药品名称DISOPHROL
申请号013483产品号004
活性成分DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE市场状态停止上市
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格6MG;120MG
治疗等效代码参比药物
批准日期1982/09/13申请机构SCHERING PLOUGH HEALTHCARE PRODUCTS 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
013483042APLetter2005/03/11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
013483042AP2005/03/10Formulation Revision
013483039AP2001/06/29Control Supplement
013483038AP2001/07/11Control Supplement
013483037AP2001/03/06Control Supplement
013483036AP2000/10/17Control Supplement
013483035AP2001/01/24Control Supplement
013483034AP2000/04/18Control Supplement
013483033AP1998/10/06Control Supplement
013483032AP1998/09/22Manufacturing Change or Addition
013483031AP1998/11/18Control Supplement
013483028AP1989/01/24Manufacturing Change or Addition
013483027AP1986/07/08Control Supplement
013483024AP1984/09/18Package Change
013483022AP1986/02/22Control Supplement
013483021AP1984/09/21Control Supplement
013483020AP1985/03/20Control Supplement
013483019AP1982/07/01Control Supplement
013483017AP1982/09/13Resubmission - Other (MarkIV)
013483016AP1982/09/13Control Supplement
013483015AP1981/09/11Labeling Revision
013483014AP1980/07/21Labeling Revision
013483013AP1980/06/13Control Supplement
013483012AP1980/05/07Control Supplement
013483011AP1978/10/02Expiration Date Change
013483010AP1978/05/15Control Supplement
013483009AP1978/08/14Control Supplement
013483008AP1976/08/30Formulation Revision
013483000AP1963/10/18Approval