Orange Book product · Generic (ANDA)
FELBAMATE
FELBAMATE
At a glance
May 31, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
FELBAMATE
Strength
600MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 211333
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of FELBAMATE
- 1993FELBATOLBrand (NDA)
NDA 020189 · MYLAN SPECIALITY LP
- 2017FELBAMATEGeneric (ANDA)
ANDA 206314 · TARO
- 2017FELBAMATEGeneric (ANDA)
ANDA 208970 · ZYDUS LIFESCIENCES
- 2017FELBAMATEGeneric (ANDA)
ANDA 207093 · TARO
- 2016FELBAMATEGeneric (ANDA)
ANDA 204595 · ALVOGEN
- 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.
