{"@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": "Tacrolimus Ointment 0.1% is a prescription topical medication used to treat moderate to severe atopic dermatitis (eczema) in patients who haven't responded well to other treatments. It works by suppressing the immune response in the skin to reduce inflammation and itching. Apply a thin layer to affected areas twice daily, avoiding use on infected skin. Manufactured by Encube Ethicals, Inc., it's available in 30g, 60g, and 100g tubes. 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 Tacrolimus ointment 0.1% \u2014 ANDA 212387 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212387", "mediaType": "text/html", "title": "Tacrolimus ointment 0.1%"}], "identifier": "ANDA212387", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "fda", "medications", "pharmaceuticals", "prescription-drugs"], "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": "Tacrolimus ointment 0.1%"}