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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103946
Company: SANOFI SYNTHELABO

Products on BLA 103946

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103946

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://web.archive.org/web/20120303004138/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
12/12/2019	SUPPL-5103	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103946s5103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103946Orig1s5103ltr.pdf
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

Labels for BLA 103946

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2019	SUPPL-5103	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103946s5103lbl.pdf
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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