药品名称GEMZAR
申请号020509产品号001
活性成分GEMCITABINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 200MG BASE/VIAL
治疗等效代码AP参比药物
批准日期1996/05/15申请机构ELI LILLY AND CO
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
48086142010/05/15YPDF格式
4808614*PED2010/11/15PDF格式
54648262012/11/07U-146PDF格式
5464826*PED2013/05/07PDF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-4282007/05/19
I-4992009/07/14
M-402008/04/26
PED2007/11/19
PED2008/10/26
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
020509077APLabel2014/05/12下载
020509077APLetter2014/05/12下载
020509075APLetter2014/06/12下载
020509075APLabel2015/10/13下载
020509072APLabel2013/05/08下载
020509069APLabel2011/02/09下载
020509064APLetter2010/03/24下载
020509064APLabel2010/03/26下载
020509039APLetter2006/07/21下载
020509037APLetter2006/04/07下载
020509033APReview2008/02/19下载
020509033APLetter2005/04/28下载
020509033APLabel2005/04/28下载
020509032APLetter2005/04/28下载
020509032APLabel2005/04/28下载
020509029APLabel2004/05/19下载
020509029APLetter2004/05/26下载
020509029APReview2007/11/19下载
020509021APLetter2002/05/01下载
020509013APLabel2003/03/07下载
020509013APLetter2005/04/07下载
020509005APLetter1998/08/25下载
020509005APLabel1998/08/25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
020509077AP2014/05/08Labeling Revision
020509076AP2014/08/11Manufacturing Change or Addition
020509075AP2014/06/10Labeling Revision
020509072AP2013/05/07Labeling Revision
020509069AP2011/02/04Labeling Revision
020509064AP2010/03/19Labeling Revision
020509039AP2006/07/14New or Modified Indication
020509037AP2006/04/05Labeling Revision
020509033AP2005/04/26Efficacy Supplement with Clinical Data to Support
020509032AP2005/04/20Labeling Revision
020509029AP2004/05/19New or Modified Indication
020509022AP2002/11/13Control Supplement
020509021AP2002/05/01Control Supplement
020509020AP2001/05/18Control Supplement
020509019AP2000/11/01Control Supplement
020509018AP2001/01/04Control Supplement
020509017AP2000/06/09Control Supplement
020509016AP2000/06/22Control Supplement
020509014AP2000/03/03Control Supplement
020509013AP2003/01/06Labeling Revision
020509011AP1998/11/23Manufacturing Change or Addition
020509010AP2000/06/23Labeling Revision
020509007AP1998/10/16Control Supplement
020509006AP1998/01/23Manufacturing Change or Addition
020509005AP1998/08/25New or Modified Indication
020509004AP1997/09/18Labeling Revision
020509003AP1997/10/10Manufacturing Change or Addition
020509002AP1997/04/11Control Supplement
020509001AP1997/02/05Manufacturing Change or Addition
020509000AP1996/05/15Approval