e-Drug3D
669
cas 75607-67-9
CLASS
ANTINEOPLASTIC
ANTIMETABOLITES
IMMUNOSUPPRESSIVE AGENTS
RAPIDLY DEPHOSPHORYLATED INTO FLUDARABINE AND THEN PHOSPHORYLATED BY DEOXYCYTIDINE KINASE TO THE ACTIVE TRIPHOSPHATE
ROUTE (list)
INJECTION ORAL
ATC code
L01BB05
PK parameters
TARGET DNA POLYMERASE ALPHA, GAMMA AND DELTA
RIBONUCLEOTIDE DIPHOSPHATE REDUCTASE
DNA PRIMASE
DNA LIGASE I
DNA polymerase alpha catalytic subunit UNIPROT P09884 POLA1
Formula:
C10H13FN5O7P
Calculated chemical properties:
MW 363.21
NB_atoms 24
XLogP -2.99
PSA 178.351
NB_HD 4
NB_HA 12
fsp3 0.50
Lipinski(0=no;1=yes) 0
NB_atoms 24
XLogP -2.99
PSA 178.351
NB_HD 4
NB_HA 12
fsp3 0.50
Lipinski(0=no;1=yes) 0
FDA
NDA 020038 (label) INN (FLUDARABINE PHOSPHATE) FLUDARA (GENZYME CORP) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED
NDA 076349 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2003
NDA 076661 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2004
NDA 022137 (label) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 077790 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 078393 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007
NDA 078544 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007
NDA 022273 (label) INN (FLUDARABINE PHOSPHATE) OFORTA (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 078610 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2009
NDA 090724 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (AREVA PHARMS) APPROVAL= AP YEAR= 2010
NDA 200647 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (EXTROVIS) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 200648 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 203738 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (ACTAVIS LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 020038 (label) INN (FLUDARABINE PHOSPHATE) FLUDARA (GENZYME CORP) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED
NDA 076349 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2003
NDA 076661 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2004
NDA 022137 (label) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 077790 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 078393 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007
NDA 078544 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007
NDA 022273 (label) INN (FLUDARABINE PHOSPHATE) OFORTA (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 078610 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2009
NDA 090724 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (AREVA PHARMS) APPROVAL= AP YEAR= 2010
NDA 200647 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (EXTROVIS) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 200648 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 203738 (pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (ACTAVIS LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED