{
  "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": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20240405",
          "review_priority": "UNKNOWN",
          "submission_class_code": "BIOEQUIV",
          "submission_class_code_description": "Bioequivalence",
          "application_docs": [
            {
              "id": "78081",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761071Orig1s019ltr.pdf",
              "date": "20240408",
              "type": "Letter"
            },
            {
              "id": "78097",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s019lbl.pdf",
              "date": "20240409",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20251016",
          "submission_class_code": "BIOSIMILAR",
          "application_docs": [
            {
              "id": "83807",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761071Orig1s031ltr.pdf",
              "date": "20251020",
              "type": "Letter"
            },
            {
              "id": "83834",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s031lbl.pdf",
              "date": "20251021",
              "type": "Label"
            },
            {
              "id": "83835",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s031lbl.pdf#page=50",
              "date": "20251021",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20230414",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "74005",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf",
              "date": "20230417",
              "type": "Label"
            },
            {
              "id": "74013",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s015ltr.pdf",
              "date": "20230417",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20240612",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78785",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761071Orig1s021ltr.pdf",
              "date": "20240613",
              "type": "Letter"
            },
            {
              "id": "78795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s021lbl.pdf",
              "date": "20240613",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20220328",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "70641",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s011ltr.pdf",
              "date": "20220329",
              "type": "Letter"
            },
            {
              "id": "70646",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s011lbl.pdf",
              "date": "20220329",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210224",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66362",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761071Orig1s001ltr.pdf",
              "date": "20210225",
              "type": "Letter"
            },
            {
              "id": "66408",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761071s001lbl.pdf",
              "date": "20210226",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20250729",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82990",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s024lbl.pdf",
              "date": "20250730",
              "type": "Label"
            },
            {
              "id": "82999",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761071Orig1s024ltr.pdf",
              "date": "20250731",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20230908",
          "review_priority": "N/A",
          "submission_class_code": "BIOEQUIV",
          "submission_class_code_description": "Bioequivalence",
          "application_docs": [
            {
              "id": "75389",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s016ltr.pdf",
              "date": "20230911",
              "type": "Letter"
            },
            {
              "id": "75442",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s016lbl.pdf",
              "date": "20230913",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20250520",
          "review_priority": "N/A",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "82217",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761071Orig1s022ltr.pdf",
              "date": "20250521",
              "type": "Letter"
            },
            {
              "id": "82231",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s022lbl.pdf",
              "date": "20250520",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20230320",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "73811",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s014ltr.pdf",
              "date": "20230323",
              "type": "Letter"
            },
            {
              "id": "73866",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s014lbl.pdf",
              "date": "20230327",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181030",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2",
          "submission_class_code_description": "Type 2 - New Active Ingredient",
          "application_docs": [
            {
              "id": "56201",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf",
              "date": "20181031",
              "type": "Label"
            },
            {
              "id": "56217",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761071Orig1s000ltr.pdf",
              "date": "20190228",
              "type": "Letter"
            },
            {
              "id": "58054",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.html",
              "date": "20190321",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20220718",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71591",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s010,s012ltr.pdf",
              "date": "20220719",
              "type": "Letter"
            },
            {
              "id": "71611",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf",
              "date": "20220720",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20220718",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71590",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s010,s012ltr.pdf",
              "date": "20220719",
              "type": "Letter"
            },
            {
              "id": "71612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf",
              "date": "20220720",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA761071",
      "sponsor_name": "SANDOZ INC",
      "openfda": {
        "application_number": [
          "BLA761071"
        ],
        "brand_name": [
          "ADALIMUMAB",
          "HYRIMOZ"
        ],
        "generic_name": [
          "ADALIMUMAB-ADAZ"
        ],
        "manufacturer_name": [
          "Sandoz Inc",
          "Cordavis Limited"
        ],
        "product_ndc": [
          "61314-325",
          "61314-327",
          "61314-332",
          "61314-391",
          "61314-454",
          "61314-473",
          "61314-476",
          "61314-509",
          "61314-517",
          "61314-531",
          "83457-100",
          "83457-101",
          "83457-102",
          "83457-103",
          "83457-108",
          "83457-107",
          "83457-113",
          "83457-112"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ADALIMUMAB"
        ],
        "rxcui": [
          "2641644",
          "2641653",
          "2641655",
          "2641660",
          "2641662",
          "2641650",
          "2641654",
          "2641658",
          "2641661",
          "2641663",
          "2641664",
          "2641665",
          "2641666",
          "2641667",
          "2641668",
          "2641669",
          "2641670",
          "2641671",
          "2641672",
          "2641673",
          "2665419",
          "2665422",
          "2665424",
          "2665426"
        ],
        "spl_id": [
          "ae54abc4-e9c5-4c5a-8fa7-968e5ad72050",
          "af358c91-4472-4fb1-87ba-001d67f2b4f8",
          "04bedd16-44e8-4761-bb65-d4678c4013af"
        ],
        "spl_set_id": [
          "3468792f-63ef-4916-8ed1-8214f327d9dd",
          "1ac7d061-3380-468c-b077-c05f8dfbc829",
          "3e303a4a-980b-4f2a-9d03-786928758637"
        ],
        "package_ndc": [
          "61314-327-64",
          "61314-327-20",
          "61314-332-64",
          "61314-325-20",
          "61314-391-64",
          "61314-454-20",
          "61314-454-36",
          "61314-454-68",
          "61314-473-64",
          "61314-473-20",
          "61314-473-92",
          "61314-476-64",
          "61314-509-64",
          "61314-517-36",
          "61314-531-64",
          "83457-100-01",
          "83457-101-01",
          "83457-102-01",
          "83457-103-01",
          "83457-108-01",
          "83457-107-01",
          "83457-113-01",
          "83457-112-01"
        ],
        "nui": [
          "N0000175610",
          "N0000175451",
          "M0001357"
        ],
        "pharm_class_epc": [
          "Tumor Necrosis Factor Blocker [EPC]"
        ],
        "pharm_class_moa": [
          "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"
        ],
        "pharm_class_cs": [
          "Antibodies, Monoclonal [CS]"
        ],
        "unii": [
          "FYS6T7F842"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "HYRIMOZ",
          "active_ingredients": [
            {
              "name": "ADALIMUMAB-ADAZ",
              "strength": "40MG/0.8ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}