{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20151008",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20260302",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "85262",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203341Orig1s027ltr.pdf",
              "date": "20260304",
              "type": "Letter"
            },
            {
              "id": "85286",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/203341s027lbl.pdf",
              "date": "20260306",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20141125",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "40289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf",
              "date": "20150105",
              "type": "Label"
            },
            {
              "id": "32413",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203341Orig1s002ltr.pdf",
              "date": "20141128",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20230926",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "75570",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf",
              "date": "20230926",
              "type": "Label"
            },
            {
              "id": "75572",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203341Orig1s025ltr.pdf",
              "date": "20230927",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20191009",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "60517",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203341Orig1s017ltr.pdf",
              "date": "20191010",
              "type": "Letter"
            },
            {
              "id": "60530",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s017lbl.pdf",
              "date": "20191010",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20181018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56045",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203341s015lbl.pdf",
              "date": "20181019",
              "type": "Label"
            },
            {
              "id": "56079",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s015ltr.pdf",
              "date": "20181023",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20180501",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54001",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s013ltr.pdf",
              "date": "20180503",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20171219",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50777",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203341s009lbl.pdf",
              "date": "20171219",
              "type": "Label"
            },
            {
              "id": "50884",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s009ltr.pdf",
              "date": "20171227",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20170413",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48039",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf",
              "date": "20170414",
              "type": "Letter"
            },
            {
              "id": "48050",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf",
              "date": "20170418",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20160404",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "19460",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf",
              "date": "20160405",
              "type": "Label"
            },
            {
              "id": "32414",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s005ltr.pdf",
              "date": "20160406",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20150922",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10199",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203341Orig1s003ltr.pdf",
              "date": "20150924",
              "type": "Letter"
            },
            {
              "id": "19459",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf",
              "date": "20151006",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20241203",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "80496",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203341Orig1s026ltr.pdf",
              "date": "20241204",
              "type": "Letter"
            },
            {
              "id": "80522",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203341s026lbl.pdf",
              "date": "20241205",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130930",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40288",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf",
              "date": "20130930",
              "type": "Label"
            },
            {
              "id": "32412",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203341Orig1s001ltr.pdf",
              "date": "20131001",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20200617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63613",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203341Orig1s018ltr.pdf",
              "date": "20200618",
              "type": "Letter"
            },
            {
              "id": "63616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203341s018lbl.pdf",
              "date": "20200618",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20230420",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "74036",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203341Orig1s024ltr.pdf",
              "date": "20230421",
              "type": "Letter"
            },
            {
              "id": "74044",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s024lbl.pdf",
              "date": "20230424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20190814",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "59705",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203341Orig1s016ltr.pdf",
              "date": "20190815",
              "type": "Letter"
            },
            {
              "id": "59724",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s016lbl.pdf",
              "date": "20190815",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120904",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10198",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203341Orig1s000ltr.pdf",
              "date": "20120906",
              "type": "Letter"
            },
            {
              "id": "19458",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf",
              "date": "20120904",
              "type": "Label"
            },
            {
              "id": "22921",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341_bosulif_toc.html",
              "date": "20120913",
              "type": "Review"
            },
            {
              "id": "24432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022090s000_SumR.pdf",
              "date": "20120913",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20210514",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "67489",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203341s020lbl.pdf",
              "date": "20210514",
              "type": "Label"
            },
            {
              "id": "67511",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203341Orig1s020ltr.pdf",
              "date": "20210517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20170413",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48040",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf",
              "date": "20170414",
              "type": "Letter"
            },
            {
              "id": "48049",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf",
              "date": "20170418",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20161117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "45907",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s006ltr.pdf",
              "date": "20161118",
              "type": "Letter"
            },
            {
              "id": "45909",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s006lbl.pdf",
              "date": "20161117",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA203341",
      "sponsor_name": "PF PRISM CV",
      "openfda": {
        "application_number": [
          "NDA203341"
        ],
        "brand_name": [
          "BOSULIF"
        ],
        "generic_name": [
          "BOSUTINIB"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc",
          "U.S. Pharmaceuticals"
        ],
        "product_ndc": [
          "0069-0135",
          "0069-0136",
          "0069-0193",
          "0069-0504",
          "0069-1014",
          "63539-117",
          "63539-193"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BOSUTINIB MONOHYDRATE"
        ],
        "rxcui": [
          "1307624",
          "1307630",
          "1307633",
          "1307635",
          "1987732",
          "1987734",
          "2669663",
          "2669665",
          "2672326",
          "2672328"
        ],
        "spl_id": [
          "ca8600d9-46e6-402d-89f9-bc6a156bf751",
          "6550da0f-5049-4056-b705-ffbcf2ac00cf"
        ],
        "spl_set_id": [
          "adc84ad5-a04d-4fee-9ba8-91f7abd928e3",
          "d5929f91-6496-4c0e-97e8-0bd524e15763"
        ],
        "package_ndc": [
          "0069-0135-01",
          "0069-0136-01",
          "0069-0193-01",
          "0069-0504-30",
          "0069-1014-15",
          "63539-117-01",
          "63539-193-30"
        ],
        "unii": [
          "844ZJE6I55"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "BOSULIF",
          "active_ingredients": [
            {
              "name": "BOSUTINIB MONOHYDRATE",
              "strength": "EQ 400MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BOSULIF",
          "active_ingredients": [
            {
              "name": "BOSUTINIB MONOHYDRATE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "BOSULIF",
          "active_ingredients": [
            {
              "name": "BOSUTINIB MONOHYDRATE",
              "strength": "EQ 500MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}