药品名称PRAVACHOL
申请号019898产品号004
活性成分PRAVASTATIN SODIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格40MG
治疗等效代码AB参比药物
批准日期1993/03/22申请机构BRISTOL MYERS SQUIBB
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
50304472008/07/09PDF格式
5030447*PED2009/01/09PDF格式
51805892008/07/09PDF格式
5180589*PED2009/01/09PDF格式
56229852014/04/22U-335PDF格式
5622985*PED2014/10/22PDF格式
5622985*PED2014/10/22U-335PDF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
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
019898066APLetter2016/07/07下载
019898066APLabel2016/07/08下载
019898064APLetter2012/11/05下载
019898064APLabel2012/11/06下载
019898063APLabel2012/11/06下载
019898063APLetter2012/11/05下载
019898062APLetter2012/02/28下载
019898062APLabel2012/02/28下载
019898062APOther2012/02/28下载
019898062APReview2012/03/30下载
019898061APLetter2011/05/20下载
019898061APLabel2011/05/23下载
019898061APReview2013/08/07下载
019898060APLetter2007/03/07下载
019898060APLabel2007/03/07下载
019898058APLabel2005/07/15下载
019898058APLetter2005/07/15下载
019898054APLetter2003/09/25下载
019898054APLabel2003/09/25下载
019898054APReview2008/08/01下载
019898052APLetter2002/10/29下载
019898052APLabel2002/10/29下载
019898051APReview2007/11/19下载
019898050APReview2008/08/04下载
019898050APLetter2002/07/12下载
019898050APLabel2002/07/12下载
019898049APReview2007/11/19下载
019898046APLetter2001/12/18下载
019898046APLabel2001/12/18下载
019898044APReview2008/08/04下载
019898043APReview2008/08/04下载
019898042APLetter2001/06/15下载
019898042APLabel2001/06/15下载
019898041APReview2008/08/04下载
019898037APReview2008/08/04下载
019898036APReview2008/08/08下载
019898035APLetter1999/10/14下载
019898035APReview1999/10/14下载
019898035APReview1999/10/14下载
019898034APLetter1999/10/14下载
019898034APReview1999/10/14下载
019898032APReview2000/02/10下载
019898032APLetter2000/02/10下载
019898031APLetter2000/06/09下载
019898031APReview2007/04/11下载
019898030APLetter2000/01/18下载
019898029APLetter2000/01/18下载
019898027APLetter2000/01/18下载
019898026APLetter2000/01/18下载
019898025APReview2008/02/19下载
019898024APReview2008/02/19下载
019898023APReview2008/02/19下载
019898020APReview1998/03/11下载
019898018APReview1998/03/27下载
019898017APReview1997/04/15下载
019898016APReview2007/11/19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
019898066AP2016/07/05Labeling Revision
019898065AP2013/05/29Manufacturing Change or Addition
019898064AP2012/10/31Labeling Revision
019898063AP2012/10/31Labeling Revision
019898062AP2012/02/28Labeling Revision
019898061AP2011/05/18Labeling Revision
019898060AP2007/02/28Efficacy Supplement with Clinical Data to Support
019898058AP2005/07/06Labeling Revision
019898054AP2003/09/05Labeling Revision
019898052AP2002/10/29Patient Population Altered
019898051AP2002/06/14Control Supplement
019898050AP2002/07/12Labeling Revision
019898049AP2002/01/14Manufacturing Change or Addition
019898046AP2001/12/18New Dosage Regimen
019898045AP2001/08/13Manufacturing Change or Addition
019898044AP2001/03/14Control Supplement
019898043AP2001/03/12Manufacturing Change or Addition
019898042AP2001/06/15Efficacy Supplement with Clinical Data to Support
019898041AP2000/08/24Formulation Revision
019898037AP2000/06/23Efficacy Supplement with Clinical Data to Support
019898036AP1999/09/13Labeling Revision
019898035AP1999/10/14Manufacturing Change or Addition
019898034AP1999/10/14New or Modified Indication
019898032AP2000/02/10New or Modified Indication
019898031AP2000/06/09New or Modified Indication
019898030AP2000/01/18New Dosage Regimen
019898029AP2000/01/18New Dosage Regimen
019898027AP2000/01/18New or Modified Indication
019898026AP2000/01/18New or Modified Indication
019898025AP1999/04/09Control Supplement
019898024AP1999/01/28Manufacturing Change or Addition
019898023AP1999/02/11Manufacturing Change or Addition
019898022AP1998/10/26Package Change
019898021AP1998/08/17Labeling Revision
019898020AP1998/03/11New or Modified Indication
019898019AP1998/05/20Labeling Revision
019898018AP1998/03/27New or Modified Indication
019898017AP1997/04/15Labeling Revision
019898016AP1996/04/04Control Supplement
019898015AP1996/07/02New or Modified Indication
019898014AP1996/02/28Control Supplement
019898013AP1996/03/22New or Modified Indication
019898012AP1996/04/30Control Supplement
019898011AP1994/09/28Labeling Revision
019898010AP1995/03/30Labeling Revision
019898009AP1994/03/02Labeling Revision
019898008AP1994/02/09Formulation Revision
019898007AP1994/02/08Labeling Revision
019898006AP1993/07/23Control Supplement
019898005AP1992/07/07Package Change
019898004AP1993/03/22Control Supplement
019898003AP1993/03/22Labeling Revision
019898001AP1992/03/18Manufacturing Change or Addition
019898000AP1991/10/31Approval