药品名称CAMPTOSAR
申请号020571产品号001
活性成分IRINOTECAN HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格40MG/2ML (20MG/ML)
治疗等效代码AP参比药物
批准日期1996/06/14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
64035692020/04/28U-449PDF格式
67943702020/05/01U-606PDF格式
6403569*PED2020/10/28PDF格式
6794370*PED2020/11/01PDF格式
历史专利信息
46044632007/08/20PDF格式
4604463*PED2008/02/20PDF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
M-342007/06/24
PED2007/12/24
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
020571048APLetter2014/12/23下载
020571048APLabel2015/01/09下载
020571042APLetter2012/07/17下载
020571042APLabel2012/07/25下载
020571037APLetter2010/05/21下载
020571037APLabel2010/05/28下载
020571036APLetter2010/05/21下载
020571036APLabel2010/05/28下载
020571033APLabel2010/05/28下载
020571033APLetter2010/05/21下载
020571032APLetter2010/05/21下载
020571032APLabel2010/05/28下载
020571031APLabel2010/05/28下载
020571031APLetter2010/05/21下载
020571030APLabel2006/08/04下载
020571030APLetter2006/08/04下载
020571028APLabel2005/07/26下载
020571028APLetter2005/07/26下载
020571027APLetter2005/07/26下载
020571027APLabel2005/07/26下载
020571026APLetter2005/06/08下载
020571026APLabel2005/06/08下载
020571024APLetter2005/07/26下载
020571024APLabel2005/07/26下载
020571023APLetter2004/12/08下载
020571023APLabel2004/12/08下载
020571021APReview2005/04/05下载
020571021APLetter2004/06/25下载
020571021APLabel2004/06/25下载
020571016APLetter2002/05/16下载
020571016APLabel2002/05/16下载
020571009APReview2000/04/20下载
020571009APLetter2000/04/20下载
020571009APLabel2000/04/20下载
020571008APLetter1998/10/22下载
020571008APReview1998/10/22下载
020571008APLabel1998/10/22下载
020571007APReview2007/07/06下载
020571006APReview2007/07/06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
020571048AP2014/12/19Labeling Revision
020571047AP2014/06/09Manufacturing Change or Addition
020571044AP2013/01/17Manufacturing Change or Addition
020571042AP2012/07/13Labeling Revision
020571037AP2010/05/14Labeling Revision
020571036AP2010/05/14Labeling Revision
020571033AP2010/05/14Labeling Revision
020571032AP2010/05/14Labeling Revision
020571031AP2010/05/14Labeling Revision
020571030AP2006/08/01Labeling Revision
020571028AP2005/07/21Labeling Revision
020571027AP2005/07/21Labeling Revision
020571026AP2005/06/07Labeling Revision
020571024AP2005/07/21Labeling Revision
020571023AP2004/12/03Labeling Revision
020571021AP2004/06/24Efficacy Supplement with Clinical Data to Support
020571017AP2002/07/30Manufacturing Change or Addition
020571016AP2002/05/16Labeling Revision
020571014AP2001/11/05Control Supplement
020571013AP2001/08/06Control Supplement
020571011AP2000/07/29Manufacturing Change or Addition
020571009AP2000/04/20New or Modified Indication
020571008AP1998/10/22Accelerated Approval
020571007AP1998/03/18Labeling Revision
020571006AP1998/01/15Formulation Revision
020571005AP1997/10/21Control Supplement
020571004AP1997/03/07Labeling Revision
020571003AP1997/06/05Package Change
020571002AP1997/12/10Control Supplement
020571001AP1997/01/03Labeling Revision
020571000AP1996/06/14Approval