Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208341
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPCLUSA | SOFOSBUVIR; VELPATASVIR | 400MG;100MG | TABLET;ORAL | Prescription | None | Yes | Yes |
EPCLUSA | SOFOSBUVIR; VELPATASVIR | 200MG;50MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/28/2016 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208341Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208341Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/14/2022 | SUPPL-20 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208341Orig1s020Corrected_ltr.pdf |
04/27/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208341s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208341Orig1s019ltr.pdf | |
06/10/2021 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208341s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208341Orig1s017ltr.pdf | |
07/14/2020 | SUPPL-15 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208341Orig1s015ltr.pdf | |
03/19/2020 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208341Orig1s014ltr.pdf | |
09/19/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208341s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208341Orig1s013ltr.pdf | |
11/15/2019 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208341s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208341Orig1s012ltr.pdf | |
11/09/2017 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s009ltr.pdf | |
08/31/2017 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s007ltr.pdf | |
02/14/2017 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s002ltr.pdf | |
08/01/2017 | SUPPL-1 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0208341Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/27/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208341s019lbl.pdf | |
06/10/2021 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208341s017lbl.pdf | |
07/14/2020 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s015lbl.pdf | |
03/19/2020 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s014lbl.pdf | |
11/15/2019 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208341s012lbl.pdf | |
09/19/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208341s013lbl.pdf | |
11/09/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s009lbl.pdf | |
08/31/2017 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf | |
08/31/2017 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf | |
08/01/2017 | SUPPL-1 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s001lbl.pdf | |
02/14/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s002lbl.pdf | |
02/14/2017 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s002lbl.pdf | |
06/28/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf |