Product/Composition:- | Tolterodine tablets/ Capsules(IR & ER) |
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Strength:- | IR: 1 mg, 2 mg; ER: 2mg, 4 mg |
Form:- | Tablets/ Capsules(IR & ER) |
Reference Brands:- | Detrol, Detrol LA(US & EU) |
MOQ | As per the manufacturer batch size |
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Tolterodine capsules and tablets are antimuscarinic agents that block bladder muscarinic receptors, reducing involuntary contractions. They alleviate symptoms of overactive bladder, including urgency, frequency, and incontinence. Benefits include improved bladder control, enhanced daily comfort, and increased quality of life for patients suffering from bladder overactivity.
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.