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FDA Drug Application 019908 by SANOFI AVENTIS US

Application Number019908
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
AP012/16/1992N11980000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S000_AmbienTOC.cfm 7/13/2005
AP012/16/1992N16043000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP07/14/1995SLR       
AP07/14/1995SLR17137002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S002_AMBIEN_AP.pdf 7/9/2007
AP01/9/1995SCP       
AP010/4/1995SCS       
AP04/18/1996SCM       
AP012/1/1999SLR       
AP04/13/2001SCM       
AP05/4/2001SCM       
AP011/15/2001SCM       
AP01/15/2002SCM       
AP05/21/2002SCM       
AP09/25/2002SCM       
AP010/4/2007SLR       
AP03/28/2007SE516127022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf 3/31/2007
AP03/28/2007SE516180022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s022ltr.pdf 4/9/2007
AP010/4/2007SLR18251025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s025_Medication Guidel.pdf 10/22/2007
AP010/4/2007SLR18269025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s025_LTR_rev2_cd_revised.pdf 10/22/2007
AP05/7/2008SLR19794027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019908s024, s027ltr.pdf 5/9/2008
AP05/7/2008SLR19891027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf 5/28/2008
AP05/7/2008SLR19892027   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085906.pdf 5/28/2008
AP04/14/2010SLR25288029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019908s029ltr.pdf 4/19/2010
AP04/14/2010SLR25290029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf 4/19/2010
AP04/19/2013SLR35796032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf 4/23/2013
AP04/19/2013SLR35826032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf 4/24/2013
AP04/19/2013SLR37259032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf 9/30/2013
AP06/5/2013SCM       
AP04/19/2013SLR35797034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf 4/23/2013
AP04/19/2013SLR35827034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf 4/24/2013
AP04/19/2013SLR37258034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf 9/30/2013
AP010/7/2014SLR40736035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019908Orig1s035,021774Orig1s016ltr.pdf 10/9/2014
AP010/7/2014SLR40745035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf 10/9/2014
AP08/11/2016SLR46769036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021774Orig1s017,019908Orig1s036ltr.pdf 8/12/2016
AP08/11/2016SLR46773036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf 8/12/2016




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