药品名称PROPULSID
申请号020210产品号001
活性成分CISAPRIDE MONOHYDRATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 10MG BASE
治疗等效代码参比药物
批准日期1993/07/29申请机构JANSSEN PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
49621152007/10/09U-79PDF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
020210032APReview2000/03/06下载
020210030APReview2000/03/06下载
020210000APReview2007/05/09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
020210032AP2000/03/06Labeling Revision
020210030AP2000/03/06Labeling Revision
020210029AP1999/11/10Manufacturing Change or Addition
020210028AP1999/04/20Manufacturing Change or Addition
020210027AP1999/01/12Manufacturing Change or Addition
020210026AP1998/08/17Labeling Revision
020210025AP1998/07/31Labeling Revision
020210024AP1998/10/06Package Change
020210023AP1998/06/16Expiration Date Change
020210022AP1998/09/22Manufacturing Change or Addition
020210020AP1998/06/26Manufacturing Change or Addition
020210019AP1998/06/02Control Supplement
020210017AP1997/11/07Labeling Revision
020210014AP1997/01/29Manufacturing Change or Addition
020210013AP1996/09/18Manufacturing Change or Addition
020210012AP1996/10/15Manufacturing Change or Addition
020210011AP1995/12/11Labeling Revision
020210008AP1995/10/03Manufacturing Change or Addition
020210007AP1995/09/15Labeling Revision
020210006AP1994/10/11Manufacturing Change or Addition
020210005AP1994/07/06Manufacturing Change or Addition
020210004AP1994/03/07Manufacturing Change or Addition
020210003AP1993/12/23Labeling Revision
020210002AP1993/09/27Labeling Revision
020210001AP1993/12/03Manufacturing Change or Addition
020210000AP1993/07/29Approval