药品注册申请号:086398
申请类型:ANDA (仿制药申请)
申请人:FOSUN PHARMA
申请人全名:FOSUN PHARMA USA INC
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 1980/07/30 1984/04/06 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
2000/01/13 SUPPL 46 Approval Manufacturing (CMC)
1996/10/28 SUPPL 45 Approval Manufacturing (CMC)
1992/01/09 SUPPL 44 Approval Labeling
1990/11/09 SUPPL 43 Approval Manufacturing (CMC)
1990/01/01 SUPPL 42 Approval Labeling
1988/01/15 SUPPL 38 Approval Manufacturing (CMC)
1987/02/06 SUPPL 34 Approval Manufacturing (CMC)
1987/01/23 SUPPL 37 Approval Manufacturing (CMC)
1984/12/19 SUPPL 32 Approval Manufacturing (CMC)
1984/12/19 SUPPL 30 Approval Manufacturing (CMC)
1984/08/06 SUPPL 29 Approval Manufacturing (CMC)
1984/05/24 SUPPL 28 Approval Manufacturing (CMC)
1984/04/27 SUPPL 27 Approval Manufacturing (CMC)
1984/04/06 SUPPL 26 Approval Manufacturing (CMC)
1984/04/06 SUPPL 25 Approval Manufacturing (CMC)
1984/04/06 SUPPL 23 Approval Manufacturing (CMC)
1983/07/01 SUPPL 21 Approval Manufacturing (CMC)
1983/02/14 SUPPL 20 Approval Manufacturing (CMC)
1982/12/17 SUPPL 19 Approval Manufacturing (CMC)
1982/12/17 SUPPL 18 Approval Manufacturing (CMC)
1982/12/17 SUPPL 17 Approval Manufacturing (CMC)
1980/07/30 ORIG 1 Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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