APPLICATION
ANDA207798
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-15
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET · ORAL
Approval history
2023-12-22Labeling · Supplement 11 · standardAP
2020-04-15UNKNOWN · 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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