Orange Book product · Generic (ANDA)
FELBAMATE
FELBAMATE
At a glance
Jan 11, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 11, 2016
10 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
FELBAMATE
Strength
400MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 204595
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FELBAMATE
- 1993FELBATOLBrand (NDA)
NDA 020189 · MYLAN SPECIALITY LP
- 2019FELBAMATEGeneric (ANDA)
ANDA 211333 · NOVITIUM PHARMA
- 2017FELBAMATEGeneric (ANDA)
ANDA 206314 · TARO
- 2017FELBAMATEGeneric (ANDA)
ANDA 208970 · ZYDUS LIFESCIENCES
- 2017FELBAMATEGeneric (ANDA)
ANDA 207093 · TARO
- 2015FELBAMATEGeneric (ANDA)
ANDA 202284 · ANI PHARMS
- 2011FELBAMATEGeneric (ANDA)
ANDA 202385 · AMNEAL PHARMS
- 2011FELBAMATEGeneric (ANDA)
ANDA 201680 · AMNEAL PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
