{
  "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": "2026-10-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20240710",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79047",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209376Orig1s007ltr.pdf",
              "date": "20240711",
              "type": "Letter"
            },
            {
              "id": "79073",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209376Orig1s007lbl.pdf",
              "date": "20240916",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200702",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "application_docs": [
            {
              "id": "63806",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209376s000lbl.pdf",
              "date": "20200706",
              "type": "Label"
            },
            {
              "id": "63809",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209376Orig1s000ltr.pdf",
              "date": "20200707",
              "type": "Letter"
            },
            {
              "id": "66312",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209376Orig1s000TOC.html",
              "date": "20210222",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20210630",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "68019",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209376s002lbl.pdf",
              "date": "20210707",
              "type": "Label"
            },
            {
              "id": "75511",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/209376Orig1s002.pdf",
              "date": "20230918",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA209376",
      "sponsor_name": "AM REGENT",
      "openfda": {
        "application_number": [
          "NDA209376"
        ],
        "brand_name": [
          "TRALEMENT",
          "MULTRYS"
        ],
        "generic_name": [
          "TRACE ELEMENTS INJECTION 4"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-9305",
          "0517-9302"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ZINC SULFATE",
          "CUPRIC SULFATE",
          "MANGANESE SULFATE",
          "SELENIOUS ACID"
        ],
        "rxcui": [
          "2693627",
          "2693633",
          "2568573",
          "2568579"
        ],
        "spl_id": [
          "98253bed-5ff4-478f-aff5-c35944fad08a",
          "5c07b457-1143-440c-9975-90c16852a103"
        ],
        "spl_set_id": [
          "a49ffb90-f307-433e-a86e-aaea6d6a9982",
          "995f1efa-aca0-4b6c-9099-f8e757c2133a"
        ],
        "package_ndc": [
          "0517-9305-01",
          "0517-9305-25",
          "0517-9302-01",
          "0517-9302-25"
        ],
        "unii": [
          "89DS0H96TB",
          "LRX7AJ16DT",
          "W00LYS4T26",
          "F6A27P4Q4R"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "MULTRYS",
          "active_ingredients": [
            {
              "name": "CUPRIC SULFATE",
              "strength": "EQ 60MCG COPPER/ML"
            },
            {
              "name": "MANGANESE SULFATE",
              "strength": "EQ 3MCG BASE/ML"
            },
            {
              "name": "SELENIOUS ACID",
              "strength": "EQ 6MCG SELENIUM/ML"
            },
            {
              "name": "ZINC SULFATE",
              "strength": "EQ 1000MCG BASE/ML (1ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "TRALEMENT",
          "active_ingredients": [
            {
              "name": "CUPRIC SULFATE",
              "strength": "EQ 0.3MG COPPER/ML"
            },
            {
              "name": "MANGANESE SULFATE",
              "strength": "EQ 55MCG BASE/ML"
            },
            {
              "name": "SELENIOUS ACID",
              "strength": "EQ 60MCG SELENIUM/ML"
            },
            {
              "name": "ZINC SULFATE",
              "strength": "EQ 3MG BASE/ML (1ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "TRALEMENT",
          "active_ingredients": [
            {
              "name": "CUPRIC SULFATE",
              "strength": "EQ 0.3MG COPPER/ML"
            },
            {
              "name": "MANGANESE SULFATE",
              "strength": "EQ 55MCG BASE/ML"
            },
            {
              "name": "SELENIOUS ACID",
              "strength": "EQ 60MCG SELENIUM/ML"
            },
            {
              "name": "ZINC SULFATE",
              "strength": "EQ 3MG BASE/ML (5ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}