01 1Alkem Laboratories
02 1Amino Chemicals
03 1Apotex Pharmachem
04 1Everlight Chemical
05 1Glenmark Life Sciences
06 1Indoco Remedies Limited
07 1Macleods Pharmaceuticals Limited
08 1Maprimed
09 1Micro Labs Limited
10 1Orchid Pharma
11 1Par Pharmaceutical
12 1Sun Pharmaceutical Industries Limited
13 1TAPI Technology & API Services
14 1Tai Heng Industry Co., Ltd
15 1Torrent Pharmaceuticals Limited
16 1Viatris
01 13RASAGILINE MESYLATE
02 1RASAGILINE MESYLATE (CODE 50855)
03 1RASAGILINE MESYLATE (NON STERILE BULK API)
04 1RASAGILINE MESYLATE (NON STERILE BULK DRUG SUBSTANCE)
01 1Argentina
02 1Canada
03 1China
04 8India
05 1Israel
06 1Malta
07 1Taiwan
08 2U.S.A
01 13Active
02 3Inactive
01 7Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23679
Submission : 2010-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22667
Submission : 2009-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25630
Submission : 2011-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-03
Pay. Date : 2012-12-20
DMF Number : 26599
Submission : 2012-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-09-26
DMF Number : 26706
Submission : 2012-12-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25366
Submission : 2011-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23687
Submission : 2010-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22782
Submission : 2009-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-06
Pay. Date : 2013-02-21
DMF Number : 24159
Submission : 2010-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-28
Pay. Date : 2016-06-08
DMF Number : 22366
Submission : 2008-12-30
Status : Active
Type : II
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