{
  "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": "17",
          "submission_status": "AP",
          "submission_status_date": "20200320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "62221",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf",
              "date": "20200323",
              "type": "Label"
            },
            {
              "id": "62265",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125557Orig1s017ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20250429",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82073",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125557s031lbl.pdf",
              "date": "20250430",
              "type": "Label"
            },
            {
              "id": "82074",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125557s031lbl.pdf#page=43",
              "date": "20250430",
              "type": "Medication Guide"
            },
            {
              "id": "82136",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125557Orig1s031ltr.pdf",
              "date": "20250505",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20230620",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "74561",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf",
              "date": "20230621",
              "type": "Label"
            },
            {
              "id": "74570",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125557Orig1s023,s026ltr.pdf",
              "date": "20230621",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20160830",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "45184",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf",
              "date": "20160830",
              "type": "Letter"
            },
            {
              "id": "45207",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf",
              "date": "20160830",
              "type": "Label"
            },
            {
              "id": "48820",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125557Orig1s005TOC.html",
              "date": "20170626",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20190418",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "58353",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf",
              "date": "20190419",
              "type": "Letter"
            },
            {
              "id": "58378",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf",
              "date": "20190424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20220218",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "70195",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf",
              "date": "20220222",
              "type": "Label"
            },
            {
              "id": "70211",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125557Orig1s021ltr.pdf",
              "date": "20220222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20180329",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53544",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf",
              "date": "20180329",
              "type": "Label"
            },
            {
              "id": "53582",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s013ltr.pdf",
              "date": "20180401",
              "type": "Letter"
            },
            {
              "id": "62294",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125557Orig1s013.pdf",
              "date": "20200324",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20240614",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "78804",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf",
              "date": "20240614",
              "type": "Label"
            },
            {
              "id": "78812",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s028Correctedltr.pdf",
              "date": "20240618",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20230620",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "74560",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf",
              "date": "20230621",
              "type": "Label"
            },
            {
              "id": "74571",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125557Orig1s023,s026ltr.pdf",
              "date": "20230621",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20170711",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48952",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf",
              "date": "20170712",
              "type": "Label"
            },
            {
              "id": "48987",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s008ltr.pdf",
              "date": "20170714",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20210311",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20251021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "83867",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125557s032lbl.pdf",
              "date": "20251022",
              "type": "Label"
            },
            {
              "id": "83879",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125557Orig1s032ltr.pdf",
              "date": "20251023",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20160830",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "45185",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf",
              "date": "20160830",
              "type": "Letter"
            },
            {
              "id": "45208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf",
              "date": "20160830",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20190418",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "58354",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf",
              "date": "20190419",
              "type": "Letter"
            },
            {
              "id": "58377",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf",
              "date": "20190424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20241217",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "80610",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s030lbl.pdf",
              "date": "20241218",
              "type": "Label"
            },
            {
              "id": "80615",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s030ltr.pdf",
              "date": "20241218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20180410",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53757",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s014ltr.pdf",
              "date": "20180420",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20210311",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "66754",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf",
              "date": "20210312",
              "type": "Label"
            },
            {
              "id": "66759",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125557Orig1s020ltr.pdf",
              "date": "20210312",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20171130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50548",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf",
              "date": "20171201",
              "type": "Label"
            },
            {
              "id": "50570",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s012ltr.pdf",
              "date": "20171201",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20240208",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s029lbl.pdf",
              "date": "20240209",
              "type": "Label"
            },
            {
              "id": "77444",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s029ltr.pdf",
              "date": "20240209",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20141203",
          "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": "39995",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf",
              "date": "20141203",
              "type": "Label"
            },
            {
              "id": "43339",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000TOC.html",
              "date": "20150112",
              "type": "Review"
            },
            {
              "id": "63251",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/353_125557 blinatumomab clinical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63252",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/352_125557 blinatumomab clinpharm bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "63253",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/354_125557 blinatumomab statistical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "9787",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125557Orig1s000ltr.pdf",
              "date": "20141204",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20210311",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20221205",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "72796",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125557Orig1s025ltr.pdf",
              "date": "20221206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20170503",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48244",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf",
              "date": "20170505",
              "type": "Label"
            },
            {
              "id": "48289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s007ltr.pdf",
              "date": "20170509",
              "type": "Letter"
            },
            {
              "id": "59049",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125557Orig1s007.pdf",
              "date": "20190613",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA125557",
      "sponsor_name": "AMGEN",
      "openfda": {
        "application_number": [
          "BLA125557"
        ],
        "brand_name": [
          "BLINCYTO"
        ],
        "generic_name": [
          "BLINATUMOMAB"
        ],
        "manufacturer_name": [
          "Amgen, Inc"
        ],
        "product_ndc": [
          "55513-160"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "1597262",
          "1597267"
        ],
        "spl_id": [
          "4a2c4b49-a991-4ac7-80b3-4b2f8f62de30"
        ],
        "spl_set_id": [
          "38b482a8-960b-4591-9857-5031ecb830aa"
        ],
        "package_ndc": [
          "55513-160-01",
          "55513-160-21",
          "55513-150-01",
          "55513-155-01"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "BLINCYTO",
          "active_ingredients": [
            {
              "name": "BLINATUMOMAB",
              "strength": "35MCG"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}