{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20250403",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "81824",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761142s003lbl.pdf",
              "date": "20250403",
              "type": "Label"
            },
            {
              "id": "81825",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761142s003lbl.pdf#page=22",
              "date": "20250403",
              "type": "Medication Guide"
            },
            {
              "id": "81878",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761142Orig1s003ltr.pdf",
              "date": "20250408",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20251211",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "84399",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761142Orig1s004ltr.pdf",
              "date": "20251212",
              "type": "Letter"
            },
            {
              "id": "84445",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761142s004lbl.pdf",
              "date": "20251218",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200611",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761142Orig1s000ltr.pdf",
              "date": "20200612",
              "type": "Letter"
            },
            {
              "id": "63503",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761142s000lbl.pdf",
              "date": "20200612",
              "type": "Label"
            },
            {
              "id": "63793",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761142Orig1s000TOC.html",
              "date": "20200706",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA761142",
      "sponsor_name": "VIELA BIO",
      "openfda": {
        "application_number": [
          "BLA761142"
        ],
        "brand_name": [
          "UPLIZNA"
        ],
        "generic_name": [
          "INEBILIZUMAB"
        ],
        "manufacturer_name": [
          "Horizon Therapeutics USA, Inc."
        ],
        "product_ndc": [
          "75987-150"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "INEBILIZUMAB"
        ],
        "rxcui": [
          "2373955",
          "2373960",
          "2373966",
          "2373967"
        ],
        "spl_id": [
          "ec8e46bc-7edf-405d-8c8e-2b2f7042fcb5"
        ],
        "spl_set_id": [
          "834db232-afb0-4dcf-93e0-009ce8245c20"
        ],
        "package_ndc": [
          "75987-150-01",
          "75987-150-03"
        ],
        "nui": [
          "N0000194013",
          "N0000191422"
        ],
        "pharm_class_epc": [
          "CD19-directed Cytolytic Antibody [EPC]"
        ],
        "pharm_class_moa": [
          "CD19-directed Antibody Interactions [MoA]"
        ],
        "unii": [
          "74T7185BMM"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "UPLIZNA",
          "active_ingredients": [
            {
              "name": "INEBILIZUMAB-CDON",
              "strength": "100MG/10ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}