美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=AMPHETAMINE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 206304 002 ANDA DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG No No 2016/04/15 (TA) -- COREPHARMA None (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 206304 003 ANDA DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG No No 2016/04/15 (TA) -- COREPHARMA None (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 206304 004 ANDA DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 20MG No No 2016/04/15 (TA) -- COREPHARMA None (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 206304 005 ANDA DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 25MG No No 2016/04/15 (TA) -- COREPHARMA None (Tentative Approval)
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 206304 006 ANDA DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 30MG No No 2016/04/15 (TA) -- COREPHARMA None (Tentative Approval)
DEXTROAMPHETAMINE SULFATE 209111 001 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG No No 2017/06/27 2017/06/27 NESHER PHARMS Discontinued
DEXTROAMPHETAMINE SULFATE 209111 002 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG No No 2017/06/27 2017/06/27 NESHER PHARMS Discontinued
DEXTROAMPHETAMINE SULFATE 209111 003 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG No No 2017/06/27 2017/06/27 NESHER PHARMS Discontinued
DEXTROAMPHETAMINE SULFATE 210059 001 ANDA DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG No No 2017/10/18 2017/10/18 NUVO PHARM Prescription
DEXTROAMPHETAMINE SULFATE 210059 002 ANDA DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG No No 2017/10/18 2017/10/18 NUVO PHARM Prescription
DEXTROAMPHETAMINE SULFATE 205673 001 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG No No 2017/10/31 2017/10/31 STRIDES PHARMA INTL Prescription
DEXTROAMPHETAMINE SULFATE 205673 002 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG No No 2017/10/31 2017/10/31 STRIDES PHARMA INTL Prescription
DEXTROAMPHETAMINE SULFATE 205673 003 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG No No 2017/10/31 2017/10/31 STRIDES PHARMA INTL Prescription
AMPHETAMINE SULFATE 211139 001 ANDA AMPHETAMINE SULFATE TABLET;ORAL 5MG No No 2018/09/26 2018/09/26 AMNEAL PHARMS Prescription
AMPHETAMINE SULFATE 211139 002 ANDA AMPHETAMINE SULFATE TABLET;ORAL 10MG No No 2018/09/26 2018/09/26 AMNEAL PHARMS Prescription
AMPHETAMINE SULFATE 211639 001 ANDA AMPHETAMINE SULFATE TABLET;ORAL 5MG No No 2019/04/17 2019/04/17 AUROLIFE PHARMA LLC Prescription
AMPHETAMINE SULFATE 211639 002 ANDA AMPHETAMINE SULFATE TABLET;ORAL 10MG No No 2019/04/17 2019/04/17 AUROLIFE PHARMA LLC Prescription
DEXTROAMPHETAMINE SULFATE 205077 001 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 5MG No No 2019/06/21 2019/06/21 STRIDES PHARMA Discontinued
DEXTROAMPHETAMINE SULFATE 205077 002 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 10MG No No 2019/06/21 2019/06/21 STRIDES PHARMA Discontinued
DEXTROAMPHETAMINE SULFATE 205077 003 ANDA DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 15MG No No 2019/06/21 2019/06/21 STRIDES PHARMA Discontinued
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