Sulfamethoxazole + Trimethoprim Tablets

Form: Tablet

Strength: 160 mg sulfamethoxazole + 800 mg trimethoprim; 80mg/400 mg

Reference Brands: Bactrim(US)

Category: Antibiotics

Sulfamethoxazole + Trimethoprim tablets are approved in both the EU and US for treating urinary, respiratory, and skin bacterial infections. In the EU, brands like Bactrim and Septra are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generic options are widely available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans for approval and post-marketing safety. For expert regulatory support, dossier management, and registration, visit PharmaTradz. We facilitate seamless market access, ensuring adherence to European and US standards for safe, effective antibiotic therapy.