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

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01 AMITRIPTYLINE (1)

02 ATENOLOL (1)

03 CARVEDILOL (1)

04 CARVEDILOL PHOSPHATE HEMIHYDRATE (1)

05 CARVEDILOL PHOSPHATE MONOHYDRATE (1)

06 CLOPIDOGREL BISULFATE (1)

07 DEXTROMETHORPHAN HYDROBROMIDE (1)

08 DIPHENHYDRAMINE CITRATE (1)

09 DIPHENHYDRAMINE HYDROCHLORIDE (1)

10 GLUCOSAMINE HYDROCHLORIDE (1)

11 GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (1)

12 GLUCOSAMINE SULFATE SODIUM CHLORIDE (1)

13 HYDRALAZINE HYDROCHLORIDE (1)

14 IBUPROFEN BULK DRUG (1)

15 IBUPROFEN DC GRADE-65% (1)

16 IBUPROFEN DC GRADE-90% (1)

17 IMIQUIMOD (1)

18 LEVETIRACETAM (2)

19 LOSARTAN POTASSIUM (1)

20 MEFENAMIC ACID USP (1)

21 MESALAMINE (1)

22 METFORMIN HYDROCHLORIDE (2)

23 METFORMIN HYDROCHLORIDE DC GRADE - 90% (1)

24 METFORMIN HYDROCHLORIDE DC GRADE - 95% (1)

25 METFORMIN SR GRADE 70% (1)

26 METHOXSALEN (1)

27 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

28 PAROXETINE HYDROCHLORIDE HEMIHYDRATE (1)

29 PAROXETINE MESYLATE (1)

30 PENICILLAMINE (1)

31 PHENAZOPYRIDINE HYDROCHLORIDE DC GRANULES (1)

32 PHENAZOPYRIDINE HYDROCHLORIDE USP (1)

33 PREGABALIN (1)

34 PROMETHAZINE HYDROCHLORIDE (1)

35 QUETIAPINE FUMARATE (1)

36 RISPERIDONE (1)

37 SALSALATE (1)

38 SERTRALINE HYDROCHLORIDE (1)

39 SERTRALINE HYDROCHLORIDE FORM I (1)

40 TRAMADOL HYDROCHLORIDE (1)

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01 WANBURY LTD (42)

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01 India (42)

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01 Active (19)

02 Inactive (23)

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01 Complete (7)

02 Blank (35)

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WANBURY LTD
Inactive
18174
N/A
2005-03-02
II
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WANBURY LTD
Inactive
20268
N/A
2007-02-13
II
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WANBURY LTD
Inactive
20308
N/A
2007-02-26
II
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WANBURY LTD
Inactive
20917
N/A
2007-09-20
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WANBURY LTD
Inactive
23467
N/A
2010-01-15
II
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WANBURY LTD
Inactive
20495
N/A
2007-04-23
II
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WANBURY LTD
Active
34241
N/A
2019-10-31
II
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WANBURY LTD
Active
19986
Complete
2021-07-13
2021-06-15
2006-11-15
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WANBURY LTD
Active
20572
Complete
2014-10-10
2013-12-23
2007-04-10
II
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WANBURY LTD
Inactive
19143
N/A
2006-01-20
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