{"@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": "Buprenorphine and Naloxone is a prescription film medication used to treat opioid dependence. It combines buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) to help reduce withdrawal symptoms and cravings. Available in buccal or sublingual forms with strengths like 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg buprenorphine/naloxone. It's a Schedule III controlled substance. 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 Buprenorphine and naloxone \u2014 ANDA 212756 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212756", "mediaType": "text/html", "title": "Buprenorphine and naloxone"}], "identifier": "ANDA212756", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "drug-safety", "health-care", "medications", "public-health"], "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": "Buprenorphine and naloxone"}