← Every applicant
Samsung Bioepis Co Ltd FDA Approvals
6 new drug approvals and 0 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| DENOSUMAB-DSSBNew drugFeb 13, 2025INJECTABLE, SUBCUTANEOUS |
| EPYSQLINew drugJul 19, 2024INJECTION, SOLUTION |
| PYZCHIVANew drugJun 28, 2024INJECTABLE, INJECTION |
| PYZCHIVANew drugJun 28, 2024INJECTABLE, SUBCUTANEOUS |
| OPUVIZNew drugMay 20, 2024INJECTABLE, INJECTION |
| BYOOVIZNew drugSep 17, 2021INJECTABLE, INJECTION |