Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207561
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENVOYA | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 150MG;150MG;200MG;EQ 10MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207561Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207561Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207561Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2022 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207561s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207561Orig1s029ltr.pdf | |
| 09/13/2021 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207561s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207561Orig1s027ltr.pdf | |
| 03/04/2021 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207561s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207561Orig1s025ltr.pdf | |
| 12/02/2020 | SUPPL-24 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207561s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207561Orig1s024ltr.pdf | |
| 03/18/2019 | SUPPL-23 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207561s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207561Orig1s023ltr.pdf | |
| 11/02/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s020ltr.pdf | |
| 12/10/2018 | SUPPL-18 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s018ltr.pdf | |
| 08/01/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s017Ltr.pdf | |
| 09/25/2017 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s014ltr.pdf | |
| 11/22/2017 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s013ltr.pdf | |
| 08/15/2017 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s011ltr.pdf | |
| 04/07/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s010ltr.pdf | |
| 09/15/2016 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s007ltr.pdf | |
| 02/15/2017 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf | |
| 02/15/2017 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf | |
| 03/08/2016 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s003ltr.pdf | |
| 12/07/2016 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s002ltr.pdf | |
| 09/07/2016 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/07/2022 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207561s029lbl.pdf | |
| 09/13/2021 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207561s027lbl.pdf | |
| 09/13/2021 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207561s027lbl.pdf | |
| 03/04/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207561s025lbl.pdf | |
| 12/02/2020 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207561s024lbl.pdf | |
| 12/02/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207561s024lbl.pdf | |
| 03/18/2019 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207561s023lbl.pdf | |
| 12/10/2018 | SUPPL-18 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s018lbl.pdf | |
| 11/02/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s020lbl.pdf | |
| 08/01/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s017lbl.pdf | |
| 11/22/2017 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s013lbl.pdf | |
| 09/25/2017 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s014lbl.pdf | |
| 08/15/2017 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s011lbl.pdf | |
| 04/07/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s010lbl.pdf | |
| 02/15/2017 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf | |
| 02/15/2017 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf | |
| 12/07/2016 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s002lbl.pdf | |
| 09/15/2016 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s007lbl.pdf | |
| 09/07/2016 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s001lbl.pdf | |
| 03/08/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s003lbl.pdf | |
| 11/05/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf |