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

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01 (S)-PREGABALIN (1)

02 ABACAVIR SULFATE USP (1)

03 ABALOPARATIDE (1)

04 ABAMETAPIR (1)

05 ACYCLOVIR USP (1)

06 ADEFOVIR DIPIVOXIL (1)

07 ALENDRONATE SODIUM USP (TRIHYDRATE) (1)

08 ALLOPURINOL USP (1)

09 ALMOTRIPTAN MALATE USP (1)

10 ALPRAZOLAM USP (1)

11 AMBRISENTAN (1)

12 AMLODIPINE (1)

13 AMLODIPINE BESILATE USP (AYP) (1)

14 AMLODIPINE BESYLATE USP (1)

15 AMLODIPINE BESYLATE USP (ADP) (1)

16 AMLODIPINE MESYLATE (1)

17 APIXABAN (1)

18 APREMILAST (CRYSTALLINE) (1)

19 ARIPIPRAZOLE MONOHYDRATE (1)

20 ARIPIPRAZOLE USP (1)

21 ARMODAFINIL (1)

22 ASENAPINE MALEATE (1)

23 ATAZANAVIR SULFATE (1)

24 ATAZANAVIR SULFATE (PROCESS-II) (1)

25 ATENOLOL USP (1)

26 ATOMOXETINE HYDROCHLORIDE USP (1)

27 ATORVASTATIN CALCIUM USP (1)

28 ATOVAQUONE USP (1)

29 ATROPINE SULFATE USP (1)

30 AZACITIDINE (1)

31 AZATHIOPRINE USP (1)

32 AZELASTINE HCl (1)

33 BACLOFEN USP (1)

34 BEDAQUILINE FUMARATE (1)

35 BICALUTAMIDE USP (1)

36 BICTEGRAVIR SODIUM (1)

37 BOSENTAN (1)

38 BROENAC SODIUM (1)

39 CANAGLIFLOZIN (1)

40 CANAGLIFLOZIN HEMIHYDRATE (1)

41 CANDESARTAN CILEXETIL USP (1)

42 CAPECITABINE USP (1)

43 CARVEDILOL PHOSPHATE (1)

44 CARVEDILOL USP (1)

45 CELECOXIB USP (1)

46 CETIRIZINE HYDROCHLORIDE USP (1)

47 CEVIMELINE HYDROCHLORIDE USP (1)

48 CHLORTHALIDONE USP (1)

49 CIPROFLOXACIN HYDROCHLORIDE USP (1)

50 CIPROFLOXACIN USP (1)

51 CITALOPRAM HYDROBROMIDE USP (2)

52 CLARITHROMYCIN USP (CLP) (1)

53 CLARITHROMYCIN USP (CXP) (1)

54 CLARITHROMYCIN USP(COP) (1)

55 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (1)

56 CLOFARABINE (1)

57 CLOPIDOGREL BISULFATE USP (1)

58 CLOZAPINE USP (1)

59 COBICISTAT ON SILICON DIOXIDE (1)

60 COBICISTAT ON SILICON DIOXIDE (PROCESS-II) (1)

61 COLESTIPOL HYDROCHLORIDE (POVIDONE PREMIX) (1)

62 DACARBAZINE USP (1)

63 DARIFENACIN HYDROBROMIDE (1)

64 DARUNAVIR (1)

65 DARUNAVIR (PROCESS-II) (1)

66 DARUNAVIR ETHANOLATE (1)

67 DEFERASIROX (1)

68 DESLORATADINE USP (1)

69 DESMOPRESSIN ACETATE USP (1)

70 DEXLANSOPRAZOLE AMORPHOUS (1)

71 DEXLANSOPRAZOLE SESQUIHYDRATE (1)

72 DIDANOSINE USP (1)

73 DIFLUNISAL, USP (1)

74 DIMETHYL FUMARATE USP (1)

75 DIPHENOXYLATE HYDROCHLORIDE USP (1)

76 DIPYRIDAMOLE USP (1)

77 DISULFIRAM USP (1)

78 DOFETILIDE USP, POLYMORPH P162B (1)

79 DOLUTEGRAVIR SODIUM (1)

80 DOLUTEGRAVIR SODIUM (PROCESS-II) (1)

81 DORAVIRINE (1)

82 DRONEDARONE HYDROCHLORIDE (1)

83 DROXIDOPA (1)

84 DULOXETINE HYDROCHLORIDE (1)

85 DULOXETINE HYDROCHLORIDE USP (1)

86 EFAVIRENZ USP (2)

87 EFAVIRENZ USP (PROCESS - II) (1)

88 EFAVIRENZ USP (PROCESS-III) (1)

89 EFAVIRENZ USP (PROCESS-IV) (1)

90 EFINACONAZOLE (1)

91 ELETRIPTAN HYDROBROMIDE (PROCESS 1) (1)

92 ELETRIPTAN HYDROBROMIDE (PROCESS 2) (1)

93 ELVITEGRAVIR (1)

94 ELVITEGRAVIR (PROCESS-II) (1)

95 EMPAGLIFLOZIN (1)

96 EMTRICITABINE (PROCESS-II) (1)

97 EMTRICITABINE (PROCESS-III) (1)

98 EMTRICITABINE USP (1)

99 ENROFLOXACIN USP (1)

100 ENZALUTAMIDE (1)

101 EPINEPHRINE BITARTRATE USP (1)

102 EPINEPHRINE USP (1)

103 EPROSARTAN MESYLATE (1)

104 ERLOTINIB HYDROCHLORIDE (2)

105 ESCITALOPRAM OXALATE USP (1)

106 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (1)

107 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I) (1)

108 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II) (1)

109 ESZOPICLONE USP (1)

110 ETHACRYNIC ACID USP (1)

111 ETRAVIRINE (1)

112 EZETIMIBE USP (1)

113 FEBUXOSTAT (1)

114 FELBAMATE USP (1)

115 FELBAMATE USP (FEL) (1)

116 FERRIC CARBOXYMALTOSE (1)

117 FEXOFENADINE HYDROCHLORIDE USP (1)

118 FINGOLIMOD HYDROCHLORIDE USP (1)

119 FLUCONAZOLE USP (1)

120 FLUCYTOSINE, USP (1)

121 FLUDROCORTISONE ACETATE USP (1)

122 FLUTICASONE PROPIONATE USP (1)

123 FOMEPIZOLE (1)

124 FORMOTEROL FUMARATE DIHYDRATE USP (1)

125 FOSAMPRENAVIR CALCIUM USP (1)

126 FROVATRIPTAN SUCCINATE MONOHYDRATE (1)

127 GABAPENTIN USP (1)

128 GATIFLOXACIN (1)

129 GEMCITABINE HYDROCHLORIDE USP (1)

130 ICATIBANT ACETATE (1)

131 ILOPERIDONE (1)

132 IMATINIB MESYLATE (1)

133 INDINAVIR SULFATE USP (1)

134 IRBESARTAN USP (1)

135 IRON DEXTRAN (1)

136 IRON SUCROSE (1)

137 ISOSULFAN BLUE (1)

138 ITRACONAZOLE USP (1)

139 LABETALOL HYDROCHLORIDE USP (1)

140 LAMIVUDINE USP (1)

141 LAMIVUDINE USP (LVD) (1)

142 LAMIVUDINE USP (PROCESS-II) (1)

143 LAMOTRIGINE USP (1)

144 LANSOPRAZOLE USP (1)

145 LANTHANUM CARBONATE (1)

146 LANTHANUM CARBONATE (PROCESS 2) (1)

147 LATANOPROST (1)

148 LEDIPASVIR (1)

149 LENALIDOMIDE (1)

150 LETROZOLE USP (1)

151 LEUPROLIDE ACETATE USP (1)

152 LEVETIRACETAM USP (1)

153 LEVOFLOXACIN USP (HEMIHYDRATE) (1)

154 LINAGLIPTIN (1)

155 LISINOPRIL USP (1)

156 LOPINAVIR (LOR) (1)

157 LOPINAVIR (LVR) (1)

158 LOPINAVIR USP (1)

159 LORATADINE USP (LCP) (1)

160 LORATADINE USP (LDP) (1)

161 LOSARTAN POTASSIUM USP (1)

162 LURASIDONE HYDROCHLORIDE (1)

163 MACITENTAN (1)

164 MAFENIDE ACETATE USP (2)

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

166 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN QUEENSLAND, AUSTRALIA. (1)

167 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROCKFORD, ILLINOIS. (1)

168 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN. (1)

169 MEMANTINE HYDROCHLORIDE USP (1)

170 MESALAMINE USP (1)

171 MIGLUSTAT (1)

172 MILNACIPRAN HYDROCHLORIDE (1)

173 MIRTAZAPINE USP (ANHYDROUS) (1)

174 MIRTAZAPINE USP (HEMIHYDRATE) (1)

175 MODAFINIL USP (1)

176 MOLINDONE HYDROCHLORIDE USP (1)

177 MONTELUKAST SODIUM USP (1)

178 MOXIFLOXACIN HYDROCHLORIDE (1)

179 NABUMETONE USP (1)

180 NADOLOL USP (1)

181 NAPROXEN SODIUM USP (1)

182 NAPROXEN USP (1)

183 NELFINAVIR MESYLATE (1)

184 NEPAFENAC (1)

185 NEPAFENAC (STERILE) (1)

186 NETUPITANT (1)

187 NEVIRAPINE HEMIHYDRATE USP (1)

188 NEVIRAPINE USP (ANHYDROUS) (1)

189 NEVIRAPINE USP (ANHYDROUS) (RAN) (1)

190 NEVIRAPINE USP, NON-STERILE BULK FORM (1)

191 O-DESMETHYL VENLAFAXINE SUCCINATE (1)

192 OCTREOTIDE ACETATE USP (1)

193 OLANZAPINE (1)

194 OLMESARTAN MEDOXOMIL USP (1)

195 OLSALAZINE SODIUM (1)

196 OMEPRAZOLE MAGNESIUM USP (1)

197 OSELTAMIVIR PHOSPHATE USP (1)

198 OXCARBAZEPINE (1)

199 PALBOCICLIB (1)

200 PALIPERIDONE PALMITATE (1)

201 PALIPERIDONE PALMITATE (STERILE) (1)

202 PALIPERIDONE USP (1)

203 PANTOPRAZOLE SODIUM USP (SESQUIHYDRATE) (1)

204 PAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE) (1)

205 PEMETREXED DISODIUM HEMIPENTAHYDRATE (1)

206 PENCICLOVIR (1)

207 PENTOSAN POLYSULFATE SODIUM (1)

208 PENTOSTATIN (1)

209 PERINDOPRIL TERT-BUTYLAMINE (1)

210 PHENOXYBENZAMINE HYDROCHLORIDE USP (1)

211 PHENTOLAMINE MESYLATE, USP (1)

212 PIOGLITAZONE HYDROCHLORIDE USP (1)

213 PIRFENIDONE (1)

214 PITAVASTATIN CALCIUM (1)

215 PLECANATIDE (1)

216 PLERIXAFOR (1)

217 POMALIDOMIDE (2)

218 PONATINIB HYDROCHLORIDE (1)

219 PRAMIPEXOLE DIHYDROCHLORIDE USP (1)

220 PRASUGREL HYDROCHLORIDE USP (1)

221 PREGABALIN (PROCESS II) (1)

222 PREGABALIN USP (1)

223 PRETOMANID (1)

224 PRIMAQUINE PHOSPHATE, USP (1)

225 PROGUANIL HYDROCHLORIDE USP (1)

226 PROPAFENONE HYDROCHLORIDE USP (1)

227 PYRAZINAMIDE USP (1)

228 QUETIAPINE FUMARATE USP (1)

229 QUINAPRIL HYDROCHLORIDE USP (1)

230 RABEPRAZOLE SODIUM (1)

231 RALTEGRAVIR POTASSIUM (1)

232 RALTEGRAVIR POTASSIUM USP (PROCESS-II) (1)

233 RASAGILINE MESYLATE (1)

234 REGADENOSON (1)

235 RILPIVIRINE HYDROCHLORIDE (1)

236 RISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE) (1)

237 RISPERIDONE USP (1)

238 RITONAVIR USP (FORM I) (1)

239 RITONAVIR USP (FORM-II) (1)

240 RIVAROXABAN USP (1)

241 RIVASTIGMINE (1)

242 RIVASTIGMINE TARTRATE USP (1)

243 RIVASTIGMINE USP (PROCESS II) (1)

244 RIZATRIPTAN BENZOATE USP (1)

245 ROFLUMILAST (1)

246 ROSIGLITAZONE (1)

247 ROSUVASTATIN CALCIUM (1)

248 ROTIGOTINE USP (1)

249 SACUBITRIL (1)

250 SACUBITRIL/VALSARTAN (1)

251 SALMETEROL XINAFOATE USP (1)

252 SAXAGLIPTIN HYDROCHLORIDE (1)

253 SELEGILINE (1)

254 SERTRALINE HYDROCHLORIDE USP (FORM II) (1)

255 SEVELAMER CARBONATE (1)

256 SEVELAMER HYDROCHLORIDE (1)

257 SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE (1)

258 SILDENAFIL (1)

259 SILDENAFIL CITRATE USP (1)

260 SIMVASTATIN USP (1)

261 SINCALIDE (1)

262 SITAGLIPTIN PHOSPHATE USP (1)

263 SODIUM FERRIC GLUCONATE COMPLEX (1)

264 SODIUM NITROPRUSSIDE USP (1)

265 SOFOSBUVIR (1)

266 STAVUDINE USP (2)

267 STAVUDINE USP (STR) (1)

268 SUCROFERRIC OXYHYDROXIDE (1)

269 SUGAMMADEX SODIUM (1)

270 SUMATRIPTAN SUCCINATE USP (1)

271 SUNITINIB MALATE (1)

272 TADALAFIL USP (1)

273 TELMISARTAN USP (1)

274 TEMAZEPAM USP (1)

275 TENOFOVIR ALAFENAMIDE FUMARATE (1)

276 TENOFOVIR ALAFERNAMIDE MONOFUMARATE (1)

277 TENOFOVIR DISOPROXIL FUMARATE (1)

278 TENOFOVIR DISOPROXIL FUMARATE (PROCESS-II) (1)

279 TERBINAFINE HYDROCHLORIDE USP (1)

280 TETRABENAZINE (2)

281 THALIDOMIDE USP (1)

282 THIOTEPA USP (1)

283 TICAGRELOR (1)

284 TIZANIDINE HYDROCHLORIDE USP (1)

285 TOFACITINIB CITRATE (1)

286 TOLMETIN SODIUM USP (1)

287 TRAZODONE HYDROCHLORIDE USP (1)

288 TRIENTINE HYDROCHLORIDE USP (1)

289 VALACYCLOVIR HYDROCHLORIDE USP (1)

290 VALACYCLOVIR HYDROCHLORIDE USP (VCR) (1)

291 VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) (1)

292 VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) FORM A (1)

293 VALSARTAN USP (1)

294 VARENICLINE TARTRATE (1)

295 VENLAFAXINE HYDROCHLORIDE USP (1)

296 VERAPAMIL HYDROCHLORIDE USP (1)

297 VILAZODONE HYDROCHLORIDE (1)

298 VORICONAZOLE USP (1)

299 VORINOSTAT (1)

300 VORTIOXETINE HYDROBROMIDE (1)

301 ZIDOVUDINE USP (PROCESS II) (1)

302 ZIDOVUDINE USP (PROCESS III) (1)

303 ZIDOVUDINE USP (PROCESS-I) (1)

304 ZIDOVUDINE, USP (1)

305 ZILEUTON USP (1)

306 ZOFENOPRIL CALCIUM (1)

307 ZOLEDRONIC ACID (1)

308 ZOLMITRIPTAN USP (1)

309 ZOLPIDEM TARTRATE USP (1)

310 ZONISAMIDE (1)

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03 MYLAN INC (2)

04 MYLAN LABORATORIES LTD (302)

05 MYLAN PHARMACEUTICALS INC A VIATRIS CO (2)

06 RISING PHARMA HOLDING INC (1)

07 UDL LABORATORIES INC (1)

08 VIATRIS GMBH AND CO KG (1)

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01 Australia (1)

02 China (7)

03 India (42)

04 U.S.A (267)

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01 Active (228)

02 Inactive (89)

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01 Complete (140)

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