Application 076446
- Type
- ANDA
- Sponsor
- IMPAX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 10MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 20MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 40MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31124 | ORIG | 2006-03-23 |