{"@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": "Monoferric (ferric derisomaltose) is an intravenous iron supplement used to treat iron deficiency anemia in adults. It's administered as an injection by healthcare providers. Manufactured by Pharmacosmos Therapeutics Inc., it's available in 100 mg/mL strength vials. 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 Ferric derisomaltose \u2014 ANDA 208171 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208171", "mediaType": "text/html", "title": "Ferric derisomaltose"}], "identifier": "ANDA208171", "issued": "2016-09-16", "keyword": ["health-care", "prescription-drugs", "pharmaceuticals", "drug", "fda"], "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": "Ferric derisomaltose"}