isosorbide dinitrate and hydralazine hydrochloride

Wilshire Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Apr 14, 2022
Approval ID: 620a0680-aad0-4923-84be-7393c0cbdcbd
Products: 1 registered
Version: 2

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 tablet, for oral use Initial U.S. Approval: 2005

Quick Stats

Total Products1

Labelers2

Label Sections17

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.