An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 204671
Company: GILEAD SCIENCES INC

Summary Review

Products on NDA 204671

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOVALDI	SOFOSBUVIR	400MG	TABLET;ORAL	Prescription	AB	Yes	Yes
SOVALDI	SOFOSBUVIR	200MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204671

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2013	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204671Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2020	SUPPL-18	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204671Orig1s018ltr.pdf
03/05/2020	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204671s017,212480s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204671Orig1s017, 212480Orig1s002ltr.pdf
09/19/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204671s016,212480s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204671Orig1s016, 212480Orig1s001ltr.pdf
08/28/2019	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204671s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204671Orig1s014ltr.pdf
10/23/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204671s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204671Orig1s013ltr.pdf
11/09/2017	SUPPL-12	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204671Orig1s012ltr.pdf
02/14/2017	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf
04/07/2017	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204671Orig1s006ltr.pdf
03/20/2015	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s004ltr.pdf
08/19/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s002ltr.pdf
11/14/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204671s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204671Orig1s001ltr.pdf

Labels for NDA 204671

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204671s017,212480s002lbl.pdf
03/05/2020	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204671s017,212480s002lbl.pdf
09/19/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204671s016,212480s001lbl.pdf
08/28/2019	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204671s014lbl.pdf
10/23/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204671s013lbl.pdf
11/09/2017	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s012lbl.pdf
04/07/2017	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s006lbl.pdf
02/14/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf
02/14/2017	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf
08/19/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf
03/20/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf
03/20/2015	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf
11/14/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204671s001lbl.pdf
12/06/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf

Therapeutic Equivalents for NDA 204671

SOVALDI

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOVALDI	SOFOSBUVIR	400MG	TABLET;ORAL	Prescription	Yes	AB	204671	GILEAD SCIENCES INC

Top