Spironolactone Tablets
Form: Tablet
Strength: 25 mg, 50 mg, 100 mg
Reference Brands: Aldactone(US & EU)
Category: Heart Disorder
Spironolactone tablets, marketed as Aldactone, are approved in the US by the FDA and in the EU via EMA for conditions like edema, hypertension, and hyperaldosteronism. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed trial and quality data, while the EMA ensures compliance with safety and manufacturing standards across Europe. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and broader global availability of spironolactone tablets, helping manage cardiovascular and hormonal health effectively worldwide
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