药品注册申请号：213782
申请类型：ANDA (仿制药申请)
申请人：ALKEM LABS LTD
申请人全名：ALKEM LABORATORIES LTD
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 BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG No No AB 2023/11/28 2023/11/28 Discontinued
002 BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG No No AB 2023/11/28 Discontinued
003 BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG No No AB 2023/11/28 Discontinued
004 BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG No No AB 2023/11/28 Discontinued
005 BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG No No AB 2023/11/28 Discontinued
006 BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG No No AB 2023/11/28 Discontinued
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
2023/11/28 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:BREXPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:0.25MG 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
205422 001 NDA REXULTI BREXPIPRAZOLE TABLET;ORAL 0.25MG Prescription Yes No AB 2015/07/10 OTSUKA
213692 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2022/08/11 TEVA PHARMS USA INC
213570 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2022/09/26 SANDOZ
213660 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/01/10 ZYDUS PHARMS
213562 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/01/31 AMNEAL
213718 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/02/03 AJANTA PHARMA LTD
213512 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/03/17 LUPIN LTD
213758 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/10/25 ANDA REPOSITORY
213669 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/11/20 HETERO LABS LTD V
213782 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2023/11/28 ALKEM LABS LTD
活性成分:BREXPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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
205422 002 NDA REXULTI BREXPIPRAZOLE TABLET;ORAL 0.5MG Prescription Yes No AB 2015/07/10 OTSUKA
213692 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2022/08/11 TEVA PHARMS USA INC
213570 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2022/09/26 SANDOZ
213660 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/01/10 ZYDUS PHARMS
213562 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/01/31 AMNEAL
213718 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/02/03 AJANTA PHARMA LTD
213512 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/03/17 LUPIN LTD
213758 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/10/25 ANDA REPOSITORY
213669 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/11/20 HETERO LABS LTD V
213782 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2023/11/28 ALKEM LABS LTD
活性成分:BREXPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:1MG 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
205422 003 NDA REXULTI BREXPIPRAZOLE TABLET;ORAL 1MG Prescription Yes No AB 2015/07/10 OTSUKA
213692 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2022/08/11 TEVA PHARMS USA INC
213570 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2022/09/26 SANDOZ
213660 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/01/10 ZYDUS PHARMS
213562 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/01/31 AMNEAL
213718 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/02/03 AJANTA PHARMA LTD
213512 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/03/17 LUPIN LTD
213758 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/10/25 ANDA REPOSITORY
213669 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/11/20 HETERO LABS LTD V
213782 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2023/11/28 ALKEM LABS LTD
活性成分:BREXPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:2MG 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
205422 004 NDA REXULTI BREXPIPRAZOLE TABLET;ORAL 2MG Prescription Yes Yes AB 2015/07/10 OTSUKA
213692 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2022/08/11 TEVA PHARMS USA INC
213570 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2022/09/26 SANDOZ
213660 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/01/10 ZYDUS PHARMS
213562 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/01/31 AMNEAL
213718 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/02/03 AJANTA PHARMA LTD
213512 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/03/17 LUPIN LTD
213758 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/10/25 ANDA REPOSITORY
213669 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/11/20 HETERO LABS LTD V
213782 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2023/11/28 ALKEM LABS LTD
活性成分:BREXPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:3MG 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
205422 005 NDA REXULTI BREXPIPRAZOLE TABLET;ORAL 3MG Prescription Yes No AB 2015/07/10 OTSUKA
213692 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2022/08/11 TEVA PHARMS USA INC
213570 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2022/09/26 SANDOZ
213660 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/01/10 ZYDUS PHARMS
213562 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/01/31 AMNEAL
213718 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/02/03 AJANTA PHARMA LTD
213512 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/03/17 LUPIN LTD
213758 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/10/25 ANDA REPOSITORY
213669 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/11/20 HETERO LABS LTD V
213782 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2023/11/28 ALKEM LABS LTD
活性成分:BREXPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:4MG 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
205422 006 NDA REXULTI BREXPIPRAZOLE TABLET;ORAL 4MG Prescription Yes No AB 2015/07/10 OTSUKA
213692 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2022/08/11 TEVA PHARMS USA INC
213570 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2022/09/26 SANDOZ
213660 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/01/10 ZYDUS PHARMS
213562 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/01/31 AMNEAL
213718 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/02/03 AJANTA PHARMA LTD
213512 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/03/17 LUPIN LTD
213758 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/10/25 ANDA REPOSITORY
213669 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/11/20 HETERO LABS LTD V
213782 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Discontinued No No AB 2023/11/28 ALKEM LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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