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): 212480
Company: GILEAD SCIENCES INC

Products on NDA 212480

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOVALDI	SOFOSBUVIR	150MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	No
SOVALDI	SOFOSBUVIR	200MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212480

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2019	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212480s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212480Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212480Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2019	SUPPL-3	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212480Orig1s003ltr.pdf
03/05/2020	SUPPL-2	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-1	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,%20212480Orig1s001ltr.pdf

Labels for NDA 212480

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204671s017,212480s002lbl.pdf
03/05/2020	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204671s017,212480s002lbl.pdf
09/19/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204671s016,212480s001lbl.pdf
08/28/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212480s000lbl.pdf

Top