药品名称KYTRIL
申请号020239产品号002
活性成分GRANISETRON HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1994/03/11申请机构HOFFMANN LA ROCHE INC
化学类型New molecular entity (NME)审评分类Standard 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
59523402016/09/14U-519PDF格式
历史专利信息
48868082007/12/29U-89PDF格式
62945482019/05/04PDF格式
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
M-1022014/04/29
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
020239023APLabel2011/05/02下载
020239023APLetter2011/09/19下载
020239021APLabel2009/10/14下载
020239021APLetter2009/11/12下载
020239018APReview2009/09/16下载
020239018APLabel2005/11/30下载
020239018APLetter2005/11/30下载
020239017APLetter2004/09/21下载
020239017APReview2009/09/16下载
020239016APReview2009/09/16下载
020239016APLetter2004/09/21下载
020239015APLetter2004/08/25下载
020239015APLabel2004/08/25下载
020239015APReview2009/01/12下载
020239008APLetter2002/08/16下载
020239008APLabel2002/08/16下载
020239007APReview2008/08/11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
020239023AP2011/04/29Efficacy Supplement with Clinical Data to Support
020239021AP2009/10/07Labeling Revision
020239018AP2005/11/23Labeling Revision
020239017AP2004/09/17Manufacturing Change or Addition
020239016AP2004/09/17Formulation Revision
020239015AP2004/08/20Formulation Revision
020239011AP2002/11/25Control Supplement
020239009AP2002/11/05Manufacturing Change or Addition
020239008AP2002/08/16New or Modified Indication
020239007AP1997/03/20Labeling Revision
020239006AP1997/05/30Formulation Revision
020239005AP1996/10/24Manufacturing Change or Addition
020239004AP1997/01/21New Dosage Regimen
020239003AP1995/11/21Labeling Revision
020239002AP1997/01/21Labeling Revision
020239001AP1994/03/11Formulation Revision
020239000AP1993/12/29Approval