Application 761352
- Type
- BLA
- Sponsor
- MERUS N.V.
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761352 | Bizengri | zenocutuzumab-zbco | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BIZENGRI | ZENOCUTUZUMAB-ZBCO | INJECTION;SOLUTION | 375MG/18.75ML | 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 |
|---|---|---|---|---|---|---|
| BIZENGRI | ZENOCUTUZUMAB | Partner Therapeutics, Inc. | 203daea4-fc87-40a4-a92f-ba2351b16de1 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | BLA761352 |
| BIZENGRI | ZENOCUTUZUMAB | Merus US, Inc. | 2a33e782-fc75-4dba-b77c-a44536ac13a5 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | BLA761352 |