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FDA Drug Application 021492 by SANOFI AVENTIS US

Application Number021492
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/9/2002N1771000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21492ltr.pdf 8/9/2002
AP08/9/2002N1772000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21492lbl.pdf 8/9/2002
AP08/9/2002N1773000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-492_Eloxatin.cfm 8/9/2002
AP08/9/2002N5419000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113746.htm 4/22/2003
AP01/14/2003SLR8944001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21492slr001ltr.pdf 6/3/2004
AP01/9/2004SE17510002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492se1-002ltr.pdf 1/12/2004
AP01/9/2004SE17564002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21492se1-002_eloxatin_lbl.pdf 1/15/2004
AP01/9/2004SE113833002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021492_s002_EloxatinTOC.cfm 3/24/2006
AP011/4/2004SE110529004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf 11/5/2004
AP011/4/2004SE110552004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492s004,005ltr.pdf 11/8/2004
AP011/4/2004SE110565005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21492s004,005ltr.pdf 11/8/2004
AP011/4/2004SE110566005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021492s004lbl.pdf 11/5/2004
AP03/9/2006SLR13761006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf 3/14/2006
AP03/9/2006SLR13766006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf 3/14/2006
AP01/10/2007SE815654008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021492s008lbl.pdf 1/16/2007
AP01/10/2007SE815664008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021492s008_ltr.pdf 1/16/2007
AP05/21/2008SE819884010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf 5/28/2008
AP03/13/2009SLR22005011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf 3/17/2009
AP03/13/2009SLR22119011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf 3/26/2009
AP012/28/2011SLR31308012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021492s012lbl.pdf 12/28/2011
AP012/28/2011SLR31321012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf 1/3/2012
AP010/12/2012SLR34100013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021492s013lbl.pdf 10/15/2012
AP010/12/2012SLR34109013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021492Orig1s013ltr.pdf 10/16/2012
AP010/1/2015SLR44119014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021492s014lbl.pdf 10/6/2015
AP010/1/2015SLR44126014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021492Orig1s014ltr.pdf 10/6/2015




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