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=ANDA214222"
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
65219-029-20 65219-029 HUMAN PRESCRIPTION DRUG Thiotepa Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20220411 N/A ANDA ANDA214222 Fresenius Kabi USA, LLC THIOTEPA 100 mg/1 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
68083-446-01 68083-446 HUMAN PRESCRIPTION DRUG Thiotepa Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20210308 N/A ANDA ANDA214222 Gland Pharma Limited THIOTEPA 15 mg/1 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
68083-503-01 68083-503 HUMAN PRESCRIPTION DRUG Thiotepa Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20220103 N/A ANDA ANDA214222 Gland Pharma Limited THIOTEPA 100 mg/1 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
43598-171-11 43598-171 HUMAN PRESCRIPTION DRUG Thiotepa Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20221101 N/A ANDA ANDA214222 Dr.Reddy's Laboratories Inc., THIOTEPA 100 mg/1 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
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