Ursodiol
Ursodiol is a prescription medication available as 300 mg oral capsules, manufactured by Laurus Labs Limited under ANDA213200. It belongs to the bile acids and salts class and is used to treat certain liver conditions like gallstones and primary biliary cholangitis by helping dissolve cholesterol in bile. Packaged as 100 capsules per bottle (NDC 42385-946-01), it was approved for marketing in April 2021. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | Ursodiol is a prescription medication available as 300 mg oral capsules, manufactured by Laurus Labs Limited under ANDA213200. It belongs to the bile acids and salts class and is used to treat certain liver conditions like gallstones and primary biliary cholangitis by helping dissolve cholesterol in bile. Packaged as 100 capsules per bottle (NDC 42385-946-01), it was approved for marketing in April 2021. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Ursodiol",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Ursodiol — ANDA 212452 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212452"
}
]
|
| identifier | ANDA212452 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"health-care",
"medications",
"pharmaceuticals",
"public-health"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Ursodiol |
