FdaApplication
BLA 761392
Identifiers
- fda_app_no: BLA761392
Properties
| Property | Value |
|---|---|
| applicant_name | Samsung Bioepis Co., Ltd. |
| application_type | BLA |
| approval_date | 2025-02-13 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DENOSUMAB-DSSB | DENOSUMAB-DSSB | 60MG/ML | INJECTABLE;SUBCUTANEOUS |
| DENOSUMAB-DSSB | DENOSUMAB-DSSB | 70MG/ML | INJECTABLE;SUBCUTANEOUS |
| OSPOMYV | DENOSUMAB-DSSB | 60MG/ML | Injection |
| XBRYK | DENOSUMAB-DSSB | 120MG/1.7ML (70MG/ML) | Injection |
4 products