Edaravone
Edaravone is a prescription intravenous solution used for medical treatment, available in strengths of 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL). Manufactured by XGen Pharmaceuticals DJB, Inc., it is approved under ANDA217565 and marketed as a single-dose vial. 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 | Edaravone is a prescription intravenous solution used for medical treatment, available in strengths of 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL). Manufactured by XGen Pharmaceuticals DJB, Inc., it is approved under ANDA217565 and marketed as a single-dose vial. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[ { "@type": "dcat:Distribution", "title": "Edaravone", "mediaType": "text/html", "description": " Access the FDA dataset for Edaravone — ANDA 216199 submitted by Mylan Institutional LLC ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216199" } ] |
| identifier | ANDA216199 |
| issued | 2016-09-16 |
| keyword |
[ "drug", "drug-safety", "health-care", "medications", "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 | Edaravone |
