Product Details for: Niktimvo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
50MG/ML
Single-Dose Vial
351(a)
Niktimvo
Disc
002
Injection
Intravenous
9MG/0.18ML (50MG/ML)
Single-Dose Vial
351(a)
Niktimvo
Rx
003
Injection
Intravenous
22MG/0.44ML (50MG/ML)
Single-Dose Vial
351(a)
Niktimvo
Rx
004
Injection
Intravenous
9MG/0.9ML (10MG/ML)
Single-Dose Vial
351(a)
Niktimvo
Rx
005
Injection
Intravenous
22MG/2.2ML (10MG/ML)
Single-Dose Vial
351(a)
Niktimvo
Rx
Proper Name
axatilimab-csfr
BLA Number
761411
Applicant
Incyte Corporation
Original Approval Date
August 14, 2024
Date of First Licensure
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