Chlorthalidone tablets

Form: Tablets

Strength: 25 mg, 50 mg, 100 mg

Reference Brands: Thalitone(US)

Category: Hypertension

Chlorthalidone tablets are approved in the US by the FDA and in the EU via EMA for hypertension and edema management. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and global availability of chlorthalidone tablets, helping manage blood pressure and fluid retention effectively worldwide.