Application 761449
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 004 | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;SUBCUTANEOUS | 162MG/0.9ML | No | No |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 86014 | 0 | SUPPL | 6 | 2026-05-22 | Cached in FDA.report object storage |
| 86009 | 0 | SUPPL | 6 | 2026-05-21 | Cached in FDA.report object storage |
| 86004 | 0 | SUPPL | 6 | 2026-05-21 | Cached in FDA.report object storage |
| 85843 | 0 | ORIG | 1 | 2026-05-07 | Cached in FDA.report object storage |
| 82180 | 0 | SUPPL | 1 | 2025-05-14 | Cached in FDA.report object storage |
| 82250 | 0 | SUPPL | 1 | 2025-05-12 | Cached in FDA.report object storage |
| 81622 | 0 | ORIG | 1 | 2025-03-18 | Cached in FDA.report object storage |
| 81600 | 0 | ORIG | 1 | 2025-03-17 | Cached in FDA.report object storage |
| 81599 | 0 | ORIG | 1 | 2025-03-17 | Cached in FDA.report object storage |