Application 761444
- Type
- BLA
- Sponsor
- SHANGHAI HENLIUS BIOTECH
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761444 | Bildyos | denosumab-nxxp | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
| 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BILDYOS | DENOSUMAB | Organon LLC | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | BLA761444 |
| Bilprevda | DENOSUMAB | Organon LLC | b1f0590e-f5bb-44ac-99a0-4aa4596c7e54 | 2026-08-18 | Warnings, Adverse reactions | BLA761444 |