FDA ANDA · ANDA216594
CARBAMAZEPINE
Sponsor: UMEDICA
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APPLICATION
ANDA216594
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-18
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-14Labeling · Supplement 16 · standardAP
2026-10-14Labeling · Supplement 14 · standardAP
2024-08-13Labeling · Supplement 5 · standardAP
2024-08-13Labeling · Supplement 3 · standardAP
2022-08-18UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →