药品注册申请号:089175
申请类型:ANDA (仿制药申请)
申请人:MIKART
申请人全名:MIKART 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
001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG No No AA 1987/01/21 1987/01/21 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
2013/10/18 SUPPL 45 Approval Labeling STANDARD
2011/06/22 SUPPL 44 Approval Labeling
2009/06/22 SUPPL 42 Approval Labeling
2002/11/20 SUPPL 35 Approval Labeling
2002/08/13 SUPPL 34 Approval Manufacturing (CMC)
2001/03/28 SUPPL 33 Approval Manufacturing (CMC)
1998/07/31 SUPPL 31 Approval Manufacturing (CMC)
1998/06/26 SUPPL 32 Approval Manufacturing (CMC)
1997/06/27 SUPPL 28 Approval Labeling
1997/06/27 SUPPL 27 Approval Manufacturing (CMC)
1997/06/27 SUPPL 26 Approval Manufacturing (CMC)
1997/06/27 SUPPL 25 Approval Manufacturing (CMC)
1997/06/27 SUPPL 24 Approval Manufacturing (CMC)
1997/01/15 SUPPL 30 Approval Manufacturing (CMC)
1997/01/15 SUPPL 29 Approval Manufacturing (CMC)
1996/03/25 SUPPL 20 Approval Manufacturing (CMC)
1996/03/25 SUPPL 19 Approval Manufacturing (CMC)
1995/10/16 SUPPL 23 Approval Manufacturing (CMC)
1995/10/16 SUPPL 22 Approval Manufacturing (CMC)
1995/08/18 SUPPL 21 Approval Manufacturing (CMC)
1995/02/08 SUPPL 18 Approval Manufacturing (CMC)
1993/11/17 SUPPL 17 Approval Labeling
1993/11/17 SUPPL 16 Approval Labeling
1993/11/17 SUPPL 15 Approval Manufacturing (CMC)
1992/01/31 SUPPL 13 Approval Labeling
1991/08/02 SUPPL 8 Approval Labeling
1991/08/02 SUPPL 7 Approval Manufacturing (CMC)
1989/07/14 SUPPL 12 Approval Labeling
1989/07/14 SUPPL 11 Approval Labeling
1989/06/02 SUPPL 10 Approval Manufacturing (CMC)
1988/12/30 SUPPL 9 Approval Manufacturing (CMC)
1988/07/12 SUPPL 6 Approval Labeling
1988/05/20 SUPPL 5 Approval Manufacturing (CMC)
1988/05/20 SUPPL 4 Approval Manufacturing (CMC)
1988/05/20 SUPPL 3 Approval Manufacturing (CMC)
1988/05/20 SUPPL 2 Approval Manufacturing (CMC)
1987/11/02 SUPPL 1 Approval Manufacturing (CMC)
1987/01/21 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:ACETAMINOPHEN; 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
088616 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 1984/11/09 ACTAVIS LABS UT INC
089175 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 1987/01/21 MIKART
040511 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No Yes AA 2003/08/27 VINTAGE PHARMS
200243 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2012/09/13 LANNETT CO INC
204984 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2017/01/10 CNTY LINE PHARMS
211106 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2018/09/26 ABHAI LLC
209587 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2018/10/31 NEXGEN PHARMA INC
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