{
  "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": "20090520",
          "application_docs": [
            {
              "id": "23914",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm243551.htm",
              "date": "20110217",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20110408",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA078630",
      "sponsor_name": "HIKMA FARMACEUTICA",
      "openfda": {
        "application_number": [
          "ANDA078630"
        ],
        "brand_name": [
          "TERBUTALINE SULFATE"
        ],
        "generic_name": [
          "TERBUTALINE SULFATE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9746",
          "0143-9375"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "TERBUTALINE SULFATE"
        ],
        "rxcui": [
          "857635"
        ],
        "spl_id": [
          "3e8736f7-de5c-4906-851f-6a10a53866ad",
          "c46b3216-1e79-4473-b4f3-951fd506ab92"
        ],
        "spl_set_id": [
          "613df3cb-4d55-4d12-ab08-a932481aaa0b",
          "0f4d3249-e022-40b6-b93d-f605e8522207"
        ],
        "package_ndc": [
          "0143-9746-01",
          "0143-9746-10",
          "0143-9375-01",
          "0143-9375-10"
        ],
        "unii": [
          "576PU70Y8E"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TERBUTALINE SULFATE",
          "active_ingredients": [
            {
              "name": "TERBUTALINE SULFATE",
              "strength": "1MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}