Orange Book product
OXYMORPHONE HYDROCHLORIDE 10MG
Orange Book ANDA 079087 · IMPAX LABORATORIES INC · Prescription
Key facts
| Proprietary name | OXYMORPHONE HYDROCHLORIDE |
|---|---|
| Active ingredients | OXYMORPHONE HYDROCHLORIDE |
| Strength | 10MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA079087 |
| Applicant holder | IMPAX LABORATORIES INC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 14, 2010 |
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.