{"@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": "Diphenoxylate Hydrochloride and Atropine Sulfate is a prescription oral solution used to treat diarrhea by slowing down bowel movements. Each 5 mL contains 2.5 mg diphenoxylate hydrochloride and 0.025 mg atropine sulfate. Manufactured by Hikma Pharmaceuticals USA Inc., it's a controlled substance (Schedule CV) to prevent abuse. 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 Diphenoxylate hydrochloride and atropine sulfate \u2014 ANDA 211362 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211362", "mediaType": "text/html", "title": "Diphenoxylate hydrochloride and atropine sulfate"}], "identifier": "ANDA211362", "issued": "2016-09-16", "keyword": ["drug-safety", "fda", "medications", "prescription-drugs", "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": "Diphenoxylate hydrochloride and atropine sulfate"}