Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103946
Company: SANOFI SYNTHELABO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELITEK RASBURICASE 1.5MG/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
07/12/2002 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/rasbsan071202LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/rasbsan071202L.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080525.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2017 SUPPL-5101 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103946s5101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103946Orig1s5101ltr.pdf
06/13/2016 SUPPL-5097 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103946s5097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103946Orig1s5097ltr.pdf
05/22/2015 SUPPL-5095 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103946s5095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5095ltr.pdf
02/03/2015 SUPPL-5094 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5094ltr.pdf
10/16/2009 SUPPL-5083 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103946s5083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103946s5083ltr.pdf
09/10/2007 SUPPL-5049 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103946s5049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103946s5049ltr.pdf
02/28/2007 SUPPL-5047 Supplement

Label is not available on this site.

09/10/2007 SUPPL-5039 Supplement

Label is not available on this site.

12/15/2004 SUPPL-5017 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103946_5017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103946_5017ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2017 SUPPL-5101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103946s5101lbl.pdf
06/13/2016 SUPPL-5097 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103946s5097lbl.pdf
05/22/2015 SUPPL-5095 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103946s5095lbl.pdf
10/16/2009 SUPPL-5083 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103946s5083lbl.pdf
09/10/2007 SUPPL-5049 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103946s5049lbl.pdf
12/15/2004 SUPPL-5017 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103946_5017lbl.pdf
07/12/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/rasbsan071202LB.pdf

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