{
  "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": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20220810",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71769",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213591Orig1s004ltr.pdf",
              "date": "20220811",
              "type": "Letter"
            },
            {
              "id": "71789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf",
              "date": "20220811",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20220121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "69959",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213591Orig1s002ltr.pdf",
              "date": "20220125",
              "type": "Letter"
            },
            {
              "id": "69968",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s002lbl.pdf",
              "date": "20220125",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200506",
          "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": "62842",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213591s000lbl.pdf",
              "date": "20200506",
              "type": "Label"
            },
            {
              "id": "62845",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213591Orig1s000ltr.pdf",
              "date": "20200507",
              "type": "Letter"
            },
            {
              "id": "63374",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213591Orig1s000TOC.html",
              "date": "20200601",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20230324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73872",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213591Orig1s007ltr.pdf",
              "date": "20230327",
              "type": "Letter"
            },
            {
              "id": "73884",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213591s007lbl.pdf",
              "date": "20230327",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240314",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77847",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213591Orig1s011ltr.pdf",
              "date": "20240315",
              "type": "Letter"
            },
            {
              "id": "77892",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf",
              "date": "20240321",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA213591",
      "sponsor_name": "NOVARTIS PHARM",
      "openfda": {
        "application_number": [
          "NDA213591"
        ],
        "brand_name": [
          "TABRECTA"
        ],
        "generic_name": [
          "CAPMATINIB"
        ],
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0078-0709",
          "0078-0716"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CAPMATINIB HYDROCHLORIDE"
        ],
        "rxcui": [
          "2362234",
          "2362240",
          "2362242",
          "2362244"
        ],
        "spl_id": [
          "0df064bb-358d-4c21-8525-9b8b9a5845a1"
        ],
        "spl_set_id": [
          "455892c3-d144-4ba8-9ab4-79cabff9876d"
        ],
        "package_ndc": [
          "0078-0709-56",
          "0078-0709-94",
          "0078-0716-56",
          "0078-0716-94"
        ],
        "unii": [
          "C2A374O70X"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "TABRECTA",
          "active_ingredients": [
            {
              "name": "CAPMATINIB HYDROCHLORIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "TABRECTA",
          "active_ingredients": [
            {
              "name": "CAPMATINIB HYDROCHLORIDE",
              "strength": "EQ 200MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}