APPLICATION
ANDA077801
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-15
LATEST ACTION
2015-01-15
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
2015-01-15Labeling · Supplement 4AP
2015-01-15Labeling · Supplement 5 · standardAP
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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