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FDA Drug Application 022292 by BOEHRINGER INGELHEIM

Application Number022292
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/2008N20087000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf 6/26/2008
AP06/23/2008N20093000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021814s005, 022292s000ltr.pdf 6/26/2008
AP06/23/2008N25541000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005, 022292_aptivus_toc.cfm 5/12/2010
AP06/23/2008N25542000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-292s000sumr.pdf 5/12/2010
AP06/19/2009SLR22813001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001ltr.pdf 6/24/2009
AP06/19/2009SLR22821001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf 6/24/2009
AP04/27/2010SLR25445002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002ltr.pdf 5/3/2010
AP04/27/2010SLR25515002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf 5/7/2010
AP08/16/2010SLR26229003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022292s003lbl.pdf 8/16/2010
AP08/16/2010SLR26367003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf 9/7/2010
AP04/5/2011SLR28472004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022292s004lbl.pdf 4/6/2011
AP04/5/2011SLR28480004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf 4/7/2011
AP02/17/2012SLR31851006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf 2/22/2012
AP02/17/2012SLR31901006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021814s013,022292s006ltr.pdf 2/27/2012
AP04/7/2014SLR38991007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021814Origs014,022292Orig1s007ltr.pdf 4/8/2014
AP04/7/2014SLR39009007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf 4/8/2014
AP03/27/2015SLR42352008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292Orig1s008ltr.pdf 4/1/2015
AP03/27/2015SLR42465008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf 4/7/2015
AP09/15/2016SLR47095009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021814Orig1s016,022292Orig1s009ltr.pdf 9/20/2016
AP09/15/2016SLR47154009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf 9/23/2016




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