药品名称DORYX
申请号050582产品号002
活性成分DOXYCYCLINE HYCLATE市场状态停止上市
剂型或给药途径CAPSULE, DELAYED RELEASE;ORAL规格EQ 75MG BASE
治疗等效代码参比药物
批准日期2001/08/13申请机构MAYNE PHARMA INTERNATIONAL FAULDING PHARM
化学类型New dosage form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
050582029APLabel2015/09/04下载
050582029APLetter2015/09/04下载
050582028APLetter2011/03/24下载
050582027APLetter2008/02/13下载
050582027APLabel2008/02/14下载
050582024APLetter2005/05/17下载
050582024APLabel2005/05/17下载
050582022APLetter2004/02/27下载
050582021APLetter2003/06/08下载
050582016APLetter2002/06/18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
050582029AP2015/09/02Labeling Revision
050582028AP2011/03/21Labeling Revision
050582027AP2008/02/07Labeling Revision
050582024AP2005/05/06Labeling Revision
050582022AP2004/02/13Labeling Revision
050582021AP2003/06/05Labeling Revision
050582018AP2002/10/25Expiration Date Change
050582017AP2002/05/22Manufacturing Change or Addition
050582016AP2002/06/18Labeling Revision
050582015AP2001/08/13Control Supplement
050582014AP2001/05/04Control Supplement
050582013AP2001/03/15Control Supplement
050582012AP1999/09/01Manufacturing Change or Addition
050582011AP1993/03/29Manufacturing Change or Addition
050582010AP1991/08/26Formulation Revision
050582009AP1991/08/26Control Supplement
050582008AP1986/05/30Formulation Revision
050582007AP1985/10/02Formulation Revision
050582006AP1985/09/17Expiration Date Change
050582004AP1985/09/17Formulation Revision
050582003AP1985/09/12Expiration Date Change
050582002AP1985/09/17Labeling Revision
050582000AP1985/07/22Approval