{"@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": "Cetirizine Hydrochloride is a prescription antihistamine used to relieve allergy symptoms such as runny nose, itchy eyes, sneezing, and hives. It comes as an oral solution with 1 mg/mL strength, typically taken by mouth. This generic medication is approved under ANDA090191 by BAJAJ MEDICAL, LLC. 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 Cetirizine hydrochloride \u2014 ANDA 078862 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078862", "mediaType": "text/html", "title": "Cetirizine hydrochloride"}], "identifier": "ANDA078862", "issued": "2016-09-16", "keyword": ["drug", "drug-information", "drug-safety", "health-care", "medications"], "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": "Cetirizine hydrochloride"}