Back to FDA Applications sponsored by BAYER HLTHCARE

FDA Drug Application 203085 by BAYER HLTHCARE

Application Number203085
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/27/2012N33858000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf 9/27/2012
AP09/27/2012N33859000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203085Orig1s000ltr.pdf 9/27/2012
AP09/27/2012N34179000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000TOC.cfm 10/26/2012
AP09/27/2012N34180000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000SumR.pdf 10/26/2012
AP05/29/2013SLR36166001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203085Orig1s001ltr.pdf 5/31/2013
AP05/29/2013SLR36216001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203085s001lbl.pdf 6/4/2013
AP011/10/2014SCM       
AP09/13/2013SCM       
AP04/13/2015SLR42526004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203085s004lbl.pdf 4/14/2015
AP04/13/2015SLR42535004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203085Orig1s004ltr.pdf 4/16/2015
AP06/7/2016SLR46272005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s005ltr.pdf 6/8/2016
AP08/26/2016SLR46890006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s006ltr.pdf 8/29/2016
AP08/26/2016SLR46911006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203085s006lbl.pdf 8/29/2016




Back to FDA Applications sponsored by BAYER HLTHCARE