Application 761232
- Type
- BLA
- Sponsor
- BEIGENE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEVIMBRA | TISLELIZUMAB-JSGR | INJECTION;SOLUTION | 100MG/10ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84442 | SUPPL | 2025-12-18 |
| 84440 | SUPPL | 2025-12-18 |
| 84379 | SUPPL | 2025-12-10 |
| 84378 | SUPPL | 2025-12-10 |
| 84377 | SUPPL | 2025-12-10 |
| 82135 | SUPPL | 2025-05-05 |
| 82265 | SUPPL | 2025-05-01 |
| 82264 | SUPPL | 2025-05-01 |
| 82090 | SUPPL | 2025-05-01 |
| 82089 | SUPPL | 2025-05-01 |
| 82088 | SUPPL | 2025-05-01 |
| 82087 | SUPPL | 2025-05-01 |
| 82086 | SUPPL | 2025-05-01 |
| 82085 | SUPPL | 2025-05-01 |
| 82084 | SUPPL | 2025-05-01 |
| 81975 | SUPPL | 2025-04-24 |
| 81974 | SUPPL | 2025-04-24 |
| 81973 | SUPPL | 2025-04-24 |
| 81972 | SUPPL | 2025-04-24 |
| 81971 | SUPPL | 2025-04-24 |
| 81970 | SUPPL | 2025-04-24 |
| 78106 | ORIG | 2024-04-10 |
| 77851 | ORIG | 2024-03-18 |
| 77850 | ORIG | 2024-03-18 |
| 77831 | ORIG | 2024-03-14 |