Dicyclomine tablets and capsules

Form: Tablets and capsules

Strength: 10 mg

Reference Brands: Bentyl(US)

Category: Gastrointestinal Drugs

Dicyclomine tablets and capsules, marketed as Bentyl, are approved in the US by the FDA and in the EU via EMA for relief of gastrointestinal spasms and irritable bowel syndrome. 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 to ensure safety and efficacy, while the EMA assesses compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability, helping patients manage GI motility issues effectively across regions.