JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Hydromorphone Hydrochloride (REMS)
U.S. Food and Drug Administration
FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for extended-release hydromorphone hydrochloride tablets; this is a regulatory action establishing risk management requirements, not a clinical efficacy or safety study.
Reported
Approval date2026-06-18
ANDA number205629
Tablet strengths approved8 mg, 12 mg, 16 mg, 24 mg