{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150526",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38605",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022345s010lbl.pdf",
              "date": "20150529",
              "type": "Label"
            },
            {
              "id": "29630",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s010ltr.pdf",
              "date": "20150528",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20151125",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "7274",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s009Ltr.pdf",
              "date": "20151127",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110610",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "43853",
              "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf",
              "date": "20110617",
              "type": "Medication Guide"
            },
            {
              "id": "44739",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000SumR.pdf",
              "date": "20110711",
              "type": "Summary Review"
            },
            {
              "id": "17276",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf",
              "date": "20110616",
              "type": "Label"
            },
            {
              "id": "21998",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.html",
              "date": "20110711",
              "type": "Review"
            },
            {
              "id": "23709",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm350197.htm",
              "date": "20131101",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "29627",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022345s000ltr.pdf",
              "date": "20110615",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20130606",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s007ltr.pdf",
              "date": "20130607",
              "type": "Letter"
            },
            {
              "id": "17278",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf",
              "date": "20130611",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120319",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17277",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf",
              "date": "20120319",
              "type": "Label"
            },
            {
              "id": "29628",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022345s001ltr.pdf",
              "date": "20120323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20160520",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17279",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf",
              "date": "20160523",
              "type": "Label"
            },
            {
              "id": "29631",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022345Orig1s011ltr.pdf",
              "date": "20160524",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20130906",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "29629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s006ltr.pdf",
              "date": "20130911",
              "type": "Letter"
            },
            {
              "id": "38604",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s006lbl.pdf",
              "date": "20130909",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20121121",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA022345",
      "sponsor_name": "GLAXOSMITHKLINE",
      "products": [
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "POTIGA",
          "active_ingredients": [
            {
              "name": "EZOGABINE",
              "strength": "400MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "POTIGA",
          "active_ingredients": [
            {
              "name": "EZOGABINE",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "POTIGA",
          "active_ingredients": [
            {
              "name": "EZOGABINE",
              "strength": "300MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "POTIGA",
          "active_ingredients": [
            {
              "name": "EZOGABINE",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}