{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20160415",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20161202",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "46011",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf",
              "date": "20161205",
              "type": "Label"
            },
            {
              "id": "46031",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s008ltr.pdf",
              "date": "20161206",
              "type": "Letter"
            },
            {
              "id": "64011",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s008.pdf",
              "date": "20210924",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20210611",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67782",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf",
              "date": "20210614",
              "type": "Label"
            },
            {
              "id": "67799",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf",
              "date": "20210628",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "42",
          "submission_status": "AP",
          "submission_status_date": "20230620",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "74575",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s042ltr.pdf",
              "date": "20230621",
              "type": "Letter"
            },
            {
              "id": "74588",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf",
              "date": "20230622",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20220321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70580",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf",
              "date": "20220322",
              "type": "Letter"
            },
            {
              "id": "70617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s034lbl.pdf",
              "date": "20220328",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20210818",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "68411",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s026ltr.pdf",
              "date": "20210819",
              "type": "Letter"
            },
            {
              "id": "68417",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s026lbl.pdf",
              "date": "20210819",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20160205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "19579",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf",
              "date": "20160304",
              "type": "Label"
            },
            {
              "id": "32575",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf",
              "date": "20160209",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20230921",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "75532",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s040ltr.pdf",
              "date": "20230922",
              "type": "Letter"
            },
            {
              "id": "75559",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf",
              "date": "20230925",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20181026",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56157",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf",
              "date": "20181029",
              "type": "Label"
            },
            {
              "id": "56175",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf",
              "date": "20181030",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20150626",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40401",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf",
              "date": "20150701",
              "type": "Label"
            },
            {
              "id": "64667",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s002.pdf",
              "date": "20210924",
              "type": "Review"
            },
            {
              "id": "10367",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf",
              "date": "20150630",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20171213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50692",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf",
              "date": "20171214",
              "type": "Label"
            },
            {
              "id": "50715",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204629Orig1s016ltr.pdf",
              "date": "20171215",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20160708",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10369",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf",
              "date": "20160712",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160121",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "63",
          "submission_status": "AP",
          "submission_status_date": "20251024",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83923",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204629s063lbl.pdf",
              "date": "20251027",
              "type": "Label"
            },
            {
              "id": "83924",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204629s063lbl.pdf#page=47",
              "date": "20251027",
              "type": "Medication Guide"
            },
            {
              "id": "83951",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204629Orig1s063,206111Orig1s046,208658Orig1s034,206073Orig1s044,212614Orig1s029ltr.pdf",
              "date": "20251028",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20140801",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "43470",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.html",
              "date": "20140909",
              "type": "Review"
            },
            {
              "id": "19577",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf",
              "date": "20140804",
              "type": "Label"
            },
            {
              "id": "24474",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf",
              "date": "20140909",
              "type": "Summary Review"
            },
            {
              "id": "32572",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf",
              "date": "20140804",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20221013",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72337",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf",
              "date": "20221014",
              "type": "Letter"
            },
            {
              "id": "72379",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s039lbl.pdf",
              "date": "20221017",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20160112",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20210611",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf",
              "date": "20210614",
              "type": "Label"
            },
            {
              "id": "67800",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, s029; 206073Orig1s027, s030; 206111Orig1s025, s026; 208658Orig1s013, s015; 212614Orig1s008, s010ltr.pdf",
              "date": "20210615",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20151204",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65830",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s007.pdf",
              "date": "20210106",
              "type": "Review"
            },
            {
              "id": "19581",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf",
              "date": "20151208",
              "type": "Label"
            },
            {
              "id": "32576",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf",
              "date": "20151208",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20230912",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75414",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s041ltr.pdf",
              "date": "20230913",
              "type": "Letter"
            },
            {
              "id": "75438",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s041lbl.pdf",
              "date": "20230913",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20160318",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65829",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s005.pdf",
              "date": "20210924",
              "type": "Review"
            },
            {
              "id": "10368",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf",
              "date": "20160322",
              "type": "Letter"
            },
            {
              "id": "19580",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf",
              "date": "20160322",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20181221",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57017",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf",
              "date": "20181226",
              "type": "Label"
            },
            {
              "id": "57065",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s019Ltr.pdf",
              "date": "20181230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20220224",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "70270",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s033ltr.pdf",
              "date": "20220228",
              "type": "Letter"
            },
            {
              "id": "70276",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf",
              "date": "20220228",
              "type": "Label"
            },
            {
              "id": "73523",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/204629Orig1s033.pdf",
              "date": "20230216",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20150626",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40402",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf",
              "date": "20150701",
              "type": "Label"
            },
            {
              "id": "64668",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s003.pdf",
              "date": "20210924",
              "type": "Review"
            },
            {
              "id": "32574",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf",
              "date": "20150630",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150626",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64666",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s001.pdf",
              "date": "20210924",
              "type": "Review"
            },
            {
              "id": "19578",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf",
              "date": "20150701",
              "type": "Label"
            },
            {
              "id": "32573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf",
              "date": "20150630",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20200124",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61663",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf",
              "date": "20200127",
              "type": "Label"
            },
            {
              "id": "61672",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf",
              "date": "20200127",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA204629",
      "sponsor_name": "BOEHRINGER INGELHEIM",
      "openfda": {
        "application_number": [
          "NDA204629"
        ],
        "brand_name": [
          "JARDIANCE"
        ],
        "generic_name": [
          "EMPAGLIFLOZIN"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0152",
          "0597-0153"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EMPAGLIFLOZIN"
        ],
        "rxcui": [
          "1545658",
          "1545664",
          "1545666",
          "1545668"
        ],
        "spl_id": [
          "09daa78d-f417-436c-a29e-029c015ca6d6"
        ],
        "spl_set_id": [
          "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565"
        ],
        "package_ndc": [
          "0597-0152-90",
          "0597-0152-07",
          "0597-0152-70",
          "0597-0152-37",
          "0597-0152-30",
          "0597-0153-37",
          "0597-0153-30",
          "0597-0153-90",
          "0597-0153-07",
          "0597-0153-70"
        ],
        "nui": [
          "N0000187059",
          "N0000187058"
        ],
        "pharm_class_epc": [
          "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Sodium-Glucose Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "HDC1R2M35U"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "JARDIANCE",
          "active_ingredients": [
            {
              "name": "EMPAGLIFLOZIN",
              "strength": "25MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "JARDIANCE",
          "active_ingredients": [
            {
              "name": "EMPAGLIFLOZIN",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}