药品名称EXIDINE
申请号019422产品号001
活性成分CHLORHEXIDINE GLUCONATE市场状态非处方药
剂型或给药途径SOLUTION;TOPICAL规格2%
治疗等效代码参比药物
批准日期1985/12/17申请机构XTTRIUM LABORATORIES INC
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
019422043APLetter2012/12/18下载
019422043APLabel2014/01/14下载
019422037APLetter2009/02/27下载
019422036APLetter2009/02/27下载
019422033APLetter2004/12/30下载
019422032APReview2007/07/09下载
019422032APLetter2003/12/23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
019422046AP2016/04/11Manufacturing Change or Addition
019422045AP2016/03/24Manufacturing Change or Addition
019422043AP2012/12/12Labeling Revision
019422037AP2009/02/25Package Change
019422036AP2009/02/25Package Change
019422033AP2004/12/20Package Change
019422032AP2003/12/19Efficacy Supplement with Clinical Data to Support
019422029AP1999/10/08Package Change
019422028AP2000/03/29Package Change
019422027AP1998/10/19Control Supplement
019422026AP1998/09/30Package Change
019422025AP1998/01/08Control Supplement
019422024AP1997/04/17Package Change
019422023AP1997/03/11Expiration Date Change
019422022AP1996/05/06Package Change
019422021AP1996/04/03Control Supplement
019422020AP1996/02/12Formulation Revision
019422019AP1996/02/06Control Supplement
019422018AP1996/02/06Control Supplement
019422017AP1995/05/10Manufacturing Change or Addition
019422016AP1995/05/10Package Change
019422015AP1992/11/06Package Change
019422009AP1989/07/28Manufacturing Change or Addition
019422007AP1988/08/12Manufacturing Change or Addition
019422006AP1988/06/28Control Supplement
019422005AP1988/04/12Expiration Date Change
019422004AP1987/09/16Manufacturing Change or Addition
019422003AP1987/09/16Package Change
019422002AP1988/03/02Package Change
019422001AP1989/12/27New or Modified Indication
019422000AP1985/12/17Approval