药品名称CARDIZEM
申请号020027产品号003
活性成分DILTIAZEM HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
批准日期1995/08/18申请机构BIOVAIL LABORATORIES INTERNATIONAL SRL
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
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
020027019APLetter2004/12/30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
020027020AP2001/06/04Control Supplement
020027019AP2004/12/21Labeling Revision
020027018AP1998/02/05Manufacturing Change or Addition
020027017AP1997/11/20Control Supplement
020027016AP1997/09/02Control Supplement
020027015AP1997/08/05Control Supplement
020027014AP1997/01/14Manufacturing Change or Addition
020027013AP1996/05/28Control Supplement
020027012AP1996/06/04Formulation Revision
020027011AP1996/04/02Labeling Revision
020027010AP1996/01/04Control Supplement
020027009AP1996/04/02Labeling Revision
020027008AP1995/10/24Control Supplement
020027007AP1995/01/12Control Supplement
020027006AP1995/08/18Formulation Revision
020027005AP1994/09/28Manufacturing Change or Addition
020027004AP1994/08/15Package Change
020027003AP1993/04/28Labeling Revision
020027002AP1994/05/24Manufacturing Change or Addition
020027001AP1992/04/01Labeling Revision
020027000AP1991/10/24Approval