{
  "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": "37",
          "submission_status": "AP",
          "submission_status_date": "20200814",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64285",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s037lbl.pdf",
              "date": "20200817",
              "type": "Label"
            },
            {
              "id": "64289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021938Orig1s037ltr.pdf",
              "date": "20200817",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20150424",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6511",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf",
              "date": "20150427",
              "type": "Letter"
            },
            {
              "id": "16617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf",
              "date": "20150428",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20081107",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16609",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf",
              "date": "20100922",
              "type": "Label"
            },
            {
              "id": "28889",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf",
              "date": "20100922",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20181213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56881",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021938Orig1s035Ltr.pdf",
              "date": "20181220",
              "type": "Letter"
            },
            {
              "id": "57150",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021938s035lbl.pdf",
              "date": "20190109",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20141219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37930",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021938s027lbl.pdf",
              "date": "20141223",
              "type": "Label"
            },
            {
              "id": "6510",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s027ltr.pdf",
              "date": "20141223",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20070202",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37919",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf",
              "date": "20070205",
              "type": "Label"
            },
            {
              "id": "21880",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s005_sutent.pdf",
              "date": "20070202",
              "type": "Review"
            },
            {
              "id": "28888",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf",
              "date": "20070212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20120420",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28894",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf",
              "date": "20120424",
              "type": "Letter"
            },
            {
              "id": "37926",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf",
              "date": "20120424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20171116",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "50435",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021938s033lbl.pdf",
              "date": "20171116",
              "type": "Label"
            },
            {
              "id": "50448",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021938Orig1s033ltr.pdf",
              "date": "20171117",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20130830",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37929",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf",
              "date": "20130909",
              "type": "Label"
            },
            {
              "id": "28897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf",
              "date": "20130904",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20070202",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37918",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf",
              "date": "20070202",
              "type": "Label"
            },
            {
              "id": "21878",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s003_sutent.pdf",
              "date": "20070202",
              "type": "Review"
            },
            {
              "id": "28887",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf",
              "date": "20070212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20110520",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6504",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf",
              "date": "20110525",
              "type": "Letter"
            },
            {
              "id": "16613",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf",
              "date": "20110520",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20151116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37932",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s031lbl.pdf",
              "date": "20151119",
              "type": "Label"
            },
            {
              "id": "28899",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s031ltr.pdf",
              "date": "20151117",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060510",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20121116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37928",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf",
              "date": "20121119",
              "type": "Label"
            },
            {
              "id": "6508",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf",
              "date": "20121119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20100701",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6503",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf",
              "date": "20100706",
              "type": "Letter"
            },
            {
              "id": "37924",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf",
              "date": "20100706",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20121116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28895",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf",
              "date": "20121119",
              "type": "Letter"
            },
            {
              "id": "37927",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf",
              "date": "20121119",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20110520",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "43555",
              "url": "http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256237.htm",
              "date": "20110520",
              "type": "FDA Press Release"
            },
            {
              "id": "28892",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf",
              "date": "20110525",
              "type": "Letter"
            },
            {
              "id": "37923",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf",
              "date": "20110520",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20100701",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16611",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf",
              "date": "20100706",
              "type": "Label"
            },
            {
              "id": "28891",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf",
              "date": "20100706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20200710",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63855",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021938Orig1s038ltr.pdf",
              "date": "20200713",
              "type": "Letter"
            },
            {
              "id": "63873",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s038lbl.pdf",
              "date": "20200713",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20081107",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37921",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf",
              "date": "20100922",
              "type": "Label"
            },
            {
              "id": "6501",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf",
              "date": "20100922",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20190507",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58613",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021938s036lbl.pdf",
              "date": "20190508",
              "type": "Label"
            },
            {
              "id": "58640",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021938Orig1s036ltr.pdf",
              "date": "20190513",
              "type": "Letter"
            },
            {
              "id": "63244",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21938S36 sunitinib CDTL clinical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20150424",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37931",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf",
              "date": "20150428",
              "type": "Label"
            },
            {
              "id": "28898",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf",
              "date": "20150427",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20081107",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37920",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf",
              "date": "20100922",
              "type": "Label"
            },
            {
              "id": "6500",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf",
              "date": "20100922",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20140611",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6509",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s026ltr.pdf",
              "date": "20140612",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20070202",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6499",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf",
              "date": "20070212",
              "type": "Letter"
            },
            {
              "id": "16608",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf",
              "date": "20070205",
              "type": "Label"
            },
            {
              "id": "21879",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s004_sutent.pdf",
              "date": "20070202",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20110520",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37925",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf",
              "date": "20110520",
              "type": "Label"
            },
            {
              "id": "6505",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf",
              "date": "20110525",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20070202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16607",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf",
              "date": "20070205",
              "type": "Label"
            },
            {
              "id": "21877",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s002_sutent.pdf",
              "date": "20070202",
              "type": "Review"
            },
            {
              "id": "28886",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf",
              "date": "20070212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20130830",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf",
              "date": "20130909",
              "type": "Label"
            },
            {
              "id": "28896",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf",
              "date": "20130904",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20151008",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20121116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6507",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf",
              "date": "20121119",
              "type": "Letter"
            },
            {
              "id": "16615",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf",
              "date": "20121119",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20100701",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf",
              "date": "20100706",
              "type": "Label"
            },
            {
              "id": "28893",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf",
              "date": "20100706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20120420",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6506",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf",
              "date": "20120424",
              "type": "Letter"
            },
            {
              "id": "16614",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf",
              "date": "20120424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20100701",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6502",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf",
              "date": "20100706",
              "type": "Letter"
            },
            {
              "id": "37922",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf",
              "date": "20100706",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060126",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "37917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf",
              "date": "20060126",
              "type": "Label"
            },
            {
              "id": "66907",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021938_sunitinib_Amend_1.pdf",
              "date": "19000101",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "66908",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N021938_sunitinib_Orig_WR.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "21876",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021938s000_021968s000_Stutent.html",
              "date": "20060406",
              "type": "Review"
            },
            {
              "id": "28885",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021938s000ltr.pdf",
              "date": "20060130",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20210830",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "68495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021938Orig1s039ltr.pdf",
              "date": "20210909",
              "type": "Letter"
            },
            {
              "id": "68513",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021938s039lbledt.pdf",
              "date": "20210902",
              "type": "Label"
            },
            {
              "id": "68514",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021938s039lbledt.pdf#page=34",
              "date": "20210902",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20090331",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "16610",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf",
              "date": "20090403",
              "type": "Label"
            },
            {
              "id": "28890",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021938s009ltr.pdf",
              "date": "20090403",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021938",
      "sponsor_name": "CPPI CV",
      "openfda": {
        "application_number": [
          "NDA021938"
        ],
        "brand_name": [
          "SUTENT"
        ],
        "generic_name": [
          "SUNITINIB MALATE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0550",
          "0069-0770",
          "0069-0980",
          "0069-0830"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SUNITINIB MALATE"
        ],
        "rxcui": [
          "616279",
          "616283",
          "616285",
          "616287",
          "616289",
          "616292",
          "1541890",
          "1541928"
        ],
        "spl_id": [
          "530eef58-b5ab-49f1-8d73-a2dae0356f24"
        ],
        "spl_set_id": [
          "43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c"
        ],
        "package_ndc": [
          "0069-0550-38",
          "0069-0770-38",
          "0069-0980-38",
          "0069-0830-38"
        ],
        "unii": [
          "LVX8N1UT73"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "SUTENT",
          "active_ingredients": [
            {
              "name": "SUNITINIB MALATE",
              "strength": "EQ 50MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SUTENT",
          "active_ingredients": [
            {
              "name": "SUNITINIB MALATE",
              "strength": "EQ 12.5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "SUTENT",
          "active_ingredients": [
            {
              "name": "SUNITINIB MALATE",
              "strength": "EQ 37.5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SUTENT",
          "active_ingredients": [
            {
              "name": "SUNITINIB MALATE",
              "strength": "EQ 25MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}