药品名称TRANSDERM SCOP
申请号017874产品号001
活性成分SCOPOLAMINE市场状态处方药
剂型或给药途径FILM, EXTENDED RELEASE;TRANSDERMAL规格1MG/72HR
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构GLAXOSMITHKLINE CONSUMER HEALTH
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
017874038APLetter2013/05/02下载
017874038APLabel2013/05/30下载
017874035APLetter2007/01/16下载
017874032APLetter2002/03/22下载
017874027APLetter2001/07/26下载
017874027APLabel2003/04/11下载
017874027APReview2007/07/09下载
017874018APReview2007/07/09下载
017874018APLabel2003/04/10下载
017874018APLetter2001/07/26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
017874040AP2013/05/15Manufacturing Change or Addition
017874038AP2013/04/30Labeling Revision
017874035AP2007/01/10Labeling Revision
017874032AP2002/03/22Labeling Revision
017874030AP2000/05/30Manufacturing Change or Addition
017874029AP1998/06/19Manufacturing Change or Addition
017874028AP1996/10/07Control Supplement
017874027AP2001/07/26Labeling Revision
017874026AP1994/05/31Control Supplement
017874025AP1993/02/10Manufacturing Change or Addition
017874024AP1993/06/28Manufacturing Change or Addition
017874023AP1992/03/05Manufacturing Change or Addition
017874022AP1990/07/10Package Change
017874018AP2001/07/26Labeling Revision
017874017AP1988/10/03Manufacturing Change or Addition
017874016AP1988/03/17Control Supplement
017874014AP1984/07/25Manufacturing Change or Addition
017874013AP1982/06/02Control Supplement
017874011AP1981/11/02Control Supplement
017874009AP1981/10/27Labeling Revision
017874006AP1981/02/09Expiration Date Change
017874005AP1981/04/10Manufacturing Change or Addition
017874001AP1980/01/28Expiration Date Change
017874000AP1979/12/31Approval