{
  "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": "2026-09-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20240807",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79339",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761123s005lbl.pdf",
              "date": "20240808",
              "type": "Label"
            },
            {
              "id": "79353",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761123Orig1s005ltr.pdf",
              "date": "20240809",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20231201",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "76722",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761123s003lbl.pdf",
              "date": "20231204",
              "type": "Label"
            },
            {
              "id": "76728",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761123Orig1s003ltr.pdf",
              "date": "20231205",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210730",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "68232",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761123s000lbl.pdf",
              "date": "20210802",
              "type": "Label"
            },
            {
              "id": "68261",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761123Orig1s000ltr.pdf",
              "date": "20210802",
              "type": "Letter"
            },
            {
              "id": "68390",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761123Orig1s000TOC.html",
              "date": "20210817",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20260807",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "86867",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761123s012lbl.pdf",
              "date": "20260811",
              "type": "Label"
            },
            {
              "id": "86967",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761123Orig1s012ltr.pdf",
              "date": "20260818",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761123",
      "sponsor_name": "ASTRAZENECA AB",
      "openfda": {
        "application_number": [
          "BLA761123"
        ],
        "brand_name": [
          "SAPHNELO"
        ],
        "generic_name": [
          "ANIFROLUMAB-FNIA"
        ],
        "manufacturer_name": [
          "AstraZeneca Pharmaceuticals LP"
        ],
        "product_ndc": [
          "0310-3040",
          "0310-3080"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ANIFROLUMAB"
        ],
        "rxcui": [
          "2565280",
          "2565286",
          "2741470",
          "2741474",
          "2741478",
          "2741482"
        ],
        "spl_id": [
          "810dc1a8-73e1-41fc-874f-2dd1d8ed1429"
        ],
        "spl_set_id": [
          "d6203302-2128-41a7-b0b4-0e6c0704d4dc"
        ],
        "package_ndc": [
          "0310-3040-00",
          "0310-3080-25",
          "0310-3080-01",
          "0310-3080-95",
          "0310-3080-75",
          "0310-3080-02"
        ],
        "nui": [
          "N0000193967",
          "N0000193968"
        ],
        "pharm_class_epc": [
          "Type I Interferon Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Type I Interferon Receptor Antagonists [MoA]"
        ],
        "unii": [
          "38RL9AE51Q"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SAPHNELO",
          "active_ingredients": [
            {
              "name": "ANIFROLUMAB-FNIA",
              "strength": "300MG/2ML(150MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}