药品注册申请号:086162
申请类型:ANDA (仿制药申请)
申请人:HIKMA INTL PHARMS
申请人全名:HIKMA INTERNATIONAL PHARMACEUTICALS 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 Yes AA 1979/06/05 1984/02/16 Prescription
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
1999/06/24 SUPPL 45 Approval Manufacturing (CMC)
1998/10/01 SUPPL 44 Approval Manufacturing (CMC)
1997/07/17 SUPPL 43 Approval Manufacturing (CMC)
1997/07/17 SUPPL 42 Approval Manufacturing (CMC)
1997/07/17 SUPPL 41 Approval Manufacturing (CMC)
1997/07/17 SUPPL 40 Approval Manufacturing (CMC)
1997/07/17 SUPPL 39 Approval Manufacturing (CMC)
1996/10/23 SUPPL 36 Approval Manufacturing (CMC)
1996/08/12 SUPPL 38 Approval Manufacturing (CMC)
1996/02/29 SUPPL 37 Approval Manufacturing (CMC)
1992/06/30 SUPPL 32 Approval Labeling
1991/01/31 SUPPL 31 Approval Manufacturing (CMC)
1989/05/24 SUPPL 28 Approval Labeling
1989/05/24 SUPPL 27 Approval Manufacturing (CMC)
1989/04/10 SUPPL 29 Approval Bioequivalence
1989/02/02 SUPPL 26 Approval Labeling
1988/11/17 SUPPL 25 Approval Manufacturing (CMC)
1988/11/17 SUPPL 24 Approval Labeling
1988/11/17 SUPPL 23 Approval Manufacturing (CMC)
1988/11/17 SUPPL 22 Approval Manufacturing (CMC)
1988/11/17 SUPPL 21 Approval Manufacturing (CMC)
1988/08/23 SUPPL 20 Approval Manufacturing (CMC)
1988/08/23 SUPPL 18 Approval Manufacturing (CMC)
1988/08/23 SUPPL 17 Approval Manufacturing (CMC)
1984/02/16 SUPPL 12 Approval Manufacturing (CMC)
1982/10/18 SUPPL 9 Approval Manufacturing (CMC)
1979/06/05 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
活性成分:ASPIRIN; BUTALBITAL; CAFFEINE 剂型/给药途径:TABLET;ORAL 规格:325MG;50MG;40MG 治疗等效代码:AA
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
086162 002 ANDA BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No Yes AA 1984/02/16 HIKMA INTL PHARMS
204195 001 ANDA BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2016/09/22 STRIDES PHARMA
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