{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20260402",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA212609",
      "sponsor_name": "CIPLA",
      "openfda": {
        "application_number": [
          "ANDA212609"
        ],
        "brand_name": [
          "NINTEDANIB CAPSULES, 100 MG AND 150 MG",
          "NINTEDANIB"
        ],
        "generic_name": [
          "NINTEDANIB"
        ],
        "manufacturer_name": [
          "EXELAN PHARMACEUTICALS INC.",
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "76282-786",
          "76282-787",
          "69097-639",
          "69097-641"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NINTEDANIB ESYLATE"
        ],
        "spl_id": [
          "e6cab487-5092-4b7b-a3c2-da94f6dc66c2",
          "128511d3-f076-4a68-993b-53ad52233ee2"
        ],
        "spl_set_id": [
          "60d8104e-cb6c-4f4f-8159-95ed57346ffa",
          "4d017c42-a823-452d-bc6f-0491dd9823e3"
        ],
        "package_ndc": [
          "76282-786-60",
          "76282-787-60",
          "69097-641-03",
          "69097-639-03"
        ],
        "unii": [
          "42F62RTZ4G"
        ],
        "rxcui": [
          "1592742",
          "1592750"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "NINTEDANIB ESYLATE",
          "active_ingredients": [
            {
              "name": "NINTEDANIB ESYLATE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "NINTEDANIB ESYLATE",
          "active_ingredients": [
            {
              "name": "NINTEDANIB ESYLATE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}