{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240419",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "78195",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218424Orig1s000lbl.pdf",
              "date": "20240422",
              "type": "Label"
            },
            {
              "id": "78196",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218424Orig1s000ltr.pdf",
              "date": "20240422",
              "type": "Letter"
            },
            {
              "id": "81919",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218424Orig1s000TOC.html",
              "date": "20250410",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA218424",
      "sponsor_name": "BAUSCH AND LOMB INC",
      "openfda": {
        "application_number": [
          "NDA218424"
        ],
        "brand_name": [
          "LUMIFY PRESERVATIVE FREE EYE DROPS"
        ],
        "generic_name": [
          "BRIMONIDINE TARTRATE"
        ],
        "manufacturer_name": [
          "Bausch & Lomb Incorporated"
        ],
        "product_ndc": [
          "24208-538"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BRIMONIDINE TARTRATE"
        ],
        "rxcui": [
          "1999016",
          "1999021"
        ],
        "spl_id": [
          "4d3fafb9-c501-72f3-e063-6294a90ab3e9"
        ],
        "spl_set_id": [
          "ef5974b9-946c-4983-80e3-32b3aa28c207"
        ],
        "package_ndc": [
          "24208-538-05",
          "24208-538-20"
        ],
        "unii": [
          "4S9CL2DY2H"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LUMIFY PRESERVATIVE FREE",
          "active_ingredients": [
            {
              "name": "BRIMONIDINE TARTRATE",
              "strength": "0.025%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION/DROPS",
          "route": "OPHTHALMIC",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}