Home Applications 125433 Application 125433
Type BLA
Sponsor JANSSEN BIOTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125433 Simponi Aria golimumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SIMPONI ARIA GOLIMUMAB INJECTABLE; INJECTION 50MG/4ML 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-350 SIMPONI ARIA golimumab Janssen Biotech, Inc. BLA Current 57894-350 SIMPONI ARIA golimumab Janssen Biotech, Inc. BLA Current 57894-350 SIMPONI ARIA golimumab Janssen Biotech, Inc. BLA Current 57894-350 SIMPONI ARIA golimumab Janssen Biotech, Inc. BLA Current 57894-350 SIMPONI ARIA golimumab Janssen Biotech, Inc. BLA Current