JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Tramadol Hydrochloride Extended-release (REMS)
U.S. Food and Drug Administration
FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) on an existing tramadol extended-release product; a regulatory action without clinical trial data.
Reported
Approval date2026-06-18
Approved strengths100 mg, 150 mg, 200 mg, 300 mg