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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by F.i.s. Fabbrica Italiana Sintetici to the U.S. FDA. Original Data : FDA Website

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01 ACETYLCYSTEINE, USP (1)

02 ALLOPURINOL (1)

03 BENZYL HYDRAZINE MSA (FIS0181) (1)

04 CALCIUM CHANNEL BLOCKER - RO 40-5967/001 (1)

05 CARBAMAZEPINE (1)

06 CHLORDIAZEPOXIDE HCL (1)

07 CLOBAZAM (2)

08 CLOMIPHENE CITRATE (1)

09 CLONAZEPAM (1)

10 CLORAZEPATE DIPOTASSIUM (1)

11 CLOTRIMAZOLE (1)

12 CMT (1)

13 DESIPRAMINE HYDROCHLORIDE (1)

14 DIAZEPAM (1)

15 DILTIAZEM HYDROCHLORIDE (2)

16 DORZOLAMIDE HYDROCHLORIDE (1)

17 DORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS) (1)

18 DUTASTERIDE (1)

19 ELETRIPTAN HYDROBROMIDE (1)

20 ENAMINE AMIDE (FIS0448) (1)

21 ENCLOMIPHENE CITRATE (1)

22 ENTACAPONE (1)

23 ERLOTINIB HYDROCHLORIDE (1)

24 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

25 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (2)

26 ESTAZOLAM (1)

27 FIS0127 (1)

28 FIS1174 (1)

29 FLURAZEPAM HCl (1)

30 FLUVASTATIN SODIUM HYDRATE USP (1)

31 FOSFOMYCIN TROMETAMOL (1)

32 FURAZOLIDONE BULK (1)

33 FUROSEMIDE (1)

34 GABAPENTIN (1)

35 IMATINIB MESYLATE (1)

36 IMATINIB MESYLATE (ALPHA FORM) (1)

37 IMATINIB MESYLATE (BETA FORM) (1)

38 INDOMETHACIN (1)

39 INDOMETHACIN SODIUM (1)

40 LENALIDOMIDE (1)

41 LORAZEPAM (1)

42 LUBIPROSTONE (1)

43 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALTE DI MONTECCHIO MAGGIORE. (1)

44 MIDAZOLAM HCI (1)

45 NEBIVOLOL HYDROCHLORIDE (1)

46 NIFEDIPINE USP (1)

47 NILOTINIB DIHYDROCHLORIDE DIHYDRATE (1)

48 NITROFURANTOIN & NITROFURANTOIN MACROCRYSTALS (1)

49 NITROFURANTOIN MONOHYDRATE (1)

50 NITROFURANTOIN MONOHYDRATE (CODE 1042-1026) (1)

51 OLOPATADINE HCI USP (1)

52 OLOPATADINE HYDROCHLORIDE (2)

53 OXAZEPAM (1)

54 OXCARBAZEPINE (2)

55 PENTAZOCINE (1)

56 PENTAZOCINE HCI (1)

57 PIROXICAM (1)

58 PRASTERONE ACETATE (1)

59 PRAZEPAM (1)

60 PROGESTERONE (1)

61 PROPOFOL (1)

62 QUAZEPAM--BULK DRUG (1)

63 QUETIAPINE FUMARATE (2)

64 RIFAXIMIN (1)

65 SAFINAMIDE (1)

66 SERTRALINE HYDROCHLORIDE (1)

67 SOLIFENACIN SUCCINATE (2)

68 SULINDAC (1)

69 TEMAZEPAM (1)

70 TERBINAFINE HCL (1)

71 TESTOSTERONE CYPIONATE (1)

72 TESTOSTERONE PROPIONATE (1)

73 THALIDOMIDE (1)

74 TRIAMTERENE (1)

75 TRIMETHOBENZAMIDE HYDROCHLORIDE (1)

76 TRIMETHOPRIM AF (ANILINE FREE) (1)

77 TRIMETHOPRIM USP, BULK FORM (1)

78 TSE 424 ACETATE (1)

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01 FABBRICA ITALIANA SINTETICI SPA (15)

02 FIS FABBRICA ITALIANA SINTETICI SPA (65)

03 PHF SA (4)

04 ZYDUS LIFESCIENCES LTD (1)

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01 Italy (76)

02 Switzerland (9)

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01 Active (52)

02 Inactive (33)

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01 Complete (37)

02 Blank (48)

URL Supplier Web Content
FIS FABBRICA ITALIANA...
Active
5091
N/A
1983-07-04
II
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FABBRICA ITALIANA SIN...
Inactive
6373
N/A
1986-05-23
II
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FIS FABBRICA ITALIANA...
Inactive
20784
N/A
2007-08-07
II
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FIS FABBRICA ITALIANA...
Active
6641
N/A
1986-10-20
II
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FIS FABBRICA ITALIANA...
Active
467
Complete
2017-11-16
2017-10-26
1962-02-15
II
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FIS FABBRICA ITALIANA...
Inactive
18080
N/A
2005-02-10
II
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FIS FABBRICA ITALIANA...
Active
24728
Complete
2015-10-02
2015-03-11
2011-02-28
II
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FIS FABBRICA ITALIANA...
Active
5674
Complete
2014-10-21
2013-07-05
1984-12-20
II
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FIS FABBRICA ITALIANA...
Active
7505
Complete
2015-05-04
2015-04-21
1988-06-01
II
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FABBRICA ITALIANA SIN...
Inactive
5922
N/A
1985-07-24
II
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