药品注册申请号：215598
申请类型：ANDA (仿制药申请)
申请人：UPSHER SMITH LABS
申请人全名：UPSHER SMITH LABORATORIES 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 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE No No AB 2022/12/12 2022/12/12 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2022/12/12 ORIG-1（原始申请） Approval 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
无
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
无
与本品治疗等效的药品
活性成分:BRIMONIDINE TARTRATE; TIMOLOL MALEATE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.2%;EQ 0.5% BASE 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
021398 001 NDA COMBIGAN BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription Yes Yes AB 2007/10/30 ABBVIE
091087 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2022/04/04 SANDOZ
091442 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2022/04/20 APOTEX
201949 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2022/10/04 FLORIDA
091086 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2022/10/31 SENTISS
215598 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2022/12/12 UPSHER SMITH LABS
215230 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2023/08/25 ALEMBIC
214987 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2024/05/16 GLENMARK PHARMS LTD
216114 001 ANDA BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC 0.2%;EQ 0.5% BASE Prescription No No AB 2024/09/10 SOMERSET
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药品NDC数据与药品包装、标签说明书
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