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

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01 ALLOPURINOL USP (1)

02 ALOGLIPTIN BENZOATE (1)

03 APIXABAN (1)

04 ARIPIPRAZOLE USP (1)

05 BESIFLOXACIN HYDROCHLORIDE (1)

06 BETAXOLOL HYDROCHLORIDE USP (1)

07 BRIMONIDINE TARTRATE USP (1)

08 BRINZOLAMIDE USP (1)

09 BROENAC SODIUM (1)

10 CANAGLIFLOZIN (1)

11 CIPROFLOXACIN HYDROCHLORIDE USP (1)

12 DICYCLOMINE HYDROCHLORIDE USP (1)

13 DORZOLAMIDE HYDROCHLORIDE USP (1)

14 FEBUXOSTAT HEMIHYDRATE (FORM G) (1)

15 GLIMEPIRIDE USP (1)

16 LACOSAMIDE USP (1)

17 LACOSAMIDE USP (PROCESS II) (1)

18 METOPROLOL SUCCINATE USP (1)

19 Metformin Hydrochloride USP, as maufactured in Raigad District, INDIA (1)

20 NEOSTIGMINE METHYLSULFATE USP (1)

21 OLOPATADINE HYDROCHLORIDE USP (1)

22 QUETIAPINE FUMARATE (1)

23 RASAGILINE MESYLATE (1)

24 RIVAROXABAN USP (1)

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01 INDOCO REMEDIES LTD (24)

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01 India (23)

02 Japan (1)

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01 Active (21)

02 Inactive (3)

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01 Complete (17)

02 Blank (7)

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INDOCO REMEDIES LTD
Active
21239
N/A
2008-01-15
II
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INDOCO REMEDIES LTD
Active
30612
Complete
2016-08-24
2016-06-29
2016-06-30
II
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INDOCO REMEDIES LTD
Active
30613
Complete
2016-09-06
2016-06-29
2016-07-20
II
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INDOCO REMEDIES LTD
Active
33962
Complete
2019-07-31
2019-07-01
2019-07-03
II
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INDOCO REMEDIES LTD
Active
29303
Complete
2017-03-06
2017-02-16
2015-07-07
II
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INDOCO REMEDIES LTD
Active
25301
N/A
2011-09-22
II
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INDOCO REMEDIES LTD
Active
22166
N/A
2008-10-29
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INDOCO REMEDIES LTD
Active
28134
Complete
2015-08-24
2015-05-15
2014-04-02
II
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INDOCO REMEDIES LTD
Active
25245
Complete
2013-10-09
2013-08-28
2011-08-18
II
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INDOCO REMEDIES LTD
Active
30951
Complete
2017-01-05
2016-09-28
2016-10-18
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