药品名称LESCOL
申请号020261产品号001
活性成分FLUVASTATIN SODIUM市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 20MG BASE
治疗等效代码AB参比药物
批准日期1993/12/31申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)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
53547722011/10/11U-109PDF格式
53547722011/10/11U-413PDF格式
5354772*PED2012/04/11PDF格式
53568962011/12/12PDF格式
5356896*PED2012/06/12PDF格式
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
I-5072009/04/10
PED2006/11/27
PED2009/10/10
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
020261048APLetter2012/11/05下载
020261048APLabel2012/11/06下载
020261046APLabel2012/02/28下载
020261046APOther2012/02/28下载
020261046APLetter2012/02/28下载
020261046APReview2012/03/30下载
020261042APLetter2011/06/28下载
020261042APLabel2011/06/28下载
020261039APLetter2007/06/14下载
020261039APLabel2007/06/14下载
020261037APLetter2006/04/05下载
020261037APLabel2006/04/05下载
020261036APLabel2006/04/12下载
020261036APLetter2006/04/13下载
020261035APLetter2006/04/13下载
020261035APLabel2006/04/12下载
020261034APLetter2005/01/11下载
020261034APLabel2005/01/11下载
020261034APReview2009/09/16下载
020261033APLetter2003/06/08下载
020261033APLabel2003/06/08下载
020261033APReview2007/04/09下载
020261032APLabel2002/09/06下载
020261032APLetter2002/09/06下载
020261032APReview2008/08/04下载
020261031APReview2008/08/04下载
020261030APLabel2003/04/22下载
020261029APReview2008/08/04下载
020261028APReview2004/06/08下载
020261028APLetter2004/06/08下载
020261028APLabel2004/06/08下载
020261025APLetter2000/12/18下载
020261024APLetter2000/10/23下载
020261024APLabel2000/10/23下载
020261022APReview1999/03/08下载
020261022APLetter1999/03/08下载
020261021APReview2008/02/19下载
020261020APReview2008/02/19下载
020261019APReview2008/04/02下载
020261018APLetter1999/03/08下载
020261018APReview1999/05/08下载
020261017APReview2008/02/19下载
020261016APReview2008/02/19下载
020261015APReview2008/02/19下载
020261014APReview2007/09/26下载
020261013APReview2007/09/26下载
020261011APReview2008/04/02下载
020261010APReview2007/09/14下载
020261009APReview2008/02/19下载
020261007APReview2008/02/19下载
020261004APReview2007/07/06下载
020261003APReview2007/07/06下载
020261002APReview2009/09/16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
020261051AP2016/09/19Manufacturing Change or Addition
020261050AP2015/11/05Manufacturing Change or Addition
020261049AP2015/06/17Manufacturing Change or Addition
020261048AP2012/10/31Labeling Revision
020261047AP2013/06/25Manufacturing Change or Addition
020261046AP2012/02/28Labeling Revision
020261042AP2011/06/17Labeling Revision
020261039AP2007/06/12Labeling Revision
020261037AP2006/03/22Labeling Revision
020261036AP2006/04/10Patient Population Altered
020261035AP2006/04/10New Dosage Regimen
020261034AP2005/01/05Labeling Revision
020261033AP2003/05/27New or Modified Indication
020261032AP2002/09/06Labeling Revision
020261031AP2002/02/11Manufacturing Change or Addition
020261030AP2001/09/25Labeling Revision
020261029AP2001/05/23Manufacturing Change or Addition
020261028AP2000/10/06Labeling Revision
020261027AP2000/07/26Manufacturing Change or Addition
020261025AP2000/12/18New or Modified Indication
020261024AP2000/10/23Efficacy Supplement with Clinical Data to Support
020261023AP1999/10/14Manufacturing Change or Addition
020261022AP1999/03/08Efficacy Supplement with Clinical Data to Support
020261021AP1999/05/14Control Supplement
020261020AP1999/04/21Package Change
020261019AP1999/01/04Labeling Revision
020261018AP1999/03/08New or Modified Indication
020261017AP1998/08/05Manufacturing Change or Addition
020261016AP1998/04/23Control Supplement
020261015AP1997/11/20Package Change
020261014AP1997/04/21Package Change
020261013AP1997/06/16Control Supplement
020261012AP1997/10/01New or Modified Indication
020261011AP1998/10/08Control Supplement
020261010AP1996/04/30Manufacturing Change or Addition
020261009AP1996/02/08Control Supplement
020261008AP1995/12/22Manufacturing Change or Addition
020261007AP1995/10/17Control Supplement
020261006AP1996/03/20New Dosage Regimen
020261005AP1995/05/03Labeling Revision
020261004AP1994/11/10Control Supplement
020261003AP1994/11/28Package Change
020261002AP1994/03/21Labeling Revision
020261001AP1995/03/13Control Supplement
020261000AP1993/12/31Approval