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Unituxin

dinutuximab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Unituxin

Proper name

dinutuximab

Licence type

351(a)

BLA number

125516

Applicant

United Therapeutics Corporation

Center

CDER

Presentations

1

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
17.5MG/5ML (3.5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 10, 2015

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 10, 2022

Sources for this page

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