药品注册申请号:211783
申请类型:ANDA (仿制药申请)
申请人:CHEMO RESEARCH SL
申请人全名:CHEMO RESEARCH SL
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 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) No No AB 2022/08/10 2022/08/10 Prescription
002 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) No No AB 2022/08/10 Prescription
003 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) No No AB 2022/08/10 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
2022/08/10 ORIG-1(原始申请) Approval STANDARD
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:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (0.25GM/PACKET) 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
022038 001 NDA DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Prescription Yes Yes AB 2007/06/04 VERTICAL PHARMS
211783 001 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Prescription No No AB 2022/08/10 CHEMO RESEARCH SL
217610 001 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Prescription No No AB 2023/08/24 NOVITIUM PHARMA
216524 001 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Prescription No No AB 2023/11/14 PADAGIS ISRAEL
217863 001 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Prescription No No AB 2024/07/12 QUAGEN
216055 001 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Prescription No No AB 2024/07/12 AMNEAL
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (0.5GM/PACKET) 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
022038 002 NDA DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Prescription Yes Yes AB 2007/06/04 VERTICAL PHARMS
211783 002 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Prescription No No AB 2022/08/10 CHEMO RESEARCH SL
217610 002 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Prescription No No AB 2023/08/24 NOVITIUM PHARMA
216524 002 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Prescription No No AB 2023/11/14 PADAGIS ISRAEL
217863 002 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Prescription No No AB 2024/07/12 QUAGEN
216055 002 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Prescription No No AB 2024/07/12 AMNEAL
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (1GM/PACKET) 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
022038 003 NDA DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Prescription Yes Yes AB 2007/06/04 VERTICAL PHARMS
211783 003 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Prescription No No AB 2022/08/10 CHEMO RESEARCH SL
217610 004 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Prescription No No AB 2023/08/24 NOVITIUM PHARMA
216524 004 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Prescription No No AB 2023/11/14 PADAGIS ISRAEL
217863 004 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Prescription No No AB 2024/07/12 QUAGEN
216055 004 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Prescription No No AB 2024/07/12 AMNEAL
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