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FDA Drug Application 021313 by MERCK SHARP DOHME

Application Number021313
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/1/2006N13589000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021313s000lbl.pdf 2/7/2006
AP02/1/2006N13613000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021313s000ltr.pdf 2/8/2006
AP02/1/2006N20179000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021313s000TOC.cfm 7/9/2008
AP07/19/2007SLR17335001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021313s001ltr.pdf 7/24/2007
AP07/19/2007SLR17353001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021313s001lbl.pdf 7/24/2007
AP012/30/2009SLR24429002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021313s002ltr.pdf 1/5/2010
AP012/30/2009SLR24494002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021313s002lbl.pdf 1/12/2010
AP03/7/2014SLR38728005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021313Orig1s005ltr.pdf 3/10/2014
AP03/7/2014SLR38736005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021313s005lbl.pdf 3/10/2014
AP010/16/2015SCM       




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