药品名称VIBRAMYCIN
申请号050480产品号001
活性成分DOXYCYCLINE CALCIUM市场状态处方药
剂型或给药途径SUSPENSION;ORAL规格EQ 50MG BASE/5ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PFIZER LABORATORIES DIV PFIZER INC
化学类型New active ingredient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
050480054APLetter2016/04/05下载
050480054APLabel2016/04/07下载
050480052APLetter2014/09/16下载
050480052APLabel2014/10/02下载
050480051APLetter2013/09/09下载
050480051APLabel2013/09/09下载
050480050APLetter2013/04/30下载
050480050APLabel2013/05/01下载
050480047APLabel2011/05/16下载
050480042APLetter2008/02/13下载
050480042APLabel2008/02/14下载
050480037APLetter2004/03/16下载
050480035APLetter2002/06/18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
050480054AP2016/03/31Labeling Revision
050480052AP2014/09/12Labeling Revision
050480051AP2013/09/04Labeling Revision
050480050AP2013/04/29Labeling Revision
050480047AP2011/05/11Labeling Revision
050480042AP2008/02/06Labeling Revision
050480037AP2004/03/12Labeling Revision
050480036AP2002/03/01Control Supplement
050480035AP2002/06/18Labeling Revision
050480034AP1992/12/15New or Modified Indication
050480033AP1982/08/31Labeling Revision
050480032AP1981/09/30Control Supplement
050480031AP1981/09/29Control Supplement
050480030AP1981/04/21Expiration Date Change
050480029AP1980/09/30Formulation Revision
050480028AP1980/08/12Labeling Revision
050480027AP1979/10/02Control Supplement
050480026AP1979/01/10Labeling Revision
050480025AP1978/11/14Expiration Date Change
050480024AP1978/09/25Control Supplement
050480023AP1978/08/01Formulation Revision
050480022AP1978/07/24Labeling Revision
050480021AP1978/07/12Labeling Revision
050480020AP1978/03/13Labeling Revision
050480019AP1977/11/23Expiration Date Change
050480018AP1977/09/30Manufacturing Change or Addition
050480017AP1977/09/23Control Supplement
050480016AP1976/09/28Package Change
050480015AP1976/09/27Control Supplement
050480014AP1976/05/26Expiration Date Change
050480013AP1976/03/26Control Supplement
050480012AP1975/11/26Package Change
050480011AP1975/10/21Package Change
050480010AP1975/09/30Control Supplement
050480009AP1975/06/30Control Supplement
050480008AP1975/04/08Control Supplement
050480007AP1975/02/25Labeling Revision
050480006AP1992/05/11Labeling Revision
050480005AP1992/05/11Labeling Revision
050480004AP1991/08/23Labeling Revision
050480002AP1975/01/06Control Supplement
050480001AP1983/03/29Labeling Revision
050480000AP1974/09/23Approval