Ledipasvir and Sofosbuvir

Asegua Therapeutics LLC🇺🇸 United States

FDA Page

Effective Date: Jun 25, 2021
Approval ID: 46f4a73b-0cd6-4902-9092-3ac79e882c1a
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use LEDIPASVIR and SOFOSBUVIR TABLETS safely and effectively. See full prescribing information for LEDIPASVIR and SOFOSBUVIR TABLETS. LEDIPASVIR and SOFOSBUVIR tablets, for oral use, 90 mg/400 mg (Authorized generic of HARVONI) Initial U.S. Approval: 2014

Quick Stats

Total Products1

Labelers2

Label Sections38

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.