FdaApplication
BLA 761444
Identifiers
- fda_app_no: BLA761444
Properties
| Property | Value |
|---|---|
| applicant_name | Shanghai Henlius Biotech, Inc. |
| application_type | BLA |
| approval_date | 2025-08-29 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BILDYOS | DENOSUMAB-NXXP | 60MG/ML | Injection |
| BILDYOS | DENOSUMAB-NXXP | 60MG/ML | Injection |
| BILPREVDA | — | 120MG/1.7ML (70MG/ML) | Injection |
3 products