{"@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": "TEVIMBRA (tislelizumab-jsgr) is an intravenous injection used as an immunotherapy drug that blocks programmed death receptor-1 (PD-1) to help the immune system fight certain cancers. Manufactured by BeOne Medicines USA, Inc., it's available as a 10 mg/mL solution concentrate, approved under BLA761232 and marketed since March 2024. 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 Tislelizumab-jsgr \u2014 ANDA 761232 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761232", "mediaType": "text/html", "title": "Tislelizumab-jsgr"}], "identifier": "ANDA761232", "issued": "2016-09-16", "keyword": ["drug-information", "drug-manufacturers", "drug-safety", "prescription-drugs", "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": "Tislelizumab-jsgr"}