药品注册申请号：203047
申请类型：ANDA (仿制药申请)
申请人：HETERO LABS LTD V
申请人全名：HETERO LABS LTD UNIT V
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 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE No No AB 2015/04/08 2015/04/08 Prescription
002 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE No No AB 2015/04/08 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
2023/02/23 SUPPL-14（补充） Approval Labeling STANDARD
2023/02/23 SUPPL-12（补充） Approval Labeling STANDARD
2015/10/26 SUPPL-1（补充） Approval Labeling STANDARD
2015/04/08 ORIG-1（原始申请） Approval
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
无
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 Discontinued No No AB 2010/05/24 CIPLA
077478 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Discontinued No No AB 2010/05/24 SANDOZ
078518 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 MYLAN PHARMS INC
079012 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 GRAVITI PHARMS
090682 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 AUROBINDO PHARMA
090216 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2010/05/24 CHARTWELL RX
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 LIFESCIENCES
209553 001 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Prescription No No AB 2020/03/18 YILING
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 Discontinued No No AB 2010/05/24 CIPLA
077478 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Discontinued No No AB 2010/05/24 SANDOZ
078518 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 MYLAN PHARMS INC
079012 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 GRAVITI PHARMS
090682 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 AUROBINDO PHARMA
090216 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2010/05/24 CHARTWELL RX
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 LIFESCIENCES
209553 002 ANDA VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Prescription No No AB 2020/03/18 YILING
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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