Drug application
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE)
Drugs@FDA ANDA 212409 · AUROBINDO PHARMA LTD
Key facts
| Drug name | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 212409 |
| Company | AUROBINDO PHARMA LTD |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | 5MG;120MG |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Mar 8, 2023 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 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.