美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=IVABRADINE HYDROCHLORIDE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
IVABRADINE HYDROCHLORIDE 214051 001 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2021/12/30 2021/12/30 INGENUS PHARMS LLC Discontinued
IVABRADINE HYDROCHLORIDE 214051 002 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 7.5MG BASE No No 2021/12/30 2021/12/30 INGENUS PHARMS LLC Discontinued
IVABRADINE HYDROCHLORIDE 215238 001 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2022/04/19 (TA) -- ALEMBIC PHARMS LTD None (Tentative Approval)
IVABRADINE HYDROCHLORIDE 215238 002 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL 7.5MG No No 2022/04/19 (TA) -- ALEMBIC PHARMS LTD None (Tentative Approval)
IVABRADINE HYDROCHLORIDE 213366 001 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2022/10/05 2022/10/05 ANNORA PHARMA Prescription
IVABRADINE HYDROCHLORIDE 213366 002 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 7.5MG BASE No No 2022/10/05 2022/10/05 ANNORA PHARMA Prescription
IVABRADINE HYDROCHLORIDE 213442 001 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2023/11/29 2023/11/29 ZYDUS PHARMS Prescription
IVABRADINE HYDROCHLORIDE 213442 002 ANDA IVABRADINE HYDROCHLORIDE TABLET;ORAL EQ 7.5MG BASE No No 2023/11/29 2023/11/29 ZYDUS PHARMS Prescription
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