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Xiaflex

collagenase clostridium histolyticum

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Xiaflex

Proper name

collagenase clostridium histolyticum

Licence type

351(a)

BLA number

125338

Applicant

Auxilium Pharmaceuticals, Inc.

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.9MG	For Injection	Intralesional	Single-Dose Vial	Rx	February 2, 2010

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 6, 2020

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