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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208341
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
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