FDA ANDA · ANDA213159
CARBAMAZEPINE
Sponsor: APOTEX
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APPLICATION
ANDA213159
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-08
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CARBAMAZEPINEDiscontinued
CARBAMAZEPINE 200MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEDiscontinued
CARBAMAZEPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEDiscontinued
CARBAMAZEPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-05Labeling · Supplement 1 · standardAP
2024-03-08UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →