Dicyclomine injection

Form: injection

Strength: 10mg/ml

Reference Brands: Bentyl(US)

Category: Gastrointestinal Drugs

Dicyclomine injection, marketed as Bentyl, is approved in the US by the FDA and in the EU via EMA for severe gastrointestinal spasms and diagnostic procedures. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For dossier preparation, regulatory pathways, and market access guidance, visit PharmaTradz. Regulatory adherence supports swift approval, safe administration, and global availability, enabling effective management of severe GI conditions and supporting patient care worldwide.