JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Oxycodone Hydrochloride (REMS)
U.S. Food and Drug Administration
FDA supplemental approval action for oxycodone hydrochloride oral solution under REMS framework; describes regulatory status, not clinical efficacy or safety data.
Reported
Approval status date2026-06-18
Product strength5 mg/5 mL