美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=MODAFINIL"
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
ARMODAFINIL 200156 003 ANDA ARMODAFINIL TABLET; ORAL 150MG No No 2012/08/29 (TA) -- WATSON LABS INC None (Tentative Approval)
ARMODAFINIL 200156 004 ANDA ARMODAFINIL TABLET;ORAL 200MG No No 2012/08/29 2012/08/29 WATSON LABS INC Discontinued
ARMODAFINIL 200156 004 ANDA ARMODAFINIL TABLET;ORAL 200MG No No 2012/08/29 (TA) 2012/08/29 WATSON LABS INC Discontinued
ARMODAFINIL 200156 005 ANDA ARMODAFINIL TABLET; ORAL 2500MG No No 2012/08/29 -- WATSON LABS INC None (Tentative Approval)
ARMODAFINIL 200156 005 ANDA ARMODAFINIL TABLET; ORAL 2500MG No No 2012/08/29 (TA) -- WATSON LABS INC None (Tentative Approval)
MODAFINIL 078963 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2012/09/26 2012/09/26 ORBION PHARMS Prescription
MODAFINIL 078963 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2012/09/26 2012/09/26 ORBION PHARMS Prescription
MODAFINIL 090543 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2012/09/26 2012/09/26 HIKMA PHARMS Discontinued
MODAFINIL 090543 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2012/09/26 2012/09/26 HIKMA PHARMS Discontinued
MODAFINIL 202566 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2012/09/27 2012/09/27 AUROBINDO PHARMA LTD Prescription
MODAFINIL 202566 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2012/09/27 2012/09/27 AUROBINDO PHARMA LTD Prescription
MODAFINIL 202700 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2012/10/18 2012/10/18 ALEMBIC Prescription
MODAFINIL 202700 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2012/10/18 2012/10/18 ALEMBIC Prescription
MODAFINIL 076715 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2012/11/01 2012/11/01 WATSON LABS INC Prescription
MODAFINIL 076715 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2012/11/01 2012/11/01 WATSON LABS INC Prescription
MODAFINIL 077667 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2014/02/03 2014/02/03 APOTEX Prescription
MODAFINIL 077667 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2014/02/03 2014/02/03 APOTEX Prescription
ARMODAFINIL 200152 001 ANDA ARMODAFINIL TABLET;ORAL 50MG No No 2014/09/24 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
ARMODAFINIL 200152 002 ANDA ARMODAFINIL TABLET;ORAL 100MG No No 2014/09/24 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
ARMODAFINIL 200152 003 ANDA ARMODAFINIL TABLET;ORAL 150MG No No 2014/09/24 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
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