{
  "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": "28",
          "submission_status": "AP",
          "submission_status_date": "20240731",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79266",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021986Orig1s028ltr.pdf",
              "date": "20240802",
              "type": "Letter"
            },
            {
              "id": "79280",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021986s028lbl.pdf",
              "date": "20240802",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20160927",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "45426",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf",
              "date": "20160929",
              "type": "Label"
            },
            {
              "id": "45490",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021986Orig1s018ltr.pdf",
              "date": "20160930",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20111007",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28984",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf",
              "date": "20111013",
              "type": "Letter"
            },
            {
              "id": "38001",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf",
              "date": "20111012",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20150812",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "6597",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf",
              "date": "20150814",
              "type": "Letter"
            },
            {
              "id": "16697",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf",
              "date": "20150813",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20101028",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "16695",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf",
              "date": "20101028",
              "type": "Label"
            },
            {
              "id": "28983",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s007ltr.pdf",
              "date": "20101103",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20140410",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "6596",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021986Orig1s014ltr.pdf",
              "date": "20140414",
              "type": "Letter"
            },
            {
              "id": "38003",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf",
              "date": "20140512",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20100728",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28982",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022072s002,021986s005ltr.pdf",
              "date": "20100809",
              "type": "Letter"
            },
            {
              "id": "37999",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf",
              "date": "20100731",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20171109",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50407",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf",
              "date": "20171114",
              "type": "Label"
            },
            {
              "id": "50427",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s020ltr.pdf",
              "date": "20171115",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20080530",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "6592",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021986s003,022072s001ltr.pdf",
              "date": "20080603",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20071108",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "21896",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf",
              "date": "20110922",
              "type": "Review"
            },
            {
              "id": "28981",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf",
              "date": "20071119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20111007",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6595",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf",
              "date": "20111013",
              "type": "Letter"
            },
            {
              "id": "16696",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf",
              "date": "20111012",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20230208",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73422",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021986Orig1s027ltr.pdf",
              "date": "20230209",
              "type": "Letter"
            },
            {
              "id": "73440",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf",
              "date": "20230209",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20170810",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "49354",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s019lbl.pdf",
              "date": "20170814",
              "type": "Label"
            },
            {
              "id": "49412",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s019ltr.pdf",
              "date": "20170815",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20210629",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "67984",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021986Orig1s025ltr.pdf",
              "date": "20210630",
              "type": "Letter"
            },
            {
              "id": "67986",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021986s025lbl.pdf",
              "date": "20210630",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20150812",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "28986",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf",
              "date": "20150814",
              "type": "Letter"
            },
            {
              "id": "38004",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf",
              "date": "20150813",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20101028",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6594",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s008ltr.pdf",
              "date": "20101103",
              "type": "Letter"
            },
            {
              "id": "38000",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf",
              "date": "20101028",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20181115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56539",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s023lbl.pdf",
              "date": "20181123",
              "type": "Label"
            },
            {
              "id": "56690",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021986Orig1s023ltr.pdf",
              "date": "20181207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060628",
          "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": "16693",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf",
              "date": "20060703",
              "type": "Label"
            },
            {
              "id": "21895",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021986_022072_SprycelTOC.html",
              "date": "20060906",
              "type": "Review"
            },
            {
              "id": "28980",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021986s000ltr.pdf",
              "date": "20060703",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20150126",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20181221",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "57019",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf",
              "date": "20181226",
              "type": "Label"
            },
            {
              "id": "57067",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021986Orig1s021Ltr.pdf",
              "date": "20181230",
              "type": "Letter"
            },
            {
              "id": "62937",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/379_21986S21 dasatinib CDTL clinical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "62938",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/381_21986S21 dasatinib statistical memo bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20130617",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "38002",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf",
              "date": "20130617",
              "type": "Label"
            },
            {
              "id": "28985",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021986Orig1s013ltr.pdf",
              "date": "20130618",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20090521",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6593",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021986s004ltr.pdf",
              "date": "20090529",
              "type": "Letter"
            },
            {
              "id": "16694",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf",
              "date": "20090525",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20071108",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37998",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf",
              "date": "20071113",
              "type": "Label"
            },
            {
              "id": "42369",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf",
              "date": "20110922",
              "type": "Review"
            },
            {
              "id": "6591",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf",
              "date": "20071119",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021986",
      "sponsor_name": "BRISTOL MYERS SQUIBB",
      "openfda": {
        "application_number": [
          "NDA021986"
        ],
        "brand_name": [
          "DASATINIB",
          "SPRYCEL"
        ],
        "generic_name": [
          "DASATINIB"
        ],
        "manufacturer_name": [
          "Prasco Laboratories",
          "E.R. Squibb & Sons, L.L.C."
        ],
        "product_ndc": [
          "66993-233",
          "66993-234",
          "66993-235",
          "66993-236",
          "66993-237",
          "66993-238",
          "0003-0524",
          "0003-0527",
          "0003-0528",
          "0003-0855",
          "0003-0852",
          "0003-0857"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DASATINIB"
        ],
        "rxcui": [
          "643105",
          "643107",
          "643109",
          "799047",
          "1045402",
          "1045406",
          "643173",
          "643175",
          "643177",
          "799830",
          "1045404",
          "1045408"
        ],
        "spl_id": [
          "19048218-75dd-45fc-8e6e-fc660d861fb7",
          "8f0a3afc-dde4-40d1-941d-68efd3f62adc"
        ],
        "spl_set_id": [
          "1931e73f-918c-4d69-9543-de9643513d05",
          "4764f37b-c9e6-4ede-bcc2-8a03b7c521df"
        ],
        "package_ndc": [
          "66993-233-60",
          "66993-234-60",
          "66993-235-60",
          "66993-236-30",
          "66993-237-30",
          "66993-238-30",
          "0003-0527-11",
          "0003-0528-11",
          "0003-0524-11",
          "0003-0855-22",
          "0003-0852-22",
          "0003-0857-22"
        ],
        "unii": [
          "RBZ1571X5H"
        ]
      },
      "products": [
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "SPRYCEL",
          "active_ingredients": [
            {
              "name": "DASATINIB",
              "strength": "80MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "SPRYCEL",
          "active_ingredients": [
            {
              "name": "DASATINIB",
              "strength": "70MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SPRYCEL",
          "active_ingredients": [
            {
              "name": "DASATINIB",
              "strength": "20MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "SPRYCEL",
          "active_ingredients": [
            {
              "name": "DASATINIB",
              "strength": "140MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "SPRYCEL",
          "active_ingredients": [
            {
              "name": "DASATINIB",
              "strength": "100MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SPRYCEL",
          "active_ingredients": [
            {
              "name": "DASATINIB",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}