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FDA Drug Application 021923 by BAYER HLTHCARE

Application Number021923
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2005N13349000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021923lbl.pdf 1/6/2006
AP012/20/2005N13401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021923ltr.pdf 1/19/2006
AP012/20/2005N13594000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021923_s000_NexavarTOC.cfm 2/8/2006
AP03/5/2007SLR16032003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s003ltr.pdf 3/15/2007
AP011/16/2007SE118440004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf 11/19/2007
AP011/16/2007SE118577004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf 11/26/2007
AP011/16/2007SE118578005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf 11/26/2007
AP011/16/2007SE118441005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf 11/19/2007
AP011/16/2007SE118442006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf 11/19/2007
AP011/16/2007SE118579006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf 11/26/2007
AP011/16/2007SE118580007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf 11/26/2007
AP011/16/2007SE118443007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf 11/19/2007
AP010/26/2010SLR26874008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf 11/3/2010
AP010/26/2010SLR26811008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf 10/28/2010
AP010/26/2010SLR26812009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf 10/28/2010
AP010/26/2010SLR26875009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf 11/3/2010
AP03/22/2011SLR28338011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s011ltr.pdf 3/25/2011
AP03/22/2011SLR28384011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s011lbl.pdf 3/28/2011
AP010/14/2011SLR30334012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s012ltr.pdf 10/17/2011
AP010/14/2011SLR30377012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s012lbl.pdf 10/20/2011
AP08/24/2012SLR33557013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021923Origs013ltr.pdf 8/27/2012
AP06/11/2013SLR36279014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s014ltr.pdf 6/12/2013
AP06/11/2013SLR36320014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s014lbl.pdf 6/18/2013
AP010/30/2013SLR37624015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s015ltr.pdf 10/31/2013
AP010/30/2013SLR37642015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s015lbl.pdf 10/31/2013
AP011/22/2013SE137882016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s016lbl.pdf 11/22/2013
AP011/22/2013SE137907016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s016ltr.pdf 11/25/2013
AP012/2/2014SCM       




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