{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20111018",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "38177",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.pdf",
              "date": "20111020",
              "type": "Label"
            },
            {
              "id": "51941",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_Original_WR.pdf",
              "date": "20110405",
              "type": "Pediatric Written Request"
            },
            {
              "id": "51942",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_Amendment_1.pdf",
              "date": "20110405",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "51943",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_Amendment_2.pdf",
              "date": "20110405",
              "type": "Pediatric Amendment 2"
            },
            {
              "id": "52937",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_statistical_BPCA.pdf",
              "date": "20110405",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "52938",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_clinpharm_BPCA.pdf",
              "date": "20110405",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "52939",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065_ixabepilone_clinical_BPCA.pdf",
              "date": "20110405",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "64238",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22065S006-Ixempra---Ixabepilone-Clinical-PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "6805",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022065s006ltr.pdf",
              "date": "20111020",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20100512",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38175",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf",
              "date": "20100517",
              "type": "Label"
            },
            {
              "id": "29186",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf",
              "date": "20100517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20091002",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "16874",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf",
              "date": "20091007",
              "type": "Label"
            },
            {
              "id": "29185",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf",
              "date": "20091013",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20230111",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73144",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022065orig1s013ltr.pdf",
              "date": "20230112",
              "type": "Letter"
            },
            {
              "id": "73147",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022065s013lbl.pdf",
              "date": "20230113",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20220121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69956",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022065Orig1s011ltr.pdf",
              "date": "20220125",
              "type": "Letter"
            },
            {
              "id": "69967",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022065Orig1s011lbl.pdf",
              "date": "20220125",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20160726",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20100512",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38176",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022065s004s005lbl.pdf",
              "date": "20100517",
              "type": "Label"
            },
            {
              "id": "6804",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022065s004,s005ltr.pdf",
              "date": "20100517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20091002",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6803",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s002,s003ltr.pdf",
              "date": "20091013",
              "type": "Letter"
            },
            {
              "id": "16875",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s002lbl.pdf",
              "date": "20091007",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090313",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "38174",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022065s001lbl.pdf",
              "date": "20090403",
              "type": "Label"
            },
            {
              "id": "6802",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022065s001ltr.pdf",
              "date": "20090317",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20161222",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20071016",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "42406",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022065TOC.html",
              "date": "20080324",
              "type": "Review"
            },
            {
              "id": "16873",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022065lbl.pdf",
              "date": "20071017",
              "type": "Label"
            },
            {
              "id": "29184",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022065s000ltr.pdf",
              "date": "20071022",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150120",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA022065",
      "sponsor_name": "R-PHARM US LLC",
      "openfda": {
        "application_number": [
          "NDA022065"
        ],
        "brand_name": [
          "IXEMPRA"
        ],
        "generic_name": [
          "IXABEPILONE"
        ],
        "manufacturer_name": [
          "R-Pharm US Operating, LLC"
        ],
        "product_ndc": [
          "70020-1910",
          "70020-1911"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "1726271",
          "1726274",
          "1726276",
          "1726278"
        ],
        "spl_id": [
          "452ab301-102b-ac80-e063-6394a90ab113"
        ],
        "spl_set_id": [
          "241f0b1e-8b95-470d-876f-bf1804daaf18"
        ],
        "package_ndc": [
          "70020-1910-1",
          "70020-1911-1"
        ],
        "route": [
          "INTRAVENOUS"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "IXEMPRA KIT",
          "active_ingredients": [
            {
              "name": "IXABEPILONE",
              "strength": "45MG/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "IXEMPRA KIT",
          "active_ingredients": [
            {
              "name": "IXABEPILONE",
              "strength": "15MG/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}