{"@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": "PROCYSBI (cysteamine bitartrate) is a prescription medication manufactured by Horizon Therapeutics USA, Inc., used to treat cystinosis by reducing cystine levels in the body. It comes as delayed-release capsules in 25 mg and 75 mg strengths, taken orally. 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 Cysteamine bitartrate \u2014 ANDA 020392 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020392", "mediaType": "text/html", "title": "Cysteamine bitartrate"}], "identifier": "ANDA020392", "issued": "2016-09-16", "keyword": ["medications", "drug", "drug-information", "fda", "drug-manufacturers"], "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": "Cysteamine bitartrate"}