Orange Book product · Brand (NDA)
FELBATOL
FELBAMATE
At a glance
Jul 29, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 1993
33 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FELBAMATE
Strength
600MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 020189
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019FELBAMATEGeneric (ANDA)
ANDA 211333 · NOVITIUM PHARMA
- 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.
