{
  "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": "20190204",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "57436",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208464s007lbl.pdf",
              "date": "20190205",
              "type": "Label"
            },
            {
              "id": "57589",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208464Orig1s007ltr.pdf",
              "date": "20190213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20240327",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78001",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208464Orig1s016,s017ltr.pdf",
              "date": "20240328",
              "type": "Letter"
            },
            {
              "id": "78008",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208464s016s017lbl.pdf",
              "date": "20240401",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170407",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47911",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208464s001lbl.pdf",
              "date": "20170410",
              "type": "Label"
            },
            {
              "id": "47983",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208464Orig1s001ltr.pdf",
              "date": "20170412",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20221017",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "72405",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208464Orig1s014ltr.pdf",
              "date": "20221018",
              "type": "Letter"
            },
            {
              "id": "72423",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf",
              "date": "20221019",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20210304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66512",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208464Orig1s012ltr.pdf",
              "date": "20210305",
              "type": "Letter"
            },
            {
              "id": "66679",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s012lbl.pdf",
              "date": "20210309",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20200818",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64308",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s010,s011ltr.pdf",
              "date": "20200819",
              "type": "Letter"
            },
            {
              "id": "64312",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf",
              "date": "20200819",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20161110",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "45888",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208464s000lbl.pdf",
              "date": "20161114",
              "type": "Label"
            },
            {
              "id": "45896",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208464Orig1s000ltr.pdf",
              "date": "20161115",
              "type": "Letter"
            },
            {
              "id": "50486",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208464Orig1s000TOC.html",
              "date": "20171127",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20200204",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "61779",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s008ltr.pdf",
              "date": "20200205",
              "type": "Letter"
            },
            {
              "id": "61849",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s008lbl.pdf",
              "date": "20200210",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20240327",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78002",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208464Orig1s016,s017ltr.pdf",
              "date": "20240328",
              "type": "Letter"
            },
            {
              "id": "78009",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208464s016s017lbl.pdf",
              "date": "20240401",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20180703",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "54780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208464Orig1s004ltr.pdf",
              "date": "20180706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20221214",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "73570",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208464Orig1s015Corrected_ltr.pdf",
              "date": "20230221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20210915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s013lbl.pdf",
              "date": "20210917",
              "type": "Label"
            },
            {
              "id": "68633",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208464Orig1s013ltr.pdf",
              "date": "20210917",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20200818",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64309",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s010,s011ltr.pdf",
              "date": "20200819",
              "type": "Letter"
            },
            {
              "id": "64314",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf",
              "date": "20200819",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA208464",
      "sponsor_name": "GILEAD SCIENCES INC",
      "openfda": {
        "application_number": [
          "NDA208464"
        ],
        "brand_name": [
          "VEMLIDY"
        ],
        "generic_name": [
          "TENOFOVIR ALAFENAMIDE"
        ],
        "manufacturer_name": [
          "Gilead Sciences, Inc."
        ],
        "product_ndc": [
          "61958-2301"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TENOFOVIR ALAFENAMIDE FUMARATE"
        ],
        "rxcui": [
          "1858261",
          "1858267"
        ],
        "spl_id": [
          "175f5d1a-aae9-43d5-b004-65eefec167d4"
        ],
        "spl_set_id": [
          "72e6b33c-0351-4070-9172-eeaa186c01d2"
        ],
        "package_ndc": [
          "61958-2301-1"
        ],
        "unii": [
          "FWF6Q91TZO"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VEMLIDY",
          "active_ingredients": [
            {
              "name": "TENOFOVIR ALAFENAMIDE FUMARATE",
              "strength": "EQ 25MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}