Cimetidine tablets

Form: Injection

Strength: 200 mg and 300 mg

Reference Brands: Tagamet(US & EU)

Category: Gastrointestinal Drugs

Cimetidine tablets, marketed as Tagamet, are approved in the US by the FDA and in the EU via EMA for treating GERD, peptic ulcers, and Zollinger-Ellison syndrome. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews comprehensive clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports swift approval, safe medication use, and worldwide availability, helping improve gastrointestinal health and prevent ulcer complications globally.