{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20201124",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65331",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022234s018lbl.pdf",
              "date": "20201125",
              "type": "Label"
            },
            {
              "id": "65355",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022234Orig1s018ltr.pdf",
              "date": "20201127",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20230515",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74260",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022234s022lbl.pdf",
              "date": "20230516",
              "type": "Label"
            },
            {
              "id": "74268",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022234Orig1s022ltr.pdf",
              "date": "20230516",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110308",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "42459",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234_docetaxel_toc.html",
              "date": "20111208",
              "type": "Review"
            },
            {
              "id": "44709",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234Orig1s000SumR.pdf",
              "date": "20111208",
              "type": "Summary Review"
            },
            {
              "id": "7074",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022234s000ltr.pdf",
              "date": "20080813",
              "type": "Letter"
            },
            {
              "id": "7075",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022234s000ltr.pdf",
              "date": "20110311",
              "type": "Letter"
            },
            {
              "id": "17107",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022234s000lbl.pdf",
              "date": "20110311",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20191011",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60555",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf",
              "date": "20191015",
              "type": "Letter"
            },
            {
              "id": "60559",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf",
              "date": "20191015",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20180802",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "55095",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s010Ltr.pdf",
              "date": "20180803",
              "type": "Letter"
            },
            {
              "id": "55106",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234Orig1s010Lbl.pdf",
              "date": "20180803",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20170927",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49874",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf",
              "date": "20170928",
              "type": "Label"
            },
            {
              "id": "49889",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022234Orig1s008ltr.pdf",
              "date": "20170929",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20160624",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20140123",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20191011",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60557",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf",
              "date": "20191015",
              "type": "Letter"
            },
            {
              "id": "60561",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf",
              "date": "20191015",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20191011",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60556",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf",
              "date": "20191015",
              "type": "Letter"
            },
            {
              "id": "60560",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf",
              "date": "20191015",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20180924",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "55620",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf",
              "date": "20180926",
              "type": "Label"
            },
            {
              "id": "55748",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s011,202356Orig1s003ltr.pdf",
              "date": "20181001",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20170125",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "49666",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s005lbl.pdf",
              "date": "20170906",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20140710",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "17108",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf",
              "date": "20140711",
              "type": "Label"
            },
            {
              "id": "29432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022234Orig1s003ltr.pdf",
              "date": "20140711",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022234",
      "sponsor_name": "HOSPIRA INC",
      "openfda": {
        "application_number": [
          "NDA022234"
        ],
        "brand_name": [
          "DOCETAXEL"
        ],
        "generic_name": [
          "DOCETAXEL",
          "DOCETAXEL ANHYDROUS"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-0365",
          "0409-4235",
          "0409-5068",
          "0409-0366",
          "0409-0367",
          "0409-0368",
          "0409-1732",
          "0409-7870",
          "0409-0201",
          "0409-0016",
          "0409-2026"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOCETAXEL",
          "DOCETAXEL ANHYDROUS"
        ],
        "rxcui": [
          "1001405",
          "1860480",
          "1093280",
          "1860619"
        ],
        "spl_id": [
          "0eff97af-e2cd-46d7-84d3-0445a0910b1a",
          "297f1202-b539-41ee-bf52-4b9b04dd3a60",
          "5b12d54f-e7fd-4369-afb3-431f6f08ec76",
          "09b23b47-fb31-434b-9ad5-9bae9303933b",
          "8156a5f8-7002-479d-a08d-3c68f92c1396"
        ],
        "spl_set_id": [
          "6b9999bb-869e-4d25-838c-23c3ab280044",
          "3104aab1-cd6e-4ad2-8e0a-286a0c5d1940",
          "644c5035-20d2-4686-beaa-bef08e99051c",
          "a0ec4bcc-93ea-4c41-a4b6-95ec19491807",
          "00c61d11-d6b7-4618-b6f6-2592dbcc8af7"
        ],
        "package_ndc": [
          "0409-4235-01",
          "0409-5068-01",
          "0409-0365-01",
          "0409-0366-01",
          "0409-0367-01",
          "0409-0368-01",
          "0409-7870-01",
          "0409-1732-01",
          "0409-0201-02",
          "0409-0201-10",
          "0409-0201-20",
          "0409-2026-01",
          "0409-0016-01"
        ],
        "unii": [
          "15H5577CQD",
          "699121PHCA"
        ],
        "nui": [
          "N0000175085",
          "N0000175592"
        ],
        "pharm_class_pe": [
          "Microtubule Inhibition [PE]"
        ],
        "pharm_class_epc": [
          "Microtubule Inhibitor [EPC]"
        ]
      },
      "products": [
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "120MG/6ML (20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "20MG/ML (20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "80MG/8ML (10MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "160MG/8ML (20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "80MG/4ML (20MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "160MG/16ML (10MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DOCETAXEL",
          "active_ingredients": [
            {
              "name": "DOCETAXEL",
              "strength": "20MG/2ML (10MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}