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=ANDA215687"
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
65219-564-20 65219-564 HUMAN PRESCRIPTION DRUG MITOMYCIN MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20230115 N/A ANDA ANDA215687 Fresenius Kabi USA, LLC MITOMYCIN 5 mg/10mL 1 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL
25021-251-50 25021-251 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20230615 N/A ANDA ANDA215687 Sagent Pharmaceuticals MITOMYCIN 20 mg/40mL 1 VIAL in 1 CARTON (25021-251-50) / 40 mL in 1 VIAL
25021-250-20 25021-250 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20230615 N/A ANDA ANDA215687 Sagent Pharmaceuticals MITOMYCIN 5 mg/10mL 1 VIAL in 1 CARTON (25021-250-20) / 10 mL in 1 VIAL
65219-566-20 65219-566 HUMAN PRESCRIPTION DRUG MITOMYCIN MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20230115 N/A ANDA ANDA215687 Fresenius Kabi USA, LLC MITOMYCIN 20 mg/40mL 1 VIAL in 1 CARTON (65219-566-20) / 40 mL in 1 VIAL
68083-483-01 68083-483 HUMAN PRESCRIPTION DRUG MITOMYCIN MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20211020 N/A ANDA ANDA215687 Gland Pharma Limited MITOMYCIN 5 mg/10mL 1 VIAL in 1 CARTON (68083-483-01) / 10 mL in 1 VIAL
68083-484-01 68083-484 HUMAN PRESCRIPTION DRUG MITOMYCIN MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20211020 N/A ANDA ANDA215687 Gland Pharma Limited MITOMYCIN 20 mg/40mL 1 VIAL in 1 CARTON (68083-484-01) / 40 mL in 1 VIAL
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