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=NDA021303"
符合检索条件的记录共 18 条，共 1 页，当前第 1 页 ，可点击列名称排序
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
66993-594-02 66993-594 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270228 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories 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 (66993-594-02)
66993-595-02 66993-595 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270331 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories 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 (66993-595-02)
66993-596-02 66993-596 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270430 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories 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 (66993-596-02)
66993-597-02 66993-597 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270531 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories 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 (66993-597-02)
66993-598-02 66993-598 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270331 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories 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 (66993-598-02)
66993-599-02 66993-599 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270331 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories 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 (66993-599-02)
0781-2329-01 0781-2329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270228 NDA AUTHORIZED GENERIC NDA021303 Sandoz 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 (0781-2329-01)
0781-2335-01 0781-2335 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270430 NDA AUTHORIZED GENERIC NDA021303 Sandoz 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 (0781-2335-01)
0781-2343-01 0781-2343 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270430 NDA AUTHORIZED GENERIC NDA021303 Sandoz 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 (0781-2343-01)
0781-2352-01 0781-2352 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270430 NDA AUTHORIZED GENERIC NDA021303 Sandoz 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 (0781-2352-01)
0781-2368-01 0781-2368 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270331 NDA AUTHORIZED GENERIC NDA021303 Sandoz 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 (0781-2368-01)
0781-2371-01 0781-2371 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 20270331 NDA AUTHORIZED GENERIC NDA021303 Sandoz 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 (0781-2371-01)
54092-381-01 54092-381 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 N/A NDA NDA021303 Takeda Pharmaceuticals America, 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 (54092-381-01)
54092-383-01 54092-383 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 N/A NDA NDA021303 Takeda Pharmaceuticals America, 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 (54092-383-01)
54092-385-01 54092-385 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 N/A NDA NDA021303 Takeda Pharmaceuticals America, 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 (54092-385-01)
54092-387-01 54092-387 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 N/A NDA NDA021303 Takeda Pharmaceuticals America, 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 (54092-387-01)
54092-389-01 54092-389 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 N/A NDA NDA021303 Takeda Pharmaceuticals America, 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 (54092-389-01)
54092-391-01 54092-391 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 N/A NDA NDA021303 Takeda Pharmaceuticals America, 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 (54092-391-01)
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