Icosapent

Dr. Reddy's Laboratories, Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 22, 2026
Approval ID: 1aca884c-c464-900d-ac06-33aee7118df8
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012

Quick Stats

Total Products1

Labelers2

Label Sections17

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.