APR 21, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Methylphenidate Hydrochloride (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of labeling changes for an existing methylphenidate hydrochloride extended-release formulation; does not report clinical trial data.
Reported
Approval date2026-04-21
Approved strengths10 mg, 30 mg, 50 mg, 60 mg