{
  "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": "20160315",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA206485",
      "sponsor_name": "FRESENIUS KABI USA",
      "openfda": {
        "application_number": [
          "ANDA206485"
        ],
        "brand_name": [
          "MAGNESIUM SULFATE"
        ],
        "generic_name": [
          "MAGNESIUM SULFATE HEPTAHYDRATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-106",
          "63323-107"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MAGNESIUM SULFATE HEPTAHYDRATE"
        ],
        "rxcui": [
          "1658259",
          "1658262",
          "1658264",
          "1658265",
          "829734"
        ],
        "spl_id": [
          "5199cf86-058a-4ad5-961b-eaba5e350e99",
          "48486022-130e-4a6a-87e7-db7c53eb5e75"
        ],
        "spl_set_id": [
          "43d658b1-2b19-44be-a346-cac11fd600b3",
          "fef9e18c-5210-4090-b564-4950ebe461c0"
        ],
        "package_ndc": [
          "63323-106-03",
          "63323-106-26",
          "63323-107-01",
          "63323-107-05",
          "63323-106-02",
          "63323-106-05",
          "63323-106-00",
          "63323-106-01",
          "63323-106-15",
          "63323-106-10"
        ],
        "unii": [
          "SK47B8698T"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MAGNESIUM SULFATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MAGNESIUM SULFATE",
              "strength": "4GM/100ML (40MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "MAGNESIUM SULFATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MAGNESIUM SULFATE",
              "strength": "20GM/500ML (40MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MAGNESIUM SULFATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MAGNESIUM SULFATE",
              "strength": "4GM/50ML (80MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "MAGNESIUM SULFATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MAGNESIUM SULFATE",
              "strength": "40GM/1000ML (40MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "MAGNESIUM SULFATE IN PLASTIC CONTAINER",
          "active_ingredients": [
            {
              "name": "MAGNESIUM SULFATE",
              "strength": "2GM/50ML (40MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}