美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA019865"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
13672-051-00 13672-051 HUMAN PRESCRIPTION DRUG Betapace sotalol HCl TABLET ORAL 19921030 N/A NDA NDA019865 Skyepharma Production SAS SOTALOL HYDROCHLORIDE 80 mg/80mg 100 mg in 1 BOTTLE (13672-051-00)
13672-052-00 13672-052 HUMAN PRESCRIPTION DRUG Betapace sotalol HCl TABLET ORAL 19921030 N/A NDA NDA019865 Skyepharma Production SAS SOTALOL HYDROCHLORIDE 120 mg/120mg 100 mg in 1 BOTTLE (13672-052-00)
13672-053-00 13672-053 HUMAN PRESCRIPTION DRUG Betapace sotalol HCl TABLET ORAL 19921030 N/A NDA NDA019865 Skyepharma Production SAS SOTALOL HYDROCHLORIDE 160 mg/160mg 100 mg in 1 BOTTLE (13672-053-00)
83107-005-10 83107-005 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Legacy Pharma USA, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 100 TABLET in 1 BOTTLE (83107-005-10)
83107-006-10 83107-006 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Legacy Pharma USA, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 100 TABLET in 1 BOTTLE (83107-006-10)
83107-007-10 83107-007 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Legacy Pharma USA, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 100 TABLET in 1 BOTTLE (83107-007-10)
83107-008-60 83107-008 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Legacy Pharma USA, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 60 TABLET in 1 BOTTLE (83107-008-60)
83107-009-60 83107-009 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Legacy Pharma USA, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 60 TABLET in 1 BOTTLE (83107-009-60)
83107-010-60 83107-010 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Legacy Pharma USA, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 60 TABLET in 1 BOTTLE (83107-010-60)
70515-105-10 70515-105 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Covis Pharma US, Inc SOTALOL HYDROCHLORIDE 80 mg/1 100 TABLET in 1 BOTTLE (70515-105-10)
70515-106-10 70515-106 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Covis Pharma US, Inc SOTALOL HYDROCHLORIDE 160 mg/1 100 TABLET in 1 BOTTLE (70515-106-10)
70515-109-10 70515-109 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA019865 Covis Pharma US, Inc SOTALOL HYDROCHLORIDE 120 mg/1 100 TABLET in 1 BOTTLE (70515-109-10)
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