Drug application
PERCODAN-DEMI (ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE)
Drugs@FDA NDA 007337 · ENDO OPERATIONS
Key facts
| Drug name | PERCODAN-DEMI |
|---|---|
| Active ingredients | ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE |
| Application type | NDA |
| Application number | 007337 |
| Company | ENDO OPERATIONS |
| Dosage forms | TABLET, ORAL |
| Strength | 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Apr 12, 1950 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 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: