01 1Alembic Pharmaceuticals Limited
02 1Apotex Pharmachem
03 1Aurobindo Pharma Limited
04 1Cipla
05 1Emcure Pharmaceuticals
06 1Glenmark Life Sciences
07 1Jubilant Generics
08 1MSN Laboratories
09 1Macleods Pharmaceuticals Limited
10 1Megafine Pharma (P) Limited
11 1Par Pharmaceutical
12 1Teva API
13 1Torrent Pharmaceuticals Limited
14 1Unimark Remedies Limited
15 1Viatris
01 12DARIFENACIN HYDROBROMIDE
02 1DARIFENACIN HYDROBROMIDE (NON STERILE BULK DRUG SUBSTANCE)
03 1DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE)
04 1DARIFENACIN HYDROBROMIDE [ROUTE CODE -'DF']
01 1Canada
02 11India
03 1Israel
04 2U.S.A
01 13Active
02 2Inactive
01 11Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-18
Pay. Date : 2013-09-26
DMF Number : 26138
Submission : 2012-06-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-03-26
DMF Number : 26824
Submission : 2013-08-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-03-19
DMF Number : 26814
Submission : 2013-02-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22184
Submission : 2008-11-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-17
Pay. Date : 2013-03-12
DMF Number : 26719
Submission : 2013-03-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-03-20
DMF Number : 26533
Submission : 2012-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-03
Pay. Date : 2012-12-11
DMF Number : 22225
Submission : 2008-11-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23269
Submission : 2009-11-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-14
DMF Number : 22206
Submission : 2008-11-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-21
Pay. Date : 2012-12-06
DMF Number : 25530
Submission : 2011-12-08
Status : Active
Type : II
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