Product Details for: Entyvio

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
108MG/0.68ML
Pre-Filled Syringe
351(a)
Entyvio
Rx
002
Injection
Subcutaneous
108MG/0.68ML
Autoinjector
351(a)
Entyvio Pen
Rx
Proper Name
vedolizumab
BLA Number
761133
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
September 27, 2023
Date of First Licensure
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