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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211790
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Discontinued None 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
03/10/2022 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-2 REMS - MODIFIED - D-N-A

Label is not available on this site.

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