{"@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": "Harvoni is a prescription medication by Gilead Sciences containing ledipasvir and sofosbuvir, used to treat chronic hepatitis C virus (HCV) infection in adults. It comes as oral pellets in strengths like 45 mg ledipasvir and 200 mg sofosbuvir per packet, taken once daily for 8-12 weeks depending on HCV genotype. It works by inhibiting HCV replication. Consult a doctor for proper use and side effects. 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 Ledipasvir and sofosbuvir \u2014 ANDA 212477 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212477", "mediaType": "text/html", "title": "Ledipasvir and sofosbuvir"}], "identifier": "ANDA212477", "issued": "2016-09-16", "keyword": ["health-care", "drug-safety", "drug-manufacturers", "medications", "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": "Ledipasvir and sofosbuvir"}