Application 761388
- Type
- BLA
- Sponsor
- GENENTECH INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIASKY | CROVALIMAB-AKKZ | INJECTABLE;INTRAVENOUS | 340MG/2ML(170MG/ML) | No | No |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 82308 | 0 | SUPPL | 1 | 2025-05-23 | Cached in FDA.report object storage |
| 79255 | 0 | ORIG | 1 | 2024-07-30 | Cached in FDA.report object storage |
| 78868 | 0 | ORIG | 1 | 2024-06-24 | Cached in FDA.report object storage |
| 78867 | 0 | ORIG | 1 | 2024-06-24 | Cached in FDA.report object storage |
| 78866 | 0 | ORIG | 1 | 2024-06-24 | Cached in FDA.report object storage |