{"@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": "Ethacrynate Sodium is a prescription loop diuretic medication used to treat fluid retention (edema) by increasing urine production. It comes as a lyophilized powder for intravenous injection, with each vial containing 50 mg of the active ingredient. Manufactured by Leading Pharma, LLC, under application ANDA208663. 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 Ethacrynate sodium \u2014 ANDA 208663 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208663", "mediaType": "text/html", "title": "Ethacrynate sodium"}], "identifier": "ANDA208663", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "drug", "medications", "pharmaceuticals", "drug-safety"], "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": "Ethacrynate sodium"}