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=NDA020727"
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
52536-006-09 52536-006 HUMAN PRESCRIPTION DRUG isosorbide dinitrate and hydralazine hydrochloride hydralazine hydrochloride and isosorbide dinitrate TABLET, FILM COATED ORAL 20220415 N/A NDA AUTHORIZED GENERIC NDA020727 Wilshire Pharmaceuticals HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5 mg/1; 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)
24338-010-09 24338-010 HUMAN PRESCRIPTION DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate TABLET, FILM COATED ORAL 20200831 N/A NDA NDA020727 Azurity HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5 mg/1; 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09)
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