APPLICATION
ANDA207382
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-24
LATEST ACTION
2024-09-10
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
2024-09-10Manufacturing (CMC) · Supplement 9 · unknownAP
2024-01-18Labeling · Supplement 6 · standardAP
2024-01-18Labeling · Supplement 5 · standardAP
2020-04-09Labeling · Supplement 2 · standardAP
2020-04-09Labeling · Supplement 1 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.