Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076575
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription AB No No
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;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
04/17/2009 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
11/18/2014 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/18/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/18/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/18/2014 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/14/2011 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

10/30/2010 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/30/2009 SUPPL-1 Labeling

Label is not available on this site.

TOPIRAMATE

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOPAMAX TOPIRAMATE 15MG CAPSULE;ORAL Prescription Yes AB 020844 JANSSEN PHARMS
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 076575 TEVA
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 077868 WATSON LABS
TOPIRAMATE TOPIRAMATE 15MG CAPSULE;ORAL Prescription No AB 078877 ZYDUS PHARMS USA INC

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOPAMAX TOPIRAMATE 25MG CAPSULE;ORAL Prescription Yes AB 020844 JANSSEN PHARMS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 076575 TEVA
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 077868 WATSON LABS
TOPIRAMATE TOPIRAMATE 25MG CAPSULE;ORAL Prescription No AB 078877 ZYDUS PHARMS USA INC

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