药品注册申请号:084500
申请类型:ANDA (仿制药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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 ESTRACE ESTRADIOL TABLET;ORAL 2MG No No None 1975/07/23 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
2005/09/12 SUPPL 44 Approval Labeling
2001/01/25 SUPPL 41 Approval Manufacturing (CMC)
1998/10/05 SUPPL 39 Approval Labeling
1997/07/28 SUPPL 38 Approval Manufacturing (CMC)
1997/01/08 SUPPL 37 Approval Labeling
1995/09/11 SUPPL 36 Approval Manufacturing (CMC)
1995/01/19 SUPPL 35 Approval Manufacturing (CMC)
1995/01/19 SUPPL 34 Approval Manufacturing (CMC)
1995/01/19 SUPPL 33 Approval Manufacturing (CMC)
1995/01/19 SUPPL 32 Approval Manufacturing (CMC)
1994/05/09 SUPPL 31 Approval Labeling
1993/01/12 SUPPL 30 Approval Labeling
1992/11/09 SUPPL 25 Approval Manufacturing (CMC)
1992/11/09 SUPPL 24 Approval Labeling
1992/11/09 SUPPL 23 Approval Manufacturing (CMC)
1992/09/08 SUPPL 22 Approval Labeling
1992/08/10 SUPPL 29 Approval Labeling
1989/07/18 SUPPL 27 Approval Manufacturing (CMC)
1989/07/18 SUPPL 26 Approval Manufacturing (CMC)
1985/12/19 SUPPL 21 Approval Manufacturing (CMC)
1983/03/10 SUPPL 17 Approval Manufacturing (CMC)
1982/06/07 SUPPL 14 Approval Manufacturing (CMC)
1975/07/23 ORIG 1 Approval
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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