01 1COSMA S.p.A
02 1Centaur Pharmaceuticals
03 1Derivados Quimicos SAU
04 1Glenmark Life Sciences
05 1Hetero Drugs
06 1Lupin Ltd
07 1MSN Laboratories
08 1Macleods Pharmaceuticals Limited
09 2Pierre Fabre
10 1RANBAXY LABORATORIES LIMITED
11 1Raks Pharma
12 1Solara Active Pharma Sciences
13 1Unichem Laboratories Limited
14 1Viatris
01 11MILNACIPRAN HYDROCHLORIDE
02 1MILNACIPRAN HYDROCHLORIDE (PROCESS I)
03 1MILNACIPRAN HYDROCHLORIDE (PROCESS II)
04 1MILNACIPRAN HYDROCHLORIDE [ROUTE CODE -MR"]
05 1MILNACIPRAN HYDROCHLORIDE, API
01 2France
02 10India
03 1Italy
04 1Spain
05 1U.S.A
01 13Active
02 2Inactive
01 10Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-09
Pay. Date : 2012-12-08
DMF Number : 26577
Submission : 2012-12-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-05
Pay. Date : 2012-12-20
DMF Number : 25717
Submission : 2012-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2012-11-07
DMF Number : 26611
Submission : 2012-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-21
Pay. Date : 2013-08-23
DMF Number : 25022
Submission : 2011-06-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-12
Pay. Date : 2012-12-07
DMF Number : 26515
Submission : 2012-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-25
Pay. Date : 2013-01-09
DMF Number : 26620
Submission : 2013-01-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-15
Pay. Date : 2012-12-21
DMF Number : 26151
Submission : 2012-06-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11501
Submission : 1995-05-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-25
Pay. Date : 2012-12-05
DMF Number : 26624
Submission : 2012-11-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-26
Pay. Date : 2012-12-11
DMF Number : 26399
Submission : 2012-09-06
Status : Active
Type : II
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