{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20260713",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "86568",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761375s001lbl.pdf",
              "date": "20260715",
              "type": "Label"
            },
            {
              "id": "86569",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761375s001lbl.pdf#page=28",
              "date": "20260715",
              "type": "Medication Guide"
            },
            {
              "id": "86607",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf",
              "date": "20260720",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250829",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "83253",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf",
              "date": "20250902",
              "type": "Label"
            },
            {
              "id": "83271",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761375Orig1s000ltr.pdf",
              "date": "20250903",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761375",
      "sponsor_name": "EISAI INC",
      "openfda": {
        "application_number": [
          "BLA761375"
        ],
        "brand_name": [
          "LECANEMAB AUTOINJECTOR"
        ],
        "generic_name": [
          "LECANEMAB-IRMB"
        ],
        "manufacturer_name": [
          "Eisai Inc."
        ],
        "product_ndc": [
          "62856-220",
          "62856-215",
          "62856-212",
          "62856-222"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "LECANEMAB-IRMB"
        ],
        "rxcui": [
          "2626147",
          "2626153",
          "2626155",
          "2626156",
          "2723406",
          "2747782"
        ],
        "spl_id": [
          "5bf59fb4-34d6-40dd-9061-a74173f14f58"
        ],
        "spl_set_id": [
          "9d1ff786-e577-410a-a273-c4d7d0e4e975"
        ],
        "package_ndc": [
          "62856-215-01",
          "62856-212-01",
          "62856-220-10",
          "62856-220-01",
          "62856-222-10",
          "62856-222-02"
        ],
        "nui": [
          "N0000193951",
          "N0000193950"
        ],
        "pharm_class_epc": [
          "Amyloid Beta-directed Antibody [EPC]"
        ],
        "pharm_class_moa": [
          "Amyloid Beta-directed Antibody Interactions [MoA]"
        ],
        "unii": [
          "12PYH0FTU9"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "LEQEMBI IQLIK",
          "active_ingredients": [
            {
              "name": "LECANEMAB-IRMB",
              "strength": "360MG/1.8ML(200MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}