Oxybutynin tablets

Form: Tablet(IR & ER)

Strength: IR: 5 mg, 10 mg; ER: 5 mg, 10 mg

Reference Brands: Ditropan, Oxybutynin XL(US)

Category: Multiple sclerosis

Oxybutynin IR and ER tablets, marketed as Ditropan and Ditropan XL, are approved in the US by the FDA and in the EU via EMA for overactive bladder management. Regulatory approval requires a detailed dossier containing clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical and quality data, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is essential for timely approval, safe use, and global availability of oxybutynin tablets, supporting effective long-term management of bladder overactivity worldwide.