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

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01 ALBUTEROL SULFATE USP (1)

02 BRIMONIDINE TARTRATE USP (1)

03 CINNARIZINE (1)

04 DANTROLENE SODIUM (1)

05 DIAZEPAM U.S.P. XXI (1)

06 DORZOLAMIDE HYDROCHLORIDE USP (1)

07 DORZOLAMIDE HYDROCHLORIDE USP (PROCESS II) (1)

08 ECONAZOLE NITRATE USP (1)

09 FACILS & GEN. OPERATING PROCEDS. FOR GR OF BULK DRUG PRODS: W/FORMU (1)

10 FLUCONAZOLE (1)

11 FLURBIPROFEN USP (1)

12 KETOCONAZOLE (1)

13 LATANOPROST USP (1)

14 LEVALBUTEROL HYDROCHLORIDE (1)

15 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MAHARASHTRA STATE, INDIA. (1)

16 METAXALONE (1)

17 METRONIDAZOLE U.S.P. XXI (1)

18 MICONAZOLE NITRATE USP (1)

19 MICONAZOLE USP (1)

20 OLOPATADINE HYDROCHLORIDE USP (1)

21 TELMISARTAN USP (1)

22 TIMOLOL MALEATE USP (1)

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01 FDC LTD (18)

02 FDC PRIVATE LTD (4)

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01 India (22)

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01 Active (10)

02 Inactive (12)

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01 Complete (5)

02 Blank (17)

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FDC LTD
Active
7809
Complete
2014-06-05
2014-05-28
1988-12-12
II
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FDC LTD
Active
20855
N/A
2007-09-17
II
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FDC LTD
Active
31934
N/A
2017-09-07
II
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FDC LTD
Inactive
17446
N/A
2004-05-27
II
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FDC PRIVATE LTD
Inactive
7025
N/A
1987-06-18
II
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FDC LTD
Inactive
20856
N/A
2007-09-17
II
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FDC LTD
Active
33576
Complete
2019-08-26
2019-06-21
2019-04-02
II
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FDC LTD
Active
10456
N/A
1993-08-09
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FDC LTD
Inactive
16632
N/A
2003-06-12
II
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FDC LTD
Active
8219
N/A
1989-09-07
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