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FDA Drug Application 021548 by VIIV HLTHCARE

Application Number021548
Application Type New Drug Application
Sponsor ApplicantVIIV HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/2003N6840000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21548ltr.pdf 10/27/2003
AP010/20/2003N6841000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21548_levixa_lbl.pdf 10/27/2003
AP010/20/2003N10469000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-548_Lexiva.cfm 10/26/2004
AP011/29/2004SLR10667002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21548s002ltr.pdf 12/2/2004
AP011/29/2004SLR10722002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21548s002lbl.pdf 12/3/2004
AP06/13/2005SLR11804004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s004ltr.pdf 6/14/2005
AP06/13/2005SLR11809004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s004lbl.pdf 6/14/2005
AP011/10/2005SLR13067005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s005lbl.pdf 11/17/2005
AP011/10/2005SLR13089005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s005ltr.pdf 11/18/2005
AP03/10/2006SLR13760007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s007lbl.pdf 3/14/2006
AP03/10/2006SLR13801007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s007ltr.pdf 3/23/2006
AP05/11/2006SLR14100008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s008lbl.pdf 5/16/2006
AP05/11/2006SLR14106008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s008ltr.pdf 5/16/2006
AP08/7/2006SLR14640009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s009lbl.pdf 8/9/2006
AP08/7/2006SLR14651009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s009LTR.pdf 8/9/2006
AP02/7/2007SLR15824010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s010ltr.pdf 2/12/2007
AP02/7/2007SLR15870010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s010lbl.pdf 2/21/2007
AP011/14/2006SLR15367011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s011lbl.pdf 11/16/2006
AP011/14/2006SLR15389011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s011ltr.pdf 11/22/2006
AP010/12/2007SE218241013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s013lbl.pdf 10/15/2007
AP010/12/2007SE218289013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s013ltr.pdf 10/22/2007
AP012/13/2007SLR18653014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s014lbl.pdf 12/14/2007
AP012/13/2007SLR18836014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s014ltr.pdf 1/9/2008
AP012/14/2007SLR18688015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s015lbl.pdf 12/27/2007
AP012/14/2007SLR18828015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s015ltr.pdf 1/9/2008
AP02/20/2008SLR19257016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s016ltr.pdf 2/22/2008
AP02/20/2008SLR19271016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s016lbl.pdf 2/25/2008
AP03/5/2008SLR19395017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s017, 022116s001ltr.pdf 3/7/2008
AP03/5/2008SLR19405017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf 3/7/2008
AP04/30/2008SLR19763019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s019, 022116s003ltr.pdf 5/5/2008
AP04/14/2009SLR22287020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s020,022116s004ltr.pdf 4/20/2009
AP09/11/2009SLR23413021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf 9/18/2009
AP09/11/2009SLR23692021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005ltr.pdf 10/26/2009
AP04/26/2010SLR25392024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021548s024, 022116s008ltr.pdf 4/29/2010
AP04/26/2010SLR25412024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf 5/3/2010
AP05/10/2011SLR28814026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021548s026,022116s010ltr.pdf 5/16/2011
AP05/10/2011SLR28836026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf 5/16/2011
AP04/27/2012S32568028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf 5/1/2012
AP04/27/2012S32593028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012ltr.pdf 5/2/2012
AP02/17/2012SLR31860029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf 2/22/2012
AP02/17/2012SLR31892029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s029,022116s013ltr.pdf 2/27/2012
AP08/28/2013SCM       
AP02/12/2013SLR35162031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116Orig1s015ltr.pdf 2/14/2013
AP02/12/2013SLR35166031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf 2/14/2013
AP03/5/2013SCM       
AP010/29/2013SCM       
AP07/17/2015SLR43416035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021548Orig1s035,022116Orig1s019ltr.pdf 7/20/2015
AP07/17/2015SLR43446035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf 7/22/2015
AP03/27/2015SLR42337036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022116Orig1s020,021548Orig1s036ltr.pdf 4/1/2015
AP03/27/2015SLR42394036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf 4/2/2015
AP03/22/2016SLR45493037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf 3/23/2016
AP03/22/2016SLR45499037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116Orig1s021ltr.pdf 3/24/2016
AP03/10/2016SCM       
AP09/15/2016SLR47086039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022116Orig1s023,021548Orig1s039ltr.pdf 9/20/2016
AP09/15/2016SLR47174039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023_21548-s39lbl.pdf 9/27/2016




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