Gadoterate meglumine
Gadoterate Meglumine is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI) to enhance visibility of body structures. It's administered intravenously as a solution in various vial sizes, manufactured by Fresenius Kabi USA, LLC. This generic drug, approved under ANDA215304, helps diagnose conditions by improving MRI scans. This information was generated using AI and is provided for informational and research purposes only.
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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 | Gadoterate Meglumine is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI) to enhance visibility of body structures. It's administered intravenously as a solution in various vial sizes, manufactured by Fresenius Kabi USA, LLC. This generic drug, approved under ANDA215304, helps diagnose conditions by improving MRI scans. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[ { "@type": "dcat:Distribution", "title": "Gadoterate meglumine", "mediaType": "text/html", "description": " Access the FDA dataset for Gadoterate meglumine — ANDA 210016 submitted by Mylan Institutional LLC ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210016" } ] |
| identifier | ANDA210016 |
| issued | 2016-09-16 |
| keyword |
[ "drug-manufacturers", "drug-safety", "health-care", "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 | Gadoterate meglumine |
