APPLICATION
ANDA076697
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-20
LATEST ACTION
2024-01-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-01-29Labeling · Supplement 17 · standardAP
2022-11-09Labeling · Supplement 12 · standardAP
2022-11-09Labeling · Supplement 16 · standardAP
2022-11-09Labeling · Supplement 7 · standardAP
2015-02-18Labeling · Supplement 4 · 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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