Application 761208
- Type
- BLA
- Sponsor
- SEAGEN
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761208 | Tivdak | tisotumab vedotin-tftv | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIVDAK | TISOTUMAB VEDOTIN-TFTV | INJECTABLE;INJECTION | 40MG | 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 |
|---|---|---|---|---|---|---|
| TIVDAK | TISOTUMAB VEDOTIN | SEAGEN INC. | c9fe3f32-4219-466e-acb9-3f609b4f4df1 | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | BLA761208 51144-003 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.