Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202123
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMPLERA | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;EQ 25MG BASE;300MG | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 08/10/2011 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202123s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123_compleratm_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/27/2019 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202123s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202123Orig1s031ltr.pdf | |
| 10/31/2018 | SUPPL-29 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202123s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202123Orig1s029ltr.pdf | |
| 04/07/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202123s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202123Orig1s027ltr.pdf | |
| 03/09/2016 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2016 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s021s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf | |
| 02/09/2016 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s023ltr.pdf | |
| 12/29/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2016 | SUPPL-21 | Efficacy-New Patient Population |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf |
| 05/05/2015 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202123Orig1s020ltr.pdf | |
| 09/16/2014 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s018ltr.pdf | |
| 07/11/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2014 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s016ltr.pdf | |
| 10/23/2013 | SUPPL-15 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s015ltr.pdf | |
| 11/08/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/2013 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s012ltr.pdf | |
| 06/20/2013 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s011ltr.pdf | |
| 05/10/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202123s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202123Orig1s006ltr.pdf | |
| 01/25/2013 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/27/2019 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202123s031lbl.pdf | |
| 10/31/2018 | SUPPL-29 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202123s029lbl.pdf | |
| 04/07/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202123s027lbl.pdf | |
| 02/23/2016 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s021s024lbl.pdf | |
| 02/09/2016 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf | |
| 02/09/2016 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf | |
| 05/05/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf | |
| 09/16/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s018lbl.pdf | |
| 06/05/2014 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf | |
| 06/05/2014 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf | |
| 12/13/2013 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf | |
| 10/23/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf | |
| 10/23/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf | |
| 06/20/2013 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf | |
| 06/20/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf | |
| 01/25/2013 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf | |
| 08/10/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202123s006lbl.pdf | |
| 08/10/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf |