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FDA Drug Application 020905 by SANOFI AVENTIS US

Application Number020905
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
AP09/10/1998N552000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20905ltr.pdf 9/10/1998
AP09/10/1998N553000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20905_arava.cfm 9/10/1998
AP09/10/1998N554000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20905lbl.pdf 9/10/1998
AP012/11/1998SCM       
AP07/20/1999SCP       
AP02/23/2000SLR       
AP02/23/2000SLR       
AP09/21/2000SCS       
AP06/13/2003SE15966006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-006ltr.pdf 6/22/2003
AP06/13/2003SE15995006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf 6/22/2003
AP06/13/2003SE118514006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S006_ARAVA.pdf 11/19/2007
AP06/13/2003SLR5994007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf 6/22/2003
AP06/13/2003SLR18513007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020905_S007_ARAVA.pdf 11/19/2007
AP06/13/2003SLR5965007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20905slr007,20905se1-006ltr.pdf 6/22/2003
AP03/5/2004SE520368012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020905_S012_ARAVA.pdf 7/31/2008
AP03/5/2004SE57851012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905se5-012ltr.pdf 3/10/2004
AP03/5/2004SE58242012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905se5-012_Arava_lbl.pdf 4/5/2004
AP011/22/2004SLR10684014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20905s014ltr.pdf 12/2/2004
AP011/22/2004SLR10711014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20905s014lbl.pdf 12/3/2004
AP010/19/2005SLR12973015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020905s015lbl.pdf 10/25/2005
AP010/19/2005SLR12974015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020905s015ltr.pdf 10/25/2005
AP011/8/2007SLR18413016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020905s016lbl.pdf 11/13/2007
AP011/8/2007SLR18457016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020905s016ltr.pdf 11/19/2007
AP04/3/2009SLR22219018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020905s018ltr.pdf 4/7/2009
AP09/9/2010SLR26441020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020905s020lbl.pdf 9/10/2010
AP09/9/2010SLR26480020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020905s020ltr.pdf 9/13/2010
AP07/8/2011SLR29474022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020905s022ltr.pdf 7/12/2011
AP07/8/2011SLR29490022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020905s022lbl.pdf 7/12/2011
AP011/2/2012SLR34272025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020905Orig1s025ltr.pdf 11/6/2012
AP011/2/2012SLR34293025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020905s025lbl.pdf 11/6/2012
AP04/29/2015SCM       
AP08/28/2015SLR43771027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020905Orig1s027ltr.pdf 9/1/2015
AP08/28/2015SLR43786027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020905s027lbl.pdf 9/3/2015
AP011/14/2014SLR41014028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020905Orig1s028ltr.pdf 11/18/2014
AP010/18/2016SLR47397031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020905s031lbl.pdf 10/19/2016
AP010/18/2016SLR47406031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020905Orig1s031ltr.pdf 10/20/2016




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