Product Details for: Rystiggo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
280MG/2ML (140MG/ML)
Single-Dose Vial
351(a)
Rystiggo
Rx
002
Injection
Subcutaneous
420MG/3ML (140MG/ML)
Single-Dose Vial
351(a)
Rystiggo
Rx
003
Injection
Subcutaneous
560MG/4ML (140MG/ML)
Single-Dose Vial
351(a)
Rystiggo
Rx
004
Injection
Subcutaneous
840MG/6ML (140MG/ML)
Single-Dose Vial
351(a)
Rystiggo
Rx
Proper Name
rozanolixizumab-noli
BLA Number
761286
Applicant
UCB, Inc.
Original Approval Date
June 26, 2023
Date of First Licensure