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

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01 5-FLUOROCYTOSINE (FLUCYTOSINE) USP (1)

02 ABACAVIR SULFATE USP (PROCESS-2) (1)

03 ABACAVIR SULFATE, USP (1)

04 APALUTAMIDE (1)

05 ATAZANAVIR SULFATE (1)

06 ATORVASTATIN CALCIUM TRIHYDRATE USP (1)

07 AZACITIDINE (1)

08 BICTEGRAVIR SODIUM (1)

09 BORTEZOMIB (1)

10 CABAZITAXEL (1)

11 CANAGLIFLOZIN (1)

12 CARBOPLATIN USP DRUG SUBSTANCE (1)

13 CARFILZOMIB (1)

14 CISPLATIN USP DRUG SUBSTANCE (1)

15 DARUNAVIR (1)

16 DOCETAXEL ANHYDROUS USP (1)

17 DOCETAXEL ANHYDROUS, USP (PROCESS-2) (1)

18 DOLUTEGRAVIR SODIUM (1)

19 DOLUTEGRAVIR SODIUM (PROCESS-2) (1)

20 DOLUTEGRAVIR SODIUM (PROCESS-3) (1)

21 EFAVIRENZ USP (1)

22 EFAVIRENZ USP (PROCESS-2) (1)

23 EMPAGLIFLOZIN (1)

24 EMTRICITABINE (1)

25 ENZALUTAMIDE (1)

26 ERLOTINIB HYDROCHLORIDE (1)

27 GEMCITABINE HYDROCHLORIDE USP (1)

28 HYDROXYCHLOROQUINE SULFATE USP (1)

29 IMATINIB MESYLATE (1)

30 IMATINIB MESYLATE (PROCESS-2) (1)

31 IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP (1)

32 LAMIVUDINE USP (1)

33 LAMIVUDINE USP (PROCESS 1) (1)

34 LOPINAVIR USP (1)

35 MACITENTAN (1)

36 METFORMIN HYDROCHLORIDE USP (1)

37 MONTELUKAST SODIUM USP (1)

38 OSELTAMIVIR PHOSPHATE USP (1)

39 OXALIPLATIN USP (1)

40 PAZOPANIB HYDROCHLORIDE (1)

41 PEMETREXED DISODIUM (1)

42 PIRFENIDONE (1)

43 PREGABALIN (1)

44 RILPIVIRINE HYDROCHLORIDE (1)

45 RITONAVIR USP (1)

46 SACUBITRIL VALSARTAN 3NA COMPLEX (1)

47 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (1)

48 SODIUM ZIRCONIUM CYCLOSILICATE (1)

49 SOFOSBUVIR (1)

50 TENOFOVIR ALAFENAMIDE FUMARATE (1)

51 TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-2) (1)

52 TENOFOVIR DISOPROXIL FUMARATE (1)

53 TENOFOVIR DISOPROXIL FUMARATE (PROCESS-2) (1)

54 TENOFOVIR DISOPROXIL FUMARATE (PROCESS-3) (1)

55 THALIDOMIDE USP (1)

56 VALSARTAN USP (1)

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LAURUS LABS LTD
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2018-09-27
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LAURUS LABS LTD
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28818
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2015-05-20
2014-11-21
2014-12-15
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2021-09-29
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2021-09-14
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LAURUS LABS LTD
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2016-09-21
2016-09-29
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2018-07-18
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LAURUS LABS LTD
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2013-06-03
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2013-02-07
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2022-01-26
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2021-12-24
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2013-09-06
2012-12-18
2012-12-19
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