{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20001103",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20000228",
          "application_docs": [
            {
              "id": "42991",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075405_cladribine_toc.html",
              "date": "20030804",
              "type": "Review"
            },
            {
              "id": "8652",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75405ta.pdf",
              "date": "20040601",
              "type": "Letter"
            },
            {
              "id": "8653",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75405ltr.pdf",
              "date": "20000228",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20130108",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20010403",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20001103",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20070207",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA075405",
      "sponsor_name": "HIKMA",
      "openfda": {
        "application_number": [
          "ANDA075405"
        ],
        "brand_name": [
          "CLADRIBINE"
        ],
        "generic_name": [
          "CLADRIBINE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9871"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CLADRIBINE"
        ],
        "rxcui": [
          "240754"
        ],
        "spl_id": [
          "5aef0cdc-fa27-47a1-8cce-2a3201aba276"
        ],
        "spl_set_id": [
          "5736aecc-cc1d-47dd-86c0-5fb2e9d70f61"
        ],
        "package_ndc": [
          "0143-9871-01"
        ],
        "nui": [
          "N0000175712"
        ],
        "pharm_class_epc": [
          "Purine Antimetabolite [EPC]"
        ],
        "unii": [
          "47M74X9YT5"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CLADRIBINE",
          "active_ingredients": [
            {
              "name": "CLADRIBINE",
              "strength": "1MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}