药品名称CARDIZEM SR
申请号019471产品号001
活性成分DILTIAZEM HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格60MG
治疗等效代码参比药物
批准日期1989/01/23申请机构BIOVAIL LABORATORIES INC
化学类型New dosage form审评分类Standard review drug
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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
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
019471031AP2001/06/04Control Supplement
019471030AP1999/12/06Manufacturing Change or Addition
019471029AP2003/03/21Labeling Revision
019471028AP1998/12/03Manufacturing Change or Addition
019471027AP1997/11/20Control Supplement
019471026AP1997/08/05Control Supplement
019471025AP1996/05/16Control Supplement
019471024AP1996/05/28Labeling Revision
019471023AP1995/03/17Control Supplement
019471021AP1994/09/14Package Change
019471020AP1994/09/14Manufacturing Change or Addition
019471019AP1995/04/03Package Change
019471018AP1994/03/18Control Supplement
019471017AP1994/03/15Control Supplement
019471016AP1993/08/02Manufacturing Change or Addition
019471015AP1993/04/01Labeling Revision
019471014AP1992/10/22Control Supplement
019471013AP1992/10/22Control Supplement
019471011AP1991/06/13Labeling Revision
019471010AP1992/07/01Labeling Revision
019471008AP1991/01/07Package Change
019471007AP1990/09/14Control Supplement
019471006AP1991/05/03Manufacturing Change or Addition
019471005AP1990/07/27Package Change
019471004AP1990/08/16Control Supplement
019471002AP1990/04/23Package Change
019471001AP1989/03/08Control Supplement
019471000AP1989/01/23Approval