APPLICATION
ANDA219939
TYPE
ANDA
ORIGINAL APPROVAL
2025-07-25
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-03-18Labeling · Supplement 1 · standardAP
2025-07-25UNKNOWN · Original · 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.
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