{
  "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": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20250407",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "81841",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761024s023lbl.pdf",
              "date": "20250408",
              "type": "Label"
            },
            {
              "id": "81914",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761024Orig1s023ltr.pdf",
              "date": "20250409",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20230814",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "75072",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s015ltr.pdf",
              "date": "20230815",
              "type": "Letter"
            },
            {
              "id": "75088",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s015lbl.pdf",
              "date": "20230816",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20250520",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "82221",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761024Orig1s021ltr.pdf",
              "date": "20250521",
              "type": "Letter"
            },
            {
              "id": "82229",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761024s021lbl.pdf",
              "date": "20250520",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20230406",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "73962",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024Orig1s011lbl.pdf",
              "date": "20230407",
              "type": "Label"
            },
            {
              "id": "73963",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s011ltr.pdf",
              "date": "20230407",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20180315",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53040",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761024s003lbl.pdf",
              "date": "20180316",
              "type": "Label"
            },
            {
              "id": "53059",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761024Orig1s003ltr.pdf",
              "date": "20180320",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160923",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2/4",
          "submission_class_code_description": "Type 2 New Active Ingredient and Type 4 New Combination",
          "application_docs": [
            {
              "id": "45479",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761024Orig1s000ltr.pdf",
              "date": "20160926",
              "type": "Letter"
            },
            {
              "id": "45862",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.html",
              "date": "20161109",
              "type": "Review"
            },
            {
              "id": "49717",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf",
              "date": "20170912",
              "type": "Label"
            },
            {
              "id": "51431",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22_761024 adalimumab-atto DPARP CDTL clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "51432",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/23_761024 adalimumab-atto gi clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51433",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21_761024 adalimumab-atto Clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51434",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20_761024 adalimumab-atto clinical DD prea.pdf",
              "date": "19000101",
              "type": "Pediatric DD Summary Review"
            },
            {
              "id": "51435",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19_761024 adalimumab atto DPARP clinpharm prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51436",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/19_761024 adalimumab atto DPARP clinpharm prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51437",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/26_761024 adalimumab-atto statistical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "51438",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/24_761024 adalimumab-atto statistical 2 prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "51439",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/25_761024 adalimumab-atto statistical 3 prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "62864",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/Amgen-Clinical-Pharmacology-Review.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20251016",
          "submission_class_code": "BIOSIMILAR",
          "application_docs": [
            {
              "id": "83800",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761024s026lbl.pdf",
              "date": "20251017",
              "type": "Label"
            },
            {
              "id": "83801",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761024s026lbl.pdf#page=60",
              "date": "20251017",
              "type": "Medication Guide"
            },
            {
              "id": "83809",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761024Orig1s026ltr.pdf",
              "date": "20251020",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20250917",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83385",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761024Orig1s022ltr.pdf",
              "date": "20250918",
              "type": "Letter"
            },
            {
              "id": "83387",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761024s022lbl.pdf",
              "date": "20250918",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20230322",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "73824",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s012ltr.pdf",
              "date": "20230323",
              "type": "Letter"
            },
            {
              "id": "73830",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s012lbl.pdf",
              "date": "20230323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20220728",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71665",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761024Orig1s010ltr.pdf",
              "date": "20220729",
              "type": "Letter"
            },
            {
              "id": "71667",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf",
              "date": "20220729",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20190613",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59067",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf",
              "date": "20190614",
              "type": "Label"
            },
            {
              "id": "59094",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761024Orig1s004ltr.pdf",
              "date": "20190617",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20240820",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "79453",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761024Orig1s019ltr.pdf",
              "date": "20240821",
              "type": "Letter"
            },
            {
              "id": "79457",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761024s019lbl.pdf",
              "date": "20240821",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20230712",
          "review_priority": "N/A",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "74748",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s017ltr.pdf",
              "date": "20230713",
              "type": "Letter"
            },
            {
              "id": "74762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s017lbl.pdf",
              "date": "20230714",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA761024",
      "sponsor_name": "AMGEN INC",
      "openfda": {
        "application_number": [
          "BLA761024"
        ],
        "brand_name": [
          "AMJEVITA"
        ],
        "generic_name": [
          "ADALIMUMAB-ATTO"
        ],
        "manufacturer_name": [
          "Nuvaila Limited",
          "Amgen, Inc",
          "Amgen USA Inc."
        ],
        "product_ndc": [
          "84612-399",
          "84612-479",
          "84612-482",
          "84612-481",
          "55513-399",
          "55513-411",
          "55513-410",
          "55513-400",
          "55513-413",
          "55513-479",
          "55513-480",
          "55513-482",
          "55513-481",
          "72511-399",
          "72511-400",
          "72511-482",
          "72511-479",
          "72511-481"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ADALIMUMAB"
        ],
        "rxcui": [
          "2663901",
          "2663904",
          "2663906",
          "2663907",
          "2663908",
          "2663910",
          "2663914",
          "2663915",
          "2627711",
          "2627717",
          "2627719",
          "2627722",
          "2627724",
          "2627725",
          "2634478",
          "2634479",
          "2663912",
          "2663913"
        ],
        "spl_id": [
          "58e52f3d-5688-461e-99e5-bdb98026f21a",
          "3657cc39-5ccd-49af-8f85-b622acc243d9",
          "1208dfda-344d-4919-b876-559e52119c8f"
        ],
        "spl_set_id": [
          "d7862491-2634-4402-b001-dcc1abf8dd58",
          "9c44bd5b-4464-40a4-8933-8680950f00f2",
          "b7178e36-6787-45ab-8fee-be59bc6a4aa4"
        ],
        "package_ndc": [
          "84612-399-01",
          "84612-479-02",
          "84612-479-01",
          "84612-482-02",
          "84612-482-01",
          "84612-481-02",
          "84612-481-01",
          "55513-411-01",
          "55513-410-02",
          "55513-410-01",
          "55513-400-01",
          "55513-400-02",
          "55513-400-91",
          "55513-413-01",
          "55513-399-01",
          "55513-479-01",
          "55513-479-02",
          "55513-480-01",
          "55513-480-02",
          "55513-482-01",
          "55513-482-02",
          "55513-481-01",
          "55513-481-02",
          "72511-400-01",
          "72511-400-02",
          "72511-482-01",
          "72511-482-02",
          "72511-399-01",
          "72511-479-02",
          "72511-481-02"
        ],
        "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": "002",
          "reference_drug": "No",
          "brand_name": "AMJEVITA",
          "active_ingredients": [
            {
              "name": "ADALIMUMAB-ATTO",
              "strength": "40MG/0.8ML"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "AMJEVITA",
          "active_ingredients": [
            {
              "name": "ADALIMUMAB-ATTO",
              "strength": "20MG/0.4ML"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}