Application 216899
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.2MG/ML | No | No |
| 002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5MG/0.5ML | No | No |
| 003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 004 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77742 | ORIG | 2024-03-07 |