MAY 28, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Oxcarbazepine (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of oxcarbazepine labeling; this is a regulatory action, not a clinical evidence report, and does not contain trial outcomes or efficacy data.
Reported
Approval date2026-05-28
ANDA number211747
Submission classLabeling