Home Applications 761070 Application 761070
Type BLA
Sponsor ASTRAZENECA AB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761070 Fasenra benralizumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FASENRA BENRALIZUMAB INJECTABLE;INJECTION 30MG/ML Yes No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1730 FASENRA Benralizumab AstraZeneca Pharmaceutica BLA Current 0310-1830 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1830 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1830 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1830 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1830 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current 0310-1830 FASENRA Benralizumab AstraZeneca Pharmaceuticals LP BLA Current