Home Applications 761061 Application 761061
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 761061 Tremfya guselkumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TREMFYA GUSELKUMAB INJECTABLE;INJECTION 100MG/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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-640 Tremfya Guselkumab Janssen Biotech, Inc. BLA Current 57894-640 Tremfya Guselkumab Janssen Biotech, Inc. BLA Current 57894-640 Tremfya Guselkumab Janssen Biotech, Inc. BLA Current 57894-640 Tremfya Guselkumab Janssen Biotech, Inc. BLA Current 57894-640 Tremfya Guselkumab Janssen Biotech, Inc. BLA Current 57894-640 Tremfya Guselkumab Janssen Biotech, Inc. BLA Current