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FDA Drug Application 020779 by AGOURON

Application Number020779
Application Type New Drug Application
Sponsor ApplicantAGOURON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/14/1997N4353000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020779ap.pdf 3/14/1997
AP06/16/1997SCM       
AP06/4/1997SCS       
AP07/31/1997SLR       
AP08/29/1997SCS       
AP08/29/1997SCE       
AP011/26/1997SCM       
AP09/30/1997SLR       
AP011/21/1997SCM       
AP02/3/1998SCM       
AP011/21/1997SCS       
AP05/4/1998SCM5545011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept.cfm 4/30/2003
AP05/4/1998SCM5546011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept_approv.pdf 4/30/2003
AP05/4/1998SCM       
AP06/5/1998SCS       
AP06/12/1998SCM       
AP07/17/1998SCS       
AP09/14/1998SCS       
AP010/30/1998SCE       
AP012/1/1998SCS       
AP05/25/1999SLR17537020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/020779_S020_VIRACEPT.pdf 8/6/2007
AP03/19/1999SCS       
AP011/24/1999SE25544022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20779S22_viracept.cfm 4/30/2003
AP011/24/1999SE25547022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20779S22_viracept_approv.pdf 4/30/2003
AP07/16/1999SCS       
AP08/6/1999SCM       
AP08/17/1999SCM       
AP05/17/2000SE717538026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020779_S026_VIRACEPT.pdf 8/6/2007
AP011/24/1999SCF       
AP02/7/2000SCS       
AP03/28/2000SLR       
AP09/15/2000SCS       
AP011/8/2000SCE       
AP04/5/2001SLR5066032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20779S32ltr.pdf 4/11/2001
AP06/19/2001SCS       
AP09/28/2001SCM       
AP010/26/2001SCM17539035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S035_VIRACEPT.pdf 8/6/2007
AP010/26/2001SCM17540036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S036_VIRACEPT.pdf 8/6/2007
AP02/5/2002SCS2791037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf 2/5/2002
AP02/5/2002SLR2792038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf 2/5/2002
AP012/20/2002SLR4897039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20778slr018,20779slr039_Viracept_lbl.pdf 4/4/2003
AP012/20/2002SLR6235039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20778slr018,20779slr039_Viracept_lbl.pdf 7/30/2003
AP08/22/2003SLR6552041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf 8/28/2003
AP08/22/2003SLR6582041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf 8/29/2003
AP03/19/2004SE58010042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf 3/24/2004
AP03/19/2004SE58247042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf 4/5/2004
AP03/19/2004SE517541042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020779_S042_VIRACEPT.pdf 8/6/2007
AP06/4/2004SLR9091044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf 6/7/2004
AP06/4/2004SLR9127044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf 6/7/2004
AP09/28/2005SLR12826045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf 9/30/2005
AP09/28/2005SLR12930045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf 10/20/2005
AP09/28/2005SLR17542045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020779_S045_VIRACEPT.pdf 8/6/2007
AP012/22/2006SLR15509046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf 12/28/2006
AP012/22/2006SLR15614046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf 1/8/2007
AP07/31/2007SLR18614048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf 12/3/2007
AP02/13/2008SLR19096050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020779s050ltr.pdf 2/14/2008
AP02/13/2008SLR19102050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf 2/14/2008
AP011/25/2008SLR21285053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf 11/26/2008
AP04/26/2010SLR25380054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf 4/28/2010
AP04/26/2010SLR25418054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf 5/3/2010
AP04/26/2010SLR25419055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf 5/3/2010
AP04/26/2010SLR25381055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf 4/28/2010
AP02/25/2011SLR27986056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf 2/28/2011
AP02/25/2011SLR28194056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf 3/10/2011
AP04/6/2012SLR32382057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf 4/9/2012
AP04/6/2012SLR32397057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf 4/11/2012
AP02/17/2012SLR31883058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf 2/24/2012
AP02/17/2012SLR31888058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf 2/27/2012
AP05/28/2013SLR36169059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf 5/31/2013
AP05/28/2013SLR36221059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf 6/4/2013
AP03/27/2015SLR42327061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf 3/31/2015
AP03/27/2015SLR42467061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf 4/7/2015
AP09/15/2016SLR47084062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf 9/20/2016
AP09/15/2016SLR47104062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf 9/20/2016




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