{"@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": "Ganirelix Acetate is a prescription injectable medication used to prevent premature ovulation in women undergoing fertility treatments. It works by blocking certain hormones and is administered subcutaneously. Manufactured by Qilu Pharmaceutical Co., Ltd., each dose contains 250 mcg in 0.5 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 Ganirelix acetate \u2014 ANDA 218855 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218855", "mediaType": "text/html", "title": "Ganirelix acetate"}], "identifier": "ANDA218855", "issued": "2016-09-16", "keyword": ["health-care", "fda", "drug-safety", "prescription-drugs", "drug-manufacturers"], "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": "Ganirelix acetate"}