{
  "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": "25",
          "submission_status": "AP",
          "submission_status_date": "20260219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "85100",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761051Orig1s025ltr.pdf",
              "date": "20260223",
              "type": "Letter"
            },
            {
              "id": "85137",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761051s025lbl.pdf",
              "date": "20260224",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20220330",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "70668",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761051Orig1s015ltr.pdf",
              "date": "20220331",
              "type": "Letter"
            },
            {
              "id": "70674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761051s015lbl.pdf",
              "date": "20220331",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20210708",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "68040",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761051Orig1s011ltr.pdf",
              "date": "20210712",
              "type": "Letter"
            },
            {
              "id": "68070",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761051s011lbl.pdf",
              "date": "20210713",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180808",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "55132",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf",
              "date": "20180808",
              "type": "Label"
            },
            {
              "id": "55133",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761051Orig1s000Ltr.pdf",
              "date": "20180808",
              "type": "Letter"
            },
            {
              "id": "55394",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761051Orig1s000TOC.html",
              "date": "20180907",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20250121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "80911",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761051Orig1s018ltr.pdf",
              "date": "20250204",
              "type": "Letter"
            },
            {
              "id": "80917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761051s018lbl.pdf",
              "date": "20250204",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA761051",
      "sponsor_name": "KYOWA KIRIN",
      "openfda": {
        "application_number": [
          "BLA761051"
        ],
        "brand_name": [
          "POTELIGEO"
        ],
        "generic_name": [
          "MOGAMULIZUMAB-KPKC"
        ],
        "manufacturer_name": [
          "Kyowa Kirin, Inc."
        ],
        "product_ndc": [
          "42747-761"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MOGAMULIZUMAB"
        ],
        "rxcui": [
          "2054081",
          "2054086"
        ],
        "spl_id": [
          "2002b8eb-c6a6-4f3f-8a58-963fe6c015c4"
        ],
        "spl_set_id": [
          "e53960ab-42a1-40d1-9c7d-eb013fe7f18f"
        ],
        "package_ndc": [
          "42747-761-01"
        ],
        "nui": [
          "N0000193866",
          "N0000193863",
          "N0000193867",
          "M0001357"
        ],
        "pharm_class_epc": [
          "Chemokine Receptor Type 4 Interaction [EPC]",
          "Monoclonal Antibody [EPC]"
        ],
        "pharm_class_moa": [
          "Chemokine Receptor Type 4 Interactions [MoA]"
        ],
        "pharm_class_cs": [
          "Antibodies, Monoclonal [CS]"
        ],
        "unii": [
          "YI437801BE"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "TBD",
          "brand_name": "POTELIGEO",
          "active_ingredients": [
            {
              "name": "MOGAMULIZUMAB-KPKC",
              "strength": "20MG/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}