{
  "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": "13",
          "submission_status": "AP",
          "submission_status_date": "20120824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6456",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021923Origs013ltr.pdf",
              "date": "20120827",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20071116",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37878",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf",
              "date": "20071119",
              "type": "Label"
            },
            {
              "id": "6451",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf",
              "date": "20071126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20110322",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6455",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s011ltr.pdf",
              "date": "20110325",
              "type": "Letter"
            },
            {
              "id": "16571",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s011lbl.pdf",
              "date": "20110328",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20230828",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "75547",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021923Orig1s026lbl.pdf",
              "date": "20230925",
              "type": "Label"
            },
            {
              "id": "75646",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021923Orig1s026ltr.pdf",
              "date": "20231003",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20171222",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50914",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021923Orig1s018ltr.pdf",
              "date": "20171227",
              "type": "Letter"
            },
            {
              "id": "50929",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021923s018lbl.pdf",
              "date": "20171227",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20101026",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16570",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf",
              "date": "20101028",
              "type": "Label"
            },
            {
              "id": "28846",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf",
              "date": "20101103",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20200709",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63841",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s024lblrpl.pdf",
              "date": "20200717",
              "type": "Label"
            },
            {
              "id": "63842",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021923Orig1s024ltr.pdf",
              "date": "20200710",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20131122",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "37882",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s016lbl.pdf",
              "date": "20131122",
              "type": "Label"
            },
            {
              "id": "6458",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s016ltr.pdf",
              "date": "20131125",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20071116",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37880",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf",
              "date": "20071119",
              "type": "Label"
            },
            {
              "id": "6453",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf",
              "date": "20071126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20200619",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63662",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s022lbl.pdf",
              "date": "20200623",
              "type": "Label"
            },
            {
              "id": "63665",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021923Orig1s022ltr.pdf",
              "date": "20200623",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20130611",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6457",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s014ltr.pdf",
              "date": "20130612",
              "type": "Letter"
            },
            {
              "id": "16573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s014lbl.pdf",
              "date": "20130618",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20071116",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37879",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf",
              "date": "20071119",
              "type": "Label"
            },
            {
              "id": "28845",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf",
              "date": "20071126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20181206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56646",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021923s020lbl.pdf",
              "date": "20181207",
              "type": "Label"
            },
            {
              "id": "56656",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021923s020ltr.pdf",
              "date": "20181207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20111014",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16572",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021923s012lbl.pdf",
              "date": "20111020",
              "type": "Label"
            },
            {
              "id": "28847",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021923s012ltr.pdf",
              "date": "20111017",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20070305",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6450",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s003ltr.pdf",
              "date": "20070315",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20181206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56645",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021923s019lbl.pdf",
              "date": "20181207",
              "type": "Label"
            },
            {
              "id": "56655",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021923s019ltr.pdf",
              "date": "20181207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20210520",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "67573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021923Orig1s025ltr.pdf",
              "date": "20210524",
              "type": "Letter"
            },
            {
              "id": "67669",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021923Orig1s025lbl.pdf",
              "date": "20210909",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20141202",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20101026",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37881",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf",
              "date": "20101028",
              "type": "Label"
            },
            {
              "id": "6454",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021923s008,s009ltr.pdf",
              "date": "20101103",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20200402",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "62437",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021923Orig1s023ltr.pdf",
              "date": "20200403",
              "type": "Letter"
            },
            {
              "id": "62527",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021923s023lbl.pdf",
              "date": "20200410",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20051201",
          "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": "37877",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021923lbl.pdf",
              "date": "20060106",
              "type": "Label"
            },
            {
              "id": "21871",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021923_s000_NexavarTOC.html",
              "date": "20060208",
              "type": "Review"
            },
            {
              "id": "28844",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021923ltr.pdf",
              "date": "20060119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20131030",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "16574",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s015lbl.pdf",
              "date": "20131031",
              "type": "Label"
            },
            {
              "id": "28848",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021923Orig1s015ltr.pdf",
              "date": "20131031",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20071116",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6452",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021923s004,s005,s006,s007.pdf",
              "date": "20071126",
              "type": "Letter"
            },
            {
              "id": "16569",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s004s005s006s007lbl.pdf",
              "date": "20071119",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021923",
      "sponsor_name": "BAYER HLTHCARE",
      "openfda": {
        "application_number": [
          "NDA021923"
        ],
        "brand_name": [
          "NEXAVAR"
        ],
        "generic_name": [
          "SORAFENIB"
        ],
        "manufacturer_name": [
          "Bayer HealthCare Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "50419-488",
          "50419-489"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SORAFENIB"
        ],
        "rxcui": [
          "597747",
          "615979"
        ],
        "spl_id": [
          "e597a26e-e04a-4f91-8c7c-a83243286396"
        ],
        "spl_set_id": [
          "b50667e4-5ebc-4968-a646-d605058dbef0"
        ],
        "package_ndc": [
          "50419-488-58",
          "50419-489-01"
        ],
        "nui": [
          "N0000175605",
          "N0000175076"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Protein Kinase Inhibitors [MoA]"
        ],
        "unii": [
          "9ZOQ3TZI87"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NEXAVAR",
          "active_ingredients": [
            {
              "name": "SORAFENIB TOSYLATE",
              "strength": "EQ 200MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}