JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Morphine Sulfate (REMS)
U.S. Food and Drug Administration
FDA supplemental approval action for morphine sulfate REMS program; establishes risk management requirements but does not report clinical trial efficacy or comparative outcomes.
Reported
Application numberANDA215584
Approval date2026-06-18
Formulations approvedMorphine sulfate 15 mg oral tablet; Morphin…