Home Applications 761133 Application 761133
Type BLA
Sponsor TAKEDA PHARMS USA Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761133 Entyvio vedolizumab 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENTYVIO VEDOLIZUMAB INJECTABLE;INTRAVENOUS 300MG No No 002 ENTYVIO VEDOLIZUMAB INJECTABLE;INJECTION 108MG/0.68ML No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENTYVIO VEDOLIZUMAB Takeda Pharmaceuticals America, Inc. 6e94621c-1a95-4af9-98d1-52b9e6f1949c 2026-04-29 Warnings, Adverse reactions Exact identifier application number: BLA761133
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 85200 SUPPL 2026-03-02 85172 SUPPL 2026-02-27 79399 ORIG 2024-08-15 78405 SUPPL 2024-05-06 78404 SUPPL 2024-05-06 78175 SUPPL 2024-04-19 78174 SUPPL 2024-04-19 77846 SUPPL 2024-03-15 77841 SUPPL 2024-03-15 77840 SUPPL 2024-03-15 77628 SUPPL 2024-02-26 77619 SUPPL 2024-02-26 77618 SUPPL 2024-02-26 75599 ORIG 2023-09-28 75586 ORIG 2023-09-28