Orange Book product · Brand (NDA)
SABRIL
VIGABATRIN
At a glance
Aug 21, 2009
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 21, 2009
17 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
VIGABATRIN
Strength
500MG/PACKET
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AA
Application
NDA 022006
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024VIGAFYDEBrand (NDA)
NDA 217684 · PYROS PHARMS
- 2009SABRILBrand (NDA)
NDA 020427 · LUNDBECK PHARMS LLC
- 2023VIGABATRINGeneric (ANDA)
ANDA 214749 · UPSHER SMITH LABS
- 2023VIGABATRINGeneric (ANDA)
ANDA 215519 · CARNEGIE
- 2023VIGABATRINGeneric (ANDA)
ANDA 214671 · ZYDUS LIFESCIENCES
- 2022VIGABATRINGeneric (ANDA)
ANDA 215363 · MSN
- 2022VIGABATRINGeneric (ANDA)
ANDA 213104 · HIKMA
- 2022VIGPODERGeneric (ANDA)
ANDA 214961 · PYROS PHARMS
- 2022VIGABATRINGeneric (ANDA)
ANDA 210042 · AMNEAL PHARMS
- 2022VIGABATRINGeneric (ANDA)
ANDA 215601 · AUROBINDO PHARMA LTD
- 2022VIGABATRINGeneric (ANDA)
ANDA 211790 · CHARTWELL RX
- 2022VIGABATRINGeneric (ANDA)
ANDA 215707 · ZYDUS LIFESCIENCES
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.
