药品名称RITALIN LA
申请号021284产品号005
活性成分METHYLPHENIDATE HYDROCHLORIDE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格60MG
治疗等效代码AB1参比药物
批准日期2014/10/27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)
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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
021284027APLetter2015/04/21下载
021284027APLabel2015/04/21下载
021284025APLetter2014/11/10下载
021284025APLabel2014/12/19下载
021284023APLetter2013/12/16下载
021284023APLabel2013/12/17下载
021284020APLabel2013/05/06下载
021284020APLetter2013/05/07下载
021284019APLetter2013/06/11下载
021284019APLabel2013/06/11下载
021284018APLabel2010/12/10下载
021284018APLetter2010/12/15下载
021284017APMedication Guide2010/11/17下载
021284017APLabel2010/11/17下载
021284017APLetter2010/11/18下载
021284011APLabel2007/05/01下载
021284011APLetter2007/05/01下载
021284010APLetter2010/04/29下载
021284010APLabel2010/05/07下载
021284010APMedication Guide2010/05/07下载
021284008APLabel2006/08/09下载
021284008APLetter2006/08/11下载
021284006APLetter2006/08/11下载
021284006APLabel2006/08/09下载
021284004APLetter2004/04/20下载
021284000APLabel2002/06/05下载
021284000APLetter2002/06/05下载
021284000APReview2002/11/20下载
021284000APOther Important Information from FDA2007/05/10下载
021284000APMedication 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
021284031AP2016/02/09Manufacturing Change or Addition
021284027AP2015/04/17Labeling Revision
021284026AP2015/06/02Manufacturing Change or Addition
021284025AP2014/10/27Manufacturing Change or Addition
021284023AP2013/12/13Labeling Revision
021284021AP2013/10/25Manufacturing Change or Addition
021284020AP2013/05/06Labeling Revision
021284019AP2013/06/07Labeling Revision
021284018AP2010/12/09Labeling Revision
021284017AP2010/11/15Labeling Revision
021284011AP2007/04/25Labeling Revision
021284010AP2010/04/27Labeling Revision
021284008AP2006/08/08Labeling Revision
021284006AP2006/08/08Labeling Revision
021284004AP2004/04/08Manufacturing Change or Addition
021284001AP2002/12/10Control Supplement
021284000AP2002/06/05Approval