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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021492
Company: SANOFI AVENTIS US

Other Important Information from FDA

Products on NDA 021492

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELOXATIN	OXALIPLATIN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
ELOXATIN	OXALIPLATIN	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021492

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2002	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21492lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21492ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-492_Eloxatin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021492s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021492Orig1s016ltr.pdf
10/01/2015	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021492s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021492Orig1s014ltr.pdf
10/12/2012	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021492s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021492Orig1s013ltr.pdf
12/28/2011	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021492s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf
03/13/2009	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf
05/21/2008	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf
01/10/2007	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021492s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021492s008_ltr.pdf
03/09/2006	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf
11/04/2004	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492s004,005ltr.pdf
11/04/2004	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492s004,005ltr.pdf
01/09/2004	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21492se1-002_eloxatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492se1-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021492_s002_EloxatinTOC.cfm
01/14/2003	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21492slr001ltr.pdf

Labels for NDA 021492

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021492s016lbl.pdf
10/01/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021492s014lbl.pdf
10/12/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021492s013lbl.pdf
12/28/2011	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021492s012lbl.pdf
03/13/2009	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf
01/10/2007	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021492s008lbl.pdf
03/09/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf
11/04/2004	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf
11/04/2004	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf
01/09/2004	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21492se1-002_eloxatin_lbl.pdf
08/09/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21492lbl.pdf

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