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=ANDA207383"
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
68083-202-01 68083-202 HUMAN PRESCRIPTION DRUG Temsirolimus Temsirolimus Injection KIT 20190826 N/A ANDA ANDA207383 Gland Pharma Limited 1 KIT in 1 CARTON (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)
65219-200-05 65219-200 HUMAN PRESCRIPTION DRUG Temsirolimus Temsirolimus KIT INTRAVENOUS 20201120 N/A ANDA ANDA207383 Fresenius Kabi USA, LLC 1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05)
72611-785-02 72611-785 HUMAN PRESCRIPTION DRUG Temsirolimus Temsirolimus Injection KIT 20200508 N/A ANDA ANDA207383 Almaject, Inc. 1 KIT in 1 CARTON (72611-785-02) * 1 mL in 1 VIAL, SINGLE-DOSE (72611-780-01) * 1.8 mL in 1 VIAL, SINGLE-DOSE (72611-782-01)
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