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Columvi
glofitamab-gxbm
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Columvi
Proper name
glofitamab-gxbm
Licence type
351(a)
BLA number
761309
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/10ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 15, 2023 |
| 2.5MG/2.5ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | June 15, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |