Orange Book product
HYDROXYZINE HYDROCHLORIDE 10MG/5ML
Orange Book ANDA 087294 · CHARTWELL RX SCIENCES LLC · Prescription
Key facts
| Proprietary name | HYDROXYZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | HYDROXYZINE HYDROCHLORIDE |
| Strength | 10MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA087294 |
| Applicant holder | CHARTWELL RX SCIENCES LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Apr 12, 1982 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.