Drug application
ASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE)
Drugs@FDA NDA 213872 · BAYER HLTHCARE
Key facts
| Drug name | ASTEPRO ALLERGY |
|---|---|
| Active ingredients | AZELASTINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 213872 |
| Company | BAYER HLTHCARE |
| Dosage forms | SPRAY, METERED, NASAL |
| Strength | 0.2055MG/SPRAY |
| Marketing status | Over-the-counter |
| Reference listed drug | Yes |
| Latest submission class | Type 8 - Partial Rx to OTC Switch |
| Latest submission status date | Jun 17, 2021 |
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: