{"@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": "Glycopyrrolate Oral Solution is a prescription medication containing glycopyrrolate (1 mg per 5 mL), an anticholinergic drug that helps reduce excessive saliva production and certain stomach secretions. Manufactured by Taro Pharmaceuticals U.S.A. Inc., it's approved under ANDA212467 for oral use. 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 Glycopyrrolate oral solution \u2014 ANDA 212467 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212467", "mediaType": "text/html", "title": "Glycopyrrolate oral solution"}], "identifier": "ANDA212467", "issued": "2016-09-16", "keyword": ["pharmaceuticals", "drug-information", "medications", "prescription-drugs", "health-care"], "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": "Glycopyrrolate oral solution"}