{"@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": "Orladeyo (berotralstat hydrochloride) is a prescription oral capsule medication manufactured by BioCryst Pharmaceuticals Inc. It works as a plasma kallikrein inhibitor to help prevent swelling attacks in people with hereditary angioedema. Available in 110 mg and 150 mg strengths, it's taken once daily. 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 Berotralstat hydrochloride \u2014 ANDA 219776 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219776", "mediaType": "text/html", "title": "Berotralstat hydrochloride"}], "identifier": "ANDA219776", "issued": "2016-09-16", "keyword": ["public-health", "drug-information", "health-care", "drug-manufacturers", "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": "Berotralstat hydrochloride"}