药品注册申请号:020487
申请类型:NDA (新药申请)
申请人:GLAXOSMITHKLINE
申请人全名:GLAXOSMITHKLINE
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 VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Yes No AB 1995/06/23 1995/06/23 Prescription
002 VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Yes Yes AB 1995/06/23 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
2010/04/19 SUPPL 16 Approval Labeling UNKNOWN
2008/09/02 SUPPL 14 Approval Efficacy PRIORITY
2007/12/11 SUPPL 13 Approval Labeling STANDARD
2005/11/23 SUPPL 7 Approval Labeling STANDARD
2004/12/03 SUPPL 5 Approval Labeling STANDARD
1997/01/13 SUPPL 4 Approval Labeling STANDARD
1996/08/09 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1995/09/08 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1995/06/23 ORIG 1 Approval Type 2 - New Active Ingredient 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 4957924 2009/06/23 U-530 PDF格式**本条是由Drugfuture回溯的历史信息**
4957924 2009/06/23 Y Y U-530 U-894 PDF格式**本条是由Drugfuture回溯的历史信息**
4957924*PED 2009/12/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5879706 2016/01/19 U-530 PDF格式**本条是由Drugfuture回溯的历史信息**
5879706 2016/01/19 Y U-530 U-894 PDF格式**本条是由Drugfuture回溯的历史信息**
5879706*PED 2016/07/19 PDF格式**本条是由Drugfuture回溯的历史信息**
6107302 2016/01/19 U-530 PDF格式**本条是由Drugfuture回溯的历史信息**
6107302 2016/01/19 Y U-530 U-894 PDF格式**本条是由Drugfuture回溯的历史信息**
6107302*PED 2016/07/19 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4957924 2009/06/23 U-530 PDF格式**本条是由Drugfuture回溯的历史信息**
4957924 2009/06/23 Y Y U-530 U-894 PDF格式**本条是由Drugfuture回溯的历史信息**
4957924*PED 2009/12/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5879706 2016/01/19 U-530 PDF格式**本条是由Drugfuture回溯的历史信息**
5879706 2016/01/19 Y U-530 U-894 PDF格式**本条是由Drugfuture回溯的历史信息**
5879706*PED 2016/07/19 PDF格式**本条是由Drugfuture回溯的历史信息**
6107302 2016/01/19 U-530 PDF格式**本条是由Drugfuture回溯的历史信息**
6107302 2016/01/19 Y U-530 U-894 PDF格式**本条是由Drugfuture回溯的历史信息**
6107302*PED 2016/07/19 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 I-403 2006/08/29**本条是由Drugfuture回溯的历史信息**
I-570 2011/09/02**本条是由Drugfuture回溯的历史信息**
NPP 2011/09/02**本条是由Drugfuture回溯的历史信息**
PED 2012/03/02**本条是由Drugfuture回溯的历史信息**
002 I-403 2006/08/29**本条是由Drugfuture回溯的历史信息**
I-570 2011/09/02**本条是由Drugfuture回溯的历史信息**
NPP 2011/09/02**本条是由Drugfuture回溯的历史信息**
PED 2012/03/02**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:VALACYCLOVIR HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 500MG 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
020487 001 NDA VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription Yes No AB 1995/06/23 GLAXOSMITHKLINE
076588 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2007/01/31 SUN PHARM INDS LTD
077135 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 CIPLA
077478 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 SANDOZ
077655 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 TEVA PHARMS
078518 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 MYLAN PHARMS INC
078656 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 WEST-WARD PHARMS INT
079012 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 TIME-CAP LABS INC
090216 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 WOCKHARDT
090682 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 AUROBINDO PHARMA
201506 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2012/04/03 JUBILANT GENERICS
090500 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2014/04/04 APOTEX
203047 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2015/04/08 HETERO LABS LTD V
079137 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2017/12/29 ZYDUS PHARMS
活性成分:VALACYCLOVIR HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 1GM 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
020487 002 NDA VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription Yes Yes AB 1995/06/23 GLAXOSMITHKLINE
076588 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2007/01/31 SUN PHARM INDS LTD
077135 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 CIPLA
077478 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 SANDOZ
077655 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 TEVA PHARMS
078518 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 MYLAN PHARMS INC
078656 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 WEST-WARD PHARMS INT
079012 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 TIME-CAP LABS INC
090216 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 WOCKHARDT
090682 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 AUROBINDO PHARMA
201506 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2012/04/03 JUBILANT GENERICS
090500 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2014/04/04 APOTEX
203047 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2015/04/08 HETERO LABS LTD V
079137 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2017/12/29 ZYDUS PHARMS
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