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FDA Drug Application 019910 by VIIV HLTHCARE

Application Number019910
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
AP09/28/1989N       
AP05/25/1990SLR       
AP05/2/1990SE5       
AP01/12/1990SE2       
AP03/2/1990SE5       
AP08/8/1994SLR       
AP010/19/1992SCE       
AP08/24/1993SLR       
AP08/8/1994SE1       
AP010/7/1994SLR       
AP02/6/1995SCS       
AP010/4/1996SE2       
AP07/20/1995SLR       
AP010/4/1996SE1       
AP03/4/1998SLR       
AP02/25/1998SCM       
AP03/30/2001SLR3206021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20518S4LTR.PDF 3/30/2001
AP03/30/2001SLR3207021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20518S4lbl.pdf 3/30/2001
AP03/30/2001SLR11446021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019655s032_019910s021_020518s004_Retrovir.cfm 4/19/2005
AP02/26/1999SCM       
AP02/1/2000SCS       
AP010/5/2001SLR5904024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19910s24lbl.pdf 6/10/2003
AP02/21/2002SLR3204025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19655s37ltr.pdf 2/21/2002
AP012/18/2002SLR3201026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20518slr010,19910slr026,19655slr038ltr.pdf 12/18/2002
AP012/18/2002SLR4886026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20518slr010,19910slr026,19655slr038_retrovir_lbl.pdf 4/4/2003
AP010/15/2003SLR6819027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19655slr039,19910slr027,20528slr011ltr.pdf 10/17/2003
AP010/15/2003SLR6826027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19655slr039,19910slr027,20528slr011_retrovir_lbl.pdf 10/17/2003
AP05/10/2006SLR14094029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019655s41,019910s29,020518s13lbl.pdf 5/16/2006
AP05/10/2006SLR14125029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019655s041, 019910s029, 020518s013LTR.pdf 5/18/2006
AP011/15/2006SLR15364032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019910s032lbl.pdf 11/16/2006
AP011/15/2006SLR15393032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019910s032ltr.pdf 11/22/2006
AP09/19/2008SE220869033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019910s033, 019655s046, 020518s016ltr.pdf 9/23/2008
AP09/19/2008SE220881033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033lbl.pdf 9/23/2008
AP011/6/2009SE524033035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019910s035lbl.pdf 11/19/2009
AP011/6/2009SE524465035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019910s035ltr.pdf 1/7/2010
AP05/17/2010SLR25583036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019910s036lbl.pdf 5/18/2010
AP05/17/2010SLR25594036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019655s049,019910s036,020518s019ltr.pdf 5/21/2010
AP011/18/2011SLR30770039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019655s052,019910s039,020518s022lbl.pdf 11/25/2011
AP011/18/2011SLR30826039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019655s052,019910s039,020518s022ltr.pdf 12/1/2011
AP05/31/2012SLR32795040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019655s053,019910s040,020518s023ltr.pdf 6/4/2012
AP05/31/2012SLR32823040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019655s053,019910s040,020518s023lbl.pdf 6/6/2012
AP012/23/2014SLR41471041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf 12/31/2014
AP012/23/2014SLR41550041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf 1/8/2015




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