{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20260108",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84725",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218171Orig1s002ltr.pdf",
              "date": "20260109",
              "type": "Letter"
            },
            {
              "id": "84734",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218171s002lbl.pdf",
              "date": "20260112",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20260226",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85192",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218171s003lbl.pdf",
              "date": "20260302",
              "type": "Label"
            },
            {
              "id": "85193",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218171Orig1s003ltr.pdf",
              "date": "20260302",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20241218",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "80629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf",
              "date": "20241219",
              "type": "Label"
            },
            {
              "id": "80647",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218171Orig1s000ltr.pdf",
              "date": "20241219",
              "type": "Letter"
            },
            {
              "id": "80855",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218171Orig1s000TOC.html",
              "date": "20250116",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA218171",
      "sponsor_name": "XCOVERY",
      "openfda": {
        "application_number": [
          "NDA218171"
        ],
        "brand_name": [
          "ENSACOVE"
        ],
        "generic_name": [
          "ENSARTINIB"
        ],
        "manufacturer_name": [
          "Xcovery Holdings, Inc."
        ],
        "product_ndc": [
          "83076-1025",
          "83076-1100"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENSARTINIB HYDROCHLORIDE"
        ],
        "rxcui": [
          "2712634",
          "2712640",
          "2712642",
          "2712644"
        ],
        "spl_id": [
          "17196ce1-224e-4359-ac54-39e035def74f"
        ],
        "spl_set_id": [
          "1e1b2f79-678a-472a-b924-66909c8a4b2e"
        ],
        "package_ndc": [
          "83076-1025-3",
          "83076-1100-6"
        ],
        "unii": [
          "C2FR6VT1BQ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ENSACOVE",
          "active_ingredients": [
            {
              "name": "ENSARTINIB HYDROCHLORIDE",
              "strength": "EQ 25MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ENSACOVE",
          "active_ingredients": [
            {
              "name": "ENSARTINIB HYDROCHLORIDE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}