APPLICATION
ANDA078499
TYPE
ANDA
ORIGINAL APPROVAL
2010-01-07
LATEST ACTION
2026-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOPIRAMATEDiscontinued
TOPIRAMATE 100MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 25MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 200MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 50MG · TABLET · ORAL
Approval history
2026-06-15Labeling · Supplement 9 · standardAP
2014-11-19Labeling · Supplement 8 · standardAP
2014-11-19Labeling · Supplement 7 · standardAP
2011-06-17Labeling · Supplement 6AP
2011-06-17Labeling · Supplement 4AP
2010-08-17Labeling · Supplement 3AP
2010-01-07OriginalAP
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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