药品注册申请号:086069
申请类型:ANDA (仿制药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN SALES LLC
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 CREAM;VAGINAL 0.01% No Yes AB 1984/01/31 1984/01/31 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
2018/08/15 SUPPL 24 Approval Labeling STANDARD
2017/06/21 SUPPL 23 Approval Labeling STANDARD
2005/08/17 SUPPL 18 Approval Labeling
2001/03/27 SUPPL 17 Approval Manufacturing (CMC)
2000/08/11 SUPPL 16 Approval Labeling
2000/08/11 SUPPL 15 Approval Manufacturing (CMC)
1998/08/03 SUPPL 12 Approval Labeling
1997/09/09 SUPPL 11 Approval Manufacturing (CMC)
1996/12/31 SUPPL 10 Approval Labeling
1994/01/14 SUPPL 9 Approval Manufacturing (CMC)
1992/09/23 SUPPL 8 Approval Labeling
1992/03/11 SUPPL 5 Approval Labeling
1991/06/07 SUPPL 7 Approval Labeling
1987/10/16 SUPPL 3 Approval Manufacturing (CMC)
1986/07/17 SUPPL 2 Approval Manufacturing (CMC)
1984/01/31 ORIG 1 Approval
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
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
活性成分:ESTRADIOL 剂型/给药途径:CREAM;VAGINAL 规格:0.01% 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
086069 001 ANDA ESTRACE ESTRADIOL CREAM;VAGINAL 0.01% Prescription No Yes AB 1984/01/31 ALLERGAN
208788 001 ANDA ESTRADIOL ESTRADIOL CREAM;VAGINAL 0.01% Prescription No No AB 2017/12/29 MYLAN
210194 001 ANDA ESTRADIOL ESTRADIOL CREAM;VAGINAL 0.01% Prescription No No AB 2018/01/22 PERRIGO UK FINCO
209767 001 ANDA ESTRADIOL ESTRADIOL CREAM;VAGINAL 0.01% Prescription No No AB 2018/03/05 ALVOGEN PINE BROOK
210488 001 ANDA ESTRADIOL ESTRADIOL CREAM;VAGINAL 0.01% Prescription No No AB 2018/03/30 TEVA PHARMS USA
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