{"@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": "Ganciclovir Sodium is an injectable antiviral medication used to treat infections caused by cytomegalovirus (CMV), often in patients with weakened immune systems. It comes as a 500 mg vial for intravenous infusion. This prescription drug is manufactured by Pharmascience Inc. and approved under ANDA207645. 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 Ganciclovir sodium \u2014 ANDA 076222 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076222", "mediaType": "text/html", "title": "Ganciclovir sodium"}], "identifier": "ANDA076222", "issued": "2016-09-16", "keyword": ["drug", "medications", "health-care", "fda", "drug-information"], "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": "Ganciclovir sodium"}