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=ANDA215890"
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
14335-120-01 14335-120 HUMAN PRESCRIPTION DRUG daptomycin daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAVENOUS 20231114 N/A ANDA ANDA215890 Hainan Poly Pharm., Co., Ltd. DAPTOMYCIN 500 mg/20mL 20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01)
70436-033-80 70436-033 HUMAN PRESCRIPTION DRUG daptomycin daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAVENOUS 20221001 N/A ANDA ANDA215890 Slate Run Pharmaceuticals, LLC DAPTOMYCIN 500 mg/20mL 20 mL in 1 VIAL, SINGLE-DOSE (70436-033-80)
83090-011-01 83090-011 HUMAN PRESCRIPTION DRUG daptomycin daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAVENOUS 20231105 N/A ANDA ANDA215890 Sintetica US LLC DAPTOMYCIN 500 mg/20mL 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE
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