药品名称LITHOBID
申请号018027产品号001
活性成分LITHIUM CARBONATE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格300MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ANI PHARMACEUTICALS 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
018027059APLetter2016/06/01下载
018027059APLabel2016/06/01下载
018027056APLetter2011/10/24下载
018027056APLabel2011/10/25下载
018027055APLetter2006/10/05下载
018027055APReview2008/04/02下载
018027051APLetter2006/04/13下载
018027049APLabel2002/10/07下载
018027049APLetter2002/10/07下载
018027046APLetter2002/10/07下载
018027046APLabel2002/10/07下载
018027040APLetter2002/10/07下载
018027040APLabel2002/10/07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
018027059AP2016/05/27Labeling Revision
018027058AP2015/05/11Manufacturing Change or Addition
018027057AP2015/01/05Manufacturing Change or Addition
018027056AP2011/10/20Labeling Revision
018027055AP2006/10/01Labeling Revision
018027051AP2006/04/07Labeling Revision
018027049AP2002/10/07Labeling Revision
018027048AP2001/10/16Expiration Date Change
018027047AP2000/12/22Expiration Date Change
018027046AP2002/10/07Labeling Revision
018027045AP1997/07/11Manufacturing Change or Addition
018027043AP1995/05/26Control Supplement
018027040AP2002/10/07Labeling Revision
018027037AP1990/05/02Formulation Revision
018027035AP2002/10/07Labeling Revision
018027034AP1990/04/20Labeling Revision
018027032AP1988/10/13Package Change
018027031AP1988/10/13Package Change
018027029AP1988/08/24Manufacturing Change or Addition
018027028AP1989/04/07Package Change
018027027AP2002/10/07Labeling Revision
018027025AP2002/10/07Labeling Revision
018027024AP1986/05/01Control Supplement
018027022AP1985/03/26Manufacturing Change or Addition
018027021AP1985/05/29Control Supplement
018027020AP1983/02/25Package Change
018027019AP1983/02/25Package Change
018027018AP1982/04/19Manufacturing Change or Addition
018027017AP1982/02/19Package Change
018027016AP1981/09/25Labeling Revision
018027015AP1981/08/06Package Change
018027013AP1981/04/06Manufacturing Change or Addition
018027010AP1980/10/02Labeling Revision
018027009AP1980/05/13Manufacturing Change or Addition
018027008AP1984/03/26Manufacturing Change or Addition
018027005AP1979/10/03Package Change
018027004AP1979/10/03Labeling Revision
018027003AP1980/01/04Labeling Revision
018027002AP1979/10/03Package Change
018027001AP1979/09/13Labeling Revision
018027000AP1979/04/27Approval