{
  "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": "10",
          "submission_status": "AP",
          "submission_status_date": "20130311",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38684",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022418s010lbl.pdf",
              "date": "20130311",
              "type": "Label"
            },
            {
              "id": "29706",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022418Orig1s010ltr.pdf",
              "date": "20130319",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20210603",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67706",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022418s019lbl.pdf",
              "date": "20210604",
              "type": "Label"
            },
            {
              "id": "67714",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022418Orig1s019ltr.pdf",
              "date": "20210607",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20121212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38683",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf",
              "date": "20121213",
              "type": "Label"
            },
            {
              "id": "7360",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf",
              "date": "20121219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090814",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "42518",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418_fibricor_toc.html",
              "date": "20100105",
              "type": "Review"
            },
            {
              "id": "44750",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418s000_SumR.pdf",
              "date": "20100105",
              "type": "Summary Review"
            },
            {
              "id": "7358",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022418s000ltr.pdf",
              "date": "20090821",
              "type": "Letter"
            },
            {
              "id": "17565",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022418lbl.pdf",
              "date": "20091001",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20190515",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58759",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022418s015lbl.pdf",
              "date": "20190516",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20120103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38681",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s006lbl.pdf",
              "date": "20120106",
              "type": "Label"
            },
            {
              "id": "7359",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s006ltr.pdf",
              "date": "20120117",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20151127",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20140106",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38685",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022418s011lbl.pdf",
              "date": "20140107",
              "type": "Label"
            },
            {
              "id": "7362",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022418Orig1s011ltr.pdf",
              "date": "20140107",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20121212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7361",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf",
              "date": "20121219",
              "type": "Letter"
            },
            {
              "id": "17566",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf",
              "date": "20121213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20190930",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60174",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022418Orig1s016ltr.pdf",
              "date": "20191001",
              "type": "Letter"
            },
            {
              "id": "60181",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022418s016lbl.pdf",
              "date": "20191001",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20120315",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "29705",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s007ltr.pdf",
              "date": "20120319",
              "type": "Letter"
            },
            {
              "id": "38682",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s007lbl.pdf",
              "date": "20120316",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20180518",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54281",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022418s014lbl.pdf",
              "date": "20180521",
              "type": "Label"
            },
            {
              "id": "54320",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022418Orig1s014ltr.pdf",
              "date": "20180524",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20250606",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022418s020lbl.pdf",
              "date": "20250609",
              "type": "Label"
            },
            {
              "id": "82511",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022418Orig1s020ltr.pdf",
              "date": "20250609",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022418",
      "sponsor_name": "ROSEMONT",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "FIBRICOR",
          "active_ingredients": [
            {
              "name": "FENOFIBRIC ACID",
              "strength": "105MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "FIBRICOR",
          "active_ingredients": [
            {
              "name": "FENOFIBRIC ACID",
              "strength": "35MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}