{"@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": "Dofetilide is an oral prescription antiarrhythmic medication used to treat irregular heartbeats like atrial fibrillation or flutter. Available as capsules in strengths of 0.125 mg, 0.25 mg, and 0.5 mg, it's manufactured by Bionpharma Inc. under application ANDA208625. 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 Dofetilide \u2014 ANDA 212750 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212750", "mediaType": "text/html", "title": "Dofetilide"}], "identifier": "ANDA212750", "issued": "2016-09-16", "keyword": ["drug", "drug-information", "medications", "pharmaceuticals", "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": "Dofetilide"}