ENTRESTO

Novartis Pharmaceuticals Corporation🇺🇸 United States

FDA Page

Effective Date: Jul 6, 2026
Approval ID: 000dc81d-ab91-450c-8eae-8eb74e72296f
Products: 7 registered
Version: 25

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO (sacubitril and valsartan) tablets, for oral use ENTRESTO SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015

Quick Stats

Total Products7

Labelers2

Label Sections46

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.