APPLICATION
ANDA077747
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-09
LATEST ACTION
2026-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXCARBAZEPINEPrescription
OXCARBAZEPINE 300MG · TABLET · ORAL
OXCARBAZEPINEPrescription
OXCARBAZEPINE 600MG · TABLET · ORAL
OXCARBAZEPINEPrescription
OXCARBAZEPINE 150MG · TABLET · ORAL
Approval history
2026-05-15Labeling · Supplement 14 · standardAP
2022-08-04Manufacturing (CMC) · Supplement 12 · unknownAP
2020-08-26Labeling · Supplement 11 · standardAP
2020-08-26Labeling · Supplement 10 · standardAP
2014-12-19Labeling · Supplement 9 · standardAP
2014-12-19Labeling · Supplement 7 · standardAP
2013-04-26Labeling · Supplement 6AP
2010-10-22Labeling · Supplement 4AP
2010-04-29Labeling · Supplement 3AP
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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