{
  "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": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20130129",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20091002",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15281",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021357s004lbl.pdf",
              "date": "20091014",
              "type": "Label"
            },
            {
              "id": "27580",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021357s004ltr.pdf",
              "date": "20091110",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20070508",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20240723",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79186",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s027,021358s025lbl.pdf",
              "date": "20240724",
              "type": "Label"
            },
            {
              "id": "79203",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021357Orig1s027;021358Orig1s025ltr.pdf",
              "date": "20240724",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20240126",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77336",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357Orig1s025; 021358Orig1s023correctedlbl.pdf",
              "date": "20240201",
              "type": "Label"
            },
            {
              "id": "77344",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021357Orig1s025; 021358Orig1s023correctedltr.pdf",
              "date": "20240129",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20180426",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53827",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf",
              "date": "20180427",
              "type": "Label"
            },
            {
              "id": "53900",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf",
              "date": "20180501",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20101220",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5154",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s009ltr.pdf",
              "date": "20101222",
              "type": "Letter"
            },
            {
              "id": "15283",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s009lbl.pdf",
              "date": "20101220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20170915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49768",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021357s015lbl.pdf",
              "date": "20170918",
              "type": "Label"
            },
            {
              "id": "49786",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021357Orig1s015ltr.pdf",
              "date": "20170919",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20130730",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36747",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf",
              "date": "20130809",
              "type": "Label"
            },
            {
              "id": "5156",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021357Orig1s013,021358Orig1s012ltr.pdf",
              "date": "20130801",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20041123",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "5152",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf",
              "date": "20041202",
              "type": "Letter"
            },
            {
              "id": "53279",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021357_Gadobendate_Clinical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "53280",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021357_Gadobendate_Clinpharm_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "53281",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021357_Gadobendate_Statistical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "21614",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021357_021358_Multihance.html",
              "date": "20050328",
              "type": "Review"
            },
            {
              "id": "23649",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm",
              "date": "20060609",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "36745",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021357lbl.pdf",
              "date": "20041203",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20120706",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "5155",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf",
              "date": "20120709",
              "type": "Letter"
            },
            {
              "id": "36746",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021357s011lbl.pdf",
              "date": "20120710",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20070904",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15280",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf",
              "date": "20070906",
              "type": "Label"
            },
            {
              "id": "27579",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021357s003, 021358s003ltr.pdf",
              "date": "20070906",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20250305",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81450",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021357Orig1s028;021358Orig1s026ltr.pdf",
              "date": "20250306",
              "type": "Letter"
            },
            {
              "id": "81498",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021357s028lbl.pdf",
              "date": "20250307",
              "type": "Label"
            },
            {
              "id": "81499",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021357s028lbl.pdf#page=17",
              "date": "20250307",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20240814",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79405",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021357s026,021358s024lbl.pdf",
              "date": "20240816",
              "type": "Label"
            },
            {
              "id": "79418",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021357Orig1s026, 021358Orig1s024ltr.pdf",
              "date": "20240816",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20181102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56308",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s018,021358s017lbl.pdf",
              "date": "20181106",
              "type": "Label"
            },
            {
              "id": "56436",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021489Orig1s010,021357Orig1s018,021358Orig1s017ltr.pdf",
              "date": "20181114",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20180426",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53828",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf",
              "date": "20180427",
              "type": "Label"
            },
            {
              "id": "53899",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s016s017,021358Orig1s015s016Ltr.pdf",
              "date": "20180501",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20180119",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "51343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf",
              "date": "20180119",
              "type": "Label"
            },
            {
              "id": "51870",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021357Orig1s014,021358Orig1s013ltr.pdf",
              "date": "20180126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20100317",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "5153",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s006ltr.pdf",
              "date": "20100322",
              "type": "Letter"
            },
            {
              "id": "15282",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s006lbl.pdf",
              "date": "20100318",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021357",
      "sponsor_name": "BRACCO",
      "openfda": {
        "application_number": [
          "NDA021357"
        ],
        "brand_name": [
          "MULTIHANCE"
        ],
        "generic_name": [
          "GADOBENATE DIMEGLUMINE"
        ],
        "manufacturer_name": [
          "BRACCO DIAGNOSTICS INC"
        ],
        "product_ndc": [
          "0270-5164"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GADOBENATE DIMEGLUMINE"
        ],
        "spl_id": [
          "0e7d3da8-78fa-b4ae-4a43-15919e900ebe"
        ],
        "spl_set_id": [
          "59077a3e-5f03-4342-ae24-856267545631"
        ],
        "package_ndc": [
          "0270-5164-12",
          "0270-5164-13",
          "0270-5164-14",
          "0270-5164-15"
        ],
        "unii": [
          "3Q6PPC19PO"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "MULTIHANCE",
          "active_ingredients": [
            {
              "name": "GADOBENATE DIMEGLUMINE",
              "strength": "7.935GM/15ML (529MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "MULTIHANCE",
          "active_ingredients": [
            {
              "name": "GADOBENATE DIMEGLUMINE",
              "strength": "2.645GM/5ML (529MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "MULTIHANCE",
          "active_ingredients": [
            {
              "name": "GADOBENATE DIMEGLUMINE",
              "strength": "10.58GM/20ML (529MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "MULTIHANCE",
          "active_ingredients": [
            {
              "name": "GADOBENATE DIMEGLUMINE",
              "strength": "5.29GM/10ML (529MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}