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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078637
Company: ACTAVIS TOTOWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPIRAMATE TOPIRAMATE 25MG TABLET;ORAL Discontinued None No No
TOPIRAMATE TOPIRAMATE 50MG TABLET;ORAL Discontinued None No No
TOPIRAMATE TOPIRAMATE 100MG TABLET;ORAL Discontinued None No No
TOPIRAMATE TOPIRAMATE 200MG TABLET;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
02/27/2013 ORIG-1 Approval

Label is not available on this site.

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