APPLICATION
ANDA216193
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-24
LATEST ACTION
2025-06-23
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
2025-06-23Labeling · Supplement 4 · standardAP
2023-03-24UNKNOWN · 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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