Product Details for: Stelara
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
130MG/26ML (5MG/ML)
Single-Dose Vial
351(a)
Stelara
Rx
Proper Name
ustekinumab
ustekinumab
BLA Number
761044
761044
Applicant
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Original Approval Date
September 23, 2016
September 23, 2016
Date of First Licensure