药品注册申请号：020375
申请类型：NDA (新药申请)
申请人：BAYER HLTHCARE
申请人全名：BAYER HEALTHCARE PHARMACEUTICALS INC
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 CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.05MG/24HR Yes No AB2 1994/12/22 1994/12/22 Prescription
002 CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.1MG/24HR Yes Yes AB2 1994/12/22 Prescription
003 CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.075MG/24HR Yes No AB2 1998/03/23 Prescription
004 CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.025MG/24HR Yes No AB2 1999/03/05 Prescription
005 CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.0375MG/24HR Yes No AB2 2003/05/27 Prescription
006 CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.06MG/24HR Yes No AB 2003/05/27 Prescription
007 MENOSTAR ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.014MG/24HR TBD No None -- 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-50（补充） Approval Labeling STANDARD
2024/02/15 SUPPL-49（补充） Approval Labeling STANDARD
2021/09/30 SUPPL-37（补充） Approval Labeling STANDARD
2021/09/30 SUPPL-36（补充） Approval Labeling STANDARD
2021/09/16 SUPPL-46（补充） Approval Labeling STANDARD
2021/09/16 SUPPL-45（补充） Approval Labeling STANDARD
2017/11/01 SUPPL-35（补充） Approval Labeling STANDARD
2017/11/01 SUPPL-34（补充） Approval Labeling STANDARD
2015/08/06 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2013/10/10 SUPPL-28（补充） Approval Labeling STANDARD
2013/10/09 SUPPL-27（补充） Approval Labeling STANDARD
2013/05/14 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
2008/01/03 SUPPL-26（补充） Approval Labeling STANDARD
2007/03/28 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
2005/12/28 SUPPL-23（补充） Approval Labeling STANDARD
2005/06/22 SUPPL-22（补充） Approval Labeling STANDARD
2005/03/18 SUPPL-21（补充） Approval Labeling STANDARD
2004/01/22 SUPPL-20（补充） Approval Labeling STANDARD
2002/12/19 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2002/09/13 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2001/04/05 SUPPL-16（补充） Approval Efficacy STANDARD
2001/04/04 SUPPL-14（补充） Approval Labeling STANDARD
1999/05/20 SUPPL-13（补充） Approval Labeling STANDARD
1999/03/05 SUPPL-11（补充） Approval Labeling STANDARD
1998/06/11 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1998/06/11 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1998/03/23 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1998/02/27 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1997/09/16 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1997/04/11 SUPPL-6（补充） Approval Efficacy STANDARD
1996/05/17 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1995/10/10 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1995/09/22 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1995/04/25 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1995/02/28 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1994/12/22 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
001 5223261 2010/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5223261 2010/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5223261 2010/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5223261 2010/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5223261 2010/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
006 5223261 2010/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
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:ESTRADIOL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:0.05MG/24HR 治疗等效代码:AB2
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
020375 001 NDA CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.05MG/24HR Prescription Yes No AB2 1994/12/22 BAYER HLTHCARE
075182 006 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.05MG/24HR Prescription No No AB2 2000/02/24 MYLAN TECHNOLOGIES
202985 003 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.05MG/24HR Discontinued No No AB2 2023/03/29 ZYDUS PHARMS
活性成分:ESTRADIOL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:0.1MG/24HR 治疗等效代码:AB2
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
020375 002 NDA CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.1MG/24HR Prescription Yes Yes AB2 1994/12/22 BAYER HLTHCARE
075182 001 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.1MG/24HR Prescription No No AB2 2000/02/24 MYLAN TECHNOLOGIES
202985 006 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.1MG/24HR Discontinued No No AB2 2023/03/29 ZYDUS PHARMS
活性成分:ESTRADIOL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:0.075MG/24HR 治疗等效代码:AB2
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
020375 003 NDA CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.075MG/24HR Prescription Yes No AB2 1998/03/23 BAYER HLTHCARE
075182 002 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.075MG/24HR Prescription No No AB2 2005/01/26 MYLAN TECHNOLOGIES
202985 005 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.075MG/24HR Discontinued No No AB2 2023/03/29 ZYDUS PHARMS
活性成分:ESTRADIOL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:0.025MG/24HR 治疗等效代码:AB2
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
020375 004 NDA CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.025MG/24HR Prescription Yes No AB2 1999/03/05 BAYER HLTHCARE
075182 003 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.025MG/24HR Prescription No No AB2 2005/01/26 MYLAN TECHNOLOGIES
202985 001 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.025MG/24HR Discontinued No No AB2 2023/03/29 ZYDUS PHARMS
活性成分:ESTRADIOL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:0.0375MG/24HR 治疗等效代码:AB2
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
020375 005 NDA CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.0375MG/24HR Prescription Yes No AB2 2003/05/27 BAYER HLTHCARE
075182 004 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.0375MG/24HR Prescription No No AB2 2006/07/20 MYLAN TECHNOLOGIES
202985 002 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.0375MG/24HR Discontinued No No AB2 2023/03/29 ZYDUS PHARMS
活性成分:ESTRADIOL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:0.06MG/24HR 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
020375 006 NDA CLIMARA ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.06MG/24HR Prescription Yes No AB 2003/05/27 BAYER HLTHCARE
075182 005 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.06MG/24HR Prescription No No AB 2006/07/20 MYLAN TECHNOLOGIES
202985 004 ANDA ESTRADIOL ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL 0.06MG/24HR Discontinued No No AB 2023/03/29 ZYDUS PHARMS
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药品NDC数据与药品包装、标签说明书
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