Drug application
CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
Drugs@FDA ANDA 078398 · PADAGIS US
Key facts
| Drug name | CETIRIZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 078398 |
| Company | PADAGIS US |
| Dosage forms | SOLUTION, ORAL |
| Strength | 5MG/5ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Jun 17, 2008 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 10–99 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.