Application 761275
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;INTRAVENOUS | 80MG/4ML | No | No |
| 003 | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;INTRAVENOUS | 200MG/10ML | No | No |
| 004 | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;INTRAVENOUS | 400MG/20ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 86013 | SUPPL | 2026-05-22 |
| 86008 | SUPPL | 2026-05-21 |
| 86003 | SUPPL | 2026-05-21 |
| 84825 | SUPPL | 2026-01-22 |
| 84819 | SUPPL | 2026-01-22 |
| 82179 | SUPPL | 2025-05-14 |
| 82248 | SUPPL | 2025-05-12 |
| 82247 | SUPPL | 2025-05-12 |
| 81598 | SUPPL | 2025-03-17 |
| 81431 | SUPPL | 2025-03-04 |
| 81388 | SUPPL | 2025-03-03 |
| 80591 | SUPPL | 2024-12-16 |
| 80582 | SUPPL | 2024-12-16 |
| 80525 | SUPPL | 2024-12-05 |
| 80504 | SUPPL | 2024-12-04 |
| 79566 | SUPPL | 2024-09-09 |
| 78878 | ORIG | 2024-06-24 |
| 77736 | ORIG | 2024-03-08 |
| 77754 | ORIG | 2024-03-07 |