药品注册申请号：090429
申请类型：ANDA (仿制药申请)
申请人：ALEMBIC LTD
申请人全名：ALEMBIC 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 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE No No AB 2010/03/24 2010/03/24 Prescription
002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE No No AB 2010/03/24 Prescription
003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No AB 2010/03/24 Prescription
004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE No No AB 2010/03/24 Prescription
005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE No No AB 2010/03/24 Prescription
006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE No No AB 2010/03/24 Prescription
007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No AB 2010/03/24 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
2010/03/24 ORIG-1（原始申请） Approval
>>>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
2020/04/07 SUPPL-7（补充） Approval Labeling-Container/Carton Labels,Labeling-Patient Package Insert,Labeling-Package Insert STANDARD
2020/04/07 SUPPL-6（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2015/11/18 SUPPL-3（补充） Approval Labeling-Package Insert STANDARD
2011/10/31 SUPPL-2（补充） Approval Labeling-Package Insert
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:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 0.25MG BASE; 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
078110 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No Yes AB 2008/05/05 PRINSTON INC
078881 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Discontinued No No AB 2008/05/05 PHARMOBEDIENT
079050 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
090411 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2012/02/07 MLV
079229 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 001 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
>>>活性成分:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 0.5MG BASE; 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
078110 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2008/05/05 PRINSTON INC
078881 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Discontinued No No AB 2008/05/05 PHARMOBEDIENT
079050 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
090411 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2012/02/07 MLV
079229 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 002 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
>>>活性成分:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 1MG BASE; 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
078110 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2008/05/05 PRINSTON INC
078881 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Discontinued No No AB 2008/05/05 PHARMOBEDIENT
079050 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
090411 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2012/02/07 MLV
079229 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 003 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
>>>活性成分:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 2MG BASE; 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
078110 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2008/05/05 PRINSTON INC
078881 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Discontinued No No AB 2008/05/05 PHARMOBEDIENT
079050 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
090411 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2012/02/07 MLV
079229 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 004 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
>>>活性成分:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 3MG BASE; 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
078110 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2008/05/05 PRINSTON INC
078881 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Discontinued No No AB 2008/05/05 PHARMOBEDIENT
079050 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
090411 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2012/02/07 MLV
079229 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 005 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
>>>活性成分:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 4MG BASE; 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
078110 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2008/05/05 PRINSTON INC
078881 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Discontinued No No AB 2008/05/05 PHARMOBEDIENT
079050 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
090411 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2012/02/07 MLV
079229 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 006 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
>>>活性成分:ROPINIROLE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 5MG BASE; 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
078881 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2008/05/19 PHARMOBEDIENT
079050 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2008/05/29 CHARTWELL RX
078110 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2008/07/11 PRINSTON INC
090411 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2009/06/01 ZYDUS LIFESCIENCES
090135 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2010/02/25 GLENMARK PHARMS LTD
090429 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2010/03/24 ALEMBIC LTD
079165 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/02/07 MLV
079229 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/11/28 ORBION PHARMS
204022 007 ANDA ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/02/28 ACCORD HLTHCARE
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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