药品注册申请号:050591
申请类型:NDA (新药申请)
申请人:GLAXOSMITHKLINE
申请人全名:GLAXOSMITHKLINE
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001 BACTROBAN MUPIROCIN OINTMENT;TOPICAL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1987/12/31 1987/12/31 Discontinued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
2017/05/08 SUPPL 34 Approval Labeling STANDARD
2015/12/14 SUPPL 33 Approval Labeling STANDARD
2015/03/19 SUPPL 30 Approval Labeling STANDARD
2014/05/22 SUPPL 32 Approval Labeling STANDARD
2001/11/09 SUPPL 26 Approval Manufacturing (CMC) STANDARD
2001/09/21 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2000/09/12 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1999/05/19 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1999/04/22 SUPPL 22 Approval Efficacy STANDARD
1997/12/03 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1996/12/24 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1996/06/06 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1996/02/21 SUPPL 15 Approval Labeling
1994/03/24 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1994/03/24 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1993/11/02 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1991/09/30 SUPPL 12 Approval Labeling
1991/04/15 SUPPL 13 Approval Labeling
1991/04/15 SUPPL 11 Approval Labeling
1991/04/15 SUPPL 10 Approval Labeling
1991/04/15 SUPPL 9 Approval Labeling
1987/12/31 ORIG 1 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)
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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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药品NDC数据与药品包装、标签说明书
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