Tolterodine tablets/ Capsules(IR & ER)

Form: Tablets/ Capsules(IR & ER)

Strength: IR: 1 mg, 2 mg; ER: 2mg, 4 mg

Reference Brands: Detrol, Detrol LA(US & EU)

Category: Multiple sclerosis

Tolterodine capsules and tablets, marketed as Detrol and Detrol LA, are approved in the US by the FDA and in the EU via EMA for overactive bladder treatment. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and manufacturing data, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring thorough compliance supports timely approval, safe use, and global availability of tolterodine products, helping improve bladder control and patient quality of life worldwide.