Product Details for: Skyrizi
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
75MG/0.83ML
Pre-Filled Syringe
351(a)
Skyrizi
Disc
002
Injection
Subcutaneous
150MG/ML
Pre-Filled Syringe
351(a)
Skyrizi
Rx
003
Injection
Subcutaneous
150MG/ML
Autoinjector
351(a)
Skyrizi
Rx
004
Injection
Subcutaneous
180MG/1.2ML (150MG/ML)
Single-Dose Cartridge
351(a)
Skyrizi
Rx
005
Injection
Subcutaneous
360MG/2.4ML (150MG/ML)
Single-Dose Cartridge
351(a)
Skyrizi
Rx
006
Injection
Subcutaneous
90MG/ML
Pre-Filled Syringe
351(a)
Skyrizi
Rx
007
Injection
Subcutaneous
180MG/1.2ML (150MG/ML)
Pre-Filled Syringe
351(a)
Skyrizi
Rx
008
Injection
Subcutaneous
55MG/0.37ML
Pre-Filled Syringe
351(a)
Skyrizi
Rx
Proper Name
risankizumab-rzaa
risankizumab-rzaa
BLA Number
761105
761105
Applicant
AbbVie Inc.
AbbVie Inc.
Original Approval Date
April 23, 2019
April 23, 2019
Date of First Licensure