{
  "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": "9",
          "submission_status": "AP",
          "submission_status_date": "20231221",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77101",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217Orig1s009lbl.pdf",
              "date": "20231221",
              "type": "Label"
            },
            {
              "id": "77110",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s009ltr.pdf",
              "date": "20231222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191114",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "60841",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s000lbl.pdf",
              "date": "20191114",
              "type": "Label"
            },
            {
              "id": "60849",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213217Orig1s000ltr.pdf",
              "date": "20191115",
              "type": "Letter"
            },
            {
              "id": "61083",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213217Orig1s000TOC.html",
              "date": "20191127",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20230119",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73254",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s007lbl.pdf",
              "date": "20230120",
              "type": "Label"
            },
            {
              "id": "73258",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s007ltr.pdf",
              "date": "20230120",
              "type": "Letter"
            },
            {
              "id": "78576",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213217Orig1s007.pdf",
              "date": "20240529",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20210914",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "68621",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s005lbl.pdf",
              "date": "20210915",
              "type": "Label"
            },
            {
              "id": "68626",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213217Orig1s005ltr.pdf",
              "date": "20210920",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20250124",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "80980",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213217s015lbl.pdf",
              "date": "20250205",
              "type": "Label"
            },
            {
              "id": "81097",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213217Orig1s015ltr.pdf",
              "date": "20250206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240307",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s011lbl.pdf",
              "date": "20240307",
              "type": "Label"
            },
            {
              "id": "77761",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213217Orig1s011ltr.pdf",
              "date": "20240308",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20210831",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "68510",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213217Orig1s004ltr.pdf",
              "date": "20210901",
              "type": "Letter"
            },
            {
              "id": "68512",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s004lbl.pdf",
              "date": "20210901",
              "type": "Label"
            },
            {
              "id": "78347",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213217Orig1s004.pdf",
              "date": "20240502",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20240604",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "78632",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213217Orig1s014ltr.pdf",
              "date": "20240702",
              "type": "Letter"
            },
            {
              "id": "78645",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s014lbl.pdf",
              "date": "20240605",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20230421",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "74038",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s010ltr.pdf",
              "date": "20230424",
              "type": "Letter"
            },
            {
              "id": "74052",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s010lbl.pdf",
              "date": "20230424",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA213217",
      "sponsor_name": "BEONE MEDICINES USA",
      "openfda": {
        "application_number": [
          "NDA213217"
        ],
        "brand_name": [
          "BRUKINSA"
        ],
        "generic_name": [
          "ZANUBRUTINIB"
        ],
        "manufacturer_name": [
          "BeOne Medicines USA, Inc."
        ],
        "product_ndc": [
          "72579-011",
          "72579-122"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ZANUBRUTINIB"
        ],
        "rxcui": [
          "2262440",
          "2262446",
          "2719220",
          "2719223"
        ],
        "spl_id": [
          "cb0c9753-cca4-421e-9512-1b710a56b342"
        ],
        "spl_set_id": [
          "3e08fe23-d70e-424c-bc51-1222e320f902"
        ],
        "package_ndc": [
          "72579-011-02",
          "72579-011-01",
          "72579-122-01"
        ],
        "nui": [
          "N0000175605",
          "N0000193934"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Bruton's Tyrosine Kinase Inhibitors [MoA]"
        ],
        "unii": [
          "AG9MHG098Z"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BRUKINSA",
          "active_ingredients": [
            {
              "name": "ZANUBRUTINIB",
              "strength": "80MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}