{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20210804",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68299",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf",
              "date": "20210805",
              "type": "Label"
            },
            {
              "id": "68309",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206143Orig1s008;209964Orig1s002ltr.pdf",
              "date": "20210830",
              "type": "Letter"
            },
            {
              "id": "68406",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf#page=24",
              "date": "20210818",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190422",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "58362",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209964lbl.pdf",
              "date": "20190422",
              "type": "Label"
            },
            {
              "id": "58363",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209964lbl.pdf#page=24",
              "date": "20190422",
              "type": "Medication Guide"
            },
            {
              "id": "58373",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209964Orig1s000ltr.pdf",
              "date": "20190424",
              "type": "Letter"
            },
            {
              "id": "60827",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209964Orig1s000TOC.html",
              "date": "20191113",
              "type": "Review"
            },
            {
              "id": "63081",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/209964 ivabradine CDTL bpca.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "63082",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/209964 ivabradine clinical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63083",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/209964 ivabradine clinpharm bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            }
          ]
        }
      ],
      "application_number": "NDA209964",
      "sponsor_name": "AMGEN INC",
      "openfda": {
        "application_number": [
          "NDA209964"
        ],
        "brand_name": [
          "CORLANOR"
        ],
        "generic_name": [
          "IVABRADINE"
        ],
        "manufacturer_name": [
          "Amgen Inc"
        ],
        "product_ndc": [
          "55513-813",
          "55513-800",
          "55513-810"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IVABRADINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1649485",
          "1649491",
          "1649493",
          "1649495",
          "2168592",
          "2168596"
        ],
        "spl_id": [
          "8ab000cd-0258-489a-b1bb-4cc1ca359d6c"
        ],
        "spl_set_id": [
          "92018a65-38f6-45f7-91d4-a34921b81d0d"
        ],
        "package_ndc": [
          "55513-800-60",
          "55513-800-99",
          "55513-810-60",
          "55513-813-01",
          "55513-813-28"
        ],
        "unii": [
          "TP19837BZK"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CORLANOR",
          "active_ingredients": [
            {
              "name": "IVABRADINE",
              "strength": "5MG/5ML (1MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}