{
  "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": "6",
          "submission_status": "AP",
          "submission_status_date": "20240306",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77752",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761234s006lbl.pdf",
              "date": "20240307",
              "type": "Label"
            },
            {
              "id": "77753",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761234s006lbl.pdf#page=23",
              "date": "20240307",
              "type": "Medication Guide"
            },
            {
              "id": "77788",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761234Orig1s006ltr.pdf",
              "date": "20240312",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20220318",
          "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": "70562",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf",
              "date": "20220318",
              "type": "Label"
            },
            {
              "id": "70563",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf#page=23",
              "date": "20220318",
              "type": "Medication Guide"
            },
            {
              "id": "70575",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761234Orig1s000ltr.pdf",
              "date": "20220321",
              "type": "Letter"
            },
            {
              "id": "70774",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761234Orig1s000TOC.html",
              "date": "20220415",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA761234",
      "sponsor_name": "BRISTOL MYERS SQUIBB",
      "openfda": {
        "application_number": [
          "BLA761234"
        ],
        "brand_name": [
          "OPDUALAG"
        ],
        "generic_name": [
          "NIVOLUMAB AND RELATLIMAB-RMBW"
        ],
        "manufacturer_name": [
          "E.R. Squibb & Sons, L.L.C."
        ],
        "product_ndc": [
          "0003-7125"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NIVOLUMAB",
          "RELATLIMAB"
        ],
        "rxcui": [
          "2596778",
          "2596784"
        ],
        "spl_id": [
          "1150d07b-4d33-4285-a242-1ecf12ed5a4c"
        ],
        "spl_set_id": [
          "b22c9d83-3256-4e17-85f7-f331a504adc6"
        ],
        "package_ndc": [
          "0003-7125-11"
        ],
        "nui": [
          "N0000191260",
          "N0000191259",
          "N0000194003",
          "N0000194002"
        ],
        "pharm_class_epc": [
          "Programmed Death Receptor-1 Blocking Antibody [EPC]",
          "Lymphocyte Activation Gene-3 Blocker [EPC]"
        ],
        "pharm_class_moa": [
          "Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
          "Lymphocyte Activation Gene-3 Antagonists [MoA]"
        ],
        "unii": [
          "31YO63LBSN",
          "AF75XOF6W3"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "OPDUALAG",
          "active_ingredients": [
            {
              "name": "NIVOLUMAB",
              "strength": "240MG"
            },
            {
              "name": "RELATLIMAB-RMBW",
              "strength": "80MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}