药品注册申请号:018584
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 BECONASE BECLOMETHASONE DIPROPIONATE AEROSOL, METERED;NASAL 0.042MG/INH No No None 1981/09/30 Approved Prior to Jan 1, 1982 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
2002/12/16 SUPPL 26 Approval Labeling STANDARD
2002/02/20 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2001/08/31 SUPPL 27 Approval Labeling STANDARD
1996/04/04 SUPPL 25 Approval Labeling STANDARD
1996/03/12 SUPPL 23 Approval Labeling STANDARD
1993/11/19 SUPPL 18 Approval Labeling STANDARD
1993/07/06 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1992/08/10 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1989/04/27 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1988/12/15 SUPPL 16 Approval Labeling STANDARD
1988/02/24 SUPPL 4 Approval Labeling STANDARD
1988/02/16 SUPPL 2 Approval Labeling STANDARD
1988/02/16 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1987/12/02 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1987/03/06 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1985/11/01 SUPPL 9 Approval Efficacy STANDARD
1985/11/01 SUPPL 8 Approval Labeling STANDARD
1985/10/04 SUPPL 11 Approval Labeling STANDARD
1985/10/04 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1984/09/15 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1981/09/30 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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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