FdaApplication
ANDA 212212
Identifiers
- fda_app_no: ANDA212212
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2026-04-23 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION |
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION |
2 products