FdaApplication
BLA 761373
Identifiers
- fda_app_no: BLA761373
Properties
| Property | Value |
|---|---|
| applicant_name | Samsung Bioepis Co., Ltd. |
| application_type | BLA |
| approval_date | 2024-06-28 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PYZCHIVA | USTEKINUMAB-TTWE | 45MG/0.5ML | Injection |
| PYZCHIVA | USTEKINUMAB-TTWE | 90MG/ML | Injection |
| PYZCHIVA | — | 45MG/0.5ML | Injection |
| PYZCHIVA | — | 90MG/ML | Injection |
| PYZCHIVA | — | 45MG/0.5ML | Injection |
5 products