{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200520",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA207551",
      "sponsor_name": "AMNEAL PHARMS CO",
      "openfda": {
        "application_number": [
          "ANDA207551"
        ],
        "brand_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "70121-1388",
          "70121-1389"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1718906",
          "1718909"
        ],
        "spl_id": [
          "af193b53-1488-401f-8f06-cc193297c4a8"
        ],
        "spl_set_id": [
          "eb1ba463-ab42-4f49-9ebe-3ad5af108326"
        ],
        "package_ndc": [
          "70121-1388-1",
          "70121-1388-8",
          "70121-1389-1",
          "70121-1389-7"
        ],
        "unii": [
          "1018WH7F9I"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "DEXMEDETOMIDINE HYDROCHLORIDE",
              "strength": "EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "DEXMEDETOMIDINE HYDROCHLORIDE",
              "strength": "EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}