Drug application
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE (BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE)
Drugs@FDA ANDA 212212 · TEVA PHARMS USA INC
Key facts
| Drug name | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE |
|---|---|
| Active ingredients | BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE |
| Application type | ANDA |
| Application number | 212212 |
| Company | TEVA PHARMS USA INC |
| Dosage forms | AEROSOL, METERED, INHALATION |
| Strength | 0.08MG/INH;0.0045MG/INH |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Apr 23, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.