药品注册申请号:021797
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB
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 BARACLUDE ENTECAVIR TABLET;ORAL 0.5MG Yes No AB 2005/03/29 2005/03/29 Prescription
002 BARACLUDE ENTECAVIR TABLET;ORAL 1MG Yes Yes AB 2005/03/29 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
2019/11/06 SUPPL 23 Approval Labeling STANDARD
2018/12/20 SUPPL 21 Approval Labeling STANDARD
2018/06/22 SUPPL 19 Approval Labeling STANDARD
2014/03/20 SUPPL 18 Approval Efficacy PRIORITY
2013/12/19 SUPPL 17 Approval Labeling STANDARD
2013/06/18 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
2013/04/16 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
2012/10/12 SUPPL 14 Approval Efficacy STANDARD
2012/10/12 SUPPL 13 Approval Efficacy STANDARD
2010/12/28 SUPPL 11 Approval Labeling UNKNOWN
2010/10/15 SUPPL 10 Approval Efficacy STANDARD
2009/07/16 SUPPL 8 Approval Efficacy UNKNOWN
2009/02/25 SUPPL 9 Approval Labeling STANDARD
2008/07/25 SUPPL 5 Approval Efficacy STANDARD
2008/06/03 SUPPL 6 Approval Labeling STANDARD
2007/07/24 SUPPL 3 Approval Labeling STANDARD
2007/03/27 SUPPL 2 Approval Efficacy UNKNOWN
2007/02/23 SUPPL 1 Approval Efficacy UNKNOWN
2005/03/29 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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 5206244 2010/10/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5206244 2015/02/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5206244*PED 2015/08/21 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5206244 2010/10/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5206244 2015/02/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5206244*PED 2015/08/21 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 D-127 2013/10/15**本条是由Drugfuture回溯的历史信息**
NCE 2010/03/29**本条是由Drugfuture回溯的历史信息**
NPP 2015/10/12**本条是由Drugfuture回溯的历史信息**
NPP 2017/03/20**本条是由Drugfuture回溯的历史信息**
PED 2014/04/15**本条是由Drugfuture回溯的历史信息**
PED 2016/04/12**本条是由Drugfuture回溯的历史信息**
PED 2017/09/20**本条是由Drugfuture回溯的历史信息**
002 D-127 2013/10/15**本条是由Drugfuture回溯的历史信息**
NCE 2010/03/29**本条是由Drugfuture回溯的历史信息**
NPP 2015/10/12**本条是由Drugfuture回溯的历史信息**
NPP 2017/03/20**本条是由Drugfuture回溯的历史信息**
PED 2014/04/15**本条是由Drugfuture回溯的历史信息**
PED 2016/04/12**本条是由Drugfuture回溯的历史信息**
PED 2017/09/20**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:ENTECAVIR 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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
021797 001 NDA BARACLUDE ENTECAVIR TABLET;ORAL 0.5MG Prescription Yes No AB 2005/03/29 BRISTOL MYERS SQUIBB
202122 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2014/08/26 TEVA PHARMS USA
205740 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2015/08/21 HETERO LABS LTD V
206217 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2015/08/26 AUROBINDO PHARMA LTD
206652 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2015/11/12 AMNEAL PHARMS
206294 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2016/11/23 PAR PHARM INC
206872 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2016/12/06 CIPLA
206672 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2017/05/11 CASI PHARMS INC
206745 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2017/06/23 ZYDUS PHARMS
205824 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2017/08/25 ACCORD HLTHCARE
208782 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2017/10/10 PRINSTON INC
208721 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2018/03/15 BRECKENRIDGE
206226 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2019/03/26 MYLAN
212126 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2019/09/25 BRIGHTGENE
212201 001 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 0.5MG Prescription No No AB 2019/11/04 YAOPHARMA CO LTD
活性成分:ENTECAVIR 剂型/给药途径:TABLET;ORAL 规格:1MG 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
021797 002 NDA BARACLUDE ENTECAVIR TABLET;ORAL 1MG Prescription Yes Yes AB 2005/03/29 BRISTOL MYERS SQUIBB
202122 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2014/08/26 TEVA PHARMS USA
205740 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2015/08/21 HETERO LABS LTD V
206217 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2015/08/26 AUROBINDO PHARMA LTD
206652 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2015/11/12 AMNEAL PHARMS
206294 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2016/11/23 PAR PHARM INC
206872 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2016/12/06 CIPLA
206672 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2017/05/11 CASI PHARMS INC
206745 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2017/06/23 ZYDUS PHARMS
205824 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2017/08/25 ACCORD HLTHCARE
208782 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2017/10/10 PRINSTON INC
208721 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2018/03/15 BRECKENRIDGE
206226 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2019/03/26 MYLAN
212126 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2019/09/25 BRIGHTGENE
212201 002 ANDA ENTECAVIR ENTECAVIR TABLET;ORAL 1MG Prescription No No AB 2019/11/04 YAOPHARMA CO LTD
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database