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ELAPRASE

BLA · Biologics License Application · Sponsor: SHIRE · Approved 2006-07-24

Drug application

FDA Application #

BLA125151

Application type

Biologics License Application

Brand name

ELAPRASE

Generic name

IDURSULFASE

Active ingredients

IDURSULFASE

Dosage form

INJECTABLE

Route

IV (INFUSION)

Marketing status

Prescription

Sponsor

SHIRE

Manufacturer

Takeda Pharmaceuticals America, Inc.

First approval

2006-07-24

Source

Authoritative

Drugs@FDA application overview

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