{
  "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": "20250603",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA217187",
      "sponsor_name": "PRECISION DOSE INC",
      "openfda": {
        "application_number": [
          "ANDA217187"
        ],
        "brand_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "generic_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Precision Dose, Inc."
        ],
        "product_ndc": [
          "68094-064"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "rxcui": [
          "808917"
        ],
        "spl_id": [
          "f59f5f6f-5038-436d-8ed4-fb1dfce51c1e"
        ],
        "spl_set_id": [
          "f44b79d0-a789-46cb-ab70-7eb33a7debaf"
        ],
        "package_ndc": [
          "68094-064-01",
          "68094-064-20"
        ],
        "unii": [
          "7FXW6U30GY"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "FOSFOMYCIN TROMETHAMINE",
          "active_ingredients": [
            {
              "name": "FOSFOMYCIN TROMETHAMINE",
              "strength": "EQ 3GM BASE/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}