{"@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": "Recorlev (levoketoconazole) is a prescription oral tablet that inhibits cortisol production, used to treat endogenous Cushing's syndrome. Manufactured by Xeris Pharmaceuticals, Inc., it comes in 150 mg strength and was approved in 2021. 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 Levoketoconazole \u2014 ANDA 214133 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214133", "mediaType": "text/html", "title": "Levoketoconazole"}], "identifier": "ANDA214133", "issued": "2016-09-16", "keyword": ["drug-safety", "drug", "drug-manufacturers", "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": "Levoketoconazole"}