01 1Alembic Pharmaceuticals Limited
02 1Bayer AG
03 1Emcure Pharmaceuticals
04 1Erregierre SpA
05 1Lusochimica
06 1Orchid Pharma
07 1Par Pharmaceutical
08 1Sanmar Speciality Chemicals Limited IN 600 086 Chennai
01 5NISOLDIPINE
02 1NISOLDIPINE (NON-STERILE BULK API)
03 1NISOLDIPINE NON STERILE BULK DRUG SUBSTANCE
04 1NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE
01 1Germany
02 4India
03 2Italy
04 1U.S.A
01 7Active
02 1Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-23
Pay. Date : 2013-09-26
DMF Number : 25365
Submission : 2011-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10167
Submission : 1993-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-06-07
DMF Number : 25750
Submission : 2012-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-10
DMF Number : 16215
Submission : 2002-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14337
Submission : 1999-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22539
Submission : 2009-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21106
Submission : 2007-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19329
Submission : 2006-04-04
Status : Inactive
Type : II
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