On this page
Entyvio Pen
vedolizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Entyvio Pen
Proper name
vedolizumab
Licence type
351(a)
BLA number
761133
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 108MG/0.68ML | Injection | Subcutaneous | Autoinjector | Rx | September 27, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |