{
  "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": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20241219",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "80669",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210854Orig1s021;214410Orig1s007ltr.pdf",
              "date": "20241220",
              "type": "Letter"
            },
            {
              "id": "80683",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf",
              "date": "20241223",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20230615",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74512",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210854s018,214410s005lbl.pdf",
              "date": "20230616",
              "type": "Label"
            },
            {
              "id": "74533",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210854Orig1s018;214410Orig1s005ltr.pdf",
              "date": "20230616",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210927",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68794",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214410Orig1s001ltr.pdf",
              "date": "20210928",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20220811",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214410Orig2s000lbl.pdf",
              "date": "20220811",
              "type": "Label"
            },
            {
              "id": "71793",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214410Orig2s000ltr.pdf",
              "date": "20220812",
              "type": "Letter"
            },
            {
              "id": "72204",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214410Orig2s000TOC.html",
              "date": "20221003",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20250530",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "82423",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210854Orig1s023,214410Orig1s008ltr.pdf",
              "date": "20250602",
              "type": "Letter"
            },
            {
              "id": "82430",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210854Orig1s023,214410Orig1s008lbl.pdf",
              "date": "20260427",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20240301",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "77693",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s020,214410s006lbl.pdf",
              "date": "20240304",
              "type": "Label"
            },
            {
              "id": "77707",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210854Orig1s020; 214410Orig1s006ltr.pdf",
              "date": "20240304",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20201123",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "65323",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf",
              "date": "20201125",
              "type": "Label"
            },
            {
              "id": "65345",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214410Orig1s000ltr.pdf",
              "date": "20201221",
              "type": "Letter"
            },
            {
              "id": "66081",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000, 210854Orig1s004, s010TOC.html",
              "date": "20210203",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA214410",
      "sponsor_name": "GENENTECH INC",
      "openfda": {
        "application_number": [
          "NDA214410"
        ],
        "brand_name": [
          "XOFLUZA"
        ],
        "generic_name": [
          "BALOXAVIR MARBOXIL"
        ],
        "manufacturer_name": [
          "Genentech, Inc."
        ],
        "product_ndc": [
          "50242-583",
          "50242-860",
          "50242-877",
          "50242-599",
          "50242-617"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BALOXAVIR MARBOXIL"
        ],
        "rxcui": [
          "2100008",
          "2100010",
          "2467537",
          "2467539",
          "2536740",
          "2536742",
          "2716798",
          "2716800"
        ],
        "spl_id": [
          "c2da90f4-a11c-46d2-be18-53d286b084cf"
        ],
        "spl_set_id": [
          "e49e1a61-1b7c-4be5-ac84-af6240b511e7"
        ],
        "package_ndc": [
          "50242-860-01",
          "50242-860-86",
          "50242-583-01",
          "50242-877-01",
          "50242-877-86",
          "50242-599-01",
          "50242-617-01"
        ],
        "unii": [
          "505CXM6OHG"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "XOFLUZA",
          "active_ingredients": [
            {
              "name": "BALOXAVIR MARBOXIL",
              "strength": "30MG/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "XOFLUZA",
          "active_ingredients": [
            {
              "name": "BALOXAVIR MARBOXIL",
              "strength": "40MG/PACKET"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "XOFLUZA",
          "active_ingredients": [
            {
              "name": "BALOXAVIR MARBOXIL",
              "strength": "2MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}