药品名称CYTOVENE
申请号020460产品号002
活性成分GANCICLOVIR市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1997/12/12申请机构ROCHE PALO ALTO LLC
化学类型New dosage form审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020460008APReview1997/12/12下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020460012AP2002/09/13Expiration Date Change
020460011AP2000/10/17Manufacturing Change or Addition
020460010AP2000/12/01Labeling Revision
020460009AP1998/10/21Manufacturing Change or Addition
020460008AP1997/12/12New Dosage Regimen
020460007AP1997/05/30Package Change
020460006AP1996/11/27New or Modified Indication
020460005AP1995/10/27New or Modified Indication
020460004AP1997/12/30Control Supplement
020460003AP1995/03/01Labeling Revision
020460002AP1995/07/20Manufacturing Change or Addition
020460000AP1994/12/22Approval