Home Applications 761145 Application 761145
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 761145 Darzalex Faspro daratumumab and hyaluronidase-fihj 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DARZALEX FASPRO DARATUMUMAB;HYALURONIDASE-FIHJ INJECTABLE;INJECTION 120MG;2000UNITS/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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab, hyaluronidase (human recombinant), histidine, histidine monohydrochloride monohydrate, methionine, polysorbate 20, and sorbitol Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current 57894-503 Darzalex Faspro daratumumab and hyaluronidase-fihj (human recombinant) Janssen Biotech, Inc. BLA Current