APPLICATION
ANDA078418
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-14
LATEST ACTION
2025-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TOPIRAMATEPrescription
TOPIRAMATE 50MG · CAPSULE · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 15MG · CAPSULE · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 25MG · CAPSULE · ORAL
Approval history
2025-08-21Labeling · Supplement 9 · standardAP
2025-08-21Labeling · Supplement 13 · standardAP
2025-08-21Labeling · Supplement 8 · standardAP
2025-08-21Labeling · Supplement 11 · standardAP
2025-08-21Labeling · Supplement 6 · standardAP
2025-08-21Labeling · Supplement 4 · standardAP
2017-01-06Labeling · Supplement 3 · standardAP
2010-12-23Labeling · Supplement 1AP
2009-10-14OriginalAP
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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