{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20260916",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "87216",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219713Orig1s004ltr.pdf",
              "date": "20260921",
              "type": "Letter"
            },
            {
              "id": "87238",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219713s004lbl.pdf",
              "date": "20260922",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250611",
          "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": "82556",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219713Orig1s000ltr.pdf",
              "date": "20250612",
              "type": "Letter"
            },
            {
              "id": "82557",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219713s000lbl.pdf",
              "date": "20250612",
              "type": "Label"
            },
            {
              "id": "82724",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219713Orig1s000TOC.html",
              "date": "20250702",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA219713",
      "sponsor_name": "NUVATION",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "IBTROZI",
          "active_ingredients": [
            {
              "name": "TALETRECTINIB ADIPATE",
              "strength": "EQ 200MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}