APPLICATION
ANDA218482
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-13
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TOPIRAMATEPrescription
TOPIRAMATE 15MG · CAPSULE · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 25MG · CAPSULE · ORAL
Approval history
2026-03-18Labeling · Supplement 3 · standardAP
2024-06-13UNKNOWN · Original · standardAP
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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