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=NDA021879"
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
59148-053-98 59148-053 HUMAN PRESCRIPTION DRUG Nuedexta dextromethorphan hydrobromide and quinidine sulfate CAPSULE, GELATIN COATED ORAL 20230103 N/A NDA NDA021879 Otsuka America Pharmaceutical, Inc DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20 mg/1; 10 mg/1 4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
59148-053-16 59148-053 HUMAN PRESCRIPTION DRUG Nuedexta dextromethorphan hydrobromide and quinidine sulfate CAPSULE, GELATIN COATED ORAL 20230103 N/A NDA NDA021879 Otsuka America Pharmaceutical, Inc DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20 mg/1; 10 mg/1 60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)
64597-301-60 64597-301 HUMAN PRESCRIPTION DRUG NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate CAPSULE, GELATIN COATED ORAL 20101201 N/A NDA NDA021879 Avanir Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20 mg/1; 10 mg/1 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)
64597-301-13 64597-301 HUMAN PRESCRIPTION DRUG NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate CAPSULE, GELATIN COATED ORAL 20101201 N/A NDA NDA021879 Avanir Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
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