{
  "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": "7",
          "submission_status": "AP",
          "submission_status_date": "20151001",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10214",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s007ltr.pdf",
              "date": "20151009",
              "type": "Letter"
            },
            {
              "id": "19468",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s007lbl.pdf",
              "date": "20151008",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20220113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69890",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203415Orig1s018; 213674Orig1s005ltr.pdf",
              "date": "20220118",
              "type": "Letter"
            },
            {
              "id": "69923",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf",
              "date": "20220119",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20150721",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40297",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s005lbl.pdf",
              "date": "20150722",
              "type": "Label"
            },
            {
              "id": "10213",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s005ltr.pdf",
              "date": "20150722",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20250321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81705",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203415s024,213674s012lbl.pdf",
              "date": "20250324",
              "type": "Label"
            },
            {
              "id": "81708",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203415Orig1s024, 213674Orig1s012ltr.pdf",
              "date": "20250325",
              "type": "Letter"
            },
            {
              "id": "81709",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203415Orig1s024, 213674Orig1s012ltr.pdf",
              "date": "20250325",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20201023",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65032",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203415Orig1s016ltr.pdf",
              "date": "20201027",
              "type": "Letter"
            },
            {
              "id": "65042",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203415s016lbl.pdf",
              "date": "20201027",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20140910",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40296",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf",
              "date": "20140910",
              "type": "Label"
            },
            {
              "id": "10212",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203415Orig1s003ltr.pdf",
              "date": "20140916",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20231116",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "76593",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213674s010,203415s022lbl.pdf",
              "date": "20231117",
              "type": "Label"
            },
            {
              "id": "76628",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213674Orig1s010; 203415Orig1s022ltr.pdf",
              "date": "20231117",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130319",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "19466",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203415s001lbl.pdf",
              "date": "20130326",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20180713",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "54886",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203415Orig1s014lbl.pdf",
              "date": "20180713",
              "type": "Label"
            },
            {
              "id": "54897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203415Orig1s014ltr.pdf",
              "date": "20180716",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160714",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120831",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "43431",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415_xtandi_toc.html",
              "date": "20120912",
              "type": "Review"
            },
            {
              "id": "44882",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415Orig1s000SumR.pdf",
              "date": "20120912",
              "type": "Summary Review"
            },
            {
              "id": "19465",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf",
              "date": "20120831",
              "type": "Label"
            },
            {
              "id": "32421",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203415Orig1s000ltr.pdf",
              "date": "20120905",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20151106",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20220909",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "72064",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203415Orig1s019; 213674Orig1s006ltr.pdf",
              "date": "20220912",
              "type": "Letter"
            },
            {
              "id": "72072",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s019,213674s006lbl.pdf",
              "date": "20220913",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20150805",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "19467",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s006lbl.pdf",
              "date": "20150921",
              "type": "Label"
            },
            {
              "id": "32422",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s006ltr.pdf",
              "date": "20150810",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20251211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84396",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203415Orig1s025,213674Orig1s015ltr.pdf",
              "date": "20251212",
              "type": "Letter"
            },
            {
              "id": "84446",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203415s025,213674s015lbl.pdf",
              "date": "20251218",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20250122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80925",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203415Orig1s023; 213674Orig1s011lbl.pdf",
              "date": "20250212",
              "type": "Label"
            },
            {
              "id": "81140",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203415Orig1s023;213674Orig1s011ltr.pdf",
              "date": "20250207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20191216",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "61285",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203415s015lbl.pdf",
              "date": "20191216",
              "type": "Label"
            },
            {
              "id": "61341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203415Orig1s015ltr.pdf",
              "date": "20191219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20140523",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20170724",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "49082",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203415s011lbl.pdf",
              "date": "20170725",
              "type": "Label"
            },
            {
              "id": "49101",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203415Orig1s011ltr.pdf",
              "date": "20170727",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20161020",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "45577",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203415s009lbl.pdf",
              "date": "20161020",
              "type": "Label"
            },
            {
              "id": "45629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203415Orig1s009ltr.pdf",
              "date": "20161021",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA203415",
      "sponsor_name": "ASTELLAS",
      "openfda": {
        "application_number": [
          "NDA203415"
        ],
        "brand_name": [
          "XTANDI"
        ],
        "generic_name": [
          "ENZALUTAMIDE"
        ],
        "manufacturer_name": [
          "Astellas Pharma US, Inc."
        ],
        "product_ndc": [
          "0469-0125",
          "0469-0625",
          "0469-0725",
          "0469-1125",
          "0469-1725"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENZALUTAMIDE"
        ],
        "rxcui": [
          "1307303",
          "1307309",
          "2390644",
          "2390646",
          "2390648",
          "2390650"
        ],
        "spl_id": [
          "cfc2fbc2-2657-407f-b0f0-bd41fb98d89e"
        ],
        "spl_set_id": [
          "b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf"
        ],
        "package_ndc": [
          "0469-0125-99",
          "0469-0625-99",
          "0469-0725-60",
          "0469-1125-56",
          "0469-1725-56"
        ],
        "nui": [
          "N0000175560",
          "N0000000243",
          "N0000185506",
          "N0000185507",
          "N0000185607"
        ],
        "pharm_class_epc": [
          "Androgen Receptor Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Androgen Receptor Antagonists [MoA]",
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]"
        ],
        "unii": [
          "93T0T9GKNU"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "XTANDI",
          "active_ingredients": [
            {
              "name": "ENZALUTAMIDE",
              "strength": "40MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}