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

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01 ALBUTEROL SULFATE USP (1)

02 ALBUTEROL USP (1)

03 ALCAFTADINE (1)

04 APIXABAN (1)

05 APREMILAST (1)

06 ARIPIPRAZOLE LAUROXIL (1)

07 ARIPIPRAZOLE MONOHYDRATE (STERILE) (1)

08 ARIPIPRAZOLE USP (ANHYDROUS FORM - B) (1)

09 BENZYL ALBUTEROL, INTERMEDIATE (1)

10 BOSENTAN MONOHYDRATE (1)

11 BRINZOLAMIDE USP (PROCESS-II) (1)

12 BRINZOLAMIDE USP (STERILE) (1)

13 BRINZOLAMIDE, USP (1)

14 CIPROFLOXACIN HYDROCHLORIDE USP (1)

15 CIPROFLOXACIN USP (1)

16 DABIGATRAN ETEXILATE MESYLATE (FORM-I) (1)

17 DAPIPRAZOLE HYDROCHLORIDE (1)

18 DEFERASIROX (1)

19 DONEPEZIL BASE (1)

20 DONEPEZIL HYDROCHLORIDE USP (FORM-I) (1)

21 DORZOLAMIDE HYDROCHLORIDE FORM II USP (1)

22 DORZOLAMIDE HYDROCHLORIDE USP (PROCESS-II) (1)

23 EDARAVONE (1)

24 ELAGOLIX SODIUM (1)

25 ENALAPRIL MALEATE (1)

26 ENALAPRIL MALEATE USP (1)

27 ENTACAPONE USP (FORM-A) (1)

28 ESCITALOPRAM OXALATE (1)

29 ETHACRYNIC ACID USP (1)

30 EZETIMIBE USP (FORM-X) (1)

31 INDACATEROL MALEATE (1)

32 IPRATROPIUM BROMIDE USP (1)

33 ITRACONAZOLE USP (1)

34 LABETALOL HYDROCHLORIDE USP (1)

35 LEVETIRACETAM USP (1)

36 LEVOFLOXACIN USP (HEMIHYDRATE) (1)

37 LINEZOLID USP (FORM-II) (1)

38 LINEZOLID USP (PROCESS-II) (1)

39 LURASIDONE HYDROCHLORIDE (1)

40 MIRABEGRON (1)

41 MIRTAZAPINE (1)

42 MIRTAZAPINE USP (ACETONE ROUTE) (1)

43 MIRTAZAPINE, USP (ANHYDROUS) (1)

44 MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP (1)

45 OFLOXACIN USP (1)

46 OLANZAPINE FORM-1 USP (1)

47 PALIPERIDONE PALMITATE (1)

48 PALIPERIDONE PALMITATE STERILE (1)

49 PALONOSETRON HYDROCHLORIDE (1)

50 PARICALCITOL, USP (1)

51 POSACONAZOLE (1)

52 PROPOFOL USP (1)

53 RAMIPRIL USP (1)

54 RIVAROXABAN (1)

55 ROPINIROLE (1)

56 ROPINIROLE HYDROCHLORIDE USP (1)

57 ROTIGOTINE USP (1)

58 SALMETEROL XINAFOATE USP (1)

59 SOTALOL HYDROCHLORIDE USP (1)

60 SUGAMMADEX SODIUM (1)

61 TAFAMIDIS (FORM-4) (1)

62 TAFAMIDIS MEGLUMINE (1)

63 TICAGRELOR FORM-II (1)

64 VILANTEROL TRIFENATATE (1)

65 VORICONAZOLE USP (1)

66 VOXELOTOR (1)

67 VOXELOTOR ADIPIC ACID CO-CRYSTAL (1)

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01 BRECKENRIDGE PHARMACEUTICAL INC (1)

02 NEULAND LABORATORIES LTD (66)

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01 India (64)

02 U.S.A (3)

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01 Active (67)

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01 Complete (35)

02 Blank (32)

NEULAND LABORATORIES ...
Active
16371
Complete
2013-09-26
2013-08-29
2003-01-20
II
NEULAND LABORATORIES ...
Active
16104
N/A
2002-08-16
II
NEULAND LABORATORIES ...
Active
28277
Complete
2015-01-05
2014-11-24
2014-05-08
II
NEULAND LABORATORIES ...
Active
32422
Complete
2018-07-16
2018-06-13
2018-01-31
II
NEULAND LABORATORIES ...
Active
36451
Complete
2023-09-26
2023-08-28
2021-11-06
II
NEULAND LABORATORIES ...
Active
22889
Complete
2021-11-18
2021-08-10
2009-06-24
II
NEULAND LABORATORIES ...
Active
26038
Complete
2015-10-13
2015-07-09
2012-05-09
II
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