omega-3-acid ethyl esters

Chartwell RX, LLC🇺🇸 United States

FDA Page

Effective Date: Dec 22, 2025
Approval ID: 331d5d9d-58d8-4b4f-8114-b28efa7276d7
Products: 1 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

OMEGA-3-ACID ETHYL ESTERS capsules These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES. OMEGA-3-ACID ETHYL ESTERS capsules, for oral use Initial U.S. Approval: 2004

Quick Stats

Total Products1

Labelers2

Label Sections18

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.