# BREYNA
> **ANDA211699** · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2022-03-15
## Drug
- **FDA Application Number:** ANDA211699
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BREYNA
- **Generic name:** BUDESONIDE AND FORMOTEROL FUMARATE
- **Active ingredients:** BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
- **Dosage form:** AEROSOL, METERED
- **Route:** INHALATION
- **Marketing status:** Prescription
- **Sponsor:** MYLAN
- **Manufacturer:** Mylan Pharmaceuticals Inc.
- **First approval:** 2022-03-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211699)
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