01 1Apotex Pharmachem
02 1Dipharma
03 1Glenmark Life Sciences
04 1Hetero Drugs
05 1Lupin Ltd
06 2MSN Laboratories
07 1Micro Labs Limited
08 1Zhejiang Jiuzhou Pharmaceutical
01 3RUFINAMIDE
02 5RUFINAMIDE USP
03 1RUFINAMIDE USP [ROUTE CODE "RU"]
01 1Canada
02 1China
03 6India
04 1Italy
01 8Active
02 1Inactive
01 8Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-21
Pay. Date : 2015-03-16
DMF Number : 29034
Submission : 2015-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-11-09
DMF Number : 25676
Submission : 2012-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-24
Pay. Date : 2012-11-06
DMF Number : 26209
Submission : 2012-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-07
Pay. Date : 2021-07-13
DMF Number : 36077
Submission : 2021-08-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-13
DMF Number : 26316
Submission : 2012-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-03
Pay. Date : 2023-04-12
DMF Number : 38182
Submission : 2023-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-10
Pay. Date : 2018-07-16
DMF Number : 32713
Submission : 2018-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-03
Pay. Date : 2018-07-26
DMF Number : 26385
Submission : 2012-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28284
Submission : 2014-05-09
Status : Inactive
Type : II
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