药品名称CLOZARIL
申请号019758产品号001
活性成分CLOZAPINE市场状态处方药
剂型或给药途径TABLET;ORAL规格25MG
治疗等效代码AB参比药物
批准日期1989/09/26申请机构HERITAGE LIFE SCIENCES BARBADOS 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
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
019758078APLetter2015/10/13下载
019758078APLabel2015/10/22下载
019758077APLabel2015/09/16下载
019758077APLetter2015/09/16下载
019758074APLetter2015/09/22下载
019758074APLabel2015/09/23下载
019758073APLetter2014/12/23下载
019758073APLabel2015/01/09下载
019758072APLabel2014/09/30下载
019758072APLetter2014/10/01下载
019758071APLabel2013/07/23下载
019758070APLabel2013/03/26下载
019758070APLetter2013/03/25下载
019758069APLetter2013/07/22下载
019758069APLabel2013/07/23下载
019758068APLetter2013/03/25下载
019758068APLabel2013/03/26下载
019758067APLabel2013/03/26下载
019758067APLetter2013/03/25下载
019758065APLabel2010/12/04下载
019758065APLetter2010/12/06下载
019758063APLetter2011/10/24下载
019758063APLabel2011/10/25下载
019758062APLabel2010/01/20下载
019758062APLetter2010/01/26下载
019758061APLetter2015/09/16下载
019758061APLabel2015/09/16下载
019758059APLetter2008/08/19下载
019758058APLetter2008/07/01下载
019758057APLetter2005/12/13下载
019758056APLetter2005/06/29下载
019758056APLabel2005/06/29下载
019758054APLetter2005/05/17下载
019758054APLabel2005/05/17下载
019758053APLetter2008/11/06下载
019758051APLetter2003/12/24下载
019758048APLetter2002/07/05下载
019758047APLabel2003/04/04下载
019758047APLetter2004/06/01下载
019758047APReview2012/03/14下载
019758045APLetter2002/01/14下载
019758045APLabel2002/01/14下载
019758044APLabel2003/06/16下载
019758035APReview2008/02/19下载
019758000APOther Important Information from FDA2011/12/22下载
019758000APOther2015/09/16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
019758079AP2016/05/06Manufacturing Change or Addition
019758078AP2015/10/08Labeling Revision
019758077AP2015/09/15Labeling Revision
019758076AP2015/11/10Manufacturing Change or Addition
019758074AP2015/09/18Labeling Revision
019758073AP2014/12/19Labeling Revision
019758072AP2014/09/29Labeling Revision
019758071AP2013/07/19Labeling Revision
019758070AP2013/03/22Labeling Revision
019758069AP2013/07/19Labeling Revision
019758068AP2013/03/22Labeling Revision
019758067AP2013/03/22Labeling Revision
019758065AP2010/12/01Labeling Revision
019758064AP2014/09/30Manufacturing Change or Addition
019758063AP2011/10/19Labeling Revision
019758062AP2010/01/14Labeling Revision
019758061AP2015/09/15Efficacy Supplement with Clinical Data to Support
019758059AP2008/08/14Labeling Revision
019758058AP2008/06/26Labeling Revision
019758057AP2005/12/05Labeling Revision
019758056AP2005/06/29Labeling Revision
019758054AP2005/05/12Labeling Revision
019758053AP2008/11/06Labeling Revision
019758051AP2003/12/23Labeling Revision
019758048AP2002/07/05Labeling Revision
019758047AP2002/12/18New or Modified Indication
019758046AP2001/12/14Manufacturing Change or Addition
019758045AP2002/01/14Labeling Revision
019758044AP2001/08/29Labeling Revision
019758043AP2001/05/18Control Supplement
019758042AP2000/05/17Manufacturing Change or Addition
019758041AP2000/03/17Labeling Revision
019758040AP1999/10/15Control Supplement
019758039AP1999/11/01Manufacturing Change or Addition
019758038AP1999/04/15Package Change
019758037AP1999/08/09Package Change
019758036AP1998/08/19Labeling Revision
019758035AP1997/09/19Labeling Revision
019758034AP1998/03/03Labeling Revision
019758033AP1997/04/25Labeling Revision
019758032AP1997/06/27Labeling Revision
019758031AP1997/01/13Control Supplement
019758030AP1996/05/07Control Supplement
019758029AP1995/11/22Manufacturing Change or Addition
019758027AP1997/04/25Labeling Revision
019758026AP1995/10/17Control Supplement
019758025AP1997/04/25Labeling Revision
019758024AP1995/05/10Manufacturing Change or Addition
019758023AP1997/04/25Labeling Revision
019758022AP1994/08/30Labeling Revision
019758021AP1994/05/20Labeling Revision
019758020AP1994/07/15Control Supplement
019758019AP1995/03/07Control Supplement
019758017AP1994/08/05Control Supplement
019758016AP1995/08/31Labeling Revision
019758015AP1995/08/31Formulation Revision
019758014AP1992/08/20Labeling Revision
019758013AP1994/08/01Package Change
019758012AP1994/03/25Control Supplement
019758011AP1992/08/10Labeling Revision
019758010AP1992/10/27Labeling Revision
019758009AP1991/09/04Control Supplement
019758008AP1991/06/12Labeling Revision
019758006AP1991/06/12Labeling Revision
019758005AP1991/06/12Labeling Revision
019758004AP1994/03/25Package Change
019758003AP1994/03/25Package Change
019758002AP1991/06/12Labeling Revision
019758001AP1990/02/05Labeling Revision
019758000AP1989/09/26Approval