药品注册申请号:086710
申请类型:ANDA (仿制药申请)
申请人:ACTAVIS ELIZABETH
申请人全名:ACTAVIS ELIZABETH LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
002 BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG No No None 1979/07/25 1983/08/23 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2001/11/02 SUPPL 46 Approval Manufacturing (CMC)
1999/10/12 SUPPL 45 Approval Labeling
1998/11/23 SUPPL 44 Approval Manufacturing (CMC)
1998/03/09 SUPPL 43 Approval Labeling
1997/05/09 SUPPL 42 Approval Manufacturing (CMC)
1996/01/18 SUPPL 41 Approval Manufacturing (CMC)
1991/11/25 SUPPL 40 Approval Labeling
1990/11/05 SUPPL 35 Approval Manufacturing (CMC)
1990/11/05 SUPPL 34 Approval Manufacturing (CMC)
1990/11/05 SUPPL 33 Approval Manufacturing (CMC)
1989/10/04 SUPPL 39 Approval Labeling
1989/08/04 SUPPL 38 Approval Labeling
1989/08/04 SUPPL 37 Approval Labeling
1985/08/13 SUPPL 30 Approval Manufacturing (CMC)
1985/08/13 SUPPL 29 Approval Manufacturing (CMC)
1985/08/13 SUPPL 28 Approval Manufacturing (CMC)
1985/08/13 SUPPL 27 Approval Manufacturing (CMC)
1985/03/15 SUPPL 26 Approval Manufacturing (CMC)
1983/10/25 SUPPL 24 Approval Manufacturing (CMC)
1983/10/25 SUPPL 20 Approval Manufacturing (CMC)
1983/07/06 SUPPL 21 Approval Manufacturing (CMC)
1979/07/25 ORIG 1 Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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