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FDA Drug Application 021687 by MSD INTL

Application Number021687
Application Type New Drug Application
Sponsor ApplicantMSD INTL
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
AP07/23/2004N9847000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21687ltr.pdf 7/28/2004
AP07/23/2004N9881000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21687lbl.pdf 7/28/2004
AP07/23/2004N10648000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin.cfm 11/22/2004
AP07/23/2004N18954000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm 1/25/2008
AP02/16/2005SCP11129001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s001ltr.pdf 2/17/2005
AP03/7/2005SLR11220002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21687s002ltr.pdf 3/10/2005
AP03/7/2005SLR11233002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21687s002lbl.pdf 3/10/2005
AP06/3/2005SLR11753003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s003ltr.pdf 6/7/2005
AP06/3/2005SLR11765003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s003lbl.pdf 6/7/2005
AP010/19/2005SLR12954004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s004lbl.pdf 10/24/2005
AP03/16/2006SE413795006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf 3/23/2006
AP03/16/2006SE413787006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf 3/22/2006
AP012/9/2005SCS13252009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021687s009lbl.pdf 12/15/2005
AP012/9/2005SCS13262009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021687s009ltr.pdf 12/15/2005
AP010/24/2006SLR15202010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s010lbl.pdf 10/25/2006
AP010/24/2006SLR15251010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s010ltr.pdf 10/26/2006
AP010/3/2006SE415049011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s011LTR.pdf 10/5/2006
AP010/3/2006SE415059011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s011lbl.pdf 10/5/2006
AP03/16/2006SLR13788013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s006,s013lbl.pdf 3/22/2006
AP03/16/2006SLR13796013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s006,s013ltr.pdf 3/23/2006
AP07/3/2006SLR14425015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s015lbl.pdf 7/5/2006
AP07/3/2006SLR14464015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s015LTR.pdf 7/13/2006
AP011/27/2006SCM15420016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021687s016lbl.pdf 12/4/2006
AP011/27/2006SCM15432016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021687s016ltr.pdf 12/4/2006
AP05/16/2007SLR16622019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s019ltr.pdf 5/29/2007
AP05/16/2007SLR16640019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s019lbl.pdf 5/29/2007
AP012/12/2007SLR18655021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021687s021lbl.pdf 12/14/2007
AP012/12/2007SLR18848021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021687s021ltr.pdf 1/9/2008
AP02/8/2008SLR19088022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021687s022ltr.pdf 2/14/2008
AP02/8/2008SLR19109022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021687s022lbl.pdf 2/14/2008
AP06/13/2008SLR       
AP06/13/2008SLR       
AP01/8/2009SLR21556029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s029ltr.pdf 1/12/2009
AP01/8/2009SLR21633029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s029lbl.pdf 1/14/2009
AP01/30/2009SLR21712030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s030ltr.pdf 2/3/2009
AP01/30/2009SLR21783030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s030lbl.pdf 2/4/2009
AP011/6/2009SLR24097032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021687s032lbl.pdf 11/23/2009
AP011/6/2009SLR24568032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021687s032ltr.pdf 1/21/2010
AP06/8/2011SLR29062033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf 6/8/2011
AP06/8/2011SLR29066033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf 6/8/2011
AP03/10/2010SLR25052034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s034lbl.pdf 3/17/2010
AP03/10/2010SLR25058034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s034ltr.pdf 3/18/2010
AP04/22/2010SLR25355036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s036ltr.pdf 4/28/2010
AP04/22/2010SLR25424036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s036lbl.pdf 5/3/2010
AP012/22/2010SLR27372037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021687s037lbl.pdf 12/26/2010
AP012/22/2010SLR27403037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021687s037ltr.pdf 12/28/2010
AP01/24/2012SE831518039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s039lbl.pdf 1/25/2012
AP01/24/2012SE831572039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687s039ltr.pdf 1/30/2012
AP06/8/2011SLR29067040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s033s040lbl.pdf 6/8/2011
AP06/8/2011SLR29061040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s033,s040ltr.pdf 6/8/2011
AP010/6/2011SLR30242041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s041ltr.pdf 10/12/2011
AP010/6/2011SLR30288041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s041lbl.pdf 10/12/2011
AP010/6/2011SLR32835041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021687Orig1s041.pdf 6/6/2012
AP012/1/2011SLR30863042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021687s042lbl.pdf 12/2/2011
AP012/1/2011SLR30879042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021687s042ltr.pdf 12/5/2011
AP02/28/2012SLR31960044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687s044ltr.pdf 2/29/2012
AP02/28/2012SLR32036044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s044lbl.pdf 3/6/2012
AP010/31/2012SLR34232046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf 11/2/2012
AP010/31/2012SLR34269046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047ltr.pdf 11/6/2012
AP010/31/2012SLR34270047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021687Orig1s046,s047ltr.pdf 11/6/2012
AP010/31/2012SLR34233047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021687s046s047lbl.pdf 11/2/2012
AP010/25/2013SLR37595048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021687Orig1s048ltr.pdf 10/28/2013
AP010/25/2013SLR37650048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021687s048lbl.pdf 10/31/2013
AP02/27/2014SLR38633050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s050ltr.pdf 2/28/2014
AP02/27/2014SLR38653050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021687s050lbl.pdf 3/4/2014
AP09/30/2014SLR40762051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021687Orig1s051ltr.pdf 10/14/2014
AP02/2/2015SLR41763053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021687Orig1s053ltr.pdf 2/3/2015
AP02/2/2015SLR41775053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021687s053lbl.pdf 2/3/2015




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