{"@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": "RALDESY is a prescription oral solution containing trazodone hydrochloride (10 mg/mL), a serotonin reuptake inhibitor used to treat major depressive disorder. Manufactured by Validus Pharmaceuticals LLC and approved under NDA218637, it comes in 150 mL and 300 mL bottles. 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 Trazodone hydrochloride oral \u2014 ANDA 218637 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218637", "mediaType": "text/html", "title": "Trazodone hydrochloride oral"}], "identifier": "ANDA218637", "issued": "2016-09-16", "keyword": ["drug-safety", "fda", "drug-manufacturers", "drug-information", "medications"], "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": "Trazodone hydrochloride oral"}