Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125291
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUMIZYME ALGLUCOSIDASE ALFA 5MG/ML POWDER; IV (INFUSION) 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
05/24/2010 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125291s000ltrR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2014 SUPPL-136 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s136ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125291Orig1s136.pdf
05/22/2014 SUPPL-133 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s133ltr.pdf
07/16/2012 SUPPL-79 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Origs0079ltr.pdf
07/09/2012 SUPPL-63 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125291s0063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Orig1s0063ltr.pdf
09/12/2011 SUPPL-43 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2014 SUPPL-136 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s136lbl.pdf
05/22/2014 SUPPL-133 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf
07/09/2012 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125291s0063lbl.pdf
05/24/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf

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