药品注册申请号:020550
申请类型:NDA (新药申请)
申请人:GLAXOSMITHKLINE
申请人全名:--
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 No None 1995/12/15 -- Prescription
002 VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET; ORAL EQ 1GM BASE No None -- 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
2003/08/29 SUPPL 19 Approval Efficacy STANDARD
2003/08/08 SUPPL 21 Approval Labeling STANDARD
2003/04/01 SUPPL 5 Approval Efficacy STANDARD
2002/12/18 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
2002/09/09 SUPPL 16 Approval Efficacy STANDARD
2002/07/03 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
2002/03/14 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
2001/06/25 SUPPL 13 Approval Labeling STANDARD
2001/06/25 SUPPL 12 Approval Efficacy STANDARD
2001/06/25 SUPPL 10 Approval Labeling STANDARD
2001/06/01 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
2000/04/20 SUPPL 11 Approval Labeling STANDARD
2000/04/20 SUPPL 9 Approval Labeling STANDARD
1999/07/22 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1999/02/02 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1998/11/25 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1997/09/26 SUPPL 3 Approval Efficacy STANDARD
1997/04/30 SUPPL 4 Approval Labeling STANDARD
1996/10/18 SUPPL 2 Approval Labeling STANDARD
1996/10/04 SUPPL 1 Approval Efficacy PRIORITY
1995/12/15 ORIG 1 Approval Type 6 - New Indication (no longer used) 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
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
与本品治疗等效的药品
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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