{"@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": "Tivdak (tisotumab vedotin) is a prescription biologic drug manufactured by Seagen Inc., approved under BLA 761208. It's an injectable powder for intravenous solution, available in 40 mg vials, used to treat certain cancers. Marketed since September 2021. 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 Tisotumab vedotin \u2014 ANDA 761208 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761208", "mediaType": "text/html", "title": "Tisotumab vedotin"}], "identifier": "ANDA761208", "issued": "2016-09-16", "keyword": ["drug", "drug-manufacturers", "health-care", "pharmaceuticals", "prescription-drugs"], "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": "Tisotumab vedotin"}