Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022116
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEXIVA | FOSAMPRENAVIR CALCIUM | EQ 50MG BASE/ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 06/14/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022116s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022116_lexiva_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2019 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
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-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022116s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022116s024ltr.pdf | |
| 09/15/2016 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022116Orig1s023,021548Orig1s039ltr.pdf | |
| 03/22/2016 | SUPPL-21 | 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-20 | Labeling, 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-19 | 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 | |
| 02/12/2013 | SUPPL-15 | 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 | |
| 02/17/2012 | SUPPL-13 | 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-12 | 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-10 | Labeling-Package Insert, Labeling-Patient 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-8 | 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-5 | 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-4 | 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-3 | 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-1 | 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/28/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021548s041,022116s025lbl.pdf | |
| 03/28/2019 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021548s041,022116s025lbl.pdf | |
| 12/01/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022116s024lbl.pdf | |
| 12/01/2017 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022116s024lbl.pdf | |
| 09/15/2016 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023lbl.pdf | |
| 09/15/2016 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022116s023lbl.pdf | |
| 03/22/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021548s037,022116s021lbl.pdf | |
| 07/17/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf | |
| 07/17/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021548s035,022116s019lbl.pdf | |
| 03/27/2015 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf | |
| 03/27/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf | |
| 03/27/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022116s020,021548s036lbl.pdf | |
| 02/12/2013 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf | |
| 02/12/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021548s031,022116s015lbl.pdf | |
| 04/27/2012 | SUPPL-12 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s028,022116s012lbl.pdf | |
| 02/17/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021548s029,022116s013lbl.pdf | |
| 05/10/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf | |
| 05/10/2011 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf | |
| 04/26/2010 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021548s024,022116s008lbl.pdf | |
| 09/11/2009 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021548s021,022116s005lbl.pdf | |
| 03/05/2008 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021548s017,022116s001lbl.pdf | |
| 06/14/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022116lbl.pdf |