{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210610",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "67766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214187s000lbl.pdf",
              "date": "20210611",
              "type": "Label"
            },
            {
              "id": "67775",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214187Orig1s000ltr.pdf",
              "date": "20210614",
              "type": "Letter"
            },
            {
              "id": "69421",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214187Orig1s000TOC.html",
              "date": "20211129",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20220427",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "70843",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214187s001lbl.pdf",
              "date": "20220428",
              "type": "Label"
            },
            {
              "id": "70857",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214187Orig1s01ltr.pdf",
              "date": "20220429",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA214187",
      "sponsor_name": "GILEAD SCIENCES INC",
      "openfda": {
        "application_number": [
          "NDA214187"
        ],
        "brand_name": [
          "EPCLUSA"
        ],
        "generic_name": [
          "VELPATASVIR AND SOFOSBUVIR"
        ],
        "manufacturer_name": [
          "Gilead Sciences, Inc."
        ],
        "product_ndc": [
          "61958-2204",
          "61958-2201",
          "61958-2203",
          "61958-2205"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VELPATASVIR",
          "SOFOSBUVIR"
        ],
        "rxcui": [
          "1799212",
          "1799218",
          "2288814",
          "2288816",
          "2584196",
          "2584199",
          "2584200",
          "2584201"
        ],
        "spl_id": [
          "4e28b652-df20-450d-9f6e-4cc6e355e223"
        ],
        "spl_set_id": [
          "7f30631a-ee3b-4cfe-866b-964df3f0a44f"
        ],
        "package_ndc": [
          "61958-2201-1",
          "61958-2203-1",
          "61958-2204-1",
          "61958-2205-1"
        ],
        "nui": [
          "N0000191256",
          "N0000190113",
          "N0000185503",
          "N0000190107",
          "N0000190108",
          "N0000190109",
          "N0000191493",
          "N0000191258"
        ],
        "pharm_class_epc": [
          "Hepatitis C Virus NS5A Inhibitor [EPC]",
          "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Breast Cancer Resistance Protein Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]",
          "RNA Replicase Inhibitors [MoA]"
        ],
        "unii": [
          "KCU0C7RS7Z",
          "WJ6CA3ZU8B"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "EPCLUSA",
          "active_ingredients": [
            {
              "name": "SOFOSBUVIR",
              "strength": "200MG/PACKET"
            },
            {
              "name": "VELPATASVIR",
              "strength": "50MG/PACKET"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "PELLETS",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "EPCLUSA",
          "active_ingredients": [
            {
              "name": "SOFOSBUVIR",
              "strength": "150MG/PACKET"
            },
            {
              "name": "VELPATASVIR",
              "strength": "37.5MG/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "PELLETS",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}