Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021752
Company: GILEAD
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 | AB | Yes | No |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|
| 10/11/2023 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021752Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021752Orig1s063ltr.pdf | |
| 06/23/2020 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021752Orig1s061ltr.pdf | |
| 07/01/2019 | SUPPL-60 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021752Orig1s060ltr.pdf |
| 05/15/2018 | SUPPL-55 | Efficacy-New Patient Population, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021752s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021752Orig1s055ltr.pdf | |
| 12/08/2017 | SUPPL-54 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 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-Assessment, REMS-Modified |
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-Medication Guide, Labeling-Package Insert, REMS-Modified |
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 |
|---|---|---|---|---|---|
| 10/11/2023 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021752Orig1s063lbl.pdf | |
| 06/23/2020 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf | |
| 05/15/2018 | SUPPL-55 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021752s055lbl.pdf | |
| 05/15/2018 | SUPPL-55 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021752s055lbl.pdf | |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.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 | |
| 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 | 201806 | HETERO LABS LTD III |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 209721 | AMNEAL PHARMS CO |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 090513 | AUROBINDO PHARMA |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 204131 | CHARTWELL RX |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 212114 | LAURUS |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 203442 | MACLEODS PHARMS LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 206436 | MYLAN |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 091055 | STRIDES PHARMA |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 090894 | TEVA PHARMS USA |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 021752 | GILEAD |
TABLET;ORAL; 100MG;150MG
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 | 100MG;150MG | TABLET;ORAL | Prescription | No | AB | 209721 | AMNEAL PHARMS CO |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET;ORAL | Prescription | No | AB | 211640 | AUROBINDO PHARMA LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET;ORAL | Prescription | Yes | AB | 021752 | GILEAD |
TABLET;ORAL; 133MG;200MG
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 | 133MG;200MG | TABLET;ORAL | Prescription | No | AB | 209721 | AMNEAL PHARMS CO |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | No | AB | 211640 | AUROBINDO PHARMA LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | Yes | AB | 021752 | GILEAD |
TABLET;ORAL; 167MG;250MG
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 | 167MG;250MG | TABLET;ORAL | Prescription | No | AB | 209721 | AMNEAL PHARMS CO |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | No | AB | 211640 | AUROBINDO PHARMA LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | Yes | AB | 021752 | GILEAD |