Home Applications 761069 Application 761069
Type BLA
Sponsor ASTRAZENECA UK LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761069 Imfinzi durvalumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMFINZI DURVALUMAB INJECTABLE;INJECTION 50MG/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 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4500 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4611 IMFINZI Durvalumab AstraZeneca Pharmaceuticals LP BLA Current