药品注册申请号:218202
申请类型:ANDA (仿制药申请)
申请人:SKG PHARMA
申请人全名:SKG PHARMA INC
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 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG No No AB 2024/04/10 2024/04/10 Prescription
002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG No No AB 2024/04/10 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
2024/04/10 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:NICARDIPINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;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
074670 001 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG Prescription No No AB 1996/10/28 ANI PHARMS
074928 001 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG Prescription No No AB 1998/03/19 EPIC PHARMA LLC
216357 001 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG Prescription No No AB 2022/12/16 GLENMARK PHARMS LTD
217555 001 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/05/03 BIONPHARMA
215377 001 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/07/17 SENORES PHARMS
218202 001 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG Prescription No No AB 2024/04/10 SKG PHARMA
活性成分:NICARDIPINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;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
074670 002 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AB 1996/10/28 ANI PHARMS
074928 002 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No Yes AB 1998/03/19 EPIC PHARMA LLC
216357 002 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AB 2022/12/16 GLENMARK PHARMS LTD
217555 002 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AB 2023/05/03 BIONPHARMA
215377 002 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AB 2023/07/17 SENORES PHARMS
218202 002 ANDA NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AB 2024/04/10 SKG PHARMA
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