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
For Injection
Intravenous
300MG
Single-Dose Vial
351(a)
Entyvio
Rx
Proper Name
vedolizumab
vedolizumab
BLA Number
125476
125476
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
May 20, 2014
May 20, 2014
Date of First Licensure