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FDA Drug Application 019951 by VIIV HLTHCARE

Application Number019951
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
AP02/2/1990N       
AP08/7/1992SCE       
AP08/8/1994SE1       
AP010/7/1994SLR       
AP02/6/1995SCS       
AP07/20/1995SLR       
AP03/22/1996SLR       
AP04/2/1996SLR       
AP02/12/1998SLR       
AP08/18/1997SCM       
AP03/4/1998SLR       
AP02/26/1999SCM       
AP02/1/2000SCS       
AP09/12/2001SLR5903016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19951s16lbl.pdf 6/10/2003
AP02/21/2002SLR3199017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19951s17ltr.pdf 2/21/2002
AP07/25/2003SLR6409018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr018_retrovir_lbl.pdf 8/6/2003
AP07/25/2003SLR9386018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr018ltr.pdf 6/16/2004
AP07/25/2003SLR6496019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19951slr019_retrovir_lbl.pdf 8/14/2003
AP07/25/2003SLR6515019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19951slr019ltr.pdf 8/15/2003
AP08/19/2002SCM       
AP07/10/2006SLR14443023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019951s023lbl.pdf 7/13/2006
AP07/10/2006SLR14452023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s023LTR.pdf 7/13/2006
AP011/15/2006SLR15392024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019951s024ltr.pdf 11/22/2006
AP011/18/2011SLR30764029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019951s029lbl.pdf 11/25/2011
AP011/18/2011SLR30775029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019951s029ltr.pdf 11/28/2011
AP05/31/2012SLR32807030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019951s030ltr.pdf 6/5/2012
AP05/31/2012SLR32821030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019951s030lbl.pdf 6/6/2012
AP012/19/2013SCM       
AP012/23/2014SLR41472032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019655Orig1s054,019910Orig1s041,019951Orig1s032,020518Orig1s024ltr.pdf 12/31/2014
AP012/23/2014SLR41552032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019910s041lbl.pdf 1/8/2015




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