{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20070904",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37060",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf",
              "date": "20070906",
              "type": "Label"
            },
            {
              "id": "5528",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf",
              "date": "20070906",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20201219",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65670",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021489Orig1s014ltr.pdf",
              "date": "20201222",
              "type": "Letter"
            },
            {
              "id": "65738",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf",
              "date": "20201228",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20181102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56311",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s010lbl.pdf",
              "date": "20181106",
              "type": "Label"
            },
            {
              "id": "56435",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021489Orig1s010,021357Orig1s018,021358Orig1s017ltr.pdf",
              "date": "20181114",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20031009",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "44128",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm",
              "date": "20060609",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "5527",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21489ltr.pdf",
              "date": "20031016",
              "type": "Letter"
            },
            {
              "id": "21689",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021489s000_ProhanceTOC.html",
              "date": "20060725",
              "type": "Review"
            },
            {
              "id": "37059",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21489_proHance_lbl.pdf",
              "date": "20031016",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20180426",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53845",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf",
              "date": "20180427",
              "type": "Label"
            },
            {
              "id": "53895",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020131Orig1s028,021489Orig1s006Ltr.pdf",
              "date": "20180501",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20250305",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81449",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020131Orig1s044;021489Orig1s025ltr.pdf",
              "date": "20250306",
              "type": "Letter"
            },
            {
              "id": "81533",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021489s025lbl.pdf",
              "date": "20250311",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140722",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5530",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021489Orig1s004ltr.pdf",
              "date": "20140724",
              "type": "Letter"
            },
            {
              "id": "15591",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021489s004lbl.pdf",
              "date": "20140724",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20240814",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79403",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s042,021489s023lbl.pdf",
              "date": "20240816",
              "type": "Label"
            },
            {
              "id": "79404",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s042,021489s023lbl.pdf#page=32",
              "date": "20240816",
              "type": "Medication Guide"
            },
            {
              "id": "79421",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s042, 021489Orig1s023ltr.pdf",
              "date": "20240816",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20101220",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5529",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf",
              "date": "20101222",
              "type": "Letter"
            },
            {
              "id": "15590",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021489s002lbl.pdf",
              "date": "20101220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20240126",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77334",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf",
              "date": "20240129",
              "type": "Label"
            },
            {
              "id": "77343",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s040; 021489Orig1s021ltr.pdf",
              "date": "20240129",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20221119",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72671",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021489Orig1s018ltr.pdf",
              "date": "20221122",
              "type": "Letter"
            },
            {
              "id": "72674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021489Orig1s018lbl.pdf",
              "date": "20221123",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20170915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49774",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021489s005lbl.pdf",
              "date": "20170919",
              "type": "Label"
            },
            {
              "id": "49780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021489Orig1s005ltr.pdf",
              "date": "20170919",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20240723",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79192",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s043,021489s024lbl.pdf",
              "date": "20240724",
              "type": "Label"
            },
            {
              "id": "79202",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s043;021489Orig1s024ltr.pdf",
              "date": "20240724",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20210506",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67443",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021489Orig1s016ltr.pdf",
              "date": "20210510",
              "type": "Letter"
            },
            {
              "id": "67473",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021489s016lbl.pdf",
              "date": "20210512",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20130813",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37061",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf",
              "date": "20130815",
              "type": "Label"
            },
            {
              "id": "27922",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf",
              "date": "20130816",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021489",
      "sponsor_name": "BRACCO",
      "openfda": {
        "application_number": [
          "NDA021489"
        ],
        "brand_name": [
          "PROHANCE"
        ],
        "generic_name": [
          "GADOTERIDOL"
        ],
        "manufacturer_name": [
          "Bracco Diagnostics Inc"
        ],
        "product_ndc": [
          "0270-1111"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GADOTERIDOL"
        ],
        "spl_id": [
          "ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2"
        ],
        "spl_set_id": [
          "e8b76200-c0aa-491b-aad7-e22d2f68496f"
        ],
        "package_ndc": [
          "0270-1111-70",
          "0270-1111-85"
        ],
        "nui": [
          "N0000175862",
          "N0000180184"
        ],
        "pharm_class_moa": [
          "Magnetic Resonance Contrast Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Paramagnetic Contrast Agent [EPC]"
        ],
        "unii": [
          "0199MV609F"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "PROHANCE MULTIPACK",
          "active_ingredients": [
            {
              "name": "GADOTERIDOL",
              "strength": "279.3MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}