Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022081
Company: GILEAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LETAIRIS AMBRISENTAN 5MG TABLET;ORAL Prescription AB Yes No
LETAIRIS AMBRISENTAN 10MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/23/2019 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf
08/23/2019 SUPPL-41 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf
11/30/2018 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf
11/30/2018 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf
11/30/2018 SUPPL-40 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022081Orig1s040lbl.pdf
10/02/2015 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf
05/05/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s029lbl.pdf
01/31/2014 SUPPL-30 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf
08/17/2013 SUPPL-19 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf
08/17/2013 SUPPL-19 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf
10/19/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s022lbl.pdf
02/15/2012 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf
02/15/2012 SUPPL-14 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf
07/19/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s018lbl.pdf
03/03/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf
03/03/2011 SUPPL-17 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf
10/13/2010 SUPPL-12 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf
10/13/2010 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf
08/05/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf
07/01/2009 SUPPL-11 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf
07/01/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf
05/29/2009 SUPPL-8 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf
05/29/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf
10/08/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s004lbl.pdf
02/14/2008 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf
06/15/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf

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