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=ANDA211546"
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
0406-0807-01 0406-0807 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single-Entity Amphetamine Product DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20231101 N/A ANDA ANDA211546 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 9.375 mg/1; 9.375 mg/1; 9.375 mg/1; 9.375 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0807-01)
0406-0803-01 0406-0803 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single-Entity Amphetamine Product DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20231101 N/A ANDA ANDA211546 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25 mg/1; 6.25 mg/1; 6.25 mg/1; 6.25 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0803-01)
0406-0804-01 0406-0804 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single-Entity Amphetamine Product DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20231101 N/A ANDA ANDA211546 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 12.5 mg/1; 12.5 mg/1; 12.5 mg/1; 12.5 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0804-01)
0406-0805-01 0406-0805 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single-Entity Amphetamine Product DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20231101 N/A ANDA ANDA211546 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125 mg/1; 3.125 mg/1; 3.125 mg/1; 3.125 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01)
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