药品注册申请号：205422
申请类型：NDA (新药申请)
申请人：OTSUKA
申请人全名：OTSUKA PHARMACEUTICAL CO 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 REXULTI BREXPIPRAZOLE TABLET;ORAL 0.25MG Yes No AB;AB 2015/07/10 2015/07/10 Prescription
002 REXULTI BREXPIPRAZOLE TABLET;ORAL 0.5MG Yes No AB;AB 2015/07/10 Prescription
003 REXULTI BREXPIPRAZOLE TABLET;ORAL 1MG Yes No AB;AB 2015/07/10 Prescription
004 REXULTI BREXPIPRAZOLE TABLET;ORAL 2MG Yes Yes AB;AB 2015/07/10 Prescription
005 REXULTI BREXPIPRAZOLE TABLET;ORAL 3MG Yes No AB;AB 2015/07/10 Prescription
006 REXULTI BREXPIPRAZOLE TABLET;ORAL 4MG Yes No AB;AB 2015/07/10 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2015/07/10 ORIG-2（原始申请） Approval Efficacy STANDARD
2015/07/10 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/05/09 SUPPL-14（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2024/12/11 SUPPL-13（补充） Approval Labeling-Container/Carton Labels STANDARD
2024/05/07 SUPPL-11（补充） Approval Efficacy-Labeling Change With Clinical Data PRIORITY
2023/05/10 SUPPL-9（补充） Approval Efficacy-New Indication PRIORITY
2022/10/06 SUPPL-8（补充） Approval Labeling-Container/Carton Labels STANDARD
2021/12/27 SUPPL-7（补充） Approval Efficacy-New Indication PRIORITY
2020/06/17 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2018/02/09 SUPPL-3（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2017/02/23 SUPPL-2（补充） Approval Labeling-Package Insert 901 REQUIRED
2016/09/23 SUPPL-1（补充） Approval Efficacy-Labeling Change With Clinical Data 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 10307419 2032/10/12 Y 2019/06/14 PDF格式
10307419*PED 2033/04/12 PDF格式
7888362 2026/04/12 Y Y 2015/07/17 PDF格式
7888362*PED 2026/10/12 PDF格式
8349840 2026/04/12 Y U-1529 2015/07/17 PDF格式
8349840*PED 2026/10/12 PDF格式
8618109 2026/04/12 U-543 U-3281 2015/07/17 PDF格式
8618109*PED 2026/10/12 PDF格式
9839637 2026/04/12 Y U-1529 U-3281 U-543 2018/01/09 PDF格式
9839637*PED 2026/10/12 PDF格式
RE48059 2028/12/23 Y 2020/07/20 PDF格式
RE48059*PED 2029/06/23 PDF格式
002 10307419 2032/10/12 Y 2019/06/14 PDF格式
10307419*PED 2033/04/12 PDF格式
7888362 2026/04/12 Y Y 2015/07/17 PDF格式
7888362*PED 2026/10/12 PDF格式
8349840 2026/04/12 Y U-1529 2015/07/17 PDF格式
8349840*PED 2026/10/12 PDF格式
8618109 2026/04/12 U-543 U-3281 2015/07/17 PDF格式
8618109*PED 2026/10/12 PDF格式
9839637 2026/04/12 Y U-543 U-1529 U-3281 2018/01/09 PDF格式
9839637*PED 2026/10/12 PDF格式
RE48059 2028/12/23 Y 2020/07/20 PDF格式
RE48059*PED 2029/06/23 PDF格式
003 10307419 2032/10/12 Y 2019/06/14 PDF格式
10307419*PED 2033/04/12 PDF格式
7888362 2026/04/12 Y Y 2015/07/23 PDF格式
7888362*PED 2026/10/12 PDF格式
8349840 2026/04/12 Y U-1529 2015/07/23 PDF格式
8349840*PED 2026/10/12 PDF格式
8618109 2026/04/12 U-543 U-3281 2015/07/23 PDF格式
8618109*PED 2026/10/12 PDF格式
9839637 2026/04/12 Y U-1529 U-543 U-3281 2018/01/09 PDF格式
9839637*PED 2026/10/12 PDF格式
RE48059 2028/12/23 Y 2020/07/20 PDF格式
RE48059*PED 2029/06/23 PDF格式
004 10307419 2032/10/12 Y 2019/06/14 PDF格式
10307419*PED 2033/04/12 PDF格式
7888362 2026/04/12 Y Y 2015/07/23 PDF格式
7888362*PED 2026/10/12 PDF格式
8349840 2026/04/12 Y U-1529 2015/07/23 PDF格式
8349840*PED 2026/10/12 PDF格式
8618109 2026/04/12 U-543 U-3281 2015/07/23 PDF格式
8618109*PED 2026/10/12 PDF格式
9839637 2026/04/12 Y U-1529 U-543 U-3281 2018/01/09 PDF格式
9839637*PED 2026/10/12 PDF格式
RE48059 2028/12/23 Y 2020/07/20 PDF格式
RE48059*PED 2029/06/23 PDF格式
005 10307419 2032/10/12 Y 2019/06/14 PDF格式
10307419*PED 2033/04/12 PDF格式
7888362 2026/04/12 Y Y 2015/07/23 PDF格式
7888362*PED 2026/10/12 PDF格式
8349840 2026/04/12 Y U-1529 2015/07/23 PDF格式
8349840*PED 2026/10/12 PDF格式
8618109 2026/04/12 U-543 U-3281 2015/07/23 PDF格式
8618109*PED 2026/10/12 PDF格式
9839637 2026/04/12 Y U-543 U-1529 U-3281 2018/01/09 PDF格式
9839637*PED 2026/10/12 PDF格式
RE48059 2028/12/23 Y 2020/07/20 PDF格式
RE48059*PED 2029/06/23 PDF格式
006 7888362 2026/04/12 Y Y 2015/07/23 PDF格式
7888362*PED 2026/10/12 PDF格式
8349840 2026/04/12 Y U-1529 2015/07/23 PDF格式
8349840*PED 2026/10/12 PDF格式
8618109 2026/04/12 U-543 U-3281 2015/07/23 PDF格式
8618109*PED 2026/10/12 PDF格式
9839637 2026/04/12 Y U-543 U-1529 U-3281 2018/01/09 PDF格式
9839637*PED 2026/10/12 PDF格式
RE48059 2028/12/23 Y 2020/07/20 PDF格式
RE48059*PED 2029/06/23 PDF格式
001 7888362 2026/04/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7888362 2027/02/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8618109 2026/04/12 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
9839637 2026/04/12 Y U-1529 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
002 7888362 2026/04/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7888362 2027/02/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8618109 2026/04/12 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
9839637 2026/04/12 Y U-543 U-1529 PDF格式**本条是由Drugfuture回溯的历史信息**
003 7888362 2026/04/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7888362 2027/02/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8618109 2026/04/12 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
9839637 2026/04/12 Y U-1529 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
004 7888362 2026/04/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7888362 2027/02/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8618109 2026/04/12 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
9839637 2026/04/12 Y U-1529 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
005 7888362 2026/04/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7888362 2027/02/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8618109 2026/04/12 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
9839637 2026/04/12 Y U-543 U-1529 PDF格式**本条是由Drugfuture回溯的历史信息**
006 7888362 2026/04/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7888362 2027/02/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8618109 2026/04/12 U-543 PDF格式**本条是由Drugfuture回溯的历史信息**
9839637 2026/04/12 Y U-543 U-1529 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 I-913 2026/05/10
M-14 2027/05/08
M-315 2028/05/09
PED 2027/11/08
PED 2026/11/10
002 I-913 2026/05/10
M-14 2027/05/08
M-315 2028/05/09
PED 2027/11/08
PED 2026/11/10
003 I-913 2026/05/10
M-14 2027/05/08
M-315 2028/05/09
PED 2027/11/08
PED 2026/11/10
004 I-913 2026/05/10
M-14 2027/05/08
M-315 2028/05/09
PED 2027/11/08
PED 2026/11/10
005 I-913 2026/05/10
M-14 2027/05/08
M-315 2028/05/09
PED 2027/11/08
PED 2026/11/10
006 I-913 2026/05/10
M-14 2027/05/08
M-315 2028/05/09
PED 2027/11/08
PED 2026/11/10
001 M-186 2019/09/23**本条是由Drugfuture回溯的历史信息**
NCE 2020/07/10**本条是由Drugfuture回溯的历史信息**
002 M-186 2019/09/23**本条是由Drugfuture回溯的历史信息**
NCE 2020/07/10**本条是由Drugfuture回溯的历史信息**
003 M-186 2019/09/23**本条是由Drugfuture回溯的历史信息**
NCE 2020/07/10**本条是由Drugfuture回溯的历史信息**
004 M-186 2019/09/23**本条是由Drugfuture回溯的历史信息**
NCE 2020/07/10**本条是由Drugfuture回溯的历史信息**
005 M-186 2019/09/23**本条是由Drugfuture回溯的历史信息**
NCE 2020/07/10**本条是由Drugfuture回溯的历史信息**
006 M-186 2019/09/23**本条是由Drugfuture回溯的历史信息**
NCE 2020/07/10**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: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 CHARTWELL RX
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
213683 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Prescription No No AB 2025/01/13 ALEMBIC
213731 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Prescription No No AB 2025/01/13 ALEMBIC
213731 001 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.25MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Prescription No No AB 2025/01/13 ALEMBIC
213731 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Prescription No No AB 2025/01/13 ALEMBIC
213731 002 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 0.5MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Prescription No No AB 2025/01/13 ALEMBIC
213731 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Prescription No No AB 2025/01/13 ALEMBIC
213731 003 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 1MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2025/01/13 ALEMBIC
213731 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2025/01/13 ALEMBIC
213731 004 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Prescription No No AB 2025/01/13 ALEMBIC
213731 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Prescription No No AB 2025/01/13 ALEMBIC
213731 005 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 3MG Discontinued No No AB 2025/02/24 APOTEX
>>>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 CHARTWELL RX
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
213683 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Prescription No No AB 2025/01/13 ALEMBIC
>>>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 CHARTWELL RX
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
213683 006 ANDA BREXPIPRAZOLE BREXPIPRAZOLE TABLET;ORAL 4MG Prescription No No AB 2025/01/13 ALEMBIC
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