e-Drug3D

883

cas 164656-23-9

CLASS

GENITO
5-ALPHA-REDUCTASE INHIBITOR
TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH)

ROUTE (list)

ORAL

PK parameters

F 60 PERCENT
Tmax 2.5 HOUR
VD 400 LITER
Cl 0.33 LITER / HOUR (EQN)
PPB 99 PERCENT
t1/2 840 HOUR

MW 528.53
NB_atoms 37
XLogP 6.58
PSA 53.213
NB_HD 2
NB_HA 4
fsp3 0.63
Lipinski(0=no;1=yes) 0

FDA
NDA 021319 (pdf not found) INN (DUTASTERIDE) AVODART (WAYLIS THERAP) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY
NDA 022460 (pdf not found) INN (DUTASTERIDE ; TAMSULOSIN HYDROCHLORIDE) JALYN (WAYLIS THERAP) APPROVAL= AP YEAR= 2010
NDA 090095 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (BARR) APPROVAL= AP YEAR= 2010
NDA 202509 (pdf not found) INN (DUTASTERIDE ; TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ANCHEN PHARMS) APPROVAL= AP YEAR= 2014
NDA 200899 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (CHARTWELL) APPROVAL= AP YEAR= 2015
NDA 202204 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (HIKMA) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 202421 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (PH HEALTH) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 202660 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015
NDA 203118 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015
NDA 204292 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (APOTEX) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 202808 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 202530 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (RISING) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 202975 (pdf not found) INN (DUTASTERIDE ; TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 204262 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ONESOURCE SPECIALTY) APPROVAL= AP YEAR= 2015
NDA 204705 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (AVIV PHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 203241 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (PHARMOBEDIENT) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 206373 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ACELLA) APPROVAL= AP YEAR= 2016
NDA 206574 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2016
NDA 204376 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ADAPTIS) APPROVAL= AP YEAR= 2017
NDA 204373 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017
NDA 207935 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 209909 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (HUMANWELL PURACAP) APPROVAL= AP YEAR= 2017
NDA 207769 (pdf not found) INN (DUTASTERIDE ; TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018
NDA 208227 (pdf not found) INN (DUTASTERIDE) DUTASTERIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 213300 (pdf not found) INN (DUTASTERIDE ; TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024