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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209195
Company: GILEAD SCIENCES INC

Products on NDA 209195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOSEVI	SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR	400MG;100MG;100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2017	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209195Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209195_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209195s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209195Orig1s004ltr.pdf
11/15/2019	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209195s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209195Orig1s003ltr.pdf
11/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209195Orig1s002ltr.pdf

Labels for NDA 209195

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2019	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209195s003lbl.pdf
09/27/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209195s004lbl.pdf
11/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s002lbl.pdf
07/18/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s000lbl.pdf

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