Home Applications 761083 Application 761083
Type BLA
Sponsor GENENTECH INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761083 Hemlibra emicizumab-kxwh 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 30MG/ML Yes No 002 HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 60MG/0.4ML Yes No 003 HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 105MG/0.7ML Yes No 004 HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 150MG 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 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-920 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-921 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-922 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current 50242-923 Hemlibra emicizumab Genentech, Inc. BLA Current