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Gazyva
obinutuzumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Gazyva
Proper name
obinutuzumab
Licence type
351(a)
BLA number
125486
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000MG/40ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | November 1, 2013 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 16, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |