Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020779
Company: AGOURON PHARMS
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 |
|---|---|---|---|---|---|
| 03/24/2021 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020778s042,020779s063,021503s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020778Orig1s042, 020779Orig1s063, 021503Orig1s025ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/24/2021 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020778s042,020779s063,021503s025lbl.pdf | |
| 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 |