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Lucentis
ranibizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lucentis
Proper name
ranibizumab
Licence type
351(a)
BLA number
125156
Applicant
Genentech, Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Disc* | June 30, 2006 |
| 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | October 13, 2016 |
| 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Disc* | August 10, 2012 |
| 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | March 20, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |