APPLICATION
ANDA076314
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2026-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOPIRAMATEDiscontinued
TOPIRAMATE 25MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 200MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 50MG · TABLET · ORAL
TOPIRAMATEDiscontinued
TOPIRAMATE 100MG · TABLET · ORAL
Approval history
2026-01-27Labeling · Supplement 19 · standardAP
2024-01-04Labeling · Supplement 18 · standardAP
2024-01-04Labeling · Supplement 17 · standardAP
2024-01-04Labeling · Supplement 15 · standardAP
2015-12-15Labeling · Supplement 14 · standardAP
2015-12-15Labeling · Supplement 12 · standardAP
2015-12-15Labeling · Supplement 13 · standardAP
2014-10-22Labeling · Supplement 10 · standardAP
2014-10-22Labeling · Supplement 11 · standardAP
2011-07-15Labeling · Supplement 9AP
2010-10-30Labeling · Supplement 3AP
2010-01-13Labeling · Supplement 1AP
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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