On this page
Tecentriq
atezolizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tecentriq
Proper name
atezolizumab
Licence type
351(a)
BLA number
761034
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,200MG/20ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | May 18, 2016 |
| 840MG/14ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 8, 2019 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 9, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |