{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20251028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83965",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s005lbl.pdf",
              "date": "20251029",
              "type": "Label"
            },
            {
              "id": "83990",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761306Orig1s005ltr.pdf",
              "date": "20251029",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20250522",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82318",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761306Orig1s003ltr.pdf",
              "date": "20250527",
              "type": "Letter"
            },
            {
              "id": "82449",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s003lbl.pdf",
              "date": "20250603",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20260609",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "86217",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761306Orig1s006ltr.pdf",
              "date": "20260611",
              "type": "Letter"
            },
            {
              "id": "86256",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761306s006lbl.pdf",
              "date": "20260616",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240913",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "79602",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761306Orig1s000correctedlbl.pdf",
              "date": "20240916",
              "type": "Label"
            },
            {
              "id": "79634",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761306Orig1s000correctedltr.pdf",
              "date": "20240916",
              "type": "Letter"
            },
            {
              "id": "79902",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761306Orig1s000TOC.html",
              "date": "20241015",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA761306",
      "sponsor_name": "ELI LILLY AND CO",
      "openfda": {
        "application_number": [
          "BLA761306"
        ],
        "brand_name": [
          "EBGLYSS"
        ],
        "generic_name": [
          "LEBRIKIZUMAB-LBKZ"
        ],
        "manufacturer_name": [
          "Eli Lilly and Company"
        ],
        "product_ndc": [
          "0002-7772",
          "0002-7797"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "LEBRIKIZUMAB"
        ],
        "rxcui": [
          "2693784",
          "2693791",
          "2693903",
          "2693907"
        ],
        "spl_id": [
          "361eb12f-8b25-4174-a653-5b857e6abd03"
        ],
        "spl_set_id": [
          "7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f"
        ],
        "package_ndc": [
          "0002-7772-01",
          "0002-7772-11",
          "0002-7772-62",
          "0002-7797-01",
          "0002-7797-11",
          "0002-7797-61"
        ],
        "nui": [
          "N0000193985",
          "N0000193986"
        ],
        "pharm_class_epc": [
          "Interleukin-13 Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Interleukin-13 Antagonists [MoA]"
        ],
        "unii": [
          "U9JLP7V031"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "EBGLYSS",
          "active_ingredients": [
            {
              "name": "LEBRIKIZUMAB-LBKZ",
              "strength": "250MG/2ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}