Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021492
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
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ELOXATIN | OXALIPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
ELOXATIN | OXALIPLATIN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
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 |
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 |