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FDA ANDA · ANDA076327

TOPIRAMATE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA076327
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2026-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2026-02-23Labeling · Supplement 13 · standardAP
2026-02-23Labeling · Supplement 11 · standardAP
2026-02-23Labeling · Supplement 8 · standardAP
2026-02-23Labeling · Supplement 14 · standardAP
2026-02-23Labeling · Supplement 12 · standardAP
2026-02-23Labeling · Supplement 10 · standardAP
2026-02-23Labeling · Supplement 9 · standardAP
2026-02-23Labeling · Supplement 7 · standardAP
2018-05-21Labeling · Supplement 6 · standardAP
2018-05-21Labeling · Supplement 4 · standardAP
2018-05-21Labeling · Supplement 5 · standardAP
2014-11-17Labeling · Supplement 1AP
2014-11-17Labeling · Supplement 3 · standardAP
2009-03-27Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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