Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020779
Company: AGOURON PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRACEPT NELFINAVIR MESYLATE EQ 250MG 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
03/14/1997 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020779ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2016 SUPPL-62 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-61 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-59 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-58 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-57 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-56 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-55 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-54 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-53 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-50 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/2008/020779s050ltr.pdf
07/31/2007 SUPPL-48 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf
12/22/2006 SUPPL-46 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-45 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/2005/020779_S045_VIRACEPT.pdf
06/04/2004 SUPPL-44 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
03/19/2004 SUPPL-42 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/2004/020779_S042_VIRACEPT.pdf
08/27/2003 SUPPL-41 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
12/20/2002 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20778slr018,20779slr039_Viracept_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20778slr018,20779slr039_Viracept_lbl.pdf
02/05/2002 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf
02/05/2002 SUPPL-37 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf
10/26/2001 SUPPL-36 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S036_VIRACEPT.pdf
10/26/2001 SUPPL-35 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020779_S035_VIRACEPT.pdf
09/28/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/19/2001 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/2001 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20779S32ltr.pdf
11/08/2000 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/15/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/2000 SUPPL-29 Labeling

Label is not available on this site.

02/07/2000 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/17/2000 SUPPL-26 Efficacy-Accelerated Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020779_S026_VIRACEPT.pdf
08/17/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/06/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-22 Efficacy-New Dosing Regimen Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20779S22_viracept_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20779S22_viracept.cfm
03/19/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1999 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/020779_S020_VIRACEPT.pdf
12/01/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1998 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/14/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/05/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/04/1998 SUPPL-11 Manufacturing (CMC) Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20778S11_viracept.cfm
11/21/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/21/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/30/1997 SUPPL-7 Labeling

Label is not available on this site.

11/26/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/29/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1997 SUPPL-3 Labeling

Label is not available on this site.

06/04/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2016 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020778s041,020779s062,021503s024lbl.pdf
03/27/2015 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf
03/27/2015 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020778s040,020779s061,021503s023lbl.pdf
05/28/2013 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf
04/06/2012 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf
02/17/2012 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s037,020779s058,021503s020lbl.pdf
02/25/2011 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf
04/26/2010 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf
04/26/2010 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf
02/13/2008 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020778s029,020779s050,021503s011lbl.pdf
07/31/2007 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020778s027,020779s048,021503s009lbl.pdf
12/22/2006 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf
09/28/2005 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021503s006lbl.pdf
06/04/2004 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf
03/19/2004 SUPPL-42 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-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20778slr020,20779slr041,21503slr002_viracept_lbl.pdf
12/20/2002 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20778slr018,20779slr039_Viracept_lbl.pdf

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