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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Pfizer Inc to the U.S. FDA. Original Data : FDA Website

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

02 1-DESOXYEPHEDRINE (1)

03 10-DEACETYL BACCATIN III (1)

04 16-METHYLDIOLONE ACETATE AND S.D. VII) 9(11)-ANHYDRO-16a METHYLPREDNIS (1)

05 17-DESOXY OXIDO (1)

06 17a-METHYLTESTOSTERONE (1)

07 5-ETHYL-2"-DEOXYURIDINE (1)

08 6-AM (6-DEOXY-6-AZIDIDIHYDROMORPHINE BITARTRATE) AMP. (1)

09 8-ARGININE VASOPRESSIN (8-AVP) (1)

10 9-AMINOCAMPTOTHECIN ACTIVE DRUG SUBSTANCE (1)

11 9-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION (1)

12 ACHROMYCIN (TETRACYCLINE) BULK (1)

13 ACTIVATED CALICHEAMICIN DERIVATIVE (1)

14 AMPHOTERICIN B (1)

15 AMPICILLIN SODIUM (2)

16 AMPICILLIN TRIHYDRATE (1)

17 ANTABUSE WITH RIBOFLAVIN TABLETS AND PLACEBO (1)

18 ANTIBIOTIC GENERAL INFORMATION (1)

19 ARA-CYTIDINE 5 - BENZOATE (U - 32,072E) (1)

20 ARTISONE ACETATE (1)

21 AT THE CHRISTIANSTED, ST. CROIX LOCATION (1)

22 AT-125 (U-42,126) ANTI-TUMOR AGENT (1)

23 ATHERO GENICS AGIX-4207 INJECTABLE EMULSION (1)

24 BACAMPICILLIN HYDROCHLORIDE (1)

25 BACITRACIN (1)

26 BENADRYL POWDER (1)

27 BETAMETHASONE 17-BENZOATE MNFG BY VISTER S.P.A.(ITALY)(FACIL.OF PD/WL (1)

28 BETAMETHASONE DIPROPIONATE (1)

29 BETAMETHASONE VALERATE (1)

30 BETAMETHASONE, 17-BENZOATE (1)

31 BETAMETHYL EPOXIDE (1)

32 BIZELESIN (U-77779) DRUG SUBSTANCE (1)

33 BONE MORPHOGENETIC PROTEIN-2 (HUMAN, RECOMBINANT, CHO CELLS, WYETH) (1)

34 BULK CHEMICALS , METHOD OF PREPARATION (1)

35 CABERGOLINE USP (1)

36 CAPSULE PLANT OPERATION AT THE DETROIT, MICHIGAN FACILITY (1)

37 CARBENICILLIN INDANYL SODIUM (2)

38 CEFIXIME (1)

39 CEFOPERAZONE SODIUM (1)

40 CF-100 OINTMENT (1)

41 CHLORAMPHENICOL (1)

42 CHLORAMPHENICOL PALMITATE (1)

43 CHLORPROPAMIDE TABLETS-PHARMACOLOGY, CLIN RPTS,G'S PROCEEDS. & CNTRL (1)

44 CHLORTETRACYCLINE HYDROCHLORIDE (3)

45 CHONDROCTIN SULFATE (1)

46 CI -404 - ACTINOBOLIN SULFATE (1)

47 CILASTATIN SODIUM (STERILE) (1)

48 CLEVIDIPINE EMULSION (1)

49 CLINDAMYCIN HYDROCHLORIDE (1)

50 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP KALAMAZOO (1)

51 CLINDAMYCIN PHOSPHATE USP (1)

52 CLINDAMYCIN PHOSPHATE USP, KALAMAZOO (1)

53 CLINICAL INVESTIGATION --CI 442 (1)

54 CLINICAL INVESTIGATION 461 (1)

55 CLINICAL INVESTIGATION-- CI-395 (1)

56 CLINICAL INVESTIGATION--CI 344 (1)

57 CLINICAL INVESTIGATION--CI 384 (1)

58 CLINICAL INVESTIGATION--CI-383 (1)

59 CLINICAL INVESTIGATION--CI-446 (1)

60 CLINICAL INVESTIGATION--CI-462 (1)

61 CLINICAL INVESTIGATION--CI423 (1)

62 CLINICAL INVESTIGATIONS--CI 400 AND 421 (1)

63 COMBINED ADRENAL HORMONE ANTIBIOTIC THERAPY (1)

64 COMPRESSED TABLETS UPRIN, 5GR(ASPIRIN ANHYDRIDE) (1)

65 CORTISONE (MICRONIZED, ACETATE AND STERILE) (1)

66 CORTISONE ACETATE USP, MICRO & NON MICRO (1)

67 COVIDARABINE (1)

68 CYCLOHEXIMIDE (ACTIDIONE) U-4527 (1)

69 CYKLOKAPRON TABLETS (1)

70 CYTARABINE (1)

71 DECARBAZINE (1)

72 DECLOMYCIN(DEMECLOCYCLINE HYDROCHLORIDE) BULK POWDER (1)

73 DEFEROXAMINE MESYLATE (1)

74 DEMECLOCYCLINE (1)

75 DEMECLOCYCLINE HYDROCHLORIDE (2)

76 DEXPROPRANOLOL INJ (1)

77 DIETHYLSTILBESTROL IMPLANTATION PELLETS (1)

78 DIFLORASONE DIACETATE (1)

79 DIHYDROFLUOCINOLONE ACETONIDE (1)

80 DINOPROSTONE USP (1)

81 DISOPYRAMIDE PHOSPHATE (1)

82 DORIPENEM (STERILE) (1)

83 DOXORUBICIN HCL (1)

84 DOXORUBICIN HYDROCHLORIDE (1)

85 DOXYCYCLINE HYCLATE (4)

86 E-Z SCRUB W/HIBICLENS (CHLORHEXIDINE GLUCONATE) (1)

87 EPOPROSTENOL SODIUM (U-53,217A) (1)

88 ERTAPENEM SODIUM (1)

89 ERYTHROMYCIN (2)

90 ERYTHROMYCIN ENTERIC-COATED TABLETS (1)

91 ERYTHROMYCIN STEARATE (2)

92 ESTRADIOL (1)

93 ESTRADIOL CYPIONATE USP (1)

94 ESTRAMUSTINE PHOSPHATE SODIUM (1)

95 ETHINYL ESTRADIOL (1)

96 ETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY (1)

97 FACILITIES & GENERAL OPERATING PROCEDURES (SANDY, UTAH LOCATION) (1)

98 FACILITIES AND CONTROLS IN WEST SUSSEX, U.K. (1)

99 FACILITIES AND OPERATING PROCEDURES IN MUENSTER, WEST GERMANY (1)

100 FACILITIES, PERSONNEL & EQUIPMENT IN SANDWICH, KENT, ENGLAND (1)

101 FACILITY AND OPERATING PROCEDURES AT THE BRUNNA FACILITY IN KUNGSANGEN, SWEDEN (1)

102 FACILITY AND OPERATING PROCEDURES IN STOCKHOLM, SWEDEN (1)

103 FACILITY AND OPERATING PROCEDURES IN STRANGNAS, SWEDEN (1)

104 FACILITY, PERSONNEL AND OPERATING PROCEDURES IN STOCKHOLM, SWEDEN (1)

105 FACILS. & CONTROLS LOCATED IN FJARDO, PUERTO RICO FACILITY (1)

106 FACILS. AND CONTROL SPECIFS IN KALAMAZOO, MICH. FACILITY (IBUPROFEN) (1)

107 FEDOTOZINE TARTRATE (1)

108 FLUMETHASONE (1)

109 FLUOROMETHOLONE MICRONIZED (1)

110 FLUOXYMESTERONE USP (1)

111 FLUPREDNISOLONE & FLUPREDNISOLONE ACETATE (1)

112 G & CONTROL PROCEDS FOR INJECT. DOS FORM AY-25,650; SCALLY ANALOGUE (1)

113 G CONTROL PROCEDURES - SPECS FOR COMMONLY USED IN RAW MATERIALS (1)

114 G, PROCESS & PACK OF INDS IN MORRIS PLAINS, NJ FACIL (710 TABOR RD) (1)

115 GEN. INFO APPLICABLE TO THE FINE CHEMICAL OPERATIONS (1)

116 GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS (1)

117 GLIPIZIDE USP (1)

118 GONADORELIN HCL (1)

119 GR FACILS FOR THE VARIOUS PLANTS OF WYETH LABS INC (CHICAGO PLANT) (1)

120 GRISEOFULVIN (2)

121 HALOPERIDOL (1)

122 HYDROGEN PEROXIDE SOLUTION 3% (1)

123 HYDROXY ACID (1)

124 HYDROXYPROGESTERONE CAPROATE (1)

125 HYDROXYPROGESTERONE CAPROATE USP (1)

126 IDARUBICIN HYDROCHLORIDE (1)

127 IMIPENEM (STERILE) (1)

128 IMIPENEM + CILASTATIN SODIUM (STERILE BULK) (1)

129 INDERAL (1)

130 INJECTABLE NOLVASAN (VET) (1)

131 INTRANASAL INSULIN (1)

132 INTRAVENOUS FAT EMULSION PRODUCT 4501 (1)

133 IODODOXORUBICIN HCL BULK DRUG SUBSTANCE (1)

134 IODODOXORUBICIN HCL FOR INJECTION (1)

135 ISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE (1)

136 L'-LYSINE MONOHYDROCHLORIDE (1)

137 L-DOPA (OR LEVODOPA) IN BULK ONLY (1)

138 L-LYSINE MONOHYDROCHLORIDE (1)

139 LAMISIL EMULSION (1)

140 LINCOMYCIN HYDROCHLORIDE USP (1)

141 LIPITOR (ATORVASTATIN CALCIUM) 10MG, 20MG, 40MG, 80MG ORALTABLETS (1)

142 LUDOX (1)

143 MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN JOHANNESHOV, SWEDEN. (1)

144 MANUF FACILITIES FOR VARIOUS PLANTS OF WYETH LABORATORIES, INC. (2)

145 MANUFACTURING ,PACKAGING AND CONTROLS PROCEDURES-THIS IS A VET MED D (1)

146 MANUFACTURING FACILITIES IN COLUMBUS, OHIO (1)

147 MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL OF THE GS/API PROCESS R&D PLANT IN NERVIANO ITALY (1)

148 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GUAYAMA, PUERTO RICO. (1)

149 MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN UPPSALA, SWEDEN. (1)

150 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES (1)

151 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARNPRIOR, ONTARIO, CANADA. (1)

152 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BRISTOL, TENNESSEE. (1)

153 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GWENT, UNITED KINGDOM. (1)

154 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HILLEROD, DENMARK. (1)

155 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILAN, ITALY. (1)

156 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MT. PROSPECT, ILL.LOCATIO. (1)

157 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PARSIPPANY, NEW JERSEY. (1)

158 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROUSES POINT, NEW YORK. (2)

159 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UPPSALA, SWEDEN. (1)

160 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF LARGE VOLUME PARENTERALS IN GLASS BOTTLES IN UPPSALS, SWEDEN. (1)

161 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

162 MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN. (1)

163 MECLOFENAMATE SODIUM (1)

164 MEDRYSONE (1)

165 MEGESTROL ACETATE USP (1)

166 MENOGAROL (U-52,047,Nsc-269148)PRODUCED KALAMAZOO, MICHIGAN FACILITIES (1)

167 MEROPENEM (NON-STERILE) (1)

168 MEROPENEM (STERILE) (1)

169 MEROPENEM + SODIUM CARBONATE (STERILE BULK) (1)

170 METHACYCLINE HYDROCHLORIDE (2)

171 METHAQUALONE HYDROCHLORIDE & METHAQUALONE BASE (1)

172 METHODS FACILITIES AND CONTROLS (1)

173 METHODS, FACILITIES AND CONTROLS (1)

174 METHODS, FACILS & CONTRLS (1)

175 METHYLPREDNISOLONE 100MG TABLETS (1)

176 METHYLPREDNISOLONE ACETATE USP (1)

177 METHYLPREDNISOLONE USP KALAMAZOO (1)

178 METHYRIDINE (1)

179 MINOCYCLINE HYDROCHLORIDE (1)

180 MINOCYCLINE HYDROCHLORIDE CAP (1)

181 MPEP (MEROPENEM INTERMEDIATE) (1)

182 MYSOLINE (PRIMIDONE) TABLETS (1)

183 N-ACETYLPROCAINAMIDE HCL. (1)

184 NEOMYCIN SULFATE (VET MED) (1)

185 NEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP (1)

186 NEOMYCIN SULFATE CAPS (THIS D CHANGED TO NDA 9-579) (1)

187 NICOTINE INHALER (1)

188 NICOTINE TRANSDERMAL DELIVERY SYSTEM (1)

189 NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE (1)

190 NSC-51173, (U-10955)--5A-ANDROSTAN-3-ONE,2A-FLUORO-17B-HYDROXY (1)

191 NT100H DRUG SUBSTANCE (1)

192 NYSTATIN BULK POWDER (1)

193 OFNE ADMIXTURE DRUG PRODUCTS (1)

194 OLEANSOMYCIN AND COCCIDIOSTATS IN POULTRY FEED (1)

195 OLSALAZINE SODIUM (1)

196 ORINASE (1)

197 OXALIPLATIN DRUG SUBSTANCE (1)

198 OXYTETRACYCLINE (5)

199 OXYTETRACYCLINE CALCIUM (2)

200 OXYTETRACYCLINE HYDROCHLORIDE (5)

201 PACKAGING OPERATION (1)

202 PACLITAXEL DRUG SUBSTANCE (2)

203 PACLITAXEL EXTRACT (1)

204 PAMIDRONIC ACID DRUG SUBSTANCE (1)

205 PELLETHANE MDI BASED URETHANE ELASTOMER (1)

206 PENICILLIN G BENZATHINE (2)

207 PENICILLIN G PROCAINE (2)

208 PENICILLIN G SODIUM (1)

209 PENICILLIN V (1)

210 PENICILLIN V POTASSIUM (2)

211 PERSONNEL FACILITIES AND OPERATING PROCEDURE (1)

212 PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES (1)

213 PERSONNEL, FACILS & GEN OPER PROCEDS AT THE LITITZ, PA FACILITY (1)

214 PFC EMULSION (1)

215 PHENYTOIN USP & PHENYTOIN SODIUM USP (1)

216 PIPERACILLIN (1)

217 PLEXIGEL (POLYETHYLENE OINT. BASE) (1)

218 PLICAMYCIN (1)

219 POLYMYXIN METHANE SULFONATE FOR TREAT. OF DISEASE IN POULTRY (VET) (1)

220 PREDNISOLONE ACETATE USP,MICRO & NON MICRO (1)

221 PREDNISOLONE SODIUM PHOSPHATE (1)

222 PREDNISOLONE USP (1)

223 PREDNISONE ACETATE, MICRO & NON-MICRO (1)

224 PREDNISONE MICRONIZED, STERILIZED AND ACETATE (1)

225 PREMARIN (CONJUGATED ESTROGENS-EQUINE) (1)

226 PROMONE (MEDROXYPROGESTERONE ACETATE (VET) (1)

227 QUALIFICATIONS OF PARKE, DAVIS & CO. RESEARCH PERSONNEL (1)

228 QUALITY CONTROL INFORMATION FOR NDA ANTIBIOTIC (1)

229 RAPAMYCIN (DOSAGE FORM) (1)

230 RESERPINE (1)

231 ROGOSIN EMULSION (1)

232 S N-263, A SULFATED POLYSACCHARIDE (VET) (1)

233 SODIUM BICARBONATE (STERILE) (1)

234 SODIUM CARBONATE (STERILE) (1)

235 SODIUM MECLOFENAMATE (1)

236 SODIUM NITROPRUSSIDE (1)

237 SOLKETAL(GLYCEROL 1,2 - ISOPROPYLIDENE ETHER) (1)

238 SPC-100270 EMULSION (1)

239 SPECTINOMYCIN HYDROCHLORIDE (1)

240 STREPTOMYCIN SULFATE (1)

241 STYRENE - MALEIC ACID COPOLYMER-TOXIC. DATA, CLIN REPTS & PHYSI CHARAC (1)

242 TAZOBACTAM ACID USP (1)

243 TAZOBACTAM USP (BH ROUTE) (1)

244 TEMAZEPAM (1)

245 TEQUIN I.V. (GATIFLOXACIN) (1)

246 TESTOLACTONE, USP (1)

247 TESTOSTERONE ENANTHATE USP (1)

248 TETRACYCLINE (4)

249 TETRACYCLINE HYDROCHLORIDE (8)

250 THN-CYCLIC (IMIPENEM INTERMEDIATE) (1)

251 THYMOXAMINE HCL BULK,MNFG BY GODECKE AG CHEMICAL,W.GERMANY(SUBSIDIARY) (1)

252 TIN ETHYL ETIOPURPURIN (TEP) EMULSION PROCESSING IN KUNGSANGEN AND STOCKHOLM, SWEDEN (1)

253 TINIDAZOLE BULK (1)

254 TOLBUTAMIDE, USP AND TOLBUTAMIDE, USP MILLED (1)

255 TRANEXAMIC ACID (1)

256 TRIAMCINOLONE (1)

257 TRIAMCINOLONE 21-ACETATE (1)

258 TRIAMCINOLONE 5 DRUG SUBSTANCE INTERMEDIATE (1)

259 TRIAMCINOLONE ACETONIDE (1)

260 TRIAZOLAM USP MICRONIZED (1)

261 TROLEANDOMYCIN (2)

262 U-32, 070E (25-HYDROXYCHOLECALCIFEROL) (1)

263 U-62,840 (1)

264 VANCOMYCIN HYDROCHLORIDE (2)

265 VIDARABINE (1)

266 VIOMYCIN SULFATE (1)

267 VIRAL AND BACTERIAL VACCINE (1)

268 VIRAL AND BACTERIAL VACCINES (1)

269 W 3361, A LIQUID ANTACID FORMULATION ---CHITOSAN ANTACID (1)

270 WARNER-LAMBERT, CAPS PLANT OPER, BROCKVILLE, ONTARIO, CAN FACILITY (1)

271 ZINC GLUCONATE (1)

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01 AMERICAN HOME PRODUCTS (1)

02 ASTRA LAKEMEDEL AB (2)

03 AYERST LABORATORIES INC (1)

04 AYERST LABORATORIES INC DIV AMERICAN HOME PRODUCTS CORP (14)

05 AYERST WYETH PHARMACEUTICALS INC (1)

06 CHAS PFIZER AND CO INC (5)

07 CORDEN PHARMA BOULDER INC (1)

08 GD SEARLE AND CO (6)

09 HOSPIRA BOULDER INC (4)

10 HOSPIRA HEALTHCARE INDIA PVT LTD (2)

11 HOSPIRA INC (15)

12 KABI PHARMACIA HEPAR INC (1)

13 KING PHARMACEUTICALS INC (1)

14 LEDERLE LABORATORIES (15)

15 PARKE DAVIS AND CO (21)

16 PARKE DAVIS DIV WARNER LAMBERT CO (14)

17 PFIZER (3)

18 PFIZER CANADA INC (1)

19 PFIZER CENTRAL RESEARCH (1)

20 PFIZER HEALTHCARE INDIA PVT LTD (13)

21 PFIZER INC (62)

22 PFIZER IRELAND PHARMACEUTICALS (1)

23 PHARMACIA AND UPJOHN (36)

24 PHARMACIA AND UPJOHN AB (4)

25 PHARMACIA AND UPJOHN CO (1)

26 PHARMACIA AND UPJOHN CO LLC (1)

27 PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC (6)

28 PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC (7)

29 PHARMACIA AND UPJOHN CORK LTD (1)

30 PHARMACIA AND UPJOHN SPA (5)

31 PHARMACIA AND UPJOHN SUB PFIZER INC (11)

32 SEARLE (1)

33 UPJOHN CO (27)

34 WARNER LAMBERT CO (3)

35 WARNER LAMBERT CO LLC (1)

36 WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIV (4)

37 WYETH INC (7)

38 WYETH LABORATORIES INC (1)

39 WYETH PHARMACEUTICALS (1)

40 WYETH PHARMACEUTICALS INC (2)

41 WYETH-AYERST LABORATORIES (6)

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01 U.S.A (310)

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01 Active (19)

02 Inactive (291)

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01 Complete (1)

02 Blank (309)

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