药品注册申请号：217350
申请类型：ANDA (仿制药申请)
申请人：ALEMBIC
申请人全名：ALEMBIC PHARMACEUTICALS 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 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2023/07/18 2023/07/18 Prescription
002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No AB 2023/07/18 Prescription
003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No AB 2023/07/18 Prescription
004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG No No AB 2023/07/18 Prescription
005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG No No AB 2023/07/18 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
2023/07/18 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:CHLORPROMAZINE HYDROCHLORIDE 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
083386 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes No AB Approved Prior to Jan 1, 1982 UPSHER SMITH LABS
209755 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/09/10 AMNEAL PHARMS CO
213368 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/01/17 ZYDUS LIFESCIENCES
213590 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/08/31 APPCO
214256 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/10/26 SUN PHARM
212996 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/01/22 LANNETT CO INC
212144 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/03/23 GLENMARK PHARMS LTD
215659 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/10/25 TEVA PHARMS
212630 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/11/29 CHARTWELL RX
213327 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/07/13 LUPIN
217350 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/07/18 ALEMBIC
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格: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
084112 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 UPSHER SMITH LABS
209755 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2018/09/10 AMNEAL PHARMS CO
213368 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2020/01/17 ZYDUS LIFESCIENCES
213590 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2020/08/31 APPCO
214256 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2020/10/26 SUN PHARM
212996 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/01/22 LANNETT CO INC
212144 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/03/23 GLENMARK PHARMS LTD
215659 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/10/25 TEVA PHARMS
212630 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/11/29 CHARTWELL RX
214827 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2022/01/27 MSN
213327 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2023/07/13 LUPIN
217350 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2023/07/18 ALEMBIC
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
084113 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 UPSHER SMITH LABS
209755 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2018/09/10 AMNEAL PHARMS CO
213368 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2020/01/17 ZYDUS LIFESCIENCES
213590 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2020/08/31 APPCO
214256 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2020/10/26 SUN PHARM
212996 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/01/22 LANNETT CO INC
212144 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/03/23 GLENMARK PHARMS LTD
215659 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/10/25 TEVA PHARMS
212630 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/11/29 CHARTWELL RX
214827 002 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2022/01/27 MSN
213327 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2023/07/13 LUPIN
217350 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2023/07/18 ALEMBIC
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
084114 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 UPSHER SMITH LABS
209755 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2018/09/10 AMNEAL PHARMS CO
213368 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/01/17 ZYDUS LIFESCIENCES
213590 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/08/31 APPCO
214256 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/10/26 SUN PHARM
212996 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/01/22 LANNETT CO INC
212144 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/03/23 GLENMARK PHARMS LTD
215659 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/10/25 TEVA PHARMS
212630 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/11/29 CHARTWELL RX
214827 003 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2022/01/27 MSN
213327 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2023/07/13 LUPIN
217350 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2023/07/18 ALEMBIC
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
084115 001 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription Yes No AB Approved Prior to Jan 1, 1982 UPSHER SMITH LABS
209755 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2018/09/10 AMNEAL PHARMS CO
213368 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2020/01/17 ZYDUS LIFESCIENCES
213590 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2020/08/31 APPCO
214256 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2020/10/26 SUN PHARM
212996 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2021/01/22 LANNETT CO INC
212144 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2021/03/23 GLENMARK PHARMS LTD
215659 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2021/10/25 TEVA PHARMS
212630 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2021/11/29 CHARTWELL RX
214827 004 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2022/01/27 MSN
213327 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2023/07/13 LUPIN
217350 005 ANDA CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2023/07/18 ALEMBIC
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