{
  "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": "21",
          "submission_status": "AP",
          "submission_status_date": "20140321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "176",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s021ltr.pdf",
              "date": "20140324",
              "type": "Letter"
            },
            {
              "id": "32992",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf",
              "date": "20140325",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "19791114",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19540331",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20230405",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73953",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009190Orig1s032ltr.pdf",
              "date": "20230406",
              "type": "Letter"
            },
            {
              "id": "73966",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009190s032lbl.pdf",
              "date": "20230410",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20140404",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "10720",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf",
              "date": "20140408",
              "type": "Label"
            },
            {
              "id": "177",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s024ltr.pdf",
              "date": "20140407",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "19850910",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20140123",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19780207",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "19791114",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20200610",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63494",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009190Orig1s029, s031ltr.pdf",
              "date": "20200612",
              "type": "Letter"
            },
            {
              "id": "63509",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf",
              "date": "20200612",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20180928",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20200610",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63493",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009190Orig1s029, s031ltr.pdf",
              "date": "20200612",
              "type": "Letter"
            },
            {
              "id": "63508",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf",
              "date": "20200612",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA009190",
      "sponsor_name": "GUERBET",
      "openfda": {
        "application_number": [
          "NDA009190"
        ],
        "brand_name": [
          "LIPIODOL"
        ],
        "generic_name": [
          "ETHIODIZED OIL"
        ],
        "manufacturer_name": [
          "Guerbet LLC"
        ],
        "product_ndc": [
          "67684-1901"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRA-ARTERIAL",
          "INTRALYMPHATIC",
          "INTRAUTERINE"
        ],
        "substance_name": [
          "ETHIODIZED OIL"
        ],
        "spl_id": [
          "46155dba-f0cf-22b8-e063-6294a90a5997"
        ],
        "spl_set_id": [
          "511d1f64-5cb9-4baa-a123-96205467e59a"
        ],
        "package_ndc": [
          "67684-1901-1",
          "67684-1901-2"
        ],
        "nui": [
          "N0000180185",
          "N0000010258"
        ],
        "pharm_class_epc": [
          "Radiographic Contrast Agent [EPC]"
        ],
        "pharm_class_moa": [
          "X-Ray Contrast Activity [MoA]"
        ],
        "unii": [
          "KZW0R0686Q"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LIPIODOL",
          "active_ingredients": [
            {
              "name": "ETHIODIZED OIL",
              "strength": "EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "OIL",
          "route": "INTRALYMPHATIC, INTRAUTERINE",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}