{"@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": "Palonosetron Hydrochloride is a prescription injectable medication used to prevent nausea and vomiting caused by chemotherapy or surgery. It's administered intravenously by healthcare professionals. Manufactured by Teva Parenteral Medicines, Inc., under ANDA090713, it's available in strengths like 0.25 mg/5 mL. 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 Palonosetron hydrochloride \u2014 ANDA 204702 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204702", "mediaType": "text/html", "title": "Palonosetron hydrochloride"}], "identifier": "ANDA204702", "issued": "2016-09-16", "keyword": ["health-care", "pharmaceuticals", "public-health", "drug-manufacturers", "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": "Palonosetron hydrochloride"}