药品名称CARDIZEM CD
申请号020062产品号004
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300MG
治疗等效代码AB3参比药物
批准日期1991/12/27申请机构VALEANT INTERNATIONAL BARBADOS SRL
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
48942402007/01/16PDF格式
50027762008/03/26PDF格式
52864972011/05/20PDF格式
53646202011/11/14U-3PDF格式
54396892012/08/08U-107PDF格式
54705842011/05/20PDF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
020062042APLabel2016/08/22下载
020062040APLabel2010/11/22下载
020062040APLetter2010/11/30下载
020062027APReview2001/07/13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
020062042AP2016/06/29Labeling Revision
020062040AP2010/11/22Labeling Revision
020062033AP2001/06/04Control Supplement
020062032AP2000/01/21Control Supplement
020062031AP1999/12/03Manufacturing Change or Addition
020062030AP1999/10/19Control Supplement
020062029AP1999/11/18Manufacturing Change or Addition
020062028AP1999/04/29Control Supplement
020062027AP1999/08/24Formulation Revision
020062026AP1999/04/15Control Supplement
020062025AP2003/03/21Labeling Revision
020062024AP1998/04/07Control Supplement
020062023AP1997/11/21Manufacturing Change or Addition
020062022AP1997/08/06Control Supplement
020062021AP1996/04/02Labeling Revision
020062019AP1996/04/02Labeling Revision
020062018AP1995/10/31Control Supplement
020062017AP1995/05/11Control Supplement
020062016AP1994/11/22Control Supplement
020062015AP1995/05/04Control Supplement
020062014AP1994/10/24Control Supplement
020062013AP1995/09/25Package Change
020062012AP1994/09/28Package Change
020062011AP1994/09/14Manufacturing Change or Addition
020062010AP1995/04/03Package Change
020062009AP1994/05/05Control Supplement
020062008AP1993/11/01Control Supplement
020062007AP1993/10/06Labeling Revision
020062006AP1993/06/29Control Supplement
020062005AP1993/04/28Labeling Revision
020062004AP1992/09/18Manufacturing Change or Addition
020062003AP1992/08/10New Dosage Regimen
020062002AP1992/08/04Manufacturing Change or Addition
020062001AP1992/10/15New or Modified Indication
020062000AP1991/12/27Approval