FDA.reportPublic FDA data

LEDIPASVIR Pharmacologic Class Indexing

Class set ID
1e452da7-c332-4c67-9553-ea8d8cfefe02
Version
3
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
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 GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014Gilead Sciences, Inc2025061610
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: 2014Asegua Therapeutics LLC202501108
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: 2014Gilead Sciences, Inc2024122617