药品名称EXIDINE
申请号019125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4%
治疗等效代码参比药物
批准日期1984/12/24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
019125042APLetter2014/10/22下载
019125042APLabel2014/10/30下载
019125040APLetter2012/11/13下载
019125034APLetter2005/05/18下载
019125028APReview2003/09/11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
019125042AP2014/10/17Labeling Revision
019125040AP2012/11/09Labeling Revision
019125034AP2005/05/16Labeling Revision
019125031AP1999/10/08Package Change
019125030AP1999/09/08Control Supplement
019125029AP1998/09/11Control Supplement
019125028AP1996/06/06Control Supplement
019125027AP1996/05/06Package Change
019125026AP1996/04/12Control Supplement
019125025AP1996/02/21Formulation Revision
019125024AP1996/02/06Control Supplement
019125023AP1996/02/06Control Supplement
019125021AP1995/08/28Formulation Revision
019125019AP1995/05/10Manufacturing Change or Addition
019125018AP1995/05/10Package Change
019125017AP1992/11/06Package Change
019125013AP1991/03/07Manufacturing Change or Addition
019125011AP1990/01/23Manufacturing Change or Addition
019125010AP1989/08/14Formulation Revision
019125006AP1988/08/25Expiration Date Change
019125004AP1989/12/27New or Modified Indication
019125003AP1985/09/04Manufacturing Change or Addition
019125001AP1986/06/09Manufacturing Change or Addition
019125000AP1984/12/24Approval