Mylan Laboratories' Abbreviated New Drug Applications (ANDAs) for Oxybutynin Chloride Extended-release Tablets, 5 mg and 10 mg has been granted tentative approval by US FDA. Oxybutynin Chloride ER Tablets are the generic version of Alza Corporation's Ditropan XL Extended-release Tablets.

Mylan is the first generic drug company to file ANDAs with the FDA for 5 mg and 10 mg Ditropan XL, and as such, the company may be eligible for 180 days of market exclusivity, according to a company release.

Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Mylan Bertek Pharmaceuticals Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.