{
  "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": "20151229",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20171025",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "ANDA206203",
      "sponsor_name": "EXELA PHARMA",
      "openfda": {
        "application_number": [
          "ANDA206203"
        ],
        "brand_name": [
          "POTASSIUM ACETATE"
        ],
        "generic_name": [
          "POTASSIUM ACETATE"
        ],
        "manufacturer_name": [
          "Exela Pharma Sciences, LLC"
        ],
        "product_ndc": [
          "51754-2004",
          "51754-2005"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "POTASSIUM ACETATE"
        ],
        "rxcui": [
          "237381"
        ],
        "spl_id": [
          "2b86b9e8-48ba-4a72-b705-48c2751016e6"
        ],
        "spl_set_id": [
          "d5f6dc05-9fb0-4a89-8c54-46112df10abd"
        ],
        "package_ndc": [
          "51754-2004-4",
          "51754-2005-4"
        ],
        "unii": [
          "M911911U02"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "POTASSIUM ACETATE",
          "active_ingredients": [
            {
              "name": "POTASSIUM ACETATE",
              "strength": "2MEQ/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued",
          "te_code": "AP"
        }
      ]
    }
  ]
}