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FDA Drug Application 205596 by MERCK SHARP DOHME

Application Number205596
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
AP03/13/2014N38796000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205596Orig1s000ltr.pdf 3/14/2014
AP03/13/2014N38849000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205596s000lbl.pdf 3/19/2014
AP03/13/2014N40749000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000TOC.cfm 10/10/2014
AP03/13/2014N40750000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000SumR.pdf 10/10/2014
AP011/16/2015SLR44504001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 11/18/2015
AP011/16/2015SLR44537001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf 11/19/2015
AP011/16/2015SLR44538003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf 11/19/2015
AP011/16/2015SLR44505003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 11/18/2015
AP09/9/2016SLR47030004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf 9/12/2016
AP09/9/2016SLR47042004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf 9/15/2016




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