Product Details for: Imaavy

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
300MG/1.62ML (185MG/ML)
Single-Dose Vial
351(a)
Imaavy
Rx
002
Injection
Intravenous
1,200MG/6.5ML (185MG/ML)
Single-Dose Vial
351(a)
Imaavy
Rx
Proper Name
nipocalimab-aahu
BLA Number
761430
Applicant
Janssen Biotech, Inc.
Original Approval Date
April 29, 2025
Date of First Licensure
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