ursodiol
Drug Details
- Generic Name
- ursodiol
- Brand Names
- URSODIOL
- Application Number
- ANDA213504
- Sponsor
- Arch Pharmalabs Limited
- NDC Codes
- 5
- Dosage Forms
- POWDER, TABLET, CAPSULE
- Routes
- ORAL
- Active Ingredients
- URSODIOL
Indications and Usage
INDICATIONS AND USAGE • Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. • Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.