{"@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": "Everolimus is an oral prescription medication that acts as an immunosuppressant and mTOR inhibitor, used to prevent organ rejection in transplant patients and treat certain cancers or conditions like tuberous sclerosis. Available as tablets in strengths of 0.25mg, 0.5mg, 0.75mg, and 1mg, manufactured by Hikma Pharmaceuticals USA Inc. 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 Everolimus \u2014 ANDA 218863 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218863", "mediaType": "text/html", "title": "Everolimus"}], "identifier": "ANDA218863", "issued": "2016-09-16", "keyword": ["drug-safety", "drug-information", "prescription-drugs", "drug-manufacturers", "public-health"], "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": "Everolimus"}