Business · 06/06/2016Updated: 10/17/2026 · 1 min read

FDA Clears APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug Products for Sale

Summary

The US Food and Drug Administration (FDA) has ruled that APRESOLINE (Hydralazine Hydrochloride) Injectable and other listed drug products were not withdrawn from sale due to safety or effectiveness concerns, allowing the FDA to continue approving abbreviated new drug applications (ANDAs) for these products.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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