药品名称COLYTE WITH FLAVOR PACKS
申请号018983产品号012
活性成分POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS市场状态处方药
剂型或给药途径FOR SOLUTION;ORAL规格240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
治疗等效代码AA参比药物
批准日期1998/10/08申请机构MEDA PHARMACEUTICALS INC
化学类型New combination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
018983047APLabel2013/08/19下载
018983047APLetter2013/08/22下载
018983037APLetter2003/11/25下载
018983035APLetter2002/09/16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
018983047AP2013/08/19Labeling Revision
018983045AP2013/04/24Manufacturing Change or Addition
018983037AP2003/10/23Labeling Revision
018983036AP2002/11/12Manufacturing Change or Addition
018983035AP2002/09/16Labeling Revision
018983034AP2002/05/16Manufacturing Change or Addition
018983033AP2000/10/12Manufacturing Change or Addition
018983032AP2000/07/20Manufacturing Change or Addition
018983031AP2000/10/16Labeling Revision
018983030AP2000/10/16Labeling Revision
018983029AP1999/11/30Manufacturing Change or Addition
018983028AP1999/07/21Package Change
018983027AP1998/04/17Package Change
018983026AP1998/10/08Package Change
018983025AP1997/12/09Manufacturing Change or Addition
018983024AP1997/01/21Manufacturing Change or Addition
018983023AP1996/09/06Manufacturing Change or Addition
018983022AP1996/01/24Formulation Revision
018983020AP1994/10/13Manufacturing Change or Addition
018983019AP1994/04/04Formulation Revision
018983018AP1994/06/06Control Supplement
018983017AP1994/02/24Manufacturing Change or Addition
018983016AP1994/04/25Expiration Date Change
018983015AP1994/04/25Expiration Date Change
018983014AP1993/03/05Package Change
018983013AP1990/06/26Package Change
018983011AP1991/11/14Formulation Revision
018983008AP1989/01/31Labeling Revision
018983007AP1989/01/31Control Supplement
018983006AP1987/06/12Manufacturing Change or Addition
018983005AP1986/08/19Manufacturing Change or Addition
018983004AP1986/03/27Expiration Date Change
018983001AP1986/08/19Labeling Revision
018983000AP1984/10/26Approval