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=ANDA206617"
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
0143-9395-01 0143-9395 HUMAN PRESCRIPTION DRUG Gemcitabine Gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20210625 N/A ANDA ANDA206617 Hikma Pharmaceuticals USA Inc. GEMCITABINE 1 g/1 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9395-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
0143-9394-01 0143-9394 HUMAN PRESCRIPTION DRUG Gemcitabine Gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20210625 N/A ANDA ANDA206617 Hikma Pharmaceuticals USA Inc. GEMCITABINE 200 mg/1 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9394-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
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