FDA BLA · BLA125151

ELAPRASE

idursulfase

Sponsor: SHIRE

APPLICATION

BLA125151

TYPE

BLA

ORIGINAL APPROVAL

2006-07-24

LATEST ACTION

2018-11-16

ROUTE

INTRAVENOUS, IV (INFUSION)

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

ELAPRASEPrescription

IDURSULFASE 6MG/3ML · INJECTABLE · IV (INFUSION)

2018-11-16Labeling · Supplement 197 · standard — Label ↗AP

2013-06-24Efficacy · Supplement 184 · priority — Label ↗AP

2013-06-24Efficacy · Supplement 152 · standard — Label ↗AP

2011-03-08Labeling · Supplement 151 · standardAP

2010-11-29Labeling · Supplement 140 · standardAP

2007-10-24Labeling · Supplement 32 · standard — Label ↗AP

2006-07-24Type 1 - New Molecular Entity · Original · priority — Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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