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Voraxaze

glucarpidase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Voraxaze

Proper name

glucarpidase

Licence type

351(a)

BLA number

125327

Applicant

BTG International Inc.

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
1,000UNITS	For Injection	Intravenous	Single-Dose Vial	Rx	January 17, 2012

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 17, 2019

Sources for this page

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