BREZTRI

AstraZeneca Pharmaceuticals LP🇺🇸 United States

FDA Page

Effective Date: Apr 27, 2026
Approval ID: 715433dc-cb2b-43ea-b6df-c5b4177adc6c
Products: 2 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BREZTRI AEROSPHERE safely and effectively. See full prescribing information for BREZTRI AEROSPHERE.BREZTRI AEROSPHERE (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation useInitial U.S. Approval: 2020

Quick Stats

Total Products2

Labelers2

Label Sections40

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.