药品注册申请号:021565
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN INC
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 ELESTAT EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% Yes Yes AT 2003/10/16 2003/10/16 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
2016/02/25 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2013/06/17 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2011/12/20 SUPPL 6 Approval Labeling UNKNOWN
2005/08/15 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2003/10/16 ORIG 1 Approval Type 1 - New Molecular Entity 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 7429602 2020/11/29 U-765 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
001 NCE 2008/10/15**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:EPINASTINE HYDROCHLORIDE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.05% 治疗等效代码:AT
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
021565 001 NDA ELESTAT EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% Prescription Yes Yes AT 2003/10/16 ALLERGAN
090870 001 ANDA EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% Prescription No No AT 2011/03/14 BRECKENRIDGE
090919 001 ANDA EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% Prescription No No AT 2011/10/31 APOTEX
090951 001 ANDA EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% Prescription No No AT 2011/10/31 SOMERSET THERAPS LLC
204055 001 ANDA EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% Prescription No No AT 2017/05/05 AKORN
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