e-Drug3D

1306

cas 608137-32-2

CLASS

NERVOUS SYSTEM
L-LYSINE-D-AMPHETAMINE
PSYCHOSTIMULANT
CENTRAL NERVOUS SYSTEM STIMULANT INDICATED FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
A PRODRUG OF DEXTROAMPHETAMINE
BLOCK THE REUPTAKE OF NOREPINEPHRINE AND DOPAMINE INTO THE PRESYNAPTIC NEURON AND INCREASE THE RELEASE OF THESE MONOAMINES INTO THE EXTRANEURONAL SPACE

ROUTE (list)

ORAL

PK parameters

MW 263.38
NB_atoms 19
XLogP 1.19
PSA 77.459
NB_HD 5
NB_HA 4
fsp3 0.53
Lipinski(0=no;1=yes) 1

FDA
NDA 021977 (label) INN (LISDEXAMFETAMINE DIMESYLATE) VYVANSE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2007
NDA 208510 (label) INN (LISDEXAMFETAMINE DIMESYLATE) VYVANSE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2017
NDA 202827 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (HIKMA) APPROVAL= AP YEAR= 2023
NDA 202830 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (AMNEAL) APPROVAL= AP YEAR= 2023
NDA 202835 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (MYLAN) APPROVAL= AP YEAR= 2023
NDA 202802 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2023
NDA 214547 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (NORWICH) APPROVAL= AP YEAR= 2023
NDA 215415 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (TEVA PHARMS) APPROVAL= AP YEAR= 2023
NDA 216944 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (APOTEX) APPROVAL= AP YEAR= 2023
NDA 211840 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SPECGX LLC) APPROVAL= AP YEAR= 2023
NDA 214134 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023
NDA 214484 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023
NDA 215330 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (RHODES PHARMS) APPROVAL= AP YEAR= 2023
NDA 215802 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (LANNETT CO INC) APPROVAL= AP YEAR= 2023
NDA 216266 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (PRINSTON INC) APPROVAL= AP YEAR= 2023
NDA 217068 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023
NDA 217194 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023
NDA 217442 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023
NDA 202836 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SANDOZ) APPROVAL= AP YEAR= 2024
NDA 218306 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (MSN) APPROVAL= AP YEAR= 2024
NDA 218604 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ELITE LABS INC) APPROVAL= AP YEAR= 2024
NDA 218850 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SPECGX LLC) APPROVAL= AP YEAR= 2024
NDA 219258 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (GRANULES) APPROVAL= AP YEAR= 2024
NDA 218987 (pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (GRANULES) APPROVAL= AP YEAR= 2025
NDA 219847 (label) INN (LISDEXAMFETAMINE DIMESYLATE) ARYNTA (AZURITY) APPROVAL= AP YEAR= 2025

e-Drug3D

1332

cas 51-64-9

CLASS

NERVOUS SYSTEM
CNS STIMULANT
AMPHETAMINES
SYMPATHOMIMETICS
BLOCK THE REUPTAKE OF NOREPINEPHRINE AND DOPAMINE
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) AND NARCOLEPSY
MONOAMINE TRANSPORTER BLOCKER

ROUTE (list)

ORAL TRANSDERMAL

PK parameters

VD 396 LITER (65 KILOGRAM)
Cl 37 LITER / HOUR (65 KILOGRAM)
PPB 20 PERCENT
t1/2 7.3 HOUR

TARGET NORADRENALINE TRANSPORTER (NAT)
DOPAMINE TRANSPORTER (DAT)

PDB
4XP9 (X-RAY STRUCTURE OF DROSOPHILA DOPAMINE TRANSPORTER BOUND TO PSYCHOSTIMULANT D-AMPHETAMINE)

Ligand code = 1WE (link to the list of PDB complexes)

Download experimental 3D coordinates of 1WE with added hydrogens

MW 135.20
NB_atoms 10
XLogP 1.58
PSA 24.621
NB_HD 2
NB_HA 1
fsp3 0.33
Lipinski(0=no;1=yes) 1

FDA
NDA 083563 (pdf not found) INN (AMPHETAMINE ADIPATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE ADIPATE ; DEXTROAMPHETAMINE SULFATE) DELCOBESE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 083735 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXAMPEX (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 083930 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084125 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084986 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 085355 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXAMPEX (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 085370 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (ANI PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 085371 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 085892 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 086521 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 010093 (pdf not found) INN (AMPHETAMINE RESIN COMPLEX ; DEXTROAMPHETAMINE RESIN COMPLEX) BIPHETAMINE 20 (UCB INC) APPROVAL= AP YEAR= 1955 DISCONTINUED
NDA 011522 (label) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) ADDERALL 10 (TEVA WOMENS) APPROVAL= AP YEAR= 1960 DISCONTINUED
NDA 083564 (pdf not found) INN (AMPHETAMINE ADIPATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE ADIPATE ; DEXTROAMPHETAMINE SULFATE) DELCOBESE (TEVA) APPROVAL= AP YEAR= 1975 DISCONTINUED
NDA 083903 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1975 DISCONTINUED
NDA 084051 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROSTAT (SHIRE) APPROVAL= AP YEAR= 1975 DISCONTINUED
NDA 083900 (pdf not found) INN (AMPHETAMINE SULFATE) BENZEDRINE (SMITH KLINE & FRENCH) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 017078 (label) INN (DEXTROAMPHETAMINE SULFATE) DEXEDRINE SPANSULE (IMPAX LABS INC) APPROVAL= AP YEAR= 1976
NDA 083902 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXEDRINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 084935 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXEDRINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 084001 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) FERNDEX (FERNDALE LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED
NDA 085652 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1980 DISCONTINUED
NDA 083901 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 040299 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (STRIDES PHARMA INTL) APPROVAL= AP YEAR= 1999 DISCONTINUED
NDA 021303 (label) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) ADDERALL XR 10 (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2001
NDA 040361 (label) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (BARR) APPROVAL= AP YEAR= 2001
NDA 040422 (label) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (BARR) APPROVAL= AP YEAR= 2002
NDA 040439 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SANDOZ) APPROVAL= AP YEAR= 2002
NDA 040444 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002
NDA 040365 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 040367 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 040436 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2002
NDA 040470 (pdf not found) INN (DEXTROAMPHETAMINE SACCHARATE) DEXTROAMP SACCHARATE AMP ASPARTATE DEXTROAMP SULFATE AND AMP SULFATE (SANDOZ) APPROVAL= AP YEAR= 2002 OBSOLETE
NDA 076137 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SENORES PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 040440 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003
NDA 040456 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 040472 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 040480 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003
NDA 076353 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003
NDA 076814 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED
NDA 040776 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (PRASCO) APPROVAL= AP YEAR= 2008
NDA 090533 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (AZURITY) APPROVAL= AP YEAR= 2011
NDA 077302 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012
NDA 200166 (pdf not found) INN (AMPHETAMINE SULFATE) EVEKEO (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 2012
NDA 203901 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012
NDA 076536 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE (BARR LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED
NDA 077488 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED
NDA 202424 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013
NDA 202893 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013
NDA 203644 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2013
NDA 090652 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 206721 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (COREPHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 208147 (label) INN (AMPHETAMINE ; AMPHETAMINE ASPARTATE ; DEXTROAMPHETAMINE SULFATE) DYANAVEL XR (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015
NDA 203548 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (AVANTHI INC) APPROVAL= AP YEAR= 2015
NDA 076852 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (IMPAX LABS) APPROVAL= AP YEAR= 2016
NDA 204326 (label) INN (AMPHETAMINE) ADZENYS XR-ODT (NEOS THERAPS) APPROVAL= AP YEAR= 2016
NDA 206304 (pdf not found) INN (DEXTROAMPHETAMINE SACCHARATE ; AMPHETAMINE ASPARTATE MONOHYDRATE ; DEXTROAMPHETAMINE SULFATE ; AMPHETAMINE SULFATE) DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE (COREPHARMA) APPROVAL= TA YEAR= 2016
NDA 206340 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016
NDA 204330 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2016
NDA 206588 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 206735 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (QUAGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 022063 (label) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) MYDAYIS (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2017
NDA 207388 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ALVOGEN) APPROVAL= AP YEAR= 2017
NDA 209111 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 204325 (label) INN (AMPHETAMINE) ADZENYS ER (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017
NDA 207340 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017
NDA 209799 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (NUVO PHARM) APPROVAL= AP YEAR= 2017
NDA 205673 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (STRIDES PHARMA INTL) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 210059 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NUVO PHARM) APPROVAL= AP YEAR= 2017
NDA 211139 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018
NDA 211352 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ELITE LABS INC) APPROVAL= AP YEAR= 2018
NDA 206159 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (PH HEALTH) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 210080 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 205401 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 2019
NDA 209905 (label) INN (AMPHETAMINE SULFATE) EVEKEO ODT (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 2019
NDA 210651 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2019
NDA 211547 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2019
NDA 211639 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2019
NDA 211715 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 212037 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ELITE LABS INC) APPROVAL= AP YEAR= 2019
NDA 212619 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (GRANULES PHARMS) APPROVAL= AP YEAR= 2019
NDA 212919 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (BIONPHARMA INC) APPROVAL= AP YEAR= 2019
NDA 205077 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 210293 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ORYZA) APPROVAL= AP YEAR= 2020
NDA 211861 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (PRINSTON INC) APPROVAL= AP YEAR= 2020
NDA 211876 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 212582 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (CEROVENE INC) APPROVAL= AP YEAR= 2020
NDA 212901 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (HAVIX) APPROVAL= AP YEAR= 2020
NDA 213898 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (MAYNE PHARMA) APPROVAL= AP YEAR= 2020
NDA 213720 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020
NDA 213763 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (NOVAST LABS) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 213980 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020
NDA 212186 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 213111 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2021
NDA 213583 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2021
NDA 213709 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021
NDA 214574 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2021
NDA 212160 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (WINDER LABS LLC) APPROVAL= AP YEAR= 2021
NDA 210526 (label) INN (AMPHETAMINE ; AMPHETAMINE ASPARTATE ; DEXTROAMPHETAMINE SULFATE) DYANAVEL XR 5 (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021
NDA 213852 (pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2021
NDA 214347 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 214403 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2021
NDA 214959 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021
NDA 215771 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (GRANULES) APPROVAL= AP YEAR= 2021
NDA 210754 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (CEDIPROF INC) APPROVAL= AP YEAR= 2022
NDA 210876 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022
NDA 215565 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2022
NDA 215401 (label) INN (DEXTROAMPHETAMINE) XELSTRYM (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2022
NDA 206095 (pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2022 DISCONTINUED
NDA 209253 (pdf not found) INN (AMPHETAMINE) AMPHETAMINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2023
NDA 217027 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (GRANULES) APPROVAL= AP YEAR= 2023
NDA 211546 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2023
NDA 215997 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023
NDA 217787 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023
NDA 214777 (pdf not found) INN (AMPHETAMINE ASPARTATE ; AMPHETAMINE SULFATE ; DEXTROAMPHETAMINE SACCHARATE ; DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (LUPIN) APPROVAL= AP YEAR= 2024
NDA 219800 (pdf not found) INN (AMPHETAMINE) AMPHETAMINE (GRANULES PHARMACEUTICALS INC) APPROVAL= TA YEAR= 2025
NDA 220284 (pdf not found) INN (AMPHETAMINE) AMPHETAMINE (GRANULES PHARMACEUTICALS INC) APPROVAL= TA YEAR= 2026