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FDA Drug Application 019655 by VIIV HLTHCARE

Application Number019655
Application Type New Drug Application
Sponsor ApplicantVIIV HLTHCARE
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
AP03/19/1987N       
AP04/21/1987SCM       
AP08/24/1993SLR       
AP010/13/1988SCF       
AP03/6/1989SCM       
AP03/13/1989SCP       
AP03/2/1990SLR       
AP08/24/1993SLR       
AP01/12/1990SE2       
AP04/30/1990SCS       
AP05/2/1990SLR       
AP08/8/1994SLR       
AP08/24/1993SLR       
AP08/8/1994SE1       
AP010/7/1994SLR       
AP02/6/1995SCS       
AP010/4/1996SE2       
AP07/20/1995SLR       
AP010/4/1996SE1       
AP03/4/1998SLR       
AP011/4/1997SCM       
AP03/30/2001SLR821032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF 3/30/2001
AP03/30/2001SLR822032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf 3/30/2001
AP03/30/2001SLR11445032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.cfm 4/19/2005
AP012/28/1998SCP       
AP02/26/1999SCM       
AP02/1/2000SCS       
AP010/5/2001SLR5919036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19655s36lbl.pdf 6/16/2003
AP02/21/2002SLR3203037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf 2/21/2002
AP012/18/2002SLR3200038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf 12/18/2002
AP012/18/2002SLR4887038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf 4/4/2003
AP010/15/2003SLR6818039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20528slr011ltr.pdf 10/17/2003
AP010/15/2003SLR6825039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf 10/17/2003
AP05/10/2006SLR14095041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf 5/16/2006
AP05/10/2006SLR14126041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf 5/18/2006
AP011/15/2006SLR15365043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s043lbl.pdf 11/16/2006
AP011/15/2006SLR15394043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s043ltr.pdf 11/22/2006
AP09/19/2008SE220870046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf 9/23/2008
AP09/19/2008SE220887046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033,019655s046,020518s016lbl.pdf 9/25/2008
AP011/6/2009SLR24107048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019655s048,020518s018lbl.pdf 11/23/2009
AP011/6/2009SLR24455048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019655s048,020518s018ltr.pdf 1/6/2010
AP05/17/2010SLR25582049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019655s049lbl.pdf 5/18/2010
AP05/17/2010SLR25593049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf 5/21/2010
AP011/18/2011SLR30769052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf 11/25/2011
AP011/18/2011SLR30825052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf 12/1/2011
AP05/31/2012SLR32794053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf 6/4/2012
AP05/31/2012SLR32824053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf 6/6/2012
AP012/23/2014SLR41470054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf 12/31/2014
AP012/23/2014SLR41551054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf 1/8/2015




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