{
  "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": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20241203",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "80533",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214628Orig1s004Correctedlbl.pdf",
              "date": "20241206",
              "type": "Label"
            },
            {
              "id": "80534",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214628Orig1s004Correctedltr.pdf",
              "date": "20241206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20221006",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "72276",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214628Orig1s000ltr.pdf",
              "date": "20221007",
              "type": "Letter"
            },
            {
              "id": "75305",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214628Orig1s000TOC.html",
              "date": "20230828",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA214628",
      "sponsor_name": "LONG GROVE PHARMS",
      "openfda": {
        "application_number": [
          "NDA214628"
        ],
        "brand_name": [
          "NOREPINEPHRINE"
        ],
        "generic_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "manufacturer_name": [
          "Long Grove Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "81298-9655",
          "81298-9659",
          "81298-9658"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "rxcui": [
          "2475337",
          "2475340",
          "2619579"
        ],
        "spl_id": [
          "329c5273-4dc5-4738-bf21-660e73d91eb9"
        ],
        "spl_set_id": [
          "759807dd-61a8-4f6f-8bf5-f6ee773c81bc"
        ],
        "package_ndc": [
          "81298-9659-1",
          "81298-9659-3",
          "81298-9655-1",
          "81298-9655-3",
          "81298-9658-1",
          "81298-9658-3"
        ],
        "unii": [
          "IFY5PE3ZRW"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE",
          "active_ingredients": [
            {
              "name": "NOREPINEPHRINE BITARTRATE",
              "strength": "EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE",
          "active_ingredients": [
            {
              "name": "NOREPINEPHRINE BITARTRATE",
              "strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE",
          "active_ingredients": [
            {
              "name": "NOREPINEPHRINE BITARTRATE",
              "strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}