{
  "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": "20230526",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "74389",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216203s000lbl.pdf",
              "date": "20230530",
              "type": "Label"
            },
            {
              "id": "74390",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216203s000lbl.pdf#page=24",
              "date": "20230530",
              "type": "Medication Guide"
            },
            {
              "id": "74395",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216203Orig1s000ltr.pdf",
              "date": "20230530",
              "type": "Letter"
            },
            {
              "id": "74613",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216203Orig1s000TOC.html",
              "date": "20230623",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA216203",
      "sponsor_name": "LEXICON PHARMS INC",
      "openfda": {
        "application_number": [
          "NDA216203"
        ],
        "brand_name": [
          "INPEFA"
        ],
        "generic_name": [
          "SOTAGLIFLOZIN"
        ],
        "manufacturer_name": [
          "Lexicon Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "70183-220",
          "70183-221",
          "70183-241",
          "70183-240"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SOTAGLIFLOZIN"
        ],
        "rxcui": [
          "2638683",
          "2638689",
          "2638691",
          "2638693"
        ],
        "spl_id": [
          "cd790640-aade-49e0-a549-6eac00d3efc2"
        ],
        "spl_set_id": [
          "1a46614e-05f6-421a-b6f4-d6f8760d643a"
        ],
        "package_ndc": [
          "70183-220-30",
          "70183-220-07",
          "70183-220-90",
          "70183-221-30",
          "70183-221-31",
          "70183-221-07",
          "70183-241-30",
          "70183-240-30",
          "70183-240-90",
          "70183-240-07"
        ],
        "nui": [
          "N0000187059",
          "N0000187058",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Sodium-Glucose Transporter 2 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "6B4ZBS263Y"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "INPEFA",
          "active_ingredients": [
            {
              "name": "SOTAGLIFLOZIN",
              "strength": "400MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "INPEFA",
          "active_ingredients": [
            {
              "name": "SOTAGLIFLOZIN",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}