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FDA Drug Application 202258 by MERCK SHARP DOHME

Application Number202258
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/13/2011N28801000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf 5/13/2011
AP05/13/2011N28802000   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm 5/13/2011
AP05/13/2011N28803000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202258Orig1s000Ltr.pdf 5/13/2011
AP05/13/2011N28840000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255471.pdf 5/17/2011
AP05/13/2011N29153000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000TOC.cfm 6/15/2011
AP05/13/2011N29154000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000SumR.pdf 6/15/2011
AP05/13/2011N31747000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm291169.htm 2/13/2012
AP07/30/2012SLR33323001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf 7/30/2012
AP07/30/2012SLR33328001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s001ltr.pdf 8/1/2012
AP04/20/2012SLR32519002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002mg.pdf 4/24/2012
AP04/20/2012SLR32520002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf 4/24/2012
AP04/20/2012SLR32524002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258s002ltr.pdf 4/24/2012
AP02/13/2013SE835174003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s003lbl.pdf 2/14/2013
AP02/13/2013SE835179003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s003ltr.pdf 2/15/2013
AP02/27/2013SE835288004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s004ltr.pdf 3/1/2013
AP02/27/2013SE835300004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s004lbl.pdf 3/1/2013
AP011/2/2012SLR34283005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s005ltr.pdf 11/6/2012
AP011/2/2012SLR34482005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s005lbl.pdf 11/28/2012
AP012/21/2012SLR34764006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s006ltr.pdf 12/26/2012
AP012/21/2012SLR34799006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf 12/28/2012
AP02/15/2013SLR35193007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf 2/20/2013
AP02/15/2013SLR35195007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s007ltr.pdf 2/20/2013
AP07/22/2013SCM       
AP09/18/2013SLR37157009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s009lbl.pdf 9/19/2013
AP09/18/2013SLR37163009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s009ltr.pdf 9/19/2013
AP04/9/2014SE839024011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s011lbl.pdf 4/10/2014
AP04/9/2014SE839026011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s011ltr.pdf 4/10/2014
AP01/17/2014SLR38335012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s012ltr.pdf 1/21/2014
AP01/17/2014SLR38346012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf 1/22/2014
AP02/7/2014SLR38478013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf 2/10/2014
AP02/7/2014SLR38494013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s013ltr.pdf 2/11/2014
AP02/24/2014SLR38579014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf 2/25/2014
AP02/24/2014SLR38593014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s014ltr.pdf 2/26/2014
AP07/28/2014SLR40028015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s015ltr.pdf 7/29/2014
AP07/28/2014SLR40043015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf 7/29/2014




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