01 1Alembic Pharmaceuticals Limited
02 2Amino Chemicals
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Boehringer Ingelheim GmbH
06 1Chr. Olesen Synthesis A.S
07 1Cipla
08 1Curia
09 1Erregierre SpA
10 1Hetero Drugs
11 1MSN Laboratories
12 1Macleods Pharmaceuticals Limited
13 1Olon S.p.A
14 1Orchid Pharma
15 1Par Pharmaceutical
16 1Perrigo API India Private Limited
17 1Piramal Pharma Solutions
18 1Sun Pharmaceutical Industries Limited
19 1Torrent Pharmaceuticals Limited
20 1Unichem Laboratories Limited
21 1Viatris
22 1Wockhardt
23 1Zydus Lifesciences
01 1PRAMIPEXOL DIHYDROCHLORIDE
02 1PRAMIPEXOLE AS PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
03 2PRAMIPEXOLE BASE
04 2PRAMIPEXOLE DIHYDROCHLORIDE
05 5PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
06 1PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH EUR
07 6PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP
08 1PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP [ROUTE CODE PP]
09 3PRAMIPEXOLE DIHYDROCHLORIDE USP
10 1PRAMIPEXOLE DIHYDROCHLORIDE USP (MONOHYDRATE)
11 1PRAMIPEXOLE DIHYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)
01 1Canada
02 1Denmark
03 1Germany
04 13India
05 2Italy
06 2Malta
07 4U.S.A
01 22Active
02 2Inactive
01 7Complete
02 17Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18836
Submission : 2005-10-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2019-02-19
DMF Number : 18297
Submission : 2005-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21413
Submission : 2008-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18701
Submission : 2005-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21791
Submission : 2008-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-05
Pay. Date : 2014-06-03
DMF Number : 19853
Submission : 2006-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21082
Submission : 2007-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21631
Submission : 2008-05-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21712
Submission : 2008-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20130
Submission : 2007-01-08
Status : Active
Type : II
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