Oxybutynin Tablets Generics - Manufacturers & Suppliers
Ditropan, Oxybutynin XL(US)
| Product/Composition:- | Oxybutynin tablets |
|---|---|
| Strength:- | IR: 5 mg, 10 mg; ER: 5 mg, 10 mg |
| Form:- | Tablet(IR & ER) |
| Reference Brands:- | Ditropan, Oxybutynin XL(US) |
| MOQ | As per the manufacturer batch size |
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Oxybutynin IR and ER tablets block overactive bladder symptoms by antagonizing muscarinic receptors, reducing involuntary bladder contractions. Benefits include decreased urgency, frequency, and incontinence episodes, improved bladder control, greater comfort, and enhanced quality of life, supporting long-term management of overactive bladder with flexible dosing options.
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.