Drug application
AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
Drugs@FDA ANDA 201999 · TEVA PHARMS USA INC
Key facts
| Drug name | AZELASTINE HYDROCHLORIDE |
|---|---|
| Active ingredients | AZELASTINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 201999 |
| Company | TEVA PHARMS USA INC |
| Dosage forms | SPRAY, METERED, NASAL |
| Strength | EQ 0.125MG BASE/SPRAY |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission class | Not Applicable |
| Latest submission status date | Sep 11, 2017 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None 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.