Drug application
OXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN, OXYCODONE HYDROCHLORIDE)
Drugs@FDA ANDA 078316 · BARR LABS INC
Key facts
| Drug name | OXYCODONE HYDROCHLORIDE AND IBUPROFEN |
|---|---|
| Active ingredients | IBUPROFEN, OXYCODONE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 078316 |
| Company | BARR LABS INC |
| Dosage forms | TABLET, ORAL |
| Strength | 400MG;5MG |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Nov 29, 2007 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: