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"
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 N/A 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 N/A 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 N/A 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 N/A 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 N/A 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 N/A 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)
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)
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 N/A 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 N/A 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 N/A 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 N/A 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 N/A 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 N/A 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)
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