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FDA ANDA · ANDA078637

TOPIRAMATE

Sponsor: ACTAVIS TOTOWA

APPLICATION
ANDA078637
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-27
LATEST ACTION
2013-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOPIRAMATEDiscontinued
TOPIRAMATE 200MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 50MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 100MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 25MG · TABLET · ORAL

Approval history

2013-02-27OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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