Product Details for: Zymfentra

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
120MG/ML
Pre-Filled Syringe
351(a)
Zymfentra
Rx
002
Injection
Subcutaneous
120MG/ML
Autoinjector
351(a)
Zymfentra
Rx
Proper Name
infliximab-dyyb
BLA Number
761358
Applicant
CELLTRION, Inc.
Original Approval Date
October 20, 2023
Date of First Licensure
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