Fomepizole
Fomepizole is an injectable prescription drug used as an antidote to treat poisoning from substances like methanol or ethylene glycol. It is administered intravenously by healthcare professionals. Manufactured by Sagent Pharmaceuticals under FDA application ANDA216791. 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 | Fomepizole is an injectable prescription drug used as an antidote to treat poisoning from substances like methanol or ethylene glycol. It is administered intravenously by healthcare professionals. Manufactured by Sagent Pharmaceuticals under FDA application ANDA216791. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Fomepizole",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Fomepizole — ANDA 078537 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078537"
}
]
|
| identifier | ANDA078537 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-safety",
"medications",
"pharmaceuticals",
"prescription-drugs"
]
|
| 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 | Fomepizole |
