药品名称FRAGMIN
申请号020287产品号004
活性成分DALTEPARIN SODIUM市场状态处方药
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格10,000IU/ML (10,000IU/ML)
治疗等效代码参比药物
批准日期1998/01/30申请机构PFIZER INC
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
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-4142006/12/10
I-5342010/05/01
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
020287067APLetter2016/08/05下载
020287067APLabel2016/08/09下载
020287063APLetter2015/10/01下载
020287063APLabel2015/10/07下载
020287062APLetter2015/01/27下载
020287062APLabel2015/01/30下载
020287050APLabel2010/10/25下载
020287050APLetter2010/10/26下载
020287049APLabel2009/12/30下载
020287049APLetter2010/01/05下载
020287035APReview2012/03/27下载
020287035APLetter2007/05/07下载
020287035APLabel2007/05/07下载
020287034APReview2008/07/31下载
020287034APLetter2004/04/29下载
020287032APLetter2003/12/16下载
020287032APLabel2003/12/16下载
020287032APReview2008/08/01下载
020287031APReview2008/08/01下载
020287031APLetter2003/07/06下载
020287029APLetter2002/11/19下载
020287027APLetter2002/11/01下载
020287023APLetter2002/04/04下载
020287022APLetter2002/04/04下载
020287021APLetter2002/04/04下载
020287018APLetter2000/08/03下载
020287018APLabel2000/08/03下载
020287017APReview2007/07/06下载
020287015APReview2007/07/06下载
020287011APLetter2003/03/10下载
020287010APLetter1999/05/25下载
020287010APLabel1999/05/25下载
020287010APReview1999/05/25下载
020287008APLetter1999/03/30下载
020287008APReview1999/03/30下载
020287008APLabel1999/03/30下载
020287005APReview1998/02/04下载
020287002APReview2008/08/11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
020287067AP2016/08/04Labeling Revision
020287063AP2015/09/29Labeling Revision
020287062AP2015/01/26Labeling Revision
020287061AP2013/10/22Manufacturing Change or Addition
020287060AP2013/10/15Labeling Revision
020287059AP2013/09/27Manufacturing Change or Addition
020287050AP2010/10/22Labeling Revision
020287049AP2009/12/23Labeling Revision
020287035AP2007/05/01New or Modified Indication
020287034AP2004/04/21Labeling Revision
020287032AP2003/12/10New or Modified Indication
020287031AP2003/07/02Labeling Revision
020287029AP2002/11/19Labeling Revision
020287028AP2002/09/11Control Supplement
020287027AP2002/11/01Labeling Revision
020287026AP2002/04/26Control Supplement
020287025AP2001/06/19Manufacturing Change or Addition
020287024AP2002/03/13Manufacturing Change or Addition
020287023AP2002/04/04Package Change
020287022AP2002/04/04Package Change
020287021AP2002/04/04Package Change
020287020AP2001/09/04Manufacturing Change or Addition
020287018AP2000/08/03New Dosage Regimen
020287017AP2000/11/14Manufacturing Change or Addition
020287016AP1999/06/30Manufacturing Change or Addition
020287015AP1999/08/05Package Change
020287012AP1999/01/22Package Change
020287011AP2003/02/27Labeling Revision
020287010AP1999/05/25New or Modified Indication
020287009AP1998/01/30Labeling Revision
020287008AP1999/03/30New or Modified Indication
020287007AP1997/01/23Manufacturing Change or Addition
020287006AP1998/01/30Formulation Revision
020287005AP1996/09/24Labeling Revision
020287004AP1997/04/08Control Supplement
020287003AP1996/03/18New Dosage Regimen
020287002AP1996/03/18Formulation Revision
020287001AP1995/08/14Labeling Revision
020287000AP1994/12/22Approval