Application 125151

Type: BLA
Sponsor: SHIRE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125151	Elaprase	idursulfase	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELAPRASE	IDURSULFASE	INJECTABLE; IV (INFUSION)	6MG/3ML	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ELAPRASE	IDURSULFASE	Takeda Pharmaceuticals America, Inc.	60cba843-5aab-4dd7-96dc-66648d413be3	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125151 ndc (product): 54092-700

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-700	ELAPRASE	idursulfase	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-700	ELAPRASE	idursulfase	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-700	ELAPRASE	idursulfase	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-700	ELAPRASE	idursulfase	Shire US Manufacturing Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56694	SUPPL	2018-12-07
56510	SUPPL	2018-11-20
31848	SUPPL	2013-06-26
9627	SUPPL	2013-06-26
39862	SUPPL	2013-06-24
18804	SUPPL	2013-06-24
39861	SUPPL	2007-11-13
9626	SUPPL	2007-11-08
9625	ORIG	2006-10-05
43305	ORIG	2006-09-26