药品名称OSMITROL 15% IN WATER IN PLASTIC CONTAINER
申请号013684产品号008
活性成分MANNITOL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格15GM/100ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982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
013684092APLabel2005/09/07下载
013684092APLetter2005/09/07下载
013684091APLetter2005/06/14下载
013684091APLabel2005/06/14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
013684101AP2015/12/23Manufacturing Change or Addition
013684100AP2015/07/15Manufacturing Change or Addition
013684099AP2015/04/08Manufacturing Change or Addition
013684097AP2013/07/19Manufacturing Change or Addition
013684092AP2005/08/26Supplement
013684091AP2005/06/09Labeling Revision
013684087AP2002/01/16Control Supplement
013684086AP2001/08/14Manufacturing Change or Addition
013684085AP1999/11/24Manufacturing Change or Addition
013684084AP1997/04/29Package Change
013684083AP1994/02/18Control Supplement
013684082AP1994/09/30Control Supplement
013684081AP1994/06/01Control Supplement
013684079AP1991/04/29Control Supplement
013684078AP1991/03/26Control Supplement
013684077AP1991/02/15Control Supplement
013684076AP1989/07/26Control Supplement
013684075AP1987/07/25Package Change
013684074AP1987/05/28Control Supplement
013684071AP1985/04/15Control Supplement
013684070AP1985/06/13Control Supplement
013684069AP1984/09/22Control Supplement
013684068AP1984/02/28Control Supplement
013684067AP1983/07/11Labeling Revision
013684065AP1985/08/28Control Supplement
013684064AP1985/08/28Control Supplement
013684063AP1984/03/16Control Supplement
013684062AP1985/01/24Control Supplement
013684060AP1982/04/08Labeling Revision
013684059AP1982/02/16Control Supplement
013684058AP1981/11/20Control Supplement
013684056AP1982/06/03Control Supplement
013684055AP1982/11/22Practioner Draft Labeling
013684054AP1982/04/16Control Supplement
013684053AP1981/08/26Labeling Revision
013684051AP1982/11/22Labeling Revision
013684050AP1982/11/22Control Supplement
013684049AP1981/06/29Control Supplement
013684048AP1981/01/21Control Supplement
013684047AP1980/07/31Control Supplement
013684046AP1981/09/08Labeling Revision
013684045AP1981/09/08Control Supplement
013684044AP1981/09/08Labeling Revision
013684043AP1981/09/08Control Supplement
013684042AP1981/04/16Control Supplement
013684041AP1980/06/18Control Supplement
013684040AP1980/05/30Control Supplement
013684039AP1980/08/07Control Supplement
013684037AP1980/06/28Control Supplement
013684036AP1979/08/02Control Supplement
013684034AP1978/10/20Control Supplement
013684033AP1978/08/07Control Supplement
013684031AP1978/03/22Control Supplement
013684030AP1980/02/25Control Supplement
013684029AP1978/06/20Control Supplement
013684028AP1978/03/24Control Supplement
013684027AP1978/02/28Control Supplement
013684026AP1977/12/14Control Supplement
013684025AP1979/08/07Labeling Revision
013684024AP1979/04/25Manufacturing Change or Addition
013684023AP1977/08/30Labeling Revision
013684022AP1977/02/07Package Change
013684021AP1976/10/07Control Supplement
013684020AP1976/07/13Final Printed Labeling - MarkIV
013684018AP1977/04/08Control Supplement
013684017AP1976/06/17Control Supplement
013684015AP1976/07/01Control Supplement
013684014AP1976/01/05Control Supplement
013684013AP1975/07/29Control Supplement
013684012AP1975/09/17Control Supplement
013684011AP1975/06/16Control Supplement
013684010AP1975/09/25Control Supplement
013684009AP1975/07/10Control Supplement
013684008AP1974/11/11Supplement
013684000AP1964/06/08Approval