药品注册申请号：022038
申请类型：NDA (新药申请)
申请人：VERTICAL PHARMS
申请人全名：VERTICAL PHARMACEUTICALS LLC
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 DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) Yes Yes AB 2007/06/04 2007/06/04 Prescription
002 DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) Yes Yes AB 2007/06/04 Prescription
003 DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) Yes Yes AB 2007/06/04 Prescription
004 DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/PACKET) Yes Yes AB 2018/08/17 Prescription
005 DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) Yes Yes AB 2019/12/12 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
2024/02/15 SUPPL-12（补充） Approval Labeling STANDARD
2023/05/23 SUPPL-10（补充） Approval Labeling STANDARD
2019/12/12 SUPPL-6（补充） Approval Efficacy STANDARD
2019/12/12 SUPPL-5（补充） Approval Labeling STANDARD
2018/08/17 SUPPL-4（补充） Approval Efficacy STANDARD
2017/11/01 SUPPL-3（补充） Approval Labeling STANDARD
2012/05/29 SUPPL-2（补充） Approval Labeling STANDARD
2007/06/04 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
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
003 NP 2010/06/04**本条是由Drugfuture回溯的历史信息**
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
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (0.75GM/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 004 NDA DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/PACKET) Prescription Yes Yes AB 2018/08/17 VERTICAL PHARMS
217610 003 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/PACKET) Prescription No No AB 2023/08/24 NOVITIUM PHARMA
216524 003 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/PACKET) Prescription No No AB 2023/11/14 PADAGIS ISRAEL
217863 003 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/PACKET) Prescription No No AB 2024/07/12 QUAGEN
216055 003 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/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% (1.25GM/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 005 NDA DIVIGEL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) Prescription Yes Yes AB 2019/12/12 VERTICAL PHARMS
217610 005 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) Prescription No No AB 2023/08/24 NOVITIUM PHARMA
216524 005 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) Prescription No No AB 2023/11/14 PADAGIS ISRAEL
217863 005 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) Prescription No No AB 2024/07/12 QUAGEN
216055 005 ANDA ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) Prescription No No AB 2024/07/12 AMNEAL
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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