药品名称TIGAN
申请号017530产品号001
活性成分TRIMETHOBENZAMIDE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格100MG/ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PAR STERILE PRODUCTS LLC
化学类型New formulation or new manufacturer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
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
017530024APLetter2008/04/22下载
017530024APLabel2008/06/05下载
017530023APLetter2005/08/31下载
017530023APLabel2005/08/31下载
017530022APLetter2005/08/31下载
017530022APLabel2005/08/31下载
017530021APLetter2005/08/31下载
017530021APLabel2005/08/31下载
017530018APReview2007/07/09下载
017530018APLetter2004/06/18下载
017530018APLabel2004/06/18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
017530024AP2008/04/18Labeling Revision
017530023AP2005/08/26Manufacturing Change or Addition
017530022AP2005/08/26Package Change
017530021AP2005/08/26Formulation Revision
017530019AP2002/06/28Manufacturing Change or Addition
017530018AP2002/04/30Labeling Revision
017530017AP2001/02/23Manufacturing Change or Addition
017530016AP1999/12/14Manufacturing Change or Addition
017530015AP1999/10/28Expiration Date Change
017530014AP1999/10/22Manufacturing Change or Addition
017530013AP1998/12/03Manufacturing Change or Addition
017530010AP1986/02/20Control Supplement
017530008AP1981/09/15Labeling Revision
017530007AP1980/09/25Manufacturing Change or Addition
017530002AP1975/12/18Control Supplement
017530001AP1975/05/12Control Supplement
017530000AP1974/07/12Approval