Drug application
ASTEPRO (AZELASTINE HYDROCHRLORIDE)
Drugs@FDA NDA 022371 · MEDA PHARMS
Key facts
| Drug name | ASTEPRO |
|---|---|
| Active ingredients | AZELASTINE HYDROCHRLORIDE |
| Application type | NDA |
| Application number | 022371 |
| Company | MEDA PHARMS |
| Dosage forms | SPRAY, METERED, NASAL |
| Strength | 0.1% |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 6 - New Indication (no longer used) |
| Latest submission status date | Aug 31, 2009 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No 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: