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=ANDA210124"
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
68001-525-27 68001-525 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20220218 N/A ANDA ANDA210124 BluePoint Laboratories FLUOROURACIL 50 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-27) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
68001-525-32 68001-525 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20220218 N/A ANDA ANDA210124 BluePoint Laboratories FLUOROURACIL 50 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-32) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
68083-292-01 68083-292 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20180105 N/A ANDA ANDA210124 Gland Pharma Limited FLUOROURACIL 50 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-292-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
68083-293-01 68083-293 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20180105 N/A ANDA ANDA210124 Gland Pharma Limited FLUOROURACIL 50 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-293-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
70700-188-22 70700-188 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20210813 N/A ANDA ANDA210124 Xiromed LLC FLUOROURACIL 50 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-188-22) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
70700-189-22 70700-189 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20210813 N/A ANDA ANDA210124 Xiromed LLC FLUOROURACIL 50 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-189-22) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
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