Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021548
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEXIVA | FOSAMPRENAVIR CALCIUM | EQ 700MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/20/2003 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21548_levixa_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21548ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-548_Lexiva.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2019 | SUPPL-41 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021548s041,022116s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021548Orig1s041, 022116Orig1s025ltr.pdf | |
| 12/01/2017 | SUPPL-40 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021548s040lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021548s040ltr.pdf | |
| 09/15/2016 | SUPPL-39 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023_21548-s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022116Orig1s023,021548Orig1s039ltr.pdf | |
| 03/10/2016 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/2016 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116Orig1s021ltr.pdf | |
| 03/27/2015 | SUPPL-36 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022116Orig1s020,021548Orig1s036ltr.pdf | |
| 07/17/2015 | SUPPL-35 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021548Orig1s035,022116Orig1s019ltr.pdf | |
| 10/29/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2013 | SUPPL-31 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116Orig1s015ltr.pdf | |
| 08/28/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s029,022116s013ltr.pdf | |
| 04/27/2012 | SUPPL-28 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012ltr.pdf | |
| 05/10/2011 | SUPPL-26 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021548s026,022116s010ltr.pdf | |
| 04/26/2010 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021548s024, 022116s008ltr.pdf | |
| 09/11/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s021_022116s005ltr.pdf | |
| 04/14/2009 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021548s020,022116s004ltr.pdf |
| 04/30/2008 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s019, 022116s003ltr.pdf |
| 03/05/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s017, 022116s001ltr.pdf | |
| 02/20/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021548s016ltr.pdf | |
| 12/14/2007 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s015ltr.pdf | |
| 12/13/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s014ltr.pdf | |
| 10/12/2007 | SUPPL-13 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s013ltr.pdf | |
| 11/14/2006 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s011ltr.pdf | |
| 02/07/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021548s010ltr.pdf | |
| 08/07/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s009LTR.pdf | |
| 05/11/2006 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s008ltr.pdf | |
| 03/10/2006 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021548s007ltr.pdf | |
| 11/10/2005 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s005ltr.pdf | |
| 06/13/2005 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021548s004ltr.pdf | |
| 11/29/2004 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21548s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21548s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/28/2019 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021548s041,022116s025lbl.pdf | |
| 03/28/2019 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021548s041,022116s025lbl.pdf | |
| 12/01/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021548s040lbledt.pdf | |
| 12/01/2017 | SUPPL-40 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021548s040lbledt.pdf | |
| 09/15/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023_21548-s39lbl.pdf | |
| 09/15/2016 | SUPPL-39 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023_21548-s39lbl.pdf | |
| 03/22/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf | |
| 07/17/2015 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf | |
| 07/17/2015 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf | |
| 03/27/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf | |
| 03/27/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf | |
| 02/12/2013 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf | |
| 02/12/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf | |
| 04/27/2012 | SUPPL-28 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf | |
| 02/17/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf | |
| 05/10/2011 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf | |
| 05/10/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf | |
| 04/26/2010 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf | |
| 09/11/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf | |
| 03/05/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf | |
| 02/20/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s016lbl.pdf | |
| 12/14/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s015lbl.pdf | |
| 12/13/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s014lbl.pdf | |
| 10/12/2007 | SUPPL-13 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s013lbl.pdf | |
| 02/07/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021548s010lbl.pdf | |
| 11/14/2006 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s011lbl.pdf | |
| 08/07/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s009lbl.pdf | |
| 05/11/2006 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s008lbl.pdf | |
| 03/10/2006 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021548s007lbl.pdf | |
| 11/10/2005 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s005lbl.pdf | |
| 06/13/2005 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021548s004lbl.pdf | |
| 11/29/2004 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21548s002lbl.pdf | |
| 10/20/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21548_levixa_lbl.pdf |