药品名称SINEMET
申请号017555产品号002
活性成分CARBIDOPA; LEVODOPA市场状态处方药
剂型或给药途径TABLET;ORAL规格25MG;250MG
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MERCK SHARP AND DOHME CORP
化学类型审评分类Priority 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
017555071APLabel2014/07/22下载
017555071APLetter2014/07/23下载
017555070APLabel2011/02/04下载
017555070APLetter2011/02/07下载
017555069APReview2013/06/03下载
017555069APLetter2009/01/06下载
017555069APLabel2009/01/06下载
017555068APLabel2014/07/22下载
017555068APLetter2014/07/23下载
017555056APLetter2014/07/23下载
017555056APLabel2014/07/22下载
017555055APLetter2001/04/11下载
017555051APLetter2001/04/11下载
017555050APLetter2001/04/11下载
017555045APLetter2001/04/11下载
017555040APLetter2001/04/11下载
017555039APLetter2001/04/11下载
017555038APLetter2001/04/11下载
017555037APLetter2001/04/11下载
017555036APLetter2001/04/11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
017555071AP2014/07/17Labeling Revision
017555070AP2011/02/01Manufacturing Change or Addition
017555069AP2008/12/31Labeling Revision
017555068AP2014/07/17Labeling Revision
017555062AP2002/09/05Manufacturing Change or Addition
017555061AP2001/10/11Manufacturing Change or Addition
017555060AP2001/03/16Control Supplement
017555059AP2001/02/01Control Supplement
017555058AP2001/02/01Control Supplement
017555057AP2001/03/16Manufacturing Change or Addition
017555056AP2014/07/17Labeling Revision
017555055AP2001/04/11Labeling Revision
017555054AP2000/06/06Manufacturing Change or Addition
017555053AP2000/04/04Manufacturing Change or Addition
017555051AP2001/04/11Labeling Revision
017555050AP2001/04/11Labeling Revision
017555048AP1997/11/26Formulation Revision
017555047AP1997/12/04Formulation Revision
017555046AP1997/11/07Package Change
017555045AP2001/04/11Labeling Revision
017555044AP1996/05/16Package Change
017555043AP1995/07/13Control Supplement
017555040AP2001/04/11Labeling Revision
017555039AP2001/04/11Labeling Revision
017555038AP2001/04/11Labeling Revision
017555037AP2001/04/11Labeling Revision
017555036AP2001/04/11Labeling Revision
017555035AP1988/04/21Labeling Revision
017555034AP1988/02/26Control Supplement
017555033AP1986/01/17Labeling Revision
017555032AP1986/01/17Labeling Revision
017555031AP1985/07/12Package Change
017555030AP1985/07/30Labeling Revision
017555029AP1985/05/06Manufacturing Change or Addition
017555028AP1984/03/02Manufacturing Change or Addition
017555027AP1984/05/11Control Supplement
017555026AP1984/09/13Control Supplement
017555025AP1986/01/17Labeling Revision
017555024AP1986/01/17Labeling Revision
017555023AP1986/01/17Labeling Revision
017555022AP1983/05/04Control Supplement
017555020AP1981/08/21Formulation Revision
017555019AP1983/06/09Package Change
017555018AP1981/09/02Labeling Revision
017555016AP1980/09/09Labeling Revision
017555015AP1981/01/12Formulation Revision
017555014AP1980/02/11Package Change
017555012AP1980/01/29Labeling Revision
017555011AP1980/01/29Manufacturing Change or Addition
017555010AP1980/03/12Labeling Revision
017555009AP1979/10/22Package Change
017555008AP1978/07/13Control Supplement
017555007AP1980/03/13Formulation Revision
017555006AP1978/03/24Labeling Revision
017555005AP1977/04/29Labeling Revision
017555004AP1978/01/25Package Change
017555003AP1978/01/26Formulation Revision
017555000AP1975/05/02Approval