Application 761425
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;SUBCUTANEOUS | 130MG/26ML(5MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84232 | SUPPL | 2025-11-19 |
| 84231 | SUPPL | 2025-11-19 |
| 84224 | SUPPL | 2025-11-19 |
| 83993 | ORIG | 2025-10-30 |
| 83358 | SUPPL | 2025-09-17 |
| 83177 | SUPPL | 2025-08-25 |
| 82156 | ORIG | 2025-08-22 |
| 78970 | ORIG | 2025-08-22 |
| 82280 | ORIG | 2025-04-30 |
| 81606 | SUPPL | 2025-03-17 |
| 81593 | SUPPL | 2025-03-17 |
| 80921 | ORIG | 2025-02-05 |
| 80735 | SUPPL | 2024-12-26 |
| 80718 | SUPPL | 2024-12-26 |
| 78953 | ORIG | 2024-07-08 |