药品名称RENAMIN W/O ELECTROLYTES
申请号017493产品号007
活性成分AMINO ACIDS市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格6.5% (6.5GM/100ML)
治疗等效代码参比药物
批准日期1982/10/15申请机构BAXTER HEALTHCARE CORP
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
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
017493067APLetter2003/01/17下载
017493066APLetter2003/05/30下载
017493065APLetter2003/01/03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
017493067AP2003/01/17Control Supplement
017493066AP2003/04/30Labeling Revision
017493065AP2003/01/03Labeling Revision
017493064AP1999/03/31Control Supplement
017493063AP1999/04/05Control Supplement
017493062AP1994/02/18Control Supplement
017493061AP1994/05/19Manufacturing Change or Addition
017493060AP1994/09/30Control Supplement
017493059AP1992/08/24Manufacturing Change or Addition
017493058AP1991/04/03Control Supplement
017493057AP1992/09/14Control Supplement
017493056AP1993/03/12Labeling Revision
017493055AP1991/03/26Control Supplement
017493054AP1990/05/04Control Supplement
017493053AP1993/03/12Labeling Revision
017493052AP1997/04/30Package Change
017493051AP1989/07/26Control Supplement
017493049AP1987/12/30Package Change
017493048AP1987/11/18Labeling Revision
017493047AP1987/07/25Package Change
017493046AP1985/09/20Labeling Revision
017493045AP1984/02/28Control Supplement
017493043AP1983/01/19Labeling Revision
017493042AP1983/01/19Control Supplement
017493041AP1985/01/24Control Supplement
017493039AP1982/07/21Manufacturing Change or Addition
017493038AP1982/03/08Control Supplement
017493037AP1982/04/06Labeling Revision
017493036AP1982/04/06Control Supplement
017493035AP1982/02/16Control Supplement
017493034AP1981/12/16Control Supplement
017493033AP1982/10/15Labeling Revision
017493032AP1982/10/15Control Supplement
017493030AP1981/06/29Control Supplement
017493029AP1981/06/17Labeling Revision
017493028AP1981/06/17Formulation Revision
017493025AP1980/07/31Control Supplement
017493024AP1980/06/03Control Supplement
017493023AP1979/06/04Control Supplement
017493021AP1979/04/27Labeling Revision
017493020AP1979/11/28Labeling Revision
017493019AP1979/11/28Control Supplement
017493018AP1978/07/28Control Supplement
017493017AP1978/07/28Labeling Revision
017493016AP1978/08/29Control Supplement
017493015AP1977/12/13Labeling Revision
017493014AP1977/08/18Control Supplement
017493013AP1977/07/12Labeling Revision
017493012AP1977/07/12Control Supplement
017493011AP1977/07/22Manufacturing Change or Addition
017493010AP1979/05/10Control Supplement
017493009AP1977/02/07Control Supplement
017493008AP1977/04/01Control Supplement
017493007AP1977/04/01Labeling Revision
017493006AP1977/12/07Labeling Revision
017493005AP1976/08/24Control Supplement
017493004AP1976/06/28Control Supplement
017493003AP1976/09/08Labeling Revision
017493001AP1976/07/19Control Supplement
017493000AP1976/03/24Approval