Orange Book product
CETIRIZINE HYDROCHLORIDE 5MG/5ML
Orange Book ANDA 078876 · CHARTWELL MOLECULAR HOLDINGS LLC · Prescription
Key facts
| Proprietary name | CETIRIZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE |
| Strength | 5MG/5ML |
| Dosage form | SOLUTION |
| Route | ORAL |
| Application | ANDA078876 |
| Applicant holder | CHARTWELL MOLECULAR HOLDINGS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 11, 2012 |
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.