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=ANDA091365"
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
16714-909-01 16714-909 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20181101 N/A ANDA ANDA091365 NorthStar Rx LLC GEMCITABINE HYDROCHLORIDE 200 mg/1 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
16714-930-01 16714-930 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20181101 N/A ANDA ANDA091365 NorthStar Rx LLC GEMCITABINE HYDROCHLORIDE 1 g/1 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
71288-113-10 71288-113 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20181101 N/A ANDA ANDA091365 Meitheal Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 200 mg/1 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
71288-114-50 71288-114 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20181101 N/A ANDA ANDA091365 Meitheal Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 1 g/1 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-114-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
55111-686-07 55111-686 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 N/A ANDA ANDA091365 Dr. Reddy's Laboratories Limited GEMCITABINE HYDROCHLORIDE 200 mg/5mL 1 VIAL, SINGLE-USE in 1 CARTON (55111-686-07) / 5 mL in 1 VIAL, SINGLE-USE
55111-687-25 55111-687 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 N/A ANDA ANDA091365 Dr. Reddy's Laboratories Limited GEMCITABINE HYDROCHLORIDE 1 g/25mL 1 VIAL, SINGLE-USE in 1 CARTON (55111-687-25) / 25 mL in 1 VIAL, SINGLE-USE
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