Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021937
Company: GILEAD SCIENCES
Company: GILEAD SCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATRIPLA | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/12/2006 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021937s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021937TOC2.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/29/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021937s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021937Orig1s044ltr.pdf | |
| 07/25/2018 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021937s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021937Orig1s043Ltr.pdf | |
| 04/07/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021937s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021937Orig1s041ltr.pdf | |
| 02/11/2016 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021937Orig1s039ltr.pdf | |
| 11/20/2015 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s037ltr.pdf | |
| 01/12/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2015 | SUPPL-34 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s034ltr.pdf | |
| 11/26/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2013 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s031ltr.pdf | |
| 11/08/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s027ltr.pdf | |
| 06/14/2012 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021937s025ltr.pdf | |
| 09/16/2011 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021937s023ltr.pdf | |
| 08/06/2010 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s019ltr.pdf | |
| 01/07/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s012ltr.pdf | |
| 10/18/2008 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s011ltr.pdf |
| 06/06/2008 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s009ltr.pdf | |
| 02/28/2008 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s007ltr.pdf | |
| 02/15/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s006ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/29/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021937s044lbl.pdf | |
| 07/25/2018 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021937s043lbl.pdf | |
| 04/07/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021937s041lbl.pdf | |
| 02/11/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf | |
| 11/20/2015 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf | |
| 01/23/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf | |
| 01/23/2015 | SUPPL-34 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf | |
| 10/23/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf | |
| 04/17/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf | |
| 06/14/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf | |
| 06/14/2012 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf | |
| 09/16/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf | |
| 08/06/2010 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf | |
| 01/07/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf | |
| 06/06/2008 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf | |
| 02/28/2008 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf | |
| 02/15/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf | |
| 07/12/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf |
ATRIPLA
TABLET;ORAL; 600MG;200MG;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATRIPLA | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 021937 | GILEAD SCIENCES |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 203041 | AUROBINDO PHARMA |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 206894 | CIPLA |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 203053 | HETERO LABS LTD V |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 213541 | LAURUS |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 204287 | MACLEODS PHARMS LTD |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 091215 | TEVA PHARMS USA |