{
  "@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 — 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": [
    "drug-manufacturers",
    "drug-safety",
    "health-care",
    "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"
}