{
  "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": "9",
          "submission_status": "AP",
          "submission_status_date": "20240405",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78085",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212839Orig1s009, s010ltr.pdf",
              "date": "20240408",
              "type": "Letter"
            },
            {
              "id": "78100",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s009s010lbl.pdf",
              "date": "20240409",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191121",
          "submission_public_notes": "FR Notice on DEA Scheduling; Date of Approval  March 10, 2020",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "61019",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212839Orig1s000ltr.pdf",
              "date": "20191122",
              "type": "Letter"
            },
            {
              "id": "61020",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf",
              "date": "20191122",
              "type": "Label"
            },
            {
              "id": "61220",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000TOC.html",
              "date": "20191210",
              "type": "Review"
            },
            {
              "id": "68933",
              "url": "https://www.federalregister.gov/documents/2020/03/10/2020-04963/schedules-of-controlled-substances-placement-of-cenobamate-in-schedule-v",
              "date": "20211008",
              "type": "Federal Register Notice"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20220627",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71463",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212839Orig1s006, s007ltr.pdf",
              "date": "20220628",
              "type": "Letter"
            },
            {
              "id": "71485",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212839s006s007lbl.pdf",
              "date": "20220630",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20250818",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83135",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212839Orig1s013ltr.pdf",
              "date": "20250819",
              "type": "Letter"
            },
            {
              "id": "83156",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212839s013lbl.pdf",
              "date": "20250820",
              "type": "Label"
            },
            {
              "id": "83157",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212839s013lbl.pdf#page=27",
              "date": "20250820",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200831",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64468",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212839Orig1s001ltr.pdf",
              "date": "20200901",
              "type": "Letter"
            },
            {
              "id": "64495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212839s001lbl.pdf",
              "date": "20200904",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20240126",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77324",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s008lbl.pdf",
              "date": "20240129",
              "type": "Label"
            },
            {
              "id": "77350",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212839Orig1s008ltr.pdf",
              "date": "20240129",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20220627",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71462",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212839Orig1s006, s007ltr.pdf",
              "date": "20220628",
              "type": "Letter"
            },
            {
              "id": "71486",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212839s006s007lbl.pdf",
              "date": "20220630",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20240405",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78086",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212839Orig1s009, s010ltr.pdf",
              "date": "20240408",
              "type": "Letter"
            },
            {
              "id": "78101",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s009s010lbl.pdf",
              "date": "20240409",
              "type": "Label"
            },
            {
              "id": "78102",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s009s010lbl.pdf#page=26",
              "date": "20240409",
              "type": "Medication Guide"
            }
          ]
        }
      ],
      "application_number": "NDA212839",
      "sponsor_name": "SK LIFE",
      "openfda": {
        "application_number": [
          "NDA212839"
        ],
        "brand_name": [
          "XCOPRI",
          "XCOPRI MAINTENANCE PACK",
          "XCOPRI TITRATION PACK"
        ],
        "generic_name": [
          "CENOBAMATE"
        ],
        "manufacturer_name": [
          "SK Life Science, Inc."
        ],
        "product_ndc": [
          "71699-025",
          "71699-201",
          "71699-050",
          "71699-202",
          "71699-100",
          "71699-150",
          "71699-203",
          "71699-103",
          "71699-200",
          "71699-104",
          "71699-204"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CENOBAMATE"
        ],
        "rxcui": [
          "2265695",
          "2265701",
          "2283503",
          "2283505",
          "2283507",
          "2283509",
          "2283511",
          "2283513",
          "2283517",
          "2283518",
          "2283520",
          "2283522",
          "2283523",
          "2283525",
          "2283527",
          "2283535",
          "2283536",
          "2283538",
          "2283539",
          "2283540",
          "2540431",
          "2540432",
          "2683673",
          "2683674"
        ],
        "spl_id": [
          "8e4ae306-0c50-4fe9-92fd-f79be8299f4e"
        ],
        "spl_set_id": [
          "565c2126-57ae-4e29-b443-723bbe7e2072"
        ],
        "package_ndc": [
          "71699-201-28",
          "71699-050-30",
          "71699-050-99",
          "71699-202-28",
          "71699-025-30",
          "71699-100-30",
          "71699-150-30",
          "71699-203-28",
          "71699-103-56",
          "71699-200-30",
          "71699-104-56",
          "71699-204-14"
        ],
        "nui": [
          "N0000181004",
          "N0000193997",
          "N0000182139",
          "N0000182140",
          "N0000190114",
          "N0000187064",
          "N0000187063",
          "N0000185506"
        ],
        "pharm_class_moa": [
          "Sodium Channel Antagonists [MoA]",
          "GABA A Receptor Positive Modulators [MoA]",
          "Cytochrome P450 2B6 Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]",
          "Cytochrome P450 2B6 Inducers [MoA]",
          "Cytochrome P450 2C8 Inducers [MoA]",
          "Cytochrome P450 3A4 Inducers [MoA]"
        ],
        "unii": [
          "P85X70RZWS"
        ]
      },
      "products": [
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "XCOPRI",
          "active_ingredients": [
            {
              "name": "CENOBAMATE",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "XCOPRI",
          "active_ingredients": [
            {
              "name": "CENOBAMATE",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "XCOPRI",
          "active_ingredients": [
            {
              "name": "CENOBAMATE",
              "strength": "25MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "XCOPRI",
          "active_ingredients": [
            {
              "name": "CENOBAMATE",
              "strength": "150MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "XCOPRI",
          "active_ingredients": [
            {
              "name": "CENOBAMATE",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "XCOPRI",
          "active_ingredients": [
            {
              "name": "CENOBAMATE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}