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FDA Drug Application 022081 by GILEAD

Application Number022081
Application Type New Drug Application
Sponsor ApplicantGILEAD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/15/2007N16853000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf 6/27/2007
AP06/15/2007N16894000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s000LTR.pdf 7/5/2007
AP06/15/2007N17655000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022081s000TOC.cfm 8/21/2007
AP06/15/2007N23269000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf 9/2/2009
AP06/15/2007N26348000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=28 9/1/2010
AP011/29/2007SLR18596001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s001ltr.pdf 12/3/2007
AP02/14/2008SLR19235002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s002ltr.pdf 2/19/2008
AP02/14/2008SLR19277002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf 2/25/2008
AP010/8/2008SLR21022004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s004ltr.pdf 10/14/2008
AP010/8/2008SLR21194004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s004lbl.pdf 11/7/2008
AP05/29/2009SLR22722008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s008ltr.pdf 6/10/2009
AP05/29/2009SLR22739008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf 6/10/2009
AP08/5/2009SLR23169010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf 8/13/2009
AP08/5/2009SLR24124010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s010ltr.pdf 11/24/2009
AP07/1/2009SLR22904011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s011ltr.pdf 7/8/2009
AP07/1/2009SLR22919011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf 7/9/2009
AP010/13/2010SLR26705012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s012ltr.pdf 10/20/2010
AP010/13/2010SLR26764012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf 10/25/2010
AP02/15/2012SE831814014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081s014ltr.pdf 2/17/2012
AP02/15/2012SE831823014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf 2/17/2012
AP08/24/2010SLR26287016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s016ltr.pdf 8/26/2010
AP03/3/2011SLR28149017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf 3/7/2011
AP03/3/2011SLR28176017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s017ltr.pdf 3/8/2011
AP03/3/2011SLR40104017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022081Orig1s017.pdf 8/1/2014
AP07/19/2011SLR29561018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s018lbl.pdf 7/20/2011
AP07/19/2011SLR29573018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s018ltr.pdf 7/21/2011
AP08/17/2013SLR36857019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf 8/21/2013
AP08/17/2013SLR36875019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022081Orig1s019ltr.pdf 8/22/2013
AP010/19/2012SLR34146022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s022lbl.pdf 10/22/2012
AP010/19/2012SLR34165022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081Orig1s022ltr.pdf 10/23/2012
AP01/10/2013SCM       
AP01/16/2013SCM       
AP07/2/2014SCM       
AP09/26/2014SCM       
AP05/5/2014SLR39227029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s029ltr.pdf 5/6/2014
AP05/5/2014SLR39235029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s029lbl.pdf 5/6/2014
AP01/31/2014SLR38428030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf 2/3/2014
AP01/31/2014SLR38443030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s030ltr.pdf 2/4/2014
AP010/29/2014S40898032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s032ltr.pdf 10/30/2014
AP010/2/2015SE844115033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022081Orig1s033ltr.pdf 10/6/2015
AP010/2/2015SE844170033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf 10/8/2015
AP09/25/2015SCM       
AP03/21/2016SCM       




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