药品名称ADALAT CC
申请号020198产品号002
活性成分NIFEDIPINE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格60MG
治疗等效代码AB1参比药物
批准日期1993/04/21申请机构ALVOGEN GROUP HOLDINGS LLC
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
48927412008/06/08PDF格式
52644462010/11/23PDF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
020198023APLabel2011/02/28下载
020198023APLetter2011/03/02下载
020198022APLabel2010/03/05下载
020198022APLetter2010/03/08下载
020198017APLetter2005/04/06下载
020198017APLabel2005/04/06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
020198026AP2016/08/29Manufacturing Change or Addition
020198025AP2016/05/17Manufacturing Change or Addition
020198024AP2015/03/09Manufacturing Change or Addition
020198023AP2011/02/28Labeling Revision
020198022AP2010/03/03Labeling Revision
020198017AP2005/04/01Labeling Revision
020198012AP1999/04/13Manufacturing Change or Addition
020198010AP1998/12/18Manufacturing Change or Addition
020198009AP1996/07/23Manufacturing Change or Addition
020198008AP1996/03/14Manufacturing Change or Addition
020198007AP1996/01/24Package Change
020198006AP1995/06/14Manufacturing Change or Addition
020198005AP1996/03/29Package Change
020198004AP1994/07/28Package Change
020198003AP1994/07/07Labeling Revision
020198002AP1993/12/06Control Supplement
020198001AP1993/07/23Labeling Revision
020198000AP1993/04/21Approval