Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214187
Company: GILEAD SCIENCES INC

Products on NDA 214187

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPCLUSA	SOFOSBUVIR; VELPATASVIR	150MG;37.5MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	No
EPCLUSA	SOFOSBUVIR; VELPATASVIR	200MG;50MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214187

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214187s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214187Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214187Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214187s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214187Orig1s01ltr.pdf

Labels for NDA 214187

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214187s001lbl.pdf
06/10/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214187s000lbl.pdf