{
  "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": "20100121"
        }
      ],
      "application_number": "ANDA090038",
      "sponsor_name": "HIKMA FARMACEUTICA",
      "openfda": {
        "application_number": [
          "ANDA090038"
        ],
        "brand_name": [
          "MILRINONE LACTATE IN DEXTROSE"
        ],
        "generic_name": [
          "MILRINONE LACTATE IN DEXTROSE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9718",
          "0143-9719"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MILRINONE LACTATE"
        ],
        "rxcui": [
          "1791840",
          "1791842"
        ],
        "spl_id": [
          "e67caf04-0a9c-4638-90a6-c959c9e0b927"
        ],
        "spl_set_id": [
          "4c2f052b-7ba2-4122-a50b-37ef2a834d61"
        ],
        "package_ndc": [
          "0143-9719-01",
          "0143-9719-10",
          "0143-9718-01",
          "0143-9718-10"
        ],
        "unii": [
          "9K8XR81MO8"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MILRINONE LACTATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MILRINONE LACTATE",
              "strength": "EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MILRINONE LACTATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MILRINONE LACTATE",
              "strength": "EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}