{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20221028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "72512",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761289Orig1s001ltr.pdf",
              "date": "20221031",
              "type": "Letter"
            },
            {
              "id": "72523",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761289s001lbl.pdf",
              "date": "20221101",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20221021",
          "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": "72513",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761289Orig1s000Correctedlbl.pdf",
              "date": "20221031",
              "type": "Label"
            },
            {
              "id": "72518",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761289Orig1s000Correctedltr.pdf",
              "date": "20221101",
              "type": "Letter"
            },
            {
              "id": "72565",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761289Orig1s000TOC.html",
              "date": "20221104",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20240724",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79205",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761289Orig1s006Correctedltr.pdf",
              "date": "20240725",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20240125",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77307",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761289s004lbl.pdf",
              "date": "20240126",
              "type": "Label"
            },
            {
              "id": "77321",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761289Orig1s004ltr.pdf",
              "date": "20240126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20230614",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "74492",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761289Orig1s002ltr.pdf",
              "date": "20230615",
              "type": "Letter"
            },
            {
              "id": "74494",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761289s002lbl.pdf",
              "date": "20230615",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA761289",
      "sponsor_name": "ASTRAZENECA AB",
      "openfda": {
        "application_number": [
          "BLA761289"
        ],
        "brand_name": [
          "IMJUDO"
        ],
        "generic_name": [
          "TREMELIMUMAB"
        ],
        "manufacturer_name": [
          "AstraZeneca Pharmaceuticals LP"
        ],
        "product_ndc": [
          "0310-4505",
          "0310-4535"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TREMELIMUMAB"
        ],
        "rxcui": [
          "2619317",
          "2619323",
          "2619325",
          "2619326"
        ],
        "spl_id": [
          "390ff583-8e40-4690-ac4c-b4eaef2229d2"
        ],
        "spl_set_id": [
          "6690679c-be2f-4588-a2e4-89fff74dd6be"
        ],
        "package_ndc": [
          "0310-4505-25",
          "0310-4535-30"
        ],
        "nui": [
          "N0000182635",
          "N0000182634",
          "N0000182157"
        ],
        "pharm_class_epc": [
          "CTLA-4-directed Blocking Antibody [EPC]"
        ],
        "pharm_class_moa": [
          "CTLA-4-directed Antibody Interactions [MoA]"
        ],
        "pharm_class_pe": [
          "Increased T Lymphocyte Activation [PE]"
        ],
        "unii": [
          "QEN1X95CIX"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "IMJUDO",
          "active_ingredients": [
            {
              "name": "TREMELIMUMAB-ACTL",
              "strength": "25MG/1.25ML(20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "IMJUDO",
          "active_ingredients": [
            {
              "name": "TREMELIMUMAB-ACTL",
              "strength": "300MG/15ML(20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}