Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022116
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-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-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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021548s026,022116s010lbl.pdf
05/10/2011 SUPPL-10 Labeling-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

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