{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20000418",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "4413",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf",
              "date": "20000418",
              "type": "Letter"
            },
            {
              "id": "14462",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf",
              "date": "20000418",
              "type": "Label"
            },
            {
              "id": "21465",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.html",
              "date": "20000418",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20070802",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20040105",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26855",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf",
              "date": "20040114",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20130503",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14465",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf",
              "date": "20130509",
              "type": "Label"
            },
            {
              "id": "26860",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf",
              "date": "20130507",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20080620",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4419",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf",
              "date": "20080624",
              "type": "Letter"
            },
            {
              "id": "36179",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf",
              "date": "20080626",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20030722",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "4415",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf",
              "date": "20030728",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20051102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4417",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf",
              "date": "20051108",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20021219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26854",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf",
              "date": "20040701",
              "type": "Letter"
            },
            {
              "id": "36175",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf",
              "date": "20030407",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "48",
          "submission_status": "AP",
          "submission_status_date": "20260609",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "86206",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021130Orig1s050, 021131Orig1s048, 021132Orig1s050ltr.pdf",
              "date": "20260611",
              "type": "Letter"
            },
            {
              "id": "86298",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021131s048lbl.pdf",
              "date": "20260622",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20210901",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68516",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021130Orig1s042; 021131Orig1s038; 021132Orig1s041ltr.pdf",
              "date": "20210902",
              "type": "Letter"
            },
            {
              "id": "68591",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s042,021131s038,021132s041lbl.pdf",
              "date": "20210913",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "20240627",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78928",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021130s046,021131s044,021132s046lbl.pdf",
              "date": "20240628",
              "type": "Label"
            },
            {
              "id": "78934",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021130Orig1s046;021131Orig1s044;021132Orig1s046ltr.pdf",
              "date": "20240628",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20170713",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48992",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021130Origs034,021131Orig1s028,021132Orig1s033ltr.pdf",
              "date": "20170714",
              "type": "Letter"
            },
            {
              "id": "48995",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf",
              "date": "20170714",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20200805",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64216",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf",
              "date": "20200806",
              "type": "Label"
            },
            {
              "id": "64223",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021130Orig1s039, s040; 021131Orig1s034, s035; 021132Orig1s038, s039ltr.pdf",
              "date": "20200806",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20140124",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4423",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf",
              "date": "20140128",
              "type": "Letter"
            },
            {
              "id": "14467",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf",
              "date": "20140127",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20211110",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69292",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021131s040lbl.pdf",
              "date": "20211112",
              "type": "Label"
            },
            {
              "id": "69296",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021131Orig1s040ltr.pdf",
              "date": "20211112",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20050512",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14464",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf",
              "date": "20050517",
              "type": "Label"
            },
            {
              "id": "26857",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf",
              "date": "20050517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20120213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26861",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf",
              "date": "20120215",
              "type": "Letter"
            },
            {
              "id": "36182",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021131s024lbl.pdf",
              "date": "20120214",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20070918",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20180201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52265",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf",
              "date": "20180202",
              "type": "Label"
            },
            {
              "id": "52296",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021130Orig1s037,021131Orig1s030,021132Orig1s035ltr.pdf",
              "date": "20180202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20040623",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "4416",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf",
              "date": "20040625",
              "type": "Letter"
            },
            {
              "id": "14463",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf",
              "date": "20040625",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20130503",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14466",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf",
              "date": "20130509",
              "type": "Label"
            },
            {
              "id": "4422",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf",
              "date": "20130507",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20080620",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4420",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf",
              "date": "20080624",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20100716",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36181",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021131s020lbl.pdf",
              "date": "20100716",
              "type": "Label"
            },
            {
              "id": "4421",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf",
              "date": "20100723",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20070426",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4418",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf",
              "date": "20070501",
              "type": "Letter"
            },
            {
              "id": "21466",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021131Orig1s012.pdf",
              "date": "20140707",
              "type": "Review"
            },
            {
              "id": "36178",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf",
              "date": "20070501",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20021219",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41971",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.html",
              "date": "20050711",
              "type": "Review"
            },
            {
              "id": "4414",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf",
              "date": "20040701",
              "type": "Letter"
            },
            {
              "id": "36176",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf",
              "date": "20030407",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20010206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20050512",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "26858",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf",
              "date": "20050517",
              "type": "Letter"
            },
            {
              "id": "36177",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf",
              "date": "20050517",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20211026",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69129",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021130Orig1s043; 021131Orig1s039; 021132Orig1s042ltr.pdf",
              "date": "20211027",
              "type": "Letter"
            },
            {
              "id": "69144",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s043,021131s039,021132s042lbl.pdf",
              "date": "20211027",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20210716",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68120",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021130Orig1s041; 021131Orig1s037; 021132Orig1s040ltr.pdf",
              "date": "20210719",
              "type": "Letter"
            },
            {
              "id": "68133",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s041,021131s037,021132s040lbl.pdf",
              "date": "20210720",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20150605",
          "submission_public_notes": "Please see <a href=\"https://www.fda.gov/STIC/\">www.fda.gov/STIC</a> for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4424",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf",
              "date": "20150610",
              "type": "Letter"
            },
            {
              "id": "36183",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf",
              "date": "20150610",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20200805",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64215",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf",
              "date": "20200806",
              "type": "Label"
            },
            {
              "id": "64224",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021130Orig1s039, s040; 021131Orig1s034, s035; 021132Orig1s038, s039ltr.pdf",
              "date": "20200806",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20140728",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20230718",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74796",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021130Orig1s044;021131Orig1s041;021132Orig1s043ltr.pdf",
              "date": "20230719",
              "type": "Letter"
            },
            {
              "id": "74806",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021130s044,021131s041,021132s043lbl.pdf",
              "date": "20230720",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20091208",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36180",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf",
              "date": "20091211",
              "type": "Label"
            },
            {
              "id": "26859",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf",
              "date": "20100126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20050210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26856",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf",
              "date": "20050211",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021131",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA021131"
        ],
        "brand_name": [
          "ZYVOX"
        ],
        "generic_name": [
          "LINEZOLID"
        ],
        "manufacturer_name": [
          "Hp Halden Pharma AS",
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "66298-7807",
          "0009-5140",
          "0009-5137",
          "0009-5136",
          "0009-5138",
          "66298-5137",
          "66298-5140",
          "0009-7807"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LINEZOLID"
        ],
        "rxcui": [
          "1662285",
          "1662286",
          "262091",
          "311345",
          "311347",
          "581614",
          "1662278",
          "1662280"
        ],
        "spl_id": [
          "19877e50-8bfb-427d-e063-6294a90a150f",
          "59c9a143-a1fa-4eeb-8fb1-dfe22de98d43",
          "1988348c-3b04-2b38-e063-6394a90ada27",
          "19883774-59a8-7251-e063-6294a90a3f5e",
          "2f3e1cfd-948d-4e75-95c1-11c7cd4be3ef"
        ],
        "spl_set_id": [
          "b0c75e79-bf29-4f1d-a45d-ae28398a52d9",
          "6e70e63b-bfd5-478d-a8ee-8ba22c9efabd",
          "ce57225b-4580-442b-8c48-8045297cbb50",
          "efe6818c-b798-4d1d-8196-6447a305ad71",
          "3e5e9975-6f36-42e4-ab46-0e75dda83592"
        ],
        "package_ndc": [
          "66298-7807-1",
          "0009-5137-01",
          "0009-5137-04",
          "0009-5140-01",
          "0009-5140-04",
          "0009-5136-01",
          "0009-5136-04",
          "0009-5138-02",
          "0009-5138-03",
          "66298-5137-1",
          "66298-5140-1",
          "0009-7807-01",
          "0009-7807-02"
        ],
        "nui": [
          "N0000175495",
          "M0361132"
        ],
        "pharm_class_epc": [
          "Oxazolidinone Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Oxazolidinones [CS]"
        ],
        "unii": [
          "ISQ9I6J12J"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "ZYVOX",
          "active_ingredients": [
            {
              "name": "LINEZOLID",
              "strength": "600MG/300ML (2MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZYVOX",
          "active_ingredients": [
            {
              "name": "LINEZOLID",
              "strength": "200MG/100ML (2MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ZYVOX",
          "active_ingredients": [
            {
              "name": "LINEZOLID",
              "strength": "400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}