{
  "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": "20250122",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "81280",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215922Orig1s000ltr.pdf",
              "date": "20250219",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "ANDA215922",
      "sponsor_name": "RUBICON RESEARCH",
      "openfda": {
        "application_number": [
          "ANDA215922"
        ],
        "brand_name": [
          "IVERMECTIN"
        ],
        "generic_name": [
          "IVERMECTIN"
        ],
        "manufacturer_name": [
          "Advagen Pharma Ltd"
        ],
        "product_ndc": [
          "72888-206",
          "72888-207"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IVERMECTIN"
        ],
        "rxcui": [
          "199998",
          "311207"
        ],
        "spl_id": [
          "2cda4d15-1149-28c0-e063-6294a90a8736"
        ],
        "spl_set_id": [
          "e88adfbc-e375-4fea-827e-6ec51ed6fd0a"
        ],
        "package_ndc": [
          "72888-206-30",
          "72888-206-08",
          "72888-206-09",
          "72888-206-66",
          "72888-207-30",
          "72888-207-08",
          "72888-207-09",
          "72888-207-66"
        ],
        "nui": [
          "N0000175484",
          "N0000181811"
        ],
        "pharm_class_epc": [
          "Antiparasitic [EPC]",
          "Pediculicide [EPC]"
        ],
        "unii": [
          "8883YP2R6D"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "IVERMECTIN",
          "active_ingredients": [
            {
              "name": "IVERMECTIN",
              "strength": "3MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "IVERMECTIN",
          "active_ingredients": [
            {
              "name": "IVERMECTIN",
              "strength": "6MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}