Home Applications 761122 Application 761122
Type BLA
Sponsor GLAXOSMITHKLINE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761122 Nucala mepolizumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUCALA MEPOLIZUMAB INJECTABLE;SUBCUTANEOUS 100MG/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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0892 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0904 Nucala mepolizumab GlaxoSmithKline LLC BLA Current 0173-0904 Nucala mepolizumab GlaxoSmithKline LLC BLA Current