{"@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": "IGALMI is a prescription medication containing dexmedetomidine, available as a sublingual film in 120 mcg and 180 mcg doses. Manufactured by BioXcel Therapeutics, Inc., it acts as a central alpha-2 adrenergic agonist and is used for general anesthesia. 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 Dexmedetomidine \u2014 ANDA 205046 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205046", "mediaType": "text/html", "title": "Dexmedetomidine"}], "identifier": "ANDA205046", "issued": "2016-09-16", "keyword": ["prescription-drugs", "drug-information", "health-care", "fda", "drug"], "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": "Dexmedetomidine"}