{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20201217",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204417s004lbl.pdf",
              "date": "20201217",
              "type": "Label"
            },
            {
              "id": "65654",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204417Orig1s004ltr.pdf",
              "date": "20201221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20240312",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77799",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204417s009lbl.pdf",
              "date": "20240313",
              "type": "Label"
            },
            {
              "id": "77800",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204417s009lbl.pdf#page=26",
              "date": "20240313",
              "type": "Medication Guide"
            },
            {
              "id": "77814",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204417Orig1s009ltr.pdf",
              "date": "20240313",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181220",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "56977",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204417s000lbl.pdf",
              "date": "20181221",
              "type": "Label"
            },
            {
              "id": "58162",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204417Orig1s000TOC.html",
              "date": "20190401",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA204417",
      "sponsor_name": "TRIPOINT",
      "openfda": {
        "application_number": [
          "NDA204417"
        ],
        "brand_name": [
          "ELEPSIA XR 1000 MG",
          "ELEPSIA XR 1500 MG"
        ],
        "generic_name": [
          "LEVETIRACETAM"
        ],
        "manufacturer_name": [
          "TRIPOINT THERAPEUTICS, LLC"
        ],
        "product_ndc": [
          "80705-100",
          "80705-101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVETIRACETAM"
        ],
        "rxcui": [
          "1605362",
          "1605368",
          "1605372",
          "1605374"
        ],
        "spl_id": [
          "3c463bee-1191-4cab-b4d0-367673db19ef"
        ],
        "spl_set_id": [
          "cac83d47-88a2-4447-a0c0-90b44ffda0ac"
        ],
        "package_ndc": [
          "80705-100-30",
          "80705-100-99",
          "80705-100-02",
          "80705-101-30",
          "80705-101-99",
          "80705-101-02"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "44YRR34555"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ELEPSIA XR",
          "active_ingredients": [
            {
              "name": "LEVETIRACETAM",
              "strength": "1GM"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ELEPSIA XR",
          "active_ingredients": [
            {
              "name": "LEVETIRACETAM",
              "strength": "1.5GM"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}