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
MODAFINIL 076597 001 ANDA MODAFINIL Tablet; Oral 100MG No No 2004/01/07 (TA) -- BARR None (Tentative Approval)
MODAFINIL 076597 002 ANDA MODAFINIL Tablet; Oral 200MG No No 2004/01/07 (TA) -- BARR None (Tentative Approval)
MODAFINIL 076596 001 ANDA MODAFINIL TABLET; ORAL 100MG No No 2005/12/16 (TA) -- TEVA PHARMS None (Tentative Approval)
MODAFINIL 076596 002 ANDA MODAFINIL TABLET; ORAL 200MG No No 2005/12/16 (TA) -- TEVA PHARMS None (Tentative Approval)
MODAFINIL 076935 001 ANDA MODAFINIL TABLET; ORAL 100MG No No 2006/12/29 (TA) -- SANDOZ None (Tentative Approval)
MODAFINIL 076935 002 ANDA MODAFINIL TABLET; ORAL 200MG No No 2006/12/29 (TA) -- SANDOZ None (Tentative Approval)
MODAFINIL 077892 001 ANDA MODAFINIL TABLET; ORAL 100MG No No 2007/07/18 (TA) -- CARACO None (Tentative Approval)
MODAFINIL 077892 002 ANDA MODAFINIL TABLET; ORAL 200MG No No 2007/07/18 (TA) -- CARACO None (Tentative Approval)
ARMODAFINIL 200043 001 ANDA ARMODAFINIL TABLET;ORAL 50MG No No 2012/06/01 2012/06/01 MYLAN PHARMS INC Prescription
ARMODAFINIL 200043 002 ANDA ARMODAFINIL TABLET;ORAL 150MG No No 2012/06/01 2012/06/01 MYLAN PHARMS INC Prescription
ARMODAFINIL 200043 003 ANDA ARMODAFINIL TABLET;ORAL 250MG No No 2012/06/01 2012/06/01 MYLAN PHARMS INC Prescription
ARMODAFINIL 200043 004 ANDA ARMODAFINIL TABLET;ORAL 100MG No No 2012/06/01 2019/05/09 MYLAN PHARMS INC Prescription
ARMODAFINIL 200043 005 ANDA ARMODAFINIL TABLET;ORAL 200MG No No 2012/06/01 2019/05/09 MYLAN PHARMS INC Prescription
MODAFINIL 076594 001 ANDA MODAFINIL TABLET;ORAL 100MG No No 2012/07/16 2012/07/16 MYLAN PHARMS INC Discontinued
MODAFINIL 076594 002 ANDA MODAFINIL TABLET;ORAL 200MG No No 2012/07/16 2012/07/16 MYLAN PHARMS INC Discontinued
ARMODAFINIL 200156 001 ANDA ARMODAFINIL TABLET; ORAL 50MG No No 2012/08/29 -- WATSON LABS INC None (Tentative Approval)
ARMODAFINIL 200156 001 ANDA ARMODAFINIL TABLET; ORAL 50MG No No 2012/08/29 (TA) -- WATSON LABS INC None (Tentative Approval)
ARMODAFINIL 200156 002 ANDA ARMODAFINIL TABLET;ORAL 100MG No No 2012/08/29 2012/08/29 WATSON LABS INC Discontinued
ARMODAFINIL 200156 002 ANDA ARMODAFINIL TABLET;ORAL 100MG No No 2012/08/29 (TA) 2012/08/29 WATSON LABS INC Discontinued
ARMODAFINIL 200156 003 ANDA ARMODAFINIL TABLET; ORAL 150MG No No 2012/08/29 -- WATSON LABS INC None (Tentative Approval)
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