Orange Book product · Generic (ANDA)
VIGABATRIN
VIGABATRIN
At a glance
May 13, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 13, 2021
5 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
VIGABATRIN
Strength
500MG/PACKET
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 214992
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of VIGABATRIN
- 2024VIGAFYDEBrand (NDA)
NDA 217684 · PYROS PHARMS
- 2009SABRILBrand (NDA)
NDA 022006 · LUNDBECK PHARMS LLC
- 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
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.
