FDA ANDA · ANDA078462
TOPIRAMATE
Sponsor: AUROBINDO PHARMA
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APPLICATION
ANDA078462
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2026-10-14
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
2026-10-14Labeling · Supplement 38 · standardAP
2025-10-07Labeling · Supplement 36 · standardAP
2024-01-04Labeling · Supplement 33 · standardAP
2023-03-08Labeling · Supplement 32 · standardAP
2023-03-08Labeling · Supplement 30 · standardAP
2022-01-10Labeling · Supplement 27 · standardAP
2022-01-10Labeling · Supplement 25 · standardAP
2022-01-10Labeling · Supplement 17 · standardAP
2022-01-10Labeling · Supplement 23 · standardAP
2022-01-10Labeling · Supplement 15 · standardAP
2022-01-10Labeling · Supplement 21 · standardAP
2022-01-10Labeling · Supplement 28 · standardAP
2022-01-10Labeling · Supplement 18 · standardAP
2022-01-10Labeling · Supplement 16 · standardAP
2022-01-10Labeling · Supplement 22 · standardAP
2022-01-10Labeling · Supplement 20 · standardAP
2014-11-20Labeling · Supplement 9 · standardAP
2014-11-20Labeling · Supplement 7AP
2014-11-20Labeling · Supplement 13 · standardAP
2014-11-20Labeling · Supplement 8 · standardAP
2014-11-20Labeling · Supplement 14 · standardAP
2011-07-07Labeling · Supplement 5AP
2010-11-04Labeling · Supplement 3AP
2010-02-23Labeling · Supplement 1AP
2010-02-23Labeling · Supplement 2AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →