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
Subcutaneous
45MG/0.5ML
Single-Dose Vial
351(a)
Stelara
Rx
002
Injection
Subcutaneous
90MG/ML
Single-Dose Vial
351(a)
Stelara
Disc
003
Injection
Subcutaneous
45MG/0.5ML
Pre-Filled Syringe
351(a)
Stelara
Rx
004
Injection
Subcutaneous
90MG/ML
Pre-Filled Syringe
351(a)
Stelara
Rx
Proper Name
ustekinumab
BLA Number
125261
Applicant
Janssen Biotech, Inc.
Original Approval Date
September 25, 2009
Date of First Licensure
Patent List Provided
Yes
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