{
  "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": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20241009",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230406",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20220628",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA203078",
      "sponsor_name": "HIKMA",
      "openfda": {
        "application_number": [
          "ANDA203078"
        ],
        "brand_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "generic_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9160",
          "0143-9396"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "rxcui": [
          "199212",
          "1730194"
        ],
        "spl_id": [
          "6c1a13e7-546c-4b06-8217-73f2c4b7ed57"
        ],
        "spl_set_id": [
          "c5a63679-0c94-4e9d-9ac0-8ee3023bd9a6"
        ],
        "package_ndc": [
          "0143-9396-01",
          "0143-9160-01",
          "0143-9160-10"
        ],
        "unii": [
          "80YS8O1MBS"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CISATRACURIUM BESYLATE",
          "active_ingredients": [
            {
              "name": "CISATRACURIUM BESYLATE",
              "strength": "EQ 10MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CISATRACURIUM BESYLATE",
          "active_ingredients": [
            {
              "name": "CISATRACURIUM BESYLATE",
              "strength": "EQ 2MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}