{
  "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": "ORIG",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20150710",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "59101",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf",
              "date": "20190617",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20230510",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "74213",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205422s009lbl.pdf",
              "date": "20230511",
              "type": "Label"
            },
            {
              "id": "74217",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205422Orig1s009ltr.pdf",
              "date": "20230511",
              "type": "Letter"
            },
            {
              "id": "75554",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/205422Orig1s009TOC.html",
              "date": "20230925",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20211227",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "69792",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205422Orig1s007ltr.pdf",
              "date": "20211228",
              "type": "Letter"
            },
            {
              "id": "69796",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205422s007lbl.pdf",
              "date": "20211229",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20200617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63626",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205422Orig1s005ltr.pdf",
              "date": "20200619",
              "type": "Letter"
            },
            {
              "id": "63641",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf",
              "date": "20200619",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20180209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52557",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf",
              "date": "20180212",
              "type": "Label"
            },
            {
              "id": "52636",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205422Orig1s003ltr.pdf",
              "date": "20180214",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160923",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "45396",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205422Orig1s001ltr.pdf",
              "date": "20160926",
              "type": "Letter"
            },
            {
              "id": "45419",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205422s001lbl.pdf",
              "date": "20160929",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20250509",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "82192",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/205422Orig1s014ltr.pdf",
              "date": "20250515",
              "type": "Letter"
            },
            {
              "id": "82207",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205422s014lbl.pdf",
              "date": "20250509",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150710",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "40466",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf",
              "date": "20150713",
              "type": "Label"
            },
            {
              "id": "43488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205422s000TOC.html",
              "date": "20150819",
              "type": "Review"
            },
            {
              "id": "10445",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205422Orig1Orig2s000ltr.pdf",
              "date": "20150713",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20221006",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72274",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205422Orig1s008ltr.pdf",
              "date": "20221007",
              "type": "Letter"
            },
            {
              "id": "72283",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205422Orig1s008lbl.pdf",
              "date": "20221011",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20260430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85815",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205422Orig1s017ltr.pdf",
              "date": "20260504",
              "type": "Letter"
            },
            {
              "id": "85829",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205422s017lbl.pdf",
              "date": "20260505",
              "type": "Label"
            },
            {
              "id": "85830",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205422s017lbl.pdf#page=40",
              "date": "20260505",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170223",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47307",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205422s002lbl.pdf",
              "date": "20170224",
              "type": "Label"
            },
            {
              "id": "47404",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205422Orig1s002ltr.pdf",
              "date": "20170302",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20241211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80559",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205422Orig1s013ltr.pdf",
              "date": "20241213",
              "type": "Letter"
            },
            {
              "id": "80568",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205422Orig1s013lbl.pdf",
              "date": "20241213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240507",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78423",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205422Orig1s011ltr.pdf",
              "date": "20240508",
              "type": "Letter"
            },
            {
              "id": "78424",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205422s011lblcorrection.pdf",
              "date": "20240508",
              "type": "Label"
            },
            {
              "id": "78441",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205422s011lblcorrection.pdf#page=37",
              "date": "20240508",
              "type": "Medication Guide"
            }
          ]
        }
      ],
      "application_number": "NDA205422",
      "sponsor_name": "OTSUKA",
      "openfda": {
        "application_number": [
          "NDA205422"
        ],
        "brand_name": [
          "REXULTI"
        ],
        "generic_name": [
          "BREXPIPRAZOLE"
        ],
        "manufacturer_name": [
          "Otsuka America Pharmaceutical, Inc."
        ],
        "product_ndc": [
          "59148-035",
          "59148-036",
          "59148-037",
          "59148-038",
          "59148-039",
          "59148-040",
          "59148-044",
          "59148-042"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BREXPIPRAZOLE"
        ],
        "rxcui": [
          "1658319",
          "1658325",
          "1658327",
          "1658329",
          "1658331",
          "1658333",
          "1658335",
          "1658337",
          "1658339",
          "1658341",
          "1658343",
          "1658345"
        ],
        "spl_id": [
          "6507f292-90e7-408c-baf5-4475fc31a06d"
        ],
        "spl_set_id": [
          "2d301358-6291-4ec1-bd87-37b4ad9bd850"
        ],
        "package_ndc": [
          "59148-035-13",
          "59148-036-13",
          "59148-036-07",
          "59148-037-13",
          "59148-037-07",
          "59148-038-13",
          "59148-038-07",
          "59148-039-13",
          "59148-039-07",
          "59148-040-13",
          "59148-040-07",
          "59148-044-14",
          "59148-042-07"
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "2J3YBM1K8C"
        ]
      },
      "products": [
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "REXULTI",
          "active_ingredients": [
            {
              "name": "BREXPIPRAZOLE",
              "strength": "3MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "REXULTI",
          "active_ingredients": [
            {
              "name": "BREXPIPRAZOLE",
              "strength": "1MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "REXULTI",
          "active_ingredients": [
            {
              "name": "BREXPIPRAZOLE",
              "strength": "0.25MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "REXULTI",
          "active_ingredients": [
            {
              "name": "BREXPIPRAZOLE",
              "strength": "4MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "REXULTI",
          "active_ingredients": [
            {
              "name": "BREXPIPRAZOLE",
              "strength": "2MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "REXULTI",
          "active_ingredients": [
            {
              "name": "BREXPIPRAZOLE",
              "strength": "0.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}