Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076314
Company: MYLAN
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
03/27/2009 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/15/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/15/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/22/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

10/22/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/15/2011 SUPPL-9 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

10/30/2010 SUPPL-3 Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels

Label is not available on this site.

01/13/2010 SUPPL-1 Labeling, REMS-Proposal

Label is not available on this site.

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