Simvastatin
Simvastatin is a prescription medication used to lower cholesterol levels in the blood, reducing the risk of heart disease and stroke. It works by inhibiting an enzyme that produces cholesterol. Available as oral tablets in strengths of 5mg, 10mg, 20mg, 40mg, and 80mg, it's manufactured by Accord Healthcare under application ANDA078155. 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 | Simvastatin is a prescription medication used to lower cholesterol levels in the blood, reducing the risk of heart disease and stroke. It works by inhibiting an enzyme that produces cholesterol. Available as oral tablets in strengths of 5mg, 10mg, 20mg, 40mg, and 80mg, it's manufactured by Accord Healthcare under application ANDA078155. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Simvastatin",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Simvastatin — ANDA 021687 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021687"
}
]
|
| identifier | ANDA021687 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-information",
"medications",
"prescription-drugs",
"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 | Simvastatin |
