Application 761392
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OSPOMYV | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 002 | XBRYK | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 70MG/ML | No | No |
| 003 | DENOSUMAB-DSSB | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
| 004 | DENOSUMAB-DSSB | DENOSUMAB-DSSB | INJECTABLE;SUBCUTANEOUS | 70MG/ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84429 | ORIG | 2025-12-15 |
| 84428 | ORIG | 2025-12-15 |
| 84017 | ORIG | 2025-10-31 |
| 84016 | ORIG | 2025-10-31 |
| 84003 | ORIG | 2025-10-31 |
| 81271 | ORIG | 2025-02-18 |
| 81260 | ORIG | 2025-02-14 |
| 81236 | ORIG | 2025-02-13 |