JUN 25, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Amlodipine AND Atorvastatin (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of labeling for a fixed-dose combination of amlodipine and atorvastatin; this is a regulatory action, not a clinical evidence report, and does not contain trial outcomes or efficacy data.
Reported
Approval status date2026-06-25
Application numberANDA200465
Formulation 1Amlodipine 2.5 mg base + Atorvastatin 10 mg…