e-Drug3D

1266

cas 80573-04-2

CLASS

METABOLISM
ANTIULCERATIVE
ANTI-INFLAMMATORY AGENTS NON-STEROIDAL
GASTROINTESTINAL AGENTS
PROSTAGLANDIN G/H SYNTHASE INHIBITOR

ROUTE (list)

ORAL

PK parameters

Tmax 0.8 HOUR
Cmax 1.42 MICROMOLAR (3 TIMES 750 MILLIGRAM)
PPB 99 PERCENT
t1/2 1.9 HOUR (SINGLE DOSE)

MW 355.30
NB_atoms 26
XLogP 0.04
PSA 136.553
NB_HD 2
NB_HA 9
fsp3 0.12
Lipinski(0=no;1=yes) 1

FDA
NDA 020610 (label) INN (BALSALAZIDE DISODIUM) COLAZAL (VALEANT PHARMS INTL) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY
NDA 077806 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (HIKMA) APPROVAL= AP YEAR= 2007
NDA 077807 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2007
NDA 077883 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (APOTEX) APPROVAL= AP YEAR= 2007
NDA 022205 (label) INN (BALSALAZIDE DISODIUM) GIAZO (VALEANT PHARMS INTL) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 206336 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (AARXION ANDA HLDING) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 206909 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2015
NDA 206529 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (LUPIN LTD) APPROVAL= TA YEAR= 2016
NDA 217592 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023
NDA 219422 (pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (CARNEGIE) APPROVAL= AP YEAR= 2025

e-Drug3D

1399

cas 89-57-6

CLASS

METABOLISM
ANTIINFLAMMATORY
IT IS POSSIBLE THAT IT DIMINISHES INFLAMMATION BY BLOCKING PRODUCTION OF ARACHIDONIC ACID METABOLITES
INHIBITOR OF CYCLOOXYGENASE
MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

ROUTE (list)

RECTAL ORAL

PK parameters

F 28 PERCENT
Tmax 6 HOUR
Cmax 17.6 MICROMOLAR
VD 21.4 LITER (65 KILOGRAM)
Cl 36.2 LITER / HOUR (65 KILOGRAM)
PPB 43 PERCENT
t1/2 1 HOUR

MW 152.13
NB_atoms 11
XLogP -0.66
PSA 77.875
NB_HD 3
NB_HA 4
fsp3 0.00
Lipinski(0=no;1=yes) 1

FDA
NDA 019618 (label) INN (MESALAMINE) ROWASA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1987
NDA 019919 (pdf not found) INN (MESALAMINE) ROWASA (MEDA PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED
NDA 019651 (label) INN (MESALAMINE) ASACOL (APIL) APPROVAL= AP YEAR= 1992 DISCONTINUED
NDA 020049 (label) INN (MESALAMINE) PENTASA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1993
NDA 021252 (label) INN (MESALAMINE) CANASA (ABBVIE) APPROVAL= AP YEAR= 2001
NDA 076751 (pdf not found) INN (MESALAMINE) MESALAMINE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004
NDA 076841 (pdf not found) INN (MESALAMINE) MESALAMINE (G AND W LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED
NDA 022000 (label) INN (MESALAMINE) LIALDA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2007
NDA 021830 (label) INN (MESALAMINE) ASACOL HD (ABBVIE) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 022301 (label) INN (MESALAMINE) APRISO (SALIX) APPROVAL= AP YEAR= 2008
NDA 204412 (label) INN (MESALAMINE) DELZICOL (ABBVIE) APPROVAL= AP YEAR= 2013 DISCONTINUED
NDA 204354 (label) INN (MESALAMINE) MESALAMINE (QUAGEN) APPROVAL= AP YEAR= 2015
NDA 091640 (label) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017
NDA 203286 (pdf not found) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017
NDA 203817 (pdf not found) INN (MESALAMINE) MESALAMINE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018
NDA 203574 (pdf not found) INN (MESALAMINE) MESALAMINE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 202065 (pdf not found) INN (MESALAMINE) MESALAMINE (SANDOZ) APPROVAL= AP YEAR= 2019
NDA 208362 (pdf not found) INN (MESALAMINE) MESALAMINE (J MOLNER) APPROVAL= AP YEAR= 2019
NDA 207448 (pdf not found) INN (MESALAMINE) MESALAMINE (RISING) APPROVAL= AP YEAR= 2019
NDA 207873 (pdf not found) INN (MESALAMINE) MESALAMINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019
NDA 211858 (pdf not found) INN (MESALAMINE) MESALAMINE (SUN PHARM) APPROVAL= AP YEAR= 2019
NDA 207271 (pdf not found) INN (MESALAMINE) MESALAMINE (MYLAN) APPROVAL= AP YEAR= 2019
NDA 208953 (pdf not found) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020
NDA 210509 (pdf not found) INN (MESALAMINE) MESALAMINE (AMNEAL) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 213377 (pdf not found) INN (MESALAMINE) MESALAMINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2020
NDA 205654 (pdf not found) INN (MESALAMINE) MESALAMINE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2020
NDA 208954 (pdf not found) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021
NDA 214242 (pdf not found) INN (MESALAMINE) MESALAMINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021
NDA 209970 (pdf not found) INN (MESALAMINE) MESALAMINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED
NDA 214585 (pdf not found) INN (MESALAMINE) MESALAMINE (SUN PHARM) APPROVAL= AP YEAR= 2022
NDA 216967 (pdf not found) INN (MESALAMINE) MESALAMINE (ALEMBIC) APPROVAL= AP YEAR= 2022
NDA 214477 (pdf not found) INN (MESALAMINE) MESALAMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023
NDA 216941 (pdf not found) INN (MESALAMINE) MESALAMINE (ENCUBE) APPROVAL= AP YEAR= 2023
NDA 217337 (pdf not found) INN (MESALAMINE) MESALAMINE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2023
NDA 217533 (pdf not found) INN (MESALAMINE) MESALAMINE (AMTA) APPROVAL= AP YEAR= 2023
NDA 216334 (pdf not found) INN (MESALAMINE) MESALAMINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2024
NDA 213191 (pdf not found) INN (MESALAMINE) MESALAMINE (TEVA PHARMS INC) APPROVAL= AP YEAR= 2024
NDA 218410 (pdf not found) INN (MESALAMINE) MESALAMINE (NOVAST LABS) APPROVAL= AP YEAR= 2024
NDA 215067 (pdf not found) INN (MESALAMINE) MESALAMINE (AMNEAL) APPROVAL= AP YEAR= 2025
NDA 215269 (pdf not found) INN (MESALAMINE) MESALAMINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2025
NDA 219028 (pdf not found) INN (MESALAMINE) MESALAMINE (RISING) APPROVAL= AP YEAR= 2025
NDA 219864 (pdf not found) INN (MESALAMINE) MESALAMINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2025
NDA 219997 (pdf not found) INN (MESALAMINE) MESALAMINE (DIFGEN PHARMS) APPROVAL= AP YEAR= 2026
NDA 220016 (pdf not found) INN (MESALAMINE) MESALAMINE (KLM LABS PVT) APPROVAL= AP YEAR= 2026