01 1Alkem Laboratories
02 1Apotex Pharmachem
03 1Esteve Quimica
04 1Glenmark Life Sciences
05 1Hetero Drugs
06 1ScinoPharm Taiwan, Ltd
07 1Standard Chem. & Pharm. Co., Ltd
08 1Sun Pharmaceutical Industries Limited
01 3RILUZOLE
02 5RILUZOLE USP
01 1Canada
02 1China
03 4India
04 1Spain
05 1Taiwan
01 7Active
02 1Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25260
Submission : 2011-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22596
Submission : 2009-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-07-10
DMF Number : 24693
Submission : 2011-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22107
Submission : 2008-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23215
Submission : 2009-10-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-23
Pay. Date : 2021-10-28
DMF Number : 15252
Submission : 2001-01-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2013-04-08
DMF Number : 26147
Submission : 2012-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22438
Submission : 2009-03-16
Status : Active
Type : II
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