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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208341
Company: GILEAD SCIENCES INC

Products on NDA 208341

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208341

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-Package Insert, Labeling-Patient 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

Labels for NDA 208341

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf
08/31/2017	SUPPL-7	Labeling-Patient 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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