{"@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": "Butalbital and Acetaminophen is a prescription oral tablet combining butalbital (a barbiturate for muscle relaxation) and acetaminophen (a pain reliever) to treat tension headaches. Available in strengths like 325mg acetaminophen with 50mg butalbital, it's a controlled substance (Schedule III) manufactured by Burel Pharmaceuticals, LLC under ANDA214088. 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 Butalbital and acetaminophen \u2014 ANDA 214088 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214088", "mediaType": "text/html", "title": "Butalbital and acetaminophen"}], "identifier": "ANDA214088", "issued": "2016-09-16", "keyword": ["prescription-drugs", "drug", "medications", "health-care", "pharmaceuticals"], "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": "Butalbital and acetaminophen"}