Application 761388
- Type
- BLA
- Sponsor
- GENENTECH INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761388 | Piasky | crovalimab-akkz | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIASKY | CROVALIMAB-AKKZ | INJECTABLE;INTRAVENOUS | 340MG/2ML(170MG/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 |
|---|---|---|---|---|---|---|
| Piasky | CROVALIMAB | Genentech, Inc. | 2597efc2-a97b-487c-b500-a67fd282a73b | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | BLA761388 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.