药品注册申请号:018226
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BUMEX BUMETANIDE INJECTABLE;INJECTION 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1983/02/28 1983/02/28 Discontinued
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
2002/10/29 SUPPL 25 Approval Labeling STANDARD
2002/10/29 SUPPL 24 Approval Labeling STANDARD
1999/02/24 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1999/01/06 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1998/02/10 SUPPL 19 Approval Labeling STANDARD
1997/04/18 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1997/03/04 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1993/10/21 SUPPL 18 Approval Labeling STANDARD
1993/06/11 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1992/07/01 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1991/03/01 SUPPL 15 Approval Labeling
1989/01/05 SUPPL 11 Approval Labeling
1988/10/14 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1987/12/10 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1987/12/10 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1985/09/06 SUPPL 7 Approval Labeling
1985/08/08 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1985/07/03 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1985/07/03 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1984/12/14 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1984/08/01 SUPPL 2 Approval Efficacy
1983/11/22 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1983/02/28 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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