Cotrimoxazole tablets

Form: Tablets

Strength: 80 mg trimethoprim / 400 mg sulfamethoxazole

Reference Brands: Bactrim, Septra(US & EU)

Category: Transplant

Cotrimoxazole tablets, marketed as Bactrim and Septra, are approved in the US by the FDA and in the EU via EMA for treating bacterial infections including urinary tract, respiratory, and skin infections. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and worldwide availability of cotrimoxazole tablets, ensuring effective antibacterial therapy for patients across the globe.