APPLICATION
ANDA077795
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-09
LATEST ACTION
2020-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 300MG · TABLET · ORAL
OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 600MG · TABLET · ORAL
OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 150MG · TABLET · ORAL
Approval history
2020-08-26Labeling · Supplement 12 · standardAP
2020-08-26Labeling · Supplement 11 · standardAP
2015-11-25Labeling · Supplement 9 · standardAP
2012-01-06Labeling · Supplement 5AP
2011-08-29Labeling · Supplement 4AP
2010-06-29Labeling · 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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