药品名称LITHIUM CITRATE
申请号018421产品号001
活性成分LITHIUM CITRATE市场状态处方药
剂型或给药途径SYRUP;ORAL规格EQ 300MG CARBONATE/5ML
治疗等效代码AA参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ROXANE LABORATORIES INC
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
018421027APLetter2011/10/25下载
018421027APLabel2011/10/25下载
018421025APLetter2016/10/28下载
018421021APLetter2003/01/31下载
018421016APLetter2001/11/26下载
018421015APLetter2001/11/26下载
018421014APLetter2001/11/26下载
018421013APLetter2001/11/26下载
018421011APLetter2001/11/26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
018421029AP2015/06/12Manufacturing Change or Addition
018421028AP2014/07/01Manufacturing Change or Addition
018421027AP2011/10/20Labeling Revision
018421025AP2016/10/25Labeling Revision
018421025AP2016/10/25Labeling Revision
018421022AP2002/11/08Control Supplement
018421021AP2003/01/31Labeling Revision
018421020AP1999/08/06Package Change
018421019AP1999/07/29Manufacturing Change or Addition
018421018AP1997/06/16Package Change
018421017AP1997/06/16Manufacturing Change or Addition
018421016AP2001/11/26Labeling Revision
018421015AP2001/11/26Labeling Revision
018421014AP2001/11/26Labeling Revision
018421013AP1989/11/26Labeling Revision
018421012AP1988/06/28Package Change
018421011AP1987/11/26Labeling Revision
018421009AP1987/09/29Manufacturing Change or Addition
018421007AP1984/07/23Formulation Revision
018421006AP1983/03/24Labeling Revision
018421004AP1983/01/31Labeling Revision
018421002AP1982/04/29Package Change
018421001AP1981/05/04Package Change
018421000AP1980/12/23Approval