药品注册申请号:021513
申请类型:NDA (新药申请)
申请人:APIL
申请人全名:ALLERGAN PHARMACEUTICALS INTERNATIONAL 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 ENABLEX DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Yes No AB 2004/12/22 2004/12/22 Prescription
002 ENABLEX DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Yes Yes AB 2004/12/22 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/01/13 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2015/12/18 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2013/12/05 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2013/09/20 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2013/08/09 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2013/04/03 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2012/03/15 SUPPL 10 Approval Labeling STANDARD
2012/01/13 SUPPL 8 Approval Labeling STANDARD
2011/04/18 SUPPL 7 Approval Labeling UNKNOWN
2010/10/19 SUPPL 6 Approval Labeling STANDARD
2008/12/12 SUPPL 5 Approval Labeling STANDARD
2008/04/18 SUPPL 4 Approval Labeling STANDARD
2005/10/20 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2004/12/22 ORIG 1 Approval Type 1 - New Molecular Entity 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 5096890 2010/03/13 Y Y U-631 PDF格式**本条是由Drugfuture回溯的历史信息**
5096890 2015/03/13 Y Y U-631 PDF格式**本条是由Drugfuture回溯的历史信息**
6106864 2016/08/21 Y U-630 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5096890 2010/03/13 Y Y U-631 PDF格式**本条是由Drugfuture回溯的历史信息**
5096890 2015/03/13 Y Y U-631 PDF格式**本条是由Drugfuture回溯的历史信息**
6106864 2016/08/21 Y U-630 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
001 NCE 2009/12/22**本条是由Drugfuture回溯的历史信息**
002 NCE 2009/12/22**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:DARIFENACIN HYDROBROMIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 7.5MG BASE 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
021513 001 NDA ENABLEX DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription Yes No AB 2004/12/22 APIL
091190 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2015/03/13 ANCHEN PHARMS
207664 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2016/09/01 CIPLA
206743 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2016/09/19 AUROBINDO PHARMA LTD
205550 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2016/10/12 JUBILANT GENERICS
205209 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2016/11/17 TORRENT
207302 001 ANDA DARIFENACIN DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2017/07/28 MACLEODS PHARMS LTD
207681 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2017/12/08 ALEMBIC PHARMS LTD
209571 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 7.5MG BASE Prescription No No AB 2019/10/22 ALAN LABS INC
活性成分:DARIFENACIN HYDROBROMIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 15MG BASE 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
021513 002 NDA ENABLEX DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription Yes Yes AB 2004/12/22 APIL
091190 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2015/03/13 ANCHEN PHARMS
207664 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2016/09/01 CIPLA
206743 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2016/09/19 AUROBINDO PHARMA LTD
205550 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2016/10/12 JUBILANT GENERICS
205209 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2016/11/17 TORRENT
207302 002 ANDA DARIFENACIN DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2017/07/28 MACLEODS PHARMS LTD
207681 002 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2017/12/08 ALEMBIC PHARMS LTD
209571 001 ANDA DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL EQ 15MG BASE Prescription No No AB 2019/10/22 ALAN LABS INC
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