Application 761373
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;INJECTION | 45MG/0.5ML | No | No |
| 002 | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;INJECTION | 90MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84230 | SUPPL | 2025-11-19 |
| 84229 | SUPPL | 2025-11-19 |
| 84223 | SUPPL | 2025-11-19 |
| 83992 | ORIG | 2025-10-30 |
| 83357 | SUPPL | 2025-09-17 |
| 83176 | SUPPL | 2025-08-25 |
| 78940 | ORIG | 2025-08-22 |
| 83162 | SUPPL | 2025-08-20 |
| 82155 | ORIG | 2025-05-05 |
| 82154 | SUPPL | 2025-05-05 |
| 82281 | SUPPL | 2025-04-30 |
| 82277 | ORIG | 2025-04-30 |
| 81605 | SUPPL | 2025-03-17 |
| 81591 | SUPPL | 2025-03-17 |
| 80920 | ORIG | 2025-02-05 |
| 80733 | SUPPL | 2024-12-26 |
| 80717 | SUPPL | 2024-12-26 |
| 78952 | ORIG | 2024-07-08 |