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=ANDA211547"
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
0406-8951-01 0406-8951 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single Entity Amphetamine Product XR Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20190422 N/A ANDA ANDA211547 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8951-01)
0406-8955-01 0406-8955 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single Entity Amphetamine Product XR Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20190422 N/A ANDA ANDA211547 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 (0406-8955-01)
0406-8953-01 0406-8953 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single Entity Amphetamine Product XR Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20190422 N/A ANDA ANDA211547 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8953-01)
0406-8952-01 0406-8952 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single Entity Amphetamine Product XR Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20190422 N/A ANDA ANDA211547 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8952-01)
0406-8956-01 0406-8956 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single Entity Amphetamine Product XR Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20190422 N/A ANDA ANDA211547 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5 mg/1; 7.5 mg/1; 7.5 mg/1; 7.5 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8956-01)
0406-8954-01 0406-8954 HUMAN PRESCRIPTION DRUG Mixed Salts of a Single Entity Amphetamine Product XR Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20190422 N/A ANDA ANDA211547 SpecGx LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5 mg/1; 5 mg/1; 5 mg/1; 5 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01)
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