BREYNA
- Product NDC
- 0378-7503
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA211699
- Marketing category
- ANDA
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 0378-7503-32 | 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER | 20230731 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| dc529fc4-bddb-4673-8202-dc401f86166f | These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006 | Mylan Pharmaceuticals Inc. | 2025-11-15 | HUMAN PRESCRIPTION DRUG LABEL | 5 |
| dc529fc4-bddb-4673-8202-dc401f86166f | These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006 | Mylan Pharmaceuticals Inc. | 2020-09-15 | HUMAN PRESCRIPTION DRUG LABEL | 3 |