药品注册申请号:019389
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 AQ BECLOMETHASONE DIPROPIONATE MONOHYDRATE SPRAY, METERED;NASAL EQ 0.042MG DIPROP/SPRAY Yes Yes None 1987/07/27 1987/07/27 Prescription
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
2019/04/12 SUPPL 34 Approval Labeling STANDARD
2014/06/17 SUPPL 33 Approval Manufacturing (CMC) STANDARD
2005/10/27 SUPPL 27 Approval Labeling STANDARD
2002/12/19 SUPPL 21 Approval Labeling STANDARD
2002/12/16 SUPPL 25 Approval Labeling STANDARD
2002/03/04 SUPPL 26 Approval Manufacturing (CMC) STANDARD
2001/08/31 SUPPL 23 Approval Labeling STANDARD
2001/07/09 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1999/02/24 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1998/03/27 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1997/05/30 SUPPL 17 Approval Labeling STANDARD
1996/11/26 SUPPL 16 Approval Labeling STANDARD
1993/11/19 SUPPL 12 Approval Labeling
1992/10/06 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1992/08/10 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1990/05/15 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1989/09/07 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1989/08/25 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1989/03/09 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1988/12/19 SUPPL 4 Approval Labeling
1988/08/19 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1988/07/08 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1987/07/27 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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