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FDA Drug Application 021814 by BOEHRINGER INGELHEIM

Application Number021814
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP06/22/2005N11864000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021814lbl.pdf 6/23/2005
AP06/22/2005N11884000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021814ltr.pdf 6/24/2005
AP06/22/2005N12713000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21814_000_AptivusTOC.cfm 9/2/2005
AP08/11/2006SLR14688001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf 8/14/2006
AP08/11/2006SLR14724001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf 8/18/2006
AP08/11/2006SLR14725002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf 8/18/2006
AP08/11/2006SLR14689002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf 8/14/2006
AP010/4/2007SE718202003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s003ltr.pdf 10/10/2007
AP010/4/2007SE718225003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf 10/10/2007
AP05/14/2007SLR16612004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s004ltr.pdf 5/29/2007
AP06/23/2008SE120088005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf 6/26/2008
AP06/23/2008SE120092005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021814s005, 022292s000ltr.pdf 6/26/2008
AP06/23/2008SE125539005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005, 022292_aptivus_toc.cfm 5/12/2010
AP06/23/2008SE125540005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-292s000sumr.pdf 5/12/2010
AP06/19/2009SLR22812006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001ltr.pdf 6/24/2009
AP06/19/2009SLR22820006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf 6/24/2009
AP04/27/2010SLR25444008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002ltr.pdf 5/3/2010
AP04/27/2010SLR25516008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf 5/7/2010
AP08/16/2010SLR26228009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf 8/16/2010
AP08/16/2010SLR26366009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf 9/7/2010
AP04/5/2011SLR28471011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf 4/6/2011
AP04/5/2011SLR28479011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf 4/7/2011
AP02/17/2012SLR31852013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf 2/22/2012
AP02/17/2012SLR31900013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021814s013,022292s006ltr.pdf 2/27/2012
AP04/7/2014SLR38990014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021814Origs014,022292Orig1s007ltr.pdf 4/8/2014
AP04/7/2014SLR39010014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf 4/8/2014
AP03/27/2015SLR42351015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292Orig1s008ltr.pdf 4/1/2015
AP03/27/2015SLR42464015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf 4/7/2015
AP09/15/2016SLR47096016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021814Orig1s016,022292Orig1s009ltr.pdf 9/20/2016
AP09/15/2016SLR47153016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf 9/23/2016




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