{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230912",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "75418",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217150Orig1s000ltr.pdf",
              "date": "20230913",
              "type": "Letter"
            },
            {
              "id": "75440",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217150s000lbl.pdf",
              "date": "20230913",
              "type": "Label"
            },
            {
              "id": "78087",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217150Orig1s000TOC.html",
              "date": "20240408",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20241230",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80788",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217150s001lbl.pdf",
              "date": "20250102",
              "type": "Label"
            },
            {
              "id": "80792",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217150Orig1s001ltr.pdf",
              "date": "20250102",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA217150",
      "sponsor_name": "SANDOZ",
      "openfda": {
        "application_number": [
          "NDA217150"
        ],
        "brand_name": [
          "CYCLOPHOSPHAMIDE"
        ],
        "generic_name": [
          "CYCLOPHOSPHAMIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-3528",
          "0781-3529",
          "0781-3530"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CYCLOPHOSPHAMIDE"
        ],
        "rxcui": [
          "2679073"
        ],
        "spl_id": [
          "3a7a4ad7-90ca-4d84-92f1-c61032067deb"
        ],
        "spl_set_id": [
          "cf2f4b95-0327-499a-a5a3-51b1bdef68c5"
        ],
        "package_ndc": [
          "0781-3528-75",
          "0781-3528-10",
          "0781-3529-70",
          "0781-3529-10",
          "0781-3530-80",
          "0781-3530-10"
        ],
        "unii": [
          "8N3DW7272P"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "CYCLOPHOSPHAMIDE",
          "active_ingredients": [
            {
              "name": "CYCLOPHOSPHAMIDE",
              "strength": "1GM/10ML (100MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "CYCLOPHOSPHAMIDE",
          "active_ingredients": [
            {
              "name": "CYCLOPHOSPHAMIDE",
              "strength": "2GM/20ML (100MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CYCLOPHOSPHAMIDE",
          "active_ingredients": [
            {
              "name": "CYCLOPHOSPHAMIDE",
              "strength": "500MG/5ML (100MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}