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=NDA022468"
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
72893-003-01 72893-003 HUMAN PRESCRIPTION DRUG Folotyn pralatrexate INJECTION INTRAVENOUS 20090924 N/A NDA NDA022468 Acrotech Biopharma Inc PRALATREXATE 20 mg/mL 1 VIAL in 1 CARTON (72893-003-01) / 1 mL in 1 VIAL
72893-005-01 72893-005 HUMAN PRESCRIPTION DRUG Folotyn pralatrexate INJECTION INTRAVENOUS 20090924 N/A NDA NDA022468 Acrotech Biopharma Inc PRALATREXATE 40 mg/2mL 1 VIAL in 1 CARTON (72893-005-01) / 2 mL in 1 VIAL
65219-550-01 65219-550 HUMAN PRESCRIPTION DRUG Pralatrexate Pralatrexate INJECTION INTRAVENOUS 20221115 N/A NDA AUTHORIZED GENERIC NDA022468 Fresenius Kabi USA, LLC PRALATREXATE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) / 1 mL in 1 VIAL, SINGLE-DOSE
65219-552-02 65219-552 HUMAN PRESCRIPTION DRUG Pralatrexate Pralatrexate INJECTION INTRAVENOUS 20221115 N/A NDA AUTHORIZED GENERIC NDA022468 Fresenius Kabi USA, LLC PRALATREXATE 40 mg/2mL 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-552-02) / 2 mL in 1 VIAL, SINGLE-DOSE
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