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Avastin
bevacizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Avastin
Proper name
bevacizumab
Licence type
351(a)
BLA number
125085
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | February 26, 2004 |
| 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | February 26, 2004 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 29, 2027 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |