Orange Book product
OXYCODONE AND ACETAMINOPHEN 500MG;5MG
Orange Book ANDA 040289 · DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC · Discontinued
Key facts
| Proprietary name | OXYCODONE AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE |
| Strength | 500MG;5MG |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA040289 |
| Applicant holder | DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 16, 1999 |
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.