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 2026-07-01
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# 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 · 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