{"@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": "TRODELVY (sacituzumab govitecan) is a prescription biologic drug manufactured by Gilead Sciences, Inc. It comes as a powder for solution, administered intravenously, with each vial containing 180 mg of the active ingredient. 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 Sacituzumab govitecan \u2014 ANDA 761115 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761115", "mediaType": "text/html", "title": "Sacituzumab govitecan"}], "identifier": "ANDA761115", "issued": "2016-09-16", "keyword": ["medications", "drug-information", "drug", "health-care", "pharmaceuticals"], "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": "Sacituzumab govitecan"}