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=ANDA217413"
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
81607-006-07 81607-006 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20230531 N/A ANDA ANDA217413 Orbicular Pharmaceutical Technologies Private Limited ARSENIC TRIOXIDE 2 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (81607-006-07) / 6 mL in 1 VIAL, SINGLE-DOSE (81607-006-06)
81607-005-11 81607-005 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20230531 N/A ANDA ANDA217413 Orbicular Pharmaceutical Technologies Private Limited ARSENIC TRIOXIDE 1 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (81607-005-11) / 10 mL in 1 VIAL, SINGLE-DOSE (81607-005-10)
72205-172-07 72205-172 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTION, SOLUTION INTRAVENOUS 20240206 N/A ANDA ANDA217413 Novadoz Pharmaceuticals LLC ARSENIC TRIOXIDE 2 mg/2mL 10 VIAL, SINGLE-DOSE in 1 CARTON (72205-172-07) / 6 mL in 1 VIAL, SINGLE-DOSE (72205-172-01)
83090-010-01 83090-010 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20231109 N/A ANDA ANDA217413 Sintetica US LLC ARSENIC TRIOXIDE 2 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-01) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)
83090-010-10 83090-010 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20231109 N/A ANDA ANDA217413 Sintetica US LLC ARSENIC TRIOXIDE 2 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-10) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)
72205-171-07 72205-171 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTION, SOLUTION INTRAVENOUS 20240206 N/A ANDA ANDA217413 Novadoz Pharmaceuticals LLC ARSENIC TRIOXIDE 1 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (72205-171-07) / 10 mL in 1 VIAL, SINGLE-DOSE (72205-171-01)
83090-009-01 83090-009 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20231109 N/A ANDA ANDA217413 Sintetica US LLC ARSENIC TRIOXIDE 1 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-01) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05)
83090-009-10 83090-009 HUMAN PRESCRIPTION DRUG ARSENIC TRIOXIDE arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20231109 N/A ANDA ANDA217413 Sintetica US LLC ARSENIC TRIOXIDE 1 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05)
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