Application 003718
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 004 | SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | INJECTABLE;INJECTION | 5MG/ML | No | No |
| 006 | SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | INJECTABLE;INJECTION | 10MG/ML | No | No |
| 008 | SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | INJECTABLE;INJECTION | 37.5MG/ML | No | No |
| 010 | SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | TABLET;ORAL | 5MG | No | No |