES AS MANUFACTURED IN HIMACHAL PRADESH INDIA

23226 A

II

10/29/2009

PHENYTOIN AS MANUFACTURED IN COMPOVERDE DI APRILIA (LT) ITALY

23227 A

II

10/23/2009

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
DAISO CO LTD

23228 I

II

10/16/2009

CHANGZHOU AHK TECH INC

23229 A

III

10/28/2009

HSIAO SUNG NON OXYGEN CHEMICAL CO LTD

23230 A

III

10/30/2009

AMPACET CORP

23231 A

III

10/30/2009

COLORS FOR PLASTICS INC

23232 A

II

10/30/2009

GLAND PHARMA LTD

SORB OO - OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG COUNTY TAIWAN AND


JIANG SU PROV CHINA FOR HSIAO SUNG NON-OXYGEN CHEMICAL CO LTD
102837 DESICCANT PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
THERMOPLASTIC RESIN COLORANT MASTERBATCH R29213 RED AS MANUFACTURED IN ELK
GROVE VILLAGE IL AND SPARTANBURG SC
DEXMEDETOMEDINE HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD INDIA

23233 A

II

4/7/2010

LUPIN LTD

DOXERCALCIFEROL AS MANUFACTURED IN MAHARASHTRA, INDIA

23234 A

II

10/23/2009

CADILA HEALTHCARE LTD

ESCITALOPRAM OXALATE (FORM -1) AS MANUFACTURED IN GUJARAT INDIA

MAGNESIUM OXIDE USP LIGHT POWDER AS MANUFACTURED IN TOKUSHIMA JAPAN

NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN SWITZERLAND

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

DAISOGEL ODS SERIES CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN HYOGO


JAPAN
CLADRIBINE NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA

Page 680

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23235 A
II
10/30/2009
MCGUFF PHARMACEUTICALS INC

SUBJECT
ASCOR L 500 (ASCORBIC ACID INJECTION USP) AS MANUFACTURED IN SANTA ANA CA

23236 A

III

10/29/2009

HSIAO SUNG NON OXYGEN CHEMICAL CO LTD

23237 A

II

10/23/2009

COVALENT LABORATORIES PRIVATE LTD

O-BUSTER OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG COUNTY TAIWAN AND


JIANG SU PROV. CHANG SHU CHINA
CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH INDIA

23238 A

III

11/2/2009

TOPPAN PRINTING CO LTD

23239 A

II

11/2/2009

FINE CHEMICALS CORP PTY LTD

HP-3 PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATHCES AS MANUFACTURED IN


FUKUOKA JAPAN FOR TOPPAN PRINTING CO LTD
ROPIVACAINE AS MANUFACTURED IN CAPE TOWN SOUTH AFRICA

23240 A

II

10/30/2009

ZACH SYSTEM SPA

OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN LONIGO ITALY

23241 A

II

11/2/2009

AREVIPHARMA GMBH

BISOPROLOL FUMARATE AS MANUFACTURED IN RADEBEUL GERMANY

23242 A

II

11/3/2009

IPC PROCESS CENTER GMBH AND CO KG

23243 A

II

11/2/2009

HAINAN POLY PHARMACEUTICAL CO LTD

23244 A

II

11/2/2009

HAINAN POLY PHARMACEUTICAL CO LTD

23245 A

II

12/24/2009

LUPIN LTD

IBUPROFEN DC100 (IBUPROFEN PH. EUR., GRANULATED) AS MANUFACTURED IN DRESDEN


GERMANY
DICLOFENAC SODIUM EXTENDED RELEASE CAPSULES AS MANUFACTURED IN HAINAN
PROVINCE CHINA
THEOPHYLLINE EXTENDED RELEASE CAPSULES AS MANUFACTURED IN HAINAN PROVINCE
CHINA
RANOLAZINE AS MANUFACTURED IN MAHARASHTRA INDIA

23246 A

II

11/6/2009

PHARMACOSMOS AS

24% IRON ISOMALTOSIDE POWDER AS MANUFACTURED IN HOLBAEK DENMARK

23247 A

II

11/5/2009

MALLADI DRUGS AND PHARMACEUTICALS LTD

LORAZEPAM AS MANUFACTURED IN TAMIL NADU INDIA

23248 I

II

11/9/2009

DINOPROST AS MANUFACTURED IN BUDAPEST HUNGARY

23249 A

II

11/9/2009

23250 A

II

11/5/2009

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS PRIVATE CO LTD
CHINOIN PHARMACEUTICAL AND CHEMICAL
WORKS PRIVATE CO LTD
MOEHS IBERICA SL

23251 A

II

11/4/2009

RA CHEM PHARMA LTD

LAMOTRIGINE USP AS MANUFACTURED IN TELANGANA, INDIA

23252 A

II

12/2/2009

SODIUM [124I] IODIDE AS MANUFACTURED IN MONTECOSARO ITALY

23253 A

III

11/5/2009

ACOM CORP (ADVANCED CENTER ONCOLOGY


MACERATA)
PRESSPART NEMO

23254 A

II

11/5/2009

UNIMARK REMEDIES LTD

LANTHANUM CARBONATE OCTAHYDRATE AS MANUFACTURED IN GUJARAT INDIA

23255 A

II

11/11/2009

MSN LABORATORIES LTD

23256 A

II

11/10/2009

DR REDDYS LABORATORIES LTD

BOSENTAN MONOHYDRATE [ROUTE CODE - BN] AS MANUFACTURED IN ANDHRA PRADESH


INDIA
LOPINAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA

23257 A

IV

11/12/2009

COREL PHARMACHEM

ACRYFLOW L, '12-HYDROXY STEARATE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA

23258 A

IV

11/11/2009

COREL PHARMACHEM

23259 A

IV

11/12/2009

COREL PHARMACHEM

KYRON T-104, CROSS-LINKED POLYACRYLATE AS MANUFACTURED IN DIST MEHSANA (NG)


INDIA
ACRYSOL K-150, PROPRIETARY MIXTURE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA

23260 A

IV

11/12/2009

COREL PHARMACHEM

23261 A

IV

11/11/2009

COREL PHARMACHEM

ACRYSOL EL-135, POLYOXYL 35 CASTOR OIL USP/NF AS MANUFACTURED IN DIST MEHSANA


(NG) INDIA
KYRON T-114, POLACRILLIC ACID AS MANUFACTURED IN DIST MEHSANA (NG) INDIA

23262 A

II

10/28/2009

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LAMOTRIGINE USP AS MANUFACTURED IN ZHEJIANG CHINA

23263 A

III

11/12/2009

MYLAN TECHNOLOGIES INC

MEDIDERM 3900 AS MANUFACTURED IN ST ALBANS VT

23264 A

II

11/11/2009

CADILA HEALTHCARE LTD

ATORVASTATIN CALCIUM (CRYSTALLINE) AS MANUFACTURED IN GUJARAT INDIA

23265 A

II

11/10/2009

ACTAVIS GROUP PTC EHF

23266 I

III

11/12/2009

ST GOBAIN PERFORMANCE PLASTICS

RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE) AS


MANUFACTURED IN TAMIL NADU INDIA
F1570 AND F1571 AS MANUFACTURED IN POESTENKILL NY

MISOPROSTOL AS MANUFACTURED IN BUDAPEST HUNGARY


FENOFIBRATE AS MANUFACTURED IN BARCELONA SPAIN

PACKAGING MATERIAL AS MANUFACTURED IN TARRAGONA SPAIN

Page 681

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23267 A
II
11/13/2009
FORMOSA LABORATORIES INC

SUBJECT
CALCIPOTRIOL MONOHYDRATE AS MANUFACTURED IN TAOYUAN TAIWAN

23268 A

II

11/13/2009

OLON SPA

CHOLINE FENOFIBRATE AS MANUFACTURED IN MULAZZANO (LO) ITALY

23269 A

II

11/12/2009

NURAY CHEMICALS PVT LTD

23270 A

II

11/16/2009

SIFAVITOR SRL

DARIFENACIN HYDROBROMIDE (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED


IN TAMIL NADU INDIA
PROGUANIL HYDROCHLORIDE AS MANUFACTURED IN LODI ITALY

23271 A

II

11/4/2009

23272 A

II

11/9/2009

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL EFAVIRENZ AS MANUFACTURED IN SHANGHAI CHINA


CO LTD
S M HERBALS PVT LTD
10 DEACETYLBACCATIN III AS MANUFACTURED IN RAJASTHAN INDIA

23273 A

II

10/27/2009

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA

23274 A

II

11/17/2009

HETERO DRUGS LTD

EPROSARTAN MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23275 A

12/16/2009

23276 A

II

11/24/2009

23277 A

III

11/16/2009

23278 A

II

11/16/2009

ORCHID CHEMICALS AND PHARMACEUTICALS LTD STERILE PROCESSING DETAILS OF PHASE - 18 AS LOCATED IN ALATHUR KANCHEEPURAM
DISTRICT INDIA
SUZHOU HOMESUN WANQING PHARMACEUTICAL MEROPENEM FOR INJECTION STERILE BULK AS MANUFACTURED IN JIANGSU PR CHINA
CO LTD
PACUR LLC
PACKAGING MATERIAL (EXTRUDED PLASTIC SHEET MATERIALS) AS MANUFACTURED IN
OSHKOSH WI
BIOCON LTD
PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN BANGALORE INDIA

23279 A

II

11/18/2009

23280 A

II

11/16/2009

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO ACARBOSE AS MANUFACTURED IN GUANGDONG PROVINCE PR CHINA
LTD
HIKMA PHARMACEUTICALS
NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN AMMAN JORDAN

23281 A

II

11/19/2009

HARMAN FINOCHEM LTD

FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23282 A

II

11/16/2009

23283 A

II

4/9/2010

CHANGZHOU SUNLIGHT PHARMACEUTICAL CO


LTD
IPCA LABORATORIES LTD

BENZOCAINE USP NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU


PROVINCE CHINA
HYDROXYZINE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

23284 A

II

12/9/2009

TARO PHARMACEUTICAL INDUSTRIES LTD

MEPROBAMATE USP AS MANUFACTURED IN HAIFA BAY ISRAEL

23285

II

12/24/2009

BIOSENSORS INTERNATIONAL

23286 A

III

11/20/2009

TAKEUCHI PRESS INDUSTRIES CO LTD

BIOLIMUS A9 ACTIVE PHARMACEUTICAL INGREDIENT (API) AS MANUFACTURED IN GUNMA


JAPAN FOR BIOSENSORS INTERNATIONAL
TAKEUCHI 4315F TUBE AS MANUFACTURED IN HYOGO JAPAN

23287 A

II

11/20/2009

FRESENIUS KABI ANTI INFECTIVES SRL

AMPICILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (ROVIGO) ITALY

23288 A

II

11/20/2009

APICORE US LLC

DISULFIRAM USP AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC

23289 A

II

11/20/2009

RAKS PHARMA PVT LTD

WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23290 A

IV

11/20/2009

SYMRISE GMBH AND CO KG

CYCLOPENTADECANOLIDE (CPD) AS MANUFACTURED IN HOLZMINDEN GERMANY

23291 A

II

12/15/2009

SUN PHARMACEUTICAL INDUSTRIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA INDIA

23292 A

II

12/24/2009

23293 A

II

12/28/2009

ORCHID CHEMICALS AND PHARMACEUTICALS LTD QUETIAPINE FUMARATE (NON STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA
INDIA
ORCHID CHEMICALS AND PHARMACEUTICALS LTD SODIUM CARBONATE (STERILE) AS MANUFACTURED IN ALATHUR INDIA

23294 A

II

12/24/2009

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFTAZIDIME (STERILE) AS MANUFACTURED IN ALATHUR INDIA

23295 A

II

12/29/2009

23296 I

IV

11/10/2009

23297 I

IV

11/10/2009

23298 I

IV

11/10/2009

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFTAZIDIME + SODIUM CARBONATE (STERILE BULK) AS MANUFACTURED IN TAMILNADU
INDIA
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
5X00149 SHEFFIELD COATING SYSTEM WHITE S AS MANUFACTURED IN NORWICH NY
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
5X00161 SHEFFIELD COATING SYSTEM WHITE 03 AS MANUFACTURED IN NORWICH NY
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
5X00162 SHEFFIELD COATING SYSTEM CLEAR PG AS MANUFACTURED IN NORWICH NY
KERRY BIO SCIENCE

Page 682

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23299 I
IV
11/10/2009
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
23300 A
II
11/18/2009
ALEMBIC PHARMACEUTICALS LTD

SUBJECT
5X00169 SHEFFIELD COATING SYSTEM WHITE PG AS MANUFACTURED IN NORWICH NY

23301 A

II

11/4/2009

JIANGSU ZW PHARMACEUTICALS CO LTD

4-(TRIFLUOROMETHOXY) ANILINE AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA

23302 I

II

11/23/2009

FLAMMA SPA

LOSARTAN POTASSIUM AS MANUFACTURED IN BERGAMO ITALY

23303 A

III

11/20/2009

FUJIMORI KOGYO CO LTD

23304 I

III

11/11/2009

TRUDELL MEDICAL INTERNATIONAL

RELEASE LINER FILM FOR USE IN PATCHES TRANSDERMAL DRUG DELIVERY (FILMBYNA **E5511 DG-2.5) AS MANUFACTURED IN SHIZUOKA PREF JAPAN
TOP MOUNTED ACTUATION INDICATOR (TMAI) AS MANUFACTURED IN ONTARIO CANADA

23305 I

II

11/25/2009

SANDOZ PRIVATE LTD

IMIPENEN STERILE AS MANUFACTURED IN MAHARASHTRA INDIA

23306 A

11/21/2009

SANDOZ PRIVATE LTD

23307 I

II

11/24/2009

SANDOZ GMBH

STERILIZATION PROCESS VALIDATION INFORMATION FOR CARBAPENEM STERILE


PRODUCTS LOCATED IN MAHARASHTRA INDIA
CILASTATIN SODIUM STERILE AS MANUFACTURED IN LANGKAMPFEN AUSTRIA

23308 A

II

7/10/2010

STAVO INDUSTRIES INC

PHARMACEUTICAL GRADE DEPTH TYPE FILTERS AS MANUFACTURED IN KINGSTON NY

23309 P

ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA

*** PENDING FILING REVIEW ***

23310 A

II

12/10/2009

USV LIMITED

ACITRETIN USP AS MANUFACTURED IN MAHARASHTRA INDIA

23311 I

II

11/20/2009

RPG LIFE SCIENCES LTD

HALOPERIDOL USP AS MANUFACTURED IN NAVI MUMBAI INDIA

23312 A

II

11/25/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

23313 I

II

11/24/2009

SANDOZ PRIVATE LTD

CARVEDILOL PHOSPHATE AS MANUFACTURED IN NETANYA ISRAEL FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
IMIPENEM AND CILASTATIN STERILE BLEND AS MANUFACTURED IN MAHARASHTRA INDIA

23314 A

II

11/27/2009

PHARMACEUTICAL WORKS POLPHARMA SA

ARIPIPRAZOLE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

23315 A

II

11/27/2009

ITF CHEMICAL LTDA

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN BAHIA BRAZIL

23316 A

III

10/7/2009

EMA PHARMACEUTICALS

23317 A

III

11/26/2009

FUJIMORI KOGYO CO LTD

23318 A

III

11/24/2009

TOPPAN PRINTING CO LTD

23319 A

II

11/1/2009

CHEMPACIFIC CORP

23320 A

III

11/28/2009

ESSEL PROPACK LTD

PACKAGING MATERIAL (13 & 20 MM COMBINATED PLASTIC ALUMINUM CAPS) AS


MANUFACTURED IN LAILLY EN VAL FRANCE
PLASTIC FILM FOR USE IN DRUG PRODUCT CONTAINER AS MANUFACTURED IN MIE
PREFECTURE JAPAN
HP-2 PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN
FUKUOKA JAPAN FOR TOPPAN PRINTING CO LTD
BGP32269 AS MANUFACTURED IN BALTIMORE MD AND ZHEJIANG CHINA FOR CHEMPACIFIC
CORPORATION
LAMINATED TUBES AS MANUFACTURED IN DADRA & NAGAR HAVELI INDIA

23321 I

II

12/10/2009

RANBAXY LABORATORIES LTD

LAMIVUDINE (DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN PUNJAB INDIA

23322 A

II

11/30/2009

MYLAN LABORATORIES LTD

VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) AS MANUFACTURED IN TELANGANA


INDIA

23324 A

II

12/1/2009

YMC CO LTD

YMC BIOPRO SERIES AS MANUFACTURED IN ISHIKAWA JAPAN FOR YMC CO LTD

23325 A

II

12/1/2009

CILAG AG

NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

23326 A

II

12/1/2009

APOTEX PHARMACHEM INC

ANASTROZOLE USP AS MANUFACTURED IN ONTARIO CANADA

23327 A

II

12/1/2009

ATENOLOL AS MANUFACTURED IN SHANGHAI PR CHINA

23328 I

II

12/1/2009

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
PHARMAZELL GMBH

23329 A

II

11/30/2009

EXCELLA GMBH

23330 A

II

11/25/2009

NINGBO TEAM PHARMACEUTICAL CO LTD

23323 P

*** PENDING FILING REVIEW ***

CARBAMAZEPINE (PROCESS II) AS MANUFACTURED IN RAUBLING FEDERAL REPUBLIC


GERMANY
AZATHIOPRINE AS MANUFACTURED IN FEUCHT GERMANY
ONDANSETRON HYDROCHLORIDE BULK FORM AS MANUFACTURED IN ZHEJIANG PROVINCE
PR CHINA

Page 683

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23331 A
V
12/2/2009
FACTA FARMACEUTICI SPA

SUBJECT
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN
TERAMO ITALY
PALONOSETRON HYDROCHLORIDE FORM A AS MANUFACTURED IN OPAVA KOMAROV CZECH
REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

23332 A

II

12/3/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

23333 A

II

4/6/2010

LUPIN LTD

23334 A

IV

12/3/2009

DAIDO CHEMICAL CORP

23335 A

II

12/2/2009

LONZA AG

SANGELOSE (HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER) AS


MANUFACTURED IN OSAKA JAPAN
VOCLOSPORIN (IE-001) AS MANUFACTURED IN VISP SWITZERLAND

23336 A

II

12/4/2009

AIR LIQUIDE HEALTHCARE AMERICA CORP

80PPM NITROGEN DIOXIDE BALANCE OXYGEN AS MANUFACTURED IN PLUMSTEADVILLE PA

23337 A

II

12/4/2009

AIR LIQUIDE HEALTHCARE AMERICA CORP

80PPM NITROGEN DIOXIDE BALANCE AIR AS MANUFACTURED IN PLUMSTEADVILLE PA

23338 A

II

2/20/2010

UNIMARK REMEDIES LTD

PALIPERIDONE AS MANUFACTURED IN GUJARAT INDIA

23339 A

II

12/4/2009

EMCURE PHARMACEUTICALS LTD

GEMCITABINE HYDROCHLORIDE USP ( E SUB) AS MANUFACTURED IN MAHARASHTRA INDIA

23340 I

III

12/3/2009

HD-PE ROUND BOTTLE 35ML AS MANUFACTURED IN NEUHAUS A RWG GERMANY

23341 A

II

11/28/2009

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG
QILU PHARMACEUTICAL CO LTD

23342 I

II

11/30/2009

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

PEMETREXED DISODIUM AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES


REPUBLIC OF CHINA
PREGABALIN AS MANUFACTURED IN ZHEJIANG CHINA

23343 A

II

11/30/2009

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

IMATINIB MESYLATE AS MANUFACTURED IN ZHEJIANG CHINA

23344 A

12/3/2009

SANOFI AVENTIS DEUTSCHLAND GMBH

23345 A

II

11/30/2009

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

FRANKFURT H600 ASEPTIC PROCESSING FACILITY LOCATED IN FRANKFURT AM MAIN


GERMANY
ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

23346 A

II

11/30/2009

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

RIVASTIGMINE TARTRATE AS MANUFACTURED IN ZHEJIANG CHINA

23347 A

II

12/7/2009

SIGNA SA DE CV

IRBESARTAN USP AS MANUFACTURED IN TOLUCA MEXICO

23348 A

III

11/15/2009

SURYAS OLDFORT PLASTICS PVT LTD

23349 A

II

11/30/2009

UNIMARK REMEDIES LTD

LDPE BASED PLASTIC FILMS FOR PHARMACEUTICAL USE AS MANUFACTURED IN SILVASSA


INDIA
TOPIRAMATE USP (PROCESS A) AS MANUFACTURED IN GUJARAT INDIA

23350 A

II

12/8/2009

GADOR SA

23351 A

II

11/30/2009

ALEMBIC PHARMACEUTICALS LTD

SODIUM IBANDRONATE AS MANUFACTURED IN PILAR PROVINCIA DE BUENOS AIRES


ARGENTINA
QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT INDIA

23352 A

III

12/4/2009

AMERICHEM INC

44225-CD5 BLUE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS OH

23353 A

II

11/30/2009

CTX LIFE SCIENCES PVT LTD

OXCARBAZEPINE (ROUTE-I) AS MANUFACTURED IN GUJARAT INDIA

23354 A

II

12/4/2009

MYLAN LABORATORIES LTD

BOSENTAN AS MANUFACTURED IN MAHARASHTRA INDIA

23355 A

II

12/2/2009

SAFC BIOSCIENCES INC

23356 A

III

12/1/2009

SIBO G DOO

EX-CELL ANTIFOAM GAMMA IRRADIATED BY SER-TAIN PROCESS AS MANUFACTURED IN


DENVER PA
CHILD RESISTANT CLOSURE CRP-045-FP AS MANUFACTURED IN SKOFJA LOKA SLOVENIA EU

23357 A

III

12/7/2009

ESSEL PROPACK LTD

LAMINATED TUBES AS MANUFACTURED IN GOA INDIA

23358 A

II

12/4/2009

23359 A

II

12/7/2009

NORTH CHINA PHARMACEUTICAL HUASHENG CO


LTD
JOST CHEMICAL CO

BACITRACIN ZINC NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HEBEI


CHINA
POTASSIUM NITRATE AS MANUFACTURED IN ST LOUIS MO

23360 I

II

12/10/2009

SANOFI AVENTIS DEUTSCHLAND GMBH

23361 A

II

11/30/2009

ZHEJIANG GARDEN BIOCHEMICAL HIGH TECH


STOCK CO LTD

FEXOFENADINE HYDROCHLORIDE (MDL 16455 A) AS MANUFACTURED IN FRANKFURT AM


MAIN GERMANY
CHOLECALCIFEROL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

Page 684

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23362 I
II
12/11/2009
CHATHAM BIOTEC LTD
23363 A

IV

12/7/2009

HENKEL CORP

SUBJECT
SEMISYNTHETIC DOCETAXEL DRUG SUBSTANCE (API) AS MANUFACTURED IN SHANGHAI
CHINA (MAINLAND) FOR CBL - CHATHAM BIOTEC LTD
DURO-TAK 87-625A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

23364 A

IV

12/7/2009

HENKEL CORP

DURO-TAK 87-626A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

23365 A

II

12/8/2009

BIOCON LTD

TACROLIMUS (PRODUCT CODE 8000255) AS MANUFACTURED IN BANGALORE INDIA

23366 A

II

3/5/2010

TARO PHARMACEUTICAL INDUSTRIES LTD

MALATHION USP AS MANUFACTURED IN HAIFA BAY ISRAEL

23367 A

II

12/14/2009

MYLAN LABORATORIES LTD

PALIPERIDONE AS MANUFACTURED IN TELANGANA INDIA

23368 A

II

12/14/2009

MYLAN LABORATORIES LTD

NEVIRAPINE USP (ANHYDROUS) (RAN) AS MANUFACTURED IN TELANGANA, INDIA

23369 A

II

1/6/2010

PRONOVA BIOPHARMA NORGE AS

OMEGA-3 ACID ETHYL ESTERS 90 AS MANUFACTURED IN ISLE OF LEWIS, SCOTLAND UK

23370 I

III

11/11/2009

STE PHARMAPACK SL

23371 A

III

12/3/2009

MARTIN SONTAG GMBH

PLASTIC MOLDED BOTTLE ASSEMBLIES FOR PACKAGING AND DELIVERY OF


PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN TARRAGONA SPAIN
CARTRIDGES FOR PHARMACEUTICAL USE AS MANUFACTURED IN ONOLZHEIM GERMANY

23372 A

II

12/15/2009

SRI KRISHNA PHARMACEUTICALS LTD

MECLIZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23373 A

II

11/23/2009

COVALENT LABORATORIES PRIVATE LTD

23374 A

II

12/16/2009

GADOR SA

7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVNA) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
ZOLEDRONIC ACID AS MANUFACTURED IN PILAR PROVINCIA DE BUENOS AIRES ARGENTINA

23375 A

II

12/8/2009

SCORA SA

23376 A

II

12/15/2009

SANOFI AVENTIS CHIMIE

GRANULAR CALCIUM CARBONATE (SCORALITE DC AND SCORALITE LOW LEAD DC) AS


MANUFACTURED IN CAFFIERS FRANCE
RPR106721 - POMA (INTERMEDIATE) AS MANUFACTURED IN VERTOLAYE FRANCE

23377 A

III

12/15/2009

MANUFACTURE GENERALE DE JOINTS MGJ

CORESEAL LINERS AS MANUFACTURED IN CHAZAY D'AZERGUES FRANCE

23378 A

II

12/16/2009

SHASUN PHARMACEUTICALS LTD

COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE INDIA

23379 A

II

12/16/2009

HETERO DRUGS LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23380 A

II

12/16/2009

AMINO CHEMICALS LTD

DEXLANSOPRAZOLE AS MANUFACTURED IN MARSA MALTA

23381 A

II

12/17/2009

NURAY CHEMICALS PVT LTD

23382 A

II

12/17/2009

NURAY CHEMICALS PVT LTD

23383 A

II

12/17/2009

EVERLIGHT CHEMICAL INDUSTRIAL CORP

ROSIGLITAZONE MALEATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


TAMIL NADU INDIA
LEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED
IN TAMIL NADU INDIA
LUBIPROSTONE AS MANUFACTURED IN TAOYUAN HSIEN TAIWAN

23384 A

12/21/2009

SANDOZ GMBH

23385 A

II

12/14/2009

BACHEM SA

23386 I

II

12/21/2009

MITSUBISHI TANABE PHARMA CORP

23387 A

II

12/18/2009

SCINOPHARM TAIWAN LTD

23388 A

II

12/18/2009

CHEMO IBERICA SA MADRID

23389 A

II

2/22/2010

SUN PHARMACEUTICAL INDUSTRIES LTD

SEVELAMER CARBONATE AS MANUFACTURED IN ZHEJIANG PROVINCE PR OF CHINA FOR


CHEMO IBERIC SA MADRID
NALOXONE HYDROCHLORIDE DIHYDRATE USP AS MANUFACTURED IN GUJARAT INDIA

23390 A

II

12/18/2009

EUTICALS INC

CHOLINE FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD MO

23391 A

III

12/18/2009

JSR CORP

ARTON SERIES AS MANUFACTURED IN CHIBA JAPAN

23392 A

IV

12/18/2009

FONA INTERNATIONAL INC

856.0196U GRAPE FLAVOR ART AS MANUFACTURED IN GENEVA IL

STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE CEPHALOSPORIN


CRYSTALLIZATION PLANT LOCATED IN KUNDL TYROL AUSTRIA
DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN VIONNAZ SWITZERLAND
MT-7716 DRUG SUBSTANCE AS MANUFACTURED IN YAMAGUCHI JAPAN FOR MITSUBISHI
TANABE PHARMA CORPORATION
DECITABINE AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC

Page 685

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23393 A
III
12/18/2009
EI DUPONT DE NEMOURS INC
23394 A

III

12/21/2009

COIM USA INC

23395 A

12/18/2009

NANOINK INC

23396 A

II

12/22/2009

SRI KRISHNA DRUGS LTD

SUBJECT
DUPONT APPEEL LIDDING RESINS AS MANUFACTURED IN ORANGE TX, ONTARIO CANADA,
ZWIJNDRECHT BELGIUM AND HIROSHIMA PREFECTURE JAPAN
NOVACOTE NC-9170-23MAC WITH CO-REACTANT CA-350 PU AS MANUFACTURED IN WEST
DEPTFORD NJ
PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION
AND PROCESS FOR HARD CAPSULES AS MANUFACTURED IN SKOKIE IL
FUROSEMIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23397 A

II

1/12/2010

LUPIN LTD

DROSPIRENONE USP AS MANUFACTURED IN MADHYA PRADESH INDIA FOR LUPIN LIMITED

23398 A

II

3/12/2010

LUPIN LTD

IRBESARTAN USP (PROCESS B) AS MANUFACTURED IN MAHARASHTRA INDIA

23399 A

II

12/21/2009

FINE CHEMICALS CORP PTY LTD

FCC-7280 AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA

23400 A

II

12/15/2009

SYN TECH CHEM AND PHARM CO LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN HSIN-YING TAIWAN ROC

23401 A

II

12/23/2009

NURAY CHEMICALS PVT LTD

23402 A

II

12/23/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

23403 A

II

12/22/2009

SIEGFRIED USA INC

RANOLAZINE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU


INDIA
LUBIPROSTONE AS MANUFACTURED IN ZAGREB CROATIA FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
OXYMORPHONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE NJ

23404 A

II

12/14/2009

CHEMISCHE FABRIK BERG GMBH

PHENOBARBITAL USP AS MANUFACTURED IN BITTERFELD-WOLFEN GERMANY

23405 A

II

12/22/2009

POLYDRUG LABORATORIES PVT LTD

FLUCONAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA

23406 A

II

12/16/2009

CENWAY PHARMACEUTICALS CO LTD

DOCETAXEL AS MANUFACTURED IN TIANJIN PR CHINA

23407 A

III

12/21/2009

AMPACET CORP

23408 A

II

12/23/2009

THE SUZUKI MENTHOL CO LTD

603192-PT UVA PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,


CARTERSVILLE GA AND HEATH OH
L-MENTHOL USP/JP AS MANUFACTURED IN KOBE JAPAN

23409 A

II

12/29/2009

MYLAN LABORATORIES LTD

VORINOSTAT AS MANUFACTURED IN MAHARASHTRA INDIA

23410 A

II

12/29/2009

MYLAN LABORATORIES LTD

LENALIDOMIDE AS MANUFACTURED IN MAHARASHTRA INDIA

23411 A

II

12/29/2009

MYLAN LABORATORIES LTD

LETROZOLE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23412 I

II

12/28/2009

RANBAXY LABORATORIES LTD

ENTACAPONE AS MANUFACTURED IN PUNJAB INDIA

23413 I

II

12/29/2009

RANBAXY LABORATORIES LTD

TROSPIUM CHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB INDIA

23414 A

II

12/29/2009

TEVA PHARMACEUTICAL INDUSTRIES LTD

23415 I

II

12/15/2009

AANJANEYA LIFECARE LTD

SUNITINIB MALATE AS MANUFACTURED IN MILAN ITALY FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
QUININE SULPHATE USP DRUG SUBSTANCE AS MANUFACTURED IN MAHAD INDIA

23416 A

II

12/22/2009

CHEMWERTH INC

23417 A

II

12/28/2009

CHEMWERTH INC

23418 A

II

12/31/2009

ACS DOBFAR SPA

AZACITIDINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG


PROVINCE CHINA FOR CHEMWERTH INC
PEMETREXED DISODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
ZHEJIANG PROVINCE CHINA FOR CHEMWERTH INC
AMPA AS MANUFACTURED IN MILANO ITALY

23419 A

II

6/30/2010

CHATTEM CHEMICALS INC

OXYCODONE HYDROCHLORIDE, USP AS MANUFACTURED IN CHATTANOOGA TN

23420 A

IV

12/18/2009

DOW CORNING CORP

DOW CORNING Q7-9180 SILICONE FLUIDS AS MANUFACTURED IN HEMLOCK MI

23421 A

II

12/30/2009

WUHAN WUYAO PHARMACEUTICAL CO LTD

METRONIDAZOLE AS MANUFACTURED IN WUHAN CHINA

23422 A

II

12/29/2009

MACLEODS PHARMACEUTICALS LTD

VALACICLOVIR HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN GUJARAT INDIA

23423 A

II

12/28/2009

SCINOPHARM TAIWAN LTD

TRAVOPROST AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC

23424 A

II

12/28/2009

ALP PHARM BEIJING CO LTD

ESZOPICLONE AS MANUFACTURED IN ZHEJIANG CHINA FOR ALP PHARM BEIJING CO LTD

23425 A

II

12/29/2009

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD

SIMVASTATIN NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING PR


CHINA

Page 686

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23426 A
II
12/31/2009
ALEMBIC PHARMACEUTICALS LTD

SUBJECT
DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

23427 A

II

1/5/2010

INDUSTRIALE CHIMICA SRL

FLUTICASONE PROPIONATE USP AS MANUFACTURED IN SARONNO (VA), ITALY

23428 A

II

1/5/2010

INDUSTRIALE CHIMICA SRL

DIENOGEST AS MANUFACTURED IN SARONNO (VARESE) ITALY

23430 A

III

7/21/2009

ASTRA PLASTIQUE

CLOSURE: REFERENCE 1442 AS MANUFACTURED IN SAINT-GEORGES DE RENEINS FRANCE

23431 A

II

1/6/2010

MYLAN LABORATORIES LTD

LAMIVUDINE USP (LVD) AS MANUFACTURED IN TELANGANA, INDIA

23432 A

II

1/6/2010

CADILA HEALTHCARE LTD

RANOLAZINE AS MANUFACTURED IN GUJARAT INDIA

23433 I

II

1/6/2010

CADILA HEALTHCARE LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

23434 A

II

1/6/2010

METAXALONE AS MANUFACTURED IN TAIPEI HSIEN TAIWAN

23435 A

II

1/6/2010

23436 A

II

12/31/2009

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH
CO LTD
AUROBINDO PHARMA LTD

23437 A

II

1/4/2010

CERBIOS PHARMA SA

23438 A

II

12/31/2009

NECTAR LIFESCIENCES LTD

23439 A

II

1/7/2010

CADILA HEALTHCARE LTD

23440 A

II

1/8/2010

SCI PHARMTECH INC

23441 A

II

1/12/2010

MYLAN LABORATORIES LTD

23442 A

II

1/8/2010

MSN PHARMACHEM PVT LTD

23443 A

II

1/11/2010

EMCURE PHARMACEUTICALS LTD

SUMATRIPTAN USP [ROUTE CODE - "SN"] (EUSB) AS MANUFACTURED IN ANDHRA PRADESH


INDIA
TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

23444 A

II

1/7/2010

PROVENTUS LIFE SCIENCES PVT LTD

PRIMIDONE AS MANUFACTURED IN CHENNAI INDIA

23445 A

III

1/11/2010

TEIJIN LTD

23446 I

II

1/8/2010

ALP PHARM BEIJING CO LTD

23447 A

III

1/12/2010

TRIMAR INTERNATIONAL CORP

23448 A

II

5/26/2010

JUBILANT GENERICS LTD

POLYETHYLENE TEREPHTHALATE RESIN (TYPE SD-M) AS MANUFACTURED IN EHIME PREF


JAPAN
CIDOFOVIR DIHYDRATE AS MANUFACTURED IN SHANDONG CHINA PC FOR ALP PHARM
BEIJING CO LTD
HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AS MANUFACTURED IN YUNLIN COUNTY
TAIWAN
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) AS MANUFACTURED IN KARNATAKA INDIA

23449 A

II

1/11/2010

MACLEODS PHARMACEUTICALS LTD

IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA

23450 A

II

1/7/2010

LAURUS LABS PRIVATE LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23451 A

II

1/11/2010

HUANGSHI MEIFENG CHEMICAL CO LTD

SULISOBENZONE AS MANUFACTURED IN HUBEI PR CHINA

23452 A

1/11/2010

OFFICE SURGEON GENERAL DEPT ARMY

23453 A

II

1/11/2010

PARABOLIC DRUGS LTD

SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS (SERPACWA)


LOCATED IN FORT DETRICK MARYLAND
CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-II AS MANUFACTURED IN PUNJAB INDIA

23454 A

III

1/14/2010

KANEKA BELGIUM NV

KANE ACE B-28A AS MANUFACTURED IN WESTERLO-OEVEL BELGIUM

23455 A

II

1/14/2010

AMINO CHEMICALS LTD

BOSENTAN MONOHYDRATE AS MANUFACTURED IN MARSA MALTA

23456 A

II

8/3/2010

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD

NAFTIFINE HYDROCHLORIDE NON-STERILE BULK DRUG AS MANUFACTURED IN SHANGHAI


CHINA

23429 P

23457 N

*** PENDING FILING REVIEW ***

MYCOPHENOLATE SODIUM AS MANUFACTURED IN TAIPEI HSIEN TAIWAN


CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS
MANUFACTURED IN ANDHRA PRADESH INDIA
CALCIUM LEVOFOLINATE AS MANUFACTURED IN BARBENGO/LUGANO SWITZERLAND
7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVCA) [NON-STERILE DRUG SUBSTANCE
INTERMEDIATE] AS MANUFACTURED IN CHANDIGARH INDIA
CLOPIDOGREL BISULFATE USP (FORM-I) (CUE ROUTE) AS MANUFACTURED IN GUJARAT INDIA
DULOXETINE HYDROCHLORIDE (FROM (S)-MMAA-OME) AS MANUFACTURED IN TAOYUAN
TAIWAN
VARENICLINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

NOT AN ASSIGNED NUMBER

Page 687

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23458 A
II
1/8/2010
QILU PHARMACEUTICAL CO LTD
23459 A

II

1/15/2010

EMCURE PHARMACEUTICALS LTD

23460 A

II

1/18/2010

DR REDDYS LABORATORIES LTD

SUBJECT
DOCETAXEL USP AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES REPUBLIC
OF CHINA
SEVELAMER CARBONATE (FOR POWDER FORMULATION) AS MANUFACTURED IN
MAHARASHTRA INDIA
RASAGILINE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23461 A

II

1/15/2010

CYALUME SPECIALTY PRODUCTS INC

CHLORPHENIRAMINE TANNATE AS MANUFACTURED IN BOUND BROOK NJ

23462 A

III

1/15/2010

DA PRO RUBBER INC

PACKAGING MATERIAL AS MANUFACTURED IN BROKEN ARROW OK

23463 A

III

1/15/2010

MINNESOTA RUBBER AND PLASTICS

23464 A

II

1/14/2010

LABORATORIO CHIMICO INTERNAZIONALE SPA

A RUBBER FLUOROELASTOMER FOR SEALING APPLICATIONS IN MEDICAL DEVICES AS


MANUFACTURED BY MINNESOTA RUBBER AND PLASTICS IN TAMAULIPAS MEXICO
FENOFIBRIC ACID CHOLINE SALT AS MANUFACTURED IN SEGRATE MI ITALY

23465 A

1/20/2010

LONZA HOUSTON INC

23466 A

II

1/20/2010

MSN LABORATORIES LTD

CLINICAL PHASE BIOLOGICS SPECIALIZING IN ADENOVIRAL BASED GENE THERAPY


PRODUCTS LOCATED IN HOUSTON TX
EPLERENONE [ROUTE CODE: PL] AS MANUFACTURED IN ANDHRA PRADESH INDIA

23467 A

II

1/15/2010

WANBURY LTD

CARVEDILOL PHOSPHATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

23468 A

III

1/8/2010

HB FULLER CO

PHC9255 AS MANUFACTURED IN MESQUITE TX

23469 A

II

1/12/2010

CHANGZHOU AHK TECH INC

23470 A

III

1/18/2010

GREEN PACK FOILS PRIVATE LTD

CYTARABINE USP NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PR


CHINA
ALUMINIUM STRIP FOIL (LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA

23471 A

III

1/18/2010

GREEN PACK FOILS PRIVATE LTD

ALUMINIUM BLISTER FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA

23472 A

II

1/21/2010

DR REDDYS LABORATORIES LTD

TELMISARTAN (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH INDIA

23473 A

II

1/21/2010

GLOCHEM INDUSTRIES LTD

CLOPIDOGREL BISULPHATE FORM-I AS MANUFACTURED IN ANDHRA PRADESH INDIA

23474 A

II

1/18/2010

PARABOLIC DRUGS LTD

CEFIXIME AS MANUFACTURED IN PUNJAB INDIA

23475 I

II

1/21/2010

SEQUENT SCIENTIFIC LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN KARNATAKA INDIA

23476 I

II

2/20/2010

UNIMARK REMEDIES LTD

ESZOPICLONE AS MANUFACTURED IN GUJARAT INDIA

23477 A

II

1/18/2010

CAMBREX PROFARMACO MILANO SRL

SODIUM PICOSULFATE AS MANUFACTURED IN MILAN ITALY

23478 A

II

1/22/2010

CYALUME SPECIALTY PRODUCTS INC

DEXTROMETHORPHAN TANNATE AS MANUFACTURED IN BOUND BROOK NJ

23479 A

II

1/22/2010

SHILPA MEDICARE LTD

TEMOZOLOMIDE AS MANUFACTURED IN KARNATAKA INIDA

23480 A

II

1/26/2010

INDUSTRIALE CHIMICA SRL

BIMATOPROST AS MANUFACTURED IN SARONNO (VARESE) ITALY

23481 A

IV

1/20/2010

UNGERER AND CO

ARTIFICIAL TUTTI FRUITTI FLAVOR FS-6943 AS MANUFACTURED IN BETHLEHEM PA

23482 A

II

1/26/2010

CYALUME SPECIALTY PRODUCTS INC

PSEUDOEPHEDRINE TANNATE AS MANUFACTURED IN BOUND BROOK NJ

23483 A

III

12/26/2009

PACKNOWCRAT INDIA PVT LTD

FLEXIBLE PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA INDIA

23484 A

II

5/7/2010

NEKTAR THERAPEUTICS

23485 A

II

2/7/2010

BGP HEALTHCARE PRIVATE LTD

N-HYDROXYSUCCINIMIDYL ESTER OF BIS (METHOXYPOLY(ETHYLENE GLYCOL) MW 20,000)


MODIFIED LYSINE AS MANUFACTURED IN HUNTSVILLE AL
NICOTINE USP AS MANUFACTURED IN GUJARAT INDIA

23486 A

II

1/27/2010

HAINAN POLY PHARMACEUTICAL CO LTD

23487 A

II

1/27/2010

HAINAN POLY PHARMACEUTICAL CO LTD

23488 A

II

1/27/2010

MSN LABORATORIES LTD

AZITHROMYCIN GRANULES FOR ORAL SUSPENSION AS MANUFACTURED IN HAINAN


PROVINCE CHINA
GLUCOSAMINE HYDROCHLORIDE PELLETS CAPSULES AS MANUFACTURED IN HAINAN
PROVINCE CHINA
PITAVASTATIN CALCIUM [ROUTE CODE: PC] AS MANUFACTURED IN ANDHRA PRADESH INDIA

23489 A

III

1/21/2010

HYUNDAI ENGINEERING PLASTICS CO LTD

PACKAGING MATERIAL AS MANUFACTURED IN CHUNGNAM KOREA

23490 A

II

1/28/2010

APOTEX PHARMACHEM INC

LUBIPROSTONE AS MANUFACTURED IN ONTARIO CANADA

23491 A

II

1/22/2010

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

VALSARTAN USP (PROCESS II) AS MANUFACTURED IN ZHEJIANG CHINA

Page 688

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23492 A
III
1/20/2010
PRETIUM PACKAGING

SUBJECT
PLASTIC PACKAGING MATERIAL AS MANUFACTURED IN PHILMONT NY

23493 A

II

1/22/2010

HUBEI HAOSUN PHARMACEUTICAL CO LTD

AMISULPRIDE AS MANUFACTURED IN HUBEI, CHINA

23494 A

II

4/30/2010

PHF SA

DUTASTERIDE AS MANUFACTURED IN MARCON VENEZIA ITALY FOR PHF SA

23495 A

II

1/29/2010

APOTEX PHARMACHEM INC

MONTELUKAST SODIUM USP AS MANUFACTURED IN ONTARIO CANADA

23496 A

II

1/29/2010

SANOFI CHIMIE

23497 A

III

1/22/2010

LG CHEM LTD

CABAZITAXEL ACETONE SOLVATE AS MANUFACTURED IN VITRY-SUR-SEINE FRANCE FOR


SANOFI CHIMIE
PP PRODUCTS AS MANUFACTURED IN SEOUL KOREA

23498 A

III

1/22/2010

LG CHEM LTD

LDPE PRODUCTS AS MANUFACTURED IN SEOUL KOREA

23499 A

III

2/1/2010

KLOCKNER PENTAPLAST

23500 A

II

2/16/2010

UNIMARK REMEDIES LTD

POLYESTER BASED PACKAGING FILMS AS MANUFACTURED IN GORDONSVILLE VIRGINIA;


MONTABAUR GERMANY AND LIEBEFELD/BERN SWITZERLAND
NITROFURANTOIN ANHYDROUS USP AS MANUFACTURED IN GUJARAT INDIA

23501 A

II

2/16/2010

UNIMARK REMEDIES LTD

NITROFURANTOIN MONOHYDRATE USP AS MANUFACTURED IN GUJARAT INDIA

23502 A

II

5/6/2010

TARO PHARMACEUTICAL INDUSTRIES LTD

MOMETASONE FUROATE USP/PH EUR MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL

23503 A

II

1/22/2010

CALYX CHEMICALS AND PHARMACEUTICALS LTD

FLUCYTOSINE AS MANUFACTURED IN MAHARASHTRA INDIA

23504 A

II

2/1/2010

BASF SE

23505 A

III

1/26/2010

KISHORE PHARMA PRODUCTS PVT LTD

SOLUPLUS AS MANUFACTURED IN LUDWIGHAFEN FEDERAL REPUBLIC OF GERMANY AND


DRESDEN FEDERAL REPUBLIC OF GERMANY FOR BASF SE
TYPE I GLASS AMPOULES AND VIALS AS MANUFACTURED IN KARNATAKA INDIA

23506 A

II

2/2/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

PACLITAXEL SEMISYNTHETIC AS MANUFACTURED IN OPAVA KOMAROV CZECH REPUBLIC

23507 I

II

1/27/2010

AREVIPHARMA GMBH

FLUTAMIDE AS MANUFACTURED IN RADEBEUL GERMANY

23508 A

II

1/16/2010

QILU PHARMACEUTICAL CO LTD

EXEMESTANE (NON STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA

23509 A

II

2/2/2010

RAKS PHARMA PVT LTD

SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23510 A

II

4/21/2010

PRONOVA BIOPHARMA NORGE AS

OMEGA-3 ACID ETHYL ESTERS 78 AS MANUFACTURED IN SCOTLAND UK

23511 A

II

1/22/2010

SUPRIYA LIFESCIENCE LTD

BROMPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA INDIA

23512 A

II

1/22/2010

SUPRIYA LIFESCIENCE LTD

PHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA INDIA

23513 A

II

2/18/2010

USV LIMITED

ATOVAQUONE USP (FORM III) AS MANUFACTURED IN MAHARASHTRA INDIA

23514 A

III

2/2/2010

IFS INDUSTRIES INC

IFS HOT MELT #M-766-2V (HM-560) AS MANUFACTURED IN READING PA

23515 A

III

1/29/2010

BASELL POLYOLEFINE ITALIA SRL

23516 A

II

2/12/2010

EUTICALS SPA

PURELL PE 3420 F AS MANUFACTURED IN WESSELING GERMANY FOR BASELL POLYOLEFINE


ITALIA SRL
GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN VARESE ITALY

23517 A

IV

2/8/2010

FONA INTERNATIONAL INC

PRODUCT # 825.744 CHERRY FLAVOR ARTIFICIAL AS MANUFACTURED IN GENEVA IL

23518 A

IV

2/9/2010

FONA INTERNATIONAL INC

PRODUCT # 877.0131U N-C MINT FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL

23519 A

II

2/8/2010

BIOCON LTD

MYCOPHENOLATE SODIUM AS MANUFACTURED IN BANGALORE INDIA

23520 A

II

2/4/2010

SIEGFRIED USA LLC

23521 A

II

2/5/2010

DERIVADOS QUIMICOS SAU

OXYCODONE HYDROCHLORIDE USP (LOW ABUK IMPURITY) AS MANUFACTURED IN


PENNSVILLE NJ
CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA SPAIN

23522 A

II

1/10/2010

HUBEI HAOSUN PHARMACEUTICAL CO LTD

IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN HUBEI, CHINA

23523 A

II

2/12/2010

NATCO PHARMA LTD

LANSOPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23524 A

II

2/11/2010

SHENZHEN HAIBIN PHARMACEUTICAL CO LTD

MEROPENEM STERILE AS MANUFACTURED IN GUANGDONG PROVINCE, PR CHINA

23525 A

II

2/3/2010

AUROBINDO PHARMA LTD

OLANZAPINE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA

Page 689

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23526 A
III
1/27/2010
CCC PLASTICS CANADA COLORS AND CHEMICALS
LTD
23527 A
III
1/14/2010
KEJARIWAL INDUSTRIES

SUBJECT
WHITE MB50-9576 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN
ONTARIO CANADA
GLASS AMPOULES AND VIALS AS MANUFACTURED IN DELHI INDIA

23528 A

II

2/11/2010

JSC OLAINFARM

AMANTADINE HYDROCHLORIDE AS MANUFACTURED IN OLAINE LATVIA

23529 A

IV

2/15/2010

EMERSON RESOURCES INC

PLASACRYL PF AS MANUFACTURED IN NORRISTOWN PA

23530 A

II

2/8/2010

QILU PHARMACEUTICAL CO LTD

23531 A

2/4/2010

BASF SE

23532 A

II

1/29/2010

FERMION OY

OXALIPLATIN (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES


REPUBLIC OF CHINA
SOLUTOL HS 15 PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN LUDWIGSHAFEN
FEDERAL REPUBLIC OF GERMANY
METHOTREXATE DISODIUM AS MANUFACTURED IN OULU FINLAND

23533 A

II

2/16/2010

MSN LABORATORIES LTD

DUTASTERIDE [ROUTE CODE - DT] AS MANUFACTURED IN ANDHRA PRADESH INDIA

23534 I

III

2/3/2010

APTAR RADOLFZELL GMBH

POWDER DISPENSING DEVICES AS MANUFACTURED IN EIGELTINGEN GERMANY

23535 A

II

1/31/2010

ALP PHARM BEIJING CO LTD

23536 A

II

1/30/2010

ALP PHARM BEIJING CO LTD

23537 A

II

2/4/2010

SCI PHARMTECH INC

URSODEOXYCHOLIC ACID (DRUG SUBSTANCE NON-STERILE) AS MANUFACTURED IN


SUZHOU JIANGSU CHINA FOR ALP PHARM BEIJING CO LTD
ADAPALENE (DRUG SUBTANCE NON-STERILE) AS MANUFACTURED IN SHANDONG CHINA FOR
ALP PHARM BEIJING CO LTD
PROPAFENONE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN TAIWAN

23538 A

III

1/13/2010

PRADEEP LAMINATORS PVT LTD

RETORT POUCHES AS MANUFACTURED IN MAHARASHTRA INDIA

23539 A

II

2/13/2010

LAURUS LABS PRIVATE LTD

LATANOPROST USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23540 A

II

2/19/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

23541 A

II

4/7/2010

LUPIN LTD

FENOFIBRATE CHOLINE AS MANUFACTURED IN ZAGREB CROATIA FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
EZETIMIBE AS MANUFACTURED IN MAHARASHTRA INDIA

23542 A

II

3/31/2010

LUPIN LTD

RITONAVIR USP AS MANUFACTURED IN MAHARASHTRA INDIA

23543 A

II

4/8/2010

LUPIN LTD

CELECOXIB USP AS MANUFACTURED IN MAHARASHTRA INDIA

23544 A

II

4/15/2010

LUPIN LTD

CEFDITOREN PIVOXIL AS MANUFACTURED IN MADHYA PRADESH INDIA

23545 A

II

3/16/2010

USV LIMITED

BEXAROTENE AS MANUFACTURED IN MAHARASHTRA INDIA

23546 P

*** PENDING FILING REVIEW ***

23547 A

II

2/17/2010

CHEMWERTH INC

23548 A

III

2/19/2010

OKADA SHIGYO CO LTD

23549 A

III

2/17/2010

AMPACET CORP

23550 A

III

2/19/2010

EI DUPONT DE NEMOURS INC

23551 A

III

11/8/2009

REGO PACKING INDUSTRY CO LTD

23552 A

II

4/8/2010

LUPIN LTD

182136 BEIGE PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE


GA AND HEATH OH
DUPONT ELVALOY AC RESINS AS MANUFACTURED IN ZWIJNDRECHT BELGIUM FOR E.I.
DUPONT DE NEMOURS INC
COLLAPSIBLE LAMINATED TUBES FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN
GUANGDON CHINA
GATIFLOXACIN AS MANUFACTURED IN MAHARASHTRA INDIA

23553 A

II

3/8/2010

SUN PHARMACEUTICAL INDUSTRIES LTD

TEMOZOLOMIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23554 A

II

2/21/2010

PERRIGO API LTD

CISATRACURIUM BESYLATE AS MANUFACTURED IN BEER SHEVA ISRAEL

23555 P

TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN SICHUAN


CHINA FOR CHEMWERTH INC
HI-GAL FILM ~ SEIBOU PE-01 AS MANUFACTURED IN OSAKA JAPAN

*** PENDING FILING REVIEW ***

23556 A

II

3/9/2010

USV LIMITED

ATOVAQUONE USP (FORM I) AS MANUFACTURED IN MAHARASHTRA INDIA

23557 A

II

2/16/2010

SPECIALTY ENZYMES AND BIOCHEMICALS CO

SERRATIOPEPTIDASE AS MANUFACTURED IN NASHIK INDIA FOR SPECIALTY ENZYMES &


BIOCHEMICALS CO

Page 690

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23558 A
II
2/19/2010
FUJIAN SOUTH PHARMACEUTICAL CO LTD
23559 A

II

2/12/2010

ARKEMA INC

SUBJECT
PACLITAXEL (NATURAL) USP (NATURAL, NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN FUJIAN PR CHINA
LUPEROX A75FP AS MANUFACTURED IN PIFFARD NY

23560 A

II

2/19/2010

HUBEI MEIKAI CHEMICAL CO LTD

OXYBENZONE AS MANUFACTURED IN HUBEI CHINA

23561 A

II

2/22/2010

SEQUENT SCIENTIFIC LTD

LUMEFANTRINE AS MANUFACTURED IN KARNATAKA INDIA

23562 A

II

2/23/2010

SHILPA MEDICARE LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN KARNATAKA INDIA

23563 A

II

2/23/2010

SHILPA MEDICARE LTD

OXALIPLATIN AS MANUFACTURED IN KARNATAKA INDIA

23564 A

II

2/23/2010

DR REDDYS LABORATORIES LTD

AZACITIDINE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23565 A

III

2/18/2010

AMPACET CORP

23566 A

II

3/3/2010

ARCH PHARMALABS LTD

23567 A

II

2/22/2010

HIKAL LTD

15571 PINK AS PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERVILLE


GA AND HEATH OH
CITALOPRAM HYDROBROMIDE USP (CYANO ROUTE) AS MANUFACTURED IN MAHARASHTRA
INDIA
MEMANTINE HYDROCHLORIDE API AS MANUFACTURED IN BANGALORE INDIA

23568 A

III

2/22/2010

LABLABO

METERED AEROSOL VALVES AS MANUFACTURED IN ANNEMASSE FRANCE

23569 A

II

2/24/2010

DR REDDYS LABORATORIES LTD

RILUZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23570 A

II

3/12/2010

UNIMARK REMEDIES LTD

NITROFURANTOIN ANHYDROUS CRYSTALS USP AS MANUFACTURED IN GUJARAT INDIA

23571 A

IV

3/16/2010

DOTTIKON EXCLUSIVE SYNTHESIS AG

DOTTISOL (ISOSORBIDE DIMETHYL ETHER) AS MANUFACTURED IN DOTTIKON SWITZERLAND

23572 A

II

2/23/2010

PARABOLIC DRUGS LTD

CEFPODOXIME PROXETIL AS MANUFACTURED IN PUNJAB INDIA

23573 A

III

3/1/2010

SABIC PETROCHEMICALS BV

23574 A

III

3/1/2010

SABIC PETROCHEMICALS BV

23575 A

III

3/1/2010

SABIC PETROCHEMICALS BV

23576 A

III

3/1/2010

SABIC PETROCHEMICALS BV

23577 A

III

3/1/2010

SABIC PETROCHEMICALS BV

23578 I

II

2/24/2010

DERIVADOS QUIMICOS SA FINE CHEMICALS

SABIC LDPE PCG00 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC


PETROCHEMICALS BV
SABIC LDPE PCG01 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC
PETROCHEMICALS BV
SABIC LDPE PCG02 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC
PETROCHEMICALS BV
SABIC LDPE PCG07 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC
PETROCHEMICALS BV
SABIC LDPE PCG09 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC
PETROCHEMICALS BV
LANSOPRAZOLE AS MANUFACTURED IN MURCIA SPAIN

23579 A

III

2/5/2010

AMCOR FLEXIBLES BURGDORF GMBH

23580 A

II

8/16/2010

SUN PHARMACEUTICAL INDUSTRIES LTD

LAMINATE POLYESTER 23 / ALUMINIUM 12 / LDPE 50 (SOP 51284) AS MANUFACTURED IN


BURGDORF SWITZERLAND
DROSPIRENONE USP AS MANUFACTURED IN GUJARAT INDIA

23581 A

II

5/28/2010

SUN PHARMACEUTICAL INDUSTRIES LTD

RIZATRIPTAN BENZOATE USP AS MANUFACTURED IN GUJARAT INDIA

23582 A

II

3/25/2010

ALKALOIDA CHEMICAL CO ZRT

HYDROXYCHLOROQUINE SULFATE USP AS MANUFACTURED IN TISZAVASVARI HUNGARY

23583 A

II

3/4/2010

23584 A

II

2/24/2010

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
ALEMBIC PHARMACEUTICALS LTD

DEXTROAMPHETAMINE SULFATE USP (PROCESS 2) AS MANUFACTURED IN WEST DEPTFORD


NJ
VALSARTAN USP (PROCESS II) AS MANUFACTURED IN GUJARAT INDIA

23585 A

II

3/2/2010

AMOLI ORGANICS PVT LTD

LEVETIRACETAM AS MANUFACTURED IN GUJARAT INDIA

23586 A

III

2/18/2010

ESSEL PROPACK LTD

LAMINATED TUBES AS MANUFACTURED IN THE NALAGARH DIST SOLAN HP INDIA

23587 I

III

2/26/2010

BERRY PLASTICS CORP

MARVELLINER 8CB1CP-PET AS MANUFACTURED IN COLUMBUS GA

23588 A

II

2/25/2010

HAMARI CHEMICALS LTD

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN OSAKA JAPAN

23589 A

II

7/30/2010

IPCA LABORATORIES LTD

AMLODIPINE BESYLATE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

23590 A

II

3/1/2010

DR REDDYS LABORATORIES LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

Page 691

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23591 A
II
3/1/2010
DR REDDYS LABORATORIES LTD

SUBJECT
RITONAVIR USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23592 A

II

2/26/2010

EGIS PHARMACEUTICALS PLC

ROSUVASTATIN AS MANUFACTURED IN BUDAPEST HUNGARY

23593 A

II

3/12/2010

UNIMARK REMEDIES LTD

HYDROXYCHLOROQUINE SULFATE USP AS MANUFACTURED IN GUJARAT INDIA

23594 A

II

2/25/2010

CQ INTERNATIONAL CO INC

23595 A

II

3/1/2010

FERMION OY

VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA FOR CQ


INTERNATIONAL CO INC
TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN OULU FINLAND

23596 A

II

3/3/2010

DR REDDYS LABORATORIES LTD

DECITABINE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23597 A

II

2/23/2010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

OLANZAPINE AS MANUFACTURED IN ZHEJIANG PR CHINA

23598 A

II

2/23/2010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED IN ZHEJIANG PR CHINA

23599 A

II

3/2/2010

MSN LABORATORIES LTD

23600 A

II

3/3/2010

SANOFI AVENTIS SPA

TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1] AS MANUFACTURED


IN ANDHRA PRADESH
KETOPROFEN AS MANUFACTURED IN FRANKFURT AM MAIN GERMANY

23601 A

II

2/26/2010

AUROBINDO PHARMA LTD

23602 A

IV

3/1/2010

HENRY H OTTENS MANUFACTURING CO INC

LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
ARTIFICIAL BUBBLE GUM FLAVOR #3266-Q AS MANUFACTURED IN PHILADELPHIA PA

23603 A

II

3/22/2010

TORRENT PHARMACEUTICALS LTD

ALFUZOSIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

23604 A

II

4/29/2010

MALLINCKRODT INC

NALBUPHINE HYDROCHLORIDE (1P) AS MANUFACTURED IN ST LOUIS MO

23605 I

II

2/22/2010

AANJANEYA LIFECARE LTD

QUININE HYDROCHLORIDE EP DRUG SUBSTANCE AS MANUFACTURED IN MAHAD INDIA

23606 I

II

2/22/2010

QILU PHARMACEUTICAL CO LTD

23607 A

III

2/23/2010

RAUMEDIC AG

23608 A

IV

3/9/2010

FONA INTERNATIONAL INC

CARBOPLATIN (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES


REPUBLIC OF CHINA
RAUMEDIC PVC-FREE COEXTRUDED FILLING TUBES (RAUMED TUBING RFT) AS
MANUFACTURED IN HELMBRECHTS GERMANY
PRODUCT # 825.666 N-C CHERRY FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL

23609 A

IV

3/9/2010

FONA INTERNATIONAL INC

PRODUCT # 805.0100U N-C BANANA FLAVOR NAT & ART AS MANUFACTURED IN GENEVA IL

23610 A

IV

3/10/2010

FONA INTERNATIONAL INC

PRODUCT # 802.0003U ANISE LIQUER TYPE FLAVOR NAT AS MANUFACTURED IN GENEVA IL

23611 A

II

4/12/2010

LUPIN LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA INDIA

23612 A

II

3/30/2011

LUPIN LTD

NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

23613 A

IV

3/8/2010

LIPIDCHEM SENDIRIAN

STEARIC ACID AS MANUFACTURED IN JOHOR MALAYSIA

23614 A

II

3/11/2010

23615 A

II

3/9/2010

SHANDONG RUIYING PIONEER PHARMACEUTICAL PIPERACILLIN AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA


CO LTD
MERCK KGAA
POTASSIUM IODIDE AS MANUFACTURED IN FRANKFURTER STR. GERMANY

23616 A

II

3/8/2010

CKD BIO CORP

23617 I

II

3/20/2010

UNIMARK REMEDIES LTD

RIFAMYCIN SODIUM NON-STERILE BULK AS MANUFACTURED IN ANSAN KYUNGGI-DO SOUTH


KOREA
OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT INDIA

23618 A

II

4/8/2010

LUPIN LTD

ABACAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA INDIA

23619 A

II

4/12/2010

LUPIN LTD

DESOGESTREL AS MANUFACTURED IN MADHYA PRADESH INDIA FOR LUPIN LTD

23620 A

II

3/11/2010

MACLEODS PHARMACEUTICALS LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

23621 A

II

3/10/2010

DR REDDYS LABORATORIES LTD

RANOLAZINE AS MANUFACTURED IN ANDHRA PRADESH INDIA

23622 A

II

3/2/2010

GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

23623 A

II

3/2/2010

ZHEJIANG GOLDEN-SHELL PHARMACEUTICAL CO


LTD
ZHEJIANG GOLDEN-SHELL PHARMACEUTICAL CO
LTD

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

Page 692

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23624 A
II
3/10/2010
DIVIS LABORATORIES LTD

SUBJECT
SUMATRIPTAN SUCCINATE AND SUMATRIPTAN AS MANUFACTURED IN ANDHRA PRADESH
INDIA
OXICONAZOLE NITRATE AS MANUFACTURED IN MAHARASHTRA INDIA

23625 A

II

3/16/2010

HARMAN FINOCHEM LTD

23626 A

2/23/2010

BASF SE

23627 A

II

3/29/2010

JUBILANT GENERICS LTD

SOLUPLUS PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN LUDWIGSHAFEN FEDERAL


REPUBLIC OF GERMANY
ZOLMITRIPTAN AS MANUFACTURED IN KARNATAKA INDIA

23628 A

II

5/26/2010

JUBILANT GENERICS LTD

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN KARNATAKA INDIA

23629 A

II

3/31/2010

23630 A

II

3/11/2010

ORCHID CHEMICALS AND PHARMACEUTICALS LTD TOLTERODINE TARTRATE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA
INDIA
CENTAUR PHARMACEUTICALS PRIVATE LTD
TIMOLOL MALEATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23631 A

II

4/26/2010

APICORE US LLC

BEXAROTENE AS MANUFACTURED IN SOMERSET NJ

23632 A

II

5/21/2010

ARCH PHARMALABS LTD

AMLODIPINE BESYLATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23633 A

II

3/31/2010

ARCH PHARMALABS LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23634 A

II

5/6/2010

ANTARIA LTD

ZINCLEAR-IM_50CCT AS MANUFACTURED IN WELSHPOOL WESTERN AUSTRALIA

23635 A

II

4/16/2010

AURISCO PHARMACEUTICAL LTD

23636 A

II

3/16/2010

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

DIDANOSINE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR AURISCO


PHARMACEUTICAL LIMITED
KETOPROFEN AS MANUFACTURED IN ZHEJIANG CHINA

23637 A

II

3/17/2010

RAKS PHARMA PVT LTD

SALSALATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23638 A

II

3/18/2010

HOVIONE FARMACIENCIA SA

23639 A

II

3/30/2010

DOXYCYCLINE MONOHYDRATE MICRONIZED AS MANUFACTURED IN TAIPA MACAU SAR FOR


HOVIONE FARMACIENCIA SA
ORCHID CHEMICALS AND PHARMACEUTICALS LTD LEVOFLOXACIN (NON-STRILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA

23640 A

II

3/17/2010

ORGAPHARM

ETHIONAMIDE DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS FRANCE

23641 A

II

3/12/2010

ALP PHARM BEIJING CO LTD

23642 A

II

3/12/2010

ALP PHARM BEIJING CO LTD

23643 A

II

3/12/2010

ALP PHARM BEIJING CO LTD

23644 A

II

3/19/2010

SIGNA SA DE CV

ITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN ZHEJIANG CHINA


FOR ALP PHARM BEIJING CO LTD
NAPHAZOLINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN
TIANJIN CHINA FOR ALP PHARM BEIJING CO LTD
NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN TIANJIN
CHINA FOR ALP PHARM BEIJING CO LTD
ABACAVIR SULFATE AS MANUFACTURED IN TOLUCA MEXICO

23645 A

II

3/15/2010

AVANTI POLAR LIPIDS INC

23646 A

III

3/16/2010

AMPACET CORP

23647 A

III

3/16/2010

AMPACET CORP

23648 I

III

3/23/2010

MITSUI CHEMICALS AMERICA INC

1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DOPC) AS MANUFACTURED IN ALABASTER


AL
782896 / DARK AMBER PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
782895 / LIGHT AMBER PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
ADMER NF458A AS MANUFACTURED IN SIDNEY OH FOR MITSUI CHEMICALS AMERICA INC

23649 A

II

3/18/2010

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN JIANGXI PROVINCE PR CHINA

23650 A

II

3/23/2010

AARTI INDUSTRIES LTD

CICLESONIDE AS MANUFACTURED IN MAHARASHTRA INDIA

23651 A

II

3/25/2010

APOTEX PHARMACHEM INDIA PVT LTD

ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN KARNATAKA, INDIA

23652 A

II

3/24/2010

INDUSTRIALE CHIMICA SRL

DESOGESTREL CN AS MANUFACTURED IN SARONNO (VARESE), ITALY

23653 A

II

3/15/2010

YONSUNG FINE CHEMICALS CO LTD

23654 A

IV

3/18/2010

NUSIL TECHNOLOGY LLC

BROMFENAC SODIUM SESQUIHYDRATE AS MANUFACTURED IN GYEONGGI-DO, REPUBLIC OF


KOREA
DDR-1370 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN CAPINTERIA, CA

23655 A

II

3/22/2010

DR REDDYS LABORATORIES LTD

DEXLANSOPRAZOLE (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 693

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23656 A
II
3/23/2010
DR REDDYS LABORATORIES LTD

SUBJECT
BIVALIRUDIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23657 A

II

4/8/2010

AUROBINDO PHARMA LTD

23658 A

II

3/27/2010

DR REDDYS LABORATORIES LTD

FLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
OLMESARTAN MEDOXOMIL (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23659 A

II

3/30/2010

CHONGQING HUAPONT PHARMACEUTICAL CO LTD LEVOCETIRIZINE HCL AS MANUFACTURED IN CHONGQING, CHINA

23660 A

II

3/16/2011

CIPLA LTD

DARUNAVIR AS MANUFACTURED IN MAHARASHTRA, INDIA

23661 A

II

7/6/2010

CIPLA LTD

DARUNAVIR HYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

23662 A

II

6/15/2010

CIPLA LTD

DARUNAVIR ETHANOLATE AS MANUFACTURED IN MAHARASHTRA INDIA

23663 A

II

5/21/2010

CIPLA LTD

ENTECAVIR MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

23664 A

II

3/30/2010

DR REDDYS LABORATORIES LTD

23665 A

III

3/22/2010

INGENIA POLYMERS CORP

23666 A

III

3/25/2010

POLYONE CORP

ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
INGENIA POLYMERS 1004 50% WHITE FOR USE IN PACKAGING MATERIALS AS
MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA; HOUSTON, TEXAS
CC10117176WE AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA

23667 I

II

4/1/2010

XIAN LIBANG PHARMACEUTICAL CO LTD

23668 A

II

3/31/2010

MACLEODS PHARMACEUTICALS LTD

23669 A

III

3/31/2010

PRAVESHA INDUSTRIES PRIVATE LTD

23670 A

II

3/31/2010

NOF CORP

23671 A

II

6/4/2010

DR REDDYS LABORATORIES LTD

23672 A

II

4/1/2010

INDUSTRIALE CHIMICA SRL

CHILD RESISTANT (CR) AND CONTINUOUS THREAD (CT) CLOSURES AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
DIMYRISTOYL PHOSPHATIDYLCHOLINE (DMPC) AS MANUFACTURED IN KUMEGUN OKAYAMA,
JAPAN FOR NOF CORP AND HYOGO, JAPAN
TESTOSTERONE AS MANUFACTURED IN MORELOS MEXICO FOR DR REDDYS LABORATORIES
LIMITED
LOTEPREDNOL ETABONATE AS MANUFACTURED IN SARONNO (VARESE), ITALY

23673 A

II

4/2/2010

EMCURE PHARMACEUTICALS LTD

PROTRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

23674 I

II

3/31/2010

JINGDEZHEN FUXIANG PHARMACEUTICAL CO LTD TAZOBACTAM AS MANUFACTURED IN JIANGXI PROVINCE, P.R. OF CHINA

23675 A

III

3/22/2010

INGENIA POLYMERS CORP

23676 A

II

4/2/2010

POLYPEPTIDE LABORATORIES SWEDEN AB

23677 A

IV

3/26/2010

UNGERER AND CO

23678 A

III

3/8/2010

TECHNIPAQ INC

23679 A

II

4/26/2010

ALKEM LABORATORIES LTD

23680 A

II

3/21/2010

AMOLI ORGANICS PVT LTD

RASAGILINE MESYLATE AS MANUFACTURED IN GUJARAT INDIA FOR ALKEM LABORATORIES


LIMITED
DICLOFENAC DIETHYLAMINE AS MANUFACTURED IN VAPI, GUJARAT, INDIA

23681 A

II

3/31/2010

RHODES TECHNOLOGIES

HYDROCODONE BITARTRATE, USP AS MANUFACTURED IN COVENTRY, RI

23682 A

II

3/29/2010

SYNBIAS PHARMA LTD

TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE

23683 A

II

4/5/2010

NORAMCO INC

23684 A

II

4/5/2010

NORAMCO INC

23685 A

II

4/6/2010

MYLAN LABORATORIES LIMITED

BUPRENORPHINE HYDROCHLORIDE (R036869) DRUG SUBSTANCE AS MANUFACTURED IN


GEEL, BELGIUM AND BEERSE, BELGIUM
BUPRENORPHINE BASE (R371605) DRUG SUBSTANCE AS MANUFACTURED IN GEEL,
BELGIUM; BEERSE, BELGIUM AND MINDEN, GERMANY
CAPECITABINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

23686 A

II

4/3/2010

CSPC WEISHENG PHARMACEUTICAL


SHIJIAZHUANG CO LTD

MELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED


IN SHAANXI PROVINCE, P. R. OF CHINA
PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN VALSAD GUJARAT, INDIA

INGENIA POLYMERS 1006, 70% WHITE FOR USE IN PACKAGING MATERIALS MANUFACTURED
IN BRANTFORD, ONTARIO; ALBERTA, CANADA AND HOUSTON, TEXAS
DESMOPRESSIN ACETATE DRUG SUBSTANCE AS MANUFACTURED IN LIMHAMN, SWEDEN
NATURAL AND ARTIFICIAL STRAWBERRY ANISE FLAVOR FS-5206 AS MANUFACTURED IN
BETHLEHEM, PA
LAMINATES FOR FLEXIBLE PACKAGING AS MANUFACTURED IN CRYSTAL LAKE, IL

SODIUM ASCORBATE AS MANUFACTURED IN HEBEI PROVINCE P.R. OF CHINA

Page 694

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
23687 A
II
5/7/2010
ORCHID CHEMICALS AND PHARMACEUTICALS LTD RASAGILINE MESYLATE (NON STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA
INDIA
23688 A
II
4/5/2010
CADILA HEALTHCARE LTD
ETODOLAC USP AS MANUFACTURED IN GUJARAT, INDIA
23689 A

II

4/5/2010

CADILA HEALTHCARE LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA

23690 A

II

4/7/2010

MSN LABORATORIES LTD

23691 A

II

4/6/2010

CYALUME SPECIALTY PRODUCTS INC

OLMESARTAN MEDOXOMIL [ROUTE CODE OX] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
DICHLORALPHENAZONE USP AS MANUFACTURED IN BOUND BROOK, NJ

23692 A

IV

4/6/2010

AMRI RENSSELAER INC

TYLOXAPOL, USP EXCIPIENT AS MANUFACTURED IN RENSSELAER, NY

23693 A

II

4/5/2010

CADILA HEALTHCARE LTD

CANDESARTAN CILEXETIL (FORM-I) AS MANUFACTURED IN GUJARAT, INDIA

23694 I

II

4/7/2010

MEDICHEM MANUFACTURING MALTA LTD

RASAGILINE MESYLATE(MED-201593/M) AS MANUFACTURED IN HAL FAR, MALTA

23695 I

II

4/7/2010

JIANGSU HENGRUI MEDICINE CO LTD

23696 A

II

3/31/2010

PARABOLIC DRUGS LTD

23697 A

II

4/7/2010

NEULAND LABORATORIES LTD

TAMSULOSIN HYDROCHLORIDE USP, NON-STERILE, BULK SUBSTANCE AS MANUFACTURED


IN JIANGSU, CHINA
CEFUROXIME AXETIL (AMORPHOUS) PROCESS II USP AS MANUFACTURED IN MOHALI
PUNJAB, INDIA
VORICONAZOLE AS MANUFACTURED IN TELANGANA INDIA

23698 A

IV

4/7/2010

NIPPON CARBIDE INDUSTRIES CO INC

NIKASOL TS-620A AS MANUFACTURED IN TOYAMA, JAPAN

23699 A

II

4/7/2010

FRESENIUS KABI ANTI INFECTIVES SRL

AMPICILLIN TRIHYDRATE STERILE AS MANUFACTURED IN VILLADOSE (ROVIGO), ITALY

23700 A

III

2/19/2010

NEMERA LE TREPORT

PACKAGING MATERIALS, PHARMACEUTICALS VALVES AS MANUFACTURED IN LE TREPORT,


FRANCE

23702 A

II

4/9/2010

ALEMBIC PHARMACEUTICALS LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

23703 A

IV

4/6/2010

VIKRAM THERMO INDIA LTD

METHACRYLIC ACID COPOLYMER, TYPE C, NF AS MANUFACTURED IN GUJARAT, INDIA

23704 A

II

4/12/2010

EUTICALS SPA

BROMFENAC AS MANUFACTURED IN LODI, ITALY

23705 A

II

4/9/2010

MACLEODS PHARMACEUTICALS LTD

SILDENAFIL CITRATE USP AS MANUFACTURED IN GUJARAT, INDIA

23706 A

IV

3/22/2010

ACG LUKAPS DOO

EXCIPIENT-HARD GELATIN CAPSULES SHELLS AS MANUFACTURED IN LUDBREG, CROATIA

23707 A

II

5/10/2010

SUN PHARMACEUTICAL INDUSTRIES LTD

RASAGILINE MESYLATE AS MANUFACTURED IN GUJARAT INDIA

23708 A

II

4/12/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

23709 A

III

4/9/2010

AMPACET CORP

VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) AS MANUFACTURED IN BEER SHEVA,


ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LIMITED
140511-K ORANGE 511 AS MANUFACTURED IN RAYONG, THAILAND

23710 A

II

4/13/2010

SEQUENT SCIENTIFIC LTD

LABETALOL HYDROCHLORIDE AS MANUFACTURED IN KARNARAKA, INDIA

23711 A

II

4/6/2010

NIPPON RIKA CO LTD

23712 A

5/11/2010

CEPHAZONE PHARMA LLC

5-AMINOLEVULINIC ACID HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN


TOCHIGI, JAPAN
STERILE MANUFACTURING FACILITY LOCATED IN POMONA CA

23713 A

IV

4/9/2010

UNGERER AND CO

NATURAL CHERRY WONF FLAVOR FQ-10519 AS MANUFACTURED IN BETHLEHEM, PA

23714 A

IV

4/9/2010

UNGERER AND CO

23715 A

II

4/13/2010

JM HUBER CORP

23716 A

II

4/13/2010

JM HUBER CORP

23717 A

II

4/13/2010

JM HUBER CORP

23718 A

II

4/13/2010

JM HUBER CORP

NATURAL AND ARTIFICIAL CRME DE MENTHE FLAVOR FT-2423 AS MANUFACTURED IN


BETHLEHEM, PA
CALCIUM CARBONATE GRANULATION WITH MALTODEXTRIN AS MANUFACTURED IN
MODESTO, CA
CALCIUM CARBONATE GRANULATION WITH ACACIA GUM AND MALTODEXTRIN AS
MANUFACTURED IN MODESTO, CA
CALCIUM CARBONATE GRANULATION WITH ACACIA GUM AS MANUFACTURED IN MODESTO,
CA
CALCIUM CARBONATE GRANULATION WITH STARCH AS MANUFACTURED IN MODESTO, CA

23701 N

NOT AN ASSIGNED NUMBER

Page 695

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23719 A
II
6/4/2010
ARCH PHARMALABS LTD

SUBJECT
BENZTROPINE MESYLATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

23720 A

IV

4/16/2010

ROQUETTE FRERES

PEARLITOL FLASH AS MANUFACTURED IN LESTREM FRANCE

23721 A

II

4/16/2010

TRIFARMA SPA

GANCICLOVIR, USP AS MANUFACTURED IN LAGHETTO (MB), ITALY

23722 A

II

4/19/2010

MSN LABORATORIES LTD

23723 I

II

4/29/2010

UNIMARK REMEDIES LTD

DEXLANSOPRAZOLE ANHYDROUS [ROUTE CODE- ?DZ?] AS MANUFACTURED IN TELANGANA,


INDIA
PROPOFOL USP AS MANUFACTURED IN GUJARAT INDIA

23724 A

II

4/14/2010

HAINAN POLY PHARMACEUTICAL CO LTD

23725 A

II

4/14/2010

HAINAN POLY PHARMACEUTICAL CO LTD

23726 A

II

4/14/2010

HAINAN POLY PHARMACEUTICAL CO LTD

23727

II

1/5/2010

II

4/19/2010

SICHUAN NEIJIANG HUIXIN PHARMACEUTICAL CO


LTD
MEDICHEM SA

23730 A

IV

4/20/2010

FONA INTERNATIONAL INC

825.572 CHERRY FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

23731 A

IV

4/20/2010

FONA INTERNATIONAL INC

815.153 BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

23732 A

IV

4/20/2010

FONA INTERNATIONAL INC

803.0048U CANDY APPPLE FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

23733 A

IV

5/7/2010

ISP PHARMA SYSTEMS LLC

ALPHA-TOCOPHEROL/PEG POWDER AS MANUFACTURED IN COLUMBIA, MD

23734 A

II

4/14/2010

HAINAN POLY PHARMACEUTICAL CO LTD

23735 A

II

4/21/2010

FORMOSA LABORATORIES INC

ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE PELLETS CAPSULES AS MANUFACTURED


IN HAINAN PROVINCE, P. R. OF CHINA
CALCIUM ACETATE USP AS MANUFACTURED IN TAOYUAN, TAIWAN

23736 A

II

4/16/2010

LAURUS LABS PRIVATE LTD

MONTELUKAST SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23737 A

II

4/26/2010

APICORE US LLC

AZATHIOPRINE USP AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC

23738 A

II

4/17/2010

MACLEODS PHARMACEUTICALS LTD

RISEDRONATE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

23739 A

II

4/21/2010

MEGAFINE PHARMA P LTD

23740 A

II

4/22/2010

CALAIRE CHIMIE SAS

ZIPRASIDONE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


NASHIK, INDIA
LAMOTRIGINE ACTIVE INGREDIENT AS MANUFACTURED IN CEDEX, FRANCE

23741 A

II

4/20/2010

ALP PHARM BEIJING CO LTD

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA

23742 A

II

4/22/2010

DERIVADOS QUIMICOS SAU

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN MURICA, SPAIN

23743 A

II

4/13/2010

RAKS PHARMA PVT LTD

CARVEDILOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23744 A

II

3/18/2010

ULKAR KIMYA SANAYI VE TICARET AS

PANTAPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN TEKIRDAG, TURKEY

23745 A

II

4/23/2010

SANDOZ PRIVATE LTD

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

23746 A

II

4/26/2010

APOTEX PHARMACHEM INC

RASAGILINE MESYLATE AS MANUFACTURED IN BANGALORE, INDIA

23747 A

II

4/26/2010

MSN LABORATORIES LTD

23748 A

II

4/26/2010

TEVA PHARMACEUTICALS INDUSTRIES LTD

23749 A

II

4/20/2010

SUPREEM PHARMACEUTICALS MYSORE PVT LTD

23750 A

IV

4/23/2010

UNGERER AND CO

SOLIFENACIN SUCCINATE [ROUTE CODE - "SF"] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ROSIGLITAZONE MALEATE AS MANUFACTURED IN ZAGREB, CROATIA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
VITAMIN D3 (CHOLECALCIFEROL) WATER SOLUBLE 100 IU/MG AS MANUFACTURED IN
MYSORE, INDIA
NATURAL PEPPERMINT FLAVOR FT-3494 AS MANUFACTURED IN BETHLEHEM, PA

23751 A

IV

4/23/2010

UNGERER AND CO

NATURAL CITRUS WONF FLAVOR FT-2811 AS MANUFACTURED IN BETHLEHEM, PA

23728 A
23729 P

FELODIPINE EXTENDED RELEASE TABLETS AS MANUFACTURED IN HAINAN PROVINCE, P. R.


OF CHINA
TRIMEBUTINE MALEATE TABLETS AS MANUFACTURED IN HAINAN PROVINCE, P. R. OF CHINA
METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS AS MANUFACTURED IN
HAINAN PROVINCE, P. R. OF CHINA
VITAMIN D2 AS MANUFACTURED IN SICHUAN, P.R. CHINA
MED-201890/E AS MANUFACTURED IN CELRA (GIRONA), SPAIN

*** PENDING FILING REVIEW ***

Page 696

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23752 A
II
4/19/2010
AREVIPHARMA GMBH

SUBJECT
SOTALOL HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY

23753 A

IV

4/26/2010

NUSIL TECHNOLOGY LLC

DDR-4355 SILICONE GEL AS MANUFACTURED IN CARPINTERIA, CA

23754 A

II

4/29/2010

GRUNENTHAL GMBH

23755 A

II

4/28/2010

SI GROUP

EXTENDED-RELEASE OXYMORPHONE HYDROCHLORIDE TABLETS AS MANUFACTURED IN


HORSHAM, PA FOR GRUNENTHAL GMBH
IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN ORANGEBURG, SC

23756 A

II

4/14/2010

RESONANCE LABORATORIES PVT LTD

BUPRENORPHINE HYDROCHLORIDE (BPNH) AS MANUFACTURED IN BANGALORE, INDIA

23757 A

II

4/14/2010

RESONANCE LABORATORIES PVT LTD

OXYBUTYNIN CHLORIDE (OBTN) AS MANUFACTURED IN BANGALORE, INDIA

23758 A

II

8/18/2010

IPCA LABORATORIES LTD

ONDANSETRON USP AS MANUFACTURED IN MADHYA PRADESH INDIA

23759 I

II

8/13/2010

IPCA LABORATORIES LTD

23760 A

II

9/15/2010

IPCA LABORATORIES LTD

RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP AS MANUFACTURED IN MADHYA


PRADESH INDIA
TORSEMIDE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

23761 A

II

4/28/2010

AVANTI POLAR LIPIDS INC

CHOLESTEROL (SEMI-SYNTHETIC) AS MANUFACTURED IN ALABASTER, AL

23762 A

II

4/20/2010

HEC PHARM CO

23763 A

II

4/21/2010

HUBEI HAOSUN PHARMACEUTICAL CO LTD

ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN HUBEI


PROVINCE, P.R. CHINA FOR HEC PHARMA CO
DASATINIB AS MANUFACTURED IN HUBEI, CHINA

23764 A

II

4/26/2010

23765 A

III

4/21/2010

7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA) AS MANUFACTURED SHANGHAI,


P.R. CHINA
PURIFIED RAYON/ RAYON COILS AS MANUFACTURED IN JALGAON, INDIA

23766 A

II

4/27/2010

SHANGHAI WHYTE ASIA PIONEER


PHARMACEUTICALS LTD
RUBY SURGICAL AND ALLIED PRODUCTS PRIVATE
LTD
MYLAN LABORATORIES LTD

23767 A

III

4/29/2010

POREX CORP

APPLICATOR TIP PART NUMBER 41505 AS MANUFACTURED IN FAIRBURN, GA

23768 A

II

5/3/2010

EMCURE PHARMACEUTICALS LTD

ZOLEDRONIC ACID AS MANUFACTURED IN MAHARASHTRA, INDIA

23769 I

II

5/3/2010

ZHUHAI UNITED LABORATORIES CO LTD

SULBACTAM SODIUM USP, NON-STERILE AS MANUFACTURED IN GUANGDONG, P.R. CHINA

23770 A

III

5/4/2010

ASAHI KASEI CHEMICALS CORP

BARRIALON-UB M0651 AS MANUFACTURED IN SUZUKA-CITY, JAPAN

23771 A

III

4/28/2010

COLORTECH INC

23772 A

III

6/4/2010

URSATECH VERPACKUNG GMBH

10296-16 NATURAL ANTIBLOCK POLYETHLENE CONCENTRATE AS MANUFACTURED IN


MORRISTOWN, TN AND BRAMPTON, ONTARIO, CANADA
3K-SYSTEM AS MANUFACTURED IN ST WENDEL GERMANY

23773 A

II

4/28/2010

LAURUS LABS PRIVATE LTD

EMTRICITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23774 A

II

5/5/2010

APOTEX PHARMACHEM INDIA PVT LTD

VARENICLINE TARTRATE AS MANUFACTURED IN KARNATAKA, INDIA

23775 A

II

5/12/2010

UNIMARK REMEDIES LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT INDIA

23776 A

II

5/3/2010

SYNCORE BIOTECHNOLOGY CO LTD

23777 A

II

4/29/2010

PRODUCTOS QUIMICOS MONTERREY SA DE CV

SCB01A (6-METHOXY-3-(3, 4, 5-TRIMETHOXYBENZOYL) INDOLE) AS MANUFACTURED IN SHANHUA, TAINAN COUNTY, TAIWAN R.O.C. FOR SYNCORE BIOTECHNOLOGY CO LTD
POTASSIUM NITRATE USP AS MANUFACTURED IN SANTA CATARINA NUEVO LEON, MEXICO

23778 A

III

4/28/2010

COLORTECH INC

23779 A

IV

4/29/2010

ADHESIVES RESEARCH INC

23780 N

ROSUVASTATIN CALCIUM AS MANUFACTURED IN TELANGANA, INDIA

10868-12 SLIP/ANTIBLOCK POLYETHYLENE CONCENTRATE AS MANUFACTURED IN


MORRISTOWN, TN AND BRAMPTON, ONTARIO, CANADA
TD-17B (A4775) AS MANUFACTURED IN GLEN ROCK, PA

NOT AN ASSIGNED NUMBER

23781 A

IV

4/30/2010

3M DRUG DELIVERY SYSTEMS

SOLVATED ACRYLATE COPOLYMER ADHESIVE R-27149 AS MANUFACTURED IN CORDOVA, IL

23782 A

4/23/2010

PATHEON ITALIA SPA

STERILE AREA 2 DEPARTMENT LOCATED IN MONZA (MB), ITALY

23783 A

III

5/5/2010

THE POLYOLEFIN CO SINGAPORE PTE LTD

COSMOPLENE W331 AS MANUFACTURED IN SINGAPORE

23784 A

II

4/30/2010

LIFE TECHNOLOGIES CORP

MYCOSEQ MYCOPLASMA DETECTION SYSTEM AS MANUFACTURED IN WARRINGTON,


GREAT BRITAIN

Page 697

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23785 A
II
3/18/2010
ULKAR KIMYA SANAYI VE TICARET AS

SUBJECT
LANSOPRAZOLE AS MANUFACTURED IN TEKIRDAG, TURKEY

23786 A

II

4/30/2010

ALP PHARM BEIJING CO LTD

EPTIFIBATIDE AS MANUFACTURED IN JIANGSU, CHINA FOR ALP PHARM BEIJING CO LTD

23787 A

II

6/24/2010

JANSSEN PHARMACEUTICA NV

23788 A

II

6/24/2010

JANSSEN PHARMACEUTICA NV

TELAPREVIR DRUG SUBSTANCE (R600109) AS MANUFACTURED IN GEEL BELGIUM AND


BEERSE BELGIUM FOR JANSSEN PHARMACEUTICA NV
TELAPREVIR SPRAY DRIED DISPERSION (INTERMEDIATE DRUG PRODUCT) AS
MANUFACTURED IN GEEL BELGIUM AND BEERSE BELGIUM FOR JANSSEN PHARMACEUTICA
NV

23789 A

II

4/22/2010

ALP PHARM BEIJING CO LTD

23790 A

II

4/30/2010

GLOCHEM INDUSTRIES LTD

23791 A

II

5/6/2010

ACTAVIS GROUP PTC EHF

23792 A

II

5/6/2010

INDUSTRIALE CHIMICA SRL

VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]


AS MANUFACTURED IN TAMIL NADU INDIA
NITAZOXANIDE AS MANUFACTURED IN SARONNO (VARESE) ITALY

23793 A

II

4/5/2010

RN LABORATORIES PVT LTD

POVIDONE IODINE USP AS MANUFACTURED IN GUJARAT INDIA

23794 A

III

6/4/2010

SABIC INNOVATIVE PLASTICS

23795 A

II

5/5/2010

INDOCO REMEDIES LTD

23796 A

II

7/9/2010

23797 I

II

5/11/2010

SUZHOU HOMESUN WANQING PHARMACEUTICAL


CO LTD
DAIICHI SANKYO ALTKIRCH SARL

23798 A

III

4/2/2010

OG CORP

STAT-LOY * PRODUCTS AS MANUFACTURED IN THORNDALE, PENNSYLVANIA (USA),


COLUMBUS INDIANA (USA), AND SAN LUIS POTOSI, MEXICO
DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN TALKUKA KHALAPUR, DISTRICT
RAIGAD, INDIA
IMIPENEM AND CILASTATIN FOR INJECTION STERILE BULK AS MANUFACTURED IN JIANGSU
CHINA
POLYSULFATED GLYCOSAMINOGLYCAN (PSGAG) AS MANUFACTURED IN ALTKIRCH CEDEX,
FRANCE
EMBOSSED CPP FILM AS MANUFACTURED IN SHIGA-PREF., JAPAN FOR OG CORPORATION

23799 A

III

5/10/2010

GERRESHEIMER PEACHTREE CITY

(PACKAGING MATERIAL) ACTIVATOR CAP AS MANUFACTURED IN PEACHTREE CITY, GA

23800 A

4/20/2010

PAR STERILE PRODUCTS LLC

STERILE MANUFACTURING FACILITY LOCATED IN ROCHESTER, MI

23801 A

II

5/26/2010

ARCH PHARMALABS LTD

23802 A

II

5/13/2010

MERCK KGAA

GEMCITABINE HYDROCHLORIDE USP (CODE: GMI) AS MANUFACTURED IN MAHARASHTRA


INDIA
SODIUM ACETATE TRIHYDRATE AS MANUFACTURED IN DARMSTADT, GERMANY

23803 A

III

9/29/2010

CODING PRODUCTS

SV-16450 AS MANUFACTURED IN KALKASKA MI

23804 A

II

5/11/2010

ENTACAPONE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

23805 A

II

5/14/2010

STANDARD CHEMICAL AND PHARMACEUTICAL CO


LTD
SCORA

23806 A

III

5/12/2010

23807 A

III

23808 A
23809 I

BRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN


SHANGDONG, P.R. CHINA FOR ALP PHARM BEIJING CO LTD
EPROSARTAN MESILATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

5/7/2010

YANGZHONG HONG YUAN PHARMACEUTICAL


PACKAGING CO LTD
KOREA ALUMINIUM CO LTD

GRANULATED MAGNESIUM CARBONATE: SCORAMAG DC 90ST AS MANUFACTURED IN


CAFFIERS, FRANCE
PACKAGING MATERIALS AND COMPONENTS FOR PARENTERAL DRUG AND BIOLOGICAL
PRODUCTS AS MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA
PACKAGING MATERIAL AS MANUFACTURED IN CHUNG-BUK, KOREA

II

5/25/2010

RELIANCE LIFE SCIENCES PVT LTD

CAPECITABINE USP AS MANUFACTURED IN NAVI MUMBAI INDIA

II

5/25/2010

RELIANCE LIFE SCIENCES PVT LTD

ESZOPICLONE AS MANUFACTURED IN NAVI MUMBAI INDIA

23810 A

II

5/18/2010

GADOR SA

DUTASTERIDE AS MANUFACTURED IN PROVINCIA DE BUENOS AIRES, ARGENTINE

23811 A

II

5/14/2010

SIFAVITOR SRL

PIPAMPERONE DIHYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY

23812 A

IV

5/12/2010

MB SUGARS AND PHARMACEUTICALS LTD

SUCROSE USP NF AS MANUFACTURED IN NASIK, MAHARASHTRA, INDIA

23813 A

II

5/18/2010

FDC LTD

LATANOPROST AS MANUFACTURED IN MUMBAI MAHARASHTRA STATE, INDIA

23814 A

II

5/20/2010

AUROBINDO PHARMA LTD

23815 A

II

5/12/2010

PHARMAZELL INDIA PRIVATE LTD

RIZATRIPTAN BENZOATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
N-ACETYLTYROSINE AS MANUFACTURED IN TAMBARAM CHENNAI, INDIA

Page 698

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23816 A
IV
5/15/2010
GANGWAL CHEMICALS PVT LTD

SUBJECT
HYDROXYPROPYL BETADEX AS MANUFACTURED IN BOISAR, INDIA

23817 A

II

12/23/2010

RANBAXY LABORATORIES LTD

BOSENTAN MONOHYDRATE AS MANUFACTURED IN PUNJAB INDIA

23818 A

IV

5/7/2010

DOW CORNING CORP

DOW CORNING E70 LIQUID SILICONE RUBBER AS MANUFACTURED IN HEMLOCK, MI

23819 A

II

5/19/2010

CHIRAL BIOSCIENCES LTD

(S)-5-CHLORO-ALPHA-(CYCLOPROPYLETHYNYL)-2-AMINO-ALPHA-(TRIFLUOROMETHYL)
BENZENE METHANOL AS MANUFACTURED IN KARNATAKA, INDIA AND ANDHRA PRADESH,
INDIA

23820 A

II

5/19/2010

CRYSTAL PHARMA SAU

23821 A

III

5/19/2010

DAI NIPPON PRINTING CO LTD

METHYLPREDNISOLONE ACETATE STERILE MICRONIZED AS MANUFACTURED IN BOECILLO


(VALLADOLID), SPAIN
IB FILM AS MANUFACTURED IN FUKUSHIMA PREF., JAPAN FOR DAI NIPPON PRINTING CO LTD

23822 A

II

5/20/2010

HETERO DRUGS LTD

FAMCICLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23823 A

II

5/20/2010

ISOCHEM SAS

23824 A

II

7/19/2010

23825 A

III

5/11/2010

23826 A

III

5/17/2010

23827 A

II

5/21/2010

23828 A

5/12/2010

23829 A

II

5/10/2010

23830 A

II

5/24/2010

VITAMIN E POLYETHYLENE GLYCOL SUCCINATE AS MANUFACTURED IN GENNEVILLIERS,


FRANCE
JANSSEN PHARMACEUTICA NV
RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE AS MANUFACTURED IN GEEL
BELGIUM AND COUNTY CORK IRELAND FOR JANSSEN PHARMACEUTICA NV
MARUTO SANGYO CO LTD
MEL, A BACKING LINER FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED
IN FUKUOKA JAPAN
MARUTO SANGYO CO LTD
MAP, A SACHET FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN
FUKUOKA JAPAN
CATALENT PHARMA SOLUTIONS LLC
PROGESTERONE SOFT GELATIN CAPSULES 100 MG AND 200 MG AS MANUFACTURED IN ST
PETERSBURG FL
STRIDES ARCOLAB LTD SPECIALTY FORMULATION PROCEDURE FOR STERILE OPERATIONS IN SPECIALTY FORMULATION FACILITY (SFF) AS
FACILITY
LOCATED IN BANGALORE INDIA
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO TELMISARTAN API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
LTD
NURAY CHEMICALS PVT LTD
PALIPERIDONE DRUG SUBSTANCE (NON-STERILE) AS MANUFACTURED IN TAMIL NADU, INDIA

23831 A

II

5/24/2010

JIANGSU HENGRUI MEDICINE CO LTD

23832 A

II

5/25/2010

CYALUME SPECIALTY PRODUCTS INC

LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU


CHINA
ISOMETHEPTENE MUCATE, USP AS MANUFACTURED IN BOUND BROOK, NJ

23833 A

II

5/26/2010

MYLAN LABORATORIES LIMITED

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

23834 A

II

6/3/2010

UNICHEM LABORATORIES LTD

EPROSARTAN MESYLATE AS MANUFACTURED IN PITHAMPUR DISTRIC - DHAR (M.P.), INDIA

23835 A

II

6/4/2010

UNICHEM LABORATORIES LTD

IRBESARTAN USP AS MANUFACTURED IN PITHAMPUR DISTRICT DHAR (MP) INDIA

23836 A

II

5/18/2010

VALDEPHARM

ESTRADIOL BENZOATE AS MANUFACTURED IN VAL DE REUIL, FRANCE

23837 A

II

6/2/2010

UNIMARK REMEDIES LTD

MONTELUKAST SODIUM (PROCESS A) AS MANUFACTURED IN GUJARAT INDIA

23838 A

II

6/17/2010

BGP HEALTHCARE PRIVATE LTD

NICOTINE POLACRILEX USP AS MANUFACTURED IN GUJARAT INDIA

23839 A

II

4/19/2010

GLAND PHARMA LTD

HEPARIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23840 A

6/9/2010

NOVOCOL PHARMACEUTICAL CANADA INC

23841 A

III

5/17/2010

23842 A

II

5/27/2010

23843 A

II

5/24/2010

NOVOCOL PHARMACEUTICAL OF CANADA INC STERILE MANUFACTURING VALIDATION AS


LOCATED IN ONTARIO CANADA
JIANGSU ZHONGJIN MATAI MEDICINAL PACKAGING ALUMINIUM FOILS PACKAGING FOR MEDICINE AS MANUFACTURED IN JIANGSU PROVINCE,
CO LTD
P.R. CHINA
CATALENT PHARMA SOLUTIONS LLC
DRONABINOL CAPSULES USP 2.5MG, 5.0MG, 10.0MG (CIII) SA MANUFACTURED IN SOMERSET,
NJ
MACLEODS PHARMACEUTICALS LTD
TOLTERODINE TARTRATE AS MANUFACTURED IN GUJARAT, INDIA

23844 A

II

6/3/2010

SIGMAPHARM LABORATORIES LLC

AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION) AS MANUFACTURED IN


BENSALEM, PA

Page 699

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23845 I
II
5/25/2010
XELLIA PHARMACEUTICALS APS

SUBJECT
MUPIROCIN USP, NON-STERILE AS MANUFACTURED IN TAIZHOU ZHEJIANG, P.R. CHINA

23846 A

III

5/24/2010

AMPACET CORP

23847 A

II

5/20/2010

ALP PHARM BEIJING CO LTD

23848 A

II

5/10/2010

LUSOCHIMICA SPA

23849 A

III

6/1/2010

OKURA INDUSTRIAL CO LTD

23850 A

II

2/10/2011

LUPIN LTD

482521 BEIGE SLIP PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
ZOLEDRONIC ACID AS MANUFACTURED IN SHANDONG, CHINA FOR ALP PHARMA BEIJING CO
LTD
FORMOTEROL FUMARATE DIHYDRATE AS MANUFACTURED IN PISA, ITALY AND LOMAGNA
(LC), ITALY
OKR EMBOSSED POLYPROPYLENE LINER AS MANUFACTURED IN KAGAWA PREFECTURE,
JAPAN
DARUNAVIR ETHANOLATE AS MANUFACTURED IN MAHARASHTRA INDIA

23851 A

III

4/29/2010

LOG PLASTICON ZRT

USA APPLICATOR AS MANUFACTURED IN TOKOL, HUNGARY

23852 A

II

5/24/2010

PCAS

DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN TURKU, FINLAND

23853 A

II

6/2/2010

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LEVETIRACETAM USP (PROCESS II) AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

23854 A

II

6/2/2010

HETERO LABS LTD

DARUNAVIR AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23855 A

II

6/3/2010

HARMAN FINOCHEM LTD

FENOFIBRIC ACID AS MANUFACTURED IN MAHARASHTRA, INDIA

23856 A

II

5/27/2010

PRODUCTOS QUIMICOS NATURALES SA DE CV

17 ALPHA-ESTRADIOL AS MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO

23857 A

III

5/19/2010

INGENIA POLYMERS CORP

23858 A

II

5/28/2010

ZHUHAI UNITED LABORATORIES CO LTD

INGENIA POLYMERS 1020 FILLED WHITE FOR USE IN PACKAGING MATERIALS AS


MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA AND HOUSTON, TEXAS
MEROPENEM USP, NON-STERILE AS MANUFACTURED IN GUANGDONG, P.R. CHINA

23859 A

II

5/27/2010

MYLAN LABORATORIES LTD

23860 A

II

6/4/2010

CADILA HEALTHCARE LTD

VALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS) AS MANUFACTURED IN TELANGANA,


INDIA
BENZOYL PEROXIDE HYDROUS AS MANUFACTURED IN GUJARAT, INDIA

23861 A

IV

6/4/2010

FONA INTERNATIONAL INC

805.219 BANANA FLAVOR, NAT WONF AS MANUFACUTERED IN GENEVA, IL

23862 A

II

5/20/2010

ST GOBAIN PERFORMANCE PLASTICS CORP

TYGON 3350 SILICONE TUBING AS MANUFACTURED IN BANGALORE, INDIA

23863 A

II

6/28/2010

APICORE US LLC

FONDAPARINUX SODIUM AS MANUFACTURED IN SOMERSET NJ

23864 A

II

6/3/2010

MSN PHARMACHEM PVT LTD

23865 A

II

6/7/2010

HETERO DRUGS LTD

SITAGLIPTIN PHOSPHATE MONOHYDRATE (ROUTE CODE SG) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
LEVOFLOXACIN HEMIHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23866 A

II

6/28/2010

23867 A

II

6/4/2010

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ISA (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR ORCHID
CHEMICALS & PHARMACEUTICALS LTD
EUTICALS SPA
SODIUM MYCOPHENOLATE AS MANUFACTURED IN ROZZANO (MI) ITALY

23869 A

IV

6/7/2010

XIANGSHAN JINAN IMPORT & EXPORT CO LTD

HARD EMPTY GELATIN CAPSULES AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

23870 A

II

7/20/2010

TRIS PHARMA INC

23871 A

II

11/29/2010

CADILA PHARMACEUTICALS LTD

METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION) AS


MANUFACTURED IN MONMOUTH JUNCTION NJ
PALIPERIDONE AS MANUFACTURED IN GUJARAT INDIA

23872 I

II

6/10/2010

CEPHALEXIN USP "YUNG SHIN" AS MANUFACTURED IN TAICHUNG, TAIWAN, R.O.C.

23873 A

II

6/10/2010

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO


LTD
MYLAN LABORATORIES LTD

23874 A

IV

6/9/2010

EVONIK INDUSTRIES AG

23875 A

II

6/9/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

23876 A

II

5/31/2010

BIOTIKA AS

RESOMER R SR FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM,


GERMANY
FLUOCINOLONE ACETONIDE (PROCESS II) AS MANUFACTURED IN RHO MILAN ITALY FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
POLYMYXIN B SULFATE AS MANUFACTURED IN SLOVENSKA LUPCA, SLOVAKIA

23868 P

*** PENDING FILING REVIEW ***

DARUNAVIR AS MANUFACTURED IN TELANGANA, INDIA

Page 700

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23877 A
II
5/31/2010
AREVIPHARMA GMBH

SUBJECT
METAXALONE AS MANUFACTURED IN RADEBEUL, GERMANY

23878 A

II

5/31/2010

BIA SEPARATIONS DOO

CIM CONVECTIVE INTERACTION MEDIA SO3 AS MANUFACTURED IN LJUBLJANA, SLOVENIA

23879 A

II

6/5/2010

NUVIEW LIFE SCIENCES

SODIUM IODINE (I-123) DRY IODINE RADIOCHEMICAL AS MANUFACTURED IN DENTAON, TX

23880 A

II

6/9/2010

CENTAUR PHARMACEUTICALS PRIVATE LTD

BRIMONIDINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

23881 A

II

6/29/2010

TORRENT PHARMACEUTICALS LTD

PALIPERIDONE AS MANUFACTURED IN GUJARAT INDIA

23882 A

IV

6/9/2010

UNGERER AND CO

NATURAL AND ARTIFICIAL ORANGE FLVP FO-9464 AS MANUFACTURED IN BETHLEHEM, PA

23883 A

II

8/4/2010

MALLINCKRODT INC

OPIUM TINCTURE 2% AS MANUFACTURED IN ST LOUIS MO

23884 A

II

6/8/2010

INDENA SPA

23885 A

II

4/29/2010

MELODY HEALTHCARE PVT LTD

N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-DEACETYLPACLITAXEL INTERMEDIATE) AS


MANUFACTURED IN SETTALA (MI), ITALY
RAMIPRIL AS MANUFACTURED IN MAHARASHTRA, INDIA

23886 A

II

8/30/2010

INDENA SPA

DOCETAXEL AS MANUFACTURED IN MILAN ITALY

23887 I

II

6/15/2010

SEQUENT SCIENTIFIC LTD

PRAZIQUANTEL AS MANUFACTURED IN KARNATAKA, INDIA

23888 A

II

6/8/2010

PERRIGO API LTD

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN BEER SHEVA, ISRAEL

23889 A

II

6/15/2010

MSN PHARMACHEM PVT LTD

OSELTAMIVIR PHOSPHATE [ROUTE CODE - OT"] AS MANUFACTURED IN TELANGANA

23890 A

II

4/27/2010

BRIDGE ORGANICS CO

CRYSTALLINE LACTONEDIOL AS MANUFACTURED IN VICKSBURG, MI

23891 A

II

6/29/2010

23892 A

II

6/7/2010

23893 A

III

6/16/2010

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFUROXIME AXETIL (CRYSTALLINE) (NON-STERILE BULK API) AS MANUFACTURED IN
ALATHUR KANCHEEPURAM DISTRICT INDIA
BIOCON LTD
HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE) AS MANUFACTURED IN
BANGALORE, INDIA.
FLOW DRY TECHNOLOGY INC
DESICCANT PRODUCTS AS MANUFACTURED IN BELEN, NM

23894 A

III

6/15/2010

CORMACK PACKAGING PTY LTD

23895 A

II

6/18/2010

NEULAND LABORATORIES LTD

CORMACK TAMPER EVIDENT (TE) CLOSURES AS MANUFACTURED IN NEW SOUTH WALES,


AUSTRALIA
PARICALCITOL, USP AS MANUFACTURED IN TELANGANA, INDIA

23896 A

II

6/18/2010

APOTEX PHARMACHEM INDIA PVT LTD

ZOLMITRIPTAN AS MANUFACTURED IN KARNATAKA, INDIA

23897 A

II

7/7/2010

CML EUROPE BV

MALATHION USP AS MANUFACTURED IN WEERT THE NETHERLANDS

23898 A

II

6/29/2010

AUROBINDO PHARMA LTD

23899 A

II

6/18/2010

SYMBIOTEC PHARMALAB LTD

MODAFINIL USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
PREDNISOLONE SODIUM PHOSPHATE USP AS MANUFACTURED IN INDORE, INDIA

23900 A

II

6/22/2010

MSN LABORATORIES LTD

23901 A

II

6/30/2010

NOVARTIS PHARMACEUTICALS CORP

23902 A

II

7/2/2010

NOVARTIS PHARMACEUTICALS CORP

23903 A

IV

6/22/2010

FONA INTERNATIONAL INC

23904 A

III

6/18/2010

AMPACET CORP

23905 A

II

7/12/2010

KD PHARMA BEXBACH GMBH

474187 GREEN PP MB AS MANUFACTURED IN DERRIDER LA, CATERSVILLE GA, HEATH OH,


AND TERRE HAUTE IN
OMEGA-3-ACIDS ETHYL ESTER AS MANUFACTURED IN BEXBACH GERMANY

23906 A

II

6/14/2010

YUNG ZIP CHEMICAL IND CO LTD

CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TACHIA TAICHUNG TAIWAN ROC

23907 I

II

6/8/2010

SINTENOVO SA DE CV

RABEPRAZOLE SODIUM AS MANUFACTURED IN JUAREZ MEXICO

23908 A

II

6/18/2010

PCAS

OLOPATADINE HCI AS MANUFACTURED IN TURKU FINLAND FOR PCAS

23909 A

II

6/18/2010

YUNG ZIP CHEMICAL IND CO LTD

DICLOFENAC EPOLAMINE AS MANUFACTURED IN TACHIA TAICHUNG TAIWAN ROC

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE [ROUTE CODE PP] AS MANUFACTURED


IN ANDHRA PRADESH, INDIA
FLUVASTATIN DRUG SUBSTANCE AS MANUFACTURED IN RINGASKIDDY CO CORK IRELAND
FOR NOVARTIS PHARMACEUTICAL CORPORATION
VALSARTAN DRUG SUBSTANCE AS MANUFACTURED IN RINGASKIDDY CO CORK IRELAND
FOR NOVARTIS PHARMACEUTICAL CORPORATION
825.0275U CHERRY FLAVOR NAT & ART AS MANUFACTURED IN GENEVA IL

Page 701

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23910 A
II
6/23/2010
ACTAVIS GROUP PTC EHF
23911 A

II

7/7/2010

PRONOVA BIOPHARMA NORGE AS

23912 A

IV

6/21/2010

TERRENE PHARMA PVT LTD

SUBJECT
CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED
IN TAMIL NADU, INDIA
EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E) AS MANUFACTURED IN ISLE OF LEWIS
SCOTLAND UK
EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN GUJARAT, INDIA

23913 A

III

6/18/2010

DYNEON GMBH

IMPROVED PFA POLYMER DISPERSIONS AS MANUFACTURED IN BURGKIRCHEN, GERMANY

23914 A

II

6/23/2010

INKE SA

SALMETEROL XINAFOATE AS MANUFACTURED IN (BARCELONA) SPAIN

23915 A

II

6/23/2010

RAKS PHARMA PVT LTD

DIVALPROEX SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23916 A

II

6/25/2010

CRYSTAL PHARMA SAU

23917 A

IV

6/25/2010

ROQUETTE FRERES

23918 A

II

12/29/2010

APICORE US LLC

MOMETASONE FUROATE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID),


SPAIN
PEA STARCH HYDROXYPROPYL PREGELATINIZED (LYCOAT RS) AS MANUFACTURED IN
LESTREM, FRANCE AND LENGRAIN, FRANCE
CABERGOLINE AS MANUFACTURED IN SOMERSET NJ

23919 A

IV

6/25/2010

ROQUETTE FRERES

23920 A

II

6/28/2010

BIOVET JOINT STOCK CO

PEA STARCH HYDROXYPROPYL (LYCOAT NG) AS MANUFACTURED IN LESTREM, FRANCE


AND LENGRAIN, FRANCE
TESTOSTERONE ENANTHATE AS MANUFACTURED IN PESHTERA, BULGARIA

23921 A

II

6/25/2010

STERLING SPA

NOMEGESTROL ACETATE AS MANUFACTURED IN PERUGIA, ITALY

23922 A

III

6/28/2010

DYNIC USA

HT13 THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR

23923 A

II

6/29/2010

NUVIEW LIFE SCIENCES

INDIUM CHLORIDE (111IN) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TX

23924 A

II

8/5/2010

APICORE US LLC

BUSULFAN USP AS MANUFACTURED IN SOMERSET NJ

23925 A

II

6/8/2010

SHASUN PHARMACEUTICALS LTD

IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN CUDDALORE, INDIA

23926 A

II

6/25/2010

HAINAN POLY PHARMACEUTICAL CO LTD

DESLORATADINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

23927 A

II

6/29/2010

MYLAN LABORATORIES LTD

ROSIGLITAZONE AS MANUFACTURED IN TELANGANA, INDIA

23928 A

IV

6/23/2010

EVONIK INDUSTRIES AG

23929 A

II

6/25/2010

PROVENTUS LIFE SCIENCES PVT LTD

RESOMER (R) RP D FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN


INGELHEIM, GERMANY
TROSPIUM CHLORIDE AS MANUFACTURED IN CHENNAI, INDIA

23930 A

II

6/29/2010

PHARMACEUTICAL WORKS POLPHARMA SA

SILDENAFIL CITRATE AS MANUFACTURED STAROGARD GDANSKI, POLAND

23931 A

III

6/30/2010

CORADIN SAS

DUAL VIALS SYSTEM AS MANUFACTURED IN MOUANS-SARTOUX, FRANCE

23932 A

III

6/29/2010

MITSUBISHI PLASTICS INC

TECHBARRIER SERIES AS MANUFACTURED IN SHIGA, JAPAN FOR MITSUBISHI PLASTICS INC

23933 A

II

6/30/2010

ERREGIERRE SPA

ENTACAPONE AS MANUFACTURED IN SAN PAOLO D ARGON (BG), ITALY

23934 A

II

6/28/2010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

23935 A

II

6/21/2010

OLON SPA

TESTOSTERONE UNDECANOATE, NON-STERILE, BULK DRUG SUBSTANCE AS


MANUFACTURED IN ZHEJIANG, P.R. CHINA
RITONAVIR AS MANUFACTURED IN MULAZZANO (LO), ITALY

23936 A

II

7/1/2010

KYOWA HAKKO KIRIN CO LTD

ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN

23937 A

II

6/30/2010

RA CHEM PHARMA LTD

ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23938 A

IV

7/2/2010

COMED CHEMICALS LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN GUJARAT, INDIA

23939 I

II

6/29/2010

DERIVADOS QUIMICOS SA FINE CHEMICALS

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN

23940 A

II

6/28/2010

SMRUTHI ORGANICS LTD

FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

23941 A

II

7/2/2010

APOTEX PHARMACHEM INDIA PVT LTD

23942 A

II

6/29/2010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN BRANTFORD, CANADA AND BANGALORE,


INDIA
ESTRADIOL USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG
P.R. CHINA

Page 702

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23943 A
IV
7/2/2010
FONA INTERNATIONAL INC

SUBJECT
926.0425U N-C VANILLA FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

23944 A

II

7/6/2010

EMCURE PHARMACEUTICALS LTD

BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

23945 A

II

7/6/2010

MSN LABORATORIES LTD

PALIPERIDONE [ROUTE CODE - PA] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23946 A

II

7/6/2010

RANBAXY LABORATORIES LTD

23947 A

II

6/14/2010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

VALGANCICLOVIR HYDROCHLORIDE, USP (PROCESS 2; SITE TOANSA) AS MANUFACTURED IN


PUNJAB, INDIA
MITOTANE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

23948 A

II

7/2/2010

VALDEPHARM

ESTRADIOL VALERATE AS MANUFACTURED IN VAL DE REUIL, FRANCE

23949 A

II

6/18/2010

ALP PHARM BEIJING CO LTD

IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN SICHUAN PROVINCE, P.R. CHINA

23950 A

IV

7/1/2010

UNGERER AND CO

NATURAL AND ARTIFICIAL LEMON FLVP FT-4174 AS MANUFACTURED IN BETHLEHEM, PA

23951 A

II

6/1/2010

ALP PHARM BEIJING CO LTD

23952 A

III

5/26/2010

COLORTECH INC

23953 A

III

5/26/2010

COLORTECH INC

23954 A

II

7/7/2010

23955 A

III

7/7/2010

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD
GEPACK SA

VINORELBINE TARTRATE AS MANUFACTURED IN HUBEI PROVINCE, P.R. CHINA FOR ALP


PHARM BEIJING CO LTD
11287-16 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN
AND ONTARIO, CANADA
10505-14 KOSHER ANTIFOG POLYETHYLENE CONCENTRATE AS MANUFACTURED IN
MORRISTOWN, TN AND ONTARIO, CANADA
ALLOPURINOL AS MANUFACTURED IN CHONGQING, P.R. CHINA

23956 A

III

6/29/2010

NOLATO JAYCARE LTD

23957 A

III

6/30/2010

E SAENG TECHNOPACK CO LTD

20ML POLYETHYLENE WHITE ROUND BOTTLE AS MANUFACTURED IN NEW CASTLE UPON


TYNE, ENGLAND
CONTAINER AND CLOSURE AS MANUFACTURED IN CHUNGNAM, KOREA

23958 A

II

7/8/2010

NORAC INC

RSN-01314 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA

23959 A

II

5/21/2010

NTP RADIOISOTOPES PTY LTD

23960 A

II

7/13/2010

EUTICALS SPA

FISSION MOLYBDENUM-99 (PRODUCED FROM LOW ENRICHED URANIUM (LEU)) AS


MANUFACTURED IN PRETORIA, REPUBLIC OF SOUTH AFRICA
DIACEREIN (PROCESS I) AS MANUFACTURED IN LODI, ITALY

23961 A

II

7/13/2010

EUTICALS SPA

DIACEREIN (PROCESS II) AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY

23962 A

II

7/8/2010

CONCORD BIOTECH LTD

CYCLOSPORINE USP AS MANUFACTURED IN AHMEDABAD, INDIA

23963 A

II

7/12/2010

SAURAV CHEMICALS LTD

HOMATROPINE METHYLBROMIDE USP AS MANUFACTURED IN PUNJAB, INDIA

23964 A

IV

7/12/2010

FONA INTERNATIONAL INC

915.0113U STRAWBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

23965 A

II

7/28/2010

UNIMARK REMEDIES LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN GUJARAT INDIA

23966 A

II

7/9/2010

CALYX CHEMICALS AND PHARMACEUTICALS LTD

LUMEFANTRINE AS MANUFACTURED IN MAHARASHTRA INDIA

23967 A

II

7/12/2010

ST GOBAIN PERFORMANCE PLASTICS CORP

SANI-TECH STHT-C AS MANUFACTURED IN TAUNTON MA

23968 A

II

7/9/2010

CALYX CHEMICALS AND PHARMACEUTICALS LTD

ARTEMETHER AS MANUFACTURED IN MAHARASHTRA INDIA

23969 A

III

7/1/2010

HMC POLYMERS CO LTD

PURELL RP271G AS MANUFACTURED IN RAYONG THAILAND

23970 A

IV

7/4/2010

TOSAF COMPOUNDS LTD

23971 A

II

7/6/2010

CHONGQING FUAN PHARMACEUTICAL CO LTD

23972 A

II

10/25/2010

SRI KRISHNA PHARMACEUTICALS LTD

EXCIPIENT, COLORANT, FLAVOR, ESSENCE, OR MATERIAL USED IN PREPARATION FOR TOSAF


COMPOUNDS AS MANUFACTURED IN KEFAR YONA ISRAEL
AZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN
CHONGQING CHINA FOR G&A ASSOCIATES LLC
SODIUM PHENYL BUTYRATE GRANULES 100% AS MANUFACTURED IN HYDERABAD INDIA

23973 A

II

8/25/2010

WUHAN WUYAO PHARMACEUTICAL CO LTD

23974 A

II

7/6/2010

PORTON PHARMACEUTICAL LTD

23975 A

II

7/15/2010

MSN LABORATORIES LTD

PET PACKAGING AS MANUFACTURED IN AZAMBUJA, PORTUGAL

ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


WUHAN, CHINA
CLINDAMYCIN PALMITATE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG AS
MANUFACTURED IN CHONGQING, P.R. CHINA
ROSUVASTATIN CALCIUM [ROUTE CODE - RT"] AS MANUFACTURED IN TELANGANA

Page 703

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
23976 A
III
7/13/2010
EVA FILSAKOVA VINAMET
23977 A

II

7/14/2010

AARTI INDUSTRIES LTD

SUBJECT
HDPE BOTTLES FOR SOLID DOSAGE FORMS AS MANUFACTURED IN MISKOVICE, CZECH
REPUBLIC
MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

23978 A

II

7/19/2010

FORMOSA LABORATORIES INC

ORLISTAT USP AS MANUFACTURED IN TAOYUAN TAIWAN

23979 A

II

7/19/2010

WUXI JIDA PHARMACEUTICAL CO LTD

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN JIANGSU PROVINCE CHINA

23980 A

II

7/19/2010

RAKS PHARMA PVT LTD

METAXALONE API AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23981 A

III

7/20/2010

GRUPA AZOTY S.A.

TARNOFORM 300 AS MANUFACTURED IN TARNOW, POLAND

23982 I

II

7/20/2010

CADILA HEALTHCARE LTD

IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

23983 A

III

7/20/2010

GRUPA AZOTY S.A.

TARNOFORM 500 AS MANUFACTURED IN TARNOW, POLAND

23984 A

II

7/13/2010

FIS FABBRICA ITALIANA SINTETICI SPA

ENTACAPONE AS MANUFACTURED IN VICENZA ITALY

23985 A

II

5/22/2010

QILU PHARMACEUTICAL CO LTD

23986 A

III

7/21/2010

AMERICAS STYRENICS LLC

23987 A

III

7/23/2010

SABIC PETROCHEMICALS BV

CISPLATIN (NON STERILE API) AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES


REPUBLIC OF CHINA
GENERAL PURPOSE POLYSTYRENE (GPPS) RESINS AS MANUFACTURED IN GALES FERRY,
CT; IRONTON, OH; CHANNAHON, IL; TORRANCE, CA AND MARIETTA, OH
SABIC PP PCGH10 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS

23988 A

III

7/23/2010

SABIC PETROCHEMICALS BV

SABIC PP PCGH19 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS

23989 A

III

7/23/2010

SABIC PETROCHEMICALS BV

SABIC HDPE PCG80063 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS

23990 A

II

7/23/2010

DIVIS LABORATORIES LTD

2-4-WING ACTIVE ESTER AS MANUFACTURED IN ANDHRA PRADESH INDIA

23991 A

II

7/22/2010

ROVI CONTRACT MANUFACTURING SL

STERILE WATER FOR INJECTION USP 2.0 ML AS MANUFACTURED IN MADRID SPAIN

23992 A

II

7/22/2010

ROVI CONTRACT MANUFACTURING SL

STERILE WATER FOR INJECTION USP 0.5 ML AS MANUFACTURED IN MADRID SPAIN

23993 A

II

7/26/2010

RANBAXY LABORATORIES LTD

ADEFOVIR DIPIVOXIL AS MANUFACTURED IN PUNJAB, INDIA

23994 A

II

7/26/2010

DR REDDYS LABORATORIES LTD

23995 A

II

7/30/2010

FRESENIUS KABI ONCOLOGY LTD

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)[PROCESS-2] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
CARBOPLATIN AS MANUFACTURED IN WEST BENGAL INDIA

23996 A

II

7/26/2010

DR REDDYS LABORATORIES LTD

BORTEZOMIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

23997 A

II

7/2/2010

ALP PHARM BEIJING CO LTD

23998 A

II

7/20/2010

ALP PHARM BEIJING CO LTD

23999 A

II

7/2/2010

ALP PHARM BEIJING CO LTD

POLYMYXIN B SULFATE USP AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM
BEIJING CO LTD
CALCITONON SALMON AS MANUFACTURED IN SHANGHAI, P.R. CHINA FOR ALP PHARM
BEIJING CO LTD
BACITRACIN AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING CO LTD

24000 A

II

7/2/2010

ALP PHARM BEIJING CO LTD

24001 A

IV

7/27/2010

GATTEFOSSE SAS

BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING CO
LTD
PLUROL OLEIQUE CC 497, AS MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE

24002 A

II

7/22/2010

CALYX CHEMICALS AND PHARMACEUTICALS LTD

HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

24003 A

II

7/27/2010

MSN PHARMACHEM PVT LTD

24004 A

II

7/28/2010

TORAY INDUSTRIES INC

MOXIFLOXACIN HYDROCHLORIDE (ANHYDROUS) [ROUTE CODE: "MP"] AS MANUFACTURED


ANDHRA PRADESH, INDIA
BPS-314d DRUG SUBSTANCE AS MANUFACTURED IN SHIZUOKA, JAPAN

24006 A

IV

7/25/2010

VIKRAM THERMO INDIA LTD

24007 A

II

7/20/2010

24008 A

III

7/29/2010

CSPC CENWAY TIANJIN PHARMACEUTICALS CO


LTD
TORAY INDUSTRIES INC

24005 N

NOT AN ASSIGNED NUMBER


METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER DISPERSION NF (METHACRYLIC
ACID COPOLYMER DISPERSION) AS MANUFACTURED IN GUJARAT, INDIA
7-AVCA AS MANUFACTURED IN TIANJIN P.R. CHINA
NYLON 6/66 RESIN T-1200P AS MANUFACTURED IN NAGOYA, JAPAN

Page 704

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24009 A
II
7/29/2010
MYLAN LABORATORIES LTD

SUBJECT
EPROSARTAN MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24010 A

IV

7/27/2010

LONZA INC

GLYCOMUL TS KFG AS MANUFACTURED IN WILLIAMSPORT, PA

24011 A

IV

7/27/2010

HENKEL CORP

DURO-TAK (TM) 87-905A PRESSURE SENSITIVE ADHESIVE AS MANUFACUTRED IN SALISBURY,


NC

24012 P

*** PENDING FILING REVIEW ***

24013 A

II

7/30/2010

ATON PHARMA INC

PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR ATON PHARMA INC

24014 A

II

7/23/2010

3D IMAGING LLC

[I-124] FIAU (FIALURIDINE) AS MANUFACTURED IN LITTLE ROCK, AR

24015 A

II

7/23/2010

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

CLOBETASOL PROPIONATE AS MANUFACTURED IN KEDAH, MALAYSIA

24016 A

II

8/23/2010

ALKEM LABORATORIES LTD

OLANZAPINE USP AS MANUFACTURED IN A P INDIA FOR ALKEM LABORATORIES LIMITED

24017 A

II

7/26/2010

CALYX CHEMICALS AND PHARMACEUTICALS LTD

IRBESARTAN AS MANUFACTURED IN MAHARASHTRA, INDIA

24018 A

II

8/2/2010

MYLAN LABORATORIES LTD

CLINDAMYCIN PALMITATE HYDROCHLORIDE USP AS MANUFACTURED IN TELANGANA, INDIA

24019 A

II

8/2/2010

YANTAI VALIANT FINE CHEMICAL CO LTD

1, 4-DIOXASPIRO[4.5]DECAN-8-ONE AS MANUFACTURED IN SHANDONG, P.R. CHINA

24020 A

II

8/11/2010

ORCHID CHEMICALS AND PHARMACEUTICALS LTD OLANZAPINE AS MANUFACTURED IN MAHARASHTRA INDIA

24021 A

II

7/20/2010

PRODUCTOS QUIMICOS NATURALES SA DE CV

DANAZOL AS MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO

24022 A

II

8/4/2010

NEULAND LABORATORIES LTD

MIRTAZAPINE, USP (ANHYDROUS) AS MANUFACTURED IN TELANGANA, INDIA

24023 A

II

6/28/2010

KUKDONG OIL AND CHEMICAL CO LTD

WHITE MINERAL OIL LILY-50 AS MANUFACTURED IN KYUNGNAM, KOREA

24024 A

II

8/10/2010

UNIQUE CHEMICALS

ATENOLOL USP AS MANUFACTURED IN GUJARAT INDIA

24025 A

III

7/30/2010

SARONG

24026 A

II

8/2/2010

MOEHS IBERICA SL

POLYVINYLCHLORIDE/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN REGGIOLO


(R.E.), ITALY
SUMATRIPTAN AS MANUFACTURED IN RUBI (BARCELONA), SPAIN

24027 A

II

8/5/2010

KREATIVE ORGANICS P LTD

24028 A

II

8/5/2010

SEQUENT SCIENTIFIC LTD

24029 A

III

7/20/2010

STARPLASTIC INDUSTRY CO LTD

24030 I

II

8/4/2010

EMCURE PHARMACEUTICALS LTD

HIGHSTAR PF SERIES AS MANUFACTURED IN HYOGO JAPAN AND HIROSHIMA JAPAN FOR


STARPLASTIC INDUSTRY CO LTD
RITONAVIR USP AS MANUFACTURED IN MAHARASHTRA INDIA

24031 A

II

8/5/2010

APOTEX PHARMACHEM INC

WARFARIN POTASSIUM ISOPROPANOL SOLVATE AS MANUFACTURED IN ONTARIO CANADA

24032 A

II

8/4/2010

DERIVADOS QUIMICOS SA FINE CHEMICALS

FENOFIBRATE AS MANUFACTURED IN MURCIA SPAIN

24033 I

II

7/14/2010

ALP PHARM BEIJING CO LTD

CISATRACURIUM BESYLATE AS MANUFACTURED IN SHAANXI PROVINCE CHINA FOR ALP


PHARM BEIJING CO LTD

24035 A

II

7/26/2010

24036 A

II

7/31/2010

24037 A

IV

8/2/2010

24038 A

II

7/30/2010

24039 A

III

7/16/2010

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO METOPROLOL TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
LTD
SHAKAI PACKAGING PVT LTD
ALUMINIUM SEALS AS MANUFACTURED IN NANI DAMAN, INDIA

24040 A

II

7/25/2010

MELODY HEALTHCARE PVT LTD

24034 N

NOT AN ASSIGNED NUMBER

24041 N
24042 A

CHOLINE MAGNESIUM TRISALICYLATE POWDER AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ARTESUNATE AS MANUFACTURED IN KARNATAKA, INDIA

ALP PHARM BEIJING CO LTD

ALVIMOPAN DIHYDRATE AS MANUFACTURED IN CHONGQING CHINA FOR ALP PHARM BEIJING


CO LTD
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO QUETIAPINE FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
LTD
CATALENT PHARMA SOLUTIONS LLC
GELATIN MASSES AS MANUFACTURED IN SOMERSET, NJ

SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER


III

7/31/2010

COGENT GLASS LTD

TUBULAR GLASS VIALS USP TYPE-I AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 705

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24043 A
III
9/23/2010
AERO PUMP GMBH

SUBJECT
METERED DOSE SYSTEMS AS MANUFACTURED IN HOCHHEIM GERMANY

24044 A

II

8/5/2010

PHARMACEUTICAL WORKS POLPHARMA SA

SOLIFENACIN SUCCINATE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

24045 A

III

7/30/2010

FRESENIUS KABI NORGE AS

24046 A

II

8/2/2010

PFANSTIEHL INC

OVALIA POLYPROPYLEN AMPOULES AS MANUFACTURED IN FELUY, BELGIUM FOR


FRESENIUS KABI NORGE AS
D-RIBOSE, HIGH PURITY (LOW ENDOTOXIN) (R-104-1) AS MANUFACTURED IN WAUKEGAN, IL

24047 A

II

8/6/2010

PARABOLIC DRUGS LTD

CEFPROZIL USP AS MANUFACTURED IN PUNJAB, INDIA

24048 A

II

7/8/2010

AMPHETAMINE SULFATE, USP (PROCESS II) AS MANUFACTURED IN WEST DEPTFORD, NJ

24049 A

II

8/2/2010

24050 A

II

8/9/2010

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP
MAHENDRA CHEMICALS

24051 A

II

8/9/2010

MAHENDRA CHEMICALS

LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

24052 A

II

11/4/2010

JUBILANT GENERICS LTD

TELMISARTAN AS MANUFACTURED IN NANJANGUD MYSORE DIST INDIA

24053 P

SODIUM OXYBATE AS MANUFACTURED IN WEST DEPTFORD, NJ


LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA

*** PENDING FILING REVIEW ***

24054 A

II

11/4/2010

JUBILANT GENERICS LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED NANJANGUD MYSORE DIST INDIA

24055 A

III

8/11/2010

WINPAK FILMS INC

PUREFLEX FILM AS MANUFACTURED IN SENOIA, GA

24056 A

II

8/3/2010

KONDUSKAR LABORATORIES PVT LTD

LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24057 A

III

8/5/2010

3M DRUG DELIVERY SYSTEMS

24058 A

III

8/5/2010

3M DRUG DELIVERY SYSTEMS

24059 A

III

8/5/2010

3M DRUG DELIVERY SYSTEMS

24060 A

III

8/5/2010

3M DRUG DELIVERY SYSTEMS

24061 A

II

8/12/2010

APOTEX PHARMACHEM INDIA PVT LTD

3M SCOTCHPAK(TM) 9753 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND


GREENVILLE, SC
3M SCOTCHPAK(TM) 9754 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
3M SCOTCHPAK(TM) 9756 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
3M SCOTCHPAK(TM) 9757 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
RIZATRIPTAN BENZOATE USP AS MANUFACTURED IN KARNATAKA, INDIA

24062 I

III

8/10/2010

24063 A

II

7/19/2010

BRIGHTWOOD PHARMMED CONSUMABLE BEIJING 3 LAYER CO-EXTRUSION POLYPROPYLENE IV INFUSION FILM AS MANUFACTURED IN
LTD
TONGZHOU INDUSTRY DISTRICT BEIJING, P.R. CHINA
VITAL HEALTH CARE PVT LTD
QUININE SULFATE USP AS MANUFACTURED IN GUJARAT, INDIA

24064 A

III

7/21/2010

GERRESHEIMER PLASTICOS SAO PAULO LTDA

ACCESSORIES FOR PACKAGING AS MFG IN SAO PAULO, BRAZIL

24065 A

IV

8/15/2010

CRODA INC

CRODALAN AWS AS MANUFACTURED IN MILL HALL, PA

24066 A

II

8/10/2010

SPECTRON MRC LLC

GALLIUM GA68 ALBUMIN AGGREGATED ([68GA]MAA) AS MANUFACTURED IN SOUTH BEND, IN

24067 A

II

8/16/2010

MYLAN LABORATORIES LTD

SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN TELANGANA, INDIA

24068 A

III

9/27/2010

ECLATIN AG

24069 A

II

1/12/2011

ARCH PHARMALABS LTD

24070 A

II

9/13/2010

ARCH PHARMALABS LTD

24071 A

II

8/10/2010

24072 A

II

8/16/2010

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP

INTERNAL PROTECTIVE LACQUER A-2079 AS MANUFACTURED IN SOLOTHURN,


SWITZERLAND
ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4ACETATE AS MANUFACTURED IN ANDHRA PRADESH INDIA
(DKT -III) 4-FLUORO- ALPHA- [2-METHYL-1 -OXO- PROPYL]-Y-OXO-N-BETA- DIPHENYL BENZENE
BUTANAMIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA
DEXTROAMPHETAMINE SACCHARATE (PROCESS2) AS MANUFACTURED IN WEST DEPTFORD,
NJ
AMPHETAMINE ASPARTATE (PROCESS2) AS MANUFACTURED IN WEST DEPTFORD, NJ

Page 706

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24073 A
II
6/30/2010
PIERRE FABRE MEDICAMENT-PLANTES &
INDUSTRIE
24074 A
III
8/9/2010
INGENIA POLYMERS CORP
24075 A

III

8/18/2010

PPG INDUSTRIES INC

SUBJECT
MILNACIPRAN HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN CELRA (GIRONA),
SPAIN FOR PIERRE FABRE MEDICAMENT-PLANTES & INDUSTRIE
INGENIA POLYMERS IT-982 FILLED WHITE AS MANUFACTURED IN ONTARIO, CANADA,
ALBERTA, CANADA AND HOUSTON, TEXAS
PPG9145-403 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH

24076 A

III

8/18/2010

PPG INDUSTRIES INC

PPG2803-302 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH

24077 A

IV

8/18/2010

FONA INTERNATIONAL INC

862.0249U N-C LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

24078 A

III

8/18/2010

PFP TERMOPOLIMEROS SL

HDPE/BO-TE FAB CONTAINER AS MANFACTURED IN BARCELONA, SPAIN

24079 A

IV

8/13/2010

AVANTOR PERFORMANCE MATERIALS INC

24080 A

II

8/16/2010

3M DRUG DELIVERY SYSTEMS

PANEXCEA(TM) MC200G AS MANUFACTURED IN MAHARASHTRA, INDIA FOR AVANTOR


PERFORMANCE MATERIALS INC
RESIQUIMOD DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS CODEX, FRANCE

24081 A

III

8/13/2010

LONSTROFF AG

RUBBER COMPOUNDS AS MANUFACTURED IN AARAU, SWITZERLAND

24082 A

II

8/17/2010

PERRIGO API LTD

DONEPEZIL HYDROCHLORIDE FORM III AS MANUFACTURED IN BEER SHEVA, ISRAEL

24083 A

II

8/18/2010

TRIAD ISOTOPES INC

24084 A

II

8/14/2010

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD

24085 A

II

8/16/2010

24086 A

II

8/31/2010

BEIJING KEYIFENG BIOTECH DEVELOPMENT CO


LTD
AUROBINDO PHARMA LTD

FLUORINE-18 SODIUM FLUORIDE AS MANUFACTURED IN CHARLESTON, SC AND NORCROSS,


GA
CHLOROTHIAZIDE USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN SHANGHAI, P.R.
CHINA
ESTRADIOL USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN BEIJING, P.R. CHINA

24087 A

II

8/18/2010

HIKAL LTD

24088 A

8/20/2010

CARDINAL HEALTH 414 LLC

POSITRON EMISSION TOMOGRAPHY (PET) FACILITIES AS LOCATED IN CHARLOTTE, NC;


COLTON, CA; COLUMBUS, OH; EAST HARTFORD, CT; FORT LAUDERDALE, FL; ORLANDO, FL;
PHOENIX, AZ

24089 A

III

6/18/2010

WINPAK HEAT SEAL PACKAGING INC

24090 A

II

8/23/2010

MSN PHARMACHEM PVT LTD

FLEXIBLE PACKAGING MATERIALS FOR POUCH/SACHET PACKAGING AS MANUFACTURED IN


QUEBEC, CANADA
ARIPIPRAZOLE [ROUTE CODE: AL1] AS MANUFACTURED IN ANDHRA PRADESH INDIA

24091 A

II

8/20/2010

PHARMATHEN INDUSTRIAL SA

24092 A

IV

8/16/2010

3M DRUG DELIVERY SYSTEMS

FLUVASTATIN SODIUM AMORPHOUS AS MANUFACTURED IN GUJARAT, INDIA FOR


PHARMATHEN INDUSTRIAL SA
SOLVATED ACRYLATE COPOLYMER ADHESIVE R-27171 AS MANUFACTURED IN CORDOVA, IL

24093 A

II

8/17/2010

3M DRUG DELIVERY SYSTEMS

RESIQUIMOD TOPICAL GEL AS MANUFACTURED IN ST. PAUL, MN

24094 A

IV

8/23/2010

DAVID MICHAEL AND CO INC

MICHAELOK NATURAL LEMON FLAVOR #676 AS MANUFACTURED IN PHILADELPHIA, PA

24095 A

III

8/2/2010

STELLA KUNSTSTOFFTECHNIK GMBH

STELLA SCREW-NECK BOTTLE SECRO PP28 AND STELLA PROTECAP PP28 AS


MANUFACTURED IN SUCY-EN-BRIE, FRANCE AND ELTVILLE, GERMANY FOR STELLA
KUNSTSTOFFTECHNIK GMBH

24096 A

II

8/12/2010

CTX LIFE SCIENCES PVT LTD

CARVEDILOL (ROUTE-II) AS MANUFACTURED IN GUJARAT, INDIA

24097 A

III

8/24/2010

ASSEM PAK INC

ELASTOMERIC STOPPERS AND CLOSURES AS MANUFACTURED IN VINELAND, NJ

24098 A

II

9/2/2010

UNICHEM LABORATORIES LTD

ARIPIPRAZOLE AS MANUFACTURED IN ROHA DIST RAIGAD INDIA

24099 A

IV

8/27/2010

SPI PHARMA INC

PHARMABURST 500 AND SL SERIES PRODUCTS AS MANUFACTURED IN GRAND HAVEN, MI

24100 A

II

8/26/2010

NUTRA SPECIALITIES PRIVATE LTD

TETRACAINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24101 A

III

8/24/2010

CONSOLIDATED BOTTLE CORP

INCH X 2 INCH NATURAL PP VIAL PRINTED WITH LINE AS MANUFACTURED IN ONTARIO,


CANADA FOR CONSOLIDATED BOTTLE CORPORATION

RIVASTIGMINE TARTRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
QUETIAPINE FUMARATE API AS MANUFACTURED IN BANGALORE, INDIA

Page 707

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24102 A
III
8/24/2010
CONSOLIDATED BOTTLE CORP
24103 A

III

8/24/2010

CONSOLIDATED BOTTLE CORP

24104 A

III

8/24/2010

CONSOLIDATED BOTTLE CORP

24105 A

III

7/21/2010

BESPAK DIV CONSORT MEDICAL PLC

24106 A

II

8/27/2010

INDOCO REMEDIES LTD

SUBJECT
1 INCH WHITE SMOOTH TOP PE CAP PLUG FINISH AS MANUFACTURED IN ONTARIO, CANADA
FOR CONSOLIDATED BOTTLE CORPORATION
1 INCH X 2 INCH NATURAL PP VIAL PRINTED WITH LINE AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
INCH WHITE SMOOTH TOP PE CAP PLUG FINISH AS MANUFACTURED IN ONTARIO, CANADA
FOR CONSOLIDATED BOTTLE CORPORATION
BK357 & BK361 VALVE EXTRACTABLES INFORMATION AS MANUFACTURED IN NORFOLK,
ENGLAND
OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA

24107 A

II

8/31/2010

DIPHARMA FRANCIS SRL

GLYCERYL TRINITRATE SOLUTION AS MANUFACTURED IN MERETO DI TOMBA (UD), ITALY

24108 A

II

8/31/2010

DAIWA PHARMACEUTICAL CO LTD

LOXOPROFEN SODIUM HYDRATE AS MANUFACTURED IN TOYAMA, JAPAN

24109 A

III

8/20/2010

APTAR FRANCE SAS

24110 A

II

8/30/2010

MACLEODS PHARMACEUTICALS LTD

APTAR UNIT DOSE AND BIDOSE SYSTEMS AS MANUFACTURED IN CONGERS, NY AND


EIGELTINGEN, GERMANY AND LE VAUDREUIL, FRANCE
CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN GUJARAT, INDIA

24111 A

IV

8/25/2010

ABELEI INC

24112 A

II

8/31/2010

PHARMAZELL DENMARK AS

24113 A

III

8/31/2010

HB FULLER CO

113a61 NATURAL & ARTIFICIAL BERRY TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA,
IL
TERBINAFINE AS TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN HVIDOVRE,
DENMARK
ADHESIVE USED IN PLASTIC CLOSURE SYSTEMS AS MANUFACTURED IN JACKSON, TN

24114 A

II

8/30/2010

GULBRANDSEN TECHNOLOGIES INC

ACHIEVE L 5440 PG SOLUTION AS MANUFACTURED IN PHILLIPSBURG, NJ

24115 I

III

6/21/2010

PLASTIAPE SPA

DESICCANT CAP AND PILL JAR AS MANUFACTURED IN LECCO, ITALY

24116 A

II

9/27/2010

AUROBINDO PHARMA LTD

ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA

24117 A

II

11/12/2010

XOMA US LLC

XOMA 3AB AS MANUFACTURED IN BERKELEY CA

24118 A

II

9/1/2010

ZHEJIANG JINHUA CONBA BIO PHARM CO LTD

OMEPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

24119 A

II

12/28/2010

IPCA LABORATORIES LTD

ZOLEDRONIC ACID AS MANUFACTURED IN DISTRICT RATLAM (MADHYA PRADESH), INDIA

24120 I

II

12/9/2010

IPCA LABORATORIES LTD

BISOPROLOL FUMARATE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

24121 A

II

12/15/2010

IPCA LABORATORIES LTD

CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN MADHYA PRADESH INDIA

24122 A

IV

8/30/2010

PFANSTIEHL INC

24123 A

II

9/1/2010

CATALENT PHARMA SOLUTIONS LLC

ALPHA, ALPHA-TREHALOSE DIHYDRATE, HIGH PURITY (LOW ENDOTOXIN), USP/NF, EP, JP (T104-4) AS MANUFACTURED IN WAUKEGAN, IL
SOFTGELS [0775279] AS MANUFACTURED IN ST. PETERSBURG, FL

24124 A

II

9/9/2010

GLENMARK GENERICS LTD

BOSENTAN AS MANUFACTURED IN GUJARAT, INDIA

24125 A

8/25/2010

JANSSEN DIAGNOSTICS BVBA

GENOTYPIC RESISTANCE TESTING FOR HCV AS LOCATED IN BEERSE, BELGIUM

24126 A

II

8/31/2010

SCINOPHARM TAIWAN LTD

CAPECITABINE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN, ROC

24127 A

II

9/3/2010

IRVINE SCIENTIFIC SALES CO

FMDF-11 (KIRIN) AS MANUFACTURED IN SANTA ANA CA

24128 A

II

8/31/2010

RPG LIFE SCIENCES LTD

24129 A

II

9/2/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

24130 A

II

8/30/2010

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

DOXORUBICIN HYDROCHLORIDE USP/EP AS MANUFACTURED IN ANKLESHWAR BHARUCH


INDIA
MYCOPHENOLATE SODIUM AS MANUFACTURED IN DEBRECEN HUNGARY FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
CLOPIDOGREL BISULFATE AS MANUFACTURED IN ZHEJIANG CHINA

24131 A

III

10/18/2010

HOSPIRA INC

ABBOJECT VIAL INJECTOR AS MANUFACTURED IN ROCKY MOUNT NC

24132 A

III

8/30/2010

AMPACET CORP

24133 A

II

8/19/2010

QILU PHARMACEUTICAL CO LTD

103177 SLIP PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE


GA AND HEATH OH
IRINOTECAN HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE PEOPLES REPUBLIC OF CHINA

Page 708

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24134 A
II
8/31/2010
NECTAR LIFESCIENCES LTD
24135 A

II

8/16/2010

VITAL LABORATORIES PVT LTD

SUBJECT
CEFTRIAXONE SODIUM (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN
CHANDIGARH INDIA
DIGOXIN AS MANUFACTURED IN GUJARAT INDIA

24136 A

II

3/4/2011

SHILPA MEDICARE LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

24137 A

III

9/3/2010

RELIANCE INDUSTRIES LTD

RELENE 1070LA17 AS MANUFACTURED IN MAHARASHTRA, INDIA

24138 A

IV

9/6/2010

LIPOID GMBH

LIPOID E 100, LIPOID E PC S, LIPOID E PC AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

24139 A

II

9/7/2010

RANBAXY LABORATORIES LTD

ATORVASTATIN CALCIUM, USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA

24140 A

III

6/8/2010

ROHM AND HAAS CO

24141 A

IV

9/14/2010

24142 A

IV

9/14/2010

24143 I

IV

9/14/2010

24144 I

IV

9/14/2010

24145 I

II

9/23/2010

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
KERRY BIO SCIENCE
USV LIMITED

PARALOID RESINS USED AS A COMPONENT IN PHARMACEUTICAL PACKAGING AS


MANUFACTURED IN LOUISVILLE, KY
LUBRITOSE SD AS MANUFACTURED IN NORWICH, NY

24146 A

III

6/23/2010

FUJIMORI KOGYO CO LTD

24147 A

II

7/27/2010

MICRON TECHNOLOGIES INC

24148 A

II

9/9/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

24149 A

IV

8/13/2010

DOW CORNING CORP

SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN ZAGREB, CROATIA FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
DOW CORNING SILMOGEN CARRIER AS MANUFACTURED IN HEMLOCK, MI

24150 A

IV

8/13/2010

DOW CORNING CORP

DOW CORNING DIMETHICONOL BLEND 20 AS MANUFACTURED IN HEMLOCK, MI

24151 A

II

8/28/2010

24152 A

II

8/1/2010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
SERATEC

ADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE) AS MANUFACTURED IN ZHEJIANG


PROVINCE PR CHINA
METHYLDOPATE HYDROCHLORIDE USP AS MANUFACTURED IN EURE ET LOIR FRANCE

24153 A

II

9/10/2010

MACLEODS PHARMACEUTICALS LTD

RIVASTIGMINE TARTRATE AS MANUFACTURED IN GUJARAT INDIA

24154 A

II

9/10/2010

INTERQUIM SA

SOLIFENACIN SUCCINATE AS MANUFACTURED IN BARCELONA SPAIN

24155 A

II

9/9/2010

ALKALOIDS CORP

24156 A

11/24/2010

XOMA US LLC

24157 A

II

1/27/2011

MALLINCKRODT INC

COLCHICINE USP (REFINED GRADE) AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR


ALKALOIDS CORPORATION
NONCLINICAL (PHARMACOLOGY, PHARMACOKINETICS, AND TOXICOLOGY) FOR XOMA 3AB
LOCATED IN BERKELEY CA
NOSCAPINE USP/EP CRYSTALS CODE 6047 AS MANUFACTURED IN ST LOUIS MO

24158 A

III

3/29/2011

SCHOTT NORTH AMERICA INC

24159 A

II

9/1/2010

TAI HENG INDUSTRY CO LTD

24160 A

II

8/31/2010

CEFTRIAXONE SODIUM (NON-STERILE) AS MANUFACTURED IN HEBEI PROVINCE PR CHINA

24161 A

II

8/29/2010

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
PERRIGO API LTD

24162 A

II

9/7/2010

HEXETIDINE AS MANUFACTURED IN GUJARAT INDIA

24163 A

II

9/24/2010

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
GLENMARK GENERICS LTD

LUBRITOSE MCC AS MANUFACTURED IN NORWICH, NY


5X00255 SHEFFCOAT CLEAR GL AS MANUFACTURED IN NORWICH, NY
5X00282 SHEFFCOAT CLEAR 02 AS MANUFACTURED IN NORWICH, NY
DOLASETRON MESYLATE USP AS MANUFACTURED IN MAHARASHTRA INDIA
PLASTIC FILMS FOR USE IN DRUG PRODUCT CONTAINER AS MANUFACTURED IN NABARICITY, JAPAN
MICRONIZATION PROCESS FACILITY AS LOCATED IN MALVERN, PA

SYRIQ PREFILLABLE GLASS SYRINGES AS MANUFACTURED IN LEBANON, PA AND


QUEENSBURY, NY FOR SCHOTT NORTH AMERICA INC
RASAGILINE MESYLATE AS MANUFACTURED IN SHANGHAI PR CHINA

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA ISRAEL

PALIPERIDONE AS MANUFACTURED IN GUJARAT INDIA

Page 709

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24164 A
III
8/19/2010
ALPHAPOINTE ASSN FOR THE BLIND

SUBJECT
POLYPROPYLENE PLASTIC BOTTLES USED FOR ORAL MEDICATION AS MANUFACTURED IN
KANSAS CITY, MO
HIGH DENSITY POLYETHYLENE PLASTIC BOTTLES USED FOR ORAL MEDICATION AS
MANUFACTURED IN KANSAS CITY, MO
NATURAL MELON WONF FLAVOR #14747 AS MANUFACTURED IN BETHLEHEM, PA

24165 A

III

8/19/2010

ALPHAPOINTE ASSN FOR THE BLIND

24166 A

IV

9/10/2010

UNGERER AND CO

24167 A

III

9/14/2010

PPG4553-603 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH

24168 A

II

9/15/2010

24169 A

III

9/14/2010

24170 A

III

9/14/2010

24171 A

III

9/10/2010

PPG INDUSTRIES INC PPG PACKAGING AND


COATINGS
3D IMAGING DRUG DESIGN AND DEVELOPMENT
LLC
PPG INDUSTRIES INC PPG PACKAGING AND
COATINGS
PPG INDUSTRIES INC PPG PACKAGING AND
COATINGS
HUDSON COLOR CONCENTRATES

24172 A

III

9/14/2010

AMERICAS STYRENICS LLC

24173 A

II

8/6/2010

GLOPEC INTERNATIONAL INC

24174 A

II

8/7/2010

SMRUTHI ORGANICS LTD

HIGH IMPACT POLYSTYRENE (HIPS) RESINS AS MANUFACTURED IN GALES FERRY, CT;


IRONTON, OH; CHANNAHON, IL; TORRANCE, CA AND MARIETTA, OH
TEMOZOLOMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR GLOPEC
INTERNATIONAL INC
S (-) AMLODIPINE BESILATE USP AS MANUFACTURED IN MAHARASHTRA, INDA

24175 A

II

9/13/2010

JIANGSU HENGRUI MEDICINE CO LTD

DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN JIANGSU, P.R. CHINA

24176 A

II

10/6/2010

24177 A

II

9/27/2010

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO


LTD
UNIMARK REMEDIES LTD

NORETHINDRONE AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES REPUBLIC OF


CHINA
RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT INDIA

24178 A

II

9/13/2010

MACLEODS PHARMACEUTICALS LTD

VALSARTAN AS MANUFACTURED IN GUJARAT, INDIA

24179 A

II

9/14/2010

SHASUN PHARMACEUTICALS LTD

KETOPROFEN AS MANUFACTURED IN CUDDALORE, INDIA

24180 A

II

9/29/2010

TORRENT PHARMACEUTICALS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT INDIA

24181 A

II

9/15/2010

MSN ORGANICS PVT LTD

PIOGLITAZONE HYDROCHLORIDE [ROUTE CODE: PG"] AS MANUFACTURED IN TELANGANA

24182 I

II

9/15/2010

ELAN DRUG DELIVERY INC

N1766 TABLETS AS MANUFACTURED IN KING PRUSSIA, PA

24183 A

II

9/15/2010

DIVIS LABORATORIES LTD

TRITYL LOSARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24184 A

II

9/13/2010

POLYDRUG LABORATORIES PVT LTD

FERROUS FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

24185 A

II

9/17/2010

CHONGQING DAXIN PHARMACEUTICAL CO LTD

VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, P.R. CHINA

24186 A

II

9/10/2010

MEGAFINE PHARMA P LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN NASHIK, INDIA

24187 A

IV

9/16/2010

HENKEL CORP

24188 A

II

9/27/2010

AUROBINDO PHARMA LTD

24189 A

II

9/20/2010

FORMOSA LABORATORIES INC

DURO-TAK(TM) 87-624A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,


NC
ENTACAPONE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH
INDIA
ERGOCALCIFEROL AS MANUFACTURED IN TAOYUAN, TAIWAN

24190 A

III

11/9/2010

AERO PUMP GMBH

24191 A

II

9/16/2010

ESSENTIAL INGREDIENTS

24192 A

II

10/6/2010

ESTRADIOL AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLE'S REPUBLIC OF CHINA

24193 A

II

9/20/2010

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO


LTD
RELIABLE BIOPHARMACEUTICAL CORP

24194 A

II

9/20/2010

KINGLAND CHEMICALS CO LTD

BENZONATATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

24195 A

II

9/17/2010

CTX LIFE SCIENCES PVT LTD

CARBAMAZEPINE USP AS MANUFACTURED IN GUJARAT, INDIA

[F-18] FDPN AS MANUFACTURED IN LITTLE ROCK, ARKANSAS


P-2238862 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
PPG4553-303 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
WHITE HC81523PVC AS MANUFACTURED IN LEOMINSTER, MA

PUMP SYSTEMS FOR ORAL AND TOPIC APPLICATIONS AS MANUFACTURED IN HOCHHEIM


GERMANY
CUROXYL 42 AS MANUFACTURED IN DEERFIELD BEACH, FL FOR ESSENTIAL INGREDENTS

CYANOMETHYL MANNOSYL ACETATE AS MANUFACTURED IN ST. LOUIS, MO

Page 710

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24196 A
II
9/21/2010
LABORATORIO CHIMICO INTERNAZIONALE SPA

SUBJECT
PREGABALIN AS MANUFACTURED IN SEGRATE MI, ITALY

24197 A

II

9/21/2010

NATIONAL JEWISH HEALTH

24198 A

II

9/21/2010

ACS DOBFAR SPA

FBC-0007 (Mn-Te-2PyP) AS MANUFACTURED IN CONCORD, OH FOR NATIONAL JEWISH


HEALTH
GENTAMICIN SULFATE AS MANUFACTURED IN BERGAMO, ITALY

24199 A

II

10/9/2010

SUN PHARMACEUTICAL INDUSTRIES LTD

SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN GUJARAT INDIA

24200 A

II

10/28/2010

JUBILANT GENERICS LTD

LEVETIRACETAM AS MANUFACTURED IN NANJANGUD MYSORE DIST INDIA

24201 I

II

9/25/2010

QILU PHARMACEUTICAL CO LTD

24202 A

II

12/15/2011

CHEM WERTH INC

CARBOPLATIN PROCESS II AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES


REPUBLIC OF CHINA
DEXMEDETOMIDINE HCL AS MANUFACTURED IN NEWBURYPORT MA

24203 A

II

8/26/2010

HAINAN POLY PHARMACEUTICAL CO LTD

TRIMEBUTINE MALEATE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

24204 A

III

9/23/2010

SK CHEMICALS CO LTD

SKYPET BR AS MANUFACTURED IN ULSAN, KOREA

24205 A

II

9/22/2010

INFA SA

MELOXICAM AS MANUFACTURED IN MURCIA, SPAIN FOR INFA S.A.

24206 A

II

9/28/2010

SMS PHARMACEUTICALS LTD

TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24207 A

II

3/4/2011

RELIANCE LIFE SCIENCES PVT LTD

IMATINIB MESYLATE AS MANUFACTURED IN NAVI MUMBAI, INDIA

24208 A

II

9/28/2010

MYLAN LABORATORIES LTD

LATANOPROST AS MANUFACTURED IN TELANGANA, INDIA

24209 A

II

10/28/2010

GLENMARK GENERICS LTD

DEFERASIROX AS MANUFACTURED IN GUJARAT INDIA

24210 A

II

9/24/2010

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

ACECLOFENAC AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA

24211 A

II

9/24/2010

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

TELMISARTAN AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA

24212 A

IV

9/24/2010

HENRY H OTTENS MANUFACTURING CO INC

24213 A

II

9/30/2010

CEDARBURG PHARMACEUTICALS INC

ARTIFICIAL BUTTERSCOTCH FLAVOR CONCENTRATE #5659 AS MANUFACTURED IN


PHILADELPHIA, PA
BRIMONIDINE TARTRATE AS MANUFACTURED IN GRAFTON, WI

24214 A

III

9/27/2010

FLEXTRUS AB

TRANSOFOIL EL-OPET/I AS MANUFACTURED IN LUND, SWEDEN

24215 A

II

9/22/2010

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

DEXAMETHASONE SODIUM PHOSPHATE AS MANUFACTURED IN KEDAH, MALAYSIA

24216 A

II

9/17/2010

24217 A

III

9/30/2010

PRODUCTOS QUIMICOS NATURALES SA DE CV


PROQUINA
BAXTER HEALTHCARE CORP

PRASTERONE (DEHYDROEPIANDROSTERONE) AS MANUFACTURED IN IXTACZOQUITLAN


VER. MEXICO
CLARITY CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN JAYUYA, PUERTO RICO

24218 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-LIGHT BLUE PP52176043 AS MANUFACTURED IN MALMO, SWEDEN

24219 A

III

9/17/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-WHITE PP00176011 AS MANUFACTURED IN MALMO, SWEDEN

24220 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-MID GREY PP7M 176017 AS MANUFACTURED IN MALMO, SWEDEN

24221 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-BROWN PP83176012 AS MANUFACTURED IN MALMO, SWEDEN

24222 A

III

9/17/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-RED PP3M176028 AS MANUFACTURED IN MALMO, SWEDEN

24223 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-ORANGE PE2M176044 AS MANUFACTURED IN MALMO, SWEDEN

24224 A

III

9/17/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-BLACK PP9M176008 AS MANUFACTURED IN MALMO SWEDEN

24225 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-BEIGE PE8M176048 AS MANUFACTURED IN MALMO SWEDEN

24226 A

III

9/21/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-BLUISH GREEN PE6M176126 AS MANUFACTURED IN MALMO SWEDEN

24227 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-BROWN PE8M176049 AS MANUFACTURED IN MALMO SWEDEN

24228 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-DARK BLUE PE5M176153 AS MANUFACTURED IN MALMO SWEDEN

24229 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-DARK BLUE PP5M176045 AS MANUFACTURED IN MALMO SWEDEN

24230 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-LIGHT BLUE PE 5 AS MANUFACTURED IN MALMO SWEDEN

24231 A

III

9/21/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-LIGHT GREEN PE6M176 AS MANUFACTURED IN MALMO SWEDEN

Page 711

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24232 A
III
9/20/2010
CLARIANT MASTERBATCHES NORDEN AB

SUBJECT
REMAFIN-MID BLUE PE52176154 AS MANUFACTURED IN MALMO SWEDEN

24233 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-MID BLUE PP5M176044 AS MANUFACTURED IN MALMO SWEDEN

24234 A

III

9/21/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-MID GREEN PE6M176127 AS MANUFACTURED IN MALMO SWEDEN

24235 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-MID GREEN PP6M176028 AS MANUFACTURED IN MALMO SWEDEN

24236 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-RED PE3M176131 AS MANUFACTURED IN MALMO SWEDEN

24237 A

III

9/21/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-VIOLET PE4M176023 AS MANUFACTURED IN MALMO SWEDEN

24238 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-MID GREY PE7M176067 AS MANUFACTURED IN MALMO, SWEDEN

24239 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-WHITE PEOM176031 AS MANUFACTURED IN MALMO SWEDEN

24240 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-MID YELLOW PE1M176076 AS MANUFACTURED IN MALMO SWEDEN

24241 A

III

9/17/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-YELLOW PP13176012 AS MANUFACTURED IN MALMO SWEDEN

24242 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-DARK GREY PE74176066 AS MANUFACTURED IN MALMO, SWEDEN

24243 A

III

9/17/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-PINK PP32176027 AS MANUFACTURED IN MALMO, SWEDEN

24244 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-VIOLET PP43176005 AS MANUFACTURED IN MALMO, SWEDEN

24245 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-BLUISH GREEN PP63176029 AS MANUFACTURED IN MALMO, SWEDEN

24246 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-BEIGE PP82176011 AS MANUFACTURED IN MALMO, SWEDEN

24247 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-BLACK PL94176008 AS MANUFACTURED IN MALMO, SWEDEN

24248 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-DARK GREY PP74176018 AS MANUFACTURED IN MALMO, SWEDEN

24249 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-LIGHT GREEN PP62176027 AS MANUFACTURED IN MALMO, SWEDEN

24250 A

III

9/20/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-PINK PE32176130 AS MANUFACTURED IN MALMO, SWEDEN

24251 A

III

9/17/2010

CLARIANT MASTERBATCHES NORDEN AB

REMAFIN-ORANGE PP23176008 AS MANUFACTURED IN MALMO, SWEDEN

24252 A

III

9/22/2010

HRJ SURGICALS

24253 A

II

9/24/2010

GULBRANDSEN TECHNOLOGIES INC

PLASTIC ITEMS USED AS PRIMARY PACKAGING MATERIAL IN PHARMACEUTICAL PRODUCTS


AS MANUFACTURED IN MAHARASHTRA, INDIA
ACHIEVE L 5440 PG SOLUTION AS MANUFACTURED IN GUJARAT, INDIA

24254 A

II

8/25/2010

LABORATORIO OPOTERAPICO ARGENTINO SA

CHONDROITIN SULFATE POWDER AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

24255 A

II

9/10/2010

ALP PHARM BEIJING CO LTD

CICLESONIDE AS MANUFACTURED IN TIANJIN, P.R. CHINA FOR ALP PHARM BEIJING CO LTD

24256 A

II

9/10/2010

ALP PHARM BEIJING CO LTD

24257 A

II

9/15/2010

ALP PHARM BEIJING CO LTD

MESALAMINE AS MANUFACTURED IN HEILONGJIANG, P.R. CHINA FOR ALP PHARM BEIJING CO


LTD
BIVALIRUDIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA FOR ALP PHARM BEIJING CO LTD

24258 A

III

10/1/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-TRANS RED PP3M176042 AS MANUFACTURED IN MALMO, SWEDEN

24259 A

III

10/1/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-TRANS YELLOW PP1M176018 AS MANUFACTURED IN MALMO, SWEDEN

24260 A

III

10/1/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-TRANS GREY PP7M176029 AS MANUFACTURED IN MALMO, SWEDEN

24261 A

III

10/1/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-TRANS BLUE PP5M176061 AS MANUFACTURED IN MALMO, SWEDEN

24262 A

III

10/1/2010

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-TRANS GREEN PP6M176048 AS MANUFACTURED IN MALMO, SWEDEN

24263 A

II

10/6/2010

AMINO CHEMICALS LTD

PALIPERIDONE AS MANUFACTURED IN MARSA, MALTA

24264 A

II

12/2/2010

APICORE US LLC

LENALIDOMIDE AS MANUFACTURED IN SOMERSET NJ

24265 A

IV

10/4/2010

PRODOTTI CHIMICI E ALIMENTARI SPA

GLYCOCHOLIC ACID AS MANUFACTURED IN BASALUZZO (AL), ITALY

24266 A

II

10/8/2010

APOTEX PHARMACHEM INC

SITAGLIPTIN PHOSPHATE MONOHYDRATE AS MANUFACTURED IN BRANTFORD ON, CANADA

24267 A

III

9/29/2010

CODING PRODUCTS

SV-17807 AS MANUFACTURED IN KALKASKA, MI

Page 712

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24268 A
III
9/29/2010
CODING PRODUCTS

SUBJECT
SV-14207 AS MANUFACTURED IN KALKASKA, MI

24269 A

III

9/29/2010

CODING PRODUCTS

SV-19820 AS MANUFACTURED IN KALKASKA, MI

24270 A

III

9/29/2010

CODING PRODUCTS

SV-17383 AS MANUFACTURED IN KALKASKA, MI

24271 A

III

8/13/2010

SARONG

24272 A

II

10/13/2010

PROTEUS SA

EMPTY SUPPOSITORY SHELLS OF POLYVINYLCHLORIDE/POLYETHYLENE FILM LAMINATE AS


MANUFACTURED IN REGGIOLO (R.E.), ITALY
NEOSAXITOXIN AS MANUFACTURED IN SANTIAGO, CHILE

24274 A

II

10/13/2010

CADILA HEALTHCARE LTD

DULOXETINE HYDROCHLORIDE (DUB ROUTE) AS MANUFACTURED IN GUJARAT, INDIA

24275 A

II

12/14/2010

TARO PHARMACEUTICAL INDUSTRIES LTD

DESLORATADINE AS MANUFACTURED IN HAIFA BAY ISRAEL

24276 I

III

9/20/2010

HMC POLYMERS CO LTD

PURELL RP270M AS MANUFACTURED IN RAYONG, THAILAND

24277 A

II

10/14/2010

ALEMBIC PHARMACEUTICALS LTD

FENOFIBRIC ACID AS MANUFACTURED IN GUJARAT, INDIA

24278 A

II

10/14/2010

PHARMAESSENTIA CORP

24279 A

III

10/7/2010

APTAR FRANCE SAS

GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TAIPEI HSIENG, TAIWAN FOR


PHARMAESSENTIA COROPRATION
LATITUDE(TM) SIDE ACTUATION DEVICE AS MANUFACTURED IN LE VAUDREUIL, FRANCE

24280 A

III

9/20/2010

POLYONE CORP

24281 A

III

9/20/2010

POLYONE CORP

CC10132659BG AS MANUFACTURED IN ASSESSE, BELGIUM AND SAINT-OUEN L'AUMONE,


FRANCE
CC10132662BG AS MANUFACTURED IN ASSESSE, BELGIUM

24282 A

III

9/20/2010

POLYONE CORP

CC00017726WE AS MANUFACTURED IN ELK GROVE, IL

24283 A

III

9/20/2010

POLYONE CORP

CC00017835WE AS MANUFACTURED IN ELK GROVE, IL

24284 A

III

9/20/2010

POLYONE CORP

CC10012890WE AS MANUFACTURED IN ELK GROVE, IL

24285 A

II

10/29/2010

AUROBINDO PHARMA LTD

24286 A

II

11/8/2010

PHF SA

TRAMADOL HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
LUBIPROSTONE AS MANUFACTURED IN BUENOS AIRES ARGENTINA FOR PHF SA

24287 I

II

12/9/2010

PHF SA

IMATINIB MESYLATE AS MANUFACTURED IN RAICHUR INDIA FOR PHA SA

24288 A

II

11/1/2010

USV LIMITED

OCTREOTIDE AS MANUFACTURED IN MAHARASHTRA INDIA

24289 A

II

10/15/2010

SEQUENT SCIENTIFIC LTD

ACYCLOVIR SODIUM AS MANUFACTURED IN KARNATAKA, INDIA

24290 I

II

10/9/2010

QILU PHARMACEUTICAL CO LTD

RISPERIDONE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA

24291 A

II

9/28/2010

JOHNSON MATTHEY INC

MORPHINE TECHNICAL ALKALOID AS MANUFACTURED IN WEST DEPTFORD, NJ

24292 A

II

9/30/2010

ALEMBIC PHARMACEUTICALS LTD

PREGABALIN AS MANUFACTURED IN GUJARAT, INDIA

24293 A

IV

10/15/2010

ABELEI INC

24294 A

IV

10/15/2010

ABELEI INC

24295 A

IV

10/15/2010

ABELEI INC

148A84 NATURAL AND ARTIFICIAL GRAPEFRUIT ORANGE FLAVOR AS MANUFACTURED IN


NORTH AURORA, IL
196A22 NATURAL AND ARTIFICIAL JUICY FRUIT TYPE FLAVOR AS MANUFACTURED IN NORTH
AURORA, IL
174A78 NATURAL AND ARTIFICIAL MINT FLAVOR AS MANUFACTURED IN NORTH AURORA, IL

24296 A

II

11/4/2010

AUROBINDO PHARMA LTD

24297 A

II

10/29/2010

IND SWIFT LABORATORIES LTD

CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
CINACALCET HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA

24298 A

II

12/17/2010

IND SWIFT LABORATORIES LTD

TEMOZOLOMIDE USP AS MANUFACTURED IN PUNJAB INDIA

24299 I

III

10/8/2010

TEKNOR COLOR CO

32,820HCC AMBER 50:1 AS MANUFACTURED IN JACKSONVILLE, TX AND HENDERSON, KY

24300 A

III

10/7/2010

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG

INJECTION BOTTLES WITH CLINCH NECK FINISH AS MANUFACTURED IN NEUHAUS A. RWG.,


GERMANY

24273 N

NOT AN ASSIGNED NUMBER

Page 713

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24301 A
III
10/9/2010
TEKNOR APEX CO
24302 A

III

10/9/2010

TEKNOR APEX CO

24303 I

III

10/9/2010

TEKNOR APEX CO

24304 A

II

10/19/2010

CATALENT PHARMA SOLUTIONS LLC

SUBJECT
MEDALIST MD-585 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY
FOR TEKNOR APEX COMPANY
MEDALIST MD-565 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY
FOR TEKNOR APEX COMPANY
MEDALIST MD-575 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY
FOR TEKNOR APEX COMPANY
DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL

24305 A

II

10/19/2010

APOTEX PHARMACHEM INDIA PVT LTD

ENTECAVIR AS MANUFACTURED IN BANGALORE KARNATAKA, INDIA

24306 A

II

10/13/2010

PHARMACEUTICAL WORKS POLPHARMA SA

ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

24307 A

II

10/19/2010

MSN ORGANICS PVT LTD

SILDENAFIL CITRATE [ROUTE CODE: "SE"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24308 A

III

10/21/2010

LANXESS DEUTSCHLAND GMBH

24309 A

II

10/13/2010

MAPRIMED SA

24310 A

II

9/17/2010

24311 A

II

10/22/2010

PRODUCTOS QUIMICOS NATURALES SA DE CV


PROQUINA
MYLAN LABORATORIES LTD

LANXESS BROMOBUTYL 2030 AS MANUFACTURED IN ZWIJNDRECHT, BELGIUM AND SARNIA,


ONTARIO, CANADA
FLECAINIDE ACETATE PROCESS II (CODE 50856) AS MANUFACTURED IN BUENOS AIRES,
ARGENTINA
TESTOSTERONE L-2 AS MANUFACTURED IN IXTACZOQUITLAN VER. MEXICO

24312 A

II

12/1/2010

ARCH PHARMALABS LTD

24313 A

II

10/18/2010

24314 I

II

11/8/2010

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
PHARMACIA AND UPJOHN SUB PFIZER INC

24315 A

II

11/30/2010

ABBVIE INC

PARICALCITOL DRUG SUBSTANCE AS MANUFACTURED IN SLIGO, IRELAND

24316 A

II

10/1/2010

YANTAI DONGCHENG BIOCHEMICALS CO LTD

ENOXAPARIN SODIUM

24317 A

II

9/28/2010

KOREA UNITED PHARMACEUTICALS INC

AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN CHUNGNAM, REPUBLIC OF KOREA

24318 A

III

10/19/2010

KJ SPECIALTY PAPER CO LTD

24319 A

III

10/19/2010

KJ SPECIALTY PAPER CO LTD

24320 A

IV

10/27/2010

SENSIENT PHARMACEUTICAL COATING SYSTEMS

DDSF-2 SERIES (DDSF-2, DDSF-2FP AND DDSF-2FPS) BACKING FILMS MADE OF PET FILM AND
UNWOVEN CLOTH LAMINATED AS MANUFACTURED IN SHIZUOKA, JAPAN
DDSF-151 SERIES (DDSF-151, DDSF-151P AND DDSF-151PS) BACKING FILMS MADE OF PET
FILM AND UNWOVEN CLOTH LAMINATED AS MANUFACTURED IN SHIZUOKA, JAPAN
SPECTRABLEND COATING SYSTEM AS MANUFACTURED IN ST LOUIS MO

24321 A

II

10/28/2010

NAVINTA LLC

24322 A

II

9/15/2010

SAFC BIOSCIENCES INC

24323 A

II

10/28/2010

TEVA PHARMACEUTICAL INDUSTRIES LTD

24324 A

II

11/2/2010

UNIMARK REMEDIES LTD

24325 A

II

10/25/2010

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

24326 A

II

10/28/2010

MACLEODS PHARMACEUTICALS LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES REPUBLIC


OF CHINA
ESZOPICLONE AS MANUFACTURED IN GUJARAT INDIA

24327 A

II

11/1/2010

SCINOPHARM TAIWAN LTD

PEMETREXED DISODIUM AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC

24328 I

II

12/21/2010

RPG LIFE SCIENCES LTD

CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MUMBAI INDIA

24329 A

III

10/27/2010

PFP TERMOPOLIMEROS SL

HDPE/BO-CRC FAB CONTAINER AS MANUFACTURED IN BARCELONA SPAIN

24330 A

II

9/10/2010

SPECTRON MRC LLC

3'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN SOUTH BEND IN

FROVATRIPTAN SUCCINATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA


ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR) AS MANUFACTURED IN HARYANA INDIA
FOR ARCH PHARMALABS LIMITED
PANTOPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
TRIAZOLAM USP MICRONIZED AS MANUFACTURED IN KALAMAZOO MI

HYDRALAZINE HYDROCHLORIDE USP (P) GRADE AS MANUFACTURED IN GUJARAT INDIA FOR


NAVINTA LLC
EX-CELL 325 PF CHO SERUM-FREE PROTEIN FREE W/O L-GLUTAMINE AS MANUFACTURED IN
DENVER PA
PERGOLIDE MESYLATE AS MANUFACTURED IN OPAVA-KOMAROV CZECH REPUBLIC FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
MONTELUKAST SODIUM (PROCESS B) AS MANUFACTURED IN GUJARAT INDIA

Page 714

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24331 A
II
10/25/2010
ERREGIERRE SPA
24332 I

II

10/8/2010

QILU PHARMACEUTICAL CO LTD

24333 A

II

10/30/2010

MACLEODS PHARMACEUTICALS LTD

SUBJECT
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH EUR AS MANUFACTURED IN SAN
PAOLO D'ARGON (BG) ITALY
ETOPOSIDE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES
REPUBLIC OF CHINA
OLANZAPINE AS MANUFACTURED IN GUJARAT INDIA

24334 A

II

4/1/2011

APICORE US LLC

ZILEUTON USP AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC

24335 A

IV

11/1/2010

AARHUSKARLSHAMN SWEDEN AB

24336 A

II

10/21/2010

ALP PHARM BEIJING CO LTD

24337 I

II

11/5/2010

EXCELLA GMBH

SHEA BUTTERS FOR USE AS EXCIPIENTS IN PHARMACEUTICAL PREPARATIONS LIPEX 102 &
LIPEX SHEASOFT AS MANUFACTURED IN KARLSHAMN SWEDEN
ADEFOVIR DIPIVOXIL AS MANUFACTURED IN JIANGSU CHINA FOR ALP PHARM BEIJING CO
LTD
GANCICLOVIR ANHYDROUS R AS MANUFACTURED IN FEUCHT GERMANY

24338 A

II

11/12/2010

GLENMARK GENERICS LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN GUJARAT INDIA

24339 A

II

3/1/2011

GLAXOSMITHKLINE LLC

CEFTAZIDIME AS MANUFACTURED IN CUMBRIA, UK FOR GLAXOSMITHKLINE LLC

24340 A

II

10/30/2010

NECTAR LIFESCIENCES LTD

24341 A

II

10/29/2010

JARI PHARMACEUTICAL CO LTD

CEFOTAXIME (NON STERILE DRUG SUBSTANCES INTERMEDIATE) AS MANUFACTURED IN


PUNJAB INDIA
GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU CHINA

24342 A

III

10/29/2010

ASSEMBLAGES FOR PREFILLED SYRINGES AS MANUFACTURED IN SHANDONG PR CHINA

24343 A

II

12/28/2010

SHANDONG WEIGAO GROUP MEDICAL POLYMER


CO LTD
TARO PHARMACEUTICAL INDUSTRIES LTD

24344 A

IV

10/31/2010

DOSHION LTD

POLACRILEX RESIN (DOSHION P551) AS MANUFACTURED IN GUJARAT INDIA

24345 A

II

11/4/2010

PHARMACEUTICAL WORKS POLPHARMA SA

TOLTERODINE L-TARTRATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

24346 A

II

11/5/2010

SANDOZ PRIVATE LTD

POSACONAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA

24347 A

II

12/1/2010

WATSON PHARMA PRIVATE LTD

24348 A

II

11/8/2010

24349 A

II

10/20/2010

24351 A

II

11/19/2010

GLENMARK GENERICS LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

24352 A

II

11/9/2010

BEIJING LUNARSUN PHARMACEUTICAL CO LTD

24353 A

II

1/10/2011

CAYMAN CHEMICAL CO

TEMOZOLOMIDE AS MANUFACTURED IN CHONGQING CHINA FOR BEIJING LUNARSUN


PHARMACEUTICAL CO LTD
BIMATOPROST DRUG SUBSTANCE AS MANUFACTURED IN ANN ARBOR MI

24354 A

II

10/30/2010

NECTAR LIFESCIENCES LTD

24355 A

III

11/4/2010

24356 A

II

11/8/2010

24357 A

IV

11/10/2010

CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB


INDIA
BORMIOLI ROCCO SPA BU PLASTICS
PET BOTTLE 500 ML - F18048 AS MANUFACTURED IN SAINT SULPICE FRANCE, RIVANAZZANO
(PV) ITALY, AND CASTELGUELFO (PR) ITALY
LIANYUNGANG RUNZHONG PHARMACEUTICAL CO ZOLEDRONIC ACID AS MANUFACTURED IN JIANGSU CHINA
LTD
SUHEUNG VIETNAM CO LTD
GELATIN HARD SHELL CAPSULES AS MANUFACTURED IN DONG NAI PROVINCE VIETNAM

24358 A

II

11/8/2010

ANHUI WANBEI PHARMACEUTICAL CO LTD

CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN ANHUI PROVINCE CHINA

24359 A

II

11/12/2010

HERAEUS PRECIOUS METALS GMBH AND CO KG

5-AMINOLEVULINIC ACID HYDROCHLORIDE AS MANUFACTURED IN HANAU GERMANY

24360 I

II

11/12/2010

MUSTAFA NEVZAT ILAC SANAYII AS

STERILE MIXTURE OF AMPICILLIN SODIUM AND SULBACTAM SODIUM (2:1) AS


MANUFACTURED IN KUNDL TYROL AUSTRIA, KOCAELI TURKEY AND ISTANBUL TURKEY FOR
MUSTAFA NEVZAT ILAC SANAYII AS

24350 P

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY ISRAEL

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN THANE


DISTRICT INDIA
HETERO DRUGS LTD
ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II AS MANUFACTURED IN ANDHRA
PRADESH INDIA
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO VENLAFAXINE HYDROCHLORIDE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
LTD
*** PENDING FILING REVIEW ***

Page 715

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24361 A
II
12/15/2010
JUBILANT GENERICS LTD

SUBJECT
ENTACAPONE AS MANUFACTURED IN KARNATAKA INDIA

24362 A

II

11/11/2010

GLOCHEM INDUSTRIES LTD

TELMISARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

24363 A

IV

11/12/2010

NUSIL TECHNOLOGY LLC

MED50 -5336 AS MANUFACTURED IN CARPINTERIA CA

24364 A

IV

11/12/2010

NUSIL TECHNOLOGY LLC

MED-6602 AS MANUFACTURED IN CARPINTERIA CA

24365 A

III

11/12/2010

LOTTE ALUMINIUM CO LTD

CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO KOREA

24366 A

III

11/8/2010

POLYESTER COILS AS MANUFACTURED IN JALGAON INDIA

24367 A

II

11/15/2010

RUBY SURGICAL AND ALLIED PRODUCTS PRIVATE


LTD
HOSPIRA BOULDER INC

24368 A

II

11/12/2010

BASF PHARMA EVIONNAZ SA

ENAMINE AMIDE AS MANUFACTURED IN EVIONNAZ SWITZERLAND

24369 A

II

11/15/2010

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

24370 A

II

11/9/2010

INTAS PHARMACEUTICALS LTD

N-METHYLPAROXETINE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR ZHEJIANG


JIUZHOU PHARMACEUTICAL CO LTD
CAPECITABINE USP AS MANUFACTURED IN GUJARAT INDIA

24371 A

II

11/25/2010

AUROBINDO PHARMA LTD

24372 A

II

11/15/2010

24373 A

II

12/1/2010

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
UNICHEM LABORATORIES LTD

MOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) AS


MANUFACTURED IN ANDHRA PRADESH INDIA
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN TAIPEI
HSIEN, TAIWAN
LACIDIPINE AS MANUFACTURED IN ROHA DIST RAIGAD INDIA

24374 A

II

12/1/2010

UNICHEM LABORATORIES LTD

TAMSULOSIN HYDROCHLORIDE USP AS MANUFACTURED IN ROHA DIST RAIGAD INDIA

24375 A

IV

11/15/2010

EASTMAN CHEMICAL CO

24376 A

II

11/1/2010

ALP PHARM BEIJING CO LTD

EASTMAN CELLULOSE ACETATE BUTYRATE (CAB-381-20BP) AS MANUFACTURED IN


KINGSPORT TN
NELARABINE AS MANUFACTURED IN JILIN PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD

24377 A

II

11/4/2010

ALP PHARM BEIJING CO LTD

24378 A

II

11/5/2010

ALP PHARM BEIJING CO LTD

VERTEPORFIN AS MANUFACTURED IN JIANGSU PROVINCE CHINA FOR ALP PHARM BEIJING


CO LTD
LANREOTIDE AS MANUFACTURED IN SHANGHAI CHINA FOR ALP PHARM BEIJING CO LTD

24379 A

IV

2/22/2011

BIOSPECTRA

UREA AS MFG IN STROUDSBURG, PA

24380 A

IV

2/22/2011

BIOSPECTRA

TROMETHAMINE AS MFG IN STROUDSBURG, PA

24381 A

II

11/17/2010

MACLEODS PHARMACEUTICALS LTD

MEMANTINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

24382 A

III

10/29/2010

EZCAP INTERNATIONAL CO LTD

CHILD RESISTANT CLOSURES AS MANUFACTURED IN KYUNGGI DO KOREA

24383 A

II

12/2/2010

24384 A

IV

8/12/2010

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL RITONAVIR USP AS MANUFACTURED IN SHANGHAI CHINA


CO LTD
SEPPIC SA
MONTANOX 80 API AS MANUFACTURED IN CASTRES CEDEX FRANCE FOR SEPPIC SA

24385 A

II

11/30/2010

FRESENIUS KABI ONCOLOGY LTD

BUSULFAN AS MANUFACTURED IN WEST BENGAL INDIA

24386 A

II

3/30/2011

EXCELLA GMBH

MASITINIB MESYLATE AS MANUFACTURED IN FEUCHT GERMANY

24387 I

II

11/22/2010

INTERQUIM SA

24388 A

II

11/23/2010

DR REDDYS LABORATORIES LTD

PALIPERIDONE AS MANUFACTURED IN BARCELONA SPAIN AND ESTADO DE MEXICO


(MEXICO) FOR INTERQUIM SA
PEMETREXED DISODIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA

24389 A

IV

11/22/2010

BASF SE

24390 A

IV

10/26/2010

NUSIL TECHNOLOGY LLC

KOLLICOAT SMARTSEAL 30 D AS MANUFACTURED IN LUDWIGHAFEN FEDERAL REPUBLIC OF


GERMANY
MED-344 (ANTIFOAM 7120) AS MANUFACTURED IN BAKERSFIELD CA

24391 A

IV

10/26/2010

NUSIL TECHNOLOGY LLC

MED-346 (ANTIFOAM 70451) AS MANUFACTURED IN BAKERSFIELD CA

24392 A

IV

10/26/2010

NUSIL TECHNOLOGY LLC

MED-347 SIMETHICONE EP AS MANUFACTURED IN BAKERSFIELD CA

24393 A

II

12/10/2010

UNICHEM LABORATORIES LTD

FENOFIBRATE USP AS MANUFACTURED IN DHAVAT-ROHA DIST RAIGAD INDIA

OXALIPLATIN DRUG SUBSTANCE AS MANUFACTURED IN BOULDER CO

Page 716

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24394 A
II
3/31/2011
LUPIN LTD

SUBJECT
PALIPERIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA

24395 A

II

3/31/2011

ACS DOBFAR SPA

CEFEPIME FOR INJECTION (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

24396 A

III

8/26/2009

TREDEGAR FILM PRODUCTS CORP

CEX-816WR ELASTIC FILM (35621, 35618) AS MANUFACTURED IN LAKE ZURICH IL

24397 A

II

11/19/2010

FORMOSA LABORATORIES INC

MYCOPHENOLATE SODIUM AS MANUFACTURED IN TAOYUAN TAIWAN

24398 A

II

9/9/2010

SEPPIC SA

MONTANOX 80 LPI AS MANUFACTURED IN CASTRES CEDEX FRANCE FOR SEPPIC SA

24399 A

IV

11/24/2010

VIKRAM THERMO INDIA LTD

METHACRYLIC ACID COPOLYMER TYPE A NF AS MANUFACTURED IN GUJARAT INDIA

24400 A

II

11/28/2010

ASAHI GLASS CO LTD

TAFLUPROST DRUG SUBSTANCE AS MANUFACTURED IN CHIBA JAPAN

24401 A

II

11/10/2010

SHANDONG YIBAO BIOLOGICS CO LTD

CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE CHINA

24402 A

II

10/25/2011

EXCELLA GMBH

LEVOTHYROXINE SODIUM AS MANUFACTURED IN FEUCHT, GERMANY

24403 A

II

11/29/2010

MYLAN LABORATORIES LTD

CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN TELANGANA, INDIA

24404 A

IV

11/29/2010

HENKEL CORP

DURO-TAK 87-608A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

24405 A

III

10/29/2010

SARONG

24406 A

II

11/30/2010

HETERO DRUGS LTD

24407 A

II

11/17/2010

OLON SPA

ALUMINUM/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN MANDELLO DEL LARIO


(LC) ITALY AND BAGNATICA (BERGAMO) ITALY FOR SARONG
PANTOPRAZOLE SODIUM SESQUIHYDRATE, USP (PROCESS II) AS MANUFACTURED IN
ANDHRA PRADESH INDIA
TOREMIFENE CITRATE AS MANUFACTURED IN RODANO (MI) ITALY

24408 A

II

12/17/2010

PHF SA

OLOPATADINE HCI USP AS MANUFACTURED IN VICENZA ITALY

24409 I

II

11/22/2010

24410 A

II

11/30/2010

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO METAXALONE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
LTD
EMCURE PHARMACEUTICALS LTD
CIDOFOVIR DIHYDRATE (E SUB) AS MANUFACTURED IN MAHARASHTRA INDIA

24411 A

II

3/1/2011

GLAXOSMITHKLINE LLC

CEFUROXIME SODIUM AS MANUFACTURED IN ULVERSTON, UK FOR GLAXOSMITHKLINE LLC

24412 A

II

12/1/2010

SANDOZ INDUSTRIAL PRODUCTS GMBH

24413 A

III

11/18/2010

ACG PHARMAPACK PVT LTD

CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN FRANKFURT GERMANY AND KUNDL


AUSTRIA FOR SANDOZ INDUSTRIAL PRODUCTS GMBH
RIGID PACKAGING FILMS AS MANUFACTURED IN MAHARASHTRA INDIA

24414 A

III

11/23/2010

TEKNOR APEX CO

24416 A

II

3/7/2011

VALDEPHARM

NORETHINDRONE AS MANUFACTURED IN VAL DE REUIL, FRANCE

24417 A

IV

12/1/2010

MEXICHEM UK LTD

BLENDS OF INHALATION GRADE 1, 1, 1, 2, 2, 2, 3-HEPTAFLUOROPROPANE AND INHALATION


GRADE 1,1,1,2-TETRAFLUOROETHANE AS MANUFACTURED IN RUNCORN CHESHIRE UNITED
KINGDOM

24418 A

II

12/2/2010

NOBILUS ENT

DIGOXIN AS MANUFACTURED IN KUTNO POLAND

24419 A

II

11/30/2010

ALEMBIC PHARMACEUTICALS LTD

CELECOXIB USP AS MANUFACTURED IN GUJARAT INDIA

24420 I

II

12/7/2010

RANBAXY LABORATORIES LTD

TRETINOIN USP (NON STERILE BULK) AS MANUFACTURED IN PUNJAB INDIA

24421 A

II

12/7/2010

DR REDDYS LABORATORIES LTD

ABACAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA

24422 A

II

12/7/2010

KREATIVE ORGANICS (P) LTD

ETODOLAC USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

24423 A

II

1/15/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

BIVALIRUDIN AS MANUFACTURED IN MAHARASHTRA INDIA

24424 A

II

12/13/2010

SRI KRISHNA PHARMACEUTICALS LTD

DOMPERIDONE PH EUR AS MANUFACTURED IN HYDERABAD INDIA

24415 N

MEDALIST MD-160A NATURAL AS MANUFACTURED IN SAINT ALBANS VT AND HENDERSON KY


FOR TEKNOR APEX COMPANY

NOT AN ASSIGNED NUMBER

24425 N

NOT AN ASSIGNED NUMBER

24426 A

III

12/14/2010

CODING PRODUCTS

TTR-71523 AS MANUFACTURED IN KALKASKA MI

24427 A

III

11/25/2010

MEDIPHARMAPLAN CO LTD

CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO KOREA

Page 717

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24428 A
III
11/29/2010
FUJIMORI KOGYO CO LTD
24429 I

II

12/8/2010

RANBAXY LABORATORIES LTD

SUBJECT
PLASTIC FILMS AND BAG FOR USE IN OUTER PACKAGING OF DRUG PRODUCT AS
MANUFACTURED IN MIE PREFECTURE JAPAN
TELBIVUDINE AS MANUFACTURED IN PUNJAB INDIA

24430 A

II

11/11/2010

OLON SPA

ACITRETIN (FORM I) AS MANUFACTURED IN GARBAGNATE MILANESE (MI) ITALY

24431 A

IV

12/6/2010

HENKEL CORP

DURO-TAK 87-6900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

24432 I

II

12/9/2010

RANBAXY LABORATORIES LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN PUNJAB INDIA

24433 I

II

12/9/2010

OCEAN NUTRITION CANADA LTD

24434 A

II

12/8/2010

APOTEX PHARMACHEM INC

24435 A

II

12/10/2010

CATALENT PHARMA SOLUTIONS LLC

24436 A

III

12/1/2010

HUBENA CO LTD

OMEGA-3 ACID ETHYL ESTERS AS MANUFACTURED IN CHARLOTTETOWN PE CANADA FOR


OCEAN NUTRITION CANADA LTD
VALGANCICLOVIR HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA INDIA FOR
APOTEX PHARMACHEM INC
SOFT GELATIN CAPSULE MANUFACTURING PROCESS FOR OET-10275167 AS
MANUFACTURED IN ST PETERSBURG FL
GLASS VIALS & GLASS AMPOULES AS MANUFACTURED IN CHOONG NAM-DO KOREA

24437 A

II

12/10/2010

VIRUPAKSHA ORGANICS PVT LTD

FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

24438 A

II

12/10/2010

PRASTERONE ACETATE AS MANUFACTURED IN JIANGSU CHINA

24439 A

II

12/8/2010

JIANGSU JIAERKE PHARMACEUTICALS GROUP


CORP LTD
ZHEJIANG HISUN PHARMACEUTICAL CO LTD

24440 A

IV

12/6/2010

UNGERER AND CO

24441 A

II

12/13/2010

MYLAN LABORATORIES LTD

CAPREOMYCIN SULFATE AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES REPUBLIC


OF CHINA
NATURAL AND ARTIFICIAL YELLOW PLUM LEMON FLAVOR FT-5399 AS MANUFACTURED IN
BETHLEHEM PA
DIPYRIDAMOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

24442 A

II

12/13/2010

MYLAN LABORATORIES LTD

RIVASTIGMINE TARTRATE USP AS MANUFACTURED MAHARASHTRA INDIA

24443 A

II

2/14/2011

PHF SA

QUETIAPINE FUMARATE AS MANUFACTURED IN QUEBEC, CANADA FOR PHF SA

24444 A

IV

12/6/2010

DOW CORNING CORP

DOW CORNING ST-DIMETHICONOL 40 AS MANUFACTURED IN HEMLOCK MI

24445 A

II

12/13/2010

MOREPEN LABORATORIES LTD

MONTELUKAST SODIUM AS MANUFACTURED IN HIMACHAL PRADESH INDIA

24446 A

II

12/15/2010

HETERO DRUGS LTD

ATOVAQUONE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH INDIA

24447 A

II

12/15/2010

RANBAXY LABORATORIES LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN PUNJAB INDIA

24448 I

II

12/15/2010

RANBAXY LABORATORIES LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA

24449 A

II

11/22/2010

SPECIALTY ENZYMES AND BIOCHEMICALS CO

24450 I

II

12/17/2010

MYLAN LABORATORIES LTD

ALPHA GALATOSIDASE AS MANUFACTURED IN SINNAR (NASHIK) INDIA FOR SPECIALTY


ENZYMES AND BIOCHEMICALS CO
ZIDOVUDINE USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH INDIA

24451 A

II

12/14/2010

LONZA AG

SECRETIN DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-L ALLEUD BELGIUM

24452 A

II

12/15/2010

MACLEODS PHARMACEUTICALS LTD

ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN GUJARAT INDIA

24453 A

II

11/18/2010

JIANGSU NHWA PHARMACEUTICAL CO LTD

FENOFIBRATE AS MANUFACTURED IN JIANGSU CHINA

24454 A

II

12/14/2010

PARABOLIC DRUGS LTD

CEFTIZOXIME SODIUM (STERILE) USP AS MANUFACTURED IN PUNJAB INDIA

24455 A

IV

12/10/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24456 A

IV

12/10/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24457 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24458 A

II

2/2/2011

GLAXOSMITHKLINE LLC

20.4573.5P PHA VANILLA FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO
(TO) ITALY
20.4562.4P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO
(TO) ITALY
58.3478.1P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO
(TO) ITALY
TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN CORK, IRELAND FOR
GLAXOSMITHKLINE LLC

Page 718

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24459 A
IV
12/10/2010
KERRY INGREDIENTS AND FLAVOURS ITALIA SPA
24460 A

12/14/2010

BASF SE

24461 A

II

12/17/2010

CATALENT PHARMA SOLUTIONS LLC

24462 A

IV

12/17/2010

NUSIL TECHNOLOGY LLC

SUBJECT
58.4108.UL PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO
(TO) ITALY
KOLLICOAT SMARTSEAL 30 D PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN
LUDWIGSHAFEN FEDERAL REPUBLIC OF GERMANY
SOFT GELATIN CAPSULE MANUFACTURING PROCESS FORMULA OET-10275188 AS
MANUFACTURED IN ST PETERSBURG FL
MED-4840 AS MANUFACTURED IN CARPINTERIA CA

24463 I

II

12/17/2010

EUTICALS INC

OMEGA-3 ACID ETHYL ESTERS DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD MO

24464 A

IV

12/17/2010

ASHA CELLULOSE I PVT LTD

ASHACEL ETHYL CELLULOSE AS MANUFACTURED IN VALSAD INDIA

24465 A

II

12/20/2010

JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD

7-AMINOCEPHALOSPORANIC ACID AS MANUFACTURED IN HENAN PR CHINA

24466 A

III

12/20/2010

THE DOW CHEMICAL COMPANY

24467 A

III

11/19/2010

SARONG

24468 A

II

2/24/2011

CONCORD BIOTECH LTD

ETHYLENE/VINYL ACETATE CO-POLYMER FORMULATIONS AS MANUFACTURED IN ELK GROVE


VILLAGE IL AND RINGWOOD IL
POLYVINYLCHLORIDE/POLVINYLIDENE CHLORIDE/POLYETHYLENE FILM LAMINATE AS
MANUFACTURED IN REGGIOLO (RE) ITALY
SIROLIMUS AS MANUFACTURED IN AHMEDABAD, INDIA

24469 A

II

12/24/2010

USV LIMITED

ZOLEDRONIC ACID AS MANUFACTURED IN MAHARASHTRA INDIA

24470 A

3/6/2013

NOVO NORDISK INC

STERILIZATION VALIDATION INFORMATION

24471 A

II

2/11/2011

GLAXOSMITHKLINE

24472 A

II

1/5/2011

IND SWIFT LABORATORIES LTD

AMOXICILLIN SODIUM AS MANUFACTURED IN WEST SUSSEX, UNITED KINGDOM FOR


GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE
TELMISARTAN AS MANUFACTURED IN PUNJAB, INDIA

24473 A

III

12/21/2010

PPG PACKAGING AND COATINGS

PPG5085-301 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH

24474 A

III

12/21/2010

PPG PACKAGING AND COATINGS

PPG5085-302 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH

24475 A

III

12/21/2010

PPG PACKAGING AND COATINGS

PPG5085-304 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH

24476 A

II

12/8/2010

SHANDONG XINHUA PHARMACEUTICAL CO LTD

MELOXICAM AS MANUFACTURED IN SHANDONG PR CHINA

24477 A

II

10/1/2010

VITAL LABORATORIES PVT LTD

24478 A

III

12/21/2010

HOSOKAWA YOKO CO LTD

24479 A

II

12/21/2010

GEDEON RICHTER PLC

SCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL BROMIDE) AS MANUFACTURED IN


GUJARAT INDIA
POLYOLEFIN BAGS AND FILM (POLYELITE SERIES) FOR PHARMACEUTICAL CONTAINER USE
AS MANUFACTURED IN NAGANO JAPAN FOR HOSOKAWA YOKO CO LTD
DIENOGEST AS MANUFACTURED IN DOROG HUNGARY

24480 A

II

12/20/2010

JIANGSU HANSOH PHARMACEUTICAL CO LTD

OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU CHINA

24481 A

II

12/22/2010

FORMOSA LABORATORIES INC

ILOPERIDONE AS MANUFACTURED IN TAOYUAN TAIWAN

24482 A

II

12/17/2010

CODING PRODUCTS

TTR-74808 AS MANUFACTURED IN KALKASKA MI

24483 A

III

12/15/2010

EASTMAN CHEMICAL CO

24484 A

III

12/22/2010

BESPAK DIV CONSORT MEDICAL PLC

24485 A

II

12/23/2010

MYLAN LABORATORIES LTD

EASTMAN TRITAN COPOLYESTER PRODUCTION AT TENNESSEE EASTMAN DIVISION AS


MANUFACTURED IN KINGSPORT TN
BK357 AND BK361 VALVE SPECIFIC INFORMATION AS MANUFACTURED IN NORFOLK,
ENGLAND
RIVASTIGMINE AS MANUFACTURED IN MAHARASHTRA INDIA

24486 A

II

10/12/2010

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN KULIM, KEDAH, MALAYSIA

24487 A

II

12/23/2010

CHEMO IBERICA SA

24488 A

IV

12/22/2010

3M DRUG DELIVERY SYSTEMS

LANSOPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE PR OF CHINA FOR CHEMO


IBERICA SA
SOLVATED ACRYLATE COPOLYMER ADHESIVE R-24449 AS MANUFACTURED IN CORDOVA IL
FOR 3M DRUG DELIVERY SYSTEMS DIVISION

Page 719

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24489 A
III
12/23/2010
BORMIOLI ROCCO SPA BU PLASTICS
24490 A

III

12/23/2010

24491 A

III

12/23/2010

24492 A

IV

12/21/2010

24493 A

III

12/20/2010

24494 A

III

12/21/2010

SUBJECT
OVERTUNING DROPPER 0.65 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY,
RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE
BORMIOLI ROCCO E FIGLIO SPA BU PLASTICA
TAMPER EVIDENT CLOSURE 15-24 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY,
RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE
BORMIOLI ROCCO SPA BU PLASTICS
LDPE BOTTLE 10 ML AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, RIVANAZZANO (PV)
ITALY, AND SAINT SULPICE FRANCE
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA
DISINTEQUIK MCC 25 AS MANUFACTURED IN ROTHSCHILD WI FOR KERRY BIOFUNCTIONAL
KERRY BIO SCIENCE
INGREDIENTS INC DBA KERRY BIOSCIENCE
BRIGHTWOOD PHARMMED CONSUMABLE BEIJING MULTILAYER FILM (MF518) AS MANUFACTURED IN HUAI ROU COUNTY BEIJING PR CHINA AND
LTD
TONGZHOU INDUSTRY DISTRICT BEIJING PR CHINA
SCHOTT KAISHA PVT LTD
NEUTRAL GLASS SULPHUR TREATED VIALS AS MANUFACTURED IN NANI DAMAN INDIA

24495 A

II

12/28/2010

COVALENT LABORATORIES PRIVATE LTD

CEFUROXIME ACID (ACETONE ROUTE) AS MANUFACTURED IN ANDHRA PRADESH INDIA

24496 A

II

2/21/2011

JUBILANT GENERICS LTD

CLOPIDOGREL BISULFATE AS MANUFACTURED IN MYSORE DIST., India

24497 A

II

12/23/2010

ROLABO OUTSOURCING SL

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ZARAGOZA, SPAIN

24498 A

II

12/28/2010

NAVINTA LLC

TAUROLIDINE AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR NAVINTA LLC

24499 A

II

12/28/2010

MYLAN LABORATORIES LTD

ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

24500 A

II

3/1/2011

PFIZER INC

TESTOSTERONE UNDECANOATE AS MANUFACTURED IN KALAMAZOO, MICHIGAN

24501 A

II

3/27/2011

JUBILANT GENERICS LTD

RIVASTIGMINE TARTRATE AS MANUFACTURED IN MYSORE DIST., INDIA

24502 A

II

3/27/2011

JUBILANT GENERICS LTD

RIVASTIGMINE AS MANUFACTURED IN MYSORE DIST., INDIA

24503 A

II

12/21/2010

MYLAN LABORATORIES LTD

DEXLANSOPRAZOLE SESQUIHYDRATE AS MANUFACTURED IN TELANGANA, INDIA

24504 A

II

12/28/2010

MYLAN LABORATORIES LTD

ELETRIPTAN HYDROBROMIDE (PROCESS 1) AS MANUFACTURED IN TELANGANA, INDIA

24505 A

II

12/21/2010

MYLAN LABORATORIES LTD

AMBRISENTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24506 A

II

12/29/2010

NEULAND LABORATORIES LTD

LINEZOLID (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24507 A

II

12/20/2010

BLOOMAGE FREDA BIOPHARM CO LTD

24508 A

II

12/20/2010

BLOOMAGE FREDA BIOPHARM CO LTD

24509 A

II

12/30/2010

MYLAN LABORATORIES LTD

SODIUM HYALURONATE (HA-EP 3.0) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. OF


CHINA
SODIUM HYALURONATE (HA-EP 1.8) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. OF
CHINA
SUNITINIB MALATE AS MANUFACTURED IN MAHARASHTRA, INDIA

24510 A

II

12/30/2010

SCINOPHARM TAIWAN LTD

CLADRIBINE AS MANUFACTURED IN TAINAN, TAIWAN

24511 A

II

12/30/2010

CHANGZHOU PHARMACEUTICAL FACTORY

EZETIMIBE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

24512 A

III

12/28/2010

AMPACET CORP

24513 A

II

3/31/2011

LUPIN LTD

502997 AS PE MB AS MANUFACTURED IN MESSANCY, BELGIUM AND TELGATE (BG), ITALY FOR


AMPACET CORP
DIENOGEST AS MANUFACTURED IN MADHYA PRADESH, INDIA

24514 A

IV

12/30/2010

SENSIENT FLAVORS LLC

24515 A

III

12/30/2010

GOPALDAS VISRAM AND CO LTD

NATURAL AND ARTIFICIAL SPRAY DRIED CITRUS TYPE FLAVORS AS MANUFACTURED IN


INDIANAPOLIS, INDIANA
BOTTLES AS MANUFACTURED IN KUNDAIM, GOA, INDIA

24516 A

II

12/31/2010

DR REDDYS LABORATORIES LTD

MONTELUKAST SODIUM [PROCESS-2] AS MANUFACTURED IN TELANGANA, INDIA

24517 I

II

1/3/2011

CADILA HEALTHCARE LTD

CAPECITABINE USP AS MANUFACTURED IN GUJARAT, INDIA

24518 I

II

12/29/2010

AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA

24519 A

II

3/22/2011

ZHEJIANG SANMEN HENGKANG


PHARMACEUTICAL CO LTD
JUBILANT GENERICS LTD

24520 A

II

1/17/2011

AUROBINDO PHARMA LTD

NEVIRAPINE ANHYDROUS USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA

REPAGLINIDE AS MANUFACTURED IN MYSORE DIST., INDIA

Page 720

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24521 A
II
5/20/2011
CHEMWERTH INC

SUBJECT
BROMFENAC SODIUM (SESQUIHYDRATE) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR
CHEMWERTH INC
DICLOFENAC EPOLAMINE AS MANUFACTURED IN GUJARAT, INDIA

24522 A

II

1/4/2011

CADILA HEALTHCARE LTD

24523 A

II

12/15/2010

BENZOCAINE AS MANUFACTURED IN GUJARAT, INDIA

24524 A

II

1/19/2011

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
GLENMARK GENERICS LTD

24525 A

II

12/31/2010

SARV BIO LABS PVT LTD

COLCHICINE USP AS MANUFACTURED IN HIMACHAL PRADESH, INDIA

24526 A

II

1/5/2011

ALEMBIC PHARMACEUTICALS LTD

METOPROLOL TARTRATE USP AS MANUFACTURED IN GUJARAT, INDIA

24527 A

II

1/4/2011

CEFAZOLIN SODIUM (STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA

24528 A

II

12/29/2010

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
FIS FABBRICA ITALIANA SINTETICI SPA

24529 I

II

12/31/2010

QILU TIANHE PHARMACEUTICAL CO LTD

CAPECITABINE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

24530 A

II

1/5/2011

DSM NUTRITIONAL PRODUCTS LTD

24531 A

II

1/6/2011

APOTEX PHARMACHEM INDIA PVT LTD

24532 A

II

1/6/2011

NURAY CHEMICALS PVT LTD

PHYTOMENADIONE (VITAMIN K1) AS MANUFACTURED IN SISSELN, SWITZERLAND FOR DSM


NUTRITIONAL PRODUCTS LTD
DOLASETRON MESYLATE MONOHYDRATE USP AS MANUFACTURED IN KARNATAKA STATE,
INDIA
ATORVASTATIN CALCIUM AMORPHOUS (NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN TAMIL NADU, INDIA

24534 A

III

12/15/2010

SUZHOU HAISHUN PACKAGING MATERIAL CO LTD

24535 A

III

12/15/2010

SUZHOU HAISHUN PACKAGING MATERIAL CO LTD

24536 A

III

12/15/2010

SUZHOU HAISHUN PACKAGING MATERIAL CO LTD

24537 A

II

1/4/2011

PARABOLIC DRUGS LTD

24538 A

II

1/7/2011

CADILA HEALTHCARE LTD

PCTFE/PVC COMPOSITE SHEET FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN


SUZHOU, P.R. CHINA
ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU, P.R.
CHINA
POLYAMIDE/ALUMINIUM/PVC COLD-FORMED FOIL FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN SUZHOU, P.R. CHINA
CEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP AS MANUFACTURED IN PUNJAB,
INDIA
ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

24539 A

III

12/15/2010

PAREKHPLAST INDIA LTD

HDPE BOTTLES WITH CAPS AS MANUFACTURED IN MAHARASHTRA, INDIA

24540 A

II

1/7/2011

MOEHS IBERICA SL

CHOLINE FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN FOR MOEHS IBERICA SL

24541 A

II

1/7/2011

MOEHS IBERICA SL

24542 A

II

1/31/2011

USV LIMITED

QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN AND SANTANDER, SPAIN


FOR MOEHS IBERICA SL
OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

24543 A

II

1/7/2011

NEWCHEM SPA

TRIAMCINOLONE ACETONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY

24544 A

II

3/2/2011

AUROBINDO PHARMA LTD

VALSARTAN USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24545 I

II

12/17/2010

SAFC INC

HALOFUGINONE LACTATE AS MANUFACTURED IN MADISON, WI

24546 A

II

1/12/2011

UQUIFA MEXICO SA DE CV

CARISOPRODOL AS MANUFACTURED IN MORELOS, MEXICO

24533 P

CHOLINE FENOFIBRATE AS MANUFACTURED IN GUJARAT STATE, INDIA

ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN VICENZA, ITALY

*** PENDING FILING REVIEW ***

24547 P

*** PENDING FILING REVIEW ***

24548 A

II

1/4/2011

24549 A

II

12/22/2010

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LEVALBUTEROL L-TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
LTD
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
TORSEMIDE, USP AS MANUFACTURED IN ZHEJIANG, CHINA

24550 I

II

12/23/2010

MYLAN LABORATORIES LTD

ZIDOVUDINE USP (PROCESS III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR MYLAN
LABORATORIES LTD

Page 721

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24551 A
III
1/5/2011
BV RUBBERFABRIEK WITTENBURG
24552 A

II

1/15/2011

MACLEODS PHARMACEUTICALS LTD

SUBJECT
TPE W4509 THERMOPLASTIC ELASTOMER COMPOUND FOR VIAL CAPS & CLOSURES AS
MANUFACTURED IN THE NETHERLANDS
RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT, INDIA

24553 A

II

1/18/2011

GEDEON RICHTER PLC

ESTRADIOL VALERATE AS MANUFACTURED IN BUDAPEST, HUNGARY

24554 A

III

12/21/2010

GERRESHEIMER REGENSBURG GMBH

ALMIRALL INHALER AS MANUFACTURED IN PFREIMD, GERMANY

24555 A

III

1/10/2011

AMPACET CORP

24556 A

III

1/10/2011

AMPACET CORP

24557 A

II

1/19/2011

HETERO DRUGS LTD

120919 SILVER PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,


CARTERSVILLE GA, AND HEATH OH
120937 GOLD PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE
GA, AND HEATH OH
CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24558 A

1/10/2011

WEST PHARMACEUTICAL SERVICES INC

DAIKYO CRYSTAL ZENITH (CZ) VIAL READY-TO-USE PROCESS

24559 A

II

1/18/2011

EMCURE PHARMACEUTICALS LTD

OXALIPLATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24560 A

II

1/19/2011

CARDINAL HEALTH 414 LLC

SODIUM ACETATE C-11 INJECTION AS MANUFACTURED IN PHOENIX, AZ

24561 A

II

1/19/2011

SYNTHON BV

24562 A

II

12/27/2010

MEDAC GESELLSCHAFT FUR KLINISCHE


SPEZIALPRAPARATE MBH

LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BLANSKO, CZECH REPUBLIC


FOR SYNTHON BV
5-AMINOLEVULINIC ACID HYDROCHLORIDE 30 MG/ML POWDER FOR ORAL SOLUTION AS
MANUFACTURED IN DESSAU-ROSSLAU, GERMANY AND WEDEL, GERMANY FOR MEDAC
GESELLSCHAFT FUER KLINISCHE SPEZIALPRAEPARATE MBH

24564 A

II

1/19/2011

MACLEODS PHARMACEUTICALS LTD

TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA

24565 A

III

1/25/2011

SHINTECH INC

24566 A

IV

1/21/2011

NIPRO PATCH CO LTD

24567 I

III

1/21/2011

POLYONE CORP

POLYVINYL CHLORIDE HOMOPOLYMER RESIN AS MANUFACTURED IN FREEPORT TX, ADDIS


LA, AND PLAQUEMINE LA FOR SHINTECH INC
A06 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SAITAMA, JAPAN FOR NIPRO
PATCH CO LTD
EM1001977260 AS MANUFACTURED IN AVON LAKE, OH

24568 I

III

1/21/2011

POLYONE CORP

EM1001977660 AS MANUFACTURED IN AVON LAKE, OH

24569 I

III

1/21/2011

POLYONE CORP

EM1001977360 AS MANUFACTURED IN AVON LAKE, OH

24570 A

III

1/21/2011

POLYONE CORP

EM1001978560 AS MANUFACTURED IN AVON LAKE, OH

24571 I

III

1/21/2011

POLYONE CORP

EM1001978460 AS MANUFACTURED IN AVON LAKE, OH

24572 I

III

1/21/2011

POLYONE CORP

EM1001977460 AS MANUFACTURED IN AVON LAKE, OH

24563 P

*** PENDING FILING REVIEW ***

24573 P

*** PENDING FILING REVIEW ***

24574 A

II

2/3/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD PALIPERIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA

24575 A

III

1/20/2011

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-BLUE PP5M176067-ZN AS MANUFACTURED IN MALMO, SWEDEN

24576 A

IV

1/20/2011

MANTROSE HAEUSER CO INC

24577 A

II

3/8/2011

JUBILANT GENERICS LTD

MANTROCEL K-100M AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA FOR


MANTROSE HAEUSER CO INC
VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN MYSORE DIST., INDIA

24578 I

II

3/10/2011

NATCO PHARMA LTD

SORAFENIB TOSYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24579 A

II

1/24/2011

MERCK AND CIE

DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

24580 A

II

1/12/2011

HENAN DONGTAI PHARM CO LTD

DICLOFENAC SODIUM AS MANUFACTURED IN HENAN PROVINCE, CHINA

24581 A

2/2/2011

FDA CDER DIV NEUROLOGY PRODUCTS

24582 A

II

3/23/2011

GLAXOSMITHKLINE LLC

FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY


MONOTHERAPY CLINICAL TRIALS
SALMETEROL XINAFOATE AS MANUFACTURED IN MONTROSE, UK; JURONG, SINGAPORE;
WARE, UK; EVREUX, FRANCE FOR GLAXOSMITHKLINE LLC

Page 722

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24583 A
II
1/26/2011
TAIZHOU TAIFA PHARMACEUTICALS CO LTD

SUBJECT
MEGESTROL ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA

24584 A

II

2/1/2011

PARABOLIC DRUGS LTD

CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-III AS MANUFACTURED IN PUNJAB, INDIA

24585 A

II

1/28/2011

SIFAVITOR SRL

HALOPERIDOL AS MANUFACTURED IN LODI, ITALY

24586 A

II

2/15/2011

IND SWIFT LABORATORIES LTD

CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN PUNJAB, INDIA

24587 A

II

3/1/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

SEVELAMER CARBONATE AS MANUFACTURED IN GUJARAT, INDIA

24588 A

II

3/23/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

MONTELUKAST SODIUM USP AS MANUFACTURED IN GUJARAT, INDIA

24589 A

II

2/1/2011

APOTEX PHARMACHEM INDIA PVT LTD

24590 A

II

1/31/2011

PHARMACEUTICAL WORKS POLPHARMA SA

RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA FOR APOTEX


PHARMACHEM INC
TADALAFIL AS MANUFACTURED IN GDANSKI, POLAND

24591 A

II

1/31/2011

ALCHYMARS ICM SM PRIVATE LTD

RISEDRONATE SODIUM USP AS MANUFACTURED IN TAMILNADU, INDIA

24592 A

II

1/31/2011

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

24593 A

II

2/1/2011

PARABOLIC DRUGS LTD

MEGESTROL ACETATE USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


ZHEJIANG, CHINA
CEFUROXIME ACID (PROCESS-III) AS MANUFACTURED IN PUNJAB, INDIA

24594 A

II

1/24/2011

AREVIPHARMA GMBH

BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY

24595 A

II

1/21/2011

HEPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, PEOPLE'S REPUBLIC OF CHINA

24596 A

II

4/19/2011

HEBEI CHANGSHAN BIOCHEMICAL


PHARMACEUTICAL CO LTD
CTX LIFE SCIENCES PVT LTD

24597 A

II

3/5/2011

IND SWIFT LABORATORIES LTD

FEXOFENADINE HYDROCHLORIDE USP AS MANUFACTURED IN PUNJAB, INDIA

24598 A

II

1/21/2011

SIFAVITOR SRL

CLODRONATE DISODIUM TETRAHYDRATE AS MANUFACTURED IN LODI, ITALY

24599 A

II

2/1/2011

DR REDDYS LABORATORIES LTD

LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24600 A

II

1/28/2011

DR REDDYS LABORATORIES LTD

PALIPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24601 A

II

1/28/2011

24602 A

III

1/13/2011

24603 A

II

1/31/2011

CHONGQING CARELIFE PHARMACEUTICAL CO LTD ENTECAVIR HYDRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, PEOPLE'S REPUBLIC OF CHINA
COLORS FOR PLASTICS INC
THERMOPLASTIC RESIN BROWN COLORANT MASTERBATCHES N08554-1, N08554-2, AND
N08554-3 AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
RAKS PHARMA PVT LTD
PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24604 I

II

1/17/2011

SHANDONG KEYUAN PHARMACEUTICAL CO LTD

METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

24605 A

III

1/21/2011

BASF SE

24606 A

III

1/21/2011

BASF SE

24607 A

III

1/21/2011

BASF SE

24608 A

II

2/3/2011

HETERO LABS LTD

ULTRADUR B4520 PRO UNCOLORED AS MANUFACTURED IN SCHWARZHEIDE, FEDERAL


REPUBLIC OF GERMANY FOR BASF SE
ULTRAFORM H4320 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL
REPUBLIC OF GERMANY
ULTRAFORM N2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,
FEDERAL REPUBLIC OF GERMANY
ZIDOVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24609 A

II

2/3/2011

HETERO LABS LTD

LAMIVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24610 A

II

2/3/2011

HETERO LABS LTD

NEVIRAPINE ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24611 A

II

2/3/2011

SYMBIOTEC PHARMALAB LTD

METHYLPREDNISOLONE ACETATE USP AS MANUFACTURED IN INDORE (M.P), INDIA

24613 I

II

10/7/2011

IPCA LABORATORIES LTD

PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

24614 A

II

2/4/2011

CENTER MOLECULAR RESEARCH LLC

OXYGEN-18 ENRICHED WATER AS MANUFACTURED IN MOSCOW, RUSSIA

24615 A

II

5/3/2011

APICORE US LLC

MAFENIDE ACETATE USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

24616 A

III

1/28/2011

AMPACET CORP

111717-B WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA; AND HEATH, OH

24612 P

IRBESARTAN USP AS MANUFACTURED IN GUJARAT, INDIA

*** PENDING FILING REVIEW ***

Page 723

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24617 A
IV
1/28/2011
ABELEI INC

SUBJECT
174A91 NATURAL & ARTIFICIAL COOL MINT FLAVOR AS MANUFACTURED IN NORTH AURORA,
IL
163814 SPRING WATER BLUE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA; AND HEATH, OH
NAFTIFINE HYDROCHLORIDE USP AS MANUFACTURED IN HAIFA BAY, ISRAEL

24618 A

III

2/3/2011

AMPACET CORP

24619 A

II

6/27/2012

TARO PHARMACEUTICAL INDUSTRIES LTD

24620 I

IV

9/8/2010

TAKASAGO INTERNATIONAL CORP

24621 A

II

2/8/2011

24622 A

III

2/4/2011

24623 A

III

2/3/2011

24624 A

II

2/8/2011

24625 A

II

3/18/2011

TAK-093146 MICRON ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN


TETERBORO, NJ
CHONGQING HUAPONT PHARMACEUTICAL CO LTD ACITRETIN AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR CHONGQING HUAPONT
PHARMACEUTICAL CO LTD
BESPAK DIV CONSORT MEDICAL PLC
BESPAK BK357 & BK361 SHARED VALVE INFORMATION AS MANUFACTURED IN NORFOLK,
ENGLAND
AMCOR FLEXIBLES BURGDORF GMBH
TTS BACKING FILM M-PETP 12/ION 12/LDPE 40 (SPECIFICATION #178 INCLUDING #SOP13209
AND #SOP79007) AS MANUFACTURED IN BURGDORF, SWITZERLAND
MSN LABORATORIES LTD
OLOPATADINE HYDROCHLORIDE [ROUTE CODE - "OH"] (EUSB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
LUPIN LTD
CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24626 A

II

2/11/2011

DERIVADOS QUIMICOS SAU

CICLETANINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN

24627 A

II

1/31/2011

NECTAR LIFESCIENCES LTD

24628 A

II

1/30/2011

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD

CEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB,


INDIA
MIFEPRISTONE AS MANUFACTURED IN HEBEI PROVINCE, CHINA

24629 A

II

2/11/2011

HETERO DRUGS LTD

RITONAVIR USP (FORM I), PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24630 A

II

2/11/2011

SYMBIOTEC PHARMALAB LTD

PREDNISOLONE HEMISUCCINATE USP AS MANUFACTURED IN INDORE (M.P), INDIA

24631 A

II

2/4/2011

SYN TECH CHEM AND PHARM CO LTD

METAXALONE USP AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

24632 I

II

2/14/2011

ALKERMES GAINESVILLE LLC

N1714 TABLETS AS MANUFACTURED IN KING OF PRUSSIA, PA

24633 A

II

2/15/2011

CILAG AG

24634 A

IV

2/12/2011

FLAMEL TECHNOLOGIES

NALOXONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN,


SWITZERLAND AND MOLINAZZO DI MONTEGGIO, SWITZERLAND FOR CILAG AG
MEDUSA PGLUVE TYPE POLYMER AS MANUFACTURED IN PESSAC, FRANCE

24635 A

III

2/7/2011

SRC MEDICAL INC

VAGINAL APPLICATORS AS MANUFACTURED IN HANOVER, MA

24636 A

II

2/7/2011

SMRUTHI ORGANICS LTD

CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24637 I

III

2/16/2011

MITSUI CHEMICALS AMERICA INC

ADMER SE800 AS MANUFACTURED IN CHIBA, JAPAN FOR MITSUI CHEMICALS AMERICA INC

24638 A

II

3/31/2011

LUPIN LTD

TELMISARTAN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24639 A

II

3/11/2011

ARCH PHARMALABS LTD

24640 A

II

2/16/2011

DR REDDYS LABORATORIES LTD

TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDE AS


MANUFACTURED IN MAHARASHTRA, INDIA
OMEPRAZOLE [PROCESS-II] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24641 A

II

2/16/2011

HETERO DRUGS LTD

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24642 A

II

2/15/2011

HOVIONE FARMACIENCIA SA

SUMATRIPTAN USP AS MANUFACTURED IN LOURES, PORTUGAL

24643 A

II

5/6/2011

ARCH PHARMALABS LTD

24644 A

II

2/16/2011

CADILA HEALTHCARE LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA,


INDIA
OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA

24645 A

II

2/15/2011

NITROFURANTOIN MACROCRYSTALS AS MANUFACTURED IN SHANDONG, CHINA

24646 A

II

11/28/2012

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO


LTD
APICORE US LLC

24647 A

II

2/18/2011

STERLING SPA

FLUTICASONE FUROATE AS MANUFACTURED IN PERUGIA, ITALY

24648 A

III

2/18/2011

IDEMITSU UNITECH CO LTD

PLALOC M-700 AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN

PERPHENAZINE USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

Page 724

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24649 A
II
2/14/2011
INKE SA

SUBJECT
ZOLMITRIPTAN AS MANUFACTURED IN BARCELONA, SPAIN

24650 A

II

1/24/2011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

RAMIPRIL AS MANUFACTURED IN ZHEJIANG, CHINA

24651 A

II

2/18/2011

STERLING SPA

ETONOGESTREL AS MANUFACTURED IN PERUGIA, ITALY

24652 A

II

2/18/2011

APTALIS PHARMATECH INC

EUR-1098 AS MANUFACTURED IN VANDALIA, OHIO

24653 I

II

1/27/2011

IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

24654 A

II

2/18/2011

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
SUVEN LIFE SCIENCES LTD

24655 A

II

2/21/2011

EMCURE PHARMACEUTICALS LTD

ESZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA

24656 A

II

2/21/2011

DR REDDYS LABORATORIES LTD

ABACAVIR SULPHATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24657 A

II

2/18/2011

YUNG ZIP CHEMICAL IND CO LTD

METOPROLOL SUCCINATE AS MANUFACTURED IN TAIWAN, R.O.C.

24658 A

III

2/18/2011

LAMINADOS FACARLYTE SA DE CV

24659 A

II

2/18/2011

ESTEVE QUIMICA SA

HEAT ACTIVATED AND ADHESIVE APPLIED PACKAGING MATERIALS AS MANUFACTURED IN


ESTADO DE MEXICO, MEXICO
DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TARRAGONA, SPAIN

24660 A

II

2/21/2011

24661 A

II

2/19/2011

ZHEJIANG MEDICINE CO LTD XINCHANG


PHARMACEUTICAL FACTORY
QILU PHARMACEUTICAL CO LTD

24662 I

II

1/29/2011

QILU PHARMACEUTICAL CO LTD

24663 A

II

4/14/2011

TARO PHARMACEUTICAL INDUSTRIES LTD

PALONOSETRON HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN SHANDONG


PROVINCE, PEOPLE'S REPUBLIC OF CHINA
TAZOBACTAM SODIUM (STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE,
PEOPLE'S REPUBLIC OF CHINA
TERCONAZOLE USP (MICRONIZED) AS MANUFACTURED IN HAIFA BAY, ISRAEL

24664 A

II

4/7/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

MESALAMINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24665 A

II

2/23/2011

HETERO LABS LTD

IRBESARTAN (FORM A) PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24666 A

II

2/23/2011

HETERO LABS LTD

ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24667 A

II

2/23/2011

HETERO DRUGS LTD

MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24668 A

II

2/24/2011

SIEGFRIED LTD

NALOXONE HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND

24669 A

II

2/25/2011

MYLAN LABORATORIES LIMITED

ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24670 A

II

2/25/2011

MYLAN LABORATORIES LTD

BICALUTAMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24671 A

II

2/25/2011

ALEMBIC PHARMACEUTICALS LTD

OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN GUJARAT, INDIA

24672 A

2/24/2011

BD DIAGNOSTIC SYSTEMS

MICROPRO MICROBIAL DETECTION SYSTEM

24673 A

III

2/18/2011

JAPAN VILENE CO LTD

24674 I

III

2/11/2011

YOUNG JIN CO LTD

MEDICAL BACKING MATERIALS OF FILM LAMINATED NON-WOVEN AS MANUFACTURED IN


SHIGA, JAPAN
CONTAINER & CLOSURE AS MANUFACTURED IN KYUNGKI-DO, KOREA

24675 A

II

2/15/2011

PHYTON BIOTECH LLC

DOCETAXEL ANHYDROUS AS MANUFACTURED IN VANCOUVER, CANADA

24676 A

III

2/14/2011

APTAR FRANCE SAS

24677 A

IV

3/11/2011

AUTHENTIX INC

APTAR UNITDOSE POWDER AND BIDOSE POWDER SYSTEMS AS MANUFACTURED IN


CONGERS, NY AND EIGELTINGEN, GERMANY; AND LE VAUDREUIL, FRANCE
AUTHENTIX SECURITY MARKER AS MANUFACTURED IN ADDISON, TX

24678 A

II

2/22/2011

PARABOLIC DRUGS LTD

OXACILLIN SODIUM USP AS MANUFACTURED IN HARYANA, INDIA

24679 A

II

2/25/2011

PARABOLIC DRUGS LTD

CEPHALOTHIN SODIUM (STERILE) BUFFERED (USP) AS MANUFACTURED IN PUNJAB, INDIA

24680 A

II

2/23/2011

PCAS

24681 A

II

2/25/2011

EMCURE PHARMACEUTICALS LTD

MIPRI AS MANUFACTURED IN ARAMON, FRANCE AND VILLENEUVE-LA-GARENNE, FRANCE


FOR PCAS
FELODIPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24682 A

IV

2/25/2011

PHOSPHOLIPID GMBH

PHOSAL 53 MCT AS MANUFACTURED IN COLOGNE, GERMANY

LOSARTAN POTASSIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

LEVOFLOXACIN DS AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

Page 725

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24683 A
III
2/28/2011
ESSEL PROPACK LTD

SUBJECT
PLASTIC CAPS AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA

24684 A

II

11/30/2010

MICRO LABS LTD INDIA

ESCITALOPRAM OXALATE AS MANUFACTURED IN KARNATAKA, INDIA

24685 A

II

3/17/2011

ALKEM LABORATORIES LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

24686 A

II

11/26/2010

MICRO LABS LTD INDIA

CELECOXIB USP AS MANUFACTURED IN KARNATAKA, INDIA

24687 A

II

11/26/2010

MICRO LABS LTD INDIA

TORSEMIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

24688 A

II

11/26/2010

MICRO LABS LTD INDIA

LOSARTAN POTASSIUM USP AS MANUFACTURED IN KARNATAKA, INDIA

24689 A

II

3/24/2011

SHILPA MEDICARE LTD

CAPECITABINE USP AS MANUFACTURED IN KARNATAKA, INDIA

24690 A

II

5/11/2011

SHILPA MEDICARE LTD

BICALUTAMIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

24691 A

II

3/2/2011

SYMBIOTEC PHARMALAB LTD

DEFLAZACORT MICRONIZED AS MANUFACTURED IN INDORE (M.P.), INDIA

24692 A

II

3/1/2011

FRED HUTCHINSON CANCER RESCTR

24693 A

II

2/28/2011

ESTEVE QUIMICA SA

MANUFACTURE AND QUALITY CONTROL OF THE BC8-DOTA MONOCLONAL ANTIBODY


CONJUGATE (BC8-DOTA) AS MANUFACTURED IN SEATTLE, WA
RILUZOLE AS MANUFACTURED IN TARRAGONA, SPAIN

24694 A

II

2/25/2011

24695 A

IV

2/24/2011

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
HENRY H OTTENS MANUFACTURING CO INC

24696 A

III

2/28/2011

ESSEL PROPACK LTD

SPRAY DRIED ARTIFICIAL CARAMEL FLAVOR # S-989 AS MANUFACTURED IN PHILADELPHIA,


PA
UNPRINTED AND PRINTED LAMINATES AS MANUFACTURED IN MAHARASHTRA, INDIA

24697 A

IV

2/27/2011

SHOWA DENKO KK

ADHERO AS MANUFACTURED IN YAMAGATA PREF., JAPAN FOR SHOWA DENKO KK

24698 A

II

3/2/2011

DR REDDYS LABORATORIES LTD

PALIPERIDONE PALMITATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24699 A

III

1/17/2011

EMA PHARMACEUTICALS

24700 A

II

3/3/2011

SRINI PHARMACEUTICALS LTD

PACKAGING MATERIAL FOR 32 MM COMBINATED ALUMINIUM CAP AS MANUFACTURED IN


LAILLY EN VAL, FRANCE
PREGABALIN AS MANUFACTURED IN CHOUTUPPAL AP, INDIA

24701 A

II

3/1/2011

WANBURY LTD

PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24702 P

VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

*** PENDING FILING REVIEW ***

24703 A

II

5/12/2011

COSMA SPA

TELMISARTAN AS MANUFACTURED IN BERGAMO, ITALY

24704 A

III

3/3/2011

APTAR RADOLFZELL GMBH

24705 A

II

3/29/2011

DR REDDYS LABORATORIES EU LTD

OPHTHALMIC DRUG DELIVERY SYSTEMS AS MANUFACTURED IN RADOLFZELL, GERMANY


AND EIGELTINGEN, GERMANY
LUBIPROSTONE AS MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM

24706 A

II

2/28/2011

TOMITA PHARMACEUTICAL CO LTD

USP CALCIUM CHLORIDE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN

24707 A

II

12/20/2010

TOMITA PHARMACEUTICAL CO LTD

USP ZINC GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN

24708 A

II

12/20/2010

TOMITA PHARMACEUTICAL CO LTD

24709 A

II

2/20/2011

HEC PHARM CO LTD

24710 A

IV

3/4/2011

FINAR LTD

USP CALCIUM GLUCONATE, MONOHYDRATE (ORAL DOSAGE FORM) AS MANUFACTURED IN


TOKUSHIMA, JAPAN
CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN
HUBEI PROVINCE, P.R. CHINA
TERTIARY BUTANOL HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA

24711 A

IV

3/7/2011

DAVID MICHAEL AND CO INC

24712 A

II

3/9/2011

ALEMBIC PHARMACEUTICALS LTD

24713 A

II

1/20/2011

AMPICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P.R. CHINA

24714 A

II

3/9/2011

NORTH CHINA PHARMACEUTICAL GROUP


SEMISYNTECH CO LTD
ALEMBIC PHARMACEUTICALS LTD

24715 A

II

3/31/2011

LUPIN LTD

RITONAVIR - COPOVIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA

MICHAELOK ARTIFICIAL STRAWBERRY FLAVOR #3095 AS MANUFACTURED IN


PHILADELPHIA, PA
WARFARIN SODIUM AMORPHOUS USP AS MANUFACTURED IN GUJARAT, INDIA

MEXILETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

Page 726

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24716 A
II
3/8/2011
HANGZHOU ZHONGMEI HUADONG
PHARMACEUTICAL CO LTD
24717 A
II
3/31/2011
GLENMARK GENERICS LTD

SUBJECT
MUPIROCIN CALCIUM AS MANUFACTURED IN HANGZHOU, CHINA

24718 A

II

3/21/2011

JUBILANT GENERICS LTD

FAMPRIDINE AS MANUFACTURED IN MYSORE DIST., INDIA

24719 A

II

3/26/2011

JUBILANT GENERICS LTD

CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN MYSORE DIST., INDIA

24720 A

II

3/25/2011

TORRENT PHARMACEUTICALS LTD

TELMISARTAN USP AS MANUFACTURED IN GUJARAT, INDIA

24721 A

II

4/1/2011

TORRENT PHARMACEUTICALS LTD

MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT, INDIA

24722 A

II

3/8/2011

ALCHYMARS ICM SM PRIVATE LTD

MAFENIDE ACETATE USP AS MANUFACTURED IN TAMILNADU, INDIA

24723 A

II

3/4/2011

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

24724 A

II

1/18/2011

TEVA PHARMACEUTICAL INDUSTRIES LTD

24725 A

II

3/5/2011

RESONANCE LABORATORIES PVT LTD

DAPTOMYCIN AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA


FOR ZHEJIANG HISUN PHARMACEUTICAL CO., LTD.
VALSARTAN AS MANUFACTURED IN UTTAR PRADESH, INDIA AND MADHYA PRADESH, INDIA
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
CLIDINIUM BROMIDE (CLDB) AS MANUFACTURED IN BANGALORE, INDIA

24726 A

II

3/1/2011

VITAL LABORATORIES PVT LTD

COLCHICINE USP AS MANUFACTURED IN GUJARAT, INDIA

24727 A

II

3/10/2011

3M DRUG DELIVERY SYSTEMS

BA058-SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (BA058-SMTS) COATING AND


DRYING PROCESS FOR THE FINISHED DRUG PRODUCT AS MANUFACTURED IN ST. PAUL, MN

24728 A

II

2/28/2011

FIS FABBRICA ITALIANA SINTETICI SPA

CLOBAZAM AS MANUFACTURED IN VICENZA, ITALY

24729 A

IV

12/10/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24730 A

IV

12/10/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24731 A

IV

12/10/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

20.4566.CP PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND


TORINO (TO), ITALY
58.3964.2P PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
20.4554.CP PHA MILK FLAVOUR

24732 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24733 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24734 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24735 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24736 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24737 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24738 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24739 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24740 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24741 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24742 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24743 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

VORICONAZOLE AS MANUFACTURED IN GUJARAT STATE, INDIA

58.3514.2P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
20.4582.2P PHA SOUR CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
20.4568.1G PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
58.4262.2L PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
20.4570.3P PHA PASSION FRUIT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
20.4564.2P PHA GRAPE FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
58.3748.UW PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
20.4563.UL PHA CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
20.4557.1G PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
58.3754.1P PHA SPEARMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
20.4561.1P PHA BLACKCURRANT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
58.3536.1P PHA LIME FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
ITALY

Page 727

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24744 A
IV
12/15/2010
KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

SUBJECT
20.4579.1P PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
58.3520.1P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) [PROCESS-3] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
MONTELUKAST SODIUM AS MANUFACTURED IN JIUTEPEC, MEXICO

24745 A

IV

12/15/2010

KERRY INGREDIENTS AND FLAVOURS ITALIA SPA

24746 A

II

3/11/2011

DR REDDYS LABORATORIES LTD

24747 A

II

3/10/2011

SINTENOVO SA DE CV

24748 A

II

3/10/2011

NECTAR LIFESCIENCES LTD

24749 A

II

3/10/2011

HENAN LIHUA PHARMACEUTICAL CO LTD

CEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB,


INDIA
PREDNISONE AS MANUFACTURED IN HENAN, CHINA

24750 A

II

3/14/2011

INDUSTRIALE CHIMICA SRL

BUMETANIDE AS MANUFACTURED IN SARONNO (VARESSE), ITALY

24751 A

II

3/10/2011

MARUHA NICHIRO CORP

24752 A

II

3/8/2011

24753 A

II

2/28/2011

SODIUM HYALURONATE FH AND SODIUM HYALURONATE FL AS MANUFACTURED IN TOCHIGIPREF, JAPAN


ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO IRBESARTAN API AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
LTD
MICRO LABS LTD INDIA
DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

24754 A

II

2/1/2011

ALEMBIC PHARMACEUTICALS LTD

AZITHROMYCIN MONOHYDRATE USP (PROCESS-II) AS MANUFACTURED IN GUJARAT, INDIA

24755 I

II

3/10/2011

CHANGZHOU PHARMACEUTICAL FACTORY

ALISKIREN HEMIFUMARATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

24756 A

II

3/31/2011

UNICHEM LABORATORIES LTD

ZOLMITRIPTAN AS MANUFACTURED IN RAIGAD, INDIA

24757 A

II

3/15/2011

SRINI PHARMACEUTICALS LTD

LEVETIRACETAM USP AS MANUFACTURED IN HYDERABAD AP, INDIA

24759 A

IV

3/14/2011

HENKEL CORP

DURO-TAK 87-6911 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

24760 A

II

3/16/2011

DPX FINE CHEMICALS AUSTRIA GMBH AND CO KG

NEOSTIGMINE METHYLSULFATE AS MANUFACTURED IN LINZ, AUSTRIA

24761 A

II

3/7/2011

QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

24762 A

II

3/15/2011

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
AARTI INDUSTRIES LTD

24763 A

II

3/15/2011

AIR LIQUIDE ELECTRONICS US LP

NITRIC OXIDE AS MANUFACTURED IN MORRISVILLE, PA

24764 A

II

3/15/2011

MACLEODS PHARMACEUTICALS LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

24765 A

II

3/28/2011

JUBILANT GENERICS LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN KARNATAKA, INDIA

24766 I

II

3/28/2011

IPCA LABORATORIES LTD

24767 A

II

4/20/2011

IPCA LABORATORIES LTD

24768 I

II

4/26/2011

IPCA LABORATORIES LTD

TRAMADOL HYDROCHLORIDE (YT3 PROCESS) AS MANUFACTURED IN MADHYA PRADESH,


INDIA
CLOPIDOGREL BISULFATE USP (XC4 PROCESS) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
FLUCONAZOLE USP (G3 PROCESS) AS MANUFACTURED IN MADHYA PRADESH, INDIA

24769 I

II

6/27/2012

IPCA LABORATORIES LTD

RITALINIC ACID AS MANUFACTURED IN MADHYA PRADESH, INDIA

24770 A

II

3/17/2011

HETERO LABS LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24771 A

III

3/10/2011

AVI GLOBAL PLAST PVT LTD

24772 A

1/31/2011

ROTEM INDUSTRIES LTD

CALENDARED RIGID PVC FILM FOR BLISTER PACKAGING AS MANUFACTURED IN DAMAN,


INDIA
CASSETTE FOR PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE TRACERLAB
MXFDG SYNTHESIS UNIT AS MANUFACTURED BY ROTEM INDUSTRIES LTD. IN MISHOR YAMIN,
ISRAEL

24773 I

III

3/10/2011

FUTURISTIC PACKAGING PRIVATE LTD

ALUMINIUM BLISTER FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA

24774 I

III

3/10/2011

FUTURISTIC PACKAGING PRIVATE LTD

ALUMINIUM STRIP FOIL (LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA

24758 P

*** PENDING FILING REVIEW ***

DIFLUNISAL AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 728

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24775 A
II
3/16/2011
SMRUTHI ORGANICS LTD

SUBJECT
CIPROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24776 A

III

3/8/2011

CHARTER NEX FILMS INC

24777 I

II

3/19/2011

EMCURE PHARMACEUTICALS LTD

NEX 1506 MONOLAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS


FALLS, MA AND MILTON, WI
THIAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24778 A

II

3/22/2011

HETERO DRUGS LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24779 A

III

3/22/2011

DOW CHEMICAL CO

24780 A

IV

3/18/2011

NIPPON FINE CHEMICAL CO LTD

24781 A

II

6/23/2011

WOCKHARDT LTD

VINYL ACETATE/VINYL CHLORIDE CO-POLYMER FORMULATIONS AS MANUFACTURED IN ELK


GROVE VILLAGE, IL
CHOLESTEROL HP AS MANUFACTURED IN HYOGO, JAPAN AND SHIZUOKA, JAPAN FOR
NIPPON FINE CHEMICAL CO LTD
PRAMIPEXOLE DIHYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

24782 A

II

3/23/2011

TEVA PHARMACEUTICALS INDUSTRIES LTD

24783 A

III

3/22/2011

TOYO INK MFG CO LTD

ERGOTAMINE TARTRATE AS MANUFACTURED IN KOMAROV, CZECH REPUBLIC FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
ELBIMA Z117 AS MANUFACTURED IN TOKYO, JAPAN

24784 A

II

3/23/2011

EMCURE PHARMACEUTICALS LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

24785 A

IV

1/6/2011

SYMRISE AG

207420 STRAWBERRY FLAVOR #68998 AS MANUFACTURED IN HOLZMINDEN GERMANY

24786 A

III

3/17/2011

ALPHAPET INC

PREFORMANCE PET 1708CC(A) AS MANUFACTURED IN DECATUR, AL

24787 A

II

3/22/2011

PARABOLIC DRUGS LTD

CEFTAZIDIME FOR INJECTION (USP) AS MANUFACTURED IN PUNJAB, INDIA

24788 A

II

3/18/2011

FORMOSA LABORATORIES INC

LAPATINIB DITOSYLATE AS MANUFACTURED IN TAOYUAN, TAIWAN

24789 A

II

3/22/2011

RA CHEM PHARMA LTD

24790 A

II

3/25/2011

ALEMBIC PHARMACEUTICALS LTD

2-(2,3-DICHLOROPHENYL) METHYLENE HYDRAZINE CARBOXIMID AMIDINE AS


MANUFACTURED IN ANDHRA PRADESH, INDIA
LINEZOLID AS MANUFACTURED IN GUJARAT, INDIA

24791 A

II

3/25/2011

HOVIONE FARMACIENCIA SA

FLUTICASONE PROPIONATE INHALATION GRADE AS MANUFACTURED IN LOURES, PORTUGAL

24792 A

III

3/25/2011

3M DRUG DELIVERY SYSTEMS

24793 A

II

3/15/2011

KYONGBO PHARMACEUTICAL CO LTD

24794 A

II

3/28/2011

EMCURE PHARMACEUTICALS LTD

BECLOMETHASONE DIPROPIONATE HFA NASAL AEROSOL VALVE AS MANUFACTURED IN


LANCASHIRE, GREAT BRITAIN FOR 3M DRUG DELIVERY SYSTEMS
CEFOTAXIME SODIUM, STERILE API AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REP OF
KOREA
DOLASETRON MESYLATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24795 A

II

3/24/2011

HENAN LIHUA PHARMACEUTICAL CO LTD

PREDNISOLONE AS MANUFACTURED IN HENAN, CHINA

24796 A

II

3/29/2011

ALEMBIC PHARMACEUTICALS LTD

WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN GUJARAT, INDIA

24797 A

II

3/29/2011

DIVIS LABORATORIES LTD

VALSARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24798 A

II

3/23/2011

PERRIGO API LTD

24799 I

II

1/8/2011

SRI VYJAYANTHI LABS PVT LTD

24800 A

II

6/27/2011

JUBILANT GENERICS LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN SHANDONG KEYUAN, CHINA FOR


PERRIGO API LTD
2,3,4,5-BIS-O-(1-METHYLETHYLIDENE)-D-FRUCTOPYRANOSE AS MANUFACTURED IN A.P.,
INDIA
QUETIAPINE FUMARATE AS MANUFACTURED IN KARNATAKA, INDIA

24801 I

III

3/24/2011

CLARIANT MASTERBATCHES NORDEN AB

MEVOPUR-PINK PE3M176130 AS MANUFACTURED IN MALMO, SWEDEN

24802 I

IV

3/31/2011

FONA INTERNATIONAL INC

862.0194U FONATECH LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

24803 I

IV

3/31/2011

FONA INTERNATIONAL INC

828.078 N-C CITRUS FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

24804 I

IV

3/31/2011

FONA INTERNATIONAL INC

828.112 N-C CITRUS FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL

24805 A

III

4/1/2011

POLYONE CORP

CC10029299WE AS MANUFACTURED IN GLENDALE, AZ AND ELK GROVE VILLAGE, IL

24806 A

III

4/1/2011

POLYONE CORP

CC10075198BG AS MANUFACTURED IN TOSSIAT, FRANCE FOR POLYONE CORP

24807 A

III

3/29/2011

AMERICHEM INC

61644-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH

Page 729

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24808 A
III
3/31/2011
REXAM HEALTHCARE OFFRANVILLE SAS

SUBJECT
EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE

24809 A

IV

3/31/2011

JRS PHARMA GMBH AND CO KG

24810 A

II

3/28/2011

MACLEODS PHARMACEUTICALS LTD

SODIUM STARCH GLYCOLATE, PH. EUR, NF, JP AS MANUFACTURED IN GUJARAT, INDIA FOR
JRS PHARMA GMBH & CO. KG
CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA

24811 A

II

3/30/2011

DR REDDYS LABORATORIES LTD

IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24812 A

II

4/1/2011

RICHTER THEMIS MEDICARE I PVT LTD

FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA

24813 A

II

3/31/2011

DR REDDYS LABORATORIES LTD

PANTOPRAZOLE SODIUM USP [PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24814 A

II

3/30/2011

DEVATS INDIA PRIVATE LTD

NIMORAZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA

24815 A

II

4/1/2011

MSN LABORATORIES LTD

24816 A

II

3/28/2011

PIRAMAL ENTERPRISES LTD

DEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE: "DP"] AS MANUFACTURED ANDHRA


PRADESH, INDIA
QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24817 A

II

3/31/2011

DR REDDYS LABORATORIES LTD

ESLICARBAZEPINE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24818 A

II

3/31/2011

DR REDDYS LABORATORIES LTD

24819 A

II

4/4/2011

MERCK AND CIE

24820 A

IV

4/1/2011

24821 A

II

3/31/2011

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
DR REDDYS LABORATORIES LTD

VALGANCICLOVIR HYDROCHLORIDE (CRYSTALLINE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
1, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC) AS MANUFACTURED IN
SCHAFFHAUSEN, SWITZERLAND
SHEFFCOAT COATING SYSTEMS AS MANUFACTURED IN NORWICH, NY

24822 A

II

3/30/2011

DR REDDYS LABORATORIES LTD

FEBUXOSTAT AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24823 A

II

3/30/2011

DR REDDYS LABORATORIES LTD

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24824 A

II

5/31/2011

NATCO PHARMA LTD

24825 A

II

4/12/2011

GLENMARK GENERICS LTD

IBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
EZETIMIBE (PROCESS II) AS MANUFACTURED IN GUJARAT, INDIA

24826 A

II

3/21/2011

24827 A

II

4/5/2011

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
MSN LABORATORIES LTD

PENICILLIN G POTASSIUM (NON-STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R.


CHINA
ZILEUTON USP [ROUTE CODE -ZN] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24828 A

II

4/5/2011

MSN LABORATORIES LTD

24829 A

II

3/31/2011

DR REDDYS LABORATORIES LTD

SALMETEROL XINAFOATE [ROUTE CODE - SX] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24830 A

II

4/5/2011

ALEMBIC PHARMACEUTICALS LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

24831 A

II

4/1/2011

DR REDDYS LABORATORIES LTD

24832 A

II

4/6/2011

ALEMBIC PHARMACEUTICALS LTD

VALGANCICLOVIR HYDROCHLORIDE (AMORPHOUS) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
ILOPERIDONE AS MANUFACTURED IN GUJARAT, INDIA

24833 I

II

4/6/2011

ALEMBIC PHARMACEUTICALS LTD

TOPIRAMATE USP AS MANUFACTURED IN GUJARAT, INDIA

24834 A

II

3/28/2011

MICRO LABS LTD INDIA

IRBESARTAN USP AS MANUFACTURED IN KARNATAKA, INDIA

24835 A

II

4/7/2011

MSN PHARMACHEM PVT LTD

APREPITANT (ROUTE CODE - AP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24836 A

III

3/25/2011

BESPAK DIV CONSORT MEDICAL PLC

24837 A

II

3/31/2011

QILU TIANHE PHARMACEUTICAL CO LTD

24838 A

II

3/26/2011

TAI HENG INDUSTRY CO LTD

BK640 NASAL INTERGRATED DOSE COUNTER AS MANUFACTURED IN NORFOLK, UNITED


KINGDOM
ZIPRASIDONE HYDROCHLORIDE (NON - STERILE API) AS MANUFACTURED IN SHANDONG
PROVINCE, CHINA
IMATINIB MESYLATE AS MANUFACTURED IN SHANGHAI CHINA

24839 A

IV

4/8/2011

MOLKEREI MEGGLE WASSERBURG GMBH AND CO CAPSULAC 60 INH US AS MANUFACTURED IN WESSERBURG, GERMANY
KG

NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 730

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24840 A
IV
4/11/2011
FONA INTERNATIONAL INC

SUBJECT
803.0115U N-C RED APPLE TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

24841 A

IV

4/11/2011

FONA INTERNATIONAL INC

825.441 N-C WILD CHERRY FLAVOR, ART AS MANUFACTURED IN GENEVA ILLINOIS

24842 A

IV

4/11/2011

FONA INTERNATIONAL INC

862.0085U N-C LEMONADE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA ILLINOIS

24843 A

III

4/11/2011

FORMOSA PLASTICS CORP PP DIV, TAIWAN.

24844 I

II

4/12/2011

ALEMBIC PHARMACEUTICALS LTD

YUNGSOX PROPYLENE RESINS AS MANUFACTURED IN KAOHSIUNG CITY, TAIWAN R.O.C. FOR


FORMOSA PLASTICS CORPORATION PP DIVISION, TAIWAN
CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN GUJARAT, INDIA

24845 A

III

4/1/2011

POLYONE CORP

LEUPROLIDE ACETATE (SPECIAL) AS MANUFACTURED IN ST. LOUIS, MO

24846 A

II

9/30/2011

MALLINCKRODT INC

24847 A

II

4/8/2011

ACEBRIGHT INDA PHARMA PRIVATE LTD

HYDROCODONE POLISTIREX FOR SUSPENSION, CODE 7490 AS MANUFACTURED IN ST.


LOUIS, MO
EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN KARNATAKA, INDIA

24848 A

II

9/30/2011

MALLINCKRODT INC

24849 A

II

5/19/2011

VIVUS INC

24850 A

IV

2/16/2011

UNGERER AND CO

24851 A

IV

2/16/2011

UNGERER AND CO

24852 A

II

5/5/2011

CIPLA LTD

24853 A

IV

2/16/2011

UNGERER AND CO

24854 A

II

6/14/2011

DR REDDYS LABORATORIES LTD

NATURAL AND ARTIFICIAL ORANGE FLAVOR FS-10783 AS MANUFACTURED IN BETHLEHEM, PA


FOR UNGERER & COMPANY.
ARTIFICIAL GRAPE FLAVOR FT - 2968 AS MANUFACTURED IN BETHLEHEM, PA FOR UNGERER
& COMPANY
TENOFOVIR DISOPROXIL FUMARATE (PROCESS B) AS MANUFACTURED IN PUNE
(MAHARASHTRA), INDIA
NATURAL BLUEBERRY WONF FLAVOR FT - 2967 AS MANUFACTURED IN BETHLEHEM, PA FOR
UNGERER & COMPANY
DOCETAXEL ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH INDIA

24855 A

II

4/12/2011

BACHEM SA

TRANDOLAPRIL AS MANUFACTURED IN VIONNAZ, SWITZERLAND

24856 A

II

4/12/2011

SYMED LABS LTD

PHENTERMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24857 A

II

4/7/2011

SMRUTHI ORGANICS LTD

ENROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24858 A

II

4/5/2011

STERLING BIOTECH LTD

24859 A

II

4/7/2011

STERLING BIOTECH LTD

DOXORUBICIN HYDROCHLORIDE(API) AS MANUFACTURED IN GUJARAT, INDIA FOR STERLING


BIOTECH LIMITED
LOVASTATIN(API) AS MANUFACTURED IN GUJARAT, INDIA FOR STERLING BIOTECH LIMITED

24860 A

4/8/2011

BIOLUMIX INC

24861 A

III

4/11/2011

HOLLAND COLOURS AMERICAS INC

MICROBIOLOGICAL RAPID METHOD TO DETECTION AND ENUMERATION OF


MICROORGANISMS IN PHARMACEUTICAL PRODUCTS AS LOCATED IN ANN ARBOR, MI
COLOR CONCENTRATES FOR PET AS MANUFACTURED IN RICHMOND, IN

24862 A

II

7/5/2011

APICORE US LLC

PENTOSTATIN AS MANUFACTURED IN SOMERSET, NJ

24863 A

II

4/6/2011

ESTEVE QUIMICA SA

24864 A

II

4/18/2011

AMBIOPHARM INC

24865 A

III

4/1/2011

ADHESIVES RESEARCH INC

ESZOPICLONE AS MANUFACTURED IN BANYERES DEL PENEDES(TARRAGONA), SPAIN FOR


ESTEVE QUIMICA, S. A.
EPTIFIBATIDE, NON-STERILE, BULK DRUG(API) AS MANUFACTURED IN NORTH AUGUSTA, SC
AND SHANGHI, CHINA FOR AMBIOPHARM INC
A4435 (EC-18B ADHESIVE) AS MANUFACTURED IN GLEN ROCK, PA

24866 A

III

4/1/2011

ADHESIVES RESEARCH INC

A4436(EC-23B ADHESIVE) AS MANUFACTURED IN GLEN ROCK , PA

24867 A

III

4/1/2011

ADHESIVES RESEARCH INC

A4437(MA-80 ADHESIVE) AS MANUFACTURED IN GLEN ROCK, PA

24868 A

II

5/2/2011

IPCA LABORATORIES LTD

ETODOLAC USP (ED6 PROCESS) AS MANUFACTURED IN MADHYA PRADESH, INDIA

24869 A

II

4/15/2011

MACLEODS PHARMACEUTICALS LTD

24870 A

III

4/4/2011

FIBERTEX NONWOVENS AS

ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT, INDIA FOR MACLEODS PHARMACEUTICALS


LIMITED
FIBERTEX TERCIE 60 AS MANUFACTURED IN SVITAVY CZECH, REPUBLIC

24871 A

II

4/18/2011

HETERO DRUGS LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

CHLORPHENIRAMINE POLISTIREX FOR SUSPENSION, CODE 7480 AS MANUFACTURED IN ST.


LOUIS, MO
AVANAFIL AS MANUFACTURED IN YAMAGUCHI, JAPAN

Page 731

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24872 A
II
4/15/2011
EMCURE PHARMACEUTICALS LTD
24873 A

II

4/18/2011

HETERO LABS LTD

SUBJECT
SEVELAMER HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA
FOR EMCURE PHARMACEUTICALS LIMITED
VALSARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24874 A

II

4/15/2011

PIRAMAL HEALTHCARE CANADA LTD

TAZAROTENE AS MANUFACTURED IN ONTARIO, CANADA

24875 A

II

4/15/2011

AMINO CHEMICALS LTD

DEXLANSOPRAZOLE ANHYDROUS AS MANUFACTURED IN MARSA, MALTA

24876 A

II

4/15/2011

SCI PHARMTECH INC

ALLOPURINOL AS MANUFACTURED IN TAOYUAN, TAIWAN

24877 A

II

5/9/2011

ARCH PHARMALABS LTD

ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6-{2[2-(4-FLUOROPHENYL)-5-(1-METHYLETHYL)-3PHENYL-4[(PHENYLAMINO) CARBONYL]-1 H-PYRROL-1-YL]ETHYL}-2,2-DIMETHYL-1,3-DIOXAN4-ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24878 A

III

4/20/2011

RPC FORMATIC GMBH

24879 A

II

4/21/2011

FDC LTD

MOUTHPIECE WITH ACTUATION INDICATOR AS MANUFACTURED IN MELLRICHSTADT,


GERMANY
MICONAZOLE USP AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

24880 I

II

7/29/2011

RELIANCE LIFE SCIENCES PVT LTD

DUTASTERIDE AS MANUFACTURED IN NAVI MUMBAI, INDIA

24881 A

II

4/22/2011

MEGAFINE PHARMA P LTD

24882 A

II

7/18/2011

AMI ORGANICS PVT LTD

24883 I

II

11/21/2011

RELIANCE LIFE SCIENCES PVT LTD

CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


DIST. NASHIK, INDIA
1-(3-CHLORO PHENYL)-4-(3-CHLOROPROPYL) PIPERAZINE HYDROCHLORIDE AS
MANUFACTURED IN GUJURAT, INDIA
NANDROLONE DECANOATE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA

24884 A

II

5/6/2011

ALKEM LABORATORIES LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT INDIA

24885 A

II

4/12/2011

CHONGQING ZEIN PHARMACEUTICAL CO LTD

ORLISTAT AS MANUFACTURED IN CHONGQING, CHINA

24886 A

II

4/25/2011

HETERO LABS LTD

LETROZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24887 A

II

4/25/2011

ANQUI LUAN PHARMACEUTICAL CO LTD

ACETAMINOPHEN DC90-3 SD AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF CHINA

24888 A

4/21/2011

COOK PHARMICA LLC

STERILE FILLING OPERATION AS LOCATED IN BLOOMINGTON, IN

24889 A

II

4/26/2011

ERREGIERRE SPA

MESALAMINE USP - PH.EUR. (HIGH DENSITY) AS MANUFACTURED IN BERGAMO, ITALY

24890 A

II

4/22/2011

FRESENIUS KABI ANTI INFECTIVES SRL

CEPHAPIRIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE, ITALY

24891 A

III

4/25/2011

TOPPAN PRINTING CO LTD

24892 A

II

4/18/2011

24893 A

II

4/26/2011

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
ZHEJIANG HISUN PHARMACEUTICAL CO LTD

HP-4, PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN


FUKUOKA, JAPAN
CEFOTAXIME SODIUM STERILE AS MANUFACTURED IN HEBEI, CHINA

24894 A

III

4/28/2011

HUDSON COLOR CONCENTRATES

24895 P
24896 A

GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF


CHINA
AMBER HC72646PVC AS MANUFACTURED IN LEOMINSTER, MA

*** PENDING FILING REVIEW ***


II

8/16/2011

24897 P

EPHAR BIOLOGICAL AND CHEMICAL CO LTD

ATORVASTATIN CALCIUM (API) AS MANUFACTURED IN ANHUI PROVINCE, P.R. CHINA

*** PENDING FILING REVIEW ***

24898 A

II

4/29/2011

MSN PHARMACHEM PVT LTD

RANOLAZINE [ROUTE CODE - RL"] AS MANUFACTURED IN TELANGANA

24899 A

II

4/5/2011

VINDHYA PHARMA INDIA PVT LTD

24900 A

III

4/25/2011

MEENAKSHI FOILS

24901 A

II

4/20/2011

FIS FABBRICA ITALIANA SINTETICI SPA

N-METHYL FLUOXETINE OXALATE(NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS


MANUFACTURED IN ANDHRA PRADESH, INDIA
"SLITTED & PRINTED FOILS AND SLITTED PVDC COATED PVC FILMS" AS MANUFACTURED IN
DAMAN, INDIA
ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN VICENZA, ITALY

24902 A

II

8/27/2012

CF PHARMA LTD

CISATRACURIUM BESYLATE VERSION FA1 AS MANUFACTURED IN BUDAPEST, HUNGARY

Page 732

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24903 A
II
4/29/2011
JIANGSU HENGRUI MEDICINE CO LTD

SUBJECT
SEVOFLURANE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU
PROVINCE, P. R. CHINA
EM1002025410 AS MANUFACTURED IN AVON LAKE, OHIO

24904 A

III

4/29/2011

POLYONE CORP

24905 A

II

5/2/2011

SMS PHARMACEUTICALS LTD

24906 A

II

4/18/2011

YONSUNG FINE CHEMICALS CO LTD

ELETRIPTAN HYDROBROMIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
BIMATOPROST AS MANUFACTURED IN GYEONGGI-DO, KS

24907 A

II

4/18/2011

YONSUNG FINE CHEMICALS CO LTD

TRAVOPROST AS MANUFACTURED IN GYCONGGI-DO, REPUBLIC OF KOREA

24908 A

IV

4/27/2011

UNGERER AND CO

NATURAL AND ARTIFICIAL LEMON LIME FLVP FT-867 AS MANUFACTURED IN BETHLEHEM, PA

24909 A

III

4/29/2011

AMPACET CORP

24910 A

IV

1/12/2011

MINGTAI CHEMICAL CO LTD

101736 AB PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,LA, CARTERSVILLE,


GA, HEATH, OH
CROSCARMELLOSE SODIUM NF(PROCESS II) AS MANUFACTURED IN TAIWAN, R. O. C.

24911 A

III

5/3/2011

SABIC EUROPE

SABIC PP PCGR02 00900 AS MANUFACTURED IN THE NETHERLANDS

24912 A

II

2/13/2012

VALDEPHARM

ETHINYL ESTRADIOL AS MANUFACTURED IN VAL DE REUIL, FRANCE

24913 A

II

5/25/2011

VALDEPHARM

NORETHINDRONE ACETATE AS MANUFACTURED IN VAL DE REUIL, FRANCE

24914 A

II

4/30/2011

CADILA HEALTHCARE LTD

PALIPERIDONE AS MANUFACTURED IN GUJARAT, INDIA

24915 A

II

5/2/2011

POLYDRUG LABORATORIES PVT LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

24916 A

II

5/4/2011

MSN PHARMACHEM PVT LTD

24917 A

II

5/2/2011

SCI PHARMTECH INC

NEBIVOLOL HYDROCHLORIDE[ROUTE CODE: "NH"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
CLINDAMYCIN PALMITATE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN, TAIWAN

24918 A

II

7/30/2011

EMCURE PHARMACEUTICALS LTD

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

24919 A

II

4/8/2011

HUBEI YITAI PHARMACEUTICAL CO LTD

ACYCLOVIR(NON-STERILE,BULK FORM) AS MANUFACTURED IN HUBEI, P. R. CHINA

24920 A

II

4/8/2011

HUBEI YITAI PHARMACEUTICAL CO LTD

24921 A

II

5/28/2011

CONCORD BIOTECH LTD

VALACYCLOVIR HYDROCHLORIDE(NON-STERILE, BULK FORM) AS MANUFACTURED IN HUBEI,


P. R. CHINA
TEMSIROLIMUS AS MANUFACTURED IN AHMEDABAD, INDIA

24922 A

II

6/8/2011

EMCURE PHARMACEUTICALS LTD

BICALUTAMIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

24923 A

II

5/2/2011

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

OMEPRAZOLE (C-015) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

24924 A

II

5/2/2011

MOEHS IBERICA SL

RABEPRAZOLE SODIUM AS MANUFACTURED IN RUBI(BARCELONA), SPAIN

24925 A

IV

5/5/2011

LIPOID GMBH

LIPOID PG 16:O/16:0 (DPPG-NA) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

24926 A

IV

5/4/2011

JRS PHARMA GMBH AND CO KG

HYPROMELLOSE USP AS MANUFACTURED IN ZACAPU, MEXICO

24927 A

II

5/2/2012

MALLINCKRODT INC

BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210 AS MANUFACTURED IN ST. LOUIS, MO

24928 A

II

5/2/2012

MALLINCKRODT INC

BUPRENORPHINE BASE EP, CODE 3205 AS MANUFACTURED IN ST. LOUIS, MO

24929 A

II

5/9/2011

ZACH SYSTEM SPA

BOSENTAN MONOHYDRATE AS MANUFACTURED IN TAMIL NADU, INDIA

24930 A

III

4/8/2011

BOREALIS AG

BORMED RD804CF AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG

24931 A

III

4/8/2011

BOREALIS AG

BORMED TD109CF AS MANUFACTURED IN BERINGEN, BELGIUM FOR BOREALIS AG

24932 A

II

5/10/2011

SYMED LABS LTD

ILOPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24933 A

II

5/11/2011

CHEMI SPA

EPTIFIBATIDE AS MANUFACTURED IN MILAN, ITLAY AND FROSINONE, ITALY

24934 A

II

5/12/2011

TEVA PHARMACEUTICAL INDUSTRIES LTD

24935 A

II

5/10/2011

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTD

ACYCLOVIR AS MANUFACTURED IN HANGZHOU, P.R. CHINA FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN ZHEJIANG, CHINA

24936 A

II

5/12/2011

ULKAR KIMYA SANAYI VE TICARET AS

ETODOLAC AS MANUFACTURED IN TEKIRDAG, TURKEY

24937 A

II

5/12/2011

ULKAR KIMYA SANAYI VE TICARET AS

ARIPIPRAZOLE AS MANUFACTURED IN TEKIRDAG, TURKEY

Page 733

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24938 I
III
1/19/2011
HUAYI ISOTOPES CORP

SUBJECT
VACUUM STERILE VIALS AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

24939 A

II

5/6/2011

SCI PHARMTECH INC

DULOXETINE HYDROCHLORIDE (FROM (S)-MMAA) AS MANUFACTURED IN TAOYUAN, TAIWAN

24940 A

IV

5/16/2011

FONA INTERNATIONAL INC

875.0040U N-C ENCAPSULATED MENTHOL AS MANUFACTURED IN GENEVA, IL

24941 A

II

5/11/2011

FRESENIUS KABI ANTI INFECTIVES SRL

BUFFERED OXACILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO) ITALY

24942 A

II

5/17/2011

GLOCHEM INDUSTRIES LTD

AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24943 A

II

5/17/2011

HETERO LABS LTD

EFAVIRENZ (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24944 A

II

8/23/2011

SHILPA MEDICARE LTD

BORTEZOMIB USP AS MFG IN KARNATAKA INDIA

24945 A

II

6/1/2011

UNIMARK REMEDIES LTD

ARMODAFINIL AS MFG IN GUJARAT INDIA

24946 A

II

10/20/2011

CHEMWERTH INC

24947 A

II

5/18/2011

HETERO LABS LTD

TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


MAHARASHTRA, INDIA FOR CHEMWERTH INC.
LAMIVUDINE, USP (FORM I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24948 A

II

10/13/2011

JUBILANT GENERICS LTD

ROPIVACAINE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

24949 A

II

11/3/2011

APICORE US LLC

CEVIMELINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

24950 A

III

5/26/2011

SELECTIVE COATINGS AND INKS INC

SCI BOND HEAT SEAL COATINGS AS MANUFACTURED IN FARMINGDALE, NJ

24951 A

IV

5/16/2011

JRS PHARMA GMBH AND CO KG

24952 A

IV

5/12/2011

UNGERER AND CO

24953 A

III

5/16/2011

SAM A ALUMINIUM CO LTD

CROSCARMELLOSE SODIUM, PH.EUR., NF, JP AS MANUFACTURED IN GUJARAT, INDIA FOR


JRS PHARMA GMBH & CO. KG
NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR FU-3869 AS MANUFACTURED IN BETHLEHEM,
PA
CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO, KOREA

24954 A

II

5/6/2011

PIRAMAL ENTERPRISES LTD

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24955 A

II

10/13/2011

JUBILANT GENERICS LTD

ZIPRASIDONE HYDROCHLORIDE USP AS MANUFACTURED IN MYSORE, INDIA

24956 A

II

5/17/2011

SM BIOMED SDN BHD

ERYTHROMYCIN BASE AS MANUFACTURED IN KEDAH DARUL AMAN, MALAYSIA

24957 A

III

5/17/2011

DOCTORPACK INDIA PVT LTD

24958 A

II

6/6/2011

CTX LIFE SCIENCES PVT LTD

PLASTIC CONTAINER CLOSURE SYSTEMS 'N' DESIGN AS MANUFACTURED IN BANGALORE,


INDIA
LAMOTRIGINE USP AS MANUFACTURED IN GUJARAT, INDIA

24959 A

II

5/2/2011

SHANGHAI DONGYUE BIOCHEM CO LTD

24960 A

II

5/5/2011

AESICA PHARMACEUTICALS LTD

24961 A

IV

5/9/2011

HENKEL CORP

CLOPIDOGREL BISULFATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR


SHANGHAI DONGYUE BIOCHEM CO., LTD
PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN NORTHUMBERLAND,
UK
DURO-TAK 87-6908 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

24962 A

II

5/5/2011

SYN TECH CHEM AND PHARM CO LTD

DICLOFENAC EPOLAMINE AS MANUFACTURED IN TAINAN CITY, TAIWAN

24963 A

II

5/18/2011

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

TAZOBACTAM AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA

24964 A

II

5/20/2011

SANDOZ GMBH

TEMSIROLIMUS AS MANUFACTURED IN TYROL, AUSTRIA

24965 A

II

7/6/2011

IPCA LABORATORIES LTD

TRIAMTERENE AS MANUFACTURED IN MADHYA PRADESH, INDIA

24966 A

IV

5/18/2011

PHOSPHAGENICS LTD

24967 A

II

4/29/2011

24968 A

II

10/14/2011

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO


LTD
APICORE US LLC

TOCOPHEROL PHOSPHATES(TPH) NOVEL DELIVERY PLATFORM AS MANUFACTURED IN


VICTORIA, AUSTRALIA
SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN CHONGQING, P. R. CHINA

24969 A

II

8/27/2012

CF PHARMA LTD

CISATRACURIUM BESYLATE VERSION FB1 AS MANUFACTURED IN BUDAPEST, HUNGARY

24970 A

II

5/24/2011

RANBAXY LABORATORIES LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA FOR RANBAXY


LABORATORIES LIMITED

NADOLOL, USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

Page 734

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
24971 A
II
5/16/2011
PERRIGO API LTD
24972 A

5/7/2011

MICROTROL STERILISATION SERVICES PVT LTD

SUBJECT
IMATINIB MESYLATE ALPHA FORM AS MANUFACTURED IN BEER SHEVA, ISRAEL, A.P., INDIA
FOR CHEMAGIS LTD
ETHYLENE OXIDE STERILISATION AS MANUFACTURED IN MAHARASHTRA, INDIA

24973 A

II

5/25/2011

HETERO DRUGS LTD

RABEPRAZOLE SODIUM AS MFG IN ANDHRA PRADESH, INDIA

24974 A

III

5/1/2011

ESKAY PACKAGING

24975 A

II

5/18/2011

24976 A

II

5/25/2011

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO


LTD
HETERO DRUGS LTD

ALUMINIUM COLLAPSIBLE TUBES SUITABLE FOR PACKAGING PHARMACEUTICAL DOSAGES


AS MANUFACTURED IN GOA, INDIA
EMTRICITABINE AS MFG IN SHIJIAZHUANG, P.R. CHINA

24977 A

II

5/18/2011

LUNAN NEW TIME BIO TECH CO LTD

MYCOPHENOLIC ACID AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA

24978 A

II

5/20/2011

NITROFURANTOIN MONOHYDRATE AS MFG IN SHANDONG, CHINA

24979 A

III

5/23/2011

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO


LTD
DOCTORPACK INDIA PVT LTD

24980 A

II

5/21/2011

24981 A

II

5/16/2011

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO


LTD
CKD BIO CORP

24982 A

II

5/25/2011

HETERO DRUGS LTD

24984 A

IV

5/25/2011

FONA INTERNATIONAL INC

915.0527U N-C STRAWBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

24985 A

IV

5/25/2011

FONA INTERNATIONAL INC

828.0030U CITRUS BLEND FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

24986 A

IV

5/25/2011

FONA INTERNATIONAL INC

862.0061U N-C LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL

24987 A

III

8/26/2011

RADPHARM SCIENTIFIC

24988 I

II

5/27/2011

SANDOZ GMBH

RADPHARM STERILE EVACUATED GLASS VIALS 10ML, 20ML, 30ML ( ESUB) AS


MAnUFACTURED IN BELCONNEN, AUSTRALIA
FILGRASTIM (G-CSF) AS MFG IN TYROL, AUSTRIA

24989 A

II

5/26/2011

PIRAMAL ENTERPRISES LTD

TOLCAPONE AS MFG IN ANDHRA PRADESH, INDIA

24990 A

III

5/26/2011

HMC POLYMERS CO LTD

PURELL RP271M AS MANUFACTURED IN RAYONG, THAILAND

24991 A

III

5/26/2011

DOCTORPACK INDIA PVT LTD

24992 A

II

5/27/2011

CORDEN PHARMA COLORADO INC

PLASTIC CONTAINER CLOSURE SYSTEM 'MRL' DESIGN AS MANUFACTURED IN BANGALORE,


INDIA
LINACLOTIDE AS MFG IN BOULDER, COLORADO

24993 A

III

5/27/2011

NUSSBAUM MATZINGEN AG

24994 A

III

5/27/2011

MYLAN TECHNOLOGIES INC

ALUMINUM CANS AS MANUFACTURED IN MATZINGEN, SWITZERLAND AND FRANKENBERG


AND RIELASINGEN, GERMANY
MEDIRELEASE 2500 AS MFG IN ST. ALBANS, VERMONT

24995 A

II

5/25/2011

ST GOBAIN PERFORMANCE PLASTICS CORP

C-FLEX ULTRA TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

24996 A

II

5/27/2011

OMEGA-3 REFINED FISH OIL AS MANUFACTURED IN ZHEJIANG, CHINA

24997 A

II

6/7/2011

ZHOUSHAN SINOMEGA BIOTECH ENGINEERING


CO LTD
AUROBINDO PHARMA LTD

24998 A

II

5/27/2011

HETERO DRUGS LTD

ARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
PROGUANIL HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24999 A

II

5/30/2011

FARMHISPANIA SA

CISATRACURIUM BESYLATE AS MANUFACTURED IN MONTMELO, SPAIN

25000 I

II

10/24/2011

INDOCO REMEDIES LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25001 A

II

5/31/2011

MACLEODS PHARMACEUTICALS LTD

EMTRICITABINE AS MANUFACTURED IN VALSAD GUJARAT, INDIA

25002 A

III

6/1/2011

FORMOSA CHEMICALS AND FIBRE CORP

TAIRIPRO POLYPROPYLENE RESINS: K1023, T3002, F4007, K4515, K4535 & K4520 AS
MANUFACTURED IN TAIPEI, TAIWAN

24983 P

CLOPIDOGREL BISULFATE (FORM-I) AS MFG IN ANDHRA PRADESH, INDIA

PLASTIC CONTAINER CLOSURE SYSTEM 'S' DESIGN AS MANUFACTURED IN BANGALORE,


INDIA
NITROFURANTOIN AS MFG IN SHANDONG, CHINA
MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
KYUNGGI-DO, SOUTH KOREA
OMEPRAZOLE MAGNESIUM AS MFG IN ANDHRA PRADESH, INDIA

*** PENDING FILING REVIEW ***

Page 735

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25003 A
II
11/4/2011
LUPIN LTD

SUBJECT
EFAVIRENZ USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25004 A

IV

5/26/2011

UNGERER AND CO

FW-3484 NAT/ ART MELON FLAVOR AS MANUFACTURED IN BETHLEHEM, PA

25005 A

II

5/19/2011

25006 A

II

5/31/2011

25007 A

II

6/1/2011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LEVETIRACETAM AS MFG IN ZHEJIANG PROVINCE, CHINA


LTD
TORONTO RESEARCH CHEMICALS INC
2-AMINO-3,8-DIMETHYLIMIDAZOL[4,5-F]QUINOXALINE-2-14C AS MANUFACTURED IN
TORONTO, CANADA
PHARMAZELL VIZAG PRIVATE LTD
RISEDRONATE SODIUM HEMIPENTAHYDRATE USP AS MFG IN ANDHRA PRADESH, INDIA

25008 A

II

6/1/2011

TOKO PHARMACEUTICAL INDUSTRIES CO LTD

TAMIBAROTENE AS MANUFACTURED IN HOKKAIDO, JAPAN

25009 A

II

6/3/2011

SEQUENT SCIENTIFIC LTD

ZIDOVUDINE AS MFG IN KARNATAKA, INDIA

25010 A

II

5/20/2011

KOPRAN LTD

ATENOLOL AS MFG IN MAHARASHTRA STATE, INDIA

25011 A

II

5/31/2011

PARABOLIC DRUGS LTD

PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN HARYANA, INDIA

25012 A

III

6/3/2011

SCHOTT NAIGAI KK

25013 A

II

6/7/2011

SHARON BIO MEDICINE LTD

INJECTION VIALS AND SCREW NECK VIALS IN CLEAR GLASS AND AMBER GLASS AS
MANUFACTURED IN OSAKA, JAPAN
KETOCONAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25014 A

II

9/5/2011

AMI ORGANICS PVT LTD

25015 A

II

9/5/2011

AMI ORGANICS PVT LTD

25016 A

II

2/21/2012

NECTAR LIFESCIENCES LTD

25017 A

II

12/22/2011

NECTAR LIFESCIENCES LTD

25018 A

II

10/11/2011

NECTAR LIFESCIENCES LTD

25019 A

IV

6/1/2011

LIPOID GMBH

25020 I

II

6/6/2011

SANOFI CHIMIE

LIPOID LIPIDMIX HSPC/MPEG2000-DSPE/CHOLESTEROL (3/1/1) AS MANUFACTURED IN


LUDWIGSHAFEN, GERMANY
SEMULOPARIN SODIUM AS MFG IN SINGAPORE

25021 A

II

6/1/2011

POLYPEPTIDE LABORATORIES SWEDEN AB

LINACLOTIDE DRUG SUBSTANCE AS MANUFACTURED IN LIMHAMN, SWEDEN

25022 A

II

6/27/2011

GLENMARK GENERICS LTD

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

25023 A

II

6/8/2011

INTERQUIM SA

OZENOXACIN AS MANUFACTURED IN BARCELONA, SPAIN

25024 A

II

6/8/2011

TEVA PHARMACEUTICAL INDUSTRIES LTD

SIMVASTATIN (ETHANOL PROCESS) AS MANUFACTURED IN DEBRECEN, HUNGARY

25025 A

II

6/7/2011

POLYPEPTIDE LABORATORIES INC

LINACLOTIDE DRUG SUBSTANCE AS MANUFACTURED IN TORRANCE, CA

25026 A

III

5/25/2011

TEXOL SRL

PERFORATED LAMINATE TOPSHEET 43 GSM AS MANUFACTURED IN ALLANO(PE), ITALY

25027 I

III

6/1/2011

KURARAY TRADING CO LTD

KG001, POLYPROPYLENE-KNITTED BACKING CLOTH FOR MEDICAL PATCHES AS


MANUFACTURED IN SAIJO-SHI, TOKYO, KAWAKITA-GUN, SABAE-SHI, JAPAN FOR KURARAY
TRADING CO., LTD.

25028 A

II

6/9/2011

HETERO LABS LTD

EFAVIRENZ(FORM-H1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25029 A

II

6/9/2011

HETERO LABS LTD

TELMISARTAN, USP (FORM A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25030 A

II

2/4/2011

VITAL LABORATORIES PVT LTD

RESERPINE USP AS MANUFACTURED IN GUJARAT, INDIA

25031 A

II

6/23/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ARMODAFINIL AS MANUFACTURED IN MAHARASHTRA, INDIA

25032 A

II

6/18/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

25033 A

III

5/3/2011

SABIC PETROCHEMICALS BV

SABIC PP PCGR25 00900 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS

25034 A

II

6/10/2011

DK PHARMA CHEM PVT LTD

FENOFIBRATE USP AS MFG IN MAHARASHTRA, INDIA

25035 A

II

5/9/2011

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD

AMPICILLIN TRIHYDRATE AS MANUFACTURED IN SHIJIAZHUANG, P.R. CHINA

1- (2,3-DICHLORO PHENYL) PIPERAZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT,


INDIA
1-[2-(2-HYDROXY ETHOXY) ETHYL] PIPERAZINE AS MANUFACTURED IN GUJARAT, INDIA
CEFEPIME HYDROCHLORIDE USP (STERILE) AS MANUFACTURED IN DISTRICT MOHALI,
(PUNJAB) INDIA
CEFEPIME HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN
DISTRICT MOHALI, (PUNJAB) INDIA
PYCA AS MANUFACTURED IN DISTRICT MOHALI, (PUNJAB) INDIA

Page 736

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25036 A
II
6/9/2011
MACLEODS PHARMACEUTICALS LTD

SUBJECT
DULOXETINE HYDROCHLORIDE AS MFG IN GUJARAT, INDIA

25037 A

III

6/8/2011

SOLVIN SA

SOLVIN 372HA AS MFG IN TAVAUX, FRANCE AND RHEINBERG, GERMANY

25038 A

IV

4/30/2011

BALAJI AMINES LTD UNIT III

POVIDONE USP-31 AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

25039 A

II

7/1/2011

EMCURE PHARMACEUTICALS LTD

SEVELAMER CARBONATE (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA

25040 A

II

7/1/2011

EMCURE PHARMACEUTICALS LTD

MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25041 A

III

6/2/2011

INEOS SERVICES BELGIUM NV

25042 A

III

6/7/2011

3M DRUG DELIVERY SYSTEMS

25043 A

II

6/13/2011

SANDOZ PRIVATE LTD

ELTEX MED HD5226EA-M AS MANUFACTURED IN LAVERA, FRANCE FOR INEOS SERVICES


BELGIUM NV
3M COTRAN 9696 TAN TRICOT FABRIC TAPE AS MANUFACTURED IN BROOKINGS, SD FOR 3M
DRUG DELIVERY SYSTEMS
LANSOPROZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA

25044 A

II

6/13/2011

CRYSTAL PHARMA SAU

25045 A

III

6/13/2011

MITSUI ELASTOMERS SINGAPORE PTE LTD

25046 A

IV

6/9/2011

NIPPON FINE CHEMICAL CO LTD

OLOPATADINE HYDROCHLORIDE, USP (PROCESS II) AS MANUFACTURED IN BOECILLO


(VALLADOLID), SPAIN
TAFMER MY-1, MY-2, XM7070, XM7080 AND NOTIO PN-9060 AS MANUFACTURED IN JURONG
ISLAND, SINGAPORE AND CHIBA, JAPAN FOR MITSUI ELASTOMERS SINGAPORE PTE LTD
PRESOME ESI AS MANUFACTURED IN TAKASAGO-CITY, JAPAN

25047 A

III

6/15/2011

TOPPAN PRINTING CO LTD

LOW ADSORPTION LAMINATED PACKAGING MATERIAL AS MFG IN GUNMA, JAPAN

25048 A

II

6/14/2011

MACLEODS PHARMACEUTICALS LTD

ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN CITY: VALSAD GUJARAT, INDIA

25049 A

II

6/9/2011

PCAS

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN LIMAY, FRANCE

25050 A

II

6/2/2011

PORTON FINE CHEMICALS LTD

ROSUVASTATIN CALCIUM AS MFG IN CHONGQING, P.R. CHINA

25051 A

II

7/5/2011

UNICHEM LABORATORIES LTD

BRIMONIDINE TARTRATE AS MANUFACTURED IN RAIGAD, INDIA

25052 A

II

6/16/2011

AMINO CHEMICALS LTD

FESOTERODINE FUMARATE AS MANUFACTURED IN MARSA, MALTA

25053 A

III

6/8/2011

3M DRUG DELIVERY SYSTEMS

25054 A

II

6/14/2011

ACEBRIGHT INDA PHARMA PRIVATE LTD

25055 A

II

7/20/2011

CADILA HEALTHCARE LTD

3M COTRAN 9714 POLYETHYLENE FILM AS MANUFACTURED FOR 3M DRUG DELIVERY


SYSTEMS
CAPECITABINE USP[DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN KARNATAKA,
INDIA
PROPAFENONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

25056 A

II

6/17/2011

FINASTERIDE AS MANUFACTURED IN HUBEI, CHINA

25057 A

III

5/12/2011

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL


CO LTD
AMCOR FLEXIBLES AS

25058 A

II

6/15/2011

RA CHEM PHARMA LTD

PHTHALAZINONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25059 A

III

6/17/2011

MINNESOTA RUBBER AND PLASTICS

"POLYISOPRENE RUBBER FOR SEALING AND OTHER MEDICAL-RELATED APPLICATIONS IN


MEDICAL DEVICES AS MANUFACTURED IN GUANGDONG, P. R. CHINA FOR MINNESOTA
RUBBER & PLASTICS

25060 A

II

6/14/2011

CHEMSPEC CHEMICALS PVT LTD

TRICLOCARBAN AS MANUFACTURED IN MAHARASHTRA, INDIA

25061 I

II

6/20/2011

PHARMACEUTICAL WORKS POLPHARMA SA

MONTELUKAST SODIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

25062 A

II

6/16/2011

RAKS PHARMA PVT LTD

DOXYCYCLINE, USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25063 A

III

6/14/2011

RAVIRAJ FOILS LTD

25064 A

II

6/21/2011

MSN PHARMACHEM PVT LTD

'CHILD RESISTANT BLISTER PACK LIDDING MATERIAL (PLAIN / PRINTED)' AS MANUFACTURED


IN GUJARAT, INDIA
PREGABALIN [ROUTE CODE - PU"] AS MANUFACTURED IN TELANGANA

25065 A

II

6/16/2011

RAKS PHARMA PVT LTD

CITALOPRAM HYDROBROMIDE, USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25066 A

III

6/14/2011

LORMAC INDUSTRIAL DISTRIBUTORS LTD

25067 A

II

6/18/2011

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

LORMAC TYPE 40 POLYETHYLENE AS MANUFACTURED IN BRIGHOUSE, UNITED KINGDOM


AND CORK, IRELAND FOR LORMAC INDUSTRIAL DISTRIBUTORS LTD.
METHYLPREDNISOLONE USP, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
ZHEJIANG, CHINA

OPP40/ALU9/OPP40 AS MFG IN DRAMMEN, NORWAY

Page 737

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25068 A
II
6/22/2011
MOEHS IBERICA SL
25069 A

II

6/22/2011

APOTEX PHARMACHEM INDIA PVT LTD

SUBJECT
ARTICAINE HCL AS MANUFACTURED IN BELGIUM AND RUBI (BCN), SPAIN FOR MOEHS
IBERICA, S. L.
LETROZOLE USP AS MANUFACTURED IN KARNATAKA STATE, INDIA

25070 A

II

6/20/2011

R.N. LABORATORIES PVT LTD.

CHLORHEXIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

25071 A

III

6/10/2011

RKW SE

HYFOL PE SOFT TEXTILE - 45701 AS MANFACTURED IN WASSERBURG, GERMANY

25072 A

III

1/22/2014

SCHOTT SCHWEIZ AG

25073 A

II

6/24/2011

APOTEX PHARMACHEM INDIA PVT LTD

PRIMARY PACKAGING MATERIAL SYRINGES AS MANUFACTURED IN ST. GALLEN,


SWITZERLAND
PALIPERIDONE AS MANUFACTURED IN KARNATAKA STATE, INDIA

25074 A

II

6/24/2011

APOTEX PHARMACHEM INDIA PVT LTD

ALPRAZOLAM USP AS MANUFACTURED IN KARNATAKA STATE, INDIA

25075 A

II

6/24/2011

COVALENT LABORATORIES PRIVATE LTD

CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN TELANGANA, INDIA

25076 A

II

6/27/2011

MYLAN LABORATORIES LTD

ELETRIPTAN HYDROBROMIDE (PROCESS 2) AS MANUFACTURED IN TELANGANA, INDIA

25077 A

III

6/18/2011

GREEN PACK FOILS PRIVATE LTD

25078 A

II

8/26/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

'CHILD RESISTANT BLISTER PACK LIDDING FOIL (PLAIN / PRINTED)'. AS MANUFACTURED IN


GUJARAT, INDIA
ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT, INDIA

25079 A

III

6/10/2011

UNITIKA LTD

EMBLET PET,S, PTH AS MANUFACTURED IN KYOTO, JAPAN FOR UNITIKA LTD.

25080 A

II

4/20/2011

F.I.S.-FABBRICA ITALIANA SINTETICI S.P.A.

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN VICENZA, ITALY

25081 A

II

7/20/2009

AARTI INDUSTRIES LTD

IFOSFAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25082 I

II

6/17/2011

MATRIX PHARMA GROUP XIAMEN LTD

ZIDOVUDINE USP AS MANUFACTURED IN XIAMEN, P.R. CHINA

25083 A

II

6/18/2011

MYLAN LABORATORIES LTD

S-PREGABALIN (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25084 I

II

6/28/2011

RANBAXY LABORATORIES LTD

25085 A

II

6/12/2011

ZHEJIANG HUAFANG PHARMACEUTICAL CO LTD

QUETIAPINE FUMARATE (NON-STERILE BULK) AS MANUFACTURED IN HARYANA, INDIA FOR


RANBAXY LABORATORIES LIMITED
CEFCAPENE PIVOXIL HYDROCHLORIDE HYDRATE AS MANUFACTURED IN ZHEJIANG, CHINA

25086 A

II

6/12/2011

ZHEJIANG HUAFANG PHARMACEUTICAL CO LTD

CEFDITOREN PIVOXIL AS MANUFACTURED IN ZHEJIANG, CHINA

25087 A

II

6/28/2011

JOHNSON MATTHEY PHARMA SERVICES

3011.H AS MANUFACTURED IN DEVENS, MA

25088 A

II

6/29/2011

HETERO DRUGS LTD

25089 A

II

6/29/2011

REGIS TECHNOLOGIES INC

CITALOPRAM HYDROBROMIDE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
DAPSONE, USP AS MANUFACTURED IN MORTON GROVE, IL

25090 A

II

7/27/2011

EXCELLA GMBH

BUPIVACAINE (S) HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY

25091 A

IV

6/20/2011

SUMITOMO SEIKA CHEMICALS CO LTD

25092 A

II

7/26/2011

USV LIMITED

PEO-1NF, A LOW MOLECULAR WEIGHT POLYETHYLENE OXIDE AS MANUFACTURED IN


HYOGO, JAPAN
EPTIFIBATIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25093 A

II

6/30/2011

RELIABLE BIOPHARMACEUTICAL CORP

FONDAPARINUX SODIUM AS MANUFACTURED IN ST. LOUIS, MO

25094 A

II

7/14/2011

NANTONG JINGHUA PHARMACEUTICAL CO LTD

FLUCYTOSINE AS MANUFACTURED IN NANTONG JIANGSU, CHINA

25095 I

II

6/24/2011

JOYANG LABORATORIES

BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, CHINA

25096 I

II

7/1/2011

MUSTAFA NEVZAT ILAC SANAYII AS

NON-STERILE SULBACTAM SODIUM AS MANUFACTURED IN CAYIROVA-KOCAELI, TURKEY

25097 A

II

6/29/2011

MOEHS IBERICA SL

25098 A

II

6/30/2011

BACHEM SA

SERTRALINE HCL FORM 1 (SCHIFF BASE) AS MANUFACTURED IN RUBI (BARCELONA), SPAIN


FOR MOEHS IBERICA S.L.
TOPOTECAN HYDROCLORIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND

25099 A

II

6/30/2011

ALEMBIC PHARMACEUTICALS LTD

BOSENTAN AS MANUFACTURED IN GUJARAT, INDIA

25100 A

II

7/4/2011

APOTEX PHARMACHEM INDIA PVT LTD

VORICONAZOLE USP AS MANUFACTURED IN BANGALORE, INDIA

25101 A

III

7/1/2011

AGI GLASPAC BHONGIR UNIT

GLASS BOTTLES USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 738

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25102 A
II
9/21/2011
SHILPA MEDICARE LTD

SUBJECT
PEMETREXED DISODIUM (HEMIPENTA HYDRATE) AS MANUFACTURED IN KARNATAKA, INDIA

25103 I

II

7/20/2011

FRESENIUS KABI ONCOLOGY LTD

DOCETAXEL AS MANUFACTURED IN WEST BENGAL, INDIA

25104 A

II

7/4/2011

MACLEODS PHARMACEUTICALS LTD

MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT, INDIA

25105 A

III

6/27/2011

PIONEER EXTRUDERS PVT LTD

COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN DAMAN, INDIA

25106 A

II

7/6/2011

SANOFI AVENTIS CHIMIE

TRIMIPRAMINE MALEATE AS MANUFACTURED IN CEDEX, FRANCE

25107 A

II

6/30/2011

YUNG ZIP CHEMICAL IND CO LTD

DICLOFENAC ACID AS MANUFACTURED IN TAICHUNG, TAIWAN

25108 A

II

5/31/2011

OG CORP

25109 A

III

7/8/2011

POLYCINE GMBH

POLYESTER KNITTING CLOTH FOR BACKING LINER AS MANUFACTURED IN FUKUI CITY,


JAPAN FOR OG CORPORATION
APP114 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY

25110 A

III

7/8/2011

POLYCINE GMBH

APP218 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY

25111 A

II

6/30/2011

MYLAN LABORATORIES LTD

DEXLANSOPRAZOLE AMORPHOUS AS MANUFACTURED IN TELANGANA, INDIA

25112 A

IV

7/8/2011

GANGWAL CHEMICALS PVT. LTD.

SUCRALOSE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25113 A

III

7/6/2011

VITEX PACKAGING GROUP

VITEX POUCH 40493 AS MANUFACTURED IN SUFFOLK, VA

25114 A

III

5/16/2011

ST GOBAIN PERFORMANCE PLASTICS CORP

D9899000-12 AS MANUFACTURED IN POESTENKILL, NEW YORK

25115 A

II

7/12/2011

HETERO LABS LTD

MARAVIROC (FORM-B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25116 A

II

7/12/2011

HETERO LABS LTD

IMATINIB MESYLATE AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25117 I

II

7/7/2011

PHARMACEUTICAL WORKS POLPHARMA SA

ROSUVASTATIN CALCIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

25118 A

II

7/12/2011

HETERO LABS LTD

SAQUINAVIR MESYLATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25119 A

II

6/20/2011

VITAL LABORATORIES PVT LTD

METHYLCOBALAMIN (MECOBALAMIN) AS MANUFACTURED IN GUJARAT, INDIA

25120 A

II

6/30/2011

SECOND PHARMA CO LTD

LEVETIRACETAM AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. CHINA

25121 A

II

7/13/2011

HETERO LABS LTD

MARAVIROC AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25122 A

II

7/13/2011

HAINAN POLY PHARMACEUTICAL CO LTD

GANCICLOVIR SODIUM AS MANUFACTURED IN ZHEJIANG, CHINA

25123 A

II

7/11/2011

PROCOS SPA

DIMIRACETAM AS MANUFACTURED IN CAMERI (NO) - ITALY

25124 A

III

7/12/2011

MITSUI MINING AND SMELTING CO LTD

OMNIBATCH AS MANUFACTURED IN CHIBA, JAPAN FOR POWDERTECH CO., LTD.

25125 A

II

7/11/2011

LIFE TECHNOLOGIES CORP

HUMAN GROWTH FACTORS AS MANUFACTURED IN FREDERICK, MD

25126 A

III

7/14/2011

THE JENARD CO DIV FEY INDUSTRIES INC

25127 A

II

5/11/2011

KOTHARI PHYTOCHEMICALS INTERNATIONAL

DISCREET SLEEVE PACKAGING FOR ORAL CONTRACEPTIVES AS MANUFACTURED IN


EDGERTON, MN FOR THE JENARD COMPANY, A DIVISION OF FEY INDUSTRIES, INC
CHLORPROPAMIDE AS MANUFACTURED IN TAMILNADU, INDIA

25128 A

II

6/30/2011

HEMMO PHARMACEUTICALS PVT LTD

LEUPRORELIN PH.EUR. AS MANUFACTURED IN DISTRICT THANE, INDIA

25129 A

II

7/15/2011

SHANDONG LUKANG PHARMACEUTICAL CO LTD

25130 A

III

6/13/2011

CHARTER NEX FILMS INC

25131 A

II

7/5/2011

JOST CHEMICAL CO

SPECTINOMYCIN HYDROCHLORIDE HCI USP, NON-STERILE, BULK DRUG SUBSTANCE AS


MANUFACTURED IN SHANDONG, P. R. CHINA
NEX S9149 SINGLE-LAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS
FALLS, MA AND MILTON, WI
CALCIUM SUCCINATE, MONOHYDRATE AS MANUFACTURED IN ST. LOUIS, MO

25132 A

II

7/5/2011

JOST CHEMICAL CO

SODIUM PHOSPHATE DIBASIC, ANHYDROUS AS MANUFACTURED IN ST. LOUIS, MO

25133 A

II

7/5/2011

JOST CHEMICAL CO

MAGNESIUM SULFATE DRIED AS MANUFACTURED IN ST. LOUIS, MO

25134 A

II

9/9/2011

WATSON PHARMA PRIVATE LTD

AMBRISENTAN AS MANUFACTURED IN MAHARASHTRA, INDIA

25135 A

II

7/5/2011

JOST CHEMICAL CO

SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE AS MANUFACTURED IN ST. LOUIS, MO

25136 A

III

7/12/2011

ARTUBE IRIDIUM INDUSTRIES INC

MONO LAYER AND COEX LAYER PLASTIC TUBES AS MANUFACTURED IN EAST


STROUDSBURG, PA

Page 739

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25137 A
III
7/11/2011
BASELL POLYOLEFINE ITALIA SRL

SUBJECT
PURELL ACP 5231 D AS MANUFACTURED IN FRANKFURT AM MAIN AND MUNCHSMUNSTER,
GERMANY FOR BASELL POLYOLEFINE ITALIA S. R. L.
CLOCORTOLONE PIVALATE NON-STERILE BULK DRUG AS MANUFACTURED IN TIANJIN, PR
CHINA
EMPTY HARD CARRAGEENAN CAPSULES AS MANUFACTURED IN JIANGSU, CHINA

25138 A

II

9/9/2011

CHEMWERTH INC

25139 A

IV

7/15/2011

25140 A

III

6/6/2011

JIANGSU ZODIAC MARINE BIOTECHNOLOGY CO


LTD
STYROLUTION EUROPE GMBH

25141 A

II

10/19/2011

LUPIN LTD

25142 A

II

8/20/2011

ARCH PHARMALABS LTD

L-5-METHYL TETRAHYDROFOLATE CALCIUM (AMORPHOUS) AS MANUFACTURED IN


MAHARASHTRA, INDIA
DOCETAXEL ANHYDROUS USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25143 A

II

9/5/2011

ARCH PHARMALABS LTD

DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25144 I

II

8/6/2011

CADILA HEALTHCARE LTD ZYFINE

ERLOTINIB HYDROCHLORIDE (FORM-A) AS MANUFACTURED IN GUJARAT, INDIA

25145 A

II

8/4/2011

JUBILANT HOLLISTERSTIER LLC

STERILE EVACUATED VIALS AS MANUFACTURED IN SPOKANE, WA

25146 A

IV

7/19/2011

UNGERER AND CO

ARTIFICIAL PINA COLADA FLAVOR FT-11512 AS MANUFACTURED IN BETHLEHEM, PA

25147 A

II

7/20/2011

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

SIROLIMUS AS MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA

25148 A

II

3/4/2011

ALP PHARM BEIJING CO LTD

25149 A

II

7/25/2011

25150 A

III

7/18/2011

25151 A

II

7/21/2011

25152 A

II

7/29/2011

DOXERCALCIFEROL AS MANUFACTURED IN LIAONING PROVINCE, CHINA FOR ALP PHARM


BEIJING CO., LTD.
MEDICHEM SA
CHLORHEXIDINE GLUCONATE SOLUTION (DGLP) AS MANUFACTURED IN CELRA (GIRONA),
SPAIN
PIRAMIDA DOO
PHARMACEUTICAL GLASS PACKAGING - AMPOULES AND VIALS AS MANUFACTURED IN
SESVETE, CROATIA
ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO AMANTADINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJINAG PROVINCE, P.R. CHINA
LTD
ALKEM LABORATORIES LTD
LANSOPRAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

25153 A

III

7/19/2011

AMPACET CORP

25154 A

II

5/20/2011

AICELLOMILIM CHEMICAL CO LTD

173834 TRANS GREEN SMC PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA,
CARTERSVILLE, GA AND HEATH, OH
ADF-03 (CLEAN BAG) AS MANUFACTURED IN GYEONGGI-DO, KOREA

25155 A

II

9/29/2011

UNICHEM LABORATORIES LTD

TOLTERODINE TARTARATE AS MANUFACTURED IN DIST. RAIGAD, INDIA

25156 I

II

11/14/2011

RELIANCE LIFE SCIENCES PVT LTD

ROCURONIUM BROMIDE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA

25157 A

5/18/2011

ROTEM INDUSTRIES LTD

CASSETTE FOR THE PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE


TRACERLAB MX FDG SYNTHESIS UNIT, TYPE B AS MANUFACTURED IN MISHOR YAMIN ,
ISRAEL

25158 A

II

7/25/2011

AMERICA STEM CELL INC

ASC-1401 AS MANUFACTURED IN ALACHUA, FLORIDA FOR AMERICA STEM CELL, INC

25159 A

III

7/26/2011

JSR CORP

25160 A

III

9/16/2011

HOSPIRA INC

JSR DYNARON SERIES (HYDROGENATED STYRENE BUTADIENE COPOLYMER) AS


MANUFACTURED IN MIE, JAPAN
ANSYR SYRINGE DRUG CONTAINER AS MANUFACTURED IN ROCKY MOUNT, NC

25161 A

II

7/25/2011

PCAS

TAZAROTENE AS MANUFACTURED IN TURKU, FINLAND FOR PCAS

25162 A

III

7/27/2011

COLORS FOR PLASTICS INC

25163 A

III

7/25/2011

ELIX POLYMERS SL

THERMOPLASTIC RESIN COLORANT MASTERBATCH N06534 BROWN AS MANUFACTURED IN


ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
ELIX ABS M210TF, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN

25164 A

IV

7/26/2011

UNGERER AND CO

NATURAL AND ARTIFICIAL CHERRY FLVP FT-9496 AS MANUFACTURED IN BETHLEHEM, PA

25165 A

II

4/14/2011

HYBIO PHARMACEUTICAL CO LTD

25166 A

II

3/30/2011

AUCTUS PHARMA LTD

BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG, P.


R. CHINA
PANTOPRAZOLE SODIUM SESQUIHYDRATE USP AS MANUFACTURED IN ANDHRA PRADESH,
INDIA

TERLUX R HD 2822 AS MANUFACTURED IN LUDWIGSHAFEN AND SCHWARZHEIDE, GERMANY

Page 740

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25167 A
II
7/19/2011
LI-COR INC
25168 A

II

7/1/2011

KOTHARI PHYTOCHEMICALS INTERNATIONAL

SUBJECT
IRDYE 800CW NHS ESTER(DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN
MORTON GROVE, IL FOR LI-COR BIOSCIENCES, INC.
TOLBUTAMIDE USP AS MANUFACTURED IN TAMILNADU, INDIA

25169 A

II

7/15/2011

TAI HENG INDUSTRY CO LTD

BOSENTAN MONOHYDRATE AS MANUFACTURED IN SHANGHAI, P.R. CHINA

25170 P

*** PENDING FILING REVIEW ***

25171 A

III

7/25/2011

CV HOLDINGS LLC

5ML GLASS COATED PARENTERAL DRUG VIAL AS MANUFACTURED IN AUBURN, ALABAMA

25172 A

II

9/9/2011

EMCURE PHARMACEUTICALS LTD

IBANDRONATE SODIUM MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25173 A

II

7/20/2011

CHITOSAN AS MANUFACTURED IN ZHEJIANG, CHINA

25174 A

II

8/2/2011

ZHEJIANG GOLDEN-SHELL PHARMACEUTICAL CO


LTD
PHARMACEUTICAL WORKS POLPHARMA SA

25175 A

II

7/29/2011

QILU PHARMACEUTICAL CO LTD

OLANZAPINE AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA

25176 A

III

8/2/2011

JIANGSU BEST NEW MEDICAL MATERIAL CO LTD

25177 A

III

8/2/2011

JIANGSU BEST NEW MEDICAL MATERIAL CO LTD

25178 A

III

8/2/2011

JIANGSU BEST NEW MEDICAL MATERIAL CO LTD

25179 A

III

2/23/2011

TEKNOR COLOR CO

BROMOBUTYL RUBBER STOPPERS FOR INFUSION BOTTLES AS MANUFACTURED IN JIANGSU,


CHINA
BROMOBUTYL RUBBER STOPPERS FOR INJECTION VIALS AS MANUFACTURED IN JIANGSU,
CHINA
FREEZE DRYING BROMOBUTYL RUBBER STOPPERS FOR INJECTION VIALS AS
MANUFACTURED IN JIANGSU, CHINA
47,264CP MOM BLUE 25/1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX

25180 P

VARDENAFIL HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

*** PENDING FILING REVIEW ***

25181 A

II

7/20/2011

N-ACETYL-D-GLUCOSAMINE AS MANUFACTURED IN ZHEJIANG, CHINA

8/3/2011

ZHEJIANG GOLDEN-SHELL PHARMACEUTICAL CO


LTD
SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

25182 A

II

25183 A

7/29/2011

ECKERT AND ZIEGLER EUROTOPE GMBH

III

7/29/2011

3M DRUG DELIVERY SYSTEMS

25185 A

II

8/11/2011

DR REDDYS LABORATORIES LTD

MODULAR-LAB RADIOPHARMACEUTICAL SYNTHESIS SYSTEMS AS MANUFACTURED IN


BERLIN, GERMANY
3M SCOTCHPAK 9758 POLYESTER FILM AS MANUFACTURED IN DECATUR, ALABAMA,
GREENVILLE, SC AND HUTCHINSON, MN FOR 3M DRUG DELIVERY SYSTEMS
BROMFENAC SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25184 A

25186 A

II

8/22/2011

DR REDDYS LABORATORIES LTD

O-DESMETHYL VENLAFAXINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25187 A

II

10/24/2011

GILEAD SCIENCES INC

25188 A

II

10/25/2011

GILEAD SCIENCES INC

25189 A

II

12/21/2011

GLAXOSMITHKLINE LLC

25190 A

II

8/4/2011

MYLAN LABORATORIES LTD

25191 I

II

8/5/2011

SPI PHARMA INC

25192 A

II

8/3/2011

OLON SPA

ELVITEGRAVIR AS MANUFACTURED IN ALBERTA, CANADA, VICENZA, ITALY AND KYUNGGI-DO,


SOUTH KOREA FOR GILEAD SCIENCES, INC
COBICISTAT ON SILICON DIOXIDE AS MANUFACTURED IN ALBERTA, CANADA AND KYUNGGIDO, SOUTH KOREA FOR GILEAD SCIENCES, INC
ALBUTEROL AS MANUFACTURED IN ANGUS, UNITED KINGDOM AND EVREUX, FRANCE FOR
GLAXO GROUP LIMITED D/B/A GLAXOSMITHKLINE
EFAVIRENZ USP(PROCESS - II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR MYLAN
LABORATORIES LIMITED
BULK ACTIMASK TASTE MASKED ACETAMINOPHEN AS MANUFACTURED IN GRAND HAVEN,
MICHIGAN
TRETINOIN TYPE 2 AS MANUFACTURED IN GARBAGNATE MILANESE (MI) - ITALY

25193 A

II

6/1/2011

OLON SPA

DIENOGEST AS MANUFACTURED IN RODANO (MI) , ITALY

25194 A

II

8/9/2011

SHARON BIO MEDICINE LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25195 A

II

8/1/2011

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

TRIMETHOPRIM AS MANUFACTURED IN SHOUGUANG CITY, CHINA

25196 A

6/3/2011

COLORCON INC

"SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCT POLYVINYL ACETATE


PHTHALATE (PVAP)" AS MANUFACTURED IN WEST POINT, PA

CLOZAPINE AS MANUFACTURED IN SHOUGUANG CITY, P.R. OF CHINA

Page 741

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25197 A
II
8/10/2011
SYMBIOTEC PHARMALAB LTD

SUBJECT
BETAMETHASONE, USP (MICRONIZED) AS MANUFACTURED IN DIST. DHAR, (M.P.), INDIA

25198 A

II

8/10/2011

GMT FINE CHEMICALS SA

LEVOLEUCOVORIN CALCIUM AS MANUFACTURED IN COUVET, SWITZERLAND

25199 A

III

8/5/2011

3M DRUG DELIVERY SYSTEMS

25200 A

II

8/5/2011

ZHEJIANG AUSUN PHARMACEUTICAL CO LTD

25201 A

II

8/5/2011

LONZA AG

3M COTRAN 9759 DOUBLE-COATED MEDICAL TAPE AS MANUFACTURED IN BROOKINGS, SD


FOR 3M DRUG DELIVERY SYSTEMS
ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG,
CHINA
FLUVOXAMINE MALEATE (SV-006) AS MANUFACTURED IN VISP, SWITZERLAND

25202 I

II

7/29/2011

QILU PHARMACEUTICAL CO LTD

25203 I

II

7/30/2011

QILU PHARMACEUTICAL CO LTD

25204 A

II

8/1/2011

FIS FABBRICA ITALIANA SINTETICI SPA

RISPERIDONE PROCESS II (NON STERILE, API) AS MANUFACTURED IN SHANDONG


PROVINCE, P. R. OF CHINA
VINORELBINE TARTRATE (PROCESS I) (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE, P. R. OF CHINA
MIDAZOLAM HCI AS MANUFACTURED IN VICENZA, ITALY

25205 A

II

7/26/2011

FIS FABBRICA ITALIANA SINTETICI SPA

IMATINIB MESYLATE (BETA FORM) AS MANUFACTURED IN VICENZA, ITALY

25206 A

II

7/27/2011

FIS FABBRICA ITALIANA SINTETICI SPA

IMATINIB MESYLATE (ALPHA FORM) AS MANUFACTURED IN VICENZA, ITALY

25207 A

II

7/11/2011

HEBEI HUARONG PHARMACEUTICAL CO LTD

ACARBOSE AS MANUFACTURED IN HEBEI, CHINA

25208 A

III

8/9/2011

ROY AND LECLAIR EMBALLAGE INC

25209 A

III

8/15/2011

MITSUBISHI GAS CHEMICAL CO INC

EYE APPLICATOR BRUSH AS MANUFACTURED IN OMAHA, NE FOR ROY AND LECLAIR


EMBALLAGE INC.
NYLON MXD-6 GRADES FOR USE IN PHARMACEUTICAL PACKAGING APPLICATIONS AS
MANUFACTURED IN COLONIAL HEIGHTS, VIRGINIA AND NIIGATA, JAPAN FOR MITSUBISHI GAS
CHEMICAL CO., INC

25210 A

IV

8/12/2011

NEOPHARM CO LTD

25211 A

II

8/5/2011

25212 A

II

8/16/2011

ZHEJIANG APELOA KANGYU BIO


PHARMACEUTICAL CO LTD
HOSPIRA BOULDER INC

25213 A

II

8/10/2011

ANHUI BBCA LIKANG PHARMACEUTICAL CO LTD

ISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN BOULDER,


CO
ACETAMINOPHEN AS MANUFACTURED IN BENGBU CITY, CHINA

25214 A

II

8/1/2011

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

SULFAMETHOXAZOLE AS MANUFACTURED IN SHOUGUANG CITY, CHINA

25215 A

III

8/18/2011

SABIC PETROCHEMICALS BV

SABIC HDPE PCG300054 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS

25216 A

II

8/11/2011

ULKAR KIMYA SANAYII VE TICARET AS

CANDESARTAN CILEXETIL AS MANUFACTURED IN TEKIRDAG, TURKEY

25217 A

II

8/26/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25218 A

II

8/18/2011

25219 A

II

8/16/2011

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
PARABOLIC DRUGS LTD

JOHNSON MATTHEY 4147.F AS MANUFACTURED IN DEVENS, MA FOR JOHNSON MATTHEY


PHARMACEUTICAL MATERIALS
CANDESARTAN CILEXETIL AS MANUFACTURED HARYANA, INDIA

25220 A

IV

8/19/2011

DAVID MICHAEL AND CO INC

NATURAL AND ARTIFICIAL LEMON FLAVOR #11980 AS MANUFACTURED IN PHILADELPHIA, PA

25221 I

II

8/22/2011

MATRIX PHARMA GROUP XIAMEN LTD

NEVIRAPINE ANHYDROUS USP AS MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA

25222 A

II

11/9/2011

SHILPA MEDICARE LTD

BENDAMUSTINE HCL AS MANUFACTURED IN KARNATAKA, INDIA

25223 A

II

12/20/2011

EPAX NORWAY AS

25224 A

II

9/16/2011

AMOLI ORGANICS PVT LTD

25225 A

II

8/16/2011

APOTEX PHARMACHEM INDIA PVT LTD

EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER) AS MANUFACTURED IN


AALESUND, NORWAY
DICLOFENAC EPOLAMINE/DICLOFENAC APOLAMINE AS MANUFACTURED IN GUJARAT STATE,
INDIA
ALMOTRIPTAN MALATE AS MANUFACTURED IN KARNATAKA, INDIA

25226 A

II

8/18/2011

DECCAN NUTRACEUTICALS PVT LTD

10-DEACETYL BACCATIN III (10-DAB III) AS MANUFACTURED IN MAHARASHTRA, INDIA

25227 A

II

8/18/2011

PERRIGO API LTD

OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN BEER SHEVA, ISRAEL

MYRISTOYL/PALMITOYL OXOSTEARAMIDE / ARACHAMIDE MEA (CODE NAME: PC-9S) AS


MANUFACTURED IN DAEJEON, KOREA
TYLOSIN TARTRATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

Page 742

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25228 A
II
8/23/2011
FARMABIOS S P A

SUBJECT
DIFLUPREDNATE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY

25229 A

II

3/7/2011

ALP PHARM BEIJING CO LTD

25230 A

6/14/2011

BIOSCAN INC

25231 A

II

11/2/2011

AMOLI ORGANICS PVT LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED IN CHONGQING, CHINA FOR ALP PHARM


BEIJING CO., LTD
F18-PLUS SYNTHESIZER FOR PRODUCTION OF PET TRACERS AS MANUFACTURED IN YORK,
PA FOR BIOSCAN, INC.
SILDENAFIL CITRATE FORM-II AS MANUFACTURED IN GUJARAT STATE, INDIA

25232 A

8/23/2011

ION BEAM APPLICATIONS SA

25233 I

III

8/17/2011

TEKNOR APEX CO

25234 A

II

8/17/2011

ROVI CONTRACT MANUFACTURING SL

25235 A

II

8/31/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD DEXLANSOPRAZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA

25236 A

II

9/16/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZOLMITRIPTAN AS MANUFACTURED IN MAHARASHTRA, INDIA

25237 A

III

8/23/2011

PRAVESHA INDUSTRIES PRIVATE LTD

MASTER BATCH/COLORANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25238 A

II

8/25/2011

HETERO DRUGS LTD

25239 A

II

11/7/2011

HOSPIRA HEALTHCARE INDIA PVT LTD

SERTRALINE HYDROCHLORDE, USP (FORM II), PROCESS II AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
DORIPENEM (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA

25240 A

II

9/19/2011

OTSUKA AMERICA PHARMACEUTICAL INC

25241 A

III

8/16/2011

CHEMIPACK INDIA PRIVATE LTD

25242 A

II

8/29/2011

HANGZHOU JIUYUAN GENE ENGINEERING CO LTD ENOXAPARIN SODIUM AS MANUFACTURED IN HANGZHOU, CHINA

25243 A

10/28/2011

WYETH LEDERLE S.R.L

25244 A

8/29/2011

ION BEAM APPLICATIONS SA

25245 A

II

8/18/2011

INDOCO REMEDIES LTD

CATANIA NON-PENICILLIN VIALS DEPARTMENT (01) ASEPTIC FACILITY AS LOCATED IN


CATANIA, ITALY
RADIO-PHARMACEUTICAL SYNTHESIS MODULE << SYNTHERAV1 >> AS MANUFACTURED IN
LOUVAIN-LA-NEUVE, BELGIUM
BROMFENAC SODIUM AS MFG IN MUMBAI INDIA

25246 A

II

6/20/2011

TOMITA PHARMACEUTICAL CO LTD

U.S.P. MANGANESE GLUCONATE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN

25247 A

II

8/26/2011

BIOCON LTD

ATORVASTATIN CALCIUM CRYSTALLINE AS MANUFACTURED IN BANGALORE, INDIA

25248 A

II

9/1/2011

AVANTI POLAR LIPIDS INC

25249 A

II

9/1/2011

NATIONAL CANCER INSTITUTE DIV CANCER


TREATMENT AND DIAGNOSIS

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC) AS MANUFACTURED IN


ALABASTER, ALABAMA
RECOMBINANT HUMAN INTERLEUKIN-15 (RHIL-15) AS MANUFACTURED IN FREDERICK, MD
FOR NATIONAL CANCER INSTITUTE (NCI), DIVISION OF CANCER TREATMENT AND DIAGNOSIS
(DCTD)

25250 A

8/29/2011

ION BEAM APPLICATIONS SA

25251 A

II

9/6/2011

LABORCHEMIE APOLDA GMBH

SYNTHERAINTEGRATED FLUIDIC PROCESSOR AS MANUFACTURED IN LOUVAIN-LA-NEUVE,


BELGIUM
DIENOGEST AS MANUFACTURED IN THURINGIA, GERMANY

25252 A

II

8/30/2011

GUFIC BIOSCIENCES LTD

PRILOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA

25253 A

III

9/1/2011

VITAPAC (HK) INDUSTRIAL LTD

25254 A

II

8/23/2011

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

DESICCANT TYPE PACKAGING MATERIAL AS MANUFACTURED IN DONGGUAN CITY, P.R. CHINA


FOR VITAPAC (HK) INDUSTRIAL LTD.
BUPROPION HYDROBROMIDE AS MANUFACTURED IN ZHEJIANG, P. R. CHINA

25255 A

II

9/1/2011

NOF CORP

25256 A

II

9/1/2011

VIFOR INTERNATIONAL INC

25257 A

II

5/3/2012

AMI ORGANICS PVT LTD

RADIO-PHARMACEUTICAL SYNTHESIS MODULE SYNTHERA V2 AS MANUFACTURED IN


LOUVAIN-LA NEUVE, BELGIUM
MEDALIST MD-555 NATURAL AS MANUFACTURED IN HENDERSON, KY AND SAINT ALBANS, VT
FOR TEKNOR APEX COMPANY
STERILE WATER FOR INJECTION, USP, 5.0 ML AS MANUFACTURED IN MADRID, SPAIN

STERILE WATER FOR INJECTION USP, 2 ML VIAL AS MANUFACTURED IN HAMELN, GERMANY


FOR OTSUKA AMERICA PHARMACEUTICAL, INC.
'HDPE BOTTLE' AS MANUFACTURED IN ANDHRA PRADESH, INDIA

DLINDMA (1,2-DILINOLEYLOXY-N,N-DIMETHYLPROPYLAMINE AS MANUFACTURED IN HYOGO


AND KANAGAWA, JAPAN
CARBOXYMETHYLATED DEXTRAN (CM DEXTRAN) AS MANUFACTURED IN GALLEN,
SWITZERLAND
1- (2-METHOXYPHENYL) PIPERAZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT,
INDIA

Page 743

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25258 A
II
10/11/2011
IPCA LABORATORIES LTD

SUBJECT
PRIMAQUINE PHOSPHATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

25259 A

II

10/11/2011

LUPIN LTD

BRIMONIDINE TARTRATE AS MANUFACTURED IN MADHYA PRADESH, INDIA

25260 A

II

9/24/2011

ALKEM LABORATORIES LTD

RILUZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

25261 A

II

9/6/2011

HETERO DRUGS LTD

RALTEGRAVIR POTASSIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25262 A

II

9/6/2011

HETERO LABS LTD

EFAVIRENZ (PROCESS III) USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25263 A

II

9/2/2011

EVERLIGHT CHEMICAL INDUSTRIAL CORP

TRAVOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN

25264 A

8/31/2011

ION BEAM APPLICATIONS SA

25265 A

II

9/7/2011

EUTICALS SPA

RADIO-PHARMACEUTICAL PURIFICATION/SEPARATION MODULE SYNTHERAHPLC AS


MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM
AZACITIDINE AS MANUFACTURED IN VARESE, ITALY

25266 A

II

9/7/2011

EUTICALS SPA

CAPECITABINE AS MANUFACTURED IN LODI, ITALY

25267 A

II

9/7/2011

EUTICALS SPA

CYTARABINE AS MANUFACTURED IN VARESE, ITALY

25268 A

II

4/27/2011

TOMITA PHARMACEUTICAL CO LTD

U.S.P. MAGNESIUM SULFATE, ANHYDROUS AS MANUFACTURED IN TOKUSHIMA, JAPAN

25269 A

II

5/10/2011

TOMITA PHARMACEUTICAL CO LTD

U.S.P. MAGNESIUM GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN

25270 A

II

5/23/2011

TOMITA PHARMACEUTICAL CO LTD

U.S.P. MAGNESIUM OXIDE HEAVY POWDER AS MANUFACTURED IN TOKUSHIMA, JAPAN

25271 A

II

5/23/2011

TOMITA PHARMACEUTICAL CO LTD

25272 A

II

2/28/2011

TOMITA PHARMACEUTICAL CO LTD

U.S.P. MAGNESIUM OXIDE HEAVY FINE GRANULAR AS MANUFACTURED IN TOKUSHIMA,


JAPAN
U.S.P. MAGALDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN

25273 A

II

10/6/2011

BAYER PHARMA AG

NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE AS MANUFACTURED IN RUBI (BCN), SPAIN

25274 A

II

10/6/2011

BAYER PHARMA AG

NICLOSAMIDE 500MG TABLET AS MANUFACTURED IN TURKU, FINLAND

25275 A

II

7/25/2011

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

EXEMESTANE AS MANUFACTURED IN KEDAH, MALAYSIA

25276 A

II

9/8/2011

BAXTER HEALTHCARE CORP

25277 A

III

8/30/2011

CELGARD LLC

25278 A

III

10/6/2011

PLASTITEC SA

25279 A

II

3/30/2012

JUBILANT GENERICS LTD

MESNA, USP/EP DRUG SUBSTANCE AS MANUFACTURED IN BIELEFELD AND


HALLE/WESTFALEN GERMANY FOR BAXTER HEALTHCARE CORPORATION
CELGARD 2300 SERIES TRANSDERMAL FLAT SHEET MEMBRANE AS MANUFACTURED IN
CHARLOTTE, NORTH CAROLINA
PVC BAGS AND ITS COMPONENTS FOR PHARMACEUTICAL SOLUTIONS AS MANUFACTURED
IN BOGOTA, COLOMBIA
LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA

25280 A

II

9/12/2011

HETERO DRUGS LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25281 A

II

9/6/2011

HETERO DRUGS LTD

RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25282 A

II

9/8/2011

PHARMACEUTICAL WORKS POLPHARMA SA

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

25283 A

II

8/31/2011

OLON SPA

25284 A

III

9/6/2011

ELIX POLYMERS SL

OTILONIUM BROMIDE AS MANUFACTURED IN GARBAGNATE MILANESE (MI), AND DORNO (PV),


ITALY
ELIX ABS M205FC, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN

25285 P

*** PENDING FILING REVIEW ***

25286 A

II

5/9/2012

CHATTEM CHEMICALS INC

METHADONE HYDROCHLORIDE USP AS MANUFACTURED IN CHATTANOOGA, TN

25287 A

II

9/9/2011

SANOFI AVENTIS SPA

RIFAMYCIN SODIUM AS MANUFACTURED IN BRINDISI, ITALY

25288 A

III

9/6/2011

ELIX POLYMERS SL

ELIX ABS M203FC, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN

25289 A

II

9/12/2011

CATALENT PHARMA SOLUTIONS LLC

AMR101 1G CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FLORIDA

25290 P

*** PENDING FILING REVIEW ***

25291 P

*** PENDING FILING REVIEW ***

25292 A

III

9/7/2011

ADVANCED FILMS LLC

MEDICAL POUCH FILM, PRODUCT CODE F-19 AS MANUFACTURED IN RICHMOND, BC, CANADA
FOR ADVANCED FILMS, LLC

Page 744

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25293 A
III
8/11/2011
TRUDELL MEDICAL INTERNATIONAL

SUBJECT
TOP MOUNT ACTUATION INDICATOR AS MANUFACTURED IN ONTARIO, CANADA

25294 A

II

9/7/2011

FUJIAN SOUTH PHARMACEUTICAL CO LTD

25295 A

II

9/7/2011

FUJIAN SOUTH PHARMACEUTICAL CO LTD

25296 A

II

9/12/2011

HETERO DRUGS LTD

10-DEACETYL-BACCATIN III (10-DAB III) (NON-STERILE) AS MANUFACTURED IN FUJIAN


PROVINCE, P. R. OF CHINA
DOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
FUJIAN PROVINCE, P. R. OF CHINA
NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25297 A

II

9/13/2011

HETERO DRUGS LTD

ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25298 A

II

9/11/2011

HIKMA PHARMACEUTICALS

GRANISETRON HYDROCHLORIDE USP AS MANUFACTURED IN AMMAN, JORDAN

25299 A

III

10/20/2011

WEENER EMPIRE PLASTICS LTD

PLASTIC CLOSURES AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

25300 A

II

9/13/2011

DISHMAN NETHERLAND B.V.

PARICALCITOL AS MANUFACTURED IN BE VEENENDAAL, THE NETHERLANDS

25301 A

II

9/22/2011

INDOCO REMEDIES LTD

BETAXOLOL HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25302 A

II

8/16/2011

VITAL HEALTH CARE PVT LTD

NIMESULIDE AS MANUFACTURED IN GIDC VAPI, INDIA

25303 A

II

9/15/2011

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

CEFEPIME FOR INJECTION AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

25304 A

II

9/13/2011

25305 A

II

9/13/2011

25306 A

II

6/9/2011

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL ATOVAQUONE AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
VITAL HEALTH CARE PVT LTD
ARTEMETHER AS MANUFACTURED IN GIDC VAPI, INDIA

25307 A

III

9/12/2011

AMPACET CORP

25308 A

II

10/3/2011

IND SWIFT LABORATORIES LTD

412978 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN


AND DERIDDER, LA AND CARTERSVILLE, GA AND HEATH, OH
ANASTROZOLE USP AS MANUFACTURED IN PUNJAB, INDIA

25309 A

II

9/20/2011

CHEMO IBERICA SA

RABEPRAZOLE SODIUM (PROCESS II) AS MANUFACTURED IN MADRID, SPAIN

25311 A

II

11/2/2011

AMOLI ORGANICS PVT LTD

SILDENAFIL CITRATE FORM-I AS MANUFACTURED IN GUJARAT STATE, INDIA

25312 A

II

10/14/2011

CRESTONE INC

CRS3123 AS MANUFACTURED IN MENLO PARK, CA FOR CRESTONE, INC.

25314 I

II

10/3/2011

CADILA HEALTHCARE LTD

ERLOTINIB HYDROCHLORIDE (FORM-B) AS MANUFACTURED IN GUJARAT, INDIA

25315 A

II

11/23/2011

APICORE US LLC

BROMFENAC SODIUM AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

25316 A

II

9/22/2011

FINE CHEMICALS CORP PTY LTD

SCOPOLAMINE (HYOSCINE) AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA

25317 A

II

9/21/2011

INTAS PHARMACEUTICALS LTD

DECITABINE AS MANUFACTURED IN STATE-GUJARAT, INDIA

25318 A

II

9/12/2011

MANGALAM DRUGS AND ORGANICS LTD

FUROSEMIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25319 A

II

8/22/2011

NEWCHEM SPA

BUDESONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY

25320 A

II

10/25/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

25321 A

II

10/24/2011

EMCURE PHARMACEUTICALS LTD

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25322 A

12/14/2011

CORDEN PHARMA LATINA SPA

ASEPTIC PENICILLIN FACILITY AS MANUFACTURED IN SERMONETA (LATINA), ITALY

25323 A

II

9/27/2011

LEK PHARMACEUTICALS DD

MYCOPHENOLATE MOFETIL (PROCESS B) AS MANUFACTURED IN MENGES, SLOVENIA

25324 A

II

9/19/2011

BACHEM SA

BRINZOLAMIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND

25325 A

II

10/21/2011

DR REDDYS LABORATORIES EU LTD

25326 A

II

9/28/2011

SANGROSE LABORATORIES PVT LTD

20 KDA METHOXYPOLY(ETHYLENE GLYCOL)-4-NITROPHENYL CARBONATE AS


MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM
CLOFAZIMINE AS MANUFACTURED IN MAVELIKARA KERALA, INDIA

25327 A

II

9/24/2011

MSN LABORATORIES LTD

ALMOTRIPTAN MALATE [ROUTE CODE - AM] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25310 P

*** PENDING FILING REVIEW ***

25313 P

*** PENDING FILING REVIEW ***

Page 745

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25328 A
II
10/21/2011
DR REDDYS LABORATORIES LTD

SUBJECT
PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25329 A

IV

9/21/2011

NIPPON FINE CHEMICAL CO LTD

N-(CARBONYL-METHOXYPOLYETHYLENEGLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3PHOSPHOETHANOLAMINE,SODIUM SALT (MPEG2000-DSPE) AS MANUFACTUED IN HYOGO,


JAPAN

25330 A

IV

9/21/2011

NIPPON FINE CHEMICAL CO LTD

1-STEAROYL-LYSOPHOSPHATIDYLCHOLINE (1-STEPC) AS MANUFACTURED IN HYOGO, JAPAN

25331 A

II

9/14/2011

ASAHI KASEI FINECHEM CO LTD

TRANEXAMIC ACID USP AS MANUFACTURED IN MIYAZAKI, JAPAN

25332 A

IV

9/16/2011

SAMSUNG FINE CHEMICALS CO LTD

HYPROMELLOSE PHTHALATE AS MANUFACTURED IN INCHEON, REPUBLIC OF KOREA

25333 A

IV

9/16/2011

SAMSUNG FINE CHEMICALS CO LTD

HYPROMELLOSE AS MANUFACTURED IN INCHEON, REPUBLIC OF KOREA

25334 A

II

10/3/2011

ALP PHARM BEIJING CO LTD

25335 A

II

10/3/2011

CENTAUR PHARMACEUTICALS PRIVATE LTD

LEUCOVORIN CALCIUM AS MANUFACTURED IN ZHEJIANG, CHINA FOR ALP PHARM BEIJING


CO., LTD.
CHLORDIAZEPOXIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25336 A

II

10/3/2011

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

25337 A

II

10/3/2011

XINJIANG NUZILINE BIO PHARMACEUTICAL CO LTD CONJUGATED ESTROGENS AS MANUFACTURED IN XINJIANG PROVINCE, CHINA

25338 I

II

9/28/2011

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

25339 A

II

10/3/2011

AIR LIQUIDE HEALTHCARE AMERICA CORP

NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1) AS MANUFACTURED


IN ZHEJIANG, CHINA
800 PPM NITROGEN DIOXIDE BALANCE AIR AS MANUFACTURED IN PLUMSTEADVILLE, PA

25340 A

II

10/3/2011

MEIJI SEIKA PHARMA CO LTD

ARBEKACIN SULFATE DRUG SUBSTANCE AS MANUFACTURED IN IWATE, JAPAN

25341 A

II

10/3/2011

MALLINCKRODT INC

25342 A

II

10/3/2011

CHEMPORT INC

H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION) AS MANUFACTURED IN


BALTIMORE, MD FOR QUESTCOR PHARMACEUTICALS, INC
OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN JEOLLANAM-DO, SOUTH KOREA

25343 A

II

10/4/2011

MYLAN LABORATORIES LTD

VORICONAZOLE USP AS MANUFACTURED IN TELANGANA, INDIA

25344 A

II

10/4/2011

HETERO LABS LTD

TEMOZOLOMIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25345 A

II

10/14/2011

CRESTONE INC

CRS3123-2HCL AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE FOR CRESTONE, INC

25346 A

II

11/4/2011

AMOLI ORGANICS PVT LTD

ATORVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT STATE, INIDA

25347 A

II

10/5/2011

VALDEPHARM

STERILE ARIPIPRAZOLE MONOHYDRATE AS MANUFACTURED IN VAL DE REUIL, FRANCE

25348 A

II

10/24/2011

CADILA HEALTHCARE LTD

DESVENLAFAXINE BASE AS MANUFACTURED IN STATE: GUJARAT, INDIA

25349 A

II

10/18/2011

DISINTEQUIK ODT AS MANUFACTURED IN NORWICH, NY

25350 I

III

10/4/2011

KERRY BIOFUNCTIONAL INGREDIENTS INC DBA


KERRY BIO SCIENCE
HUAYI ISOTOPES CORP

25351 A

III

10/4/2011

NYPRO INC

25352 A

III

10/4/2011

NYPRO INC

25353 A

III

10/5/2011

AMPACET CORP

25354 A

II

10/5/2011

MEGAFINE PHARMA P LTD

25355 A

II

10/5/2011

AMI LIFE SCIENCES PRIVATE LTD

MDI ACTUATOR/ DOSE COUNTER ASSEMBLY AS MANUFACTURED IN COUNTY DUBLIN,


IRELAND FOR NYPRO INC
CONCEPT ONE DRY POWDER INHALER AS MANUFACTURED IN FONTENAY SUR EURE,
FRANCE FOR NYPRO INC
112761 WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; CARTERSVILLE, GA; HEATH,
OH; DERIDDER ,LA
BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN DIST.
NASHIK, INDIA
TADALAFIL AS MANUFACTURED IN STATE GUJARAT, INDIA

25356 A

II

10/5/2011

MSN LABORATORIES LTD

AZELASTINE HYDROCHLORIDE USP [ROUTE CODE - AH"] AS MANUFACTURED IN TELANGANA

25357 I

II

11/3/2011

USV LIMITED

SEVELAMER CARBONATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25358 A

II

10/6/2011

SMS PHARMACEUTICALS LTD

SILDENAFIL CITRATE (UNIT-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

MX CASSETTES AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

Page 746

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25359 A
III
10/6/2011
AMPACET CORP
25360 A

II

10/6/2011

LABORATORIOS IMPERIALES SA DE CV

SUBJECT
169240 BLUE/HR POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN;
DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH
BISMUTH SUBSALICYLATE AS MANUFACTURED IN MORELOS, MEXICO

25361 A

II

11/16/2011

UNIMARK REMEDIES LTD

BUSPIRONE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25362 A

II

10/25/2011

UNIMARK REMEDIES LTD

MOXIFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25363 A

II

10/6/2011

SCI PHARMTECH INC

25364 A

II

10/7/2011

CENTAUR PHARMACEUTICALS PRIVATE LTD

(+)-THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID. HCI (5TC) AS MANUFACTURED IN


TAOYUAN, TAIWAN
TEMAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25365 A

II

10/7/2011

ALEMBIC PHARMACEUTICALS LTD

NISOLDIPINE AS MANUFACTURED IN GUJARAT, INDIA

25366 A

II

10/7/2011

MAPRIMED SA

RASAGILINE MESYLATE (CODE 50855) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

25367 A

II

10/28/2011

MALLINCKRODT INC

PARACETAMOL DC 272N (GELATIN) AS MANUFACTURED IN GREENVILE, ILLINOIS

25368 A

II

10/3/2011

ALP PHARM BEIJING CO LTD

25369 A

IV

9/30/2011

UNGERER AND CO

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR


ALP PHARM BEIJING CO., LTD.
ARTIFICIAL ROSE FLAVOR FU-6326 AS MANUFACTURED IN BETHLEHEM, PA

25370 A

II

10/3/2011

IBA MOLECULAR NORTH AMERICA INC

3'-DEOXY-3'-[18F]FLUOROTHYMIDINE AS MANUFACTURED IN TOTOWA, NJ

25371 A

II

10/11/2011

GE HEALTHCARE INC

25372 A

II

10/11/2011

SANDOZ PRIVATE LTD

FASTLAB FDG CITRATE CASSETTE PACK AS MANUFACTURED IN LIEGE, BELGIUM FOR GE


HEALTHCARE INC
DORIPENEM MONOHYDRATE, STERILE AS MANUFACTURED IN MAHARASHTRA, INDIA

25373 A

II

10/11/2011

ALEMBIC PHARMACEUTICALS LTD

FELODIPINE USP AS MANUFACTURED IN GUJARAT, INDIA

25374 A

III

10/11/2011

INDIAN EXTRUSIONS

HDPE BOTTLES WITH CAPS AS MANUFACTURED IN DAMAN, INDIA

25375 A

III

2/10/2012

RADPHARM SCIENTIFIC, A DIVISION OF GLOBAL


MEDICAL SOLUTIONS

RADPHARM GAMMA STERILIZED EMPTY VIALS 10ML, 20ML AND 30ML AS MANUFACTURED IN
BELCONNEN, AUSTRALIA FOR RADPHARM SCIENTIFIC, A DIVISION OF GLOBAL MEDICAL
SOLUTIONS

25376 A

III

10/12/2011

AMPACET CORP

25377 A

IV

10/12/2011

ABELEI INC

25378 A

II

10/12/2011

QILU PHARMACEUTICAL CO LTD

25379 A

IV

10/12/2011

MEXICHEM UK LTD

25380 A

II

10/13/2011

CENTAUR PHARMACEUTICALS PRIVATE LTD

154313 RED PE MB AS MANUFACTURED IN GRAND DUCHE DE, LUXEMBOURG FOR AMPACET


CORPORATION
PRODUCT #174A95 NAT. & ART. MINT FLAVOR POWDER AS MANUFACTURED IN NORTH
AURORA, IL
ROPIVACAINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE, P. R. OF CHINA
INHALATION GRADE 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE FOR USE IN METERED DOSE
INHALERS AS MANUFACTURED IN EL DORADO, AR FOR MEXICHEM UK LTD
NORTRIPTYLINE HCI USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25381 A

II

10/13/2011

25382 A

II

10/13/2011

25383 A

III

10/13/2011

CSPC ZHONGNUO PHARMACEUTICAL


SHIJIAZHUANG CO LTD
DISHMAN PHARMACEUTICALS AND CHEMICALS
LTD
TEKNOR COLOR CO

25384 A

III

4/30/2012

SHRIJI POLYMERS INDIA LTD

040,121TCS FDA TR BLUE 2% AS MANUFACTURED IN HENDERSONK, KY AND JACKSONVILLE,


TX
HIGH PERFORMANCE BOTTLES

25385 A

II

10/14/2011

CHEMI SPA

MESALAMINE CRYSTALLIZED, USP AS MANUFACTURED IN FROSINONE, ITALY

25386 A

III

10/14/2011

3M DRUG DELIVERY SYSTEMS

25387 A

II

10/14/2011

FRESENIUS KABI ANTI INFECTIVES SRL

SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (SMTS) ARRAY FOR BA058-SMTS AS


MANUFACTURED IN ST. PAUL, MN AND FLORENCE, KY FOR 3M DRUG DELIVERY SYSTEMS
BUFFERED NAFCILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY

25388 A

III

12/2/2011

WOLFE TORY MEDICAL, INC.

VAXINATOR ATOMIZATION TIP AS MANUFACTURED IN SALT LAKE CITY, UT

25389 A

II

10/17/2011

PIRAMAL ENTERPRISES LTD

ACYCLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN HEBEI PROVINCE, THE P. R. OF


CHINA
CHOLESTEROL HP AS MANUFACTURED IN GUJARAT, INDIA

Page 747

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25390 A
II
10/17/2011
CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
25391 A
V
10/17/2011
MEDISIZE CORP

SUBJECT
CEFIXIME NON-STERILE AS MANUFACTURED IN HEBEI PROVINCE, CHINA

25392 A

III

10/17/2011

UPM RAFLATAC OY

RP 31 PURUS AS MANUFACTURED IN TAMPERE, FINLAND

25393 A

II

10/18/2011

EUTICALS SPA

BUSULFAN AS MANUFACTURED IN VARESE, ITALY

25394 A

II

10/18/2011

EUTICALS SPA

BENDAMUSTINE HYDROCHLORIDE HYDRATE AS MANUFACTURED IN VARESE, ITALY

25395 A

IV

10/18/2011

UNGERER AND CO

N/A FRUIT TOPNOTE FLAVOR FU-6558 AS MANUFACTURED IN BETHLEHEM, PA

25396 A

III

10/18/2011

AMPACET CORP

25397 A

IV

10/18/2011

UNGERER AND CO

183538 BROWN PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
NATURAL ORANGE WONF FLAVOR FU-6556 AS MANUFACTURED IN BETHLEHEM, PA

25398 A

IV

10/18/2011

UNGERER AND CO

N/A CREAM FLAVOR FU-6557 AS MANUFACTURED IN BETHLEHEM, PA

25399 A

II

11/7/2011

GLAND CHEMICALS PRIVATE LTD

PEMETREXED DISODIUM 2.5 HYDRATE AS MANUFACTURED IN KARNATAKA, INDIA

25400 A

II

11/3/2011

GLAND PHARMA LTD

ARGATROBAN MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25401 A

II

11/4/2011

GLAND PHARMA LTD

INDOMETHACIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25402 A

II

10/20/2011

MEGAFINE PHARMA P LTD

25403 A

IV

8/1/2011

BHARAT COATS

25404 I

II

10/20/2011

JOYANG LABORATORIES

MEMANTINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


DIST. NASHIK, INDIA
PROTECTAB EC-1, PROTECTAB HP-1(ORGANIC), PROTECTAB HP-1 (AQUEOUS) AND
PROTECTAB MB-1 AS MANUFACTURED IN TAMILNADU, INDIA
BACITRACIN USP AS MANUFACTURED IN JIANGSU, CHINA

25405 A

II

10/20/2011

CHANGZHOU RUIMING PHARMACEUTICAL CO LTD

FELODIPINE AS MANUFACTURED IN JIANGSU, CHINA

25406 A

II

10/21/2011

CIDOFOVIR DIHYDRATE AS MANUFACTURED IN SHANDONG, CHINA

25407 A

III

10/21/2011

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO


LTD
NOVAPET SA

25408 A

IV

10/21/2011

FMC CORP FMC BIOPOLYMER DIV

25409 A

III

10/21/2011

LUCAS PACKAGING GROUP

25410 A

II

10/24/2011

MACLEODS PHARMACEUTICALS LTD

ALUBRA SODIUM STEARYL FUMARATE AS MANUFACTURED IN QUAKERTOWN, PA AND DIST.


RAIGAD, INDIA FOR FMC CORPORATION
AIRLESS METERED DOSE (AMD) PEN AS MANUFACTURED IN REEDSVILLE, PA FOR LUCAS
PACKAGING GROUP
ENTACAPONE AS MANUFACTURED IN GUJARAT, INDIA

25411 A

II

10/24/2011

HETERO LABS LTD

25412 A

II

10/24/2011

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

25413 A

IV

10/24/2011

TAKASAGO INTERNATIONAL CORP

25414 A

IV

10/24/2011

TAKASAGO INTERNATIONAL CORP

25415 A

IV

10/24/2011

TAKASAGO INTERNATIONAL CORP

25416 A

IV

10/25/2011

IDEAL CURES PVT LTD

HYDRALAZINE HYDROCHLORIDE, USP (PARENTERAL GRADE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1) AS MANUFACTURED IN
ZHEJIANG, CHINA
TAK-100176 MICRON NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN
TETERBORO, NJ
TAK-081662 MICRON NATURAL & ARTIFICIAL COOL PEPPERMINT FLAVOR AS
MANUFACTURED IN TETERBORO, NJ
TAK-100094 MICRON NATURAL & ARTIFICIAL CITRUS FLAVOR AS MANUFACTURED IN
TETERBORO, NJ
ESPHERES NEUTRAL PELLETS AS MANUFACTURED IN JAMMU & KASHMIR, INDIA

25417 A

II

10/26/2011

LAB EXPRESS INTERNATIONAL INC

CHLORHEXIDINE GLUCONATE SOLUTION USP 20% AS MANUFACTURED IN FAIRFIELD, NJ

25418 A

II

10/26/2011

SYMED LABS LTD

MECLIZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25419 P

INSERTER FOR LNG IUS 13.5 MG AND INSERTER FOR MIRENA

NOVAPET CR POLYESTER RESIN AS MANUFACTURED IN BARBASTRO(HUESCA), SPAIN

*** PENDING FILING REVIEW ***

25420 A

II

11/22/2011

OCEAN NUTRITION CANADA LTD

HIGH EPA INTERMEDIATE FISH OIL AS MANUFACTURED IN NOVA SCOTIA, CANADA

25421 A

II

3/1/2012

EXCELLA GMBH

DEFEROXAMINE MESYLATE USP AS MANUFACTURED IN FEUCHT, GERMANY

Page 748

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25422 A
IV
10/26/2011
FONA INTERNATIONAL INC

SUBJECT
815.0020U BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

25423 A

III

10/26/2011

TEKNOR COLOR CO

43,777HCP BLUE 25:1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX

25424 A

II

11/3/2011

AUROBINDO PHARMA LTD

25425 A

II

11/28/2011

DR REDDYS LABORATORIES LTD

SILDENAFIL CITRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
LINEZOLID AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25426 A

II

10/28/2011

HETERO DRUGS LTD

25427 A

II

1/3/2012

AMOLI ORGANICS PVT LTD

25428 A

10/26/2011

WEST PHARMACEUTICAL SERVICES INC

25429 A

IV

10/28/2011

ABELEI INC

25430 A

IV

10/28/2011

ABELEI INC

25431 A

III

10/28/2011

POLYCINE GMBH

25432 A

III

9/22/2011

EXTRAL SA DE CV

25433 A

II

12/29/2011

EMCURE PHARMACEUTICALS LTD

ALUMINUM BARRIER LAMINATION (ABL) AND PLASTIC BARRIER LAMINATION (PBL)


IMPRESSION AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO
BUSULFAN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25434 A

II

12/31/2011

SUN PHARMACEUTICAL INDUSTRIES LTD

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

25435 I

II

12/6/2011

RELIANCE LIFE SCIENCES PVT LTD

LOTEPREDNOL ETABONATE AS MANUFACTURED IN NAVI MUMBAI, INIDA

25436 A

II

10/31/2011

AVANTI POLAR LIPIDS INC

25437 A

III

10/31/2011

SIBO G DOO

1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PROCESS II (DSPC II) AS


MANUFACTURED IN ALABASTER, ALABAMA
CONTAINERS SIBO AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA

25438 A

IV

10/31/2011

SEPPIC SA

MONTANE 20 PPI AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S. A.

25439 A

III

10/31/2011

BRUNA SEALS LLC

CLOSURE LINERS AS MANUFACTURED IN MIAMI AND DORAL, FL

25440 A

II

10/31/2011

MAC CHEM PRODUCTS INDIA PVT LTD

SUCCINYLCHOLINE CHLORIDE USP AS MANUFACTURED IN DISTRICT THANE, INDIA

25441 A

III

10/31/2011

ESSEL PROPACK LTD

25442 A

III

10/11/2011

SANDLER AG

LAMINATED TUBES (MURBAD UNIT) AS MANUFACTURED IN DIST. THANE MAHARASHTRA,


INDIA
NONWOVEN SAWABOND 4163 AS MANUFACTURED IN SCHWARZENBACH/SAALE, GERMANY

25443 A

II

11/28/2011

ORCHID CHEMICALS AND PHARMACEUTICALS LTD CEFEPIME HCI USP AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA

25444 A

II

12/20/2012

GLAXOSMITHKLINE LLC

25445 P

SERTRALINE HYDROCHLORIDE, USP (FORM 1) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
CELECOXIB AS MANUFACTURED IN GUJARAT STATE, INDIA
WESTAR READY-TO-USE (RU) GAMMA IRRADIATED ELASTOMERS AS MANUFACTURED IN
JERSEY SHORE, PA FOR WEST PHARMACEUTICAL SERVICES, INC
113A68 NATURAL & ARTIFICIAL BERRY TYPE FLAVOR POWDER AS MANUFACTURED IN NORTH
AURORA, IL
144A147 NATURAL & ARTIFICIAL TROPICAL TYPE FLAVOR POWDER AS MANUFACTURED IN
NORTH AURORA, IL
APP147 AS MANUFACTURED IN SCHIFFWEILER, GERMANY

CLOBETASOL PROPIONATE AS MANUFACTURED IN MONTROSE, UK FOR GLAXOSMITHKLINE


LLC

*** PENDING FILING REVIEW ***

25446 A

II

11/14/2011

CADILA HEALTHCARE LTD

IRBESARTAN USP AS MANUFACTURED IN STATE: GUJARAT, INDIA

25447 A

II

2/8/2012

CADILA HEALTHCARE LTD

DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA

25448 A

II

11/2/2011

SYMBIOTEC PHARMALAB LTD

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN INDORE (M.P.), INDIA

25449 A

IV

11/2/2011

CELANESE EVA PERFORMANCE POLYMERS

25450 I

11/1/2011

ROTEM INDUSTRIES LTD

25451 A

III

11/2/2011

AMPACET CORP

25452 A

III

11/2/2011

AMPACET CORP

ETHYLENE VINYL ACETATE COPOLYMER, ATEVA K2356.XO1 AS MANUFACTURED IN


ALBERTA, CANADA
DISPOSABLE CASSETTE FOR VIAL FILLER SYSTEM AS MANUFACTURED IN BEER-SHEVA,
ISRAEL
100665 MOLD RELEASE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEALTH, OH
122103 SILVER PEARL PE MB AS MANFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEALTH, OH

Page 749

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25453 A
III
11/2/2011
AMPACET CORP
25454 A

II

12/16/2011

CHEMSPEC API

SUBJECT
169617 PEARL VIOLET PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEALTH , OH
MENADIOL SODIUM DIPHOSPHATE AS MANUFACTURED IN FAIRFIELD, NJ

25455 A

II

11/3/2011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

CANDESARTAN CILEXETIL AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. OF CHINA

25456 A

II

11/3/2011

VASUDHA PHARMA CHEM LTD

CYPROHEPTADINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25457 A

II

11/3/2011

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

25458 A

III

11/3/2011

GIL PLASTIC PRODUCTS LTD

PENTETIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE PHARMA


INC
PLASTIC JARS AND BOTTLES AS MANUFACTURED IN ASHDOD, ISRAEL

25459 A

IV

11/3/2011

CELANESE EVA PERFORMANCE POLYMERS

25460 A

II

11/16/2011

JUBILANT HOLLISTERSTIER LLC

ETHYLENE VINYL ACETATE COPOLYMER, ATEVA K2357.X01 AS MANUFACTURED IN ALBERTA,


CANADA
STERILE EMPTY VIALS AS MANUFACTURED IN SPOKANE, WA

25461 A

II

10/20/2011

CHENG FONG CHEMICAL CO LTD

PROCAINAMIDE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN

25462 A

II

12/14/2011

PAR PHARMACEUTICAL INC

PIMOZIDE USP AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR PHARMACEUTICAL, INC

25463 A

IV

11/4/2011

CELANESE EVA PERFORMANCE POLYMERS

25464 A

II

11/4/2011

25465 A

II

11/4/2011

ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE K2418.X01 AS MANUFACTURED IN


ALBERTA, CANADA
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO CLOPIDOGREL BISULFATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
LTD
KEKULE PHARMA LTD
NILUTAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25466 A

II

11/4/2011

SYN TECH CHEM AND PHARM CO LTD

TOLPERISONE HYDROCHLORIDE AS MANUFACTURED IN TAINAN CITY, TAIWAN

25467 A

II

11/4/2011

EXEMED PHARMACEUTICALS

METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25468 I

II

11/4/2011

HUAYI ISOTOPES CO

RK-100 AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

25469 I

II

11/4/2011

HUAYI ISOTOPES CO

OXYGEN-18 WATER AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

25470 A

II

11/29/2011

ARCH PHARMALABS LTD

25471 A

III

3/22/2012

PADMA POLYTEX INDIA PVT LTD

CLOPIDOGREL CAMPHOR SULPHONATE SALT AS MANUFACTURED IN HARYANA, INDIA FOR


ARCH PHARMALABS LIMITED
PLASTIC POUCHES (POLY BAGS) AS MANUFACTURED IN UJJAIN,(M.P.) INDIA

25472 A

II

1/10/2012

MACLEODS PHARMACEUTICALS LTD

ARIPIPRAZOLE AS MANUFACTURED IN GUJRAT, INDIA

25473 A

III

11/10/2011

METALCO S.R.L.

25474 I

II

11/8/2011

FINORGA SAS

ALUMINUM CONTAINERS FOR BULK DRUGS SUBSTANCES AS MANUFACTURED IN


MONTECARLO (LU), ITALY
FENOFIBRATE AS MANUFACTURED IN MOURENX, FRANCE

25475 A

IV

11/7/2011

PHOSPHOLIPID GMBH

PHOSAL 35 SB AS MANUFACTURED IN COLOGNE, GERMANY

25476 A

III

11/10/2011

FUJIMORI KOGYO CO LTD

25477 A

II

11/10/2011

FRESENIUS KABI ANTI INFECTIVES SRL

RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES ** E-0010 GT AS
MANUFACTURED IN SHIZUOKA PREF., JAPAN
AMPICILLIN SODIUM/SULBACTAM SODIUM AS MANUFACTURED IN VILLADOSE (RO), ITALY

25478 A

II

11/10/2011

ICROM SPA

25479 A

II

11/4/2011

MEISSNER FILTRATION PRODUCTS INC

BRINZOLAMIDE (MICRONIZED AND NON MICRONIZED, STERILE AND NON STERILE) AS


MANUFACTURED IN CONCOREZZO, ITALY
FLUOROFLEX BIOCONTAINERS AS MANUFACTURED IN CAMARILLO, CA

25480 A

III

11/10/2011

AURIGA POLYMERS INC

POLYETHYLENE TEREPHTHALATE RESINS, SPARTANBURG, SC

25481 I

II

11/10/2011

DERIVADOS QUIMICOS SA

DIOXANONE AS MANUFATURED IN MURCIA (SPAIN)

25482 A

II

11/9/2011

HETERO LABS LTD

BORTEZOMIB (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25483 A

II

11/9/2011

TEVA PHARMACEUTICAL INDUSTRIES LTD

25484 A

II

12/6/2011

EMCURE PHARMACEUTICALS LTD

IRBESARTAN AS MANUFACTURED IN MALANPUR AND GAJRAULA, INDIA FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD.
ANASTROZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25485 A

III

11/9/2011

PG FOILS LTD

PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN RAJASTHAN, INDIA

Page 750

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25486 A
II
11/9/2011
TOYOX CO LTD

SUBJECT
TOYOX SILICONE HOSE SERIES AS MANUFACTURED IN TOYAMA-PREF., JAPAN FOR TOYOX
COMPANY LTD.
CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF NEUTRAL-BOROSILICATE GLASS
(TYPE I, USP) TUBING, DANYANG CITY, P.R. CHINA
SOLIFENACIN SUCCINATE AS MANUFACTURED IN VICENZA, ITALY FOR PHF SA

25487 A

III

11/9/2011

JIANGSU CHAOHUA GLASSWORK CO LTD

25488 I

II

12/23/2011

PHF SA

25489 A

III

11/9/2011

JIANGSU CHAOHUA GLASSWORK CO LTD

25490 A

II

11/9/2011

AVANTI POLAR LIPIDS INC

25491 A

II

12/8/2011

SHILPA MEDICARE LTD

CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF LOW-BOROSILICATE GLASS


TUBING ( TYPEI, USP) DANYANG CITY, P.R CHINA
1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PROCESS II (DMPC II) AS
MANUFACTURED IN ALABASTER, AL
BUSULFAN USP AS MANUFACTURED IN KARNATAKA, INDIA

25492 A

II

11/14/2011

APOTEX PHARMACHEM INDIA PVT LTD

LINEZOLID AS MANUFACTURED IN BANGALORE, INDIA

25493 A

II

11/14/2011

APOTEX PHARMACHEM INDIA PVT LTD

LANSOPRAZOLE USP AS MANUFACTURED IN BANGALORE, INDIA

25494 A

II

11/14/2011

APOTEX PHARMACHEM INDIA PVT LTD

OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN BANGALORE, INDIA

25495 A

II

11/14/2011

INTAS PHARMACEUTICALS LTD

DOCETAXEL ANHYDROUS USP AS MANUFACTURED IN GUJARAT, INDIA

25496 I

II

1/3/2012

PIRAMAL HEALTHCARE UK LTD

SPIRONOLACTONE USP AS MANUFACTURED IN NORTHUMBERLAND, ENGLAND

25497 A

II

12/22/2011

CHEMSPEC-API

ISOCARBOXAZID AS MANUFACTURED IN FAIRFIELD, NJ

25498 A

II

11/14/2011

GLOCHEM INDUSTRIES LTD

LEVODOPA AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25499 A

II

11/14/2011

PANTOPRAZOLE SODIUM AS MANUFACTURED IN HANGZHOU, CHINA

25500 A

III

11/14/2011

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
PFP TERMOPOLIMEROS SL

25501 A

II

11/14/2011

SUNBIO, INC.

25502 A

III

11/14/2011

CONSOLIDATED BOTTLE CORP

25503 A

II

12/20/2011

ALEMBIC PHARMACEUTICALS LTD

METHOXY POLYETHYLENE GLYCOL BENZOTRIAZOLYL CARBONATE 20,000 AS


MANUFACTURED IN ANYANG CITY, S. KOREA
"1" X 2" NATURAL PP VIAL PRINTED WITH LINE - BLUE" AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT, INDIA

25504 A

II

6/3/2011

SANOFI AVENTIS DEUTSCHLAND GMBH

PREDNICARBATE AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY

25505 A

II

11/16/2011

BD BIOSCIENCES ADVANCED BIOPROCESSING

25506 A

II

11/17/2011

25507 A

II

11/18/2011

DISHMAN PHARMACEUTICALS AND CHEMICALS


LIMITED
SIEGFRIED USA LLC

BD RECHARGE WITHOUT GLUCOSE AND L-GLUTAMINE AS MANUFACTURED IN MIAMI, FL;


SPARKS, MD AND SARANAC LAKE, NY FOR BD BIOSCIENCE ADVANCED BIOPROCESSING
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

25508 A

II

11/18/2011

ICEUTICA OPERATIONS LLC

MELOXICAM SOLUMATRIX TM CAPSULES, AS MANUFACTURED IN KANSAS CITY, MO

25509 A

II

11/18/2011

ZHUHAI RUNDU PHARMACEUTICAL CO LTD

25510 A

II

11/18/2011

ZHUHAI RUNDU PHARMACEUTICAL CO LTD

IRBESARTAN AS MANUFACTURED IN GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF


CHINA
VALSARTAN AS MANUFACTURED IN GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA

25511 A

II

11/18/2011

JIANGSU HENGRUI MEDICINE CO LTD

25512 A

II

11/21/2011

HERAEUS PRECIOUS METALS GMBH AND CO KG

CISATRACURIUM BESYLATE, NON-STERILE, BULK DRUG SUBSTANCE, AS MANUFACTURED IN


JIANGSU PROVINCE, CHINA
BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN HANAU, GERMANY

25513 A

II

11/22/2011

MSN ORGANICS PVT LTD

TADALAFIL [ROUTE CODE - "TD"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25514 A

II

11/22/2011

SMS PHARMACEUTICALS LTD

ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25515 A

III

11/22/2011

AGUA FARMA PLASTICOS SA DE CV

25516 A

III

11/22/2011

HBR PACKAGING

HDPE & LDPE BOTTLES AS MANUFACTURED IN JALISCO, MEXICO FOR AGUA FARMA
PLASTICOS, S.A DE C.V.
ALUMINIUM VIAL SEALS AS MANUFACTURED IN THANE, INDIA

BOTE 1500ML HDPE/BO-TE US AS MANUFACTURED IN BARCELONA, SPAIN

BUPRENORPHINE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE, NEW JERSEY

Page 751

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25517 A
II
12/6/2011
AUROBINDO PHARMA LTD
25518 A

III

11/22/2011

CHROMA CORP

SUBJECT
ATAZANAVIR SULFATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
PC57088 PURPLE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS

25519 A

II

11/23/2011

WUXI JIDA PHARMACEUTICAL CO LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

25520 A

3/25/2011

IONISOS IBERICA

FACILITY AND PROCEDURES FOR ELECTRON BEAM STERILIZATION IN TARANCON, SPAIN

25521 I

II

11/23/2011

JIANGSU HENGRUI MEDICINE CO LTD

25522 A

III

11/23/2011

AMERICHEM INC

CAPECITABINE USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN


JIANGSU, CHINA
61936-CD2 TAN COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH

25523 A

II

11/28/2011

ICROM SPA

AMISULPRIDE AS MANUFACTURED IN CONCOREZZO, ITALY

25524 A

II

11/28/2011

CHONGQING HUAPONT PHARMACEUTICAL CO LTD BENDAMUSTINE HCL AS MANUFACTURED IN CHONGQING , P.R. CHINA

25525 A

II

11/28/2011

PHYTON BIOTECH LLC

25526 A

II

11/28/2011

FRESENIUS KABI ANTI INFECTIVES SRL

25527 A

II

11/28/2011

ALEMBIC PHARMACEUTICALS LTD

PACLITAXEL PRODUCED BY PLANT CELL FERMENTATION USP AS MANUFACTURED IN DELTA,


BC, CANADA
BUFFERED PENICILLIN G POTASSIUM STERILE AS MANUFACTURED IN CERNUSCO SUL
NAVIGILIO, ITALY
O-DESMETHYL VENLAFAXINE AS MANUFACTURED IN GUJARAT, INDIA

25528 A

II

12/17/2014

CHEMWERTH INC

NEPAFENAC AS MANUFACTURED IN MAHARASHTRA, INDIA FOR CHEMWERTH INC

25529 P

*** PENDING FILING REVIEW ***

25530 A

II

12/8/2011

TORRENT PHARMACEUTICALS LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN GUJARAT, INDIA

25531 A

II

5/14/2012

CHENGDU SHENGNUO BIOPHARM CO LTD

BIVALIRUDIN (NON-STERILE BULK DRUG) AS MANUFACTURED IN SICHUAN, CHINA

25532 A

II

12/16/2011

FRESENIUS KABI ONCOLOGY LTD

DECITABINE AS MANUFACTURED IN WEST BENGAL, INDIA

25533 A

II

11/30/2011

25534 A

II

11/30/2011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO METAXALONE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA


LTD
SYMBIOTEC PHARMALAB LTD
TESTOSTERONE UNDECANOATE AS MANUFACTURED IN (M.P.), INDIA

25535 A

II

11/30/2011

SYMBIOTEC PHARMALAB LTD

TESTOSTERONE PROPIONATE, USP (MICRONIZED) AS MANUFACTURED IN (M.P.), INDIA

25536 A

II

11/29/2011

DAEWOONG BIO INC

URSODIOL USP AS MANUFACTURED IN KYUNGGI-DO, KOREA

25537 A

II

11/29/2011

SEIKAGAKU CORP

SODIUM HYALURONATE AS MANUFACTURED IN KANAGAWA, JAPAN

25538 A

II

12/6/2011

COSMA SPA

GLICLAZIDE AS MANUFACTURED IN BERGAMO, ITALY

25539 A

III

12/2/2011

VERSALIS SPA

RIBLENE MP 31 R AS MANUFACTURED IN FERRARA, ITALY

25540 A

III

12/2/2011

POLIMERI EUROPA SPA

RIBLENE MR 10 R AS MANUFACTURED IN FERRARA, ITALY

25541 A

II

12/1/2011

FERMION OY

OSPEMIFENE AS MANUFACTURED IN OULU, FINLAND

25542 A

II

12/1/2011

DJADA PHARMACEUTICAL SA

BEXAROTENE AS MANUFACTURED IN CHONGQING, CHINA FOR DJADA PHARMACEUTICAL SA

25543 A

II

12/1/2011

NEULAND LABORATORIES LTD

EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25544 A

II

12/1/2011

HIKMA PHARMACEUTICALS PLC

MILRINONE, USP AS MANUFACTURED IN AMMAN, JORDAN

25545 A

II

12/1/2011

FRESENIUS KABI ANTIINFECTIVES SRL

25546 A

II

12/1/2011

LG LIFE SCIENCES LTD

PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED AS


MANUFACTURED IN CERNUSCO SUL NAVIGLIO, ITALY
MONTELUKAST SODIUM AS MANUFACTURED IN ULSAN, KOREA

25547 A

II

12/2/2011

SYMBIOTEC PHARMALAB LTD

FLUMETHASONE AS MANUFACTURED IN INDORE, INDIA

25548 A

II

12/2/2011

ALPHORA RESEARCH INC

TREPROSTINIL SODIUM AS MANUFACTURED IN ONTARIO, CANADA

25549 A

II

12/2/2011

SCINOPHARM TAIWAN LTD

ENTECAVIR MONOHYDRATE AS MANUFACTURED IN TAINAN, TAIWAN

25550 A

II

12/2/2011

HETERO LABS LTD

ETRAVIRINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 752

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25551 A
V
12/2/2011
ROTEM INDUSTRIES LTD
25552 A

II

12/5/2011

ZHEJIANG TIANYU PHARMACEUTICAL CO LTD

SUBJECT
CASSETTE FOR THE PRODUCTION OF FLUORINE-18 SODIUM FLUORIDE ON THE TRACERLAB
MX SYNTHESIS UNIT AS MANUFACTURED IN BEER SHEVA, ISRAEL
TELMISARTAN METHYL ESTER AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

25553 A

IV

12/5/2011

LIPOID GMBH

LIPOID SODIUM OLEATE B AS MANUFACTURED IN LUDWIQSHAFEN, GERMANY

25554 A

III

12/5/2011

SUZHOU HAISHUN PACKAGING MATERIAL CO LTD

25555 A

III

12/5/2011

HANGZHOU PLASTICS INDUSTRIAL CO LTD

25556 A

II

12/27/2011

GLAND PHARMA LTD

LAMINATED FILMS AND POUCHES (PET/A1/PE) FOR PHARMACEUTICAL PACKAGING AS


MANUFACTURED IN SUZHOU, P.R. CHINA
PVC SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS MANUFACTURED IN HANGZHOU,
CHINA
DALTEPARIN SODIUM PH.EUR. AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25557 A

II

12/6/2011

SHARON BIO MEDICINE LTD

NIFEDIPINE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA

25558 A

III

12/7/2011

BORMIOLI ROCCO SPA BU PLASTICS

25559 A

II

3/15/2012

RELIANCE LIFE SCIENCES PVT LTD

DROPPER 1.00 MM AS MANUFACTURED IN CASTELGUELFO(PR),RIVANAZZANO, ITALY, SAINT


SULPICE, FRANCE
PEMETREXED DISODIUM AS MANUFACTURED IN NAVI MUMBAI, INDIA

25560 A

II

12/22/2011

ALCHYMARS ICM SM PRIVATE LTD

SODIUM PHENYLBUTYRATE AS MANUFACTURED IN TAMILNADU, INDIA

25561 A

II

5/2/2012

NECTAR LIFESCIENCES LTD

25562 A

IV

9/4/2012

NECTAR LIFESCIENCES LTD

25563 A

II

12/9/2011

GLOCHEM INDUSTRIES LTD

CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE (PROCESS-II) AS MANUFACTURED


IN PUNJAB, INDIA
HARD GELATIN CAPSULE SHELL (PROCESS-II) AS MANUFACTURED IN DISTT. SOLAN (H.P),
INDIA
CARBIDOPA AS MANUFACTURED IN TELANGANA, INDIA

25564 A

II

12/8/2011

KOTHARI PHYTOCHEMICALS INTERNATIONAL

25565 A

II

12/6/2011

COPPERHEAD INVESTMENTS INC

25566 A

IV

12/8/2011

FONA INTERNATIONAL INC

METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MADURAI DISTRICT, TAMILNADU,


INDIA
SDM12, DILUTED NITROGLYCERIN USP AS MANUFACTURED IN TAMAQUA, PENNSYLVANIA
FOR COPPERHEAD INVESTMENTS INC
815.086 BUBBLEGUM FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

25567 A

II

12/8/2011

HETERO LABS LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA

25568 A

II

12/8/2011

NEULAND LABORATORIES LTD

MONTELUKAST SODIUM AS MANUFACTURED IN TELANGANA, INDIA

25569 A

II

2/24/2012

LUPIN LTD

FOSAMPRENAVIR CALCIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

25570 A

II

12/29/2011

NECTAR LIFESCIENCES LTD

CEFDINIR USP AS MANUFACTURED IN PUNJAB, INDIA

25571 A

III

12/13/2011

YAMANI YAKUHIN CO LTD

DRYEN SILICA GEL DESICCANT AS MANUFACTURED IN SHIGA, JAPAN

25572 A

II

12/13/2011

HETERO DRUGS LTD

APREPITANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25573 A

II

12/12/2011

NORAC INC

NGT-10100 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA

25574 A

II

12/12/2011

25575 A

III

12/12/2011

25576 A

II

12/12/2011

SHANDONG FANGMING PHARMACEUTICAL GROUP GLICLAZIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA


CO LTD
AMPACET CORP
111818-K BLOMITE 818 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET
CORPORATION
QILU PHARMACEUTICAL CO LTD
DOCETAXEL TRIHYDRATE AS MANUFACTURED IN SHANDONG P.R. CHINA

25577 A

II

12/12/2011

MYLAN LABORATORIES LTD

ILOPERIDONE AS MANUFACTURED IN TELANGANA, INDIA

25578 A

II

12/12/2011

MYLAN LABORATORIES LTD

FOSAMPRENAVIR CALCIUM AS MANUFACTURED IN TELANGANA, INDIA

25579 A

II

12/12/2011

MYLAN LABORATORIES LTD

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25580 A

II

1/11/2012

PAR PHARMACEUTICAL INC

25581 A

II

12/13/2011

ALEMBIC PHARMACEUTICALS LTD

PHENOXYBENZAMINE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA FOR


PAR PHARMACEUTICAL INC
FAMOTIDINE USP AS MANUFACTURED IN GUJARAT, INDIA

25582 A

II

12/14/2011

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

CELECOXIB AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA

25583 A

II

12/13/2011

SMILAX LABORATORIES LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 753

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25584 A
II
12/23/2011
FERMENTA BIOTECH LTD
25585 A

III

12/13/2011

GUJARAT FOILS LTD

25586 A

III

12/7/2011

AMPACET CORP

25587 A

II

12/13/2011

HETERO DRUGS LTD

SUBJECT
CHOLECALCIFEROL USP (CRYSTALLINE VITAMIN D3) AS MANUFACTURED IN HIMACHAL
PRADESH, INDIA
BLISTER FOIL (BARE / COATED / PRINTED ALUMINIUM FOIL) AS MANUFACTURED IN GUJARAT,
INDIA
474974 GREEN PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA,
CARTERSVILLE, GA, HEATH, OH
ACYCLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25588 A

II

3/20/2012

EMCURE PHARMACEUTICALS LTD

PROPAFENONE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25589 I

II

12/21/2011

POLYPEPTIDE LABORATORIES SWEDEN AB

TERLIPRESSIN ACETATE AS MANUFACTURED IN LIMHAMN, SWEDEN

25590 A

II

1/30/2012

API INC

PROCARBAZINE HYDROCHLORIDE AS MANUFACTURED IN FAIRFIELD, NJ

25591 A

III

3/20/2012

SHRIJI POLYMERS INDIA PVT LTD

25592 A

II

12/19/2011

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

LIQUID MEDICATION DISPENSERS AS MANUFACTURED IN MADHYA PRADESH, INDIA FOR


SHRIJI POLYMERS INDIA LTD
CAPECITABINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

25593 A

II

12/19/2011

FARMABIOS S P A

25594 A

II

1/19/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

25595 A

II

6/6/2012

K+S KALI GMBH

25596 A

III

11/22/2011

INDIAN EXTRUSIONS

POTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP AS MANUFACTURED IN DEUTSCHLAND,


GERMANY
POLYPROPYLENE (PP) AND PET BOTTLES WITH CAPS AS MANUFACTURED IN DAMAN, INDIA

25597 A

IV

12/13/2011

CABOT SANMAR LTD

CAB-O-SIL M-5P FUMED SILICA AS MANUFACTURED IN TAMIL NADU, INDIA

25598 A

II

12/20/2011

HAYASHIBARA CO LTD

MALTOSE MONOHYDRATE AS MANUFACTURED IN OKAYAMA, JAPAN

25599 A

12/20/2011

HAUPT PHARMA WOLFRATSHAUSEN GMBH

ASEPTIC PROCESS VALIDATION AS MANUFACTURED IN WOLFRATSHAUSEN, GERMANY

25600 A

III

12/20/2011

FUJIMORI KOGYO CO LTD

25601 A

III

12/15/2011

KRAIBURG TPE GMBH AND CO KG

LAMINATED SHEET FOR USE IN OUTER PACKAGING OF DRUG PRODUCT AS MANUFACTURED


IN YOKOHAMA CITY, JAPAN
THERMOLAST M-TM#HET AS MANUFACTURED IN WALDKRAIBURG, GERMANY

25602 A

III

12/21/2011

KRAIBURG TPE GMBH AND CO KG

THERMOLAST M - TM(3 TO 7)MHD AS MANUFACTURED IN WALDKRAIBURG, GERMANY

25603 A

III

12/21/2011

KRAIBURG TPE GMBH AND CO KG

THERMOLAST M - TM(3 TO 4)RST AS MANUFACTURED IN WALDKRAIBURG, GERMANY

25604 A

III

12/15/2011

KRAIBURG TPE GMBH AND CO KG

THERMOLAST M-TM # ADT AS MANUFACTURED IN WALDKRAIBURG, GERMANY

25605 A

II

12/20/2011

WUXI JIDA PHARMACEUTICAL CO. LTD.

RISPERIDONE AS MANUFACTURED IN JIANGYIN CITY, CHINA

25606 A

II

12/13/2011

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

TESTOSTERONE PROPIONATE NON-STERILE BULK AS MANUFACTURED IN ZHEJIANG, CHINA

25607 A

III

12/21/2011

KRAIBURG TPE GMBH AND CO KG

THERMOLAST M - TM#LFT AS MANUFACTURED IN WALDKRAIBURG, GERMANY

25608 A

II

12/22/2011

SMS PHARMACEUTICALS LTD

25609 A

II

10/25/2011

JIANGXI FUSHINE PHARMACEUTICAL CO LTD

RANITIDINE HYDROCHLORIDE USP (UNIT-VII) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
SULBACTAM AS MANUFACTURED IN JINGDEZHEN CITY, CHINA

25610 A

III

12/19/2011

EVONIK INDUSTRIES AG

DEGALAN PM 555 AS MANUFACTURED IN DARMSTADT, GERMANY

25611 A

III

12/19/2011

EVONIK INDUSTRIES AG

DEGALAN VP 4164 E AS MANUFACTURED IN DARMSTADT, GERMANY

25612 A

II

12/22/2011

MEDICHEM MANUFACTURING MALTA LTD

MED-200400/M AS MANUFACTURED IN HAL FAR BBG, MALTA

25613 A

II

2/12/2011

VITAL LABORATORIES PVT LTD

SCOPOLAMINE HYDRO BROMIDE AS MANUFACTURED IN GUJARAT, INDIA

25614 A

II

12/21/2011

HETERO DRUGS LTD

FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25615 A

II

12/20/2011

FARMABIOS S P A

BUDESONIDE MICRONIZED STERILE AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY

25616 A

III

12/13/2011

AMPACET CORP

100671 PP UV MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE,


GA AND HEATH, OH

METHYLTESTOSTERONE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV),


ITALY
DOXERCALCIFEROL AS MANUFACTURED IN GUJARAT, INDIA

Page 754

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
25617 A
II
12/19/2011
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL EMTRICITABINE AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
25618 A
II
12/22/2011
NEULAND LABORATORIES LTD
PEMETREXED DISODIUM (FORM IV) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
NEULAND LABORATORIES LTD
25619 A
II
12/16/2011
SOCIETE INDUSTRIELLE DES OLEAGINEUX
BXR US REFINED SOYBEAN OIL AS MANUFACTURED IN CEDEX, FRANCE
25620 A

II

12/16/2011

SOCIETE INDUSTRIELLE DES OLEAGINEUX

BXR US REFINED OLIVE OIL AS MANUFACTURED IN CEDEX, FRANCE

25621 A

II

12/22/2011

TEVA PHARMACEUTICAL INDUSTRIES LTD

OMEPRAZOLE AS MANUFACTURED IN PRUDNICKA CESTA 54 CROATIA

25622 A

II

12/23/2011

EUTICALS SPA

ROCURONIUM BROMIDE AS MANUFACTURED IN ROZZANO (MI), ITALY

25623 A

II

12/23/2011

INKE SA

RIZATRIPTAN BENZOATE AS MANUFACTURED IN BARCELONA, SPAIN

25624 A

II

12/27/2011

MAC CHEM PRODUCTS INDIA PVT LTD

DACARBAZINE USP AS MANUFACTURED IN DISTRICT THANE, INDIA

25625 I

II

12/23/2011

JIANGSU HANSOH PHARMACEUTICAL CO LTD

25626 I

II

12/23/2011

JIANGSU HENGRUI MEDICINE CO LTD

25627 A

III

12/12/2011

THURINGER PHARMAGLAS GMBH AND CO KG

25628 A

II

12/22/2011

SIEGFRIED USA LLC

25629 A

II

12/23/2011

CRYSTAL PHARMA SAU

DULOXETINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED


IN JIANGSU, CHINA
AZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED
IN JIANGSU, CHINA
VIALS AND AMPOULES MADE OF TUBULAR GLASS AS MANUFACTURED IN
NEUHAUS/RENNWEG, GERMANY
OXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY) AS MANUFACTURED IN
PENNSVILLE, NEW JERSEY
BUDESONIDE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN

25630 A

II

12/27/2011

EVERLIGHT CHEMICAL INDUSTRIAL CORP

RASAGILINE MESYLATE AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN

25631 A

II

12/5/2011

HUNAN YUANTONG PHARMACEUTICAL CO LTD

DIOSMIN AS MANUFACTURED IN HUNAN PROVINCE, CHINA

25632 A

II

12/13/2011

VITAL LABORATORIES PVT LTD

YOHIMBINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA

25633 A

II

2/15/2012

APICORE US LLC

CLOFARABINE AS MANUFACTURED IN GUJARAT, INDIA

25634 A

II

12/27/2011

SCINOPHARM TAIWAN LTD

BIVALIRUDIN AS MANUFACTURED IN TAINAN, TAIWAN

25635 A

III

11/20/2011

VIVEK POLYMER (INDIA)

PLASTIC BOTTLES AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA

25636 A

II

12/28/2011

RAKS PHARMA PVT LTD

CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25637 A

II

12/29/2011

HETERO DRUGS LTD

FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25638 A

II

12/29/2011

PHARMACEUTICAL WORKS POLPHARMA SA

IBANDRONATE SODIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

25639 A

II

12/29/2011

MYLAN LABORATORIES LTD

SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25640 A

II

12/27/2011

SUZHOU LIXIN PHARMACEUTICAL CO LTD

PEMETREXED DISODIUM AS MANUFACTURED IN JIANGSU, CHINA

25641 I

II

12/28/2011

QILU PHARMACEUTICAL CO LTD

ADEFOVIR DIPIVOXIL (NON STERILE, API) AS MANUFACTURED IN SHANDONG, CHINA

25642 A

II

12/28/2011

MEGAFINE PHARMA P LTD

PALIPERIDONE (NON- STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK, INDIA

25643 A

III

1/3/2012

FILM WRAPPER FOR TRANSDERMAL PATCHES AS MANUFACTURED IN RONSBERG, GERMANY

25644 A

II

1/29/2011

HUHTAMAKI FLEXIBLE PACKAGING GERMANY


GMBH & CO KG
CHEMWERTH INC

25645 A

IV

12/27/2011

IDEAL CURES PVT LTD

MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG,


GERMANY FOR CHEMWERTH INC
ECOPAL TM RANGE OF ACRYLIC POLYMERS AS MANUFACTURED IN GUJARAT, INDIA

25646 A

II

2/16/2012

CADILA HEALTHCARE LTD

SALMETEROL XINAFOATE USP AS MANUFACTURED IN GUJARAT, INDIA

25647 A

II

2/21/2012

CADILA HEALTHCARE LTD

ETHACRYNIC ACID USP AS MANUFACTURED IN GUJARAT, INDIA

25648 A

II

12/30/2011

RAKS PHARMA PVT LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25649 A

II

1/16/2012

RANBAXY LABORATORIES LTD

FOSAMPRENAVIR CALCIUM AS MANUFACTURED IN PUNJAB, INDIA

25650 A

II

1/10/2012

AUROBINDO PHARMA LTD

RALOXIFENE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED


IN ANDHRA PRADESH, INDIA

Page 755

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25651 A
II
12/30/2011
MYLAN LABORATORIES LTD

SUBJECT
PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25652 A

II

12/30/2011

MYLAN LABORATORIES LTD

DESMOPRESSIN ACETATE USP AS MANUFACTURED IN TELANGANA, INDIA

25653 A

II

12/30/2011

MYLAN LABORATORIES LTD

EZETIMIBE AS MANUFACTURED IN TELANGANA, INDIA

25654 A

II

1/3/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

25655 A

III

12/30/2011

INTERNATIONAL CONVERTER LLC

25656 A

II

1/13/2012

WOCKHARDT LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN GAJRAULA, MALANPUR IN INDIA FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
FLEXIBLE PACKAGING FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN
CALDWELL, OH AND LUKA, MS
DESVENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

25657 A

II

2/20/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN MAHARASHTRA, INDIA

25658 P

*** PENDING FILING REVIEW ***

25659 A

II

12/30/2011

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MITOMYCIN ALTERNATIVE PROCESS AS MANUFACTURED IN TAIZHOU, ZHEJIANG, CHINA

25660 I

II

3/23/2012

IPCA LABORATORIES LTD

ESCITALOPRAM OXALATE AS MANUFACTURED IN MADHYA PRADESH, INDIA

25661 P

*** PENDING FILING REVIEW ***

25662 A

II

3/27/2012

IPCA LABORATORIES LTD

TRIMETHOPRIM USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

25663 A

II

1/3/2012

TORRENT PHARMACEUTICALS LTD

REPAGLINIDE AS MANUFACTURED IN GUJARAT, INDIA

25664 A

II

12/10/2010

ALP PHARM BEIJING CO LTD

FEBUXOSTAT AS MANUFACTURED IN HUBEI, CHINA FOR ALP PHARM BEIJING CO LTD

25665 A

II

12/30/2011

SCINOPHARM TAIWAN LTD

BORTEZOMIB AS MANUFACTURED IN TAINAN, TAIWAN

25666 A

II

12/22/2011

ALP PHARM BEIJING CO LTD

25667 A

II

2/2/2012

CHEMWERTH INC

CILOSTAZOL USP AS MANUFACTURED IN CHONGQING, CHINA FOR ALP PHARM BEIJING CO


LTD
BUSULFAN USP NON-STERILE BULK DRUG AS MANUFACTURED IN SICHUAN PROVINCE, P. R.
OF CHINA FOR CHEMWERTH INC

25669 A

II

2/16/2012

UNIMARK REMEDIES LTD

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

25670 A

II

1/17/2012

SRI KRISHNA PHARMACEUTICALS LTD

BUTORPHANOL TARTRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25671 A

III

12/28/2011

H AND H GLASS INC

AMBER AND FLINT GLASS AS MANUFACTURED IN HSINCHU, TAIWAN FOR H & H GLASS INC

25672 A

II

1/4/2012

SAMYANG GENEXBIO CORP

DOCETAXEL ANHYDROUS AS MANUFACTURED IN DAEJEON, KOREA

25673 A

II

4/10/2012

LUNDBECK PHARMACEUTICALS ITALY SPA

ETHOTOIN AS MANUFACTURED IN PADOVA, ITALY FOR LUNDBECK LLC

25675 A

IV

12/30/2011

ILE PHARMACEUTICAL MATERIALS CO LTD

ENTERIC FILM COATING SYSTEMS AS MANUFACTURED IN TIANJIN, CHINA

25676 A

II

1/4/2012

AMINO CHEMICALS LTD

RUFINAMIDE USP AS MANUFACTURED IN MARSA, MALTA

25677 A

II

1/4/2012

AMINO CHEMICALS LTD

DICLOFENAC EPOLAMINE AS MANUFACTURED IN MARSA, MALTA

25678 A

II

1/4/2012

SAMYANG GENEXBIO CORP

DOCETAXEL TRIHYDRATE AS MANUFACTURED IN SEOL, KOREA

25679 A

II

1/5/2012

DAEWOONG BIO INC

STERILE MEROPENEM AS MANUFACTURED IN KYUNGGI-DO, KOREA

25680 A

II

1/5/2012

DAEWOONG BIO INC

IOPROMIDE AS MANUFACTURED IN KYUNGGI-DO, KOREA

25681 A

II

1/3/2012

JARI PHARMACEUTICAL CO LTD

OXALIPLATIN AS MANUFACTURED IN JIANGSU, CHINA

25682 A

II

1/6/2012

MSN LABORATORIES LTD

25683 A

II

12/22/2011

ICROM SPA

FOSAPREPITANT DIMEGLUMINE [ROUTE CODE - "FD"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
RISPERIDONE AS MANUFACTURED IN CONCOREZZO, ITALY

25684 A

1/6/2012

DURECT CORP

SUCROSE ACETATE ISOBUTYRATE (SAIB) AS MANUFACTURED IN VACAVILLE, CA

25685 A

II

12/20/2011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA

25668 P

*** PENDING FILING REVIEW ***

25674 P

*** PENDING FILING REVIEW ***

Page 756

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25686 A
II
1/9/2012
HETERO LABS LTD

SUBJECT
IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
CARISOPRODOL AS MANUFACTURED IN MAHARASHTRA, INDIA

25687 A

II

1/2/2012

POLYDRUG LABORATORIES PVT LTD

25688 A

III

1/6/2012

OREM ACCESS BIO INC

25689 A

III

12/20/2011

SIBO G DOO

MOISTURE AND ODOUR REGULATING PRODUCTS AS MANUFACTURED IN HYDERABAD,


ANDHRA PRADESH, INDIA
CLOSURES SIBO AS MANUFACTURED IN SLOVENIA, EUROPE

25690 A

IV

1/9/2012

FONA INTERNATIONAL INC

PRODUCT # 889.0069U PEACH FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

25691 A

IV

1/10/2012

LIPOID GMBH

25692 A

III

1/3/2012

ADHESIVES RESEARCH INC

LIPOID PE 16:0/16:0-PEG 5000 (MPEG 5000-DPPE) AS MANUFACTURED IN LUDWIGSHAFEN,


GERMANY
MA-69 (R-9667) AS MANUFACTURED IN GLEN ROCK, PA

25693 A

II

1/4/2012

AVRA LABORATORIES PRIVATE LTD

IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25694 A

II

1/18/2012

AUROBINDO PHARMA LTD

25695 A

II

5/15/2012

ENALTEC LABS PRIVATE LTD

TADALAFIL USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
DALFAMPRIDINE AS MANUFACTURED IN MAHARASHTRA, INDIA

25696 I

II

3/20/2012

USV LIMITED

COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25697 A

II

12/30/2011

SHANDONG KEXING BIOPRODUCTS CO LTD

25698 A

II

12/30/2011

SHANDONG KEXING BIOPRODUCTS CO LTD

25699 A

IV

1/10/2012

CELANESE EVA PERFORMANCE POLYMERS

25700 A

II

1/9/2012

FORMOSA LABORATORIES INC

RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR AS MANUFACTURED


IN ZHANG QIU-SHANDONG, CHINA
RECOMBINANT HUMAN ERYTHROPOIETIN AS MANUFACTURED IN ZHANG QIU-SHANDONG,
CHINA
ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE TM K2390.X01 AS MANUFACTURED IN
ALBERTA, CANADA
LINEZOLID AS MANUFACTURED IN TAOYUAN, TAIWAN

25701 A

II

1/9/2012

FORMOSA LABORATORIES INC

ULIPRISTAL ACETATE AS MANUFACTURED IN TAOYUAN, TAIWAN

25702 A

III

1/9/2012

GREINER PACKAGING GMBH

25703 A

II

4/9/2012

BIOCON LTD

250ML AND 950 ML PLASTIC BOTTLE INTENDED FOR PACKAGING ORAL SOLID DOSAGE
FORMS AS MANUFACTURED IN WERNBERG, AUSTRIA. RASTATT, GERMANY
TRAVOPROST USP DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA

25704 A

IV

10/22/2011

FONA INTERNATIONAL INC

856.061 GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL

25705 A

II

1/9/2012

25706 A

II

12/29/2011

QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO


LTD
KYONGBO PHARMACEUTICAL CO LTD

25707 A

II

12/20/2011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

TERBINAFINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG


PROVINCE, P. R. OF CHINA
MEROPENEM STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REP OF
KOREA
VORICONAZOLE USP AS MANUFACTURED IN ZHEJIANG, CHINA

25708 A

IV

1/16/2012

CELANESE EVA PERFORMANCE POLYMERS

25709 A

II

1/9/2012

25710 A

II

12/29/2011

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL


CO LTD
KYONGBO PHARMACEUTICAL CO LTD

25711 A

II

2/18/2012

MACLEODS PHARMACEUTICALS LTD

CEFTAZIDIME STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REPUBLIC OF


KOREA
RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

25712 A

II

1/18/2012

HETERO DRUGS LTD

OMEPRAZOLE, USP (FORM B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25713 A

II

1/5/2012

MSN ORGANICS PVT LTD

TOPIRAMATE USP [ROUTE CODE - "TI"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25714 A

II

1/16/2012

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

25715 I

II

1/17/2012

VIWIT PHARMACEUTICAL CO LTD

POTASSIUM CLAVULANATE, DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1 AS


MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA
APREPITANT (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN TENGZHOU, CHINA

25716 A

II

1/14/2012

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

STERILE CEFAZOLIN SODIUM PROCESS 1 AS MANUFACTURED IN JINAN CITY, CHINA

ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE K2389.X01 AS MANUFACTURED IN


ALBERTA, CANADA
HYDROXYCHLOROQUINE SULFATE (USP) AS MANUFACTURED IN SHANGHAI, P. R. CHINA

Page 757

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25717 A
II
2/23/2012
COSMA SPA

SUBJECT
MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN CISERANO(BERGAMO), ITALY

25718 A

II

1/16/2012

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

CLAVULANATE POTASSIUM AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA

25719 A

II

1/16/2012

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

25720 A

II

1/19/2012

APOTEX PHARMACHEM INDIA PVT LTD

POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO


1:1 AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA
CAPECITABINE USP AS MANUFACTURED IN BANGALORE, INDIA

25721 A

II

12/20/2011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

25722 A

III

1/11/2012

HANGZHOU PLASTICS INDUSTRIAL CO LTD

25723 A

III

1/11/2012

HANGZHOU PLASTICS INDUSTRIAL CO LTD

25724 A

III

1/11/2012

HANGZHOU PLASTICS INDUSTRIAL CO LTD

25725 A

III

12/10/2011

GUJARAT FOILS LTD

25726 A

II

1/25/2012

CHENG FONG CHEMICAL CO LTD

CARVEDILOL DIHYDROGEN PHOSPHATE HEMIHYDRATE USP AS MANUFACTURED IN


ZHEJIANG, CHINA
PP/A1/PVC/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN HANGZHOU, CHINA
PVC/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN HANGZHOU, CHINA
PVC/PE/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN HANGZHOU, CHINA
STRIP FOIL (BARE/COATED/LAMINATED/PRINTED/ALUMINUM FOIL) AS MANUFACTURED IN
GUJARAT, INDIA
4-PHENYLBUTYRIC ACID SODIUM SALT AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN

25727 A

II

3/26/2012

LUPIN LTD

DESVENLAFAXINE BENZOATE AS MANUFACTURED IN GUJARAT, INDIA

25728 A

II

1/19/2011

BIOCON LTD

HYDROXY ECHINOCANDIN AS MANUFACTURED IN BANGALORE, INDIA

25729 A

IV

1/23/2012

FONA INTERNATIONAL INC

825.527 N-C CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL

25730 A

II

1/24/2012

MSN LABORATORIES LTD

BICALUTAMIDE USP [ROUTE CODE - "BL"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25731 A

II

1/25/2012

NS PHARMA INC

25732 A

III

1/19/2012

ADVANCED SCIENTIFICS INC

25733 A

II

1/26/2012

NEULAND LABORATORIES LTD

NS-018 ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN YOKKAICHI, MIE, JAPAN FOR NS


PHARMA INC
POLYETHLENE BAGS AND TRANSFER TUBE ASSEMBLIES AS MANUFACTURED IN
MILLERSBURG, PA
DEFERASIROX AS MANUFACTURED IN TELANGANA, INDIA

25734 A

II

3/8/2012

DR REDDYS LABORATORIES LTD

ZOLMITRIPTAN (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25735 A

II

1/26/2012

BACHEM SA

ZIPRASIDONE HCL H2O AS MANUFACTURED IN VIONNAZ, SWITZERLAND

25736 A

II

1/24/2012

BCN PEPTIDES

VASOPRESSIN AS MANUFACTURED IN BARCELONA, SPAIN

25737 I

II

12/20/2011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG, CHINA

25738 A

II

2/7/2012

WISDOM PHARMCEUTICAL CO LTD

BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA

25739 A

IV

1/10/2012

TAKASAGO INTERNATIONAL CORP

DMF ORANGE FLAVOR OT-42107 AS MANUFACTURED IN IBARAKI, JAPAN

25740 A

II

1/26/2012

POLYMED THERAPEUTICS INC

25741 A

IV

1/28/2012

TOAGOSEI CO LTD

25742 A

II

1/25/2012

SIGNA SA DE CV

BORTEZOMIB DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED


THERAPEUTICS INC
POLYACRYLATE POLYMERS- ARONVIS AH-105, AH-105X, AH-106X, MX, SX, AND JURYMER AC10H AS MANUFACTURED IN KAGAWA AND FUKUSHIMA, JAPAN
TELMISARTAN USP/EP AS MANUFACTURED IN TOLUCA ESTADO DE MEXICO, MEXICO

25743 A

II

6/18/2012

JUHUA GROUP CORP PHARMACEUTICAL FACTORY DIFLUNISAL USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

25744 A

II

2/23/2012

EMCURE PHARMACEUTICALS LTD

MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25745 A

II

3/26/2012

DR REDDYS LABORATORIES LTD

ASENAPINE MALEATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25746 A

II

1/31/2012

APOTEX PHARMACHEM INDIA PVT LTD

MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN BANGALORE, INDIA

25747 I

II

1/30/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

25748 A

II

1/30/2012

BLUE ZONE TECHNOLOGIES LTD

DESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX AS MANUFACTURED IN PRIGORJE


BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
DESFLURANE USP AS MANUFACTURED IN ONTARIO, CANADA

Page 758

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25749 A
II
1/30/2012
TEVA PHARMACEUTICALS INDUSTRIES LTD
25750 A

II

3/20/2012

EMCURE PHARMACEUTICALS LTD

SUBJECT
DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN BEER SHEVA, ISRAEL AND PRIGORJE
BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
NISOLDIPINE AS MANUFACTURED IN MAHARASHTRA, INDIA

25751 A

II

2/24/2012

LUPIN LTD

DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA

25752 A

II

2/10/2012

PAN DRUGS LTD

GUAIFENESIN USP AS MANUFACTURED IN GUJARAT, INDIA

25753 A

II

4/2/2012

LUPIN LTD

RALTEGRAVIR POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

25754 A

IV

2/3/2012

FONA INTERNATIONAL INC

856.485 N-C GRAPE FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

25755 A

IV

1/10/2012

JUKU ORCHEM PRIVATE LTD

MICROCRYSTALLINE CELLULOSE USP AS MANUFACTURED IN TAMILNADU, INDIA

25756 A

III

2/1/2012

DA PRO RUBBER INC

DPXB433-5 AS MANUFACTURED IN BROKEN ARROW, OK

25757 A

III

2/27/2012

SANNER GMBH

25758 A

II

2/3/2012

PFANSTIEHL INC

DESICCANT CARTRIDGES AS MANUFACTURED IN BENSHEIM, GERMANY; KUNSHAN, CHINA;


BUDAPEST, HUNGARY FOR SANNER GMBH
PODOPHYLLOTOXIN (P-126) AS MANUFACTURED IN WAUKEGAN, IL

25759 A

II

1/18/2012

JIANGSU YEW PHARMACEUTICAL CO LTD

PACLITAXEL AS MANUFACTURED IN JIANGSU, CHINA

25760 A

II

2/3/2012

LIFECORE BIOMEDICAL LLC

25761 A

II

2/24/2012

UNIMARK REMEDIES LTD

SODIUM HYALURONATE POWDER, SPECIFICATION LPD-9800037, PH 4.0 PROCESS AS


MANUFACTURED IN CHASKA, MN
FEBUXOSTATE AS MANUFACTURED IN GUJARAT, INDIA

25762 A

II

2/8/2012

AMOLI ORGANICS PVT LTD

LEVETIRACETAM USP [ROUTE CODE - LVS] AS MANUFACTURED IN GUJARAT STATE, INDIA

25763 A

II

3/19/2012

EMCURE PHARMACEUTICALS LTD

IBUTILIDE FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25764 A

II

3/20/2012

EMCURE PHARMACEUTICALS LTD

RIZATRIPTAN BENZOATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25765 A

II

3/19/2012

EMCURE PHARMACEUTICALS LTD

ARGATROBAN MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25766 A

II

7/25/2012

MALLINCKRODT INC

HYDROMORPHONE HYDROCHLORIDE USP (NP), MALLINCKRODT INC. CODE 3222 AS


MANUFACTURED IN ST. LOUIS, MISSOURI

25768 A

II

3/1/2012

ORCHID CHEMICALS AND PHARMACEUTICALS LTD RISEDRONATE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

25769 A

II

2/7/2012

POLYMED THERAPEUTICS INC

25770 A

II

2/9/2012

HETERO LABS LTD

25771 I

II

6/29/2012

THE PROCTER AND GAMBLE CO

25767 N

NOT AN ASSIGNED NUMBER

25772 P

CABAZITAXEL MONOHYDRATE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED


THERAPEUTICS INC
QUETIAPINE FUMARATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
ALIGN PRODUCT CONTAINING BIFANTIS (BIFIDOBACTERIUM LONGUM SUBSP. INFANTIS
36524) AS MANUFACTURED IN HOLLAND, MI FOR THE PROCTER & GAMBLE COMPANY

*** PENDING FILING REVIEW ***

25773 A

II

3/29/2012

GLENMARK GENERICS LTD

SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN GUJARAT STATE, INDIA

25774 A

III

2/7/2012

PROMENS HF

POLYETHYLENE VIALS AS MANUFACTURED IN LANGESKOV, DENMARK FOR PROMENS HR.

25775 A

II

12/30/2011

LAMOTRIGINE AS MANUFACTURED IN HUBEI TIANMEN PROVINCE, CHINA

25776 A

II

9/30/2013

WATERSTONE PHARMACEUTICALS HUBEI


TIANMEN CO LTD
MALLINCKRODT INC

25777 A

II

2/13/2012

APOTEX PHARMACHEM INC

25778 A

II

2/27/2012

ALEMBIC PHARMACEUTICALS LTD API DIV

DESVENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN BRANTFORD


ONTARIO, CANADA
FLUOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25779 A

II

2/14/2012

INOGENT LABORATORIES PRIVATE LTD

LAMOTRINGINE AS MANUFACTURED IN HYDERABAD, INDIA

25780 A

III

2/10/2012

CHARTER NEX FILMS INC

25781 A

II

2/10/2012

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD

NEX 1509 SINGLE-LAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS


FALLS, MA
ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES AS MANUFACTURED IN
TAIZHOU, CHINA

METHYLPHENIDATE HYDROCHLORIDE USP (NP) AS MANUFACTURED IN ST. LOUIS, MO

Page 759

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25782 A
III
1/31/2012
AMCOR FLEXIBLES GENT

SUBJECT
EXTRUDED FILMS AND LAMINATES FOR PACKAGING AS MANUFACTURED IN GENT, BELGIUM

25783 A

II

2/13/2012

VINORELBINE TARTRATE, USP AS MANUFACTURED IN GUANGDONG, CHINA

25784 A

II

2/15/2012

GUANGZHOU HANFANG PHARMACEUTICAL CO


LTD
AVANTI POLAR LIPIDS INC

25785 A

II

1/30/2012

MICRO LABS LTD INDIA

25786 A

IV

2/14/2012

FMC CORP FMC BIOPOLYMER DIV

AVICEL(R) DG BINDER - MICROCRYSTALLINE CELLULOSE AND ANHYDROUS DICALCIUM


PHOSPHATE AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA FOR FMC CORP( FMC
BIOPOLYMER DIV)

25787 A

II

3/27/2012

LUPIN LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25788 P

(5Z,8Z, 11Z)-N-CYCLOPROPYL-14-(N-ISOPROPYL-HEXANAMIDO) TETRADECA-5,8,11TRIENAMIDE (CMX-20) AS MANUFACTURED IN ALABASTER, ALABAMA


MELOXICAM USP AS MANUFACTURED IN KARNATAKA, INDIA

*** PENDING FILING REVIEW ***

25789 A

II

3/1/2013

CHEMSPEC API

CALCIUM LEVOMEFOLATE AS MANUFACTURED IN FAIRFIELD, NJ

25790 A

II

1/19/2012

MEITEK TECHNOLOGY QINGDAO CO LTD

CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

25791 A

II

2/14/2012

FARMABIOS S P A

MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY

25792 A

II

6/29/2012

MACLEODS PHARMACEUTICALS LTD

CELECOXIB AS MANUFACTURED IN GUJARAT, INDIA

25793 A

II

4/9/2012

MACLEODS PHARMACEUTICALS LTD

IBANDRONATE SODIUM MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

25794 A

II

3/14/2012

MACLEODS PHARMACEUTICALS LTD

LANSOPRAZOLE AS MANUFACTURED IN GUJARAT, INDIA

25795 A

II

4/9/2012

MACLEODS PHARMACEUTICALS LTD

VARDENAFIL HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

25796 A

II

2/17/2012

CRYSTAL PHARMA SAU

25797 A

II

2/17/2012

CHROMO LABORATORIES INDIA PRIVATE LTD

DROSPIRENONE NON MICRONIZED AND MICRONIZED AS MANUFACTURED IN BOECILLO


(VALLADOLID), SPAIN
CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25798 A

II

2/16/2012

SYMBIOTEC PHARMALAB LTD

BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN MADHYA PRADESH, INDIA

25799 A

III

2/17/2012

DOCTORPACK INDIA PVT LTD

25800 A

II

2/21/2012

HETERO LABS LTD

25801 A

II

2/22/2012

HEINKE TECHNOLOGY INC

25802 A

III

2/8/2012

AVANTIS PACKAGING INC

PLASTIC CONTAINER CLOSURE SYSTEM 'SQUEEZE NASAL SPRAY/NEBULIZER SYSTEM' AS


MANUFACTURED IN BANGALORE, INDIA
BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
PRE-FILLED VAGINAL APPLICATOR WITH SIDE DISPERSION TIP AS MANUFACTURED IN
LINCOLN, NE
PLASTIC BOTTLES & CONTAINERS AS MANUFACTURED IN QUEBEC, CANADA

25803 A

II

2/10/2012

SYMRISE AG

25804 I

II

3/27/2012

EMCURE PHARMACEUTICALS LTD

210363 NATURAL & ARTIFICIAL FLAVOR LEMON TYPE AS MANUFACTURED IN HOLZMINDEN,


GERMANY
DOCETAXEL USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25805 A

II

3/26/2012

EMCURE PHARMACEUTICALS LTD

ZILEUTON USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25806 A

II

3/27/2012

EMCURE PHARMACEUTICALS LTD

PROMETHAZINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25807 A

II

3/31/2012

EMCURE PHARMACEUTICALS LTD

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

25808 A

II

3/27/2012

EMCURE PHARMACEUTICALS LTD

ETODOLAC USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25809 A

II

3/30/2012

EMCURE PHARMACEUTICALS LTD

ACAMPROSATE CALCIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

25810 A

II

3/14/2012

AUROBINDO PHARMA LTD

25811 A

II

12/22/2011

25812 A

IV

2/15/2012

JOHNSON MATTHEY INC PHARMACEUTICAL


MATERIALS GROUP
ABELEI INC

TELMISARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
JOHNSON MATTHEY 1319 AS MANUFACTURED IN WEST DEPTFORD, NJ
164A50 NATURAL LEMON LIME FLAVOR WONF POWDER AS MANUFACTURED IN NORTH
AURORA, IL

Page 760

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25813 A
III
2/17/2012
PROMENS HF

SUBJECT
CYCLOOLEFIN VIALS AS MANUFACTURED IN LANGESKOV, DENMARK FOR PROMENS HF.

25814 A

II

2/22/2012

CATALENT PHARMA SOLUTIONS LLC

MDV3100, 40MG, CAPSULES (SOFTGELS) AS MANUFACTURED IN ST. PETERSBURG, FL

25815 A

II

2/22/2012

APOTEX PHARMACHEM INDIA PVT LTD

25816 A

II

4/2/2012

LUPIN LTD

TADALAFIL USP AS MANUFACTURED BY SRINI PHARMACEUTICALS LTD IN ANDHRA PRADESH,


INDIA FOR APOTEX PHARMACHEM INDIA PVT LTD
ESTRADIOL HEMIHYDRATE AS MANUFACTURED IN MADHYA PRADESH, INDIA

25817 A

II

2/22/2012

NEULAND LABORATORIES LTD

BRINZOLAMIDE, USP AS MANUFACTURED IN TELANGANA, INDIA

25818 I

II

2/20/2012

APOTEX PHARMACHEM INDIA PVT LTD

LEVOTHYROXINE SODIUM USP AS MANUFACTURED IN BANGALORE, INDIA

25819 A

III

4/5/2012

NAGL MANUFACTURING CO

FLO-THRU APPLICATOR AS MANUFACTURED IN OMAHA, NE

25820 A

II

4/2/2012

LUPIN LTD

AZITHROMYCIN MONOHYDRATE USP (PROCESS B) AS MANUFACTURED IN GUJARAT, INDIA

25821 A

II

2/23/2012

25822 A

II

2/23/2012

NINGBO RENJIAN PHARMACEUTICAL GROUP CO


LTD
FUJIAN SOUTH PHARMACEUTICAL CO LTD

25823 A

II

10/12/2011

MELODY HEALTHCARE PVT LTD

HUMAN CHORIONIC GONADOTROPIN USP AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA
PACLITAXEL (SEMI-SYNTHETIC) USP NON STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA
MONTELUKAST SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

25824 A

IV

2/24/2012

FONA INTERNATIONAL INC

826.595 CHOCOLATE EXTRACT, NAT AS MANUFACTURED IN GENEVA, IL

25825 A

II

2/22/2012

JIANGXI SYNERGY PHARMACEUTICAL CO LTD

GABAPENTIN[H] AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA

25826 A

II

2/24/2012

OLON SPA

BENDAMUSTINE HCL AS MANUFACTURED IN RODANO (MI), ITALY

25827 A

II

2/22/2012

SWATI SPENTOSE PVT LTD

PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

25828 A

II

3/24/2012

CTX LIFE SCIENCES PVT LTD

ALENDRONATE SODIUM USP AS MANUFACTURED IN GUJARAT, INDIA

25829 A

II

3/24/2012

CTX LIFE SCIENCES PVT LTD

TERAZOSIN HYDROCHLORIDE DIHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA

25830 A

II

2/22/2012

SWATI SPENTOSE PVT LTD

LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA

25831 A

II

2/24/2012

ST GOBAIN PERFORMANCE PLASTICS CORP

25832 A

IV

2/28/2012

FONA INTERNATIONAL INC

25833 A

IV

2/28/2012

FONA INTERNATIONAL INC

TYGON 2475 HIGH PURITY TUBING AND TYGON 2475 I.B. HIGH PURITY PRESSURE TUBING
AS MANUFACTURED IN AKRON, OHIO
800.119 TOASTED ALMOND FLAVOR EMULSION, NAT WONF AS MANUFACTURED IN GENEVA,
IL
816.0530U BUTTER TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

25834 A

III

2/21/2012

AMPACET CORP

25835 A

II

2/17/2012

SUNBIO INC

25836 A

IV

4/1/2012

EMCURE PHARMACEUTICALS LTD

110730 WHITE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
METHOXY POLYETHYLENE GLYCOL PROPIONALDEHYDE 20,000 AS MANUFACTURED IN
ANYANG CITY, S. KOREA
PREMIX FOR BUSULFAN (WITHOUT ACTIVE) AS MANUFACTURED IN MAHARASHTRA, INDIA

25837 A

II

2/21/2012

MSN LABORATORIES LTD

DEFERASIROX [ROUTE CODE - DR] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25838 A

IV

2/29/2012

ASAHI KASEI CHEMICALS CORP

25839 A

III

3/2/2012

DOCTORPACK INDIA PVT LTD

25840 A

II

11/22/2011

NANDU CHEMICAL INDUSTRIES

PREGELATINIZED STARCH (USP / NF) AS MANUFACTURED IN NARA, JAPAN FOR ASAHI KASEI
CHEMICALS CORPORATION
PLASTIC CONTAINER CLOSURE SYSTEM 'TR' DESIGN AS MANUFACTURED IN BANGALORE,
INDIA
'POTASSIUM CHLORIDE BP' AS MANUFACTURED IN KARNATAKA, INDIA

25841 A

II

11/22/2011

NANDU CHEMICAL INDUSTRIES

'MAGNESIUM CHLORIDE HEXAHYDRATE BP' AS MANUFACTURED IN KARNATAKA, INDIA

25842 A

III

3/1/2012

POLYONE CORP

CC10132453WE (WHITE PEARL PP/PE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

25843 A

II

3/6/2012

MAC CHEM PRODUCTS INDIA PVT LTD

PACLITAXEL USP AS MANUFACTURED IN DISTRICT THANE, INDIA

25844 I

II

2/29/2012

ZHUHAI UNITED LABORATORIES CO LTD

CEFOTAXIME SODIUM USP AS MANUFACTURED IN GUANGDONG, P. R. CHINA

25845 A

II

2/27/2012

AREVIPHARMA GMBH

TORASEMIDE AS MANUFACTURED IN RADEBEUL, GERMANY

25846 A

II

3/2/2012

THRESHOLD PHARMACEUTICALS INC

SN35006 AS MANUFACTURED IN NORTH SYRACUSE, NY FOR PROACTA, INC.

Page 761

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25847 A
II
3/2/2012
THRESHOLD PHARMACEUTICALS INC

SUBJECT
SN33962 AS MANUFACTURED IN NORTH SYRACUSE, NY FOR PROACTA, INC

25848 A

II

3/1/2012

SECOND PHARMA CO LTD

VALSARTAN AS MANUFACTURED IN SHANGYU CITY, P. R. CHINA

25849 A

II

3/13/2012

AMOLI ORGANICS PVT LTD

HYDROCHLOROTHIAZIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

25850 A

II

3/5/2012

SAVIOR LIFETEC CORP TAINAN BRANCH

STERILE SODIUM BICARBONATE USP AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

25851 A

II

2/28/2012

ORCHEV PHARMA PVT LTD

25852 A

III

3/8/2012

25853 A

II

3/23/2012

25854 A

II

3/30/2012

JIANGSU HUALAN NEW PHARMACEUTICAL


MATERIAL CO LTD
3D IMAGING DRUG DESIGN AND DEVELOPMENT
LLC
LUPIN LTD

RANITIDINE HYDROCHLORIDE USP (POLYMORPH FORM - II) CRYSTALLINE POWDER GRADE


AND DC GRADE AS MANUFACTURED IN GUJARAT STATE, INDIA
BUTYL RUBBER STOPPERS AS MANUFACTURED IN CHONGQING CITY, CHINA FOR JIANGSU
HUALAN NEW PHARMACEUTICAL MATERIAL CO., LTD
SODIUM IODIDE I 124 AS MANUFACTURED IN LITTLE ROCK, ARKANSAS

25855 A

II

3/24/2012

DR REDDYS LABORATORIES LTD

GLATIRAMER ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25856 A

II

3/30/2012

NORAMCO INC

CODEINE PHOSPHATE AS MANUFACTURED IN ATHENS, GA AND WILMINGTON, DE

25857 A

II

6/13/2012

PAR PHARMACEUTICAL INC

TOLCAPONE, USP AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR PHARMACEUTICAL INC

25858 A

II

3/30/2012

DR REDDYS LABORATORIES LTD

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25859 P

ESTRADIOL VALERATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

*** PENDING FILING REVIEW ***

25860 A

II

3/7/2012

ULKAR KIMYA SANAYII VE TICARET AS

OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN TEKIRDAG, TURKEY

25861 A

II

3/7/2012

ULKAR KIMYA SANAYII VE TICARET AS

IRBESARTAN USP AS MANUFACTURED IN TEKIRDAG, TURKEY

25862 A

IV

3/9/2012

FONA INTERNATIONAL INC

906.0312U RASPBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

25863 I

II

3/7/2012

OLON SPA

ROTIGOTINE AS MANUFACTURED IN RODANO (MI), ITALY

25865 A

II

3/30/2012

DR REDDYS LABORATORIES LTD

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25866 A

II

3/28/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

GANIRELIX ACETATE AS MANUFACTURED IN MAHARASHTRA, INDIA

25867 A

II

3/2/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

25868 A

II

4/20/2012

IND SWIFT LABORATORIES LTD

SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN MADHYA PRADESH, INDIA FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD.
CLOPIDOGREL CAMPHOR SULFONATE AS MANUFACTURED IN PUNJAB, INDIA

25869 A

II

3/31/2012

UNIMARK REMEDIES LTD

MEROPENEM TECHNICAL AS MANUFACTURED IN STATE-GUJARAT, INDIA

25870 A

II

3/30/2012

ARCH PHARMALABS LTD

PACLITAXEL USP (SEMI-SYNTHETIC) AS MANUFACTURED IN MAHARASHTRA, INDIA

25871 A

II

12/22/2011

ERREGIERRE SPA

RIVASTIGMINE AS MANUFACTURED IN BERGAMO, ITALY

25872 A

II

3/30/2012

DR REDDYS LABORATORIES LTD

LENALIDOMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25873 A

II

3/30/2012

DR REDDYS LABORATORIES LTD

ESCITALOPRAM OXALATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25874

II

3/12/2012

DERIVADOS QUIMICOS SAU

25875 A

II

3/16/2012

25876 A

III

3/13/2012

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
SHAILY ENGINEERING PLASTICS LTD

RACEPINEPHRINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN FOR SIFAVITOR


S.R.L
AMOXICILLIN TRIHYDRATE (PURIMOX) AS MANUFACTURED IN PUNJAB, INDIA FOR DSM
SINOCHEM PHARMACEUTICALS NETHERLANDS B.V.
LOGENGES HANDLE AS MANUFACTURED IN STATE-GUJARAT, INDIA

25877 A

II

3/2/2012

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

LANSOPRAZOLE AS MANUFACTURED IN SHOUGUANG CITY, CHINA

25878 A

II

12/12/2011

ANYGEN CO LTD

LEUPRORELIN ACETATE AS MANUFACTURED IN JEOLLANAM-DO, SOUTH KOREA

25879 A

II

4/4/2012

LUPIN LTD

LOSARTAN POTASSIUM USP (CRYSTALLINE) AS MANUFACTURED IN MUMBAI, INDIA

25880 A

II

3/30/2012

DR REDDYS LABORATORIES LTD

BAZEDOXIFENE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25864 P

*** PENDING FILING REVIEW ***

Page 762

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25881
II
3/3/2012
MSN LABORATORIES PRIVATE LTD
A

SUBJECT
TROSPIUM CHLORIDE [ROUTE CODE - ''TC''] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25882 A

II

3/19/2012

COVALENT LABORATORIES PRIVATE LTD

CEFDINIR USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25883 A

II

3/16/2012

APTALIS PHARMA SRL

25884 A

III

3/5/2012

ESS DEE ALUMINIUM LTD

25885 A

III

3/6/2012

BORMIOLI ROCCO SPA BU PLASTICS

25886 A

III

3/6/2012

BORMIOLI ROCCO SPA BU PLASTICS

25887 A

II

4/2/2012

ALEMBIC PHARMACEUTICALS LTD API DIV

PANCREATIC ENZYME PRODUCT (PEP) DELAYED RELEASE CAPSULES 750 U USPL AS


MANUFACTURED IN MILAN, ITALY
NON TOXIC FOOD/ PHARMA GRADE PLAIN AND PRINTED 3 PLY; 4 PLY LAMINATE AS
MANUFACTURED IN NANI DAMAN, INDIA
SYRINGE DOSING 0,5-5ML AS MANUFACTURED IN SAINT SULPICE, FRANCE; CASTELGUELFO
(PR), ITALY; RIVANAZZANO (PV), ITALY
BOTTLE PET 130 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV),
ITALY; SAINT SULPICE, FRANCE
SOLIFENACIN SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA

25888 A

II

3/30/2012

JUBILANT GENERICS LTD

DEFERASIROX AS MANUFACTURED IN KARNATAKA, INDIA

25889 A

II

3/29/2012

JUBILANT GENERICS LTD

CINACALCET HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA

25890 A

II

3/29/2012

JUBILANT GENERICS LTD

DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA

25891 A

II

3/12/2012

ZHUHAI UNITED LABORATORIES CO LTD

25892 A

II

4/9/2012

CTX LIFE SCIENCES PVT LTD

MEROPENEM FOR INJECTION BULK STERILE AS MANUFACTURED IN GUANGDONG, P. R.


CHINA
AMIODARONE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25893 A

II

2/20/2012

ALP PHARM BEIJING CO LTD

25894 A

II

3/19/2012

FORMOSA LABORATORIES INC

ARGATROBAN HYDRATE AS MANUFACTURED IN SUZHOU, CHINA FOR ALP PHARM BEIJING


CO., LTD
IXABEPILONE AS MANUFACTURED IN TAOYUAN, TAIWAN

25895 A

II

3/19/2012

LABORATORIOS IMPERIALES SA DE CV

BISMUTH SUBNITRATE AS MANUFACTURED IN MORELOS, MEXICO

25896 A

III

3/13/2012

AMERICHEM INC

62838-F50 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH

25897 A

II

3/31/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

ANASTROZOLE AS MANUFACTURED IN TAIZHOU CITY, CHINA

25898 A

II

3/21/2012

ALEMBIC PHARMACEUTICALS LTD API DIV

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

25899 A

II

3/2/2012

CSPC INNOVATION PHARM CO LTD

PENTOXIFYLLINE AS MANUFACTURED IN SHIJIAZHUANG CITY, CHINA

25900 A

III

2/29/2012

BOREALIS AG

BORMED HE9601-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG

25901 A

II

4/2/2012

AUROBINDO PHARMA LTD

CLINDAMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25902 A

II

3/23/2012

DR REDDYS LABORATORIES LTD

25903 A

II

3/19/2012

LAURUS LABS PRIVATE LTD

ATORVASTATIN CALCIUM (BUTYLATED HYDROXY ANISOLE PREMIX) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
BIMATOPROST AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25904 A

II

3/1/2012

QILU TIANHE PHARMACEUTICAL CO LTD

PIPERACILLIN (NON-STERILE API) AS MANUFACTURED IN JINAN, CHINA

25905 A

II

7/18/2012

SHILPA MEDICATE LTD

ZOLEDRONIC ACID AS MANUFACTURED IN KARNATAKA, INDIA

25906 A

II

6/19/2012

GLAXOSMITHKLINE LLC

25907 A

II

3/30/2012

UNICHEM LABORATORIES LTD

25908 A

II

4/2/2012

ALP PHARM BEIJING CO LTD

25909 A

II

4/18/2012

TRIS PHARMA INC

VILANTEROL TRIFENATATE (GW642444) AS MANUFACTURED IN JURONG, SINGAPORE;


HERTFORDSHIRE, UK FOR GLAXOSMITHKLINE LLC
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN DIST.
RAIGAD, INDIA
ALVIMOPAN DIHYDRATE AS MANUFACTURED IN SUZHOU, CHINA FOR ALP PHARM BEIJING CO
LTD
METHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)

25910 A

II

5/8/2012

DR REDDYS LABORATORIES LTD

RIVASTIGMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25911 A

III

2/10/2012

SIDDHI FOILS

ALUMINIUM FOIL PLAIN AND PRINTED, LAMINATED AND HEAT SEAL LACQUER (HSL) COATED
FOR PHARMACEUTICAL TABLETS/ CAPSULES/ SOLID DOSAGE FORMS COLD FORM ALU ALU
FOIL PLAIN AND PRINTED AS MANUFACTURED IN UTTARAKHAND, INDIA

Page 763

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25912 A
V
10/22/2012
GRAND RIVER ASEPTIC MANUFACTURING

SUBJECT
STERILE CONTRACT MANUFACTURING FACILITY AS MANUFACTURED IN GRAND RAPIDS, MI

25913 A

II

5/5/2012

NECTAR LIFESCIENCES LTD

25914 A

II

3/27/2012

UQUIFA MEXICO SA DE CV

CEFEPIME FOR INJECTION USP (STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED


DISTRICT MOHALI (PUNJAB), INDIA
ALBENDAZOLE AS MANUFACTURED IN MORELOS, MEXICO

25915 A

II

4/2/2012

CADILA HEALTHCARE LTD

BOSENTAN MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

25916 A

II

5/17/2012

CADILA HEALTHCARE LTD

FESOTERODINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

25917 A

III

3/22/2012

AMPACET CORP

25918 A

II

3/28/2012

INDUSTRIALE CHIMICA SRL

25919 A

III

3/22/2012

AMPACET CORP

25920 A

III

3/22/2012

AMPACET CORP

25921 A

III

3/22/2012

AMPACET CORP

25922 A

III

3/21/2012

AMERICHEM INC

432619 YELLOW PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
BRINZOLAMIDE, USP AS MANUFACTURED IN SARONNO (VARESE), ITALY AND BUCHAREST,
ROMANIA FOR INDUSTRIALE CHIMICA S. R. L.
454113 RED PP MP AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE,
GA AND HEATH, OH
474268 GREEN PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
463728 BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
61918-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH

25923 A

III

3/28/2012

SYMETAL ALUMINIUM FOIL INDUSTRY SA

25924 A

II

3/30/2012

IRIX MANUFACTURING INC

LACQUERED BLISTER FOIL 20 - 25 MICRONS ALLOY 1200 AS MANUFACTURED IN ATHENS,


GREECE
LATANOPROST AS MANUFACTURED IN GREENVILLE, SC

25925 A

II

3/27/2012

MEITEK TECHNOLOGY QINGDAO CO LTD

CHONDROITIN SULFATE CALCIUM AS MANUFACTURED IN QINGDAO CITY

25926 A

II

3/30/2012

AMRI RENSSELAER INC

PENTOBARBITAL SODIUM, USP DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER,


NEW YORK

25928 A

II

3/5/2012

TOMITA PHARMACEUTICAL CO LTD

N.F. CALCIUM SILICATE (AS FLORITE R) AS MANUFACTURED IN TOKUSHIMA, JAPAN

25929 A

II

4/3/2012

AARTI DRUGS LTD

DICLOFENAC EPOLAMINE AS MANUFACTURED IN MAHARASHTRA, INDIA

25930 A

II

3/30/2012

SHARON BIO MEDICINE LTD

MOXIFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

25931 A

II

4/2/2012

INDUSTRIALE CHIMICA SRL

LATANOPROST AS MANUFACTURED IN SARONNO (VARESE), ITALY

25932 A

II

3/27/2012

ERREGIERRE SPA

25933 A

II

3/27/2012

FARMABIOS S P A

N-[4-(TRIFLUOROMETHYL)BENZYL]-4-METHOXYBUTYRAMIDE AS MANUFACTURED IN SAN


PAOLO D'ARGON (BERGAMO), ITALY
BUSULFAN AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY

25934 A

II

3/27/2012

SPLACK SA

25935 A

II

5/19/2012

GLAND PHARMA LTD

"SILIPAC; CARBONPAC; MIXPAX; MOLPAC" - DESICCANT BAGS AS MANUFACTURED IN ATIBAIA,


SP BRAZIL
TIGECYCLINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25936 A

II

5/29/2012

TOPCHEM PHARMACEUTICALS LTD

ETHACRYNIC ACID AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND

25937 A

II

4/20/2012

TOPCHEM PHARMACEUTICALS LTD

BRETYLIUM TOSYLATE AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND

25938 A

II

6/6/2012

GLAND CHEMICALS PRIVATE LTD

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

25939 A

II

4/2/2012

FARMAK AS

REGADENOSON AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

25940 A

III

6/6/2012

SOOD PLASTICS PRIVATE LTD

PLASTIC CLOSURES AS MANUFACTURED IN PUNJAB, INDIA

25941 A

III

5/25/2012

SOOD PLASTICS PRIVATE LTD

PLASTIC BOTTLES AS MANUFACTURED IN PUNJAB, INDIA

25942 A

II

3/30/2012

NANOTHERAPEUTICS INC

25943 A

II

3/30/2012

NANOTHERAPEUTICS INC

TRIAPINE DRUG SUBSTANCE AS MANUFACTURED IN LENEXA, KS FOR


NANOTHERAPEUTICS, INC
TRIAPINE INJECTION AS MANUFACTURED IN CHARLESTON , SC FOR NANOTHERAPEUTICS,
INC

25927 P

*** PENDING FILING REVIEW ***

Page 764

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25944 A
II
4/3/2012
LIPOID GMBH

SUBJECT
LIPOID S 100 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY; KOLN, GERMANY FOR
LIPOID GMBH
HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION STERILE FREEZE-DRYING
POWDER (BROMOBUTYL) AS MANUFACTURED IN DENGFENG CITY, CHINA
CEFTRIAXONE SODIUM USP AS MANUFACTURED IN GUANGDONG, P. R. CHINA

25945 A

III

3/16/2012

25946 I

II

2/29/2012

ZHENGZHOU AOXIANG PHARMACEUTICAL


PACKING CO LTD
ZHUHAI UNITED LABORATORIES CO LTD

25947 A

II

5/17/2012

THERAPEUTIC PROTEINS INTERNATIONAL LLC

25948 A

III

4/6/2012

RACER TECHNOLOGY PTE LTD

25949 A

III

3/16/2012

25950 A

III

3/16/2012

25951 I

II

3/30/2012

ZHENGZHOU AOXIANG PHARMACEUTICAL


PACKING CO LTD
ZHENGZHOU AOXIANG PHARMACEUTICAL
PACKING CO LTD
SYNKEM SAS

COMPOUND FILGRASTIM (G-CSF) CONCENTRATED SOLUTION, EP AS MANUFACTURED IN


CHICAGO, IL
OINTMENT APPLICATOR AS MANUFACTURED IN CHANGI SOUTH INDSTURIAL ESTATE,
SINGAPORE
HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION (BROMOBUTYL) AS
MANUFACTURED IN DENGFENG CITY, CHINA
HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION STERILE POWDER (BROMOBUTYL)
AS MANUFACTURED IN DENGFENG CITY, CHINA
QUETIAPINE FUMARATE AS MANUFACTURED IN CHENOVE, FRANCE

25952 A

III

2/4/2012

RAVIRAJ FOILS LTD

'ALU-ALU (COLD FORMING BLISTER) LAMINATE' AS MANUFACTURED IN GUJARAT, INDIA

25953 A

III

3/17/2012

ASAHI RUBBER INC

25954 A

II

10/26/2011

FERMION OY

RUBBER GASKET FOR DISPOSABLE SYRINGE AS MANUFACTURED IN FUKUSHIMA,


PREFECTURE, JAPAN
QUETIAPINE FUMARATE "ALTERNATIVE PROCESS" AS MANUFACTURED IN HANKO, FINLAND

25955 A

II

3/29/2012

RAKS PHARMA PVT LTD

DOXYCYCLINE HYCLATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25956 A

II

4/11/2012

SHASUN PHARMACEUTICALS LTD

PITAVASTATIN CALCIUM AS MANUFACTURED IN CUDDALORE, INDIA

25957 A

II

4/10/2012

CF PHARMA LTD

METHOTREXATE AS MANUFACTURED IN BUDAPEST, HUNGARY

25958 A

II

3/1/2012

HUNAN YUXIN PHARMACEUTICAL CO LTD

MOMETASONE FUROATE AS MANUFACTURED IN SHAOYANG CITY, CHINA

25959 A

IV

4/10/2012

FONA INTERNATIONAL INC

926.0701U FONATECH VANILLA TYPE FLAVOR, NAT (CFT) AS MANUFACTURED IN GENEVA, IL

25960 A

III

3/1/2012

EASTMAN CHEMICAL CO

25961 A

II

10/31/2013

MALLINCKRODT INC

EASTMAN 168 NON-PHTHALATE PLASTICIZER PRODUCTION AS MANUFACTURED IN TEXAS


CITY, TX
HYDROCODONE BITARTRATE USP CRYSTALS(NP) AS MANUFACTURED IN ST. LOUIS,
MISSOURI

25963 A

II

3/6/2012

SWATI SPENTOSE PRIVATE LTD

LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

25964 A

II

3/27/2012

PARABOLIC DRUGS LTD

DEFERASIROX AS MANUFACTURED IN HARYANA, INDIA

25965 A

III

4/12/2012

SEKISUI ALVEO AG

ALVEOLIT TA SRZ POLYMER FOAMS AS MANUFACTURED IN LUCERNE, SWITZERLAND

25966 A

IV

4/10/2012

ILE PHARMACEUTICAL MATERIALS CO LTD

COMPLETE FILM COATING SYSTEMS AS MANUFACTURED IN TIANJIN, CHINA

25967 A

IV

4/12/2012

SYMRISE INC

25968 A

II

3/15/2012

QILU TIANHE PHARMACEUTICAL CO LTD

910009 EVOSPRAY NATURAL LIME FLAVOR WONF AS MANUFACTURED IN TETERBORO, NJ


AND BRANCHBURG, NJ FOR SYMRISE INC
TAZOBACTAM ACID (PROCESS V, NON-STERILE API) AS MANUFACTURED IN JINAN, CHINA

25969 A

II

4/2/2012

SEKISUI ALVEO AG

ALVEOLIT TL SRZ AS MANUFACTURED IN LUCERNE, SWITZERLAND

25970 A

II

4/12/2012

INCELL CORP LLC

25971 A

III

4/10/2012

SCG PERFORMANCE CHEMICALS CO LTD

ZSOL:F, ZSOL:M AND ZSOL:MH BIOPROCESSING BUFFER FAMILY AS MANUFACTURED IN SAN


ANTONIO, TX
POLYPROPYLENE EL-PRO P655IM AS MANUFACTURED IN RAYONG, THAILAND FOR SCG
PERFORMANCE CHEMICALS CO., LTD.

II

4/16/2012

25962 P

*** PENDING FILING REVIEW ***

25972 P
25973 A

*** PENDING FILING REVIEW ***


LABORATORIO CHIMICO INTERNAZIONALE SPA

ETHACRYNIC ACID AS MANUFACTURED IN SEGRATE MI ITALY

Page 765

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
25974 A
III
4/17/2012
JAPAN POLYPROPYLENE CORP

SUBJECT
NOVATEC/WELNEX/WINTEC PP SERIES AS MANUFACTURED IN MIE, JAPAN FOR JAPAN
POLYPROPYLENE CORPORATION
ARTIFICIAL CHERRY FLAVOR #5578 AS MANUFACTURED IN PHILADELPHIA, PA

25975 A

IV

4/10/2012

HENRY H OTTENS MANUFACTURING CO INC

25976 A

II

4/23/2012

AUROBINDO PHARMA LTD

25977 A

4/17/2012

ACS DOBFAR SPA

25978 A

II

5/16/2012

RELIANCE LIFE SCIENCES PVT LTD

PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED


IN ANDHRA PRADESH, INDIA
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATION AS LOCATED IN
TRIBIANO (MI), ITALY
ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN NAVI MUMBAI, INDIA

25979 A

IV

5/5/2012

SUNIL HEALTHCARE LTD

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTHAN, INDIA

25980 A

II

4/16/2012

SYN TECH CHEM AND PHARM CO LTD

GRANISETRON BASE AS MANUFACTURED IN TAINAN CITY, TAIWAN

25981 A

III

4/13/2012

NOLATO JAYCARE LTD

25982 A

II

4/18/2012

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD

60, 75 AND 100ML HDPE WHITE ROUND BOTTLES AS MANUFACTURED IN NEWCASTLE UPON
TYNE, ENGLAND
CLARITHROMYCIN USP AS MANUFACTURED IN ZHEJIANG, P. R. CHINA

25983 I

II

4/19/2012

CHEMI SPA

ZOLEDRONIC ACID HEMIPENTAHYDRATE AS MANUFACTURED IN FROSINONE, ITALY

25984 A

IV

4/23/2012

BHARAT STARCH INDUSTRIES

SODIUM STARCH GLYCOLATE USP AS MANUFACTURED IN YAMUNA NAGAR, INDIA

25985 A

III

4/20/2012

ST GOBAIN PERFORMANCE PLASTICS CORP

SANI-TECH ULTRA 65 SILICONE TUBING AS MANUFACTURED IN TAUNTON, MA

25986 A

II

4/20/2012

RA CHEM PHARMA LTD

ITRACONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

25987 A

II

4/23/2012

HOVIONE FARMACIENCIA SA

25988 A

II

4/23/2012

CQ INTERNATIONAL CO INC

MOMETASONE FUROATE MONOHYDRATE INHALATION GRADE AS MANUFACTURED IN


LOURES, PORTUGAL
DECITABINE AS MANUFACTURED IN JIANGSU, CHINA FOR CQ INTERNATIONAL CO INC

25989 A

II

4/13/2012

CAMBREX PROFARMACO MILANO SRL

EPINEPHRINE AS MANUFACTURED IN MILAN, ITALY

25990 A

III

4/25/2012

MPI RELEASE

RELEASE LINER 2-MIL PET C1S 15-0121 AS MANUFACTURED IN GREENFIELD, IN

25991 A

IV

4/20/2012

SYNKEM SAS

SODIUM STEARYL FUMARATE AS MANUFACTURED IN CHENOVE, FRANCE

25992 A

II

4/28/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

FLUVASTATIN SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

25993 A

II

5/7/2012

SRI KRISHNA PHARMACEUTICALS LTD

GLIPIZIDE USP AS MANUFACTURED IN MEDAK DIST, A.P, INDIA

25995 A

III

4/25/2012

MITSUI CHEMICALS INC

25996 A

II

4/24/2012

ZHEJIANG JINHUA CONBA BIO PHARM CO LTD

25997 A

III

4/23/2012

KAYGEE LOPAREX INDIA PVT LTD

25998 A

III

4/23/2012

KAYGEE LOPAREX INDIA PVT LTD

25999 A

III

4/23/2012

KAYGEE LOPAREX INDIA PVT LTD

26000 A

III

4/23/2012

KAYGEE LOPAREX INDIA PVT LTD

26001 A

III

4/23/2012

KAYGEE LOPAREX INDIA PVT LTD

26002 A

III

4/24/2012

AMPACET CORP

26003 A

II

4/19/2012

BACHEM SA

RELEASE LINERS GRADE XL-TDP 62 YELLOW MADE WITH PLATINUM CURE CHEMISTRY ON
YELLOW GLASSINE AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
RELEASE LINERS GRADE XL-TDP 62 WHITE MADE WITH PLATINUM CURE CHEMISTRY ON
WHITE GLASSINE AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
RELEASE LINERS GRADE XL-TDP 80 MADE WITH PLATINUM CURE CHEMISTRY ON GLASSINE
PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
RELEASE LINERS GRADE XL-TDP 90 MADE WITH PLATINUM CURE CHEMISTRY ON GLASSINE
PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
RELEASE LINERS GRADE XL-TDP 120 MADE WITH PLATINUM CURE CHEMISTRY ON GLASSINE
PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
455899 RED SMC PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
DEFERASIROX AS MANUFACTURED IN VIONNAZ,SWITZERLAND

26004 A

II

4/20/2012

PIRAMAL ENTERPRISES LTD

SULINDAC AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26005 A

II

8/12/2012

SUZHOU APAC PHARMATECH CO LTD

EWJPB, API AS MANUFACTURED IN WUJIANG CITY, CHINA

25994 N

NOT AN ASSIGNED NUMBER


APEL APL6011T, APL6013T, APL6015T, APL6509T, AND APL8008T AS MANUFACTURED IN OSAKA,
JAPAN
ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE

Page 766

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26006 A
V
5/25/2013
HALOZYME THERAPEUTICS INC

SUBJECT
PRE-CLINICAL AND LABORATORY INFORMATION (RHUPH20)

26007 A

III

4/27/2012

CONSOLIDATED BOTTLE CORP

26008 A

III

4/25/2012

CLARIANT PRODUCTION FRANCE

20ML NATURAL EUROPEAN DOSAGE CUP PP ROUND, GRADUATED (2.5ML TO 20ML) AS


MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION
SORB-IT PACKETS AS MANUFACTURED IN SAINT-MAMMES -FRANCE

26009 A

II

3/21/2012

QILU TIANHE PHARMACEUTICAL CO LTD

26010 A

III

4/11/2012

CHROMA CORP

26011 P

PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (STERILE API) AS MANUFACTURED IN


JINAN, CHINA
PC85234B BLACK COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL

*** PENDING FILING REVIEW ***

26012 P

*** PENDING FILING REVIEW ***

26013 A

II

6/1/2012

APICORE US LLC

ETHACRYNIC ACID USP AS MANUFACTURED IN GUJARAT, INDIA

26014 A

III

5/1/2012

26015 A

III

5/1/2012

BOEHRINGER INGELHEIM PHARMA GMBH AND CO


KG
BOEHRINGER INGELHEIM MICROPARTS GMBH

26016 A

II

4/30/2012

CERBIOS PHARMA SA

26017 A

II

5/2/2012

HETERO DRUGS LTD

CONTAINER CLOSURE FOR RESPIMAT AQUEOUS SOLUTIONS AS MANUFACTURED IN


INGELHEIM AM RHEIN, GERMANY
RESPIMAT INHALER FOR AQUEOUS SOLUTIONS AS MANUFACTURED IN DORTMUND,
GERMANY
(6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT AS MANUFACTURED IN
BARBENGO/LUGANO, SWITZERLAND
RIZATRIPTAN BENZOATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26018 A

II

7/13/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

CAPECITABINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26019 A

II

5/22/2012

FRESENIUS KABI ONCOLOGY LTD

TEMSIROLIMUS AS MANUFACTURED IN WEST BENGAL, INDIA

26020 A

II

5/2/2012

SYMBIOTEC PHARMALAB LTD

ETHINYL ESTRADIOL, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH, INDIA

26021 A

II

5/2/2012

SYMBIOTEC PHARMALAB LTD

26022 A

II

4/28/2012

26023 A

II

4/25/2012

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
MYLAN LABORATORIES LTD

ETHYNODIOL DIACETATE, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH,


INDIA
ATORVASTATIN CALCIUM, NON-STERILE BULK DRUG SUBSTANCES AS MANUFACTURED IN
TAIZHOU, CHINA
DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

26024 A

II

5/3/2012

MSN LABORATORIES LTD

26025 A

II

4/20/2012

AVRA LABORATORIES PRIVATE LTD

ESMOLOL HYDROCHLORIDE [ROUTE CODE - "EH"] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
10-HYDROXYCAMPTOTHECIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26026 A

II

5/8/2012

PROTEUS SA

NEOSAXITOXIN 200G/ML AS MANUFACTURED IN SANTIAGO, CHILE

26027 A

II

4/25/2012

KONDUSKAR LABORATORIES PVT LTD

OXCARBAZEPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26028 A

II

5/5/2012

DIVIS LABORATORIES LTD

TELMISARTAN, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26029 A

II

5/8/2012

MAC CHEM PRODUCTS INDIA PVT LTD

CARBOPLATIN USP AS MANUFACTURED IN DISTRICT THANE, INDIA

26030 A

II

5/8/2012

VANCOMYCIN HYDROCHLORIDE, LYOPHILIZED AS MANUFACTURED IN FUZHOU CITY, CHINA

26031 A

II

4/27/2012

LIVZON GROUP FUZHOU FUXING


PHARMACEUTICAL CO LTD
KREATIVE ORGANICS P LTD

26032 A

II

8/16/2012

EXCELLA GMBH

TEMOZOLOMIDE AS MANUFACTURED IN FEUCHT, GERMANY

26033 A

II

5/23/2012

IPCA LABORATORIES LTD

26034 A

III

11/15/2010

INGENIA POLYMERS CORP

26035 A

II

6/1/2012

AUROBINDO PHARMA LTD

CETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS) AS MANUFACTURED IN MADHYA


PRADESH, INDIA
INGENIA POLYMERS 1023 FILLED WHITE AS MANUFACTURED IN ONTARIO, CANADA; ALBERTA,
CANADA; HOUSTON, TEXAS FOR INGENIA POLYMERS CORPORATION
OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26036 A

III

5/4/2012

LEVOSIL SPA

DESICCANT BAGS AS MANUFACTURED IN CHIUSA SAN MICHELE (TO), ITALY

26037 I

II

5/7/2012

JIANGSU HENGRUI MEDICINE CO LTD

MESNA USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA

SALSALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 767

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26038 A
II
5/9/2012
NEULAND LABORATORIES LTD

SUBJECT
BOSENTAN MONOHYDRATE AS MANUFACTURED IN TELANGANA, INDIA

26039 A

II

5/7/2012

BLOOMAGE FREDA BIOPHARM CO LTD

SODIUM HYALURONATE (HA-P-0.5) AS MANUFACTURED IN JINAN CITY, P. R. OF CHINA

26040 A

IV

5/8/2012

SYMRISE INC

26041 A

II

5/11/2012

JIANGSU HENGRUI MEDICINE CO LTD

26042 A

II

5/8/2012

RAKS PHARMA PVT LTD

992583 NATURAL PEPPERMINT FLAVOR POWDER 605030 AS MANUFACTURED IN


TETERBORO, NJ AND BRANCHBURG, NJ
CYCLOPHOSPHAMIDE, USP, STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
JIANGSU, CHINA
LINEZOLID AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26043 A

II

1/31/2013

FEBUXOSTAT AS MANUFACTURED IN CHONGQING, CHINA

26044 A

II

5/15/2012

CHONGQING SHENGHUAXI PHARMACEUTICAL CO


LTD
HETERO LABS LTD

26045 A

II

5/15/2012

HETERO DRUGS LTD

ZIPRASIDONE HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26046 A

IV

5/3/2012

FRUTAROM USA

26047 A

II

6/8/2012

UNIMARK REMEDIES LTD

NATURAL & ARTIFICIAL BLACKBERRY FLAVOR 3251351091.00 AS MANUFACTURED IN


CORONA, CA
CEFIXIME USP AS MANUFACTURED IN GUJARAT, INDIA

26048 A

II

5/23/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

SIMVASTATIN (BHA ADDED) AS MANUFACTURED IN TAIZHOU CITY, CHINA

26049 A

II

6/14/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

DEMECLOCYCLINE HYDROCHLORIDE AS MANUFACTURED IN TAIZHOU CITY, CHINA

26050 A

II

7/20/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MINOCYCLINE HYDROCHLORIDE AS MANUFACTURED IN TAIZHOU CITY, CHINA

26051 A

III

4/23/2012

SHREE NAINA POLYMERS INC

PET BOTTLES AS MANUFACTURED IN HIMACHAL PRADESH, INDIA

26052 A

II

5/14/2012

SIEGFRIED LTD

BUPRENORPHINE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND

26053 A

III

4/25/2012

SUN PACKMET PRIVATE LTD

26054 A

IV

5/16/2012

CAPSUGEL MANUFACTURING INC

26055 A

7/27/2012

ENTERIS BIOPHARMA INC

PLAIN/PRINTED ALUMINIUM FOILS (STRIP/BLISTER) AS MANUFACTURED IN HIMACHAL


PRADESH, INDIA
COMPLIANCE IDENTIFIER CAPSULES AS MANUFACTURED IN GRAFFENSTADEN, FRANCE AND
CAMBRIDGE, MA
3-O-LAUROYL-L-CARNITINE HYDROCHLORIDE (LLC) PRECLINICAL AND CLINICAL DATA

26056

II

8/31/2012

PRONOVA BIOPHARMA NORGE AS

26057 A

IV

5/14/2012

WILSHIRE TECHNOLOGIES INC

26058 A

III

4/23/2012

SHREE NAINA PACKWELL INC

OMEGA-3-ACID ETHYL ESTERS, AS MANUFACTURED IN SANDEFJORD, NORWAY AND


KALUNDBORG, DENMARK
PHYTOSQUENE AS MANUFACTURED IN CHARLES CITY, IOWA FOR WILSHIRE
TECHNOLOGIES INC
GLASS AMPOULES AND VIALS AS MANUFACTURED IN HIMACHAL PRADESH, INDIA

26059 A

II

5/25/2012

AMPHASTAR NANJING PHARMACEUTICALS INC

SEMI-PURIFIED HEPARIN SODIUM AS MANUFACTURED IN JIANGSU CHINA

26060 A

5/15/2012

ACS DOBFAR SPA

26061 A

II

5/9/2012

QILU PHARMACEUTICAL CO LTD

26062 A

II

5/2/2012

KOPRAN LTD

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AS MANUFACTURED


IN MILAN, ITALY - VALE ADDETTA PLANT - LYOPHILIZATION PLANT NO, 2
EXEMESTANE (NON-STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA
FOR QILU PHARMACEUTICAL CO LTD
PREGABALIN AS MANUFACTURED IN MAHARASHTRA INDIA

26063 A

II

5/17/2012

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

LCA45 AS MANUFACTURED IN ZHEJIANG CHINA

26064 A

II

5/19/2012

INDO PHYTO CHEMICALS PRIVATE LTD

LEVONORGESTREL USP AS MANUFACTURED IN UTTRAKHAND INDIA

26065 A

II

5/11/2012

PIRAMAL ENTERPRISES LTD

APREPITANT AS MANUFACTURED IN ANDHRA PRADESH INDIA

26066 A

II

5/15/2012

AMOXICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P. R. CHINA

26067 A

II

5/18/2012

NORTH CHINA PHARMACEUTICAL GROUP


SEMISYNTECH CO LTD
MAPRIMED SA

26068 A

II

5/17/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

ETORICOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

ZOLEDRONIC ACID MONOHYDRATE (CODE 50787) AS MANUFACTURED IN BUENOS AIRES,


ARGENTINA
EZETIMIBE AS MANUFACTURED IN UTTAR PRADESH, INDIA FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD

Page 768

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26069 A
IV
4/26/2012
TIANJIN KAIWEI AND YONGLI UNITED CHEMICAL
CO LTD
26070 A
II
6/15/2012
INTERNATIONAL MEDICATION SYSTEMS LTD

SUBJECT
WHITE MINERAL OIL AS MANUFACTURED IN TIANJIN, CHINA

26071 A

II

5/31/2012

CADILA HEALTHCARE LTD

FEBUXOSTAT API AS MANUFACTURED IN GUJARAT, INDIA

26072 A

II

7/2/2012

CADILA HEALTHCARE LTD

OLANZAPINE USP AS MANUFACTURED IN GUJARAT, INDIA

26073 A

II

5/31/2012

CADILA HEALTHCARE LTD

ROSUVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA

26074 A

II

5/22/2012

HETERO DRUGS LTD

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26075 A

II

5/18/2012

CHEMWERTH INC

26076 A

II

5/21/2012

SEQUENT SCIENTIFIC LTD

ARSENIC TRIOXIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN


FREIBURG, GERMANY FOR CHEMWERTH INC
PRAZIQUANTEL AS MANUFACTURED IN KARNATAKA, INDIA

26077 A

II

6/13/2012

WATSON PHARMA PRIVATE LTD

OXYBUTYNIN BASE AS MANUFACTURED IN MAHARASHTRA, INDIA

26078 A

II

5/22/2012

MSN LABORATORIES LTD UNIT II

CAPECITABINE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26079 A

II

5/23/2012

HETERO DRUGS LTD

26080 A

II

5/22/2012

HETERO DRUGS LTD

VALGANCICLOVIR HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA


FOR HETERO DRUGS LIMITED
FENOFIBRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26081 A

II

5/14/2012

CAYMAN PHARMA SRO

LATANOPROST AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC

26082 A

II

5/18/2012

NAGAOKA AND CO LTD

MENTHA OIL JP AS MANUFACTURED IN HYOGO, JAPAN

26083 A

II

5/24/2012

SHASUN PHARMACEUTICALS LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN CUDDALORE, INDIA

26084 A

II

5/22/2012

RAKS PHARMA PVT LTD

ATORVASTATIN CALCIUM STABILIZED AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26085 A

II

6/28/2012

GLENMARK GENERICS LTD

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

26086 A

II

5/24/2012

SIGMA ALDRICH MANUFACTURING LLC

HYALURONIDASE AS MANUFACTURED IN ST LOUIS MO

26087 A

II

5/23/2012

RAKS PHARMA PVT LTD

DEXLANSOPRAZOLE API AS MANUFACTURED IN ANDHRA PRADESH INDIA

26088 A

II

5/16/2012

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTD

26089 A

III

5/21/2012

SMITHS MEDICAL ASD INC

26090 A

III

5/30/2012

LUXFER GAS CYLINDERS

26091 A

II

12/30/2013

HUBEI HONCH PHARMACEUTICAL CO LTD

SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS) AS MANUFACTURED IN TAIZHOU


CITY, CHINA
ENTERAL MEDICATION CASSETTE RESERVOIR AS MANUFACTURED IN TIJUANA MEXICO FOR
SMITHS MEDICAL ASD INC
COMPRESSED GAS CYLINDER PACKAGE (ALTERNATIVE PROCESS) AS MANUFACTURED IN
GRAHAM, NC
VINORELBINE TARTRATE AS MANUFACTURED IN QICHUN COUNTY, CHINA

26092 A

IV

4/23/2012

GC CHEMIE PHARMIE LTD

NOVOCOAT - HYPROMELLOSE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA

26093 A

IV

4/23/2012

GC CHEMIE PHARMIE LTD

NOVODONE-CR CROSPOVIDONE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA

26094 A

IV

4/23/2012

GC CHEMIE PHARMIE LTD

NOVODONE POVIDONE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA

26095 A

III

5/30/2012

26096 A

III

5/22/2012

JIANGSU HUALAN NEW PHARMACEUTICAL


MATERIAL CO LTD
BORMIOLI ROCCO SPA BU PLASTICA

BUTYL RUBBER STOPPERS COVERED WITH POLYSTER FILMS AS MANUFACTURED IN


JIANGSU PROVINCE CHINA
SPECIAL CHILD-PROOF CP O28 MM AS MANUFACTURED IN CASTELGUELFO (PR), ITALY;
RIVANAZZANO (PV), ITALY; SAINT SULPICE, FRANCE FOR BORMIOLI ROCCO S.P.A. - B.U.
PLASTICA

26097 A

II

5/26/2012

ZHEJIANG TIANYU PHARMACEUTICAL CO LTD

MONTELUKAST BACKONE DIOL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

26098 A

II

6/8/2012

MEIJI SEIKA PHARMA CO LTD

26099 A

II

5/30/2012

HETERO DRUGS LTD

ARBEKACIN FREE BASE DRUG SUBSTANCE (ME1100) AS MANUFACTURED IN IWATE, JAPAN


AND KANAGAWA-KEN, JAPAN
ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26100 A

II

5/30/2012

HETERO DRUGS LTD

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26101 A

II

5/18/2012

BIOCON LTD

ORLISTAT AS MANUFACTURED IN BANGALORE, INDIA

HEPARIN SODIUM USP AS MANUFACTURED IN SOUTH EL MONTE, CA

Page 769

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26102 A
II
9/7/2012
AUROBINDO PHARMA LTD
26103 A

II

11/28/2012

TARO PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
PROGUANIL HYDROCHLORIDE USP AS MANUFACTURED IN HAIFA BAY, ISRAEL

26104 A

II

5/30/2012

OLON SPA

ASENAPINE MALEATE AS MANUFACTURED IN RODANO (MI), ITALY

26105 A

II

9/30/2012

EMCURE PHARMACEUTICALS LTD

ZOLMITRIPTAN AS MANUFACTURED IN MAHARASHTRA, INDIA

26106 A

III

5/15/2012

EQUISTAR CHEMICALS LP A LYONDELLBASELL


INDUSTRIES CO

POLYPROPYLENE RESINS FOR MEDICAL APPLICATIONS AS MANUFACTURED IN PASADENA,


TX AND WEST LAKE, LA FOR EQUISTAR CHEMICALS, LP, A LYONDELLBASELL INDUSTRIES
COMPANY

26107 A

II

5/31/2012

HUBEI HAOSUN PHARMACEUTICAL CO LTD

OXALIPLATIN AS MANUFACTURED IN HUBEI, CHINA

26108 A

II

5/31/2012

CATALENT PHARMA SOLUTIONS LLC

WC3042-08P CAPSULE AS MANUFACTURED IN ST PETERSBURG FL

26109 A

II

5/30/2012

ALENDRONATE SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

26110 A

II

5/31/2012

MINSHENG GROUP SHAOXING PHARMACEUTICAL


CO LTD
CATALENT PHARMA SOLUTIONS LLC

26111 A

II

5/29/2012

ZHUHAI UNITED LABORATORIES CO LTD

26112 A

II

5/31/2012

CAMBREX CHARLES CITY INC

POTASSIUM CLAVULANATE - MICROCRYSTALLINE CELLULOSE (1:1) AS MANUFACTURED IN


GUANGDONG PR CHINA
DICLOFENAC EPOLAMINE AS MANUFACTURED IN CHARLES CITY, IA

26113 A

II

6/4/2012

HETERO DRUGS LTD

TETRABENAZINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26114 I

II

5/28/2012

ZHUHAI UNITED LABORATORIES CO LTD

CEFUROXIME SODIUM USP AS MANUFACTURED IN GUANGDONG PR CHINA

26115 I

II

5/28/2012

ZHUHAI UNITED LABORATORIES CO LTD

CEFOPERAZONE SODIUM USP AS MANUFACTURED IN GUANGDONG PR CHINA

26116 A

II

6/4/2012

HETERO LABS LTD

ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26117 A

II

5/30/2012

MYLAN LABORATORIES LTD

ADEFOVIR DIPIVOXIL AS MANUFACTURED IN MAHARASHTRA, INDIA

26118 A

III

6/1/2012

KYODO PRINTING CO LTD

26119 A

IV

6/1/2012

26120 A

IV

6/1/2012

26122 A

II

6/4/2012

HETERO LABS LTD

26123 A

II

5/28/2012

SHARON BIO MEDICINE LTD

26124 A

III

5/31/2012

AMCOR FLEXIBLES BURGDORF GMBH

26125 A

II

6/4/2012

CRYSTAL PHARMA LTD

26126 A

II

6/4/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

26127 A

II

6/5/2012

POSH CHEMICALS PRIVATE LTD

AZACITIDINE AS MANUFACTURED IN VERCELLY, ITALY FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
SULFASALAZINE USP AS MANUFACTURED IN HYDERABAD, INDIA

26128 A

II

6/5/2012

DAIICHI FINE CHEMICAL CO LTD

TRANEXAMIC ACID DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN

26129 A

II

6/5/2012

TRIFARMA SPA

COLOCORTOLONE PIVALATE AS MANUFACTURED IN CERIANO LAGHETTO (MB) ITALY FOR

26130 A

II

5/30/2012

SARV BIO LABS PVT LTD

THIOCOLCHICOSIDE AS MANUFACTURED IN PARDESH, INDIA

26131 A

II

6/6/2012

HETERO DRUGS LTD

GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26132 A

II

5/25/2012

SHANDONG XINHUA PHARMACEUTICAL CO LTD

AMLODIPINE BESYLATE AS MANUFACTURED IN SHANDONG, PR CHINA

26133 A

II

5/14/2012

BETTS INDIA PRIVATE LTD

LAMINATED TUBES USED FOR PACKAGING AS MANUFACTURED IN GOA, INDIA AND SOLAN,
INDIA

26121 P

WC3042-05, CAPSULE AS MANUFACTURED IN ST.PETERSBURG, FLORIDA

MOISTCATCH SERIES FOR MOISTURE ABSORBING MATERIAL AS MANUFACTURED IN IBARAKI


JAPAN
THE NIPPON SYNTHETIC CHEMICAL INDUSTRY CO GOHSENOL EG AS MANUFACTURED IN KUMAMOTO JAPAN
LTD
FONA INTERNATIONAL INC
825.0047U CHERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL
*** PENDING FILING REVIEW ***
ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
TELMISARTAN USP AS MANUFACTURED MAHARASHTRA, INDIA
COMPOUND PACKAGING MATERIAL PAPER/OPA/ALUMINIUM/ION AS MANUFACTURED IN
BURGDORF, SWITZERLAND
SOLIFENACIN SUCCINATE AS MANUFACTURED IN ZEJTUN, MALTA

Page 770

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26134 P
*** PENDING FILING REVIEW ***

SUBJECT

26135 A

II

6/5/2012

POLYONE CORP

CC10161654XX (AMBER ARCH) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

26136 A

II

6/7/2012

HETERO DRUGS LTD

LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26137 A

II

6/8/2012

SUNNY PHARMTECH INC

CYCLOPHOSPHAMIDE AS MANUFACTURED IN TAIWAN, P. R. OF CHINA

26138 A

II

6/27/2012

ALEMBIC PHARMACEUTICALS LTD API DIV

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN GUJARAT, INDIA

26139 A

II

4/5/2013

MACLEODS PHARMACEUTICALS LTD

TADALAFIL AS MANUFACTURED IN GUJARAT, INDIA

26140 A

III

5/31/2012

ST GOBAIN PERFORMANCE PLASTICS CORP

POLYESTER FILM C/1/S WITH 4130 SILICONE RELEASE COATING, POLYESTER FILM C/1/S
WITH 4140 SILICONE RELEASE COATING AS MANUFACTURED IN WORCESTER,
MASSACHUSETTS

26141 A

III

6/8/2012

COLORS FOR PLASTICS INC

26142

II

6/8/2012

NERPHARMA SRL

26143 A

II

4/28/2012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

THERMOPLASTIC RESIN COLORANT MASTERBATCHES B24338 BLUE 286C, E16055 GREEN


369C AND W05255 WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, ILLINOS
BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED
IN MILAN, ITALY
OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ZHEJIANG, CHINA

26144 A

II

7/17/2012

UBE INDUSTRIES LTD

DS-1442B DRUG SUBSTANCE AS MANUFACTURED IN YAMAGUCHI, JAPAN

26145 A

II

7/2/2012

CADILA HEALTHCARE LTD

PHENTERMINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

26146 A

II

4/18/2011

SIGNA SA DE CV

GEMFIBROZIL USP (GEA PROCESS) AS MANUFACTURED IN TOLUCA, MEXICO

26147 A

II

6/8/2012

RILUZOLE AS MANUFACTURED IN TAINAN CITY, TAIWAN

26148 A

II

6/12/2012

STANDARD CHEMICAL AND PHARMACEUTICAL CO


LTD
FARMABIOS S P A

26149 A

III

5/25/2012

MEGAPLAST GMBH

26150 A

II

2/8/2012

APOTEX PHARMACHEM INC

26151 A

II

6/9/2012

MSN PHARMACHEM PVT LTD

26152 A

III

5/29/2012

26153 A

II

6/1/2012

CCC PLASTICS CANADA COLORS AND CHEMICALS WHITE MB50-936 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN
LTD
ONTARIO, CANADA
SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD MOMETASONE FUROATE AS MANUFACTURED IN KEDAH, MALAYSIA

26154 A

III

5/23/2012

SIPPEX

POLYPROPYLENE BAGS WITH CONNECTORS AS MANUFACTURED IN COURZIEU, FRANCE

26155 A

III

5/23/2012

SIPPEX

PVC BAGS WITH CONNECTORS AS MANUFACTURED IN COURZIEU, FRANCE

26156 A

II

6/8/2012

MSN LABORATORIES LTD

AMBRISENTAN [ROUTE CODE - AB] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26157 A

IV

6/13/2012

GM CHEMIE PVT LTD

26158 A

II

5/28/2012

PARABOLIC DRUGS LTD

CELLULOSE ACETATE PHTHALATE (CELLACEFATE) USP AS MANUFACTURED IN


MAHARASHTRA, INDIA
BOSENTAN MONOHYDRATE AS MANUFACTURED IN HARYANA, INDIA

26159 A

II

6/15/2012

CKD BIO CORP

RIFAMYCIN O, NON-STERILE API AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA

26160 I

II

6/11/2012

APTALIS PHARMATECH INC

26161 I

II

6/11/2012

APTALIS PHARMATECH INC

26162 I

II

6/11/2012

APTALIS PHARMATECH INC

26163 A

II

6/11/2012

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

26164 A

II

6/7/2012

CENTAUR PHARMACEUTICALS PRIVATE LTD

TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG AS MANUFACTURED IN VANDALIA,


OHIO
EMTRICITABINE RAPIDLY DISINTEGRATING TABLETS, 40 MG AS MANUFACTURED IN
VANDALIA, OHIO
EMTRICITABINE AND TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG/40 MG AS
MANUFACTURED IN VANDALIA, OHIO
VENLAFAXINE HYDROCHLORIDE CRYSTALLINE FORM B (VERSION NUMBER: 1) AS
MANUFACTURED IN ZHEJIANG, CHINA
ES-ZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA

FLUNISOLIDE HEMIHYDRATE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV)


ITALY
AIRLESS PUMP DISPENSERS AS MANUFACTURED IN VILLINGEN SCHWENNINGEN GERMANY
ROSUVASTATIN CALCIUM (ROS) AS MANUFACTURED IN BRANTFORD ONTARIO, CANADA AND
TOLUCA ESTADO DE, MEXICO FOR APOTEX PHARMACHEM INC
MILNACIPRAN HYDROCHLORIDE [ROUTE CODE -MR"] AS MANUFACTURED IN TELANGANA

Page 771

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26165 A
III
6/15/2012
ZHONGSHAN CITY CONSTRONG MEDICAL
PACKAGING MATERIAL CO LTD
26166 A
II
6/19/2012
SYMBIOTEC PHARMALAB LTD

SUBJECT
NON-PVC MEDICAL PACKING FILM AS MANUFACTURED IN GUANGDONG, CHINA

26167 A

II

7/7/2012

CADILA PHARMACEUTICALS LTD

VALSARTAN USP (PROCESS 2) AS MANUFACTURED IN GUJARAT, INDIA

26168 A

IV

6/6/2012

JC BIOLOGY TECHNOLOGY CO LTD

26169 A

6/15/2012

ACS DOBFAR SPA

26170 A

II

1/23/2013

CIPLA LTD

BRIGHT POLY UNFILLED HARD SHELL PULLULAN CAPSULES AS MANUFACTURED IN SHANXI


PROVINCE, CHINA
STERILE FINISHED PRODUCTS AS STERILE PROCESSING OPERATIONS, AND LOCATED IN
MILANO, ITALY- VIALE ADDETTA PLANT- LYOPHILIZATION PLANT NO.1
IMATINIB MESYLATE (A-FORM) AS MANUFACTURED IN BANGALORE, INDIA

26172 A

II

6/7/2012

CHONGQING PHAR SCIN CO LTD

26173 A

II

10/26/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

HYDROTALCITE NON STERILE, DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING CITY,


P.R. CHINA
FESOTERODINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

26174 A

II

10/9/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

LACOSAMIDE AS MANUFACTURED IN GUJARAT INDIA

26175 A

7/16/2012

CORDEN PHARMA LATINA SPA

ASEPTIC ONCOLOGICAL FACILITY AS MANUFACTURED IN SERMONETA (LATINA), ITALY

26176 A

II

6/28/2012

UNIMARK REMEDIES LTD

26177 A

II

7/13/2012

NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS) AS MANUFACTURED IN GUJARAT,


INDIA
ORCHID CHEMICALS AND PHARMACEUTICALS LTD ALMOTRIPTAN MALATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26178 A

II

6/22/2012

HETERO DRUGS LTD

RITONAVIR PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26179 A

II

6/25/2012

CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

26180 A

II

6/22/2012

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
DELTA BIOTECH SA

26181 A

II

6/22/2012

DELTA BIOTECH SA

LATANOPROST AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

26182 A

II

7/11/2012

GLOPEC INTERNATIONAL INC

26183 A

II

6/26/2012

CRYSTAL PHARMA SAU

ACITRETIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR GLOPEC INTERNATIONAL


INC
ETHINYL ESTRADIOL AS MANUFACTURED IN VALLADOLID, SPAIN

26184 A

II

6/28/2012

ASENCE PHARMA PRIVATE LTD

26185 A

II

6/28/2012

HETERO LABS LIMITED

AMPHOTERICIN B USP [ORAL GRADE] AS MANUFACTURED IN GUJARAT, INDIA FOR ASENCE


PHARMA PRIVATE LIMITED
ESCITALOPRAM OXALATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26186 A

6/26/2012

LONZA AG

POTENT COMPOUND PRODUCTION (PCP) FACILITY AT LONZA VISP SITE

26188 A

IV

6/29/2012

FONA INTERNATIONAL INC

825.0062U N-C CHERRY BERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

26189 A

II

6/29/2012

FRESENIUS KABI ANTI INFECTIVES SRL

26190 A

II

6/14/2012

FIS FABBRICA ITALIANA SINTETICI SPA

HETACILLIN POTASSIUM STERILE AS MANUFACTURED IN CERNUSCO SUL NAVIGLIO (MI),


ITALY AND VILLADOSE (RO), ITALY
SOLIFENACIN SUCCINATE AS MANUFACTURED IN ALTE DI MONTECCHIO MAGGIORE, ITALY

26191 A

II

6/29/2012

CRYSTAL PHARMA SAU

CLOBETASOL PROPIONATE MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN

26192 A

II

7/3/2012

AARTI DRUGS LTD

PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26193 A

III

6/25/2012

AMPACET CORP

11078-E WHITE PE MB AS MANUFACTURED IN MESSANCY, BELGIUM

26194 A

II

6/25/2012

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

LEVETIRACETAM AS MANUFACTURED IN HUBEI PROVINCE, CHINA

26195 A

II

7/2/2012

NEULAND LABORATORIES LTD

PALIPERIDONE PALMITATE AS MANUFACTURED in telANGANA, INDIA

26196 A

IV

7/3/2012

JSR LIFE SCIENCES CORP

STYRENE ISOPRENE BLOCK COPOLYMER AS MANUFACTURED IN IBARAKI, JAPAN

26197 A

IV

8/16/2012

LIFECELL INTERNATIONAL PRIVATE LTD

DMSO 55%W/V DEXTRAN-40 5%W/V SOLUTION AS MANUFACTURED IN CHENNAI, INDIA

26198 A

II

7/10/2012

CTX LIFE SCIENCES PVT LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA

26171 P

TESTOSTERONE ENANTHATE, USP AS MANUFACTURED IN MADHYA PRADESH (M.P.), INDIA

*** PENDING FILING REVIEW ***

26187 P

TRAVOPROST AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

*** PENDING FILING REVIEW ***

Page 772

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26199 A
V
6/28/2012
PIRAMAL HEALTHCARE UK LTD

SUBJECT
GRANGEMOUTH SITE (SUITE 5)

26200 A

II

7/3/2012

UNION QUIMICO FARMACEUTICA SA UQUIFA SA

LINEZOLID AS MANUFACTURED IN BARCELONA, SPAIN

26201 A

III

6/8/2012

AMI POLYMERS PVT LTD

26202 A

II

7/5/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

SILICON TUBES & BRAIDED HOSES (PLATINUM CURED & PEROXIDE CURED) AS MIRA ROAD
AND SILVASSA, INDIA
ANASTROZOLE AS MANUFACTURED IN SICHUAN, CHINA

26203 A

III

3/26/2012

REXAM HEALTHCARE OFFRANVILLE SAS

26204 A

II

7/9/2012

HETERO DRUGS LTD

26205 A

II

6/29/2012

PCI SYNTHESIS

EYE DROPPERS SETS (10ML LDPE BOTTLE+ LDPE NOZZLE + PP CAPS) AS MANUFACTURED
IN OFFRANVILLE, FRANCE
DORZOLAMIDE HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
PCI-114234 AS MANUFACTURED IN NEWBURYPORT, MASSACHUSETTS

26206 A

II

7/10/2012

HETERO DRUGS LTD

SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26207 A

II

7/10/2012

HETERO LABS LTD

PAZOPANIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26208 I

II

6/29/2012

JARI PHARMACEUTICAL CO LTD

TORSEMIDE AS MANUFACTURED IN JIANGSU, CHINA

26209 A

II

10/23/2012

GLENMARK GENERICS LTD

RUFINAMIDE AS MANUFACTURED IN GUJARAT, INDIA

26210 I

II

9/27/2012

CADILA PHARMACEUTICALS LTD

RUPATADINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

26211 A

IV

7/5/2012

TAKASAGO INTERNATIONAL CORP

CHERRY MICRON OT-22685 AS MANUFACTURED IN SHIZAUOKA, JAPAN

26212 A

IV

7/5/2012

TAKASAGO INTERNATIONAL CORP

CHERRY FLAVOR OT-83853 AS MANUFACTURED IN KANAGAWA, JAPAN

26213 A

II

8/5/2012

AVA, INC.

26214 A

II

11/9/2012

LUPIN LTD

CHLORHEXIDINE GLUCONATE 20% SOLUTION, USP AS MANUFACTURED IN WILLOWBROOK,


IL
ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN GUJRAT, INDIA

26215 A

II

2/6/2013

LUPIN LTD

ATORVASTATIN CALCIUM TRIHYDRATE USP AS MANUFACTURED IN GUJRAT, INDIA

26216 A

III

9/18/2012

EMPHASYS INDUSTRIAL

CDM-HALER AS MANUFACTURED IN BOITUVA/SP, BRAZIL FOR EMPHASYS INDUSTRIAL

26217 A

II

7/12/2012

HETERO DRUGS LTD

FEBUXOSTAT (FORM-H1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26218 A

II

7/12/2012

DELAVAU LLC

26219 A

IV

7/11/2012

FUJI SILYSIA CHEMICAL LTD

26220 A

IV

7/5/2012

UNGERER AND CO

CALCIUM CARBONATE/MAGNESIUM HYDROXIDE GRANULATION AS MANUFACTURED IN


PHILADELPHIA, PENNSYLVANIA
SYNTHETIC AMORPHOUS SILICA PRODUCTS - SYLYSIA/ADSOLIDER AS MANUFACTURED IN
MIYAZAKI-KEN, JAPAN
ARTIFICIAL STRAWBERRY FLAVOR FV-3179 AS MANUFACTURED IN BETHLEHEM,
PENNSYLVANIA

26222 A

III

6/25/2012

AMPACET CORP

100664-E MOLD RELEASE PE MB AS MANUFACTURED IN BELGIUM, EUROPE

26223 A

II

7/16/2012

ASYMCHEM LABORATORIES INC

DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN TIANJIN, CHINA

26224 A

II

12/17/2012

IROKO PHARMACEUTICALS LLC

26225 I

II

8/16/2012

SANOFI PASTEUR INC

ZORVOLEX(TM) (DICLOFENAC) CAPSULES AS MANUFACTURED IN KANSAS CITY, MO FOR


IROKO PHARMACEUTICALS, LLC
PEGYLATED RECOMBINANT ANTI-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY
(KB001-A) DRUG SUBSTANCE AS MANUFACTURED IN BERKSHIRE, UNITED KINGDOM FOR
SANOFI PASTEUR, INC

26226 A

II

11/28/2012

TARO PHARMACEUTICAL INDUSTRIES LTD

OXICONAZOLE NITRATE, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL

26227 A

III

7/10/2012

TOPPAN PRINTING CO LTD

26228 A

II

10/26/2012

UNIV TEXAS MD ANDERSON CANCER CENTER

A PET/SILICONE LINER FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED


IN FUKUOKA, JAPAN
3'-DEOXY-3'-[F-18] FLUOROTHYMIDINE (18F-FLT) AS MANUFACTURED IN HOUSTON, TX

26229 A

II

7/31/2012

APOGEPHA ARZNEIMITTEL GMBH

26230 A

II

6/22/2012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

26221 P

*** PENDING FILING REVIEW ***

P4 AS MANUFACTURED IN RADEBEUL, GERMANY AND DRESDEN, GERMANY FOR APOGEPHA


ARZNEIMITTEL GMBH
EPROSARTAN MESYLATE AS MANUFACTURED IN ZHEJIANG, CHINA

Page 773

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26231 A
IV
7/13/2012
ILE PHARMACEUTICAL MATERIALS CO LTD
26232 A

IV

7/13/2012

26234 A

III

6/12/2012

ESS DEE ALUMINIUM LTD

26235 A

II

7/13/2012

APOTEX PHARMACHEM INDIA PVT LTD

NON TOXIC FOOD CONTACT GRADE SOFT ALUMINIUM HOUSE FOIL (PLAIN & PRINTED) AS
MANUFACTURED IN NANI DAMAN (U.T.), INDIA
CABERGOLINE USP AS MANUFACTURED IN BANGALOR, INDIA

26236 A

II

7/12/2012

PERRIGO API LTD

ROTIGOTINE AS MANUFACTURED IN JINAN CITY, CHINA FOR CHEMAGIS LTD

26237 A

III

7/19/2012

MITSUI CHEMICALS INC

TAFMER A-0585X AS MANUFACTURED IN CHIBA, JAPAN

26238 A

II

7/6/2012

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

PACA INTERMEDIATE AS MANUFACTURED IN JINAN, CHINA

26239 A

II

8/1/2012

AUROBINDO PHARMA LTD

26240 A

II

2/28/2012

SHANDONG LONGLIVE BIO TECHNOLOGY CO LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (NON-STERILE DRUG SUBSTANCE) AS


MANUFACTURED IN ANDHRA PRADESH, INDIA
XYLO-OLIGOSACCHARIDES AS MANUFACTURED IN YUCHENG CITY, P.R. OF CHINA

26241 A

II

9/4/2012

ALEMBIC PHARMACEUTICALS LTD API DIV

FESOTERODINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

26242 A

II

7/17/2012

LAURUS LABS PRIVATE LIMITED

EFAVIRENZ USP (PROCESS-2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26243 A

III

7/23/2012

KRISHNA FOILS

PHARMACEUTICALS FOILS & FLEXIBLE PACKAGING PRODUCTS AS MANUFACTURED IN


AHMEDABAD INDIA

26245 A

II

7/23/2012

26246 A

II

26247 A

II

26248 A

26233 P

ILE PHARMACEUTICAL MATERIALS CO LTD

SUBJECT
ETHYLCELLULOSE AQUEOUS DISPERSION (PROFESSIONAL) (NON-STERILE, BULK FORM) AS
MANUFACTURED IN TIANJIN , CHINA
ETHYLCELLULOSE AQUEOUS DISPERSION (REGULAR) (NON-STERILE, BULK FORM) AS
MANUFACTURED IN TIANJIN , CHINA

*** PENDING FILING REVIEW ***

26244 P

*** PENDING FILING REVIEW ***


TRANS CHLOROATOVAQUONE AS MANUFACTURED IN GUJARAT, INDIA

7/31/2012

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
CTX LIFE SCIENCES PVT LTD

8/10/2012

HEBEI JIHENG GROUP PHARMACEUTICAL CO LTD

ACETAMINOPHEN AS MANUFACTURED IN HENGSHUI CITY, CHINA

II

8/10/2012

HEBEI JIHENG GROUP PHARMACEUTICAL CO LTD

ACETAMINOPHEN DC 90% AS MANUFACTURED IN HENGSHUI CITY, CHINA

26249 A

II

7/26/2012

AARTI INDUSTRIES LTD

LOTEPREDNOL ETABONATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26250 A

II

10/26/2012

RANBAXY LABORATORIES LTD

LACOSAMIDE AS MANUFACTURED IN PUNJAB, INDIA

26251 A

II

9/10/2012

CADILA HEALTHCARE LTD

SILODOSIN AS MANUFACTURED IN GUJARAT, INDIA

26252 A

II

7/23/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

LETROZOLE AS MANUFACTURED IN SICHUAN, CHINA

26253 A

II

7/10/2012

BEIJING GEYUAN TIANRUN BIO TECH CO LTD

TRYPSIN AS MANUFACTURED IN BEIJING CITY

26254 A

II

7/27/2012

SINTENOVO SA DE CV

PALIPERIDONE AS MANUFACTURED IN ESTADO DE MEXICO

26255 A

II

7/26/2012

INCELL CORP LLC

ZTM: A1 AND ZTM: A2 DEFINED CULTURE MEDIA AS MANUFACTURED IN SAN ANTONIO, TX

26256 A

II

2/21/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

DECITABINE AS MANUFACTURED IN MAHARASHTRA, INDIA

26257 A

II

8/12/2012

26258 A

II

7/30/2012

2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4-(BENZYLOXY)-3-(BENZYLOXYMETHYL)-2-METHYLENE
CYCLOPENTYL]-6H-PURINE-6-ONE(ET1) AS MANUFACTURED IN JIANGSU, CHINA
ENOXAPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA

26259 A

III

7/27/2012

26260 A

III

7/27/2012

26261 A

III

7/18/2012

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO.,


LTD.
HEBEI CHANGSHAN BIOCHEMICAL
PHARMACEUTICAL CO LTD
SHENG ZOU RUBBER AND PLASTICS SUZHOU CO
LTD
SHENG ZOU RUBBER AND PLASTICS SUZHOU CO
LTD
NIPRO STERILE GLASS GERMANY AG

26262 A

II

7/25/2012

IOL CHEMICALS AND PHARMACEUTICALS LTD

OMEPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA

26263 P

PREGABALIN AS MANUFACTURED IN GUJARAT, INDIA

FORMULATION C25(C25B) RUBBER STOPPER AS MANUFACTURED IN SUZHOU CITY, CHINA


FORMULATION C31(C31B) AS MANUFACTURED IN SUZHOU CITY, CHINA
STERILE TUBULAR GLASS VIALS AS MANUFACTURED IN MUNNERSTADT, GERMANY

*** PENDING FILING REVIEW ***

Page 774

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26264 I
II
8/16/2012
SANOFI PASTEUR INC

SUBJECT
PEGYLATED RECOMBINANT ANIT-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY (KB001A) DRUG PRODUCT AS MANUFACTURED IN VITRY-SUR-SEINE CEDEX, FRANCE AND ONTARIO,
CANADA FOR SANOFI PASTEUR, INC.

26265 A

III

8/1/2012

26266 A

II

7/31/2012

BRIGHTWOOD PHARMMED CONSUMABLE BEIJING MULTILAYER TUBE (MF800) AS MANUFACTURED IN BEIJING, P.R. CHINA
LTD
PHARMACEUTICAL WORKS POLPHARMA SA
CARBAMAZEPINE AS MANUFACTURED IN GDANSKI, POLAND

26267 A

II

7/30/2012

VUAB PHARMA AS

OXALIPLATIN AS MANUFACTURED IN BRNO CEZCH REPUBLIC

26268 I

II

7/20/2012

WARFARIN SODIUM (NON-STERILE, API) AS MANUFACTURED IN LINYI COUNTY, P.R. CHINA

26269 A

II

7/30/2012

QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO


LTD
PROCOS SPA

26270 A

II

7/21/2012

MSN PHARMACHEM PVT LTD

LACOSAMIDE [ROUTE CODE - LD"] AS MANUFACTURED IN TELANGANA

26271 A

II

8/1/2012

ETHYL ICOSAPENTATE AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN

26272 A

II

8/1/2012

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
GALAXY SURFACTANTS LTD

26273 A

III

7/23/2012

OH SUNG PLASTIC CO LTD

CONTAINER & CLOSURE AS MANUFACTURED IN CHUNGCHEONGBUK-DO, SOUTH KOREA

26274 A

III

8/1/2012

TWIST OFF PORT AS MANUFACTURED IN BEIJING CITY, CHINA

26275 A

II

10/31/2012

BEIJING AUSTAR HANSEN PACKAGING


TECHNOLOGY LTD
LUPIN LTD

26276 A

II

7/30/2012

DEAD SEA BROMINE CO LTD

MAGNESIUM OXIDE AS MANUFACTURED IN MOBILE POST ARAVA, ISRAEL

26277 A

III

7/17/2012

OG CORP

EMBOSSED PET FILM AS MANUFACTURED IN SHIGA-PREF., JAPAN

26278 A

IV

7/27/2012

DINESH REMEDIES LTD

HARD GELATIN CAPSULE SHELLS AS MANUFACTURED IN GUJARAT, INDIA

26279 A

IV

7/31/2012

DOW CORNING CORP

26280 A

II

8/2/2012

SHANGHAI AJINOMOTO AMINO ACID CO LTD

26281 A

II

5/24/2012

MAC CHEM PRODUCTS INDIA PVT LTD

DOW CORNING SILASTIC BIOMEDICAL GRADE ETR ELASTOMERS AS MANUFACTURED IN


HEMLOCK, MICHIGAN
L-LYSINE MONOHYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC
OF CHINA
CYTARABINE USP AS MANUFACTURED IN BOISAR, INDIA

26282 A

II

8/14/2012

RELIANCE LIFE SCIENCES PVT LTD

BORTEZOMIB AS MANUFACTURED IN NAVI MUMBAI, INDIA

26283 A

III

8/1/2012

BULK PACKAGING LINERS PVT LTD

PE FILM 40 FEET CONTAINER LINER AS MANUFACTURED IN KARNATAKA, INDIA

26284 A

III

8/1/2012

BULK PACKING LINERS PVT LTD

PE FILM 20 FEET CONTAINER LINER AS MANUFACTURED IN KARNATAKA, INDIA

26285 A

III

7/18/2012

NOLATO JAYCARE LTD

OVERCAP AS MANUFACTURED IN NEWCASTLE UPON TYNE ENGLAND

26286 A

III

7/17/2012

NOLATO JAYCARE LTD

26287 A

II

6/28/2012

JIANSHI YUANTONG BIOENGINEERING CO LTD

20ML MK2 POLYETHYLENE WHITE ROUND BOTTLE AS MANUFACTURED IN NEWCASTLE


UPON TYNE, ENGLAND
RUTIN AS MANUFACTURED IN ENSHI CITY, HUBEI PROVIENCE P.R. CHINA

26288 A

II

6/28/2012

HUNAN YUANTONG PHARMACEUTICAL CO LTD

TROXERUTIN AS MANUFACTURED IN CHANGSHA CITY, HUNAN PROVINCE P.R. CHINA

26289 A

II

9/7/2012

MSN ORGANICS PVT LTD

FEBUXOSTAT [ROUTE CODE FUG] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26290 P
26291 A

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN CAMERI, ITALY

OCTINOXATE AS MANUFACTURED IN MAHARASHTRA, INDIA

FESOTERODINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

*** PENDING FILING REVIEW ***


II

7/26/2012

26292 P

FARMABIOS S P A

EXEMESTANE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI, ITALY

*** PENDING FILING REVIEW ***

26293 A

III

8/9/2012

AMCOR FLEXIBLES GENT

26294 A

II

3/8/2013

APICORE US LLC

26295 A

II

8/9/2012

HEC PHARM USA INC

AF GENT EXTRUDED FILMS AND LAMINATES FOR PACKAGING AS MANUFACTURED IN GENT,


BELGIUM
MIGLUSTAT AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
LEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI
PROVINCE CHINA

Page 775

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26296 A
III
8/9/2012
CONSOLIDATED BOTTLE CORP
26297 A

II

8/2/2012

FIS FABBRICA ITALIANA SINTETICI SPA

SUBJECT
120ML WHITE LDPE FLAT OVAL BOTTLE 20/410 AS MANUFACTURED IN CONCORD ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
OLOPATADINE HCL AS MANUFACTURED IN VICENZA, ITALY

26298 A

8/9/2012

VALDEPHARM

STERILIZATION PROCESS VALIDATION FOR USE IN CEDEX, FRANCE

26299 A

II

8/22/2012

CIPLA LTD

ABACAVIR SULFATE USP AS MANUFACTURED IN PUNE MAHARASHTRA, INDIA

26300 A

IV

7/24/2012

SEPPIC SA

MONTANOX 80 PPI AS MANUFACTURED IN CASTRES CEDEX FRANCE

26301 A

II

8/8/2012

TOMITA PHARMACEUTICAL CO LTD

26302 A

II

8/8/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

26303 A

II

8/13/2012

HETERO DRUGS LTD

U.S.P. MAGNESIUM SULFATE HEPTAHYDRATE AS MANUFACTURED IN NARUTO, TOKUSHIMA


JAPAN
URSODEOXYCHOLIC ACID AS MANUFACTURED IN PENGZHOU CITY,SICHUAN PROVINCE,
CHINA
LOPINAVIR AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26304 A

II

7/30/2012

26305 A

II

8/3/2012

26306 A

III

8/8/2012

26307 A

II

8/14/2012

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LAROPIPRANT AS MANUFACTURED IN DONGYANG CITY, ZHEJIANG PROVINCE, CHINA
LTD
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL RILPIVIRINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
COLORTECH INC
11525-16 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN,
TENNESSEE AND ONTARIO, CANADA
HETERO DRUGS LTD
ENTECAVIR MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26308 A

II

8/3/2012

CENTAUR PHARMACEUTICALS PRIVATE LTD

TETRABENAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA

26309 A

III

8/8/2012

KOREA ALUMINUM CO LTD

CR(CHILD RESISTANT) FILM/PEEL & PUSH AS MANUFACTURED IN CHUNG-BUK, KOREA

26310 A

II

8/8/2012

26311 A

II

9/4/2012

LIVZON GROUP FUZHOU FUXING


PHARMACEUTICAL CO LTD
ZHEJIANG HISUN PHARMACEUTICAL CO LTD

VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN FUZHOU CITY, FUJIAN PROVINCE,


P.R. CHINA
TIGECYCLINE AS MANUFACTURED IN TAIZHOU CITY, CHINA

26312 A

II

9/21/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

BLEOMYCIN SULFATE PROCESS II AS MANUFACTURED IN TAIZHOU CITY, CHINA

26313 A

II

8/30/2012

AUROBINDO PHARMA LTD

26314 A

II

8/24/2012

AUROBINDO PHARMA LTD

26315 A

IV

8/10/2012

VANDERBILT MINERALS LLC

LACOSAMIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
VALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
VEEGUM; NATIONAL FORMULARY GRADES AS MANUFACTURED IN MURRAY, KY

26316 A

II

10/9/2012

LUPIN LTD

RUFINAMIDE AS MANUFACTURED IN GUJRAT, INDIA

26317 A

II

8/27/2012

MACLEODS PHARMACEUTICALS LTD

PREGABALIN AS MANUFACTURED IN GUJARAT, INDIA

26318 A

II

9/22/2012

MACLEODS PHARMACEUTICALS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA

26319 A

II

8/29/2012

UNIMARK REMEDIES LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

26320 A

III

8/16/2012

VERSALIS SPA

FLEXIRENE MR 50 A AS MANUFACTURED IN DUNKERQUE FRANCE FOR VERSALIS S.P.A.

26321 A

II

7/26/2012

GEDEON RICHTER PLC

CARIPRAZINE HYDROCHLORIDE AS MANUFACTURED IN DOROG, HUNGARY

26322 A

II

8/17/2012

ACEBRIGHT INDA PHARMA PRIVATE LTD

26323 A

II

10/15/2012

GLENMARK GENERICS LTD

IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED IN KARNATAKA,


INDIA
LACOSAMIDE AS MANUFACTURED IN GUJARAT, INDIA

26324 A

II

9/6/2012

PAN DRUGS LTD

GUAIFENESIN USP (NEW ROUTE) AS MANUFACTURED IN GUJARAT, INDIA

26325 P

*** PENDING FILING REVIEW ***

26326 A

II

8/21/2012

AMBIOPHARM INC

26327 A

III

8/14/2012

3M DRUG DELIVERY SYSTEMS

GLUCAGON, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH


AUGUSTA, SC, AND SHANGHAI, CHINA
3M COTRAN 9697 TAN NONWOVEN POLYURETHANE TAPE AS MANUFACTURED IN
BROOKINGS, SD

Page 776

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26328 A
II
8/18/2012
SICHUAN XIELI PHARMACEUTICAL CO LTD

SUBJECT
DOCETAXEL AS MANUFACTURED IN PENGZHOU CITY, CHINA

26329 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26330 A

II

6/13/2012

HEMMO PHARMACEUTICALS PVT LTD

SHENGZOU FORMULATION A03(A03B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY


AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
OCTREOTIDE ACETATE AS MANUFACTURED IN DISTRICT THANE, INDIA

26331 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26332 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26333 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26334 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26335 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26336 A

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26337 A

II

1/31/2013

CHEMWERTH INC

26338 A

II

3/1/2013

CHEMWERTH INC

26339 A

II

11/29/2012

GLAXOSMITHKLINE LLC

26340 A

II

4/24/2013

IROKO PHARMACEUTICALS LLC

26341 A

II

8/31/2012

EMCURE PHARMACEUTICALS LTD

SHENG ZOU RUBBER STOPPER FORMULATION A18(A18B) AS MANUFACTURED IN HEFEI CITY


AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
SHENG ZOU RUBBER STOPPER FORMULATION A04(A04B) AS MANUFACTURED IN HEFEI CITY
AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
SHENG ZOU FORMULATION A01 (A01B) RUBBER STOPPER AS MANUFACTURED IN HEFIEI
CITY, CHINA AND SUZHOU CITY CHINA FOR SHENG ZOU RUBBER AND PLASTICS
SHENG ZOU FORMULATION A41(A41B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY,
CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
SHENG ZOU FORMULATION K02 (K02B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY,
CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
SHENG ZOU FORMULATION F22 (F22B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY,
CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
ETHACRYNIC ACID NON-STERILE BULK DRUG AS MANUFACTURED IN MAHARASHTRA, INDIA
FOR CHEMWERTH, INC
ETHACRYNATE SODIUM NON-STERILE, BULK DRUG AS MANUFACTURED IN MAHARASHTRA,
INDIA FOR CHEMWERTH, INC
UMECLIDINIUM BROMIDE AS MANUFACTURED IN HERTFORDSHIRE, UK AND JURONG,
SINGAPORE FOR GLAXOSMITHKLINE
TIFORBEX (INDOMETHACIN) CAPSULES AS MANUFACTURED IN KANSAS CITY, MO FOR IROKO
PHARMACEUTICALS, LLC
SULFAMETHOXAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26342 A

II

8/16/2012

ZHEJIANG KANGLE PHARMACEUTICAL CO LTD

ACETAMINOPHEN DC90 AS MANUFACTURED IN WENZHOU CITY, CHINA

26343 A

II

8/21/2012

NIVIKA CHEMO PHARMA PVT LTD

NEBIVOLOL HCI AS MANUFACTURED IN GUJARAT, INDIA

26344 P

*** PENDING FILING REVIEW ***

26345 A

II

8/17/2012

APOTEX PHARMACHEM INDIA PVT LTD

FESOTERODINE FUMARATE AS MANUFACTURED IN BANGALORE, INDIA

26346 A

II

8/8/2012

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

26347 A

II

8/23/2012

NEULAND LABORATORIES LTD

STERILE CEFUROXIME SODIUM PROCESS 1, BULK ANTIBIOTIC DRUG SUBSTANCE AS


MANUFACTURED IN SHANDONG CHINA
DAPIPRAZOLE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

26348 A

II

5/31/2013

KESHAVA ORGANICS PVT LTD

PYRILAMINE MALEATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26349 A

II

9/7/2012

ALEMBIC PHARMACEUTICALS LTD API DIV

LACOSAMIDE AS MANUFACTURED IN GUJARAT, INDIA

26350 A

II

6/14/2013

CONCORD BIOTECH LTD

EVEROLIMUS AS MANUFACTURED IN AHMEDABAD, INDIA

26351 A

II

8/23/2012

MOREPEN LABORATORIES LTD

ATORVASTATIN CALCIUM TRIHYDRATE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA

26352 A

II

8/24/2012

SIEMENS MOLECULAR IMAGING INC

SODIUM ACETATE C11 INJECTION AS MANUFACTURED IN OVERLAND PARK, KS

26353 A

II

9/28/2012

HOSPIRA INC

26354 A

II

8/22/2012

ACS DOBFAR SPA

NT100H DRUG SUBSTANCE AS MANUFACTURED IN THEBARTON, AUSTRALIA FOR HOSPIRA,


INC
CEFPROZIL AS MANUFACTURED IN MILANO, ITALY

26355 A

II

8/27/2012

MAC CHEM PRODUCTS INDIA PVT LTD

BICALUTAMIDE USP AS MANUFACTURED IN BOISAR, INDIA

26356 A

II

8/20/2012

PHARMAZELL VIZAG PRIVATE LTD

CELECOXIB USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26357 A

II

8/26/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

DESVENLAFAXINE BASE AS MANUFACTURED IN BHIND, INDIA AND BEER SHEVA, ISRAEL FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD.

26358 P

*** PENDING FILING REVIEW ***

Page 777

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26359 A
II
9/28/2012
CHROMO LABORATORIES INDIA PRIVATE LTD

SUBJECT
ZAFIRLUKAST PREMIX-50% W/W AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26360 A

II

8/20/2012

BLOOMAGE FREDA BIOPHARM CO LTD

SODIUM HYALURONATE (HA-E 3.0) AS MANUFACTURED IN JINAN CITY, P.R. OF CHINA

26361 A

II

8/28/2012

ALKERMES GAINESVILLE LLC

26362 A

II

8/23/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

N1752 EXTENDED RELEASE TABLETS, 18MG AS MANUFACTURED IN ATHLONE, IRELAND FOR


ALKERMES GAINESVILLE LLC
IMATINIB MESYLATE AS MANUFACTURED IN PENGZHOU CITY, CHINA

26363 P

*** PENDING FILING REVIEW ***

26364 P

*** PENDING FILING REVIEW ***

26365 A

II

12/13/2013

TARO PHARMACEUTICAL INDUSTRIES LTD

CLOCORTOLONE PIVALATE USP, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL

26366 A

II

11/27/2012

MALLINCKRODT INC

NORBUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO

26367 A

II

4/30/2014

CODY LABORATORIES INC

MORPHINE BASE INTERMEDIATE AS MANUFACTURED IN CODY, WYOMING

26368 A

II

12/19/2014

CODY LABORATORIES INC

HYDROMORPHONE BASE INTERMEDIATE AS MANUFACTURED IN CODY, WYOMING

26369 A

II

9/10/2012

AUROBINDO PHARMA LTD

26370 A

II

9/7/2012

MSN PHARMACHEM PVT LTD

26371 A

IV

8/31/2012

WILD FLAVORS INC

CEFIXIME USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
FESOTERODINE FUMARATE [ROUTE CODE FF] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
NATURAL PEPPERMINT FLAVOR WONF #FALT526 AS MANUFACTURED IN ERLANGER, KY

26372 A

III

8/7/2012

SAMSUNG P AND S CO LTD

CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO, SOUTH KOREA

26373 A

8/3/2012

MICROTROL STERILISATION SERVICES PVT LTD

ETHYLENE OXIDE STERILISATION

26374 A

II

8/29/2012

SYN TECH CHEM AND PHARM CO LTD

CROTAMITON AS MANUFACTURED IN TAINAN CITY, TAIWAN

26375 A

II

9/5/2012

ASENCE PHARMA PRIVATE LTD

26376 A

II

9/5/2012

MEDICHEM MANUFACTURING MALTA LTD

AMPHOTERICIN B USP [PARENTERAL GRADE] AS MANUFACTURED IN VADODARA, GUJARAT,


INDIA FOR ASENCE PHARMA PRIVATE LIMITED
MED-200850/M (LACOSAMIDE) AS MANUFACTURED IN HAL FAR BBG, MALTA

26377 A

II

9/4/2012

JIANGSU HENGRUI MEDICINE CO LTD

26378 A

II

7/22/2013

CHEMWERTH INC

26379 A

II

9/24/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

26380 A

II

9/5/2012

AMBIOPHARM INC

26381 A

II

9/27/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

26382 A

II

9/5/2012

EUTICALS INC

DESVENLAFAXINE FUMARATE AS MANUFACTURED IN BEER SHEVA, ISRAEL AND BHIND


(MADHYA PRADESH), INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
LEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH
AUGUST, SC, SHANGHAI, CHINA, AND HAIKOU CITY, CHINA FOR AMBIOPHARM, INC
LACOSAMIDE AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
LACOSAMIDE AS MANUFACTURED IN SPRINGFIELD, MO

26383 A

II

9/5/2012

MYLAN LABORATORIES LTD

THIOTEPA USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26384 A

IV

9/5/2012

NIPPON SODA CO LTD

26385 A

II

9/29/2012

MSN LABORATORIES LTD

HYDROXYPROPYL CELLULOSE OR HPC AS MANUFACTURED IN NIIGATA, JAPAN FOR NIPPON


SODA CO., LTD
RUFINAMIDE [ROUTE CODE RU] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26386 A

II

11/6/2012

MSN LABORATORIES LTD UNIT II

IMATINIB MESYLATE [ROUTE CODE-" IT"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26387 A

II

9/14/2012

AUROBINDO PHARMA LTD

26388 A

II

9/12/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

PREGABALIN (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN PENGZHOU CITY, CHINA

26389 A

II

9/4/2012

FARMABIOS S P A

26390 A

III

9/7/2012

TERUMO CORP

DEXMEDETOMIDINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS


MANUFACTURED IN LIANYUNGANG, JIANGSU, CHINA
DIFLUPREDNATE AS MANUFACTURED IN TIANJIN, CHINA FOR CHEMWERTH INC

STERILIZED MEDROXYPROGESTERONE ACETATE USP ( MICRONIZED) AS MANUFACTURED IN


GROPELLO CAIROLI (PV), ITALY
PLAJEX-READY-TO-FILL PLASTIC SYRINGES AS MANUFACTURED IN SHIZUOKA, JAPAN

Page 778

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26391 A
II
9/5/2012
C S BIO CO
26392 A

II

8/30/2012

26394 A

IV

8/29/2012

UNGERER AND CO

26395 A

III

9/4/2012

ANDWIN SCIENTIFIC

26396 A

II

9/10/2012

CHROMO LABORATORIES INDIA PRIVATE LTD

NATURAL CHERRY WONF FLAVOR FV-7380 AS MANUFACTURED IN BETHLEHEM,


PENNSYLVANIA
SEALSAFE SELF-SEALING DOSING ADAPTERS AS MANUFATCURED IN WOODLAND HILLS,
CALIFORNIA
REPAGLINIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26397 A

II

9/6/2012

HETERO LABS LTD

VALSARTAN (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26398 A

II

9/7/2012

SUL OXIDOS INDUSTRIA E COMERCIO LTDA

ZINC OXIDE AS MANUFACTURED IN SANTA CATARINA, BRAZIL

26399 A

II

9/6/2012

MYLAN LABORATORIES LTD

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26400 A

II

9/3/2012

EVONIK REXIM SAS

L-PROLINE AS MANUFACTURED IN HAM, FRANCE

26401 A

II

11/5/2012

DR REDDYS LABORATORIES LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26402 A

II

9/18/2012

NAPROXEN SODIUM GRANULE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

26403 A

II

9/3/2012

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
SICHUAN XIELI PHARMACEUTICAL CO LTD

26404 A

II

9/19/2012

HISUN PHARMACEUTICAL HANGZHOU CO LTD

MYCOPHENOLIC ACID AS MANUFACTURED IN FUYANG CITY AND HANGZHOU CITY, CHINA

26405 A

II

11/23/2012

HISUN PHARMACEUTICAL HANGZHOU CO LTD

26406 A

II

12/16/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MYCOPHENOLATE MOFETIL AS MANUFACTURED IN FUYANG CITY, HANGZHOU CITY AND


ZHEJIANG, CHINA
PITAVASTATIN CALCIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26407 A

IV

8/29/2012

UNGERER AND CO

ARTIFICIAL CARAMEL FLAVOR FV-7382 AS MANUFACTURED IN BETHLEHEM, PA

26409 A

III

8/22/2012

26410 A

III

26411 A

II

26412 A
26413 A

26393 P

RAKS PHARMA PVT LTD

SUBJECT
TRIPTORELIN ACETATE, NON- STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
MENLO PARK, CA
FESOTERODINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

*** PENDING FILING REVIEW ***

26408 P

CAPECITABINE AS MANUFACTURED IN SICHUAN, CHINA

*** PENDING FILING REVIEW ***


CODE NAME: G60T-004 AS MANUFACTURED IN TIANJIN, P.R. CHINA

9/7/2012

TIANJIN BOKELIN MEDICAL PACKAGING


TECHNOLOGY CO LTD
NYPRO INC

8/20/2012

MANHATTAN ISOTOPE TECHNOLOGY LLC

STRONTIUM-82 DRUG SUBSTANCE AS MANUFACTURED IN LUBBOCK, TEXAS

9/7/2012

DAIKYO SEIKO LTD

RSV COMPONENT WASHING PROCESS AT HANDEA II BUILDING B IN OCHIGI, JAPAN

III

8/21/2012

VERSALIS SPA

FLEXIRENE MT 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE FOR VERSALIS SPA

26414 A

II

9/14/2012

NEULAND LABORATORIES LTD

ROPINIROLE AS MANUFACTURED IN TELANGANA, INDIA

26415 A

III

9/14/2012

SUMITOMO RUBBER INDUSTRIES LTD

RUBBER CLOSURE AS MANUFACTURED IN HYOGO, JAPAN

26416 A

II

9/14/2012

FERMION OY

CARBIDOPA AS MANUFACTURED IN HANKO, FINLAND

26417 A

II

10/1/2012

ALEMBIC PHARMACEUTICALS LTD

FEBUXOSTAT AS MANUFACTURED IN GUJARAT, INDIA

26418 A

II

9/11/2012

DIVIS LABORATORIES LTD

IRBESARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26419 A

II

9/27/2012

UNIMARK REMEDIES LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN GUJARAT, INDIA

26420 A

II

9/6/2012

QILU TIANHE PHARMACEUTICAL CO LTD

OLMESARTAN MEDOXOMIL (NON-STERILA API) AS MANUFACTURED IN JINAN, CHINA

26421 A

III

7/13/2012

26422 A

II

9/11/2012

26423 A

II

9/14/2012

SHIJIAZHUANG ZHONGHUI LEECHDOM PACKING


CO LTD
ZHEJIANG CHARIOTEER PHARMACEUTICAL CO
LTD
HETERO DRUGS LTD

HDPE BOTTLES FOR ORAL SOLID PREPARATION AS MANUFACTURED IN SHIJIAZHUANG CITY,


P.R. CHINA
VALGANCICLOVIR HYDROCHLORIDE, CRYSTALLINE (DRUG SUBSTANCE) AS MANUFACTURED
IN XIANJU, P.R. CHINA
SILODOSIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26424 A

II

9/11/2012

ACEBRIGHT INDA PHARMA PRIVATE LTD

IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED IN


KARNATAKA, INDIA

TABLET APPLICATOR AS MANUFACTURED IN HOSUR, INDIA FOR NYPRO INC

Page 779

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
26425 I
II
9/11/2012
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO SITAGLIPTIN PHOSPHATE ANHYDROUS AS MANUFACTURED IN DONGYANG CITY, CHINA
LTD
26426 A
II
9/11/2012
UNIV MISSOURI RESEARCH REACTOR CENTER
POTASSIUM MOLYBDATE (MO-99) FINAL INTERMEDIATE RADIOCHEMICAL AS MANUFACTURED
IN COLUMBIA, MISSOURI
26427 A
II
9/17/2012
HETERO DRUGS LTD
FESOTERODINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26428 A

IV

9/18/2012

FONA INTERNATIONAL INC

PRODUCT # 807.0439U MIXED BERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

26429 A

II

9/17/2012

ST GOBAIN PERFORMANCE PLASTICS CORP

BIO-SIL(R) 1450 AS MANUFACTURED IN TAUNTON, MA

26430 A

II

9/18/2012

INDO PHYTO CHEMICALS PRIVATE LTD

TESTOSTERONE USP AS MANUFACTURED IN UTTARAKHAND, INDIA

26431 A

II

9/11/2012

LAURUS LABS PRIVATE LTD

PEMETREXED DISODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26432 A

III

9/17/2012

ROSELABS BIOSCIENCE LTD

26433 A

IV

9/12/2012

26434 A

II

9/17/2012

26435 A

III

9/17/2012

ANKIT PULPS & BOARDS PVT LTD (PHARMA


DIVISION)
ZHEJIANG XIANJU XIANMING PHARMACEUTICAL
CO LTD
ROSELABS BIOSCIENCE LTD

ROSE-FILL-LT-2.25 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 2.25 ML) AS


MANUFACTURED IN GUJARAT, INDIA
MICROCRYSTALLINE CELLULOSE (USP) OF VARIOUS GRADES AS MANUFACTURED IN
MAHARASHTRA, INDIA
PROGESTERONE, USP AS MANUFACTURED IN ZHEJIANG, CHINA

26436 A

III

9/17/2012

ROSELABS BIOSCIENCE LTD

26437 A

II

9/12/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

26438 A

II

9/18/2012

CATALENT PHARMA SOLUTIONS LLC

26439 A

II

11/6/2012

UNIMARK REMEDIES LTD

PALONOSETRON HC1 0.50 MG SOFTGELS (1.5 OVAL) AS MANUFACTURED IN SOMERSET, NEW


JERSEY
MONTELUKAST SODIUM USP (PROCESS-C) AS MANUFACTURED IN GUJARAT, INDIA

26440 A

II

10/31/2012

GLAND CHEMICALS PRIVATE LTD

BORTEZOMIB AS MANUFACTURED IN KARNATAKA, INDIA

26441 A

II

10/25/2012

GLAND CHEMICALS PRIVATE LTD

ROCURONIUM BROMIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

26442 P

ROSE-FILL-LT-5.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 5.0 ML) AS


MANUFACTURED IN GUJARAT, INDIA
ROSE-FILL-LT-1.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 1.0 ML) AS
MANUFACTURED IN GUJARAT, INDIA
TRIMETAZIDINE DIHYDROCHLORIDE AS MANUFACTURED IN PENGZHOU CITY, CHINA

*** PENDING FILING REVIEW ***

26443 A

II

1/11/2013

CIPLA LTD

RITONAVIR USP AS MANUFACTURED IN BANGALORE, INDIA

26444 A

II

11/1/2012

DR REDDYS LABORATORIES LTD

PLERIXAFOR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26445 A

II

9/30/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

BUDESONIDE USP AS MANUFACTURED IN GUJARAT, INDIA

26446 A

II

9/26/2012

BIOPHORE INDIA PHARMACEUTICALS PVT. LTD

26447 A

II

9/26/2012

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

26448 A

II

9/17/2012

MACFARLAN SMITH LTD A JOHNSON MATTHEY CO

ZILEUTON AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA


PHARMACEUTICALS PVT. LTD.
PHYTONADIONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA
PHARMACEUTICALS PVT. LTD.
BUPRENORPHINE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM

26449 A

II

9/7/2012

XIWANG PHARMACEUTICAL CO LTD

DEXTROSE MONOHYDRATE AS MANUFACTURED IN BINZHOU CITY, P.R. CHINA

26450 A

II

9/7/2012

XIWANG PHARMACEUTICAL CO LTD

DEXTROSE ANHYDROUS AS MANUFACTURED IN BINZHOU CITY, P.R. CHINA

26451 A

II

8/9/2012

HUNAN LIJIE BIOCHEMICAL CO LTD

CHLOROXYLENOL AS MANUFACTURED IN CHANGSHA, CHINA

26452 A

II

9/27/2012

AUROBINDO PHARMA LTD

26453 A

II

9/20/2012

HYBIO PHARMACEUTICAL CO LTD

26454 A

II

8/30/2012

BEIJING GEYUAN TIANRUN BIO TECH CO LTD

GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
EPTIFIBATIDE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG,
P.R. CHINA
CHYMOTRYPSIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN BEIJING, CHINA

26455 A

II

9/21/2012

ARGUS PHARMACEUTICALS LTD

ORLISTAT AS MANUFACTURED IN CHANGSHA, CHINA

26456 A

II

9/18/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

GEFITINIB AS MANUFACTURED IN PENGZHOU CITY, CHINA

Page 780

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26457 A
II
9/12/2012
WUXI KAILI PHARMACEUTICAL CO LTD

SUBJECT
EPTIFIBATIDE AS MANUFACTURED IN YIXING CITY, P.R. CHINA

26458 A

II

9/18/2012

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

METHYLPREDNISOLONE, USP BULK AS MANUFACTURED IN TIANJIN, CHINA

26459 A

II

9/21/2012

SANDOZ PRIVATE LTD

SILODOSIN AS MANUFACTURED IN MAHARASHTRA, INDIA

26460 A

II

9/18/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

SORAFENIB TOSYLATE AS MANUFACTURED IN PENGZHOU, CHINA

26461 A

II

9/20/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

VIDAGLIPTIN AS MANUFACTURED IN PENGZHOU, CHINA

26462 A

II

9/18/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

CABAZITAXEL AS MANUFACTURED IN PENGZHOU, CHINA

26463 A

II

10/6/2012

EMCURE PHARMACEUTICALS LTD

RITONAVIR USP (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA

26464 A

II

9/18/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

SUNITINIB MALATE AS MANUFACTURED IN PENGZHOU, CHINA

26465 A

II

9/20/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

LAPATINIB TOSYLATE AS MANUFACTURED IN PENGZHOU, CHINA

26466 A

II

9/21/2012

TOMITA PHARMACEUTICAL CO LTD

USP SODIUM SULFATE, ANHYDROUS AS MANUFACTURED IN TOKUSHIMA, JAPAN

26467 A

II

9/21/2012

GLOCHEM INDUSTRIES LTD

26468 A

II

9/20/2012

ERREGIERRE SPA

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED AT VISAKHPATNAM DISTRICT FACILITY


IN ANDHRA PRADESH, INDIA
DEFERASIROX AS MANUFACTURED IN BERGAMO, ITALY

26469 A

II

11/16/2012

NECTAR LIFESCIENCES LTD

26470 A

II

9/17/2012

RESONANCE LABORATORIES PVT LTD

CEFTAZIDIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN TEHSIL DERA


BASSI, INDIA
GLYCOPYRROLATE AS MANUFACTURED IN BANGALORE, INDIA

26471 A

III

9/21/2012

26472 A

II

10/6/2012

EQUISTAR CHEMICALS LP A LYONDELLBASELL


INDUSTRIES CO
CADILA HEALTHCARE LTD

PRO-FAX SR257M POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN BAYPORT,


TEXAS AND LAKE CHARLES, LOUISIANA
LACOSAMIDE AS MANUFACTURED IN GUJARAT, INDIA

26473 A

II

9/21/2012

INCELL CORP LLC

ZAPR RED BLOOD CELL LYSING BUFFER AS MANUFACTURED IN SAN ANTONIO, TEXAS

26474 A

II

9/11/2012

JIAXING HENGJIE BIOPHARMACEUTICAL CO LTD

26475 A

II

10/3/2012

DR REDDYS LABORATORIES LTD

CHONDROITIN SULFATE SODIUM (NON STERILE, BULK FORM) AS MANUFACTURED IN


JIAXING, P.R. CHINA
DUTASTERIDE (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26476 A

II

9/21/2012

ZHEJIANG MEDICINE CO LTD XINCHANG


PHARMACEUTICAL FACTORY
*** PENDING FILING REVIEW ***

26479 A

II

5/2/2013

CHEMWERTH INC

26480 A

II

10/12/2012

MSN ORGANICS PVT LTD

26481 A

II

9/26/2012

INTERQUIM SA

DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG AS MANUFACTURED IN


MAHARASHTRA, INDIA FOR CHEMWERTH, INC
(2R,3R)-3(3-METHOXY PHENYL)-N,N,2-TRIMETHYL PENTANE-1-AMINE HYDROCHLORIDE
[ROUTE CODE TPT4] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
ROTIGOTINE AS MANUFACTURED IN BARCELONA, SPAIN

26482 A

II

9/24/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

DIOSMIN AS MANUFACTURED IN PENGZHOU, CHINA

26483 A

II

10/12/2012

AMOLI ORGANICS PVT LTD

CLOTRIMAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

26484 A

II

9/27/2012

SIGNA SA DE CV

LACOSAMIDE AS MANUFACTURED IN TOLUCA MX, MEXICO

26477 P
26478 P

BOSENTAN MONOHYDRATE AS MANUFACTURED IN XINCHANG, P.R. CHINA

*** PENDING FILING REVIEW ***

26485 P

*** PENDING FILING REVIEW ***

26486 P

*** PENDING FILING REVIEW ***

26487 A

II

9/24/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

TROXERUTIN AS MANUFACTURED IN SICHUAN, CHINA

26488 A

II

9/21/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

SOY ISOFLAVONES AS MANUFACTURED IN SICHUAN, CHINA

26489 A

II

9/27/2012

AMBIOPHARM INC

26490 A

II

9/27/2012

EUTICALS INC

GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH


AUGUSTA, SC AND SHANGHAI, CHINA
TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD,
MISSOURI

Page 781

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26491 A
II
9/27/2012
LEK PHARMACEUTICALS DD

SUBJECT
FESOTERODINE FUMARATE AS MANUFACTURED IN LJUBLJANA, SLOVENIA

26492 A

II

9/27/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN PENGZHOU, CHINA

26493 A

II

9/28/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

TELBIVUDINE AS MANUFACTURED IN PENGZHOU, CHINA

26494 A

II

9/25/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

DASATINIB AS MANUFACTURED IN PENGZHOU, CHINA

26495 A

II

9/26/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN PENGZHOU, CHINA

26496 A

III

9/25/2012

COIM USA INC

NOVACOTE HS-8256 AS MANUFACTURED IN OFFANENGO, ITALY FOR COIM USA, INC

26497 A

II

9/28/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

NILOTINIB AS MANUFACTURED IN PENGZHOU, CHINA

26498 A

II

9/28/2012

CHEMI SPA

26499 A

II

9/26/2012

MYLAN LABORATORIES LTD

FESOTERODINE FUMARATE AS MANUFACTURED IN FROSINONE, ITALY AND BAHIA, BRAZIL


FOR CHEMI SPA
RIVASTIGMINE USP (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA

26500 A

II

9/27/2012

SHASUN PHARMACEUTICALS LTD

LEVETIRACETAM AS MANUFACTURED IN CUDDALORE, INDIA

26501 A

II

9/27/2012

HETERO LABS LTD

ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26502 A

II

9/26/2012

SYN TECH CHEM AND PHARM CO LTD

NAFTOPIDIL AS MANUFACTURED IN TAINAN, TAIWAN

26503 A

II

10/13/2012

INTAS PHARMACEUTICALS LTD

FESOTERODINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

26504 A

II

9/26/2012

SYN TECH CHEM AND PHARM CO LTD

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN, TAIWAN

26505 A

II

10/30/2012

26506 A

IV

10/1/2012

AMPICILLIN TRIHYDRATE (PURICILLIN) AS MANUFACTURED IN PUNJAB, INDIA FOR DSM


SINOCHEM PHARMACEUTICALS NETHERLANDS B.V.
VACANT CAPSULE AS MANUFACTURED IN SHANXI, CHINA

26507 A

II

10/24/2012

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
SHANXI GUANGSHENG MEDICINAL CAPSULE CO
LTD
WOCKHARDT LTD

26508 A

II

9/28/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

HESPERIDIN AS MANUFACTURED IN PENGZHOU, CHINA

26509 A

II

9/28/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

RUTOSIDE TRIHYDRATE AS MANUFACTURED IN PENGZHOU, CHINA

26510 A

III

9/28/2012

ROSELABS POLYMERS LTD.

26511 A

III

9/28/2012

ROSELABS POLYMERS LTD.

26512 A

III

9/28/2012

ROSELABS POLYMERS LTD.

26513 A

II

9/28/2012

MERCK AND CIE

ROSEPOLY FILL LT 5 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 5 ML)


AS MANUFACTURED IN GUJART, INDIA
ROSEPOLY FILL LT 2.25 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 2.25
ML) AS MANUFACTURED IN GUJARAT, INDIA
ROSEPOLY FILL LT 1 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 1 ML)
AS MANUFACTURED IN GUJART, INDIA
(R)-DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

26514 A

II

10/25/2012

ZHEJIANG EXCEL PHARMACEUTICAL CO LTD

GABAPENTIN USP AS MANUFACTURED IN ZHEJIANG, CHINA

26515 A

II

10/1/2012

HETERO LABS LTD

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26516 A

III

10/1/2012

PROLAMINA CORP

26517 A

II

9/22/2012

HEMMO PHARMACEUTICALS PVT LTD

FLEXIBLE PACKAGING FOR PHARMACEUTICALS APPLICATIONS AS MANUFACTURED IN


WESTFIELD, MA, NEENAH, WI, AND TERREBONNE QC CANADA
OXYTOCIN AS MANUFACTURED IN TURBHE, INDIA

26518 A

II

6/21/2013

CADILA PHARMACEUTICALS LTD

NATEGLINIDE FORM H AS MANUFACTURED IN GUJARAT, INDIA

26519 A

II

10/23/2012

ALKEM LABORATORIES LTD

TAPENTADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

26520 A

II

10/19/2012

INTAS PHARMACEUTICALS LTD

LACOSAMIDE AS MANUFACTURED IN GUJARAT, INDIA

26521 A

II

10/3/2012

IRVINE SCIENTIFIC SALES CO

BALANCD CHO FEED 3 AS MANUFACTURED IN SANTA ANA, CALIFORNIA

26522 A

II

10/3/2012

IRVINE SCIENTIFIC SALES CO

26523 A

II

10/3/2012

IRVINE SCIENTIFIC SALES CO

BALANCD CHO FEED 2 (PRODUCT NUMBER 94121) AS MANUFACTURED IN SANTA ANA,


CALIFORNIA
BALANCD CHO FEED 1 (PRODUCT NUMBER 94119) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA

FESOTERODINE FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 782

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26524 A
II
10/3/2012
IRVINE SCIENTIFIC SALES CO

SUBJECT
BALANCD CHO GROWTH A (PRODUCT NUMBER 94120) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
MOXIFLOXACIN HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
POLYVINYL CHLORIDE (PVC) PELLETS, MEDICAL GRADE AS MANUFACTURED IN KAOHSIUNG
CITY, TAIWAN REPUBLIC OF CHINA
PRODUCT # 936.1368U ARTIFICIAL FLAVOR AS MANUFACTURED IN GENEVA, ILLINOIS

26525 A

II

10/4/2012

HETERO DRUGS LTD

26526 A

III

10/2/2012

NAN YA PLASTICS CORP

26527 A

IV

10/4/2012

FONA INTERNATIONAL INC

26528 A

II

9/14/2012

CILAG AG

26529 I

II

10/8/2012

ST PHARM CO LTD

METHYLNALTREXONE BROMIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND AND


MONTEGGIO, SWITZERLAND FOR CILAG AG
STAVUDINE DRUG SUBSTANCE AS MANUFACTURED IN GYEONGGI-DO, KOREA

26530 A

II

9/28/2012

KURASHIKI TEXTILE MANUFACTURING CO LTD

KURANBON AS MANUFACTURED IN OKAYAMA, JAPAN

26531 A

II

3/12/2013

LUPIN LTD

26532 A

II

9/27/2012

AVANTI POLAR LIPIDS INC

L-5-METHYLTETRAHYDROFOLATE CALCIUM (CRYSTALLINE) AS MANUFACTURED IN


MAHARASHTRA, INDIA
DODECYLPHOSPHOCHOLINE (DPC) AS MANUFACTURED IN ALABASTER, ALABAMA

26533 A

II

9/30/2012

MEGAFINE PHARMA P LTD

26534 A

II

10/10/2012

ITF CHEMICAL LTDA

DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


NASHIK, INDIA
TEMOZOLOMIDE, USP AS MANUFACTURED IN BAHIA, BRAZIL

26535 A

III

9/24/2012

AMERICHEM INC

58616-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OHIO

26536 A

II

10/17/2012

AMOLI ORGANICS PVT LTD

TELMISARTAN USP MANUFACTURED IN GUJARAT, INDIA

26537 A

II

10/22/2012

WATSON PHARMA PRIVATE LTD

OXYBUTYNIN CHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26538 A

II

10/8/2012

DAEWOONG BIO INC

STERILE MEROPENEM FOR INFECTION AS MANUFACTURED IN KYUNGGI-DO, KOREA

26539 A

II

10/8/2012

26540 A

II

10/11/2012

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
BIOCON LTD

VALACYCLOVIR HYDROCHLORIDE, ANHYDROUS FORM II AS MANUFACTURED IN XIANJU,


CHINA
ROSUVASTATIN CALCIUM AS MANUFACTURED IN BANGALORE, INDIA

26541 A

II

10/3/2012

PORTON FINE CHEMICALS LTD

NICOTINE USP AS MANUFACTURED IN CHONGQING, CHINA

26542 A

III

10/12/2012

POLINAS PLASTIK SANAYII VE TICARETI AS

26543 A

II

10/11/2012

GLOCHEM INDUSTRIES LTD

26544 A

II

10/30/2012

JIANGXI TIANXIN PHARMACEUTICAL CO LTD

BIAXIALLY ORIENTED POLYPROPYLENE FILM NAMED AS 525 AS MANUFACTURED IN MANISA,


TURKEY
PHTHALIMIDO AMLODIPINE (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
PYRIDOXINE HYDROCHLORIDE AS MANUFACTURED IN JIANGXI, CHINA

26545 A

II

11/14/2012

SAI LIFE SCIENCES LTD

PARICALCITOL USP, NON-STERILE BULK DRUG AS MANUFACTURED IN KARNATAKA, INDIA

26546 A

II

9/25/2012

PIRAMAL ENTERPRISES LTD

VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26547 A

II

12/6/2012

NATCO ORGANICS LTD

BORTEZOMIB AS MANUFACTURED IN TAMILNADU, INDIA

26548 A

II

10/5/2012

GULBRANDSEN TECHNOLOGIES INC

ACHIEVE DA 1097 CP AS MANUFACTURED IN GUJARAT, INDIA

26549 A

II

9/25/2012

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

FEBUXOSTAT AS MANUFACTURED IN HUBEI, CHINA

26550 A

II

9/14/2012

MAC CHEM PRODUCTS INDIA PVT LTD

LETROZOLE USP AS MANUFACTURED IN DISTRICT THANE, INDIA

26551 A

II

9/18/2012

MELODY HEALTHCARE PVT LTD

TIGECYCLINE AS MANUFACTURED IN MAHARASHTRA, INDIA

26552 A

II

5/12/2014

LACAMAS LABORATORIES INC

1LZD-LINEZOLID, STEP 1 (1LZD) AS MANUFACTURED IN PORTLAND, OREGON

26553 A

IV

10/16/2012

UNGERER AND CO

N/A CHERRY FLAVOR FV-7379 AS MANUFACTURED IN BETHLEHEM, PA

26554 A

II

9/14/2012

MAC CHEM PRODUCTS INDIA PVT LTD

IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP AS MANUFACTURED IN DISTRICT THANE,


INDIA

IV

10/16/2012

26555 P
26556 A

*** PENDING FILING REVIEW ***


NEOPHARM CO LTD

METHYL CAPROOYL TYROSINATE (CODE NAME: DEFENSAMIDE) AS MANUFACTURED IN


DAEJEON, KOREA

Page 783

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26557 A
II
10/10/2012
AMPACET CORP

SUBJECT
140891 ORANGE PP MB AS MANUFACTURED IN TERRE HAUTE, INDIANA

26558 A

III

9/20/2012

INVISTA RESINS AND FIBERS GMBH

26559 I

II

10/15/2012

26560 A

III

10/12/2012

26561 A

II

9/28/2012

26562 A

II

10/24/2012

POLYETHYLENE TEREPHTHALATE RESINS USED IN PACKAGING AS MANUFACTURED IN


GERSTHOFEN, GERMANY
HUATAI BIOPHARM INC
OMEGA-3-ACID ETHYL ESTERS (NON-STERILE, BULK FORM) AS MANUFACTURED IN SICHUAN,
P.R. CHINA
BASF SE
ULTRAFORM W2320 003 PRO TR UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
LIANYUNGANG RUNZHONG PHARMACEUTICAL CO PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN LIANYUNGANG, CHINA
LTD
MELODY HEALTHCARE PVT LTD
ALBUTEROL SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26563 A

II

9/14/2012

MELODY HEALTHCARE PVT LTD

TERBUTALINE SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26564 A

III

10/10/2012

AMPACET CORP

26565 A

III

10/10/2012

AMPACET CORP

26566 A

III

10/9/2012

AMPACET CORP

181356 DARK BROWN PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
454458 PEARL RED PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
164364-K BLUE 364 AS MANUFACTURED IN RAYONG, THAILAND

26567 A

III

10/10/2012

AMPACET CORP

26568 A

III

10/10/2012

AMPACET CORP

26569 A

III

10/10/2012

26570 A

II

10/16/2012

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG
KINOMEGA BIOPHARM INC.

26571 A

II

11/29/2012

TEVA PHARMACEUTICAL INDUSTRIES LTD

26572 A

II

10/25/2012

IRVINE SCIENTIFIC SALES CO

26573 A

III

12/28/2012

KURARAY CO LTD

26574 A

II

10/25/2012

IRVINE SCIENTIFIC SALES CO

26575 A

II

10/25/2012

IRVINE SCIENTIFIC SALES CO

26576 A

II

10/22/2012

FUKUZYU PHARMACEUTICAL CO LTD

BALANCD CHO FEED 2 (PRODUCT NUMBER 91129) AS MANUFACTURED IN SANTA ANA


CALIFORNIA
BALANCD CHO FEED 1 (PRODUCT NUMBER 91127) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
NPS-005 AS MANUFACTURED IN TOYAMA, JAPAN

26577 A

II

12/3/2012

CENTAUR PHARMACEUTICALS PRIVATE LTD

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26578 A

II

1/11/2013

RPG LIFE SCIENCES LTD

MYCOPHENOLATE MOFETIL USP ( ESUB) AS MANUFACTURED IN MUMBAI, INDIA

26579 A

II

10/24/2012

MELODY HEALTHCARE PVT LTD

LEVOSALBUTAMOL SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26580 A

II

10/26/2012

MAC CHEM PRODUCTS INDIA PVT LTD

DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN DISTRICT THANE, INDIA

26581 A

II

10/26/2012

MAC CHEM PRODUCTS INDIA PVT LTD

ANASTROZOLE USP AS MANUFACTURED IN DISTRICT THANE, INDIA

26582 A

II

2/11/2013

LUPIN LTD

FEBUXOSTAT (MICRONIZED) ( ESUB) AS MANUFACTURED IN GUJARAT, INDIA

26583 A

IV

10/26/2012

FONA INTERNATIONAL INC

863.002 N-C LEMON-LIME FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA ILLINOIS

26584 A

IV

10/26/2012

FONA INTERNATIONAL INC

884.628 N-C ORANGE FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, ILLINOIS

26585 A

II

10/29/2012

IRVINE SCIENTIFIC SALES CO

26586 A

II

10/23/2012

IOL CHEMICALS AND PHARMACEUTICALS LTD

BALANCD CHO FEED 3 (PRODUCT NUMBER 99471) AS MANUFACTURED IN SANTA ANA,


CALIFORNIA
LANSOPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA

131617 YELLOW PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
401198 HIGH HEAT PA PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
WHITE PE-BOTTLE 60ML AS MANUFACTURED IN NEUHAUS A. RWG., GERMANY
OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN DEYANG CITY, CHINA
ATORVASTATIN CALCIUM ( ESUB) AS MANUFACTURED IN UTTAR PRADESH, INDIA AND
MADHYA PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
BALANCD CHO GROWTH A ( PRODUCT NUMBER 91128) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
HYBRAR-HYBRAR(TM) 7311F, HYBRAR(TM) 7125F AND SEPTON(TM) 2004F HYDROGENATED
STYRENE- ISOPRENE, BUTADIENE OR ISOPRENE/BUTADIENE BLOCK COPOLYMERS

Page 784

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26587 A
III
10/26/2012
WEST PHARMACEUTICAL SERVICES INC

SUBJECT
NOVAGUARD SA SAFE SYSTEM AS MANUFACTURED IN VAUDREUIL, FRANCE

26588 A

III

10/16/2012

UFLEX LTD

PET + ALUMINIUM FOIL + POLY LAMINATES AS MANUFACTURED IN JAMMU, INDIA

26589 A

II

12/30/2013

WISDOM PHARMCEUTICAL CO LTD

MEFENAMIC ACID AS MANUFACTURED IN JIANGSU, CHINA

26590 A

III

10/16/2012

UFLEX LTD

PAPER + POLY + ALUMINIUM FOIL + POLY LAMINATE AS MANUFACTURED IN JAMMU, INDIA

26591 A

III

10/16/2012

UFLEX LTD

26592 A

10/22/2012

NORTHSTAR MEDICAL RADIOISOTOPES LLC

POLYAMIDE (NYLON) + ALUMINUM FOIL + PVC LAMINATE AS MANUFACTURED IN JAMMU,


INDIA
TECHNEGEN GENERATOR SYSTEM AS MANUFACTURED IN MADISON, WISCONSIN

26593 A

II

12/23/2012

WISDOM PHARMCEUTICAL CO LTD

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA

26594 A

II

12/17/2012

SYMPHONY PHARMA LIFESCIENCES PRIVATE LTD

LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26595 A

II

10/30/2012

LAURUS LABS PRIVATE LTD

26596 A

II

11/5/2012

AMOLI ORGANICS PVT LTD

DOCETAXEL ANHYDROUS, USP (PROCESS-2) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ASCORBIC ACID USP AS MANUFACTURED IN GUJARAT, INDIA

26597 A

II

11/2/2012

26598 A

III

10/26/2012

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
NEW AGE INDUSTRIES INC

VALGANCICLOVIR HYDROCHLORIDE, AMORPHOUS (DRUG SUBSTANCE) AS MANUFACTURED


IN XIANJU, CHINA
ADVANTAPURE SILICONE APST TUBING NI201 AS MANUFACTURED IN SHOUTHAMPTON, PA

26599 A

II

12/21/2012

GLENMARK GENERICS LTD

RASAGILINE MESYLATE AS MANUFACTURED IN GUJARAT STATE, INDIA.

26601 A

II

11/7/2012

SIGMUND LINDNER GMBH

SILIBEADS-CERAMIC BEADS TYPE ZY AS MANUFACTURED IN WARMENSTEINACH, GERMANY

26602 A

10/22/2012

EVONIK INDUSTRIES AG

EUDRAGIT L/S AS MANUFACTURED IN DARMSTADT, GERMANY

26603 A

II

11/12/2012

HETERO LABS LTD

PLERIXAFOR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26604 A

II

12/21/2012

HISUN PHARMACEUTICAL HANGZHOU CO LTD

DAPTOMYCIN AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

26605 A

II

12/27/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26606 A

II

12/30/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

IMATINIB MESYLATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26607 A

II

2/8/2013

RANBAXY LABORATORIES LTD

FEBUXOSTAT AS MANUFACTURED IN PUNJAB, INDIA

26608 A

III

11/12/2012

AMERICAN PACKAGING CORP

26609 A

III

11/9/2012

SELENIS CANADA INC

PILL PACK OVERWRAP POUCH - PRINTED LAMINATION AS MANUFACTURED IN COLUMBUS,


WI, STORY CITY, IA AND ROCHESTER, NEW YORK
POLY(ETHYLENE TEREPHTHALATE) AS MANUFACTURED IN MONTREAL, QUEBEC CANADA

26610 A

II

11/2/2012

NANYANG PUKANG PHARMACEUTICAL CO LTD

LINCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN NANYANG, CHINA

26611 A

II

11/7/2012

DERIVADOS QUIMICOS SAU

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ALCANTARILLA, SPAIN

26612 A

IV

11/8/2012

FINAR LTD

ACETONITRILE HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA

26613 A

III

11/9/2012

SANNER GMBH

26614 A

II

12/13/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

CONTAINER PACKAGING MATERIAL AS MANUFACTURED IN BENSHEIM, GERMANY, KUNSHAN,


CINA, AND BUDAPEST, HUNGARY
PEMETREXED DISODIUM HEPTAHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26615 A

II

12/20/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

DESVENLAFAXINE FUMARATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26616 A

III

11/7/2012

AMPACET CORP

26617 A

III

10/30/2012

AMPACET CORP

26618 A

II

11/12/2012

MEIJI SEIKA PHARMA CO LTD

433548 TRANSP YELLOW SMC PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,


LA, CATERSVILLE, GA AND HEATH, OH
466276 MYLAN BLUE SLIP PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA,
CARTERSVILLE, GA AND HEATH, OH
ME1111 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO-KEN, JAPAN

26619 A

II

10/29/2012

NTP RADIOISOTOPES SOC LTD

26600 P

*** PENDING FILING REVIEW ***

FISSION IODINE-131 (PRODUCED FROM LOW ENRICHED URANIUM(LEU) NORMAL PRODUCT


AS MANUFACTURED IN PRETORIA, SOUTH AFRICA

Page 785

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26620 A
II
1/9/2013
LUPIN LTD

SUBJECT
MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

26621 A

III

11/16/2012

ASAHI KASEI CHEMICALS CORPORATION

26622 A

II

11/19/2012

BIAL PORTELA AND CA SA

TUFTEC STYRENE BLOCK POLYMER WITH 1,3-BUTADIENE, HYDROGENATED AS


MANUFACTURED IN KANAGAWA, JAPAN
ESLICARBAZEPINE ACETATE AS MANUFACTURED IN VISP SWITZERLAND

26623 A

II

12/31/2012

CATALENT PHARMA SOLUTIONS LLC

SOFT GELATIN CAPSULE - OET-10275258 AS MANUFACTURED IN ST. PETERSBURG, FL

26624 A

II

11/19/2012

RAKS PHARMA PVT LTD

MILNACIPRAN HYDROCHLORIDE, API AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26625 A

IV

11/12/2012

UNGERER AND CO

ARTIFICIAL BUBBLEGUM FLAVOR FS-12019 AS MANUFACTURED IN BETHLEHEM, PA

26626 A

III

11/8/2012

PRETIUM PACKAGING

PLASTIC PACKAGING MATERICALS AS MANUFACTURED IN PARIS, ILLINOIS

26627 A

II

11/15/2012

IOL CHEMICALS AND PHARMACEUTICALS LTD

LAMOTRIGINE AS MANUFACTURED IN PUNJAB, INDIA

26628 A

III

11/12/2012

LOTTE CHEMICAL DAESAN PLANT

POLYPROPYLENE (PP) - SB-520Y AS MANUFACTURED IN CHUNGNAM, KOREA

26629

III

11/15/2012

LOTTE CHEMICAL YEOSU PLANT

26630 A

II

12/7/2012

APOTEX PHARMACHEM INC

POLYPROPYLENE (PP) - SB-520Y, SB-550Y, SB-740D, SFC-750D, SFO-130A AS MANUFACTURED


IN CHULLANAMDO, KOREA
ADEFOVIR DIPIVOXIL AS MANUFACTURED IN ONTARIO, CANADA

26631 A

II

1/22/2013

APOTEX PHARMACHEM INC

ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ONTARIO, CANADA

26632 A

II

3/5/2013

CADILA PHARMACEUTICALS LTD

BOSENTAN MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

26633 A

III

4/9/2013

SHANGHAI BLOPAK CO LTD

26634 A

IV

11/16/2012

BEIJING YINGMAO PHARMACEUTICAL CO LTD

COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN


SHANGHAI, CHINA
GASTRIC FILM COATING SYSTEM AS MANUFACTURED IN BEIJING, P.R. CHINA

26635 A

II

9/27/2012

OLON SPA

CLOFARABINE AS MANUFACTURED IN MILAN, ITALY

26636 A

III

8/14/2012

THE PAPER PRODUCTS LTD

PRIMARY PACKAGING MATERIAL, FLEXIBLE LAMINATES SPECIALIZED POUCHES, IN 1 PLY,


2PLY, 3PLY, 4PLY, 5PLY, 6PLY AND SHRINK SLEEVES AND LABELS FOR PHARMACEUTICAL
SOLID DOSAGE FORM AS MANUFACTURED IN UNION TERRITORY, INDIA

26637 A

II

12/10/2012

SIGNA SA DE CV

EZETIMIBE AS MANUFACTURED IN TOLUCA, EDO MEXICO

26638 A

11/20/2012

FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LTD

ABC5000 CONTRACT MANUFACTURING FACILITIES FOR THE MANUFACTURE OF


BIOTECHNOLOGY DRUG SUBSTANCES

26640 A

II

12/21/2012

SIGNA SA DE CV

PROGESTERONE USP AS MANUFACTURED IN TOLUCA, ESTADO DE MEXICO

26641 A

II

1/24/2013

INTERPHARMA PRAHA A S

26642 A

II

11/26/2012

SHASUN PHARMACEUTICALS LTD

IOHEXOL DRUG SUBSTANCE, FOR ORAL PRODUCTS AS MANUFACTURED IN MODRANY,


CZECH REPUBLIC
MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN PUDUCHERRY, INDIA

26643 A

II

11/26/2012

SANOCHEMIA PHARMAZEUTIKA AG

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN NEUFELD, AUSTRIA

26644 A

III

11/22/2012

JAPAN VILENE CO LTD

MEDICAL RELEASE LINER FILM, DL-01 AS MANUFACTURED IN SAITAMA, JAPAN

26645 A

III

11/20/2012

AMPACET CORP

113375-K BLOMITE 75 AS MANUFACTURED IN RAYONG, THAILAND

26646 A

III

11/26/2012

STELLA KUNSTSTOFFTECHNIK GMBH

26647 A

II

11/8/2012

SEVEN STAR PHARMACEUTICAL CO LTD

PLASTIC BOTTLE PP28, 50 ML, ACP 6031 D AN SECRO PP28 CHILDPROOF CLOSURE AS
MANUFACTURED IN KASTELLAUN AND ELTVILLE, GERMANY
GADOPENTETATE DIMEGLUMINE AS MANUFACTURED IN NEW TAIPEI, TAIWAN

26648 A

II

11/29/2012

AMOLI ORGANICS PVT LTD

CHLORTHALIDONE USP AS MANUFACTURED IN GUJARAT, INDIA

26649 A

II

12/28/2012

FRESENIUS KABI ONCOLOGY LTD

BUPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN WEST BENGAL, INDIA

26650 A

II

12/25/2012

FRESENIUS KABI ONCOLOGY LTD

ROPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN WEST BENGAL INDIA

26651 A

II

12/26/2012

ZOLEDRONIC ACID AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

26652 A

II

12/26/2012

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO


LTD
YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO
LTD

26639 P

*** PENDING FILING REVIEW ***

DOCETAXEL TRIHYDRATE AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

Page 786

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26653 A
IV
9/28/2012
SEPPIC SA

SUBJECT
SEPISPERSE LIQUID (AP, K, M, AS) AS MANUFACTURED IN CEDEX, FRANCE

26654 A

PHYTONADIONE USP, NON STERILE, BULK DRUG AS MANUFACTURED IN SHANGHAI, CHINA

II

11/19/2012

26655 N

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD


NOT AN ASSIGNED NUMBER

26656 A

II

12/21/2012

FRESENIUS KABI ONCOLOGY LTD

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN WEST BENGAL, INDIA

26657 A

II

1/15/2013

MYLAN LABORATORIES LTD

FEBUXOSTAT AS MANUFACTURED IN MAHARASHTRA, INDIA

26658 A

II

11/15/2012

HUBEI HONGYUAN PHARMACEUTICAL CO LTD

METRONIDAZOLE AS MANUFACTURED IN HUBEI PROVIENCE, CHINA

26659 A

II

4/25/2012

QIDONG DONGYUE PHARMACEUTICAL CO LTD

ACYCLOVIR AS MANUFACTURED IN JIANGSU CHINA

26660 A

II

11/29/2012

FLUOROMED LP

26661 A

III

3/16/2013

RELIANCE INDUSTRIES LTD

PERFLUORO(T-BUTYCYCLOHEXANE),96.0%(TRADE NAME APF-150M) AS MANUFACTURED IN


ROUND ROCK, TX
RELPET G5801 AS MANUFACTURED IN GUJARAT, INDIA

26662 A

II

4/3/2013

LUPIN LTD

DONEPEZIL HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

26663 A

IV

11/30/2012

SEIKAGAKU CORP

SODIUM CHONDROITIN SULFATE (ND) AS MANUFACTURED IN KANAGAWA, JAPAN

26664 A

II

3/11/2013

TARO PHARMACEUTICAL INDUSTRIES LTD

DICHLORPHENAMIDE USP AS MANUFACTURED IN HAIFA BAY, ISRAEL

26665 A

II

12/12/2012

CHEMPORT INC

EPA960EE AS MANUFACTURED IN JEOLLANAM-DO, KOREA

26666 A

III

11/29/2012

ROSELABS BIOSCIENCE LTD

26667 A

II

8/12/2013

IPCA LABORATORIES LTD

ROSE-FILL-SN-1 M1 (STERILE PRE FILLABLE GLASS SYRINGES 1.0 ML WITH STACKED


NEEDLE) AS MANUFACTURED IN GUJARAT, INDIA
BISOPROLOL FUMARATE USP (PROCESS II) AS MANUFACTURED IN MADHYA PRADESH, INDIA

26668 P

*** PENDING FILING REVIEW ***

26669 P

*** PENDING FILING REVIEW ***

26670 A

III

11/29/2012

26671 A

III

11/27/2012

26672 A

II

11/20/2012

26673 A

II

1/23/2013

ROSE-FILL-LT-3.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 3.0 ML) AS


MANUFACTURED IN GUJARAT, INDIA
EQUISTAR CHEMICALS LP A LYONDELLBASELL
PRO-FAX SB891 POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN BAYPORT, TX
INDUSTRIES CO
AND LAKE CHARLES, LA
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL ATAZANAVIR SULFATE AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
LUPIN LTD
PREGABALIN (PROCESS-B) ( ESUB) AS MANUFACTURED IN GUJARAT, INDIA

26674 A

IV

11/29/2012

ABELEI INC

PRODUCT # 160A30 NATURAL LEMON FLAVOR AS MANUFACTURED IN NORTH AURORA, IL

26675 A

III

11/20/2012

HSIAO SUNG NON OXYGEN CHEMICAL CO LTD

26676 A

II

12/4/2012

BCN PEPTIDES SA

O-BUSTER-E (ENZYME) - OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG, TAIWAN


AND CHANG SU, CHINA
NESIRITIDE AS MANUFACTURED IN BARCELONA, SPAIN

26677 A

II

2/19/2013

CORLINE SYSTEMS AB

CORLINE HEPARIN CONJUGATE AS MANUFACTURED IN UPPSALA, SWEDEN

26678 P

ROSELABS BIOSCIENCE LTD

*** PENDING FILING REVIEW ***

26679 P

*** PENDING FILING REVIEW ***

26680 A

II

1/7/2013

BIOIBERICA SA

HEPARIN SODIUM (PROCESS P024900) AS MANUFACTURED IN BARCELONA, SPAIN

26681 A

II

11/15/2012

LABORCHEMIE APOLDA GMBH

D-PENICILLAMINE HYDROCHLORIDE AS MANUFACTURED IN THURINGIA, GERMANY

26682 A

II

12/6/2012

AMINO CHEMICALS LTD

SAPROPTERIN DIHYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA

26683 A

III

12/3/2012

UNIVERSAL MEDICAP LTD

RUBBER CLOSURES AS MANUFACTURED IN GUJARAT, INDIA

26684 A

II

12/4/2012

PIRAMAL ENTERPRISES LTD

IRBESARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26685 A

II

12/7/2012

NOSCH LABS PRIVATE LTD

PANTOPRAZOLE SODIUM, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26686 A

IV

4/8/2012

NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD

SODIUM STEARYL FUMARATE USP AS MANUFACTURED IN NAGPUR, INDIA

26687 A

II

12/7/2012

HETERO LABS LTD

IMATINIB MESYLATE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 787

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26688 A
II
12/7/2012
HETERO LABS LTD

SUBJECT
PACLITAXEL, USP (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26689 A

II

12/18/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

QUETIAPINE FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26690 A

II

12/19/2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

VALSARTAN AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26692 A

II

1/18/2013

LABORCHEMIE APOLDA GMBH

MENGLYTATE AS MANUFACTURED IN THURINGIA, GERMANY

26693 A

II

12/21/2012

NATCO PHARMA LTD

SORAFENIB TOSYLATE (SOT) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26694 A

II

1/24/2013

INKE SA

OLANZAPINE AS MANUFACTURED IN BARCELONA, SPAIN

26695 A

II

10/19/2012

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTD

ZIDOVUDINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN TAIZHOU, P.R. CHINA

26696 A

III

12/26/2012

FRESENIUS KABI DEUTSCHLAND GMBH

26697 A

IV

12/11/2012

FINAR LTD

26698 A

IV

12/11/2012

FINAR LTD

FREEFLEX PACKAGING SYSTEM (POLYOLEFIN BAG) AS MANAFACTURED IN HALDEN,


NORWAY FOR FRESENIUS KABI DEUTSCHLAND GMBH
MONOSODIUM GLYCIN CARBONATE HIGH PURITY GRADE (HP) AS MANUFACTURED IN
GUJARAT, INDIA
CYCLOHEXANE HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA

26699 A

II

1/9/2013

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

CEFPROZIL AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

26700 A

II

3/22/2013

DR REDDYS LABORATORIES LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26701 A

II

12/31/2012

USV LTD

LINEZOLID AS MANUFACTURED IN MAHARASHTRA, INDIA

26702 A

IV

12/11/2012

FINAR LTD

N,N-DIMETHYL ACETAMIDE HIGH PURITY (HP) AS MANUFACTURED IN GUJARAT, INDIA

26703 A

IV

12/11/2012

FINAR LTD

BENZENE SULPHONIC ACID HIGH PURITY (HP) AS MANUFACTURED IN GUJARAT, INDIA

26704 A

II

12/18/2012

NATCO PHARMA LTD

26705 A

III

2/1/2013

KEYSTONE CAP CO

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN TAMILNADU, INDIA FOR NATCO


PHARMA LTD
THREADED METAL CLOSURES AS MANUFACTURED IN COLUMBIA, PA

26706 A

II

12/24/2012

MACLEODS PHARMACEUTICALS LTD

RASAGILINE MESYLATE AS MANUFACTURED IN GUJARAT, INDIA

26707 A

III

12/10/2012

LOPAREX BV

26708 A

II

12/11/2012

ITF CHEMICAL LTDA

RELEASE LINER BASED ON POLYESTER WITH 1 OR 2 SIDES SOLVENT LESS SILICONE


COATING AS MANUFACTURED IN APELDOORN, THE NETHERLANDS
DECITABINE AS MANUFACTURED IN HUBEI, PR CHINA FOR ITF CHEMICAL LTDA

26709 A

II

1/15/2013

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275260] AS MANUFACTURED IN PETERSBURG, FL

26710 A

IV

12/11/2012

MK SILICONE PRODUCTS PVT LTD

SILICONE TRANSPARENT TUBING AS MANUFACTURED IN MUMBAI, INDIA

26711 A

II

12/3/2012

BASF SE

L-MENTHOL AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

26712 A

II

12/6/2012

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTD

LEVOFLOXACIN AS MANUFACTURED IN TAIZHOU, P.R. CHINA

26713 A

IV

11/8/2012

MB SUGARS AND PHARMACEUTICALS LTD

CONFECTIONERS SUGAR (USP) AS MANUFACTURED IN MAHARASHTRA, INDIA

26714 A

II

2/28/2013

UNIV TEXAS MD ANDERSON CANCER CENTER

F 18 SODIUM FLUOROACETATE (18F-FACE) INJECTION AS MANUFACTURED IN HOUSTON, TX

26715 A

II

7/19/2013

HELSINN ADVANCED SYNTHESIS SA

NETUPITANT AS MANUFACTURED IN BIASCA, SWITZERLAND

26716 A

II

12/11/2012

BCN PEPTIDES SA

LEUPROLIDE (LEUPRORELIN) AS MANUFACTURED IN BARCELONA, SPAIN

26691 P

*** PENDING FILING REVIEW ***

26717 P

*** PENDING FILING REVIEW ***

26718 A

II

3/4/2013

JUBILANT GENERICS LTD

FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN NANJANGUD, INDIA

26719 A

II

3/7/2013

JUBILANT GENERICS LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN NANJANGUD, INDIA

26720 A

II

3/4/2013

JUBILANT GENERICS LTD

BUPROPION HYDROBROMIDE AS MANUFACTURED IN NANJANGUD INDIA

26721 A

II

2/24/2014

LABORCHEMIE APOLDA GMBH

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN THURINGIA, GERMANY

26722 A

II

12/29/2012

SUN PHARMACEUTICAL INDUSTRIES LTD

FEBUXOSTAT AS MANUFACTURED IN MAHARASHTRA, INDIA

26723 A

II

1/4/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 788

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26724 A
II
11/28/2012
SIGMUND LINDNER GMBH

SUBJECT
SILIBEADS - CERAMIC BEADS TYPE ZY PREMIUM AS MANUFACTURED IN WARMENSTEINACH,
GERMANY
ABIRATERONE ACETATE AS MANUFACTURED IN PERUGIA, ITALY

26725 A

II

11/28/2012

STERLING SPA

26726 A

II

1/24/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

26727 A

II

11/5/2012

SHAANXI HUIFENG PHARMACEUTICAL LTD

26728 A

II

12/14/2012

26729 A

IV

12/12/2012

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS PRIVATE CO LTD
JRS PHARMA LP

26730 A

III

12/12/2012

26731 A

III

12/18/2012

26732 A

III

12/6/2012

26733 A

IV

12/12/2012

26734 A

II

1/7/2013

PROSOLV ODT (CO-PROCESSED EXCIPIENT FOR ORAL DISSOLVING TABLET) AS


MANUFACTURED IN BETHLEHEM, PENNSYLVANIA FOR JRS PHARMA LP
KUNSHAN WISEPAC DESICCANT CO LTD
DESICCANT (SILICA GEL WITH TYVEK 1059B AS PACKAGING MATERIALS) AS MANUFACTURED
IN JIANGSU, CHINA
AMERICAN PACKAGING CORP
INHALATION DRUG OVERWRAP AS MANUFACTURED IN ROCHESTER, NY, STORY CITY, IA AND
COLUMBUS, WI
SANNER GMBH
CLOSURES AS MANUFACTURED IN BENSHEIM, GERMANY, KUNSHAN, CHINA AND BUDAPEST,
HUNGARY
HANGZHOU GAOCHENG BIOTECH AND HEALTH CO MICROCRYSTALLINE CELLULOSE SPHERES, USP AS MANUFACTURED IN HANGZHOU, CHINA
LTD
ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD CRUDE CARBIDOPA AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

26735 A

II

1/9/2013

PROVEPHARM SAS

METHYLENE BLUE AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE

26736 A

III

12/17/2012

NEMERA LE TREPORT

SP3 PUMPS FOR SPRAY DRUG PRODUCTS AS MANUFACTURED IN TREPORT, FRANCE

26737 A

IV

12/10/2012

SUGAR SPHERES, USP AS MANUFACTURED IN HANGZHOU, CHINA

26738 A

II

12/17/2012

26739 A

II

1/11/2013

HANGZHOU GAOCHENG BIOTECH & HEALTH CO.


LTD.
HANGZHOU HUADONG MEDICINE GROUP
KANGRUN PHARMACEUTICAL CO LTD
WISDOM PHARMCEUTICAL CO LTD

26740 A

II

2/1/2013

WISDOM PHARMCEUTICAL CO LTD

FASUDIL HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA

26741 A

II

12/31/2012

APOTEX PHARMACHEM INDIA PVT LTD

FEBUXOSTAT AS MANUFACTURED IN BANGALORE, INDIA

26742 A

II

12/20/2012

LOPAREX LLC

FLUORINE SILICONE COATED RELEASE LINERS AS MANUFACTURED IN IOWA CITY, IA

26743 A

II

2/26/2013

WOCKHARDT BIO AG

ARIPIPRAZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA FOR WOCKHARDT BIO AG

26744 A

IV

12/18/2012

BEIJING YINGMAO PHARMACEUTICAL CO LTD

ENTERIC FILM COATING SYSTEM AS MANUFACTURED IN BEIJING, P.R. CHINA

26745 A

II

12/19/2012

SICHUAN XIELI PHARMACEUTICAL CO LTD

TAUROURSODEOXYCHOLIC ACID AS MANUFACTURED IN PENGZHOU CITY, CHINA

26746 A

II

12/20/2012

HETERO DRUGS LTD

ELTROMBOPAG OLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26747 A

II

12/20/2012

HETERO DRUGS LTD

NABUMETONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26748 A

III

12/17/2012

TEKNOR COLOR CO

84,060CP YELLOW 2% AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX

26749 A

III

12/17/2012

AMPACET CORP

7010575 SLIP PE MB AS MANUFACTURED IN CATERSVILLE, GA

26750 A

III

12/17/2012

AMPACET CORP

103233 TACKIFER PE MB AS MANUFACTURED IN CATERSVILLE, GA

26751 A

II

12/20/2012

HETERO LABS LTD

ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26752 A

II

12/21/2012

HETERO DRUGS LTD

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26753 A

II

12/21/2012

HETERO LABS LTD

CYCLOPHOSPHAMIDE MONOHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26754 A

III

10/16/2012

UFLEX LTD

PET + POLY + ALUMINIUM FOIL + POLY LAMINATE AS MANUFACTURED IN JAMMU, INDIA

26755 A

II

12/18/2012

NORAC PHARMA

ETO-10100 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CALIFORNIA

METHYLDOPA AS MANUFACTURED IN HANGZHOU, P. R. CHINA FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
RUTOSIDE TRIHYDRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN XIANYANG,
CHINA
LATANOPROST AS MANUFACTURED IN BUDAPEST, HUNGARY

EVEROLIMUS AS MANUFACTURED IN ZHEJIANG, P.R. CHINA


LAMIVUDINE AS MANUFACTURED IN JIANGSU, CHINA

Page 789

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26756 A
II
1/30/2013
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

SUBJECT
(3S, 4R) ALCOHOL COMPOUND (CHEMICAL NAME: (3S, 4R)-4-(4-FLUOROPHENYL)-3HYDROXYMETHYL-1-METHYLPIPERIDINE) AS MANUFACTURED IN ZHEJIANG, CHINA FOR
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

26757 A

II

12/21/2012

POLYPEPTIDE LABORATORIES FRANCE

EPTIFIBATIDE AS MANUFACTURED IN STRASBOURG, FRANCE

26758 A

II

12/28/2012

ROVI CONTRACT MANUFACTURING SL

26759 A

III

12/25/2012

ROSELABS POLYMERS LTD

26760 A

III

12/25/2012

ROSELABS POLYMERS LTD

26761 A

II

12/20/2012

SOUVIN PHARMACEUTICALS I PVT LTD

STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE AS MANUFACTURED IN MADRID,


SPAIN AND BARCELONA SPAIN FOR ROVI CONTRACT MANUFACTURING SL
STERILE DISPOSABLE PREFILLABLE POLYMER SYRINGES 1.0 ML WITH STACKED NEEDLE AS
MANUFACTURED IN GUJARAT, INDIA
STERILE DISPOSABLE PREFILLABLE POLYMER SYRINGES 2.25 ML WITH STACKED NEEDLE AS
MANUFACTURED IN GUJARAT, INDIA
TOLNAFTATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26762 A

II

12/26/2012

SHASUN PHARMACEUTICALS LTD

26763

II

12/28/2012

HEC PHARM CO LTD

26764 A

II

12/27/2012

SCINOPHARM TAIWAN LTD

26765 A

II

12/27/2012

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

26766 A

II

12/20/2012

26767 A

II

12/7/2012

26768 A

II

8/24/2012

26769

II

12/28/2012

26770 A

II

12/28/2012

ROCURONIUM BROMIDE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


XIANJU, CHINA
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL LUMEFANTRINE AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL TENOFOVIR AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL METHOCARBAMOL AS MANUFACTURED IN ZHEJIANG, CHINA
CO LTD
HEC PHARM CO LTD
PRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED
IN GUANGDONG PROVINCE, CHINA FOR HEC PHARM USA INC.
SCINOPHARM TAIWAN LTD
LEUPROLIDE MESYLATE AS MANUFACTURED IN TAIWAN, R.O. CHINA

26771 A

II

12/20/2012

SOUVIN PHARMACEUTICAL I PVT LTD

MEFENAMIC ACID BP AS MANUFACTURED IN MAHARASHTRA, INDIA

26772 A

II

12/20/2012

SOUVIN PHARMACEUTICAL I PVT LTD

DIPHENHYDRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26773 A

12/31/2012

EVONIK INDUSTRIES AG WERK ROHEM

EUDRAGIT RL/RS

26774 A

II

12/19/2012

LAURUS LABS PRIVATE LTD

BORTEZOMIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26775 A

IV

12/3/2012

HEUBACH COLOUR PVT LTD

DRIED ALUMINIUM HYDROXIDE GEL USP AS MANUFACTURED IN GUJARAT, INDIA

26776 A

II

12/27/2012

CHEMO IBERICA SA

26777 A

II

12/26/2012

MYLAN LABORATORIES LTD

ALISKIREN HEMIFUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR CHEMO


IBERICA SA
SILDENAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26778 A

II

1/7/2013

DAPTOMYCIN API AS MANUFACTURED IN ZHEJIANG, CHINA

26779 A

II

12/24/2012

26780 A

IV

1/2/2013

ZHEJIANG MEDICINE CO LTD XINCHANG


PHARMACEUTICAL FACTORY
CHONGQING PHARMACEUTICAL RESEARCH
INSTITUTE CO LTD
HUBEI GREENHOME FINE CHEMICAL CO LTD

26781 A

II

4/9/2013

LUPIN LTD

ROSUVASTATIN CALCIUM AS MANUFACTURED IN MANDIDEEP, INDIA

26782 A

II

4/18/2013

LUPIN LTD

OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN GUJARAT, INDIA

26783 A

II

3/11/2013

GLENMARK GENERICS LTD

SITAGLIPTIN PHOSPHATE MONOHYDRATE AS MANUFACTURED IN GUJARAT STATE, INDIA

26784 A

II

2/5/2013

MSN LABORATORIES LTD UNIT II

26785 A

II

3/8/2013

MSN ORGANICS PVT LTD

PALONOSETRON HYDROCHLORIDE [ROUTE CODE PI] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
ASENAPINE MALEATE [ROUTE CODE AN] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE, USP AS MANUFACTURED IN TAMIL


NADU, INDIA
OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU CITY, P.R.
CHINA FOR HEC PHARM USA INC
ROFLUMILAST AS MANUFACTURED IN JIANGSU, CHINA FOR SCINOPHARM TAIWAN LTD

ABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN


CHONGQING, PEOPLE'S REPUBLIC OF CHINA
BENZYL ALCOHOL AS MANUFACTURED IN HUBEI PROVINCE, CHINA

Page 790

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26786 A
II
2/8/2013
MSN ORGANICS PVT LTD

SUBJECT
TADALAFIL [ROUTE CODE - "TP"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26787 I

II

1/3/2013

PHARMACEUTICAL WORKS POLPHARMA SA

ACYCLOVIR AS MANUFACTURED IN GDANSKI, POLAND

26788 A

III

1/1/2013

MULTIPLAST POLYMER PVT LTD

26789 A

II

1/4/2013

NOSCH LABS PRIVATE LTD

PLASTIC HDPE BOTTLES FOR PHARMACEUTICAL USE AS MANUFACTURED IN


MAHARASHTRA, INDIA
DULOXETINE HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26790 A

III

1/4/2013

HSIAO SUNG NON OXYGEN CHEMICAL CO LTD

26791 A

II

12/30/2012

YAOPHARMA CO LTD

26792 A

II

1/17/2013

INTAS PHARMACEUTICALS LTD

DESICCANT AS MANUFACTURED IN TAICHUNG CITY, TAIWAN AND JIANG SU PROV., CHINA


FOR HSIAO SUNG NON OXYGEN CHEMICAL CO LTD
CLINDAMYCIN PALMITATE HC1 USP(NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN CHONGQING, PEOPLES REPUBLIC OF CHINA
PACLITAXEL USP (SEMI-SYNTHETIC) AS MANUFACTURED IN GUJARAT, INDIA

26793 A

II

1/15/2013

CATALENT PHARMA SOLUTIONS LLC

SOFTGEL CAPSULE [OET-10275263] AS MANUFACTURED IN ST. PETERSBURG, FLORDIA

26794 A

II

12/27/2012

SUVEN LIFE SCIENCES LTD

DOXOFYLLINE USP AS MANUFACTURED IN TELANGANA, INDIA

26795 A

II

2/6/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

EPTIFIBATIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26796 A

II

3/14/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

OMEPRAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26797 A

II

1/7/2013

STERLING SPA

DESOXYCORTICOSTERONE PIVALATE AS MANUFACTURED IN PERUGIA, ITALY

26798 A

IV

1/8/2013

SEPPIC SA

SEPICOAT AS MANUFACTURED IN CASTRES CEDEX, FRANCE

26799 A

II

1/7/2013

LEE PHARMA LTD

LANSOPRAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26800 A

II

12/13/2012

CAMBREX CHARLES CITY INC

SUFENTANIL CITRATE AS MANUFACTURED IN CHARLES CITY, IOWA

26801 A

II

1/4/2013

ZHEJIANG ZONE BANNER CHEMICAL CO LTD

3-CHLORO-IMINODIBENZYL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26802

II

1/5/2013

HEC PHARM CO LTD

26803 A

II

1/9/2013

26804 A

II

1/31/2013

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL


CO LTD
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

IRBESARTAN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI


PROVINCE, P.R. CHINA FOR HEC PHARM USA INC.
DUTASTERIDE AS MANUFACTURED IN HUBEI, CHINA

26805 A

II

12/18/2012

FRESENIUS KABI ANTI INFECTIVES SRL

CLOXACILLIN BENZATHINE STERILE AS MANUFACTURED IN MILAN, ITALY

26806 A

II

8/6/2012

FARMHISPANIA SA

26807 A

II

2/20/2013

GLENMARK GENERICS LTD

METFORMIN HYDROCHLORIDE / 0.75% COLLOIDAL SILICON DIOXIDE BLEND AS


MANUFACTURED IN MONTMELO, SPAIN
FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

26808 A

II

2/18/2013

CENTAUR PHARMACEUTICALS PRIVATE LTD

TRANYLCYPROMINE SULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26809 A

IV

1/16/2013

JC BIOLOGY TECHNOLOGY CO LTD

26810 A

III

1/10/2013

SAGAR RUBBER PRODUCTS PVT LTD

26811 A

II

1/15/2013

HEC PHARM USA INC

26812 A

III

1/3/2013

CHARTER NEX FILMS INC

26813 A

II

2/5/2013

IND SWIFT LABORATORIES LTD

UNFILLED HARD SHELL HYPROMELLOSE CAPSULES AS MANUFACTURED IN SHANXI


PROVINCE, CHINA
RUBBER GASKET FOR PRE-FILLED SYRINGES (RFS/RFU) AS MANUFACTURED IN GUJARAT,
INDIA
FELODIPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI
PROVINCE, P.R. CHINA FOR HEC PHARM USA INC
CHARTER NEX FILMS GRADE C8082 AS MANUFACTURED IN TURNERS FALLS, MA AND
MILTON, WI
COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA

26814 A

II

2/15/2013

EMCURE PHARMACEUTICALS LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26815 A

II

2/1/2013

EMCURE PHARMACEUTICALS LTD

FEBUXOSTAT AS MANUFACTURED IN MAHARASHTRA, INDIA

26816 A

II

9/5/2013

ACIC FINE CHEMICALS INC

26817 A

III

1/18/2013

AVERY DENNISON

CYSTEAMINE BITARTRATE AS MANUFACTURED IN TOLUCA, MEXICO FOR ACIC FINE


CHEMICALS INC.
S-2060N ADHESIVE AS MANUFACTURED IN HARYANA, INDIA FOR AVERY DENNISON

METOPROLOL SUCCINATE AS MANUFACTURED IN ZHEJIANG, CHINA

Page 791

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
SUBJECT
26818 A
II
1/6/2013
LIANYUNGANG GUIKE PHARMACEUTICAL CO., LTD. CAPECITABINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN JIANGSU, CHINA
26819 A

II

2/8/2013

EVEROLIMUS PRE-MIX AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN

1/31/2013

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
ZHEJIANG HISUN PHARMACEUTICAL CO LTD

26820 A

II

26821 A

III

1/17/2013

SHREE RAMA MULTI TECH LTD

26822 A

LAMI TUBES AS MANUFACTURED IN GUJARAT, INDIA

III

1/18/2013

YMC CO LTD

YMC- TRIART SERIES AS MANUFACTURED IN ISHIKAWA, JAPAN

26823 A

III

1/18/2013

BORMIOLI ROCCO SPA BU PLASTICA

PET BOTTLE

26824 A

II

8/23/2013

APOTEX PHARMACHEM INC

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ONTARIO,CANADA

26825 A

II

3/30/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

TEMSIROLIMUS AS MANUFACTURED IN MAHARASHTRA, INDIA

26826 A

II

3/19/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

PALIPERIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA

26827 A

III

12/20/2012

LOPAREX LLC

FLUORINE SILICONE COATED RELEASE LINERS PRODUCT TYPE ONE AS MANUFACTURED IN


IOWA CITY, IA

26829 A

II

2/13/2013

APOTEX PHARMACHEM INDIA PVT LTD

ESZOPICLONE AS MANUFACTURED IN BANGALORE, INDIA

26830 A

II

1/31/2013

FORTEQ NIDAU AG

MIRENA INSERTER PROJECT AS MANUFACTURED IN NIDAU, SWITZERLAND

26831 A

III

1/18/2013

26832 A

II

2/20/2013

EQUISTAR CHEMICALS LP A LYONDELLBASELL


INDUSTRIES CO
POLYPEPTIDE LABORATORIES SWEDEN AB

26833 A

II

2/27/2013

ALEMBIC PHARMACEUTICALS LTD API DIV

PRO-FAX RP512H POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN PASADENA,


TX AND WEST LAKE, LA
LEUPROLIDE ACETATE AS MANUFACTURED IN THANE, INDIA FOR POLYPEPTIDE
LABORATORIES (SWEDEN) AB
DEFERASIROX AS MANUFACTURED IN GUJARAT, INDIA

26834 A

III

1/15/2013

JOBAN GLASS CO., LTD

26835 A

II

3/15/2013

26836 A

III

1/21/2013

26837 A

II

1/14/2013

26839 A

IV

1/17/2013

TAKASAGO INTERNATIONAL CORP

26840 A

IV

1/17/2013

TAKASAGO INTERNATIONAL CORP

26841 A

II

3/29/2013

TARO PHARMACEUTICAL INDUSTRIES LTD

26842 A

IV

1/17/2013

TAKASAGO INTERNATIONAL CORP

26843 A

II

1/22/2013

HEC PHARM USA INC

26844 A

II

1/18/2013

SHANDONG XINHUA PHARMACEUTICAL CO LTD

TAK-122134 MICRON INTENSATES NATURAL AND ATIFICIAL PEPPERMINT EXTRA FLAVOR AS


MANUFACTURED IN TETERBORO, NJ
SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN
GUANGDONG PROVINCE, P.R. CHINA
ASPIRIN REFINED AS MANUFACTURED IN SHANDONG, P.R. CHINA

26845 A

II

12/15/2012

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

RIBAVIRIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

26846 A

II

2/7/2013

LAURUS LABS PRIVATE LTD

AZACITIDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26847 A

II

12/15/2012

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

AZATHIOPRINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

26848 A

II

2/13/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

FEBUXOSTAT AS MANUFACTURED IN ZHEJIANG, CHINA

26849 A

II

12/30/2012

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD

MERCAPTOPURINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

26828 P

MEROPENEM STERILE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

*** PENDING FILING REVIEW ***

26838 P

TUBULAR VIALS FOR PHARMACEUTICAL USE AS MANUFACTURED IN FUKUSHIMA


PREFECTURE, JAPAN
TEVA PHARMACEUTICAL INDUSTRIES LTD
FULVESTRANT AS MANUFACTURED IN MILAN, ITALY FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
COLORS FOR PLASTICS INC
THERMOPLASTICS RESIN R34151 RED/1797C COLORANT MASTERBATCH AS
MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS AND SPARTANBURG, SC
SHANGHAI DESANO CHEMICAL PHARMACEUTICAL PRAZIQUANTEL AS MANUFACTURED IN SHANGHAI, CHINA
CO LTD
*** PENDING FILING REVIEW ***
MICRON INTENSATES NATURAL AND ARTIFICIAL COOL SPEARMINT FLAVOR TAK-122461 AS
MANUFACTURED IN TETERBORO, NJ
TAK-122311 MICRON INTENSATES ARTIFICAL ICE FLAVOR AS MANUFACTURED IN
TETERBORO, NJ
DESOXIMETASONE USP, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL

Page 792

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26850 A
II
1/25/2013
ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

SUBJECT
MAP(VERSION NO.:1) (5R,6S)-3-[(DIPHENOXYPHOSPHINYL)OXYL-6-[(1R)-1-HYDROXYETHYL]-7OXO-1-AZABICYCLO[3.2.0]HEPT-2-ENE-2-CARBOXYLIC ACID (4-NITROPHENYL) METHYL ESTER
AS MANUFACTURED IN ZHEJIANG API BASE, P.R. CHINA

26851 A

III

1/30/2013

MITSUBISHI GAS CHEMICAL CO INC

T-ESTER AS MANUFACTURED IN KANAGAWA, JAPAN

26852 A

II

3/15/2013

JUBILANT GENERICS LTD

APREPITANT AS MANUFACTURED IN MYSORE, INDIA

26853

III

1/25/2013

BPREX HEALTHCARE OFFRANVILLE SAS

26854 A

IV

2/4/2013

FIRMENICH INC

EYE DROPPERS SETS (PP SOFT BOTTLES + PP SOFT NOZZLE + HDPE CAPS) AS
MANUFACTURED IN OFFRANVILLE, FRANCE
FRAGRANCE FORMULAS AS MANUFACTURED IN PLAINSBORO, NJ

26855 A

II

1/30/2013

STERLING SPA

FULVESTRANT AS MANUFACTURED IN PERUGIA, ITALY

26856 A

II

10/18/2013

AZTREONAM AS MANUFACTURED IN CHONGQING, CHINA

26857 A

II

1/28/2013

CHONGQING SHENGHUAXI PHARMACEUTICAL CO


LTD
GANGWAL CHEMICALS PVT LTD

26858 A

III

1/4/2013

ASTRA PLASTIQUE

26859 A

IV

1/23/2013

HENKEL CORP

CLOSURE PHARMASAFE MADE OUT OF THERMOPLASTIC MATERIALS AS MANUFACTURED IN


SAINT-GEORGES DE RENEINS, FRANCE
DURO-TAK 87-4900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

26860 A

1/29/2013

LUBRIZOL ADVANCED MATERIALS INC

TOXICOLOGY AND REGULATORY REVIEW-CARBOMER CLASS OF POLYMERS

26861 A

II

2/4/2013

GEDEON RICHTER PLC

ULIPRISTAL ACETATE MICRONIZED AS MANUFACTURED IN DOROG, HUNGARY

26862 A

II

1/22/2013

CHIRAL QUEST SUZHOU CO LTD

26863 A

II

2/4/2013

GANGWAL CHEMICALS PVT LTD

(S)-3-METHYLAMINO-1-(THIOPHENE-2-YL)PROPAN-1-OL AS MANUFACTURED IN JIANGXI


PROVINCE, CHINA
SALMETEROL XINAFOATE IP/BP AS MANUFACTURED IN MAHARASHTRA, INDIA

26864 A

II

3/22/2013

JANSSEN PHARMACEUTICA NV

SIMEPREVIR (R494617) DRUG SUBSTANCE AS MANUFACTURED IN GEEL, BELGIUM

26865 A

II

2/14/2013

AUROBINDO PHARMA LTD

26866 A

III

1/30/2013

APTAR FRANCE SAS

BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
APTAR ELECTRONIC ANCILLARY COMPONENTS AS MANUFACTURED IN LE VAUDREUIL,
FRANCE; CONGERS, NY, EIGELTINGEN, GERMANY AND RADOLFZELL, GERMANY FOR APTAR
FRANCE S.A.S.

26867 A

III

1/30/2013

E-ONEMEDI

CONTAINER & CLOSURE AS MANUFACTURED IN CHUNGCHEONGBUK-DO, SOUTH KOREA

26868 A

IV

1/22/2013

SUITTAR AS MANUFACTURED IN TIANJIN, P.R. CHINA

26869 A

IV

1/22/2013

26870 A

II

2/7/2013

TIANJIN BOKELIN MEDICAL PACKAGING


TECHNOLOGY CO LTD
TIANJIN BOKELIN MEDICAL PACKAGING
TECHNOLOGY CO LTD
SYMED LABS LTD

26871 A

II

2/4/2013

RA CHEM PHARMA LTD

MIDAZOLAM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26872 A

II

1/13/2013

ISOCHEM SAS

ECONAZOLE NITRATE AS MANUFACTURED IN VERT LE PETIT, FRANCE

26873 A

II

2/1/2013

PHARMACEUTICAL WORKS POLPHARMA SA

SODIUM SALICYLATE AS MANUFACTURED IN GDANSKI, POLAND

26874 A

III

1/17/2013

HUHTAMAKI RONSBERG

26875 A

III

1/30/2013

26876 A

III

1/30/2013

26877 A

II

5/20/2013

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG
HPT HOCHWERTIGE PHARMATECHNIK GMBH CO
KG
LUPIN LTD

SIDE SEALED FLAT POUCH FOR DRUGS APPLIED AS FAST DISSOLVING ORAL FILM AS
MANUFACTURED IN RONSBERG, GERMANY
ROUND WHITE PE- BOTTLE 300 ML (P-4029) AS MANUFACTURED IN NEUHAUS A. RWG.
GERMANY
SQUARE WHITE PE- BOTTLE 300 ML (P 4030) AS MANUFACTURED IN NEUHAUS A. RWG.,
GERMANY
BIMATOPROST AS MANUFACTURED IN MADHYA PRADESH, INDIA

26878 A

II

4/19/2013

LUPIN LTD

TRAVOPROST USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

26879 A

II

4/12/2013

LUPIN LTD

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

ISOXSUPRINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

NATRACOLOR AS MANUFACTURED IN TIANJIN, P.R. CHINA


KETOROLAC TROMETHAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 793

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26880 A
II
3/21/2013
CI NATURMEGA SA

SUBJECT
OMEGA-3 FISH OIL ETHYL ESTER 84% AS MANUFACTURED IN BARRANQUILLA, COLOMBIA

26881 A

II

2/4/2013

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTD

SPIRONOLACTONE AS MANUFACTURED IN ZHEJIANG, CHINA

26882 A

II

3/25/2013

USV LIMITED

NATEGLINIDE USP [MICRONISED] AS MANUFACTURED IN MAHARASHTRA, INDIA

26883 A

II

2/6/2013

26884 A

IV

12/19/2012

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL MEFLOQUINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI CHINA


CO LTD
HENKEL CORP
DURO-TAK 87-9900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

26885 A

II

3/27/2013

GLENMARK GENERICS LTD

SITAGLIPTIN PHOSPHATE ANHYDROUS AS MANUFACTURED IN GUJARAT STATE, INDIA

26886 A

II

2/13/2013

INTERQUIM SA

CELECOXIB AS MANUFACTURED IN BARCELONA, SPAIN

26887 A

III

2/6/2013

CODING PRODUCTS

SV-17809 AS MANUFACTURED IN KALKASKA, MI

26888 A

III

2/11/2013

MULTISORB TECHNOLOGIES

STABILOX HEAT SEAL LABEL AS MANUFACTURED IN BUFFALO, NY

26889 A

II

11/28/2012

CALYX CHEMICALS AND PHARMACEUTICALS LTD

VALGANCICLOVIR HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26890 A

II

3/4/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN ZHEJIANG, CHINA

26891 A

II

4/17/2013

SHENZHEN TECHDOW PHARMACEUTICAL CO LTD

ENOXAPARIN SODIUM USP AS MANUFACTURED IN SHENZHEN CITY, P. R. OF CHINA

26892 A

II

2/26/2013

KD PHARMA BEXBACH GMBH

EICOSAPENTAENOIC ACID ETHYL ESTER AS MANUFACTURED IN BEXBACH, GERMANY

26893 A

II

3/14/2014

XIAN LIBANG PHARMACEUTICAL CO LTD

FULVESTRANT AS MANUFACTURED IN SHAANXI, CHINA

26894 A

II

7/30/2014

CHEMWERTH INC

ABIRATERONE ACETATE AS MANUFACTURED IN TIANJIN, P. R. CHINA FOR CHEMWERTH INC

26895 A

II

3/1/2013

ULTRAGENYX PHARMACEUTICAL INC

26896 A

III

2/14/2013

SCHOTT KAISHA PVT LTD

TRIHEPTANOIN ULTRAPURE AS MANUFACTURED IN WITTEN, GERMANY FOR ULTRAGENYX


PHARMACEUTICAL INC
GLASS AMPOULES & VIALS AS MANUFACTURED IN GUJARAT, INDIA

26897 A

IV

2/13/2013

EVONIK CORP

100 DL MPEG 5000 3.5CE AS MANUFACTURED IN BIRMINGHAM, AL

26898 A

IV

2/12/2013

9000188 NAT MASKING TYPE FLAVOR AS MANUFACTURED IN COMMERCE, CA

26899 A

IV

2/18/2013

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
FONA INTERNATIONAL INC

26900 A

III

2/20/2013

CADILLAC PRODUCTS PACKAGING CO

COMMERCIAL N AS MANUFACTURED IN DALLAS, GEORGIA

26901 A

II

3/26/2013

ALKEM LABORATORIES LTD

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

26902 A

III

2/15/2013

SHL PHARMA LLC

26903 A

IV

2/13/2013

UNGERER AND CO

EPINEPHRINE AUTO-INJECTOR AS MANUFACTURED IN TAOYUAN, TAIWAN FOR SHL PHARMA


LLC
ARTIFICIAL BANANA FLVP FT-8072 AS MANUFACTURED IN BETHLEHEM, PA

26904 A

II

2/27/2013

APOTEX FERMENTATION INC

SIROLIMUS DRUG SUBSTANCE AS MANUFACTURED IN MANITOBA, CANADA

26905 A

IV

2/13/2013

UNGERER AND CO

NAT/ART CREME DE VANILLA FLVP FT-8073 AS MANUFACTURED IN BETHLEHEM, PA

26906 A

II

3/21/2013

TARO PHARMACEUTICAL INDUSTRIES LTD

ATOVAQUONE USP, MICRONIZED AS MANUFACTURED IN HAIFA, ISRAEL

26907 P

877.237 MINT FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

*** PENDING FILING REVIEW ***

26908 A

IV

2/13/2013

UNGERER AND CO

ARTIFICAL CARAMEL FLAVOR FV-8873 AS MANUFACTURED IN BETHLEHEM, PA

26909 A

II

3/26/2013

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275261] AS MANUFACTURED IN ST. PETERSBURG, FL

26910 P

*** PENDING FILING REVIEW ***

26911 A

II

2/21/2013

MAC CHEM PRODUCTS INDIA PVT LTD

EXEMESTANE AS MANUFACTURED IN DISTRICT THANE, INDIA

26912 A

II

9/9/2013

EXAMETAZIME AS MANUFACTURED IN RADEBERG, GERMANY

26913 A

II

2/20/2013

ABX ADVANCED BIOCHEMICAL COMPOUNDS


GMBH
NOSCH LABS PRIVATE LTD

26914 A

II

2/21/2013

NOSCH LABS PRIVATE LTD

LANSOPRAZOLE, USP AS MANUFACTURED IN ANDHRA PRADESH , INDIA

RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 794

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26915 A
V
2/21/2013
ACS DOBFAR SPA

SUBJECT
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AS LOCATED IN
MILANO, ITALY - VIALE ADDETTA PLANT - STERILE PLANT NO.3
PLASTIC HDPE BOTTLES FOR PHARMACEUTICAL USE AS MANUFACTURED IN
MAHARASHTRA, INDIA
COMPOUND PACKAGING MATERIAL PAPER/ALUMINIUM/BAREX AS MANUFACTURED IN
BURGDORF, SWITZERLAND
VALRUBICIN USP AS MANUFACTURED IN DONETSK, UKRAINE

26916 A

III

2/25/2013

MULTIPLAST POLYMER PVT LTD

26917 A

III

2/22/2013

AMCOR FLEXIBLES BURGDORF GMBH

26918 A

II

2/26/2013

SYNBIAS PHARMA LTD

26919 A

II

2/25/2013

26920 A

III

2/21/2013

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
LANXESS DEUTSCHLAND GMBH

26921 A

II

2/26/2013

MAPRIMED SA

26922 A

II

3/30/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

26923 A

II

5/16/2013

MEDICHEM SA

TRETINOIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA


PHARMACEUTICALS PVT. LTD
MED-200056/E AS MANUFACTURED IN CELRA GIRONA, SPAIN

26924 A

II

4/29/2013

MEDICHEM MANUFACTURING MALTA LTD

SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN HAL FAR, MALTA

26925 A

II

3/25/2013

GLENMARK GENERICS LTD

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

26926 A

II

9/27/2013

SPECTRUM PHARMACEUTICALS INC

26927 A

II

3/26/2013

JUBILANT GENERICS LTD

BELINOSTAT DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY FOR SPECTRUM


PHARMACEUTICALS, INC
ESLICARBAZEPINE ACETATE AS MANUFACTURED IN NANJANGUD, INDIA

26928 A

II

3/28/2013

JUBILANT GENERICS LTD

LINEZOLID FORM 1 AS MANUFACTURED IN MYSORE DISTRICT, INDIA

26929 A

II

3/29/2013

JUBILANT GENERICS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN MYSORE DISTRICT, INDIA

26930 A

III

2/27/2013

SURYA POLYCONTAINER

26931 A

II

3/14/2013

WISDOM PHARMCEUTICAL CO LTD

PLASTIC HDPE & PP BOTTLES & CLOSURES & PLUGS AS MANUFACTURED IN SILVASSA, D &
NH INDIA
FLUPIRTINE MALEATE AS MANUFACTURED IN JIANGSU, CHINA

26932 A

III

2/27/2013

MEDIPHARMAPLAN CO LTD

26934 A

II

3/31/2013

EMCURE PHARMACEUTICALS LTD

COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26935 I

II

3/28/2013

EMCURE PHARMACEUTICALS LTD

RALTEGRAVIR POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

26936 A

II

2/28/2013

NEULAND LABORATORIES LTD

BRINZOLAMIDE USP (STERILE) AS MANUFACTURED IN TELANGANA, INDIA

26937 A

II

3/5/2013

FARMABIOS S P A

LOTEPREDNOL ETABONATE AS MANUFACTURED IN PAVIA, ITALY

26938 A

II

2/14/2014

GLENMARK GENERICS LTD

26939 A

III

11/24/2014

STULL TECHNOLOGIES

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (D058 PROCESS) AS MANUFACTURED IN GUJARAT,


INDIA
PACKAGING MATERIAL

26940 A

II

4/11/2013

ARIAD PHARMACEUTICALS INC

26941 A

IV

2/28/2013

LONZA

RIDAFOROLIMUS DRUG SUBSTANCE AS MANUFACTURED IN BUBENDORF, SWITZERLAND


FOR ARIAD PHARMACEUTICALS, INC
POLYGLYCEROL-6 AS MANUFACTURED IN WILLIAMSPORT, PA

26942 A

II

3/14/2013

WISDOM PHARMCEUTICAL CO LTD

TIROFIBAN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA

26943 A

II

3/4/2013

ZHEJIANG YIZHOU CHEMICAL CO LTD

26944 A

II

2/28/2013

CODING PRODUCTS

TYRAMINE HYDROCHLORIDE (VERSION NO.:1) AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA
TTR-76356 AS MANUFACTURED IN KALKASKA, MICHIGAN

26945 A

II

3/4/2013

PROCOS SPA

ILOPERIDONE AS MANUFACTURED IN NOVARA, ITALY

26933 P

TOPIRAMATE USP AS MANUFACTURED IN GUJARAT, INDIA


LANXESS BROMOBUTYL 2230 AS MANUFACTURED IN ONTARIO CANADA FOR LANXESS
DEUTSCHLAND GMBH
ARIPIPRAZOLE AS MANUFACTURED IN BUENOS ARIES, ARGENTINA

MP-3000 (NON-PVC MEDICAL TUBE FOR IV SOLUTION BAG) MP-5000 (NON-PVC MEDICAL FILM
FOR IV SOLUTION & BLOOD BAG) AS MANUFACTURED IN CHUNGCHEONGBUK-DO, KOREA

*** PENDING FILING REVIEW ***

Page 795

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26946 A
II
3/4/2013
AK & MN BIOFARM CO LTD

SUBJECT
EPA ETHYL ESTER 70 AS MANUFACTURED IN ULSAN KOREA

26947 A

II

3/31/2013

EMCURE PHARMACEUTICALS LTD

ENOXAPARIN SODIUM USP AS MANUFACTURED IN MAHARASHTRA INDIA

26948 A

II

3/29/2013

EMCURE PHARMACEUTICALS LTD

DECITABINE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

26949 A

II

3/30/2013

EMCURE PHARMACEUTICALS LTD

PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26950 A

II

6/11/2013

EMCURE PHARMACEUTICALS LTD

TRIMETHOBENZAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

26951 A

II

3/30/2013

AUROBINDO PHARMA LTD

26952 A

III

2/28/2013

PROMENS HF

26953 A

II

3/7/2013

26954 A

II

3/9/2013

ZHEJIANG JIUZHOU PHARMACETICAL CO LTD


PLANT NO 3
SAURAV CHEMICALS LTD

PRASUGREL HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
AIR FREE VINCI AND AIR FREE VEGA AS MANUFACTURED IN LANGESKOV, DENMARK FOR
PROMENS HF.
10- METHOXY IMINOSTILBENE (VERSION NO.:1) AS MANUFACTURED IN ZHEJIANG PROVINCE,
CHINA
DIETHYLCARBAMAZINE CITRATE AS MANUFACTURED IN PUNJAB, INDIA

26955 A

II

3/6/2013

26956 A

II

3/29/2013

RECORDATI INDUSTRIA CHIMICA E


FARMACEUTICA SPA
MSN LABORATORIES PVT LTD

26957 A

II

4/6/2013

MSN LABORATORIES PVT LTD

26958

II

3/30/2013

MSN LABORATORIES PRIVATE LTD

26959 A

II

3/9/2013

SAURAV CHEMICALS LTD

PRASUGREL HYDROCHLORIDE [ROUTE CODE - "PR"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
DEXKETOPROFEN TROMETAMOL AS MANUFACTURED IN PUNJAB, INDIA

26960 A

III

2/25/2013

COSTER TECHNOLOGIE SPECIALI SPA

20MM AEROSOL VALVES AS MANUFACTURED IN TRENTO, ITALY

26961 A

II

3/18/2013

SIFAVITOR SRL

PIROXICAM AS MANUFACTURED IN LODI, ITALY

26962 A

II

3/3/2013

26963 A

II

6/28/2013

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO


LTD
LUPIN LTD

LINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAIZHOU,


CHINA
DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

26964 A

III

3/9/2013

ALUTECH PACKAGING PVT LTD

PLAIN, COLOURED AND/OR PRINTED ALU- ALU FOIL "SILPACK" TM PACKAGING MATERIAL AND
ALUMINIUM FOILS FOR PHARMACEUTICAL, MEDICAL, BIOLOGICAL AND FOOD INDUSTRY AS
MANUFACTURED IN NEW DELHI, INDIA

26965 A

II

3/8/2013

CHANGZHOU PHARMACEUTICAL FACTORY

AGOMELATINE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

26966 A

II

1/29/2013

FINECURE PHARMACEUTICALS LTD

26967 A

II

3/5/2013

RAKS PHARMA PVT LTD

FINEMOX CV 625 (CO- AMOXICLAV TABLETS BP 625 MG) AS MANUFACTURED IN


UTTARAKHAND, INDIA
ESCITALOPRAM OXALATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26968 A

II

12/6/2013

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275266] AS MANUFACTURED IN ST. PETERSBURG, FL

26969 A

II

3/6/2013

FRESENIUS KABI ANTI INFECTIVES SRL

CEPHAPIRIN BENZATHINE STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY

26970 A

II

12/8/2012

OMKAR SPECIALITY CHEMICALS LTD

SELENIUM SULFIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

26971 A

II

3/4/2013

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTD

SIMVASTATIN AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

26972 A

II

4/1/2013

MSN LABORATORIES PVT LTD

EZETIMIBE [ROUTE CODE - EZ] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26973 A

II

3/23/2013

MSN ORGANICS PVT LTD

ASENAPINE MALEATE [ROUTE CODE "AOI"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26974 A

II

4/5/2013

MSN PHARMACHEM PVT LTD

26975 A

II

4/29/2013

MSN LABORATORIES PVT LTD

26976 A

II

3/26/2013

ALEMBIC PHARMACEUTICALS LTD API DIV

SITAGLIPTIN PHOSPHATE ANHYDROUS [ROUTE CODE - SA"] AS MANUFACTURED IN


TELANGANA
ALISKIREN HEMIFUMARATE [ROUTE CODE - "AF"] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

CARGLUMIC ACID AS MANUFACTURED IN LATINA, ITALY


DRONEDARONE HYDROCHLORIDE [ROUTE CODE: DD] AS MANUFACTURED IN TELANGANA,
INDIA
SILODOSIN [ROUTE CODE - "SD"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 796

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
26977 A
II
5/3/2013
GLENMARK GENERICS LTD

SUBJECT
SAXAGLIPTIN MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

26978 A

II

6/21/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

26979 A

II

3/15/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

CASPOFUNGIN ACETATE AS MANUFACTURED IN UTTAR PRADESH, INDIA AND DEBRECEN,


HUNGARY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
V5537 (3-(2-AMINOETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-4H-PYRIDO{1,2-A}PYRIMIDINE-4ONE,DIHYDROCHLORIDE)(VERSION NO.:1) AS MANUFACTURED IN ZHEJIANG PROVINCE,
CHINA

26980 A

II

3/15/2013

ZHEJIANG ZONE BANNER CHEMICAL CO LTD

26981 A

III

2/14/2012

SANWARIYA PACKAGING PVT LTD

26982 A

II

3/12/2013

ZHEJIANG ZONE BANNER CHEMICAL CO LTD

26983 A

II

3/14/2013

26984 A

II

3/12/2013

HANGZHOU HUADONG MEDICINE GROUP


KANGRUN PHARMACEUTICAL CO LTD
EDMOND PHARMA SRL

26985 A

III

3/6/2013

MS JINDAL ALUMINIUM LTD

26986 A

III

2/27/2013

LINHARDT GMBH AND CO KG

HEAT SEAL LACQUER COATED BLISTER FOIL (PLAIN /PRINTED) AS MANUFACTURED IN


KARNATAKA, INDIA
LAMINATED TUBES FOR THE COSMETIC, PHARMACEUTICAL OR FOOD SECTOR AS
MANUFACTURED IN HAMBRUCKEN, GERMANY AND PAUSA, GERMANY FOR LINHARDT GMBH
AND CO. KG

26987 A

III

3/6/2013

MS JINDAL ALUMINIUM LTD

POLY LAMINATED STRIP FOIL (PLAIN /PRINTED) AS MANUFACTURED IN KARNATAKA, INDIA

26988 A

III

3/6/2013

MS JINDAL ALUMINIUM LTD

BARE ALUMINIUM FOIL AS MANUFACTURED IN KARNATAKA, INDIA

26989 A

III

3/6/2013

MS JINDAL ALUMINIUM LTD

PRINTED ALUMINIUM FOIL AS MANUFACTURED IN BANGALORE, INDIA

26990 A

III

3/6/2013

MS JINDAL ALUMINIUM LTD

26991 A

III

3/15/2013

CHROMA CORP

OPA (ORIENTED POLY AMIDE) / ALUMINIUM FOIL/PVC LAMINATE AS MANUFACTURED IN


KARNATAKA, INDIA
PC302483C PINK COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS

26992 A

II

3/20/2013

HETERO LABS LTD

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

26993 A

II

3/29/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

CAPECITABINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

26994 A

III

3/19/2013

DAIKIN INDUSTRIES LTD

26995 A

II

3/15/2013

ERREGIERRE SPA

NEOFLON PCTFE FILM AS MANUFACTURED IN JIANGSU, CHINA; INNER MONGOLIA, CHINA


AND SHANGHAI, P.R. CHINA FOR DAIKIN INDUSTRIES, LTD.
ZILEUTON USP AS MANUFACTURED IN BERGAMO, ITALY

26996 A

II

3/7/2013

ULKAR KIMYA SANAYII VE TICARET AS

CANDESARTAN CILEXETIL USP AS MANUFACTURED IN TEKIRDAG, TURKEY

26997 A

II

3/7/2013

ULKAR KIMYA SANAYII VE TICARET AS

PANTOPRAZOLE SODIUM SESQUIHYDRATE USP AS MANUFACTURED IN TEKIRDAG, TURKEY

26998 A

III

3/20/2013

V SANTOS SA

GLASS PACKAGING FOR PHARMACEUTICALS AS MANUFACTURED IN MADRID, SPAIN

26999 A

II

3/20/2013

KOHJIN BIO CO LTD

LIQUID CELL GROWTH MEDIUM FOR HUMAN CELLS AS MANUFACTURED IN SAITAMA, JAPAN

27001 A

III

3/12/2013

BORMIOLI ROCCO SPA BU PLASTICA

27002 A

II

3/15/2013

27003 A

III

3/15/2013

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO


LTD
CHARTER NEX FILMS INC

27004 A

III

3/14/2013

AMPACET CORP

27000 P

1-[2-AMINO-1-(4-METHOXYPHENYL)ETHYL]-CYCLOHEXANOL HYDROCHLORIDE (VERSION


NO.:1) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
PRINTED BLISTER ALUMINIUM FOIL FOR PHARMACEUTICAL USE AS MANUFACTURED IN
MADHYA PRADESH, INDIA
2-(3-BENZOYLPHENYL) PROPANENITRILE (VERISION NO.:1) AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
SIROLIMUS (INTERMEDIATE) AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
DEXMEDETOMIDINE HCI AS MANUFACTURED IN MILANO, ITALY

*** PENDING FILING REVIEW ***


PP MEASURING CUP AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV),
ITALY; AND SAINT SULPICE, FRANCE FOR BORMIOLI ROCCO SPA- BU PLASTICA
LAMIVUDINE FORM I AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA
323456A AS MANUFACTURED IN TURNERS FALLS, MA
465798 MYLAN BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OHIO

Page 797

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27005 A
II
3/2/2013
SUPRIYA LIFESCIENCE LTD
27006 A

II

6/6/2013

EXCELLA GMBH

SUBJECT
RIBOFLAVIN 5' - PHOSPHATE SODIUM (USP + IH) AS MANUFACTURED IN MAHARASHTRA,
INDIA
BUSULFAN AS MANUFACTURED IN FEUCHT, GERMANY

27007 A

II

4/12/2013

LUPIN LTD

LAMIVUDINE (PROCESS-B) AS MANUFACTURED IN MAHARASHTRA, INDIA

27008 A

II

3/21/2013

FARMABIOS S P A

DELTA-1-CORTIENIC ACID AS MANUFACTURED IN PAVIA, ITALY

27009 A

III

3/25/2013

HEINKE TECHNOLOGY INC

TABLET DISPENSING VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN, NE

27010 A

III

2/28/2013

UNITED CLOSURES AND PLASTICS LTD

24MM MEDI-LOC CLOSURES AS MANUFACTURED IN NORWICH, ENGLAND

27011 I

II

3/26/2013

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

27012 A

III

3/26/2013

SHINKO CHEMICAL CO LTD

DUTASTERIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG,


CHINA
EYEDROP CONTAINER RT-5 AS MANUFACTURED IN ISHIKAWA, JAPAN

27013 A

III

3/27/2013

MITSUBISHI CHEMICAL CORP

RABALON AS MANUFACTURED IN MIE, JAPAN

27014 A

IV

3/26/2013

FONA INTERNATIONAL INC

884.010 N-C ORANGE CREAM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

27015 A

III

3/20/2013

C AND K PROPACK CO LTD

ALUALU AS MANUFACTURED IN GYENGGI-DO, KOREA

27016 A

IV

3/12/2013

SIGACHI CELLULOS P LTD

MICRO CRYSTALLINE CELLULOSE AS MANUFACTURED IN GUJARAT, INDIA

27017 A

II

3/26/2013

SIGMA ALDRICH IRELAND LTD

BENZYL ALCOHOL AS MANUFACTURED IN ARKLOW, IRELAND

27018 A

II

9/18/2013

27019 A

III

3/20/2013

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO BENDAMUSTINE HCL AS MANUFACTURED IN JIANGSU, CHINA


LTD
CONSOLIDATED BOTTLE CORP
"8 GALLON BLUE OPEN HEAD DRUM WITH LEVER LOCK BAND, BLACK PE COVER & WHITE
RUBBER GASKET" AS MANUFACTURED IN SWEETWATER, TENNESSEE FOR CONSOLIDATED
BOTTLE CORPORATION

27020 A

IV

3/28/2013

WILSHIRE TECHNOLOGIES INC

27021 A

II

4/9/2013

AUROBINDO PHARMA LTD

27022 A

II

3/29/2013

STERLING SPA

27023 A

II

4/1/2013

OMNIABIOS S.R.L.

27024 N

PHYTOCHOL AS MANUFACTURED IN SAYREVILLE, NJ AND OVERLAND, MO FOR WILSHIRE


TECHNOLOGIES INC
METHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
MOMETASONE FUROATE MONOHYDRATE (D90<10UM) AS MANUFACTURED IN PERUGIA, ITALY
S-ADENOSYL-L-METHIONINE DISULFATE TOSYLATE [SAM-PTS] DRY POWDER AS
MANUFACTURED IN BRESCIA, ITALY

NOT AN ASSIGNED NUMBER

27025 A

II

10/30/2013

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275282] AS MANUFACTURED IN ST. PETERSBURG, FL

27026 A

II

4/2/2013

MAC CHEM PRODUCTS INDIA PVT LTD

CAPECITABINE AS MANUFACTURED IN DISTRICT THANE, INDIA

27027 A

II

4/2/2013

MAC CHEM PRODUCTS INDIA PVT LTD

27028 A

II

4/2/2013

MAC CHEM PRODUCTS INDIA PVT LTD

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN DISTRICT


THANE, INDIA
OXALIPLATIN AS MANUFACTURED IN DISTRICT THANE, INDIA

27029 A

III

4/1/2013

COLORS FOR PLASTICS INC

27030 I

II

3/25/2013

GW PHARMA LTD

R34215 RED/1797C COLORANT MASTERBATCH AS MANUFACTURED IN ELK GROVE VILLAGE,


IL AND SPARTANBURG, SC
GWP42003-P* AS MANUFACTURED IN KENT, UNITED KINGDOM

27031 A

II

4/1/2013

UNIMAX CHEMICALS PVT LTD

ERYTHROMYCIN (HIGH PURITY) AS MANUFACTURED IN DISTRICT THANE, INDIA

27032 A

II

3/29/2013

JOHNSON MATTHEY PHARMA SERVICES

4235.D AS MANUFACTURED IN DEVENS, MA

27033 A

II

4/3/2013

KYONGBO PHARMACEUTICAL CO LTD

CEFIXIME BULK AS MANUFACTURED IN CHUNGCHEONGNAM-DO, REPUBLIC OF KOREA

27034 A

III

3/25/2013

SVAM PACKAGING INDUSTRIES PVT LTD

27035 A

II

3/29/2013

CONTIPRO PHARMA AS

ALUBLIS/TROBLIS COLD FORMING BLISTER FOIL (ALU-ALU FOIL) AS MANUFACTURED IN


HARYANA,INDIA
SODIUM HYALURONATE AS MANUFACTURED IN DOLNI DOBROUC, CZECH REPUBLIC

27036 A

II

7/10/2013

MALLINCKRODT INC

COMPAP SDCRSL AS MANUFACTURED IN GREENVILLE, ILLINOIS

Page 798

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27037 A
II
6/29/2013
MSN LABORATORIES PVT LTD

SUBJECT
DABIGATRAN ETEXILATE MESYLATE [ROUTE CODE - DE"] AS MANUFACTURED IN TELANGANA

27038 A

II

4/20/2013

MSN PHARMACHEM PVT LTD

DARUNAVIR [ROUTE CODE - DI"] AS MANUFACTURED IN TELANGANA

27039 A

II

5/16/2013

MSN ORGANICS PVT LTD

ILOPERIDONE [ROUTE CODE - "IO"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27040 A

II

5/16/2013

MSN PHARMACHEM PVT LTD

VILDAGLIPTIN [ROUTE CODE - "VG''] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27041 A

II

5/28/2013

MSN PHARMACHEM PVT LTD

27042 A

II

5/31/2013

MSN LABORATORIES PVT LTD UNIT II

27043 A

II

5/30/2013

MSN LABORATORIES PVT LTD UNIT II

27044 A

II

5/29/2013

MSN LABORATORIES PVT LTD UNIT II

MONTELUKAST SODIUM [ROUTE CODE - "MK"] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ERLOTINIB HYDROCHLORIDE [ROUTE CODE - "ER"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
GEMCITABINE HYDROCHLORIDE USP [ROUTE CODE - "GH"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
BIMATOPROST [ROUTE CODE - "BM"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27045 A

II

4/19/2013

SRI KRISHNA PHARMACEUTICALS LTD

GLYBURIDE USP AS MANUFACTURED IN A. P., INDIA

27047 A

II

9/16/2013

MACLEODS PHARMACEUTICALS LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN VALSAD, INDIA

27048 A

II

6/12/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

27049 A

II

4/3/2013

HAINAN YEW PHARMACEUTICAL CO LTD

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA


FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
PACLITAXEL (SEMI-SYNTHETIC) AS MANUFACTURED IN HAINAN PROVINCE, P.R. CHINA

27050 A

III

4/1/2013

LOTTE CHEMICAL

J-560M AS MANUFACTURED IN DAEJON, KOREA

27051 A

II

4/1/2013

ST GOBAIN PERFORMANCE PLASTICS CORP

C- FLEX R70-082 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

27052 A

II

4/3/2013

HETERO DRUGS LTD

TOLVAPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27053 A

III

3/27/2013

COLORTECH INC

27054 A

II

4/1/2013

ST GOBAIN PERFORMANCE PLASTICS CORP

11616-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN,


TENNESSEE AND ONTARIO, CANADA
C-FLEX R70-050 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

27055 A

IV

4/1/2013

NIPPON FINE CHEMICAL CO LTD

A LIPOSOMAL EXCIPIENT, PRESOME SIIG AS MANUFACTURED IN HYOGO, JAPAN

27056 A

II

4/1/2013

ST GOBAIN PERFORMANCE PLASTICS CORP

C-FLEX R70-072 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

27057 A

II

4/1/2013

ST GOBAIN PERFORMANCE PLASTICS CORP

C-FLEX R70-374 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

27058 A

II

4/1/2013

ST GOBAIN PERFORMANCE PLASTICS CORP

C-FLEX R70-001 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

27059 A

II

6/7/2013

NOVARTIS PHARMACEUTICALS CORP

27060 A

II

7/31/2013

ENTERIS BIOPHARMA INC

TERBINAFINE AS MANUFACTURED IN BASEL, SWITZERLAND AND RINGASKIDDY, IRELAND


FOR NOVARTIS PHARMACEUTICALS CORPORATION
RECOMBINANT PEPTIDE UGP302 AS MANUFACTURED IN BOONTON, NJ

27061 A

II

3/21/2013

CATALENT FRANCE BEINHEIM SA

211002432 AS MANUFACTURED IN BEINHEIM, FRANCE

27062 A

III

3/22/2013

PROMENS HF

KIDPOT AS MANUFACTURED IN GEOVREISSET, FRANCE

27063 A

III

3/27/2013

ESSEL DE MEXICO SA DE CV

27064 A

II

5/6/2013

CADILA PHARMACEUTICALS LTD

'PRINTED LAMINATES & LAMINATED TUBES AS MANUFACTURED IN EXHACIENDA SAN


MIGUEL, MEXICO
RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27065 A

III

3/30/2013

SAGAR RUBBER PRODUCTS PVT LTD

27066 A

II

4/5/2013

KYONGBO PHARMACEUTICAL CO LTD

RFS & RFU RUBBER CLOSURE (RUBBER STOPPER) FOR INJECTABLES AS MANUFACTURED IN
GUJARAT, INDIA
ENTECAVIR AS MANUFACTURED IN CHUNGCHEONGNAM-DO, REPUBLIC OF KOREA

27067 A

II

3/15/2013

PJ HEALTHCARE

AZITHROMYCIN TASTE MASKING GRANULES 7.5% AS MANUFACTURED IN GUJARAT, INDIA

27068 A

III

4/8/2013

BADGER COLOR CONCENTRATES INC

PLASTIC COLORANTS AS MANUFACTURED IN MUKWONAGO, WI AND KINGS MOUNTAIN, NC

27069 A

II

4/2/2013

VIWIT PHARMACEUTICAL CO LTD

ELETRIPTAN HYDROBROMIDE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN


SHANDONG, CHINA

27046 P

*** PENDING FILING REVIEW ***

Page 799

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27070 A
II
4/8/2013
CAMBREX CHARLES CITY INC

SUBJECT
SGD-1910 AS MANUFACTURED IN CHARLES CITY, IA

27071 A

II

6/14/2014

NECTAR LIFESCIENCES LTD

CEFPODOXIME PROXETIL USP AS MANUFACTURED IN PUNJAB, INDIA

27072 A

IV

4/6/2013

NIPPON FINE CHEMICAL CO LTD

27073 A

II

4/8/2013

JOST CHEMICAL CO

A LIPOSOMAL EXCIPIENT, HYDROGENATED PHOSPHATIDYLCHOLINE (SOY), HSPC AS


MANUFACTURED IN HYOGO, JAPAN
MAGNESIUM CITRATE TRIBASIC ANHYDROUS AS MANUFACTURED IN ST. LOUIS, MO

27074 A

IV

4/11/2013

FONA INTERNATIONAL INC

805.018 BANANA FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

27075 A

III

4/11/2013

POLYONE CORP

CC10130826WE (SELSUN BLUE PEARL) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

27076 A

II

4/2/2013

HANGZHOU HONRY BIOTECH CORP

DORZOLOMIDE HYDROCHLORIDE AS MANUFACTURED IN HANGZHOU CITY, CHINA

27077 A

II

6/14/2013

LUPIN LTD

ILOPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR LUPIN LTD

27078 A

II

5/20/2013

APOTEX PHARMACHEM INDIA PVT LTD

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA

27079

III

4/10/2013

NEMERA LA VERPILLIERE

27080 A

III

4/9/2013

AMPACET CORP

27081 A

II

5/24/2013

KAKEN PHARMACEUTICAL CO LTD

27082 A

II

4/20/2013

ALP PHARM BEIJING CO LTD

NOVELIA (R) PRESERVATIVE FREE SYSTEM AS MANUFACTURED IN LA VERPILLIERE CEDEX,


FRANCE
150217 PEACH PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA;
CATERSVILLE, GA AND HEATH, OH
EFINACONAZOLE AS MANUFACTURED IN GIFU PREF, JAPAN FOR KAKEN PHARMACEUTICAL
CO., LTD
SILODOSIN AS MANUFACTURED SHANDONG, CHINA FOR ALP PHARM BEIJING CO., LTD

27083 A

II

7/17/2013

WOCKHARDT BIO AG

27084 A

II

5/27/2013

WOCKHARDT BIO AG

SAXAGLIPTIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA FOR


WOCKHARDT BIO AG
SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN GUJARAT, INDIA FOR WOCKHARDT BIO AG

27085 A

II

4/2/2013

QILU TIANHE PHARMACEUTICAL CO LTD

CAPECITABINE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

27086 A

II

5/17/2013

MYLAN LABORATORIES LTD

ASENAPINE MALEATE AS MANUFACTURED IN TELANGANA, INDIA

27087 A

II

5/9/2013

LAURUS LABS PRIVATE LTD

27088 A

II

5/8/2013

APOTEX PHARMACHEM INDIA PVT LTD

TENOFOVIR DISOPROXIL FUMARATE (PROCESS-2) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA

27089 A

II

5/9/2013

LAURUS LABS PRIVATE LTD

IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27090 A

III

4/18/2013

TORAY INDUSTRIES INC

POLYETHYLENE TEREPHTHALATE RESIN T-290M

27091 P

*** PENDING FILING REVIEW ***

27092 A

II

5/2/2013

DR REDDYS LABORATORIES LTD

27093 A

II

5/24/2013

BIOCON SA

27094 A

III

3/11/2013

PHARMA TRADE SRL

27095 A

III

4/2/2013

JINAN LINUO GLASSWORK CO LTD

20 KDA METHOXYPOLY(ETHYLENE GLYCOL) PROPIONALDEHYDE AS MANUFACTURED IN


WEST YORKSHIRE, UNITED KINGDOM
INSULIN GLARGINE (RDNA ORIGIN) AS MANUFACTURED IN BANGALORE, INDIA FOR BIOCON
SA
CRIMP CAPS FOR PHARMACEUTICALS AND COSMETICS USED AS SECONDARY PACKAGING
AS MANUFACTURED IN VASTO (CH), ITALY
NEUTRAL BOROSILICATE GLASS AMPOULE AS MANUFACTURED IN JINAN, P.R. CHINA

27096 A

III

4/2/2013

JINAN LINUO GLASSWORK CO LTD

NEUTRAL BOROSILICATE GLASS TUBULAR VIAL AS MANUFACTURED IN JINAN, P.R. CHINA

27097 A

II

4/19/2013

27098 A

II

8/2/2013

ZHEJIANG LIAOYUAN PHARMACEUTICALS CO.,


LTD.
MEGHMANI UNICHEM LLP

(+)-METHYL-(2-CHLOROPHENYL)-(2-THIOPHEN-2YL-ETHYLAMINO) ACETATE HYDROCHLORIDE


AS MANUFACTURED IN LINHAI CITY, P.R. CHINA
ACETAMINOPHEN, USP AS MANUFACTURED IN GUJARAT, INDIA

27099 A

III

3/14/2013

VERSALIS SPA

ERACLENE MP 90U AS MANUFACTURED IN BRINDISI, ITALY

27100 A

III

3/14/2013

VERSALIS SPA

ERACLENE BB 82 AS MANUFACTURED IN BRINDISI, ITALY

27101 A

III

4/19/2013

TECTUBES SWEDEN AB

PLASTIC AND ALMINUM TUBES AS MANUFACTURED IN HJO, SWEDEN AND ASTORP, SWEDEN

Page 800

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27102 A
II
5/13/2013
SUN PHARMACEUTICAL INDUSTRIES LTD

SUBJECT
DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27103 A

III

4/22/2013

BD MEDICAL PHARMACEUTICAL SYSTEMS

27104 A

II

5/10/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

BD NEOPAK (STERILE) SYRINGE SYSTEM AS MANUFACTURED IN LE PONTE-DE-CLAIX,


FRANCE AND COLUMBUS, NEBRASKA
PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

27105 A

II

4/26/2013

PIRAMAL ENTERPRISES LTD

METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27106 A

II

5/7/2013

AUROBINDO PHARMA LTD

27107 A

II

4/24/2013

TRIFARMA SPA

PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
ZOLEDRONIC ACID AS MANUFACTURED IN (MB), ITALY

27108 A

III

4/15/2013

BOREALIS AG

27109

II

4/20/2013

HEC PHARM CO LTD

27110 A

II

7/29/2013

27111 A

II

5/9/2013

ABX ADVANCED BIOCHEMICAL COMPOUNDS


GMBH
AUROBINDO PHARMA LTD

27112 A

IV

4/29/2013

FONA INTERNATIONAL INC

BORMED LE6607-PH AS MANUFACTURED IN SCHWECHAT- MANNSWORTH, AUSTRIA FOR


BOREALIS AG
ENTACAPONE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU CITY, P.R.
CHINA FOR HEC PHARM USA INC
ABX-[18F]FDG CASSETTE FOR GE TRACERLAB MX SYNTHESIZER AS MANUFACTURED IN
RADEBERG, GERMANY
SAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
915.0642U N-C STRAWBERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

27113 A

III

4/12/2013

KEY INTERNATIONAL INC

PLASTIC POLYMER ALLOY AS MANUFACTURED IN CRANBURY, NJ

27114 A

II

4/18/2013

JIANSHI YUANTONG BIOENGINEERING CO LTD

HESPERIDIN AS MANUFACTURED IN ENSHI, CHINA

27115 A

II

4/22/2013

CHIRAL QUEST SUZHOU CO LTD

27116 A

II

6/4/2013

PHF SA

(R)-3-(TERT-BUTOXYCARBONYLAMINO)-4-(2,4,5-TRIFLUOROPHENYL)BUTANOIC ACID AS
MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA FOR CHIRAL QUEST CO., LTD
LENALIDOMIDE AS MANUFACTURED IN OLAINE, LATVIA FOR PHF SA

27117 A

II

4/30/2013

BILLICUM PHARMACEUTICALS, INC.

AP1903 INJECTION AS MANUFACTURED IN CHARLESTON, SOUTH CAROLINA

27118 A

III

4/9/2013

AXIUM PLASTICS

HDPE BOTTLES AS MANUFACTURED IN NEW ALBANY, OH AND LAWRENCEVILLE, GA

27119 A

II

5/1/2013

HETERO DRUGS LTD

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27120 A

II

4/30/2013

INDUSTRIALE CHIMICA SRL

TIOTROPIUM BROMIDE METHANOL SOLVATE AS MANUFACTURED IN SARONNO, ITALY

27121 A

II

4/29/2013

COVALENT LABORATORIES PRIVATE LTD

CEFIXIME USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27122 P

*** PENDING FILING REVIEW ***

27123 A

II

7/7/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

EXENATIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
GABAPENTIN BUTANOL PROCESS AS MANUFACTURED IN VILLANTERIO PAVIA, ITALY FOR
TEVA PHARMACEUTICALS INDUSTRIES LTD
GLYCEROL PHENYLBUTYRATE AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR
PHARMACEUTICAL, INC
ZELAS 7025 AS MANUFACTURED IN MIE, JAPAN

27124 A

II

7/3/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

27125 A

II

7/3/2013

PAR PHARMACEUTICAL INC

27126 A

III

5/3/2013

MITSUBISHI CHEMICAL CORP

27127 A

III

5/15/2013

VORA PACKAGING PVT. LTD.

27128 A

II

7/22/2013

EPAX NORWAY AS

"BOTTLE CAP SEALS & LINERS (EXPANDED POLYETHYLENE CAP LINERS & INDUCTION HEAT
SEALS)" AS MANUFACTURED IN MAHARASHTRA, INDIA
EPAX 6015 TGN US API AS MANUFACTURED IN AALESUND, NORWAY

27129 A

III

5/3/2013

BEYONDEVICES LDA

VAGINAL APPLICATOR AS MANUFACTURED IN SOBRAL DE MONTE AGRACO, PORTUGAL

27130 A

II

4/26/2013

ONO PHARMACEUTICAL CO LTD

ALPROSTADIL ALFADEX AS MANUFACTURED IN SHIZUOKA, JAPAN

27131 A

II

6/2/2000

NEKTAR THERAPEUTICS

27132 A

II

5/22/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL CARBONATE, MW 12, 000 AS


MANUFACTURED IN HUNSTSVILLE, AL
TOLVAPTAN AS MANUFACTURED IN ZHEJIANG, CHINA

27133 A

II

5/2/2013

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD

GANCICLOVIR USP (NON-STERILE API) AS MANUFACTURED IN XIANHU, P.R. CHINA

Page 801

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27134 A
IV
5/1/2013
NUSIL TECHNOLOGY LLC

SUBJECT
DDU-4353 SILICONE AS MANUFACTURED IN CARPINTERIA, CA

27135 A

II

5/31/2013

APOTEX PHARMACHEM INDIA PVT LTD

TETRABENAZINE AS MANUFACTURED IN BANGALORE, INDIA

27136 A

III

5/17/2011

THE JENARD CO DIV FEY INDUSTRIES INC

27137 A

III

5/2/2013

JAUSS POLYMER LTD

SLEEVE FOR THE PROTECTION OF A MULTI-DOSAGE PHARMACEUTICAL BLISTER PACKAGE


AS MANUFACTURED IN EDGERTON , MN
PET BOTTLES FOR PHARMACEUTICALS AS MANUFACTURED IN HIMACHAL PRADESH, INDIA

27138 A

II

11/10/2000

NEKTAR THERAPEUTICS

27139 A

II

5/6/2013

IOL CHEMICALS AND PHARMACEUTICALS LTD

METHOXYPOLY (ETHYLENE GLYCOL)- PROPIONALDEHYDE, MW 20, 000 AS MANUFACTURED


IN HUNSTSVILLE, AL
METFORMIN HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA

27140 A

II

4/25/2013

QILU TIANHE PHARMACEUTICAL CO LTD

TAZOBACTAM SODIUM (STERILE API) AS MANUFACTURED IN JINAN, CHINA

27141 P

*** PENDING FILING REVIEW ***

27142 N

NOT AN ASSIGNED NUMBER

27143 A

II

5/8/2013

ACEBRIGHT INDIA PHARMA PRIVATE LTD

27144 A

II

6/25/2013

MYLAN LABORATORIES LTD

TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED


IN KARNATAKA, INDIA
PITAVASTATIN CALCIUM AS MANUFACTURED IN TELANGANA, INDIA

27145 A

II

5/4/2013

MICROBIOPHARM JAPAN CO LTD

PARICALCITOL, USP AS MANUFACTURED IN SHIZUOKA, JAPAN

27146 A

II

6/26/2013

MYLAN LABORATORIES LTD

SAXAGLIPTIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

27147 A

II

6/28/2013

MYLAN LABORATORIES LTD

TETRABENAZINE AS MANUFACTURED IN TELANGANA, INDIA

27148 A

III

1/9/2013

CHING HAI CHEMICAL INDUSTRIAL CO LTD

SILICA GEL AS MANUFACTURED IN DALI CITY, TAIWAN (R.O.C)

27149 I

II

12/14/1988

BACHEM AG

(H-GLY-HIS-LYS-OH) 2 COPPER CHELATE MANUFACTURED IN BUBENDORF, SWITZERLAND.

27150 N

NOT AN ASSIGNED NUMBER

27151 N

NOT AN ASSIGNED NUMBER

27152 N

NOT AN ASSIGNED NUMBER

27153 N

NOT AN ASSIGNED NUMBER

27154 N

NOT AN ASSIGNED NUMBER

27155 P

*** PENDING FILING REVIEW ***

27156 A

II

6/14/2013

27157 N

CASPOFUNGIN (ACETATE) AS MANUFACTURED IN KARNATAKA, INDIA FOR XELLIA


PHARMACEUTICALS APS

NOT AN ASSIGNED NUMBER

27158 N
27159 A

XELLIA PHARMACEUTICALS APS

NOT AN ASSIGNED NUMBER


II

5/21/2013

27160 N

RAKS PHARMA PVT LTD

TRAMADOL HYDROCHLORIDE USP API (PROCESS-2) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA

NOT AN ASSIGNED NUMBER

27161 A

II

5/31/2013

RAKS PHARMA PVT LTD

DRONEDARONE HYDROCHLORIDE API AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27162 A

II

8/6/2013

INDENA SPA

27163 A

III

3/28/2013

WEST PHARMACEUTICAL SERVICES INC

27164 A

II

5/21/2013

AMOLI ORGANICS PVT LTD

PACLITAXEL/S SEMISYNTHETIC PROCESS, USP/EP AS MANUFACTURED IN SETTALA (MI),


ITALY
DAIKYO CRYSTAL ZENITH READY-TO-USE - CARTRIDGE SYSTEM AS MANUFACTURED IN
TOCHIGI, JAPAN
OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA

27165 A

II

5/22/2013

AMRI RENSSELAER INC

DIATRIZOATE MEGLUMINE, USP AS MANUFACTURED IN RENSSELAER, NEW YORK

27166 A

II

6/28/2013

DR REDDYS LABORATORIES LTD

ESZOPICLONE [PROCESS-3] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27167 A

II

5/31/2013

APOTEX PHARMACHEM INDIA PVT LTD

EXEMESTANE AS MANUFACTURED IN BANGALORE, INDIA

Page 802

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27168 A
II
6/11/2013
AUROBINDO PHARMA LTD
27169 A

II

12/12/2013

CATALENT PHARMA SOLUTIONS LLC

SUBJECT
MEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA FOR AUROBINDO PHARMA LIMITED
SOFTGELS [OET-00775174] AS MANUFACTURED IN ST. PETERSBURG, FL

27170 I

II

7/3/2013

MEDICHEM MANUFACTURING MALTA LTD

BEPOTASTINE BESILATE AS MANUFACTURED IN HAL FAR, MALTA

27171 A

II

5/31/2013

APOTEX PHARMACHEM INDIA PVT LTD

OLOPATADINE HYDROCHLORIDE USP AS MANUFACTURED IN BANGALORE, INDIA

27172 A

II

5/6/2013

NEWGEN BIOTECH INC

SERRAPEPTASE AS MANUFACTURED IN NINGBO CITY, CHINA

27173 A

II

5/6/2013

NEWGEN BIOTECH INC

BROMELAIN AS MANUFACTURED IN NINGBO CITY, CHINA

27174 A

II

6/27/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

27175 A

III

8/28/2013

FRANPLAST SRL

SAXAGLIPTIN MONOHYDRATE AS MANUFACTURED IN PRIGORJE BRDOVECKO CROATIA FOR


TEVA PHARMACEUTICAL INDUSTRIES LTD
CHEMITON HMB SERIES AS MANUFACTURED IN PROVAGLIO D'ISEO (BS), ITALY

27176 A

III

5/13/2013

CHROMA CORP

PC23258B WHITE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS

27177 A

III

5/13/2013

CHROMA CORP

PC23258A WHITE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS

27178 A

III

5/13/2013

CHROMA CORP

PC56252C BLUE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS

27179 A

II

7/16/2013

XELLIA PHARMACEUTICALS LTD

27180 A

II

5/24/2013

HARMAN FINOCHEM LTD

DAPTOMYCIN AS MANUFACTURED IN BUDAPEST, HUNGARY FOR XELLIA PHARMACEUTICALS


LTD
LIDOCAINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27181 A

II

6/7/2013

NEW ZEALAND PHARMACEUTICALS LTD

CHOLIC ACID AS MANUFACTURED IN PALMERSTON NORTH, NEW ZEALAND

27182 A

II

5/23/2013

FINORGA SAS

ICOSAPENT ETHYL AS MANUFACTURED IN MOURENX, FRANCE

27183 A

III

5/9/2013

27184 A

IV

5/15/2013

CANADA COLORS AND CHEMICALS LTD DBA CCC


PLASTICS
NOVO EXCIPIENTS PVT LTD

WHITE MB50-949POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN


ONTARIO, CANADA
NOVOMIX AS MANUFACTURED IN MAHARASHTRA, INDIA

27185 A

II

7/17/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

ASENAPINE MALEATE AS MANUFACTURED IN GUJARAT, INDIA

27186 A

II

8/9/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

TETRABENAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA

27187 A

II

6/24/2013

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275265] AS MANUFACTURED IN ST. PETERSBURG, FL

27188 A

II

9/13/2013

CEDARBURG PHARMACEUTICALS INC

RIBOFLAVIN 5'-PHOSPHATE SODIUM AS MANUFACTURED IN GRAFTON, WISCONSIN

27189 A

II

6/14/2013

RAKS PHARMA PVT LTD

27190 A

II

9/2/2013

RAKS PHARMA PVT LTD

SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE API AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
OMEPRAZOLE MAGNISIUM, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27191 A

IV

5/15/2013

NOVO EXCIPIENTS PVT LTD

NOVOPOWER AS MANUFACTURED IN MAHARASHTRA, INDIA

27192 A

II

6/18/2013

AURONEXT PHARMA PRIVATE LTD

MEROPENEM FOR INJECTION (STERILE BULK) AS MANUFACTURED IN RAJASTHAN, INDIA

27193 A

III

5/5/2013

TULSTAR PRODUCTS INC

27194 A

II

7/4/2013

ALEMBIC PHARMACEUTICALS LTD API DIV

PCTFE RESIN AS MANUFACTURED IN INNER MONGOLIA, CHINA FOR TULSTAR PRODUCTS,


INC.
ASENAPINE MALEATE AS MANUFACTURED IN GUJARAT, INDIA

27195 A

II

5/24/2013

TIANJIN TIANYAO PHARMACEUTICALS CO LTD

DEXAMETHASONE SODIUM PHOSPHATE, USP BULK AS MANUFACTURED IN TIANJIN, CHINA

27196 A

II

5/30/2013

HOVIONE FARMACIENCIA SA

27197 A

II

5/30/2013

HETERO DRUGS LTD

27198 A

II

6/10/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

BECLOMETHASONE DIPROPIONATE MONOHYDRATE USP AS MANUFACTURED IN LOURES,


PORTUGAL
RISEDRONATE SODIUM HEMI-PENTAHYDRATE, UPS AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
LOSARTAN POTASSIUM, USP AS MANUFACTURED IN ZHEJIANG, CHINA

27199 A

IV

5/15/2013

FRUTAROM USA

27200 A

III

5/29/2013

MEYER SEALS ALFELDER KUNSTSTOFFWERKE


HERM MEYER GMBH

CHERRY SPRAY DRIED NATURAL TYPE FLAVOR 3209187501.00 AS MANUFACTURED IN


CORONA, CA
CLOSURE LINERS AS MANUFACTURED IN ALFELD, GERMANY AND UBON RATCHATHANI,
THAILAND FOR MEYER SEALS, ALFELDER KUNSTOFFWERKE HERM. MEYER GMBH.

Page 803

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27201 A
II
7/5/2013
APOTEX PHARMACHEM INDIA PVT LTD
27202 A

II

6/27/2013

HISUN PHARMACEUTICAL HANGZHOU CO LTD

SUBJECT
SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20% AS MANUFACTURED IN BANGALORE,
INDIA
TACROLIMUS AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27203 A

IV

6/5/2013

FONA INTERNATIONAL INC

915.0213U N-C FRESH STRAWBERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, ILLINOIS

27204 A

II

6/17/2013

AARTI INDUSTRIES LTD

BUPROPION HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

27205 A

II

6/15/2013

MSN LABORATORIES PVT LTD UNIT II

27206 A

II

6/21/2013

MSN PHARMACHEM PVT LTD

BENDAMUSTINE HYDROCHLORIDE [ROUTE CODE - "BH"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
AGOMELATINE [ROUTE CODE - AG1"] AS MANUFACTURED IN TELANGANA

27207 A

II

6/10/2013

ZIDOVUDINE AS MANUFACTURED IN JIANGSU, CHINA

27208 A

II

7/12/2013

SHANGHAI SHYNDEC PHARMACEUTICAL HAIMEN


CO LTD
RHODES TECHNOLOGIES INC

27209 A

II

7/1/2013

ALAND JIANGSU NUTRACEUTICAL CO LTD

ASCORBIC ACID, USP, PH. EUR AS MANUFACTURED IN JIANGSU, CHINA

27210 A

II

6/3/2013

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

BETHAMETHASONE VALERATE AS MANUFACTURED IN KEDAH, MALAYSIA

27211 A

II

6/28/2013

DR REDDYS LABORATORIES LTD

CINACALCET HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27212 A

II

6/28/2013

DR REDDYS LABORATORIES LTD

SAXAGLIPTIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27213 A

II

9/12/2013

DR REDDYS LABORATORIES LTD

TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYANO-2-AZABICYCLO[3.1.0]HEXAN-2-YL)1-((1R, 3R,5R,7S)-3HYDROXYADAMANTAN-1-YL)-2-OXOETHYL)CARBAMATE AS MANUFACTURED IN ANDHRA


PRADESH, INDIA

27214 A

II

6/20/2013

MSN PHARMACHEM PVT LTD

APREPITANT [ROUTE CODE - "AP2"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27215 A

II

6/12/2013

AMBIOPHARM INC

27216 A

II

7/1/2013

27217 A

II

6/14/2013

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
SCINOPHARM TAIWAN LTD

LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH


AUGUSTA, SC
EVEROLIMUS AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN

27218 A

II

6/26/2013

HISUN PHARMACEUTICAL HANGZHOU CO LTD

PNEUMOCANDIN B0 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27219 A

II

7/9/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

OLANZAPINE AS MANUFACTURED IN TAIZHOU CITY, CHINA

27220 A

III

6/17/2013

CILICANT CHEM PRIVATE LTD

DESICCANT POUCH AS MANUFACTURED IN PUNE, INDIA

27221 A

III

7/1/2013

COSPACK PLASTICS PRODUCTS CO LTD

27222 A

II

9/6/2013

ALP PHARM BEIJING CO LTD

27223 A

II

6/29/2013

EMCURE PHARMACEUTICALS LTD

LAMINATE TUBES & COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL PACKAGING AS


MANUFACTURED IN GUANGDONG, CHINA
CALCIPOTRIENE HYDRATE AS MANUFACTURED IN LIAONING, CHINA FOR ALP PHARM BEIJING
CO., LTD
DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

27224 A

II

6/29/2013

EMCURE PHARMACEUTICALS LTD

PERPHENAZINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27225 A

II

6/15/2013

27226 A

IV

6/18/2013

SHANGHAI SINE PHARMACEUTICAL


LABORATORIES CO LTD
EVONIK CORP

27227 A

III

6/11/2013

AMPACET CORP

27228 A

III

6/11/2013

AMPACET CORP

27229 A

II

6/4/2013

HEBEI HUARONG PHARMACEUTICAL CO LTD

RABEPRAZOLE SODIUM AS MANUFACTURED IN SHANGHAI, CHINA FOR SHANGHAI SINE


PHARMACEUTICAL LABORATORIES CO LTD
POLY(D, L-LACTIDE CO-CAPROLACTONE) AND POLY(L-LACTIDE-CO-CAPROLACTONE) AS
MANUFACTURED IN BIRMINGHAM, AL
466276-KQ MYLAN BLUE SLIP 276 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET
CORPORATION
111343 BLUE WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
HYDROXOCOBALAMIN ACETATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA

27230 A

II

6/27/2013

INTAS PHARMACEUTICALS LTD

PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27231 A

II

6/19/2013

HETERO LABS LTD

SIMVASTATIN, USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

METHYLPHENIDATE HCL USP AS MANUFACTURED IN COVENTRY, RI

BIMATOPROST AS MANUFACTURED IN TAINAN, TAIWAN

Page 804

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27232 A
II
6/19/2013
HETERO LABS LTD

SUBJECT
PRALATREXATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27233 A

II

7/30/2013

CADILA HEALTHCARE LTD

LINEZOLID AS MANUFACTURED IN GUJARAT, INDIA

27234 A

II

7/9/2013

AUROBINDO PHARMA LTD

27235 A

II

6/11/2013

YONSUNG FINE CHEMICALS CO LTD

MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
ISOPROPYL UNOPROSTONE AS MANUFACTURED IN GYEONGGI-DO, REPUBLIC OF KOREA

27236 A

III

6/18/2013

COGENT GLASS LTD

MOULDED GLASS VIALS USP TYPE-I AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27237 A

III

6/18/2013

COGENT GLASS LTD

27238 A

III

6/21/2013

BESPAK DIV CONSORT MEDICAL PLC

27239 A

II

6/29/2013

MSN PHARMACHEM PVT LTD

27240 A

II

6/29/2013

MSN LABORATORIES PVT LTD

TUBULAR GLASS VIALS AND AMPOULES USP TYPE-I AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
BK640 GENERIC ORAL INTEGRATED DOSE COUNTER AS MANUFACTURED IN NORFOLK,
ENGLAND
SAXAGLIPTIN HYDROCHLORIDE [ROUTE CODE - "SH"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
VIGABATRIN USP [ROUTE CODE - "VB"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27241 A

II

9/27/2013

IPCA LABORATORIES LTD

PROMETHAZINE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

27242 A

II

7/23/2013

LUPIN LTD

PITAVASTATIN CALCIUM AS MANUFACTURED IN MADHYA PRADESH, INDIA

27243 A

II

6/18/2013

SICHUAN DEEBIO PHARMACEUTICALS CO., LTD.

HEPARIN SODIUM AS MANUFACTURED IN GUANGHAN CITY, P. R. CHINA

27244 A

II

7/23/2013

CIPLA LTD

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

27245 A

II

7/25/2013

IPCA LABORATORIES LTD

MESALAMINE USP (MZ3 PROCESS) AS MANUFACTURED IN MADHYA PRADESH, INDIA

27246 A

II

6/28/2013

JUBILANT GENERICS LTD

TADALAFIL-USP AS MANUFACTURED IN MYSORE, INDIA

27247 A

II

6/25/2013

TIANJIN SEGA PHARMA CO LTD

LAMIVUDINE USP AS MANUFACTURED IN TIANJIN, P.R. CHINA

27248 A

II

6/4/2013

27249 A

IV

6/4/2013

THE UNITED LABORATORIES INNER MONGOLIA CO 6-AMINO-PENICILLANIC ACID (6-APA) BULK DRUG SUBSTANCE AS MANUFACTURED IN INNER
LTD
MANGOLIA, P.R. CHINA
DMV FONTERRA EXCIPIENTS GMBH CO KG
MICROCRYSTALINE CELLULOSE (SPRAY DRIED) AS MANUFACTURED IN GOCH, GERMANY

27250 A

II

6/21/2013

CEDARBURG PHARMACEUTICALS INC

27251 A

II

9/17/2013

CADILA HEALTHCARE LTD

27252 A

II

7/17/2013

IPCA LABORATORIES LTD

27253 A

II

7/24/2013

MYLAN LABORATORIES LTD

27255 A

II

7/16/2013

HETERO DRUGS LTD

PITAVASTATIN CALCIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27256 A

II

9/20/2013

JUBILANT GENERICS LTD

VORICONAZOLE USP AS MANUFACTURED IN KARNATAKA, INDIA

27257 A

II

9/28/2013

JUBILANT GENERICS LTD

PALIPERIDONE PALMITATE AS MANUFACTURED IN KARNATAKA, INDIA

27258 A

II

7/15/2013

NANJING LIFENERGY R AND D CO LTD

27259 A

II

7/15/2013

AMINO CHEMICALS LTD

IRON SUCROSE AS MANUFACTURED IN JIANGSU, P. R. CHINA FOR NANJING LIFENERGY R&D


CO LTD
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN MARSA, MALTA

27260 A

II

7/29/2013

APICORE US LLC

PRIMAQUINE PHOSPHATE, USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

27261 A

II

6/21/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

27262 A

IV

6/21/2013

NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD

CARBAMAZEPINE PROCESS B (VERSION NO.: 1) AS MANUFACTURED IN ZHEJIANG PROVINCE,


CHINA
CALCIUM STEARATE USP/NF AS MANUFACTURED IN MAHARASHTRA, INDIA

27263 A

III

6/12/2013

PEARL POLYMERS LTD

PET BOTTLES FOR PHARMACEUTICALS AS MANUFACTURED IN HIMACHAL PRADESH, INDIA

27264 A

III

6/14/2013

ROBIN INDUSTRIES INC

EY-111206 AS MANUFACTURED IN BERLIN, OH FOR ROBIN INDUSTRIES, INC

27254 P

FLUOXYMESTERONE ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN GRAFTON,


WISCONSIN
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) AS MANUFACTURED IN GUJARAT,
INDIA
RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP AS MANUFACTURED IN MADHYA
PRADESH, INDIA
RILPIVIRINE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

*** PENDING FILING REVIEW ***

Page 805

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27265 A
II
6/25/2013
HYBIO PHARMACEUTICAL CO LTD

SUBJECT
NESIRITIDE CITRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
GUANGDONG, P.R. CHINA
CLINDAMYCIN HYDROCHLORIDE (PROCESS B) AS MANUFACTURED IN TAIZHOU CITY, P.R.
CHINA
DX401 JS STYRENE-ISOPRENE-STYRENE COPOLYMER AS MANUFACTURED IN IBARAKI,
JAPAN FOR KRATON POLYMERS US LLC
SAXAGLIPTIN HYDROCHLORIDE PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27266 A

II

7/8/2013

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

27267 A

IV

6/28/2013

KRATON POLYMERS US LLC

27268 A

II

7/2/2013

HETERO DRUGS LTD

27269 A

III

6/27/2013

SICHUAN HUILI INDUSTRY CO LTD

27270 A

III

6/27/2013

SICHUAN HUILI INDUSTRY CO LTD

27271 A

II

7/15/2013

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

27272 A

II

9/19/2013

NAVINTA LLC

27273 A

II

10/24/2013

CATALENT PHARMA SOLUTIONS LLC

BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA,


INDIA FOR NAVINTA LLC
SOFTGELS [OET-10275226] AS MANUFACTURED IN ST. PETERSBURG, FL

27274 A

II

3/24/2014

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275268] AS MANUFACTURED IN ST. PETERSBURG, FL

27275 A

III

6/27/2013

SICHUAN HUILI INDUSTRY CO LTD

27276 A

II

9/22/2013

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

27277 A

III

6/27/2013

SICHUAN HUILI INDUSTRY CO LTD

27278 A

III

6/27/2013

SICHUAN HUILI INDUSTRY CO LTD

POLYVINYL CHLORIDE/POLYVINYLIDENE CHLORIDE (PVC/PVDC) COMPOSITE SHEET FOR


PACKAGING OF SOLID DOSAGE FORMS AS MANUFACTURED IN CHENGDU, P.R. CHINA
CLINDAMYCIN PALMITATE HYDROCHLORIDE (PROCESS B) AS MANUFACTURED IN ZHEJIANG
PROVINCE, P.R. CHINA
POLYVINYL CHLORIDE (PVC) SHEET FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED
IN CHENGDU, P.R. CHINA
POLYAMIDE/ALUMINUM/POLYVINYL CHLORIDE (PA/AL/PVC) COLD FORMING COMPOSITE
SHEET FOR PACKAGING OF SOLID DOSAGE FORMS AS MANUFACTURED IN CHENGDU, P.R.
CHINA

27279 A

III

6/27/2013

SICHUAN HUILI INDUSTRY., LTD.

27280 A

II

7/5/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

27281 A

III

7/3/2013

TRUDELL MEDICAL INTERNATIONAL

27282 A

II

10/24/2013

GLAND PHARMA LTD

POLYESTER/ALUMINUM/CASTING POLYPROPYLENE (PET/AL/CPP) COMPOSITE FILM/BAG FOR


PHARMACEUTICAL PACKAGING AS MANUFACTURED IN CHENGDU, P.R. CHINA
1-[2-AMINO-1-(4-METHOXYPHENYL) ETHYL] CYCLOHEXANOL HYDROCHLORIDE (VERSION
NO.:1) AS MANUFACTURED IN TAIZHOU CITY, CHINA
TOP MOUNTED ACTUATION INDICATOR (TMAI) - P/N 102545 AS MANUFACTURED IN ONTARIO,
CANADA
INDOMETHACIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27283 A

III

5/9/2013

ALPHA PHARMA DAMAN PRIVATE LTD

PET BOTTLES AS MANUFACTURED IN DAMAN, INDIA

27284 A

II

7/16/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27285 A

II

12/31/2013

LUPIN LTD

27286 A

II

8/26/2013

UNICHEM LABORATORIES LTD

FROVATRIPTAN SUCCINATE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA


FOR BIOPHORE INDIA PHARMACEUTICALS PVT. LTD
ASENAPINE MALEATE (MICRONIZED) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR
LUPIN LTD
TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, INDIA

27287 A

II

8/20/2013

UNICHEM LABORATORIES LTD

PALIPERIDONE AS MANUFACTURED IN RAIGAD, INDIA

27288 A

III

6/28/2013

AMPACET CORP

27289 A

III

6/27/2013

SICHUAN HUILI INDUSTRY CO LTD

27290 A

II

7/8/2013

CHEMO IBERICA SA

7011641 AB PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DEFIDDER, LA; CARTERSVILLE,


GA AND HEATH, OH
POLYESTER/ALUMINUM/POLYETHYLENE (PET/AL/PE) COMPOSITE FILM/BAG FOR
PHARMACEUTICAL PACKAGING AS MANUFACTURED IN CHENGDU, P.R. CHINA
ASENAPINE MALEATE AS MANUFACTURED IN MADRID, SPAIN

27291 A

II

7/8/2013

SHISEIDO CO LTD

SHISEIDO SODIUM HYALURONATE SZE GRADE-EP AS MANUFACTURED IN SHIZUOKA, JAPAN

27292 A

II

6/30/2013

MEGAFINE PHARMA P LTD

ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN


MAHARASHTRA, INDIA

ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN CHENGDU, P.R.


CHINA
BOPET/VMPET/PE COMPOSITE FILM/BAG FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN CHENGDU, P.R. CHINA
CLINDAMYCIN PHOSPHATE (PROCESS B) AS MANUFACTURED IN TAIZHOU CITY, P.R. CHINA

Page 806

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27293 A
II
7/3/2013
FARMABIOS SPA
27294 A

IV

7/5/2013

LIPOID GMBH

27295 A

II

7/10/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

27296 A

III

6/28/2013

27297 A

II

7/19/2013

27298 A

II

8/23/2013

TIANJIN BOKELIN MEDICAL PACKAGING


TECHNOLOGY CO LTD
3D IMAGING DRUG DESIGN AND DEVELOPMENT
LLC
TEVA PHARMACEUTICAL INDUSTRIES LTD

27299 P

SUBJECT
TIROFIBAN HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GROPELLO CAIROLI
(PAVIA), ITALY
LIPOID PG 14:0/14:0 NH4 (DMPG-NH4) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY
AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
G60T-002 AS MANUFACTURED IN TIANJIN, P.R. CHINA
FLUOROMISONIDAZOLE F 18 INJECTION AS MANUFACTURED IN LITTLE ROCK, AR
PRALATREXATE AS MANUFACTURED IN MILAN, ITALY AND OPAVA - KOMAROV CZECH
REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.

*** PENDING FILING REVIEW ***

27300 A

II

8/8/2013

SIGMAPHARM LABORATORIES LLC

AMORPHOUS ASENAPINE MALEATE AS MANUFACTURED IN BENSALEM, PA

27301 A

II

10/1/2013

DPA-713 I 124 INJECTION AS MANUFACTURED IN LITTLE ROCK, ARKANSAS

27302 A

II

7/29/2013

3D IMAGING DRUG DESIGN AND DEVELOPMENT


LLC
AUROBINDO PHARMA LTD

27303 A

II

9/27/2013

GLENMARK GENERICS LTD

EZETIMIBE (D067 PROCESS) AS MANUFACTURED IN GUJARAT, INDIA

27304 A

III

7/1/2013

LORMAC INDUSTRIAL DISTRIBUTORS LTD

LRMAC TYPE 3A POLYETHYLENE AS MANUFACTURED IN FORGE HILL, CORK IRELAND

27305 A

IV

7/8/2013

UNGERER AND CO

ARTIFICIAL JUICY RASPBERRY FLAVOR FW-4870 AS MANUFACTURED IN BETHLEHEM, PA

27306

II

7/10/2013

NERPHARMA SRL

27307 A

II

7/26/2013

MSN LABORATORIES PVT LTD UNIT II

MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN NERVIANO MILAN,


ITALY
LATANOPROST USP [ROUTE CODE LO ] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27308 A

II

7/31/2013

MSN LABORATORIES PVT LTD UNIT II

27309 A

II

7/30/2013

MSN PHARMACHEM PVT LTD

DOCETAXEL ANHYDROUS USP [ROUTE CODE - DL] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
SAXAGLIPTIN MONOHYDRATE [ROUTE CODE - SC"] AS MANUFACTURED IN TELANGANA

27310 A

II

7/26/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

GEFITINIB AS MANUFACTURED IN TAIZHOU CITY, CHINA

27311 A

II

9/9/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

27312 A

II

9/24/2013

HISUN PHARMACEUTICAL HANGZHOU CO LTD

DOXORUBICIN HYDROCHLORIDE USP (FERMENTATION) AS MANUFACTURED IN TAIZHOU


CITY, CHINA
ORLISTAT AS MANUFACTURED IN ZHEJIANG, CHINA

27313 A

II

10/8/2013

ACS DOBFAR SPA

NAFCILLIN SODIUM FOR INJECTION (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

27314 A

II

7/26/2013

TRIS PHARMA INC

COD-CPM ER ORAL SUSPENSION AS MANUFACTURED IN MONMOUTH JUNCTION, NJ

27315 P

ARMODAFINIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

*** PENDING FILING REVIEW ***

27316 A

II

7/26/2013

SIGNA SA DE CV

ASENAPINE MALEATE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO

27317 A

III

7/11/2013

LEVOSIL SPA

CLAY DESICCANT BAGS TYPE A AS MANUFACTURED IN TURIN, ITALY

27318 A

III

7/11/2013

LEVOSIL SPA

100% COBALT FREE HUMIDITY INDICATOR CARDS AS MANUFACTURED IN TURIN, ITALY

27319 A

II

7/16/2013

CHUNG JIN BIOTECH CO LTD

ISOLATED AND PURIFIED BEEVENOM AS MANUFACTURED IN GYEONGGI-DO, KOREA

27320 A

8/20/2013

MECKESSON SPECIALTY HEALTH

TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) ACCESS PROGRAM

27321 A

II

7/8/2013

CHUNG JIN BIOTECH CO LTD

PURIFIED BEEVENOM AS MANUFACTURED IN GYEONGGI-DO, KOREA

27322 A

II

3/4/2014

COSMA SPA

27323 A

III

7/17/2013

ST GOBAIN PERFORMANCE PLASTICS

DICLOFENAC HYDROXY ETHYL PYRROLIDINE AS MANUFACTURED IN CISERANO (BERGAMO),


ITALY
NORTON ETFE E4 CT-1S AS MANUFACTURED IN WAYNE, NJ

27324 A

II

7/2/2013

JSR LIFE SCIENCES CORP

AMSPHERE PROTEIN A JWT203 AS MANUFACTURED IN IBARAKI, JAPAN

27325 A

II

7/19/2013

FARMABIOS SPA

METHYLPREDNISOLONE ACETATE STERILE AS MANUFACTURED IN GROPELLO CAIROLI (PV),


ITALY

Page 807

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27326 A
III
7/15/2013
SENXING PHARMACEUTICAL CONSUMABLE
BEIJING LTD
27327 A
III
7/18/2013
REXAM HEALTHCARE OFFRANVILLE SAS

SUBJECT
RUBBER DISC AS MANUFACTURED IN BEIJING, P.R. CHINA

27328 A

III

7/22/2013

WATSON MARLOW LTD

27329 A

IV

7/22/2013

FONA INTERNATIONAL INC

BIOPRENE THERMOPLASTIC ELASTOMER TUBING AS MANUFACTURED IN CORNWALL,


ENGLAND
884.038 N-C ORANGE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

27330 A

IV

7/22/2013

FONA INTERNATIONAL INC

862.0428U N-C LEMON FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

27331 A

II

11/5/2013

TARO PHARMACEUTICAL INDUSTRIES LTD

FELBAMATE USP AS MANUFACTURED IN HAIFA, ISRAEL

27332 N

NASONEX BOTTLES AND CAPS AS MANUFACTURED IN OFFRANVILLE, FRANCE

NOT AN ASSIGNED NUMBER

27333 A

II

7/31/2013

CADILA HEALTHCARE LTD

PITAVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA

27334 A

II

5/13/2013

ALLIANCE ENZYME PVT LTD

PAPAIN (LIQUID) AS MANUFACTURED IN GUJARAT, INDIA

27335 P

*** PENDING FILING REVIEW ***

27336 A

II

9/27/2013

JIANGSU HENGRUI MEDICINE CO LTD

FONDAPARINUX SODIUM AS MANUFACTURED IN JIANGSU, CHINA

27337 A

III

7/17/2013

WITTENBURG B.V.

27338 A

III

7/24/2013

WITTENBURG B.V.

27339 A

II

7/18/2013

POLYMED THERAPEUTICS INC

27340 A

II

9/20/2013

FIS FABBRICA ITALIANA SINTETICI SPA

CAWITON MO SERIES FOR MEDICAL & PHARMACEUTICAL USE AS MANUFACTURED IN


ZEEWOLDE, NETHERLANDS
CAWITON MT-SERIES FOR MEDICAL & PHARMACEUTICAL APPLICATIONS AS MANUFACTURED
IN ZEEWOLDE, NETHERLANDS
CABAZITAXEL ETHYL ACETATE SOLVATE DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, CHINA
PRASTERONE ACETATE AS MANUFACTURED IN VICENZA, ITALY

27342 A

III

7/24/2013

DITTA INDIVIDUALE PAOLO GOBBI FRATTINI

27343 A

IV

7/25/2013

KERRY BIOFUNCTIONAL INGREDIENTS INC

27345 A

III

7/10/2013

SCORPION CONTAINERS PRIVATE LTD

FLIP OFF SEALS AS MANUFACTURED IN GUJARAT, INDIA

27346 A

III

7/10/2013

SCORPION CONTAINERS PRIVATE LTD

ROPP CAPS AS MANUFACTURED IN GUJARAT, INDIA

27347 A

II

9/3/2013

RUBICON RESEARCH PVT LTD

COATED DEXTROMETHORPHAN POLISTIREX AS MANUFACTURED IN MAHARASHTRA, INDIA

27348 A

II

9/24/2013

HOSPIRA HEALTHCARE INDIA PVT LTD

ERTAPENEM SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA

27341 N

NOT AN ASSIGNED NUMBER

27344 N

NOT AN ASSIGNED NUMBER

27349 N
27350 A

PLASTIC BAGS FOR PHARMACEUTICAL SOLUTIONS AND THEIR COMPONENTS AS


MANUFACTURED IN SONDRIO, ITALY
LUBRITOSE MANNITOL AS MANUFACTURED IN NORWICH, NY

NOT AN ASSIGNED NUMBER


II

8/14/2013

27351 N

BAL PHARMA LTD

BEPOTASTINE BESILATE AS MANUFACTURED IN BANGALORE, INDIA

NOT AN ASSIGNED NUMBER

27352 A

II

7/15/2013

SUNBIO INC

27353 A

II

7/29/2013

27354 A

II

7/29/2013

DSM SINOCHEM PHARMACEUTICALS


NETHERLANDS BV
HETERO DRUGS LTD

27355 A

III

7/31/2013

27356 A

III

7/17/2013

JIANGSU HUALAN NEW PHARMACEUTICAL


MATERIAL CO LTD
AMPACET CORP

27357 A

IV

4/23/2013

GC CHEMIE PHARMIE LTD

METHOXY POLYETHYLENE GLYCOL AMINE 2,000 AS MANUFACTURED IN ANYANG CITY,


S.KOREA
PNEUMOCANDIN B0 AS MANUFACTURED IN SHANGHAI, P.R. CHINA FOR DSM SINOCHEM
PHARMACEUTICALS NETHERLANDS B.V.
PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
HALOGENATED BUTYL RUBBER COMPONENTS AS MANUFACTURED IN JIANGYIN LINGANG
NEW CITY, CHINA
1000071-N AS PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA,
CARTERSVILLE, GA AND HEATH, OH
NOVODONE - CR CROSPOVIDONE USP-NF AS MANUFACTURED IN QUZHOU, P.R. CHINA FOR
G.C. CHEMIE PHARMIE LTD.

Page 808

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27358 A
IV
4/23/2013
GC CHEMIE PHARMIE LTD
27359 A

III

7/29/2013

3M DRUG DELIVERY SYSTEMS

27360 N

NOT AN ASSIGNED NUMBER

27361 N

NOT AN ASSIGNED NUMBER

27362 N

NOT AN ASSIGNED NUMBER

SUBJECT
NOVODONE PROVIDONE USP-35 AS MANUFACTURED IN QUZHOU, P.R. CHINA FOR G.C.
CHEMIE PHARMIE LTD.
25 UL VALVE A66060 AS MANUFACTURED IN LANCASHIRE, GREAT BRITAIN FOR 3M DRUG
DELIVERY SYSTEMS

27363 A

II

8/1/2013

27364 A

II

8/22/2013

27366 A

II

9/18/2013

DK PHARMA CHEM PVT LTD

27367 A

II

7/31/2013

CHONGQING HUAPONT PHARMACEUTICAL CO LTD CALCIPOTRIOL MONOHYDRATE AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR
CHONGQING HUAPONT PHARMACEUTICAL CO., LTD.
NOT AN ASSIGNED NUMBER

27369 A

II

7/31/2013

APTALIS PHARMATECH INC

APT-5020 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA, OHIO

27370 A

II

8/30/2013

MYLAN LABORATORIES LTD

ROTIGOTINE AS MANUFACTURED IN MAHARASHTRA, INDIA

27365 N

NOT AN ASSIGNED NUMBER

27368 N

27371 N

PROBENECID (PBX) AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER

27372 N
27373 A

CHONGQING HUAPONT PHARMACEUTICAL CO LTD CALCIPOTRIOL ANHYDROUS AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR
CHONGQING HUAPONT PHARMACEUTICAL CO., LTD.
AUROBINDO PHARMA LTD
CINACALCET HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

NOT AN ASSIGNED NUMBER


II

7/31/2013

27375 A

II

7/31/2013

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

PANTOPRAZOLE SODIUM AS MANUFACTURED IN SHOUGUANG CITY, CHINA

27376 A

II

8/1/2013

OLON SPA

ABIRATERONE ACETATE AS MANUFACTURED IN MILANO, ITALY

27374 N

BLOOMAGE FREDA BIOPHARM CO LTD

SODIUM HYALURONATE (HA-E 2.0) AS MANUFACTURED IN JINAN CITY, P.R. OF CHINA

NOT AN ASSIGNED NUMBER

27377 N

NOT AN ASSIGNED NUMBER

27378 A

II

9/16/2013

PAR PHARMACEUTICAL INC

27379 A

II

9/17/2013

MYLAN LABORATORIES LTD

27380 A

II

12/20/2013

SIGNA SA DE CV

27381 A

II

8/23/2013

SUZHOU HOMESUN PHARMACEUTICAL CO LTD

27382 I

II

9/23/2013

CADILA HEALTHCARE LTD

TIAGABINE HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN ESTADO DE


MEXICO, MEXICO
CEFMETAZOLE SODIUM AS MANUFACTURED IN TAICANG CITY, CHINA FOR CHENGDU
JUNXIANG PHARMACEUTICAL TECHNOLOGY CO., LTD
ARSENIC TRIOXIDE AS MANUFACTURED IN GUJARAT, INDIA

27383 A

II

8/1/2013

FARCHEMIA SRL

SECNIDAZOLE AS MANUFACTURED IN TREVIGLIO, ITALY

27384 P

ALOSETRON HYDROCHLORIDE AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR


PHARMACEUTICAL, INC
CLOZAPINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

*** PENDING FILING REVIEW ***

27385 A

II

9/10/2013

ZHEJIANG CHANGMING PHARMACEUTICAL CO LTD LISINOPRIL DIHYDRATE USP (NON-STERILE) AS MANUFACTURED IN TIANTAI, CHINA

27386 A

II

8/16/2013

BAL PHARMA LTD

27387 I

II

8/29/2013

APTUIT SCIENTIFIC OPERATIONS INC

27388 A

II

8/22/2013

EMCURE PHARMACEUTICALS LTD

II

8/30/2013

27389 N
27390 A
27391 N

BEPOTASTINE BESILATE AS MANUFACTURED IN BANGALORE, INDIA FOR BAL PHARMA


LIMITED.
SODIUM PHENYLACETATE AS MANUFACTURED IN KANSAS CITY, MO FOR APTUIT SCIENTIFIC
OPERATIONS, LLC.
ESOMEPRAZOLE SODIUM (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER


EMCURE PHARMACEUTICALS LTD

PROPOFOL USP AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER

Page 809

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27392 N
NOT AN ASSIGNED NUMBER
27393 N
27394

SUBJECT

NOT AN ASSIGNED NUMBER


II

8/7/2013

HEC PHARM CO LTD

II

8/1/2013

SHANDONG RENHETANG PHARMACEUTICAL CO


LTD
NOT AN ASSIGNED NUMBER

27398 A

II

7/30/2013

27399 A

II

11/1/2013

CHONGQING HUAPONT PHARMACEUTICAL CO LTD TRETINOIN AS MANUFACTURED IN CHONGQING P. R. CHINA FOR CHONGQING HUAPONT
PHARMACEUTICAL CO., LTD
CONCORD BIOTECH LTD
ROMIDEPSIN AS MANUFACTURED IN AHMEDABAD, INDIA

27400 A

II

9/25/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

27401 A

II

8/31/2013

AUROBINDO PHARMA LTD

27402 A

II

2/20/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

27403 A

II

9/1/2013

ALKEM LABORATORIES LTD

GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS) AS MANUFACTURED IN


NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA

27404 A

IV

5/24/2013

EVONIK INDUSTRIES AG WERK ROHEM

EUDRAGIT RL/RS AS MANUFACTURED IN DARMSTADT, GERMANY

27405 A

II

1/2/2014

NAVINTA LLC

SEVELAMER CARBONATE AS MANUFACTURED IN GUJARAT, INDIA FOR NAVINTA LLC

27406 A

II

8/2/2013

JARI PHARMACEUTICAL CO LTD

TORSEMIDE AS MANUFACTURED IN JIANGSU, CHINA

27407 A

II

7/31/2013

BIA SEPARATIONS DOO

CIM CONVECTIVE INTERACTION MEDIA HIC AS MANUFACTURED IN AJDOVSCINA, SLOVENIA

27408 A

III

8/8/2013

PARAS ENTERPRISE

ALUMINIUM FOILS AS MANUFACTURED IN GUJARAT, INDIA

27409 A

IV

8/9/2013

NB ENTREPRENEURS

27410 A

II

8/1/2013

MURLI KRISHNA PHARMA PVT LTD

MICROCRYSTALLINE CELLULOSE USP OF VARIOUS GRADES AS MANUFACTURED IN


MAHARASHTRA, INDIA
ITRACONAZOLE PELLETS 22.0 % W/W AS MANUFACTURED IN MAHARASHTRA, INDIA

27411 A

II

8/1/2013

MURLI KRISHNA PHARMA PVT LTD

OMEPRAZOLE PELLETS 8.5 % W/W AS MANUFACTURED IN MAHARASHTRA, INDIA

27412 A

II

8/1/2013

MURLI KRISHNA PHARMA PVT LTD

CLARITHROMYCIN PELLETS 42.0 % W/W AS MANUFACTURED IN MAHARASHTRA, INDIA

27413 A

II

8/1/2013

MURLI KRISHNA PHARMA PVT LTD

LANSOPRAZOLE PELLETS 8.5 % W/W AS MANUFACTURED IN MANHARASHTRA, INDIA

27414 A

III

7/26/2013

PRETIUM PACKAGING LLC

PLASTIC PACKAGING MATERIAL AS MANUFACTURED IN HAZLETON, PA

27415 A

IV

8/2/2013

UNGERER AND CO

NATURAL AND ARTIFICIAL MENTHOL FLAVOR FP-4594 AS MANUFACTURED IN BETHLEHEM, PA

27416 A

III

8/9/2013

AMERICAN TECHNICAL MOLDING INC

MOLDED PLASTIC COMPONENTS AS MANUFACTURED IN CLEARWATER, FL

27417 A

IV

8/14/2013

QUZHOU JIANHUA NANHANG INDUSTRIAL CO LTD

POVIDONE K30 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27418 A

II

8/13/2013

NEULAND LABORATORIES LTD

PROPOFOL USP AS MANUFACTURED IN TELANGANA, INDIA

27419 A

II

8/12/2013

AVESTA PHARMA PVT LTD

POLYETHYLENE GLYCOL NF AS MANUFACTURED IN MAHARASHTRA, INDIA

27420 A

II

8/24/2013

MSN LABORATORIES PVT LTD UNIT II

EPOPROSTENOL SODIUM [ROUTE CODE - ED] AS MANUFACTURED IN TELANGANA, INDIA

27421 A

II

8/26/2013

MSN PHARMACHEM PVT LTD

DARUNAVIR ETHANOLATE [ROUTE CODE - DN] AS MANUFACTURED IN TELANGANA, INDIA

27422 A

II

8/31/2013

MSN LABORATORIES PVT LTD

27423 A

II

8/26/2013

27424 A

II

8/14/2013

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL


CO LTD
BELLICUM PHARMACEUTICALS INC

PAZOPANIB HYDROCHLORIDE [ROUTE CODE - "PY"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
16A-HYDROXYPREDNISOLONE AS MANUFACTURED IN E-ZHOU CITY, P. R. OF CHINA

27395 A
27396 N
27397 N

MOXIFLOXACIN HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE AS


MANUFACTURED IN YIDU CITY, P.R. CHINA
DIFENIDOL HYDROCHLORIDE AS MANUFACTURED IN LINYI, CHINA

NOT AN ASSIGNED NUMBER

ROMIDEPSIN AS MANUFACTURED IN MILAN, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES


LTD
ENTECAVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

AP1903 DRUG SUBSTANCE AS MANUFACTURED IN ONTARIO, CANADA FOR BELLICUM


PHARMACEUTICALS, INC.

Page 810

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27425 A
III
8/8/2013
PACK MATES PACKAGING INDIA PRIVATE LTD

SUBJECT
FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN HYBERABAD, INDIA

27426 A

PA/AL/PVC COLD- FORMED FOIL FOR SOLID PHARMACEUTICAL PACKAGING AS


MANUFACTURED IN YANGZHOU CITY, CHINA

III

7/26/2013

27428 A

II

3/13/2014

DK PHARMA CHEM PVT LTD

TRIMETHOBENZAMIDE HYDROCHLORIDE (TBZ) AS MANUFACTURED IN MAHARASHTRA, INDIA

27429 A

II

7/18/2013

AVRA LABORATORIES PRIVATE LTD

7-ETHYL-10-HYDROXYCAMPTOTHECIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27430 A

II

7/23/2013

SHANDONG XINHUA PHARMACEUTICAL CO LTD

CARBIDOPA AS MANUFACTURED IN SHANDONG, P.R. CHINA

27431 A

II

8/2/2013

ZHEJIANG XIANJU PHARMACEUTICAL CO LTD

27432 A

II

9/12/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

TESTOSTERONE ENANTHATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


ZHEJIANG, CHINA
BORTEZOMIB AS MANUFACTURED IN TAIZHOU CITY, CHINA

27433 A

II

9/27/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27434 A

II

8/29/2013

HISUN PHARMACEUTICAL HANGZHOU CO LTD

FR179642 AS MANUFACTURED ZHEJIANG PROVINCE, CHINA

27435 A

II

9/25/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MICAFUNGIN SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27436 A

II

8/14/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

DARUNAVIR AS MANUFACTURED IN ZHEJIANG, CHINA

27437 A

II

8/14/2013

JOST CHEMICAL CO

SODIUM PHOSPHATE DIBASIC DIHYDRATE AS MANUFACTURED IN ST. LOUIS, MO

27438 A

II

8/10/2013

RUYUAN HEC PHARM CO LTD

27439 A

II

9/30/2013

ALEMBIC PHARMACEUTICALS LTD

SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG


PROVINCE, P.R. CHINA
TOPIRAMATE AS MANUFACTURED IN GUJARAT INDIA

27440 A

II

8/15/2013

27441 A

II

9/26/2013

27442 A

II

9/13/2013

YICHANG CHANGJIANG PHARMACEUTICAL CO LTD INSULIN HUMAN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU CITY,
P.R. CHINA
QILU PHARMACEUTICAL CO LTD
CABAZITAXEL AS MANUFACTURED IN SHANDONG P. R. CHINA FOR QILU PHARMACEUTICAL
CO., LTD
CIPLA LTD
GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN BANGALORE, INDIA

27443 A

II

12/3/2013

GLENMARK GENERICS LTD

LINEZOLID D111 PROCESS AS MANUFACTURED IN GUJARAT, INDIA

27444 A

II

11/20/2013

WISDOM PHARMCEUTICAL CO LTD

ENTECAVIR AS MANUFACTURED IN JIANGSU, CHINA

27445 A

III

8/19/2013

SENSOPLAST PACKMITTELTECHNIK GMBH

CONTAINER CLOSURE SYSTEMS AS MANUFACTURED IN OBERHONNEFELD, GERMANY

27446 A

II

11/15/2013

UNIQUE CHEMICALS

CILNIDIPINE AS MANUFACTURED IN GUJARAT, INDIA

27447 A

II

10/14/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

TESTOSTERONE USP AS MANUFACTURED IN GUJARAT, INDIA

27448 A

II

9/10/2013

MICRO LABS LTD

RASAGILINE MESYLATE AS MANUFACTURED IN BANGALORE, INDIA

27449 A

III

8/16/2013

GREEN PACK FOILS PRIVATE LTD

PET-FOIL-POLY LAMINATES AS MANUFACTURED IN GUJARAT, INDIA

27450 A

III

8/10/2013

GREEN PACK FOILS PRIVATE LTD

COLD FORMING BLISTER (ALU-ALU) LAMINATE AS MANUFACTURED IN GUJARAT, INDIA

27451 A

II

11/1/2013

APOTEX PHARMACHEM INC

BUDESONIDE USP AS MANUFACTURED IN ONTARIO, CANADA

27452 A

II

9/20/2013

GLENMARK GENERICS LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27453 A

II

8/20/2013

27454 A

II

9/25/2013

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO


LTD
MYLAN LABORATORIES LTD

VALACYCLOVIR HYDROCHLORIDE ANHYDROUS FORM I AS MANUFACTURED IN ZHEJIANG


PROVINCE, P. R. CHINA
EFAVIRENZ USP (PROCESS-III) AS MANUFACTURED IN TELANGANA, INDIA

27455 A

II

9/24/2013

MYLAN LABORATORIES LTD

EMTRICITABINE (PROCESS-II) AS MANUFACTURED IN TELANGANA, INDIA

27456 A

II

9/24/2013

MYLAN LABORATORIES LTD

27457 A

II

8/31/2013

MSN LABORATORIES PVT LTD

27458 A

II

9/6/2013

CTX LIFE SCIENCES PVT LTD

TENOFOVIR DISOPROXIL FUMARATE (PROCESS-II) AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
DOCETAXEL TRIHYDRATE USP [ROUTE CODE - "DO"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
LEVETIRACETAM AS MANUFACTURED IN GUJARAT, INDIA

27427 P

YANGZHOU JEREL PACKING MATERIAL CO., LTD


*** PENDING FILING REVIEW ***

Page 811

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27459 A
V
11/22/2013
MEDIMMUNE LLC
27460 P

SUBJECT
FACILITIES AND EQUIPMENT INFORMATION FOR THE MEDIMMUNE LLC, FREDERICK
MANUFACTURING CENTER

*** PENDING FILING REVIEW ***

27461 A

II

3/31/2014

CIPLA LTD

BUDESONIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27462 A

II

9/27/2013

CIPLA LTD

LOPINAVIR USP AS MANUFACTURED IN BANGALORE, INDIA

27463 A

II

9/29/2013

CADILA HEALTHCARE LTD

PITAVASTATIN MAGNESIUM MANUFACTURED IN GUJARAT, INDIA

27464 A

II

9/18/2013

IPCA LABORATORIES LTD

MIDODRINE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

27465 A

II

8/27/2013

ICROM SPA

BEPOTASTINE BESILATE AS MANUFACTURED IN CONCOREZZO, ITALY

27466 A

II

8/26/2013

ASYMCHEM LABORATORIES TIANJIN CO LTD

TAMOXIFEN CITRATE AS MANUFACTURED IN TIANJIN, CHINA

27467 A

II

3/29/2014

ACETAMINOPHEN USP AS MANUFACTURED IN GUJARAT, INDIA

27468 A

II

5/7/2014

FARMSON PHARMACEUTICAL GUJARAT PRIVATE


LTD
CIVENTICHEM LLC

27469 A

II

9/30/2013

CIVENTICHEM LLC

ISOPROTERENOL HYDROCHLORIDE USP AS MANUFACTURED IN CARY, NC

27470 A

II

9/23/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27471 A

III

12/13/2013

INDIAN OIL CORP LTD

ALOSETRON HYDROCHLORIDE AS MANUFACTURED IN VISAKHAPATNAM, INDIA FOR


BIOPHORE INDIA PHARMACEUTICALS PVT. LTD
PROPEL PP2120MC AS MANUFACTURED IN HARYANA, INDIA

27472 A

II

9/17/2013

RAKS PHARMA PVT LTD

27473 A

II

9/3/2013

NEULAND LABORATORIES LTD

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ETHACRYNIC ACID USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27474 A

II

9/13/2013

FORMOSA LABORATORIES INC

MIFEPRISTONE AS MANUFACTURED IN TAOYUAN, TAIWAN

27475 A

II

9/17/2013

FORMOSA LABORATORIES INC

FONDAPARINUX SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN

27476 A

III

8/15/2013

SSS PLASTICS PVT LTD

BOTTLES AND CLOSURES AS MANUFACTURED IN GUJARAT, INDIA

27477 A

II

8/19/2013

27478 A

II

8/28/2013

CHONGQING FUAN PHARMACEUTICAL GROUP CO


LTD
IMAX DIAGNOSTIC IMAGING HOLDING LTD

27479 A

II

9/27/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

TIGECYCLINE AS MANUFACTURED IN CHANGSHOU, CHINA FOR CHONGQING FUAN


PHARMACEUTICAL (GROUP) CO., LTD.
IODIXANOL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR IMAX DIAGNOSTIC
IMAGING HOLDING LIMITED
TADALAFIL USP AS MANUFACTURED IN LINHAI, CHINA

27480 A

III

8/22/2013

AMPACET CORP

27482 A

II

9/29/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27483 A

II

9/20/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27484 A

II

9/27/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27485 A

II

9/28/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27486 A

II

9/22/2013

YUNNAN HANDE BIO-TECH CO LTD

THIAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR


BIOPHORE INDIA PHARMACEUTICALS PVT. LTD
BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
BIOPHORE INDIA PHARMACEUTICALS PVT LTD
ISOTRETINOIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA
PHARMACEUTICALS PVT LTD.
MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
BIOPHORE INDIA PHARMACEUTICALS PVT LTD
10-DAB SYNTHESIZED PACLITAXEL API MANUFACTURED IN KUNMING. P.R. CHINA

27487 A

II

9/23/2013

SHILPA MEDICARE LTD

AZACITIDINE AS MANUFACTURED IN KARNATAKA, INDIA

27488 A

II

9/26/2013

SHILPA MEDICARE LTD

DECITABINE AS MANUFACTURED IN KARNATAKA, INDIA

27489 A

II

9/26/2013

SHILPA MEDICARE LTD

LETROZOLE USP AS MANUFACTURED IN KARNATAKA, INDIA

II

9/27/2013

27481 P

469837 BLUE SMC PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA,


CARTERSVILLE, GA AND HEATH, OH

*** PENDING FILING REVIEW ***

27490 P
27491 A

SODIUM NITROPRUSSIDE USP AS MANUFACTURED IN CARY, NC

*** PENDING FILING REVIEW ***


CTX LIFE SCIENCES PVT LTD

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

Page 812

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27492 A
II
9/27/2013
CTX LIFE SCIENCES PVT LTD
27493 P

SUBJECT
COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

*** PENDING FILING REVIEW ***

27494 A

II

9/25/2013

UNICHEM LABORATORIES LTD

RANOLAZINE AS MANUFACTURED IN MADHYA PRADESH, INDIA

27495 A

III

9/6/2013

MITSUBISHI GAS CHEMICAL CO INC

OA RESIN AS MANUFACTURED IN KANAGAWA, JAPAN

27496 A

II

9/23/2013

27497 A

II

9/3/2013

POLYCARBON INDUSTRIES INC DBA PCI


SYNTHESIS
OLON SPA

PCI-104234 NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN NEWBURYPORT,


MA
BEZAFIBRATE AS MANUFACTURED IN DORNO (PV) ,ITALY

27498 N

NOT AN ASSIGNED NUMBER

27499 I

NOT AN ASSIGNED NUMBER

27500 A

II

9/30/2013

MALLINCKRODT INC

DEXTROMETHADONE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO

27501 A

II

9/19/2013

AUROBINDO PHARMA LTD

CELECOXIB USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27502 A

II

9/19/2013

AUROBINDO PHARMA LTD

ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27503 A

II

9/24/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

PALIPERIDONE AS MANUFACTURED IN ZHEJIANG, CHINA

27504 A

II

9/19/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG, CHINA

27505 A

II

9/30/2013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

AMBRISENTAN AS MANUFACTURED IN ZHEJIANG, CHINA

27506 A

III

9/9/2013

AVERY DENNISON

HP104 ADHESIVE AS MANUFACTURED IN KUNSHAN, CHINA

27507 N
27508 A

NOT AN ASSIGNED NUMBER


II

9/11/2013

27509 N
27510 A

GUANG'AN KINGDAY PHARMA AND CHEM CO LTD

AZTREONAM USP AS MANUFACTURED IN SICHUAN PROVINCE, P.R. CHINA

NOT AN ASSIGNED NUMBER


II

9/11/2013

YANCHENG YOUHUA PHARMACEUTICAL AND


CHEMICAL TECHNOLOGY CO LTD
*** PENDING FILING REVIEW ***

BACITRACIN USP AS MANUFACTURED IN YANCHENG, PEOPLES REPUBLIC OF CHINA

27512 A

II

9/21/2013

IPCA LABORATORIES LTD

ETODOLAC USP (ED7 PROCESS) AS MANUFACTURED IN MADHYA PRADESH, INDIA

27513 A

II

9/6/2013

CILAG AG

27514 A

II

10/10/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

REMIFENTANIL HCI DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN,


SWITZERLAND
PALIPERIDONE AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD

II

9/30/2013

27511 P

27515 N
27516 A

NOT AN ASSIGNED NUMBER


CADILA HEALTHCARE LTD

27517 N

NOT AN ASSIGNED NUMBER

27518 I

NOT AN ASSIGNED NUMBER

27519 N

NOT AN ASSIGNED NUMBER

27520 N

NOT AN ASSIGNED NUMBER

27521 N

NOT AN ASSIGNED NUMBER

27522 A

IV

9/9/2013

27524 A

II

10/23/2013

TEVA PHARMACEUTICAL INDUSTRIES LTD

27525 A

II

4/27/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

27523 N

THE DOW CHEMICAL CO

RIVASTIGMINE AS MANUFACTURED IN GUJARAT, INDIA

AFFINISOL HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE AS


MANUFACTURED IN BOMLITZ, GERMANY FOR THE DOW CHEMICAL COMPANY

NOT AN ASSIGNED NUMBER


TIOTROPIUM BROMIDE AS MANUFACTURED IN RHO (MILAN) AND SANTHIA (VERCELLY), ITALY
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
ATORVASTATIN CALCIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL AND NETANYA, ISREAL
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.

Page 813

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27526 A
IV
9/18/2013
NOVOZYMES AS
27527 A

II

9/27/2013

SANDOZ GMBH

SUBJECT
SODIUM HYALURONATE FROM BACILLUS SUBTILIS (TOPICAL GRADE): HYASIS(R) 850T AS
MANUFACTURED IN TIANJIN, CHINA FOR NOVOZYMES AS
CEFIXIME AS MANUFACTURED IN KUNDL, AUSTRIA

27528 A

II

9/27/2013

CIPLA LTD

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

27529 A

III

8/29/2013

ROBIN INDUSTRIES INC

27530 A

III

9/4/2013

ROBIN INDUSTRIES INC

27531 A

II

9/26/2013

STEROID SPA

EY-111214; USP CLASS VI APPROVED CHLOROBUTYL COMPOUND FOR SYRINGE TIP


APPLICATIONS AS MANUFACTURED IN BERLIN, OHIO FOR ROBIN INDUSTRIES INC.
I-5715; USP CLASS VI APPROVED POLYISOPRENE COMPOUND FOR PLUNGER TIP
APPLICATIONS AS MANUFACTURED IN BERLIN, OHIO FOR ROBIN INDUSTIRES INC
TESTOSTERONE UNDECANOATE AS MANUFACTURED IN COLOGNO, MONZESE (MI), ITALY

27532 A

II

9/21/2013

MACLEODS PHARMACEUTICALS LTD

TROSPIUM CHLORIDE AS MANUFACTURED IN VALSAD, INDIA

27533 A

II

9/29/2013

MACLEODS PHARMACEUTICALS LTD

OSELTAMIVIR PHOSPHATE AS MANUFACTURED IN GUJARAT, INDIA

27534 A

II

9/13/2013

AMOLI ORGANICS PVT LTD

LINEZOLID [FORM-1] AS MANUFACTURED IN GUJARAT, INDIA

27535 A

III

9/5/2013

ROBIN INDUSTRIES INC

27536 A

IV

9/12/2013

FREUND CORP

I-4318; USP CLASS VI APPROVED POLYISOPRENE COMPOUND FOR PLUNGER TIP


APPLICATIONS MANUFACTURED IN BERLIN, OHIO FOR ROBIN INDUSTRIES INC.
NONPAREIL-105 AS MANUFACTURED IN HAMAMATSU CITY, JAPAN

27537 A

III

9/11/2013

COIM USA INC

NOVACOTE HS-8243 AS MANUFACTURED IN OFFANENGO,ITALY FOR COIM USA, INC

27538 A

II

9/23/2013

MICRO LABS LTD

TELMISARTAN USP AS MANUFACTURED IN BANGALORE, INDIA

27539 A

II

9/26/2013

MICRO LABS LTD

OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN KARNATAKA, INDIA

27540 A

III

9/10/2013

BOREALIS AG

BORMED SB815MO AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG

27541 A

10/18/2013

PFIZER INC

MODULAR VIRAL CLEARANCE

27542 A

III

9/13/2013

TAISEI KAKO CO LTD

PLASTIC SYRINGES (VFP-ARD-5ML) AS MANUFACTURED IN IBARAKI CITY, JAPAN

27543 A

II

9/27/2013

SCINOPHARM TAIWAN LTD

DECITABINE AS MANUFACTURED IN JIANGSU, CHINA FOR SCINOPHARM TAIWAN, LTD.

27544 A

II

9/9/2013

BIOSYN ARZNEIMITTEL GMBH

SODIUM SELENITE PENTAHYDRATE AS MANUFACTURED IN FELLBACH, GERMANY

27545 A

II

9/9/2013

BIOSYN ARZNEIMITTEL GMBH

27546 A

II

10/22/2014

TAIZHOU TAIFA PHARMACEUTICALS CO LTD

SELENIUM 5 MG TABLETS AS MANUFACTURED IN ENNIGERLOH, GERMANY FOR BIOSYN


ARZNEIMITTEL GMBH
MEDROXYPROGESTERONE ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA

27547 A

II

9/23/2013

AREVIPHARMA GMBH

BUPRENORPHINE AS MANUFACTURED IN RADEBEUL, GERMANY

27548 A

IV

12/17/2013

ASHLAND SPECIALITY INGREDIENTS GP

AQUARIUS(TM) COATING SYSTEMS AS MANUFACTURED IN WILMINGTON, DE

27549 A

III

9/10/2013

PRECIS PHARMA CONTAINERS

PLASTIC CONTAINERS AND CLOSURES AS MANUFACTURED IN KARNATAKA, INDIA

27550 A

II

9/30/2013

AUROBINDO PHARMA LTD

SOLIFENACIN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27551 A

II

9/30/2013

AUROBINDO PHARMA LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27552 A

III

9/13/2013

POLYONE CORP

CC1012852460 (PE LITE BLUE 278C) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

27553 A

II

9/10/2013

OLON SPA

ALITRETINOIN AS MANUFACTURED IN GARBAGNATE MILANESE (MI) , ITALY

27554 A

II

9/13/2013

OLON SPA

ROTIGOTINE POLYMORPH II AS MANUFACTURED RODANO (MI) , ITALY

27555 A

III

9/17/2013

WEST PHARMACEUTICAL SERVICES INC

NOVAPURE SYSTEM AS MANUFACTURED IN JERSEY SHORE, PA

27556 A

II

11/26/2013

DOW CORNING CORP

27557 A

II

11/26/2013

DOW CORNING CORP

DOW CORNING(R) Q7-2587 30% SIMETHICONE EMULSION USP AS MANUFACTURED IN


HEMLOCK, MI
DOW CORNING(R) MEDICAL ANTIFOAM A COMPOUND AS MANUFACTURED IN HEMLOCK, MI

27558 A

II

8/25/2013

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

L-Ala-pAF-OH HCl AS MANUFACTURED IN TIANMEN, CHINA

27559 A

II

12/21/2013

ENALTEC LABS PRIVATE LTD

ALCAFTADINE AS MANUFACTURED IN MAHARASTRA, INDIA

27560 A

II

9/16/2013

SAMYANG BIOPHARMACEUTICALS CORP

SEMISYNTHETIC PACLITAXEL AS MANUFACTURED IN DAEJEON, KOREA

Page 814

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27561 A
IV
11/26/2013
DOW CORNING CORP
27562 P

SUBJECT
DOW CORNING (R) 7-9245 30% SIMETHICONE EMULSION AND DOW CORNING (R) MEDICAL
ANTIFOAM C EMULSION AS MANUFACTURED IN HEMLOCK, MI

*** PENDING FILING REVIEW ***

27563 A

II

12/30/2013

SCINOPHARM TAIWAN LTD

FONDAPARINUX SODIUM AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

27564 A

II

12/30/2013

SCINOPHARM TAIWAN LTD

GALANTAMINE AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

27565 P

*** PENDING FILING REVIEW ***

27566 P

*** PENDING FILING REVIEW ***

27567 A

II

12/28/2014

SCINOPHARM TAIWAN LTD

PACLITAXEL AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA.

27568 A

II

9/25/2013

CENTAUR PHARMACEUTICALS PRIVATE LTD

ZALEPLON USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27569 A

II

9/27/2013

MSN LABORATORIES PVT LTD

BORTEZOMIB [ROUTE CODE "BR"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27570 A

II

9/30/2013

MSN PHARMACHEM PRIVATE LTD

LURASIDONE HYDROCHLORIDE [ROUTE CODE - LN"] AS MANUFACTURED IN TELANGANA

27571 A

II

9/30/2013

MSN LABORATORIES PVT LTD

PRASUGREL [ROUTE CODE - 'LP'] AS MANUFACTURED IN TELANGANA, INDIA

27573 A

II

12/6/2013

HOUSTON CYCLOTRON PARTNERS LP

3'-DEOXY-3' -[18F] FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN HOUSTON, TEXAS

27574 A

II

7/25/2013

CAMBREX PROFARMACO MILANO SRL

CYSTEAMINE BITARTRATE (RP) AS MANUFACTURED IN PAULLO, (MILAN) ITALY

27575 A

III

9/17/2013

CYTECH COATINGS PVT LTD

LAMINATION ADHESIVES AS MANUFACTURED IN GUJARAT, INDIA.

27572 P

*** PENDING FILING REVIEW ***

27576 N
27577 A

NOT AN ASSIGNED NUMBER


II

12/19/2013

27578 N

POLYPEPTIDE LABORATORIES SWEDEN AB

VASOPRESSIN AS MANUFACTURED IN LIMHAMN, SWEDEN

NOT AN ASSIGNED NUMBER

27579 A

II

9/30/2013

IPCA LABORATORIES LTD

CHLORTHALIDONE USP (CT6 PROCESS) AS MANUFACTURED IN MADHYA PRADESH, INDIA

27580 A

II

9/20/2013

SEQUENT SCIENTIFIC LTD

ETOMIDATE AS MANUFACTURED IN KARNATAKA, INDIA

27581 A

III

9/17/2013

BORMIOLI ROCCO SPA BU PLASTICA

27582 A

III

9/18/2013

NEW AGE INDUSTRIES INC

DROPPER TSD LDPE AS MANUFACTURED IN CASTELGUELFO (PR) ITALY; RIVANAZZANO (PV)


ITALY; AND SAINT SULPICE, FRANCE
ADVANTAPURE SILICONE APST TUBING NI202 AS MANUFACTURED IN SOUTHAMPTON, PA

27583 A

II

10/21/2013

VASUDHA PHARMA CHEM LTD

PIMOZIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27584 A

II

12/5/2013

ALP PHARM BEIJING CO LTD

27585 A

II

11/27/2013

27586 A

II

9/24/2013

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH


CO LTD
MOEHS IBERICA SL

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR ALP


PHARM BEIJING CO., LTD
CASPOFUNGIN ACETATE AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN

27587 A

III

9/23/2013

BOREALIS AG

27588 A

IV

9/25/2013

FONA INTERNATIONAL INC

27589 A

II

9/29/2013

ALP PHARM BEIJING CO LTD

27591 A

II

10/30/2013

SINOPEP JIANGSU INC

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA

27592 A

II

11/28/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

CINACALCET HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27593 A

II

3/20/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

FOSAMPRENAVIR CALCIUM AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR


TEVA PHARMACEUTICAL INDUSTRIES LTD.

27590 N

PRILOCAINE HYDROCHLORIDE AS MANUFACTURED IN LESSINES BELGIUM FOR MOEHS


IBERICA S.L.
BORMED LE6600-PH AS MANUFACTURED SCHWECHAT-MANNSWORTH, AUSTRIA FOR
BOREALIS AG
PRODUCT # 815.016 N-C BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
CLOPIDOGREL BISULFATE FORM II AS MANUFACTURED IN ZHEJIANG, CHINA FOR ALP PHARM
BEIJING CO., LTD

NOT AN ASSIGNED NUMBER

Page 815

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27594 A
III
9/2/2013
SCORPION CONTAINERS PRIVATE LTD

SUBJECT
HDPE BOTTLE SET (BOTTLE, CAP, MEASURING CUP) AS MANUFACTURED IN GUJARAT, INDIA

27595 A

III

9/25/2013

3M DRUG DELIVERY SYSTEMS DIVISION

27596 A

II

11/5/2013

27597 A

II

9/25/2013

JIANGSU GRAND XIANLE PHARMACEUTICAL CO


LTD
VIWIT PHARMACEUTICAL CO LTD

3M COTRAN 9695 TAN SPUNLACE NONWOVEN TAPE AS MANUFACTURED IN BROOKINGS,


SD FOR 3M DRUG DELIVERY SYSTEMS DIVISION
MEGESTROL ACETATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

27598 A

II

9/26/2013

KREATIVE ORGANICS PRIVATE LTD

GLIPIZIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27599 A

II

9/26/2013

EUTICALS INC

SODIUM OXYBATE AS MANUFACTURED IN SPRINGFIELD, MISSOURI

27600 A

II

2/26/2014

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO


LTD
*** PENDING FILING REVIEW ***

ENTECAVIR MONOHYDRATE AS MANUFACTURED IN TAIWAN, R.O. CHINA

27602 A

II

10/1/2013

HETERO LABS LTD

LAPATINIB DITOSYLATE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27603 A

II

10/1/2013

NOF CORP

27604 A

III

9/23/2013

STERI-PLAS PTY LTD

A-SUCCINIMIDYLOXYSUCCINYL-w-METHOXY, POLYOXYETHYLENE MW:4,500 AS


MANUFACTURED KAWASAKI-SHI, KANAGAWA, JAPAN
150ML TABLET BOTTLE AS MANUFACTURED IN MOOREBANK NSW, AUSTRALIA

27605 A

II

9/30/2013

ALCHEM INTERNATIONAL LTD

DIGOXIN USP AS MANUFACTURED IN HARYANA, INDIA

27606 A

III

9/27/2013

TEKNOR COLOR CO

71,094HCP ORANGE 50:1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX

27607 A

II

8/2/2013

PHAEX POLYMERS PRIVATE LTD

CHOLESTYRAMINE RESIN USP AS IN MANUFACTURED MAHARASHTRA, INDIA

27608 A

II

9/30/2013

SIGMA ALDRICH IRELAND LTD

27609 A

II

10/24/2013

BHARAT PHARMA

SODIUM BENZOATE AS MANUFACTURED IN WICKLOW, ILRELAND FOR SIGMA ALDRICH


IRELAND LTD.
DILUTED NITROGLYCERIN USP AS MANUFACTURED IN LALITPUR, INDIA

27610 A

II

1/10/2014

GLENMARK GENERICS LTD

APREPITANT (BO74 PROCESS) AS MANUFACTURED IN GUJARAT STATE, INDIA

27611 A

II

9/30/2013

HIKAL LTD

DONEPEZIL HYDROCHLORIDE API AS MANUFACTURED IN KARNATAKA, INDIA

27612 A

II

11/30/2013

MSN LABORATORIES PVT LTD

ROFLUMILAST [ROUTE CODE - RO"] AS MANUFACTURED IN TELANGANA

27613 A

III

10/4/2013

MINNESOTA RUBBER AND PLASTICS

27614 A

II

10/11/2013

MSN LABORATORIES PVT LTD

27615 A

II

10/21/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

SILICONES FOR SEALING APPLICATIONS IN MEDICAL DEVICES AS MANUFACTURED IN


LITCHFIELD, MN
POSACONAZOLE AMORPHOUS [ROUTE CODE PKA] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
PRAVASTATIN SODIUM USP (PROCESS II) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27616 A

II

11/19/2013

EMCURE PHARMACEUTICALS LTD

EPL 001 AS MANUFACTURED IN MAHARASHTRA, INDIA

27617 A

II

10/25/2013

EMCURE PHARMACEUTICALS LTD

27618 A

II

12/27/2013

EMCURE PHARMACEUTICALS LTD

GEMCITABINE HYDROCHLORIDE USP (PROCESS II) AS MANUFACTURED IN MAHARASHTRA,


INDIA
OLSALAZINE SODIUM (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA

27619 A

IV

9/26/2013

SEPPIC SA

SEPITRAP 80 AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S.A.

27620 A

II

10/1/2013

PHARMACEUTICAL WORKS POLPHARMA SA

DABIGATRAN ETEXILATE METHANESULFONATE AS MANUFACTURED IN GDANSKI, POLAND

27621 A

III

9/17/2013

BORMIOLI ROCCO SPA BU PLASTICA

27622 A

II

9/27/2013

IRVINE SCIENTIFIC SALES CO

BOTTLE LDPE 3-5 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV),


ITALY; AND SAINT SULPICE, FRANCE
DSP06B POWDER AS MANUFACTURED IN SANTA ANA, CA

27623 A

II

10/18/2013

INDUSTRIALE CHIMICA SRL

DALFAMPRIDINE AS MANUFACTURED IN SARONNO (VARESE), ITALY

27624 A

II

9/23/2013

MURLI KRISHNA PHARMA PVT LTD

ORLISTAT PELLETS 50.0% W/W AS MANUFACTURED IN MAHARASHTRA, INDIA

27601 P

(2R, 3S)-2[(1R)-1-[3,5-BIS(TRIFLUOROMETHYL)PHENYL]ETHOXY]-3-(4-FLUOROPHENYL)MORPHOLINE, 4-METHYLBENZENESULFONATE AS MANUFACTURED SHANDONG PROVINCE,


CHINA

Page 816

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27625 A
II
10/8/2013
IRVINE SCIENTIFIC SALES CO

SUBJECT
PRIME-XV AFSC EXPANSION MEDIUM AS MANUFACTURED IN SANTA ANA, CA

27626 A

II

9/23/2013

MURLI KRISHNA PHARMA PVT LTD

TACROLIMUS PELLETS 5.0% W/W AS MANUFACTURED IN MAHARASHTRA, INDIA

27627 A

II

10/8/2013

KREATIVE ORGANICS PRIVATE LTD

SODIUM PICOSULFATE USP AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH, INDIA

27628 A

II

12/27/2013

3D IMAGING DRUG DESIGN AND DEVELOPMENT


LLC
NOT AN ASSIGNED NUMBER

[I-124]CLR1404 INJECTION AS MANUFACTURED IN LITTLE ROCK, ARKANSAS

27630 A

III

10/8/2013

CLARIANT CORP

27631 A

II

7/19/2013

HUNAN YUXIN PHARMACEUTICAL CO LTD

MATERIAL FOR PLASTIC PACKAGING AS MANUFACTURED IN LEWISTON, ME; MALMO,


SWEDEN; SINGAPORE
16A-HYDROXY PREDNISOLONE AS MANUFACTURED IN HUNAN PROVINCE, P.R. CHINA

27632 A

II

10/9/2013

ASYMCHEM LIFE SCIENCE TIANJIN CO LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN TIANJIN, CHINA

27633 A

II

10/28/2013

HETERO DRUGS LTD

ROSUVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27634 A

II

11/12/2013

INDOCO REMEDIES LTD

RASAGILINE MESYLATE AS MANUFACTURED IN NAVI MUMBAI, INDIA

27629 N

27635 P

*** PENDING FILING REVIEW ***

27636 A

II

12/4/2013

APOTEX PHARMACHEM INDIA PVT LTD

TOLVAPTAN AS MANUFACTURED IN BANGALORE, INDIA

27637 A

II

11/1/2013

ALKEM LABORATORIES LTD

DALFAMPRIDINE AS MANUFACTURED IN GUJARAT, INDIA

27638 A

III

10/8/2013

TOPPAN PRINTING CO LTD

27639 A

II

10/31/2013

TORRENT PHARMACEUTICALS LTD

A PET/EVA BACKING FILM FOR TRANSDERMAL DRUG DELIVERY PATCHES AS


MANUFACTURED IN FUKUOKA, JAPAN FOR TOPPAN PRINTING CO., LTD
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA

27640

III

10/8/2013

GERRESHEIMER REGENSBURG GMBH

27641 N

NOT AN ASSIGNED NUMBER

27642 N

NOT AN ASSIGNED NUMBER

27643 N

NOT AN ASSIGNED NUMBER

27644 N

NOT AN ASSIGNED NUMBER

MDI COUNTER AS MANUFACTURED IN HORSOVSKY TYN, CZECH REPUBLIC FOR


GERRESHEIMER REGENSBURG GMBH

27645 A

II

12/19/2013

LUPIN LTD

LATANOPROST USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

27646 A

II

10/17/2013

SODIUM PICOSULFATE AS MANUFACTURED IN GUJARAT, INDIA

27647 A

II

10/15/2013

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
PROCOS SPA

27648 A

II

1/8/2014

TEVA PHARMACEUTICALS INDUSTRIES LTD

27649 A

II

10/21/2013

27650 A

II

3/3/2014

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
PIRAMAL ENTERPRISES LTD

DEFERASIROX AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD.
GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27651 A

II

12/19/2013

CHENGDU SHENGNUO BIOPHARM CO LTD

EPTIFIBATIDE AS MANUFACTURED IN SICHUAN, CHINA

27652 A

III

10/7/2013

DONGWON SYSTEMS

ALUALU AS MANUFACTURED IN CHUNGNAM, KOREA

27653 A

IV

10/16/2013

716206 NAT & ART RASPBERRY FLAVOR AS MANUFACTURED IN CLARK, NJ

27654 A

III

10/9/2013

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
BOREALIS AG

27655 A

III

10/23/2013

HAEMOTRONIC SPA

27656 A

III

10/9/2013

BOREALIS AG

27657 A

III

10/23/2013

ZEON CORP

DALFAMPRIDINE (INN: FAMPRIDINE) AS MANUFACTURED IN CAMERI NOVARA, ITALY

DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

BORMED HE7541-PH AS MANUFACTURED IN SCHWECHAT-MANNSWORTH, AUSTRIA FOR


BOREALIS AG
PVC-FREE PLASTIC CONTAINERS FOR INFUSION AS MANUFACTURED IN MIRANDOLA (MO),
ITALY AND CARBONARA DI PO (MN), ITALY
BORMED HE2581-PH AS MANUFACTURED IN SCHWECHAT-MANNSWORTH, AUSTRIA FOR
BOREALIS AG
CYCLO OLEFIN POLYMER 3 AS MANUFACTURED IN OKAYAMA, JAPAN

Page 817

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27658 A
III
11/13/2013
NYPRO INC

SUBJECT
QVAR MDI ACTUATOR / DOSE COUNTER ASSEMBLY AS MANUFACTURED IN COUNTY DUBLIN,
COUNTY WATERFORD, IRELAND FOR NYPRO INC.
BETIATIDE AS MANUFACTURED IN RADEBERG, GERMANY

27659 A

II

12/20/2013

ABX ADVANCED BIOCHEMICAL COMPOUNDS


BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN
GMBH

27660 A

II

10/25/2013

NUTRI GRANULATIONS

27661 A

II

10/21/2013

PHARMACEUTICAL WORKS POLPHARMA SA

DIRECTLY COMPRESSIBLE GRANULATED CALCIUM CARBONATE WITH GUM ACACIA AS


MANUFACTURED IN LA MIRADA, CA
RIVAROXABAN AS MANUFACTURED IN GDANSKI, POLAND

27662 A

II

11/18/2013

SUN PHARMACEUTICAL INDUSTRIES LTD

DALFAMPRIDINE AS MANUFACTURED IN GUJARAT, INDIA

27663 A

II

2/14/2014

SUN PHARMACEUTICAL INDUSTRIES LTD

LEVALBUTEROL HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

27664 A

II

10/25/2013

HEC PHARM GROUP

27665 A

II

7/30/2014

GLENMARK GENERICS LTD

ATORVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


HUBEI PROVINCE, P.R. CHINA FOR HEC PHARM GROUP
TELAPREVIR AS MANUFACTURED IN GUJARAT, INDIA

27666 A

II

10/28/2013

ROVI CONTRACT MANUFACTURING SL

27667 A

II

10/10/2013

CAMBREX CHARLES CITY INC

27668 A

II

11/1/2013

PROGESTERONE AS MANUFACTURED IN HUBEI, P.R. CHINA

27669 I

II

12/18/2013

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL


CO LTD
CADILA HEALTHCARE LTD

27670 A

II

11/19/2013

27671 A

III

10/28/2013

POLYCARBON INDUSTRIES INC DBA PCI


SYNTHESIS
VP INDUSTRIAL CORP

PCI-104400 NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN NEWBURYPORT,


MA.
SILICA GEL PACKED IN TYVEK BAGS AS MANUFACTURED IN CHENNAI , INDIA

27672 A

II

12/25/2013

AURISCO PHARMACEUTICAL LTD

27673 A

II

11/12/2013

AMOLI ORGANICS PVT LTD

EPLERENONE AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. CHINA FOR AURISCO


PHARMACEUTICAL LIMITED
LINEZOLID [FORM-II] AS MANUFACTURED IN GUJARAT, INDIA

27674 A

II

10/29/2013

AVANTI POLAR LIPIDS INC

27675 A

II

10/8/2013

BIOCON LTD

27676 A

III

10/29/2013

POLYONE CORP

27677 A

III

10/19/2013

M AND H PLASTICS

27678 A

II

12/13/2013

PAR PHARMACEUTICAL INC

HDPE, PETE, PTCG BOTTLES AS MANUFACTURED IN WINCHESTER, VA, AND BECCLES,


ENGLAND
DAPSONE USP AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR PHARMACEUTIAL, INC

27679 A

II

10/30/2013

FARMAK AS

ZILEUTON AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC

27680 A

II

10/16/2013

YONSUNG FINE CHEMICALS CO LTD

TREPROSTINIL SODIUM AS MANUFACTURED IN GYEONGGI-DO, REPUBLIC OF KOREA

27681 A

II

10/31/2013

IRVINE SCIENTIFIC SALES CO

PRIME-XV TUMORSPHERE SFM AS MANUFACTURED IN SANTA ANA, CA

27682 A

II

10/31/2013

IRVINE SCIENTIFIC SALES CO

PRIME-XV NPC EXPANSION XSFM AS MANUFACTURED IN SANTA ANA, CA

27683 A

III

10/30/2013

POLYONE CORP

27684 A

III

10/30/2013

POLYONE CORP

CC10170184XX(WHITE ABS) AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND NORWALK,


OH
CC10189184XX (BLUE) AS MANUFACTURED IN ELK GROVE VILLAGE IL, AND NORWALK, OH

27685 A

III

10/30/2013

POLYONE CORP

27686 A

II

11/1/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

CC10180743XX (OM WHITE) AS MANUFACTURED IN ELK GROVE VILLIAGE, IL AND NORWALK,


OH
MEROPENEM, STERILE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

27687 A

II

10/31/2013

3M PURIFICATION INC

LIFEASSURE PFC SERIES FILTERS AS MANUFACTURED IN MERIDEN, CT

27688 A

IV

10/28/2013

NUSIL TECHNOLOGY LLC

DDU-4331 LIQUID SILICONE ELASTOMER (S) AS MANUFACTURED IN CARPINTERIA, CA

STERILE WATER FOR INJECTION, 1 ML PREFILLED SYRINGE AS MANUFACTURED IN MADRID,


SPAIN
OPIUM TINCTURE 2% AS MANUFACTURED IN CHARLES CITY, IA

IMATINIB MESYLATE (AMORPHOUS) AS MANUFACTURED IN GUJARAT, INDIA

(5S, 6R, E)-METHYL 5,6-DIHYDROXY-8-(2-((R,E)-3-HYDROXYOCT-1-ENYL)PHENYL)OCT-7ENOATE(9,12-BENZO-LXA4) AS MANUFACTURED IN ALABASTER, AL


ROSUVASTATIN CALCIUM(PRODUCT CODE 8004368) AS MANUFACTURED IN BANGALORE AND
ANDHRA PRADESH, INDIA
CC10105451XX (197C PINK PE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

Page 818

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27689 A
IV
10/28/2013
NUSIL TECHNOLOGY LLC

SUBJECT
DDU-1135 RTV SILICONE ADHESIVE (S) AS MANUFACTURED IN CARPINTERIA, CA

27690 A

IV

10/28/2013

NUSIL TECHNOLOGY LLC

DDU-4342 RTV SILICONE ELASTOMER (S) AS MANUFACTURED IN CARPINTERIA, CA

27691 A

IV

10/28/2013

NUSIL TECHNOLOGY LLC

DDU-4352 SILICONE GEL AS MANUFACTURED IN CARPINTERIA, CA

27692 A

II

10/20/2013

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD

LEVONORGESTREL (MICRONIZED) AS MANUFACTURED IN HEBEI PROVINCE, CHINA

27693 A

III

10/22/2013

ANHUI HUAFENG PHARMACEUTICAL RUBBER CO


LTD

POLYPROPYLENE THERMOPLASTIC ELASTOMER COMBINATION CAP FOR PLASTIC


CONTAINERS FILLED WITH AQUEOUS PARENTERAL PREPARATIONS AS MANUFACTURED IN
ANHUI PROVINCE, P.R., CHINA

27694 A

II

10/31/2013

LONZA AG

ETH06 (TRABECTEDIN INTERMEDIATE) AS MANUFACTURED IN VISP, SWITZERLAND

27695 A

III

10/30/2013

VPET USA

PET BOTTLES, JARS AND CONTAINERS FOR PHARMACEUTICAL AND FOOD APPLICATION BY
STRETCH-BLOW-MOLDING PROCESS AS MANUFACTURED IN FONTANA, CA, PORT HURON, MI
AND TAIWAN

27696 A

II

11/29/2013

ZY PHARMACEUTICALS CO LTD

TIGECYCLINE AS MANUFACTURED IN HUBEI PROVINCE, CHINA

27697 A

II

12/18/2013

CADILA HEALTHCARE LTD

ATORVASTATIN CALCIUM USP (AVE ROUTE) AS MANUFACTURED IN GUJARAT, INDIA

27698 A

III

10/22/2013

ANHUI HUAFENG PHARMACEUTICAL RUBBER CO


LTD

ETFE COATED CHLORINATED BUTYL RUBBER STOPPER FOR INJECTABLE PRODUCTS


(AQUEOUS PARENTERAL PREPARATIONS, POWDERS AND LYOPHILIZED POWDERS) AS
MANUFACTURED IN ANHUI PROVINCE, P.R., CHINA

27699 A

III

10/22/2013

ANHUI HUAFENG PHARMACEUTICAL RUBBER CO


LTD

ETFE COATED BROMINATED BUTYL RUBBER STOPPER FOR INJECTABLE PRODUCTS


(AQUEOUS PARENTERAL PREPARATIONS, POWDERS AND LYOPHILIZED POWDERS) AS
MANUFACTURED IN ANHUI PROVINCE, P.R.,CHINA

27700 A

II

1/20/2014

JOHNSON MATTHEY B1396 AS MANUFACTURED IN WEST DEPTFORD, NJ

27701 A

II

11/6/2013

JOHNSON MATTHEY PHARMACEUTICAL


MATERIALS
SAI LIFE SCIENCES LTD

27702 A

II

11/28/2013

BIOCON LTD

27703 A

II

10/21/2013

KREITCHMAN PET CENTER

HUMAN INSULIN DRUG SUBSTANCE (rDNA ORIGIN) AS MANUFACTURED IN BANGALORE,


INDIA
[11C]-MDL100907 AS MANUFACTURED IN NEW YORK, NY.

27704 A

II

9/26/2013

JIAZHONG NOVEL MATERIAL CORP

HYBRID SILICA MICROSPHERE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

27705 A

II

1/23/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

27706 A

II

9/26/2013

JIAZHONG NOVEL MATERIAL CORP

ESZOPICLONE AS MANUFACTURED IN GUAYAMA, PUERTO RICO FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
BONDED SILICA MICROSPHERE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

27707 A

II

9/26/2013

JIAZHONG NOVEL MATERIAL CORP

SILICA MICROSPHERE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA

27708 A

II

11/11/2013

SEQUENT SCIENTIFIC LTD

CITICOLINE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA

27709 A

III

11/8/2013

ONLY FOR CHILDREN PHARMACEUTICALS

27710 A

II

11/11/2013

27711 A

IV

10/8/2013

DSM FINE CHEMICALS AUSTRIA NFG GMBH AND


CO KG
HAYASHIBARA CO LTD

CONTAINER CLOSURE SYSTEM NAMED THE SHAKER AS MANUFACTURED IN TREFFORTCUISIAT, FRANCE FOR ONLY FOR CHILDREN PHARMACEUTICALS
SILVER SULFADAZINE AS MANUFACTURED IN LINZE, AUSTRIA

27712 A

III

11/8/2013

COLORS FOR PLASTICS INC

THERMOPLASTIC RESIN B25271 BLUE 5415C AND W09473 WHITE Q610-7-5 COLORANT
MASTERBATCHES AS MANUFACTURED IN ELK GROOVE VILLAGE, IL AND SPARTANBURG, SC

27713 A

II

9/21/2013

CALYX CHEMICALS AND PHARMACEUTICALS LTD

AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

27714 A

II

1/13/2014

POLYPEPTIDE LABORATORIES SWEDEN AB

27715 A

II

10/22/2013

HUBEI HAOSUN PHARMACEUTICAL CO LTD

EXENDIN-4 ACETATE (EXENATIDE) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR


POLYPEPTIDE LABORATORIES (SWEDEN) AB
TEMOZOLOMIDE AS MANUFACTURED IN HUBEI, P.R. CHINA

27716 A

IV

11/13/2013

FONA INTERNATIONAL INC

884.114 N-C ORANGE FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

DAPSONE USP AS MANUFACTURED IN KARNATAKA, INDIA

PULLULAN AS MANUFACTURED IN OKAYAMA, JAPAN

Page 819

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27717 A
II
11/11/2013
FARMABIOS SPA

SUBJECT
LOTEPREDNOL ETABONATE STERILE MICRONIZED AS MANUFACTURED IN GROPELLO
CAIROLI (PV), ITALY
FERUMOXYTOL AS MANUFACTURED IN MENGES, SLOVENIA

27718 A

II

11/26/2013

LEK PHARMACEUTICALS DD

27719 A

II

12/17/2013

LEK PHARMACEUTICALS DD

27720 A

II

11/22/2013

MSN LABORATORIES PVT LTD

27721 A

II

11/30/2013

MSN LABORATORIES PVT LTD

ENTECAVIR MONOHYDRATE AS MANUFACTURED IN ONTARIO, CANADA; WESTFALEN


GERMANY AND BALERNA, SWITZERLAND FOR LEK PHARMACEUTICALS D.D.
POSACONAZOLE (FORM-I) [ROUTE CODE - "PJ1"] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
TOFACITINIB CITRATE [ROUTE CODE - TT"] AS MANUFACTURED IN TELANGANA

27722 A

II

12/6/2013

PAR PHARMACEUTICAL INC

COLCHICINE USP AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR PHARMACEUTICAL, INC

27723 A

II

12/12/2013

PEPTISYNTHA SA

GLATIRAMER ACETATE AS MANUFACTURED IN BRUSSELS, BELGIUM

27724 A

II

12/19/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN ZHJIANG PROVINCE, CHINA

27725 A

II

12/31/2013

HISUN PHARMACEUTICAL HANGZHOU CO LTD

SIROLIMUS AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27726 A

II

1/31/2014

CADILA PHARMACEUTICALS LTD

PHTHALOYL AMLODIPINE AS MANUFACTURED IN GUJARAT, INDIA

27727 A

II

12/27/2013

MYLAN LABORATORIES LTD

ELVITEGRAVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27728 A

II

12/24/2013

MYLAN LABORATORIES LTD

RALTEGRAVIR POTASSIUM AS MANUFACTURED IN TELANGANA, INDIA

27729 A

II

12/20/2013

MYLAN LABORATORIES LTD

OCTREOTIDE ACETATE AS MANUFACTURED IN TELANGANA, INDIA

27730 A

II

12/17/2013

MYLAN LABORATORIES LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

27731 A

II

12/6/2013

VASUDHA PHARMA CHEM LTD

LOPERAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27732 A

II

2/6/2014

ASH STEVENS INC

8-CHLOROADENOSINE AS MANUFACTURED IN DETROIT, MI

27733 A

II

11/25/2013

JOYANG LABORATORIES

BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, CHINA

27734 A

II

11/13/2013

SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

27735 A

III

9/20/2013

27736 A

III

11/11/2013

DANYANG XIANGHE PHARMACEUTICAL


PACKAGING CO LTD
RAJAT VINYLS PRIVATE LTD

27737 A

II

11/15/2013

ICEUTICA INC

27738 A

IV

11/12/2013

LIPOID GMBH

INJECTION VIALS MADE OF NEUTRAL BOROSILICATE GLASS TUBING AS MANUFACTURED IN


JIANGSU PROVINCE, CHINA
RIGID PVC FILM FOR PHARMACEUTICAL AND FOOD PACKAGING APPLICATION AS
MANUFACTURED IN GUJARAT, INDIA
SOLUMATRIX ABIRATERONE ACETATE DRUG PRODUCT INTERMEDIATE AS
MANUFACTURED IN QUAKERTOWN, PA FOR ICEUTICA INC.
LIPOID PURIFIED OLEIC ACID (PH.EUR.) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY

27739 A

11/18/2013

ZHUHAI UNITED LABORATORIES CO LTD

27740 A

IV

8/2/2013

PJ HEALTHCARE

27741 A

II

10/5/2013

JIANGSU HUANXIN HIGH-TECH MATERIALS CO LTD CHLOROXYLENOL AS MANUFACTURED IN JIANGSU, P. R. CHINA

27742 A

III

11/11/2013

PACKAGING INDIA PVT LTD

27744 A

II

12/30/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

CELECOXIB USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27745 A

II

11/12/2013

SCI PHARMTECH INC

27746 A

II

12/2/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

(S)-3-(METHYLAMINO)-1-(2-THIENYL) PROPAN-1-OL [(S)-MMAA] AS MANUFACTURED IN


TAOYUAN, TAIWAN
PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27747 A

III

11/15/2013

KUNSHAN WISEPAC DESICCANT CO LTD

WISEMINI PACKED DESICCANT FOR PHARMACEUTICAL INDUSTRY WITH MOLECULE SIEVE AS


ABSORBENT, TYVEK 1059B AS PACKAGING MATERIAL AS MANUFACTURED IN JIANGSU, CHINA

27748 A

IV

10/25/2013

PJ HEALTHCARE

INNOKOAT AS MANFUACTURED IN GUJARAT AND DAMAN, INDIA

27743 P

STERILIZATION PROCESS VALIDATION INFORMATION FOR CARBOPENEM STERILE


PRODUCTS
PNEU 112 GRANULES AS MANUFACTURED IN GUJARAT, INDIA
PLAIN OR PRINTED POLYETHLENE TETRAPTHALATE/ ALUMINIUM FOIL/ POLYETHYLENE
LAMINATES AS MANUFACTURED IN PONDICHERRY, INDIA

*** PENDING FILING REVIEW ***

Page 820

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27749 P
*** PENDING FILING REVIEW ***

SUBJECT

27750 A

II

11/18/2013

ASYMCHEM LABORATORIES TIANJIN CO LTD

ANASTROZOLE AS MANUFACTURED IN TIANJIN, CHINA

27751 A

III

3/15/2013

CHROMA CORPORATION

PC90261A CLARIFYING CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS

27752 A

II

3/28/2014

AVANTOR PERFORMANCE MATERIALS INC

SODIUM ACETATE TRIHYDRATE AS MANUFACTURED IN PHILLIPSBURG, NJ

27753 A

II

4/25/2014

AVANTOR PERFORMANCE MATERIALS INC

POTASSIUM PHOSPHATE MONOBASIC AS MANUFACTURED IN PHILLIPSBURG, NJ

27754 A

II

4/25/2014

AVANTOR PERFORMANCE MATERIALS INC

27755 A

II

3/28/2014

AVANTOR PERFORMANCE MATERIALS INC

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AS MANUFACTURED IN PHILLIPSBURG,


NJ
POTASSIUM PHOSPHATE DIBASIC AS MANUFACTURED IN PHILLIPSBURG, NJ

27756 A

II

11/20/2013

SHASUN PHARMACEUTICALS LTD

PANTOPRAZOLE SODIUM, USP AS MANUFACTURED IN CUDDALORE, INDIA

27757 A

IV

11/20/2013

FONA INTERNATIONAL INC

865.0037U LIME EXTRACT, NAT AS MANUFACTURED IN GENEVA, IL

27758 A

IV

11/20/2013

FONA INTERNATIONAL INC

825.0597U N-C CHERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

27759 A

II

11/21/2013

AMBIOPHARM INC

27760 A

III

11/7/2013

27761 A

II

12/10/2013

OCTREOTIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH


AUGUSTA, SC; SHANGHAI, CHINA
JIANGSU ZHONGJIN MATAI MEDICINAL PACKAGING PA/AL/PVC COLD FORMING COMPOSITE SHEET FOR PACKAGING OF SOLID DOSAGE FORMS
CO LTD
AS MANUFACTURED IN JIANGSU, CHINA
NISSAN CHEMICAL INDUSTRIES LTD
PITAVASTATIN CALCIUM ( ASYMMETRIC SYNTHESIS METHOD) AS MFG IN YAMAGUCHI, JAPAN

27762 A

II

12/13/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

OXALIPLATIN AS MANUFACTURED IN ZHEJIANG, CHINA

27763 A

II

12/16/2013

DUTASTERIDE ACID AS MANUFACTURED IN HUBEI, P.R. CHINA

27764 A

II

11/20/2013

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL


CO LTD
WANBURY LTD

27765 A

II

11/21/2013

INALCO SAS DI GIOVANNI CIPOLLETTI AND C

27766 A

IV

11/21/2014

SE TYLOSE GMBH AND CO KG

LACTITOL MONOHYDRATE AS MANUFACTURED IN PISTOIA, ITALY FOR INALCO S.A.S. DI


GIOVANNI CIPOLLETTI & C.
HYPROMELLOSE USP (TYLOPUR)

27767 A

II

12/26/2013

CADILA HEALTHCARE LTD

ENTECAVIR AS MANUFACTURED IN GUJARAT, INDIA

27768 A

III

12/18/2013

KAKEN PHARMACEUTICAL CO LTD

PLASTIC CONTAINER FOR TOPICAL SOLUTION AS MANUFACTURED IN SHIZUOKA, JAPAN

27769 A

II

12/26/2013

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

ROSUVASTATIN CALCIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27770 A

12/11/2013

EVONIK INDUSTRIES AG

EUDRAGIT? E

27771 A

II

1/10/2014

EMCURE PHARMACEUTICALS LTD

DOCETAXEL TRIHYDRATE USP (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA

27772 A

II

11/26/2013

IRVINE SCIENTIFIC SALES CO

PRIME-XV MSC EXPANSION SFM AS MANUFACTURED IN SANTA ANA, CA

27773 A

II

12/13/2013

NOVOZYMES AS

27774 A

II

12/11/2013

HETERO LABS LTD

SODIUM HYALURONATE FROM BACILLUS SUBTILIS (PARENTERAL GRADE): HYASIS(R) 850P AS


MANUFACTURED IN TIANJIN, CHINA FOR NOVOZYMES AS
DUTASTERIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27775 A

11/26/2013

WEST PHARMACEUTICAL SERVICES INC

STEAM STERILIZATION PROCESS

27776 A

II

11/27/2013

ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.

AMIKACIN SULFATE USP AS MANUFACTURED IN ZHEJIANG, CHINA

27777 A

II

9/6/2013

27778 A

II

12/26/2013

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL ROSUVASTATIN CALCIUM AS MANUFACTURED IN SHANGHAI, CHINA


CO LTD
S AND B PHARMA INC DBA NORAC PHARMA
PEN-10101 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA

27779 A

II

3/28/2014

ALP PHARM BEIJING CO LTD

ROFLUMILAST AS MANUFACTURED IN SHANDONG, CHINA FOR ALP PHARM BEIJING CO., LTD

27780 A

II

12/27/2013

ALEMBIC PHARMACEUTICALS LTD API DIV

VALSARTAN USP AS MANUFACTURED IN GUJARAT, INDIA

27781 A

II

12/31/2013

ALEMBIC PHARMACEUTICALS LTD API DIV

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN GUJARAT, INDIA

27782 A

III

11/26/2013

PLASTIQUES VENTHENAT

EXTRUSION ACRYTER FILM AS MANUFACTURED IN BARBEZIEUX, FRANCE

QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 821

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27783 A
II
11/25/2013
SYMBIOTEC PHARMALAB LTD
27784 A

II

12/18/2013

SANDOZ PRIVATE LTD

SUBJECT
METHYLPREDNISOLONE, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
APREPITANT AS MANUFACTURED IN MAHARASHTRA, INDIA

27785 A

II

1/8/2014

SANDOZ PRIVATE LTD

MEROPENEM TRIHYDRATE, STERILE AS MANUFACTURED MAHARASHTRA, INDIA

27786 P

*** PENDING FILING REVIEW ***

27787 A

II

12/10/2013

MSN LABORATORIES PVT LTD

PALIPERIDONE PALMITATE [ROUTE CODE - PM"] AS MANUFACTURED IN TELANGANA

27788 A

II

6/13/2014

IND SWIFT LABORATORIES LTD

DUTASTERIDE AS MANUFACTURED IN PUNJAB, INDIA

27789 A

III

11/25/2013

TECHMER PM

27790 A

IV

12/3/2013

DAVID MICHAEL AND CO INC

PM17418 BOTTLE BLOW BLEND COMPOUND AS MANUFACTURED IN RANCHO DOMINGUEZ,


CA
MICHAELOK NATURAL AND ARTIFICIAL ORANGE FLAVOR #4356 AS MANUFACTURED IN
PHILADELPHIA, PA

27791 P

*** PENDING FILING REVIEW ***

27792 A

II

12/26/2013

CADILA HEALTHCARE LTD

PREGABALIN (PGC ROUTE) AS MANUFACTURED IN GUJARAT, INDIA

27793 A

II

11/20/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

SORAFENIB TOSYLATE (VERSION NO.: 1) AS MANUFACTURED IN ZHEJIANG, CHINA

27794 A

II

11/29/2013

SHANGHAI ACANA PHARMTECH CO., LTD.

FONDAPARINUX INTERMEDIATE N3 AS MANUFACTURED IN SHANGHAI, P. R. CHINA

27795 A

II

12/21/2013

AUROBINDO PHARMA LTD

ISOSULFAN BLUE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27796 A

IV

1/28/2014

EVONIK INDUSTRIES AG

EUDRAGIT L/S AS MANUFACTURED IN DARMSTADT, GERMANY

27797 A

II

12/30/2013

EMCURE PHARMACEUTICALS LTD

CLOFARABINE AS MANUFACTURED IN MAHARASHTRA, INDIA

27798 A

III

11/18/2013

SAMET PLAST

MASTER BATCHES AS MANUFACTURED IN GUJARAT, INDIA

27799 A

III

12/3/2013

BOREALIS AG

BORMED HG820MO AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG

27800 A

II

12/23/2013

MICRO LABS LTD

BROMFENAC SODIUM SESQUIHYDRATE AS MANUFACTURED IN KARNATAKA, India

27801 A

II

12/8/2013

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD

AZAERYTHROMYCIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

27802 A

II

12/9/2013

R.N. LABORATORIES PVT LTD.

CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT, INDIA

27803 A

III

2/23/2014

INDIAN OIL CORP LTD

PROPEL HDPE 012DB54 AS MANUFACTURED IN HARYANA, INDIA.

27804 A

II

5/23/2014

GLENMARK GENERICS LTD

TELMISARTAN USP (D010 PROCESS) AS MANUFACTURED IN GUJARAT, INDIA

27805 A

II

12/28/2013

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27806 A

II

1/8/2014

RELIABLE BIOPHARMACEUTICAL CORP

PHYTONADIONE (ROUTE B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE


INDIA PHARMACEUTICALS PVT. LTD.
CHLORAMPHENICOL HEMISUCCINATE AS MANUFACTURED IN ST. LOUIS, MO

27807 A

II

12/31/2013

MSN LABORATORIES PVT LTD

RIVAROXABAN [ROUTE CODE "RR"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27808 A

II

12/28/2013

MSN LABORATORIES PVT LTD

27809 A

II

12/6/2013

POLYMED THERAPEUTICS INC

27810 A

II

12/16/2013

GLOCHEM INDUSTRIES LTD

TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
PEMETREXED DISODIUM 2.5 HYDRATE DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, P.R. CHINA FOR POLYMED THERAPEUTICS, INC.
AMLODIPINE BESYLATE (PROCESS 1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27811 A

II

12/23/2013

TRIFARMA SPA

FLUPHENAZINE DECANOATE AS MANUFACTURED IN ROZZANO (MI), ITALY

27812 A

II

12/27/2013

ALCHYMARS ICM SM PRIVATE LTD

SODIUM NITROPRUSSIDE USP AS MANUFACTURED IN TAMILNADU, INDIA

27813 A

II

3/14/2014

JUBILANT GENERICS LTD

ROSUVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN KARNATAKA, INDIA

27814 A

III

12/28/2013

ALPHAMED BOTTLES INC

HDPE BOTTLES AS MANUFACTURED IN HAUPPAUGE, NEW YORK

27815 A

III

12/11/2013

TOSOH CORP

PETROTHENE 170K PACKAGING MATERIAL AS MANUFACTURED IN MIE, JAPAN

27816 A

II

2/25/2014

JOHNSON MATTHEY PHARMA SERVICES

4245.C (MILLED) AS MANUFACTURED IN DEVENS, MA

27817 A

III

12/10/2013

POLYONE CORP

EM10031235XX (PELL-80AE TRANS RO BACONC) AS MANUFACTURED IN AVON LAKE, OH

Page 822

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27818 A
II
12/11/2013
SYN-TECH CHEM AND PHARM CO LTD

SUBJECT
ZOLMITRIPTAN AS MANUFACTURED IN TAINAN CITY, TAIWAN

27819 A

II

12/30/2013

INTAS PHARMACEUTICALS LTD

DALFAMPRIDINE AS MANUFACTURED IN GUJARAT, INDIA

27820 A

II

12/30/2013

INTAS PHARMACEUTICALS LTD

TRAZODONE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

27821 A

II

12/30/2013

INTAS PHARMACEUTICALS LTD

AZACITIDINE AS MANUFACTURED IN GUJARAT, INDIA

27822 A

II

1/21/2014

ORIL INDUSTRIE

PERINDOPRIL ARGININE AS MANUFACTURED IN BOLBEC, FRANCE

27823 P

*** PENDING FILING REVIEW ***

27824 I

II

12/11/2013

GW PHARMA LTD

EPIDIOLEX AS MANUFACTURED IN SITTINGBOURNE KENT, UNITED KINGDOM

27825 A

II

12/16/2013

SANOFI AVENTIS SPA

ARTESUNATE AS MANUFACTURED IN GARESSIO, ITALY

27826 A

II

2/4/2014

GLAND PHARMA LTD

DEXRAZOXANE (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27827 A

II

12/1/2013

SHANDONG XINHUA PHARMACEUTICAL CO LTD

PHENOBARBITAL AS MANUFACTURED IN SHANDONG, P.R. CHINA

27828 A

IV

12/16/2013

FONA INTERNATIONAL INC

852.272 N-C TUTTI FRUTTI FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

27829 A

II

12/24/2013

MSN LABORATORIES PVT LTD

ABIRATERONE ACETATE [ROUTE CODE "AY"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27830 A

II

12/30/2013

MSN LABORATORIES PVT LTD

27831 A

II

3/3/2014

MSN LABORATORIES PVT LTD

FINGOLIMOD HYDROCHLORIDE [ROUTE CODE "FH"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
CABAZITAXEL [ROUTE CODE "CZ"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27832 A

II

1/24/2014

SUN PHARMACEUTICAL INDUSTRIES LTD

LEUPROLIDE ACETATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27833 A

II

1/13/2014

JIANGSU HENGRUI MEDICINE CO LTD

TOLVAPTAN AS MANUFACTURED IN JIANGSU, CHINA

27834 A

II

2/6/2014

LUPIN LTD

DEXLANSOPRAZOLE AS MANUFACTURED IN GUJARAT, INDIA

27835 A

II

12/31/2013

LUPIN LTD

LACOSAMIDE AS MANUFACTURED IN GUJARAT, INDIA

27836 A

II

12/12/2013

QIDONG DONGYUE PHARMACEUTICAL CO LTD

DEXTROMETHORPHAN HYDROBROMIDE AS MANUFACTURED IN JIANGSU, CHINA

27837 A

II

3/6/2014

AMPHASTAR NANJING PHARMACEUTICALS INC

BECLOMETHASONE DIPROPIONATE AS MANUFACTURED IN JIANGSU, CHINA

27838 P

*** PENDING FILING REVIEW ***

27839 A

II

1/6/2014

INTAS PHARMACEUTICALS LTD

PREGABALIN AS MANUFACTURED IN GUJARAT, INDIA

27840 A

III

12/19/2013

BOREALIS AG

BORMED RJ88OMO AS MANUFACTURED IN BERINGEN, BELGIUM FOR BOREALIS AG

27841 A

II

12/23/2013

TOBRAMYCIN SULFATE AS MANUFACTURED IN FUJIAN PROVINCE, P.R. CHINA

27842 A

II

1/7/2014

LIVZON GROUP FUZHOU FUXING


PHARMACEUTICAL CO LTD
AUROBINDO PHARMA LTD

27843 A

II

1/9/2014

AUROBINDO PHARMA LTD

DALFAMPRIDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27844 A

II

12/20/2013

MACCO ORGANIQUES INC

SODIUM ACETATE ANHYDROUS AS MANUFACTURED IN QUEBEC, CANADA

27845 A

III

12/20/2013

BROMOBUTYL RUBBER AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

27846 A

III

12/20/2013

27847 A

III

11/12/2013

ZHEJIANG CENWAY NEW SYNTHETIC MATERIALS


CO LTD
ZHEJIANG CENWAY NEW SYNTHETIC MATERIALS
CO LTD
SCORPION CONTAINERS PRIVATE LTD

27848 A

II

1/7/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

27849 A

III

12/20/2013

27850 A

III

8/12/2013

27851 A

III

9/2/2013

ZHEJIANG CENWAY NEW SYNTHETIC MATERIALS


CO LTD
BRIGHTWOOD PHARMMED CONSUMABLE
(BEIJING) LIMITED
BEIJING AUSTAR HANSEN PACKAGING
TECHNOLOGY LTD

VORICONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

BUTYL RUBBER AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA


PET BOTTLE SET (BOTTLE, CAP, MEASURING CUP) AS MANUFACTURED IN HIMACHAL
PRADESH, INDIA
ENTECAVIR MONOHYDRATE AS MANUFACTURED IN ZHEJIANG, CHINA
CHLOROBUTYL RUBBER AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
NON-PVC IV SOFT BAG AS MANUFACTURED IN BEIJING, P.R. CHINA
SHP-O CAP AND SHP-O PORT AS MANUFACTURED IN BEIJING, P.R. CHINA

Page 823

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27852 A
III
12/18/2013
TRIMURTHI POLYMERS

SUBJECT
PET BOTTLES AS MANUFACTURED IN UNION TERRITORY OF DADRA & NAGAR HAVELI, INDIA

27853 A

II

12/24/2013

27854 A

IV

12/18/2013

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
UNGERER AND CO

27855 A

III

12/23/2013

WINPAK HEAT SEAL PACKAGING INC

ABIRATERONE ACETATE AS MANUFACTURED IN WUHAN, P.R. CHINA FOR HUBEI BIOCAUSE


HEILEN PHARMACEUTICAL CO., LTD.
NAT. MARASCHINO CHERRY TYPE CONCENTRATE FI FW-9004 AS MANUFACTURED IN
BETHLEHEM, PA
FLEXIBLE PACKAGING MATERIALS FOR LIDDING AS MANUFACTIUED QUEBEC, CANADA

27856 A

III

12/20/2013

STAR PLASTIC INDUSTRIES

27857 A

III

12/20/2013

27858 A

II

12/23/2013

PLASTIC CONTAINERS, JARS, BOTTLES, CAPS AND CLOSURES AS MANUFACTURED IN


GUJARAT, INDIA
ZHEJIANG HUAHAI PHARMACEUTICAL PACKAGING HDPE BOTTLES, 40 CC & 75 CC AS MANUFACTURED IN ZHEJIANG, CHINA
PRODUCTS CO LTD
IRVINE SCIENTIFIC SALES CO
DME HIGH GLUCOSE-LIQUID # 9031 AS MANUFACTURED IN SANTA ANA, CA

27859 A

II

1/28/2014

EMCURE PHARMACEUTICALS LTD

FLECAINIDE ACETATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27860 A

II

1/29/2014

MSN LABORATORIES PVT LTD

TERIFLUNOMIDE [ROUTE CODE "TO"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27861 P

*** PENDING FILING REVIEW ***

27862 A

II

1/24/2014

MSN LABORATORIES PVT LTD

CLOFARABINE [ROUTE CODE "CF"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27863 A

II

1/31/2014

MSN LABORATORIES PVT LTD

TRAVOPROST USP [ROUTE CODE - "TS"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27864 A

IV

1/2/2014

FONA INTERNATIONAL INC

807.0274U N-C WILD BERRY TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

27865 A

II

1/27/2014

MSN LABORATORIES PVT LTD

27866 A

II

3/5/2014

GLENMARK GENERICS LTD

CARBOPROST TROMETHAMINE USP [ROUTE CODE "CE"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
DIMETHYL FUMARATE AS MANUFACTURED IN GUJARAT, INDIA

27867 A

II

1/27/2014

SYMBIOTEC PHARMALAB LTD

LEVONORGESTREL EP/USP, MICRONIZED AS MANUFACTURED IN MADHYA PRADESH, INDIA

27868 A

II

12/19/2013

FIRST RARE MATERIALS CO LTD

BISMUTH CITRATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA

27869 A

II

12/19/2013

FIRST RARE MATERIALS CO LTD

BISMUTH SUBCARBONATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA

27870 A

II

12/19/2013

FIRST RARE MATERIALS CO LTD

BISMUTH SUBNITRATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA

27871 A

II

12/19/2013

FIRST RARE MATERIALS CO LTD

BISMUTH SUBSALICYLATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA

27872 A

II

12/4/2013

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

CELECOXIB AS MANUFACTURED IN HUBEI PROVINCE, CHINA

27873 A

II

1/28/2014

AUROBINDO PHARMA LTD

FONDAPARINUX SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27874 A

II

12/23/2013

IRVINE SCIENTIFIC SALES CO

DME HIGH GLUCOSE-LIQUID #9024 AS MANUFACTURED IN SANTA ANA, CA

27875 A

1/28/2014

LYOPHILIZATION SERVICES OF NEW ENGLAND

ASEPTIC MANUFACTURING FACILITY

27876 A

II

12/31/2013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

ATAZANAVIR SULFATE AS MANUFACTURED IN ZHEJIANG, CHINA

27877 A

IV

3/13/2014

EVONIK INDUSTRIES AG

EUDRAGIT E AS MANUFACTURED IN DARMSTADT, GERMANY

27878 A

IV

12/16/2013

HENKEL CORP

DURO-TAK 87-6909 AS MANUFACTURED IN SALISBURY, NC

27879 A

II

2/7/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

27880 A

II

1/3/2014

27881 A

III

1/2/2014

SHANDONG RONGYUAN PHARMACEUTICAL CO


LTD
NYPRO INC

ROSUVASTATIN CALCIUM PROCESS G AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR


TEVA PHARMACEUTICAL INDUSTRIES LTD
TRIMETHOPRIM AS MANUFACTURED IN SHANDONG, P.R. CHINA

27882 A

II

1/24/2014

HENAN TOPFOND PHARMACEUTICAL CO LTD

27883 A

II

1/6/2014

INTERQUIM SA DE CV

TWINCAPS (R) DRY POWDER INHALER COMPONENTS AS MANUFACTURED IN CO DUBLIN,


IRELAND FOR NYPRO, INC.
SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN HENAN PROVINCE, P.R. CHINA FOR
HENAN TOPFOND PHARMACEUTICAL CO., LTD
DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO

27884 A

II

12/10/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

MECOBALAMIN JP AS MANUFACTURED IN HARYANA, INDIA

Page 824

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27885 A
II
12/2/2013
MAHIMA LIFE SCIENCES PRIVATE LTD

SUBJECT
AZITHROMYCIN USP (DIHYDRATE) AS MANUFACTURED IN HARYANA, INDIA

27886 A

II

12/5/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

CHLORAMPHENICOL PALMITATE USP AS MANUFACTURED IN HARYANA, INDIA

27887 A

II

12/20/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

OFLOXACIN USP AS MANUFACTURED IN HARYANA, INDIA

27888 A

II

12/10/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

DEXAMETHASONE USP AS MANUFACTURED IN HARYANA, INDIA

27889 A

II

12/15/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

ERYTHROMYCIN ESTOLATE USP AS MANUFACTURED IN HARYANA, INDIA

27890 A

II

12/5/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

BETAMETHASONE USP AS MANUFACTURED IN HARYANA, INDIA

27891 A

II

12/15/2013

MAHIMA LIFE SCIENCES PRIVATE LTD

ERYTHROMYCIN STEARATE USP AS MANUFACTURED IN HARYANA, INDIA

27892 A

II

3/25/2014

GLENMARK GENERICS LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN GUJARAT, INDIA

27893 A

III

1/22/2014

INDIAN OIL CORP LTD

PROPEL PP1110MAS AS MANUFACTURED IN HARYANA, INDIA

27894 A

II

4/21/2014

27895 A

II

2/18/2014

POLYCARBON INDUSTRIES INC DBA PCI


SYNTHESIS
DR REDDYS LABORATORIES LTD

PCI-103101 NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN NEWBURYPORT,


MA
CABAZITAXEL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27896 A

II

2/6/2014

DR REDDYS LABORATORIES LTD

EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

27897 A

III

1/3/2014

SHREE GAURAV RUBBER PRODUCTS

27898 A

II

4/30/2014

AMSA SPA

SILICON RUBBER TUBING PEROXIDE/PLATINUM TREATED AS MANUFACTURED IN


MAHARASHTRA, INDIA
LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN COMO, ITALY

27899 A

III

1/3/2014

SHREE GAURAV RUBBER PRODUCTS

SILICONE RUBBER BRAIDED TUBING AS MANUFACTURED IN MAHARASHTRA, INDIA

27900 A

II

1/9/2014

POLYMED THERAPEUTICS INC

27901 A

II

2/5/2014

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

27902 A

II

1/10/2014

ASYMCHEM LIFE SCIENCE TIANJIN CO LTD

PACLITAXEL USP (SEMI-SYNTHETIC) AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR


POLYMED THERAPEUTICS, INC.
CLOFARABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA
PHARMACEUTICALS PVT. LTD
ATORVASTATIN CALCIUM AS MANUFACTURED IN TIANJIN, CHINA

27903 A

II

2/5/2014

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTD

CLAVULANATE POTASSIUM, USP AS MANUFACTURED IN SHANXI, CHINA

27904 A

II

2/19/2014

AJINOMOTO OMNICHEM SA

MICONAZOLE NITRATE AS MANUFACTURED IN WETTEREN, BELGIUM

27905 A

II

2/3/2014

RELIANCE LIFE SCIENCES PVT LTD

LENALIDOMIDE AS MANUFACTURED IN NAVI MUMBAI, INDIA

27906 A

IV

1/7/2014

SYMRISE AG

27907 A

II

3/24/2014

GLENMARK GENERICS LTD

650722 NATURAL & ARTIFICIAL FLAVOR CRANBERRY TYPE SPRAY DRIED AS MANUFACTURED
IN HOLZMINDEN, GERMANY
LINAGLIPTIN AS MANUFACTURED IN GUJARAT, INDIA

27908 A

II

3/25/2014

NAVINTA LLC

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA FOR NAVINTA LLC

27909 A

II

2/13/2014

ALKEM LABORATORIES LTD

ARIPIPRAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA

27910 A

II

4/17/2014

TARO PHARMACEUTICAL INDUSTRIES LTD

ILOPERIDONE, MICRONIZED AS MANUFACTURED IN HAIFA, ISRAEL

27911 P

*** PENDING FILING REVIEW ***

27912 P

*** PENDING FILING REVIEW ***

27913 A

III

1/6/2014

AMERICHEM INC

46344-CD4-801 AMBER AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM

27914 A

IV

1/10/2014

SEPPIC SA

SEPIFILM AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S.A.

27915 A

II

3/11/2014

HEC PHARM CO LTD

27916 A

III

1/15/2014

BOREALIS AG

METOPROLOL SUCCINATE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


HUBEI PROVINCE, P. R. CHINA FOR HEC PHARM CO., LTD
BORMED SC876CF AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG

27917 A

II

4/10/2014

HEC PHARM CO LTD

27918 A

II

4/8/2014

HEC PHARM CO LTD

CLOPIDOGREL BISULFATE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


HUBEI PROVINCE, P.R CHINA FOR HEC PHARM CO., LTD
ESOMEPRAZOLE MAGNESIUM DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN HUBEI PROVINCE, P. R. CHINA FOR HEC PHARM CO., LTD

Page 825

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27919 A
III
8/19/2014
NYPRO INC

SUBJECT
LEVER OPERATED MULTI-DOSE INHALER AS MANUFACTURED FOR NYPRO INC

27920 A

II

2/19/2014

SYMBIOTEC PHARMALAB LTD

ESTERIFIED ESTROGENS USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

27921 A

II

1/15/2014

SUPRIYA LIFESCIENCE LTD

KETAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27922 A

II

1/17/2014

SANDOZ PRIVATE LTD

27923 A

II

3/7/2014

APOTEX PHARMACHEM INDIA PVT LTD

MEROPENEM WITH SODIUM CARBONATE, STERILE BLEND AS MANUFACTURED IN


MAHARASHTRA, INDIA
ETRAVIRINE AS MANUFACTURED IN BANGALORE, INDIA

27924 A

III

2/17/2014

LLC SCHOTT PHARMACEUTICAL PACKAGING

27925 A

II

1/17/2014

METROCHEM API PRIVATE LTD

PRIMARY PACKAGING MATERIAL (AMPOULES VIALS) AS MANUFACTURED IN ZAVOLZHYE,


RUSSIA
ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN HYDERABAD, INDIA

27926 A

II

2/7/2014

AUROBINDO PHARMA LTD

SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27927 A

II

3/28/2014

SHILPA MEDICARE LTD

IMATINIB MESYLATE AS MANUFACTURED IN KARNATAKA INDIA

27928 A

II

1/17/2014

METROCHEM API PRIVATE LTD

OMEPRAZOLE AS MANUFACTURED IN HYDERABAD, INDIA

27929 A

III

1/15/2014

MITSUI CHEMICALS TOHCELLO INC

27930 A

III

1/17/2014

DANAPAK FLEXIBLES AS

27931 A

II

1/21/2014

M/S ZCL CHEMICALS LTD

RELEASE FILM AS MANUFACTURED IN TOKUSHIMA, JAPAN FOR MITSUI CHEMICALS


TOHCELLO, INC
DANAEXTRA 15-35 COMPOUND PACKAGING MATERIAL AS MANUFACTURED IN SLAGELSE AND
HORSENS, DENMARK
D-THREO RITALINIC ACID HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27932 A

II

1/21/2014

ZCL CHEMICALS LTD

THREO PHENYL-2- PIPERIDYL ACETAMIDE AS MANUFACTURED IN GUJARAT, INDIA

27933 A

II

2/4/2014

MICRO LABS LTD

ARTEMETHER AS MANUFACTURED IN BANGALORE, INDIA.

27934 A

IV

1/13/2014

EMERSON RESOURCES INC

PLASACRYL HTP20 AS MANUFACTURED IN NORRISTOWN, PA

27935 A

II

6/27/2014

LABORCHEMIE APOLDA GMBH

D-PENICILLAMINE (NEEDLES) AS MANUFACTURED IN THURINGIA, GERMANY

27936 A

III

1/15/2014

AL CAN EXPORTS PVT LTD

ALUMINIUM CONTAINERS AS MANUFACTURED IN MAHARASHTRA, INDIA

27937 A

III

1/22/2014

CONSOLIDATED BOTTLE CORP

27938 A

II

1/24/2014

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD

60ML WHITE HDPE ROUND 38/400 HEAVY WEIGHT [013917] AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
LEVODOPA AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

27939 A

II

4/2/2014

CADILA HEALTHCARE LTD

MESALAMINE USP (PROCESS-II) AS MANUFACTURED IN GUJARAT, INDIA

27940 A

III

1/15/2014

AMPACET CORP

27941 A

IV

1/14/2014

UNGERER AND CO

463935 BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
375620 METHYL SALICYLATE SYNTHETIC AS MANUFACTURED IN BETHLEHEM, PA

27942 A

IV

1/15/2014

27943 A

IV

1/6/2014

27944 A

IV

12/16/2013

27945 A

II

4/13/2014

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
TEVA PHARMACEUTICAL INDUSTRIES LTD

27946 A

II

3/12/2014

IPCA LABORATORIES LTD

ULIPRISTAL ACETATE AS MANUFACTURED IN VERCELLI, ITALY FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
TELMISARTAN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

27947 A

II

2/26/2014

DR REDDYS LABORATORIES LTD

VORICONAZOLE, USP (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27948 A

IV

1/21/2014

30620292 NAT FL MODULATOR (MASKING) FMT ? PWD AS MANUFACTURED IN CLARK, NJ

27949 A

IV

1/20/2014

27950 A

II

1/28/2014

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
DIVIS LABORATORIES LTD

30619798 NAT FL MOD (MASKING) FMT ? SD AS MANUFACTURED IN CLARK, NJ


30617089 NAT FL MOD (MOUTHFEEL) FMT ? AS MANUFACTURED IN CLARK, NJ
30619722 NAT FL MOD (SWEET) FMT ? PWD AS MANUFACTURED IN CLARK, NJ

30617086 NAT FL MODULATOR (MASKING) FMT ? AS MANUFACTURED IN CLARK, NJ


OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 826

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27951 A
II
1/29/2014
IRVINE SCIENTIFIC SALES CO

SUBJECT
L-GLUTAMINE (200MM)- LIQUID AS MANUFACTURED IN SANTA ANA, CA

27952 A

II

1/29/2014

IRVINE SCIENTIFIC SALES CO

NON-ESSENTIAL AMINO ACIDS 100X FOR MEM-LIQUID AS MANUFACTURED IN SANTA ANA, CA

27953 A

II

3/18/2014

ITF CHEMICAL LTDA

AZACYTIDINE AS MANUFACTURED IN HUBEI, P. R. OF CHINA FOR ITF CHEMICAL LTDA

27954 A

II

3/13/2014

MYLAN LABORATORIES LTD

27955 A

II

2/12/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I) AS MANUFACTURED IN


TELANGANA, INDIA
PREGABALIN AS MANUFACTURED IN ZHEJIANG, CHINA

27956 A

II

4/11/2014

AARTI INDUSTRIES LTD

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

27957 A

III

1/20/2014

YABAO PHARMACEUTICAL GROUP CO LTD

HDPE BOTTLE AND CHILD-RESISTANT CLOSURE AS MANUFACTURED IN SHANXI, CHINA

27958 A

II

5/30/2014

EMCURE PHARMACEUTICALS LTD

IRON SUCROSE COMPLEX SOLUTION AS MANUFACTURED IN MAHARASHTRA, INDIA

27959 A

II

2/13/2014

AUROBINDO PHARMA LTD

27960 A

II

4/4/2014

DR REDDYS LABORATORIES LTD

DEXTROMETHORPHAN HYDROBROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27961 A

III

1/31/2014

TAKEUCHI PRESS INDUSTRIES CO LTD

TAKEUCHI 4317F TUBE AS MANUFACTURED IN HYOGO, JAPAN

27962 A

III

1/31/2014

FORMOSA PLASTICS CORP PP DIV

TAISOX POLYETHYLENE RESINS AS MANUFACTURED IN TAIWAN, R.O.C.

27963 A

II

4/11/2014

LUPIN LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

27964 A

II

1/31/2014

EGIS PHARMACEUTICALS PUBLIC LTD CO

AMLODIPINE BESYLATE API AS MANUFACTURED IN BUDAPEST, HUNGARY

27965 P

*** PENDING FILING REVIEW ***

27966 A

II

3/12/2014

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTD

27967 A

II

3/5/2014

LAURUS LABS PRIVATE LTD

27968 A

IV

1/30/2014

27969 A

II

3/17/2014

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
TEVA PHARMACEUTICAL INDUSTRIES LTD

27970 A

II

2/20/2014

HETERO DRUGS LTD

RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN VERCELLI, ITALY FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD.
LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27971 A

II

1/20/2014

BASELL POLIOLEFINE ITALIA SRL

CEFEPIME HYDROCHLORIDE STERILE AS MANUFACTURED IN VILLADOSE ROME, ITALY

27972 A

II

2/12/2014

GLAND PHARMA LTD

REGADENOSON AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27973 A

II

5/28/2014

FERMION OY

ODM-201 AS MANUFACTURED IN HANKO, FINLAND

27974 A

III

2/4/2014

BASELL POLIOLEFINE ITALIA SRL

27975 A

II

7/31/2014

CREMER OLEO GMBH AND CO KG

PURELL ACP 5531 B AS MANUFACTURED IN MUNCHSMUNSTER, GERMANY FOR BASELL


POLIOLEFINE ITALIA S.R.L.
MEDIUM-CHAIN TRIGLYCERIDES AS MANUFACTURED IN WITTEN, GERMANY

27976 A

II

3/18/2014

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTD

27977 A

II

6/27/2014

D K PHARMACHEM PVT LTD

CLAVULANATE POTASSIUM DILUTED 1:1 WITH MICROCRYSTALLINE CELLULOSE AS


MANUFACTURED IN SHANXI, CHINA
FENOFIBRATE USP (PROCESS B) AS MANUFACTURED IN MAHARASHTRA, INDIA

27978 A

II

2/20/2014

INTAS PHARMACEUTICALS LTD

CABAZITAXEL (AMORPHOUS) AS MANUFACTURED IN GUJARAT, INDIA

27979 A

II

3/14/2014

ORIL INDUSTRIE

IVABRADINE HYDROCHLORIDE AS MANUFACTURED IN BOLBEC, FRANCE

27980 A

II

3/14/2014

ORIL INDUSTRIE

AZEPAN AS MANUFACTURED IN BOLBEC, FRANCE

27981 A

II

3/14/2014

LABORATORIOS SERVIER SL

BUTAMINE HYDROCHLORIDE AS MANUFACTURED IN TOLEDO, SPAIN

27982 A

II

2/18/2014

CRYSTAL PHARMA SAU

ALCAFTADINE AS MANUFACTURED IN VALLADOLID, SPAIN

27983 A

II

3/28/2014

APOTEX PHARMACHEM INDIA PVT LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA

27984 N

CLAVULANATE POTASSIUM Diluted 1:1 with Silicon Dioxide AS MANUFACTURED IN SHANXI,


CHINA
THALIDOMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
709932 N & A TROPICAL PUNCH FL AS MANUFACTURED IN CLARK, NJ

NOT AN ASSIGNED NUMBER

Page 827

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
27985 A
III
2/14/2014
DSM ENGINEERING PLASTICS EUROPE B.V.

SUBJECT
ARNITE T06 202/A AS MANUFACTURED IN EMMEN, THE NETHERLANDS FOR DSM
ENGINEERING PLASTICS EUROPE B.V.
DELAMINATING CO-EXTRUDED BAG-IN-BOTTLE SYSTEMS AS MANUFACTURED IN SAULGRUBALTENAU, FEDERAL REPUBLIC OF GERMANY
EXCIPIENT HARD GELATIN CAPSULE SHELLS - PITHAMPUR AS MANUFACTURED IN MADHYA
PRADESH, INDIA
PET BOTTLES AS MANUFACTURED IN KARNATAKA, INDIA

27986 A

III

2/6/2014

GAPLAST GMBH

27987 A

IV

1/18/2014

ACG ASSOCIATED CAPSULES PVT LTD

27988 A

III

2/6/2014

GARDEN POLYMERS PVT LTD

27989 A

II

2/12/2014

STERLING CHEMICAL MALTA LTD

27990 A

II

3/1/2014

SUN PHARMACEUTICAL INDUSTRIES LTD

ABIRATERONE ACETATE AS MANUFACTURED IN BIRZEBBUGIA, MALTA AND PERUGIA, ITALY


FOR STERLING CHEMICAL MALTA LTD
OCTREOTIDE ACETATE (PROCESS-II) AS MANUFACTURED IN MAHARASHTRA, INDIA

27991 A

II

3/11/2014

UNICHEM LABORATORIES LTD

RIZATRIPTAN BENZOATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

27992

II

2/28/2014

EGIS PHARMACEUTICALS PRIVATE LTD

27993 A

II

5/19/2014

ALP PHARM BEIJING CO LTD

27994 A

III

2/18/2014

ARIFLEX SPA

27995 A

II

2/24/2014

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL


CO LTD
NOT AN ASSIGNED NUMBER

BUTAMINE HYDROCHLORIDE DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN


KERESZTURI UT, HUNGARY
ALOGLIPTIN BENZOATE AS MANUFACTURED IN HUBEI, CHINA FOR ALP PHARM BEIJING CO
LTD
ALUMINIUM FOIL DRUG PACKAGING MATERIAL LACQUERED ON BOTH SIDES AS
MANUFACTURED IN SPINETTA MARENGO (AL), ITALY
MEDROXYPROGESTERONE ACETATE AS MANUFACTURED IN HUBEI, P.R. CHINA

27997 A

II

2/14/2014

HETERO LABS LTD

DARUNAVIR ETHANOLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27998 A

II

2/10/2014

AK AND MN BIOFARM CO LTD

AK & MN BIOFARM ICOSAPENTATE AS MANUFACTURED IN ULSAN, KOREA

27999 A

III

2/14/2014

POLYONE CORP

CC10187865XX (EX GREEN) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28000 A

III

2/14/2014

POLYONE CORP

CC10187864XX (EZ YELLOW) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28001 A

III

2/14/2014

POLYONE CORP

CC10187866XX (EZ RED) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28002 A

III

2/14/2014

POLYONE CORP

CC10187870XX (EZ ROYAL BLUE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28003 A

III

2/14/2014

POLYONE CORP

CC10187868XX (EZ BLACK) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28004 A

III

2/14/2014

POLYONE CORP

CC10187869XX (EZ LIGHT BLUE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28005 A

III

2/14/2014

POLYONE CORP

CC10187863XX (EX GREY) AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28006 A

II

2/14/2014

IRVINE SCIENTIFIC SALES CO

IS CHO-V IUF - POWDER AS MANUFACTURED IN SANTA ANA, CA

28007 A

III

2/17/2014

DOWELL MOULDS

28008 A

II

6/5/2014

SIGNA SA DE CV

PLASTIC BOTTLES, CAPS, JARS AND PLASTIC PACKAGING BLISTERS AS MANUFACTURED IN


GUJARAT, INDIA
LANTHANUM CARBONATE HYDRATE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO

28009 A

II

2/26/2014

MSN LABORATORIES PVT LTD

APIXABAN [ROUTE CODE "AX"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28010 A

II

2/26/2014

MSN LABORATORIES PVT LTD

TOLVAPTAN [ROUTE CODE "TN"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28011 A

II

3/3/2014

MSN LABORATORIES PVT LTD

28012 A

II

3/3/2014

MSN LABORATORIES PVT LTD

28013 A

II

3/15/2014

MSN LABORATORIES PVT LTD

28014 A

II

3/3/2014

MSN PHARMACHEM PRIVATE LTD

28015 A

II

4/10/2014

RAKS PHARMA PVT LTD

FORMOTEROL FUMARATE USP [ROUTE CODE "FL"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
BEPOTASTINE BESILATE [ROUTE CODE - "BB"] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
ARFORMOTEROL TARTRATE [ROUTE CODE - "LT"] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
CLOPIDOGREL BISULFATE USP (FORM-1) [ROUTE CODE "CS1"] AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
LEVOMILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

27996 N

28016 P

*** PENDING FILING REVIEW ***

Page 828

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28017 P
*** PENDING FILING REVIEW ***

SUBJECT

28018 A

II

2/13/2014

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

VENLAFAXINE BASE AS MANUFACTURED IN ZHEJIANG, CHINA

28019 A

III

2/4/2014

SORICH FOILS PVT LTD

COATED/PLAIN/PRINTED ALUMINIUM FOIL, GLASSINE PAPER & LAMINATES, PRINTED/PLAIN


ALU-ALU FOIL, PRINTED/PLAIN CHILD RESISTANT FOIL (CR FOIL) FOR PHARMACEUTICAL
TABLET/CAPSULE PACKAGING AND FLEXIBLE PACKAGING FOR FOOD INDUSTRY AS
MANUFACTURED IN GUJARAT, INDIA

28020 A

II

2/19/2014

SHASUN PHARMACEUTICALS LTD

CELECOXIB, USP AS MANUFACTURED IN CUDDALORE, INDIA

28022 A

II

5/8/2014

LEK PHARMACEUTICALS DD

ROSUVASTATIN CALCIUM (PROCESS B) AS MANUFACTURED IN MENGES, SLOVENIA

28023 A

II

3/21/2014

LEK PHARMACEUTICALS DD

RAPAMYCIN AS MANUFACTURED IN MENGES, SLOVENIA

28024 A

II

3/25/2014

DR REDDYS LABORATORIES LTD

AGOMELATINE PHOSPHORIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28025 A

II

2/18/2014

HIKAL LTD

VENLAFAXINE BASE AS MANUFACTURED IN KARNATAKA AND MAHARASHTRA, INDIA

28026 A

II

2/19/2014

METROCHEM API PRIVATE LTD

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28027 A

II

2/6/2014

RL FINE CHEM

DOXYLAMINE SUCCINATE AS MANUFACTURED IN BANGALORE, INDIA

28028 A

II

3/18/2014

MACLEODS PHARMACEUTICALS LTD

ROSUVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA

28029 A

II

3/28/2014

APOTEX PHARMACHEM INDIA PVT LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN BANGALORE, INDIA

28030 A

II

5/15/2014

GLAND PHARMA LTD

28031 A

II

3/7/2014

CRYSTAL PHARMA SAU

28032 A

IV

2/18/2014

EMILIO CASTELLI SAS

ARGATROBAN MONOHYDRATE (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
LOTEPREDNOL ESTABONATE STERILE MICRONIZED AS MANUFACTURED IN VALLADOLID,
SPAIN
SUGAR SPHERES NF AS MANUFACTURED IN BOVISIO MASCIAGO (MB) ITALY

28033 A

II

12/23/2013

ZHEJIANG STARRY PHARMACEUTICAL CO LTD

IOPAMIDOL AS MANUFACTURED IN ZHEJIANG, CHINA

28034 A

II

2/21/2014

SIFAVITOR SRL

LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN FRAZIONE MAIRANO (LO), ITALY

28035 A

II

2/18/2014

TAKASAGO INTERNATIONAL CORP

RHA AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN

28036 A

III

2/17/2014

EI DUPONT DE NEMOURS AND CO INC

320G-201 ONE COAT CLEAR AS MANUFACTURED IN MECHELEN, BELGIUM FOR E.I. DUPONT
DE NEMOURS & CO., INC.

28038 A

II

3/27/2014

DR REDDYS LABORATORIES LTD

28039 A

II

4/11/2014

LUPIN LTD

ABIRATERONE ACETATE AS MANUFACTURED IN MORELOS, MEXICO FOR DR. REDDY'S


LABORATORIES LIMITED
DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN GUJARAT, INDIA

28040 A

II

4/30/2014

CODY LABORATORIES INC

MORPHINE SULFATE, USP AS MANUFACTURED IN CODY, WYOMING

28041 A

II

6/27/2014

CODY LABORATORIES INC

HYDROCODONE BITARTRATE, USP AS MANUFACTURED IN CODY, WYOMING

28042 A

III

2/14/2014

DURAN GROUP GMBH

DURAN BOROSILICATE GLASS 3.3 CONTAINERS CLEAR GLASS AND AMBER COLOURED
GLASS AS MANUFACTURED IN MAINZ, GERMANY; WERTHEIM/MAIN, GERMANY AND PULA,
CROATIA FOR DURAN GROUP GMBH

28043 A

II

3/8/2014

UMICORE ARGENTINA SA

OXALIPLATIN AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

28044 A

III

2/14/2014

DURAN GROUP GMBH

DURAN? CLOSURES MADE FROM PFA WITHOUT AND WITH SEALING DISC AS
MANUFACTURED IN OESTRICH-WINKEL, GERMANY AND HILDESHEIM, GERMANY FOR DURAN
GROUP GMBH

28045 A

II

2/18/2014

SKUNY BIOSCIENCE CO LTD

OMEGA-3-ACID ETHYL ESTERS 90 AS MANUFACTURED IN SICHUAN, P.R. CHINA

28046 A

II

3/9/2014

UMICORE ARGENTINA SA

CISPLATIN AS MANUFACTURED IN BUENOS AIRES PROVINCE, ARGENTINA

28047 A

II

3/10/2014

UMICORE ARGENTINA SA

CARBOPLATIN AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

28048 A

II

3/12/2014

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

DECITABINE AS MANUFACTURED IN ZHEJIANG, CHINA

28021 P

*** PENDING FILING REVIEW ***

28037 P

*** PENDING FILING REVIEW ***

Page 829

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28049 A
II
3/7/2014
JUBILANT GENERICS LTD

SUBJECT
GUANFACINE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

28050 A

II

3/31/2014

JUBILANT GENERICS LTD

ALISKIREN HEMIFUMARATE AS MANUFACTURED IN KARNATAKA, INDIA

28051 A

II

5/5/2014

CIPLA LTD

CINACALCET HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

28052 A

II

3/28/2014

JUBILANT GENERICS LTD

DEXLANSOPRAZOLE AS MANUFACTURED IN KARNATAKA, INDIA

28053

II

3/29/2014

JUBILANT GENERICS LTD

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP AS MANUFACTURED IN KARNATAKA, INDIA

II

3/29/2014

JUBILANT GENERICS LTD

ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP AS MANUFACTURED IN KARNATAKA, INDIA

28055 A

II

3/28/2014

WISDOM PHARMCEUTICAL CO LTD

BENDAMUSTINE INTERMEDIATE (EUSB) AS MANUFACTURED IN JIANGSU, CHINA

28056 A

II

3/28/2014

ALEMBIC PHARMACEUTICALS LTD

RIVAROXABAN AS MANUFACTURED IN GUJARAT, INDIA

28057 A

II

3/28/2014

ALEMBIC PHARMACEUTICALS LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28058 A

II

3/28/2014

ALEMBIC LTD

LOVASTATIN USP AS MANUFACTURED IN GUJARAT, INDIA

28059 A

II

3/28/2014

UNICHEM LABORATORIES LTD

CETIRIZINE HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

28060 A

II

3/28/2014

UNICHEM LABORATORIES LTD

PIROXICAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28061 A

II

2/21/2014

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

BCK (4-NITROBENZYL(5R,6S)-6-[(1R)-1- HYDROXYETHYL]-3,7-DIOXO-1AZABICYCLO[3.2.0]HEPTANE-2-CARBOXYLATE) AS MANUFACTURED IN ZHEJIANG PROVINCE,


P.R. CHINA

28062 A

II

2/28/2014

HETERO DRUGS LTD

METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28063 A

II

2/26/2014

IRVINE SCIENTIFIC SALES CO

28064 A

II

2/26/2014

IRVINE SCIENTIFIC SALES CO

PBS 1X DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION-LIQUID AS MANUFACTURED


IN SANTA ANA, CA
HEPES BUFFER SOLUTION 1M-LIQUID AS MANUFACTURED IN SANTA ANA, CA

28065 A

II

3/17/2014

APOTEX FERMENTATION INC

TACROLIMUS AS MANUFACTURED IN MANITOBA, CANADA

28066 A

II

2/28/2014

HENAN LIHUA PHARMACEUTICAL CO LTD

HYDROCORTISONE AS MANUFACTURED IN HENAN, CHINA

28067 A

III

2/19/2014

BORMIOLI ROCCO SPA BU PHARMA PLASTIC

28068 A

IV

3/5/2014

FONA INTERNATIONAL INC

BOTTLE LDPE 15 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV),


ITALY AND SAINT SULPICE, FRANCE
856.0232U GRAPE TYPE FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

28069 A

II

2/25/2014

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND


TECHNOLOGY CO LTD
*** PENDING FILING REVIEW ***

TENOFOVIR (DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN HUBEI PROVINCE,


P.R. CHINA

28071 A

II

3/20/2014

MSN LABORATORIES PVT LTD

MIRABEGRON [ROUTE CODE "MG"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28072 A

II

3/22/2014

MSN PHARMACHEM PRIVATE LTD

28073 A

II

3/24/2014

MSN ORGANICS PRIVATE LTD

28074 A

IV

3/5/2014

28075 A

II

3/6/2014

ZHONGSHAN CAPSULE STARCH MATERIAL


TECHNOLOGY CO LTD
TEVA PHARMACEUTICAL INDUSTRIES LTD

VILAZODONE HYDROCHLORIDE [ROUTE CODE "VN"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
RIVASTIGMINE TARTRATE USP [ROUTE CODE "RM"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
PREGELATINIZED HYDROXYPROPYL STARCH AS MANUFACTURED IN GUANGDONG, CHINA

28076 A

II

4/21/2014

APOTEX PHARMACHEM INDIA PVT LTD

28077 A

II

4/10/2014

HOUSTON CYCLOTRON PARTNERS LP

28078 A

II

3/18/2014

EMCURE PHARMACEUTICALS LTD

28054

A
A

28070 P

28079 P

BUPRENORPHINE AS MANUFACTURED IN KOMAROV, CZECH REPUBLIC FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD.
LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA
FLUOROLEVODOPA F 18 INJECTION (6-[18F]FLUORO-L-DOPA) AS MANUFACTURED IN
HOUSTON, TEXAS
DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

*** PENDING FILING REVIEW ***

Page 830

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28080 A
IV
3/5/2014
CI FARMACAPSULAS SA

SUBJECT
ACID RESISTANT CAPSULES (AR CAPS ) AS MANUFACTURED IN BARRANQUILLA, COLOMBIA

28081 A

IV

2/26/2014

GM CHEMIE PVT LTD

HYPROMELLOSE PHTHALATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28082 A

IV

3/4/2014

28083 A

IV

3/4/2014

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
*** PENDING FILING REVIEW ***

30623270 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NEW


JERSEY
30623266 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NEW
JERSEY

28085 A

II

5/2/2014

CIPLA LTD

DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

28086 A

II

3/25/2014

MSN LABORATORIES PVT LTD

28087 A

II

3/31/2014

CIPLA LTD

DAPAGLIFLOZIN PROPANEDIOL [ROUTE CODE "DQ"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
MONTELUKAST SODIUM USP AS MANUFACTURED IN BANGALORE, INDIA

28084 P

28088 P

*** PENDING FILING REVIEW ***

28089 A

III

2/19/2014

QUALITY PLASTICS LLC

POLYETHYLENE BOTTLES AS MANUFACTURED IN PRESCOTT, ARIZONA

28090 A

II

3/10/2014

SRIKEM LABORATORIES PVT LTD

PERMETHRIN AS MANUFACTURED IN NAVI MUMBAI, INDIA

28091 A

II

4/1/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

PAROXETINE MESYLATE AS MANUFACTURED IN ZHEJIANG, CHINA

28092 A

II

3/27/2014

MSN LABORATORIES PVT LTD

28093 A

II

3/26/2014

MSN LABORATORIES PVT LTD

AZILSARTAN KAMEDOXOMIL [ROUTE CODE "AK"] AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
ACLIDINIUM BROMIDE [ROUTE CODE "AU"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28094 A

II

3/26/2014

MSN LABORATORIES PVT LTD

28095 A

II

3/27/2014

MSN LABORATORIES PVT LTD

PEMETREXED DISODIUM HEPTAHYDRATE [ROUTE CODE "PT"] AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
AVANAFIL [ROUTE CODE "AV"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28096 A

II

3/28/2014

MSN LABORATORIES PVT LTD

RIFAXIMIN [ROUTE CODE "RX"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28097 A

II

3/28/2014

MSN LABORATORIES PVT LTD

RIFAXIMIN [ROUTE CODE "RFa"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28098 A

II

3/28/2014

MSN PHARMACHEM PRIVATE LTD

LINAGLIPTIN [ROUTE CODE "LG"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28099 A

II

3/28/2014

MSN LABORATORIES PVT LTD

28100 A

II

4/5/2014

MSN LABORATORIES PVT LTD

PEMETREXED DISODIUM HEMIPENTAHYDRATE [ROUTE CODE "PN"] AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
AZACITIDINE [ROUTE CODE "AJ"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28101 A

II

4/1/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28102 A

II

7/15/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28103 A

IV

3/12/2014

28104 A

III

3/11/2014

GUANGDONG YUE ER KANG PHARMACEUTICAL


CO LTD
BINNY WADS PVT LTD

28105 A

II

3/20/2014

TYCHE INDUSTRIES LTD

NEVIRAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28106 A

II

3/13/2014

FINE CHEMICALS CORP PTY LTD

REMIFENTANIL HYDROCHLORIDE AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA

28107 A

II

3/12/2014

POLYMED THERAPEUTICS INC

28108 A

II

3/24/2014

MICRO LABS LTD

AZACITIDINE USP AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED


THERAPEUTICS, INC.
LUMEFANTRINE USP AS MANUFACTURED IN KARNATAKA, INDIA

28109 A

II

1/15/2014

JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD

D-7ACA AS MANUFACTURED IN HENAN, P.R. CHINA

28110 A

II

2/20/2014

KAIYUAN HENGTAI PHARMA CO LTD

TICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R, 6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO3AH-CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY) ETHANOL L-TARTARIC ACID (1:1) (CAS:376608-650) AS MANUFACTURED IN LIAONING PROVINCE, P.R. CHINA

CABAZITAXEL AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD
NILOTINIB HYDROCHLORIDE AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
HYDROXYPROPYL STARCH VACANT CAPSULE AS MANUFACTURED IN GUANGDONG, CHINA
EPE (EXPANDED POLYETHYLENE) LINERS/SHEET AS MANUFACTURED IN HARYANA, INDIA

Page 831

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28111 A
II
2/20/2014
KAIYUAN HENGTAI PHARMA CO LTD

SUBJECT
TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS:
145783-15-9) AS MANUFACTURED IN LIAONING PROVINCE, P.R. CHINA
TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE (R)2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8) AS MANUFACTURED IN LIAONING
PROVINCE, P.R. CHINA

28112 A

II

2/20/2014

KAIYUAN HENGTAI PHARMA CO LTD

28113 A

III

3/14/2014

POLYONE CORP

T270.0 AS MANUFACTURED IN BETHEL, CONNECTICUT FOR POLYONE CORP.

28114 A

III

3/14/2014

POLYONE CORP

T270.5 AS MANUFACTURED IN BETHEL, CONNECTICUT FOR POLYONE CORPORATION

28115 A

III

3/14/2014

POLYONE CORP

T623.8 AS MANUFACTURED IN LAND, FINLAND FOR POLYONE CORPORATION

28116 A

III

3/12/2014

COLORS FOR PLASTICS INC

28117 A

II

2/9/2014

THERMOPLASTIC RESIN B25026 BLUE 279C AND G27947 COOL GREY 6C COLORANT
MASTERBATCHES AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
WEINAN HIGH TECH NEW ELECTRONIC CHEMICAL P-[[(1S)-2-[4-(BENZOYLAMINO)-2-OXO-1(2H)-PYRIMIDINYL]-1(HYDROXYMETHYL)ETHOXY]METHYL]PHOSPHONIC ACID DIETHYL ESTER AS
CO LTD
MANUFACTURED IN SHANXI PROVINCE, CHINA

28118 A

II

4/27/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28119 A

II

4/16/2014

MEDICHEM SA

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN MADHYA PRADESH, INDIA FOR


TEVA PHARMACEUTICAL INDUSTRIES LTD
MED-300179/E (INTERMEDIATE) AS MANUFACTURED IN CELRA (GIRONA), SPAIN

28120 A

II

4/4/2014

CHEMISCHE FABRIK BERG GMBH

METHENAMINE HIPPURATE AS MANUFACTURED IN BITTERFELD-WOLFEN, GERMANY

28121 A

II

3/31/2014

DR REDDYS LABORATORIES LTD

RIVAROXABAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28122 A

II

4/16/2014

CADILA PHARMACEUTICALS LTD

ATORVASTATIN CALCIUM FORM-I AS MANUFACTURED IN GUJARAT, INDIA

28123 A

II

3/18/2014

SHASUN PHARMACEUTICALS LTD

PREGABALIN AS MANUFACTURED IN CUDDALORE, INDIA

28124 A

II

3/17/2014

SYMBIOTEC PHARMALAB LTD

DESOGESTREL EP/BP, MICRONIZED AS MANUFACTURED IN MADHYA PRADESH, INDIA

28125 A

II

3/17/2014

STERLING SPA

NOMEGESTROL ACETATE CODE 204622 AS MANUFACTURED IN PERUGIA, ITALY

28126 A

II

4/18/2014

MYLAN LABORATORIES LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

28127 A

II

3/31/2014

DR REDDYS LABORATORIES LTD

28128 A

II

3/31/2014

RAKS PHARMA PVT LTD

ESOMEPRAZOLE MAGNESIUM [AMORPHOUS] [PRODUCT CODE: ADR] AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
RITONAVIR, USP (FORM-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28129 A

II

4/1/2014

CIPLA LTD

ATAZANAVIR SULPHATE (METHANOL ROUTE) AS MANUFACTURED IN MAHARASHTRA, INDIA

28130 A

IV

3/18/2014

HENKEL CORP

GELVA GMS 3087 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

28131 A

IV

3/20/2014

FONA INTERNATIONAL INC

807.174 MIXED BERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, ILLINOIS

28132 A

II

3/24/2014

CEDARBURG PHARMACEUTICALS INC

28133 A

II

4/17/2014

28134 A

II

4/2/2014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO


LTD
INDOCO REMEDIES LTD

BULK ETHANOLAMINE OLEATE API IN SOLUTION AS MANUFACTURED IN GRAFTON,


WISCONSIN
VILDAGLIPTIN AS MANUFACTURED IN BEIJING, CHINA

28135 A

II

3/31/2014

DR REDDYS LABORATORIES LTD

28136 A

IV

3/13/2014

TAKASAGO INTERNATIONAL CORP

28137 A

II

3/20/2014

SYMBIOTEC PHARMALAB LTD

28138 A

IV

3/20/2014

PHARMA 73 SA

28139 A

II

4/18/2014

CADILA PHARMACEUTICALS LTD

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE [PRODUCT CODE: ERM] AS MANUFACTURED IN


ANDHRA PRADESH, INDIA
PUMA WHIZZLE - FLAVOUR TEG - 10353526 AS MANUFACTURED IN ZULPICH, GERMANY FOR
TAKASAGO INTERNATIONAL CORPORATION
BECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED) AS
MANUFACTURED IN MADHYA PRADESH, INDIA
HPE 1 - CHITIN GLUCAN COMPLEX AS MANUFACTURED IN CASTANHEIRA DO RIBATEJO,
PORTUGAL FOR PHARMA 73, S.A.
CARVEDILOL AS MANUFACTURED IN GUJARAT, INDIA

28140 A

II

3/31/2014

KD PHARMA BEXBACH GMBH

EPA 550/DHA 200 FFA AS MANUFACTURED IN BEXBACH, GERMANY AND HOMBURG, GERMANY

BRINZOLAMIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 832

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28141 A
V
4/29/2014
PHARMALUCENCE INC

SUBJECT
STERILE PROCESSING FACILITY

28142 A

II

4/23/2014

TAI HENG INDUSTRY CO LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, P. R. CHINA

28143 A

III

3/24/2014

MINNESOTA RUBBER AND PLASTICS

28144 A

II

3/29/2014

PIRAMAL ENTERPRISES LTD

914M, A FLUOROELASTOMER RUBBER FOR SEALING AND OTHER MEDICAL-RELATED


APPLICATIONS IN MEDICAL DEVICES AS MANUFACTURED IN LITCHFIELD, MINNESOTA
PERINDOPRIL ERBUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28145 A

III

3/17/2014

AMPACET CORP

28146 A

II

4/9/2014

TYCHE INDUSTRIES LTD

28147 A

III

3/17/2014

AMPACET CORP

28148 A

II

4/27/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28149 A

II

4/23/2014

MACLEODS PHARMACEUTICALS LTD

4500166-N PINK PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA,


CARTERSVILLE, GA AND HEATH, OH
FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN OPAVA - KOMAROV, CZECH REPUBLIC
AND UTTAR PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
FEBUXOSTAT AS MANUFACTURED IN GUJRAT, INDIA

28150 A

III

3/26/2014

FONA INTERNATIONAL INC

822.0174U CARAMEL MAILLARD FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

28151 A

II

3/27/2014

REVIMMUNE INC

CYT107 AS MANUFACTURED IN PRINCETON, NJ FOR REVIMMUNE, INC.

28152 A

III

3/28/2014

ARIFLEX SPA

COLD FORMABLE FOIL LAMINATE AS MANUFACTURED IN SPINETTA MARENGO (AL), ITALY

28153 A

II

6/1/2012

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

MOMETASONE FUROATE AS MANUFACTURED IN KEDAH, MALAYSIA

28154 A

III

4/4/2014

INDIAN OIL CORP LTD

PROPEL HDPE 180M50 AS MANUFACTURED IN HARYANA, INDIA

28155 A

IV

3/24/2014

ACG ASSOCIATED CAPSULES PVT LTD

EXCIPIENT CELLULOSE CAPSULE SHELLS AS MANUFACTURED IN MADHYA PRADESH, INDIA

28156 A

II

3/27/2014

SHASUN PHARMACEUTICALS LTD

CINACALCET HYDROCHLORIDE AS MANUFACTURED IN PUDUCHERRY, INDIA

28157 A

II

6/12/2014

MERCK KGAA

SAFINAMIDE METHANESULFONATE AS MANUFACTURED IN DARMSTADT, GERMANY

28158 A

II

5/15/2014

MAPRIMED SA

28159 A

II

4/21/2014

HETERO LABS LTD

FLECAINIDE ACETATE PROCESS III (CODE 50970) AS MANUFACTURED IN BUENOS AIRES,


ARGENTINA
CABAZITAXEL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28160 A

II

4/4/2014

CHEMCON GMBH

28161 A

II

12/26/2013

PERRIGO API LTD

SODIUM NITROPRUSSIDE DIHYDRATE AS MANUFACTURED IN FREIBURG IM BREISGAU,


GERMANY
TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN BEER SHEVA, ISRAEL

28162 A

II

5/30/2014

SHILPA MEDICARE LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA

28163 A

II

3/27/2014

PERRIGO API LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN BEER SHEVA, ISRAEL

28164 A

II

4/22/2014

TORRENT PHARMACEUTICALS LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28165 A

II

4/23/2014

HEC PHARM CO LTD

28166 A

III

3/27/2014

AMPACET CORP

28167 A

III

3/18/2014

TEKNOR COLOR CO

FINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED


IN GUANGDONG PROVINCE, P.R. CHINA FOR HEC PHARM CO., LTD
113099 BLUE WHITE SLIP PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
16,386HCPP MAGENTA 227C 50:1 AS MANUFACTURED IN HENDERSON, KY

28168 A

II

3/31/2014

IRVINE SCIENTIFIC SALES CO

RPMI MEDIUM 1640 - LIQUID AS MANUFACTURED IN SANTA ANA, CALIFORNIA

28169 A

II

3/31/2014

IRVINE SCIENTIFIC SALES CO

28170 A

II

3/28/2014

CHEMPORT INC

28171 A

II

4/1/2014

SYMED LABS LTD

PBS 1X DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION WITHOUT CALCIUM AND


MAGNESIUM SALTS - LIQUID AS MANUFACTURED IN SANTA ANA, CALIFORNIA
E550D200FFA (OMEGA-3-POLYUNSATURATED FREE FATTY ACIDS) AS MANUFACTURED IN
SOUTH JEOLLA PROVINCE, KOREA
ESZOPICLONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28172 A

III

4/11/2014

ALPHAMED BOTTLES INC

CLOSURES AS MANUFACTURED IN HAUPPAUGE, NEW YORK

28173 A

II

4/14/2014

LUPIN LTD

EZETIMIBE (PROCESS B) AS MANUFACTURED IN MAHARASHTRA, INDIA

10053-K AMSTAT 53 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET


CORPORATION
TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 833

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28174 A
III
4/1/2014
POLYONE CORP

SUBJECT
CC00012728XX AS MANUFACTURED IN ELK GROVE VILLAGE, IL

28175 A

II

5/15/2014

PAR PHARMACEUTICAL INC

28176 A

II

4/18/2014

PAR PHARMACEUTICAL INC

28177 A

II

8/5/2014

HETERO DRUGS LTD

FERRIC CITRATE AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR PHARMACEUTICAL,


INC.
TIZANIDINE HYDROCHLORIDE, USP AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR
PHARMACEUTICAL, INC
DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28178 A

II

4/28/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28179 A

III

4/4/2014

ARTE CORP

28180 A

II

4/2/2014

KATAYAMA SEIYAKU CO LTD

28181 A

III

4/3/2014

AMPACET CORP

28182 A

II

5/18/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28183 A

III

3/15/2014

INNOVOPAK INC

28184 P

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN PRIGORJE BRDOVECKO CROATIA


FOR TEVA PARMACEUTICAL INDUSTRIES LTD
DUAL CHAMBER PREFILLABLE SYRINGE WITH CAP (WITHOUT NEEDLE) AS MANUFACTURED
IN IBARAKI PREFECTURE, JAPAN
LULICONAZOLE AS MANUFACTURED IN TOYAMA, JAPAN
151249 RED HDPE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
IMATINIB MESYLATE FORM ALPHA AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
POLY-PROPYLENE DOSAGE CUP AS MANUFACTURED IN ONTARIO, CANADA

*** PENDING FILING REVIEW ***

28185 A

IV

4/2/2014

TAKASAGO INTERNATIONAL CORP

TOOTHPASTE FLAVOR F-91250 AS MANUFACTURED IN SHIZIOKA, JAPAN

28186 A

III

4/7/2014

POLYLAB INTERNATIONAL

28187 A

II

4/24/2014

28188 A

IV

4/7/2014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO


LTD
ANTARES HEALTH PRODUCTS INC

PLASTIC CONTAINERS FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN KUNDLI


(HARYANA), INDIA
ALOGLIPTIN BENZOATE AS MANUFACTURED IN BEIJING, CHINA

28189 A

IV

4/8/2014

FONA INTERNATIONAL INC

ANTARES VITAMIN E TPGS, NF GRADE AS MANUFACTURED IN DOUGLAS, GA FOR ANTARES


HEALTH PRODUCTS INC.
815.0084U BUBBLE GUM FLAVOR ART AS MANUFACTURED IN GENEVA, IL

28190 A

II

6/26/2014

BAYER PHARMA AG

AZELAIC ACID (A) AS MANUFACTURED IN BERGKAMEN, GERMANY

28191 A

II

5/15/2014

CORDEN PHARMA LATINA SPA

CEFEPIME/L-ARGININE STERILE BLEND AS MANUFACTURED IN SERMONETA (LATINA), ITALY

II

6/16/2014

APICORE US LLC

PHENTOLAMINE MESYLATE, USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

28194 A

II

6/15/2014

APICORE US LLC

TETRABENAZINE USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

28195 A

III

3/31/2014

BASELL POLIOLEFINE ITALIA SRL

PURELL RP315M AS MANUFACTURED IN FERRARA, ITALY

28196 A

II

4/10/2014

NOF CORP

[A-METHOXY-W-AMINOPROPYL, POLY (OXYETHYLENE)]-BLOCK-POLY (L-SODIUM GLUTAMATE)


AS MANUFACTURED IN KANAGAWA PREFECTURE, JAPAN

28198 A

IV

3/27/2014

28199 A

II

28200 A

28192 P
28193

*** PENDING FILING REVIEW ***

28197 P

*** PENDING FILING REVIEW ***


SODIUM STARCH GLYCOLATE TYPE A AS MANUFACTURED IN ANHUI, P.R. CHINA

4/10/2014

ANHUI SUNHERE PHARMACEUTICAL EXCIPIENTS


CO LTD
VIWIT PHARMACEUTICAL CO LTD

II

4/18/2014

ALP PHARM BEIJING CO LTD

DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA FOR ALP PHARM


BEIJING CO., LTD

28202 A

III

4/10/2014

COLORTECH INC

28203 A

IV

4/14/2014

ABELEI INC

28201 P

RIVAROXABAN (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN SHANGHAI, CHINA

*** PENDING FILING REVIEW ***


10868-18 SLIP/ANTIBLOCK POLYETHYLENE CONCENTRATE AS MANUFACTURED IN
MORRISTOWN, TENNESSEE AND ONTARIO, CANADA
148A76 NATURAL GRAPE TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA, ILLINOIS

Page 834

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28204 P
*** PENDING FILING REVIEW ***
28205 P

SUBJECT

*** PENDING FILING REVIEW ***

28206 A

II

5/21/2014

ASTRAZENECA LP

METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE 25/12.5,50/12.5


AND100/12.5 TABLETS AS MANUFACTURED IN SODERTALJE, SWEDEN FOR ASTRAZENECA LP

28207 A

III

4/11/2014

SHANDONG DAWN POLYMER CO LTD

28208 A

II

4/18/2014

AMOLI ORGANICS PVT LTD

THERMOPLASTIC VULCANIZATE FOR PHARMACEUTICAL STOPPERS AND SEALS AS


MANUFACTURED IN SHANDONG PROVINCE, CHINA
DICLOFENAC FREE ACID AS MANUFACTURED IN GUJARAT, INDIA

28209 A

II

5/23/2014

CLAROCHEM IRELAND LTD

CL1109 AS MANUFACTURED IN DUBLIN, IRELAND

28210 A

II

4/25/2014

UNIMARK REMEDIES LTD

DORIPENEM CRUDE (INTERMEDIATE) AS MANUFACTURED IN GUJARAT, INDIA

28211 A

II

4/30/2014

PAR PHARMACEUTICAL INC

28212 A

II

5/3/2014

AURONEXT PHARMA PRIVATE LTD

MIDODRINE HYDROCHLORIDE USP AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR


PHARMACEUTICAL INC
DORIPENEM MONOHYDRATE (STERILE) AS MANUFACTURED IN RAJASTHAN, INDIA

28213 A

III

4/14/2014

VERSALIS SPA

PHARMALENE BC 82 PH AS MANUFACTURED IN BRINDISI, ITALY

28214 A

III

4/14/2014

VERSALIS SPA

PHARMALENE MP 90 PH AS MANUFACTURED IN BRINDISI, ITALY

28215 A

III

4/14/2014

VERSALIS SPA

RIBLENE FL 34 F AS MAUFACTURED IN DUNKERQUE, FRANCE

28216 P

*** PENDING FILING REVIEW ***

28217 A

II

4/21/2014

SYMED LABS LTD

LANTHANUM CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28218 A

III

4/10/2014

SONA EXTRUSION PRIVATE LTD

ALUMINIUM COLLAPSIBLE TUBES AND CONTAINERS AS MANUFACTURED IN GUJARAT, INDIA

28220 A

III

7/24/2014

STURGIS MOLDED PRODUCTS

AUXILIARY COMPONENTS

28221 A

II

5/6/2014

SYNBIAS PHARMA LTD

VINORELBINE TARTRATE AS MANUFACTURED IN DONETSK, UKRAINE

28222 A

II

5/30/2014

S AND B PHARMA INC DBA NORAC PHARMA

SPB-10101 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CALIFORNIA

28219 P

*** PENDING FILING REVIEW ***

28223 P

*** PENDING FILING REVIEW ***

28224 A

III

4/17/2014

THE PAPER PRODUCTS LTD

28225 A

II

4/22/2014

HONOUR LAB LTD

FLEXIBLE LAMINATES, POUCHES (IN 2PLY, 3PLY, 4PLY), SPECIALIZED CARTONS AND LABELS
AS MANUFACTURED IN ANDHRA PRADESH, INDIA
FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28226 A

II

8/13/2014

RHODES TECHNOLOGIES INC

NALOXONE HCl DIHYDRATE, USP AS MANUFACTURED IN COVENTRY, RI

28227 A

IV

4/17/2014

HENKEL CORP

GELVA GMS 788 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

28228 A

II

4/21/2014

GULBRANDSEN TECHNOLOGIES INC

28229 A

IV

4/18/2014

MANE INC

28230 A

II

9/11/2014

ENALTEC LABS PRIVATE LTD

ACHIEVE D 5490 CP AS MANUFACTURED IN GUJARAT, INDIA FOR GULBRANDSEN


TECHNOLOGIES INC.
FLAVORINGS FOR PHARMACEUTICAL USE AS MANUFACTURED IN LEBANON, OHIO; MILFORD,
OHIO; WOODLAWN, OHIO AND BAR SUR LOUP, FRANCE
TROSPIUM CHLORIDE USP AS MANUFACTURED IN MAHARASTRA, INDIA

28231 A

II

5/27/2014

MEDICHEM MANUFACTURING MALTA LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN HAL FAR, MALTA

28232 A

III

4/27/2014

AMISHA VINYLS PVT LTD

NON-TOXIC RIGID PVC FILM FOR PHARMACEUTICAL BLISTER PACKAGING, FOOD PRODUCTS
AND THERMOFORMING APPLICATIONS AS MANUFACTURED IN NANI DAMAN, INDIA

28233 A

IV

4/25/2014

PFANSTIEHL INC

28234 A

IV

11/3/2014

CATALENT PHARMA SOLUTIONS LLC

D-GALACTOSE, PLANT DERIVED, HIGH PURITY LOW ENDOTOXIN, USP/NF, EP (G-126-1) AS


MANUFACTURED IN WAUKEGAN, IL
SOFTGELS [OET-10275299]

28235 A

II

6/19/2014

EMCURE PHARMACEUTICALS LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 835

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28236 A
IV
4/18/2014
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
28237 A
IV
4/18/2014
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
28238 A
IV
4/18/2014
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
28239 A
IV
4/21/2014
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
28240 A
IV
4/18/2014
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
28241 A
IV
4/21/2014
KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
28242 A
II
5/14/2014
URQUIMA SA

SUBJECT
30625750 NAT FL MODULATOR (MASKING) FMT AS MANUFACTURED IN CLARK, NEW JERSEY

28243 A

IV

4/18/2014

30625757 NAT FL MOD (MOUTHFEEL) FMT AS MANUFACTURED IN CLARK, NEW JERSEY

28244 A

II

4/28/2014

KERRY INGREDIENTS AND FLAVOURS DBA


MASTERTASTE INC
ACEBRIGHT INDIA PHARMA PRIVATE LTD

28245 A

II

6/25/2014

QILU ANTIBIOTICS PHARMACEUTICAL CO LTD

28246 A

II

5/19/2014

SOLUTEX GC SL

STERILE CEFTAROLINE FOSAMIL WITH ARGININE AS MANUFACTURED IN SHANDONG


PROVINCE, CHINA
OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN MALLEN (ZARAGOZA), SPAIN

28247 A

II

6/16/2014

APICORE US LLC

FLUCYTOSINE, USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

28248 A

II

5/1/2014

NOF CORP

MPEG5000DPPE (N-(METHOXYPOLYETHYLENEGLYCOLCARBAMOYL)-1,2-DIPALMITOYL-SNGLYCERO-3-PHOSPHATIDYL-ETHANOLAMINE,MONOSODIUM SALT) AS MANUFACTURED IN


HYOGO, JAPAN

28249 A

III

4/30/2014

APEX PLASTICS INC

12OZ MILK OF MAGNESIA AS MANUFACTURED IN BROOKFIELD, MISSOURI

28250 A

II

5/1/2014

IRVINE SCIENTIFIC SALES CO

RPMI MEDIUM 1640 WITHOUT L-GLUTAMINE - LIQUID AS MANUFACTURED IN SANTA ANA,


CALIFORNIA

28252 A

II

6/4/2014

RAKS PHARMA PVT LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28253 A

II

4/30/2014

IRVINE SCIENTIFIC SALES CO

ALPHA MEM EARLE'S SALTS - LIQUID AS MANUFACTURED IN SANTA ANA, CA

28254 A

II

4/25/2014

PRASTERONE ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA

28255 A

II

4/28/2014

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO


LTD
AUSTIN PHARMA LLC

28256 A

II

5/2/2014

IBA MOLECULAR NORTH AMERICA INC

68GA-DOTA-TOC AS MANUFACTURED IN SOMERSET, NJ

28257 A

III

4/29/2014

AZTEC TECHNOLOGIES

28258 A

II

2/4/2014

FRESENIUS KABI ANTI INFECTIVES SRL

MOISTURE AND ODOUR REGULATING PRODUCTS AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
CEFEPIME ARGININE STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY

28259 A

IV

5/2/2014

FONA INTERNATIONAL INC

884.0107U N-C JUICY ORANGE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

28260 A

II

5/30/2014

DR REDDYS LABORATORIES LTD

VILAZODONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28261 A

IV

6/19/2014

ALBANY MOLECULAR RESEARCH INC

SODIUM TARTRATE, NF AS MANUFACTURED IN ALBANY, NY

28262 A

II

6/23/2014

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

NILUTAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA


PHARMACEUTICALS PVT LTD

28264 A

II

6/6/2014

MYLAN LABORATORIES LTD

FLUTICASONE PROPIONATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28265 A

IV

5/6/2014

FONA INTERNATIONAL INC

815.0052U N-C BUBBLEGUM TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

28266 A

IV

5/6/2014

JAPAN CORN STARCH CO LTD

GRASTAR AS MANUFACTURED IN AICHI, JAPAN

28251 P

30625760 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NEW


JERSEY
30625759 NAT FL MOD (MASKING) FMT SD AS MANUFACTURED IN CLARK, NEW JERSEY
30627948 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NEW
JERSEY
30625761 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NEW
JERSEY
30627945 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NEW
JERSEY
ALBACONAZOLE AS MANUFACTURED IN BARCELONA, SPAIN

LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN KARNATAKA, INDIA

*** PENDING FILING REVIEW ***

28263 P

CANNABIDIOL AS MANUFACTURED IN ROUND ROCK, TX

*** PENDING FILING REVIEW ***

Page 836

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28267 A
II
5/6/2014
ALCHYMARS ICM SM PRIVATE LTD

SUBJECT
6-METHYLENE ANDROST-4-ENE-3, 17-DIONE (6-MAD) DRUG SUBSTANCE INTERMEDIATE AS
MANUFACTURED IN TAMIL NADU, INDIA
MIXING SPATULA AS MANUFACTURED IN LINCOLN, NE

28268 A

III

4/30/2014

HEINKE TECHNOLOGY INC

28269 A

III

4/29/2014

3M DRUG DELIVERY SYSTEMS

28270 A

III

4/30/2014

BORMIOLI ROCCO SPA BU PHARMA PLASTIC

28271 A

II

4/25/2014

SEWON CELLONTECH CO LTD

28272 A

III

4/15/2014

ROY AND LECLAIR EMBALLAGE INC

28273 A

II

5/5/2014

BACHEM AMERICAS INC

28274 A

IV

5/6/2014

WEI MING PHARMACEUTICAL MFG CO LTD

28275 A

II

5/6/2014

28276 A

II

6/11/2014

LIVZON GROUP FUZHOU FUXING


PHARMACEUTICAL CO LTD
BIOCON LTD

28277 A

II

5/8/2014

NEULAND LABORATORIES LTD

ALCAFTADINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28278 A

II

6/11/2014

CADILA HEALTHCARE LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28279 A

II

6/7/2014

UNIMARK REMEDIES LTD

MEROPENEM USP (STERILE) AS MANUFACTURED IN GUJARAT, INDIA

28280 A

II

5/30/2014

UNIMARK REMEDIES LTD

DORIPENEM STERILE AS MANUFACTURED IN GUJARAT, INDIA

28281 A

II

6/12/2014

CADILA HEALTHCARE LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28282 A

II

5/28/2014

HARMAN FINOCHEM LTD

CHOLINE FENOFIBRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

28283 A

II

5/5/2014

BASF PHARMACHEMIKALIEN GMBH CO KG

(-)-EPHEDRINE SULFATE AS MANUFACTURED IN MINDEN, F. R. OF GERMANY

28284 A

II

5/9/2014

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD

RUFINAMIDE AS MANUFACTURED IN ZHEJIANG, CHINA

28285 A

II

5/29/2014

CADILA HEALTHCARE LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN GUJARAT, INDIA

28286 A

III

5/13/2014

SABIC PETROCHEMICALS BV

SABIC PP PCGR40L AS MANUFACTURED IN GELEEN, THE NETHERLANDS

28287 A

II

6/13/2014

DIPHARMA FRANCIS SRL

FEXOFENADINE HYDROCHLORIDE USP FORM A AS MANUFACTURED IN MERETO DI TOMBA


(UD), ITALY

28288 A

II

11/26/2014

28289 A

II

6/19/2014

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO


FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN JIANGSU, CHINA
LTD
ALKEM LABORATORIES LTD
SODIUM OXYBATE AS MANUFACTURED IN GUJARAT, INDIA

28290 A

III

5/10/2014

CHEMIPACK INDIA PRIVATE LTD

H.D.P.E. CANISTERS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28291 A

III

5/13/2014

KUNSTSTOFFWERK KREMSMUNSTER GMBH

28292 A

II

6/24/2014

ALP PHARM BEIJING CO LTD

28293 A

II

6/12/2014

LAURUS LABS PRIVATE LTD

PP28 CHILD RESISTANT CAPS T/E WITH VARIOUS LINERS AS MANUFACTURED IN


KREMSMNSTER, AUSTRIA
ABIRATERONE ACETATE AS MANUFACTURED IN INNO MONGOLIA, CHINA FOR ALP PHARM
BEIJING CO LTD
CABAZITAXEL AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28295 A

II

8/12/2014

28296 A

II

28297 A

II

28298 A

II

28294 P

3M PACKAGING FILM PF200M AS MANUFACTURED IN COTTAGE GROVE, MN; DECATUR, AL


AND HUTCHINSON, MN
SYRINGE DOSING 5ML WITH COVER AS MANUFACTURED IN CASTELGUELFO (PR), ITALY;
RIVANAZZANO (PV), ITALY AND SAINT SULPICE, FRANCE
ATELOCOLLAGEN POWDER AS MANUFACTURED IN SEOUL, KOREA
INJECTION MOLDED COMPONENTS AS MANUFACTURED IN QUEBEC, CANADA FOR
ROY+LECLAIR EMBALLAGE INC.
LINACLOTIDE (BULK) AS MANUFACTURED IN TORRANCE, CALIFORNIA
CYCLOCEL (MICROCRYSTALLINE CELLULOSE, NF/EP) AS MANUFACTURED IN TAIWAN, R. O.
CHINA
KANAMYCIN SULFATE AS MANUFACTURED IN FUJIAN PROVINCE, P.R. CHINA
FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA

*** PENDING FILING REVIEW ***

5/23/2014

POLYCARBON INDUSTRIES INC DBA PCI


SYNTHESIS
UNIMARK REMEDIES LTD

PODOPHYLLOTOXIN 184 NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


NEWBURYPORT, MA
IMIPENEM CRUDE (INTERMEDIATE) AS MANUFACTURED IN GUJARAT, INDIA

6/4/2014

HETERO DRUGS LTD

6/11/2014

LUPIN LTD

BUPROPION HYDROCHLORIDE (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH,


INDIA
GLYCEROL PHENYLBUTYRATE AS MANUFACTURED IN KARNATAKA, INDIA FOR LUPIN LIMITED

Page 837

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28299 A
II
5/28/2014
CTX LIFE SCIENCES PVT LTD

SUBJECT
SEVELAMER CARBONATE AS MANUFACTURED IN GUJARAT, INDIA

28300 A

II

5/24/2014

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

28301 A

II

6/5/2014

SIGMAPHARM LABORATORIES LLC

MELPHALAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA


PHARMACEUTICALS PVT. LTD.
AMORPHOUS DOFETILIDE AS MANUFACTURED IN BENSALEM. PA

28302 A

II

5/15/2014

ZHEJIANG KANGLE PHARMACEUTICAL CO LTD

ACETAMINOPHEN DC90 FINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

28303 A

II

7/10/2014

SUN PHARMACEUTICAL INDUSTRIES LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

28304 A

II

5/13/2014

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD

ESTRONE AS MANUFACTURED IN HEBEI PROVINCE, CHINA

28305 A

5/16/2014

DAIKYO SEIKO LTD

DAIKYO RUV PROCESS

28306 A

II

5/16/2014

DIVIS LABORATORIES LTD

PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28307 A

III

5/14/2014

ARMOR SAS

AXR 600R THERMAL TRANSFER RIBBON AS MANUFACTURED IN LA CHEVROLIERE, FRANCE

28308 A

II

6/17/2014

TOPCHEM PHARMACEUTICALS LTD

TOLCAPONE AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND

28309 A

II

5/22/2014

TOPHARMAN SHANDONG CO LTD

TELMISARTAN AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA

28310 A

II

7/4/2014

OMEPRAZOLE, USP, "YUNG SHIN" (ESUB) AS MANUFACTURED IN TAIWAN, R.O.C.

28311 A

III

5/6/2014

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO


LTD
APTAR FRANCE SAS

28312 A

II

5/19/2014

PROCOS SPA

GUANFACINE HYDROCHLORIDE AS MANUFACTURED IN CAMERI (NO), ITALY

28313 A

III

4/26/2014

CINCORP INTERNATIONAL LTD

HDPE BOTTLES/CONTAINERS AS MANUFACTURED IN UTTAR PRADESH, INDIA

28314 A

II

6/10/2014

BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD

POSACONAZOLE AS MANUFACTURED IN JIANGSU, CHINA FOR BRIGHTGENE BIO-MEDICAL


TECHNOLOGY CO., LTD

28316 A

II

6/25/2014

DR REDDYS LABORATORIES LTD

PEMETREXED DITROMETHAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28317 A

III

4/26/2014

CINCORP INTERNATIONAL LTD

CLOSURES AND MEASURING CUPS AS MANUFACTURED IN UTTAR PRADESH, INDIA

28318 A

III

5/9/2014

HUDSON COLOR CONCENTRATES

WHITE HC80510LD AS MANUFACTURED IN LEOMINSTER, MA

28319 A

II

5/19/2014

PHARMACEUTICAL WORKS POLPHARMA SA

SILDENAFIL BASE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

28321 A

II

6/3/2014

UNIMARK REMEDIES LTD

CILASTATIN ACID (INTERMEDIATE) AS MANUFACTURED IN GUJARAT, INDIA

28322 A

II

7/8/2014

MAPRIMED SA

28323 A

II

6/5/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

FINGOLIMOD HYDROCHLORIDE (CODE 50996) AS MANUFACTURED IN BUENOS AIRES,


ARGENTINA
RIVAROXABAN AS MANUFACTURED IN ZHEJIANG, CHINA

28324 A

IV

6/25/2014

ASHLAND SPECIALITY INGREDIENTS GP

28325 A

II

5/29/2014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO


LTD
*** PENDING FILING REVIEW ***

28327 A

III

5/27/2014

RAVAGO MANUFACTURING AMERICAS

CRYSTALADD HM-237 AS MANUFACTURED IN MANCHESTER, TN

28328 A

IV

5/27/2014

FONA INTERNATIONAL INC

805.011 N-C BANANA FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

28329 A

II

5/21/2014

GALAXY SURFACTANTS LTD

OCTOCRYLENE AS MANUFACTURED IN MAHARASHTRA, INDIA

28330 A

III

5/15/2014

SICHUAN HUILI INDUSTRY CO LTD

28331 A

5/23/2014

HAUPT PHARMA WOLFRATSHAUSEN GMBH

PCTFE/PVC COMPOSITE SHEET FOR PACKAGING OF SOLID DOSAGE FORMS AS


MANUFACTURED IN SICHUAN, P.R. CHINA
STERILE DEPARTMENT 2, ASEPTIC PROCESS VALIDATION OF CYTOTOXIC PRODUCTS

28315 P

APTAR METHODS FOR CONTROLLING PACKAGING COMPONENTS AS MANUFACTURED IN


RADOLFZELL AND EIGELTINGEN, GERMANY; LE NEUBOURG, VERNEUIL, CHARLEVAL AND LE
VAUDREUIL, FRANCE FOR APTAR FRANCE S.A.S.

*** PENDING FILING REVIEW ***

28320 P

*** PENDING FILING REVIEW ***

28326 P

BENECELPH DC HYPROMELLOSE AS MANUFACTURED IN READING, PA AND DOELBEVEREN, BELGIUM FOR ASHLAND SPECIALTY INGREDIENTS GP
SITAGLIPTIN PHOSPHATE MONOHYDRATE AS MANUFACTURED IN BEIJING, CHINA

Page 838

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28332 A
III
5/14/2014
AMPACET CORP
28333 A

II

6/13/2014

CIPLA LTD

SUBJECT
1800268-NQ AMBER PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
IMATINIB MESYLATE (BETA FORM) AS MANUFACTURED IN BANGALORE, INDIA

28334 A

II

6/13/2014

DR REDDYS LABORATORIES LTD

ROSUVASTATIN CALCIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28335 A

II

5/24/2014

HIKAL LTD

GABEPENTIN (A01804) AS MANUFACTURED IN BANGALORE, INDIA

28336 A

II

5/23/2014

MEGAFINE PHARMA P LTD

28337 A

II

5/30/2014

IRVINE SCIENTIFIC SALES CO

DAR-IV (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN


MAHARASHTRA, INDIA
BALANCD MDCK - LIQUID AS MANUFACTURED IN SANTA ANA, CA

28338 A

II

5/30/2014

IRVINE SCIENTIFIC SALES CO

BALANCD MDCK - POWDER AS MANUFACTURED IN SANTA ANA, CA

28339 A

II

6/17/2014

CHIROGATE INTERNATIONAL INC

UNOPROSTONE ISOPROPYL AS MANUFACTURED IN TAIWAN, CHINA

28341 A

II

6/11/2014

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

ARIPIPRAZOLE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

28342 A

II

6/19/2014

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

DASATINIB AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

28343 A

II

7/18/2014

APOTEX PHARMACHEM INC

VILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE AS MANUFACTURED IN


BRANTFORD ONTARIO, CANADA

28340 P

*** PENDING FILING REVIEW ***

28344 P

*** PENDING FILING REVIEW ***

28345 P

*** PENDING FILING REVIEW ***

28346 A

II

5/29/2014

ZHEJIANG TIANYU PHARMACEUTICAL CO LTD

LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG, CHINA

28347 A

IV

5/30/2014

DAVID MICHAEL AND CO INC

NATURAL AND ARTIFICIAL GRAPE FLAVOR #27069 AS MANUFACTURED IN PHILADELPHIA, PA

28348 A

II

6/3/2014

3M PURIFICATION INC

28349 A

II

6/27/2014

SHILPA MEDICARE LTD

EMPHAZE AEX HYBRID PURIFIER CAPSULES AS MANUFACTURED IN ST. PAUL, MN;


COLUMBIA, MO AND MERIDEN, CT
IMATINIB MESYLATE (IMN) AS MANUFACTURED IN KARNATAKA, INDIA

28350 A

II

5/30/2014

28351 A

II

6/2/2014

LIVZON GROUP FUZHOU FUXING


PHARMACEUTICAL CO LTD
TEVA PHARMACEUTICAL INDUSTRIES LTD

28352 A

II

7/7/2014

NEULAND LABORATORIES LTD

28353 A

II

7/3/2014

CERBIOS PHARMA SA

AMLODIPINE BESYLATE (PROCESS II) AS MANUFACTURED IN GUAYAMA, PUERTO RICO FOR


TEVA PHARMACEUTICAL INDUSTRIES LTD.
DABIGATRAN ETEXILATE MESYLATE (FORM-I) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
DOXERCALCIFEROL AS MANUFACTURED IN BARBENGO/LUGANO, SWITZERLAND

28354 A

II

8/6/2014

MYLAN LABORATORIES LTD

VILAZODONE HYDROCHLORIDE AS MANUFACTURED IN TELANGANA, INDIA

28355 A

II

6/20/2014

XELLIA PHARMACEUTICALS APS

28356 A

II

6/16/2014

UNIMARK REMEDIES LTD

BACITRACIN ZINC, STERILE AS MANUFACTURED IN ZHEJIANG, CHINA AND CORONA, CA FOR


XELLIA PHARMACEUTICALS APS
IMIPENEM USP (STERILE) AS MANUFACTURED IN GUJARAT, INDIA

28357 A

II

6/5/2014

HETERO DRUGS LTD

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28358 A

II

6/11/2014

ALCHYMARS ICM SM PRIVATE LTD

BISMUTH SUBCITRATE POTASSIUM AS MANUFACTURED IN TAMIL NADU, INDIA

28359 A

II

12/15/2014

MAPRIMED SA

BENZNIDAZOLE (CODE 50954) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA

28360 A

II

6/30/2014

CIPLA LTD

VALGANCICLOVIR HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28361 A

II

6/6/2014

YABAO PHARMACEUTICAL GROUP CO LTD

PROMESTRIENE AS MANUFACTURED IN SHANXI, CHINA

28362 A

III

6/4/2014

COLORS FOR PLASTICS INC

28363 A

III

5/29/2014

SHREE GAURAV POLYMERS PVT LTD

THERMOPLASTIC RESIN PRE-COLOR COMPOUNDS B25400-P BLUE AND B25401-P BLUE AS


MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
SILICON RUBBER TUBING PEROXIDE/PLATINUM TREATED AS MANUFACTURED IN GUJARAT,
INDIA

COLISTIMETHATE SODIUM AS MANUFACTURED IN FUJIAN PROVINCE, P.R. CHINA

Page 839

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28364 A
III
5/29/2014
SHREE GAURAV POLYMERS PVT LTD

SUBJECT
SILICONE RUBBER BRAIDED TUBING AS MANUFACTURED IN GUJARAT, INDIA

28365 A

II

6/12/2014

UNIMARK REMEDIES LTD

CILASTATIN SODIUM USP (STERILE) AS MANUFACTURED IN GUJARAT, INDIA

28366 A

IV

5/30/2014

MASTERTASTE INC DBA KERRY INC

30626205 NAT FL MOD (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NJ

28367 A

IV

6/2/2014

NORTHWESTERN EXTRACT CO

LIME FLAVORING #1921 AS MANUFACTURED IN GERMANTOWN, WI

28368 A

II

11/25/2014

TAIHO PHARMACEUTICAL CO LTD

TIPIRACIL HYDROCHLORIDE (TPI) AS MANUFACTURED IN SAITAMA, JAPAN

28369 A

II

8/28/2014

GLENMARK GENERICS LTD

VILAZODONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28370 A

IV

6/9/2014

FONA INTERNATIONAL INC

889.0066U PEACH FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

28371 A

II

6/16/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

TOPIRAMATE AS MANUFACTURED IN ZHEJIANG, CHINA

28372 A

II

6/19/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA

28373 P

*** PENDING FILING REVIEW ***

28374 A

III

6/4/2014

NOLATO JAYCARE LTD

CR SPRAY COLLAR AND CAP AS MANUFACTURED IN NEWCASTLE UPON TYNE, ENGLAND

28375 A

II

6/9/2014

PCAS

ESOMEPRAZOLE SODIUM AS MANUFACTURED IN TURKU, FINLAND

28376 A

II

6/6/2014

SRIKEM LABORATORIES PVT LTD

HYDROXYZINE HYDROCHLORIDE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA

28377 A

III

6/5/2014

AMPACET CORP

28378 A

III

6/11/2014

PFP TERMOPOLIMEROS SL

1700634-N TEAL PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;


CARTERSVILLE, GA AND HEATH, OH
PILD-CRC AL CONTAINER AS MANUFACTURED IN FIGARO (BARCELONA) , SPAIN

28379 A

II

6/30/2014

APOTEX PHARMACHEM INDIA PVT LTD

DEFERASIROX AS MANUFACTURED IN BANGALORE, INDIA

28380 A

II

5/20/2014

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

LANSOPRAZOLE AS MANUFACTURED IN HUBEI, CHINA

28381 A

II

6/18/2014

UNIMARK REMEDIES LTD

28382 A

II

6/19/2014

UNIMARK REMEDIES LTD

28383 A

II

6/13/2014

HETERO LABS LTD

STERILE MIXTURE FOR IMIPENEM, CILASTATIN SODIUM AND SODIUM BICARBONATE (DRUG
PRODUCT INTERMEDIATE) AS MANUFACTURED IN GUJARAT, INDIA
STERILE MIXTURE FOR MEROPENEM AND SODIUM CARBONATE (DRUG PRODUCT
INTERMEDIATE) AS MANUFACTURED IN GUJARAT, INDIA
ABIRATERONE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28384 A

II

6/13/2014

JILIN ASYMCHEM LABORATORIES CO LTD

PITAVASTATIN CALCIUM AS MANUFACTURED IN JILIN, CHINA

28385 A

II

6/3/2014

CAMBREX PROFARMACO MILANO SRL

EPINEPHRINE BITARTRATE AS MANUFACTURED IN MILAN, ITALY

28386 A

II

6/3/2014

WUHAN ZY PHARMACEUTICAL CO LTD

POSACONAZOLE AS MANUFACTURED IN HUBEI PROVINCE, CHINA

28387 A

II

6/24/2014

INTAS PHARMACEUTICALS LTD

FINGOLIMOD HYDROCHLORIDE (FORM 1) AS MANUFACTURED IN GUJARAT, INDIA

28388 A

II

8/5/2014

MSN PHARMACHEM PRIVATE LTD

28389 A

II

6/16/2014

DAIICHI FINE CHEMICAL CO LTD

VILAZODONE HYDROCHLORIDE [ROUTE CODE "VH"] AS MANUFACTURED IN ANDHRA


PRADESH, INDIA
OLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN

28390 A

II

6/30/2014

CADILA HEALTHCARE LTD

DULOXETINE HYDROCHLORIDE USP (PROCESS-II) AS MANUFACTURED IN GUJARAT, INDIA

28391 A

II

6/16/2014

SEQUENT SCIENTIFIC LTD

28392 A

II

6/30/2014

DR REDDYS LABORATORIES LTD

ERTAPENEM SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR SEQUENT


SCIENTIFIC LTD.
MIRABEGRON [PRODUCT CODE: AEB] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28393 A

III

6/15/2014

ADHESIVES RESEARCH INC

SR-26 (A-4493) AS MANUFACTURED IN GLEN ROCK, PA

28394 A

III

6/15/2014

ADHESIVES RESEARCH INC

MA-111 (A-5181-99) AS MANUFACTURED IN GLEN ROCK, PA

28395 A

II

8/22/2014

SUN PHARMACEUTICAL INDUSTRIES LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA

28396 A

II

6/30/2014

PIRAMAL ENTERPRISES LTD

PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28397 A

II

7/8/2014

EMCURE PHARMACEUTICALS LTD

NEOSTIGMINE METHYLSULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28398 A

II

6/17/2014

SHODHANA LABORATORIES LTD

DULOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 840

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28399 A
IV
6/18/2014
FONA INTERNATIONAL INC

SUBJECT
915.1071U STRAWBERRY FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

28400 A

II

10/22/2014

CATALENT PHARMA SOLUTIONS LLC

SOFTGELS [OET-10275198] AS MANUFACTURED IN ST. PETERSBURG, FLORIDA

28401 A

II

7/30/2014

LUPIN LTD

VILAZODONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28402 A

IV

6/18/2014

SPI PHARMA INC

PHARMABURST 530 AS MANUFACTURED IN GRAND HAVEN, MI

28403 A

II

6/10/2014

SHANDONG XINHUA PHARMACEUTICAL CO LTD

IBUPROFEN SODIUM AS MANUFACTURED IN SHANDONG, P.R. CHINA

28404 A

II

6/26/2014

LINAGLIPTIN AS MANUFACTURED IN BEIJING, CHINA

28405 A

II

7/11/2014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO


LTD
DR REDDYS LABORATORIES LTD

28407 A

IV

6/12/2014

28408 A

IV

6/16/2014

28409 A

II

6/19/2014

28406 P

LOMUSTINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

*** PENDING FILING REVIEW ***

28410 P

JIAOZUO ZHONGWEI SPECIAL PRODUCTS


PHARMACEUTICAL CO LTD
JIAOZUO ZHONGWEI SPECIAL PRODUCTS
PHARMACEUTICAL CO LTD
VIWIT PHARMACEUTICAL CO LTD

POVIDONE AS MANUFACTURED IN HENAN PROVINCE, CHINA


CROSPOVIDONE AS MANUFACTURED IN HENAN PROVINCE CHINA
LULICONAZOLE AS MANUFACTURED IN SHANGHAI, CHINA

*** PENDING FILING REVIEW ***

28411 A

II

6/26/2014

PERRIGO API LTD

LORATADINE AS MANUFACTURED DISTRICT THANE, INDIA FOR PERRIGO API LTD

28412 A

II

7/7/2014

ZACH SYSTEM SA

ABIRATERONE ACETATE AS MANUFACTURED IN AVRILLE CEDEX, FRANCE

28413 A

II

9/23/2014

JIANGSU HENGRUI MEDICINE CO LTD

28414 A

II

10/7/2014

IRIX MANUFACTURING INC

28415 A

II

6/19/2014

UNION QUIMICO FARMACEUTICA SA

DESFLURANE, USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU,


CHINA
TRAVOPROST, USP AS MANUFACTURED IN
FLORENCE, SC
MIVACURIUM CHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN

28416 A

II

6/20/2014

ASYMCHEM LIFE SCIENCE TIANJIN CO LTD

SAPROPTERIN AS MANUFACTURED IN TIANJIN, CHINA

28417 A

II

7/21/2014

SUN PHARMACEUTICAL INDUSTRIES LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

28418 A

II

7/29/2014

ITF CHEMICAL LTDA

BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN BAHIA, BRAZIL

28419 A

II

7/10/2014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN ZHEJIANG, CHINA

28420 A

II

6/25/2014

OPTIMUS DRUGS PRIVATE LTD

28421 A

II

6/21/2014

HIKAL LTD

(1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON


INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
BUPROPION HYDROCHLORIDE USP [PROCESS-2] AS MANUFACTURED IN KARNATAKA, INDIA

28422 A

II

6/13/2014

SKUNY BIOSCIENCE CO LTD

ICOSAPENT ETHYL AS MANUFACTURED IN SICHUAN, P. R. CHINA

28423 A

II

7/8/2014

CEDARBURG PHARMACEUTICALS

ATROPINE SULFATE, USP AS MANUFACTURED IN GRAFTON, WI

28424 A

II

7/28/2014

GLAND PHARMA LTD

SODIUM PHENYLACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28425 A

II

6/16/2014

SKUNY BIOSCIENCE CO LTD

DOCOSAHEXAENOIC ACID ETHYL ESTER AS MANUFACTURED IN SICHUAN, P. R. CHINA

28426 A

IV

6/16/2014

HENKEL CORP

GELVA GMS 737 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC

28427 A

6/26/2014

DOW CORNING CORP

DOW CORNING SILAC HYBRID PRESSURE SENSITIVE ADHESIVES

28428 P

*** PENDING FILING REVIEW ***

28429 A

III

6/20/2014

REXAM PHARMA PACKAGING INDIA PVT. LTD

HDPE PLASTIC CONTAINER AS MANUFACTURED IN BANGALORE, INDIA

28430 A

III

6/30/2014

TERUMO CORP

I-COATING STOPPERS AS MANUFACTURED IN SHIZUOKA, JAPAN

28431 A

II

6/30/2014

SMS PHARMACEUTICALS LTD

LEVETIRACETAM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28432 A

II

7/22/2014

MEDICHEM SA

NEPAFENAC AS MANUFACTURED IN CELRA (GIRONA), SPAIN

Page 841

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28433 A
II
7/28/2014
AARTI INDUSTRIES LTD

SUBJECT
VENLAFAXINE HYDROCHLORIDE POLYMORPH B AS MANUFACTURED IN MAHARASHTRA,
INDIA
CASSETTE FOR THE PRODUCTION OF FLUORINE-18 SODIUM FLUORIDE USING AN
AUTOMATED SYNTHESIS UNIT, VERSION B
MULTILAYER TABLET BOTTLE SERIE (ASPEN) AS MANUFACTURED IN NEUHAUS A. RWG.,
GERMANY
WISECAN DESICCANT CANISTER AS MANUFACTURED IN JIANGSU, CHINA

28434 A

6/26/2014

ROTEM INDUSTRIES LTD

28435 A

III

6/23/2014

28436 A

III

6/30/2014

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG
KUNSHAN WISEPAC DESICCANT CO LTD

28437 A

III

12/15/2014

BAXTER HEALTHCARE CORP

28438 A

II

8/8/2014

MYLAN LABORATORIES LTD

28439 A

II

7/16/2014

EMCURE PHARMACEUTICALS LTD

28440 A

II

9/4/2014

MYLAN LABORATORIES LTD

4'-ACETYLOXY 2, 4-DIFLUOROBIPHENYL AS MANUFACTURED IN ANDHRA PRADESH, INDIA


FOR EMCURE PHARMACEUTICALS LTD
ROFLUMILAST AS MANUFACTURED IN MAHARASHTRA, INDIA

28441 A

II

6/20/2014

MINAKEM

BUDESONIDE MICRONIZED AS MANUFACTURED IN DUNKERQUE, FRANCE FOR MINAKEM

28442 A

II

7/15/2014

AUROBINDO PHARMA LTD

DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28443 A

II

8/4/2014

TORRENT PHARMACEUTICALS LTD

GUANFACINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

28444 A

II

7/2/2014

CHINOIN PHARMACEUTICAL AND CHEMICAL


WORKS PRIVATE CO LTD
NOT AN ASSIGNED NUMBER

OLMESARTAN MEDOXOMIL AS MANUFACTURED IN BUDAPEST, HUNGARY

28446 A

II

8/28/2014

DR REDDYS LABORATORIES LTD

TICAGRELOR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28447 A

II

7/9/2014

INTAS PHARMACEUTICALS LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28448 A

II

7/22/2014

AUROBINDO PHARMA LTD

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28449 A

IV

6/16/2014

POLYETHYLENE GLYCOL 4000

28450 A

IV

6/16/2014

TIANJIN BOKELIN MEDICAL PACKAGING


TECHNOLOGY CO LTD
TIANJIN BOKELIN MEDICAL PACKAGING
TECHNOLOGY CO LTD
*** PENDING FILING REVIEW ***

28452 A

II

8/14/2014

HEC PHARM CO LTD

28453 A

II

10/23/2014

HEC PHARM CO LTD

28454 A

II

9/28/2014

HEC PHARM CO LTD

28455 A

II

7/31/2014

PIRAMAL ENTERPRISES LTD

AZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN


HUBEI PROVINCE, P. R. CHINA FOR HEC PHARM CO. LTD
AZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED
IN GUANGDONG PROVINCE, CHINA FOR HEC PHARM CO. LTD
ESCITALOPRAM OXALATE NON-STERILE BULK SUBSTANCE AS MANUFACTURED IN
GUANGDONG PROVINCE. P. R. CHINA FOR HEC PHARM CO LTD
BACLOFEN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28456 A

II

7/1/2014

KAIYUAN HENGTAI PHARMA CO LTD

TICAGRELOR (CAS: 274693-27-5) AS MANUFACTURED IN LIAONING, P.R. CHINA

28457 A

II

6/23/2014

HINDUSTAN HERBALS LTD

THIOCOLCHICOSIDE AS MANUFACTURED IN ROHTAK HARYANA, INDIA

28458 A

II

9/16/2014

CHIROGATE INTERNATIONAL INC

TREPROSTINIL AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA

28445 N

28451 P

28459 N

VIAFLO CONTAINER CLOSURE SYSTEM AS MANUFACTURED FOR BAXTER HEALTHCARE


CORP
COBICISTAT ON SILICON DIOXIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

POLYETHYLENE GLYCOL 6000

NOT AN ASSIGNED NUMBER

28460 A

II

7/21/2014

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD

28461 A

IV

7/1/2014

JRS PHARMA GMBH AND CO KG

28462 A

II

7/8/2014

MINAKEM

28463 N

NOT AN ASSIGNED NUMBER

28464 N

NOT AN ASSIGNED NUMBER

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R.


CHINA
PROSOLV EASYTAB
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN DUNKERQUE, FRANCE
FOR MINAKEM

Page 842

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28465 N
NOT AN ASSIGNED NUMBER
28466 N

SUBJECT

NOT AN ASSIGNED NUMBER

28467 A

III

7/11/2014

OREM ACCESS BIO INC

ORAL SYRINGE PRODUCTS

28468 A

II

7/14/2014

IRVINE SCIENTIFIC SALES CO

HUMAN SERUM ALBUMIN -LIQUID AS MANUFACTURED IN SANTA ANA, CA

28469 A

II

7/11/2014

IRVINE SCIENTIFIC SALES CO

28470 A

II

10/31/2014

TARO PHARMACEUTICAL INDUSTRIES LTD

ISCOVE'S MODIFIED DULBECCO'S MEDIUM - LIQUID AS MANUFACTURED IN SANTA ANA,


CALIFORNIA
TAZAROTENE, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL

28471 A

II

7/31/2014

INTERQUIM SA

ROFLUMILAST AS MANUFACTURED IN BARCELONA, SPAIN

28472 A

II

11/20/2014

JIANGSU HENGRUI MEDICINE CO LTD

CASPOFUNGIN ACETATE AS MANUFACTURED IN JIANGSU, CHINA

28473 A

II

7/7/2014

NANDU CHEMICALS PVT LTD

SODIUM CHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

28474 A

II

9/16/2014

UNICHEM LABORATORIES LTD

GLIPIZIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA

28475 A

II

7/25/2014

INTAS PHARMACEUTICALS LTD

DABIGATRAN ETEXILATE MESYLATE FORM-I AS MANUFACTURED IN GUJARAT, INDIA

28476 A

III

6/20/2014

GAPLAST GMBH

CHILD RESISTANT DESICCANT CLOSURE

28477 N

NOT AN ASSIGNED NUMBER

28478 A

IV

7/15/2014

FONA INTERNATIONAL INC

915.0435U N-C STRAWBERRY FLAVOR, ART

28479 A

II

11/20/2014

YUKI GOSEI KOGYO CO LTD

TRIFLURIDINE AS MANUFACTURED IN FUKUSHIMA, JAPAN

28480 A

III

7/15/2014

ADHESIVES RESEARCH INC

SILICONE AND NON-SILICONE LINERS SERIES 4000, 5000, 6000 AND 7000

28481 A

III

7/9/2014

AMPACET CORP

GOLD SMC PP MB 4300218-NE

28482 A

III

7/9/2014

AMPACET CORP

BLUE SMC PP MB 4600444-N

28483 A

II

12/19/2014

IROKO PROPERTIES INC

28484 A

III

7/15/2014

BOREALIS AG

VIVLODEX (TM) CAPSULES AS MANUFACTURED IN KANSAS CITY, MO AND CAGUAS, PR FOR


IROKO PROPERTIES INC
BORMED RB801CF-11

28485 A

III

7/15/2014

BOREALIS AG

BORMED RE816CF

28486 A

III

7/15/2014

BOREALIS AG

BORMED RD804CF-11

28487 A

III

7/15/2014

BOREALIS AG

BORMED RD808CF-11

28488 A

II

7/16/2014

OPTIMUS DRUGS PRIVATE LTD

28489 A

III

7/16/2014

POLYONE CORP

3-(4-CHLORO-BUTYL)-1H-INDOLE-5-CARBONITRILE (VILAZODONE INTERMEDIATE) AS


MANUFACTURED IN ANDHRA PRADESH, INDIA
CC10156886XX

28490 A

II

8/8/2014

AURISCO PHARMACEUTICAL LTD

28491 A

III

7/16/2014

MEIWEI LTD

28493 A

II

9/24/2014

ALEMBIC PHARMACEUTICALS LTD

VILAZODONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28494 A

II

9/30/2014

ALEMBIC PHARMACEUTICALS LTD

CLONIDINE USP AS MANUFACTURED IN GUJARAT, INDIA

28495 A

II

10/31/2014

SAI LIFE SCIENCES LTD

PIMOZIDE USP AS MANUFACTURED IN KARNATAKA, INDIA

28492 P

16-ALPHA-HYDROXYPREDNISOLONE AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R.


CHINA FOR AURISCO PHARMACEUTICAL LIMITED
O2ZERO/02O OXYGEN ABSORBERS

*** PENDING FILING REVIEW ***

28496 N

NOT AN ASSIGNED NUMBER

28497 A

III

7/15/2014

AMPACET CORP

4600000-N PURPLE PEARL

28498 A

IV

5/23/2014

28499 A

III

7/23/2014

MOLKEREI MEGGLE WASSERBURG GMBH AND CO RETALAC


KG
FPC FLEXIBLE PACKAGING CORP
STRIP PACK LAMINATES, FPC SPECIFICATIONS; 47595, 57192 AND 57193.

Page 843

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28500 A
II
7/22/2014
SHANGHAI NEW HUALIAN PHARMACEUTICAL CO
LTD
28501 A
II
7/27/2014
BEIJING HUIKANG BOYUAN CHEMICAL TECH CO
LTD
28502 A
II
8/5/2014
STERLING CHEMICAL MALTA LTD

SUBJECT
HYDROCORTISONE AS MANUFACTURED IN SHANGHAI, CHINA

28503 A

III

7/21/2014

FARMAGOMMA SRL

RUBBER COMPOUNDS

28504 A

II

7/23/2014

OPTIMUS DRUGS PRIVATE LTD

28505 A

II

8/4/2014

HONOUR LAB LTD

5-(PIPERAZIN-1-YL) BENZOFURAN-2-CARBOXAMIDE (VILAZODONE INTERMEDIATE) AS


MANUFACTURED IN ANDHRA PRADESH, INDIA
EMTRICITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28506 A

II

7/22/2014

CHONGQING HUAPONT PHARMACEUTICAL CO LTD ROFLUMILAST AS MANUFACTURED IN CHONGQING, P.R. CHINA

28507 A

II

7/14/2014

ZHEJIANG SUPOR PHARMACEUTICALS CO LTD

TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

28508 A

IV

7/21/2014

NUSIL TECHNOLOGY LLC

DDU-4320 SILICONE ELASTOMER

28509 A

IV

7/28/2014

AJINOMOTO NORTH AMERICA INC

ADVANTAME AS MANUFACTURED IN MIE, JAPAN FOR AJINOMOTO NORTH AMERICA, INC

28510 A

IV

7/25/2014

ARPITHA AROMATICS

MIXED FRUIT FLAVOUR 3A NO.1

28511 A

II

7/25/2014

KYONGBO PHARMACEUTICAL CO LTD

IMATINIB MESYLATE AS MANUFACTURED IN CHUNGCHEONGNAM-DO, REPUBLIC OF KOREA

28512 A

II

12/3/2014

ZHEJIANG RUIBANG LABORATORIES INC

CYCLOSPORINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

28513 I

II

6/23/2014

CHENGDU SHENGNUO BIOPHARM CO LTD

LIRAGLUTIDE AS MANUFACTURED IN SICHUAN, CHINA

28514 A

III

7/23/2014

AMPACET CORP

131311 CREAM SLIP HDPE MB

28515 A

III

7/29/2014

FPC FLEXIBLE PACKAGING CORP

HIGH BARRIER FOIL POUCH STOCK, FPC SPECIFICATIONS; 43535 AND 43536

28516 A

II

8/27/2014

HETERO DRUGS LTD

ROFLUMILAST AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28517 A

III

7/28/2014

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 31-2001D

28518 A

II

7/30/2014

HENAN LIHUA PHARMACEUTICAL CO LTD

PREDNISOLONE ACETATE USP AS MANUFACTURED IN HENAN, CHINA

28520 A

III

7/28/2014

MULTI PLASTICS MANUFACTURING LLC

MANUFACTURING OF PLASTIC BOTTLES FOR FOOD AND PHARMACEUTICAL USE

28521 A

III

7/25/2014

FOIL CAP

28522 A

III

7/25/2014

28523 A

II

12/2/2014

BEIJING AUSTAR HANSEN PACKAGING


TECHNOLOGY LTD
BEIJING AUSTAR HANSEN PACKAGING
TECHNOLOGY LTD
MACLEODS PHARMACEUTICALS LTD

28524 A

II

8/24/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

TACROLIMUS AS MANUFACTURED IN OPAVA, KOMAROV, CZECH REPUBLIC FOR TEVA


PHARMACEUTICAL INDUSTRIES LTD

28519 P

BENDAMUSTINE HCl AS MANUFACTURED IN BEIJING, CHINA


LEVONORGESTREL AS MANUFACTURED IN BIRZEBBUGIA, MALTA

*** PENDING FILING REVIEW ***

28525 N

EURO CAP
ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

NOT AN ASSIGNED NUMBER

28526 N

NOT AN ASSIGNED NUMBER

28527 A

II

8/1/2014

SIFAVITOR SRL

PERHEXILINE MALEATE AS MANUFACTURED IN FRAZIONE MAIRANO (LO), ITALY

28528 A

IV

7/30/2014

SOCIETE INDUSTRIELLE DES OLEAGINEUX

REFINED SOYBEAN OIL IV

28529 A

IV

7/31/2014

FONA INTERNATIONAL INC

825.0445U CHERRY FLAVOR, NAT & ART

28530 A

II

7/28/2014

28531 A

II

7/31/2014

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
CHONGQING DAXIN PHARMACEUTICAL CO LTD

HOMATROPINE METHYLBROMIDE AS MANUFACTURED IN HUBEI PROVINCE, THE PEOPLE'S


REPUBLIC OF CHINA FOR HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD
MEVASTATIN AS MANUFACTURED IN CHONGQING, PEOPLE'S REPUBLIC OF CHINA

28532 A

II

8/1/2014

BACHEM AMERICAS INC

VASOPRESSIN, USP (BULK) AS MANUFACTURED IN TORRANCE, CALIFORNIA

28533 N
28534 A

NOT AN ASSIGNED NUMBER


III

7/31/2014

RENEWSYS INDIA PVT LTD

COLD FORMING ALUMINIUM FOIL LAMINATE FOR PACKING

Page 844

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28535 N
NOT AN ASSIGNED NUMBER

SUBJECT

28536 A

INNOJIT

IV

7/25/2014

28537 N

PJ HEALTHCARE
NOT AN ASSIGNED NUMBER

28538 A

II

9/2/2014

DR REDDYS LABORATORIES LTD

CAPECITABINE [PROCESS-II] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28539 A

IV

8/1/2014

MASTERTASTE INC DBA KERRY INC

30634656 NAT FL MOD (MASKING) FMT SD

28540 A

III

8/4/2014

COLD FORMING FOIL

28541 A

II

9/25/2014

NANTONG HUIDESENG PACKAGING MATERIAL CO


LTD
AMPAC FINE CHEMICALS LLC

28542 A

IV

7/31/2014

FONA INTERNATIONAL INC

807.0602U N-C BERRY FLAVOR, ART

28543 A

II

8/5/2014

IRVINE SCIENTIFIC SALES CO

PRIME-XV OSTEOGENIC DIFFERENTIATION SFM AS MANUFACTURED IN SANTA ANA, CA

28544 A

III

7/31/2014

POLYETHYLENE TEREPHTHALATE RESINS

28545 A

IV

7/31/2014

INDORAMA VENTURES POLYMERS MEXICO S DE


RL DE CV
FONA INTERNATIONAL INC

28546 A

II

7/25/2014

RIFAMYCIN S AS MANUFACTURED IN HENAN PROVINCE, P. R. CHINA

28547 A

II

7/8/2014

28548 A

II

7/3/2014

LUOHE NANJIECUN PHARMACEUTICAL GROUP


PHARMACY CO LTD
CHINA GATEWAY PHARMACEUTICAL
DEVELOPMENT CO LTD
SHOUGUANG FUKANG PHARMACEUTICAL CO LTD

28549 A

IV

8/6/2014

FONA INTERNATIONAL INC

28550 A

II

7/30/2014

28551 A

II

7/30/2014

28552 A

II

8/7/2014

28553 A

IV

8/4/2014

CHONGQING HUAPONT PHARMACEUTICAL CO LTD PARICALCITOL AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR CHONGQING HUAPONT
PHARMACEUTICAL CO LTD
CHONGQING HUAPONT PHARMACEUTICAL CO LTD MOXIFLOXACIN HCL AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR CHONGQING
HUAPONT PHARMACEUTICAL CO. LTD
BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD FONDAPARINUX INTERMEDIATE FSC AS MANUFACTURED IN JIANGSU, CHINA FOR
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD
MASTERTASTE INC DBA KERRY INC
30632117 NAT FL MOD (MASKING) FMT

28554 A

II

9/30/2014

PERRIGO API LTD

28555 A

IV

8/8/2014

RAMA INDUSTRIES LTD

FLUTICASONE FUROATE AS MANUFACTURED IN BEER SHEVA, ISRAEL AND MADHYA


PRADESH, INDIA
GELATINE TYPE B

28556 A

II

9/23/2014

RELIANCE LIFE SCIENCES PVT LTD

SORAFENIB TOSYLATE AS MANUFACTURED IN NAVI MUMBAI, INDIA

28557 A

IV

8/4/2014

MASTERTASTE INC DBA KERRY INC

30631914 N&A COOLING FL FMT

28558 A

II

8/13/2014

SEQUENT SCIENTIFIC LTD

ALBENDAZOLE AS MANUFACTURED IN KARNATAKA, INDIA

28559 A

IV

8/14/2014

FONA INTERNATIONAL INC

944.0660U N-C TROPICAL BLEND FLAVOR, NAT & ART

28560 A

IV

8/14/2014

FONA INTERNATIONAL INC

926.1292U N-C VANILLA CREME FLAVOR, NAT & ART

28561 A

II

10/16/2014

AREVIPHARMA GMBH

DIMETHYL FUMARATE AS MANUFACTURED IN RADEBEUL, GERMANY

28562 A

II

10/9/2014

EMCURE PHARMACEUTICALS LTD

PEMETREXED DISODIUM HEMIPENTAHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

28563 A

II

9/16/2014

TOPHARMAN SHANDONG CO LTD

ARIPIPRAZOLE AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA

28564 A

III

8/15/2014

MEADWESTVACO CALMAR GMBH

HIMARK CR SPRAYER MEDICAL DEVICE

II

8/14/2014

28565 N
28566 A
28567 P

TAPENTADOL HCI AS MANUFACTURED IN RANCHO CORDOVA, CA

815.0074U BUBBLE GUM FLAVOR,NAT & ART

MONTELUKAST SODIUM AS MANUFACTURED IN SHANGHAI, CHINA


ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN SHANDONG PROVINCE,
CHINA
884.0244U N-C ORANGE FLAVOR, NAT WONF

NOT AN ASSIGNED NUMBER


YABAO PHARMACEUTICAL GROUP CO LTD

DIPYRIDAMOLE USP AS MANUFACTURED IN SHANXI, CHINA

*** PENDING FILING REVIEW ***

Page 845

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28568 P
*** PENDING FILING REVIEW ***

SUBJECT

28569 A

II

11/18/2014

LUPIN LTD

METAXALONE AS MANUFACTURED IN GUJARAT, INDIA

28570 A

II

8/8/2014

ANHUI WORLDBEST PHARMACEUTICAL CO LTD

28571 A

III

8/18/2014

DUYTAN PLASTICS MANUFACTURING CORP

L-MENTHOL USP AS MANUFACTURED IN ANHUI PROVINCE, CHINA FOR ANHUI WORLDBEST


PHARMACEUTICAL CO., LTD
HDPE/PET PHARMACEUTICAL PACKAGING

28572 A

III

2/19/2014

BORMIOLI ROCCO SPA BU PLASTIC

BOTTLE LDPE 30 ML

28573 A

III

8/19/2014

SOLVIN SA

SOLVIN 258RD

28574 A

II

12/31/2014

CADILA PHARMACEUTICALS LTD

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

28575 A

IV

8/15/2014

MASTERTASTE INC DBA KERRY INC

30621251 NAT Fl MOD (MASKING) FMT SD

28576 A

IV

8/15/2014

MASTERTASTE INC DBA KERRY INC

30631976 NAT Fl MOD (MASKING) FMT SD

28577 A

IV

8/15/2014

MASTERTASTE INC DBA KERRY INC

30631971 NAT Fl MOD (MASKING) FMT SD

28578 A

IV

8/15/2014

MASTERTASTE INC DBA KERRY INC

30621242 NAT Fl MOD (MASKING) FMT SD

28579 A

IV

8/18/2014

MASTERTASTE INC DBA KERRY INC

30632403 N&A RASPBERRY FL

28580 A

II

9/25/2014

AMPAC FINE CHEMICALS LLC

TEMOZOLOMIDE AS MANUFACTURED IN RANCHO CORDOVA, CA

28581 A

II

10/1/2014

ALKEM LABORATORIES LTD

ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

28582 A

III

8/14/2014

FLEX FILMS EUROPA SP ZOO

BI-AXIALLY ORIENTED POLYETHYLENE TEREPHTHALATE (BOPET) FILMS

28583 A

II

8/18/2014

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTD

SIMVASTATIN (WITH 0.01% BHA) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

28584 A

II

8/26/2014

FONDAPARINUX SODIUM AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

28585 A

III

8/13/2014

HANGZHOU ZHONGMEI HUADONG


PHARMACEUTICAL CO LTD
ARAYMONDLIFE

28586 A

II

6/9/2014

JINZHOU JIUTAI PHARMACEUTICAL CO LTD

BENZOCAINE AS MANUFACTURED IN LIAONING PROVINCE, CHINA

28587 N

PLASTIC INJECTION MOLDED CLOSURE SYSTEM

NOT AN ASSIGNED NUMBER

28588 A

III

8/20/2014

AMPACET CORP

404449-K AMCLEAR 49

28589 A

III

8/8/2014

HIMALAYAN CAPSCON INDUSTRIES

HDPE DRY SYRUP BOTTLES, SCREW CAPS AND MEASURING CAPS

28590 A

II

8/26/2014

ASYMCHEM LIFE SCIENCE TIANJIN CO LTD

SUMATRIPTAN SUCCINATE AS MANUFACTURED IN TIANJIN, CHINA

28591 A

III

8/26/2014

FLEXTRUS AB

TRANSOFOIL E-OPET/l 2481134-0004 (UNPRINTED) AND 2281134-0003 (PRINTED)

28592 A

IV

8/20/2014

UNGERER AND CO

NAT/ART MANGO FLVP FV-658

28593 A

IV

8/28/2014

FONA INTERNATIONAL INC

915.0543U STRAWBERRY TYPE FLAVOR, NAT & ART

28594 A

III

7/27/2014

GREEN PACK FOILS PRIVATE LTD

BLISTER PACK LIDDING FOIL WITH POLYETHYLENE AS SELANT LAYER

28595 A

III

7/27/2014

GREEN PACK FOILS PRIVATE LTD

CHILD RESISTANT BLISTER PACK LIDDING FOIL: PET FILM BASED

28596 A

II

9/5/2014

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

LINEZOLID AS MANUFACTURED IN ZHEJIANG, CHINA

28597 A

II

10/31/2014

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MOXIFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

28598 A

II

9/9/2014

JUBILANT GENERICS LTD

BOSENTAN MONOHYDRATE AS MANUFACTURED IN KARNATAKA, INDIA

28599 A

II

9/17/2014

CADILA HEALTHCARE LTD

PHTHALOYL AMLODIPINE AS MANUFACTURED IN GUJARAT, INDIA

28600 A

IV

8/20/2014

UNGERER AND CO

NAT/ART MASKING FLVP FV-9111

28601 A

II

10/7/2014

WOCKHARDT BIO AG

PALIPERIDONE AS MANUFACTURED IN GUJARAT, INDIA FOR WOCKHARDT BIO AG

28602 A

III

7/18/2014

ICM PLASTICS PVT LTD

28603 A

III

9/9/2014

LYONDELLBASELL AUSTRALIA PTY LTD

RIGID PVC FILM/PVDC COATED PVC FILM/PVC FILM LAMINATED WITH PE AND COATED WITH
PVDC
MOPLEN HP400L POLYPROPYLENE HOMOPOLYMER

28604 P

*** PENDING FILING REVIEW ***

Page 846

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28605 A
III
9/25/2014
POPPE AHRENSBOK GMBH

SUBJECT
GASKETS MADE OF N185/01

28606 A

III

8/2/2014

BORMIOLI ROCCO SPA BU PLASTICA

LDPE DROPPER WITH COVER

28607 A

IV

8/31/2014

ABITEC CORP

CAPROL PGE 860

28608 A

II

10/31/2014

GLAND PHARMA LTD

DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28609 A

III

8/20/2014

MOMENTIVE PERFORMANCE MATERIALS

FUSED QUARTZ GLASS FOR PHARMACEUTICAL PACKAGING MATERIALS

28610 N

NOT AN ASSIGNED NUMBER

28611 N

NOT AN ASSIGNED NUMBER

28612 A

II

11/5/2014

DIPHARMA FRANCIS SRL

28613 A

II

9/3/2014

YABAO PHARMACEUTICAL GROUP CO LTD

28614 A

II

9/2/2014

28615 A

II

8/29/2014

HYOSCYAMINE SULFATE AS MANUFACTURED IN HUBEI PROVINCE, THE PEOPLE'S REPUBLIC


OF CHINA FOR HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD
BACITRACIN USP AS MANUFACTURED IN HEBEI CHINA

28616 A

II

9/8/2014

28617 A

II

9/18/2014

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO


LTD
NORTH CHINA PHARMACEUTICAL HUASHENG CO
LTD
YANCHENG YOUHUA PHARMACEUTICAL AND
CHEMICAL TECHNOLOGY CO LTD
SUN PHARMACEUTICAL INDUSTRIES LTD

28618 A

II

10/8/2014

CONCORD BIOTECH LTD

MUPIROCIN USP AS MANUFACTURED IN GUJARAT, INDIA

28619 A

IV

9/29/2014

ION EXCHANGE INDIA LTD

POLACRILEX RESIN (INDION-464)

28620 A

III

9/1/2014

BOREALIS AG

BORMED HJ875MO AS MANUFACTURED IN BERINGEN BELGIUM FOR BOREALIS AG

28621 A

II

9/9/2014

SIEGFRIED USA LLC

OPIUM TINCTURE, 2% AS MANUFACTURED IN PENNSVILLE NJ

28622 A

III

9/6/2014

BHAVYA POLYMERS

SILICONE RUBBER EXTRUDED AND MOULDED PRODUCTS

28623 A

II

7/18/2014

EASTMAN CHEMICAL CO

EASTMAN GLACIAL ACETIC ACID, USP AS MANUFACTURED IN KINGSPORT, TN

28624 A

IV

9/8/2014

ROBERTET FLAVORS INC

ORANGE FLAVOR WONF, NATURAL NV-15558

28625 A

II

10/27/2014

3D IMAGING DRUG DESIGN AND DEVELOPMENT


LLC
NOT AN ASSIGNED NUMBER

I-124-MIBG INJECTION AS MANUFACTURED IN LITTLE ROCK, ARKANSAS

28627 A

II

9/10/2014

HONOUR LAB LTD

NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA

28628 A

II

9/8/2014

ALKALOIDS CORP

28629 A

II

9/8/2014

ALKALOIDS CORP

28630 A

III

7/31/2014

BORMIOLI ROCCO SPA BU PLASTIC

DIGOXIN MICRO USP AS MANUFACTURED IN MAHARASHTRA INDIA FOR ALKALOIDS


CORPORATION
METHSCOPOLAMINE BROMIDE AS MANUFACTURED IN TELANGANA INDIA FOR ALKALOIDS
CORPORATION
PLUG FOR SINGLE-DOSE

28631 A

III

7/31/2014

BORMIOLI ROCCO SPA BU PLASTIC

PLUNGER FOR SINGLE-DOSE

28632 A

III

7/31/2014

BORMIOLI ROCCO SPA BU PLASTIC

PET SINGLE DOSE BOTTLE

28633 A

III

7/31/2014

BORMIOLI ROCCO SPA BU PLASTIC

TAMPER EVIDENT CAP FOR SINGLE-DOSE

28634 A

II

9/8/2014

SYN-TECH CHEM AND PHARM CO LTD

RIZATRIPTAN BENZOATE AS MANUFACTURED IN TAIWAN, R. O. CHINA

28635 A

II

10/14/2014

MYLAN LABORATORIES LTD

ATAZANAVIR SULFATE (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28626 N

28636 N

POLYMYXIN B SULFATE USP AS MANUFACTURED IN JIANGSU PROVINCE, THE PEOPLE'S


REPUBLIC OF CHINA
EPINEPHRINE USP AS MANUFACTURED IN GUJARAT, INDIA

NOT AN ASSIGNED NUMBER

28637 N
28638 A

FEXOFENADINE HYDROCHLORIDE USP FORM l AS MANUFACTURED IN MERETO DI TOMBA


(UD), ITALY
GEFITINIB AS MANUFACTURED IN SHANXI CHINA

NOT AN ASSIGNED NUMBER


II

9/15/2014

ZHUHAI UNITED LABORATORIES CO LTD

POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1 AS


MANUFACTURED IN GUANGDONG PR CHINA

Page 847

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28639 A
III
9/12/2014
EXTRAL SA DE CV

SUBJECT
ALUMINUM COLLAPSIBLE TUBES AND MULTILAYER LAMINATED TUBES

28640 A

II

9/15/2014

CINACALCET HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

28641 A

III

9/1/2014

DISHMAN PHARMACEUTICALS AND CHEMICALS


LTD
NUPLAS INDUSTRIES LTD

28642 A

II

9/16/2014

SYMED LABS LTD

LINEZOLID (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH INDIA

28643 A

IV

9/10/2014

TOMITA PHARMACEUTICAL CO LTD

USP MAGNESIUM TRISILICATE

28644 A

IV

9/10/2014

TOMITA PHARMACEUTICAL CO LTD

NF CALCIUM SILICATE (FLORITE R)

28645 A

III

9/12/2014

DAE HEUNG IBN INC

CONTAINER

28646 A

III

9/10/2014

DONGJUN INDUSTRIAL CO LTD

ALU - ALU FOIL

28647 A

III

9/8/2014

EYE DROPPER SYSTEM (OPHTHALMIC)

28648 A

II

9/15/2014

HPT HOCHWERTIGE PHARMATECHNIK GMBH CO


KG
RA CHEM PHARMA LTD

28649 N

RIGID POLY VINYL CHLORIDE (PVC) FILM FOR PHARMA BLISTER PACKING

TAMSULOSIN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

NOT AN ASSIGNED NUMBER

28650 A

IV

10/23/2014

SANDOZ INDUSTRIAL PRODUCTS GMBH

L-ARGININE STERILE

28651 A

II

11/3/2014

GLENMARK GENERICS LTD

POTASSIUM CHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA

28652 A

IV

9/17/2014

SUBHASH CHEMICAL INDUSTRIES PVT LTD

HARIOL IPM (ISOPROPYL MYRISTATE USP-NF)

28653 A

III

9/10/2014

BINNY WADS PVT LTD

INDUCTION HEAT SEAL LINERS/ROLLS

28654 A

II

10/10/2014

CADILA HEALTHCARE LTD

SITAGLIPTIN PHOSPHATE ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA

28655 A

II

9/3/2014

JIANGXI HONGYUAN PHARMACEUTICAL CO LTD

PROGESTERONE AS MANUFACTURED IN JIANGXI PROVINCE CHINA

28656 A

II

10/22/2014

CADILA HEALTHCARE LTD

VILAZODONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA

28657 A

II

10/31/2014

CADILA HEALTHCARE LTD

ROFLUMILAST AS MANUFACTURED IN GUJARAT, INDIA

28658 A

II

9/29/2014

IVABRADINE HYDROCHLORIDE AS MANUFACTURED IN BEIJING, CHINA

28659 A

II

10/7/2014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO


LTD
AMOLI ORGANICS PVT LTD

28660 N

ROSUVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA

NOT AN ASSIGNED NUMBER

28661 N

NOT AN ASSIGNED NUMBER

28662 A

IV

12/17/2014

CAPSUGEL MANUFACTURING INC

28663 A

II

9/19/2014

HIKAL LTD

EMPTY TWO PIECE HARD ENTERIC DRUG DELIVERY CAPSULES AS MANUFACTURED FOR
CAPSUGEL MANUFACTURING INC
PREGABALIN API AS MANUFACTURED IN KARNATAKA, INDIA

28664 A

II

9/25/2014

LI-COR INC

IRDYE 800CW CARBOXYLATE AS MANUFACTURED IN MORTON GROVE, IL FOR LI-COR INC

28665 A

II

9/23/2014

ENOXAPARIN SODIUM USP AS MANUFACTURED IN SHANDONG, PR CHINA

28666 A

III

9/23/2014

SHANDONG CHENZHONG BIOPHARMACEUTICAL


CO LTD
EMS CHEMIE NORTH AMERICA INC

28667 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY XE 3706 WHITE 6513

28668 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY XE 3706 BLACK 9915

28669 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY XE 3706 GREY 9242

28670 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY XE 3706 GREY 9243

28671 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY XE 3707 GREY 9241

28672 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY XE 3707 NATURAL

28673 A

III

9/23/2014

EMS CHEMIE NORTH AMERICA INC

GRIVORY HT3 XE 4027 BLACK 9916

28674 A

II

9/24/2014

PHARMACEUTICAL WORKS POLPHARMA SA

TICAGRELOR AS MANUFACTURED IN STAROGARD GDANSKI POLAND

GRIVORY GV-6H NATURAL

Page 848

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28675 A
II
9/22/2014
LIAOYUAN SILVER EAGLE PHARMACEUTICAL CO
LTD
28676 A
II
10/8/2014
MEDICHEM SA

SUBJECT
ETHACRIDINE LACTATE MONOHYDRATE AS MANUFACTURED IN JILIN PROVINCE CHINA

28677 A

II

10/15/2014

MANNKIND CORP

AFREZZA INHALATION POWDER AND AFREZZA INHALER AS MANUFACTURED IN DANBURY, CT

28678 A

II

9/26/2014

NOF CORP

28679 A

9/26/2014

BIOGEN IDEC US LTD PARTNERSHIP

A-(3'-{[1,2-DI(MYRISTYLOXY)PROPANOXY]CARBONYLAMINO}PROPYL)-W-METHOXY,
POLYOXYETHYLENE AS MANUFACTURED IN KANAGAWA, JAPAN
FACILITIES AND EQUIPMENT INFORMATION

28680 A

II

9/25/2014

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD

DIENOGEST (MICRONIZED) AS MANUFACTURED IN HEBEI PROVINCE CHINA

28681 A

II

9/19/2014

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD

STLTDO AS MANUFACTURED IN ZHEJIANG CHINA

28682 A

IV

9/29/2014

SD FINE CHEM LTD

ADENINE USP

28683 A

IV

9/29/2014

SD FINE CHEM LTD

CALAMINE BP

28684 A

IV

9/29/2014

SD FINE CHEM LTD

CLOVE OIL BP

28685 A

IV

9/29/2014

SD FINE CHEM LTD

CREATININE USP

28686 A

IV

9/29/2014

SD FINE CHEM LTD

DIBASIC SODIUM PHOSPHATE ANHYDROUS USP

28687 A

IV

9/29/2014

SD FINE CHEM LTD

DIPOTASSIUM HYDROGEN PHOSPHATE BP

28688 A

IV

9/29/2014

SD FINE CHEM LTD

GLACIAL ACETIC ACID BP

28689 A

II

10/1/2014

EMCURE PHARMACEUTICALS LTD

28690 A

IV

9/29/2014

SD FINE CHEM LTD

(S)- METHYL-3- (4-BIS(2-HYDROXYETHYL) AMINO) PHENYL) -2 - (TERTBUTOXYCARBONYLAMINO) PROPANOATE AS MANUFACTURED IN MAHARASHTRA, INDIA
MAGNESIUM SULPHATE BP

28691 A

IV

9/29/2014

SD FINE CHEM LTD

MENTHOL BP

28692 A

IV

9/29/2014

SD FINE CHEM LTD

POTASSIUM DIHYDROGEN PHOSPHATE BP

28693 A

IV

9/29/2014

SD FINE CHEM LTD

POTASSIUM IODIDE USP

28694 A

IV

9/29/2014

SD FINE CHEM LTD

SODIUM CITRATE USP

28695 A

IV

9/29/2014

SD FINE CHEM LTD

SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE BP

28696 A

IV

9/29/2014

SD FINE CHEM LTD

STARCH BP

28697 A

II

9/22/2014

PERLMAN SCOTT B MD

28698 A

III

9/26/2014

AMPACET CORP

[18] FLT, 3'-DEOXY-3'-[18F] FLUOROTHYMIDINE AS MANUFACTURED IN MADISON, WI FOR DR.


SCOTT B. PERLMAN C/O UNIVERSITY OF WISCONSIN-MADISON
4600454-N TRANS LIGHT BLUE SMC PP MB

28699 A

II

9/28/2014

ASYMCHEM LIFE SCIENCE TIANJIN CO LTD

SALMETEROL XINAFOATE AS MANUFACTURED IN TIANJIN CHINA

28700 A

II

9/28/2014

YABAO PHARMACEUTICAL GROUP CO LTD

DIMETHYL FUMARATE AS MANUFACTURED IN SHANXI CHINA

28701 A

II

10/8/2014

INDUSTRIALE CHIMICA SRL

ABIRATERONE ACETATE AS MANUFACTURED IN SARONNO (VARESE), ITALY

28702 A

II

10/10/2014

INTAS PHARMACEUTICALS LTD

VILAZODONE HYDROCHLORIDE (AMORPHOUS) AS MANUFACTURED IN GUJARAT, INDIA

28703 A

III

10/1/2014

SANVIC INC

KS PACK

28704 A

II

11/6/2014

KYOWA HAKKO KIRIN CO LTD

28705 A

IV

10/3/2014

SD FINE CHEM LTD

KW-6356 DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN FOR KYOWA HAKKO


KIRIN CO LTD
ACETONE USP

28706 A

IV

10/3/2014

SD FINE CHEM LTD

BENZYL ALCOHOL BP

28707 A

IV

10/3/2014

SD FINE CHEM LTD

BORIC ACID BP

28708 A

IV

10/3/2014

SD FINE CHEM LTD

CITRIC ACID ANHYDROUS USP

28709 A

IV

10/3/2014

SD FINE CHEM LTD

CITRIC ACID MONOHYDRATE BP

MED-300006/E (INTERMEDIATE) AS MANUFACTURED IN CELRA (GIRONA), SPAIN

Page 849

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28710 A
IV
10/3/2014
SD FINE CHEM LTD

SUBJECT
DEXTROSE ANHYDROUS USP

28711 A

IV

10/3/2014

SD FINE CHEM LTD

DICHLOROMETHANE BP

28712 A

IV

10/3/2014

SD FINE CHEM LTD

DISODIUM EDTA USP

28713 A

IV

10/3/2014

SD FINE CHEM LTD

GLYCERINE BP

28714 A

IV

10/3/2014

SD FINE CHEM LTD

HYDROGEN PEROXIDE SOLUTION 6% BP

28715 A

IV

10/3/2014

SD FINE CHEM LTD

ISOPROPYL ALCOHOL USP

28716 A

IV

10/3/2014

SD FINE CHEM LTD

LIQUID PARAFFIN BP

28717 A

IV

10/3/2014

SD FINE CHEM LTD

MANNITOL USP

28718 A

IV

10/3/2014

SD FINE CHEM LTD

SODIUM CHLORIDE USP

28719 A

IV

10/3/2014

SD FINE CHEM LTD

SODIUM HYDROXIDE PELLETS BP

28720 A

IV

10/3/2014

SD FINE CHEM LTD

WHITE SOFTPARAFFIN BP

28721 A

II

10/14/2014

AUROBINDO PHARMA LTD

DOLUTEGRAVIR SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28722 A

III

9/25/2014

SILICAGEL PRODUCTS MFG CO

SILICA GEL CANISTERS 1G & 3G

28723 A

II

9/30/2014

EDMOND PHARMA SRL

LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN PADERNO DUGNANO (MI), ITALY

28724 A

III

10/2/2014

BPREX HEALTHCARE OFFRANVILLE SAS

NOVELIA BOTTLES

28725 A

III

10/2/2014

POLYONE CORP

CC10205756XX

28726 A

II

10/7/2014

PEROXYCHEM LLC

HYDROGEN PEROXIDE 50% API GRADE AS MANUFACTURED IN BAYPORT TX

28727 A

II

10/2/2014

BIOVECTRA INC

ENCLOMIPHENE CITRATE AS MANUFACTURED IN CHARLOTTETOWN PE, CANADA

28728 A

IV

10/31/2014

XHALE INC

SMART(TM) SOFTGELS AS MANUFACTURED FOR XHALE INC.

28729 P

*** PENDING FILING REVIEW ***

28730 A

III

10/6/2014

MOISTOP ENTERPRISES PVT LTD

SILICAGEL DESICCANT CANISTERS

28731 A

II

9/25/2014

ANHUI WORLDBEST PHARMACEUTICAL CO LTD

28732 A

II

10/7/2014

SANOFI CHIMIE

PEPPERMINT OIL USP/NF AS MANUFACTURED IN ANHUI PROVINCE CHINA FOR ANHUI


WORLDBEST PHARMACEUTICAL CO LTD
AVANAFIL AS MANUFACTURED IN SISTERON CEDEX, FRANCE

28733 A

9/10/2014

ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY

CVs OF CLINICAL INVESTIGATORS

28734 A

II

10/6/2014

RA CHEM PHARMA LTD

TOLCAPONE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

28735 A

II

8/10/2014

CHONGQING HUAPONT PHARMACEUTICAL CO LTD NAFTIFINE HYDROCHLORIDE AS MANUFACTURED IN CHONGQING PR CHINA

28736 A

II

9/30/2014

LINHAI TIANYU PHARMACEUTICAL CO LTD

MONTELUKAST BACKONE DIOL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

28737 A

II

10/8/2014

YABAO PHARMACEUTICAL GROUP CO LTD

28738 A

IV

9/10/2014

HENKEL CORP

28739 A

II

11/5/2014

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

28740 A

II

10/31/2014

BIOPHORE INDIA PHARMACEUTICALS PVT LTD

28741 A

II

10/13/2014

ECKERT AND ZIEGLER RADIOPHARMA INC

IRON SUCROSE AS MANUFACTURED IN SICHUAN PROVINCE CHINA FOR YABAO


PHARMACEUTICAL GROUP CO LTD
GELVA GME 3011 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED FOR HENKEL
CORPORATION
DIATRIZOATE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA
PHARMACEUTICALS PVT LTD
DIATRIZOATE MEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT LTD
68GE/68GA-GENERATOR AS MANUFACTURED IN BERLIN GERMANY

28742 A

II

12/12/2014

PFIZER INC

28743 A

III

9/30/2014

TECHNICAL ALUMINIUM FOIL CO LLC

CABERGOLINE USP AS MANUFACTURED IN RODANO, ITALY AND ASCOLI PICENO, ITALY FOR
PFIZER INC
ALUMINIUM FOIL PLAIN/PRINTED/COATED AND LAMINATED

28744 A

III

9/29/2014

DAGA POLY LAMINATORS P LTD

LAMINATED, COATED AND PRINTED ALUMINIUM FOIL

Page 850

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28745 A
III
9/15/2014
HIMALAYAN POLYMER INDUSTRIES

SUBJECT
PLASTIC CONTAINERS AND CLOSURES

28746 A

ALITRETINOIN AS MANUFACTURED IN MINDEN GERMANY

II

10/8/2014

28747 P

BASF PHARMACHEMIKALIEN GMBH CO KG


*** PENDING FILING REVIEW ***

28748 A

II

10/31/2014

MYLAN LABORATORIES LTD

LINAGLIPTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28749 A

II

12/10/2014

MYLAN LABORATORIES LTD

EPINEPHRINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28750 A

II

12/13/2014

MYLAN LABORATORIES LTD

EPINEPHRINE BITARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28751 A

IV

10/20/2014

SUDEEP PHARMA LTD

ANHYDROUS DIBASIC CALCIUM PHOSPHATE USP

28752 A

III

10/10/2014

BOREALIS AG

BORMED LE6609-PH AS MANUFACTURED FOR BOREALIS AG

28753 N

NOT AN ASSIGNED NUMBER

28754 A

II

10/15/2014

TRANSO PHARM HANDELS GMBH

28755 A

III

9/30/2014

HUAYI ISOTOPES CO

PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR


TRANSO-PHARM HANDELS-GMBH
STERILE VACUUM VIAL

28756 A

II

10/29/2014

INTAS PHARMACEUTICALS LTD

DOCETAXEL ANHYDROUS USP (PROCESS II) AS MANUFACTURED IN GUJARAT, INDIA

28757 A

III

9/7/2014

PRINT N PACK

PRINTED/PLAIN BLISTER FOIL, STRIP FOIL, ALU-ALU COLD FORM FOIL, GLASSINE

28758 A

II

12/8/2014

JIANGSU HANSOH PHARMACEUTICAL CO LTD

PEMETREXED DIACID AS MANUFACTURED IN JIANGSU, CHINA

28760 A

III

10/16/2014

RAVAGO MANUFACTURING AMERICAS

CRYSTALADD HM-237B

28761 A

III

10/14/2014

ROBIN INDUSTRIES INC

I-341050-07 AS MANUFACTURED FOR ROBIN INDUSTRIES INC

28762 A

II

11/30/2014

ASPEN GLOBAL INC

FONDAPARINUX SODIUM AS MANUFACTURED IN SEINE MARITIME FRANCE, SISTERON


CEDEX FRANCE, AB OSS THE NETHERLANDS AND WETTEREN BELGIUM FOR ASPEN GLOBAL
INC

28763 A

II

12/22/2014

SIGNA SA DE CV

28764 A

II

10/30/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP AS MANUFACTURED IN ESTADO DE


MEXICO, MEXICO
ABIRATERONE ACETATE AS MANUFACTURED IN MILAN, ITALY FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD

28759 N

NOT AN ASSIGNED NUMBER

28765 N
28766 A

NOT AN ASSIGNED NUMBER


II

11/19/2014

28767 N

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD

LINAGLIPTIN AS MANUFACTURED IN ZHEJIANG, CHINA

NOT AN ASSIGNED NUMBER

28768 A

III

11/6/2014

CREDENCE MEDSYSTEMS INC

CREDENCE COMPANION GUIDE-ON NEEDLE

28769 A

II

11/11/2014

TEVA PHARMACEUTICAL INDUSTRIES LTD

28770 A

II

10/16/2014

OLON SPA

LINAGLIPTIN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL


INDUSTRIES LTD
TOREMIFENE CITRATE AS MANUFACTURED IN MULAZZANO (LO) ITALY

28771 A

II

10/21/2014

JIANGXI FUSHINE PHARMACEUTICAL CO LTD

BETA-METHYL VINYL PHOSPHATE AS MANUFACTURED IN JIANGXI CHINA

28772 A

III

10/15/2014

SPT CAP AND SPT PORT

28773 A

III

10/15/2014

28774 A

III

10/13/2014

BEIJING AUSTAR HANSEN PACKAGING


TECHNOLOGY LTD
BEIJING AUSTAR HANSEN PACKAGING
TECHNOLOGY LTD
CHENGDU JINGU MEDICINE PACKING CO LTD

28775 A

III

10/13/2014

CHENGDU JINGU MEDICINE PACKING CO LTD

NEUTRAL BOROSILICATE GLASS TUBULAR VIAL

28776 A

III

10/16/2014

LOPAREX LLC

GRADE 47270 - D 76# BL KFT H/H 6330LN/000

28777 A

II

10/21/2014

HETERO DRUGS LTD

28778 A

IV

9/24/2014

HENKEL CORP

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS-III) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
GELVA GMS 2397 AS MANUFACTURED FOR HENKEL CORPORATION

TWIN HEAD CAP


NEUTRAL BOROSILICATE GLASS AMPOULE

Page 851

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28779 A
II
8/15/2014
ENZYMEKING BIOTECHNOLOGY CO LTD

SUBJECT
CHYMOTRYPSIN AS MANUFACTURED IN INNER MONGOLIA, CHINA

28780 A

II

8/15/2014

ENZYMEKING BIOTECHNOLOGY CO LTD

TRYPSIN AS MANUFACTURED IN INNER MONGOLIA, CHINA

28781 A

II

11/18/2014

MEDICHEM MANUFACTURING MALTA LTD

MED-200028/M AS MANUFACTURED IN HAL FAR, MALTA

28782 A

III

10/20/2014

AMPACET CORP

4600454-NA TRANS BLUE SMC PP MB

28783 A

II

10/27/2014

NCM USA LLC

ZIRCONIUM-89 (ZR-89) OXALATE SOLUTION AS MANUFACTURED IN BRONX NY

28784 A

II

10/28/2014

HARMAN FINOCHEM LTD

LIDOCAINE HCI USP AS MANUFACTURED IN MAHARASHTRA INDIA

28785 A

II

12/22/2014

HEC PHARM CO LTD

LINAGLIPTIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG


PROVINCE, P.R. CHINA FOR HEC PHARM CO LTD

28786 N

NOT AN ASSIGNED NUMBER

28787 N

NOT AN ASSIGNED NUMBER

28788 N

NOT AN ASSIGNED NUMBER

28789 A

II

10/30/2014

OPTIMUS DRUGS PRIVATE LTD

28790 A

II

10/30/2014

OPTIMUS DRUGS PRIVATE LTD

28791 A

III

10/29/2014

HEBEI XINFUDA PLASTIC PRODUCTS CO LTD

28792 A

II

11/12/2014

MERCK SHARP AND DOHME CORP

28793 A

II

11/12/2014

MERCK SHARP AND DOHME CORP

MK -2048A DRUG PRODUCT AS MANUFACTURED IN AB OSS, THE NETHERLANDS FOR MERCK


SHARP AND DOHME CORP
MK-4176 DRUG SUBSTANCE AS MANUFACTURED IN RAHWAY, NJ AND SINGAPORE

28794 A

IV

10/31/2014

CAPSCANADA CORP

EMPTY HARD VEGETABLE CAPSULES SHELLS

28795 A

IV

10/27/2014

JIANGSU ADVOCATING BIO TECHNOLOGY CO LTD

VACANT CAPSULES FROM HYDROXYPROPYL STARCH

28796 A

III

10/16/2014

HDPE BOTTLE

28797 A

II

11/24/2014

TIANJIN BOKELIN MEDICAL PACKAGING


TECHNOLOGY CO LTD
MACLEODS PHARMACEUTICALS LTD

28798 N

17-IODO-ANDROSTA-5,16-DIENE-3B-OL (ABIRATERONE INTERMEDIATE) AS MANUFACTURED


IN ANDHRA PRADESH INDIA
4-(4-AMINOPHENYL) MORPHOLIN-3-ONE [RIVAROXABAN INTERMEDIATE, (PROCESS-1)] AS
MANUFACTURED IN ANDHRA PRADESH INDIA
PLASTIC BOTTLES AND CAPS WITH DRYING AGENT

LACOSAMIDE AS MANUFACTURED IN GUJARAT, INDIA

NOT AN ASSIGNED NUMBER

28799 A

II

11/12/2014

MERCK SHARP AND DOHME CORP

MK-2048 DRUG SUBSTANCE AS MANUFACTURED IN RAHWAY, NJ AND AICHI, JAPAN

28800 A

II

11/12/2014

CRYSTAL PHARMA SAU

28801 A

II

11/5/2014

HETERO LABS LTD

MEDROXYPROGESTERONE ACETATE STERILE MICRONIZED AS MANUFACTURED IN


VALLADOLID, SPAIN
CISPLATIN USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

28802 A

II

12/31/2014

AURONEXT PHARMA PRIVATE LTD

IMIPENEM USP (STERILE) AS MANUFACTURED IN RAJASTHAN, INDIA

28803 A

II

11/26/2014

BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD

28804 A

II

12/19/2014

CODY LABORATORIES INC

FIDAXOMICIN CRYSTALLINE AS MANUFACTURED IN JIANGSU, CHINA FOR BRIGHTGENE BIOMEDICAL TECHNOLOGY CO., LTD
HYDROMORPHONE HYDROCHLORIDE USP AS MANUFACTURED CODY, WYOMING

28805 A

II

10/15/2014

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

DEFERASIROX AS MANUFACTURED IN HUBEI PROVINCE CHINA

28806 A

II

11/5/2014

OPTIMUS DRUGS PRIVATE LTD

28807 A

II

11/6/2014

SYMED LABS LTD

3-DIETHYLBORANYL-PYRIDINE (ABIRATERONE INTERMEDIATE) AS MANUFACTURED IN


ANDHRA PRADESH INDIA
RIVAROXABAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

28809 A

IV

11/4/2014

FONA INTERNATIONAL INC

861.0362U HONEY FLAVOR, ART

28810 A

III

10/31/2014

NEW AGE INDUSTRIES INC

ADVANTAPURE TPE ADVANTAFLEX BIOPHARMACEUTICAL GRADE TUBING

28811 A

III

10/31/2014

NEW AGE INDUSTRIES INC

ADVANTAPURE LIQUID INJECTION MOLDING GRADE SILICONE (LIM) COMPONENTS NI206

28812 A

II

12/10/2014

MYLAN LABORATORIES LTD

TICAGRELOR AS MANUFACTURED IN MAHARASHTRA, INDIA

28808 P

*** PENDING FILING REVIEW ***

Page 852

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28813 A
II
12/22/2014
MYLAN LABORATORIES LTD

SUBJECT
ETRAVIRINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28814 A

III

10/15/2014

ANEETA TECHNOPACK P LTD

ALUMINIUM COLLAPSIBLE TUBES

28815 A

II

11/8/2014

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND


TECHNOLOGY CO LTD
NOT AN ASSIGNED NUMBER

TENOFOVIR DISOPROXIL FUMARATE (DRUG SUBSTANCE) AS MANUFACTURED HUBEI


PROVINCE PR CHINA

II

12/15/2014

28816 N
28817 N
28818 A

NOT AN ASSIGNED NUMBER


LAURUS LABS PRIVATE LTD

28819 N

NOT AN ASSIGNED NUMBER

28820 N

NOT AN ASSIGNED NUMBER

28821 P

ABACAVIR SULFATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

*** PENDING FILING REVIEW ***

28822 A

III

11/3/2014

LEADMEDI

INHALER OVER CAP

28823 A

II

11/26/2014

BACHEM AG

TETRACOSACTIDE AS MANUFACTURED IN BUBENDORF, SWITZERLAND

II

11/12/2014

28824 N
28825 A

NOT AN ASSIGNED NUMBER

28826 N

VASUDHA PHARMA CHEM LTD

DESLORATADINE AS MANUFACTURED IN TELANGANA INDIA

NOT AN ASSIGNED NUMBER

28827 A

III

11/12/2014

POLYONE CORP

CC00021179XX

28828 A

II

11/17/2014

LIFECORE BIOMEDICAL LLC

SODIUM HYALURONATE, LSA-9850025 PROCESS AS MANUFACTURED IN CHASKA, MN

28829 A

IV

11/7/2014

TAIAN RUITAI CELLULOSE CO LTD

HYDROXYPROPYL METHYL CELLULOSE (COTTON)

28830 A

IV

11/7/2014

TAIAN RUITAI CELLULOSE CO LTD

HYDROXYPROPYL METHYL CELLULOSE (WOOD)

28831 A

II

12/27/2014

MYLAN LABORATORIES LTD

DIMETHYL FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA

28832 N
28833 A

NOT AN ASSIGNED NUMBER


II

12/5/2014

28834 N

MEDICHEM SA

QUETIAPINE FUMARATE AS MANUFACTURED IN CELRA (GIRONA), SPAIN

NOT AN ASSIGNED NUMBER


IV

8/10/2014

TUDAPETROL MINERALOLERZEUGNISSE NILS


HANSEN KG

PIONIER PLW

28836 A

IV

11/7/2014

TAIAN RUITAI CELLULOSE CO LTD

ETHYLCELLULOSE

28837 A

II

10/31/2014

HEC PHARM CO LTD

28838 A

II

11/17/2014

ASYMCHEM LIFE SCIENCE TIANJIN CO LTD

AZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM AS


MANUFACTURED IN HUBEI PROVINCE PR CHINA
REPAGLINIDE AS MANUFACTURED IN TIANJIN CHINA

28839 A

IV

11/12/2014

JIANGSU ADVOCATING BIO TECHNOLOGY CO LTD

VACANT CAPSULES FROM HYPROMELLOSE

28835 A

28840 N

NOT AN ASSIGNED NUMBER

28841 N

NOT AN ASSIGNED NUMBER

28842 A

II

12/20/2014

MSN LABORATORIES PRIVATE LTD

ELTROMBOPAG OLAMINE [ROUTE CODE - "EA"] AS MANUFACTURED IN TELANGANA, INDIA

28843 A

II

11/26/2014

CRYSTAL PHARMA SAU

ALTRENOGEST AS MANUFACTURED IN VALLADOLID, SPAIN

28844 A

III

11/19/2014

CHARTER NEX FILMS INC

CHARTER NEX FILM GRADE 5048SDMF

28845 A

II

11/17/2014

JOST CHEMICAL CO

POTASSIUM GLUCONATE ANHYDROUS AS MANUFACTURED IN ST LOUIS, MO

28846 A

IV

11/20/2014

SD FINE CHEM LTD

SODIUM LAURYL SULPHATE BP

28847 A

IV

11/20/2014

SD FINE CHEM LTD

DIBASIC POTASSIUM PHOSPHATE USP

28848 A

IV

11/20/2014

SD FINE CHEM LTD

TRIACETIN USP

28849 A

IV

11/20/2014

SD FINE CHEM LTD

CHLOROFORM BP

Page 853

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28850 A
IV
11/20/2014
SD FINE CHEM LTD

SUBJECT
DISODIUM HYDROGEN PHOSPHATE DIHYDRATE BP

28851 A

IV

11/20/2014

SD FINE CHEM LTD

DISODIUM HYDROGEN PHOSPHATE DODECAHYDRATE BP

28852 A

IV

11/20/2014

SD FINE CHEM LTD

DIBASIC SODIUM PHOSPHATE DODECAHYDRATE USP

28853 A

IV

11/20/2014

SD FINE CHEM LTD

DIBASIC SODIUM PHOSPHATE DIHYDRATE USP

28854 A

IV

11/20/2014

SD FINE CHEM LTD

ANHYDROUS DISODIUM HYDROGEN PHOSPHATE BP

28855 A

IV

11/20/2014

SD FINE CHEM LTD

DIPOTASSIUM PHOSPHATE BP

28856 A

IV

11/20/2014

SD FINE CHEM LTD

MONOBASIC SODIUM PHOSPHATE DIHYDRATE USP

28857 A

IV

11/20/2014

SD FINE CHEM LTD

POTASSIUM HYDROGEN PHOSPHATE

28858 A

IV

11/20/2014

SD FINE CHEM LTD

SODIUM PHOSPHATE

28859 A

IV

11/20/2014

SD FINE CHEM LTD

MONOBASIC POTASSIUM PHOSPHATE USP

28860 N

NOT AN ASSIGNED NUMBER

28861 N

NOT AN ASSIGNED NUMBER

28862 A

II

12/2/2014

EMCURE PHARMACEUTICALS LTD

SM ARG-I AS MANUFACTURED IN MAHARASHTRA, INDIA

28863 A

III

11/12/2014

SIMAL PACKAGING PVT LTD

ALUMINIUM COLLAPSIBLE TUBES

28864 N

NOT AN ASSIGNED NUMBER

28865 N
28866 A

NOT AN ASSIGNED NUMBER


II

12/5/2014

VIWIT PHARMACEUTICAL CO LTD

28867 N

NOT AN ASSIGNED NUMBER

28868 N

NOT AN ASSIGNED NUMBER

28869 N

NOT AN ASSIGNED NUMBER

APREPITANT AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

28870 A

II

11/19/2014

ISOCHEM SAS

SOLIFENACIN SUCCINATE AS MANUFACTURED IN GENNEVILLIERS FRANCE

28871 A

IV

11/17/2014

TOMITA PHARMACEUTICAL CO LTD

USP MAGNESIUM OXIDE HEAVY POWDER

28872 A

IV

11/17/2014

TOMITA PHARMACEUTICAL CO LTD

USP MAGNESIUM OXIDE HEAVY FINE GRANULAR

28873 A

II

11/26/2014

NOF CORP

28874 A

III

10/31/2014

CONSOLIDATED BOTTLE CORP

POLY(OXY-1,2-ETHANEDIYL), A-METHYL -W-{6-[(2,5-DIOXO-1 -PYRROLIDINYL)OXY]-6OXOHEXYLOXY} - AS MANUFACTURED IN KANAGAWA PREFECTURE JAPAN


18MM WHITE LDPE NASAL SPRAY PLUG [CBC 009084]

28875 A

III

11/26/2014

POLYONE CORP

CC00002623XX

28876 A

III

11/25/2014

PRECISION MEDICAL INC

PET PACKAGING

28877 N

NOT AN ASSIGNED NUMBER

28878 N

NOT AN ASSIGNED NUMBER

28879 N

NOT AN ASSIGNED NUMBER

28880 N

NOT AN ASSIGNED NUMBER

28881 A

III

11/13/2014

QENOS PTY LTD

ALKATANE HD0490

28882 A

II

12/3/2014

KREITCHMAN PET CENTER

PBR28 C11 INJECTION AS MANUFACTURED IN NEW YORK, NY

28883 A

IV

11/26/2014

NIPPON FINE CHEMICAL CO LTD

A LIPOSOMAL EXCIPIENT, DIOLEOYL PHOSPHATIDYLCHOLINE (DOPC)

28884 A

IV

11/26/2014

NIPPON FINE CHEMICAL CO LTD

A LIPOSOMAL EXCIPIENT, DIOLEOYL PHOSPHATIDYLETHANOLAMINE (DOPE)

28885 N

NOT AN ASSIGNED NUMBER

28886 N

NOT AN ASSIGNED NUMBER

28887 N

NOT AN ASSIGNED NUMBER

Page 854

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28888 N
NOT AN ASSIGNED NUMBER
28889 N

SUBJECT

NOT AN ASSIGNED NUMBER

28890 A

III

11/27/2014

S S ENTERPRISES

28891 A

III

12/3/2014

SAINT GOBAIN PERFORMANCE PLASTICS

28892 A

IV

12/3/2014

STAR TECH SPECIALTY PRODUCTS CO LTD

LAMINATED, COATED, PRINTED/PLAIN BLISTER FOIL, STRIP FOIL, ALU-ALU COLD FORM FOIL,
CR FOIL, GLASSINE, LAMINATES, POUCHES, PVC, TAGGERS, WADS
ALUMINIZED POLYESTER FILM C/1/S WITH 8310 SILICONE RELEASE COATING, AND COS WITH
4130 SILICONE RELEASE COATING
POVIDONE

28893 A

III

12/1/2014

AICELLOMILIM CHEMICAL CO LTD

CLEAN BAG LAS-04

28894 A

III

11/18/2014

BROMINATED BUTYL RUBBER STOPPER FOR INJECTION

28895 A

III

11/18/2014

28896 A

II

12/22/2014

HEBEI FIRST RUBBER MEDICAL TECHNOLOGY CO


LTD
HEBEI FIRST RUBBER MEDICAL TECHNOLOGY CO
LTD
SUN PHARMACEUTICAL INDUSTRIES LTD

28897 N

NOT AN ASSIGNED NUMBER

28898 N

NOT AN ASSIGNED NUMBER

28899 N

BROMINATED BUTYL RUBBER STOPPER FOR INJECTION STERILE POWDER


ACITRETIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA

NOT AN ASSIGNED NUMBER

28900 A

II

12/31/2014

ALEMBIC PHARMACEUTICALS LTD

VARDENAFIL HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA

28901 A

II

12/10/2014

MEDICHEM MANUFACTURING MALTA LTD

BEPOTASTINE BESILATE AS MANUFACTURED IN HAL FAR, MALTA

28902 A

III

12/1/2014

AMPACET CORP

1600955-K BLUE 955

28903 A

III

12/2/2014

3M DRUG DELIVERY SYSTEMS DIVISION

3M SCOTCHPAK 9755W RELEASE LINER AS MANUFACTURED IN NEVADA MO

28904 A

III

11/28/2014

JAYANTI ELASTOMER PROCESSOR

28905 A

II

12/23/2014

RAKS PHARMA PVT LTD

SILICONE AND VITON RUBBER TUBES/SLEEVES, STRIPS, CORDS, SHEETS, GASKETS, O


RINGS AND OTHER RUBBER PARTS
ABIRATERONE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

28906 N

NOT AN ASSIGNED NUMBER

28907 N

NOT AN ASSIGNED NUMBER

28908 N

NOT AN ASSIGNED NUMBER

28909 A

III

12/9/2014

CONSOLIDATED BOTTLE CORP

28910 A

III

12/9/2014

CONSOLIDATED BOTTLE CORP

24MM WHITE DAB-O-MATIC PP CAP WITH STEP [CBC 003790] AS MANUFACTURED FOR
CONSOLIDATED BOTTLE CORPORATION
24MM WHITE DAUBER LDPE PLUG OVER SIZED APPLICATOR WITH GREEN LDPE/MDPE
SPRING VALVE & WHITE NYLON OVER BLUE NEOPRENE COVER PAD [CBC 014541] AS
MANUFACTURED FOR CONSOLIDATED BOTTLE CORPORATION

28911 A

III

12/9/2014

CI KASEI CO LTD

SANZIP TAPE EM TYPE

28912 A

II

12/5/2014

LONZA AG

28913 A

II

12/10/2014

HETERO LABS LTD

BIVALIRUDIN (TM-001-2G) AS MANUFACTURED IN VISP, SWITZERLAND, AND BRAINE-I ALLEUD,


BELGIUM FOR LONZA AG.
OXALIPLATIN USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

28914 N

NOT AN ASSIGNED NUMBER

28915 N

NOT AN ASSIGNED NUMBER

28916 A

II

12/23/2014

MEDICHEM MANUFACTURING MALTA LTD

RIVAROXABAN AS MANUFACTURED IN HAL FAR, MALTA

28917 A

III

12/5/2014

AMPACET CORP

4600555-N BLUE SMC PP MB

28918 N

NOT AN ASSIGNED NUMBER

28919 A

II

12/24/2014

28920 A

II

12/15/2014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO


LTD
CHEMO IBERICA SA

SOFOSBUVIR AS MANUFACTURED IN BEIJING, CHINA


LEVOFLOXACIN AS MANUFACTURED IN MADRID SPAIN

Page 855

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28921 P
*** PENDING FILING REVIEW ***
28922 N
28923 A

SUBJECT

NOT AN ASSIGNED NUMBER


II

12/25/2014

28925 A

II

12/31/2014

UNICHEM LABORATORIES LTD

WARFARIN SODIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

28926 A

II

12/10/2014

TOMITA PHARMACEUTICAL CO LTD

USP MAGNESIUM HYDROXIDE AS MANUFACTURED IN TOKUSHIMA JAPAN

28927 A

II

12/10/2014

MEGAFINE PHARMA P LTD

RIVAROXABAN (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN MAHARASHTRA


INDIA

28924 N

ZHEJIANG HISUN PHARMACEUTICAL CO LTD

TICAGRELOR AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

NOT AN ASSIGNED NUMBER

28928 N

NOT AN ASSIGNED NUMBER

28929 P

*** PENDING FILING REVIEW ***

28930 P

*** PENDING FILING REVIEW ***

28931 N

NOT AN ASSIGNED NUMBER

28932 N

NOT AN ASSIGNED NUMBER

28933 N

NOT AN ASSIGNED NUMBER

28934 N

NOT AN ASSIGNED NUMBER

28935 A

III

12/16/2014

CLARIANT PRODUCTION FRANCE

STANDARD DESICCANT BAGS AND PACKETS

28936 A

II

12/20/2014

DIVIS LABORATORIES LTD

28937 A

IV

12/5/2014

BIOGRUND GMBH

VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS FORM) AS MANUFACTURED IN ANDHRA


PRADESH INDIA
TOPMILL PRE-MIXED EXCIPIENTS SYSTEM FOR COLORING OF ORAL SOLID-DOSAGE
FORMS

28938 N

NOT AN ASSIGNED NUMBER

28939 P

*** PENDING FILING REVIEW ***

28940 N

NOT AN ASSIGNED NUMBER

28941 N

NOT AN ASSIGNED NUMBER

28942 A

II

12/4/2014

WATERSTONE PHARMACEUTICALS HUBEI CO LTD

EZETIMIBE AS MANUFACTURED IN HUBEI CHINA

28943 A

III

12/18/2014

LOPAREX LLC

GRADE 52387 - 3.0 MZ PET U4162T1/000

28944 A

II

12/22/2014

HETERO LABS LTD

BEXAROTENE AS MANUFACTURED IN ANDHRA PRADESH INDIA

28945 A

II

12/19/2014

DPX FINE CHEMICALS AUSTRIA GMBH AND CO KG

COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN LINZ AUSTRIA

28946 A

III

12/18/2014

LOPAREX LLC

GRADE 51497 - 3.0 MZ PET U4166T/000

28948 A

II

12/22/2014

IRVINE SCIENTIFIC SALES CO

C36 (GLUCOSE 5G/L) POWDER AS MANUFACTURED IN SAITAMA JAPAN

28949 A

II

12/22/2014

IRVINE SCIENTIFIC SALES CO

PRIME-XV ADIPOGENIC DIFFERENTIATION SFM AS MANUFACTURED IN SANTA ANA, CA

28950 A

II

12/8/2014

CHENGZHI LIFE SCIENCE CO LTD

D-RIBOSE AS MANUFACTURED IN JIANGXI PROVINCE CHINA FOR CHENGZHI LIFE SCIENCE


CO LTD

28952 A

II

12/23/2014

ACEBRIGHT INDIA PHARMA PRIVATE LTD

28953 A

III

12/17/2014

AMPACET CORP

28947 N

NOT AN ASSIGNED NUMBER

28951 N

NOT AN ASSIGNED NUMBER

28954 N

NOT AN ASSIGNED NUMBER

28955 N

NOT AN ASSIGNED NUMBER

28956 N

NOT AN ASSIGNED NUMBER

ATAZANAVIR SULPHATE [DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN


KARNATAKA INDIA
1600353-NQ PRL PURPLE PE MB

Page 856

4Q2014EXCEL
4Q2014TEXT
DMF# STATUS TYPEI SUBMIT DATE HOLDER
28957 N
NOT AN ASSIGNED NUMBER
28958 N

NOT AN ASSIGNED NUMBER

28959 N

NOT AN ASSIGNED NUMBER

28960 N

NOT AN ASSIGNED NUMBER

28961 N

NOT AN ASSIGNED NUMBER

28962 N

SUBJECT

NOT AN ASSIGNED NUMBER

28963 A

III

12/22/2014

ROLLPRINT PACKAGING PRODUCTS INC

RPP# 21-2041

28964 A

III

12/20/2014

BEIJING AUSTAR PHARMMED CONSUMABLE LTD

PP MEDICAL GRANULE FOR IV INNER CAP

28965 A

III

12/20/2014

BEIJING AUSTAR PHARMMED CONSUMABLE LTD

PP MEDICAL GRANULE FOR IV SOFT PLASTIC BOTTLE

28966 A

II

12/26/2014

IRVINE SCIENTIFIC SALES CO

RIME-XV CHONDROGENIC DIFFERENTIATION XSFM AS MANUFACTURED IN SANTA ANA, CA

28967 A

II

12/29/2014

IRVINE SCIENTIFIC SALES CO

PRIME-XV FREEZIS AS MANUFACTURED IN SANTA ANA, CA

28968 A

IV

12/24/2014

NUSIL TECHNOLOGY LLC

CSF-3101

28969 N
28970 A

NOT AN ASSIGNED NUMBER


III

12/17/2014

28971 N
28972 A

APR 600 THERMAL TRANSFER RIBBON

NOT AN ASSIGNED NUMBER


IV

12/29/2014

28973 N
28974 A

ARMOR SAS
STAR TECH SPECIALTY PRODUCTS CO LTD

CROSPOVIDONE

NOT AN ASSIGNED NUMBER


III

12/19/2014

AMPACET CORP

111717 WHITE PE MB

Page 857

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