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01 15,6-DIHYDRO-3-(4-MORPHOLINYL)-1-[4-(2-OXO-1-PIPERIDINYL)PHENYL]-2(1H)-PYRIDINONE (AXBN20)
02 1AMLODIPINE BESYLATE USP
03 1APIXABAN
04 1DABIGATRAN ETEXILATE MESYLATE
05 1DEXTROMETHORPHAN HYDROBROMIDE USP
06 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
07 1HYDROXYCHLOROQUINE SULFATE USP
08 1LABETALOL HYDROCHLORIDE USP
09 1LEVETIRACETAM USP
10 1OMEPRAZOLE USP
11 1PANTOPRAZOLE SODIUM SESQUIHYDRATE USP
12 1PREGABALIN USP
13 1RIVAROXABAN
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01 1APOTEX PHARMACHEM INDIA PVT LTD
02 12SRINI PHARMACEUTICALS PRIVATE LTD
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01 13India
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01 13Active
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01 7Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34633
Submission : 2020-04-27
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-03-14
DMF Number : 22622
Submission : 2009-03-13
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35250
Submission : 2020-10-08
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35253
Submission : 2020-09-28
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-09-21
Pay. Date : 2021-07-29
DMF Number : 32848
Submission : 2018-06-04
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-07-27
Pay. Date : 2021-06-16
DMF Number : 32909
Submission : 2018-06-30
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34765
Submission : 2020-03-26
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-07-01
Pay. Date : 2021-04-12
DMF Number : 34073
Submission : 2019-08-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2023-01-19
Pay. Date : 2023-01-17
DMF Number : 24757
Submission : 2011-03-15
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-11
DMF Number : 22471
Submission : 2009-01-30
Status : Active
Type : II

Srini Pharmaceuticals is a supplier offers 36 products (APIs, Excipients or Intermediates).
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