Hydralazine tablets

Form: Tablets

Strength: 10 mg, 25 mg, 50 mg, 100 mg

Reference Brands: Apresoline(US & Eu)

Category: Hypertension

Hydralazine tablets, marketed as Apresoline, are approved in the US by the FDA and in the EU via EMA for managing severe hypertension and heart failure. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Adequate regional adherence supports timely approval, safe medication use, and worldwide availability, helping healthcare providers manage cardiovascular risks effectively across regions.