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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021356
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIREAD TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription AB Yes Yes
VIREAD TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription AB Yes No
VIREAD TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription AB Yes No
VIREAD TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/24/2019 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf
04/24/2019 SUPPL-58 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf
12/11/2018 SUPPL-57 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s057,022577s013lbl.pdf
07/30/2018 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021356s056,022577s012lbl.pdf
04/07/2017 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021356s055,022577s011lbl.pdf
02/16/2016 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf
05/29/2015 SUPPL-49 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf
10/23/2013 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf
07/24/2013 SUPPL-46 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf
04/02/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf
04/02/2013 SUPPL-47 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf
08/16/2012 SUPPL-42 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf
08/07/2012 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf
01/18/2012 SUPPL-38 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s038lbl.pdf
11/18/2011 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s041lbl.pdf
09/19/2011 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s037lbl.pdf
10/14/2010 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s035lbl.pdf
10/01/2010 SUPPL-34 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s034lbl.pdf
03/24/2010 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s033lbl.pdf
11/10/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s028lbl.pdf
10/07/2009 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s027lbl.pdf
11/04/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s026lbl.pdf
08/11/2008 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s025lbl.pdf
05/21/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf
03/08/2006 SUPPL-16 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021356s016lbl.pdf
11/30/2005 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s017lbl.pdf
05/12/2005 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s011lbl.pdf
07/01/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21356slr010_viread_lbl.pdf
10/31/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr006_viread_lbl.pdf
10/14/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr005_viread_lbl.pdf
08/15/2003 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356se5-003_viread_lbl.pdf
12/02/2002 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21356slr001_Viread_lbl.pdf
10/26/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21356lbl.pdf
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