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FDA Drug Application 201023 by SANOFI AVENTIS US

Application Number201023
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
AP06/17/2010N25755000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf 6/17/2010
AP06/17/2010N25761000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201023s000ltr.pdf 6/21/2010
AP06/17/2010N26045000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000TOC.cfm 7/30/2010
AP06/17/2010N26046000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000SumR.pdf 7/30/2010
AP010/4/2012SLR33984003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201023s003lbl.pdf 10/5/2012
AP010/4/2012SLR33995003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201023Orig1s003ltr.pdf 10/9/2012
AP04/25/2013SLR35882007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201023Orig1s007ltr.pdf 4/30/2013
AP03/13/2013SCM       
AP09/11/2013SCM       
AP03/14/2014SLR       
AP011/19/2014SLR41063011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201023s011lbl.pdf 11/20/2014
AP011/19/2014SLR41064011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201023Orig1s011ltr.pdf 11/21/2014
AP03/14/2014SLR       
AP01/5/2015SCM       
AP06/11/2015SCM       
AP06/18/2015SLR43083015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201023s015lbl.pdf 6/19/2015
AP06/18/2015SLR43088015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201023Orig1s015ltr.pdf 6/22/2015
AP05/27/2016SCM       
AP09/12/2016SLR47047017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201023Orig1s017ltr.pdf 9/15/2016
AP09/12/2016SLR47065017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201023s017lbl.pdf 9/15/2016




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