Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203100
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STRIBILD | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 150MG;150MG;200MG;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 |
|---|---|---|---|---|---|---|---|
| 08/27/2012 | 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/2012/203100s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/0203100Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/09/2021 | SUPPL-36 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203100s036lblet.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203100Orig1s036_CORRECTED_ltr.pdf | |
| 08/21/2020 | SUPPL-35 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203100s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203100Orig1s035ltr.pdf | |
| 02/06/2019 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203100s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203100Orig1s034ltr.pdf | |
| 11/02/2018 | SUPPL-33 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203100Orig1s33ltr.pdf | |
| 08/07/2018 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203100Orig1s032ltr.pdf | |
| 08/30/2017 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s030ltr.pdf | |
| 05/04/2017 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s029ltr.pdf | |
| 04/07/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s028ltr.pdf | |
| 01/27/2017 | SUPPL-25 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203100Orig1s025ltr.pdf | |
| 09/15/2016 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s024ltr.pdf | |
| 02/19/2016 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s021ltr.pdf | |
| 08/10/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/2015 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203100Orig1s016ltr.pdf | |
| 06/08/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2014 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s011ltr.pdf | |
| 08/28/2014 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s010ltr.pdf | |
| 10/23/2013 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s009ltr.pdf | |
| 11/08/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s004ltr.pdf | |
| 05/03/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/09/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203100s036lblet.pdf | |
| 09/09/2021 | SUPPL-36 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203100s036lblet.pdf | |
| 08/21/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203100s035lbl.pdf | |
| 08/21/2020 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203100s035lbl.pdf | |
| 02/06/2019 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203100s034lbl.pdf | |
| 11/02/2018 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s033lbl.pdf | |
| 11/02/2018 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s033lbl.pdf | |
| 08/07/2018 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203100s032lbl.pdf | |
| 08/30/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s030lbl.pdf | |
| 05/04/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf | |
| 05/04/2017 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s029lbl.pdf | |
| 04/07/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s028lbl.pdf | |
| 01/27/2017 | SUPPL-25 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203100s025lbl.pdf | |
| 09/15/2016 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s024lbl.pdf | |
| 02/19/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf | |
| 02/19/2016 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf | |
| 07/28/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf | |
| 07/28/2015 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf | |
| 12/17/2014 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf | |
| 08/28/2014 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s010lbl.pdf | |
| 10/23/2013 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s009lbl.pdf | |
| 10/02/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf | |
| 08/27/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf |