Application 761384
- Type
- BLA
- Sponsor
- ABBVIE INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761384 | Emrelis | telisotuzumab vedotin-tllv | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMRELIS | TELISOTUZUMAB VEDOTIN-TLLV | VIAL;SINGLE-DOSE | 20MG | No | No |
| 002 | EMRELIS | TELISOTUZUMAB VEDOTIN-TLLV | VIAL;SINGLE-DOSE | 100MG | 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 |
|---|---|---|---|---|---|---|
| EMRELIS | TELISOTUZUMAB VEDOTIN | AbbVie Inc. | bc04f980-3957-4e35-ab81-8ec2ffe87215 | 2025-05-25 | Warnings, Adverse reactions | BLA761384 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.