{
  "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": "20231101",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 10",
          "submission_class_code_description": "Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated",
          "application_docs": [
            {
              "id": "76037",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215151Orig1s000ltr.pdf",
              "date": "20231102",
              "type": "Letter"
            },
            {
              "id": "76038",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215151s000lbl.pdf",
              "date": "20231102",
              "type": "Label"
            },
            {
              "id": "78445",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215151Orig1s000TOC.html",
              "date": "20240510",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20240717",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79118",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218710Orig1s000,215151Orig1s006ltr.pdf",
              "date": "20240717",
              "type": "Letter"
            },
            {
              "id": "79329",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215151s006,218710s000lbl.pdf",
              "date": "20240807",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20251106",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84126",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215151Orig1s009ltr.pdf",
              "date": "20251107",
              "type": "Letter"
            },
            {
              "id": "84128",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215151s009lbl.pdf",
              "date": "20251107",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA215151",
      "sponsor_name": "PHATHOM",
      "openfda": {
        "application_number": [
          "NDA215151"
        ],
        "brand_name": [
          "VOQUEZNA"
        ],
        "generic_name": [
          "VONOPRAZAN FUMARATE"
        ],
        "manufacturer_name": [
          "Phathom Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "81520-100",
          "81520-200"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VONOPRAZAN FUMARATE"
        ],
        "rxcui": [
          "2604800",
          "2669507",
          "2669513",
          "2669515"
        ],
        "spl_id": [
          "cf9b3216-c9d6-4673-8693-b1ba3273c11d"
        ],
        "spl_set_id": [
          "0cc52ac5-77ec-4d66-a770-762a1a960914"
        ],
        "package_ndc": [
          "81520-100-30",
          "81520-200-30"
        ],
        "unii": [
          "4QW3X4AMLB"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "VOQUEZNA",
          "active_ingredients": [
            {
              "name": "VONOPRAZAN FUMARATE",
              "strength": "EQ 20MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VOQUEZNA",
          "active_ingredients": [
            {
              "name": "VONOPRAZAN FUMARATE",
              "strength": "EQ 10MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}