Drug application
AZELASTINE HYDROCHLORIDE ALLERGY (AZELASTINE HYDROCHLORIDE)
Drugs@FDA ANDA 216421 · APOTEX
Key facts
| Drug name | AZELASTINE HYDROCHLORIDE ALLERGY |
|---|---|
| Active ingredients | AZELASTINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 216421 |
| Company | APOTEX |
| Dosage forms | SPRAY, METERED, NASAL |
| Strength | 0.2055MG/SPRAY |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | May 29, 2024 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: