{
  "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": "45",
          "submission_status": "AP",
          "submission_status_date": "20051003",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9560",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0045ltr.pdf",
              "date": "20051020",
              "type": "Letter"
            },
            {
              "id": "18746",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf",
              "date": "20051010",
              "type": "Label"
            },
            {
              "id": "22772",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s045.pdf",
              "date": "20150309",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "411",
          "submission_status": "AP",
          "submission_status_date": "20190111",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57260",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125057Orig1s411ltr.pdf",
              "date": "20190118",
              "type": "Letter"
            },
            {
              "id": "58982",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125057Orig1s411lbl.pdf",
              "date": "20190606",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "322",
          "submission_status": "AP",
          "submission_status_date": "20130424",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48417",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125057Orig1s322.pdf",
              "date": "20170517",
              "type": "Review"
            },
            {
              "id": "18754",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf",
              "date": "20130429",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "403",
          "submission_status": "AP",
          "submission_status_date": "20171214",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50712",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s403ltr.pdf",
              "date": "20171215",
              "type": "Letter"
            },
            {
              "id": "50830",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf",
              "date": "20171222",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "367",
          "submission_status": "AP",
          "submission_status_date": "20140930",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "39809",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf",
              "date": "20141002",
              "type": "Label"
            },
            {
              "id": "31795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s367ltr.pdf",
              "date": "20141002",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "381",
          "submission_status": "AP",
          "submission_status_date": "20140807",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "43300",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125057Orig1s381.pdf",
              "date": "20160728",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "278",
          "submission_status": "AP",
          "submission_status_date": "20120524",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9570",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s0278ltr.pdf",
              "date": "20120530",
              "type": "Letter"
            },
            {
              "id": "18752",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf",
              "date": "20120529",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "401",
          "submission_status": "AP",
          "submission_status_date": "20170421",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "48116",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s401lbl.pdf",
              "date": "20170426",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "94",
          "submission_status": "AP",
          "submission_status_date": "20070730",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9563",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s094ltr.pdf",
              "date": "20070801",
              "type": "Letter"
            },
            {
              "id": "18748",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf",
              "date": "20070731",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "128",
          "submission_status": "AP",
          "submission_status_date": "20110314",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "31787",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s128ltr.pdf",
              "date": "20110325",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "276",
          "submission_status": "AP",
          "submission_status_date": "20111226",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39807",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf",
              "date": "20120315",
              "type": "Label"
            },
            {
              "id": "9569",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s276ltr.pdf",
              "date": "20120105",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "215",
          "submission_status": "AP",
          "submission_status_date": "20110225",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "18751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf",
              "date": "20110304",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "310",
          "submission_status": "AP",
          "submission_status_date": "20130513",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9572",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s310ltr.pdf",
              "date": "20130515",
              "type": "Letter"
            },
            {
              "id": "18753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf",
              "date": "20130513",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20040618",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "43298",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125057Orig1s023.pdf",
              "date": "20130909",
              "type": "Review"
            },
            {
              "id": "9559",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/125057_0023ltr.pdf",
              "date": "20040707",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "355",
          "submission_status": "AP",
          "submission_status_date": "20140226",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39808",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf",
              "date": "20140227",
              "type": "Label"
            },
            {
              "id": "31793",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s355_replace_ltr.pdf",
              "date": "20140227",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "213",
          "submission_status": "AP",
          "submission_status_date": "20100729",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "22775",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125057Orig1s0213.pdf",
              "date": "20160203",
              "type": "Review"
            },
            {
              "id": "31790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s0213ltr.pdf",
              "date": "20100803",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "280",
          "submission_status": "AP",
          "submission_status_date": "20141224",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "9571",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s280ltr.pdf",
              "date": "20150108",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "108",
          "submission_status": "AP",
          "submission_status_date": "20070905",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39803",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf",
              "date": "20070907",
              "type": "Label"
            },
            {
              "id": "31784",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s108_ltr.pdf",
              "date": "20070907",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "418",
          "submission_status": "AP",
          "submission_status_date": "20201216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65641",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s418, s419ltr.pdf",
              "date": "20201221",
              "type": "Letter"
            },
            {
              "id": "65657",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf",
              "date": "20201221",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "114",
          "submission_status": "AP",
          "submission_status_date": "20080221",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53151",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125057s114_Adalimumab (Humira)_Clinical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "53152",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125057s114_Adalimumab (Humira)_Clinpharm_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "53153",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/0125057s114_Adalimumab (Humira)_Statistical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "18750",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf",
              "date": "20080226",
              "type": "Label"
            },
            {
              "id": "31786",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s114ltr.pdf",
              "date": "20080226",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "424",
          "submission_status": "AP",
          "submission_status_date": "20250716",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82885",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125057Orig1s424ltr.pdf",
              "date": "20250717",
              "type": "Letter"
            },
            {
              "id": "82895",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125057s424lbl.pdf",
              "date": "20250721",
              "type": "Label"
            },
            {
              "id": "82896",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125057s424lbl.pdf#page=59",
              "date": "20250721",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "254",
          "submission_status": "AP",
          "submission_status_date": "20110713",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9567",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s254ltr.pdf",
              "date": "20120105",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "327",
          "submission_status": "AP",
          "submission_status_date": "20130919",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18755",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf",
              "date": "20130924",
              "type": "Label"
            },
            {
              "id": "31792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s327ltr.pdf",
              "date": "20130920",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "394",
          "submission_status": "AP",
          "submission_status_date": "20151123",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39810",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf",
              "date": "20151125",
              "type": "Label"
            },
            {
              "id": "44790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125057Orig1s394SumR.pdf",
              "date": "20160311",
              "type": "Summary Review"
            },
            {
              "id": "9575",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s394ltr.pdf",
              "date": "20151124",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "408",
          "submission_status": "AP",
          "submission_status_date": "20180928",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "55769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s408ltr.pdf",
              "date": "20181001",
              "type": "Letter"
            },
            {
              "id": "55788",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s408lbl.pdf",
              "date": "20181003",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "20060728",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39801",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf",
              "date": "20060831",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "110",
          "submission_status": "AP",
          "submission_status_date": "20080118",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39804",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf",
              "date": "20080327",
              "type": "Label"
            },
            {
              "id": "43299",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110TOC.html",
              "date": "20090324",
              "type": "Review"
            },
            {
              "id": "24356",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110_SumR.pdf",
              "date": "20090324",
              "type": "Summary Review"
            },
            {
              "id": "31785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s0110ltr.pdf",
              "date": "20080125",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "406",
          "submission_status": "AP",
          "submission_status_date": "20180802",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "55096",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s406ltr.pdf",
              "date": "20180803",
              "type": "Letter"
            },
            {
              "id": "55103",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf",
              "date": "20180803",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "46",
          "submission_status": "AP",
          "submission_status_date": "20051003",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39799",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf",
              "date": "20051010",
              "type": "Label"
            },
            {
              "id": "22773",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s046.pdf",
              "date": "20150309",
              "type": "Review"
            },
            {
              "id": "31782",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0046ltr.pdf",
              "date": "20051020",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "60",
          "submission_status": "AP",
          "submission_status_date": "20070216",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39800",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf",
              "date": "20070223",
              "type": "Label"
            },
            {
              "id": "31783",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s060LTR.pdf",
              "date": "20070223",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "384",
          "submission_status": "AP",
          "submission_status_date": "20141029",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "161",
          "submission_status": "AP",
          "submission_status_date": "20100408",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "31788",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s161ltr.pdf",
              "date": "20100617",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "390",
          "submission_status": "AP",
          "submission_status_date": "20141106",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "368",
          "submission_status": "AP",
          "submission_status_date": "20140514",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9574",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s368ltr.pdf",
              "date": "20140520",
              "type": "Letter"
            },
            {
              "id": "18758",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf",
              "date": "20140515",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "410",
          "submission_status": "AP",
          "submission_status_date": "20181206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf",
              "date": "20181207",
              "type": "Label"
            },
            {
              "id": "56660",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057s410ltr.pdf",
              "date": "20181207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "89",
          "submission_status": "AP",
          "submission_status_date": "20070227",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39802",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf",
              "date": "20070307",
              "type": "Label"
            },
            {
              "id": "9562",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s089Ltr.pdf",
              "date": "20070306",
              "type": "Letter"
            },
            {
              "id": "22774",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125057_S0089.pdf",
              "date": "20130409",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20021231",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "39797",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm",
              "date": "20040316",
              "type": "Label"
            },
            {
              "id": "43296",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.html",
              "date": "20040316",
              "type": "Review"
            },
            {
              "id": "44425",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm",
              "date": "20111220",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "66958",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/338_125057S408 adalimumab multidisciplinary prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "9558",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm",
              "date": "20040316",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "402",
          "submission_status": "AP",
          "submission_status_date": "20170428",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "48176",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s402lbl.pdf",
              "date": "20170501",
              "type": "Label"
            },
            {
              "id": "48202",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s402ltr.pdf",
              "date": "20170502",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "95",
          "submission_status": "AP",
          "submission_status_date": "20061109",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9564",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf",
              "date": "20061114",
              "type": "Letter"
            },
            {
              "id": "18749",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf",
              "date": "20061114",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "232",
          "submission_status": "AP",
          "submission_status_date": "20120928",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39806",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf",
              "date": "20121002",
              "type": "Label"
            },
            {
              "id": "48416",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125057Orig1s232.pdf",
              "date": "20170517",
              "type": "Review"
            },
            {
              "id": "9566",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057Orig1s232ltr.pdf",
              "date": "20121003",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "366",
          "submission_status": "AP",
          "submission_status_date": "20140530",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18757",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf",
              "date": "20140603",
              "type": "Label"
            },
            {
              "id": "31794",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s366ltr.pdf",
              "date": "20140603",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "196",
          "submission_status": "AP",
          "submission_status_date": "20101118",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39805",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf",
              "date": "20100223",
              "type": "Label"
            },
            {
              "id": "31789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125057s0196ltr.pdf",
              "date": "20091203",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "224",
          "submission_status": "AP",
          "submission_status_date": "20100929",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9565",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s224ltr.pdf",
              "date": "20101019",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "400",
          "submission_status": "AP",
          "submission_status_date": "20161017",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "50170",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf",
              "date": "20171024",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "141",
          "submission_status": "AP",
          "submission_status_date": "20090311",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "356",
          "submission_status": "AP",
          "submission_status_date": "20140923",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "67005",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125057Orig1s356.pdf",
              "date": "20210407",
              "type": "Review"
            },
            {
              "id": "9573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s356ltr.pdf",
              "date": "20140925",
              "type": "Letter"
            },
            {
              "id": "18756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf",
              "date": "20140926",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20040730",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39798",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf",
              "date": "20040806",
              "type": "Label"
            },
            {
              "id": "43297",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125057Orig1s016.pdf",
              "date": "20150311",
              "type": "Review"
            },
            {
              "id": "31781",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125057_0016ltr.pdf",
              "date": "20040806",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "399",
          "submission_status": "AP",
          "submission_status_date": "20170327",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "47741",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf",
              "date": "20170328",
              "type": "Label"
            },
            {
              "id": "47765",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s399ltr.pdf",
              "date": "20170329",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "271",
          "submission_status": "AP",
          "submission_status_date": "20111213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9568",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s271ltr.pdf",
              "date": "20120105",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "419",
          "submission_status": "AP",
          "submission_status_date": "20201216",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "65642",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s418, s419ltr.pdf",
              "date": "20201221",
              "type": "Letter"
            },
            {
              "id": "65658",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf",
              "date": "20201221",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "397",
          "submission_status": "AP",
          "submission_status_date": "20160630",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "39811",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf",
              "date": "20160705",
              "type": "Label"
            },
            {
              "id": "85138",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/125057Orig1s397.pdf",
              "date": "20260224",
              "type": "Review"
            },
            {
              "id": "9576",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125057Orig1s397ltr.pdf",
              "date": "20160701",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "425",
          "submission_status": "AP",
          "submission_status_date": "20251223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "84615",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125057Orig1s425ltr.pdf",
              "date": "20251231",
              "type": "Letter"
            },
            {
              "id": "84663",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125057s425lbl.pdf",
              "date": "20260106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "65",
          "submission_status": "AP",
          "submission_status_date": "20060623",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "255",
          "submission_status": "AP",
          "submission_status_date": "20110907",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "31791",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s255ltr.pdf",
              "date": "20110913",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "417",
          "submission_status": "AP",
          "submission_status_date": "20210224",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "66360",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125057Orig1s417ltr.pdf",
              "date": "20210225",
              "type": "Letter"
            },
            {
              "id": "66363",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf",
              "date": "20210225",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "71",
          "submission_status": "AP",
          "submission_status_date": "20061109",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9561",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf",
              "date": "20061114",
              "type": "Letter"
            },
            {
              "id": "18747",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf",
              "date": "20061114",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "409",
          "submission_status": "AP",
          "submission_status_date": "20181016",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "55968",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s409ltr.pdf",
              "date": "20181017",
              "type": "Letter"
            },
            {
              "id": "56009",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf",
              "date": "20181018",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "423",
          "submission_status": "AP",
          "submission_status_date": "20231103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "76380",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125057Orig1s423ltr.pdf",
              "date": "20231106",
              "type": "Letter"
            },
            {
              "id": "76387",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125057s423lbl.pdf",
              "date": "20231106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "415",
          "submission_status": "AP",
          "submission_status_date": "20200311",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62131",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s415ltr.pdf",
              "date": "20200312",
              "type": "Letter"
            },
            {
              "id": "62136",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf",
              "date": "20200312",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "393",
          "submission_status": "AP",
          "submission_status_date": "20150909",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58921",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125057Orig1s393.pdf",
              "date": "20190603",
              "type": "Review"
            },
            {
              "id": "31796",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s393ltr.pdf",
              "date": "20150914",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20030912",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "BLA125057",
      "sponsor_name": "ABBVIE INC",
      "openfda": {
        "application_number": [
          "BLA125057"
        ],
        "brand_name": [
          "HUMIRA"
        ],
        "generic_name": [
          "ADALIMUMAB"
        ],
        "manufacturer_name": [
          "Cordavis Limited",
          "AbbVie Inc."
        ],
        "product_ndc": [
          "83457-124",
          "83457-554",
          "83457-243",
          "83457-616",
          "83457-817",
          "0074-0124",
          "0074-3799",
          "0074-4339",
          "0074-9374",
          "0074-0243",
          "0074-0554",
          "0074-0067",
          "0074-2540",
          "0074-1539",
          "0074-0616",
          "0074-0817"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "797544",
          "1726844",
          "1726846",
          "1872979",
          "1872980",
          "1921009",
          "1921010",
          "1921016",
          "1921017",
          "1921238",
          "1921240",
          "727703",
          "727705",
          "763564",
          "763565",
          "825169",
          "825170",
          "1594352",
          "1594357",
          "1594358",
          "1655726",
          "1655728",
          "1656703",
          "1801277",
          "1801278",
          "1855523",
          "1855524",
          "1855526",
          "1855527",
          "1872983",
          "1872984",
          "1872985",
          "1872986",
          "1873086",
          "1873087",
          "1921244",
          "1921245",
          "1921467",
          "1921468",
          "2531133",
          "2531134"
        ],
        "spl_id": [
          "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89",
          "8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a"
        ],
        "spl_set_id": [
          "4977567e-3525-44ac-9ff5-f1e74b053950",
          "608d4f0d-b19f-46d3-749a-7159aa5f933d"
        ],
        "package_ndc": [
          "83457-554-02",
          "83457-553-01",
          "83457-927-01",
          "83457-124-02",
          "83457-123-01",
          "83457-243-02",
          "83457-242-01",
          "83457-616-02",
          "83457-615-01",
          "83457-817-02",
          "83457-816-01",
          "0074-3799-02",
          "0074-3799-71",
          "0074-3799-06",
          "0074-3799-03",
          "0074-4339-02",
          "0074-4339-07",
          "0074-4339-71",
          "0074-4339-73",
          "0074-4339-01",
          "0074-4339-74",
          "0074-9374-71",
          "0074-0243-02",
          "0074-0243-71",
          "0074-0554-01",
          "0074-0554-02",
          "0074-0554-04",
          "0074-0554-06",
          "0074-0554-71",
          "0074-0554-74",
          "0074-0554-73",
          "0074-0067-02",
          "0074-2540-01",
          "0074-2540-03",
          "0074-0124-74",
          "0074-0124-73",
          "0074-0124-01",
          "0074-0124-03",
          "0074-0124-02",
          "0074-0124-04",
          "0074-1539-03",
          "0074-0616-71",
          "0074-0616-02",
          "0074-0817-02"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "HUMIRA",
          "active_ingredients": [
            {
              "name": "ADALIMUMAB",
              "strength": "40MG/0.8ML"
            }
          ],
          "dosage_form": "VIAL",
          "route": null,
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "HUMIRA",
          "active_ingredients": [
            {
              "name": "ADALIMUMAB",
              "strength": "40MG/0.8ML"
            }
          ],
          "dosage_form": "SYRINGE",
          "route": null,
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}