{
  "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": "20180418",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20200608",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA210364",
      "sponsor_name": "AUROBINDO PHARMA USA",
      "openfda": {
        "application_number": [
          "ANDA210364"
        ],
        "brand_name": [
          "ECONAZOLE NITRATE"
        ],
        "generic_name": [
          "ECONAZOLE NITRATE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "59651-945"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ECONAZOLE NITRATE"
        ],
        "spl_id": [
          "5773bc55-511b-4168-a917-7c1f69e0853e"
        ],
        "spl_set_id": [
          "74e5bbc9-eaea-405e-b64b-b3527c5ea084"
        ],
        "package_ndc": [
          "59651-945-14",
          "59651-945-30",
          "59651-945-85"
        ],
        "unii": [
          "H438WYN10E"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ECONAZOLE NITRATE",
          "active_ingredients": [
            {
              "name": "ECONAZOLE NITRATE",
              "strength": "1%"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CREAM",
          "route": "TOPICAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}