{"@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": "GOPRELTO is a prescription nasal solution containing 4% cocaine hydrochloride (equivalent to 40 mg/mL). It is a DEA Schedule II controlled substance, manufactured by LXO US INC., and approved under NDA209963 for medical use. 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 Cocaine hydrochloride \u2014 ANDA 209575 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209575", "mediaType": "text/html", "title": "Cocaine hydrochloride"}], "identifier": "ANDA209575", "issued": "2016-09-16", "keyword": ["drug", "drug-information", "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": "Cocaine hydrochloride"}