Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125058
Company: BIOMARIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDURAZYME LARONIDASE 2.9MG/ML VIAL Prescription None No No
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://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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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