{
  "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": "20120717",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20161227",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20260205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85229",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202668Orig1s011,202669Orig1s011ltr.pdf",
              "date": "20260303",
              "type": "Letter"
            },
            {
              "id": "85246",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202668Orig1s011lbl.pdf",
              "date": "20260303",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20240321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77970",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202668Orig1s009;202669Orig1s009ltr.pdf",
              "date": "20240326",
              "type": "Letter"
            },
            {
              "id": "77997",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202668s009lbl.pdf",
              "date": "20240327",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "ANDA202668",
      "sponsor_name": "EUGIA PHARMA SPECLTS",
      "openfda": {
        "application_number": [
          "ANDA202668"
        ],
        "brand_name": [
          "FLUOROURACIL"
        ],
        "generic_name": [
          "FLUOROURACIL"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-496",
          "55150-497"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FLUOROURACIL"
        ],
        "rxcui": [
          "1791701",
          "1791736"
        ],
        "spl_id": [
          "7784c6bc-2624-42ba-a4ea-c63624eecec9"
        ],
        "spl_set_id": [
          "199ef964-8a9b-403e-a2ae-759280b3d1d1"
        ],
        "package_ndc": [
          "55150-496-01",
          "55150-496-10",
          "55150-497-01",
          "55150-497-10"
        ],
        "nui": [
          "N0000000233",
          "N0000175595"
        ],
        "pharm_class_moa": [
          "Nucleic Acid Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Nucleoside Metabolic Inhibitor [EPC]"
        ],
        "unii": [
          "U3P01618RT"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "FLUOROURACIL",
          "active_ingredients": [
            {
              "name": "FLUOROURACIL",
              "strength": "500MG/10ML (50MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "FLUOROURACIL",
          "active_ingredients": [
            {
              "name": "FLUOROURACIL",
              "strength": "1GM/20ML (50MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}