{
  "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": "17",
          "submission_status": "AP",
          "submission_status_date": "20200615",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63579",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s017lbl.pdf",
              "date": "20200615",
              "type": "Label"
            },
            {
              "id": "63650",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022405Orig1s017replacementltr.pdf",
              "date": "20200713",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20250514",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82244",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022405s023lbl.pdf",
              "date": "20250514",
              "type": "Label"
            },
            {
              "id": "82245",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022405s023lbl.pdf#page=21",
              "date": "20250514",
              "type": "Medication Guide"
            },
            {
              "id": "82300",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022405Orig1s023ltr.pdf",
              "date": "20250523",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20230413",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "73988",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022405Orig1s021ltr.pdf",
              "date": "20230414",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20170224",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20170516",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48460",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022405Orig1s009ltr.pdf",
              "date": "20170519",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140331",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17327",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf",
              "date": "20140401",
              "type": "Label"
            },
            {
              "id": "29691",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022405Orig1s007ltr.pdf",
              "date": "20140402",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20131127",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7333",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s005ltr.pdf",
              "date": "20131205",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20121009",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38664",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf",
              "date": "20121012",
              "type": "Label"
            },
            {
              "id": "7332",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022405Orig1s003ltr.pdf",
              "date": "20121011",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20260127",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "84848",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022405Orig1s026ltr.pdf",
              "date": "20260128",
              "type": "Letter"
            },
            {
              "id": "84866",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022405s026lbl.pdf",
              "date": "20260128",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110622",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38663",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf",
              "date": "20110629",
              "type": "Label"
            },
            {
              "id": "29689",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s001ltr.pdf",
              "date": "20110629",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20250626",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82676",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022405Orig1s024ltr.pdf",
              "date": "20250627",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20200605",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63439",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s016lbl.pdf",
              "date": "20200605",
              "type": "Label"
            },
            {
              "id": "63442",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022405Orig1s016ltr.pdf",
              "date": "20200608",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20240307",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77758",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022405Orig1s022ltr.pdf",
              "date": "20240308",
              "type": "Letter"
            },
            {
              "id": "77767",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022405s022lbl.pdf",
              "date": "20240308",
              "type": "Label"
            },
            {
              "id": "77768",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022405s022lbl.pdf#page=21",
              "date": "20240308",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20181012",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "55913",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022405s014lbl.pdf",
              "date": "20181015",
              "type": "Label"
            },
            {
              "id": "55967",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022405Orig1s14ltr.pdf",
              "date": "20181017",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110406",
          "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": "42509",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000TOC.html",
              "date": "20110503",
              "type": "Review"
            },
            {
              "id": "44748",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000SumR.pdf",
              "date": "20110503",
              "type": "Summary Review"
            },
            {
              "id": "17325",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf",
              "date": "20110415",
              "type": "Label"
            },
            {
              "id": "24029",
              "title": "REMS",
              "url": "http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=11",
              "date": "20110708",
              "type": "Other"
            },
            {
              "id": "29688",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s000ltr.pdf",
              "date": "20110411",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160728",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "29692",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022405Orig1s010ltr.pdf",
              "date": "20160801",
              "type": "Letter"
            },
            {
              "id": "38665",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf",
              "date": "20160802",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20130703",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17326",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf",
              "date": "20130705",
              "type": "Label"
            },
            {
              "id": "29690",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s004ltr.pdf",
              "date": "20130708",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20220328",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "70637",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022405Orig1s019ltr.pdf",
              "date": "20220329",
              "type": "Letter"
            },
            {
              "id": "70656",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022405s019lbl.pdf",
              "date": "20220330",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20250923",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "83446",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022405Orig1s025ltr.pdf",
              "date": "20250925",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022405",
      "sponsor_name": "GENZYME CORP",
      "openfda": {
        "application_number": [
          "NDA022405"
        ],
        "brand_name": [
          "CAPRELSA"
        ],
        "generic_name": [
          "VANDETANIB"
        ],
        "manufacturer_name": [
          "Genzyme Corporation"
        ],
        "product_ndc": [
          "58468-7820",
          "58468-7840"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VANDETANIB"
        ],
        "rxcui": [
          "1098416",
          "1098418",
          "1114074",
          "1114096"
        ],
        "spl_id": [
          "abb9eb38-c6a9-49e9-8e90-852f95773feb"
        ],
        "spl_set_id": [
          "e5721cb8-4185-47b9-bbb3-1c587e558a03"
        ],
        "package_ndc": [
          "58468-7820-3",
          "58468-7840-3"
        ],
        "nui": [
          "N0000175605",
          "N0000175076",
          "N0000185503",
          "N0000187061"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Protein Kinase Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "YO460OQ37K"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CAPRELSA",
          "active_ingredients": [
            {
              "name": "VANDETANIB",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "CAPRELSA",
          "active_ingredients": [
            {
              "name": "VANDETANIB",
              "strength": "300MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}