FDA BLA · BLA761133

ENTYVIO

vedolizumab

Sponsor: TAKEDA PHARMS USA

APPLICATION

BLA761133

TYPE

BLA

ORIGINAL APPROVAL

2023-09-27

LATEST ACTION

2026-02-25

ROUTE

SUBCUTANEOUS, INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

ENTYVIOPrescription

VEDOLIZUMAB 300MG · INJECTABLE · INTRAVENOUS

ENTYVIOPrescription

VEDOLIZUMAB 108MG/0.68ML · INJECTABLE · INJECTION

2026-02-25Labeling · Supplement 14 · standard — Letter ↗AP

2024-04-18Labeling · Supplement 6 · standard — Letter ↗AP

2024-04-18Labeling · Supplement 5 · standard — Letter ↗AP

2024-03-14Labeling · Supplement 4 · standard — Label ↗AP

2024-02-23Labeling · Supplement 3 · standard — Label ↗AP

2023-09-27Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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