{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20180611",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54597",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207795Orig1s002ltr.pdf",
              "date": "20180614",
              "type": "Letter"
            },
            {
              "id": "54609",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207795s002lbl.pdf",
              "date": "20180619",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20171102",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "50364",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207795Orig1s000lbl.pdf",
              "date": "20171113",
              "type": "Label"
            },
            {
              "id": "50465",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207795Orig1s000ltr.pdf",
              "date": "20171120",
              "type": "Letter"
            },
            {
              "id": "50754",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207795Orig1s000TOC.html",
              "date": "20171218",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA207795",
      "sponsor_name": "BAUSCH AND LOMB",
      "openfda": {
        "application_number": [
          "NDA207795"
        ],
        "brand_name": [
          "VYZULTA"
        ],
        "generic_name": [
          "LATANOPROSTENE BUNOD"
        ],
        "manufacturer_name": [
          "Bausch & Lomb Incorporated"
        ],
        "product_ndc": [
          "24208-504"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "LATANOPROSTENE BUNOD"
        ],
        "rxcui": [
          "1988394",
          "1988399"
        ],
        "spl_id": [
          "12648511-1ae2-aaf8-e063-6394a90a2297"
        ],
        "spl_set_id": [
          "60ce7900-a677-4fc2-88d0-1603baa9dbd4"
        ],
        "package_ndc": [
          "24208-504-05",
          "24208-504-06",
          "24208-504-02",
          "24208-504-01"
        ],
        "unii": [
          "I6393O0922"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VYZULTA",
          "active_ingredients": [
            {
              "name": "LATANOPROSTENE BUNOD",
              "strength": "0.024%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION/DROPS",
          "route": "OPHTHALMIC",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}