药品注册申请号：206174
申请类型：ANDA (仿制药申请)
申请人：AJANTA PHARMA LTD
申请人全名：AJANTA PHARMA 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 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG No No AB 2016/09/12 2016/09/12 Prescription
002 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG No No AB 2016/09/12 Prescription
003 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG No No AB 2016/09/12 Prescription
004 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG No No AB 2016/09/12 Prescription
005 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG No No AB 2016/09/12 Prescription
006 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG No No AB 2016/09/12 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
2023/06/15 SUPPL-34（补充） Approval Labeling STANDARD
2023/06/15 SUPPL-12（补充） Approval Labeling STANDARD
2023/06/15 SUPPL-10（补充） Approval Labeling STANDARD
2023/06/15 SUPPL-2（补充） Approval Labeling STANDARD
2017/08/04 SUPPL-3（补充） Approval Manufacturing (CMC)
2016/09/12 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:ARIPIPRAZOLE 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
021436 006 NDA ABILIFY ARIPIPRAZOLE TABLET;ORAL 2MG Prescription Yes No AB 2002/11/15 OTSUKA
201519 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2015/04/28 TORRENT
202101 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2015/04/28 ALEMBIC
205064 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2015/04/28 HETERO LABS LTD V
078583 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2015/07/24 APOTEX
203908 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2015/10/08 AUROBINDO PHARMA
204838 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2016/06/17 AMNEAL PHARMS
206174 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2016/09/12 AJANTA PHARMA LTD
206383 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2016/09/29 SCIEGEN PHARMS INC
204111 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2016/10/07 MACLEODS PHARMS LTD
206251 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2016/12/07 ACCORD HLTHCARE
091279 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Discontinued No No AB 2017/01/09 BRECKENRIDGE
202683 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2017/05/23 ORBION PHARMS
205363 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2017/12/04 PRINSTON INC
207105 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2019/02/21 ALKEM LABS LTD
203025 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2021/12/01 UNICHEM
213037 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2023/10/02 SUNSHINE
205589 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG Prescription No No AB 2024/03/18 LUPIN
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格: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
021436 005 NDA ABILIFY ARIPIPRAZOLE TABLET;ORAL 5MG Prescription Yes No AB 2002/11/15 OTSUKA
201519 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2015/04/28 TORRENT
202101 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2015/04/28 ALEMBIC
205064 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2015/04/28 HETERO LABS LTD V
078583 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2015/07/24 APOTEX
203908 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2015/10/08 AUROBINDO PHARMA
204838 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2016/06/17 AMNEAL PHARMS
206174 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2016/09/12 AJANTA PHARMA LTD
206383 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2016/09/29 SCIEGEN PHARMS INC
204111 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2016/10/07 MACLEODS PHARMS LTD
206251 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2016/12/07 ACCORD HLTHCARE
091279 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Discontinued No No AB 2017/01/09 BRECKENRIDGE
202683 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2017/05/23 ORBION PHARMS
205363 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2017/12/04 PRINSTON INC
207105 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2019/02/21 ALKEM LABS LTD
203025 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2021/12/01 UNICHEM
213037 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2023/10/02 SUNSHINE
205589 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG Prescription No No AB 2024/03/18 LUPIN
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
021436 001 NDA ABILIFY ARIPIPRAZOLE TABLET;ORAL 10MG Prescription Yes Yes AB 2002/11/15 OTSUKA
201519 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2015/04/28 TORRENT
202101 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2015/04/28 ALEMBIC
205064 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2015/04/28 HETERO LABS LTD V
078583 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2015/07/24 APOTEX
203908 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2015/10/08 AUROBINDO PHARMA
204838 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2016/06/17 AMNEAL PHARMS
206174 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2016/09/12 AJANTA PHARMA LTD
206383 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2016/09/29 SCIEGEN PHARMS INC
204111 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2016/10/07 MACLEODS PHARMS LTD
206251 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2016/12/07 ACCORD HLTHCARE
091279 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Discontinued No No AB 2017/01/09 BRECKENRIDGE
202683 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2017/05/23 ORBION PHARMS
205363 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2017/12/04 PRINSTON INC
207105 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2019/02/21 ALKEM LABS LTD
203025 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2021/12/01 UNICHEM
213037 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2023/10/02 SUNSHINE
205589 003 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG Prescription No No AB 2024/03/18 LUPIN
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:15MG 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
021436 002 NDA ABILIFY ARIPIPRAZOLE TABLET;ORAL 15MG Prescription Yes No AB 2002/11/15 OTSUKA
201519 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2015/04/28 TORRENT
202101 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2015/04/28 ALEMBIC
205064 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2015/04/28 HETERO LABS LTD V
078583 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2015/07/24 APOTEX
203908 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2015/10/08 AUROBINDO PHARMA
204838 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2016/06/17 AMNEAL PHARMS
206174 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2016/09/12 AJANTA PHARMA LTD
206383 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2016/09/29 SCIEGEN PHARMS INC
204111 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2016/10/07 MACLEODS PHARMS LTD
206251 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2016/12/07 ACCORD HLTHCARE
091279 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Discontinued No No AB 2017/01/09 BRECKENRIDGE
202683 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2017/05/23 ORBION PHARMS
205363 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2017/12/04 PRINSTON INC
207105 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2019/02/21 ALKEM LABS LTD
203025 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2021/12/01 UNICHEM
205589 004 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG Prescription No No AB 2024/03/18 LUPIN
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:20MG 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
021436 003 NDA ABILIFY ARIPIPRAZOLE TABLET;ORAL 20MG Prescription Yes No AB 2002/11/15 OTSUKA
201519 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2015/04/28 TORRENT
202101 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2015/04/28 ALEMBIC
205064 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2015/04/28 HETERO LABS LTD V
078583 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2015/07/24 APOTEX
203908 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2015/10/08 AUROBINDO PHARMA
204838 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2016/06/17 AMNEAL PHARMS
206174 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2016/09/12 AJANTA PHARMA LTD
206383 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2016/09/29 SCIEGEN PHARMS INC
204111 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2016/10/07 MACLEODS PHARMS LTD
206251 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2016/12/07 ACCORD HLTHCARE
091279 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Discontinued No No AB 2017/01/09 BRECKENRIDGE
202683 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2017/05/23 ORBION PHARMS
205363 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2017/12/04 PRINSTON INC
207105 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2019/02/21 ALKEM LABS LTD
203025 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2021/12/01 UNICHEM
205589 005 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG Prescription No No AB 2024/03/18 LUPIN
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET;ORAL 规格:30MG 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
021436 004 NDA ABILIFY ARIPIPRAZOLE TABLET;ORAL 30MG Prescription Yes No AB 2002/11/15 OTSUKA
201519 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2015/04/28 TORRENT
202101 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2015/04/28 ALEMBIC
205064 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2015/04/28 HETERO LABS LTD V
078583 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2015/07/24 APOTEX
203908 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2015/10/08 AUROBINDO PHARMA
204838 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2016/06/17 AMNEAL PHARMS
206174 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2016/09/12 AJANTA PHARMA LTD
206383 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2016/09/29 SCIEGEN PHARMS INC
204111 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2016/10/07 MACLEODS PHARMS LTD
206251 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2016/12/07 ACCORD HLTHCARE
091279 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Discontinued No No AB 2017/01/09 BRECKENRIDGE
202683 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2017/05/23 ORBION PHARMS
205363 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2017/12/04 PRINSTON INC
207105 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2019/02/21 ALKEM LABS LTD
203025 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2021/12/01 UNICHEM
205589 006 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG Prescription No No AB 2024/03/18 LUPIN
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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