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FDA Drug Application 204819 by BAYER HLTHCARE

Application Number204819
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
AP010/8/2013N37403000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204819Orig1s000ltr.pdf 10/10/2013
AP010/8/2013N37419000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=149 10/15/2013
AP010/8/2013N37449000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf 10/17/2013
AP010/8/2013N37545000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372062.pdf 10/24/2013
AP010/8/2013N37687000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm 11/5/2013
AP010/8/2013N37688000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000SumR.pdf 11/5/2013
AP06/11/2014S39520001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf 6/12/2014
AP05/6/2014SLR39244002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf 5/8/2014
AP05/6/2014SLR39284002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf 5/12/2014
AP02/23/2015SCM       
AP012/4/2015S44668004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf 12/7/2015
AP010/4/2016S47293007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204819Orig1s007ltr.pdf 10/6/2016




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