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

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01 5-FLUOROURACIL (1)

02 ABIRATERONE ACETATE (1)

03 ACETAZOLAMIDE (1)

04 ACETYLSULFISOXAZOLE (1)

05 ACYCLOVIR (1)

06 ACYCLOVIR USP (3)

07 ADAPALENE USP (1)

08 AFATINIB DIMALEATE (1)

09 ALBUTEROL SULPHATE (SALBUTAMOL) (1)

10 ALCLOMETASONE DIPROPIONATE (1)

11 ALENDRONATE MONOSODIUM TRIHYDRATE (1)

12 ALLOPURINOL (1)

13 ALLOPURINOL USP (1)

14 ALPHA METHYLDOPA USP (1)

15 AMCINONIDE (2)

16 AMITRIPTYLINE HCL USP DRUG SUBSTANCE (1)

17 AMLODIPINE BESYLATE (1)

18 AMLODIPINE BESYLATE (PROCESS II) (1)

19 AMOXICILLIN SODIUM (1)

20 AMOXICILLIN TRIHYDRATE USP (1)

21 AMPICILLIN TRIHYDRATE (1)

22 ANASTROZOLE (1)

23 APIXABAN (1)

24 ARIPIPRAZOLE (1)

25 ARMODAFINIL (1)

26 ARMODAFINIL 7SM1029 (1)

27 ATENOLOL (1)

28 ATOMOXETINE HYDROCHLORIDE (1)

29 ATORVASTATIN CALCIUM (5)

30 ATRACURIUM BESYLATE (1)

31 AZACITIDINE (1)

32 AZITHROMYCIN DIHYDRATE (1)

33 AZITHROMYCIN MONOHYDRATE (2)

34 AZITHROMYCIN N (1)

35 AZTREONAM (1)

36 AZTREONAM USP (1)

37 BECLOMETHASONE DIPROPIONATE (1)

38 BECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE (1)

39 BECLOMETHASONE DIPROPIONATE MONOHYDRATE (1)

40 BETAMETHASONE ACETATE (1)

41 BETAMETHASONE DIPROPIONATE (1)

42 BETAMETHASONE VALERATE (1)

43 BICALUTAMIDE (1)

44 BIVALIRUDIN (1)

45 BLEOMYCIN SULFATE (1)

46 BORTEZOMIB (1)

47 BREXPIPRAZOLE (1)

48 BROMOCRIPTINE MESYLATE (1)

49 BUDESONIDE (2)

50 BUPRENORPHINE (1)

51 BUPRENORPHINE HYDROCHLORIDE (1)

52 BUTORPHANOL TARTRATE (1)

53 CABAZITAXEL (1)

54 CABERGOLINE (1)

55 CALCIPOTRIENE USP (1)

56 CALCITRIOL USP (1)

57 CANDESARTAN CILEXETIL (1)

58 CAPECITABINE (1)

59 CARBAMAZEPINE USP (2)

60 CARBIDOPA (1)

61 CARBIDOPA USP (DRUG SUBSTANCE) (1)

62 CARBOPLATIN (1)

63 CARFILZOMIB (1)

64 CARVEDILOL PHOSPHATE (1)

65 CARVEDILOL USP (1)

66 CASPOFUNGIN (1)

67 CASPOFUNGIN ACETATE (1)

68 CEFACLOR USP (1)

69 CEFADROXIL (1)

70 CEFAZOLIN SODIUM (1)

71 CEFDINIR HYDRATE (1)

72 CEFPROZIL (1)

73 CEPHALEXIN (1)

74 CEPHALOSPORIN G (1)

75 CEPHRADINE (1)

76 CHLORTHALIDONE (1)

77 CILOSTAZOL USP (1)

78 CINACALCET HYDROCHLORIDE (1)

79 CISATRACURIUM BESYLATE (1)

80 CLARITHROMYCIN USP (1)

81 CLOBETASOL PROPIONATE (2)

82 CLOMIPHENE CITRATE (1)

83 CLOPIDOGREL BISULFATE USP (1)

84 CLOXACILLIN SODIUM (1)

85 CO-POLYMER-1 (COP-1) (1)

86 CRISABOROLE (1)

87 CYCLACILLIN (1)

88 CYCLOSPORINE (2)

89 CYCLOSPORINE ID: 741310 (1)

90 CYCLOSPORINE ID: 741710 (1)

91 DABIGATRAN ETEXILATE MESYLATE (1)

92 DARIFENACIN HYDROBROMIDE (1)

93 DASATINIB ANHYDROUS (1)

94 DASATINIB MONOHYDRATE (1)

95 DAUNORUBICIN HYDROCHLORIDE (1)

96 DEFERASIROX (1)

97 DEFEROXAMINE MESYLATE (1)

98 DESFESOTERODINE SUCCINATE (1)

99 DESLORATADINE DRUG SUBSTANCE (1)

100 DESMOPRESSIN ACETATE USP (1)

101 DESONIDE (1)

102 DESVENLAFAXINE BASE (1)

103 DESVENLAFAXINE FUMARATE (1)

104 DESVENLAFAXINE SUCCINATE (1)

105 DESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX (1)

106 DEXRAZOXANE (ICRF-187) (1)

107 DICLOXACILLIN SODIUM (1)

108 DIFLORASONE DIACETATE BULK DRUG (1)

109 DIFLUPREDNATE (1)

110 DIHYDRO DANE SALT (1)

111 DIHYDROERGOTAMINE MESYLATE (1)

112 DILTIAZEM HYDROCHLORIDE USP (1)

113 DIMETHYL FUMARATE (2)

114 DIROXIMEL FUMARATE (1)

115 DOCETAXEL (1)

116 DONEPEZIL HYDROCHLORIDE (1)

117 DORZOLAMIDE HCL (1)

118 DOXEPIN HCL USP (1)

119 DOXERCALCIFEROL DRUG SUBSTANCE (1)

120 DOXORUBICIN HYDROCHLORIDE (1)

121 DROSPIRENONE (1)

122 DULOXETINE HCL DRUG SUBSTANCE (1)

123 ELETRIPTAN HYDROBROMIDE (1)

124 EMPAGLIFLOZIN (1)

125 EPIRUBICIN HYDROCHLORIDE LYOPHILIZED (1)

126 EPIRUBICIN HYDROCHLORIDE PRECIPITATED (1)

127 EPTIFIBATIDE (1)

128 ERGOLOID MESYLATES (1)

129 ERGONOVINE MALEATE (1)

130 ERGOTAMINE TARTRATE (1)

131 ERLOTINIB HCL (1)

132 ESTROGENIC LIQUIDS (1)

133 ESTROGENIC POWDERS (1)

134 ESZOPICLONE ( PROCESS I ) (1)

135 ESZOPICLONE (PROCESS II) (1)

136 ETODOLAC (1)

137 ETOPOSIDE (1)

138 EXENATIDE (1)

139 EZETIMIBE (1)

140 EZETIMIBE DRUG SUBSTANCE (1)

141 FAMCICLOVIR (1)

142 FEBUXOSTAT (1)

143 FENOFIBRATE CHOLINE (1)

144 FEXOFENADINE BASE (1)

145 FEXOFENADINE HYDROCHLORIDE (1)

146 FINGOLIMOD HYDROCHLORIDE (1)

147 FLUDARABINE PHOSPHATE (1)

148 FLUDROCORTISONE ACETATE (1)

149 FLUNISOLIDE ANHYDROUS (1)

150 FLUNISOLIDE ANHYDROUS (NEW PROCESS) (1)

151 FLUOCINOLONE ACETONIDE (PROCESS I) (1)

152 FLUOCINOLONE ACETONIDE - PROCESS II (1)

153 FLUOCINONIDE (1)

154 FLUOCINONIDE (NEW PROCESS) (1)

155 FLUOROMETHOLONE-17-ACETATE (1)

156 FLUOXETINE HCI (1)

157 FLUTICASONE PROPIONATE (1)

158 FLUVASTATIN SODIUM (1)

159 FLUVOXAMINE MALEATE (1)

160 FORMOTEROL FUMARATE DIHYDRATE (1)

161 FOSAMPRENAVIR CALCIUM (1)

162 FULVESTRANT (2)

163 FUROSEMIDE USP (1)

164 GABAPENTIN (1)

165 GABAPENTIN BUTANOL PROCESS (1)

166 GALANTHAMINE HYDROBROMIDE (1)

167 GATIFLOXACIN (1)

168 GEIBROZIL USP (1)

169 GEMCITABINE HYDROCHLORIDE (1)

170 GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS) (1)

171 HALOBETASOL PROPIONATE (1)

172 HALOPERIDOL (1)

173 HALOPERIDOL DECANOATE (1)

174 HYDROCHLOROTHIAZIDE (2)

175 HYDROCORTISONE BUTYRATE DRUG SUBSTANCE (1)

176 IBANDRONATE SODIUM (1)

177 IBRUTINIB (1)

178 ICATIBANT ACETATE (1)

179 IDARUBICIN HYDROCHLORIDE (1)

180 IMATINIB MESYLATE (1)

181 IMATINIB MESYLATE FORM ALPHA (1)

182 IMIPRAMINE HYDROCHLORIDE USP (1)

183 IMIQUIMOD (1)

184 IRBESARTAN (1)

185 IRBESARTAN USP (1)

186 LABETALOL HYDROCHLORIDE (2)

187 LACOSAMIDE (1)

188 LAMOTRIGINE (1)

189 LANSOPRAZOLE (1)

190 LATANOPROST (1)

191 LETROZOLE (1)

192 LEUPROLIDE ACETATE (1)

193 LEVALBUTEROL HYDROCHLORIDE (1)

194 LEVETIRACETAM (1)

195 LEVODOPA (1)

196 LEVOFLOXACIN (1)

197 LINACLOTIDE (1)

198 LINAGLIPTIN (1)

199 LINEZOLID (1)

200 LISINOPRIL DRUG SUBSTANCE (1)

201 LISURIDE (1)

202 LISURIDE HYDROGENMALEATE (1)

203 LOPERAMIDE HYDROCHLORIDE (1)

204 LORAZEPAM (1)

205 LOSARTAN POTASSIUM (2)

206 LOVASTATIN USP (1)

207 LR-103 (1)

208 LUBIPROSTONE (1)

209 LURASIDONE HYDROCHLORIDE (1)

210 MACITENTAN (1)

211 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEER SHEVA, ISREAL. (1)

212 MEDROXYPROGESTERONE ACETATE (1)

213 MEGESTROL ACETATE (1)

214 MEMANTINE HYDROCHLORIDE (1)

215 MESALAZINE N (1)

216 METFORMIN HYDROCHLORIDE DRUG SUBSTANCE (1)

217 METHYLDOPA (1)

218 METHYLERGONOVINE MALEATE USP (1)

219 METHYLPREDNISOLONE HEMISUCCINATE, BULK INTERMEDIATE (1)

220 METOPROLOL SUCCINATE (1)

221 METOPROLOL TARTRATE (1)

222 METOPROLOL TARTRATE USP (1)

223 MICAFUNGIN SODIUM (1)

224 MIRTAZAPINE (1)

225 MISOPROSTOL (1)

226 MISOPROSTOL HPMC DISPERSION 1:100 (1)

227 MITOMYCIN (1)

228 MITOXANTRONE HYDROCHLORIDE USP (1)

229 MODAFINIL (1)

230 MOMETASONE FUROATE USP (1)

231 MONTELUKAST SODIUM (2)

232 MUPIROCIN (2)

233 MUPIROCIN CALCIUM (1)

234 MUPIROCIN CALCIUM DIHYDRATE (1)

235 MYCOPHENOLATE MOFETIL DRUG SUBSTANCE (1)

236 MYCOPHENOLATE SODIUM (1)

237 NAC-GAMMA CALICHEAMICIN ACBUT OSU(PIVOTAL INTERMEDIATE) (1)

238 NAPROXEN (1)

239 NAPROXEN AND NAPROXEN SODIUM USP (1)

240 NAPROXEN SODIUM (1)

241 NATEGLINIDE (1)

242 NEFAZODONE HYDROCHLORIDE USP (1)

243 NIFEDIPINE (1)

244 NILOTINIB HYDROCHLORIDE (1)

245 NILOTINIB HYDROCHLORIDE FORM ALPHA (1)

246 NITISINONE (1)

247 NORGESTIMATE BULK DRUG SUBSTANCE (1)

248 OCTREOTIDE ACETATE (1)

249 OLANZAPINE USP (1)

250 OLMESARTAN MEDOXOMIL USP (1)

251 OMEPRAZOLE (1)

252 ONDANSETRON BASE (1)

253 ONDANSETRON HCL DIHYDRATE (1)

254 ONDANSETRON HYDROCHLORIDE DIHYDRATE (1)

255 OXACILLIN SODIUM (1)

256 OXALIPLATIN (1)

257 OXAZEPAM (1)

258 PACLITAXEL (1)

259 PACLITAXEL SEMISYNTHETIC (1)

260 PACLITAXEL SEMISYNTHETIC (9-DHB) (1)

261 PACLITAXEL SEMISYNTHETIC (FROM 10-DAB) (1)

262 PALBOCICLIB (1)

263 PALIPERIDONE (1)

264 PALONOSETRON HCL (1)

265 PALONOSETRON HYDROCHLORIDE (1)

266 PAMIDRONATE BULK CHEMICAL (1)

267 PANCURONIUM BROMIDE (1)

268 PANTOPRAZOLE SODIUM (2)

269 PARAHYDROXY DANE SALT (1)

270 PARICALCITOL USP (1)

271 PAROXETINE HYDROCHLORIDE HEMIHYDRATE (1)

272 PEMETREXED DIACID (1)

273 PENICILLIN G SULFOXIDE (1)

274 PENICILLIN V POTASSIUM (1)

275 PENTOXIFYLLINE USP (1)

276 PERAMPANEL (1)

277 PERGOLIDE MESYLATE (1)

278 PILOPEX 2 EYE DROPS (1)

279 PIOGLITAZONE HYDROCHLORIDE (1)

280 POTASSIUM CITRATE USP (1)

281 PRALATREXATE (1)

282 PRASUGREL HYDROCHLORIDE (1)

283 PRAVASTATIN SODIUM (1)

284 PREDNICARBATE DRUG SUBSTANCE (1)

285 PREGABALIN D9333 (1)

286 PREGABALIN DRUG SUBSTANCE (1)

287 PROBENECID USP (1)

288 QUETIAPINE FUMARATE DRUG SUBSTANCE (1)

289 RALOXIFENE HYDROCHLORIDE (1)

290 RALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE (1)

291 RAMELTEON (1)

292 RASAGILINE MESYLATE (1)

293 RISEDRONATE SODIUM (1)

294 RISPERIDONE USP (1)

295 RIVAROXABAN (1)

296 ROCURONIUM BROMIDE (1)

297 ROMIDEPSIN (1)

298 ROSIGLITAZONE MALEATE (1)

299 ROSUVASTATIN CALCIUM (BULK) (1)

300 ROSUVASTATIN CALCIUM PROCESS G (1)

301 ROSUVASTATIN CALCIUM PROCESS G 2410 (1)

302 ROTIGOTINE (1)

303 SACUBITRIL/VALSARTAN (1)

304 SAXAGLIPTIN MONOHYDRATE (1)

305 SD-809 DEUTETRABENAZINE (1)

306 SELEGILINE HYDROCHLORIDE (1)

307 SERTRALINE HYDROCHLORIDE (1)

308 SILDENAFIL CITRATE (1)

309 SILVER SULFADIAZINE (1)

310 SIMVASTATIN (1)

311 SIMVASTATIN (ETHANOL PROCESS) (1)

312 SITAGLIPTIN PHOSPHATE (2)

313 SITAGLIPTIN PHOSPHATE ENZYMATIC (1)

314 SODIUM ALENDRONATE (1)

315 SOFOSBUVIR 1213 (1)

316 SOFOSBUVIR 1613 (1)

317 SOLIFENACIN SUCCINATE (1)

318 SORAFENIB TOSYLATE (1)

319 SUGAMMADEX SODIUM (1)

320 SULFAMETHOXAZOLE (1)

321 SULFAMETHOXAZOLE USP (1)

322 SUNITINIB MALATE (1)

323 SYNTHETIC CONJUGATED ESTROGENS, A(F00375) (1)

324 TACROLIMUS (1)

325 TADALAFIL (1)

326 TAMOXIFEN CITRATE USP (1)

327 TELMISARTAN (1)

328 TERAZOSIN HCI 2H20 (1)

329 TERAZOSIN HCI DIHYDRATE (1)

330 TERAZOSIN HYDROCHLORIDE (1)

331 TERBINAFINE HYDROCHLORIDE (1)

332 TERFENADINE (1)

333 TERGURIDE HYDROGENMALEATE (1)

334 TERIPARATIDE ACETATE (1)

335 THIOTEPA (1)

336 TICAGRELOR (1)

337 TICLOPIDINE HCL (1)

338 TIGECYCLINE (1)

339 TIMOLOL MALEATE (1)

340 TIOTROPIUM BROMIDE (1)

341 TOBRAMYCIN (1)

342 TOLTERODINE TARTRATE (1)

343 TORSEMIDE (2)

344 TRAZODONE HYDROCHLORIDE (1)

345 TRAZODONE HYDROCHLORIDE USP (1)

346 TRIAMCINOLONE ACETONIDE (1)

347 TRIAMCINOLONE ACETONIDE MICRONIZED STERILE (1)

348 TRIMETHOPRIM USP (1)

349 TRIMIPRAMINE MALEATE (1)

350 ULIPRISTAL ACETATE (1)

351 UMECLIDINIUM BROMIDE (1)

352 VALACYCLOVIR HYDROCHLORIDE (1)

353 VALRUBICIN (AD-32) (1)

354 VALSARTAN (2)

355 VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE (1)

356 VECURONIUM BROMIDE (1)

357 VENLAFAXINE HYDROCHLORIDE (2)

358 VERAPAMIL HYDROCHLORIDE (1)

359 VILAZODONE HYDROCHLORIDE (1)

360 WARFARIN SODIUM CLATHRATE (1)

361 ZALEPLON (1)

362 ZIPRASIDONE HYDROCHLORIDE (1)

363 ZOLEDRONATE DISODIUM (1)

364 ZOLEDRONIC ACID (1)

365 ZOLMITRIPTAN (1)

366 ZOLPIDEM TARTRATE (2)

367 ZONISAMIDE (1)

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01 ACELLA PHARMACEUTICALS LLC (1)

02 FLAMMA SPA (2)

03 TAPI PUERTO RICO INC (1)

04 TEVA GROUP (7)

05 TEVA PHARMACEUTICAL FINE CHEMICALS SRL (1)

06 TEVA PHARMACEUTICAL INC (1)

07 TEVA PHARMACEUTICAL INDUSTRIES LTD (362)

08 TEVA PHARMACEUTICALS INDUSTRIES LTD (4)

09 TEVA PHARMACEUTICALS USA INC (9)

10 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD (2)

11 ZYDUS LIFESCIENCES LTD (2)

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01 Ireland (1)

02 Israel (388)

03 Mexico (2)

04 U.S.A (1)

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01 Active (299)

02 Inactive (93)

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01 Complete (223)

02 Blank (169)

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TEVA PHARMACEUTICAL I...
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