药品注册申请号:050746
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MUPIROCIN CALCIUM CREAM;TOPICAL EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/12/11 1997/12/11 Discontinued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
2020/02/19 SUPPL 22 Approval Labeling STANDARD
2017/05/08 SUPPL 21 Approval Labeling STANDARD
2015/12/16 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2015/12/14 SUPPL 20 Approval Labeling STANDARD
2015/03/19 SUPPL 13 Approval Labeling STANDARD
2014/05/22 SUPPL 18 Approval Labeling STANDARD
2001/11/15 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2001/11/09 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2001/09/21 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2000/12/13 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2000/07/14 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/10/06 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1999/05/19 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1998/09/04 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1998/06/10 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/12/11 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)
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
001 5569672 2013/10/29 U-1358 PDF格式**本条是由Drugfuture回溯的历史信息**
6025389 2014/10/20 Y U-1122 PDF格式**本条是由Drugfuture回溯的历史信息**
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
更多信息
药品NDC数据与药品包装、标签说明书
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