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 |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 84322 | 0 | ORIG | 2 | 2025-11-26 | Cached in FDA.report object storage |
| 84320 | 0 | ORIG | 1 | 2025-11-26 | Cached in FDA.report object storage |
| 84319 | 0 | ORIG | 2 | 2025-11-26 | Cached in FDA.report object storage |
| 84001 | 0 | ORIG | 2 | 2025-10-31 | Cached in FDA.report object storage |
| 81745 | 0 | ORIG | 1 | 2025-03-27 | Cached in FDA.report object storage |
| 81725 | 0 | ORIG | 1 | 2025-03-25 | Cached in FDA.report object storage |