{"@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": "Cyclobenzaprine Hydrochloride is a prescription muscle relaxant that helps relieve muscle spasms and pain. Available as oral tablets in 5mg, 7.5mg, and 10mg strengths, it's manufactured by Rising Pharma Holdings, Inc. under the brand FEXMID. 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 Cyclobenzaprine hydrochloride \u2014 ANDA 078218 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078218", "mediaType": "text/html", "title": "Cyclobenzaprine hydrochloride"}], "identifier": "ANDA078218", "issued": "2016-09-16", "keyword": ["prescription-drugs", "drug", "fda", "drug-information", "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": "Cyclobenzaprine hydrochloride"}