药品名称CELESTONE SOLUSPAN
申请号014602产品号001
活性成分BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格3MG/ML;EQ 3MG BASE/ML
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MERCK SHARP AND DOHME CORP
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
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
014602059APLabel2015/02/05下载
014602059APLetter2015/02/06下载
014602058APLetter2014/07/08下载
014602058APLabel2014/07/08下载
014602056APReview2013/06/04下载
014602047APLabel2008/06/26下载
014602047APLetter2008/06/30下载
014602019APLetter2006/07/21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
014602059AP2015/02/04Labeling Revision
014602058AP2014/07/03Labeling Revision
014602057AP2014/05/21Manufacturing Change or Addition
014602056AP2013/03/13Manufacturing Change or Addition
014602055AP2013/01/09Manufacturing Change or Addition
014602047AP2008/06/24Labeling Revision
014602025AP2001/07/24Control Supplement
014602024AP2000/04/10Control Supplement
014602023AP1999/10/08Control Supplement
014602022AP1999/07/15Control Supplement
014602021AP1997/07/21Control Supplement
014602020AP1996/11/13Manufacturing Change or Addition
014602019AP2006/07/12Labeling Revision
014602018AP1995/05/03Control Supplement
014602017AP1994/04/13Labeling Revision
014602016AP1994/03/14Package Change
014602015AP1993/09/07Labeling Revision
014602014AP1992/12/17Labeling Revision
014602013AP1992/02/06Manufacturing Change or Addition
014602012AP1987/07/01Control Supplement
014602011AP1990/05/01Manufacturing Change or Addition
014602010AP1986/06/10Manufacturing Change or Addition
014602009AP1982/06/30Manufacturing Change or Addition
014602008AP1982/11/04Manufacturing Change or Addition
014602006AP1979/08/08Labeling Revision
014602000AP1965/03/03Approval