{
  "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": "62",
          "submission_status": "AP",
          "submission_status_date": "20180622",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54706",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125370Orig1s062_761043Orig1s002 Ltr.pdf",
              "date": "20180627",
              "type": "Letter"
            },
            {
              "id": "54728",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf",
              "date": "20180629",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "79",
          "submission_status": "AP",
          "submission_status_date": "20230215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73530",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125370Orig1s079;761043Orig1s022ltr.pdf",
              "date": "20230216",
              "type": "Letter"
            },
            {
              "id": "73541",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf",
              "date": "20230217",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "85",
          "submission_status": "AP",
          "submission_status_date": "20250620",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82630",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125370s085lbl.pdf",
              "date": "20250623",
              "type": "Label"
            },
            {
              "id": "82631",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125370s085lbl.pdf#page=38",
              "date": "20250623",
              "type": "Medication Guide"
            },
            {
              "id": "82637",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125370Orig1s085ltr.pdf",
              "date": "20250624",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20120330",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9723",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125370s016ltr.pdf",
              "date": "20120402",
              "type": "Letter"
            },
            {
              "id": "18889",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf",
              "date": "20120402",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "67",
          "submission_status": "AP",
          "submission_status_date": "20190913",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60007",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf",
              "date": "20190916",
              "type": "Label"
            },
            {
              "id": "60018",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s067, 761043Orig1s005ltr.pdf",
              "date": "20190917",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "81",
          "submission_status": "AP",
          "submission_status_date": "20240516",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s081lbl.pdf",
              "date": "20240520",
              "type": "Label"
            },
            {
              "id": "78496",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s081lbl.pdf#page=43",
              "date": "20240520",
              "type": "Medication Guide"
            },
            {
              "id": "78502",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125370Orig1s081ltr.pdf",
              "date": "20240520",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "73",
          "submission_status": "AP",
          "submission_status_date": "20201216",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65611",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf",
              "date": "20201217",
              "type": "Label"
            },
            {
              "id": "65643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s073_761043Orig1s013ltr.pdf",
              "date": "20201221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "20170118",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "46917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf",
              "date": "20170118",
              "type": "Label"
            },
            {
              "id": "46934",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125370Orig1s057ltr.pdf",
              "date": "20170124",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "71",
          "submission_status": "AP",
          "submission_status_date": "20200924",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64675",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s071ltr.pdf",
              "date": "20200925",
              "type": "Letter"
            },
            {
              "id": "64711",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s071lbl.pdf",
              "date": "20200929",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "20161202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "46021",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf",
              "date": "20161202",
              "type": "Label"
            },
            {
              "id": "46046",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125370Orig1s055ltr.pdf",
              "date": "20161206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "20131213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39939",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf",
              "date": "20131217",
              "type": "Label"
            },
            {
              "id": "31943",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125370Orig1s047ltr.pdf",
              "date": "20131217",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "20140403",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18890",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf",
              "date": "20140404",
              "type": "Label"
            },
            {
              "id": "31944",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125370Orig1s053ltr.pdf",
              "date": "20140404",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "78",
          "submission_status": "AP",
          "submission_status_date": "20220726",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71639",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125370Orig1s078ltr.pdf",
              "date": "20220727",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "68",
          "submission_status": "AP",
          "submission_status_date": "20200117",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "61619",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf",
              "date": "20200122",
              "type": "Label"
            },
            {
              "id": "61626",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s068, 761043Orig1s008ltr.pdf",
              "date": "20200123",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "82",
          "submission_status": "AP",
          "submission_status_date": "20240209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77467",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s082,761043s028lbl.pdf",
              "date": "20240212",
              "type": "Label"
            },
            {
              "id": "77476",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125370Orig1s082; 761043Orig1s028ltr.pdf",
              "date": "20240212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110309",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "43324",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000TOC.html",
              "date": "20110422",
              "type": "Review"
            },
            {
              "id": "44805",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000SumR.pdf",
              "date": "20110422",
              "type": "Summary Review"
            },
            {
              "id": "18888",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf",
              "date": "20110311",
              "type": "Label"
            },
            {
              "id": "31942",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125370s000ltr.pdf",
              "date": "20110316",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "64",
          "submission_status": "AP",
          "submission_status_date": "20190426",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58475",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s064; 761043Orig1s007_REPLACEMENTltr.pdf",
              "date": "20190430",
              "type": "Letter"
            },
            {
              "id": "58490",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf",
              "date": "20190430",
              "type": "Label"
            },
            {
              "id": "63279",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125370S64 belimumab unireview prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            }
          ]
        }
      ],
      "application_number": "BLA125370",
      "sponsor_name": "HUMAN GENOME SCIENCES INC.",
      "openfda": {
        "application_number": [
          "BLA125370"
        ],
        "brand_name": [
          "BENLYSTA"
        ],
        "generic_name": [
          "BELIMUMAB"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC"
        ],
        "product_ndc": [
          "49401-101",
          "49401-102",
          "49401-088"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BELIMUMAB"
        ],
        "rxcui": [
          "1656395",
          "1656398",
          "1656400",
          "1656402",
          "1939296",
          "1939299",
          "1939346",
          "1939348"
        ],
        "spl_id": [
          "379d7f58-8f17-44b3-8336-6fe8ef015aed"
        ],
        "spl_set_id": [
          "2fa3c528-1777-4628-8a55-a69dae2381a3"
        ],
        "package_ndc": [
          "49401-102-01",
          "49401-101-01",
          "49401-088-42",
          "49401-088-47",
          "49401-088-50",
          "49401-088-01",
          "49401-088-35",
          "49401-088-02",
          "49401-088-61"
        ],
        "nui": [
          "N0000182156",
          "N0000182637",
          "N0000182636"
        ],
        "pharm_class_pe": [
          "Decreased B Lymphocyte Activation [PE]"
        ],
        "pharm_class_epc": [
          "B Lymphocyte Stimulator-specific Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "B Lymphocyte Stimulator-directed Antibody Interactions [MoA]"
        ],
        "unii": [
          "73B0K5S26A"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "BENLYSTA",
          "active_ingredients": [
            {
              "name": "BELIMUMAB",
              "strength": "400MG"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "BENLYSTA",
          "active_ingredients": [
            {
              "name": "BELIMUMAB",
              "strength": "120MG"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}