{
  "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": "2026-09-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20260826",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "87060",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220910Orig1s000ltr.pdf",
              "date": "20260828",
              "type": "Letter"
            },
            {
              "id": "87078",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220910Orig1s000lbl.pdf",
              "date": "20260901",
              "type": "Label"
            },
            {
              "id": "87090",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220910Orig1s000lbl.pdf#page=20",
              "date": "20260901",
              "type": "Medication Guide"
            }
          ]
        }
      ],
      "application_number": "NDA220910",
      "sponsor_name": "REVOLUTION MEDICINES",
      "openfda": {
        "application_number": [
          "NDA220910"
        ],
        "brand_name": [
          "RASONQUE"
        ],
        "generic_name": [
          "DARAXONRASIB"
        ],
        "manufacturer_name": [
          "Revolution Medicines, Inc."
        ],
        "product_ndc": [
          "85219-101",
          "85219-104"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DARAXONRASIB"
        ],
        "rxcui": [
          "2750160",
          "2750166",
          "2750168",
          "2750170"
        ],
        "spl_id": [
          "107d4cd9-2e5e-419d-9449-7ef84f5fbcc9"
        ],
        "spl_set_id": [
          "13a65923-d072-4dac-8620-8eabbf8c3641"
        ],
        "package_ndc": [
          "85219-101-01",
          "85219-104-01"
        ],
        "unii": [
          "B6T47Y2UAP"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "RASONQUE",
          "active_ingredients": [
            {
              "name": "DARAXONRASIB",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "RASONQUE",
          "active_ingredients": [
            {
              "name": "DARAXONRASIB",
              "strength": "150MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}