Breo Ellipta

GlaxoSmithKline LLC🇺🇸 United States

FDA Page

Effective Date: Nov 7, 2024
Approval ID: 96428df1-ea05-431a-98d3-1ec2c4b63878
Products: 3 registered
Version: 29

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BREO ELLIPTA safely and effectively. See full prescribing information for BREO ELLIPTA. BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder), for oral inhalation useInitial U.S. Approval: 2013

Quick Stats

Total Products3

Labelers2

Label Sections21

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.