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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125058
Company: BIOMARIN

Products on BLA 125058

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALDURAZYME	LARONIDASE	2.9MG/ML	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2003	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/larobio043003LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/larobio043003L.htm https://web.archive.org/web/20170118085125/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080438.htm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2023	SUPPL-246	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125058s246lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125058Orig1s246ltr.pdf
12/04/2019	SUPPL-244	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125058s244lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125058Orig1s244ltr.pdf
04/03/2013	SUPPL-220	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125058Orig1s220ltr.pdf
07/13/2011	SUPPL-209	Supplement		Label is not available on this site.
05/14/2010	SUPPL-186	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125058s0186lbl.pdf
05/20/2009	SUPPL-161	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf
05/20/2009	SUPPL-160	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf
08/25/2009	SUPPL-158	Supplement		Label is not available on this site.
04/14/2008	SUPPL-154	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125058s154ltr.pdf

Labels for BLA 125058

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2023	SUPPL-246	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125058s246lbl.pdf
12/04/2019	SUPPL-244	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125058s244lbl.pdf
04/03/2013	SUPPL-220	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf
05/14/2010	SUPPL-186	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125058s0186lbl.pdf
05/20/2009	SUPPL-161	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf
05/20/2009	SUPPL-160	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf
04/30/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/larobio043003LB.pdf

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