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	2026-09-01

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IMJUDO	TREMELIMUMAB	AstraZeneca Pharmaceuticals LP	6690679c-be2f-4588-a2e4-89fff74dd6be	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: BLA761289 ndc (product): 0310-4535 ndc (product): 0310-4505

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79205	SUPPL	2024-07-25
77321	SUPPL	2024-01-26
77307	SUPPL	2024-01-26
74494	SUPPL	2023-06-15
74492	SUPPL	2023-06-15
72565	ORIG	2022-11-04
72524	SUPPL	2022-11-01
72523	SUPPL	2022-11-01
72518	ORIG	2022-11-01
72514	ORIG	2022-10-31
72513	ORIG	2022-10-31
72512	SUPPL	2022-10-31
72455	ORIG	2022-10-24