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FDA Drug Application 020778 by AGOURON

Application Number020778
Application Type New Drug Application
Sponsor ApplicantAGOURON
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
AP03/14/1997N4352000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020778ap.pdf 3/14/1997
AP06/4/1997SCS       
AP07/31/1997SLR       
AP010/6/1997SCE       
AP012/19/1997SCM       
AP09/30/1997SLR       
AP04/24/1998SCM       
AP010/30/1998SCE       
AP05/25/1999SLR17533010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020778_S010_VIRACEPT.pdf 8/6/2007
AP011/24/1999SE2       
AP05/17/2000SE717534012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020778_S012_VIRACEPT.pdf 8/6/2007
AP03/28/2000SLR       
AP04/5/2001SLR5065014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20778S14ltr.pdf 4/11/2001
AP012/21/2001SCM17535015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020778_S015_VIRACEPT.pdf 8/6/2007
AP02/5/2002SCS2789016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf 2/5/2002
AP02/5/2002SLR2790017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf 2/5/2002
AP012/20/2002SLR4896018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20778slr018,20779slr039_Viracept_lbl.pdf 4/4/2003
AP012/20/2002SLR6234018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20778slr018,20779slr039_Viracept_lbl.pdf 7/30/2003
AP08/22/2003SLR6551020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf 8/28/2003
AP08/22/2003SLR6581020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf 8/29/2003
AP03/19/2004SE58009022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf 3/24/2004
AP03/19/2004SE58246022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf 4/5/2004
AP03/19/2004SE517536022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020778_S022_VIRACEPT.pdf 8/6/2007
AP06/4/2004SLR9089023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf 6/7/2004
AP06/4/2004SLR9126023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf 6/7/2004
AP09/28/2005SLR12827024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf 9/30/2005
AP09/28/2005SLR12929024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf 10/20/2005
AP012/22/2006SLR15510025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf 12/28/2006
AP012/22/2006SLR15615025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf 1/8/2007
AP07/31/2007SLR18615027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf 12/3/2007
AP02/13/2008SLR19099029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s029ltr.pdf 2/14/2008
AP02/13/2008SLR19101029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf 2/14/2008
AP011/25/2008SLR21284032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf 11/26/2008
AP04/26/2010SLR25378033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf 4/28/2010
AP04/26/2010SLR25420033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf 5/3/2010
AP04/26/2010SLR25421034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf 5/3/2010
AP04/26/2010SLR25379034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf 4/28/2010
AP02/25/2011SLR27985035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf 2/28/2011
AP02/25/2011SLR28193035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf 3/10/2011
AP04/6/2012SLR32381036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf 4/9/2012
AP04/6/2012SLR32396036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf 4/11/2012
AP02/17/2012SLR31884037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf 2/24/2012
AP02/17/2012SLR31887037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf 2/27/2012
AP05/28/2013SLR36168038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf 5/31/2013
AP05/28/2013SLR36222038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf 6/4/2013
AP03/27/2015SLR42326040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf 3/31/2015
AP03/27/2015SLR42466040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf 4/7/2015
AP09/15/2016SLR47083041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf 9/20/2016
AP09/15/2016SLR47103041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf 9/20/2016




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