Icosapent Ethyl

AvKARE🇺🇸 United States

FDA Page

Effective Date: Dec 5, 2023
Approval ID: 0bc72bd8-1f33-b01c-e063-6394a90a77ea
Products: 1 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

Icosapent Ethyl Capsules Rx Only 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. Initial U.S. Approval: 2012

Quick Stats

Total Products1

Labelers2

Label Sections16

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.