ursodiol

FDA Drug Profile — 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

1 INDICATIONS AND USAGE Ursodiol tablets 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cholangitis. (1)