药品名称LIPITOR
申请号020702产品号002
活性成分ATORVASTATIN CALCIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 20MG BASE
治疗等效代码AB参比药物
批准日期1996/12/17申请机构PFIZER INC
化学类型New molecular entity (NME)审评分类Priority 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
59691562016/07/08YPDF格式
5969156*PED2017/01/08PDF格式
历史专利信息
46818932009/09/24YYU-161PDF格式
4681893*PED2010/03/24U-161PDF格式
52739952010/12/28YYU-162PDF格式
5273995*PED2011/06/28U-162PDF格式
56861042014/11/11YU-213PDF格式
5686104*PED2015/05/11PDF格式
5686104*PED2015/05/11U-213PDF格式
61269712013/01/19YPDF格式
6126971*PED2013/07/19PDF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-4342007/07/30
I-4712008/09/21
I-5232010/03/02
M-362007/07/30
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
020702065APLetter2015/03/13下载
020702065APLabel2015/03/17下载
020702064APLetter2014/05/22下载
020702064APLabel2014/05/28下载
020702063APLabel2012/11/02下载
020702063APLetter2012/11/05下载
020702062APLetter2012/11/05下载
020702062APLabel2012/11/02下载
020702060APLabel2012/02/28下载
020702060APLetter2012/02/28下载
020702060APReview2012/03/30下载
020702057APLetter2009/04/01下载
020702057APLabel2009/04/03下载
020702056APLabel2009/06/22下载
020702056APLetter2010/11/05下载
020702056APReview2013/08/06下载
020702050APLabel2007/09/26下载
020702050APLetter2007/10/04下载
020702049APLabel2007/01/18下载
020702049APLetter2007/01/25下载
020702047APLetter2007/03/07下载
020702047APLabel2007/03/07下载
020702046APLetter2006/06/27下载
020702046APPatient Package Insert2006/06/28下载
020702044APLabel2006/08/09下载
020702044APLetter2006/08/09下载
020702043APLetter2005/10/14下载
020702042APLetter2005/10/20下载
020702042APLabel2005/09/30下载
020702039APLetter2004/08/02下载
020702039APReview2008/08/01下载
020702037APReview2008/08/01下载
020702037APLetter2003/10/09下载
020702037APLabel2003/10/10下载
020702036APLabel2003/05/29下载
020702036APLetter2003/06/08下载
020702036APReview2007/09/26下载
020702035APReview2007/09/26下载
020702034APLetter2004/06/08下载
020702034APLabel2004/06/08下载
020702033APLetter2002/10/18下载
020702033APLabel2002/10/18下载
020702031APReview2007/12/06下载
020702030APReview2007/12/06下载
020702029APLetter2002/04/22下载
020702029APLabel2002/04/22下载
020702028APReview2007/12/06下载
020702027APReview2008/07/31下载
020702027APLetter2004/05/26下载
020702027APPatient Package Insert2004/05/27下载
020702025APLetter2001/06/15下载
020702025APLabel2001/06/15下载
020702025APReview2002/04/10下载
020702024APReview2008/02/19下载
020702022APReview2007/07/06下载
020702021APReview2007/11/19下载
020702018APLetter1999/12/02下载
020702018APReview2001/02/26下载
020702014APReview1998/12/14下载
020702013APReview2007/11/19下载
020702012APReview2007/11/19下载
020702011APReview2007/11/19下载
020702010APReview2007/11/19下载
020702009APReview2007/11/19下载
020702008APReview2007/07/06下载
020702005APLetter1998/07/10下载
020702005APReview1998/07/10下载
020702004APReview1998/10/23下载
020702003APLetter1998/07/10下载
020702003APReview1998/11/12下载
020702002APReview1997/11/28下载
020702000APReview2010/03/16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
020702065AP2015/03/11Labeling Revision
020702064AP2014/05/21Labeling Revision
020702063AP2012/10/31Labeling Revision
020702062AP2012/10/31Labeling Revision
020702061AP2012/11/30Manufacturing Change or Addition
020702060AP2012/02/28Labeling Revision
020702057AP2009/03/27Labeling Revision
020702056AP2009/06/17Labeling Revision
020702050AP2007/09/26Labeling Revision
020702049AP2007/01/16Labeling Revision
020702047AP2007/03/02New or Modified Indication
020702046AP2006/06/23Labeling Revision
020702044AP2006/08/07Labeling Revision
020702043AP2005/10/11Labeling Revision
020702042AP2005/09/21New or Modified Indication
020702039AP2004/07/30New or Modified Indication
020702037AP2003/09/29Control Supplement
020702036AP2003/05/12Labeling Revision
020702035AP2002/07/02Control Supplement
020702034AP2002/04/22Labeling Revision
020702033AP2002/10/18Patient Population Altered
020702032AP2002/04/08Package Change
020702031AP2001/12/27Manufacturing Change or Addition
020702030AP2001/12/27Manufacturing Change or Addition
020702029AP2002/04/22Efficacy Supplement with Clinical Data to Support
020702028AP2001/11/20Control Supplement
020702027AP2004/05/24Labeling Revision
020702025AP2001/06/08Efficacy Supplement with Clinical Data to Support
020702024AP2000/11/14Manufacturing Change or Addition
020702022AP2000/04/07Formulation Revision
020702021AP1999/12/01Package Change
020702020AP1999/12/22Manufacturing Change or Addition
020702018AP1999/12/02New or Modified Indication
020702014AP1998/08/28Labeling Revision
020702013AP1998/06/25Control Supplement
020702012AP1998/06/03Labeling Revision
020702011AP1998/08/04Manufacturing Change or Addition
020702010AP1998/04/29Manufacturing Change or Addition
020702009AP1998/03/23Manufacturing Change or Addition
020702008AP1997/11/05Labeling Revision
020702007AP1998/02/06Control Supplement
020702005AP1998/07/10New or Modified Indication
020702004AP1998/02/02Labeling Revision
020702003AP1998/07/10New or Modified Indication
020702002AP1997/10/28Labeling Revision
020702001AP1997/07/18Control Supplement
020702000AP1996/12/17Approval