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FDA Drug Application 021652 by VIIV HLTHCARE

Application Number021652
Application Type New Drug Application
Sponsor ApplicantVIIV HLTHCARE
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
AP08/2/2004N9938000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21652ltr.pdf 8/5/2004
AP08/2/2004N9945000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21652lbl.pdf 8/5/2004
AP08/2/2004N15209000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021652s000_EpzicomTOC.cfm 10/25/2006
AP08/2/2004N15919000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088592.pdf 2/28/2007
AP08/3/2006SLR14687003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021652s003lbl.pdf 8/14/2006
AP08/3/2006SLR14726003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021652s003LTR.pdf 8/18/2006
AP05/7/2007SLR16476005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021652s005lbl.pdf 5/9/2007
AP05/7/2007SLR16477005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021652s005ltr.pdf 5/9/2007
AP03/9/2009SLR21985008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021652s008ltr.pdf 3/11/2009
AP03/9/2009SLR22123008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021652s008lbl.pdf 3/26/2009
AP02/2/2011SLR27715010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s010lbl.pdf 2/4/2011
AP02/2/2011SLR27757010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021652s010ltr.pdf 2/7/2011
AP08/4/2010S26196011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf 8/10/2010
AP05/13/2011SLR28848013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf 5/17/2011
AP011/18/2011SLR30743014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021652s014ltr.pdf 11/22/2011
AP011/18/2011SLR30793014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s014lbl.pdf 11/29/2011
AP03/12/2012SLR32091015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s015lbl.pdf 3/12/2012
AP03/12/2012SLR32097015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021652s015ltr.pdf 3/13/2012
AP05/18/2012SLR32726016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s016lbl.pdf 5/22/2012
AP05/18/2012SLR32741016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021652s016ltr.pdf 5/22/2012
AP02/19/2015SLR41878018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s018lbl.pdf 2/20/2015
AP02/19/2015SLR41897018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s018ltr.pdf 2/24/2015
AP09/17/2015SE843915019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s019ltr.pdf 9/18/2015
AP09/29/2015SLR44060021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s021ltr.pdf 10/1/2015
AP09/29/2015SLR44156021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf 10/7/2015




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