FDA ANDA · ANDA215663
TOPIRAMATE
Sponsor: AJANTA PHARMA LTD
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APPLICATION
ANDA215663
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-15
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TOPIRAMATEPrescription
TOPIRAMATE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
TOPIRAMATEPrescription
TOPIRAMATE 25MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-10-05Labeling · Supplement 6 · standardAP
2025-07-23Labeling · Supplement 4 · standardAP
2024-05-30Labeling · Supplement 3 · standardAP
2023-08-15UNKNOWN · Original · standardAP
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