MAY 12, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Spironolactone AND Hydrochlorothiazide (Labeling)
U.S. Food and Drug Administration
FDA supplemental labeling approval for a fixed-dose combination antihypertensive; regulatory authorization does not convey clinical efficacy evidence.
Reported
Approval date2026-05-12
Spironolactone dose25 mg
Hydrochlorothiazide dose25 mg