FDA ANDA · ANDA206210
TOPIRAMATE
Sponsor: ACTAVIS LABS FL
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APPLICATION
ANDA206210
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-10
LATEST ACTION
2026-10-15
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
2026-10-15Labeling · Supplement 7 · standardAP
2025-10-23Labeling · Supplement 5 · standardAP
2025-10-23Labeling · Supplement 2 · standardAP
2023-03-10UNKNOWN · Original · standardAP
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