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FDA ANDA · ANDA213311

CARBAMAZEPINE

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APPLICATION
ANDA213311
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-13
LATEST ACTION
2024-01-09
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

2024-01-09Labeling · Supplement 3 · standardAP
2021-04-13UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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