Application 761449
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761449 | Tyenne | tocilizumab-aazg | 351(k) Biosimilar | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 004 | TYENNE | TOCILIZUMAB-AAZG | INJECTABLE;SUBCUTANEOUS | 162MG/0.9ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TYENNE | TOCILIZUMAB-AAZG | Fresenius Kabi USA, LLC | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | BLA761449 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.