Skip to content

On this page

Imfinzi

durvalumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Imfinzi

Proper name

durvalumab

Licence type

351(a)

BLA number

761069

Applicant

AstraZeneca UK Ltd

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
120MG/2.4ML (50MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	May 1, 2017
500MG/10ML (50MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	May 1, 2017

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 4, 1931

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity