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=BLA761379"
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
65219-826-26 65219-826 HUMAN PRESCRIPTION DRUG Otulfi ustekinumab-aauz INJECTION, SOLUTION SUBCUTANEOUS 20240222 N/A BLA BLA761379 Fresenius Kabi USA, LLC USTEKINUMAB 90 mg/mL 1 SYRINGE in 1 CARTON (65219-826-26) / 1 mL in 1 SYRINGE
65219-828-05 65219-828 HUMAN PRESCRIPTION DRUG Otulfi ustekinumab-aauz SOLUTION INTRAVENOUS 20240222 N/A BLA BLA761379 Fresenius Kabi USA, LLC USTEKINUMAB 130 mg/26mL 1 VIAL in 1 CARTON (65219-828-05) / 26 mL in 1 VIAL
65219-824-01 65219-824 HUMAN PRESCRIPTION DRUG Otulfi ustekinumab-aauz INJECTION, SOLUTION SUBCUTANEOUS 20240222 N/A BLA BLA761379 Fresenius Kabi USA, LLC USTEKINUMAB 45 mg/.5mL 1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE
65219-866-26 65219-866 HUMAN PRESCRIPTION DRUG USTEKINUMAB-AAUZ ustekinumab-aauz INJECTION, SOLUTION SUBCUTANEOUS 20251115 N/A BLA BLA761379 Fresenius Kabi USA, LLC USTEKINUMAB 90 mg/mL 1 SYRINGE in 1 CARTON (65219-866-26) / 1 mL in 1 SYRINGE
65219-822-05 65219-822 HUMAN PRESCRIPTION DRUG Otulfi ustekinumab-aauz INJECTION, SOLUTION SUBCUTANEOUS 20250929 N/A BLA BLA761379 Fresenius Kabi USA, LLC USTEKINUMAB 45 mg/.5mL 1 VIAL in 1 CARTON (65219-822-05) / .5 mL in 1 VIAL
65219-862-01 65219-862 HUMAN PRESCRIPTION DRUG USTEKINUMAB-AAUZ ustekinumab-aauz INJECTION, SOLUTION SUBCUTANEOUS 20251115 N/A BLA BLA761379 Fresenius Kabi USA, LLC USTEKINUMAB 45 mg/.5mL 1 SYRINGE in 1 CARTON (65219-862-01) / .5 mL in 1 SYRINGE
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