JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Codeine Sulfate (REMS)
U.S. Food and Drug Administration
FDA supplemental approval action for codeine sulfate REMS program; describes regulatory classification and product specifications without clinical trial data.
Reported
Approval status date2026-06-18
Approved product strengths15 mg, 30 mg, 60 mg