Harvoni

Gilead Sciences, Inc🇺🇸 United States

FDA Page

Effective Date: Jun 28, 2021
Approval ID: f4ec77e4-bae8-4db0-b3d5-bde09c5fa075
Products: 4 registered
Version: 16

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HARVONI safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use HARVONI (ledipasvir and sofosbuvir) oral pellets Initial U.S. Approval: 2014

Quick Stats

Total Products4

Labelers2

Label Sections43

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.