{"@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": "Diclofenac Sodium is a prescription topical gel containing 3% diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID). It's applied to the skin to help reduce pain and swelling from conditions like osteoarthritis or minor injuries. Manufactured by Padagis Israel Pharmaceuticals Ltd under ANDA210893. 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 Diclofenac sodium \u2014 ANDA 216548 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216548", "mediaType": "text/html", "title": "Diclofenac sodium"}], "identifier": "ANDA216548", "issued": "2016-09-16", "keyword": ["drug", "drug-safety", "fda", "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": "Diclofenac sodium"}