01 1Apicore LLC
02 1Emcure Pharmaceuticals
03 1Enaltec Labs Private Limited
04 1Fujifilm Diosynth Biotechnologies
05 1Hetero Drugs
06 1Procos
07 1Raks Pharma
08 1Siegfried AG
09 1Solara Active Pharma Sciences
10 1Taro Pharmaceutical Industries
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 : 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 : 2014-01-06
Pay. Date : 2013-11-06
DMF Number : 27331
Submission : 2013-11-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39207
Submission : 2023-12-01
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
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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