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Sarclisa
isatuximab-irfc
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Sarclisa
Proper name
isatuximab-irfc
Licence type
351(a)
BLA number
761113
Applicant
Sanofi-Aventis U.S. LLC
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/5ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 2, 2020 |
| 500MG/25ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 2, 2020 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 20, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |