Application 761309
- Type
- BLA
- Sponsor
- GENENTECH INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761309 | Columvi | glofitamab-gxbm | 351(a) | Rx | 2026-09-01 |
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 |
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 |
|---|---|---|---|---|---|---|
| Columvi | GLOFITAMAB | Genentech, Inc. | 3516e753-f064-4d30-9bd5-e3f2e143f75d | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | BLA761309 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.