Home Applications 125370 Application 125370
Type BLA
Sponsor HUMAN GENOME SCIENCES INC. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125370 Benlysta belimumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENLYSTA BELIMUMAB INJECTABLE; INJECTION 120MG No No 002 BENLYSTA BELIMUMAB INJECTABLE; INJECTION 400MG 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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab GlaxoSmithKline LLC BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-101 BENLYSTA belimumab GlaxoSmithKline LLC BLA Current 49401-101 BENLYSTA belimumab GlaxoSmithKline LLC BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab GlaxoSmithKline LLC BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab Human Genome Sciences, Inc. BLA Current 49401-102 BENLYSTA belimumab GlaxoSmithKline LLC BLA Current 49401-102 BENLYSTA belimumab GlaxoSmithKline LLC BLA Current