{
  "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": "20230113",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA215808",
      "sponsor_name": "FRESENIUS KABI USA",
      "openfda": {
        "application_number": [
          "ANDA215808"
        ],
        "brand_name": [
          "KETAMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "KETAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "65219-186",
          "65219-184",
          "65219-188"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "KETAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "238083",
          "238082",
          "238084"
        ],
        "spl_id": [
          "cc4da24f-92ef-40c9-a77d-afa3164bb5b8",
          "9acdebb0-6e88-42b2-ac45-da51aaad0f3c"
        ],
        "spl_set_id": [
          "ac2e715d-251c-4e3f-b91c-972f466d0beb",
          "cc67b0fd-ca73-49f6-b5ca-705dc7331776"
        ],
        "package_ndc": [
          "65219-186-13",
          "65219-186-23",
          "65219-184-01",
          "65219-184-20",
          "65219-188-01",
          "65219-188-10",
          "65219-186-01",
          "65219-186-05"
        ],
        "unii": [
          "O18YUO0I83"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "KETAMINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "KETAMINE HYDROCHLORIDE",
              "strength": "EQ 100MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "KETAMINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "KETAMINE HYDROCHLORIDE",
              "strength": "EQ 10MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "KETAMINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "KETAMINE HYDROCHLORIDE",
              "strength": "EQ 50MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}