Application 218586
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERIDONE | RISPERIDONE | POWDER;INTRAMUSCULAR | 12.5MG/VIAL | No | No |
| 002 | RISPERIDONE | RISPERIDONE | POWDER;INTRAMUSCULAR | 25MG/VIAL | No | No |
| 003 | RISPERIDONE | RISPERIDONE | POWDER;INTRAMUSCULAR | 37.5MG/VIAL | No | No |
| 004 | RISPERIDONE | RISPERIDONE | POWDER;INTRAMUSCULAR | 50MG/VIAL | No | No |