Application 215508
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EDARAVONE | EDARAVONE | SOLUTION;INTRAVENOUS | 30MG/100ML (0.3MG/ML) | No | No |
| 002 | EDARAVONE | EDARAVONE | INJECTION;SOLUTION | 60mg/100mL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78837 | ORIG | 2024-06-20 |