Home Applications 125326 Application 125326
Type BLA
Sponsor GLAXO GRP LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125326 Arzerra ofatumumab 351(a) Disc 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARZERRA OFATUMUMAB INJECTABLE; INJECTION 100MG/5ML No No 002 KESIMPTA OFATUMUMAB INJECTABLE;INJECTION 20MG/0.4ML 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 0078-0669 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0669 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0669 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0669 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0669 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0690 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0690 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0690 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0690 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-0690 ARZERRA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-1007 KESIMPTA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-1007 KESIMPTA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-1007 KESIMPTA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-1007 KESIMPTA ofatumumab Novartis Pharmaceuticals Corporation BLA Current 0078-1007 KESIMPTA ofatumumab Novartis Pharmaceuticals Corporation BLA Current