Isosorbide dinitrate and hydralazine hydrochloride

Ingenus Pharmaceuticals, LLC🇺🇸 United States

FDA Page

Effective Date: May 11, 2022
Approval ID: 8f54d5a3-169f-48dd-9250-2c176d2bd9ad
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLETS.Isosorbide dinitrate and hydralazine hydrochloride tablets, for oral useInitial U.S. Approval: 2005

Quick Stats

Total Products1

Labelers2

Label Sections16

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.