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FDA Drug Application 022401 by BOEHRINGER INGELHEIM

Application Number022401
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2009N23609000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf 10/16/2009
AP010/16/2009N23716000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022401s000ltr.pdf 11/2/2009
AP010/16/2009N25153000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022401_twynsta_toc.cfm 3/31/2010
AP010/16/2009N25154000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/22401s000sumr.pdf 3/31/2010
AP07/27/2010SLR26036002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022401s002ltr.pdf 7/29/2010
AP07/27/2010SLR26061002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022401s002lbl.pdf 7/31/2010
AP01/18/2012N31437004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s004ltr.pdf 1/23/2012
AP01/18/2012N31469004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf 1/23/2012
AP06/6/2011SLR29042005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s005lbl.pdf 6/6/2011
AP06/6/2011SLR29050005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s005ltr.pdf 6/7/2011
AP010/19/2012SLR34142007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf 10/22/2012
AP010/19/2012SLR34163007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf 10/23/2012
AP010/19/2012SLR34143009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf 10/22/2012
AP010/19/2012SLR34164009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf 10/23/2012
AP011/14/2011SLR30576010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf 11/14/2011
AP011/14/2011SLR30599010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s010ltr.pdf 11/16/2011
AP03/29/2012SLR32306011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf 3/30/2012
AP03/29/2012SLR32326011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s011ltr.pdf 4/2/2012
AP011/14/2012SLR34400012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s012lbl.pdf 11/15/2012
AP011/14/2012SLR34406012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s012ltr.pdf 11/16/2012
AP012/11/2014SCM       
AP012/12/2014SLR41241016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022401Orig1s016ltr.pdf 12/15/2014
AP012/12/2014SLR41269016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf 12/16/2014
AP011/19/2015SCM       
AP01/13/2016SLR44969018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022401Orig1s018ltr.pdf 1/15/2016
AP01/13/2016SLR45015018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022401s018lbl.pdf 1/25/2016




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