e-Drug3D

342

cas 148-82-3

CLASS

ANTINEOPLASTIC
ALKYLATING
MYELOABLATIVE AGONISTS

ROUTE (list)

ORAL INJECTION INTRAVENOUS

PK parameters

F 74 PERCENT
Tmax 1 HOUR
VD 32.5 LITER (65 KILOGRAM)
Cl 27.3 LITER / HOUR (65 KILOGRAM)
PPB 72 PERCENT
t1/2 1.5 HOUR

MW 304.19
NB_atoms 19
XLogP 0.59
PSA 60.903
NB_HD 2
NB_HA 4
fsp3 0.46
Lipinski(0=no;1=yes) 1

FDA
NDA 014691 (label) INN (MELPHALAN) ALKERAN (APOTEX) APPROVAL= AP YEAR= 1964 DISCONTINUED
NDA 020207 (label) INN (MELPHALAN HYDROCHLORIDE) ALKERAN (APOTEX) APPROVAL= AP YEAR= 1992 DISCONTINUED
NDA 090270 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2009
NDA 090299 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2009 DISCONTINUED
NDA 090303 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2010
NDA 207155 (label) INN (MELPHALAN HYDROCHLORIDE) EVOMELA (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2016
NDA 204773 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (PH HEALTH) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 206018 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ACTAVIS LLC) APPROVAL= AP YEAR= 2016
NDA 201379 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017
NDA 207809 (pdf not found) INN (MELPHALAN) MELPHALAN (ALVOGEN) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 203393 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017
NDA 203655 (label) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017
NDA 204817 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ALMAJECT) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 207032 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (USWM) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 209826 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (GLAND) APPROVAL= AP YEAR= 2019
NDA 211463 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ARTHUR GRP) APPROVAL= AP YEAR= 2019
NDA 209197 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (BPI LABS) APPROVAL= AP YEAR= 2020
NDA 209323 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ACTAVIS LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 210947 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 212960 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2021
NDA 201848 (label) INN (MELPHALAN HYDROCHLORIDE) HEPZATO (DELCATH SYSTEMS INC) APPROVAL= AP YEAR= 2023
NDA 217110 (label) INN (MELPHALAN HYDROCHLORIDE) IVRA (APOTEX) APPROVAL= AP YEAR= 2023
NDA 215024 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (HETERO LABS) APPROVAL= AP YEAR= 2024
NDA 206523 (pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2024

e-Drug3D

2019

cas 380449-51-4

CLASS

ANTINEOPLASTIC
A PEPTIDE CONJUGATED ALKYLATING DRUG
TREATMENT OF REFRACTORY MULTIPLE MYELOMA
NITROGEN MUSTARD DRUG
PRODRUG

ROUTE (list)

INTRAVENOUS

PK parameters

Tmax 0.5 HOUR
VD 35 LITER
Cl 692 LITER / HOUR
t1/2 0.035 HOUR

MW 498.41
NB_atoms 33
XLogP 3.27
PSA 80.073
NB_HD 3
NB_HA 6
fsp3 0.42
Lipinski(0=no;1=yes) 1

FDA
NDA 214383 (label) INN (MELPHALAN FLUFENAMIDE HYDROCHLORIDE) PEPAXTO (ONCOPEPTIDES AB) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY DISCONTINUED OBSOLETE