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=ANDA202766"
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
0143-9461-01 0143-9461 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B Sulfate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20250930 N/A ANDA ANDA202766 Hikma Pharmaceuticals USA Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 1 VIAL, GLASS in 1 CARTON (0143-9461-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
0143-9461-10 0143-9461 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B Sulfate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20250930 N/A ANDA ANDA202766 Hikma Pharmaceuticals USA Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 10 VIAL, GLASS in 1 CARTON (0143-9461-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
70594-049-01 70594-049 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B Sulfate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20181001 N/A ANDA ANDA202766 Xellia Pharmaceuticals USA LLC POLYMYXIN B SULFATE 500000 [USP'U]/1 1 VIAL, GLASS in 1 CARTON (70594-049-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
70594-049-02 70594-049 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B Sulfate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20181001 N/A ANDA ANDA202766 Xellia Pharmaceuticals USA LLC POLYMYXIN B SULFATE 500000 [USP'U]/1 10 VIAL, GLASS in 1 CARTON (70594-049-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
63323-367-44 63323-367 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B Sulfate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20150909 N/A ANDA ANDA202766 Fresenius Kabi USA, LLC POLYMYXIN B SULFATE 500000 [USP'U]/1 10 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41)
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