Ursodiol is a generic version of Axcan’s Urso 250mg and Urso Forte tablets.
The final approval has been given for Glenmark’s abbreviated new drug application (ANDA) for generic Ursodiol tablets USP for 250mg and 500mg strengths.
Glenmark, the US subsidiary of India-based Glenmark Pharmaceuticals, expects to begin shipping of the drug from its New Jersey facility soon.