{
  "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": "12",
          "submission_status": "AP",
          "submission_status_date": "20250310",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "81540",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214755Orig1s012ltr.pdf",
              "date": "20250312",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230501",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "71622",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214755Orig1s000ltr.pdf",
              "date": "20230502",
              "type": "Letter"
            },
            {
              "id": "74150",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214755Orig1s000lbl.pdf",
              "date": "20230502",
              "type": "Label"
            },
            {
              "id": "74154",
              "url": "https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=401",
              "date": "20231107",
              "type": "REMS"
            },
            {
              "id": "76005",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214755Orig1s000TOC.html",
              "date": "20231031",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20241016",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79910",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214755Orig1s006ltr.pdf",
              "date": "20241017",
              "type": "Letter"
            },
            {
              "id": "79943",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s006lbl.pdf",
              "date": "20241021",
              "type": "Label"
            },
            {
              "id": "79944",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s006lbl.pdf#page=29",
              "date": "20241021",
              "type": "Medication Guide"
            },
            {
              "id": "84209",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214755Orig1s006.pdf",
              "date": "20251119",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20241218",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "80657",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214755Orig1s011ltr.pdf",
              "date": "20241220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20240926",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s007lbl.pdf",
              "date": "20240926",
              "type": "Label"
            },
            {
              "id": "79756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214755Orig1s007ltr.pdf",
              "date": "20240927",
              "type": "Letter"
            },
            {
              "id": "80488",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/214755Orig1s007.pdf",
              "date": "20241204",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20231031",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "76031",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214755Orig1s003ltr.pdf",
              "date": "20231102",
              "type": "Letter"
            },
            {
              "id": "77203",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/214755Orig1s003.pdf",
              "date": "20240111",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA214755",
      "sponsor_name": "AVADEL CNS",
      "openfda": {
        "application_number": [
          "NDA214755"
        ],
        "brand_name": [
          "LUMRYZ"
        ],
        "generic_name": [
          "SODIUM OXYBATE"
        ],
        "manufacturer_name": [
          "Avadel CNS Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "13551-001",
          "13551-002",
          "13551-003",
          "13551-004",
          "13551-005"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM OXYBATE"
        ],
        "rxcui": [
          "2636822",
          "2636828",
          "2636830",
          "2636832",
          "2636834",
          "2636836",
          "2636838",
          "2636840",
          "2698135",
          "2698136"
        ],
        "spl_id": [
          "bd9a6c48-be50-44e5-8cbb-87cbaafe936d"
        ],
        "spl_set_id": [
          "10e5e40c-52f3-4c73-8a34-2c29c690a934"
        ],
        "package_ndc": [
          "13551-001-07",
          "13551-001-30",
          "13551-002-07",
          "13551-002-30",
          "13551-003-07",
          "13551-003-30",
          "13551-004-07",
          "13551-004-30",
          "13551-005-01"
        ],
        "unii": [
          "7G33012534"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "LUMRYZ",
          "active_ingredients": [
            {
              "name": "SODIUM OXYBATE",
              "strength": "7.5GM/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LUMRYZ",
          "active_ingredients": [
            {
              "name": "SODIUM OXYBATE",
              "strength": "4.5GM/PACKET"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FOR SUSPENSION, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "LUMRYZ",
          "active_ingredients": [
            {
              "name": "SODIUM OXYBATE",
              "strength": "9GM/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "LUMRYZ",
          "active_ingredients": [
            {
              "name": "SODIUM OXYBATE",
              "strength": "6GM/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}