APPLICATION
ANDA077627
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-27
LATEST ACTION
2025-12-04
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
2025-12-04Labeling · Supplement 27 · standardAP
2024-02-22Labeling · Supplement 24 · standardAP
2023-02-16Labeling · Supplement 18 · standardAP
2023-02-16Labeling · Supplement 16 · standardAP
2023-02-16Labeling · Supplement 14 · standardAP
2023-02-16Labeling · Supplement 20 · standardAP
2023-02-16Labeling · Supplement 8 · standardAP
2023-02-16Labeling · Supplement 19 · standardAP
2023-02-16Labeling · Supplement 17 · standardAP
2023-02-16Labeling · Supplement 23 · standardAP
2023-02-16Labeling · Supplement 21 · standardAP
2023-02-16Labeling · Supplement 9 · standardAP
2014-12-01Labeling · Supplement 7 · standardAP
2011-07-14Labeling · Supplement 4AP
2010-01-28Labeling · 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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