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FDA Drug Application 021774 by SANOFI AVENTIS US

Application Number021774
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/2/2005N12751000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021774lbl.pdf 9/8/2005
AP09/2/2005N12752000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021774ltr.pdf 9/8/2005
AP09/2/2005N14248000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021774s000_AmbienTOC.cfm 6/7/2006
AP09/2/2005N16044000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP09/2/2005N23881000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085908.pdf 11/16/2009
AP012/20/2007SE118759003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf 1/9/2008
AP012/20/2007SE118717003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf 1/8/2008
AP012/20/2007SE118718004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf 1/8/2008
AP012/20/2007SE118760004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf 1/9/2008
AP012/20/2007SE118761005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf 1/9/2008
AP012/20/2007SE118719005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf 1/8/2008
AP012/20/2007SE118720007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf 1/8/2008
AP012/20/2007SE118762007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf 1/9/2008
AP012/20/2007SE118763008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf 1/9/2008
AP012/20/2007SE118721008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf 1/8/2008
AP04/14/2010SLR25284010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021774s010ltr.pdf 4/19/2010
AP04/14/2010SLR25291010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf 4/19/2010
AP04/19/2013SLR35794013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf 4/23/2013
AP04/19/2013SLR37260013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf 9/30/2013
AP04/19/2013SLR35828013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf 4/24/2013
AP04/19/2013SLR35829015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf 4/24/2013
AP04/19/2013SLR37261015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf 9/30/2013
AP04/19/2013SLR35795015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf 4/23/2013
AP010/7/2014SLR40737016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019908Orig1s035,021774Orig1s016ltr.pdf 10/9/2014
AP010/7/2014SLR40744016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf 10/9/2014
AP08/11/2016SLR46770017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021774Orig1s017,019908Orig1s036ltr.pdf 8/12/2016
AP08/11/2016SLR46772017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf 8/12/2016




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