药品注册申请号:018225
申请类型:NDA (新药申请)
申请人:VALIDUS PHARMS
申请人全名:VALIDUS 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
001 BUMEX BUMETANIDE TABLET;ORAL 1MG Yes No AB 1983/02/28 1983/02/28 Prescription
002 BUMEX BUMETANIDE TABLET;ORAL 0.5MG Yes No AB 1983/02/28 Prescription
003 BUMEX BUMETANIDE TABLET;ORAL 2MG Yes No AB 1985/06/14 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
2024/01/17 SUPPL-29(补充) Approval Manufacturing (CMC) N/A
2018/08/08 SUPPL-28(补充) Approval Labeling STANDARD
2017/05/04 SUPPL-26(补充) Approval Labeling STANDARD
2015/09/28 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2010/01/21 SUPPL-24(补充) Approval Labeling UNKNOWN
2003/05/13 SUPPL-22(补充) Approval Labeling STANDARD
2002/10/29 SUPPL-19(补充) Approval Labeling STANDARD
2002/10/29 SUPPL-18(补充) Approval Labeling STANDARD
2001/11/09 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1999/02/24 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1999/01/06 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1998/02/10 SUPPL-13(补充) Approval Labeling STANDARD
1997/11/20 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1994/08/12 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1993/10/21 SUPPL-11(补充) Approval Labeling STANDARD
1991/06/11 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1991/03/01 SUPPL-10(补充) Approval Labeling
1989/08/28 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1989/01/05 SUPPL-6(补充) Approval Labeling
1987/12/10 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1985/12/18 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1985/09/06 SUPPL-5(补充) Approval Labeling
1985/06/14 SUPPL-2(补充) Approval Efficacy
1984/02/09 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1983/11/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1983/02/28 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
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:BUMETANIDE 剂型/给药途径:TABLET;ORAL 规格:1MG 治疗等效代码:AB
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
018225 001 NDA BUMEX BUMETANIDE TABLET;ORAL 1MG Prescription Yes No AB 1983/02/28 VALIDUS PHARMS
074225 002 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 1MG Prescription No No AB 1995/04/24 HERITAGE PHARMA
074700 002 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 1MG Prescription No No AB 1996/11/21 SANDOZ
209724 002 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 1MG Prescription No No AB 2017/10/18 AMNEAL PHARMS CO
209916 002 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 1MG Prescription No No AB 2018/01/23 UPSHER SMITH LABS
202900 002 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 1MG Prescription No No AB 2018/04/30 ZYDUS PHARMS
213458 002 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 1MG Prescription No No AB 2023/07/24 TARO
活性成分:BUMETANIDE 剂型/给药途径:TABLET;ORAL 规格:0.5MG 治疗等效代码:AB
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
018225 002 NDA BUMEX BUMETANIDE TABLET;ORAL 0.5MG Prescription Yes No AB 1983/02/28 VALIDUS PHARMS
074225 001 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG Prescription No No AB 1995/04/24 HERITAGE PHARMA
074700 001 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG Prescription No No AB 1996/11/21 SANDOZ
209724 001 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG Prescription No No AB 2017/10/18 AMNEAL PHARMS CO
209916 001 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG Prescription No No AB 2018/01/23 UPSHER SMITH LABS
202900 001 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG Prescription No No AB 2018/04/30 ZYDUS PHARMS
213458 001 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG Prescription No No AB 2023/07/24 TARO
活性成分:BUMETANIDE 剂型/给药途径:TABLET;ORAL 规格:2MG 治疗等效代码:AB
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
018225 003 NDA BUMEX BUMETANIDE TABLET;ORAL 2MG Prescription Yes No AB 1985/06/14 VALIDUS PHARMS
074225 003 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 2MG Prescription No No AB 1995/04/24 HERITAGE PHARMA
074700 003 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 2MG Prescription No Yes AB 1996/11/21 SANDOZ
209724 003 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 2MG Prescription No No AB 2017/10/18 AMNEAL PHARMS CO
209916 003 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 2MG Prescription No No AB 2018/01/23 UPSHER SMITH LABS
202900 003 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 2MG Prescription No No AB 2018/04/30 ZYDUS PHARMS
213458 003 ANDA BUMETANIDE BUMETANIDE TABLET;ORAL 2MG Prescription No No AB 2023/07/24 TARO
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