{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191114",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "60846",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209445Orig1s000ltr.pdf",
              "date": "20191115",
              "type": "Letter"
            },
            {
              "id": "60850",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf",
              "date": "20191115",
              "type": "Label"
            },
            {
              "id": "61345",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000TOC.html",
              "date": "20191219",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20211112",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69308",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209445Orig1s004ltr.pdf",
              "date": "20211115",
              "type": "Letter"
            },
            {
              "id": "69312",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209445s004lbl.pdf",
              "date": "20211115",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20200925",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64694",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209445s002lbl.pdf",
              "date": "20200928",
              "type": "Label"
            },
            {
              "id": "64738",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209445Orig1s002ltr.pdf",
              "date": "20200929",
              "type": "Letter"
            },
            {
              "id": "64882",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209445Orig1s002.pdf",
              "date": "20201008",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20250606",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82493",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209445s009lbl.pdf",
              "date": "20250609",
              "type": "Label"
            },
            {
              "id": "82507",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209445Orig1s009ltr.pdf",
              "date": "20250609",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20260701",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "86458",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209445Orig1s012ltr.pdf",
              "date": "20260706",
              "type": "Letter"
            },
            {
              "id": "86521",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209445s012lbl.pdf",
              "date": "20260710",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA209445",
      "sponsor_name": "SHIONOGI",
      "openfda": {
        "application_number": [
          "NDA209445"
        ],
        "brand_name": [
          "FETROJA"
        ],
        "generic_name": [
          "CEFIDEROCOL SULFATE TOSYLATE"
        ],
        "manufacturer_name": [
          "Shionogi Inc."
        ],
        "product_ndc": [
          "59630-266"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CEFIDEROCOL SULFATE TOSYLATE"
        ],
        "rxcui": [
          "2265706",
          "2265711"
        ],
        "spl_id": [
          "64c35e73-1daa-4a82-a3c2-a737dec6eeae"
        ],
        "spl_set_id": [
          "75c0c785-38e0-4049-a6fb-b77581f5b35c"
        ],
        "package_ndc": [
          "59630-266-01",
          "59630-266-10"
        ],
        "unii": [
          "TTP8LBP45D"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "FETROJA",
          "active_ingredients": [
            {
              "name": "CEFIDEROCOL SULFATE TOSYLATE",
              "strength": "EQ 1GM BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "POWDER",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}