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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125151
Company: SHIRE

Products on BLA 125151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELAPRASE	IDURSULFASE	6MG/3ML	INJECTABLE; IV (INFUSION)	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2006	ORIG-1	Approval		N/A; Orphan	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125151s0000_Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125151s0000_ElapraseTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2018	SUPPL-197	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125151s197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125151Orig1s197ltr.pdf
06/24/2013	SUPPL-184	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184ltr.pdf
06/24/2013	SUPPL-152	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0152lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184ltr.pdf
03/08/2011	SUPPL-151	Supplement		Label is not available on this site.
11/29/2010	SUPPL-140	Supplement		Label is not available on this site.
10/24/2007	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125151s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125151s032ltr.pdf

Labels for BLA 125151

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2018	SUPPL-197	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125151s197lbl.pdf
11/16/2018	SUPPL-197	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125151s197lbl.pdf
06/24/2013	SUPPL-184	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0184lbl.pdf
06/24/2013	SUPPL-152	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0152lbl.pdf
10/24/2007	SUPPL-32	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125151s032lbl.pdf

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