Application 761309
- Type
- BLA
- Sponsor
- GENENTECH INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLUMVI | GLOFITAMAB-GXBM | INJECTABLE;INJECTION | 2.5MG/2.5ML(1MG/ML) | No | No |
| 002 | COLUMVI | GLOFITAMAB-GXBM | INJECTABLE;INJECTION | 10MG/10ML(1MG/ML) | No | No |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 83961 | 0 | SUPPL | 4 | 2025-10-28 | Cached in FDA.report object storage |
| 83940 | 0 | SUPPL | 4 | 2025-10-28 | Cached in FDA.report object storage |
| 82530 | 0 | SUPPL | 3 | 2025-06-10 | Cached in FDA.report object storage |
| 82529 | 0 | SUPPL | 3 | 2025-06-10 | Cached in FDA.report object storage |
| 75002 | 0 | ORIG | 1 | 2023-07-18 | Cached in FDA.report object storage |
| 74773 | 0 | ORIG | 1 | 2023-07-18 | Cached in FDA.report object storage |
| 74501 | 0 | ORIG | 1 | 2023-06-16 | Cached in FDA.report object storage |