01 1Taro Pharmaceutical Industries
02 1Apicore LLC
03 1Emcure Pharmaceuticals
04 1Enaltec Labs Private Limited
05 1Fujifilm Diosynth Biotechnologies
06 1Hetero Drugs
07 1Procos
08 1Raks Pharma
09 1Siegfried AG
10 1Solara Active Pharma Sciences
11 2Viatris
12 1Blank
01 12-PHENYL-1,3-PROPANEDIOL DICARBAMATE
02 6FELBAMATE
03 4FELBAMATE USP
04 1FELBAMATE USP (FEL)
05 1FELBAMATE, USP
01 6India
02 1Italy
03 1Switzerland
04 3U.S.A
05 1United Kingdom
06 1Blank
01 8Active
02 5Inactive
01 6Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-11-06
DMF Number : 27331
Submission : 2013-11-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-02
Pay. Date : 2015-07-08
DMF Number : 29408
Submission : 2015-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7267
Submission : 1987-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-03
Pay. Date : 2015-02-13
DMF Number : 21247
Submission : 2008-01-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 31181
Submission : 2016-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8304
Submission : 1989-11-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-25
Pay. Date : 2024-07-18
DMF Number : 22810
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2015-01-19
DMF Number : 22958
Submission : 2009-07-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39207
Submission : 2023-12-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9352
Submission : 1991-09-16
Status : Inactive
Type : II
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