e-Drug3D

788

cas 68693-11-8

CLASS

NERVOUS SYSTEM
CNS STIMULANT
TARGETS UNKNOWN
ANOREXIGENIC AGENTS
MODAFINIL HAS WAKE-PROMOTING ACTIONS SIMILAR TO SYMPATHOMIMETIC AGENTS LIKE AMPHETAMINE
RACEMIC L-ISOMER AND D-ISOMER DO NOT INTERCONVERT

ROUTE (list)

ORAL

PK parameters

Tmax 3 HOUR
VD 58 LITER (65 KILOGRAM)
Cl 2.6 LITER / HOUR (EQN)
PPB 60 PERCENT
t1/2 15 HOUR

MW 273.35
NB_atoms 19
XLogP 2.01
PSA 59.558
NB_HD 2
NB_HA 3
fsp3 0.13
Lipinski(0=no;1=yes) 1

FDA
NDA 020717 (label) INN (MODAFINIL) PROVIGIL (NUVO PHARMS) APPROVAL= AP YEAR= 1998
NDA 076597 (pdf not found) INN (MODAFINIL) MODAFINIL (BARR) APPROVAL= TA YEAR= 2004
NDA 076595 (pdf not found) INN (MODAFINIL) MODAFINIL (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2004 OBSOLETE
NDA 076596 (pdf not found) INN (MODAFINIL) MODAFINIL (TEVA PHARMS) APPROVAL= TA YEAR= 2005
NDA 076935 (pdf not found) INN (MODAFINIL) MODAFINIL (SANDOZ) APPROVAL= TA YEAR= 2006
NDA 077892 (pdf not found) INN (MODAFINIL) MODAFINIL (CARACO) APPROVAL= TA YEAR= 2007
NDA 021875 (label) INN (ARMODAFINIL) NUVIGIL (NUVO PHARMS) APPROVAL= AP YEAR= 2007
NDA 076594 (pdf not found) INN (MODAFINIL) MODAFINIL (NATCO PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 076715 (pdf not found) INN (MODAFINIL) MODAFINIL (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 078963 (pdf not found) INN (MODAFINIL) MODAFINIL (ORBION PHARMS) APPROVAL= AP YEAR= 2012
NDA 200043 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012
NDA 090543 (pdf not found) INN (MODAFINIL) MODAFINIL (HIKMA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 202566 (pdf not found) INN (MODAFINIL) MODAFINIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012
NDA 202700 (pdf not found) INN (MODAFINIL) MODAFINIL (ALEMBIC) APPROVAL= AP YEAR= 2012
NDA 200156 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 077667 (pdf not found) INN (MODAFINIL) MODAFINIL (APOTEX) APPROVAL= AP YEAR= 2014
NDA 200152 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2014
NDA 200751 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (LUPIN LTD) APPROVAL= AP YEAR= 2016
NDA 202768 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2016
NDA 207196 (pdf not found) INN (MODAFINIL) MODAFINIL (APPCO) APPROVAL= AP YEAR= 2017
NDA 209966 (pdf not found) INN (MODAFINIL) MODAFINIL (CADILA) APPROVAL= AP YEAR= 2017
NDA 206069 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018
NDA 201514 (pdf not found) INN (ARMODAFINIL) ARMODAFINIL (COREPHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED