药品名称ZANAFLEX
申请号020397产品号001
活性成分TIZANIDINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 4MG BASE
治疗等效代码AB参比药物
批准日期1996/11/27申请机构ACORDA THERAPEUTICS INC
化学类型New molecular entity (NME)审评分类Standard review drug
罕用药/孤儿药
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
020397026APLetter2013/11/08下载
020397026APLabel2013/11/08下载
020397023APLetter2013/03/21下载
020397021APLabel2006/08/04下载
020397021APLetter2006/08/04下载
020397014APLetter2002/11/27下载
020397004APReview2007/07/09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
020397026AP2013/11/07Labeling Revision
020397025AP2016/05/27Manufacturing Change or Addition
020397023AP2013/03/19Labeling Revision
020397021AP2006/07/28Labeling Revision
020397016AP2002/05/17Manufacturing Change or Addition
020397015AP2002/04/10Expiration Date Change
020397014AP2002/11/27Labeling Revision
020397013AP2001/08/22Manufacturing Change or Addition
020397012AP2001/08/21Manufacturing Change or Addition
020397011AP2001/03/20Manufacturing Change or Addition
020397010AP2000/12/07Manufacturing Change or Addition
020397008AP2000/08/21Manufacturing Change or Addition
020397007AP2000/06/26Manufacturing Change or Addition
020397005AP1999/06/15Manufacturing Change or Addition
020397004AP2000/02/04Manufacturing Change or Addition
020397003AP1997/10/23Manufacturing Change or Addition
020397002AP1997/09/02Package Change
020397001AP1997/09/02Control Supplement
020397000AP1996/11/27Approval