ZANAFLEX(TIZANIDINE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	ZANAFLEX
申请号	020397	产品号	002
活性成分	TIZANIDINE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	否
批准日期	2000/02/04	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	是

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
无
历史专利信息
无

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
020397	026	AP	2013/11/07	Labeling Revision
020397	025	AP	2016/05/27	Manufacturing Change or Addition
020397	023	AP	2013/03/19	Labeling Revision
020397	021	AP	2006/07/28	Labeling Revision
020397	016	AP	2002/05/17	Manufacturing Change or Addition
020397	015	AP	2002/04/10	Expiration Date Change
020397	014	AP	2002/11/27	Labeling Revision
020397	013	AP	2001/08/22	Manufacturing Change or Addition
020397	012	AP	2001/08/21	Manufacturing Change or Addition
020397	011	AP	2001/03/20	Manufacturing Change or Addition
020397	010	AP	2000/12/07	Manufacturing Change or Addition
020397	008	AP	2000/08/21	Manufacturing Change or Addition
020397	007	AP	2000/06/26	Manufacturing Change or Addition
020397	005	AP	1999/06/15	Manufacturing Change or Addition
020397	004	AP	2000/02/04	Manufacturing Change or Addition
020397	003	AP	1997/10/23	Manufacturing Change or Addition
020397	002	AP	1997/09/02	Package Change
020397	001	AP	1997/09/02	Control Supplement
020397	000	AP	1996/11/27	Approval