药品注册申请号：076077
申请类型：ANDA (仿制药申请)
申请人：IVAX SUB TEVA PHARMS
申请人全名：IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG No No AB 2004/07/29 2004/07/29 Discontinued
002 FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG No No AB 2004/07/29 Discontinued
003 FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG No No AB 2004/07/29 Discontinued
004 FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG No No AB 2004/07/29 Discontinued
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/10/24 SUPPL-21（补充） Approval Labeling STANDARD
2023/10/24 SUPPL-20（补充） Approval Labeling STANDARD
2023/10/24 SUPPL-19（补充） Approval Labeling STANDARD
2021/10/06 SUPPL-18（补充） Approval Labeling STANDARD
2019/07/16 SUPPL-16（补充） Approval Labeling STANDARD
2019/07/16 SUPPL-15（补充） Approval Labeling STANDARD
2019/07/16 SUPPL-14（补充） Approval Labeling STANDARD
2019/07/16 SUPPL-13（补充） Approval Labeling STANDARD
2015/03/18 SUPPL-11（补充） Approval Labeling STANDARD
2015/03/18 SUPPL-10（补充） Approval Labeling STANDARD
2012/01/23 SUPPL-6（补充） Approval Labeling
2012/01/23 SUPPL-5（补充） Approval Labeling
2010/12/27 SUPPL-4（补充） Approval Labeling
2008/06/27 SUPPL-2（补充） Approval Labeling
2004/07/29 ORIG-1（原始申请） Approval
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019949 001 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 50MG Prescription Yes No AB 1990/01/29 PFIZER
076077 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Discontinued No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 TARO
076658 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 CHARTWELL
076957 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2005/09/28 THINQ PHARM-CRO PVT
077253 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2006/01/25 GLENMARK PHARMS LTD
077731 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2011/03/07 ANI PHARMS
208963 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
209146 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Discontinued No No AB 2023/10/20 LUPIN LTD
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:100MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019949 002 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 100MG Prescription Yes No AB 1990/01/29 PFIZER
076077 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Discontinued No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 TARO
076658 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 CHARTWELL
076957 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2005/09/28 THINQ PHARM-CRO PVT
077253 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2006/01/25 GLENMARK PHARMS LTD
077731 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2011/03/07 ANI PHARMS
208963 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
209146 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Discontinued No No AB 2023/10/20 LUPIN LTD
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:150MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019949 004 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 150MG Prescription Yes No AB 1994/06/30 PFIZER
076077 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Discontinued No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 TARO
076658 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 CHARTWELL
077253 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2006/01/25 GLENMARK PHARMS LTD
077731 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2011/03/07 ANI PHARMS
208963 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
076957 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2017/02/27 THINQ PHARM-CRO PVT
209146 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Discontinued No No AB 2023/10/20 LUPIN LTD
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:200MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019949 003 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 200MG Prescription Yes Yes AB 1990/01/29 PFIZER
076077 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Discontinued No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 TARO
076658 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 CHARTWELL
076957 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2005/09/28 THINQ PHARM-CRO PVT
077253 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2006/01/25 GLENMARK PHARMS LTD
077731 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2011/03/07 ANI PHARMS
208963 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
209146 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Discontinued No No AB 2023/10/20 LUPIN LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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