dexamfetamine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anorexics 841 51-64-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dextroamphetamine
  • S-Amphetamine
  • D-Amphetamine
  • dexadrine
  • dexamfetamine
  • dextroamphetamine sulfate
  • dextroamphetamine saccharate
  • dextroamphetamine adipate
  • dextroamphetamine resin complex
The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.
  • Molecular weight: 135.21
  • Formula: C9H13N
  • CLOGP: 1.74
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 1
  • TPSA: 26.02
  • ALOGS: -1.89
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
15 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 0 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 40 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 7.40 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 75 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Sept. 9, 1955 FDA UCB INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 520.34 36.42 179 529 101445 2255932
Prescribed overdose 453.78 36.42 76 632 1748 2355629
Product quality issue 192.74 36.42 51 657 10778 2346599
Inappropriate schedule of product administration 172.73 36.42 48 660 12156 2345221
Disturbance in attention 156.46 36.42 38 670 5647 2351730
Product substitution issue 140.01 36.42 34 674 5035 2352342
Anxiety 123.81 36.42 46 662 29313 2328064
Feeling abnormal 110.59 36.42 40 668 23541 2333836
Fatigue 93.34 36.42 52 656 84821 2272556
Somnolence 88.61 36.42 34 674 23451 2333926
Depression 86.09 36.42 35 673 28097 2329280
Weight decreased 78.98 36.42 33 675 28338 2329039
Rhabdomyolysis 70.44 36.42 21 687 6683 2350694
Insomnia 68.38 36.42 29 679 25758 2331619
Product physical issue 67.57 36.42 14 694 996 2356381
Condition aggravated 65.53 36.42 30 678 31949 2325428
Therapeutic product effect decreased 64.51 36.42 22 686 10767 2346610
Agitation 64.00 36.42 22 686 11029 2346348
Headache 58.83 36.42 38 670 80141 2277236
Neuroleptic malignant syndrome 57.50 36.42 14 694 2066 2355311
Off label use 56.73 36.42 36 672 73562 2283815
Tremor 53.92 36.42 23 685 20638 2336739
Nausea 53.90 36.42 41 667 112148 2245229
Overdose 51.40 36.42 22 686 19885 2337492
Product use issue 50.72 36.42 19 689 12150 2345227
Dry mouth 49.96 36.42 17 691 8236 2349141
Unevaluable event 48.72 36.42 17 691 8874 2348503
No adverse event 47.57 36.42 17 691 9511 2347866
Paranoia 47.28 36.42 12 696 2095 2355282
Hypothermia 47.05 36.42 12 696 2136 2355241
Serotonin syndrome 45.57 36.42 13 695 3527 2353850
Hypertension 44.71 36.42 22 686 27339 2330038
Therapeutic response unexpected 44.46 36.42 13 695 3846 2353531
Dizziness 40.89 36.42 27 681 58638 2298739
Migraine 38.49 36.42 15 693 10638 2346739
Decreased appetite 37.78 36.42 20 688 28871 2328506
Malaise 37.31 36.42 25 683 55560 2301817
Bruxism 36.50 36.42 8 700 741 2356636

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 350.59 51.41 131 486 63670 1682494
Prescribed overdose 223.13 51.41 44 573 1726 1744438
Aggression 184.41 51.41 50 567 8065 1738099
Product substitution issue 137.25 51.41 33 584 3253 1742911
Product quality issue 130.86 51.41 36 581 6057 1740107
Anxiety 109.00 51.41 39 578 15488 1730676
Insomnia 103.46 51.41 38 579 16238 1729926
Inappropriate schedule of product administration 97.50 51.41 30 587 7429 1738735
Oppositional defiant disorder 91.71 51.41 13 604 57 1746107
Abnormal behaviour 89.19 51.41 27 590 6315 1739849
Decreased eye contact 85.94 51.41 12 605 46 1746118
Psychomotor hyperactivity 78.79 51.41 19 598 1874 1744290
Bruxism 78.68 51.41 14 603 303 1745861
Feeling abnormal 77.96 51.41 28 589 11138 1735026
Coordination abnormal 77.86 51.41 18 599 1479 1744685
Suicidal ideation 77.36 51.41 26 591 8492 1737672
Sydenham's chorea 75.30 51.41 9 608 4 1746160
Somnolence 73.77 51.41 30 587 16709 1729455
Posterior reversible encephalopathy syndrome 72.81 51.41 17 600 1458 1744706
Impulsive behaviour 71.65 51.41 14 603 510 1745654
Depression 70.46 51.41 29 588 16640 1729524
Sleep disorder 68.82 51.41 20 597 4043 1742121
Therapeutic product effect decreased 68.30 51.41 22 595 6275 1739889
Disturbance in attention 68.01 51.41 20 597 4214 1741950
Crying 67.55 51.41 16 601 1459 1744705
Speech disorder 66.60 51.41 20 597 4528 1741636
Headache 64.38 51.41 34 583 34342 1711822
Homicidal ideation 63.16 51.41 13 604 618 1745546
Fatigue 62.16 51.41 38 579 50743 1695421
No adverse event 59.85 51.41 19 598 5163 1741001
Educational problem 57.51 51.41 10 607 188 1745976
Agitation 56.25 51.41 22 595 11004 1735160
Depressed mood 56.19 51.41 16 601 3000 1743164
Dyskinesia 52.46 51.41 16 601 3803 1742361
Mood altered 52.17 51.41 14 603 2108 1744056

Pharmacologic Action:

SourceCodeDescription
ATC N06BA02 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
FDA EPC N0000175739 Central Nervous System Stimulant
FDA PE N0000175729 Central Nervous System Stimulation
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Narcolepsy indication 60380001 DOID:8986
Attention deficit hyperactivity disorder indication 406506008
Gilles de la Tourette's syndrome contraindication 5158005 DOID:11119
Dependent drug abuse contraindication 6525002
Bipolar disorder contraindication 13746004 DOID:3312
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Feeling agitated contraindication 24199005
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Anorexia nervosa contraindication 56882008 DOID:8689
Aggressive behavior contraindication 61372001
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Arteriosclerotic vascular disease contraindication 72092001
Cardiomyopathy contraindication 85898001 DOID:0050700
Weight loss contraindication 89362005
Structural disorder of heart contraindication 128599005
Seizure disorder contraindication 128613002
Motor tic disorder contraindication 230337001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Cardiovascular event risk contraindication 395112001
Visual impairment contraindication 397540003
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006
Hypertensive urgency contraindication 443482000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.89 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
12.5MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 6913768 May 24, 2023 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
3.125MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 6913768 May 24, 2023 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
6.25MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 6913768 May 24, 2023 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
9.375MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 6913768 May 24, 2023 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
12.5MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9173857 May 12, 2026 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
3.125MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9173857 May 12, 2026 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
6.25MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9173857 May 12, 2026 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
9.375MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9173857 May 12, 2026 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
12.5MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL June 20, 2020 NEW PRODUCT
3.125MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL June 20, 2020 NEW PRODUCT
6.25MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL June 20, 2020 NEW PRODUCT
9.375MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL June 20, 2020 NEW PRODUCT
12.5MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
3.125MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
6.25MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
9.375MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
12.5MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY
3.125MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY
6.25MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY
9.375MG MYDAYIS SHIRE DEV LLC N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter RELEASING AGENT Ki 6.68 WOMBAT-PK CHEMBL
Synaptic vesicular amine transporter Transporter INHIBITOR CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 7 IUPHAR CHEMBL
Amine oxidase [flavin-containing] A Enzyme Ki 4.84 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.24 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 5.18 PDSP
Trace amine-associated receptor 1 GPCR EC50 6.87 WOMBAT-PK
Cocaine- and amphetamine-regulated transcript protein Transcription factor WOMBAT-PK
Alpha-1A adrenergic receptor GPCR WOMBAT-PK
Alpha-2A adrenergic receptor GPCR WOMBAT-PK
Serotonin (5-HT) receptor GPCR Kd 5.35 CHEMBL
Trace amine-associated receptor 1 GPCR EC50 6 CHEMBL
Sodium-dependent dopamine transporter Transporter IC50 5.31 CHEMBL
Amine oxidase [flavin-containing] A Enzyme Ki 4.91 CHEMBL
Trace amine-associated receptor 1 GPCR EC50 7.25 CHEMBL
Trace amine-associated receptor 1 GPCR EC50 8.70 CHEMBL

External reference:

IDSource
D003913 MESH_DESCRIPTOR_UI
4019978 VUID
N0000148062 NUI
C0011812 UMLSCUI
D02078 KEGG_DRUG
387278002 SNOMEDCT_US
50868004 SNOMEDCT_US
4019978 VANDF
001793 NDDF
3288 RXNORM
d00804 MMSL
5826 PUBCHEM_CID
CHEMBL612 ChEMBL_ID
CHEMBL1200782 ChEMBL_ID
G83415V073 UNII
350708-40-6 SECONDARY_CAS_RN
1430 INN_ID
1WE PDB_CHEM_ID
DB01576 DRUGBANK_ID
2147 IUPHAR_LIGAND_ID
CHEMBL3544971 ChEMBL_ID
CHEMBL3989844 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1328 CAPSULE, EXTENDED RELEASE 1.25 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1328 CAPSULE, EXTENDED RELEASE 1.25 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1329 CAPSULE, EXTENDED RELEASE 2.50 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1329 CAPSULE, EXTENDED RELEASE 2.50 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1330 CAPSULE, EXTENDED RELEASE 3.75 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1330 CAPSULE, EXTENDED RELEASE 3.75 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1331 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1331 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1332 CAPSULE, EXTENDED RELEASE 6.25 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1332 CAPSULE, EXTENDED RELEASE 6.25 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1333 CAPSULE, EXTENDED RELEASE 7.50 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1333 CAPSULE, EXTENDED RELEASE 7.50 mg ORAL NDA AUTHORIZED GENERIC 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1486 CAPSULE 1.25 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1486 CAPSULE 1.25 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1487 CAPSULE 2.50 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1487 CAPSULE 2.50 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1488 CAPSULE 3.75 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1488 CAPSULE 3.75 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1489 CAPSULE 5 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1489 CAPSULE 5 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1490 CAPSULE 6.25 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1490 CAPSULE 6.25 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1491 CAPSULE 7.50 mg ORAL ANDA 20 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1491 CAPSULE 7.50 mg ORAL ANDA 20 sections
Dextroamphetamine SulfateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-1702 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 14 sections
Dextroamphetamine SulfateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-1703 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA AUTHORIZED GENERIC 14 sections
Dextroamphetamine SulfateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-1704 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA AUTHORIZED GENERIC 14 sections
Dextroamphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-9927 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 15 sections
Dextroamphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-9928 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA AUTHORIZED GENERIC 15 sections
Dextroamphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0115-9929 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA AUTHORIZED GENERIC 15 sections