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
Subcutaneous
45MG/0.5ML
Pre-Filled Syringe
351(k) Interchangeable
Pyzchiva
Rx
002
Injection
Subcutaneous
90MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Pyzchiva
Rx
003
Injection
Subcutaneous
45MG/0.5ML
Single-Dose Vial
351(k) Interchangeable
Pyzchiva
Rx
004
Injection
Subcutaneous
45MG/0.5ML
Autoinjector
351(k) Interchangeable
Pyzchiva
Rx
005
Injection
Subcutaneous
90MG/ML
Autoinjector
351(k) Interchangeable
Pyzchiva
Rx
Proper Name
ustekinumab-ttwe
Reference Product Proper Name
ustekinumab
Reference Product Properietary Name
Stelara
BLA Number
761373
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
June 28, 2024
Date of First Licensure
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