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FDA Drug Application 021144 by SANOFI AVENTIS US

Application Number021144
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/1/2004N8235000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf 4/5/2004
AP04/1/2004N8301000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21144ltr.pdf 4/7/2004
AP04/1/2004N9725000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-144_Ketek.cfm 7/8/2004
AP04/1/2004N9731000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107824.htm 7/13/2004
AP04/1/2004N24002000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088615.pdf 11/19/2009
AP02/9/2005SE811098001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf 2/11/2005
AP02/9/2005SE811107001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf 2/11/2005
AP02/3/2005SLR11099003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf 2/11/2005
AP02/3/2005SLR11108003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf 2/11/2005
AP011/2/2005SLR13021004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021144s004lbl.pdf 11/3/2005
AP011/2/2005SLR13035004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021144s004ltr.pdf 11/8/2005
AP04/8/2005SCS11369005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s005ltr.pdf 4/12/2005
AP06/29/2006SLR14391011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf 7/3/2006
AP06/29/2006SLR14402011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021144s011ltr.pdf 7/3/2006
AP02/12/2007SLR15777012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf 2/12/2007
AP02/12/2007SLR15878012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021144s012ltr.pdf 2/23/2007
AP02/12/2007SLR31785012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021144Orig1s012Approv.pdf 2/14/2012
AP012/8/2010SLR27257013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s013lbl.pdf 12/8/2010
AP012/8/2010SLR27262013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf 12/10/2010
AP012/8/2010SLR27258014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf 12/9/2010
AP012/8/2010SLR27263014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf 12/10/2010
AP06/20/2011SLR29355015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021144s015ltr.pdf 6/29/2011
AP07/11/2013SCM       
AP02/26/2014SCM       
AP03/9/2015SLR42305018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s018ltr.pdf 3/27/2015
AP03/9/2015SLR42306018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s018lbl.pdf 3/27/2015
AP011/4/2015SLR44425019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s019ltr.pdf 11/9/2015
AP011/4/2015SLR44438019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf 11/12/2015




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