{
  "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": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20120206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16505",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021877s005lbl.pdf",
              "date": "20120206",
              "type": "Label"
            },
            {
              "id": "28758",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021877s005ltr.pdf",
              "date": "20120207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20091215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16504",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf",
              "date": "20091216",
              "type": "Label"
            },
            {
              "id": "28757",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf",
              "date": "20091224",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20180703",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "54778",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021877Orig1s008ltr.pdf",
              "date": "20180706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20150604",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20250311",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "81546",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021877Orig1s014lbl.pdf",
              "date": "20250313",
              "type": "Label"
            },
            {
              "id": "81547",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021877Orig1s014ltr.pdf",
              "date": "20250313",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20091215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37804",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf",
              "date": "20091216",
              "type": "Label"
            },
            {
              "id": "6361",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf",
              "date": "20091224",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20190802",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "72910",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021877Orig1s012correctedlbl.pdf",
              "date": "20221215",
              "type": "Label"
            },
            {
              "id": "72911",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021877Orig1s012correctedltr.pdf",
              "date": "20221216",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20190731",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "59539",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021877Orig1s010ltr.pdf",
              "date": "20190801",
              "type": "Letter"
            },
            {
              "id": "59546",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021877s010lbl.pdf",
              "date": "20190802",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20181129",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56607",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021877s009lbl.pdf",
              "date": "20181130",
              "type": "Label"
            },
            {
              "id": "56819",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21877Orig1s009ltr.pdf",
              "date": "20181220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20051028",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "37803",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021877lbl.pdf",
              "date": "20051101",
              "type": "Label"
            },
            {
              "id": "42335",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021877_s000_ArranonTOC.html",
              "date": "20060106",
              "type": "Review"
            },
            {
              "id": "6360",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021877ltr.pdf",
              "date": "20051101",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021877",
      "sponsor_name": "SANDOZ",
      "openfda": {
        "application_number": [
          "NDA021877"
        ],
        "brand_name": [
          "ARRANON"
        ],
        "generic_name": [
          "NELARABINE"
        ],
        "manufacturer_name": [
          "Sandoz Inc",
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "66758-165",
          "0078-0683"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NELARABINE"
        ],
        "rxcui": [
          "603566",
          "616366"
        ],
        "spl_id": [
          "0015d51c-784c-4f0d-938c-6c81decd5903",
          "b1a3f864-56e1-44da-b2d0-7158d0945513"
        ],
        "spl_set_id": [
          "0f9051de-5c4d-4c0f-8c19-e15214498cca",
          "fffa5d75-0dba-4ad7-a252-5f60fa28489a"
        ],
        "package_ndc": [
          "66758-165-94",
          "0078-0683-06",
          "0078-0683-61"
        ],
        "nui": [
          "N0000000233",
          "N0000175595"
        ],
        "pharm_class_moa": [
          "Nucleic Acid Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Nucleoside Metabolic Inhibitor [EPC]"
        ],
        "unii": [
          "60158CV180"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ARRANON",
          "active_ingredients": [
            {
              "name": "NELARABINE",
              "strength": "250MG/50ML (5MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}