Home Applications 761036 Application 761036
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 761036 Darzalex daratumumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DARZALEX DARATUMUMAB INJECTABLE;INJECTION 100MG/5ML Yes No 002 DARZALEX DARATUMUMAB INJECTABLE;INJECTION 400MG/20ML Yes 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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-502 DARZALEX Daratumumab Janssen Biotech, Inc. BLA Current 57894-505 Darzalex IV Daratumumab Janssen Biotech, Inc. BLA Current 57894-505 Darzalex IV Daratumumab Janssen Biotech, Inc. BLA Current 57894-505 Darzalex IV Daratumumab Janssen Biotech, Inc. BLA Current 57894-505 Darzalex IV Daratumumab Janssen Biotech, Inc. BLA Current 57894-505 Darzalex IV Daratumumab Janssen Biotech, Inc. BLA Current