FDA ANDA · ANDA212524
CARBAMAZEPINE
Sponsor: TORRENT
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APPLICATION
ANDA212524
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-13
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-05Labeling · Supplement 2 · standardAP
2025-01-13UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →