{
  "@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": "Ketotifen Fumarate Ophthalmic Solution is an over-the-counter eye drop used to relieve itching caused by allergies. It works by blocking histamine, a substance that triggers itchiness. Apply one drop in each affected eye twice daily, or as directed. Available in 5 mL bottles. 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 Ketotifen fumarate — ANDA 077958 submitted by Mylan Institutional LLC\n    ",
      "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077958",
      "mediaType": "text/html",
      "title": "Ketotifen fumarate"
    }
  ],
  "identifier": "ANDA077958",
  "issued": "2016-09-16",
  "keyword": [
    "drug",
    "drug-information",
    "drug-manufacturers",
    "fda",
    "pharmaceuticals"
  ],
  "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": "Ketotifen fumarate"
}