药品名称DARVON COMPOUND
申请号010996产品号006
活性成分ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格389MG;32.4MG;32MG
治疗等效代码参比药物
批准日期1983/03/08申请机构XANODYNE PHARMACEUTICS INC
化学类型New combination审评分类Priority 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
010996068APLetter2004/06/01下载
010996061APLetter2002/08/01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
010996068AP2004/05/27Manufacturing Change or Addition
010996065AP1999/02/24Manufacturing Change or Addition
010996064AP1998/10/05Manufacturing Change or Addition
010996063AP1998/08/10Control Supplement
010996062AP1998/04/06Package Change
010996061AP2002/08/01Labeling Revision
010996060AP1992/09/15Package Change
010996058AP1994/09/02Labeling Revision
010996057AP1992/09/15Control Supplement
010996055AP1994/08/23Labeling Revision
010996048AP1987/04/16Control Supplement
010996047AP1986/12/16Control Supplement
010996042AP1986/07/16Labeling Revision
010996041AP1986/09/02Manufacturing Change or Addition
010996040AP1986/04/21Labeling Revision
010996037AP1986/04/21Labeling Revision
010996036AP1985/01/28Control Supplement
010996035AP1983/03/08Formulation Revision
010996034AP1981/10/28Labeling Revision
010996033AP1981/10/28Labeling Revision
010996032AP1981/05/20Labeling Revision
010996031AP1980/04/16Labeling Revision
010996030AP1979/09/26Labeling Revision
010996029AP1979/07/17Final Printed Labeling - MarkIV
010996028AP1979/03/26Labeling Revision
010996027AP1978/10/13Package Change
010996026AP1978/05/26Expiration Date Change
010996024AP1980/01/18Control Supplement
010996023AP1977/05/03Package Change
010996022AP1977/05/03Package Change
010996020AP1976/07/23Labeling Revision
010996014AP1975/01/06Labeling Revision
010996000AP1957/11/12Approval