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FDA Drug Application 205786 by MERCK SHARP DOHME

Application Number205786
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2013N38136000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf 12/23/2013
AP012/20/2013N38198000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf 12/31/2013
AP012/20/2013N39685000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205786Orig1s000TOC.cfm 6/27/2014
AP012/20/2013N39686000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205786Orig1s000SumR.pdf 6/27/2014
AP04/8/2014SLR39022001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf 4/10/2014
AP04/8/2014SLR39027001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf 4/10/2014
AP02/18/2015SLR41874002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf 2/19/2015
AP02/18/2015SLR41884002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf 2/20/2015
AP02/20/2015SLR41893003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf 2/23/2015
AP02/20/2015SLR41909003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf 2/24/2015




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