Application 021044
- Type
- NDA
- Sponsor
- PURDUE PHARMA LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 12MG | No | No |
| 002 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 16MG | No | No |
| 003 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 24MG | No | No |
| 004 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 32MG | No | No |