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FDA Drug Application 205053 by MERCK SHARP DOHME

Application Number205053
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/25/2013N42149000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205053Orig1s000TOC.cfm 3/16/2015
AP011/25/2013N42150000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205053Orig1s000SumR.pdf 3/16/2015
AP011/25/2013N37937000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205053s000lbl.pdf 11/26/2013
AP011/25/2013N37948000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205053Orig1s000ltr.pdf 11/27/2013
AP06/11/2014SLR39521001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205053Orig1s001ltr.pdf 6/12/2014
AP06/11/2014SLR43675001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205053s1lbl.pdf 8/19/2015
AP011/16/2015SLR44502002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 11/18/2015
AP011/16/2015SLR44539002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf 11/19/2015
AP011/16/2015SLR44540004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf 11/19/2015
AP011/16/2015SLR44503004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 11/18/2015
AP09/9/2016SLR47031005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf 9/12/2016
AP09/9/2016SLR47041005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf 9/15/2016




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