{"@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": "Naproxen Sodium is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, reduce inflammation, and lower fever. This film-coated tablet contains 220 mg of naproxen sodium per dose, taken orally. Manufactured by Spirit Pharmaceuticals LLC under application ANDA207612, it is now discontinued. 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 Naproxen sodium \u2014 ANDA 202807 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202807", "mediaType": "text/html", "title": "Naproxen sodium"}], "identifier": "ANDA202807", "issued": "2016-09-16", "keyword": ["drug-information", "drug", "drug-safety", "drug-manufacturers", "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": "Naproxen sodium"}