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Entyvio

vedolizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Entyvio

Proper name

vedolizumab

Licence type

351(a)

BLA number

761133

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
108MG/0.68ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	September 27, 2023
300MG	For Injection	Intravenous	Single-Dose Vial	Rx	May 20, 2014

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity