Product Details for: Pyzchiva
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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(k) Interchangeable
Pyzchiva
Rx
Proper Name
ustekinumab-ttwe
ustekinumab-ttwe
Reference Product Proper Name
ustekinumab
ustekinumab
Reference Product Properietary Name
Stelara
Stelara
BLA Number
761425
761425
Applicant
Samsung Bioepis Co., Ltd.
Samsung Bioepis Co., Ltd.
Original Approval Date
June 28, 2024
June 28, 2024
Date of First Licensure