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FDA Drug Application 022252 by BAYER HLTHCARE

Application Number022252
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/6/2010N25532000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022252s000ltr.pdf 5/12/2010
AP05/6/2010N25577000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022252s000lbl.pdf 5/17/2010
AP05/6/2010N25708000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1TOC.cfm 6/6/2010
AP05/6/2010N25709000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf 6/6/2010
AP02/13/2012SE831784001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf 2/14/2012
AP02/13/2012SE831793001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252s001ltr.pdf 2/15/2012
AP03/14/2012N32132002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022252Orig2s000ltr.pdf 3/16/2012
AP03/14/2012N32142002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s002lbl.pdf 3/16/2012
AP08/22/2013SLR36872003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022252s003lbl.pdf 8/22/2013
AP08/22/2013SLR36879003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022252Orig1s003ltr.pdf 8/23/2013
AP08/21/2015SLR43701004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022252Orig1s004ltr.pdf 8/24/2015
AP08/21/2015SLR43710004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf 8/25/2015




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