Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021752
Company: GILEAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription AB Yes Yes
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET;ORAL Prescription None Yes No
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET;ORAL Prescription None Yes No
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/02/2004 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21752lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21752ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_TruvadaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2017 SUPPL-53 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021752Orig1S053ltr.pdf
06/08/2017 SUPPL-52 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021752Orig1s052ltr.pdf
02/25/2016 SUPPL-50 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021752Orig1s050ltr.pdf
03/10/2016 SUPPL-47 Efficacy-New Patient Population, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021752Orig1s047ltr.pdf
07/11/2014 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-44 REMS-Modified, REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021752Orig1s044ltr.pdf
12/16/2013 SUPPL-43 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s043ltr.pdf
10/23/2013 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s042ltr.pdf
11/08/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/08/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/21/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/17/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/17/2013 SUPPL-35 Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s035ltr.pdf
11/27/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/16/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021752Orig1s031ltr.pdf
07/16/2012 SUPPL-30 Efficacy-New Indication, REMS Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021752Orig1s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752_truvada_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752Orig1s030SumR.pdf
07/08/2011 SUPPL-27 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021752s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021752s027ltr.pdf
01/15/2010 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/06/2009 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021752s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021752s019ltr.pdf
11/04/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021752s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021752s017ltr.pdf
05/16/2008 SUPPL-16 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021752s016ltr.pdf
05/21/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021356s021, 021752s011ltr.pdf
10/05/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021752s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021752s006ltr.pdf
03/08/2006 SUPPL-5 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021752s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021752s005ltr.pdf
03/25/2005 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21752s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21752s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021752_S002_TRUVADA.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/21/2017 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf
04/21/2017 SUPPL-53 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf
03/10/2016 SUPPL-47 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf
03/10/2016 SUPPL-47 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf
02/25/2016 SUPPL-50 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s050lbl.pdf
02/25/2016 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s050lbl.pdf
12/16/2013 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s043lbl.pdf
10/23/2013 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s042lbl.pdf
06/17/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf
06/17/2013 SUPPL-35 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf
06/17/2013 SUPPL-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf
07/16/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s031lbl.pdf
07/16/2012 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s030lbl.pdf
07/16/2012 SUPPL-30 REMS Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s030lbl.pdf
07/08/2011 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021752s027lbl.pdf
07/08/2011 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021752s027lbl.pdf
11/06/2009 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021752s019lbl.pdf
11/04/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021752s017lbl.pdf
05/21/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf
03/08/2006 SUPPL-5 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021752s005lbl.pdf
10/05/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021752s006lbl.pdf
03/25/2005 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21752s002lbl.pdf
08/02/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21752lbl.pdf

TRUVADA

TABLET;ORAL; 200MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 090894 TEVA PHARMS USA
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription Yes AB 021752 GILEAD

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