APPLICATION
ANDA078069
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-11
LATEST ACTION
2025-08-15
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
2025-08-15Labeling · Supplement 23 · standardAP
2023-08-08Labeling · Supplement 18 · standardAP
2020-08-28Labeling · Supplement 13 · standardAP
2020-08-28Labeling · Supplement 12 · standardAP
2015-12-03Labeling · Supplement 8 · standardAP
2015-12-03Labeling · Supplement 9 · standardAP
2015-01-20Labeling · Supplement 6 · standardAP
2015-01-20Labeling · Supplement 4AP
2011-12-29Labeling · Supplement 3AP
2011-08-30Labeling · Supplement 2AP
2010-06-29Labeling · Supplement 1AP
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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