{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240404",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "78248",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217677Orig1s001lbl.pdf",
              "date": "20240425",
              "type": "Label"
            },
            {
              "id": "78249",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217677Orig1s001ltr.pdf",
              "date": "20240425",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20260310",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "85342",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217677Orig1s006ltr.pdf",
              "date": "20260312",
              "type": "Letter"
            },
            {
              "id": "85361",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217677s006lbl.pdf",
              "date": "20260312",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20231127",
          "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": "76667",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf",
              "date": "20231215",
              "type": "Label"
            },
            {
              "id": "76669",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217677Orig1s000correctedltr.pdf",
              "date": "20231227",
              "type": "Letter"
            },
            {
              "id": "77150",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217677Orig1s000TOC.html",
              "date": "20231227",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA217677",
      "sponsor_name": "SPRINGWORKS",
      "openfda": {
        "application_number": [
          "NDA217677"
        ],
        "brand_name": [
          "OGSIVEO"
        ],
        "generic_name": [
          "NIROGACESTAT"
        ],
        "manufacturer_name": [
          "SpringWorks Therapeutics, Inc."
        ],
        "product_ndc": [
          "82448-100",
          "82448-150"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NIROGACESTAT"
        ],
        "rxcui": [
          "2680360",
          "2680362",
          "2680363",
          "2680364",
          "2680366",
          "2680368",
          "2680369",
          "2680370"
        ],
        "spl_id": [
          "39192daa-3e54-4741-adad-7d3742860396"
        ],
        "spl_set_id": [
          "f172e6ff-3190-41b0-b95a-58a7ef9e9e1e"
        ],
        "package_ndc": [
          "82448-100-14",
          "82448-150-14"
        ],
        "nui": [
          "N0000194115",
          "N0000194116",
          "N0000190114",
          "N0000185607"
        ],
        "pharm_class_epc": [
          "Gamma Secretase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Gamma Secretase Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]"
        ],
        "unii": [
          "QZ62892OFJ"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "OGSIVEO",
          "active_ingredients": [
            {
              "name": "NIROGACESTAT HYDROBROMIDE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "OGSIVEO",
          "active_ingredients": [
            {
              "name": "NIROGACESTAT HYDROBROMIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OGSIVEO",
          "active_ingredients": [
            {
              "name": "NIROGACESTAT HYDROBROMIDE",
              "strength": "EQ 50MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}