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

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01 ADENOSINE USP (1)

02 ALFUZOSIN HYDROCHLORIDE (1)

03 ANHYDROUS AZITHROMYCIN (1)

04 ARIPIPRAZOLE (1)

05 AZITHROMYCIN USP (1)

06 AZITHROMYCIN-FORM I (1)

07 BETHANECHOL CHLORIDE USP (1)

08 CAPTOPRIL (1)

09 CEFOTAXIME SODIUM (STERILE) (1)

10 CEFTAZIDIME FOR INJECTION (1)

11 CEFUROXIME AXETIL (AMORPHOUS) (2)

12 CEFUROXIME AXETIL(CRYSTALLINE) USP (1)

13 CEFUROXIME SODIUM (STERILE) (1)

14 CHLOROTHIAZIDE SODIUM (1)

15 CIPROFLOXACIN HYDROCHLORIDE, USP (1)

16 CITALOPRAM HYDROBROMIDE (2)

17 CLARITHROMYCIN (1)

18 CLARITHROMYCIN USP (1)

19 CLOPIDOGREL BISULFATE USP (FORM-1) (1)

20 CYANOCOBALAMIN USP (1)

21 D-OXYPHEN BASE (1)

22 D-OXYPHENE BASE (1)

23 DESVENLAFAXINE SUCCINATE MONOHYDRATE (1)

24 DEXTROMETHORPHAN HYDROBROMIDE USP (1)

25 DEXTROPROPOXYPHENE NAPSYLATE (PROPOXYPHENE NAPSYLATE USP) (1)

26 DIVALPROEX SODIUM (1)

27 DONEPEZIL HYDROCHLORIDE (1)

28 DOXAZOSIN MESYLATE (1)

29 DULOXETINE HYDROCHLORIDE USP (1)

30 ENALAPRIL MALEATE (1)

31 ENTACAPONE USP (1)

32 EPINEPHRINE USP (1)

33 ESZOPICLONE (1)

34 FACILITIES AT ANKLESHWAR, INDIA (1)

35 FACILITY AND OPERATING PROCEDURES IN CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA (1)

36 FAMOTIDINE USP (1)

37 FELODIPINE (1)

38 FESOTERODINE FUMARATE (1)

39 FEXOFENADINE HYDROCHLORIDE (2)

40 FLUCONAZOLE (1)

41 FLUOXETINE HYDROCHLORIDE (1)

42 FLUOXETINE HYDROCHLORIDE USP (1)

43 FOSAPREPITANT DIMEGLUMINE (1)

44 GRANISETRON HYDROCHLORIDE (1)

45 LANSOPRAZOLE USP (1)

46 LORAIDINE (1)

47 METFORMIN HYDROCHLORIDE (1)

48 NIACIN (1)

49 NICARDIPINE HYDROCHLORIDE (1)

50 NIZATIDINE USP (1)

51 OCTREOTIDE ACETATE (1)

52 OMEPRAZOLE (1)

53 OXYBUTYNIN CHLORIDE USP (1)

54 PALIPERIDONE USP (1)

55 PALONOSETRON HYDROCHLORIDE USP (1)

56 PANTOPRAZOLE SODIUM USP (1)

57 PIOGLITAZONE HYDROCHLORIDE (1)

58 PIROXICAM (1)

59 PRAMIPEXOLE DIHYDROCHLORIDE USP (1)

60 RANITIDINE HYDROCHLORIDE (1)

61 RANITIDINE HYDROCHLORIDE USP (FORM II) (1)

62 REGADENOSON (AMORPHOUS) (1)

63 SAXAGLIPTIN HYDROCHLORIDE (1)

64 SITAGLIPTIN PHOSPHATE (1)

65 STERILE CEFTRIAXONE SODIUM USP (1)

66 STERILE SODIUM CARBONATE (1)

67 TAMSULOSIN HYDROCHLORIDE (1)

68 TRANDOLAPRIL (1)

69 VALACYCLOVIR HYDROCHLORIDE (1)

70 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE (1)

71 ZOLEDRONIC ACID MONOHYDRATE (1)

72 ZOLPIDEM TARTRATE (1)

73 ZONISAMIDE USP (1)

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01 WOCKHARDT AMERICAS INC (1)

02 WOCKHARDT BIO AG (10)

03 WOCKHARDT LTD (65)

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01 India (74)

02 Switzerland (1)

03 U.S.A (1)

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01 Active (38)

02 Inactive (38)

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01 Complete (12)

02 Blank (64)

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WOCKHARDT LTD
Active
20071
Complete
2015-12-01
2015-11-23
2007-05-15
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WOCKHARDT LTD
Active
20439
N/A
2007-04-06
II
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WOCKHARDT LTD
Active
18073
N/A
2005-02-11
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WOCKHARDT BIO AG
Active
26743
Complete
2013-08-26
2013-02-19
2013-02-26
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WOCKHARDT LTD
Inactive
14480
N/A
1999-10-14
II
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WOCKHARDT LTD
Inactive
16268
N/A
2002-11-25
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WOCKHARDT LTD
Active
16119
N/A
2002-08-27
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WOCKHARDT LTD
Active
8028
N/A
1989-04-24
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WOCKHARDT LTD
Inactive
16839
N/A
2003-09-09
II
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WOCKHARDT LTD
Inactive
16794
N/A
2003-08-28
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