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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2013/10/18 SUPPL-45(补充) Approval Labeling STANDARD
2011/06/22 SUPPL-44(补充) Approval Labeling
2009/06/22 SUPPL-42(补充) Approval Labeling
2002/11/20 SUPPL-35(补充) Approval Labeling
2002/08/13 SUPPL-34(补充) Approval Manufacturing (CMC)
2001/03/28 SUPPL-33(补充) Approval Manufacturing (CMC)
1998/07/31 SUPPL-31(补充) Approval Manufacturing (CMC)
1998/06/26 SUPPL-32(补充) Approval Manufacturing (CMC)
1997/06/27 SUPPL-28(补充) Approval Labeling
1997/06/27 SUPPL-27(补充) Approval Manufacturing (CMC)
1997/06/27 SUPPL-26(补充) Approval Manufacturing (CMC)
1997/06/27 SUPPL-25(补充) Approval Manufacturing (CMC)
1997/06/27 SUPPL-24(补充) Approval Manufacturing (CMC)
1997/01/15 SUPPL-30(补充) Approval Manufacturing (CMC)
1997/01/15 SUPPL-29(补充) Approval Manufacturing (CMC)
1996/03/25 SUPPL-20(补充) Approval Manufacturing (CMC)
1996/03/25 SUPPL-19(补充) Approval Manufacturing (CMC)
1995/10/16 SUPPL-23(补充) Approval Manufacturing (CMC)
1995/10/16 SUPPL-22(补充) Approval Manufacturing (CMC)
1995/08/18 SUPPL-21(补充) Approval Manufacturing (CMC)
1995/02/08 SUPPL-18(补充) Approval Manufacturing (CMC)
1993/11/17 SUPPL-17(补充) Approval Labeling
1993/11/17 SUPPL-16(补充) Approval Labeling
1993/11/17 SUPPL-15(补充) Approval Manufacturing (CMC)
1992/01/31 SUPPL-13(补充) Approval Labeling
1991/08/02 SUPPL-8(补充) Approval Labeling
1991/08/02 SUPPL-7(补充) Approval Manufacturing (CMC)
1989/07/14 SUPPL-12(补充) Approval Labeling
1989/07/14 SUPPL-11(补充) Approval Labeling
1989/06/02 SUPPL-10(补充) Approval Manufacturing (CMC)
1988/12/30 SUPPL-9(补充) Approval Manufacturing (CMC)
1988/07/12 SUPPL-6(补充) Approval Labeling
1988/05/20 SUPPL-5(补充) Approval Manufacturing (CMC)
1988/05/20 SUPPL-4(补充) Approval Manufacturing (CMC)
1988/05/20 SUPPL-3(补充) Approval Manufacturing (CMC)
1988/05/20 SUPPL-2(补充) Approval Manufacturing (CMC)
1987/11/02 SUPPL-1(补充) Approval Manufacturing (CMC)
1987/01/21 ORIG-1(原始申请) 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 Yes 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 STRIDES PHARMA
040864 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2008/12/01 GRANULES
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 Discontinued No No AA 2017/01/10 ALVOGEN
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 LGM PHARMA
203647 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2020/09/21 STRIDES PHARMA
214287 001 ANDA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG Prescription No No AA 2024/01/18 QUAGEN
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database