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FDA Drug Application 020164 by SANOFI AVENTIS US

Application Number020164
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
AP03/29/1993N7714000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-164ltr.pdf 2/25/2004
AP03/29/1993N8196000   http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-164_lbl.pdf 4/5/2004
AP03/29/1993N9747000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-164_review.pdf 7/15/2004
AP03/29/1993N37718000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm373741.htm 11/7/2013
AP03/14/1994SLR       
AP03/9/1995SE1       
AP03/15/1996SCM20573004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S004_LOVENOX_INJECTION.pdf 8/11/2008
AP01/30/1996SLR20572005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S005_LOVENOX INJ.pdf 8/11/2008
AP05/27/1997SLR       
AP03/7/1997SCP       
AP05/6/1997SE1       
AP06/26/1996SCP20571009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S009_LOVENOX INJ.pdf 8/11/2008
AP01/30/1998SE19184010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox_approv.pdf 6/8/2004
AP01/30/1998SE15510010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox.cfm 4/29/2003
AP02/24/1998SCS20546011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020164_S011_LOVENOX.pdf 8/8/2008
AP010/23/1996SCM20570012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S012_LOVENOX_INJECTION.pdf 8/11/2008
AP05/16/1997SCM20560013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020164_S013_LOVENOX_INJECTION.pdf 8/11/2008
AP01/27/1997SLR       
AP012/31/1998SE1377015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S15_Lovenox.cfm 7/3/2000
AP012/31/1998SE1378015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20164s15ltr.pdf 12/31/1998
AP012/31/1998SE1379015   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20164s15lbl.pdf 12/31/1998
AP03/27/1998SE1       
AP05/27/1997SLR       
AP03/3/1999SCP20531019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S019_LOVENOX.pdf 8/8/2008
AP08/3/2000SE82758020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S20LTR.PDF 8/4/2000
AP04/20/1999SLR20530021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S021_LOVENOX.pdf 8/8/2008
AP07/21/1999SCS20529022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S022_LOVENOX.pdf 8/8/2008
AP011/8/1999SCM20528023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S023_LOVENOX_INJECTION.pdf 8/8/2008
AP07/22/1999SCS20527024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S024_LOVENOX.pdf 8/8/2008
AP09/14/1999SCS20526026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S026_LOVENOX.pdf 8/8/2008
AP010/5/1999SCS       
AP09/28/1999SLR       
AP06/2/2000SCF20489030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S030_LOVENOX_INJECTION.pdf 8/4/2008
AP010/5/1999SLR       
AP01/27/2000SCM20488032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S032_LOVENOX_INJECTION.pdf 8/4/2008
AP05/30/2000SE82757034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S34ltr.pdf 9/27/2000
AP04/4/2000SCP       
AP011/17/2000SE11479036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf 11/17/2000
AP011/17/2000SE11480036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf 11/17/2000
AP011/17/2000SLR1538037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf 11/17/2000
AP011/17/2000SLR1539037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf 11/17/2000
AP06/20/2000SCM20487038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S038_LOVENOX_INJECTION.pdf 8/4/2008
AP010/24/2000SCS20486039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S039_LOVENOX_INJECTION.pdf 8/4/2008
AP01/9/2002SLR20452040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf 8/4/2008
AP01/9/2002SLR2754040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf 1/9/2002
AP012/14/2000SCM20485041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S041_LOVENOX_INJECTION.pdf 8/4/2008
AP07/5/2001SCM20468042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020164_S042_LOVENOX_INJECTION.pdf 8/4/2008
AP01/23/2003SCM20431043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S043_LOVENOX_INJECTION.pdf 8/1/2008
AP01/23/2003SCM4767043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164scm043ltr.pdf 1/23/2003
AP011/30/2001SCS20466044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020164_S044_LOVENOX INJ.pdf 8/4/2008
AP01/9/2002SLR20453045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf 8/4/2008
AP01/9/2002SLR2755045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf 1/9/2002
AP01/9/2002SLR2756046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf 1/9/2002
AP01/9/2002SLR20454046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf 8/4/2008
AP012/18/2003SLR7346048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr048ltr.pdf 12/23/2003
AP07/1/2003SLR6094050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr050ltr.pdf 7/8/2003
AP07/1/2003SLR20430050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S050_LOVENOX INJ.pdf 8/1/2008
AP06/20/2003SLR20429051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S051_LOVENOX INJ.pdf 8/1/2008
AP06/20/2003SLR6045051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr051ltr.pdf 7/6/2003
AP010/20/2004SCM10461053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164s053ltr.pdf 10/26/2004
AP07/23/2004SCS9858055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164s055ltr.pdf 7/28/2004
AP07/23/2004SCS9874055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20164s055lbl.pdf 7/28/2004
AP07/23/2004SCS15276055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S055_Lovenox_Approval_Package.pdf 10/26/2006
AP04/13/2004SLR8373056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr056ltr.pdf 4/20/2004
AP04/13/2004SLR20421056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S056_LOVENOX INJ.pdf 8/1/2008
AP05/18/2004SLR17153057   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S057_LOVENOX INJECION_AP.pdf 7/9/2007
AP05/18/2004SLR8659057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr057ltr.pdf 5/26/2004
AP04/21/2004SLR17152058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S058_LOVENOX INJECTION_AP.pdf 7/9/2007
AP04/21/2004SLR8440058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr058ltr.pdf 4/29/2004
AP03/7/2005SLR11224063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20164s063ltr.pdf 3/10/2005
AP01/12/2007SCP15657070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020164s070lbl.pdf 1/16/2007
AP01/12/2007SCP15663070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020164s070ltr.pdf 1/16/2007
AP05/16/2007SLR16618075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022138s000,020164s075ltr.pdf 5/29/2007
AP05/16/2007SLR16626075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022138,020164s075lbl.pdf 5/29/2007
AP05/16/2007SLR22082075   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022138_020164_lovenox_enoxaparin_sodium_toc.cfm 3/24/2009
AP012/10/2012SCM       
AP07/16/2008SLR20258080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020164s080ltr.pdf 7/18/2008
AP07/16/2008SLR20266080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020164s080lbl.pdf 7/22/2008
AP07/23/2009SLR23091083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s083lbl.pdf 7/30/2009
AP07/23/2009SLR23100083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020164s083ltr.pdf 7/31/2009
AP012/23/2009SLR24373085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s085lbl.pdf 12/30/2009
AP012/23/2009SLR24380085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020164s085ltr.pdf 12/31/2009
AP012/6/2012SCM       
AP04/13/2011SLR28544092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s092ltr.pdf 4/15/2011
AP04/13/2011SLR28580092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s092lbl.pdf 4/19/2011
AP04/20/2011SLR28594093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s093lbl.pdf 4/21/2011
AP04/20/2011SLR28597093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s093ltr.pdf 4/22/2011
AP09/6/2013SCM       
AP011/28/2012SCM       
AP06/5/2013SLR36241100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s100ltr.pdf 6/7/2013
AP06/5/2013SLR36272100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s100lbl.pdf 6/11/2013
AP010/23/2013SLR37560102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s102ltr.pdf 10/25/2013
AP010/23/2013SLR37631102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s102lbl.pdf 10/31/2013
AP09/27/2013SCM       
AP05/29/2014SCM       
AP08/3/2015SCM       
AP08/24/2015SCM       




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