Drug application
BREZTRI AEROSPHERE (BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRROLATE)
Drugs@FDA NDA 212122 · ASTRAZENECA AB
Key facts
| Drug name | BREZTRI AEROSPHERE |
|---|---|
| Active ingredients | BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRROLATE |
| Application type | NDA |
| Application number | 212122 |
| Company | ASTRAZENECA AB |
| Dosage forms | AEROSOL, METERED, INHALATION |
| Strength | 0.16MG/INH;0.0048MG/INH;0.009MG/INH |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission status date | Jul 23, 2020 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
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.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: