{"@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": "Fingolimod Hydrochloride is a generic prescription drug, equivalent to 0.5 mg of fingolimod base per capsule, used orally to treat relapsing forms of multiple sclerosis. Manufactured by Ascend Laboratories, LLC under ANDA208004, it modulates sphingosine 1-phosphate receptors to reduce immune cell migration into the central nervous system. 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 Fingolimod hydrochloride \u2014 ANDA 207991 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207991", "mediaType": "text/html", "title": "Fingolimod hydrochloride"}], "identifier": "ANDA207991", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "drug-safety", "fda", "health-care", "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": "Fingolimod hydrochloride"}