{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20260121",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "84792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761498s000lbl.pdf",
              "date": "20260121",
              "type": "Label"
            },
            {
              "id": "84793",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761498s000lbl.pdf#page=52",
              "date": "20260121",
              "type": "Medication Guide"
            },
            {
              "id": "84818",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761498Orig1s000ltr.pdf",
              "date": "20260122",
              "type": "Letter"
            },
            {
              "id": "85025",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761498Orig1s000TOC.html",
              "date": "20260212",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA761498",
      "sponsor_name": "CELLTRION INC",
      "openfda": {
        "application_number": [
          "BLA761498"
        ],
        "brand_name": [
          "AVTOZMA"
        ],
        "generic_name": [
          "TOCILIZUMAB"
        ],
        "manufacturer_name": [
          "CELLTRION USA, Inc."
        ],
        "product_ndc": [
          "72606-045",
          "72606-042",
          "72606-043",
          "72606-044"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "TOCILIZUMAB"
        ],
        "rxcui": [
          "2705443",
          "2705448",
          "2705450",
          "2705451",
          "2705452",
          "2705453"
        ],
        "spl_id": [
          "d7f95a0e-a3de-48f2-bbd6-a30b4b740761"
        ],
        "spl_set_id": [
          "581c288f-8015-40ef-a4c3-683c96db193d"
        ],
        "package_ndc": [
          "72606-042-01",
          "72606-042-02",
          "72606-043-01",
          "72606-043-02",
          "72606-044-01",
          "72606-044-02",
          "72606-045-01",
          "72606-045-02",
          "72606-045-03",
          "72606-045-04",
          "72606-045-05",
          "72606-045-06"
        ],
        "nui": [
          "N0000190478",
          "N0000190480"
        ],
        "pharm_class_moa": [
          "Interleukin 6 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Interleukin-6 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "I031V2H011"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "AVTOZMA",
          "active_ingredients": [
            {
              "name": "TOCILIZUMAB-ANOH",
              "strength": "400MG/20ML(20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "IV (INFUSION)",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "AVTOZMA",
          "active_ingredients": [
            {
              "name": "TOCILIZUMAB-ANOH",
              "strength": "80MG/4ML(20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "IV (INFUSION)",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "AVTOZMA",
          "active_ingredients": [
            {
              "name": "TOCILIZUMAB-ANOH",
              "strength": "162MG/20ML(20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "AVTOZMA",
          "active_ingredients": [
            {
              "name": "TOCILIZUMAB-ANOH",
              "strength": "200MG/10ML(20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "IV (INFUSION)",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}