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FDA Drug Application 020449 by SANOFI AVENTIS US

Application Number020449
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
AP05/14/1996N       
AP04/28/1997SCS       
AP011/22/1999SCF       
AP05/15/1998SCM       
AP01/6/1998SLR675004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20449S004_Taxotere.pdf 7/11/2000
AP06/22/1998SE7721005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf 6/22/1998
AP06/22/1998SLR843006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf 6/22/1998
AP02/23/1999SCM       
AP012/6/1999SCS       
AP05/18/1999SCS       
AP03/31/1999SCM       
AP012/23/1999SE11341011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20449S11LTR.PDF 12/23/1999
AP012/23/1999SE11342011   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20449S11LBL.PDF 12/23/1999
AP012/23/1999SE13380011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20449-S011_Taxotere.cfm 7/5/2001
AP09/28/2000SCM       
AP09/28/2000SCS       
AP011/30/2000SCM       
AP04/24/2003SLR5508016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020449s016lbl.pdf 4/28/2003
AP04/24/2003SLR5726016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr016ltr.pdf 5/29/2003
AP07/9/2002SLR9443017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf 6/18/2004
AP07/9/2002SLR3374017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf 1/30/2003
AP011/27/2002SE13377018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20449se1-018ltr.pdf 11/27/2002
AP011/27/2002SE13379018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf 11/27/2002
AP011/27/2002SE16111018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-449s018_Taxotere.cfm 7/8/2003
AP07/30/2002SLR9444019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf 6/18/2004
AP07/30/2002SLR3375019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf 1/30/2003
AP01/3/2003SLR3921022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf 1/30/2003
AP01/3/2003SLR3922022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf 1/30/2003
AP05/19/2004SE18569028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf 5/19/2004
AP05/19/2004SE18658028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449se1-028ltr.pdf 5/26/2004
AP05/19/2004SE111421028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s028_Taxotere.cfm 4/15/2005
AP08/18/2004SE111453029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s029_Taxotere.cfm 4/27/2005
AP08/18/2004SE110023029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s029lbl.pdf 8/19/2004
AP08/18/2004SE110051029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449s029ltr.pdf 8/25/2004
AP01/6/2005SLR10928031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20449s031ltr.pdf 1/11/2005
AP08/11/2005SLR12595033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s033ltr.pdf 8/15/2005
AP08/11/2005SLR12598033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020449s033lbl.pdf 8/15/2005
AP011/5/2005SLR13095034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s034ltr.pdf 11/18/2005
AP03/22/2006SE113859035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449S035ltr.pdf 4/5/2006
AP03/22/2006SE113865035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf 4/5/2006
AP03/22/2006SE139758035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449Orig1s035.pdf 7/7/2014
AP06/7/2006SLR14250036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s036LTR.pdf 6/8/2006
AP06/7/2006SLR14253036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036PI.pdf 6/8/2006
AP06/7/2006SLR14254036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036lbl.pdf 6/8/2006
AP010/17/2006SE115128039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf 10/18/2006
AP010/17/2006SE115183039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s039ltr.pdf 10/23/2006
AP010/17/2006SE130056039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449s039.pdf 9/22/2011
AP06/3/2010SLR39759043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s043.pdf 7/7/2014
AP06/3/2010SLR25719043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s043ltr.pdf 6/8/2010
AP04/20/2010SLR25340044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf 4/23/2010
AP04/20/2010SLR25404044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf 5/3/2010
AP09/28/2007SE118133045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020449s045ltr.pdf 10/4/2007
AP09/28/2007SE118165045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf 10/4/2007
AP04/20/2010SLR25405053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf 5/3/2010
AP04/20/2010SLR25341053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf 4/23/2010
AP08/2/2010SCM34085054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s054.pdf 10/15/2012
AP05/13/2010SE525561059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf 5/17/2010
AP05/13/2010SE525579059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s059ltr.pdf 5/18/2010
AP04/13/2012SCM42517063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf 4/14/2015
AP09/7/2011SLR29977064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s064ltr.pdf 9/12/2011
AP09/7/2011SLR30026064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf 9/16/2011
AP012/15/2011SLR31087065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s065lbl.pdf 12/20/2011
AP012/15/2011SLR31106065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s065ltr.pdf 12/20/2011
AP011/21/2012SCM       
AP06/26/2013SLR36393069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s069ltr.pdf 6/27/2013
AP06/26/2013SLR36504069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf 7/8/2013
AP08/15/2013SCM       
AP012/13/2013SLR38047071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s071ltr.pdf 12/16/2013
AP012/13/2013SLR38089071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf 12/17/2013
AP05/15/2014SCM       
AP011/14/2014SLR41001073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020449Orig1s073ltr.pdf 11/17/2014
AP011/14/2014SLR41049073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf 11/20/2014
AP05/17/2016SCM       
AP012/11/2015SLR44766075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020449Orig1s075ltr.pdf 12/15/2015
AP012/11/2015SLR44767075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf 12/15/2015
AP012/11/2015SLR46643075   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020449Orig1s075.pdf 7/27/2016




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