{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20231206",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "76747",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761198s000lbl.pdf",
              "date": "20231207",
              "type": "Label"
            },
            {
              "id": "76750",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761198Orig1s000ltr.pdf",
              "date": "20231207",
              "type": "Letter"
            },
            {
              "id": "78073",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761198Orig1s000TOC.html",
              "date": "20240405",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA761198",
      "sponsor_name": "BIO-THERA SOLUTIONS LTD",
      "openfda": {
        "application_number": [
          "BLA761198"
        ],
        "brand_name": [
          "AVZIVI TNJN",
          "AVZIVI"
        ],
        "generic_name": [
          "BEVACIZUMAB",
          "BEVACIZUMAB-TNJN"
        ],
        "manufacturer_name": [
          "Bio-Thera Solutions, Ltd."
        ],
        "product_ndc": [
          "82143-001",
          "82143-002"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BEVACIZUMAB-TNJN"
        ],
        "rxcui": [
          "2700735",
          "2700742",
          "2700744",
          "2700745"
        ],
        "spl_id": [
          "3fff12d3-d86b-14e4-e063-6294a90a122e"
        ],
        "spl_set_id": [
          "a3976cf9-9edb-4ca2-9375-9bcd2e32f5b4"
        ],
        "package_ndc": [
          "82143-001-01",
          "82143-002-01"
        ],
        "unii": [
          "2S9ZZM9Q9V"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "TBD",
          "brand_name": "AVZIVI",
          "active_ingredients": [
            {
              "name": "BEVACIZUMAB-TNJN",
              "strength": "400MG/16ML(25MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "AVZIVI",
          "active_ingredients": [
            {
              "name": "BEVACIZUMAB-TNJN",
              "strength": "100MG/4ML(25MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}