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Imaavy
nipocalimab-aahu
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Imaavy
Proper name
nipocalimab-aahu
Licence type
351(a)
BLA number
761430
Applicant
Janssen Biotech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,200MG/6.5ML (185MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | April 29, 2025 |
| 300MG/1.62ML (185MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | April 29, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |