Orange Book product
XANAX XR 0.5MG
Orange Book NDA 021434 · UPJOHN US 2 LLC · Prescription
Key facts
| Proprietary name | XANAX XR |
|---|---|
| Active ingredients | ALPRAZOLAM |
| Strength | 0.5MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | NDA021434 |
| Applicant holder | UPJOHN US 2 LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jan 17, 2003 |
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.