Application 761334
- Type
- BLA
- Sponsor
- INCYTE CORP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYNYZ | RETIFANLIMAB-DLWR | INJECTABLE;INTRAVENOUS | 500MG/20ML(25MG/ML) | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85984 | SUPPL | 2026-05-19 |
| 85980 | SUPPL | 2026-05-19 |
| 85612 | SUPPL | 2026-03-31 |
| 85610 | SUPPL | 2026-03-31 |
| 85662 | SUPPL | 2026-03-30 |
| 84485 | SUPPL | 2025-12-22 |
| 84463 | SUPPL | 2025-12-19 |
| 82306 | SUPPL | 2025-05-23 |
| 82239 | SUPPL | 2025-05-15 |
| 78245 | SUPPL | 2024-04-25 |
| 78241 | SUPPL | 2024-04-24 |
| 74015 | ORIG | 2023-04-19 |
| 73826 | ORIG | 2023-03-23 |
| 73815 | ORIG | 2023-03-22 |
| 73814 | ORIG | 2023-03-22 |