Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021356
Company: GILEAD SCIENCES INC
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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021356s058,022577s014lbl.pdf | |
| 04/24/2019 | SUPPL-58 | Labeling-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 |