Orange Book product
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML
Orange Book ANDA 090474 · APOZEAL PHARMACEUTICALS INC · Over the counter
Key facts
| Proprietary name | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE |
| Strength | 5MG/5ML |
| Dosage form | SOLUTION |
| Route | ORAL |
| Application | ANDA090474 |
| Applicant holder | APOZEAL PHARMACEUTICALS INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 30, 2009 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.