01 1Alembic Pharmaceuticals Limited
02 1Apotex Pharmachem
03 1Biocon
04 1Emcure Pharmaceuticals
05 1Glenmark Life Sciences
06 1HEC Pharm
07 1HONOUR LAB LTD
08 1Intas Pharmaceuticals
09 3MSN Laboratories
10 1Maprimed
11 1Novugen
12 1Shilpa Medicare
13 1Sun Pharmaceutical Industries Limited
14 1Tai Heng Industry Co., Ltd
15 1Teva API
16 1Viatris
17 1Zhejiang Huahai Pharmaceutical
18 1Zydus Lifesciences
01 1FINGOLIMOD
02 5FINGOLIMOD HYDROCHLORIDE
03 1FINGOLIMOD HYDROCHLORIDE (CODE 50996)
04 1FINGOLIMOD HYDROCHLORIDE (FORM 1)
05 1FINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
06 9FINGOLIMOD HYDROCHLORIDE USP
07 1FINGOLIMOD HYDROCHLORIDE USP (FORM-I)
08 1FINGOLIMOD HYDROCHLORIDE USP [ROUTE CODE "FH"]
01 1Argentina
02 1Canada
03 3China
04 12India
05 1Israel
06 1U.A.E
07 1U.S.A
01 19Active
02 1Inactive
01 18Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-10
Pay. Date : 2014-03-24
DMF Number : 28057
Submission : 2014-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2014-03-28
DMF Number : 27983
Submission : 2014-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-02-20
DMF Number : 26807
Submission : 2013-02-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-17
Pay. Date : 2014-04-15
DMF Number : 28165
Submission : 2014-04-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-06-16
DMF Number : 28225
Submission : 2014-04-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-25
Pay. Date : 2014-06-17
DMF Number : 27830
Submission : 2013-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-29
Pay. Date : 2014-04-30
DMF Number : 28162
Submission : 2014-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-04-01
DMF Number : 28142
Submission : 2014-04-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-04-25
DMF Number : 28148
Submission : 2014-04-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2013-12-09
DMF Number : 27730
Submission : 2013-12-17
Status : Active
Type : II
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