JUL 13, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Oxcarbazepine (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling change to an established generic oxcarbazepine suspension; regulatory action without clinical trial data.
Reported
Approval date2026-07-13
FormulationSuspension, oral, 300 mg/5 mL
Application typeANDA217782 (Abbreviated New Drug Applicatio…