Nystatin Oral Suspensions/Tablets

Form: Tablets/Suspensions

Strength: Tab: 500,000 units, 1,000,000 units; Sus: 100,000 units/mL, 500,000 units/5 mL

Reference Brands: Mycostatin, Nilstat, Nystop(US)

Category: Anti-fungal

Nystatin tablets and suspension are approved in the EU and US for treating superficial candidiasis. In the EU, formulations like Nystan are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on comprehensive clinical data; generic versions are available. Both regions require detailed dossiers for approval and ongoing pharmacovigilance to ensure safety and efficacy. For expert assistance with regulatory dossiers, registration, and compliance, visit PharmaTradz. We streamline market access for nystatin tablets and suspension, ensuring adherence to European and American standards for safe, effective antifungal therapy.