{
  "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": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "66",
          "submission_status": "AP",
          "submission_status_date": "20130814",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1306",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s066ltr.pdf",
              "date": "20130816",
              "type": "Letter"
            },
            {
              "id": "11494",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf",
              "date": "20130815",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "20110908",
          "review_priority": "N/A",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1303",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s058ltr.pdf",
              "date": "20110913",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "56",
          "submission_status": "AP",
          "submission_status_date": "20110225",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17373",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s056ltr.pdf",
              "date": "20110303",
              "type": "Letter"
            },
            {
              "id": "33732",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf",
              "date": "20110304",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "48",
          "submission_status": "AP",
          "submission_status_date": "20070314",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1300",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019384s048lbl.pdf",
              "date": "20070315",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "20120209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf",
              "date": "20120210",
              "type": "Label"
            },
            {
              "id": "1304",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s062ltr.pdf",
              "date": "20120213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "54",
          "submission_status": "AP",
          "submission_status_date": "20090427",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf",
              "date": "20090511",
              "type": "Label"
            },
            {
              "id": "17372",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s054ltr.pdf",
              "date": "20090504",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "46",
          "submission_status": "AP",
          "submission_status_date": "20060922",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11486",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf",
              "date": "20060925",
              "type": "Label"
            },
            {
              "id": "17369",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s046LTR.pdf",
              "date": "20060927",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "60",
          "submission_status": "AP",
          "submission_status_date": "20111018",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf",
              "date": "20111104",
              "type": "Label"
            },
            {
              "id": "17375",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s060ltr.pdf",
              "date": "20111020",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20010416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17366",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf",
              "date": "20010423",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "52",
          "submission_status": "AP",
          "submission_status_date": "20081003",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11487",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf",
              "date": "20081009",
              "type": "Label"
            },
            {
              "id": "1301",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s052ltr.pdf",
              "date": "20081007",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "19970620",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40901",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S036_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "20080923",
          "review_priority": "PRIORITY",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "33731",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf",
              "date": "20081003",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "19951226",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "42",
          "submission_status": "AP",
          "submission_status_date": "20040723",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1298",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf",
              "date": "20040728",
              "type": "Letter"
            },
            {
              "id": "11484",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf",
              "date": "20040728",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "19960718",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "40900",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S034_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "19980209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20040723",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11483",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf",
              "date": "20040728",
              "type": "Label"
            },
            {
              "id": "1297",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf",
              "date": "20040728",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19880628",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "19920306",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "19960618",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20228",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S032_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "19940701",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20226",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S024_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19880128",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "19920417",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "19960718",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20227",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S030_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "67",
          "submission_status": "AP",
          "submission_status_date": "20160726",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1307",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019384Orig1s067ltr.pdf",
              "date": "20160726",
              "type": "Letter"
            },
            {
              "id": "11495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf",
              "date": "20160726",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19870318",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "19941024",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "59",
          "submission_status": "AP",
          "submission_status_date": "20110527",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17374",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s059ltr.pdf",
              "date": "20110531",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "65",
          "submission_status": "AP",
          "submission_status_date": "20130327",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1305",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s065ltr.pdf",
              "date": "20130329",
              "type": "Letter"
            },
            {
              "id": "11493",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf",
              "date": "20130401",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "49",
          "submission_status": "AP",
          "submission_status_date": "20080923",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17370",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s049ltr.pdf",
              "date": "20080926",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "63",
          "submission_status": "AP",
          "submission_status_date": "20120615",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11492",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf",
              "date": "20120618",
              "type": "Label"
            },
            {
              "id": "17377",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s063ltr.pdf",
              "date": "20120618",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "20110610",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1302",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf",
              "date": "20110617",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "20070320",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "61",
          "submission_status": "AP",
          "submission_status_date": "20110916",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11490",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf",
              "date": "20110920",
              "type": "Label"
            },
            {
              "id": "17376",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s061ltr.pdf",
              "date": "20110921",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20010416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17367",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf",
              "date": "20010423",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "20090212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17371",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s053ltr.pdf",
              "date": "20090213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "45",
          "submission_status": "AP",
          "submission_status_date": "20060516",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11485",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf",
              "date": "20060518",
              "type": "Label"
            },
            {
              "id": "17368",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s045LTR.pdf",
              "date": "20060521",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20010416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1296",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf",
              "date": "20010423",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "19960912",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40898",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S029_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20040723",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1299",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf",
              "date": "20040728",
              "type": "Letter"
            },
            {
              "id": "33730",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf",
              "date": "20040728",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "19961206",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20229",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S035_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "19951129",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S027_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19861031",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "57445",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384Orig1s000rev.pdf",
              "date": "19901119",
              "type": "Review"
            },
            {
              "id": "23133",
              "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf",
              "date": "20130816",
              "type": "Medication Guide"
            },
            {
              "id": "23961",
              "title": "Medication Guide",
              "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf",
              "date": "20110315",
              "type": "Other"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "19920506",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "19970115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40899",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S031_NOROXIN.pdf",
              "date": "20080404",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19880128",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "19911126",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "19930629",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19880128",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "NDA019384",
      "sponsor_name": "MERCK",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NOROXIN",
          "active_ingredients": [
            {
              "name": "NORFLOXACIN",
              "strength": "400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}