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FDA Drug Application 202343 by MERCK SHARP DOHME

Application Number202343
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
AP010/7/2011N30231000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202343s000ltr.pdf 10/7/2011
AP010/7/2011N30233000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202343s000lbl.pdf 10/7/2011
AP010/7/2011N30234000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf 10/7/2011
AP010/7/2011N33174000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000TOC.cfm 7/13/2012
AP010/7/2011N33175000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000SumR.pdf 7/13/2012
AP09/18/2012SE833802001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf 9/20/2012
AP09/18/2012SE833812001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf 9/24/2012
AP09/18/2012SE833805001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004mg.pdf 9/20/2012
AP09/18/2012SLR33806002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004mg.pdf 9/20/2012
AP09/18/2012SLR33813002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf 9/24/2012
AP09/18/2012SLR33803002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf 9/20/2012
AP09/18/2012SLR33804004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004lbl.pdf 9/20/2012
AP09/18/2012SLR33814004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1S001,S002,S004ltr.pdf 9/24/2012
AP09/18/2012SLR33807004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s001s002s004mg.pdf 9/20/2012
AP010/31/2012SLR34314005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf 11/6/2012
AP010/31/2012SLR34277005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf 11/6/2012
AP02/11/2013SLR35139006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s006lbl.pdf 2/11/2013
AP02/11/2013SLR35153006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s006ltr.pdf 2/13/2013
AP010/31/2012SLR34278007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202343Orig1s005,s007ltr.pdf 11/6/2012
AP010/31/2012SLR34315007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202343s005s007lbl.pdf 11/6/2012
AP010/25/2013SLR37590008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s008ltr.pdf 10/28/2013
AP010/25/2013SLR37648008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s008lbl.pdf 10/31/2013
AP011/8/2013SCM       
AP08/19/2013SLR36839010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202343s010lbl.pdf 8/19/2013
AP08/19/2013SLR36870010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202343Orig1s010ltr.pdf 8/22/2013
AP02/24/2014SLR38578011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202343s011lbl.pdf 2/25/2014
AP02/24/2014SLR38595011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202343Orig1s011ltr.pdf 2/26/2014




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