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Application 761309
- Type
- BLA
- Sponsor
- GENENTECH INC
Application Products#
Product, Drug, Ingredient table| 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, Submission type, Date table| Document | Submission type | Date |
|---|
| 83961 | SUPPL | 2025-10-28 |
| 83940 | SUPPL | 2025-10-28 |
| 82530 | SUPPL | 2025-06-10 |
| 82529 | SUPPL | 2025-06-10 |
| 75002 | ORIG | 2023-07-18 |
| 74773 | ORIG | 2023-07-18 |
| 74501 | ORIG | 2023-06-16 |