Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203094
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYBOST | COBICISTAT | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/2014 | ORIG-2 | Approval | Efficacy | STANDARD |
Label is not available on this site. |
||
| 09/24/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/09/2021 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203094s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203094Orig1s016ltr.pdf | |
| 08/21/2020 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203094s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203094Orig1s015ltr.pdf | |
| 10/03/2019 | SUPPL-14 | Efficacy-New Patient Population, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203094Orig1s014ltr.pdf | |
| 08/22/2019 | SUPPL-13 | Efficacy-New Patient Population, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203094Orig1s013ltr.pdf | |
| 10/30/2018 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203094Orig1s012ltr.pdf | |
| 07/27/2018 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203094Orig1s011ltr.pdf | |
| 08/28/2017 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203094Orig1s008ltr.pdf | |
| 05/04/2017 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203094Orig1s007ltr.pdf | |
| 06/17/2016 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203094Orig1s005ltr.pdf | |
| 04/15/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/2015 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203094Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203094Orig1s003ltr.pdf | |
| 04/17/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2015 | 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-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203094s016lbl.pdf | |
| 09/09/2021 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203094s016lbl.pdf | |
| 08/21/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203094s015lbl.pdf | |
| 08/21/2020 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203094s015lbl.pdf | |
| 10/03/2019 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf | |
| 10/03/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf | |
| 10/03/2019 | SUPPL-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf | |
| 08/22/2019 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf | |
| 08/22/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf | |
| 08/22/2019 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf | |
| 10/30/2018 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s012lbl.pdf | |
| 07/27/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s011lbl.pdf | |
| 08/28/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf | |
| 08/28/2017 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf | |
| 05/04/2017 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf | |
| 05/04/2017 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf | |
| 06/17/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf | |
| 06/17/2016 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf | |
| 11/25/2015 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203094Orig1s003lbl.pdf | |
| 09/24/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf |