e-Drug3D

631

cas 79902-63-9

CLASS

CARDIOVASCULAR
HYPOCHOLESTEROLEMIC
ANTILIPEMIC AGENTS
HYDROXYMETHYLGLUTARYL-COA (HMG-COA) REDUCTASE INHIBITORS
STATIN

ROUTE (list)

ORAL

PK parameters

F 5 PERCENT
Tmax 4 HOUR
PPB 95 PERCENT
t1/2 4.5 HOUR

MW 418.55
NB_atoms 30
XLogP 4.59
PSA 65.437
NB_HD 1
NB_HA 5
fsp3 0.76
Lipinski(0=no;1=yes) 1

FDA
NDA 019766 (label) INN (SIMVASTATIN) ZOCOR (ORGANON) APPROVAL= AP YEAR= 1991
NDA 021687 (label) INN (EZETIMIBE ; SIMVASTATIN) VYTORIN (ORGANON) APPROVAL= AP YEAR= 2004
NDA 076532 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (TEVA PHARMS) APPROVAL= TA YEAR= 2005
NDA 076052 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 076285 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 076685 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (WATSON LABS TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 077691 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006
NDA 077752 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2006
NDA 077766 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 077837 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2006
NDA 078034 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (BIOCON PHARMA) APPROVAL= AP YEAR= 2006
NDA 021961 (label) INN (SIMVASTATIN) SIMVASTATIN (SYNTHON PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 078103 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (LUPIN) APPROVAL= AP YEAR= 2007
NDA 078425 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 OBSOLETE
NDA 022078 (label) INN (SIMVASTATIN) SIMCOR (ABBVIE) APPROVAL= AP YEAR= 2008 OBSOLETE
NDA 078155 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2008
NDA 078735 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (OXFORD PHARMS) APPROVAL= AP YEAR= 2010
NDA 090868 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (PHARMOBEDIENT) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 090383 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (MICRO LABS) APPROVAL= AP YEAR= 2011
NDA 202343 (label) INN (SIMVASTATIN ; SITAGLIPTIN PHOSPHATE) JUVISYNC (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 200895 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (HETERO LABS LTD III) APPROVAL= AP YEAR= 2014
NDA 206679 (label) INN (SIMVASTATIN) FLOLIPID (SALERNO PHARMS) APPROVAL= AP YEAR= 2016
NDA 201890 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 200909 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017
NDA 202968 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (WATSON LABS INC) APPROVAL= AP YEAR= 2017
NDA 206557 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017
NDA 208831 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 209222 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017
NDA 208699 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019
NDA 200082 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2020
NDA 211394 (pdf not found) INN (SIMVASTATIN) SIMVASTATIN (YILING) APPROVAL= AP YEAR= 2024
NDA 211663 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 209461 (pdf not found) INN (EZETIMIBE ; SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (TORRENT) APPROVAL= AP YEAR= 2025 DISCONTINUED