JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Methadone Hydrochloride (REMS)
U.S. Food and Drug Administration
FDA supplemental approval action for methadone hydrochloride REMS; describes regulatory status only, not clinical trial data or efficacy evidence.
Reported
Approval date2026-06-18
Application numberANDA204166
Dose approved10 mg