药品注册申请号:079150
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA
申请人全名:AUROBINDO PHARMA LTD
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 FOR SUSPENSION;ORAL 50MG/5ML No No AB 2009/09/18 2009/09/18 Prescription
002 FLUCONAZOLE FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML No No AB 2009/09/18 Prescription
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
2024/07/16 SUPPL-26(补充) Approval Labeling STANDARD
2023/12/27 SUPPL-23(补充) Approval Labeling STANDARD
2023/03/17 SUPPL-21(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-19(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-18(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-16(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-13(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-12(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-11(补充) Approval Labeling STANDARD
2023/01/19 SUPPL-10(补充) Approval Labeling STANDARD
2015/02/27 SUPPL-8(补充) Approval Labeling STANDARD
2015/02/27 SUPPL-7(补充) Approval Labeling STANDARD
2015/02/27 SUPPL-6(补充) Approval Labeling STANDARD
2012/01/23 SUPPL-4(补充) Approval Labeling
2012/01/23 SUPPL-3(补充) Approval Labeling
2010/12/27 SUPPL-2(补充) Approval Labeling
2009/09/18 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
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
与本品治疗等效的药品
活性成分:FLUCONAZOLE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:50MG/5ML 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
020090 001 NDA DIFLUCAN FLUCONAZOLE FOR SUSPENSION;ORAL 50MG/5ML Prescription Yes No AB 1993/12/23 PFIZER
079150 001 ANDA FLUCONAZOLE FLUCONAZOLE FOR SUSPENSION;ORAL 50MG/5ML Prescription No No AB 2009/09/18 AUROBINDO PHARMA
活性成分:FLUCONAZOLE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:200MG/5ML 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
020090 002 NDA DIFLUCAN FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML Prescription Yes Yes AB 1993/12/23 PFIZER
079150 002 ANDA FLUCONAZOLE FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2009/09/18 AUROBINDO PHARMA
215738 001 ANDA FLUCONAZOLE FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2023/09/21 HAINAN POLY
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