APPLICATION
ANDA201193
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-03
LATEST ACTION
2025-04-03
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 300MG/5ML · SUSPENSION · ORAL
Approval history
2025-04-03Labeling · Supplement 9 · standardAP
2020-10-28Labeling · Supplement 5 · standardAP
2020-10-28Labeling · Supplement 4 · standardAP
2015-07-24Labeling · Supplement 3 · standardAP
2015-07-24Labeling · Supplement 1 · standardAP
2012-10-03Not Applicable · OriginalAP
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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