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FDA ANDA · ANDA079162

TOPIRAMATE

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA079162
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2026-04-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2026-04-24Labeling · Supplement 13 · standardAP
2026-04-24Labeling · Supplement 26 · standardAP
2026-04-24Labeling · Supplement 24 · standardAP
2026-04-24Labeling · Supplement 16 · standardAP
2026-04-24Labeling · Supplement 12 · standardAP
2026-04-24Labeling · Supplement 27 · standardAP
2026-04-24Labeling · Supplement 21 · standardAP
2014-12-01Labeling · Supplement 4AP
2014-12-01Labeling · Supplement 5 · standardAP
2011-06-24Labeling · Supplement 3AP
2010-12-28Labeling · Supplement 2AP
2010-01-27Labeling · Supplement 1AP
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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