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FDA Drug Application 021503 by AGOURON

Application Number021503
Application Type New Drug Application
Sponsor ApplicantAGOURON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/2003N5580000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021503lbl.pdf 5/6/2003
AP04/30/2003N5743000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21503ltr.pdf 5/29/2003
AP04/30/2003N13285000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021503s000_ViraceptTOC.cfm 12/16/2005
AP03/19/2004SE58011001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf 3/24/2004
AP03/19/2004SE58248001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf 4/5/2004
AP03/19/2004SE517543001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021503_S001_VIRACEPT.pdf 8/6/2007
AP08/22/2003SLR6553002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf 8/28/2003
AP08/22/2003SLR6583002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf 8/29/2003
AP06/4/2004SLR9093003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf 6/7/2004
AP06/4/2004SLR9128003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf 6/7/2004
AP09/28/2005SLR12825006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf 9/30/2005
AP09/28/2005SLR12931006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf 10/20/2005
AP09/28/2005SLR17544006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021503_S006_VIRACEPT.pdf 8/6/2007
AP012/22/2006SLR15508007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf 12/28/2006
AP012/22/2006SLR15613007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf 1/8/2007
AP07/31/2007SLR17453009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf 8/2/2007
AP02/13/2008SLR19097011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021503s011ltr.pdf 2/14/2008
AP02/13/2008SLR19103011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf 2/14/2008
AP011/25/2008SLR21286014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf 11/26/2008
AP04/26/2010SLR25377015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf 4/28/2010
AP04/26/2010SLR25416015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf 5/3/2010
AP04/26/2010SLR25376016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf 4/28/2010
AP04/26/2010SLR25417016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf 5/3/2010
AP02/25/2011SLR27987017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf 2/28/2011
AP02/25/2011SLR28047017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf 3/4/2011
AP04/6/2012SLR32383018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf 4/9/2012
AP04/6/2012SLR32398018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf 4/11/2012
AP02/17/2012SLR31882020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf 2/24/2012
AP02/17/2012SLR31889020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf 2/27/2012
AP05/28/2013SLR36170021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf 5/31/2013
AP05/28/2013SLR36220021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf 6/4/2013
AP03/27/2015SLR42328023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf 3/31/2015
AP03/27/2015SLR42468023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf 4/7/2015
AP09/15/2016SLR47082024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf 9/20/2016
AP09/15/2016SLR47105024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf 9/20/2016




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