Orange Book product
OXYCODONE HYDROCHLORIDE AND IBUPROFEN 400MG;5MG
Orange Book ANDA 078316 · BARR LABORATORIES INC · Discontinued
Key facts
| Proprietary name | OXYCODONE HYDROCHLORIDE AND IBUPROFEN |
|---|---|
| Active ingredients | IBUPROFEN, OXYCODONE HYDROCHLORIDE |
| Strength | 400MG;5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA078316 |
| Applicant holder | BARR LABORATORIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 29, 2007 |
At a glance
- None 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.