{"@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": "Fosfomycin Tromethamine is an oral antibiotic used to treat uncomplicated urinary tract infections (UTIs) in adults. It comes as a 3-gram granule packet that is mixed with water and taken as a single dose. This generic version is approved under ANDA214554 and manufactured by ALKEM LABS LTD. 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 Fosfomycin tromethamine \u2014 ANDA 216600 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216600", "mediaType": "text/html", "title": "Fosfomycin tromethamine"}], "identifier": "ANDA216600", "issued": "2016-09-16", "keyword": ["medications", "drug-safety", "health-care", "public-health", "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": "Fosfomycin tromethamine"}