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FDA Drug Application 203971 by BAYER HLTHCARE

Application Number203971
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
AP05/15/2013N36073000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203971lbl.pdf 5/15/2013
AP05/15/2013N36079000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203971Orig1s000ltr.pdf 5/16/2013
AP05/15/2013N36364000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000TOC.cfm 6/21/2013
AP05/15/2013N36365000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203971Orig1s000SumR.pdf 6/21/2013
AP02/16/2015SCM       
AP05/12/2015SCM       
AP09/10/2015SCM       
AP03/18/2016SLR45471007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203971s007lbl.pdf 3/22/2016
AP03/18/2016SLR45476007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203971Orig1s007ltr.pdf 3/22/2016
AP01/22/2016SCM       
AP04/29/2016SCM       
AP05/12/2016SCM       




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