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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213104
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2022 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

VIGABATRIN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SABRIL VIGABATRIN 500MG TABLET;ORAL Prescription Yes AB 020427 LUNDBECK PHARMS LLC
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 210042 AMNEAL PHARMS
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 215601 AUROBINDO PHARMA LTD
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 215109 DEXCEL
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 211539 DR REDDYS
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 213104 HIKMA
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 209822 TEVA PHARMS USA
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 215707 ZYDUS
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