Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103979
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FABRAZYME AGALSIDASE BETA 5MG/VIAL VIAL; INTRAVENOUS Prescription None No No
FABRAZYME AGALSIDASE BETA 35MG/VIAL VIAL; INTRAVENOUS 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
04/24/2003 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf https://web.archive.org/web/20170202073410/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm128159.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103979_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2018 SUPPL-5303 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103979Orig1s5303ltr.pdf
05/14/2010 SUPPL-5135 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf
12/17/2008 SUPPL-5107 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103979s5107ltr.pdf
09/29/2006 SUPPL-5066 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf
09/29/2006 SUPPL-5065 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf
09/29/2006 SUPPL-5058 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2018 SUPPL-5303 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf
12/18/2018 SUPPL-5303 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf
05/14/2010 SUPPL-5135 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf
12/17/2008 SUPPL-5107 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf
09/29/2006 SUPPL-5066 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf
09/29/2006 SUPPL-5065 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf
09/29/2006 SUPPL-5058 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf
04/24/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf

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