Orange Book product
CETIRIZINE HYDROCHLORIDE HIVES 10MG
Orange Book ANDA 077829 · UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD · Over the counter
Key facts
| Proprietary name | CETIRIZINE HYDROCHLORIDE HIVES |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE |
| Strength | 10MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA077829 |
| Applicant holder | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Aug 26, 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.