Nizatidine capsules

Form: Capsules

Strength: 150 mg

Reference Brands: Axid(US & EU)

Category: Gastrointestinal Drugs

Nizatidine capsules, marketed as Axid, are approved in the US by the FDA and in the EU via EMA for treating gastric ulcers, GERD, and Zollinger-Ellison syndrome. Regulatory approval requires comprehensive dossiers 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 detailed guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe use, and global availability of nizatidine capsules, helping improve gastrointestinal health and prevent ulcer complications worldwide.