药品注册申请号:214031
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 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No AB 2020/08/04 2020/08/04 Prescription
002 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No AB 2020/08/04 Prescription
003 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 2020/08/04 Prescription
004 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE No No AB 2020/08/04 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
2023/06/30 SUPPL-4(补充) Approval Labeling STANDARD
2020/08/04 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
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
与本品治疗等效的药品
活性成分:VARDENAFIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 2.5MG 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
091347 001 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2012/05/03 TEVA PHARMS
208960 001 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2018/10/31 ZYDUS PHARMS
209057 001 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2018/10/31 CROSSMEDIKA SA
204632 001 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2019/10/22 MACLEODS PHARMS LTD
214031 001 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2020/08/04 ALEMBIC
活性成分:VARDENAFIL 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
091347 002 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2012/05/03 TEVA PHARMS
208960 002 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2018/10/31 ZYDUS PHARMS
209057 002 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2018/10/31 CROSSMEDIKA SA
204632 002 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/10/22 MACLEODS PHARMS LTD
214031 002 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2020/08/04 ALEMBIC
活性成分:VARDENAFIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG 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
091347 003 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/05/03 TEVA PHARMS
208960 003 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/10/31 ZYDUS PHARMS
209057 003 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/10/31 CROSSMEDIKA SA
204632 003 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/10/22 MACLEODS PHARMS LTD
214031 003 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2020/08/04 ALEMBIC
活性成分:VARDENAFIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 20MG 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
091347 004 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/05/03 TEVA PHARMS
208960 004 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No Yes AB 2018/10/31 ZYDUS PHARMS
209057 004 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/10/31 CROSSMEDIKA SA
204632 004 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/10/22 MACLEODS PHARMS LTD
214031 004 ANDA VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2020/08/04 ALEMBIC
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