Product Details for: Otulfi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
45MG/0.5ML
Pre-Filled Syringe
351(k) Interchangeable
Otulfi
Rx
002
Injection
Subcutaneous
90MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Otulfi
Rx
003
Injection
Intravenous
130MG/26ML (5MG/ML)
Single-Dose Vial
351(k) Interchangeable
Otulfi
Rx
004
Injection
Subcutaneous
45MG/0.5ML
Single-Dose Vial
351(k) Interchangeable
Otulfi
Rx
Proper Name
ustekinumab-aauz
Reference Product Proper Name
ustekinumab
Reference Product Properietary Name
Stelara
BLA Number
761379
Applicant
Fresenius Kabi USA, LLC
Original Approval Date
September 27, 2024
Date of First Licensure
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