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Enflonsia
clesrovimab-cfor
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Enflonsia
Proper name
clesrovimab-cfor
Licence type
351(a)
BLA number
761432
Applicant
Merck Sharp & Dohme LLC
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 105MG/0.7ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | June 9, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |