{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20180126",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "52119",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf",
              "date": "20180130",
              "type": "Label"
            },
            {
              "id": "52121",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125513Orig1s003ltr.pdf",
              "date": "20180130",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20240710",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79045",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125513Orig1s033ltr.pdf",
              "date": "20240711",
              "type": "Letter"
            },
            {
              "id": "79081",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125513s033lbl.pdf",
              "date": "20240715",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20151023",
          "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": "39982",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf",
              "date": "20151026",
              "type": "Label"
            },
            {
              "id": "44813",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000SumR.pdf",
              "date": "20151203",
              "type": "Summary Review"
            },
            {
              "id": "22818",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000TOC.html",
              "date": "20151203",
              "type": "Review"
            },
            {
              "id": "31988",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125513Orig1s000ltr.pdf",
              "date": "20151026",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20161018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "45567",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125513Orig1s002ltr.pdf",
              "date": "20161020",
              "type": "Letter"
            },
            {
              "id": "47273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf",
              "date": "20170222",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20200612",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63567",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125513s018lbl.pdf",
              "date": "20200615",
              "type": "Label"
            },
            {
              "id": "63572",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125513Orig1s018ltr.pdf",
              "date": "20200616",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA125513",
      "sponsor_name": "ALEXION PHARM",
      "openfda": {
        "application_number": [
          "BLA125513"
        ],
        "brand_name": [
          "STRENSIQ"
        ],
        "generic_name": [
          "ASFOTASE ALFA"
        ],
        "manufacturer_name": [
          "Alexion Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "25682-010",
          "25682-013",
          "25682-016",
          "25682-019"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ASFOTASE ALFA"
        ],
        "rxcui": [
          "1720263",
          "1720268",
          "1720271",
          "1720272",
          "1720275",
          "1720276",
          "1720278",
          "1720280"
        ],
        "spl_id": [
          "404d99e5-991e-4353-bb9f-29dfa00a43b3"
        ],
        "spl_set_id": [
          "3387574f-5eaa-4501-a71d-4cbfbd563031"
        ],
        "package_ndc": [
          "25682-010-01",
          "25682-010-12",
          "25682-013-01",
          "25682-013-12",
          "25682-016-01",
          "25682-016-12",
          "25682-019-01",
          "25682-019-12"
        ],
        "nui": [
          "N0000191865",
          "M0000712"
        ],
        "pharm_class_epc": [
          "Tissue-nonspecific Alkaline Phosphatase [EPC]"
        ],
        "pharm_class_cs": [
          "Alkaline Phosphatase [CS]"
        ],
        "unii": [
          "Z633861EIM"
        ]
      },
      "products": [
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "STRENSIQ",
          "active_ingredients": [
            {
              "name": "ASFOTASE ALFA",
              "strength": "80MG/0.8ML"
            }
          ],
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "STRENSIQ",
          "active_ingredients": [
            {
              "name": "ASFOTASE ALFA",
              "strength": "28MG/0.7ML"
            }
          ],
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "STRENSIQ",
          "active_ingredients": [
            {
              "name": "ASFOTASE ALFA",
              "strength": "40MG/ML"
            }
          ],
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "STRENSIQ",
          "active_ingredients": [
            {
              "name": "ASFOTASE ALFA",
              "strength": "18MG/0.45ML"
            }
          ],
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}