APPLICATION
ANDA078986
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-25
LATEST ACTION
2023-08-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2023-08-08Labeling · Supplement 14 · standardAP
2022-11-08Labeling · Supplement 12 · standardAP
2022-11-08Labeling · Supplement 11 · standardAP
2022-11-08Labeling · Supplement 5 · standardAP
2014-03-18Labeling · Supplement 2 · standardAP
2011-11-25OriginalAP
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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