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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078499
Company: AIPING PHARM INC
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
01/07/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/19/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/19/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

06/17/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/17/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/17/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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