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FDA Drug Application 022116 by VIIV HLTHCARE

Application Number022116
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/14/2007N16804000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022116lbl.pdf 6/18/2007
AP06/14/2007N16928000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022116s000ltr.pdf 7/5/2007
AP06/14/2007N23811000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022116_lexiva_toc.cfm 11/10/2009
AP03/5/2008SLR19396001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s017, 022116s001ltr.pdf 3/7/2008
AP03/5/2008SLR19404001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf 3/7/2008
AP04/30/2008SLR19764003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s019, 022116s003ltr.pdf 5/5/2008
AP04/14/2009SLR22288004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s020,022116s004ltr.pdf 4/20/2009
AP09/11/2009SLR23414005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf 9/18/2009
AP09/11/2009SLR23693005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005ltr.pdf 10/26/2009
AP04/26/2010SLR25393008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021548s024, 022116s008ltr.pdf 4/29/2010
AP04/26/2010SLR25411008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf 5/3/2010
AP05/10/2011SLR28815010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021548s026,022116s010ltr.pdf 5/16/2011
AP05/10/2011SLR28835010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf 5/16/2011
AP04/27/2012S32567012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf 5/1/2012
AP04/27/2012S32594012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012ltr.pdf 5/2/2012
AP02/17/2012SLR31859013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf 2/22/2012
AP02/17/2012SLR31893013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s029,022116s013ltr.pdf 2/27/2012
AP02/12/2013SLR35163015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116Orig1s015ltr.pdf 2/14/2013
AP02/12/2013SLR35165015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf 2/14/2013
AP07/17/2015SLR43417019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021548Orig1s035,022116Orig1s019ltr.pdf 7/20/2015
AP07/17/2015SLR43445019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf 7/22/2015
AP03/27/2015SLR42336020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022116Orig1s020,021548Orig1s036ltr.pdf 4/1/2015
AP03/27/2015SLR42395020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf 4/2/2015
AP03/22/2016SLR45491021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf 3/23/2016
AP03/22/2016SLR45500021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116Orig1s021ltr.pdf 3/24/2016
AP09/15/2016SLR47085023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022116Orig1s023,021548Orig1s039ltr.pdf 9/20/2016
AP09/15/2016SLR47122023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023lbl.pdf 9/20/2016




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