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Sarclisa Escena
isatuximab-irfc
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Sarclisa Escena
Proper name
isatuximab-irfc
Licence type
351(a)
BLA number
761445
Applicant
Sanofi-Aventis U.S. LLC
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,400MG/10ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | July 9, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |