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 | Title | Submission type | Submission no. | Date | Storage |
|---|
| 86013 | 0 | SUPPL | 22 | 2026-05-22 | Cached in FDA.report object storage |
| 86008 | 0 | SUPPL | 22 | 2026-05-21 | Cached in FDA.report object storage |
| 86003 | 0 | SUPPL | 22 | 2026-05-21 | Cached in FDA.report object storage |
| 84825 | 0 | SUPPL | 19 | 2026-01-22 | Cached in FDA.report object storage |
| 84819 | 0 | SUPPL | 19 | 2026-01-22 | Cached in FDA.report object storage |
| 82179 | 0 | SUPPL | 4 | 2025-05-14 | Cached in FDA.report object storage |
| 82248 | 0 | SUPPL | 4 | 2025-05-12 | Cached in FDA.report object storage |
| 82247 | 0 | SUPPL | 4 | 2025-05-12 | Cached in FDA.report object storage |
| 81598 | 0 | SUPPL | 15 | 2025-03-17 | Cached in FDA.report object storage |
| 81431 | 0 | SUPPL | 8 | 2025-03-04 | Cached in FDA.report object storage |
| 81388 | 0 | SUPPL | 8 | 2025-03-03 | Cached in FDA.report object storage |
| 80591 | 0 | SUPPL | 13 | 2024-12-16 | Cached in FDA.report object storage |
| 80582 | 0 | SUPPL | 13 | 2024-12-16 | Cached in FDA.report object storage |
| 80525 | 0 | SUPPL | 11 | 2024-12-05 | Cached in FDA.report object storage |
| 80504 | 0 | SUPPL | 11 | 2024-12-04 | Cached in FDA.report object storage |
| 79566 | 0 | SUPPL | 1 | 2024-09-09 | Cached in FDA.report object storage |
| 78878 | 0 | ORIG | 1 | 2024-06-24 | Cached in FDA.report object storage |
| 77736 | 0 | ORIG | 1 | 2024-03-08 | Cached in FDA.report object storage |
| 77754 | 0 | ORIG | 1 | 2024-03-07 | Cached in FDA.report object storage |