Composition
- Active ingredients
- BUDESONIDE 0.08MG/INH; FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BUDESONIDE 0.08MG/INH; FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · Aerosol, meteredThis page
- BUDESONIDE 0.16MG/INH; FORMOTEROL FUMARATE DIHYDRATE 0.0045MG/INH · Aerosol, meteredANDA211699-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA211699.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Breyna
- Active substance
- budesonide
- Route
- Inhalation
- Dosage form
- Aerosol, metered
- Applicant
- Mylan
- Status
- Prescription
- FDA approval
- 15 Mar 2022
- Application
- ANDA211699-001