药品名称RITALIN
申请号010187产品号006
活性成分METHYLPHENIDATE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格10MG
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NOVARTIS PHARMACEUTICALS CORP
化学类型New dosage form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
010187080APLetter2015/04/21下载
010187080APLabel2015/04/21下载
010187077APLetter2013/12/16下载
010187077APLabel2013/12/17下载
010187074APLetter2013/06/11下载
010187074APLabel2013/06/11下载
010187073APLabel2010/12/10下载
010187073APLetter2010/12/15下载
010187072APLabel2010/11/17下载
010187072APLetter2010/11/18下载
010187069APLabel2007/05/01下载
010187069APLetter2007/05/01下载
010187067APLabel2006/08/09下载
010187067APLetter2006/08/11下载
010187066APLetter2006/08/11下载
010187066APLabel2006/08/09下载
010187060APLetter2002/01/11下载
010187058APLetter2004/05/27下载
010187057APLetter2004/05/27下载
010187000APOther Important Information from FDA2007/05/10下载
010187000APMedication Guide2009/11/20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
010187084AP2016/05/27Manufacturing Change or Addition
010187081AP2015/10/02Manufacturing Change or Addition
010187080AP2015/04/17Labeling Revision
010187078AP2014/07/14Manufacturing Change or Addition
010187077AP2013/12/13Labeling Revision
010187076AP2014/02/07Manufacturing Change or Addition
010187075AP2013/10/25Manufacturing Change or Addition
010187074AP2013/06/07Labeling Revision
010187073AP2010/12/09Labeling Revision
010187072AP2010/11/15Labeling Revision
010187069AP2007/04/25Labeling Revision
010187067AP2006/08/08Labeling Revision
010187066AP2006/08/08Labeling Revision
010187062AP2002/06/12Control Supplement
010187061AP2002/05/29Manufacturing Change or Addition
010187060AP2002/01/11Labeling Revision
010187059AP2001/08/15Control Supplement
010187058AP2004/05/21Labeling Revision
010187057AP2004/05/21Labeling Revision
010187056AP2000/01/11Manufacturing Change or Addition
010187055AP1999/04/13Package Change
010187054AP1998/11/24Manufacturing Change or Addition
010187053AP1998/09/17Manufacturing Change or Addition
010187052AP1998/08/12Control Supplement
010187051AP1998/04/24Control Supplement
010187050AP1998/02/20Labeling Revision
010187048AP1997/07/09Labeling Revision
010187047AP1995/12/15Labeling Revision
010187046AP1997/07/09Labeling Revision
010187045AP1995/06/01Control Supplement
010187044AP1994/08/19Manufacturing Change or Addition
010187043AP1994/05/31Control Supplement
010187042AP1997/07/09Labeling Revision
010187041AP1994/03/07Control Supplement
010187040AP1990/03/09Manufacturing Change or Addition
010187039AP1997/07/09Labeling Revision
010187038AP1987/12/08Control Supplement
010187037AP1986/01/21Labeling Revision
010187036AP1985/03/13Control Supplement
010187034AP1985/10/10Control Supplement
010187032AP1981/02/18Labeling Revision
010187031AP1980/03/06Formulation Revision
010187030AP1980/02/15Formulation Revision
010187028AP1975/09/09Control Supplement
010187026AP1979/10/12Control Supplement
010187025AP1975/09/09Control Supplement
010187024AP1975/09/09Control Supplement
010187023AP1975/09/09Control Supplement
010187021AP1975/02/21Control Supplement
010187000AP1955/12/05Approval