药品名称AREDIA
申请号020036产品号003
活性成分PAMIDRONATE DISODIUM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格60MG/VIAL
治疗等效代码参比药物
批准日期1993/05/06申请机构NOVARTIS PHARMACEUTICALS CORP
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)
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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
020036041APLabel2012/06/06下载
020036041APLetter2012/06/07下载
020036039APLetter2011/04/04下载
020036039APLabel2011/04/11下载
020036035APLetter2008/12/18下载
020036035APLabel2009/01/02下载
020036034APLetter2008/01/09下载
020036034APLabel2007/12/14下载
020036032APLetter2005/11/18下载
020036032APLabel2005/11/18下载
020036031APLetter2005/10/14下载
020036031APLabel2005/10/14下载
020036030APLetter2005/02/03下载
020036030APLabel2005/02/03下载
020036030APReview2009/01/12下载
020036029APLetter2004/03/28下载
020036028APLetter2004/01/09下载
020036028APReview2007/08/06下载
020036026APLetter2002/07/12下载
020036024APLetter2001/08/20下载
020036024APLabel2001/08/20下载
020036024APReview2004/05/27下载
020036020APReview2008/02/19下载
020036020APLetter2003/10/16下载
020036016APReview1998/09/22下载
020036016APLetter1998/09/22下载
020036015APReview1998/09/22下载
020036015APLetter1998/09/22下载
020036005APReview2004/01/06下载
020036004APLabel2003/04/30下载
020036004APLetter2004/09/10下载
020036004APReview2004/01/06下载
020036003APReview2004/01/06下载
020036002APReview2004/01/06下载
020036001APReview2004/01/06下载
020036000APLetter2003/12/02下载
020036000APLabel2003/12/02下载
020036000APReview2004/01/06下载
020036000APOther Important Information from FDA2008/01/07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
020036041AP2012/05/31Labeling Revision
020036039AP2011/04/07Labeling Revision
020036035AP2008/12/12Labeling Revision
020036034AP2007/12/11Labeling Revision
020036032AP2005/11/16Labeling Revision
020036031AP2005/10/11Labeling Revision
020036030AP2005/02/02Labeling Revision
020036029AP2004/03/24Labeling Revision
020036028AP2004/01/09Labeling Revision
020036026AP2002/07/12Efficacy Supplement with Clinical Data to Support
020036025AP2002/02/12Manufacturing Change or Addition
020036024AP2001/08/20New Dosage Regimen
020036023AP2001/11/15Control Supplement
020036022AP2002/01/03Manufacturing Change or Addition
020036021AP2001/03/07Control Supplement
020036020AP2003/10/09Labeling Revision
020036019AP2000/03/31Control Supplement
020036018AP2000/04/28Manufacturing Change or Addition
020036016AP1998/09/22Labeling Revision
020036015AP1998/09/22Labeling Revision
020036014AP1998/09/10Manufacturing Change or Addition
020036013AP1998/10/05Manufacturing Change or Addition
020036011AP1996/07/16New or Modified Indication
020036009AP1995/09/01New or Modified Indication
020036008AP1994/12/08Control Supplement
020036007AP1994/09/21New or Modified Indication
020036006AP1995/04/17Control Supplement
020036005AP1993/06/09Labeling Revision
020036004AP1994/04/15New Dosage Regimen
020036003AP1992/07/21Labeling Revision
020036002AP1993/05/06Control Supplement
020036001AP1993/05/06Formulation Revision
020036000AP1991/10/31Approval