{ "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": "67", "submission_status": "AP", "submission_status_date": "20191107", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60816", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019950Orig1s066, s067ltr.pdf", "date": "20191112", "type": "Letter" }, { "id": "62435", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019950s066,s067lbl.pdf", "date": "20200403", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19950320", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "59", "submission_status": "AP", "submission_status_date": "20111116", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "34128", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf", "date": "20111121", "type": "Label" }, { "id": "1840", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf", "date": "20111121", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "73", "submission_status": "AP", "submission_status_date": "20230712", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "74750", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019949Orig1s074;019950Orig1s073;020090Orig1s055ltr.pdf", "date": "20230713", "type": "Letter" }, { "id": "74759", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019950s073lbl.pdf", "date": "20230714", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19940708", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20150601", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20110426", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12092", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf", "date": "20110429", "type": "Label" }, { "id": "1839", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf", "date": "20110429", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "20240212", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "77480", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019949Orig1s072; 019950Orig1s071; 020090Orig1s053ltr.pdf", "date": "20240213", "type": "Letter" }, { "id": "77484", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019950s071,020090s053lbl.pdf", "date": "20240213", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19931013", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "20140728", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "20130913", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19880", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf", "date": "20130917", "type": "Letter" }, { "id": "34129", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf", "date": "20130917", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20040324", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12089", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf", "date": "20040405", "type": "Label" }, { "id": "19876", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf", "date": "20040328", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "53", "submission_status": "AP", "submission_status_date": "20100805", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12090", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf", "date": "20100810", "type": "Label" }, { "id": "19878", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf", "date": "20100810", "type": "Letter" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19900129", "review_priority": "STANDARD", "submission_class_code": "TYPE 3", "submission_class_code_description": "Type 3 - New Dosage Form" }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "20041007", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12088", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf", "date": "20041008", "type": "Label" }, { "id": "1838", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf", "date": "20041008", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "19990929", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20080331", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19877", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf", "date": "20080404", "type": "Letter" }, { "id": "34127", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf", "date": "20080416", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19930614", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "19980213", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19950309", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20041007", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19875", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf", "date": "20041008", "type": "Letter" }, { "id": "34126", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf", "date": "20041008", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "19970219", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19940822", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20041007", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19874", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf", "date": "20041008", "type": "Letter" }, { "id": "34125", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf", "date": "20041008", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19931230", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19920929", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20200908", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "64533", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019949Orig1s069,019950Orig1s068,020090Orig1s050ltr.pdf", "date": "20200909", "type": "Letter" }, { "id": "64538", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019949s069,019950s068lbl.pdf", "date": "20200910", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "19951222", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "66", "submission_status": "AP", "submission_status_date": "20191107", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60815", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019950Orig1s066, s067ltr.pdf", "date": "20191112", "type": "Letter" }, { "id": "62436", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019950s066,s067lbl.pdf", "date": "20200403", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "20230117", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "73242", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019949Orig1s073;019950Orig1s072;020090Orig1s054ltr.pdf", "date": "20230118", "type": "Letter" }, { "id": "73244", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019950s072lbl.pdf", "date": "20230118", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19930622", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20110606", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12091", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf", "date": "20110606", "type": "Label" }, { "id": "19879", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf", "date": "20110608", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "20220309", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "70476", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019949Orig1s071, 019950Orig1s070, 020090Orig1s052ltr.pdf", "date": "20220310", "type": "Letter" }, { "id": "70512", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019949Orig1s071,019950Orig1s070,020090Orig1s052lbl.pdf", "date": "20220315", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20140324", "submission_public_notes": "Please see www.fda.gov/STIC 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": "1841", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf", "date": "20140325", "type": "Letter" }, { "id": "34130", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf", "date": "20140325", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19930210", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "19990222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20020807", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19931013", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "19970805", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19940630", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20010305", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "19960806", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19941123", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19931013", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "19990929", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "20211025", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "69119", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019949s070,019950s069,020090s051lbledt.pdf", "date": "20211026", "type": "Label" }, { "id": "69138", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019949Orig1s070; 019950Orig1s069; 020090Orig1s051ltr.pdf", "date": "20211027", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19960723", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" } ], "application_number": "NDA019950", "sponsor_name": "PFIZER", "products": [ { "product_number": "005", "reference_drug": "Yes", "brand_name": "DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER", "active_ingredients": [ { "name": "FLUCONAZOLE", "strength": "400MG/200ML (2MG/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER", "active_ingredients": [ { "name": "FLUCONAZOLE", "strength": "200MG/100ML (2MG/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "DIFLUCAN IN SODIUM CHLORIDE 0.9%", "active_ingredients": [ { "name": "FLUCONAZOLE", "strength": "200MG/100ML (2MG/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "006", "reference_drug": "Yes", "brand_name": "DIFLUCAN IN SODIUM CHLORIDE 0.9%", "active_ingredients": [ { "name": "FLUCONAZOLE", "strength": "400MG/200ML (2MG/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "004", "reference_drug": "Yes", "brand_name": "DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER", "active_ingredients": [ { "name": "FLUCONAZOLE", "strength": "400MG/200ML (2MG/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER", "active_ingredients": [ { "name": "FLUCONAZOLE", "strength": "200MG/100ML (2MG/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" } ] } ] }