budesonide, glycopyrrolate, and formoterol fumarate
Drug Details
- Generic Name
- budesonide, glycopyrrolate, and formoterol fumarate
- Brand Names
- BREZTRI
- Application Number
- NDA212122
- Sponsor
- AstraZeneca Pharmaceuticals LP
- NDC Codes
- 1
- Dosage Forms
- AEROSOL, METERED
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- BUDESONIDE, FORMOTEROL, GLYCOPYRROLATE
Indications and Usage
1 INDICATIONS AND USAGE BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1 , 5.2) ] . BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1) Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1 , 5.1 , 5.2)