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Elaprase

idursulfase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Elaprase

Proper name

idursulfase

Licence type

351(a)

BLA number

125151

Applicant

Takeda Pharmaceuticals U.S.A., 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
6MG/3ML (2MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	July 24, 2006

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	July 24, 2013

Sources for this page

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