药品名称PERCODAN-DEMI
申请号007337产品号005
活性成分ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格325MG;2.25MG;0.19MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ENDO PHARMACEUTICALS INC
化学类型New combination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
007337046APLetter2010/07/30下载
007337046APLabel2010/07/31下载
007337045APLabel2010/03/18下载
007337045APLetter2010/03/18下载
007337043APLabel2006/08/14下载
007337043APLetter2006/08/21下载
007337029APLetter2004/06/15下载
007337029APLabel2004/06/15下载
007337024APReview2003/08/08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
007337048AP2014/01/21Manufacturing Change or Addition
007337047AP2013/09/24Manufacturing Change or Addition
007337046AP2010/07/28Labeling Revision
007337045AP2010/03/11Labeling Revision
007337043AP2006/08/11Formulation Revision
007337030AP2002/04/29Manufacturing Change or Addition
007337029AP2004/06/10Labeling Revision
007337027AP1995/03/17Control Supplement
007337025AP1994/04/19Control Supplement
007337024AP1989/06/14Labeling Revision
007337023AP1994/04/20Package Change
007337022AP1987/12/17Control Supplement
007337020AP1986/07/10Labeling Revision
007337018AP1983/11/03Package Change
007337016AP1982/03/04Control Supplement
007337014AP1980/01/24Formulation Revision
007337012AP1976/01/28Control Supplement
007337011AP1975/07/28Labeling Revision
007337010AP1975/03/31Control Supplement
007337009AP1975/03/31Control Supplement
007337000AP1950/04/12Approval