Drug application
ROXICET (ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE)
Drugs@FDA ANDA 089351 · HIKMA PHARMS
Key facts
| Drug name | ROXICET |
|---|---|
| Active ingredients | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 089351 |
| Company | HIKMA PHARMS |
| Dosage forms | SOLUTION, ORAL |
| Strength | 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Dec 3, 1986 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
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.