Home Applications 103976 Application 103976
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103976 Xolair omalizumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XOLAIR OMALIZUMAB VIAL 150MG/VIAL No No 002 XOLAIR OMALIZUMAB SYRINGE 75MG/0.5ML No No 003 XOLAIR OMALIZUMAB SYRINGE 150MG/ML No No 004 XOLAIR OMALIZUMAB SYRINGE 300MG/2ML 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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-040 XOLAIR omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-214 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current 50242-215 Xolair PFS omalizumab Genentech, Inc. BLA Current