{"@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": "Pramipexole Dihydrochloride is a generic prescription medication available as extended-release oral tablets in strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg. It acts as a dopamine agonist to help manage symptoms of Parkinson's disease and restless legs syndrome. Manufactured by Ingenus Pharmaceuticals, LLC, under application ANDA213444. 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 Pramipexole dihydrochloride \u2014 ANDA 090781 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090781", "mediaType": "text/html", "title": "Pramipexole dihydrochloride"}], "identifier": "ANDA090781", "issued": "2016-09-16", "keyword": ["drug", "pharmaceuticals", "medications", "public-health", "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": "Pramipexole dihydrochloride"}