{"@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": "Argatroban is a prescription injectable medication used as an anticoagulant to prevent blood clots by inhibiting thrombin, a key clotting protein. It's administered intravenously as a 1 mg/mL solution. Manufactured by Gland Pharma Limited, it was approved via ANDA 217848 and became available in July 2023. 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 Argatroban \u2014 ANDA 212035 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212035", "mediaType": "text/html", "title": "Argatroban"}], "identifier": "ANDA212035", "issued": "2016-09-16", "keyword": ["health-care", "medications", "drug-manufacturers", "fda", "drug"], "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": "Argatroban"}