FdaApplication
ANDA 211699
Identifiers
- fda_app_no: ANDA211699
Properties
| Property | Value |
|---|---|
| applicant_name | MYLAN PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2022-03-15 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BREYNA | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION |
| BREYNA | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION |
2 products