药品注册申请号：208002
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS CO
申请人全名：AMNEAL PHARMACEUTICALS CO GMBH
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 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG No No AB 2019/01/03 2019/01/03 Prescription
002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG No No AB 2019/01/03 Prescription
003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG No No AB 2019/01/03 Prescription
004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG No No AB 2019/01/03 Prescription
005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG No No AB 2019/01/03 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
2024/12/03 SUPPL-4（补充） Approval Labeling STANDARD
2024/12/03 SUPPL-3（补充） Approval Labeling STANDARD
2019/01/03 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:LURASIDONE HYDROCHLORIDE 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
200603 003 NDA LATUDA LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription Yes No AB 2011/12/07 SUNOVION PHARMS INC
208002 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/01/03 AMNEAL PHARMS CO
208028 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/01/03 INVAGEN PHARMS
208031 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/01/03 LUPIN LTD
208049 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/01/03 ACCORD HLTHCARE
208055 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/01/03 TORRENT
208066 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/01/04 SUN PHARM
208052 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/03/19 ZYDUS PHARMS
208058 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/09/04 HERITAGE PHARMA AVET
212091 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2020/12/28 ADAPTIS
213248 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2021/05/13 ALEMBIC
208047 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2021/08/24 DR REDDYS
208037 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2022/09/09 MSN
212244 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2022/12/13 ALKEM LABS LTD
208045 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2023/03/10 AUROBINDO PHARMA LTD
212124 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2023/06/09 MACLEODS PHARMS LTD
218174 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2024/08/21 ANNORA PHARMA
210388 001 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2024/12/06 JUBILANT GENERICS
活性成分:LURASIDONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:40MG 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
200603 001 NDA LATUDA LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription Yes Yes AB 2010/10/28 SUNOVION PHARMS INC
208002 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/01/03 AMNEAL PHARMS CO
208028 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/01/03 INVAGEN PHARMS
208031 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/01/03 LUPIN LTD
208049 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/01/03 ACCORD HLTHCARE
208055 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/01/03 TORRENT
208066 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/01/04 SUN PHARM
208052 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/03/19 ZYDUS PHARMS
208058 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/09/04 HERITAGE PHARMA AVET
212091 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2020/12/28 ADAPTIS
213248 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2021/05/13 ALEMBIC
208047 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2021/08/24 DR REDDYS
208037 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2022/09/09 MSN
212244 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2022/12/13 ALKEM LABS LTD
208045 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2023/03/10 AUROBINDO PHARMA LTD
212124 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2023/06/09 MACLEODS PHARMS LTD
218174 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2024/08/21 ANNORA PHARMA
210388 002 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2024/12/06 JUBILANT GENERICS
活性成分:LURASIDONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:60MG 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
200603 005 NDA LATUDA LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription Yes No AB 2013/07/12 SUNOVION PHARMS INC
208002 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/01/03 AMNEAL PHARMS CO
208028 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/01/03 INVAGEN PHARMS
208031 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/01/03 LUPIN LTD
208049 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/01/03 ACCORD HLTHCARE
208066 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/01/04 SUN PHARM
208052 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/03/19 ZYDUS PHARMS
208058 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2019/09/04 HERITAGE PHARMA AVET
212091 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2020/12/28 ADAPTIS
213248 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2021/05/13 ALEMBIC
208047 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2021/08/24 DR REDDYS
208037 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2022/09/09 MSN
212244 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2022/12/13 ALKEM LABS LTD
208045 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2023/03/10 AUROBINDO PHARMA LTD
212124 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2023/06/09 MACLEODS PHARMS LTD
218174 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2024/08/21 ANNORA PHARMA
210388 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2024/12/06 JUBILANT GENERICS
活性成分:LURASIDONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:80MG 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
200603 002 NDA LATUDA LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription Yes No AB 2010/10/28 SUNOVION PHARMS INC
208002 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/01/03 AMNEAL PHARMS CO
208028 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/01/03 INVAGEN PHARMS
208031 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/01/03 LUPIN LTD
208049 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/01/03 ACCORD HLTHCARE
208055 003 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/01/03 TORRENT
208066 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/01/04 SUN PHARM
208052 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/03/19 ZYDUS PHARMS
208058 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2019/09/04 HERITAGE PHARMA AVET
212091 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2020/12/28 ADAPTIS
213248 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2021/05/13 ALEMBIC
208047 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2021/08/24 DR REDDYS
208037 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2022/09/09 MSN
212244 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2022/12/13 ALKEM LABS LTD
208045 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2023/03/10 AUROBINDO PHARMA LTD
212124 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2023/06/09 MACLEODS PHARMS LTD
218174 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2024/08/21 ANNORA PHARMA
210388 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2024/12/06 JUBILANT GENERICS
活性成分:LURASIDONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:120MG 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
200603 004 NDA LATUDA LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription Yes No AB 2012/04/26 SUNOVION PHARMS INC
208002 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/01/03 AMNEAL PHARMS CO
208028 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/01/03 INVAGEN PHARMS
208031 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/01/03 LUPIN LTD
208049 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/01/03 ACCORD HLTHCARE
208055 004 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/01/03 TORRENT
208066 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/01/04 SUN PHARM
208052 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2019/03/19 ZYDUS PHARMS
212091 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2020/12/28 ADAPTIS
213248 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2021/05/13 ALEMBIC
208037 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2022/09/09 MSN
212244 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2022/12/13 ALKEM LABS LTD
208058 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2023/02/28 HERITAGE PHARMA AVET
208045 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2023/03/10 AUROBINDO PHARMA LTD
212124 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2023/06/09 MACLEODS PHARMS LTD
218174 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2024/08/21 ANNORA PHARMA
210388 005 ANDA LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2024/12/06 JUBILANT GENERICS
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