Application 761398
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BOMYNTRA | DENOSUMAB-BNHT | INJECTION | 120MG/1.7ML (70 MG/ML) | No | No |
| 002 | CONEXXENCE | DENOSUMAB-BNHT | INJECTION | 60MG/ML | No | No |