Application 210506
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
| 002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | No | No |
| 003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76063 | ORIG | 2023-11-02 |