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=ANDA212037"
符合检索条件的记录共 48 条，共 3 页，当前第 1 页 ，可点击列名称排序
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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
64850-510-01 64850-510 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Elite Laboratories, Inc. 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 (64850-510-01)
64850-514-01 64850-514 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Elite Laboratories, Inc. 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 (64850-514-01)
35573-466-02 35573-466 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Burel Pharmaceuticals, 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 (35573-466-02)
0527-5510-37 0527-5510 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191218 N/A ANDA ANDA212037 Lannett Company, Inc. 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 (0527-5510-37)
64850-513-01 64850-513 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Elite Laboratories, Inc. 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 (64850-513-01)
35573-465-02 35573-465 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Burel Pharmaceuticals, 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 (35573-465-02)
35573-469-02 35573-469 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Burel Pharmaceuticals, 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 (35573-469-02)
0527-5513-37 0527-5513 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191218 N/A ANDA ANDA212037 Lannett Company, Inc. 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 (0527-5513-37)
64850-511-01 64850-511 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Elite Laboratories, Inc. 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 (64850-511-01)
64850-515-01 64850-515 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Elite Laboratories, Inc. 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 (64850-515-01)
35573-467-02 35573-467 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Burel Pharmaceuticals, 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 (35573-467-02)
0527-5511-37 0527-5511 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191218 N/A ANDA ANDA212037 Lannett Company, Inc. 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 (0527-5511-37)
64850-512-01 64850-512 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Elite Laboratories, Inc. 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 (64850-512-01)
35573-464-02 35573-464 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Burel Pharmaceuticals, 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 (35573-464-02)
35573-468-02 35573-468 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191216 N/A ANDA ANDA212037 Burel Pharmaceuticals, 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 (35573-468-02)
0527-5512-37 0527-5512 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20191218 N/A ANDA ANDA212037 Lannett Company, Inc. 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 (0527-5512-37)
51407-549-01 51407-549 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20201119 N/A ANDA ANDA212037 Golden State Medical Supply, Inc. 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 (51407-549-01)
51407-553-01 51407-553 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20201119 N/A ANDA ANDA212037 Golden State Medical Supply, Inc. 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 (51407-553-01)
72162-2055-1 72162-2055 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20230614 N/A ANDA ANDA212037 Bryant Ranch Prepack 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 (72162-2055-1)
72162-2055-3 72162-2055 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20230614 N/A ANDA ANDA212037 Bryant Ranch Prepack 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 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2055-3)
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