{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160527",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "20000",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf",
              "date": "20160601",
              "type": "Label"
            },
            {
              "id": "23055",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000TOC.html",
              "date": "20160707",
              "type": "Review"
            },
            {
              "id": "24537",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000SumR.pdf",
              "date": "20160707",
              "type": "Summary Review"
            },
            {
              "id": "32915",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf",
              "date": "20160531",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20170828",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49583",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf",
              "date": "20170830",
              "type": "Label"
            },
            {
              "id": "49639",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s002,s007ltr.pdf",
              "date": "20170831",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20171101",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "50322",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s005ltr.pdf",
              "date": "20171107",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170526",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "48574",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf",
              "date": "20170531",
              "type": "Label"
            },
            {
              "id": "48575",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf#page=24",
              "date": "20170531",
              "type": "Medication Guide"
            },
            {
              "id": "48602",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s001ltr.pdf",
              "date": "20170531",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170828",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49584",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf",
              "date": "20170830",
              "type": "Label"
            },
            {
              "id": "49640",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s002,s007ltr.pdf",
              "date": "20170831",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761029",
      "sponsor_name": "BIOGEN",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "TBD",
          "brand_name": "ZINBRYTA",
          "active_ingredients": [
            {
              "name": "DACLIZUMAB",
              "strength": "150MG/ML"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}