Amoxycillin + Potassium Clavulanate Tablets

Form: Tablets

Strength: 500 mg/125 mg, 875 mg/125 mg, 2 g/125 mg

Reference Brands: Augmentin, Augmentin XR(US); Augmentin, Amoxiclav(EU)

Category: Antibiotics

Amoxicillin Potassium + Clavulanate tablets are approved in both EU and US for treating bacterial infections. In the EU, brands like Augmentin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data; generics are also available. Both regions require detailed dossiers, including clinical trial results and pharmacovigilance plans, for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for amoxicillin-clavulanate tablets, ensuring adherence to European and US standards for safe, effective antibacterial therapy.