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FDA Drug Application 204569 by MERCK SHARP DOHME

Application Number204569
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP08/13/2014N40234000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pdf 8/14/2014
AP08/13/2014N40235000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf 8/14/2014
AP08/13/2014N40478000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000TOC.cfm 9/12/2014
AP08/13/2014N40479000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000SumR.pdf 9/12/2014
AP011/7/2014SLR40976001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf 11/10/2014
AP011/7/2014SLR40978001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s001ltr.pdf 11/12/2014
AP04/30/2015SCM       
AP05/3/2016SCM       
AP05/27/2016SLR46197004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204569Orig1s004ltr.pdf 5/31/2016




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