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 2026-07-01
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# 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 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