药品名称BENTYL PRESERVATIVE FREE
申请号008370产品号002
活性成分DICYCLOMINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10MG/ML
治疗等效代码AP参比药物
批准日期1984/10/15申请机构FOREST 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
008370033APLetter2013/01/15下载
008370033APLabel2013/01/15下载
008370032APLabel2011/08/01下载
008370032APLetter2011/08/02下载
008370031APLetter2007/02/12下载
008370031APLabel2007/02/21下载
008370030APLetter2002/08/12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
008370034AP2016/10/12Manufacturing Change or Addition
008370033AP2013/01/11Labeling Revision
008370032AP2011/08/01Labeling Revision
008370031AP2007/02/02Labeling Revision
008370030AP2002/08/12Labeling Revision
008370029AP2000/06/23Package Change
008370028AP1999/08/17Labeling Revision
008370027AP1996/09/06Labeling Revision
008370026AP1991/12/23Labeling Revision
008370025AP1991/03/18Control Supplement
008370024AP1990/09/25Labeling Revision
008370023AP1993/01/04Manufacturing Change or Addition
008370022AP1988/02/18Manufacturing Change or Addition
008370021AP1987/02/06Labeling Revision
008370020AP1985/06/12Control Supplement
008370019AP1985/05/13Labeling Revision
008370018AP1984/10/15Control Supplement
008370017AP1984/10/15Labeling Revision
008370013AP1989/08/04Practioner Draft Labeling
008370000AP1952/08/13Approval