Application 761322
- Type
- BLA
- Sponsor
- SANDOZ INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761322 | Tyruko | natalizumab-sztn | 351(k) Biosimilar | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYRUKO | NATALIZUMAB-SZTN | INJECTABLE;INJECTION | 300MG/15ML(20MG/ML) | 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 |
|---|---|---|---|---|---|---|
| TYRUKO | NATALIZUMAB-SZTN | Sandoz Inc | ef653c36-dd4b-4e71-9d2d-40b8fea24b67 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | BLA761322 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.