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FDA Drug Application 020518 by VIIV HLTHCARE

Application Number020518
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
AP012/19/1995N       
AP010/4/1996SCF       
AP03/4/1998SLR       
AP06/12/1998SCM       
AP03/30/2001SLR3208004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf 3/30/2001
AP03/30/2001SLR3209004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF 3/30/2001
AP03/30/2001SLR11447004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.cfm 4/19/2005
AP02/26/1999SCM       
AP04/2/1999SCS       
AP02/1/2000SCS       
AP010/5/2001SLR5463008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518s8lbl.pdf 4/25/2003
AP02/21/2002SLR3205009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf 2/21/2002
AP012/18/2002SLR3202010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf 12/18/2002
AP012/18/2002SLR4880010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf 4/4/2003
AP010/15/2003SLR7916011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20518slr011_retrovir_lbl.pdf 3/11/2004
AP010/15/2003SLR7917011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20518slr011ltr.pdf 3/11/2004
AP05/10/2006SLR14093013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf 5/16/2006
AP05/10/2006SLR14124013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf 5/18/2006
AP011/20/2006SLR15379015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020518s015lbl.pdf 11/22/2006
AP011/20/2006SLR15440015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020518s015ltr.pdf 12/4/2006
AP09/19/2008SE220871016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf 9/23/2008
AP09/19/2008SE220886016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf 9/25/2008
AP011/6/2009SLR24108018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf 11/23/2009
AP011/6/2009SLR24456018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019655s048,020518s018ltr.pdf 1/6/2010
AP05/17/2010SLR25584019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020518s019lbl.pdf 5/18/2010
AP05/17/2010SLR25595019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf 5/21/2010
AP011/18/2011SLR30771022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf 11/25/2011
AP011/18/2011SLR30827022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf 12/1/2011
AP05/31/2012SLR32796023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf 6/4/2012
AP05/31/2012SLR32822023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf 6/6/2012
AP012/23/2014SLR41473024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf 12/31/2014
AP012/23/2014SLR41553024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf 1/8/2015




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