APPLICATION
ANDA077802
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-09
LATEST ACTION
2026-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXCARBAZEPINEPrescription
OXCARBAZEPINE 600MG · TABLET · ORAL
OXCARBAZEPINEPrescription
OXCARBAZEPINE 150MG · TABLET · ORAL
OXCARBAZEPINEPrescription
OXCARBAZEPINE 300MG · TABLET · ORAL
Approval history
2026-05-28Labeling · Supplement 29 · standardAP
2025-09-17Labeling · Supplement 24 · standardAP
2020-08-25Labeling · Supplement 17 · standardAP
2020-08-25Labeling · Supplement 15 · standardAP
2020-08-25Labeling · Supplement 13 · standardAP
2015-01-20Labeling · Supplement 8 · standardAP
2015-01-20Labeling · Supplement 11 · standardAP
2012-01-19REMS · Supplement 5AP
2011-12-28Labeling · Supplement 4AP
2010-06-29Labeling · Supplement 2AP
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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