药品注册申请号:088616
申请类型:ANDA (仿制药申请)
申请人:ACTAVIS LABS UT INC
申请人全名:ACTAVIS LABORATORIES UT 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
001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG No No AA 1984/11/09 1984/11/09 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
2014/12/10 SUPPL 64 Approval Labeling STANDARD
2011/06/23 SUPPL 62 Approval Labeling
2002/07/18 SUPPL 41 Approval Labeling
2002/03/06 SUPPL 45 Approval Manufacturing (CMC)
2001/08/15 SUPPL 44 Approval Manufacturing (CMC)
2001/07/30 SUPPL 43 Approval Manufacturing (CMC)
1999/07/26 SUPPL 40 Approval Manufacturing (CMC)
1999/07/01 SUPPL 39 Approval Manufacturing (CMC)
1999/07/01 SUPPL 38 Approval Manufacturing (CMC)
1999/07/01 SUPPL 37 Approval Manufacturing (CMC)
1998/10/16 SUPPL 36 Approval Labeling
1998/02/20 SUPPL 33 Approval Labeling
1996/11/20 SUPPL 35 Approval Labeling
1996/04/23 SUPPL 34 Approval Manufacturing (CMC)
1995/08/04 SUPPL 31 Approval Manufacturing (CMC)
1995/02/16 SUPPL 30 Approval Manufacturing (CMC)
1993/09/27 SUPPL 29 Approval Labeling
1993/08/20 SUPPL 28 Approval Manufacturing (CMC)
1992/05/26 SUPPL 24 Approval Manufacturing (CMC)
1992/04/16 SUPPL 27 Approval Labeling
1992/01/30 SUPPL 26 Approval Labeling
1991/12/17 SUPPL 25 Approval Labeling
1991/10/03 SUPPL 23 Approval Manufacturing (CMC)
1991/08/05 SUPPL 22 Approval Labeling
1991/08/05 SUPPL 14 Approval Labeling
1990/09/11 SUPPL 21 Approval Labeling
1990/08/24 SUPPL 20 Approval Labeling
1990/05/10 SUPPL 18 Approval Labeling
1990/03/21 SUPPL 16 Approval Manufacturing (CMC)
1990/03/21 SUPPL 15 Approval Manufacturing (CMC)
1990/03/21 SUPPL 12 Approval Manufacturing (CMC)
1990/03/21 SUPPL 11 Approval Manufacturing (CMC)
1989/05/15 SUPPL 13 Approval Labeling
1988/10/18 SUPPL 10 Approval Manufacturing (CMC)
1986/06/19 SUPPL 8 Approval Manufacturing (CMC)
1986/06/19 SUPPL 7 Approval Manufacturing (CMC)
1986/06/19 SUPPL 6 Approval Manufacturing (CMC)
1986/06/19 SUPPL 5 Approval Manufacturing (CMC)
1985/07/30 SUPPL 2 Approval Manufacturing (CMC)
1985/07/19 SUPPL 4 Approval Manufacturing (CMC)
1985/07/19 SUPPL 3 Approval Manufacturing (CMC)
1985/07/19 SUPPL 1 Approval Manufacturing (CMC)
1984/11/09 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
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database