{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20101215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20040421",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4828",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf",
              "date": "20040429",
              "type": "Letter"
            },
            {
              "id": "14785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf",
              "date": "20040504",
              "type": "Label"
            },
            {
              "id": "21557",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.html",
              "date": "20070110",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "59",
          "submission_status": "AP",
          "submission_status_date": "20260128",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84869",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021266s059,021267s069,021630s049lbl.pdf",
              "date": "20260129",
              "type": "Label"
            },
            {
              "id": "84875",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021266Orig1s059,021267Orig1s069,021630Orig1s049ltr.pdf",
              "date": "20260129",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20050707",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4830",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf",
              "date": "20050715",
              "type": "Letter"
            },
            {
              "id": "14789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf",
              "date": "20050708",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "20250312",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81558",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021266Orig1s057; 021267Orig1s067; 021630Orig1s047ltr.pdf",
              "date": "20250314",
              "type": "Letter"
            },
            {
              "id": "81575",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021266s057,021267s067,021630s047lbl.pdf",
              "date": "20250317",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20050324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4829",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf",
              "date": "20050329",
              "type": "Letter"
            },
            {
              "id": "14788",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf",
              "date": "20050329",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "49",
          "submission_status": "AP",
          "submission_status_date": "20210125",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65978",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s049,021267s059,021630s038lbl.pdf",
              "date": "20210126",
              "type": "Label"
            },
            {
              "id": "65993",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s049,021267Orig1s059,021630Orig1s038ltr.pdf",
              "date": "20210126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "20210114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65927",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s047, 021267Orig1s057, 021630Orig1s036ltr.pdf",
              "date": "20210119",
              "type": "Letter"
            },
            {
              "id": "65982",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s047,021267s057,021630s036lbl.pdf",
              "date": "20210126",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20190129",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "57380",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021266s039,021267s050,021630s029lbl.pdf",
              "date": "20190130",
              "type": "Label"
            },
            {
              "id": "57557",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021266Orig1s039, 021267Orig1s050, 021630Oirg1s029ltr.pdf",
              "date": "20190213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "20221018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72408",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021266Orig1s053,021267Orig1s063,021630Orig1s042ltr.pdf",
              "date": "20221019",
              "type": "Letter"
            },
            {
              "id": "72431",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s053,021267s063,021630s042lbl.pdf",
              "date": "20221021",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "45",
          "submission_status": "AP",
          "submission_status_date": "20190430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58497",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021630s034,021266s045,021267s055lbl.pdf",
              "date": "20190501",
              "type": "Label"
            },
            {
              "id": "58517",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021266Orig1s045;021267Orig1s055;021630Orig1s034ltr.pdf",
              "date": "20190502",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20140407",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14797",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf",
              "date": "20140408",
              "type": "Label"
            },
            {
              "id": "27277",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf",
              "date": "20140408",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "51",
          "submission_status": "AP",
          "submission_status_date": "20211013",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68983",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s051, 021267Orig1s061, 021630Orig1s040ltr.pdf",
              "date": "20211014",
              "type": "Letter"
            },
            {
              "id": "68995",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s051,021267s061,021630s040lbl.pdf",
              "date": "20211014",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20100617",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27274",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf",
              "date": "20100624",
              "type": "Letter"
            },
            {
              "id": "36511",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf",
              "date": "20100624",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20170728",
          "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": "49157",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s043,021267s054,021630s032lbl.pdf",
              "date": "20170731",
              "type": "Label"
            },
            {
              "id": "49187",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s043,021267Orig1s054,021630Orig1s032ltr.pdf",
              "date": "20170802",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20111116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27276",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf",
              "date": "20111121",
              "type": "Letter"
            },
            {
              "id": "36514",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf",
              "date": "20111121",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20100617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36510",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf",
              "date": "20100624",
              "type": "Label"
            },
            {
              "id": "27273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf",
              "date": "20100624",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20170615",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48742",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s041,021267Orig1s053,021630Orig1s031ltr.pdf",
              "date": "20170616",
              "type": "Letter"
            },
            {
              "id": "48762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf",
              "date": "20170619",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20061201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4833",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf",
              "date": "20061228",
              "type": "Letter"
            },
            {
              "id": "14793",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf",
              "date": "20061204",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20110601",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4838",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf",
              "date": "20110602",
              "type": "Letter"
            },
            {
              "id": "36513",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf",
              "date": "20110616",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20100617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4835",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf",
              "date": "20100624",
              "type": "Letter"
            },
            {
              "id": "14794",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf",
              "date": "20100624",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20101215",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4836",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf",
              "date": "20101221",
              "type": "Letter"
            },
            {
              "id": "14796",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf",
              "date": "20101226",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20080310",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4834",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf",
              "date": "20080313",
              "type": "Letter"
            },
            {
              "id": "36509",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf",
              "date": "20080313",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20020524",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "14784",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf",
              "date": "20100428",
              "type": "Label"
            },
            {
              "id": "21556",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_21-267_Vfend.html",
              "date": "20100428",
              "type": "Review"
            },
            {
              "id": "27265",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21266ltr.pdf",
              "date": "20100428",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20060310",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14791",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf",
              "date": "20060322",
              "type": "Label"
            },
            {
              "id": "27270",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf",
              "date": "20060322",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20040421",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "42063",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.html",
              "date": "20070110",
              "type": "Review"
            },
            {
              "id": "14786",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf",
              "date": "20040504",
              "type": "Label"
            },
            {
              "id": "27267",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf",
              "date": "20040429",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20051218",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4831",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf",
              "date": "20060119",
              "type": "Letter"
            },
            {
              "id": "14790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf",
              "date": "20060105",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20030328",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36506",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf",
              "date": "20030328",
              "type": "Label"
            },
            {
              "id": "27266",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21267slr003,21266slr002ltr.pdf",
              "date": "20030414",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "48",
          "submission_status": "AP",
          "submission_status_date": "20200904",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64521",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021266s048,021267s058,021630s037lbl.pdf",
              "date": "20200908",
              "type": "Label"
            },
            {
              "id": "64526",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021266Orig1s048, 021267Orig1s058, 021630Orig1s037ltr.pdf",
              "date": "20200908",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "54",
          "submission_status": "AP",
          "submission_status_date": "20220816",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71818",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021266Orig1s054, 021267Orig1s064, 021630Orig1s043ltr.pdf",
              "date": "20220817",
              "type": "Letter"
            },
            {
              "id": "71830",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s054,021267s064,021630s043lbl.pdf",
              "date": "20220817",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "60",
          "submission_status": "AP",
          "submission_status_date": "20260219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85104",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021266Orig1s060, 021267Orig1s070, 021630Orig1s050ltr.pdf",
              "date": "20260223",
              "type": "Letter"
            },
            {
              "id": "85125",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021266s060lbl.pdf",
              "date": "20260224",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20150203",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4839",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf",
              "date": "20150205",
              "type": "Letter"
            },
            {
              "id": "14798",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf",
              "date": "20150205",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "52",
          "submission_status": "AP",
          "submission_status_date": "20220128",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70012",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021266Orig1s052; 021267Orig1s062; 021630Orig1s041ltr.pdf",
              "date": "20220131",
              "type": "Letter"
            },
            {
              "id": "70030",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s052,021267s062,021630s041lbl.pdf",
              "date": "20220201",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20130301",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "20210415",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67091",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s050,021267s060,021630s039lbl.pdf",
              "date": "20210419",
              "type": "Label"
            },
            {
              "id": "67094",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s050; 021267Orig1s060; 021630Orig1s039ltr.pdf",
              "date": "20210419",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20101215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20080530",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27272",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf",
              "date": "20080603",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20060519",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4832",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf",
              "date": "20060522",
              "type": "Letter"
            },
            {
              "id": "36508",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf",
              "date": "20060522",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20101121",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4837",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf",
              "date": "20101130",
              "type": "Letter"
            },
            {
              "id": "36512",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s032lbl.pdf",
              "date": "20101121",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20041221",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "21558",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266Orig1s009.pdf",
              "date": "20121109",
              "type": "Review"
            },
            {
              "id": "27269",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf",
              "date": "20041229",
              "type": "Letter"
            },
            {
              "id": "36507",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf",
              "date": "20041229",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20080205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf",
              "date": "20080214",
              "type": "Label"
            },
            {
              "id": "27271",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s016ltr.pdf",
              "date": "20080207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20100617",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf",
              "date": "20100624",
              "type": "Label"
            },
            {
              "id": "27275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf",
              "date": "20100624",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20040204",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14787",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf",
              "date": "20040303",
              "type": "Label"
            },
            {
              "id": "27268",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr007,21267slr007ltr.pdf",
              "date": "20040227",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021266",
      "sponsor_name": "PF PRISM CV",
      "openfda": {
        "application_number": [
          "NDA021266"
        ],
        "brand_name": [
          "VFEND"
        ],
        "generic_name": [
          "VORICONAZOLE"
        ],
        "manufacturer_name": [
          "Roerig"
        ],
        "product_ndc": [
          "0049-3170",
          "0049-3180",
          "0049-3190",
          "0049-3160"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VORICONAZOLE"
        ],
        "rxcui": [
          "349434",
          "349435",
          "351209",
          "352218",
          "352219",
          "352220",
          "465355",
          "546624"
        ],
        "spl_id": [
          "cf9f1b2e-eeb4-48bb-9f1a-c2b8d94dfbea"
        ],
        "spl_set_id": [
          "ce3ef5cf-3087-4d92-9d94-9eb8287228db"
        ],
        "package_ndc": [
          "0049-3170-30",
          "0049-3180-30",
          "0049-3190-28",
          "0049-3160-44"
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182141",
          "N0000182140",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "unii": [
          "JFU09I87TR"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "VFEND",
          "active_ingredients": [
            {
              "name": "VORICONAZOLE",
              "strength": "200MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VFEND",
          "active_ingredients": [
            {
              "name": "VORICONAZOLE",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}