Orange Book product
HYDROXYZINE HYDROCHLORIDE 10MG/5ML
Orange Book ANDA 210634 · APOZEAL PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | HYDROXYZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | HYDROXYZINE HYDROCHLORIDE |
| Strength | 10MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA210634 |
| Applicant holder | APOZEAL PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 26, 2019 |
At a glance
- 1–9 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.