# BREZTRI AEROSPHERE
> **NDA212122** · New Drug Application · Sponsor: ASTRAZENECA AB · Approved 2020-07-23
## Drug
- **FDA Application Number:** NDA212122
- **Application type:** New Drug Application
- **Brand name:** BREZTRI AEROSPHERE
- **Generic name:** BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE
- **Active ingredients:** BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
- **Dosage form:** AEROSOL, METERED
- **Route:** INHALATION
- **Marketing status:** Prescription
- **Sponsor:** ASTRAZENECA AB
- **Manufacturer:** AstraZeneca Pharmaceuticals LP
- **First approval:** 2020-07-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212122)
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