Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Alembic Pharmaceuticals Limited
03 1Aurobindo Pharma Limited
04 1Biocon
05 1Emcure Pharmaceuticals
06 1Formosa Laboratories
07 1Glenmark Life Sciences
08 1HONOUR LAB LTD
09 1Intas Pharmaceuticals
10 1MSN Laboratories
11 1Maprimed
12 1Megafine Pharma (P) Limited
13 1Natco Pharma
14 1Olon S.p.A
15 1Optimus Pharma
16 1Raks Pharma
17 1Shilpa Medicare
18 1Tianjin Weijie Pharmaceutical Co., Ltd.
19 1Unichem Laboratories Limited
20 1Zydus Lifesciences
01 18TERIFLUNOMIDE
02 1TERIFLUNOMIDE DRUG SUBSTANCE
03 1TERIFLUNOMIDE [ROUTE CODE "TO"]
01 1Argentina
02 1China
03 1Germany
04 15India
05 1Italy
06 1Taiwan
01 20Active
01 18Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-03
Pay. Date : 2016-02-19
DMF Number : 30220
Submission : 2016-03-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-06
Pay. Date : 2016-02-22
DMF Number : 28898
Submission : 2016-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-02-29
DMF Number : 30297
Submission : 2016-03-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-03
Pay. Date : 2016-01-28
DMF Number : 29862
Submission : 2015-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-19
Pay. Date : 2015-03-20
DMF Number : 28991
Submission : 2015-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-06
Pay. Date : 2015-09-08
DMF Number : 29701
Submission : 2015-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-09-24
DMF Number : 29802
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-13
Pay. Date : 2015-09-23
DMF Number : 27860
Submission : 2014-01-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2015-10-16
DMF Number : 29851
Submission : 2015-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-23
Pay. Date : 2015-09-22
DMF Number : 29705
Submission : 2015-09-29
Status : Active
Type : II
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