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FDA Drug Application 200153 by MERCK SHARP DOHME

Application Number200153
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/3/2013N35966000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200153Orig1s000ltr.pdf 5/7/2013
AP05/3/2013N35999000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf 5/9/2013
AP05/3/2013N37316000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153_liptruzet_toc.cfm 10/3/2013
AP05/3/2013N37317000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153Orig1s000SumR.pdf 10/3/2013
AP02/13/2014SCM       
AP05/16/2014SCM39322003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200153s003lbl.pdf 5/19/2014
AP05/16/2014SCM39331003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200153Orig1s003ltr.pdf 5/20/2014




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