Drug application
PERCOCET (ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE)
Drugs@FDA ANDA 040330 · OZANTRI
Key facts
| Drug name | PERCOCET |
|---|---|
| Active ingredients | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 040330 |
| Company | OZANTRI |
| Dosage forms | TABLET, ORAL |
| Strength | 325MG;2.5MG |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Jun 25, 1999 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- 10–99 Therapeutic equivalents
- Yes FDA letters on file
- Yes 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: