Home Applications 761289 Application 761289
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 761289 Imjudo tremelimumab-actl 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS 25MG/1.25ML(20MG/ML) No No 002 IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS 300MG/15ML(20MG/ML) No 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-4505 IMJUDO tremelimumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4505 IMJUDO tremelimumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4505 IMJUDO tremelimumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4535 IMJUDO tremelimumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4535 IMJUDO tremelimumab AstraZeneca Pharmaceuticals LP BLA Current 0310-4535 IMJUDO tremelimumab AstraZeneca Pharmaceuticals LP BLA Current