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Zynyz
retifanlimab-dlwr
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zynyz
Proper name
retifanlimab-dlwr
Licence type
351(a)
BLA number
761334
Applicant
Incyte Corporation
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 500MG/20ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 22, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 22, 2030 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |