{
  "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": "8",
          "submission_status": "AP",
          "submission_status_date": "20251008",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83695",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213716s008lbl.pdf",
              "date": "20251009",
              "type": "Label"
            },
            {
              "id": "83696",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213716s008lbl.pdf#page=25",
              "date": "20251009",
              "type": "Medication Guide"
            },
            {
              "id": "83701",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213716Orig1s008ltr.pdf",
              "date": "20251009",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20240429",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78308",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213716Orig1s004ltr.pdf",
              "date": "20240430",
              "type": "Letter"
            },
            {
              "id": "78322",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213716s004lbl.pdf",
              "date": "20240430",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210122",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "65974",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213716Orig1s000ltr.pdf",
              "date": "20210125",
              "type": "Letter"
            },
            {
              "id": "66002",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf",
              "date": "20210127",
              "type": "Label"
            },
            {
              "id": "66342",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000TOC.html",
              "date": "20210224",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA213716",
      "sponsor_name": "AURINIA",
      "openfda": {
        "application_number": [
          "NDA213716"
        ],
        "brand_name": [
          "LUPKYNIS"
        ],
        "generic_name": [
          "VOCLOSPORIN"
        ],
        "manufacturer_name": [
          "Aurinia Pharma U.S., Inc."
        ],
        "product_ndc": [
          "75626-001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VOCLOSPORIN"
        ],
        "rxcui": [
          "2475400",
          "2475406"
        ],
        "spl_id": [
          "413a060a-faf5-af00-e063-6394a90af847"
        ],
        "spl_set_id": [
          "9f489295-1156-52c7-5fd0-5c4c52f9b813"
        ],
        "package_ndc": [
          "75626-001-01",
          "75626-001-02"
        ],
        "nui": [
          "N0000175457",
          "N0000175458",
          "N0000185503",
          "N0000190107",
          "N0000190108"
        ],
        "pharm_class_epc": [
          "Calcineurin Inhibitor Immunosuppressant [EPC]"
        ],
        "pharm_class_moa": [
          "Calcineurin Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"
        ],
        "unii": [
          "2PN063X6B1"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LUPKYNIS",
          "active_ingredients": [
            {
              "name": "VOCLOSPORIN",
              "strength": "7.9MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}