{"@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": "Amiodarone Hydrochloride is a prescription medication used to treat irregular heartbeats (arrhythmias). This generic oral tablet, available in 200 mg strength, is manufactured by Unichem Pharmaceuticals (USA), Inc. and packaged by Bryant Ranch Prepack. It belongs to the antiarrhythmic drug class and inhibits certain enzymes. 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 Amiodarone hydrochloride \u2014 ANDA 075424 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=075424", "mediaType": "text/html", "title": "Amiodarone hydrochloride"}], "identifier": "ANDA075424", "issued": "2016-09-16", "keyword": ["pharmaceuticals", "drug-information", "drug-manufacturers", "health-care", "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": "Amiodarone hydrochloride"}