{
  "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": "21",
          "submission_status": "AP",
          "submission_status_date": "20240418",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78179",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211994s021lbl.pdf",
              "date": "20240419",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20220120",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "69944",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s012s013lbl.pdf",
              "date": "20220121",
              "type": "Label"
            },
            {
              "id": "69949",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211994Orig1s012,s013ltr.pdf",
              "date": "20220121",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20200324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62312",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211994Orig1s004ltr.pdf",
              "date": "20200325",
              "type": "Letter"
            },
            {
              "id": "62314",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s004lbl.pdf",
              "date": "20200325",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20210323",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66860",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211994Orig1s011ltr.pdf",
              "date": "20210324",
              "type": "Letter"
            },
            {
              "id": "66876",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s011lbl.pdf",
              "date": "20210325",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20240405",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78083",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211994Orig1s018, s019ltr.pdf",
              "date": "20240408",
              "type": "Letter"
            },
            {
              "id": "78090",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211994s018s019lbl.pdf",
              "date": "20240408",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20200806",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64230",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211994Orig1s006,s007ltr.pdf",
              "date": "20200807",
              "type": "Letter"
            },
            {
              "id": "64240",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s006s007lbl.pdf",
              "date": "20200807",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20230125",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "73294",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211994Orig1s014ltr.pdf",
              "date": "20230126",
              "type": "Letter"
            },
            {
              "id": "73325",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211994s014lbl.pdf",
              "date": "20230130",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20191024",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60671",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211994Orig1s005ltr.pdf",
              "date": "20191025",
              "type": "Letter"
            },
            {
              "id": "60681",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s005lbl.pdf",
              "date": "20191025",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20231103",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "76551",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211994Orig1s020correctedltr.pdf",
              "date": "20231113",
              "type": "Letter"
            },
            {
              "id": "76555",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211994Orig1s020correctedlbl.pdf",
              "date": "20231113",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20220120",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "69945",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s012s013lbl.pdf",
              "date": "20220121",
              "type": "Label"
            },
            {
              "id": "69948",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211994Orig1s012,s013ltr.pdf",
              "date": "20220121",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20210301",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "66447",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211994Orig1s010ltr.pdf",
              "date": "20210302",
              "type": "Letter"
            },
            {
              "id": "66453",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s010lbl.pdf",
              "date": "20210302",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20240405",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78084",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211994Orig1s018, s019ltr.pdf",
              "date": "20240408",
              "type": "Letter"
            },
            {
              "id": "78094",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211994s018s019lbl.pdf",
              "date": "20240409",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20251028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83974",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211994s023lbl.pdf",
              "date": "20251029",
              "type": "Label"
            },
            {
              "id": "83987",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211994Orig1s023ltr.pdf",
              "date": "20251029",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190408",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "application_docs": [
            {
              "id": "58267",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s000lbl.pdf",
              "date": "20190410",
              "type": "Label"
            },
            {
              "id": "58279",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211994Orig1s000ltr.pdf",
              "date": "20190410",
              "type": "Letter"
            },
            {
              "id": "59165",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211994Orig1s000TOC.html",
              "date": "20190624",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20221007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72290",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211994Orig1s015ltr.pdf",
              "date": "20221011",
              "type": "Letter"
            },
            {
              "id": "72305",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s015lbl.pdf",
              "date": "20221011",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20200806",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64231",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211994Orig1s006,s007ltr.pdf",
              "date": "20200807",
              "type": "Letter"
            },
            {
              "id": "64239",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s006s007lbl.pdf",
              "date": "20200807",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA211994",
      "sponsor_name": "VIIV HLTHCARE",
      "openfda": {
        "application_number": [
          "NDA211994"
        ],
        "brand_name": [
          "DOVATO"
        ],
        "generic_name": [
          "DOLUTEGRAVIR SODIUM AND LAMIVUDINE"
        ],
        "manufacturer_name": [
          "ViiV Healthcare Company"
        ],
        "product_ndc": [
          "49702-246"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOLUTEGRAVIR SODIUM",
          "LAMIVUDINE"
        ],
        "rxcui": [
          "2122519",
          "2122526"
        ],
        "spl_id": [
          "9b88da25-ebce-49ae-8c8a-dcee6f465957"
        ],
        "spl_set_id": [
          "68e45422-43ed-4cfb-9356-fae88d14a53a"
        ],
        "package_ndc": [
          "49702-246-13",
          "49702-246-33",
          "49702-246-62"
        ],
        "nui": [
          "N0000175656",
          "N0000175462",
          "N0000009947"
        ],
        "pharm_class_epc": [
          "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]",
          "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Nucleoside Reverse Transcriptase Inhibitors [MoA]"
        ],
        "unii": [
          "1Q1V9V5WYQ",
          "2T8Q726O95"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DOVATO",
          "active_ingredients": [
            {
              "name": "DOLUTEGRAVIR SODIUM",
              "strength": "EQ 50MG BASE"
            },
            {
              "name": "LAMIVUDINE",
              "strength": "300MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}