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

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01 AMINOCAPROIC ACID USP (1)

02 ANAGRELIDE HYDROCHLORIDE USP (1)

03 APIXABAN (1)

04 ARTEMETHER (1)

05 BEMPEDOIC ACID (1)

06 BESIFLOXACIN HYDROCHLORIDE (1)

07 BISOPROLOL FUMARATE USP (1)

08 BRIMONIDINE TARTRATE USP (1)

09 BRIVARACETAM (1)

10 BROENAC SODIUM SESQUIHYDRATE (1)

11 CELECOXIB USP (1)

12 CELECOXIB USP (PROCESS-II) (1)

13 CLOBAZAM (1)

14 CROMOLYN SODIUM USP (1)

15 DABIGATRAN ETEXILATE MESYLATE (1)

16 DALFAMPRIDINE USP (1)

17 DAPAGLIFLOZIN (1)

18 DARUNAVIR ETHANOLATE (1)

19 DIMETHYL FUMARATE (1)

20 DOLUTEGRAVIR SODIUM (1)

21 DORZOLAMIDE HYDROCHLORIDE USP (1)

22 ESCITALOPRAM OXALATE (1)

23 ESCITALOPRAM OXALATE USP (1)

24 EZETIMIBE USP (1)

25 GLIMEPIRIDE USP (1)

26 IRBESARTAN USP (1)

27 ISOPROTERENOL HYDROCHLORIDE USP (1)

28 LEVOMILNACIPRAN HYDROCHLORIDE (1)

29 LIFITEGRAST (1)

30 LOSARTAN POTASSIUM USP (1)

31 LUMEFANTRINE USP (1)

32 MELOXICAM USP (1)

33 METHAZOLAMIDE USP (1)

34 METHENAMINE HIPPURATE USP (1)

35 MIRABEGRON (1)

36 MIRTAZAPINE USP (1)

37 NAPHAZOLINE HYDROCHLORIDE USP (1)

38 NETARSUDIL DIMESYLATE (1)

39 OLMESARTAN MEDOXOMIL USP (1)

40 OXCARBAZEPINE USP (1)

41 PENTOSAN POLYSULFATE SODIUM (1)

42 PIRFENIDONE (1)

43 PRAZIQUANTEL USP (1)

44 RASAGILINE MESYLATE (1)

45 RIVAROXABAN (1)

46 RUFINAMIDE USP (1)

47 SODIUM NITROPRUSSIDE USP (1)

48 SOLIFENACIN SUCCINATE (1)

49 TELMISARTAN USP (1)

50 TENOFOVIR ALAFENAMIDE HEMIFUMARATE (1)

51 TICAGRELOR (1)

52 TIMOLOL MALEATE USP (1)

53 TOFACITINIB CITRATE (1)

54 TORSEMIDE USP (2)

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02 MICRO LABS LTD INDIA (2)

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01 India (55)

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01 Active (52)

02 Inactive (3)

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01 Complete (49)

02 Blank (6)

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2020-09-15
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2022-06-23
2022-06-08
2022-06-01
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MICRO LABS LTD
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2016-10-06
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2016-08-12
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MICRO LABS LTD
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27933
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2014-02-04
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MICRO LABS LTD
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37788
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2023-05-09
2023-03-31
2023-03-20
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MICRO LABS LTD
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2017-11-30
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MICRO LABS LTD
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37601
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2022-12-16
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2022-11-11
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MICRO LABS LTD
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34362
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2020-02-26
2020-02-05
2019-12-21
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MICRO LABS LTD
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2020-02-18
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