{"@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": "Testosterone Gel, 1% is a prescription medication containing testosterone, an androgen hormone. It's applied to the skin (transdermal) to treat low testosterone levels in men, often due to hypogonadism. Available in gel packets or metered doses, it's a controlled substance (Schedule III). Consult a doctor for proper use and risks. 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 Testosterone gel, 1% \u2014 ANDA 212984 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212984", "mediaType": "text/html", "title": "Testosterone gel, 1%"}], "identifier": "ANDA212984", "issued": "2016-09-16", "keyword": ["fda", "drug-information", "prescription-drugs", "health-care", "medications"], "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": "Testosterone gel, 1%"}