药品名称RITALIN-SR
申请号018029产品号001
活性成分METHYLPHENIDATE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格20MG
治疗等效代码AB参比药物
批准日期1982/03/30申请机构NOVARTIS PHARMACEUTICALS 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
018029049APLetter2015/04/21下载
018029049APLabel2015/04/21下载
018029047APLetter2013/12/16下载
018029047APLabel2013/12/17下载
018029044APLetter2013/06/11下载
018029044APLabel2013/06/11下载
018029043APLabel2010/12/10下载
018029043APLetter2010/12/15下载
018029042APLabel2010/11/17下载
018029042APLetter2010/11/18下载
018029040APLabel2007/05/01下载
018029040APLetter2007/05/01下载
018029038APLabel2006/08/09下载
018029038APLetter2006/08/11下载
018029037APLetter2006/08/11下载
018029037APLabel2006/08/09下载
018029032APLetter2002/01/11下载
018029029APLetter2004/05/27下载
018029028APLetter2004/05/27下载
018029000APOther Important Information from FDA2007/05/10下载
018029000APMedication 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
018029052AP2015/12/01Manufacturing Change or Addition
018029049AP2015/04/17Labeling Revision
018029047AP2013/12/13Labeling Revision
018029045AP2013/10/25Manufacturing Change or Addition
018029044AP2013/06/07Labeling Revision
018029043AP2010/12/09Labeling Revision
018029042AP2010/11/15Labeling Revision
018029040AP2007/04/25Labeling Revision
018029038AP2006/08/08Labeling Revision
018029037AP2006/08/08Labeling Revision
018029034AP2002/06/12Control Supplement
018029033AP2002/05/29Manufacturing Change or Addition
018029032AP2002/01/11Labeling Revision
018029031AP2001/08/15Control Supplement
018029030AP2001/03/13Control Supplement
018029029AP2004/05/21Approval
018029028AP2004/05/21Labeling Revision
018029027AP1999/04/15Package Change
018029026AP1998/11/24Manufacturing Change or Addition
018029025AP1998/09/17Manufacturing Change or Addition
018029024AP1998/08/12Control Supplement
018029023AP1998/04/24Control Supplement
018029022AP1998/02/20Labeling Revision
018029020AP1997/07/09Labeling Revision
018029019AP1995/12/15Labeling Revision
018029018AP1997/07/09Labeling Revision
018029017AP1994/08/19Manufacturing Change or Addition
018029016AP1994/05/31Control Supplement
018029015AP1993/06/18Control Supplement
018029014AP1994/04/15Control Supplement
018029013AP1997/07/09Labeling Revision
018029012AP1994/03/09Control Supplement
018029011AP1990/03/09Manufacturing Change or Addition
018029010AP1997/07/09Labeling Revision
018029009AP1988/07/21Control Supplement
018029008AP1987/04/20Control Supplement
018029007AP1986/10/07Control Supplement
018029006AP1986/01/21Labeling Revision
018029005AP1985/03/13Expiration Date Change
018029004AP1983/09/14Control Supplement
018029002AP1988/10/31Control Supplement
018029000AP1982/03/30Approval