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Drugs@FDA: FDA-Approved Drugs

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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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2024	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212480s004,204671s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212480Orig1s4,204671Orig1s19ltr.pdf
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
12/23/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212480s004,204671s019lbl.pdf
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

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