{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20140916",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "43477",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000TOC.html",
              "date": "20141017",
              "type": "Review"
            },
            {
              "id": "44908",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000SumR.pdf",
              "date": "20141017",
              "type": "Summary Review"
            },
            {
              "id": "10387",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204760Orig1s000ltr.pdf",
              "date": "20140917",
              "type": "Letter"
            },
            {
              "id": "19592",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf",
              "date": "20140919",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20160822",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45112",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf",
              "date": "20160823",
              "type": "Label"
            },
            {
              "id": "45159",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf",
              "date": "20160822",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20200413",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62554",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf",
              "date": "20200414",
              "type": "Label"
            },
            {
              "id": "62555",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf#page=16",
              "date": "20200414",
              "type": "Medication Guide"
            },
            {
              "id": "62573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204760Orig1s009ltr.pdf",
              "date": "20200415",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20180228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52783",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204760Orig1s007ltr.pdf",
              "date": "20180301",
              "type": "Letter"
            },
            {
              "id": "52798",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf",
              "date": "20180302",
              "type": "Label"
            },
            {
              "id": "52799",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf#page=16",
              "date": "20180302",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20170801",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49212",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204760Orig1s005ltr.pdf",
              "date": "20170802",
              "type": "Letter"
            },
            {
              "id": "49223",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204760s005lbl.pdf",
              "date": "20170803",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20160822",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45113",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf",
              "date": "20160823",
              "type": "Label"
            },
            {
              "id": "45158",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf",
              "date": "20160822",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160722",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10388",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s001ltr.pdf",
              "date": "20160726",
              "type": "Letter"
            },
            {
              "id": "19593",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s001lbl.pdf",
              "date": "20160725",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20190529",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58889",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf",
              "date": "20190530",
              "type": "Label"
            },
            {
              "id": "58890",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf#page=16",
              "date": "20190530",
              "type": "Medication Guide"
            },
            {
              "id": "58945",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204760Orig1s008ltr.pdf",
              "date": "20190604",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA204760",
      "sponsor_name": "AVERITAS",
      "openfda": {
        "application_number": [
          "NDA204760"
        ],
        "brand_name": [
          "MOVANTIK"
        ],
        "generic_name": [
          "NALOXEGOL OXALATE"
        ],
        "manufacturer_name": [
          "RedHill Biopharma Ltd",
          "Valinor Pharma, LLC"
        ],
        "product_ndc": [
          "57841-1301",
          "57841-1300",
          "82625-8801",
          "82625-8802"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NALOXEGOL OXALATE"
        ],
        "rxcui": [
          "1551782",
          "1551917",
          "1551923",
          "1601373"
        ],
        "spl_id": [
          "27e98e6d-9faf-3a94-e063-6394a90a1dcb",
          "6747ab38-787e-4cd4-9626-b79b0432bc36"
        ],
        "spl_set_id": [
          "300a6474-ebcd-4404-8040-48fdcfcc1635",
          "28596788-b73f-4247-85fc-3105f51fff5a"
        ],
        "package_ndc": [
          "57841-1300-1",
          "57841-1300-2",
          "57841-1300-3",
          "57841-1300-4",
          "57841-1301-1",
          "57841-1301-2",
          "57841-1301-3",
          "57841-1301-4",
          "82625-8801-1",
          "82625-8801-2",
          "82625-8801-3",
          "82625-8801-4",
          "82625-8802-1",
          "82625-8802-2",
          "82625-8802-3",
          "82625-8802-4"
        ],
        "unii": [
          "65I14TNM33"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "MOVANTIK",
          "active_ingredients": [
            {
              "name": "NALOXEGOL OXALATE",
              "strength": "EQ 25MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "MOVANTIK",
          "active_ingredients": [
            {
              "name": "NALOXEGOL OXALATE",
              "strength": "EQ 12.5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}