药品名称TIAZAC
申请号020401产品号005
活性成分DILTIAZEM HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格360MG
治疗等效代码AB4参比药物
批准日期1995/09/11申请机构VALEANT PHARMACEUTICALS NORTH AMERICA LLC
化学类型New dosage form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
55297912013/06/25PDF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
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
020401036APLabel2010/11/22下载
020401036APLetter2010/11/30下载
020401034APLetter2007/07/05下载
020401019APReview2001/06/06下载
020401013APReview2001/12/04下载
020401007APReview1998/01/30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
020401041AP2015/11/20Manufacturing Change or Addition
020401036AP2010/11/22Labeling Revision
020401034AP2007/06/21Labeling Revision
020401025AP2002/10/03Manufacturing Change or Addition
020401023AP2001/11/26Manufacturing Change or Addition
020401022AP2001/09/24Manufacturing Change or Addition
020401021AP2000/11/29Manufacturing Change or Addition
020401020AP2001/07/03Control Supplement
020401019AP2000/03/24Labeling Revision
020401018AP2000/02/17Manufacturing Change or Addition
020401016AP1999/10/13Control Supplement
020401015AP2000/04/05Labeling Revision
020401014AP1999/02/17Manufacturing Change or Addition
020401013AP1998/10/16Formulation Revision
020401012AP1999/01/28Control Supplement
020401011AP1997/08/14Manufacturing Change or Addition
020401010AP1997/09/22Manufacturing Change or Addition
020401009AP1997/09/09Package Change
020401008AP1997/09/03Manufacturing Change or Addition
020401007AP1998/01/30New or Modified Indication
020401006AP1997/10/01Labeling Revision
020401005AP1996/06/26Manufacturing Change or Addition
020401004AP1997/03/14Manufacturing Change or Addition
020401003AP1996/05/16Manufacturing Change or Addition
020401002AP1996/05/29Manufacturing Change or Addition
020401001AP1996/07/23Manufacturing Change or Addition
020401000AP1995/09/11Approval