Application 761444
- Type
- BLA
- Sponsor
- SHANGHAI HENLIUS BIOTECH
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761444 | Bildyos | denosumab-nxxp | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BILDYOS | DENOSUMAB-NXXP | INJECTABLE;INJECTION | 60MG/ML | No | No |
| 002 | BILPREVDA | DENOSUMAB-NXXP | INJECTABLE;INJECTION | 120MG/1.7ML(70MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84425 | ORIG | 2025-12-15 |
| 84424 | ORIG | 2025-12-15 |
| 84000 | ORIG | 2025-11-21 |
| 83669 | ORIG | 2025-11-21 |
| 84023 | ORIG | 2025-10-31 |
| 84022 | ORIG | 2025-10-31 |
| 83676 | ORIG | 2025-10-07 |