Gadobutrol
Gadobutrol is a prescription intravenous contrast agent used to enhance magnetic resonance imaging (MRI) scans, helping doctors visualize body structures more clearly. Manufactured by Fresenius Kabi USA, LLC, it's available in solution form with a concentration of 604.72 mg/mL in vials of 2 mL, 7.5 mL, 10 mL, or 15 mL. This gadolinium-based drug works by improving MRI contrast for better diagnosis. 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 | Gadobutrol is a prescription intravenous contrast agent used to enhance magnetic resonance imaging (MRI) scans, helping doctors visualize body structures more clearly. Manufactured by Fresenius Kabi USA, LLC, it's available in solution form with a concentration of 604.72 mg/mL in vials of 2 mL, 7.5 mL, 10 mL, or 15 mL. This gadolinium-based drug works by improving MRI contrast for better diagnosis. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[ { "@type": "dcat:Distribution", "title": "Gadobutrol", "mediaType": "text/html", "description": " Access the FDA dataset for Gadobutrol — ANDA 216081 submitted by Mylan Institutional LLC ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216081" } ] |
| identifier | ANDA216081 |
| issued | 2016-09-16 |
| keyword |
[ "drug-information", "fda", "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 | Gadobutrol |
