药品名称CALAN SR
申请号019152产品号001
活性成分VERAPAMIL HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格240MG
治疗等效代码AB参比药物
批准日期1986/12/16申请机构PFIZER INC
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
019152039APLetter2016/08/25下载
019152039APLabel2016/09/06下载
019152038APLetter2013/10/28下载
019152038APLabel2013/10/28下载
019152035APLabel2011/12/02下载
019152035APLetter2011/12/05下载
019152033APLetter2010/04/02下载
019152033APLabel2010/04/04下载
019152032APLetter2009/07/08下载
019152032APLabel2009/07/09下载
019152030APLetter2002/11/26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
019152039AP2016/08/24Labeling Revision
019152038AP2013/10/28Labeling Revision
019152037AP2013/01/10Manufacturing Change or Addition
019152035AP2011/12/01Labeling Revision
019152033AP2010/03/31Labeling Revision
019152032AP2009/07/01Labeling Revision
019152030AP2002/11/26Control Supplement
019152029AP2001/02/14Control Supplement
019152028AP2001/02/12Expiration Date Change
019152027AP2000/07/14Manufacturing Change or Addition
019152026AP2001/09/28Labeling Revision
019152025AP1998/12/11Manufacturing Change or Addition
019152024AP1997/05/16Manufacturing Change or Addition
019152023AP1998/01/13Labeling Revision
019152022AP1993/11/05Package Change
019152020AP1995/03/17Manufacturing Change or Addition
019152019AP1992/09/23Expiration Date Change
019152017AP1992/09/03Labeling Revision
019152016AP1992/05/04Expiration Date Change
019152015AP1994/07/28Manufacturing Change or Addition
019152014AP1991/03/06Formulation Revision
019152013AP1990/01/19Manufacturing Change or Addition
019152012AP1989/05/17Package Change
019152011AP1989/03/30Manufacturing Change or Addition
019152010AP1989/06/14Package Change
019152009AP1989/12/15New Dosage Regimen
019152008AP1988/09/22Labeling Revision
019152007AP1989/08/08Package Change
019152006AP1991/03/06Manufacturing Change or Addition
019152005AP1988/07/20Labeling Revision
019152004AP1988/11/30Manufacturing Change or Addition
019152003AP1988/11/30Manufacturing Change or Addition
019152002AP1988/11/30Manufacturing Change or Addition
019152001AP1987/09/24Package Change
019152000AP1986/12/16Approval