{
  "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": "20260203",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "84923",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220406Orig1s000ltr.pdf",
              "date": "20260205",
              "type": "Letter"
            },
            {
              "id": "84940",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220406s000lbl.pdf",
              "date": "20260205",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA220406",
      "sponsor_name": "AVYXA HOLDINGS",
      "openfda": {
        "application_number": [
          "NDA220406"
        ],
        "brand_name": [
          "VYKOURA"
        ],
        "generic_name": [
          "LEUCOVORIN CALCIUM"
        ],
        "manufacturer_name": [
          "Avyxa Pharma, LLC"
        ],
        "product_ndc": [
          "83831-147",
          "83831-148",
          "83831-149"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEUCOVORIN CALCIUM"
        ],
        "rxcui": [
          "2104714",
          "2735355",
          "2735359",
          "2735364",
          "2735365",
          "2735366"
        ],
        "spl_id": [
          "c655613e-4381-461e-8e2d-4121be761c04"
        ],
        "spl_set_id": [
          "d122b875-435e-4e00-b945-7a0546df95c2"
        ],
        "package_ndc": [
          "83831-147-05",
          "83831-148-35",
          "83831-149-50"
        ],
        "unii": [
          "RPR1R4C0P4"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "VYKOURA",
          "active_ingredients": [
            {
              "name": "LEUCOVORIN CALCIUM",
              "strength": "EQ 500MG BASE/50ML (EQ 10MG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAMUSCULAR, INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VYKOURA",
          "active_ingredients": [
            {
              "name": "LEUCOVORIN CALCIUM",
              "strength": "EQ 50MG BASE/5ML (EQ 10MG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAMUSCULAR, INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "VYKOURA",
          "active_ingredients": [
            {
              "name": "LEUCOVORIN CALCIUM",
              "strength": "EQ 350MG BASE/35ML (EQ 10MG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAMUSCULAR, INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}