{"@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": "AMJEVITA (adalimumab-atto) is a biosimilar medication to Humira, containing the active ingredient adalimumab, a monoclonal antibody that blocks tumor necrosis factor (TNF) to reduce inflammation. It's administered via subcutaneous injection in strengths like 20 mg/0.4 mL and 40 mg/0.8 mL, used to treat autoimmune conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Manufactured by Amgen Inc., it's a prescription drug approved under BLA761024. 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 Adalimumab-atto \u2014 ANDA 761024 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761024", "mediaType": "text/html", "title": "Adalimumab-atto"}], "identifier": "ANDA761024", "issued": "2016-09-16", "keyword": ["fda", "health-care", "drug-safety", "medications", "drug-information"], "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": "Adalimumab-atto"}