Home Applications 125476 Application 125476
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 125476 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;INJECTION 300MG 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 · 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: BLA125476 ndc (product): 64764-300
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current 64764-300 Entyvio vedolizumab Takeda Pharmaceuticals America, Inc. BLA Current