Application 761449
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 004 | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;SUBCUTANEOUS | 162MG/0.9ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 86014 | SUPPL | 2026-05-22 |
| 86009 | SUPPL | 2026-05-21 |
| 86004 | SUPPL | 2026-05-21 |
| 85843 | ORIG | 2026-05-07 |
| 82180 | SUPPL | 2025-05-14 |
| 82250 | SUPPL | 2025-05-12 |
| 81622 | ORIG | 2025-03-18 |
| 81600 | ORIG | 2025-03-17 |
| 81599 | ORIG | 2025-03-17 |