Home Applications 761210 Application 761210
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 761210 Rybrevant amivantamab-vmjw 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RYBREVANT AMIVANTAMAB-VMJW INJECTABLE;INJECTION 350MG/7ML(50MG/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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-501 Rybrevant Amivantamab Janssen Biotech, Inc. BLA Current 57894-501 Rybrevant Amivantamab Janssen Biotech, Inc. BLA Current 57894-501 Rybrevant Amivantamab Janssen Biotech, Inc. BLA Current 57894-501 Rybrevant Amivantamab Janssen Biotech, Inc. BLA Current 57894-501 Rybrevant Amivantamab Janssen Biotech, Inc. BLA Current