e-Drug3D

680

cas 58581-89-8

CLASS

RESPIRATORY SYSTEM
H1 ANTIHISTAMINE ANTAGONIST
PHTHALAZINONE DERIVATIVE

ROUTE (list)

NASAL OPHTHALMIC

PK parameters

F 40 PERCENT
Tmax 2.5 HOUR
VD 942 LITER
Cl 32.5 LITER / HOUR
PPB 88 PERCENT
t1/2 22 HOUR

MW 381.89
NB_atoms 27
XLogP 4.30
PSA 33.808
NB_HD 0
NB_HA 4
fsp3 0.36
Lipinski(0=no;1=yes) 1

FDA
NDA 020114 (label) INN (AZELASTINE HYDROCHLORIDE) ASTELIN (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 1996 DISCONTINUED
NDA 021127 (label) INN (AZELASTINE HYDROCHLORIDE) OPTIVAR (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2000 DISCONTINUED
NDA 022203 (label) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO (VIATRIS) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 077954 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2009
NDA 022371 (label) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO (MEDA PHARMS) APPROVAL= AP YEAR= 2009 NEWAPPLICATION
NDA 078621 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2009
NDA 078738 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 090423 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 201846 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 202236 (label) INN (AZELASTINE HYDROCHLORIDE ; FLUTICASONE PROPIONATE) DYMISTA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2012
NDA 202305 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2012
NDA 091444 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 202743 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 090176 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 203660 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 207243 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 208199 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 091409 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017
NDA 202609 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 207712 (pdf not found) INN (AZELASTINE HYDROCHLORIDE ; FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (APOTEX) APPROVAL= AP YEAR= 2017
NDA 204660 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017
NDA 208156 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017
NDA 207411 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019
NDA 207610 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2019
NDA 209620 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019
NDA 210032 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 210092 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (GLAND) APPROVAL= AP YEAR= 2020
NDA 212289 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020
NDA 212775 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 208111 (pdf not found) INN (AZELASTINE HYDROCHLORIDE ; FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021
NDA 213872 (label) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO ALLERGY (BAYER HLTHCARE) APPROVAL= AP YEAR= 2021
NDA 216576 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2024
NDA 216421 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE ALLERGY (APOTEX) APPROVAL= AP YEAR= 2024
NDA 216801 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 216561 (pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2025
NDA 208436 (pdf not found) INN (AZELASTINE HYDROCHLORIDE ; FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2025