Home Applications 761406 Application 761406
Type BLA
Sponsor BIOCON BIOLOGICS INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761406 Yesintek ustekinumab-kfce 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YESINTEK USTEKINUMAB-KFCE INJECTABLE;INJECTION 45MG/0.5ML No No 002 YESINTEK USTEKINUMAB-KFCE INJECTABLE;INJECTION 90MG/ML 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 YESINTEK USTEKINUMAB Biocon Biologics Inc. 12a75613-ee33-d30a-215b-2a51cfa19b00 2026-03-17 Warnings, Adverse reactions Exact identifier application number: BLA761406
Documents# Document, Submission type, Date table Document Submission type Date 84720 SUPPL 2026-01-08 84719 SUPPL 2026-01-08 84717 ORIG 2026-01-08 82719 ORIG 2025-06-30 82718 ORIG 2025-06-30 82137 ORIG 2025-05-05 82275 ORIG 2025-04-30 80468 ORIG 2024-12-02 80454 ORIG 2024-11-29