Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021503
Company: AGOURON PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRACEPT NELFINAVIR MESYLATE EQ 625MG BASE TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021503lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21503ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021503s000_ViraceptTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021503Orig1s024,020778Orig1s041,020779Orig1s062ltr.pdf
03/27/2015 SUPPL-23 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/20778Orig1s040,20779Orig1s061,21503Orig1s023ltr.pdf
05/28/2013 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020778Orig1s038,020779Orig1s059,021503Orig1s021ltr.pdf
02/17/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778s037,020779s058,021503s020ltr.pdf
04/06/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020778Orig1s036,020779Orig1s057,021503Orig1s018ltr.pdf
02/25/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020778s035,020779s056,021503s017ltr.pdf
04/26/2010 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf
04/26/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020778s033,s034,020779s054,s055,021503s015,s016ltr.pdf
11/25/2008 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020778s032, 020779s053, 021503s014ltr.pdf
02/13/2008 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021503s011ltr.pdf
07/31/2007 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf
12/22/2006 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020778s025, 020779s046, 021503s007ltr.pdf
09/28/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020778s024,020779s045,021503s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021503_S006_VIRACEPT.pdf
06/04/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778slr003,20779slr044,21503slr003ltr.pdf
08/27/2003 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20778slr020,20779slr041,21503slr002ltr.pdf
03/19/2004 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20778se5-022,20779se5-042,21503se5-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021503_S001_VIRACEPT.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf
03/27/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf
03/27/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf
05/28/2013 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf
04/06/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf
02/17/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf
02/25/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf
04/26/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf
04/26/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf
02/13/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf
07/31/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf
12/22/2006 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf
09/28/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf
06/04/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf
03/19/2004 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf
08/27/2003 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf
04/30/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021503lbl.pdf

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