{"@type": "dcat:Dataset", "accessLevel": "public", "accrualPeriodicity": "R/P1Y", "bureauCode": ["009:10"], "contactPoint": {"@type": "vcard:Contact", "fn": "Division of Drug Information", "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", "description": "\n        Access the FDA dataset for Edaravone \u2014 ANDA 216199 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216199", "mediaType": "text/html", "title": "Edaravone"}], "identifier": "ANDA216199", "issued": "2016-09-16", "keyword": ["drug", "drug-safety", "medications", "health-care", "prescription-drugs"], "landingPage": "https://www.fda.gov/drugs", "license": "https://open.fda.gov/license", "modified": "2025-03-17", "programCode": ["009:002"], "publisher": {"@type": "org:Organization", "name": "U.S. Food and Drug Administration"}, "theme": ["FDA"], "title": "Edaravone"}