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=NDA021151"
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
70515-119-06 70515-119 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA021151 Covis Pharma US, Inc SOTALOL HYDROCHLORIDE 120 mg/1 60 TABLET in 1 BOTTLE (70515-119-06)
70515-116-06 70515-116 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA021151 Covis Pharma US, Inc SOTALOL HYDROCHLORIDE 160 mg/1 60 TABLET in 1 BOTTLE (70515-116-06)
70515-115-06 70515-115 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 N/A NDA NDA021151 Covis Pharma US, Inc SOTALOL HYDROCHLORIDE 80 mg/1 60 TABLET in 1 BOTTLE (70515-115-06)
13672-054-00 13672-054 HUMAN PRESCRIPTION DRUG Betapace AF sotalol HCl TABLET ORAL 20000222 N/A NDA NDA021151 Skyepharma Production SAS SOTALOL HYDROCHLORIDE 80 mg/80mg 60 mg in 1 BOTTLE (13672-054-00)
13672-055-00 13672-055 HUMAN PRESCRIPTION DRUG Betapace AF sotalol HCl TABLET ORAL 20000222 N/A NDA NDA021151 Skyepharma Production SAS SOTALOL HYDROCHLORIDE 120 mg/120mg 60 mg in 1 BOTTLE (13672-055-00)
13672-056-00 13672-056 HUMAN PRESCRIPTION DRUG Betapace AF sotalol HCl TABLET ORAL 20000222 N/A NDA NDA021151 Skyepharma Production SAS SOTALOL HYDROCHLORIDE 160 mg/160mg 60 mg in 1 BOTTLE (13672-056-00)
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