{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "20120424",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9669",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125277s0050ltr.pdf",
              "date": "20120427",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20110405",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9667",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s032ltr.pdf",
              "date": "20110517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "81",
          "submission_status": "AP",
          "submission_status_date": "20201228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "65772",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf",
              "date": "20201228",
              "type": "Label"
            },
            {
              "id": "65773",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf#page=13",
              "date": "20201228",
              "type": "Medication Guide"
            },
            {
              "id": "65778",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125277Orig1s081ltr.pdf",
              "date": "20201229",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "65",
          "submission_status": "AP",
          "submission_status_date": "20130410",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9670",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125277Orig1s065ltr.pdf",
              "date": "20130416",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "71",
          "submission_status": "AP",
          "submission_status_date": "20140908",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "39894",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf",
              "date": "20140909",
              "type": "Label"
            },
            {
              "id": "9672",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s071ltr.pdf",
              "date": "20140910",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20091201",
          "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": "39893",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.pdf",
              "date": "20091202",
              "type": "Label"
            },
            {
              "id": "43314",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000TOC.html",
              "date": "20100214",
              "type": "Review"
            },
            {
              "id": "44796",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000SumR.pdf",
              "date": "20100214",
              "type": "Summary Review"
            },
            {
              "id": "9666",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125277s000ltr.pdf",
              "date": "20091208",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20110817",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9668",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s037ltr.pdf",
              "date": "20110913",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "70",
          "submission_status": "AP",
          "submission_status_date": "20140328",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9671",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s70ltr.pdf",
              "date": "20140402",
              "type": "Letter"
            },
            {
              "id": "18843",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf",
              "date": "20140401",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA125277",
      "sponsor_name": "DYAX CORP.",
      "openfda": {
        "application_number": [
          "BLA125277"
        ],
        "brand_name": [
          "KALBITOR"
        ],
        "generic_name": [
          "ECALLANTIDE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "47783-101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ECALLANTIDE"
        ],
        "rxcui": [
          "884698",
          "884702"
        ],
        "spl_id": [
          "1992039f-246f-4057-899b-987d45df152f"
        ],
        "spl_set_id": [
          "f56aec67-c662-477c-b866-bfc23e8809cf"
        ],
        "package_ndc": [
          "47783-101-01"
        ],
        "nui": [
          "N0000192750",
          "N0000184151"
        ],
        "pharm_class_epc": [
          "Plasma Kallikrein Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Kallikrein Inhibitors [MoA]"
        ],
        "unii": [
          "5Q6TZN2HNM"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "KALBITOR",
          "active_ingredients": [
            {
              "name": "ECALLANTIDE",
              "strength": "10MG/ML"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}